CN107693539A

CN107693539A - The medical composition and its use of various trace elements

Info

Publication number: CN107693539A
Application number: CN201610647167.6A
Authority: CN
Inventors: 刘力
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-08-09
Filing date: 2016-08-09
Publication date: 2018-02-16

Abstract

The present invention provides one kind of multiple micro- pharmaceutical compositions and with its way, prepare prevention or treatment people and mammal microelement deficiencies, such as the medicine of the multi-microelement injecta of zinc, manganese, copper, selenium, fluorine, iodine deficiency and its syndrome so that corresponding product is in clinical process with more preferable security, compliance and with new applicable crowd etc..

Description

The medical composition and its use of various trace elements

Technical field

The present invention relates to pharmaceutical technology field, is specifically to provide prevention or treatment zinc, manganese, copper, selenium, fluorine, iodine deficiency And its one kind of multiple the micro-element injection pharmaceutical compositions and its preparation and use of syndrome etc..

Background technology

Zinc is indispensable trace element in organism, participates in the synthesis of many enzymes in vivo, and there is important physiology to adjust Save function.In tissue respiration, synthesis, erythrocyte membrane and hematopoiesis of the zinc to protein play an important role.Zinc energy and sulphur Alcohol combines, and blocks mercaptan and Tie Jietai, suppresses the catalytic oxidation of iron and forms free radical, zinc can also suppress the peroxide of fat Change acts on, and the attack that stabilizing cell membrane is allowed to free radical has more resistance, therefore, zinc not only cell growth but also to cell Protection significant (Wuzhong, the clinical practice of zinc preparation, Chinese journals of practical medicine, the 7th phase of volume 15 in 1999, p587- 588)。

Iron participates in the conjunction of hemoglobin, myoglobins, cytochromes, cytochrome oxidase, peroxidase and catalase Into, and with acetyl coenzyme A, succinate dehydrogenase, xanthine oxidase, cytochrome reductase it is active closely related.Research Prove：There is competence exertion biochemical action in the presence of more than half enzyme and factor iron content or iron in tricarboxylic circulation, complete Physiological function；When the utilization of iron deficiency or iron is bad, mentioned component is not normal, cause the transport of oxygen, storage, the transport of carbon dioxide and The disturbed metabolic processes such as release, the transmission of electronics, redox, pathological change is produced, finally produces various diseases.

Chromium (III) has a variety of biochemical functions as a kind of essential trace element of life, take part in glucide generation Thank, the process such as lipid material metabolism, chromium is lacked in human body will cause the generation of many diseases, and chromium can be used as glucose tolerance factor Constituent, assist insulin play physiological function.

Molybdenum is the constituent of xanthine oxidase/dehydrogenase, aldehyde oxidase and sulfite oxidase, so as to know it For trace element necessary to human body and animals and plants.Research shows that molybdenum also has obvious anticaries action, and formation of the molybdenum to urinary calculus has by force Strong inhibitory action, human body lack molybdenum and are susceptible to suffer from kidney stone.

Copper participates in hematopoiesis and the metabolism of iron, influences the formation of collagen and bone tissue, and be some copper enzymes composition into Point.

Trace element manganese is the constituent of a variety of enzymes, participates in energy and fat metabolism, promote bone normal growth and Development, the enzyme system of activation chondroitin sulfate synthesis is participated in, promotes the synthesis of sclerotin；Must can not in normal brain function is maintained Lack, have certain relation with intellectual development, thinking, emotion, behavior.Manganese plays the role of to prevent anaemia, and manganese deficiency also can be to health Have undesirable effect, mainly there is the following aspects：1st, the synthesis of bone is suppressed, the time, which has been grown, will result in cartilage development not It is good, ossify slow, long bone is short, deformity of joint, and the empty increase of bone, sclerotin hardness has declined, and toughness reduces, osteoporosis, easily In fracture.Famine can also influence phosphatase activity in bone, cause stagnation of growing.2nd, slow down the metabolism of cell, add The aging of fast people.3rd, cause neurasthenia syndrome, influence intelligence development.4th, the reduction of insulin synthesis and secretion, shadow are caused Ring glycometabolism.

Trace iodine is the required composition of thyroid hormone (T3, T4), and iodine is played by thyroxine promotes protein The effects such as synthesis, regulation energetic supersession and tachyauxesis development.Appropriate Trace Element Fluorine can reduce carious tooth illness rate and mitigation The carious tooth state of an illness, and bone can be accelerated to be formed, promote growth.

Substantial amounts of survey data illustrates there there is directly the height of Se content with the incidence of disease of cancer in regional a food and soil Connect relation.Scientific research finds that selenium has many pharmacological actions, for example strengthen immunity：Organic Selenium can remove interior free yl, Vivotoxin, generation that is anti-oxidant, can effectively suppressing lipid peroxide are excluded, prevents blood clot, removes cholesterol, strengthens people Body immunity function.Prevent diabetes：Selenium is the active component for forming glutathione peroxidase, and it can prevent beta Cell of islet Oxidative demage, make its function normal, promote sugared part metabolism, reduce blood glucose and glucose in urine, improve the symptom of diabetic.Prevent white Cataract or glaucoma：Selenium can protect retina, the finish of reinforcing glass body, improve eyesight, prevent cataract.Prevent heart and brain blood Pipe disease：Selenium is the important element for maintaining heart normal function, plays the role of to protect and repairs to heart human body.Human body blood selenium water Flat reduction, the hypofunction for removing free radical in vivo can be caused, cause hazardous material deposition to increase, blood pressure rise, vascular wall Thickening, blood vessel elasticity reduces, VPV is slack-off, send oxygen function reduction, so as to induce the rise of the incidence of disease of cardiovascular and cerebrovascular disease, But supply Se scientific has preferable effect to prevention cardiovascular and cerebrovascular disease, hypertension, artery sclerosis etc..

Generally speaking, trace element keeps machine to meeting human nutrition needs and maintaining human body biochemical reaction to be normally carried out Body eubolism and physiological function play an important roll.When trace element is insufficient, the activity reduction or complete of enzyme can be made Lose, obstacle will occur for the synthesis and metabolism of hormone, protein, vitamin etc., cause organism metabolism to be lacked of proper care, severe patient can endanger And life.Caused by 30% disease is directly microelement deficiencies or imbalance.As zinc-deficiency can cause mouth, eye, anus or vulva Portion's redness, papule, eczema.And for example iron is one of main component for forming hemoglobin, and iron deficiency can cause hypoferric anemia.Document Report：Iron content, copper, zinc total amount are reduced in body, can weaken immunologic mechanism (resist the disease strength), are reduced resistance against diseases, are helped Long bacterium infection, and the metainfective death rate is also higher.Trace element it is disease-resistant, give protection against cancer, promote longevity etc. and all also to rise Very important effect.Therefore, for a long time, the clinically more extensive clinical practice of trace element.

However, multi-microelement injecta (the medicine Tracutil of Germany's manufacture) is used for the supplement and one of trace element The treatment of a little diseases, but many deficiencies be present, multi-microelement injecta (Tracutil) maintain under very low acidity and A large amount of zinc chloride are used as main ingredient etc., the medicine has the too strong grade serious adverse reaction of blood vessel irritation, poison in Clinical practice The situation and other potential safety factors that property is excessive and patient's compliance is poor.Prior art various trace elements are noted The component zinc chloride penetrated in liquid (German Tracutil) is used as strong acid in daily electrical maintenance welding, has severe corrosive, Severe irritation and skin and mucous membrane can be burnt, allergic dermatitis occur during long-term steam contact, producers will wear anti-when working Protective spectacles, anti-poison respirator, emgloves, to protect skin, eyes, respiratory apparatus, workshop ventilation is good, After Hours to wash heat Water takes a shower.Human Physiology pH commonly reaches 7.4 or so, and the pH value in preparation needs to maintain very low level in the prior art, and one As between pH value is 2.0~2.6, strong acidity the medicine of different intravenously administrables prepare and clinical vein transfusion in bring it is certain The safety risks of degree and some adverse reactions, including blood vessel irritation or phlebitis, local necrosis, patient tolerability difference or Clinical accident etc., although such adverse reaction has been reported that these are by long-standing neglect.

The multi-microelement injecta (Tracutil) of prior art is yet present is not suitable for height in some cases The situation of the patient of blood chlorine, acid poisoning and renal insufficiency etc., unknown in advance or clinical application can in the case of being difficult to know Adverse consequences can be brought；【Bibliography：Document 1, Li Zhaoquan, 12 clinical analysis of intracranial hematoma complicated by postoperative hypernatremia are real With sacred disease magazine, 05 phase in 2005, p.44-45；Document 2, Zhang Xuejun, Chen Zhiqin, Li Hua, high sodium hyperchloremia after cerebral hemorrhage The clinical research of disease, apoplexy and sacred disease magazine, the 5th phase of volume 24 in 2007, p.609-611；Document 3, season hamming, 11 Heavy head-brain injury merging hyperglycaemia, hypernatremia, hyperchloremia experiences on diagnosis and treatment, Jiangsu Clinical Medical Journals, the 6th phase of volume 2 in 1998, P.505,507；Document 4, Yin Peida, the pathogenesis of distal renal tubular acidosis, foreign medical science (clinical practice fascicle), 1982 12 phases of year；Document 5, Zhou Lei, etc., 12 RTA patient Analysis Initial Misdiagnosis and nursing, Chinese Quotation Analysis, 17 phases in 2005；】.

Therefore, it is necessary to be reformed and innovated to the multi-microelement injecta of the above-mentioned drug standards, medicine is reduced not Good reaction, potential potential safety hazard is reduced, improve the security and compliance and clinical treatment effect etc. of clinical application.

The content of the invention

The present invention relates to pharmaceutical technology field, be specifically to provide prevention or treatment iron, zinc, manganese, copper, selenium, molybdenum, chromium, One kind of multiple the micro-element injection pharmaceutical compositions and its preparation and use of fluorine, iodine deficiency and its syndrome etc..

The pharmaceutical composition of the various trace elements of the injection of the present invention, a unit dose or unit formulation or list The ratio between the molal quantity of main ingredient component or molfraction are in the said composition of position volume：Iron content (Fe) be 3.15~3.85 μm of ol, Zinc (Zn) is 4.50~5.55 μm of ol, manganese (Mn) is 0.90~1.10 μm of ol, copper (Cu) is 1.08~1.32 μm of ol, selenium (Se) is 0.027~0.033 μm of ol, molybdenum (Mo) are 0.009~0.011 μm of ol, chromium (Cr) is 0.018~0.022 μm of ol, iodine (I) is 0.09~0.11 μ/ml, fluorine (F) should be 2.7~3.3 μm of ol；In said one unit dose or unit formulation or unit volume 0.05~50 times of molal quantity containing above-mentioned each main ingredient component in said composition；Said composition and pharmaceutically acceptable auxiliary material Or excipient composition injection；Said one dosage unit or unit volume can be 1ml or 2ml or 2.5ml or 3ml or 5ml Or 10ml or 15ml or 20ml or 40ml or 50ml or 100ml etc.；

Above-mentioned micro- existence form can be again with being combined into phase with acid, alkali after its atom is combined with other atoms The pharmaceutical salts answered or its ion are combined into corresponding pharmaceutical salts with acid, alkali；Wherein, iron or molysite are selected from ferrous or ferric iron Pharmaceutical salts, ferrous gluconate or its hydrate, D- or L- or DL- L-aminobutanedioic acids are ferrous, D- or L- or DL- L-aminobutanedioic acids Iron, ferrous sulfate, iron ammonium sulfate, ferrous lactate, ferrous citrate or their hydrate, or L-aminobutanedioic acid iron, ferric sulfate, Iron chloride, sodium gluconate iron, ferric lactate, ironic citrate, ferric citrate, ferric acetate or its hydrate, phosphoglycerol are ferrous Or ferric glycerophosphate or its hydrate or iron ion pharmaceutically acceptable salt or one kind or more in their chiral isomer Kind；

Zinc or zinc salt are selected from zinc and are selected from zinc sulfate, zinc gluconate, lactobionic acid zinc, zinc citrate, zinc lactate or Pfansteihl One in zinc, zinc acetate, D- or L- or DL- L-aminobutanedioic acids zinc or their hydrate or zinc ion pharmaceutically acceptable salt Kind is a variety of；

Copper or mantoquita are selected from copper chloride, copper sulphate, copper gluconate, lactobionic acid copper, copper citrate, copper lactate or Pfansteihl Copper, copper acetate, D- or L- or DL- L-aminobutanedioic acids copper or or they hydrate or bivalent cupric ion pharmaceutically acceptable salt or One or more in their chiral isomer；

Manganese or manganese salt are selected from manganese chloride, manganese sulfate, manganese gluconate, lactobionic acid manganese, manganese citrate, manganese lactate or Pfansteihl Manganese, manganese acetate, D- or L- or DL- L-aminobutanedioic acids manganese or their hydrate or divalent manganesetion pharmaceutically acceptable salt or it Chiral isomer in one or more；

Fluorine or villiaumite are selected from the one or more of sodium fluoride or the acceptable pharmaceutical salts of potassium fluoride or fluorine ion；Selenium is selected from The one or more of sodium selenite or its hydrate or the acceptable pharmaceutical salts of selenous acid；Iodine or salt compounded of iodine are selected from KI or iodate One or more in the acceptable pharmaceutical salts of sodium or iodide ion；

Molybdenum or molybdenum salt are selected from molybdic acid or sodium molybdate or its molybdic acid sodium hydrate, ammonium molybdate or ammonium molybdate hydrate or molybdic acid One or more in pharmaceutically acceptable salt；

Chromium or salt 3 are selected from chromium chloride, chromium sulfate, chromium gluconate [(C6H11O7)₃Cr], chromium citrate, D- or L- or DL- L-aminobutanedioic acids chromium, Chromic lactate, chromic acetate or their hydrates or one kind in trivalent chromic ion pharmaceutically acceptable salt or It is a variety of.

Furtherly, the pharmaceutical composition of the various trace elements of injection of the invention, a unit dose or list The ratio between the molal quantity of main ingredient component or molfraction are in the said composition of position preparation or unit volume：Iron content (Fe) be 3.15~ 3.85 μm of ol, zinc (Zn) are 4.50~5.55 μm of ol, manganese (Mn) is 0.90~1.10 μm of ol, copper (Cu) is 1.08~1.32 μ Mol, selenium (Se) are 0.027~0.033 μm of ol, molybdenum (Mo) is 0.009~0.011 μm of ol, chromium (Cr) is 0.018~0.022 μ Mol, iodine (I) are 0.09~0.11 μ/ml, fluorine (F) should be 2.7~3.3 μm of ol, in said one unit dose or unit formulation Or 0.05~50 times of molal quantity in the said composition of unit volume containing above-mentioned each main ingredient component；Said composition with pharmaceutically Acceptable auxiliary material or excipient form injection；Said one dosage unit or unit volume can be 1ml or 2ml or 3ml Or 5ml or 10ml or 20ml or 40ml or 50ml or 100ml etc.；

Wherein, iron or molysite be selected from ferrous ferrous gluconate or its hydrate, D- or L- or DL- L-aminobutanedioic acids, D- or L- or DL- L-aminobutanedioic acids iron, ferrous sulfate, iron ammonium sulfate, ferrous lactate, ferrous citrate or their hydrate, OR gate Winter propylhomoserin iron, ferric sulfate, iron chloride, sodium gluconate iron, ferric lactate, ironic citrate, ferric citrate, ferric acetate or its hydration Thing, phosphoglycerol be ferrous or ferric glycerophosphate or its hydrate or iron ion pharmaceutically acceptable salt or theirs is chiral different One or more in structure body；

Zinc or zinc salt are selected from zinc and are selected from zinc sulfate, zinc gluconate, lactobionic acid zinc, zinc citrate, zinc lactate or Pfansteihl Zinc, zinc acetate, D- or L- or DL- L-aminobutanedioic acids zinc or their hydrate or zinc ion pharmaceutically acceptable salt or they Chiral isomer in one or more；

Copper or mantoquita are selected from copper chloride, copper sulphate, copper gluconate, lactobionic acid copper, copper citrate, copper lactate or Pfansteihl Copper, copper acetate, D- or L- or DL- L-aminobutanedioic acids copper or or they hydrate or bivalent cupric ion pharmaceutically acceptable salt or One or more in their chiral isomer；Manganese or manganese salt be selected from manganese chloride, manganese sulfate, manganese gluconate, lactobionic acid manganese, Manganese citrate, manganese lactate or Pfansteihl manganese, manganese acetate, D- or L- or DL- L-aminobutanedioic acids manganese or their hydrate or bivalent manganese One or more in ion pharmaceutically acceptable salt or their chiral isomer；

Fluorine or villiaumite are selected from the one or more of sodium fluoride or the acceptable pharmaceutical salts of potassium fluoride or fluorine ion；Selenium is selected from The one or more of sodium selenite or its hydrate or the acceptable pharmaceutical salts of selenous acid；Iodine is selected from KI or sodium iodide or iodine One or more in the acceptable pharmaceutical salts of ion；

Chromium is selected from chromium chloride, chromium sulfate, chromium gluconate [(C6H11O7)₃Cr], chromium citrate, L- or D- or DL- door winters Propylhomoserin chromium or their hydrate, Chromic lactate, chromic acetate or their hydrates or trivalent chromic ion pharmaceutically acceptable salt or One or more in their chiral isomer；

Pharmaceutically acceptable auxiliary material or excipient are in addition to water for injection, it may include pharmaceutically acceptable amide-type chemical combination Thing (for example niacinamide, Pyrazinamide, acetamide, urea, thiocarbamide etc.), pharmaceutically acceptable aminated compounds (for example ethylenediamine, Diethylamine, diethanol amine, triethanolamine, meglumine, Portugal's ethamine, aminoguanidine, hydroxyethyltheophylline), amino acid or its pharmaceutical salts, example Such as：D- or L- or DL-Lys or Lysine Acetate or arginine or acetic arginine or taurine or glycine OR gate winter ammonia Acid or Monosodium L-aspartate or D- or L- or DL-histidine or cysteine or methionine or its salt, it is pharmaceutically acceptable organic Acid or its salt, for example L-AA, citric acid or sodium citrate or lactic acid, sodium lactate, lactobionic acid, sodium lactonic, grape Saccharic acid, sodium gluconate, pharmaceutically acceptable alcohol compound, for example sorbierite or mannitol or lactitol or xylitol, D- Mannitol, D- D-sorbites or antierythrite include its hydrate or their pharmaceutically acceptable salt etc. or their hand One or more in property isomers, sorbierite include anhydrous sorbierite or the water thing of sorbierite half or 1 water sorbierite or instant mountain One or more in pears alcohol etc., it is above-mentioned to include its chiral isomer；It is pharmaceutically acceptable auxiliary in addition to water for injection One or more contents in the injection of a unit dose in material or excipient are selected from 0.0010~0.040g；Or can To be expressed as：One or more in pharmaceutically acceptable auxiliary material or excipient in addition to water for injection are in a unit dose Content in the injection of amount can be or selected from 0.0010~0.040g/ml.

Further, the pharmaceutical composition of various trace elements of the invention, a unit dose or unit formulation or unit The ratio between the molal quantity of main ingredient component or molfraction are in the said composition of volume：Iron content (Fe) is 3.15~3.85 μm of ol, zinc (Zn) it is 4.50~5.55 μm of ol, manganese (Mn) is 0.90~1.10 μm of ol, copper (Cu) is 1.08~1.32 μm of ol, selenium (Se) is 0.027~0.033 μm of ol, molybdenum (Mo) are 0.009~0.011 μm of ol, chromium (Cr) is 0.018~0.022 μm of ol, iodine (I) is 0.09~0.11 μ/ml, fluorine (F) should be 2.7~3.3 μm of ol；In said one unit dose or unit formulation or unit volume 0.05~50 times of molal quantity containing above-mentioned each main ingredient component in said composition；Said composition and pharmaceutically acceptable auxiliary material Form injection；Said one dosage unit or unit volume can be 1ml or 2ml or 3ml or 5ml or 10ml or 20ml or 40ml or 50ml or 100ml etc.；

Wherein, iron or molysite are selected from ferrous gluconate or its hydrate or ferrous gluconate dihydrate, L- or D- L-aminobutanedioic acid ferrous iron or its hydrate, DL- L-aminobutanedioic acids ferrous iron or its hydrate, frerrous chloride, the hydrate of frerrous chloride 4 (FeCl₂·4H₂O), the hydrate of ferrous sulfate 7, iron ammonium sulfate, ferrous lactate, the hydrate of ferrous lactate 3, ferrous citrate or Their hydrate, or D- or L- or DL- L-aminobutanedioic acids iron or its hydrate, ferric sulfate, the hydrate of ferric sulfate 7, iron chloride, chlorine Change the hydrate of iron 6 (FeCl36H2O), sodium gluconate iron, ferric lactate, ironic citrate, ferric citrate, ferric acetate or its water One or more in compound, phosphoglycerol ferrous iron or ferric glycerophosphate or its hydrate or their chiral isomer；

Zinc or zinc salt are selected from zinc sulfate, white vitriol, monohydrate zinc sulphate, zinc gluconate or zinc gluconate hydration Thing, zinc gluconate (II) dihydrate, the hydrate of zinc gluconate 3, lactobionic acid zinc or lactobionic acid zinc hydrate, zinc citrate Or the zinc of citric acid three or its zinc citrate hydrate zinc citrate dihydrate, zinc lactate, the hydrate of Pfansteihl zinc 3, Pfansteihl One in zinc, the hydrate of Pfansteihl zinc 3, zinc acetate, the hydrate of zinc acetate 2, D- or L- or DL- L-aminobutanedioic acids zinc or its hydrate Kind is several；

Copper or mantoquita are selected from copper chloride, the hydrate of copper chloride 2, copper sulphate, copper sulfate monohydrate, three brochanites, five water sulphur Sour copper, copper gluconate, the hydrate of copper gluconate 1, the hydrate (C of copper gluconate 2₁₂H₂₂O₁₄Cu·2H₂O), lactobionic acid copper Or lactobionic acid copper hydrate, copper citrate or the bronze medal of citric acid three or its hydrate of copper citrate 2.5, copper lactate or Pfansteihl copper or Its hydrate, D- or L- or DL- L-aminobutanedioic acids copper or their hydrate, copper acetate or its hydrate of copper acetate 1 [(Ac)₂Cu·H₂O] in one or more；

Manganese or manganese salt are selected from manganese chloride or its hydrate [or the hydrate of manganese chloride 1 or the hydrate (MnCl of manganese chloride 2₂· 2H₂) or the hydrate (MnCl of manganese chloride 4 O₂·4H₂O) or the hydrate of manganese chloride 5 or the hydrate of manganese chloride 6], manganese sulfate or, sulfuric acid The hydrate of manganese 1, manganese gluconate or manganese gluconate hydrate, lactobionic acid manganese or lactobionic acid manganese hydrate, manganese citrate or lemon Lemon three manganese of acid or manganese citrate hydrate, manganese lactate or Pfansteihl manganese or its hydrate, manganese acetate or the hydrate of manganese acetate 4, D- Or the one or more in L- or DL- L-aminobutanedioic acids manganese or its hydrate；

One or more in acceptable pharmaceutical salts of the fluorine selected from sodium fluoride or potassium fluoride or fluorine；Selenium is selected from selenous acid Sodium, the hydrate (Na of sodium selenite 5₂SeO₃·5H₂O), one kind or several in sodium hydrogen selenite or the acceptable pharmaceutical salts of selenous acid Kind；One or more of the iodine in KI or sodium iodide；

Molybdenum or molybdenum salt are selected from molybdic acid or sodium molybdate, the hydrate (Na of sodium molybdate 2₂MoO₄·2H₂O), ammonium molybdate, the water of ammonium molybdate 4 One or more in compound, the hydrate of ammonium heptamolybdate 4；

Chromium or chromic salts are selected from chromium chloride, the hydrate of chromium chloride 6, chromium sulfate, the hydrate of chromium sulfate 6, chromium gluconate or Portugal Grape saccharic acid chromium hydrate, chromium citrate or chromium citrate hydrate, Chromic lactate or Pfansteihl chromium or its hydrate, L- or D- or One kind or more of DL- L-aminobutanedioic acids chromium or their hydrate (such as hydrate of L-ASPARTIC ACID chromium 3), chromic acetate or its hydrate Kind；

Pharmaceutically acceptable auxiliary material or excipient can include：Pharmaceutically acceptable amides compound (for example nicotinoyl Amine, Pyrazinamide, acetamide, urea, thiocarbamide etc.), pharmaceutically acceptable aminated compounds (for example ethylenediamine, diethylamine, diethyl Hydramine, triethanolamine, meglumine, Portugal's ethamine, aminoguanidine, hydroxyethyltheophylline), chiral or racemization or D- or L- or the ammonia of racemization Base acid or its pharmaceutical salts salt, such as D- or L- or DL-Lys, Lysine Acetate, cysteine, methionine, arginine or acetic acid It is arginine or L-aminobutanedioic acid or Monosodium L-aspartate, glutamic acid, glycine, taurine, alanine, valine, leucine, different bright Propylhomoserin, serine, threonine, cysteine, cystine, methionine, asparagine, glutamine, 5- oxylysines, group ammonia Acid, phenylalanine, tyrosine, tryptophan, 3- hydroxy-prolines, 4- hydroxy-prolines, proline, homocysteine, high Guang ammonia Acid, homoserine, ornithine, citrulling, creatine, 3- alanine, theanine, 2-amino-butyric acid, 4-Aminobutanoicacid, 2- amino- 2 Methylpropionic acid, 2- methyl -3- alanines, 2,6- diaminopimelic acids, 2- amino-3-phenyl butyrics, phenylglycine, knife Conavanine, canaline, 4- hydroxyarginines, 4- hydroxyls ornithine, homoarginine, 4- hydroxyhomoarginines, beta-lysine, 2,4-diamino-butanoic, 2,3- diaminopropionic acids, 2- methyl serines etc., or trehalose, or pharmaceutically acceptable organic acid or Its salt, or unit or polybasic carboxylic acid or its pharmaceutical salts, example L-AA, citric acid or sodium citrate or lactic acid, sodium lactate, Lactobionic acid, sodium lactonic, gluconic acid, sodium gluconate, pharmaceutically acceptable alcohol compound, for example maltitol, sorb Alcohol, mannitol, lactitol, xylitol, antierythrite or its hydrate or their pharmaceutically acceptable salt or their chirality One or more in isomers etc., sorbierite include D- D-sorbites, anhydrous sorbierite or the water thing of sorbierite half or 1 water sorb One or more in alcohol or sorbitol instant etc., it is above-mentioned to include its chiral isomer；In addition to water for injection pharmaceutically One or more contents in the injection of a unit dose in acceptable auxiliary material or excipient can be or be selected from 0.0010~0.040g/ml.

The present invention various trace elements pharmaceutical composition more preferably, a unit dose or unit formulation or unit bodies The ratio between the molal quantity of main ingredient component or molfraction are in long-pending said composition：Iron content (Fe) is 3.5 μm of ol, zinc (Zn) is 5.0 μ Mol, manganese (Mn) are 1.0 μm of ol, copper (Cu) is 1.2 μm of ol, selenium (Se) is 0.03 μm of ol, molybdenum (Mo) is 0.01 μm of ol, chromium (Cr) Be 0.10 μm of ol for 0.02 μm of ol, iodine (I), fluorine (F) should be 3.0 μm of ol；

Contain above-mentioned each main ingredient component in the said composition of said one unit dose or unit formulation or unit volume 0.25~50 times of molal quantity；Said composition and pharmaceutically acceptable auxiliary material or excipient composition injection；Said one Dosage unit or unit volume can be 1ml or 2ml or 3ml or 5ml or 10ml or 15ml or 20ml or 40ml or 50ml or 100ml etc.；

Furtherly, for the present invention various trace elements pharmaceutical composition more preferably, a unit dose or list The ratio between the weight number of main ingredient component or parts by weight are in the said composition of position preparation or unit volume：The hydrate of frerrous chloride 4 The 626.25-765.42 μ g or hydrate 847.04-1035.27 μ g of the iron chloride 6 or hydrate 1518.84- of ferrous gluconate 2 1856.35 μ g or ferric citrate 1536.7-1878.18 μ g or the multiple hydrate 629.8-769.75 μ g of ferric sulfate or glucose Sour sodium iron or its solvated compounds 180-220 μ g (weight is in terms of iron) or D- or L- or DL- L-aminobutanedioic acid ferrous irons 1007.69- The 1231.62 μ g or hydrate 850.56-1039.58 μ g of the ferrous lactate 3 or hydrate 875.73-1070.34 μ g of ferrous sulfate 7 or Ferric glycerophosphate or α-ferric glycerophosphate or β-ferric glycerophosphate or its hydrate 979.43-1197.08 μ g are (with ferric glycerophosphate Anhydride weight calculation amount),

Zinc gluconate or zinc gluconate hydrate, the zinc gluconate dihydrate or hydrate of zinc gluconate 3 2050.56-2506.24 μ g (with zinc gluconate anhydride weight calculation amount) or white vitriol 1294.02-1581.58 μ g or vinegar The sour hydrate 986.18-1205.33 μ g of zinc or zinc acetate 2 (with the hydrated basis weight of zinc acetate 2) or D- or L- or DL- door winter ammonia Sour zinc or D- or L- or DL- L-aminobutanedioic acid zinc hydrate 1483.11-1812.69 μ g (with L-aminobutanedioic acid zinc anhydride weight calculation amount),

Copper gluconate or the hydrate 490.15-599.07 μ g of the hydrate of copper gluconate 1 or copper gluconate 2 are (with Portugal Grape saccharic acid copper anhydride weight calculation amount) or the hydrate 184.14-225.06 μ g of copper chloride 2 or copper sulphate or cupric sulfate pentahydrate 269.65-329.58 μ g (with cupric sulfate pentahydrate weight calculation amount) or D- or L- or DL- L-aminobutanedioic acids copper or D- or L- or DL- door winter ammonia Sour copper hydrate 354.46-433.23 μ g (with L-aminobutanedioic acid copper anhydride weight calculation amount) or the hydrate 215.62- of copper acetate 1 263.54 μ g,

Manganese chloride or the hydrate 178.13-217.71 μ g of the hydrate of manganese chloride 2 or manganese chloride 4 are (with the hydrated basis of manganese chloride 4 Weight) or manganese gluconate or the hydrate 400.72-489.76 μ g of manganese gluconate 2 (with manganese gluconate anhydride weight calculation amount) Or the hydrate 152.11-185.91mg or D- of manganese sulfate 1 or L- or DL- L-aminobutanedioic acids manganese or D- or L- or DL- L-aminobutanedioic acid manganese Hydrate 287.22-351.04 μ g (with L-aminobutanedioic acid anhydrous manganese thing weight calculation amount),

The hydrate 4.77-5.83 μ g of chromium chloride 6 or chromium gluconate or chromium gluconate hydrate (with chromium gluconate without Water thing weight calculation amount) 11.48-14.03 μ g or D- or the hydrate 9.06-11.07mg of L- or DL- L-aminobutanedioic acids chromium 3 or chromium citrate (weight is in terms of chromium),

The hydrate 2.18-2.66 μ g of sodium molybdate 2 or seven water ammonium molybdate 11.12-13.59 μ g,

The hydrate 7.10-8.68 μ g of sodium selenite 5 or sodium selenite 4.67-5.71 μ g or sodium hydrogen selenite 4.08- 4.98mg

Sodium fluoride 113.4-138.6 μ g or potassium fluoride 156.87-191.73 μ g,

KI 14.94-18.26 μ g or sodium iodide 13.49-16.49 μ g；

Contain above-mentioned each main ingredient component in the said composition of said one unit dose or unit formulation or unit volume Weight number or 0.25~50 times of parts by weight；Said composition can inject with pharmaceutically acceptable auxiliary material or excipient composition Agent；One or more notes in a unit dose in pharmaceutically acceptable auxiliary material or excipient in addition to water for injection The content penetrated in agent can be or be more preferably 0.0030~0.030g/ml, more preferably selected from 0.0010~0.040g/ml 0.0040~0.025g/ml.

This of the pharmaceutical composition of the various trace elements of the present invention, a unit dose or unit formulation or unit volume The ratio between the weight number of main ingredient component or parts by weight can be in composition：The μ g of 3 hydrate of zinc gluconate 2548.65 or grape Saccharic acid zinc is (with C₁₂H₂₂O₁₄Zn weight calculations amount) 2278.4 μ g or L- or DL- L-aminobutanedioic acids zinc 1647.9 μ g or D- or L- or DL- door winters The μ g of propylhomoserin zinc hydrate 1647.9 (with L-aminobutanedioic acid zinc weight calculation amount), the μ g of 4 hydrate of frerrous chloride 695.84 or iron chloride 6 are hydrated The μ g of the thing 941.15 or μ g of 2 hydrate of ferrous gluconate 1687.6 or the μ g (weight is in terms of iron) of sodium gluconate iron 200 or lemon The sour μ g of iron ammonium 1707.44 or iron chloride FeCl₃·6H₂O) 941.15 μ g or the μ g of 7 hydrate of ferrous sulfate 973.04 or ferrous lactate The μ g or D- of 3 hydrate 945.07 or L- or DL- L-aminobutanedioic acids 1119.65 μ g of ferrous iron or ferric sulfate or ferrous sulfate hydrate 699.77 μ g (weight is in terms of ferric sulfate) ferric glycerophosphates or α ferric glycerophosphates or β ferric glycerophosphates or the μ g of their hydrate 1088.26 (with ferric glycerophosphate weight calculation amount), the μ g of 4 hydrate of ammonium heptamolybdate 12.36 or μ g of 2 hydrate of sodium molybdate 2.42, chromium gluconate The 12.75 μ g or μ g of 6 hydrate of chromium chloride 5.33 or 5.3 μ g or μ g of 3 hydrate of L-ASPARTIC ACID chromium 10.07, the water of copper gluconate 2 The μ g of the compound 587.856 or μ g of 1 hydrate of copper gluconate 566.2 or the μ g of copper gluconate 544.608 or cupric sulfate pentahydrate The 299.616 μ g or D- or μ g of the L- or DL- L-aminobutanedioic acids copper 393.84 or μ g or D- of L-aminobutanedioic acid copper 393.84 or L- or DL- door winters The μ g of propylhomoserin copper hydrate 393.84 (with L-aminobutanedioic acid copper weight calculation amount) or μ g of 2 hydrate of copper chloride 204.58, the hydrate of manganese chloride 2 The 125.8 μ g or μ g of 4 hydrate of the manganese chloride 197.92 or μ g of 2 hydrate of the manganese gluconate 481.3 or μ of 1 hydrate of manganese sulfate 169.0 The μ g or D- of g L- or DL- L-aminobutanedioic acids manganese 319.13 or the μ g of L- or DL- L-aminobutanedioic acid manganese hydrate 319.13 are (with L-aminobutanedioic acid manganese Weight calculation amount), the μ g of sodium fluoride 126 or μ g of potassium fluoride 174.3, the μ g of 5 hydrate of sodium selenite 7.89 or sodium selenite (Na2SeO3) 5.19 μ g or μ g of sodium hydrogen selenite 4.53, the μ g of sodium iodide 14.99 or the μ g of KI 16.6；In said one unit dose or unit Weight number containing above-mentioned each main ingredient component or 0.25~50 times of parts by weight in the said composition of preparation or unit volume；Should Composition can be with pharmaceutically acceptable auxiliary material or excipient composition injection；Said one dosage unit or unit volume can be with It is 1ml or 2ml or 3ml or 5ml or 10ml or 20ml or 40ml or 50ml or 100ml etc.；In addition to water for injection pharmaceutically One or more content in the injection of a unit dose in acceptable auxiliary material or excipient is selected from 0.0010~ 0.040g, it is more preferably 0.0030~0.030g, more preferably 0.0040~0.025g；Or it can be expressed as：Except water for injection Outside pharmaceutically acceptable auxiliary material or excipient in one or more content in the injection of a unit dose It can be or selected from 0.0010~0.040g/ml, be more preferably 0.0030~0.030g/ml, more preferably 0.0040~ 0.025g/ml。

This of the pharmaceutical composition of the various trace elements of the present invention, a unit dose or unit formulation or unit volume The ratio between the weight number of main ingredient component or parts by weight can be in composition：White vitriol (ZnSO₄·7H₂O) 1437.8 μ g or μ g of 2 hydrate of zinc acetate 1095.75, the μ g (weight is in terms of iron) of sodium gluconate iron 200 or μ g of ferric citrate 1707.44, seven The μ g of 4 hydrate of ammonium molybdate 12.36 or μ g of 2 hydrate of sodium molybdate 2.42, the μ g of the chromium gluconate 12.75 or hydrate of chromium chloride 6 5.33 μ g or 5.3 μ g or D- or μ g of 3 hydrate of L- or DL- L-aminobutanedioic acids chromium 10.07, the μ g of 2 hydrate of copper gluconate 587.856 Or the μ g of 1 hydrate of the copper gluconate 566.2 or μ g of copper gluconate 544.608 or μ g of cupric sulfate pentahydrate 299.616, manganese chloride 2 The μ g of the hydrate 125.8 or μ g of 4 hydrate of manganese chloride 197.92 or μ g of 2 hydrate of manganese gluconate 481.3, μ g of sodium fluoride 126, Asia μ g of 5 hydrate of sodium selenate 7.89, the μ g of sodium iodide 14.99 or the μ g of KI 16.6；In said one unit dose or unit formulation Or the weight number containing above-mentioned each main ingredient component or 0.25~50 times of parts by weight in the said composition of unit volume；The combination Thing can be with pharmaceutically acceptable auxiliary material or excipient composition injection；Said one dosage unit or unit volume can be 1ml or 2ml or 2.5ml or 3ml or 5ml or 10ml or 20ml or 40ml or 50ml or 100ml etc..

Further it is stated another way, for the medicine composition injection of the various trace elements of the present invention, a list The ratio between the weight number of main ingredient component or parts by weight are or are selected from position dosage or the said composition of unit formulation or unit volume： Zinc gluconate or zinc gluconate hydrate, zinc gluconate dihydrate or the μ g of 3 hydrate of zinc gluconate 2278.4 (with Zinc gluconate anhydride weight calculation amount) or the μ g or D- of L- or DL- L-aminobutanedioic acids zinc 1647.9 or the hydration of L- or DL- L-aminobutanedioic acids zinc The μ g of thing 1647.9 (with L-aminobutanedioic acid zinc weight calculation amount)；Ferrous gluconate or the μ g of 2 hydrate of ferrous gluconate 1687.6 are (with Portugal 2 hydrated basis weight of grape saccharic acid ferrous iron)；The μ g of 6 hydrate of chromium chloride 5.3 or the μ g of 6 hydrate of chromium chloride 5.33 or chromium gluconate Or the μ g of chromium gluconate hydrate 12.75 (with chromium gluconate weight calculation amount)；The μ g of 2 hydrate of sodium molybdate 2.42 or ammonium heptamolybdate 4 The μ g of hydrate 12.36；Copper gluconate or the hydrate of copper gluconate 1 or the μ g of 2 hydrate of copper gluconate 544.6 are (with grape Saccharic acid copper weight calculation amount)；Manganese gluconate or the μ g of 2 hydrate of manganese gluconate 481.27 (are counted weight with the hydrate of manganese gluconate 2 Amount) 1 hydrate of manganese sulfate, the 169 μ g or μ g of 4 hydrate of manganese chloride 197.9；The μ g of sodium fluoride 126；Sodium selenite or the water of sodium selenite 5 Compound or the μ g of sodium hydrogen selenite 7.89 (with the hydrated basis weight of sodium selenite 5), the μ g of KI 16.6 or the μ g of sodium iodide 14.989； Contain the weight number of above-mentioned each main ingredient component in the said composition of said one unit dose or unit formulation or unit volume Or 0.25~50 times of parts by weight；Said composition can be prepared into injection with pharmaceutically acceptable auxiliary material or excipient；Remove One or more injections in a unit dose in pharmaceutically acceptable auxiliary material or excipient outside water for injection In content can be or selected from 0.0010~0.040g/ml be more preferably 0.0030~0.030g/ml, more preferably 0.0040~0.025g/ml l；Said one dosage unit or unit volume can be 1ml or 2ml or 2.5ml or 3ml or 5ml Or 10ml or 20ml or 40ml or 50ml or 100ml etc..

Further it is stated another way, for the medicine composition injection of the various trace elements of the present invention, a list The ratio between the weight number of main ingredient component or parts by weight are or are selected from position dosage or the said composition of unit formulation or unit volume： Zinc gluconate or zinc gluconate hydrate, zinc gluconate dihydrate or the μ g of 3 hydrate of zinc gluconate 2278.4 (with Zinc gluconate anhydride weight calculation amount) or white vitriol (ZnSO₄·7H₂O) 1437.8 μ g or the hydrate 1095.75 of zinc acetate 2 The μ g or D- of μ g or L- or DL- L-aminobutanedioic acids zinc 1647.9 or the μ g of L- or DL- L-aminobutanedioic acid zinc hydrate 1647.9 are (with L-aminobutanedioic acid Zinc weight calculation amount)；Ferric glycerophosphate or α-ferric glycerophosphate or β-ferric glycerophosphate or the μ g of their hydrate 1088.26 are (with sweet Oleophosphoric acid iron weight calculation amount)；The μ g of 6 hydrate of chromium chloride 5.3 or the μ g of 6 hydrate of chromium chloride 5.33 or chromium gluconate or gluconic acid The μ g of chromium hydrate 12.75 (with chromium gluconate weight calculation amount)；The μ g of 2 hydrate of sodium molybdate 2.42 or the hydrate 12.36 of ammonium heptamolybdate 4 μg；Copper gluconate or the hydrate of copper gluconate 1 or the μ g of 2 hydrate of copper gluconate 544.6 (are counted weight with copper gluconate Amount)；Manganese gluconate or the μ g of 2 hydrate of manganese gluconate 481.27 (with the hydrated basis weight of manganese gluconate 2)；Sodium fluoride 126μg；Sodium selenite or the μ g of the hydrate of sodium selenite 5 or sodium hydrogen selenite 7.89 (with the hydrated basis weight of sodium selenite 5), iodine Change the μ g of the potassium 16.6 or μ g of sodium iodide 14.989；In the said composition of said one unit dose or unit formulation or unit volume 0.25~50 times of weight number or parts by weight containing above-mentioned each main ingredient component；Said composition can with it is pharmaceutically acceptable auxiliary Material or excipient are prepared into injection；One kind or more in pharmaceutically acceptable auxiliary material or excipient in addition to water for injection Content of the kind in the injection of a unit dose is selected from 0.0010~0.040g, is more preferably 0.0030~0.030g, more Preferably 0.0040~0.025g；Or it can be expressed as：Pharmaceutically acceptable auxiliary material or excipient in addition to water for injection In it is one or more in unit dose can be 0.0010~0.040g/ by the content in the injection of solvent of water Ml, it is more preferably 0.0030~0.030g/ml, more preferably 0.0040~0.025g/ml；Pharmaceutically acceptable auxiliary material or tax Shape agent can be more preferably：D- or L- or DL-Lys, Lysine Acetate, cysteine, methionine, arginine, acetic acid essence ammonia Acid, L-aminobutanedioic acid, Monosodium L-aspartate, glutamic acid, glycine, taurine, valine, threonine, cysteine, cystine, paddy Acid amides, 5- oxylysines, histidine, 3- hydroxy-prolines, 4- hydroxy-prolines, proline, ornithine, citrulling, creatine, 3- alanine, theanine, 2-amino-butyric acid, 4-Aminobutanoicacid, 2- amino-2-methyls propionic acid, 2- methyl -3- alanines, 2, 6- diaminopimelic acids, 2- amino-3-phenyl butyrics, 4- hydroxyarginines, 4- hydroxyls ornithine, 4- hydroxyhomoarginines, 2, 4- diaminobutyric acids, L-AA, citric acid, sodium citrate, lactic acid, sodium lactate, lactobionic acid, sodium lactonic, gluconic acid, Sodium gluconate, trehalose, urea, thiocarbamide, maltitol, sorbierite, mannitol, lactitol, xylitol, antierythrite or its One or more in hydrate or their pharmaceutically acceptable salt or their chiral isomer etc., said one dosage list Position or unit volume can be 1ml or 2ml or 2.5ml or 3ml or 5ml or 10ml or 20ml or 40ml or 50ml or 100ml etc..

It is pointed out that contain in composition in a unit dose or a unit formulation or a unit volume Main ingredient component：In the present invention, can be according to the quantitative relation between the molecular weight of individual component in itself or quality, in decimal point position On number or it is accurate in the digit of different decimal points and is extended, or according to the regular further analogy to round up, for example, chlorine Change between ferrous iron the μ g of 4 hydrate 695.835 and 695.84 μ g and 695.8 μ g and 696 μ g；2548.65 μ g of zinc gluconate with Between 2548.7 μ g and 2549；Between the μ g of 2 hydrate of ferrous gluconate 1687.595 and 1687.60 μ g and 1688 μ g；Molybdic acid Between the μ g of 2 hydrate of sodium 4.85 and 4.9 μ g；The μ g of 1 hydrate of copper gluconate 566.232 and 566.23 μ g, 566.2 μ g, 566 μ g Between；Between the 481.27 μ g and 481.3 μ g and 481 μ g and 482 μ g of the hydrate of manganese gluconate 2, the μ of 6 hydrate of chromium chloride 5.3 Between g and 5.33 μ g, or weight between the μ g of sodium iodide 14.989 and 15 μ g be equal effect or can mutual equivalent substitution, because Effective digital is different and has omitted or has accepted or rejected；Other or other components can by that analogy, other combinations of the invention The effective digital of main ingredient or auxiliary material accepts or rejects mode in thing or principle is also identical with this.

Change a component to say, the pharmaceutical composition of various trace elements, a unit dose or unit formulation or unit volume Said composition in main ingredient component weight number or the ratio between parts by weight be or be selected from：Zinc gluconate or zinc gluconate hydration Thing, the hydrate of zinc gluconate 2 or the μ g of 3 hydrate of zinc gluconate 2278.4 (with zinc gluconate anhydride weight calculation amount)；Portugal Grape saccharic acid ferrous iron or the μ g of 2 hydrate of ferrous gluconate 1687.6 (with the hydrated basis weight of ferrous gluconate 2)；Chromium chloride 6 The μ g of hydrate 5.3 or 5.33 μ g；The μ g of 2 hydrate of sodium molybdate 2.42；Copper gluconate or the hydrate of copper gluconate 1 or glucose Sour the μ g of 2 hydrate of copper 544.608 or 544.61 μ g or 544.6 μ g (with copper gluconate weight calculation amount)；Manganese gluconate or grape The μ g of 2 hydrate of saccharic acid manganese 481.27 (with the hydrated basis weight of manganese gluconate 2)；The μ g of sodium fluoride 126；Sodium selenite or selenous acid The hydrate of sodium 5 or the μ g of sodium hydrogen selenite 7.89 (with the hydrated basis weight of sodium selenite 5), the μ g of KI 16.6 or sodium iodide 14.989μg；Contain above-mentioned each main ingredient component in the said composition of said one unit dose or unit formulation or unit volume Weight number or 0.20~50 times of parts by weight；Said composition can be common with other pharmaceutically acceptable auxiliary materials or excipient Form injection；One or more in pharmaceutically acceptable auxiliary material or excipient in addition to water for injection are in a unit Content in the injection of dosage is selected from 0.0010~0.040g, is more preferably 0.0030~0.030g, and more preferably 0.0040 ~0.025g；Or it can be expressed as：One kind or more in pharmaceutically acceptable auxiliary material or excipient in addition to water for injection What it is kind in unit dose can be 0.0010~0.040g/ml by the content in the injection of solvent of water, more preferably for 0.0030~0.030g/ml, more preferably 0.0050~0.025g/ml；Pharmaceutically acceptable auxiliary material or excipient can be compared with It is preferred that：D- or L- or DL-Lys, Lysine Acetate, cysteine, methionine, arginine, acetic arginine, L-aminobutanedioic acid, Monosodium L-aspartate, glutamic acid, glycine, taurine, valine, threonine, cysteine, cystine, glutamine, 5- hydroxyls Lysine, histidine, 3- hydroxy-prolines, 4- hydroxy-prolines, proline, ornithine, citrulling, creatine, 3- alanine, tea Propylhomoserin, 2-amino-butyric acid, 4-Aminobutanoicacid, 2- amino-2-methyls propionic acid, 2- methyl -3- alanines, 2,6- diaminourea heptan two Acid, 2- amino-3-phenyl butyrics, 4- hydroxyarginines, 4- hydroxyls ornithine, 4- hydroxyhomoarginines, 2,4-diamino-butanoic, L-AA, citric acid, sodium citrate, lactic acid, sodium lactate, lactobionic acid, sodium lactonic, gluconic acid, sodium gluconate, sea Algae sugar, urea, thiocarbamide, maltitol, sorbierite, mannitol, lactitol, xylitol, antierythrite or its hydrate or they Pharmaceutically acceptable salt or their chiral isomer etc. in one or more, said one dosage unit or unit volume Can be 1ml or 2ml or 2.5ml or 3ml or 5ml or 10ml or 20ml or 40ml or 50ml or 100ml etc..

In addition, the pharmaceutical composition of various trace elements of the present invention can also be expressed as, 100 or 1,000 unit doses or The ratio between the weight number of main ingredient component or parts by weight can be in the said composition of unit formulation or unit volume：

Zinc gluconate hydrate 2278.4mg (in terms of zinc gluconate anhydride), the hydrate of frerrous chloride 4 695.8mg, the hydrate 2.42mg of sodium molybdate 2, the hydrate 5.3mg of chromium chloride 6, the hydrate (CuCl of copper chloride 2₂·2H₂O) 204.6mg, the hydrate (MnCl of manganese chloride 4₂·4H₂O) 197.9mg, sodium fluoride 126mg, sodium selenite 6.9mg or sodium selenite Pentahydrate (Na₂SeO₃·5H₂O) 7.89mg, KI (KI) 16.6mg；

Contain above-mentioned each main ingredient component in the said composition of said one unit dose or unit formulation or unit volume Weight number or 0.20~50 times of parts by weight；Said composition can inject with pharmaceutically acceptable auxiliary material or excipient composition Agent；One or more notes in a unit dose in pharmaceutically acceptable auxiliary material or excipient in addition to water for injection The content penetrated in agent is selected from 0.0010~0.040g, is more preferably 0.0030~0.030g, more preferably 0.0040~0.025g； Or it can be expressed as：The one or more in pharmaceutically acceptable auxiliary material or excipient in addition to water for injection are at one Unit dose can be or selected from 0.0010~0.040g/ml using water as the content in the injection of solution, more preferably for 0.0030~0.030g/ml, more preferably 0.0040~0.025g/ml；

The pharmaceutical composition of the various trace elements of the injection of the present invention, wherein, iron or molysite are more preferably from grape Saccharic acid ferrous iron or its hydrate or ferrous gluconate dihydrate, L- or D- L-aminobutanedioic acids ferrous iron or its hydrate, DL- doors Winter propylhomoserin ferrous iron or its hydrate, the hydrate (FeCl of frerrous chloride 4₂·4H₂O), the hydrate of ferrous sulfate 7, iron ammonium sulfate, Ferrous lactate, the hydrate of ferrous lactate 3, ferrous citrate or their hydrate, or D- or L- or DL- L-aminobutanedioic acids iron or its Hydrate, the hydrate of ferric sulfate 7, the hydrate of iron chloride 6 (FeCl36H2O), sodium gluconate iron, ferric lactate, ironic citrate, In ferric citrate or its hydrate, phosphoglycerol ferrous iron or ferric glycerophosphate or its hydrate or their chiral isomer It is one or more of；

Zinc or zinc salt are more more preferably from white vitriol, zinc gluconate or zinc gluconate hydrate, zinc gluconate 2 Hydrate, the hydrate of zinc gluconate 3, lactobionic acid zinc or lactobionic acid zinc hydrate, zinc citrate or the zinc of citric acid three or its lemon Lemon acid zinc hydrate zinc citrate dihydrate, zinc lactate, the hydrate of Pfansteihl zinc 3, the hydrate of zinc acetate 2, D- or L- or DL- One or more in L-aminobutanedioic acid zinc or its hydrate；

Copper or mantoquita are more preferably hydrated from the hydrate of copper chloride 2, cupric sulfate pentahydrate, copper gluconate, copper gluconate 1 Thing, the hydrate (C of copper gluconate 2₁₂H₂₂O₁₄Cu·2H₂O), lactobionic acid copper or lactobionic acid copper hydrate, copper lactate or Pfansteihl Copper or its hydrate, D- or L- or DL- L-aminobutanedioic acids copper or their hydrate, copper acetate or its hydrate of copper acetate 1 [(Ac)₂Cu·H₂O] in one or more；

Manganese or manganese salt are more preferably from manganese chloride or its hydrate [or the hydrate of manganese chloride 1 or the hydrate of manganese chloride 2 (MnCl₂·2H₂) or the hydrate (MnCl of manganese chloride 4 O₂·4H₂O) or the hydrate of manganese chloride 5 or the hydrate of manganese chloride 6], sulfuric acid Manganese or, the hydrate of manganese sulfate 1, manganese gluconate or manganese gluconate hydrate, lactobionic acid manganese or lactobionic acid manganese hydrate, lemon The sour manganese of manganese or citric acid three or manganese citrate hydrate, manganese lactate or Pfansteihl manganese or its hydrate, manganese acetate or the water of manganese acetate 4 One or both of compound, D- or L- or DL- L-aminobutanedioic acids manganese or its hydrate；

Fluorine is more preferably from the one or more in sodium fluoride or potassium fluoride；Selenium preferably is selected from sodium selenite, sodium selenite 5 is hydrated Thing (Na₂SeO₃·5H₂O), the one or more in sodium hydrogen selenite；Iodine preferably is selected from one kind or several in KI or sodium iodide Kind；

Molybdenum or molybdenum salt are more preferably from molybdic acid or sodium molybdate, the hydrate (Na of sodium molybdate 2₂MoO₄·2H₂O), ammonium molybdate, molybdic acid One or more in the hydrate of ammonium 4, the hydrate of ammonium heptamolybdate 4；

Chromium or chromic salts are more preferably from chromium chloride, the hydrate of chromium chloride 6, chromium gluconate or chromium gluconate hydrate, lemon Lemon acid chromium or chromium citrate hydrate, Chromic lactate or Pfansteihl chromium or its hydrate, L- or D- or DL- L-aminobutanedioic acids chromium or they Hydrate (such as hydrate of L-ASPARTIC ACID chromium 3) in one or more；

Pharmaceutically acceptable auxiliary material or excipient are preferably certainly：D- or L- or the amino acid of racemization or its salt, such as D- or L- or the lysine or Lysine Acetate of racemization, the cysteine or cysteine hydrochloride of D- or L- or racemization, D- or L- disappear Methionine, D- or the L- of rotation or the arginine or acetic arginine of racemization, D- or L- or DL-histidine or D- or L- or racemization L-aminobutanedioic acid or Monosodium L-aspartate or D- or L- or the glutamic acid or glycine or taurine etc. of racemization, or citric acid or Sodium citrate or lactic acid or sodium lactate or lactobionic acid or sodium lactonic or gluconic acid or sodium gluconate or sorbierite (mountain Pears alcohol anhydride or the water thing of sorbierite half or sorbitol instant etc.) or mannitol or lactitol or xylitol or antierythrite or its One or more in hydrate or their pharmaceutically acceptable salt etc..

The multi-microelement injecta and its preparation technology of the present invention：Method one, step 1, by pharmaceutically acceptable salt Or other auxiliary materials or excipient are dissolved with appropriate water for injection, with appropriate water for injection dissolving or with pharmaceutically acceptable PH adjusting agent is acidified；Step 2, iron ion salt or ferrous ion pharmaceutically acceptable salt, manganese ion can pharmaceutically be connect Salt, copper ion pharmaceutically acceptable salt, the chromium ion pharmaceutically acceptable salt received are dissolved with appropriate water for injection one by one Or dissolved with the water for injection of appropriate acidifying；Step 3, the acceptable pharmaceutical salts of zinc ion are dissolved with appropriate water for injection Or the water for injection dissolving of appropriate acidifying；Step 4, villiaumite dissolved with appropriate water for injection；It is step 5, molybdic acid is medicinal Salt, selenous acid pharmaceutical salts, KI or the pharmaceutical salts of sodium iodide or iodide ion are dissolved with appropriate water for injection respectively；Step 6, The solution of step 2 is sufficiently mixed uniformly with the solution of step 4 respectively；Step 7, the solution of step 3 and the solution of step 1 mixed It is even, then with being mixed with the solution of step 6, then the solution with step 5 easily mixes；Step 8, with pharmaceutically acceptable pH Conditioning agent adjusts pH value between 3.0~5.5, and preferable ph is between 3.5~4.5, or milipore filter removes thermal source, or adds activity Carbon decoloring, decarburization is filtered, then moisturizing constant volume, refined filtration, examined, it is filling, seal, sterilize, pack, examine.Wherein, the note of acidifying Penetrate and be acidified with water system with pharmaceutically acceptable pH adjusting agent, its pH is generally between 3.0-5.6.

It is or method two, step 1, pharmaceutically acceptable salt or other auxiliary materials or excipient is water-soluble with appropriate injection Solution, is acidified with pharmaceutically acceptable pH adjusting agent；Step 2, by manganese ion pharmaceutically acceptable salt, copper ion pharmacy Upper acceptable salt dissolves with appropriate water for injection dissolving or with the water for injection of appropriate acidifying respectively；Step 3, by zinc from The acceptable pharmaceutical salts of the son water for injection of appropriate acidifying dissolves；Step 4, iron ion salt or ferrous ion pharmaceutically may be used The salt of receiving, chromium ion pharmaceutically acceptable salt is dissolved respectively with appropriate water for injection or the injection with appropriate acidifying Water dissolves；Step 5, villiaumite dissolved with appropriate water for injection；Step 6, molybdic acid pharmaceutical salts, selenous acid pharmaceutical salts are used respectively Appropriate water for injection dissolving；Step 7, by the pharmaceutical salts of KI or sodium iodide or iodide ion respectively with appropriate water for injection Dissolving；Step 8, the solution of step 2 is sufficiently mixed uniformly with the solution of step 1 respectively；Step 9, solution and step by step 3 Rapid 8 solution mixes；Step 10, solution of the solution of step 4 respectively successively with step 5 fully mixed, then with step 9 Solution easily mix；Step 11, the solution of step 6 and the solution of step 10 fully mixed, then the solution of step 7 is added Wherein, mix, then with the pH value of pharmaceutically acceptable pH adjusting agent regulation solution between 3.0~5.5, preferable ph exists Between 3.5~4.5；Step 12, solution is added to activated carbon decolorizing, filter decarburization, or filtering with microporous membrane, or use retention phase pair Molecular mass is 50,000 to 300,000 membrane filtration, or above-mentioned filter method is used in mixed way, it is preferred to use retention relative molecular mass 3000~60000 milipore filter removes remaining thermal source, moisturizing constant volume；0.22 μm of miillpore filter or ultrafiltration etc. carry out refined filtration, examine, It is filling, seal, sterilize, pack, examine.Wherein, the upper acceptable pH adjusting agent of the injection water system medication of acidifying is sour by it Change, its pH is generally between 3.0-5.6.

Pharmaceutical composition and pharmaceutically acceptable auxiliary material or excipient composition injection in the present invention；Except water for injection Outside pharmaceutically acceptable auxiliary material or excipient in one or more content in the injection of a unit dose It is more preferably 0.0030~0.030g selected from 0.0010~0.040g, more preferably 0.0040~0.025g；Or it can express For：In pharmaceutically acceptable auxiliary material or excipient in addition to water for injection it is one or more unit dose with Water is that the content in the injection of solution can be or be more preferably 0.0030~0.030g/ selected from 0.0010~0.040g/ml Ml, more preferably 0.0050~0.025g/ml.

For the drug combination injection in invention, every 1000ml of its pH adjusting agent pharmaceutically received in the present invention Parenteral solution can contain 0.0001-200.00 grams or more, and used pH adjusting agent is calculated with its active ingredient or molecular formula Its weight is calculated corresponding volume according to data such as concentration or density or calculated with molar concentration (M) or equivalent concentration (N). Used pH adjusting agent is added in the solution of composition during preparation of preparation in form of an aqueous solutions.When using alkali Property solution to adjust pH value when (such as one or more of sodium hydroxide, trisodium citrate, sodium gluconate), regulation process In, or it can be adjusted jointly with the mixed solution of soda acid, then adjusted with another kind, also can be after a kind of excess with pharmaceutically acceptable Acid solution adjusts back (for example, acetic acid, lactic acid, citric acid, gluconic acid solution), to control a suitable pH value, otherwise also So.

Pharmaceutically acceptable pH adjusting agent can be pharmaceutically acceptable inorganic acid or organic acid, inorganic base or organic The lewis acid or alkali of alkali or broad sense, one or several kinds can be contained, can be acetic acid and acetate, such as acetic acid Sodium etc., lactic acid and lactic acid pharmaceutical salts, citric acid pharmaceutical salts, sodium hydroxide, trihydroxy aminomethane, diethanol amine, monoethanolamine, two Isopropanolamine, 2- amino -2- (methylol) 1,3-PDs amine, N- methyl glucoses amine and their salt, multi-hydroxy carboxy acid and Pharmaceutical salts, such as glucuronic acid, gluconic acid, lactobionic acid, malic acid, threonic acid, glucoheptonic acid, amino acid or their pharmacy One or several kinds in upper acceptable salt etc..

The pharmaceutically acceptable antioxidant and stabilizer contained in the pharmaceutical compositions of the present invention can be sulfurous acid And its salt, bisulfites, pyrosulfite, dithionite, TGA and its pharmaceutical salts, thiolactic acid and its medicinal Salt, thio-2 acid and salt, amino acid and its pharmaceutical salts；Tartaric acid, sorbic acid or its pharmaceutical salts, nitrate, acetic acid are medicinal Salt, citrate, EDTA and edta salt, such as EDETATE SODIUM, the sodium of EDTA tetra-, Ca-EDTA sodium salt (including sodium ethylene diamine tetracetate Calcium or the hydrate of sodium ethylene diamine tetracetate calcium 2, the hydrate of sodium ethylene diamine tetracetate calcium 4), N- bis- (2- ethoxys) glycine, One kind in maltitol, xylitol, sorbierite, mannitol, taurine, amino acid or its pharmaceutically acceptable salt etc. or It is several；The salt of above-mentioned substance selects its pharmaceutically acceptable salt.

Pharmaceutically preservative or bacteriostatic agent can be contained in the injection of the pharmaceutical compositions of the present invention, as sorbic acid or its One or more in pharmaceutical salts, methyl hydroxybenzoate, phenmethylol, anesin, Benzethonium etc..

In the injection of pharmaceutical composition of the present invention, pharmaceutically acceptable isotonic regulator can be used, pharmaceutically Acceptable isotonic regulator can be glucose, fructose, maltitol, xylitol, sorbierite, mannitol, inverted sugar, dextrorotation One or more in sugared acid anhydride, sodium lactate or sodium lactonic, gluconic acid or sodium gluconate etc..

Injection removes thermal source and degerming mode in preparing can add the activated carbon with liquid measure 0.005~1% to remove thermal source, Miillpore filter is degerming and pressure sterilizing, can also use heat sterilization, remove thermal source.In hyperfiltration process, flat board can be selected in ultrafilter Formula, rolling, tubular type, hollow fiber form or circle boxlike etc., preferably rolling and hollow fiber form ultrafilter, using retention average molecular After the filter membrane that quality is 50,000 to 300,000 removes most of heat generation material and bacterium, then using retention relative molecular mass 3000 ~60000 milipore filter removes remaining thermal source, the preferably milipore filter of relative molecular mass 6000~20000.

The pharmaceutical composition of the present invention is to mouse writhing reaction experiment

1st, test objective

The power of multi-microelement injecta pharmaceutical composition writhing response after intraperitoneal administration of the present invention is observed, with Investigate the degree of the adverse reaction of the pharmaceutical composition of different groups.

2nd, animal subject：Adult healthy white mouse, male and female half and half, body weight 18-22g.

3rd, test method：Mouse writhing method

Mouse 60, male and female half and half, fasting (can't help water) 12h, it is randomly divided into 6 groups, respectively vehicle control group, Duo Zhongwei Secondary element primary standard medicine composition injection is primary standard control group (multi-microelement injecta (German Tracutil) (prepared by the program with reference to the method for embodiment 5), 13 groups of 1 group of embodiment, 5 groups of embodiment, 5 groups of embodiment and embodiment.Administering mode For intraperitoneal injection, dosage is 0.2ml respectively, gives the parenteral solution of vehicle control group 0.2ml glucose 5% respectively, Multi-microelement injecta control group solution in primary standard control group intraperitoneal injection table 1 (control group solution ph is 2.5) After 0.2ml, remaining each group intraperitoneal injection embodiment solution 0.2ml, mouse produces writhing response in 15min after observation administration Number.

4th, result is found, vehicle control group does not produce writhing response, and the note of the various trace elements in table 1 below is injected intraperitoneally The number for penetrating liquid primary standard control group generation writhing response is approximately 2.2 times of embodiment 1,4.1 times of 4 groups of embodiment, reality respectively Apply 5 groups of example 4.7 times, 3.2 times or more of 13 groups of embodiment, the results showed that, the adverse reaction of pharmaceutical composition of the invention Degree is significantly less than primary standard control group.

The various trace elements medicine composition injection control group of table 1.

Furtherly, the invention provides improved or more have the multi-microelement injecta pharmaceutical composition of advantage, The present invention also embodies further advantage simultaneously：1st, eliminate that corrosivity is strong or the zinc chloride of strong toxicity so that combination of the invention The toxicity of thing is reduced, and the incidence of serious toxicity reaction can be reduced compared with the composition of zinc chloride in the prior art etc.；2nd, originally The pharmaceutical composition of invention, selection substitute the strong zinc chloride of corrosivity, can subtracted compared with the composition of zinc chloride in the prior art Less or reduce the excitant of intravenously administrable and local necrosis occurs, improve the security of medication, be advantageous to improve patient to medicine Compliance；3rd, after the big acid chlorization zinc of dosage in stock blend is removed in optimization, relative to original prescription, composition is contributed to inject The overall lifting of agent acidity so that match somebody with somebody being mixed with other present or future listing medicines in clinical medicine disposal process During parenteral solution processed, the pH value difference between different pharmaceutical preparation is reduced, is advantageous to the stability after solution is prepared and Clinical practice When security and validity and patient tolerance；4th, the new composition provided, selection substitute zinc chloride etc., can removed Most of chlorion, reduces the incidence of hyperchloremia, and expands adaptation population, for example embodiment 4 or embodiment 5 or embodiment 6 etc.；5th, it is unfavorable for the treatment of autism children containing a large amount of salt acid compositions, to self-closing disease but require supplementation with micro The patient of the pharmaceutical composition of element, selection zinc gluconate etc. substitutes zinc chloride etc., there is provided one is safer and more effective or more Selection, perhaps this more current pharmacy or clinical ignore or have no promotion；6th, for having occurred or easily having occurred acid poisoning Patient new selection is provided, or reduce potential adverse reaction；The 7th, the preparation of different size or lower unit dose are provided Composition, so that Clinical practice is convenient, reduce waste etc.；8th, present invention simultaneously provides the pharmaceutical composition of supplement phosphorus.

Multi-microelement injecta pharmaceutical composition of the invention, prevent suitable for preparation for offer or treat zinc, Application in the multi-microelement injecta medicine of iron, molybdenum, chromium, manganese, copper, selenium, fluorine, iodine deficiency and its syndrome etc. so that The tolerance or new adaptation population or more preferable specific aim and more preferable clinical safety that product has had more on Clinical practice Property etc.；It is more suitable for the patient or children of hyperchloremia, acid poisoning etc..

Embodiment

Except in embodiment and when indicated otherwise, all numerical value used should be by specification and claims It is interpreted as being modified with term " about " in all examples, therefore, unless the contrary indication, this specification and appended The numerical parameter gone out given in claims is approximation, the required property that it can be according to sought by by present disclosure Matter and change, at least, and not be intended to limit the application of doctrine of equivalents right, each numerical parameter takes an examination The number and routine for considering effective digital round up method to explain.

Although the number range and parameter that set the wide scope of disclosure are approximations.But institute in a particular embodiment The numerical value provided is reported as precisely as possible, and any number is substantially comprising some by finding in their own test The error that standard deviation is necessarily led to.

It is pointed out that unless in text clearly in addition explanation, used in this specification and the appended claims Singulative "one", " one kind " and "the" include the plural form of referring to thing, so, such as.If refer to containing " one Mixture including two or more compounds during the composition of kind compound ", it is further noted that unless herein clearly Ground illustrates that term "or" generally includes "and/or" in addition.

Pharmaceutical composition

" pharmaceutical composition " used herein refers to the composition of medicine, and described pharmaceutical composition can contain at least one Pharmaceutically acceptable carrier.

" pharmaceutically acceptable excipient " used herein refers to the medicine that the compound for being applied to occasionally provide herein is administered With carrier or solvent, it includes, and well known to a person skilled in the art any examples of such carriers suitable for specific administration mode.

In the preparation technology of various embodiments of the present invention, the situation of the title of each component has been limited in the prescription of embodiment Under, for simplicity for each component in prescription, the simplification appellation or the property omitted address of following manner can be carried out, for example, can be with The hydrate of zinc gluconate 3 in prescription is referred to as zinc gluconate hydrate or zinc gluconate；Or ferrous gluconate 2 Hydrate is referred to as ferrous gluconate hydrate or ferrous gluconate；Or the hydrate of copper gluconate 1 is referred to as glucose Sour copper hydrate or copper gluconate；Or the hydrate of chromium chloride 6 is referred to as chromium chloride hydrate or chromium chloride；Or the water of manganese chloride 4 Compound is referred to as manganese chloride hydrate or manganese chloride；Or sodium selenite pentahydrate is referred to as sodium selenite；L-ASPARTIC ACID manganese Hydrate is referred to as L-aminobutanedioic acid manganese hydrate or L-ASPARTIC ACID manganese or L-aminobutanedioic acid manganese etc., and the rest may be inferred for other components.

In order to further appreciate that the present invention, the preferred embodiment of the invention is described with reference to embodiment, still It should be appreciated that these descriptions are simply further explanation the features and advantages of the present invention, rather than to the claims in the present invention Limitation.

Illustrate the effect of the present invention with specific embodiment below, but protection scope of the present invention is not limited by following examples System.

Specific embodiment

The preparation of the various trace elements drug combination injection of embodiment 1

Prescription：Zinc gluconate hydrate (C₁₂H₂₂O₁₄Zn) 2278.4mg (in terms of zinc gluconate anhydride)

Hydrate (the FeCl of frerrous chloride 4₂·4H₂O) 695.8mg

Hydrate (the Na of sodium molybdate 2₂MoO₄·2H₂O) 2.42mg

The hydrate of chromium chloride 6 (CrCl36H2O) 5.3mg

Hydrate (the CuCl of copper chloride 2₂·2H₂O) 204.6mg

Hydrate (the MnCl of manganese chloride 4₂·4H₂O) 197.9mg

Sodium fluoride (NaF) 126mg

Sodium selenite pentahydrate (Na₂SeO₃·5H₂O) 7.89mg

KI (KI) 16.6mg

Sorbierite (C₆H₁₄O₆) 30g

Taurine 30g

Sodium gluconate 10g

2M gluconic acid solutions and 1M sodium citrate solutions are appropriate

Appropriate water for injection

Add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sodium gluconate of recipe quantity, sorbierite, The water for injection stirring and dissolving of taurine proper amount of fresh, pH value is acidified to 3.2 with gluconic acid solution；Step 2, by chlorine Change ferrous 4 hydrates, the hydrate of chromium chloride 6, the hydrate of copper chloride 2, the hydrate of manganese chloride 4 to be acidified with gluconic acid solution respectively Fresh water for injection stirring and dissolving, solution is set to keep clarification；Step 3, the appropriate note of zinc gluconate hydrate acidifying Penetrate and dissolved with water, solution is kept clarification；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by sodium molybdate 2 Hydrate, the hydrate of sodium selenite 5, KI are respectively with appropriate water for injection stirring and dissolving；Step 6, the solution by step 3 Mixed with the solution of step 1；Step 7, the solution of step 2 is sufficiently mixed uniformly with the solution of step 4 successively, then with step 6 Solution mix, then the solution with step 5 easily mixes；Step 8, with 2M gluconic acid solutions and 1M sodium citrate solutions PH value is adjusted to 3.2, benefit adds to the full amount of water for injection, and stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, Using retention relative molecular mass 8000-20000 ultrafiltration membrance filter, by 5ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

Take appropriate above-mentioned sample lucifuge to be placed in 30 DEG C, placed 6 months in the environment of relative humidity 75% ± 5%, solution Keep clear and bright, the pH value for determining solution is 3.2.

The preparation of the various trace elements drug combination injection of embodiment 2

Prescription：The hydrate 2548.65mg of zinc gluconate 3, the hydrate 695.8mg of frerrous chloride 4, the hydrate of sodium molybdate 2 2.42mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 204.6mg of copper chloride 2, the hydrate 197.9mg of manganese chloride 4, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, taurine 10g, sorbierite 300g, sodium gluconate 8g, 2M Gluconic acid solution and 2M sodium lactate solutions are appropriate, appropriate water for injection, add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the taurine of recipe quantity, sodium gluconate, The water for injection stirring and dissolving of sorbierite proper amount of fresh, gluconic acid solution is acidified pH value to 4.0；Step 2, by protochloride The hydrate of iron 4, the hydrate of chromium chloride 6, the hydrate of copper chloride 2, the hydrate of manganese chloride 4 are acidified suitable with gluconic acid solution respectively The water for injection stirring and dissolving of amount, solution is set to keep clarification；The note of step 3, the hydrate of zinc gluconate 3 acidifying fresh amount Penetrate and dissolved with water；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by the hydrate of sodium molybdate 2, sodium selenite 5 Hydrate, KI use the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6, by the molten of the solution of step 3 and step 1 Liquid mixes；Step 7, the solution of step 2 is sufficiently mixed uniformly with the solution of step 4 successively, then mixed with the solution of step 6, Then the solution with step 5 easily mixes；Step 8, with 2M gluconic acid solutions and 2M sodium gluconate solutions adjust pH value To 3.4, benefit adds to the full amount of water for injection, and stir simultaneously 0.22 μm of miillpore filter 15min of circulating filtration；Then, using retention Relative molecular mass 6000-20000 ultrafiltration membrance filter, 10ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 3

Prescription：The hydrate 2548.65mg of zinc gluconate 3, the hydrate 695.8mg of frerrous chloride 4, the hydrate of sodium molybdate 2 2.42mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 204.6mg of copper chloride 2, the hydrate 197.9mg of manganese chloride 4, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, taurine 30g, sorbierite 20g, glycine 20g, glucose Sour 20g, sodium gluconate 10g, 2M gluconic acid solution and 2M sodium lactate solutions are appropriate, 5M sodium hydroxide solutions are appropriate, injection With appropriate amount of water, add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the taurine of recipe quantity, sorbierite, sweet ammonia Acid, gluconic acid, the water for injection stirring and dissolving of sodium gluconate proper amount of fresh, it is molten with gluconic acid solution and sodium hydroxide Liquid adjusts the pH value of solution to 4.0 jointly；Step 2, by the hydrate of iron chloride 6, the hydrate of chromium chloride 6, the hydrate of copper chloride 2, With the water for injection stirring and dissolving of gluconic acid solution acidifying, (three kinds of solution ph are acidified to the hydrate of manganese chloride 4 respectively respectively 3.0、3.5、3.6)；Step 3, the zinc gluconate hydrate water for injection of acidifying fresh amount dissolve；Step 4, it will be fluorinated Sodium is dissolved with fresh water for injection；Step 5, by molybdic acid sodium hydrate, sodium selenite hydrate, KI respectively with appropriate new Fresh water for injection stirring and dissolving；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, the solution by step 2 It is sufficiently mixed uniformly with the solution of step 4, then is mixed with the solution of step 6 successively, then the solution with step 5 easily mixes It is even；Step 8, with 2M gluconic acid solutions and 2M sodium lactate solutions pH value is adjusted to 3.3, benefit adds to the full amount of water for injection, stirring Uniform and 0.22 μm of miillpore filter 20min of circulating filtration；Then, using retention relative molecular mass 8000-20000 milipore filter Filtering, 10ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 4

Prescription：Zinc gluconate 2278.4mg, the hydrate 1687.6mg of ferrous gluconate 2, the hydrate of chromium chloride 6 5.3mg, the hydrate 2.42mg of sodium molybdate 2, the hydrate 566.2mg of copper gluconate 1, the hydrate 481.3mg of manganese gluconate 2, Sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 50g, sodium gluconate 10g, 3M grape Sugar acid solution and 2M sodium gluconate aqueous solutions are appropriate, appropriate water for injection, add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, use the sorbierite of recipe quantity, sodium gluconate The water for injection stirring and dissolving of proper amount of fresh, gluconic acid solution is acidified pH value to 4.0；Step 2, by ferrous gluconate 2 Hydrate, the hydrate of chromium chloride 6, the hydrate of copper gluconate 2, the hydrate of manganese gluconate 2 are respectively with gluconic acid solution acid Change fresh water for injection stirring and dissolving；The appropriate injection that step 3, zinc gluconate are acidified with gluconic acid solution is water-soluble Solution；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI uses the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6, the solution of the solution of step 3 and step 1 mixed； Step 7, the solution of step 2 is sufficiently mixed uniformly with the solution of step 4 successively, then mixed with the solution of step 6, then with step Rapid 5 solution easily mixes；Step 8, with 3M gluconic acid solutions and 2M sodium gluconate solutions pH value is adjusted to 4.3, mend Add to the full amount of water for injection, stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, using retention average molecular Quality 8000-20000 ultrafiltration membrance filter, 5ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.Appropriate above-mentioned sample is taken to keep away Light is placed in 30 DEG C, is placed 6 months in the environment of relative humidity 75% ± 5%, and solution keeps clear and bright, and the pH value for determining solution is 4.3。

The preparation of the various trace elements drug combination injection of embodiment 5

Prescription：The hydrate 2548.65mg of zinc gluconate 3, the hydrate 1687.6mg of ferrous gluconate 2, the water of chromium chloride 6 Compound 5.3mg, the hydrate 2.42mg of sodium molybdate 2, the hydrate 566.2mg of copper gluconate 1, the hydrate of manganese gluconate 2 481.3mg, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 10g, taurine 20g, L- Theanine 40g, 2M gluconic acid solution and 2M sodium gluconate solutions are appropriate, appropriate water for injection, adds to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, taurine, L- tea The water for injection stirring and dissolving of propylhomoserin proper amount of fresh, with the pH value of gluconic acid solution souring soln to 4.0；Step 2, by Portugal 2 hydrates of grape saccharic acid ferrous iron, the hydrate of chromium chloride 6, the hydrate of copper gluconate 1, the hydrate of manganese gluconate 2 use grape respectively Sugar acid solution is acidified fresh water for injection stirring and dissolving；Step 3, by the hydrate of zinc gluconate 3 with gluconic acid solution acid The appropriate water for injection dissolving changed；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, sodium molybdate 2 is hydrated Thing, the hydrate of sodium selenite 5, KI use the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6, the solution by step 3 Mixed with the solution of step 1；Step 7, the solution of step 2 is sufficiently mixed uniformly with the solution of step 4 successively, then with step 6 Solution mix, then the solution with step 5 easily mixes；It is step 8, molten with 2M gluconic acid solutions and 2M sodium gluconates Liquid adjusts pH value to 4.3, and benefit adds to the full amount of water for injection, and stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；So Afterwards, using retention relative molecular mass 10000-20000 ultrafiltration membrance filter, it is seen that after foreign matter and pH value inspection, 10ml/ branch fills Envelope, 121 DEG C of 15min sterilizings, is produced.Appropriate above-mentioned sample lucifuge is taken to be placed in 30 DEG C, in the environment of relative humidity 75% ± 5% Place 6 months, solution keeps clear and bright, and the pH value for determining solution is 4.2.

The preparation of the various trace elements drug combination injection of embodiment 6

Prescription：The hydrate 2548.65mg of zinc gluconate 3, the hydrate 1687.6mg of ferrous gluconate 2, the water of chromium chloride 6 Compound 5.33mg, the hydrate 2.42mg of sodium molybdate 2, the hydrate 566.2mg of copper gluconate 1, the hydrate of manganese gluconate 2 481.3mg, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 5g, glycine 10g, L- Theanine 30g, sodium gluconate 5g, 2M gluconic acid solution and 2M sodium gluconate solutions are appropriate, appropriate water for injection, filling Penetrate with water to full dose 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, glycine, L- tea The water for injection stirring and dissolving of propylhomoserin, sodium gluconate proper amount of fresh, with gluconic acid solution and gluconic acid solution solution The pH value of common regulation solution is to 4.0；Step 2, by the hydrate of ferrous gluconate 2, the hydrate of chromium chloride 6, copper gluconate 1 Hydrate, the hydrate of manganese gluconate 2 are acidified fresh water for injection stirring and dissolving with gluconic acid solution respectively；Step 3, incite somebody to action The appropriate water for injection that the hydrate of zinc gluconate 3 is acidified with gluconic acid solution dissolves；Step 4, by sodium fluoride with fresh Water for injection dissolves；Step 5, by the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI respectively use proper amount of fresh injection Blunge dissolving；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, by the solution of step 2 successively and step Rapid 4 solution is sufficiently mixed uniformly, then is mixed with the solution of step 6, and then the solution with step 5 easily mixes；Step 8, PH value is adjusted to 4.3 with 2M gluconic acid solutions and 2M sodium gluconate solutions, and benefit adds to the full amount of water for injection, and stirs simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, with retention relative molecular mass 10000-30000 ultrafiltration membrance filter, warp After visible foreign matters and pH value check, by 10ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 7

Prescription：The hydrate 2548.65mg of zinc gluconate 3, the hydrate 1687.6mg of ferrous gluconate 2, the water of chromium chloride 6 Compound 5.3mg, the hydrate 2.42mg of sodium molybdate 2, the hydrate 566.2mg of copper gluconate 1, the hydrate of manganese gluconate 2 481.3mg, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, xylitol 10g, glycine 20g, Portugal Grape saccharic acid 30g, sodium gluconate 20g, 2M gluconic acid solution and 2M sodium gluconate solutions are appropriate, 5M sodium hydroxide solutions are fitted Amount, appropriate water for injection, add to the full amount of water for injection 4000ml

Preparation technology：Supplementary material, step 1, xylitol, glycine, grape by recipe quantity are weighed or prepared by recipe quantity The water for injection stirring and dissolving of saccharic acid, sodium gluconate proper amount of fresh, it is molten with gluconic acid solution and 5M sodium hydroxide solutions Liquid adjusts the pH value of solution to 4.2 jointly；Step 2, by ferrous gluconate hydrate, chromium chloride hydrate, copper gluconate Hydrate, manganese gluconate hydrate are acidified fresh water for injection stirring and dissolving with gluconic acid solution respectively；Step 3, incite somebody to action The appropriate water for injection that zinc gluconate hydrate is acidified with gluconic acid solution dissolves；Step 4, by sodium fluoride with fresh note Penetrate and dissolved with water；Step 5, by molybdic acid sodium hydrate, sodium selenite hydrate, KI respectively use proper amount of fresh water for injection Stirring and dissolving；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, by the solution of step 2 successively with step 4 Solution be sufficiently mixed uniformly, then mixed with the solution of step 6, then the solution with step 5 easily mixes；Step 8, use 2M Gluconic acid solution and 2M sodium gluconate solutions adjust pH value to 4.3, and benefit adds to the full amount of water for injection, and stirs and circulates Filter 0.22 μm of miillpore filter 20min；Then, then through 0.22 μm of filtering with microporous membrane, after visible foreign matters and pH value check, press 2ml/ branch embeddings, 121 DEG C of 15min sterilizings, are produced.

The preparation of the various trace elements drug combination injection of embodiment 8

Prescription：The hydrate 2548.65mg of zinc gluconate 3, the hydrate 1687.6mg of ferrous gluconate 2, the water of chromium chloride 6 Compound 5.3mg, the hydrate 2.42mg of sodium molybdate 2, the hydrate 566.2mg of copper gluconate 1, the hydrate of manganese gluconate 2 481.3mg, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 300g, 4M gluconic acid Solution and 2M sodium gluconates are appropriate, appropriate water for injection, add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite proper amount of fresh of recipe quantity Water for injection stirring and dissolving, pH value is acidified to 4.0 with gluconic acid solution；Step 2, by ferrous gluconate hydrate, Chromium chloride hydrate, gluconic acid copper hydrate, manganese gluconate hydrate are acidified fresh note with gluconic acid solution respectively Penetrate dissolving of blunging；Step 3, zinc gluconate are dissolved with the appropriate water for injection being acidified with gluconic acid solution；Step 4th, sodium fluoride is dissolved with water for injection；Step 5, by molybdic acid sodium hydrate, sodium selenite hydrate, KI respectively with appropriate Fresh water for injection stirring and dissolving；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, by the molten of step 2 Liquid is sufficiently mixed uniformly with the solution of step 4 successively, then is mixed with the solution of step 6, and then the solution with step 5 easily mixes It is even；Step 8, pH value is adjusted with 4M gluconic acid solutions and 2M sodium gluconate solutions to 4.2, benefit adds to the full amount of water for injection, Stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, using the super of retention relative molecular mass 5000-10000 Membrane filtration, 15ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 9

Prescription：The hydrate 2548.65mg of zinc gluconate 3, the hydrate 1687.6mg of ferrous gluconate 2, the water of chromium chloride 6 Compound 5.3mg, the hydrate 2.42mg of sodium molybdate 2, L-ASPARTIC ACID copper hydrate 393.84mg (with L-aminobutanedioic acid copper weight calculation amount), The hydrate 481.3mg of manganese gluconate 2, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorb Alcohol 300g, taurine 2g, glycine 10g, 3M gluconic acid solution and 2M sodium gluconate solutions are appropriate, appropriate water for injection, Add to the full amount of water for injection 1000ml

Preparation technology：Supplementary material, step 1, taurine, glycine and sorb by recipe quantity are weighed or prepared by recipe quantity The water for injection stirring and dissolving of alcohol proper amount of fresh, pH value is acidified to 3.5 with gluconic acid solution；Step 2, by glucose It is molten that sour ferrous iron, chromium chloride, L-aminobutanedioic acid copper, L-aminobutanedioic acid manganese are acidified fresh water for injection stirring with gluconic acid solution respectively Solution；Step 3, the water for injection dissolving by zinc gluconate with gluconic acid solution acidifying fresh amount；Step 4, by sodium fluoride Dissolved with fresh water for injection；Step 5, by the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI respectively with appropriate new Fresh water for injection stirring and dissolving；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, the solution by step 2 It is sufficiently mixed uniformly with the solution of step 4, then is mixed with the solution of step 6 successively, then the solution with step 5 easily mixes It is even；Step 8, pH value is adjusted with 3M gluconic acid solutions and 2M sodium gluconate solutions to 4.2, benefit adds to the full amount of water for injection, Stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, using the super of retention relative molecular mass 5000-10000 Membrane filtration, 20ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 10

Prescription：Zinc gluconate 2278.4mg, the hydrate 1687.6mg of ferrous gluconate 2, the hydrate of sodium molybdate 2 4.85mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 566.2mg of copper gluconate 1, the hydrate 481.3mg of manganese gluconate 2, Sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 100g, glycine 20g, gluconic acid 5g, 2M gluconic acid solution and 2M sodium gluconate solutions are appropriate, 1M sodium hydroxide solutions are appropriate, appropriate water for injection, filling Penetrate with water to full dose 1000ml

Preparation technology：Supplementary material, step 1, sorbierite, glycine, grape by recipe quantity are weighed or prepared by recipe quantity The water for injection stirring and dissolving of saccharic acid proper amount of fresh, the pH of solution is adjusted with gluconic acid solution and sodium hydroxide solution solution It is worth to 4.0；Step 2, ferrous gluconate, chromium chloride, copper gluconate, manganese gluconate are used to gluconic acid solution acid respectively Change the water for injection stirring and dissolving of fresh amount；Step 3, the zinc gluconate water for injection of acidifying fresh amount dissolve；Step Rapid 4, sodium fluoride is dissolved with fresh water for injection；Step 5, by the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI The water for injection stirring and dissolving of proper amount of fresh is used respectively；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, The solution of step 2 is sufficiently mixed uniformly with the solution of step 4 successively, then mixed with the solution of step 6, then with step 5 Solution easily mix；Step 8, with 3M gluconic acid solutions and 2M sodium gluconate solutions pH value is adjusted to 4.0, add injection With water to full dose, stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, using retention relative molecular mass 5000-10000 ultrafiltration membrance filter, 40ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 11

Prescription：Zinc gluconate 2278.4mg, the hydrate 1687.6mg of ferrous gluconate 2, the hydrate of chromium chloride 6 5.3mg, the hydrate 2.42m of sodium molybdate 2, the hydrate 5.33mg of chromium chloride 6, the hydrate 566.2mg of copper gluconate 1, manganese sulfate 1 Hydrate 169.01mg, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 10g, ox sulphur Sour 200g, 1M gluconic acid solution and 1M sodium gluconate solutions are appropriate, appropriate water for injection, add to the full amount of water for injection 2000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, taurine with appropriate Fresh water for injection stirring and dissolving, above-mentioned solution ph is acidified to 4.0 with gluconic acid solution；It is step 2, gluconic acid is sub- Iron, chromium chloride, copper gluconate, manganese sulfate are acidified the water for injection stirring and dissolving of fresh amount with gluconic acid solution respectively； Step 3, the water for injection dissolving by zinc gluconate acidifying fresh amount；Step 4, by sodium fluoride with fresh water for injection Dissolving；Step 5, the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI stirred with the water for injection of proper amount of fresh respectively Dissolving；Step 6, the solution of the solution of step 3 and step 1 mixed, it is step 7, the solution of step 2 is molten with step 4 successively Liquid is sufficiently mixed uniformly；The solution with step 6 mixes again, and then the solution with step 5 easily mixes；Step 8, with 3M grapes Sugar acid solution and 2M sodium gluconate solutions adjust pH value to 4.0, and benefit adds to the full amount of water for injection, and stir simultaneously circulating filtration 0.22 μm of miillpore filter 20min；Then, using retention relative molecular mass 5000-10000 ultrafiltration membrance filter, by 10ml/ branch Embedding, 121 DEG C of 15min sterilizings, is produced.

The preparation of the various trace elements drug combination injection of embodiment 12

Prescription：The hydrate 2708.65mg of zinc gluconate 3, the hydrate 1687.6mg of ferrous gluconate 2, the water of chromium chloride 6 Compound 5.3mg, the hydrate 2.42mg of sodium molybdate 2, the hydrate 495.2mg of copper gluconate 1, the hydrate 180.92mg of manganese chloride 4, Sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 2g, glycine 5g, taurine 10g, tea Propylhomoserin 8g, cysteine 0.5g, Cit 1g, 3M gluconic acid solution and 3M sodium gluconate solutions are appropriate, water for injection In right amount, add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, glycine, ox sulphur Acid, theanine, cysteine, the water for injection stirring and dissolving of Cit proper amount of fresh, with gluconic acid solution by solution PH value is acidified to 4.1；Step 2, ferrous gluconate, chromium chloride, copper gluconate, manganese chloride used into gluconic acid solution respectively It is acidified the water for injection stirring and dissolving of fresh amount；Step 3, the zinc gluconate water for injection of acidifying fresh amount dissolve； Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by sodium molybdate, sodium selenite, KI respectively with appropriate new Fresh water for injection stirring and dissolving；Step 6, the solution of the solution of step 3 and step 1 mixed, step 7, the solution by step 2 It is sufficiently mixed uniformly with the solution of step 4 successively；The solution with step 6 mixes again, and then the solution with step 5 easily mixes It is even；Step 8, pH value is adjusted with 3M gluconic acid solutions and 3M sodium gluconate solutions to 4.2, benefit adds to the full amount of water for injection, Stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, using the super of retention relative molecular mass 5000-10000 Membrane filtration, it is seen that after inspection of foreign substance is qualified, 5ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 13

Prescription：The hydrate 2548.65mg of zinc gluconate 3, the hydrate 1687.6mg of ferrous gluconate 2, the water of sodium molybdate 2 Compound 2.4mg, the hydrate 4.9mg of chromium chloride 6, the hydrate 210mg of copper chloride 2, manganese gluconate 450mg, sodium fluoride 120mg, The hydrate 7.6mg of sodium selenite 5, KI 17.3mg, sorbierite 50g, taurine 30g, glycine 10g, 3- hydroxy-proline 10g, 3M gluconic acid solution are appropriate, 3M lactic acid solutions and 3M sodium gluconate solutions are appropriate, appropriate water for injection, add injection Water is to full dose 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, glycine, ox sulphur Acid, the water for injection stirring and dissolving of 3- hydroxy-proline proper amount of fresh, solution is acidified pH value extremely with 3M gluconic acid solutions 3.8；Step 2, by ferrous gluconate, chromium chloride, copper chloride, manganese gluconate respectively with gluconic acid solution be acidified it is fresh Appropriate water for injection stirring and dissolving；Step 3, the hydrate of zinc gluconate 3 are acidified fresh appropriate injection with gluconic acid solution Dissolved with water；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by sodium molybdate, sodium selenite, KI point Not Yong proper amount of fresh water for injection stirring and dissolving；Step 6, the solution of the solution of step 3 and step 1 mixed, step 7, will The solution of step 2 is sufficiently mixed uniformly with the solution of step 4 successively；Mixed again with the solution of step 6, then with step 5 Solution easily mixes；Step 8, with 3M lactic acid solutions and sodium gluconate solution pH value is adjusted to 3.9, benefit injects water to complete Amount, stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, using retention relative molecular mass 6000-20000 Ultrafiltration membrance filter, by 2ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 14

Prescription：The hydrate 1095.75mg of zinc acetate 2, the hydrate 1737mg of ferrous gluconate 2, chromium gluconate 11.6mg (weight is in terms of anhydride), the hydrate 2.5mg of sodium molybdate 2, copper gluconate 520mg, manganese gluconate 500mg, fluorine Change sodium 120mg, the hydrate 8.2mg of sodium selenite 5, KI 17.5mg, sorbierite 20g, glycine 80g, sodium gluconate 5g, 3M gluconic acid solutions and 1M sodium gluconate solutions are appropriate, appropriate water for injection, add to the full amount of water for injection 1000ml

Preparation technology：Supplementary material, step 1, sorbierite, glycine, grape by recipe quantity are weighed or prepared by recipe quantity The water for injection stirring and dissolving of sodium saccharate proper amount of fresh, gluconic acid solution is acidified pH value to 4.0；Step 2, by glucose 2 hydrates of sour ferrous iron, chromium gluconate, copper gluconate, manganese gluconate are acidified fresh note with gluconic acid solution respectively Penetrate dissolving of blunging；Step 3, the hydrate of zinc acetate 2 is acidified fresh appropriate water for injection with gluconic acid solution dissolved； Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, iodate Potassium uses the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6, the solution of the solution of step 3 and step 1 mixed, step 7th, the solution of step 2 is sufficiently mixed uniformly with the solution of step 4 successively；Mixed again with the solution of step 6, then with step 5 Solution easily mix；Step 8, with 3M gluconic acid solutions and 1M sodium gluconate solutions pH value is adjusted to 4.1, add note Penetrate with water to full dose, stir and 0.22 μm of miillpore filter 20min of circulating filtration；Then, using retention relative molecular mass 10000-30000 ultrafiltration membrance filter, 10ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 15

Prescription：White vitriol 1437.8mg, ferrous sulfate hydrate 699.77mg (weight is in terms of ferric sulfate), sodium molybdate 2 Hydrate 2.42mg, the hydrate 5.33mg of chromium chloride 6, copper gluconate 544.61mg, the hydrate 481.3mg of manganese gluconate 2, Potassium fluoride 174.3mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 50g, mannitol 2g, glycine 30g, sodium gluconate 10g, 4M gluconic acid solution and 4M sodium gluconate solutions are appropriate, appropriate water for injection, add injection Water is to full dose 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, mannitol, sweet ammonia Acid, the water for injection stirring and dissolving of sodium gluconate proper amount of fresh, gluconic acid solution is acidified pH value to 3.6；Step 2, By ferrous sulfate hydrate, the hydrate of chromium chloride 6, copper gluconate, the hydrate of manganese gluconate 2 respectively with gluconic acid solution acid Change the water for injection stirring and dissolving of fresh amount；Step 3, the appropriate injection for being acidified white vitriol with gluconic acid solution Water dissolves；Step 4, sodium fluoride dissolved with water for injection；Step 5, by the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, iodine Change the water for injection stirring and dissolving that potassium uses proper amount of fresh respectively；Step 6, the solution of the solution of step 3 and step 1 mixed, step Rapid 7, the solution of step 2 is sufficiently mixed uniformly with the solution of step 4 successively；Mixed again with the solution of step 6, then with step 5 solution easily mixes；Step 8, with 3M gluconic acid solutions and 1M sodium gluconate solutions pH value is adjusted to 3.6, add Water for injection is to full dose, and stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, using retention average molecular matter 5000-10000 ultrafiltration membrance filter is measured, 3ml/ branch embeddings, 115 DEG C of 30min sterilizings, is produced.

The preparation of the various trace elements drug combination injection of embodiment 16

Prescription：The hydrate 2293.79mg of zinc gluconate 3, the hydrate 1856.35mg of ferrous gluconate 2, sodium molybdate 2 Hydrate 2.18mg, the hydrate 5.83mg of chromium chloride 6, the hydrate 509.6mg of copper gluconate 1, the hydrate of manganese gluconate 2 529.4mg, sodium fluoride 113.4mg, the hydrate 8.68mg of sodium selenite 5, KI 14.94mg, sorbierite 60g, taurine 60g, citrulling 20g, 3M gluconic acid solution and 2M sodium gluconate solutions are appropriate, appropriate water for injection, are injected water to Full dose 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, taurine, melon ammonia The water for injection stirring and dissolving of acid proper amount of fresh, gluconic acid solution is acidified pH value to 4.0；It is step 2, gluconic acid is sub- The water for injection stirring that iron, chromium chloride, copper gluconate, manganese gluconate are acidified fresh amount with gluconic acid solution respectively is molten Solution；Step 3, the appropriate water for injection dissolving for being acidified the hydrate of zinc gluconate 3 with gluconic acid solution；Step 4, it will be fluorinated Sodium is dissolved with water for injection；It is step 5, sodium molybdate, sodium selenite, KI is molten with the stirring of the water for injection of proper amount of fresh respectively Solution；Step 6, the solution of the solution of step 3 and step 1 mixed, step 7, by the solution of the step 2 successively solution with step 4 It is sufficiently mixed uniformly；The solution with step 6 mixes again, and then the solution with step 5 easily mixes；Step 8, with 3M glucose Acid solution and 2M sodium gluconate solutions adjust pH value to 4.5, and benefit adds to the full amount of water for injection, and stir simultaneously circulating filtration 0.22 μm of miillpore filter 20min；Then, filled using retention relative molecular mass 5000-10000 ultrafiltration membrance filter, 15ml/ branch Envelope, 121 DEG C of 15min sterilizings, is produced.

The preparation of the various trace elements drug combination injection of embodiment 17

Prescription：Hydrate 2803.52mg mg of zinc gluconate 3, the hydrate 1518.84mg of ferrous gluconate 2, molybdic acid The hydrate 2.67mg of sodium 2, the hydrate 4.77mg of chromium chloride 6, the hydrate 622.86mg of copper gluconate 1, manganese gluconate 2 are hydrated Thing 433.14mg, sodium fluoride 138.6mg, the hydrate 7.1mg of sodium selenite 5, KI 18.26mg, sorbierite 230g, taurine 100g, 3M gluconic acid solution and 2M sodium gluconate solutions are appropriate, appropriate water for injection, add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, taurine with appropriate Fresh water for injection stirring and dissolving, gluconic acid solution is acidified pH value to 4.0；Step 2, by manganese gluconate, glucose The sour copper water for injection of appropriate acidifying dissolves；Step 3, the injection by the hydrate of zinc gluconate 3 with appropriate acidifying Water dissolves；Step 4, the hydrate of ferrous gluconate 2, chromium chloride dissolved with the water for injection of appropriate acidifying respectively；Step 5th, sodium fluoride is dissolved with appropriate water for injection；Step 6, the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5 are used respectively and fitted The water for injection dissolving of amount；Step 7, KI dissolved with appropriate water for injection；Step 8, by the solution of step 2 respectively and The solution of step 1 is sufficiently mixed uniformly；Step 9, the solution of the solution of step 3 and step 8 mixed；Step 10, by step 4 Solution of the solution respectively successively with step 5 fully mixes, and then the solution with step 9 easily mixes；Step 11, by step 6 Solution and the solution of step 10 fully mix, then the solution of step 7 is added thereto, mixed, it is then molten with 3M gluconic acids Liquid and 2M sodium gluconates adjust pH value to 4.3, moisturizing constant volume；Step 12, by solution retention relative molecular mass be 50,000 to 100000 membrane filtration, then remove thermal source, 0.22 μm of miillpore filter mistake with the milipore filter of retention relative molecular mass 8000~30000 Filter, presses 10ml/ branch embeddings after inspection, seal, and 121 DEG C of 15min sterilizings, packs, examines, produce.Appropriate above-mentioned sample is taken to keep away Light is placed in 30 DEG C, is placed 6 months in the environment of relative humidity 75% ± 5%, and solution keeps clear and bright, and the pH value for determining solution is 4.2。

The preparation of the various trace elements drug combination injection of embodiment 18

Prescription：The hydrate 2548.65mg of zinc gluconate 3, sodium gluconate iron 200mg (weight is in terms of iron), sodium molybdate 2 Hydrate 2.42mg, chromium gluconate 12.1mg, L L-aminobutanedioic acid copper hydrate 393.84mg (with L-aminobutanedioic acid copper weight calculation amount), L-aminobutanedioic acid manganese hydrate 319.13mg (with L-aminobutanedioic acid manganese weight calculation amount), sodium fluoride 126mg, the hydrate of sodium selenite 5 7.89mg, sodium iodide 14.99mg, sorbierite 50g, glycine 30g, L-arginine 5g, xylitol 10g, 3M gluconic acid solution With sodium gluconate solution is appropriate, appropriate water for injection, add to the full amount of water for injection 2000ml

Preparation technology：Supplementary material, step 1, sorbierite, glycine, the L- essence by recipe quantity are weighed or prepared by recipe quantity The water for injection stirring and dissolving of propylhomoserin, xylitol proper amount of fresh, gluconic acid solution is acidified pH value to 4.5；Step 2, incite somebody to action L-aminobutanedioic acid manganese hydrate, L-aminobutanedioic acid copper are dissolved with appropriate water for injection；Step 3, the hydrate of zinc gluconate 3 is used and fitted The water for injection dissolving of amount；Step 4, sodium gluconate iron, chromium gluconate dissolved with the water for injection of fresh amount respectively； Step 5, sodium fluoride dissolved with appropriate water for injection；Step 6, by sodium molybdate, the hydrate of sodium selenite 5 respectively with appropriate Water for injection dissolves；Step 7, KI dissolved with appropriate water for injection；Step 8, by the solution of step 2 successively respectively and The solution of step 1 is sufficiently mixed uniformly；Step 9, the solution of the solution of step 3 and step 8 mixed；Step 10, by step 4 Solution of the solution respectively successively with step 5 fully mixes, and then the solution with step 9 easily mixes；Step 11, by step 6 Solution and the solution of step 10 fully mix, then the solution of step 7 is added thereto, mixes, then use gluconic acid solution With sodium gluconate regulation pH value to 4.5, moisturizing constant volume；Step 12, by solution use with retention relative molecular mass 20000~ 40000 ultrafiltration membrance filter, then with 0.22 μm of filtering with microporous membrane, 10ml/ branch embeddings are pressed after inspection, seal, 121 DEG C of 15min Sterilizing, pack, examine, produce.

The preparation of the various trace elements drug combination injection of embodiment 19

Prescription：L L-aminobutanedioic acid zinc hydrates 1647.9mg (with L-aminobutanedioic acid zinc anhydride weight calculation amount), sodium gluconate iron 180mg (weight is in terms of iron), chromium gluconate 12.8mg, the hydrate 2.42mg of sodium molybdate 2, the hydrate of copper gluconate 1 566.2mgg, the hydrate 481.3mg of manganese gluconate 2, sodium fluoride 126mg, sodium hydrogen selenite 4.53mg, KI 16.6mg, Sorbierite 10g, lactitol 5g, antierythrite 50g, glycine 20g, methionine 2g, gluconic acid 10g, sodium gluconate 10g, 2M gluconic acid solution and 2M sodium gluconate solutions are appropriate, appropriate water for injection, add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the glycine of recipe quantity, lactitol, red moss Sugar alcohol, methionine, gluconic acid, the water for injection stirring and dissolving of sodium gluconate and sorbierite proper amount of fresh, by grape Sugar acid solution is acidified pH value to 3.5；Step 2, by the hydrate of manganese gluconate 2, the appropriate acidifying of the hydrate of copper gluconate 2 Water for injection (pH=4.5) dissolving；Step 3, the water for injection dissolving by the appropriate acidifying of L L-aminobutanedioic acid zinc hydrates； Step 4, sodium gluconate iron, chromium gluconate dissolved with the water for injection of fresh amount respectively；Step 5, sodium fluoride used Appropriate water for injection dissolving；Step 6, the hydrate of sodium molybdate 2, sodium hydrogen selenite dissolved with appropriate water for injection respectively； Step 7, KI dissolved with appropriate water for injection；Step 8, solution of the solution of step 2 successively respectively with step 1 filled Divide well mixed；Step 9, the solution of the solution of step 3 and step 8 mixed；Step 10, by the solution of step 4 respectively successively Fully mixed with the solution of step 5, then the solution with step 9 easily mixes；Step 11, solution and step by step 6 10 solution is fully mixed, then the solution of step 7 is added thereto, and is mixed, then with gluconic acid solution and sodium gluconate PH value is adjusted to 4.5, moisturizing constant volume；Step 12, solution is used to the milipore filter for retaining relative molecular mass 10000~30000 Filtering, then through 0.22 μm of filtering with microporous membrane, 10ml/ branch embeddings are pressed after inspection, are sealed, 121 DEG C of 15min sterilizings, are packed, inspection Test, produce.

The preparation of the various trace elements drug combination injection of embodiment 20

Prescription zinc gluconate 2278.4mg, ferric citrate 1707.44mg, the hydrate 12.36mg of ammonium heptamolybdate 4, chlorine Change the hydrate 5.33mg of chromium 6, the hydrate 566.2mg of copper gluconate 1, the hydrate 481.3mg of manganese gluconate 2, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 20g, glycine 30g, sodium gluconate 5g, 2M Lactic acid solution and appropriate sodium gluconate solution, 1M sodium hydroxide solutions be appropriate, appropriate water for injection, adds to the full amount of water for injection 1000ml

Preparation technology：Supplementary material, step 1, glycine, sorbierite, grape by recipe quantity are weighed or prepared by recipe quantity The water for injection stirring and dissolving of sodium saccharate proper amount of fresh, lactic acid solution is acidified pH value to 3.5；Step 2, by manganese gluconate 2 hydrates, the hydrate of copper gluconate 1 water for injection of appropriate acidifying dissolve, and clarify holding；Step 3, by glucose The sour zinc water for injection of appropriate acidifying dissolves；Step 4, by ferric citrate, chromium gluconate respectively with lactic acid solution The water for injection dissolving of fresh amount, clarifies holding；Step 5, sodium fluoride dissolved with appropriate water for injection；Step 6, incite somebody to action The hydrate of ammonium heptamolybdate 4, sodium hydrogen selenite are dissolved with appropriate water for injection respectively；Step 7, by KI with appropriate injection Dissolved with water；Step 8, the solution of step 2 is sufficiently mixed uniformly with the solution of step 1 respectively successively；Step 9, by step 3 Solution and the solution of step 8 mix；Step 10, solution of the solution of step 4 respectively successively with step 5 fully mixed, then Easily mixed with the solution of step 9；Step 11, the solution of step 6 and the solution of step 10 fully mixed, then by step 7 Solution be added thereto, mix, then adjust pH value to 4.0 with 2M lactic acid solutions solution and 2M sodium gluconates, moisturizing constant volume； Step 12, solution is used to the ultrafiltration membrance filter for retaining relative molecular mass 10000~30000, then through 0.22 μm of miillpore filter Filtering, presses 10ml/ branch embeddings after inspection, seal, and 121 DEG C of 15min sterilizings, packs, examines, produce.

The preparation of the various trace elements drug combination injection of embodiment 21

Prescription：Zinc gluconate 3 hydrate 2548.65mg, α-ferric glycerophosphate hydrate 1088.26mg are (with glycerine phosphorus Sour anhydrous ferric thing weight calculation amount), the hydrate 5.3mg of chromium chloride 6, the hydrate 2.42mg of sodium molybdate 2, the hydrate of copper gluconate 1 566.2mg, the hydrate 481.3mg of manganese gluconate 2, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 20g, taurine 30g, methionine 2g, about 2M gluconic acid solutions and 2M sodium gluconate solutions are appropriate, note Penetrate and use appropriate amount of water, add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, taurine, egg ammonia The water for injection stirring and dissolving of acid proper amount of fresh, with the pH value of gluconic acid solution souring soln to 4.0；Step 2, by glycerine It is molten that ferric phosphate, chromium chloride, copper gluconate, manganese gluconate are acidified fresh water for injection stirring with gluconic acid solution respectively Solution；Step 3, the appropriate water for injection dissolving for being acidified zinc gluconate with gluconic acid solution；Step 4, by sodium fluoride with new Fresh water for injection dissolving；It is step 5, sodium molybdate, sodium selenite, KI is molten with the stirring of the water for injection of proper amount of fresh respectively Solution；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, by the solution of the step 2 successively solution with step 4 It is sufficiently mixed uniformly, then is mixed with the solution of step 6, then the solution with step 5 easily mixes；Step 8, with about 2M grapes Sugar acid solution adjusts pH value to 4.3 with 2M sodium gluconate solutions, and benefit adds to the full amount of water for injection, and stirs and is circulated throughout Filter 0.22 μm of miillpore filter 20min；Then, using retention relative molecular mass 10000-20000 ultrafiltration membrance filter, it is seen that different After thing and pH value check, 10ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the various trace elements drug combination injection of embodiment 22

Prescription：The hydrate 2548.65mg of zinc gluconate 3, ferric glycerophosphate 1088.26mg, L-ASPARTIC ACID chromium 3 are hydrated Thing 10.07mg, the hydrate 2.42mg of sodium molybdate 2, the hydrate 566.2mg of copper gluconate 1, the hydrate of manganese gluconate 2 481.3mg, sodium fluoride 126mg, the hydrate 7.89mg of sodium selenite 5, KI 16.6mg, sorbierite 50g, sorbic acid 1g, 2M Gluconic acid solution and 2M sodium gluconate solutions are appropriate, appropriate water for injection, add to the full amount of water for injection 1000ml

Preparation technology：Weigh or prepare supplementary material by recipe quantity, step 1, by the sorbierite of recipe quantity, sorbic acid with appropriate Fresh water for injection stirring and dissolving, with the pH value of gluconic acid solution and sodium gluconate solution regulation solution to 4.0；Step 2nd, ferric glycerophosphate, L-ASPARTIC ACID chromium, copper gluconate, manganese gluconate are acidified with gluconic acid solution respectively fresh Water for injection stirring and dissolving；Step 3, the appropriate injection for being acidified the hydrate of zinc gluconate 3 with gluconic acid solution are water-soluble Solution；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, sodium molybdate, sodium selenite, KI are used respectively and fitted Measure fresh water for injection stirring and dissolving；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, by step 2 Solution is sufficiently mixed uniformly with the solution of step 4 successively, then is mixed with the solution of step 6, then easy with the solution of step 5 Mix；Step 8, with 2M gluconic acid solutions and 2M sodium gluconate solutions pH value is adjusted to 4.2, benefit injects water to complete Amount, stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, using retention relative molecular mass 10000-20000 Ultrafiltration membrance filter, it is seen that after foreign matter and pH value check, 10ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

Embodiment 23, pharmaceutical composition intravascular injection irritation test

1st, test objective：Observe animal the physiological saline of drip-feed 0.9%, the present invention medicine composition injection and After comparison medicine parenteral solution, caused vascular stimulation response situation.

2nd, test material：2.1. animal：The white Female rabbits of the big ear of adult healthy New Zealand, 2.5~3.0kg of body weight.

2.2. tested material：Medicine composition injection and various trace elements the medicine composition injection control of the present invention Group, compound method：Each embodiment of pharmaceutical composition (prepared by embodiment 6, embodiment 12, the method for embodiment 21) of the present invention is taken respectively Parenteral solution and the parenteral solution 4ml of various trace elements medicine composition injection control group be added to 100ml 0.9% physiology In salt solution, mix.

3rd, test method：Female rabbits 5, the 1st unused any medicine, make the observation of blank parallel control；Other 4 points Not in auris dextra edge drip-feed contrast solution (the various trace elements medicine composition injection pair that the component according to table 1 is prepared (prepared with reference to the program of the method for embodiment 5 according to group [multi-microelement injecta (German Tracutil)], then use physiology salt Water prepared and diluted) and prepared respectively by embodiment 6, embodiment 12, the method for embodiment 21, then normal saline dilution is molten Liquid；Administered volume is 13.5ml/kg, and drip velocity is 25~30 drops/min；Left auricular vein the capacity physiological saline such as is given and made Control, drip velocity are identical with by reagent.Once a day, continuous drip 5 days.During instillation, the observation ear edge of naked eyes timing daily The irritative response of vein.Rabbit is put to death within 7th day, in bilateral auricular vein proximal part away from being taken at injection site 1.0cm~1.5cm Material, fixed with formaldehyde, do conventional organization section, carry out pathological examination.

4th, result of the test

4.1. naked eyes result：

Drip-feed the present embodiment each group (embodiment 6, embodiment 12, the method for embodiment 21), the vein of administration is compared with physiology salt Water is to the slight expansion of lateral vein, after drug withdrawal 24h, it is seen that the oozing of blood at acupuncture forms subcutaneous induration around vein, administration side with Give drip-feed physiological saline side no significant difference, other macroscopic results and physiological saline side no significant difference.

Repeatedly struggle is more violent for animal during instillation for various trace elements medicine composition injection control group, prompts Control group has certain excitant to body, can cause vascular pain, and has that the congestion of blood vessel is rubescent, and vascular endothelial cell is slight The inflammatory reaction situation such as swelling, peripheral tissue edema.

4.2. pathological examination：

Blank control group：See that venous blood tube chamber is complete under mirror, have no narrow, its tube wall has no inflammatory cell infiltration.

Physiological saline side：See that venous blood tube chamber is complete under (left auricular vein, instillation normal saline solution) mirror, its tube wall is shown in A little inflammatory cell infiltration.It is remaining to have no obvious lesion.

Test medicine group of the present invention：See venous blood tube chamber under (right auricular vein, the pharmaceutical composition for the present invention that instils) mirror Completely, its tube wall is shown in a little inflammatory cell infiltration.It is remaining to have no obvious lesion.

Venous blood tube chamber swelling, tube wall inflammation are seen under control drug group (right auricular vein, instillation control drug group solution) mirror Property cellular infiltration is obvious.

5th, conclusion (of pressure testing)

Rabbit auricular vein instil the present invention pharmaceutical composition of the invention dilute solution after 5 days, injection site without Finding of naked eye irritative response, and the irritative response of finding of naked eye be present in the control group for planting microelement composition.Micro- disease Reason inspection result shows, has no blood vessel structure exception, endothelial injuries, thrombosis and other pathological changes, this result and solvent Control group is consistent；The damage on pathology then be present in control drug group.Prompting：The pharmaceutical composition of the present invention is to blood vessel without obvious thorn Swash property, and the control group of various trace elements composition then has obvious excitant to blood vessel.

Industrial applicibility etc. and its explanation etc.：

The present invention is described in detail above by embodiment and embodiment, it will nevertheless be understood that these are said Bright that any restrictions are not formed to the scope of the present invention, person skilled substantially can be in the spirit without departing from the present invention and guarantor In the case of protecting scope, technical solutions and their implementation methods of the present invention can be carried out with a variety of modifications, improvement and replacement and group Close, to realize the technology of the present invention, these are because falling within the scope of protection of the present invention.In particular, it will be understood that The change of many details is possible, and all similar replacements and change are apparent for a person skilled in the art , they are considered as being included in the spirit, scope and content of the present invention, and the present invention is not limited to above-described embodiment.

Claims

1. various trace elements pharmaceutical composition, it is characterised in that：This of one unit dose or unit formulation or unit volume The ratio between the molal quantity of main ingredient component or molfraction are in composition：Iron content (Fe) is 3.15~3.85 μm of ol, zinc (Zn) is 4.50~5.55 μm of ol, manganese (Mn) they are 0.90~1.10 μm of ol, copper (Cu) is 1.08~1.32 μm of ol, selenium (Se) be 0.027~ 0.033 μm of ol, molybdenum (Mo) are 0.009~0.011 μm of ol, chromium (Cr) is 0.018~0.022 μm of ol, iodine (I) is 0.09~0.11 μ/ml, fluorine (F) should be 2.7~3.3 μm of ol；Or in said one unit dose or unit formulation or the said composition of unit volume In 0.25~50 times of molal quantity containing above-mentioned each main ingredient component；

Wherein, iron or molysite are selected from ferrous or ferric pharmaceutical salts, ferrous gluconate or its hydrate, D- or L- door winter ammonia Sour ferrous iron, DL- L-aminobutanedioic acids ferrous iron, ferrous sulfate, frerrous chloride, iron ammonium sulfate, ferrous lactate, ferrous citrate or they Hydrate, or L-aminobutanedioic acid iron, ferric sulfate, iron chloride, sodium gluconate iron, ferric lactate, ironic citrate, ferric citrate, One or more in ferric glycerophosphate, ferric acetate or its hydrate or iron ion pharmaceutically acceptable salt；

Zinc or zinc salt are selected from zinc and are selected from zinc sulfate, zinc gluconate, lactobionic acid zinc, zinc citrate, zinc lactate or Pfansteihl zinc, vinegar One or more in sour zinc, L-aminobutanedioic acid zinc or their hydrate or zinc ion pharmaceutically acceptable salt；

Copper or mantoquita be selected from copper chloride, copper sulphate, copper gluconate, lactobionic acid copper, copper citrate, copper lactate or Pfansteihl copper, One in copper acetate, D- or L- or DL- L-aminobutanedioic acids copper or their hydrate or bivalent cupric ion pharmaceutically acceptable salt Kind is a variety of；

Manganese or manganese salt be selected from manganese chloride, manganese sulfate, manganese gluconate, lactobionic acid manganese, manganese citrate, manganese lactate or Pfansteihl manganese, In manganese acetate, L-ASPARTIC ACID manganese, DL- L-aminobutanedioic acids manganese or their hydrate or divalent manganesetion pharmaceutically acceptable salt One or more；

Fluorine or villiaumite are selected from the one or more of sodium fluoride or the acceptable pharmaceutical salts of potassium fluoride or fluorine ion；Selenium is selected from sub- selenium The one or more of sour sodium or its hydrate or the acceptable pharmaceutical salts of selenous acid；Iodine is selected from KI or sodium iodide or iodide ion Acceptable pharmaceutical salts in one or more；

Molybdenum or molybdenum salt are selected from can pharmaceutically connecing for sodium molybdate or its molybdic acid sodium hydrate, ammonium molybdate or ammonium molybdate hydrate or molybdic acid One or more in the salt received；

Chromium or chromic salts be selected from chromium chloride, chromium sulfate, chromium gluconate, chromium citrate, Chromic lactate, L-aminobutanedioic acid chromium, chromic acetate or One or more in their hydrates or trivalent chromic ion pharmaceutically acceptable salt.

2. various trace elements pharmaceutical composition according to claim 1, it is characterised in that：One unit dose or unit The ratio between the molal quantity of main ingredient component or molfraction are in the said composition of preparation or unit volume：Iron content (Fe) be 3.15~ 3.85 μm of ol, zinc (Zn) are 4.50~5.55 μm of ol, manganese (Mn) is 0.90~1.10 μm of ol, copper (Cu) is 1.08~1.32 μ Mol, selenium (Se) are 0.027~0.033 μm of ol, molybdenum (Mo) is 0.009~0.011 μm of ol, chromium (Cr) is 0.018~0.022 μ Mol, iodine (I) are 0.09~0.11 μ/ml, fluorine (F) should be 2.7~3.3 μm of ol；In said one unit dose or unit formulation Or 0.25~50 times of molal quantity in the said composition of unit volume containing above-mentioned each main ingredient component；Said composition with pharmaceutically Acceptable auxiliary material or excipient form injection；

Wherein, iron or molysite are selected from ferrous or ferric pharmaceutical salts, ferrous gluconate or its hydrate or gluconic acid is sub- Iron dihydrate, D- or L-ASPARTIC ACID ferrous iron, DL- L-aminobutanedioic acids ferrous iron, ferrous sulfate, iron ammonium sulfate, ferrous lactate, lemon Lemon acid ferrous iron or their hydrate, or L-aminobutanedioic acid iron, ferric sulfate, iron chloride, sodium gluconate iron, ferric lactate, citric acid Iron, ferric glycerophosphate, ferric citrate, ferric acetate or its hydrate or one kind in iron ion pharmaceutically acceptable salt or It is a variety of；

Manganese or manganese salt be selected from manganese chloride, manganese sulfate, manganese gluconate, lactobionic acid manganese, manganese citrate, manganese lactate or Pfansteihl manganese, One in manganese acetate, D- or L- or DL- L-aminobutanedioic acids manganese or their hydrate or divalent manganesetion pharmaceutically acceptable salt Kind is a variety of；

Fluorine or fluorine mantoquita are selected from the one or more of sodium fluoride or the acceptable pharmaceutical salts of potassium fluoride or fluorine ion；Selenium or selenium salt One or more selected from sodium selenite or its hydrate or the acceptable pharmaceutical salts of selenous acid；Iodine or salt compounded of iodine be selected from KI or One or more in the acceptable pharmaceutical salts of sodium iodide or iodide ion；

Chromium or chromic salts be selected from chromium chloride, chromium sulfate, chromium gluconate, chromium citrate, L-aminobutanedioic acid chromium, Chromic lactate, chromic acetate or One or more in their hydrates or trivalent chromic ion pharmaceutically acceptable salt.

3. according to the various trace elements pharmaceutical composition described in claim 1,2, it is characterised in that：One unit dose or list The ratio between the molal quantity of main ingredient component or molfraction are in the said composition of position preparation or unit volume：Iron content (Fe) be 3.15~ 3.85 μm of ol, zinc (Zn) are 4.50~5.55 μm of ol, manganese (Mn) is 0.90~1.10 μm of ol, copper (Cu) is 1.08~1.32 μ Mol, selenium (Se) are 0.027~0.033 μm of ol, molybdenum (Mo) is 0.009~0.011 μm of ol, chromium (Cr) is 0.018~0.022 μ Mol, iodine (I) are 0.09~0.11 μ/ml, fluorine (F) should be 2.7~3.3 μm of ol；In said one unit dose or unit formulation Or 0.25~50 times of molal quantity in the said composition of unit volume containing above-mentioned each main ingredient component；Said composition with pharmaceutically Acceptable auxiliary material or excipient form injection；

Wherein, iron or molysite be selected from ferrous gluconate or its hydrate or ferrous gluconate dihydrate, D- or L- or DL- L-aminobutanedioic acids ferrous iron, ferrous sulfate, iron ammonium sulfate, ferrous lactate, ferrous citrate or their hydrate, or D- or It is L- or DL- L-aminobutanedioic acids iron, ferric sulfate, iron chloride, the hydrate of iron chloride 6, sodium gluconate iron, ferric lactate, ironic citrate, sweet One or more in oleophosphoric acid iron, ferric citrate, ferric acetate or its hydrate；

Zinc or zinc salt are selected from zinc sulfate, white vitriol, monohydrate zinc sulphate, zinc gluconate or zinc gluconate hydrate, Portugal The hydrate of grape saccharic acid zinc 2, the hydrate of zinc gluconate 3, lactobionic acid zinc or lactobionic acid zinc hydrate, zinc citrate or citric acid three Zinc or its zinc citrate hydrate zinc citrate dihydrate, zinc lactate, the hydrate of Pfansteihl zinc 3, Pfansteihl zinc, Pfansteihl zinc One or more in 3 hydrates, zinc acetate, the hydrate of zinc acetate 2, D- or L- or DL- L-aminobutanedioic acids zinc or its hydrate；

Copper or mantoquita be selected from copper chloride, the hydrate of copper chloride 2, copper sulphate, copper sulfate monohydrate, three brochanites, cupric sulfate pentahydrate, Copper gluconate, the hydrate of copper gluconate 1, the hydrate of copper gluconate 2, lactobionic acid copper or lactobionic acid copper hydrate, lemon The sour bronze medal of copper or citric acid three or its hydrate of copper citrate 2.5, copper lactate or Pfansteihl copper or its hydrate, D- or L- or DL- One or more in L-aminobutanedioic acid copper or their hydrate, copper acetate or its hydrate of copper acetate 1；

Manganese is selected from manganese chloride or the hydrate of manganese chloride 1 or the hydrate of manganese chloride 2 or the hydrate of manganese chloride 4 or the water of manganese chloride 5 Compound or the hydrate of manganese chloride 6, manganese sulfate or, the hydrate of manganese sulfate 1, manganese gluconate, manganese gluconate hydrate, lactose Sour manganese or lactobionic acid manganese hydrate, manganese citrate or the manganese of citric acid three or manganese citrate hydrate, manganese lactate or Pfansteihl manganese or Its hydrate, manganese acetate or the hydrate of manganese acetate 4, L-ASPARTIC ACID manganese, DL- L-aminobutanedioic acids manganese or one kind in its hydrate or It is several；

One or more in the acceptable pharmaceutical salts of fluorine or villiaumite selected from sodium fluoride or potassium fluoride or fluorine；

One kind in sodium selenite, the hydrate of sodium selenite 5, sodium hydrogen selenite or the acceptable pharmaceutical salts of selenous acid of selenium or It is several；One or more of the iodine in KI or sodium iodide；

One kind in sodium molybdate, the hydrate of sodium molybdate 2, ammonium molybdate, the hydrate of ammonium molybdate 4, the hydrate of ammonium heptamolybdate 4 of molybdenum or It is several；

Chromium or chromic salts are selected from chromium chloride, the hydrate of chromium chloride 6, chromium sulfate, the hydrate of chromium sulfate 6, chromium gluconate or glucose Sour chromium hydrate, chromium citrate or chromium citrate hydrate, Chromic lactate or Pfansteihl chromium or its hydrate, D- or L- or DL- doors The one or more of winter propylhomoserin chromium or D- or the hydrate of L- or DL-- L-aminobutanedioic acids chromium 3, chromic acetate or its hydrate.

In above-mentioned composition and pharmaceutically acceptable auxiliary material or excipient composition injection, the pharmacy in addition to water for injection One or more contents in the injection of a unit dose in upper acceptable auxiliary material or excipient are selected from 0.0010 ~0.040g, it is more preferably 0.0030~0.030g, more preferably 0.0040~0.025g.

4. according to the various trace elements pharmaceutical composition described in claim 1,3, it is characterised in that：One unit dose or list The ratio between the molal quantity of main ingredient component or molfraction are in the said composition of position preparation or unit volume：Iron content (Fe) is 3.5 μ Mol, zinc (Zn) are 5.0 μm of ol, manganese (Mn) is 1.0 μm of ol, copper (Cu) is 1.2 μm of ol, selenium (Se) is 0.03 μm of ol, molybdenum (Mo) is 0.01 μm of ol, chromium (Cr) are 0.02 μm of ol, iodine (I) is 0.10 μm of ol, fluorine (F) should be 3.0 μm of ol；

The rubbing containing above-mentioned each main ingredient component in the said composition of said one unit dose or unit formulation or unit volume 0.25~50 times of that number；Said composition and pharmaceutically acceptable auxiliary material or excipient composition injection；In said medicine group In the injection of compound, the one or more in the pharmaceutically acceptable auxiliary material or excipient in addition to water for injection are at one Content in the injection of unit dose is selected from 0.0010~0.040g/ml, is more preferably 0.0030~0.030g/ml, more excellent Elect 0.0050~0.025g/ml as；

Wherein, iron or molysite are selected from ferrous gluconate or its hydrate or ferrous gluconate dihydrate, L-ASPARTIC ACID Ferrous iron, DL- L-aminobutanedioic acids ferrous iron, ferrous sulfate, the hydrate of ferrous sulfate 7, iron ammonium sulfate, the hydrate of ferrous lactate 3, lemon Sour ferrous or their hydrate, or L-aminobutanedioic acid iron, ferric sulfate, ferrous sulfate hydrate, iron chloride, the hydrate of iron chloride 6, Portugal Grape sodium saccharate iron, ferric glycerophosphate, ferric lactate, ironic citrate, ferric citrate, ferric acetate or one kind or several in its hydrate Kind；

Copper or mantoquita be selected from copper chloride, the hydrate of copper chloride 2, copper sulphate, copper sulfate monohydrate, three brochanites, cupric sulfate pentahydrate, Copper gluconate, the hydrate of copper gluconate 1, the hydrate of copper gluconate 2, lactobionic acid copper or lactobionic acid copper hydrate, lemon The sour bronze medal of copper or citric acid three or its hydrate of copper citrate 2.5, copper lactate or Pfansteihl copper or its hydrate, copper acetate or its vinegar One or more in the sour hydrate of copper 1；

Manganese or manganese salt are selected from manganese chloride or the hydrate of manganese chloride 1 or the hydrate of manganese chloride 2 or the hydrate of manganese chloride 4 or chlorination The hydrate of the manganese 5 or hydrate of manganese chloride 6, the manganese sulfate or hydrate of manganese sulfate 1, manganese gluconate, manganese gluconate hydrate, Lactobionic acid manganese or lactobionic acid manganese hydrate, the manganese citrate or manganese of citric acid three or manganese citrate hydrate, manganese lactate or Pfansteihl Manganese or its hydrate, the manganese acetate or hydrate of manganese acetate 4, D- or L- or DL- L-aminobutanedioic acids manganese or one kind in its hydrate or It is several；

One or more in acceptable pharmaceutical salts of the fluorine selected from sodium fluoride or potassium fluoride or fluorine；

Selenium or selenium salt are in sodium selenite, the hydrate of sodium selenite 5, sodium hydrogen selenite or the acceptable pharmaceutical salts of selenous acid It is one or more of；One or more of the iodine in KI or sodium iodide；

Molybdenum or molybdenum salt are in sodium molybdate, the hydrate of sodium molybdate 2, ammonium molybdate, the hydrate of ammonium molybdate 4, the hydrate of ammonium heptamolybdate 4 It is one or more of；

Chromium or chromic salts are selected from chromium chloride, the hydrate of chromium chloride 6, chromium sulfate, the hydrate of chromium sulfate 6, chromium gluconate or glucose Sour chromium hydrate, chromium citrate or chromium citrate hydrate, Chromic lactate or Pfansteihl chromium or its hydrate, D- or L- or DL- doors The one or more of winter propylhomoserin chromium or D- or the hydrate of L- or DL- L-aminobutanedioic acids chromium 3, chromic acetate or its hydrate.

5. the various trace elements pharmaceutical composition according to claim 1-3, it is characterised in that：The lot of trace of the present invention The medicine composition injection of element, main ingredient component in a unit dose or the said composition of unit formulation or unit volume The ratio between weight number or parts by weight are：The hydrate 626.25-765.42 μ g of the frerrous chloride 4 or hydrate 847.04- of iron chloride 6 The 1035.27 μ g or hydrate 1518.84-1856.35 μ g of ferrous gluconate 2 or ferric citrate 1536.7-1878.18 μ g or (weight is with iron by the multiple hydrate 629.8-769.75 μ g of ferric sulfate or sodium gluconate iron or its solvated compounds 180-220 μ g Meter) or the D- or L- or DL- L-aminobutanedioic acid ferrous iron 1007.69-1231.62 μ g or hydrate 850.56-1039.58 μ of ferrous lactate 3 The g or hydrate 875.73-1070.34 μ g of ferrous sulfate 7 or ferric glycerophosphate or α-ferric glycerophosphate or β-ferric glycerophosphate or Its hydrate 979.43-1197.08 μ g (with ferric glycerophosphate anhydride weight calculation amount),

Zinc gluconate or zinc gluconate hydrate, the zinc gluconate dihydrate or hydrate of zinc gluconate 3 2050.56-2506.24 μ g (with zinc gluconate anhydride weight calculation amount) or white vitriol 1294.02-1581.58 μ g or vinegar The sour hydrate 986.18-1205.33 μ g of zinc or zinc acetate 2 (with the hydrated basis weight of zinc acetate 2) or L- or D- or DL- door winter ammonia Sour zinc or L- or D- or DL- L-aminobutanedioic acid zinc hydrate 1483.11-1812.69 μ g (with L-aminobutanedioic acid zinc anhydride weight calculation amount),

Copper gluconate or the hydrate 490.15-599.07 μ g of the hydrate of copper gluconate 1 or copper gluconate 2 are (with glucose Sour copper anhydride weight calculation amount) or the hydrate 184.14-225.06 μ g of copper chloride 2 or copper sulphate or cupric sulfate pentahydrate 269.65- 329.58 μ g (with cupric sulfate pentahydrate weight calculation amount) or D- or L- or DL- L-aminobutanedioic acids copper or D- or L- or DL- L-aminobutanedioic acid copper waters Compound 354.46-433.23 μ g (with L-aminobutanedioic acid copper anhydride weight calculation amount) or the hydrate 215.62-263.54 μ g of copper acetate 1,

Manganese chloride or the hydrate 178.13-217.71 μ g of the hydrate of manganese chloride 2 or manganese chloride 4 (are counted weight with the hydrate of manganese chloride 4 Amount) or manganese gluconate or the hydrate 400.72-489.76 μ g of manganese gluconate 2 (with manganese gluconate anhydride weight calculation amount) or The hydrate 152.11-185.91mg or D- of manganese sulfate 1 or L- or DL- L-aminobutanedioic acids manganese or D- or L- or DL- L-aminobutanedioic acid manganese water Compound 287.22-351.04 μ g (with L-aminobutanedioic acid anhydrous manganese thing weight calculation amount),

The hydrate 4.77-5.83 μ g of chromium chloride 6 or chromium gluconate or chromium gluconate hydrate are (with chromium gluconate anhydride Weight calculation amount) 11.48-14.03 μ g or D- or the hydrate 9.06-11.07mg of L- or DL- L-aminobutanedioic acids chromium 3 or chromium citrate (weight In terms of chromium), the hydrate 2.18-2.66 μ g of sodium molybdate 2 or seven water ammonium molybdate 11.12-13.59 μ g, the hydrate of sodium selenite 5 7.10-8.68 μ g or sodium selenite 4.67-5.71 μ g or sodium hydrogen selenite 4.08-4.98mg, sodium fluoride 113.4-138.6 μ g or Potassium fluoride 156.87-191.73 μ g,

KI 14.94-18.26 μ g or sodium iodide 13.49-16.49 μ g；

Contain the weight of above-mentioned each main ingredient component in the said composition of said one unit dose or unit formulation or unit volume Measure number or parts by weight 0.25~50 times；Said composition can be with pharmaceutically acceptable auxiliary material or excipient composition injection； In the injection of aforementioned pharmaceutical compositions, one kind in pharmaceutically acceptable auxiliary material or excipient in addition to water for injection Or a variety of contents in the injection of a unit dose are selected from 0.0010~0.040g, more preferably for 0.0030~ 0.030g, more preferably 0.0040~0.025g.

6. the various trace elements pharmaceutical composition according to claim 1-5, it is characterised in that：The lot of trace of the present invention The medicine composition injection of element, main ingredient component in a unit dose or the said composition of unit formulation or unit volume The ratio between weight number or parts by weight are：The μ g of white vitriol 1437.8 or μ g of 2 hydrate of zinc acetate 1095.75, sodium gluconate The μ g (weight is in terms of iron) of iron 200 or μ g of ferric citrate 1707.44, the μ g of 4 hydrate of ammonium heptamolybdate 12.36 or sodium molybdate 2 are hydrated μ g of thing 2.42, the μ g of chromium gluconate 12.75 or the μ g of 6 hydrate of chromium chloride 5.33 or 5.3 μ g or the hydrate of L-ASPARTIC ACID chromium 3 10.07 μ g, the μ g of 2 hydrate of copper gluconate 587.856 or the μ g of 1 hydrate of copper gluconate 566.2 or copper gluconate 544.608 μ g or μ g of cupric sulfate pentahydrate 299.616, the μ g of 2 hydrate of manganese chloride 125.8 or the μ g of 4 hydrate of manganese chloride 197.92 or μ g of 2 hydrate of manganese gluconate 481.3, μ g of sodium fluoride 126, μ g of 5 hydrate of sodium selenite 7.89, the μ g of sodium iodide 14.99 or iodine Change the μ g of potassium 16.6；Contain above-mentioned each main ingredient group in the said composition of said one unit dose or unit formulation or unit volume Point weight number or 0.25~50 times of parts by weight；Said composition can be noted with pharmaceutically acceptable auxiliary material or excipient composition Penetrate agent；In the injection of aforementioned pharmaceutical compositions, in the pharmaceutically acceptable auxiliary material or excipient in addition to water for injection One or more content in the injection of a unit dose be selected from 0.0010~0.040g, more preferably for 0.0030~ 0.030g, more preferably 0.0040~0.025g.

7. the various trace elements pharmaceutical composition according to claim 1-5, it is characterised in that：One unit dose or list The ratio between the weight number of main ingredient component or parts by weight are in the said composition of position preparation or unit volume：

Zinc gluconate or zinc gluconate hydrate, the zinc gluconate dihydrate or μ of 3 hydrate of zinc gluconate 2278.4 G (with zinc gluconate anhydride weight calculation amount) or the D- or μ g or D- of L- or DL- L-aminobutanedioic acids zinc 1647.9 or L- or DL- door winter ammonia The sour μ g of zinc hydrate 1647.9 (with L-aminobutanedioic acid zinc weight calculation amount)；Ferrous gluconate or the hydrate of ferrous gluconate 2 1687.6 μ g (with the hydrated basis weight of ferrous gluconate 2)；The μ g of 6 hydrate of the chromium chloride 5.3 or μ g of 6 hydrate of chromium chloride 5.33 Or chromium gluconate or the μ g of chromium gluconate hydrate 12.75 (with chromium gluconate weight calculation amount)；The μ g of 2 hydrate of sodium molybdate 2.42 Or the μ g of 4 hydrate of ammonium heptamolybdate 12.36；Copper gluconate or the hydrate of copper gluconate 1 or the hydrate of copper gluconate 2 544.6 μ g (with copper gluconate weight calculation amount) or the μ g of cupric sulfate pentahydrate 299.616；Manganese gluconate or manganese gluconate 2 are hydrated The μ g or μ of 4 hydrate of manganese chloride 197.9 of the μ g of thing 481.27 (with the hydrated basis weight of manganese gluconate 2) 1 hydrate of manganese sulfate 169 g；The μ g of sodium fluoride 126；Sodium selenite or the μ g of the hydrate of sodium selenite 5 or sodium hydrogen selenite 7.89 are (with the hydrated basis of sodium selenite 5 Weight), the μ g of KI 16.6 or the μ g of sodium iodide 14.989；In this of said one unit dose or unit formulation or unit volume Weight number containing above-mentioned each main ingredient component or 0.25~50 times of parts by weight in composition；Said composition can be with pharmaceutically may be used The auxiliary material or excipient of receiving are prepared into injection；In the injection of aforementioned pharmaceutical compositions, the medicine in addition to water for injection One or more contents in the injection of a unit dose in acceptable auxiliary material or excipient are selected from 0.0010~0.040g, it is more preferably 0.0030~0.030g, more preferably 0.0040~0.025g.

8. the various trace elements pharmaceutical composition according to claim 1-4, it is characterised in that：The lot of trace of the present invention The medicine composition injection of element, main ingredient component in a unit dose or the said composition of unit formulation or unit volume The ratio between weight number or parts by weight are：

Zinc gluconate or zinc gluconate hydrate, the zinc gluconate dihydrate or μ of 3 hydrate of zinc gluconate 2278.4 G (with zinc gluconate anhydride weight calculation amount) or the μ g of the white vitriol 1437.8 or μ g or D- of 2 hydrate of zinc acetate 1095.75 or The μ g or D- of L- or DL- L-aminobutanedioic acids zinc 1647.9 or the μ g of L- or DL- L-aminobutanedioic acid zinc hydrate 1647.9 are (in terms of L-aminobutanedioic acid zinc Weight)；Ferric glycerophosphate or α-ferric glycerophosphate or β-ferric glycerophosphate or the μ g of their hydrate 1088.26 are (with glycerine phosphorus Sour iron weight calculation amount)；The μ g of 6 hydrate of the chromium chloride 5.3 or μ g of 6 hydrate of chromium chloride 5.33 or chromium gluconate or chromium gluconate water The μ g of compound 12.75 (with chromium gluconate weight calculation amount)；The μ g of 2 hydrate of the sodium molybdate 2.42 or μ g of 4 hydrate of ammonium heptamolybdate 12.36； Copper gluconate or the hydrate of copper gluconate 1 or the μ g of 2 hydrate of copper gluconate 544.6 (with copper gluconate weight calculation amount) or The μ g of cupric sulfate pentahydrate 299.616；Manganese gluconate or the μ g of 2 hydrate of manganese gluconate 481.27 are (with the hydrate of manganese gluconate 2 Weight calculation amount) or the μ g of 4 hydrate of manganese chloride 197.9；The μ g of sodium fluoride 126；Sodium selenite or the hydrate of sodium selenite 5 or hydrogen selenite The μ g of sodium 7.89 (with the hydrated basis weight of sodium selenite 5), the μ g of KI 16.6 or the μ g of sodium iodide 14.989；In said one unit Weight number or parts by weight containing above-mentioned each main ingredient component in the said composition of dosage or unit formulation or unit volume 0.25~50 times；Said composition can be prepared into injection with pharmaceutically acceptable auxiliary material or excipient；Combined in said medicine In the injection of thing, the one or more in the pharmaceutically acceptable auxiliary material or excipient in addition to water for injection are in a list Content in the injection of position dosage is selected from 0.0010~0.040g, is more preferably 0.0030~0.030g, more preferably 0.0040~0.025g.

9. the various trace elements pharmaceutical composition according to claim 1-5, it is characterised in that：The lot of trace of the present invention The medicine composition injection of element, main ingredient component in a unit dose or the said composition of unit formulation or unit volume The ratio between weight number or parts by weight are：The hydrate of zinc gluconate 3 or zinc gluconate are (with C₁₂H₂₂O₁₄Zn weight calculations amount) 2278.4 μ g, μ g of 2 hydrate of ferrous gluconate 1687.6, μ g of 2 hydrate of sodium molybdate 2.42, the μ g of 6 hydrate of chromium chloride 5.3 or chromium chloride The μ g of 6 hydrate 5.33 or the μ g of chromium gluconate or chromium gluconate hydrate 12.75 (with chromium gluconate weight calculation amount), glucose 2 hydrate of the sour hydrate of copper or copper gluconate 1 or copper gluconate 544.6 μ g (with copper gluconate weight calculation amount) manganese sulfate 1 The μ g of hydrate 169 or μ g of 4 hydrate of manganese chloride 197.9, μ g of sodium fluoride 126, μ g of 5 hydrate of sodium selenite 7.89, sodium iodide The 14.99 μ g or μ g of KI 16.6；Contain in the said composition of said one unit dose or unit formulation or unit volume The weight number of above-mentioned each main ingredient component or 0.20~4 times of parts by weight；Said composition can with pharmaceutically acceptable auxiliary material or Excipient forms injection；It is pharmaceutically acceptable auxiliary in addition to water for injection in the injection of aforementioned pharmaceutical compositions One or more contents in the injection of a unit dose in material or excipient are selected from 0.0010~0.040g, more excellent Elect 0.0030~0.030g, more preferably 0.0050~0.025 as.

10. the various trace elements pharmaceutical composition according to claim 1-5, it is characterised in that：Wherein, iron or molysite compared with It preferably is selected from ferrous gluconate or its hydrate or ferrous gluconate dihydrate, L- or D- L-aminobutanedioic acids ferrous iron or its water Compound, DL- L-aminobutanedioic acids ferrous iron or its hydrate, the hydrate of frerrous chloride 4, the hydrate of ferrous sulfate 7, iron ammonium sulfate, breast Sour ferrous iron, the hydrate of ferrous lactate 3, ferrous citrate or their hydrate, or D- or L- or DL- L-aminobutanedioic acids iron or its water Compound, the hydrate of ferric sulfate 7, the hydrate of iron chloride 6, sodium gluconate iron, ferric lactate, ironic citrate, ferric citrate or its One or more in hydrate, phosphoglycerol ferrous iron or ferric glycerophosphate or its hydrate or their chiral isomer；

Zinc or zinc salt are more more preferably hydrated from white vitriol, zinc gluconate or zinc gluconate hydrate, zinc gluconate 2 Thing, the hydrate of zinc gluconate 3, lactobionic acid zinc or lactobionic acid zinc hydrate, zinc citrate or the zinc of citric acid three or its citric acid Zinc hydrate zinc citrate dihydrate, zinc lactate, the hydrate of Pfansteihl zinc 3, the hydrate of zinc acetate 2, D- or L- or DL- door winters One or more in propylhomoserin zinc or its hydrate；

Copper or mantoquita are more preferably from the hydrate of copper chloride 2, cupric sulfate pentahydrate, copper gluconate, the hydrate of copper gluconate 1, Portugal The hydrate of grape saccharic acid copper 2, lactobionic acid copper or lactobionic acid copper hydrate, copper lactate or Pfansteihl copper or its hydrate, D- or L- or DL- L-aminobutanedioic acids copper or their hydrate, copper acetate or its hydrate of copper acetate 1 [(Ac)₂Cu ﹒ H₂O] in one kind or several Kind；

Manganese or manganese salt are more preferably from manganese chloride or its hydrate or the hydrate of manganese chloride 1 or the hydrate of manganese chloride 2 or manganese chloride 4 Hydrate or the hydrate of manganese chloride 5 or the hydrate of manganese chloride 6, manganese sulfate or, the hydrate of manganese sulfate 1, manganese gluconate or grape Saccharic acid manganese hydrate, lactobionic acid manganese or lactobionic acid manganese hydrate, manganese citrate or the manganese of citric acid three or manganese citrate hydrate, breast Sour manganese or Pfansteihl manganese or its hydrate, the manganese acetate or hydrate of manganese acetate 4, D- or L- or DL- L-aminobutanedioic acids manganese or its hydration One or both of thing；

Fluorine is more preferably from the one or more in sodium fluoride or potassium fluoride；Selenium preferably be selected from sodium selenite, the hydrate of sodium selenite 5, One or more in sodium hydrogen selenite；Iodine preferably is selected from the one or more in KI or sodium iodide；

Molybdenum or molybdenum salt are more preferably from molybdic acid or sodium molybdate, the hydrate (Na of sodium molybdate 2₂MoO₄·2H₂O), ammonium molybdate, the water of ammonium molybdate 4 One or more in compound, the hydrate of ammonium heptamolybdate 4；

Chromium or chromic salts are more preferably from chromium chloride, the hydrate of chromium chloride 6, chromium gluconate or chromium gluconate hydrate, citric acid Chromium or chromium citrate hydrate, Chromic lactate or Pfansteihl chromium or its hydrate, L- or D- or DL- L-aminobutanedioic acids chromium or their water One or more in compound (such as hydrate of L-ASPARTIC ACID chromium 3).

11. the various trace elements pharmaceutical composition according to claim 1-9, it is characterised in that：The pharmaceutical composition The preparation method of injection is selected from：Method one, step 1, by pharmaceutically acceptable salt or other auxiliary materials or excipient with appropriate Water for injection dissolves, and is acidified with appropriate water for injection dissolving or with pharmaceutically acceptable pH adjusting agent；Step 2, incite somebody to action Iron ion salt or ferrous ion pharmaceutically acceptable salt, manganese ion pharmaceutically acceptable salt, copper ion are pharmaceutically acceptable Salt, chromium ion pharmaceutically acceptable salt is one by one with appropriate water for injection dissolving or water-soluble with the injection of appropriate acidifying Solution；It is step 3, the acceptable pharmaceutical salts of zinc ion are water-soluble with the injection of appropriate water for injection dissolving or appropriate acidifying Solution；Step 4, villiaumite dissolved with appropriate water for injection；Step 5, by molybdic acid pharmaceutical salts, selenous acid pharmaceutical salts, KI or The pharmaceutical salts of sodium iodide or iodide ion are dissolved with appropriate water for injection respectively；Step 6, by the solution of step 2 respectively with step 4 Solution be sufficiently mixed uniformly；Step 7, the solution of the solution of step 3 and step 1 mixed, then mixed with the solution with step 6 Even, then the solution with step 5 easily mixes；Step 8, adjusted with pharmaceutically acceptable pH adjusting agent pH value 3.0~ Between 5.5, preferable ph is between 3.5~4.5, or milipore filter removes thermal source, or adds activated carbon decolorizing, filters decarburization, then Moisturizing constant volume, refined filtration, examine, it is filling, seal, sterilize, pack, examine.Wherein, can be connect in the injection water system medication of acidifying The pH adjusting agent received is acidified, and its pH is generally between 3.0-5.6；

Or method two, step 1, dissolve pharmaceutically acceptable salt or other auxiliary materials or excipient with appropriate water for injection, use Pharmaceutically acceptable pH adjusting agent is acidified；Step 2, manganese ion pharmaceutically acceptable salt, copper ion pharmaceutically may be used The salt of receiving dissolves with appropriate water for injection dissolving or with the water for injection of appropriate acidifying respectively；Step 3, can by zinc ion The pharmaceutical salts of the receiving water for injection of appropriate acidifying dissolves；It is step 4, iron ion salt or ferrous ion is pharmaceutically acceptable Salt, chromium ion pharmaceutically acceptable salt is respectively with appropriate water for injection dissolving or water-soluble with the injection of appropriate acidifying Solution；Step 5, villiaumite dissolved with appropriate water for injection；Step 6, by molybdic acid pharmaceutical salts, selenous acid pharmaceutical salts respectively with appropriate Water for injection dissolving；It is step 7, the pharmaceutical salts of KI or sodium iodide or iodide ion are water-soluble with appropriate injection respectively Solution；Step 8, the solution of step 2 is sufficiently mixed uniformly with the solution of step 1 respectively；Step 9, solution and step by step 3 8 solution mixes；Step 10, solution of the solution of step 4 respectively successively with step 5 fully mixed, then with step 9 Solution easily mixes；Step 11, the solution of step 6 and the solution of step 10 fully mixed, then the solution of step 7 is added it In, mix, then with the pH value of pharmaceutically acceptable pH adjusting agent regulation solution between 3.0~5.5, preferable ph exists Between 3.5~4.5；Step 12, solution is added to activated carbon decolorizing, filter decarburization, or filtering with microporous membrane, or use retention phase pair Molecular mass is 50,000 to 300,000 membrane filtration, or above-mentioned filter method is used in mixed way, it is preferred to use retention relative molecular mass 3000~60000 milipore filter removes remaining thermal source, moisturizing constant volume；0.22 μm of miillpore filter or ultrafiltration etc. carry out refined filtration, examine, It is filling, seal, sterilize, pack, examine；Wherein, the upper acceptable pH adjusting agent of the injection water system medication of acidifying is sour by it Change, its pH is generally between 3.0-5.6.

12. the preparation method of various trace elements pharmaceutical composition according to claim 11, it is characterised in that：The combination Thing and pharmaceutically acceptable auxiliary material or excipient form injection pH value between 3.0-5.0, pH value preferably 3.5-4.5 it Between.

13. various trace elements pharmaceutical composition according to claims 1 to 9, it is characterised in that：Its purposes is：System It is standby to prevent or treat people and the various trace elements of mammal zinc, manganese, copper, selenium, fluorine, iodine, phosphorus, potassium deficiency and its syndrome Application in medicine.