CN107854485A

CN107854485A - The medical composition and its use of the various trace elements of injection

Info

Publication number: CN107854485A
Application number: CN201610842287.1A
Authority: CN
Inventors: 刘力
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-09-22
Filing date: 2016-09-22
Publication date: 2018-03-30

Abstract

The present invention provides to prepare prevention or treat people to be lacked with mammal various trace elements, as the multi-microelement injecta of zinc, manganese, copper, selenium, fluorine, iodine deficiency and its syndrome medicine in application so that corresponding product is in clinical process with more preferable security, compliance and with new adaptation population etc..

Description

The medical composition and its use of the various trace elements of injection

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.It is external Once had been reported that：Iron content, copper, zinc total amount are reduced in body, can be weakened immunologic mechanism (resist the disease strength), be reduced disease-resistant energy Power, bacterium infection is encouraged, and the metainfective death rate is also higher.Trace element it is disease-resistant, give protection against cancer, promote longevity etc. all Also play very important effect.Therefore, for a long time, the clinically more extensive clinical practice of trace element.

However, and there is many deficiencies, various trace elements note in multi-microelement injecta (I) preparation of prior art Penetrate under the acidity that liquid (I) [the Sanitation Ministry medicine standard (two) the 5th] remains very low and use a large amount of zinc chloride as main ingredient etc., The various trace elements composite preparation of other document reports there is also it is same the problem of (document 1, Chinese patent CN200510051485.8；Document 2, Chinese patent CN201310376235.6；Document 3, Chinese patent CN201010575729.3；Document 4, Chinese patent CN201010575729.3；Document 5, CN03112712.6).The medicine is For the supplement of trace element and the treatment of some diseases, but it is serious bad anti-the too strong grade of blood vessel irritation to be clinically present Answer, the excessive and other potential safety factor of toxicity, and the situation that patient's compliance is poor.Prior art lot of trace member Component zinc chloride in plain parenteral solution (I) is used as strong acid in daily electrical maintenance welding, has severe corrosive, can severe irritation And skin and mucous membrane are burnt, allergic dermatitis occurs when contacting for long-term steam, and producers will wear work clothes when working, wear protection Glasses, anti-poison respirator, emgloves, to protect skin, eyes, respiratory apparatus.Workshop ventilation is good, After Hours to wash hot water Shower.And zinc chloride dosage in prescription is very big, more ignored for a long time.Human Physiology pH commonly reaches 7.4 or so, existing skill PH value in art in preparation is in very low level, between its pH value is 2.0~2.6, medicine of the strong acidity in different intravenously administrables Prepare and bring a certain degree of safety risks and some adverse reactions, including blood vessel irritation or quiet with clinical vein transfusion Arteries and veins is scorching or clinic is unexpected etc., or causes curative effect of medication to decline.

The multi-microelement injecta (I) (the Sanitation Ministry medicine standard (two) the 5th) of prior art is yet present It is not suitable for the situation of the patient of hyperchloremia, acid poisoning and renal insufficiency etc. in some cases, especially unknown or difficult in advance Adverse consequences may be brought by being taken in the case of to know；【Bibliography：Document 1, Li Zhaoquan, intracranial hematoma complicated by postoperative are high 12 clinical analysis of natremia, practical sacred disease magazine, 05 phase in 2005, p.44-45；Document 2, Zhang Xuejun, Chen Zhiqin, Lee China, the clinical research of Hypernatremia and Hyperchloremia after cerebral hemorrhage, apoplexy and sacred disease magazine, the 5th phase of volume 24 in 2007, p.609- 611；Document 3, season hamming, 11 heavy head-brain injuries merge hyperglycaemia, hypernatremia, hyperchloremia experiences on diagnosis and treatment, Jiangsu clinical medicine Magazine, the 6th phase of volume 2 in 1998, p.505,507；Document 4, Yin Peida, the pathogenesis of distal renal tubular acidosis, state Outer medical science (clinical practice fascicle), phase nineteen eighty-two 12；Document 5, Zhou Lei, etc. 12 RTA patient's Analysis Initial Misdiagnosis With 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 national drug standards, medicine is reduced Thing adverse 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 1.8~2.2 μm of ol/ml, Zinc (Zn) is 9.0~11.0 μm of ol/ml, manganese (Mn) is 0.45~0.55 μm of ol/ml, copper (Cu) is 1.8~2.2 μm of ol/ml, selenium (Se) it is 0.032~0.048 μm of ol/ml, molybdenum (Mo) is 0.016~0.024 μm of ol/ml, chromium (Cr) is 0.016~0.024 μ Mol/ml, iodine (I) are 0.08~0.12 μ/ml, fluorine (F) should be 4.5~5.5 μm of ol/ml；In said one unit dose or list 0.025~20 times of molal quantity containing above-mentioned each main ingredient component in the said composition of position preparation or unit volume；Said composition With pharmaceutically acceptable auxiliary material or excipient composition injection；

Wherein, iron or molysite are selected from ferrous or ferric pharmaceutical salts, ferrous gluconate or its hydrate or glucose The ferrous dihydrate of acid, 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 One or more in iron, ferric citrate, 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, the one or more in zinc acetate, L-aminobutanedioic acid zinc or their hydrate or zinc ion pharmaceutically acceptable salt；

Copper is selected from copper chloride, copper sulphate, copper gluconate, lactobionic acid copper, copper citrate, copper lactate or Pfansteihl copper, vinegar Sour copper, L-ASPARTIC ACID manganese, DL- L-aminobutanedioic acids manganese or or their hydrate or bivalent cupric ion pharmaceutically acceptable salt in One or more；

Manganese is selected from manganese chloride, manganese sulfate, manganese gluconate, lactobionic acid manganese, manganese citrate, manganese lactate or Pfansteihl manganese, vinegar In sour manganese, L-ASPARTIC ACID manganese, DL- L-aminobutanedioic acids manganese or their hydrate or divalent manganesetion pharmaceutically acceptable salt It is one or more；

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

Molybdenum is selected from the pharmaceutically acceptable of sodium molybdate or its molybdic acid sodium hydrate, ammonium molybdate or ammonium molybdate hydrate or molybdic acid Salt in one or more；

Chromium is selected from chromium chloride, chromium sulfate, chromium gluconate [(C6H11O7)₃Cr], chromium citrate, chromium acetylacetonate, lactic acid One or more in chromium, chromic acetate or their hydrates or trivalent chromic ion pharmaceutically acceptable salt.

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 1.8~ 2.2 μm of ol/ml, zinc (Zn) they are 9.0~11.0 μm of ol/ml, manganese (Mn) is 0.45~0.55 μm of ol/ml, copper (Cu) be 1.8~ 2.2 μm of ol/ml, selenium (Se) are 0.032~0.048 μm of ol/ml, molybdenum (Mo) is 0.016~0.024 μm of ol/ml, chromium (Cr) is 0.016~0.024 μm of ol/ml, iodine (I) are 0.08~0.12 μ/ml, fluorine (F) should be 4.5~5.5 μm of ol/ml, lysine or vinegar Sour lysine or arginine or acetic arginine or taurine or glycine or L-aminobutanedioic acid or Monosodium L-aspartate or citric acid or Sodium citrate or gluconic acid or sodium gluconate or sorbierite or mannitol or lactitol or xylitol or antierythrite or its One or more in hydrate or their pharmaceutically acceptable salt are 0.10~0.35g/ml；In said one unit dose Or 0.025~20 times of molal quantity in the said composition of unit formulation or unit volume containing above-mentioned each main ingredient component；The group Compound and pharmaceutically acceptable auxiliary material or excipient composition injection；

Wherein, iron or molysite are selected from ferrous gluconate or its hydrate or ferrous gluconate dihydrate, L- door winters Propylhomoserin ferrous iron, DL- L-aminobutanedioic acids ferrous iron, ferrous sulfate, iron ammonium sulfate, ferrous lactate, ferrous citrate or their hydration Thing, or L-aminobutanedioic acid iron, ferric sulfate, iron chloride, sodium gluconate iron, ferric lactate, ironic citrate, ferric citrate, ferric acetate Or the one or more in its hydrate or iron ion pharmaceutically acceptable salt；

Copper or mantoquita are selected from copper chloride, copper sulphate, copper gluconate, lactobionic acid copper, copper citrate, copper lactate or Pfansteihl Copper, copper acetate, L-ASPARTIC ACID manganese, DL- L-aminobutanedioic acids manganese or or they hydrate or bivalent cupric ion it is pharmaceutically acceptable Salt in one or more；Manganese or manganese salt are selected from manganese chloride, manganese sulfate, manganese gluconate, lactobionic acid manganese, manganese citrate, breast Sour manganese or Pfansteihl manganese, manganese acetate, L-ASPARTIC ACID manganese, DL- L-aminobutanedioic acids manganese or their hydrate or divalent manganesetion medicine One or more in acceptable salt；

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；

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

Chromium is selected from chromium chloride, chromium sulfate, chromium gluconate [(C6H11O7)₃Cr], chromium citrate, chromium acetylacetonate, lactic acid One or more in chromium, chromic acetate or their hydrates or trivalent chromic ion pharmaceutically acceptable salt；

Lysine or Lysine Acetate or arginine or acetic arginine or taurine or glycine or L-aminobutanedioic acid OR gate Winter propylhomoserin sodium or citric acid or sodium citrate or gluconic acid or sodium gluconate or sorbierite or mannitol or lactitol or wood Sugar alcohol or antierythrite include its hydrate or their pharmaceutically acceptable salt, and sorbierite includes anhydrous sorbierite or sorb The water thing of alcohol half or 1 water sorbierite or sorbitol instant.

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 1.8~2.2 μm of ol/ml, zinc (Zn) it is 9.0~11.0 μm of ol/ml, manganese (Mn) is 0.45~0.55 μm of ol/ml, copper (Cu) is 1.8~2.2 μm of ol/ml, selenium (Se) it is 0.032~0.048 μm of ol/ml, molybdenum (Mo) is 0.016~0.024 μm of ol/ml, chromium (Cr) is 0.016~0.024 μ Mol/ml, iodine (I) are 0.08~0.12 μ/ml, fluorine (F) should be 4.5~5.5 μm of ol/ml, lysine or Lysine Acetate or essence Propylhomoserin or acetic arginine or taurine or glycine or L-aminobutanedioic acid or Monosodium L-aspartate or citric acid or sodium citrate or Portugal Grape saccharic acid or sodium gluconate or sorbierite or mannitol or lactitol or xylitol or antierythrite or its hydrate or they Pharmaceutically acceptable salt in one or more be 0.10~0.35g/ml；In said one unit dose or unit formulation or 0.025~20 times of molal quantity containing above-mentioned each main ingredient component in the said composition of unit volume；Said composition with pharmaceutically Acceptable auxiliary material forms injection；

Wherein, iron is selected from ferrous gluconate or its hydrate or ferrous gluconate dihydrate, L-ASPARTIC ACID are sub- Iron, DL- L-aminobutanedioic acids ferrous iron, ferrous sulfate, iron ammonium sulfate, ferrous lactate, ferrous citrate or their hydrate, OR gate Winter propylhomoserin iron, ferric sulfate, iron chloride, the hydrate of iron chloride 6 (FeCl36H2O), sodium gluconate iron, ferric lactate, citric acid One or more in iron, ferric citrate, ferric acetate or its hydrate；

Zinc is selected from zinc sulfate, white vitriol, monohydrate zinc sulphate, zinc gluconate or zinc gluconate hydrate, grape Saccharic acid zinc (II) dihydrate, the hydrate of zinc gluconate 3, lactobionic acid zinc or lactobionic acid zinc hydrate, zinc citrate or lemon Sour three zinc or its zinc citrate hydrate zinc citrate dihydrate, zinc lactate, the hydrate of Pfansteihl zinc 3, Pfansteihl zinc, L- breasts One kind in the sour hydrate of zinc 3, zinc acetate, the hydrate of zinc acetate 2, L-ASPARTIC ACID zinc, DL- L-aminobutanedioic acids zinc or its hydrate It is or several；Copper is selected from copper chloride, the hydrate of copper chloride 2, copper sulphate, copper sulfate monohydrate, three brochanites, cupric sulfate pentahydrate, Portugal Grape saccharic acid copper, the hydrate of copper gluconate 1, the hydrate (C of copper gluconate 2₁₂H₂₂O₁₄Cu·2H₂O), lactobionic acid copper or lactose Sour 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 hydration Thing, copper acetate or its hydrate of copper acetate 1 [(Ac)₂Cu·H₂O] in one or more；

Manganese is selected from manganese chloride or its hydrate [or the hydrate of manganese chloride 1 or the hydrate (MnCl of manganese chloride 2₂·2H₂) or chlorine O Change the hydrate (MnCl of manganese 4₂·4H₂O) or the hydrate of manganese chloride 5 or the hydrate of manganese chloride 6], manganese sulfate or, manganese sulfate 1 is hydrated Thing, manganese gluconate or manganese gluconate hydrate, lactobionic acid 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 One or more in manganese, 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 in sodium molybdate, the hydrate of sodium molybdate 2, ammonium molybdate, the hydrate of ammonium molybdate 4, the hydrate of ammonium heptamolybdate 4 one Kind is several；Chromium is selected from chromium chloride, the hydrate of chromium chloride 6, chromium sulfate, the hydrate of chromium sulfate 6, chromium gluconate or gluconic acid Chromium hydrate, chromium citrate or chromium citrate hydrate, Chromic lactate or Pfansteihl chromium or its hydrate, chromium acetylacetonate, acetic acid The one or more of chromium or its hydrate；

It is pointed out that contain in composition in a unit dose or a unit formulation or a unit volume Main ingredient component：For example, between white vitriol 2869.4813mg and 2869.48mg and 2869.5mg and 2870mg, glucose It is equivalent or effects equivalent in the present invention between sour copper 905.1245mg and 905.125mg, 905.12mg, 905.1mg , omit or accepted or rejected because effective digital is different；The significant figure of main ingredient or auxiliary material in other compositions of the present invention Word accepts or rejects mode or principle is also identical with this.

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 in position dosage or the said composition of unit formulation or unit volume：Glucose Sour zinc or zinc gluconate hydrate, zinc gluconate dihydrate or the hydrate 4547.1mg of zinc gluconate 3 are (with glucose Sour zinc anhydride weight calculation amount)；Ferrous gluconate or the hydrate 968.28mg of ferrous gluconate 2 are (with the water of ferrous gluconate 2 Compound weight calculation amount)；The hydrate 5.33mg of chromium chloride 6；The hydrate 4.85mg of sodium molybdate 2；Copper gluconate or the water of copper gluconate 1 Compound or the hydrate 977mg of copper gluconate 2 (with the hydrated basis weight of copper gluconate 2)；Manganese gluconate or gluconic acid The hydrate 240.73mg of manganese 2 (with the hydrated basis weight of manganese gluconate 2)；Sodium fluoride 210mg；Sodium selenite or sodium selenite 5 Hydrate or sodium hydrogen selenite 10.5mg (with the hydrated basis weight of sodium selenite 5), KI 16.6mg or sodium iodide 14.989mg；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 0.20~4 times of parts by weight；Said composition can be prepared into note with pharmaceutically acceptable auxiliary material or excipient Penetrate agent.

In the present invention, can be according to the quantitative relation between the molecular weight of individual component in itself or quality, in scale Go up or be accurate in the digit of different decimal points and extended, or according to the regular further analogy to round up, for example, grape Between the 4547.10397mg and 4547.104mg and 4547.1mg and 4547mg of saccharic acid zinc；The hydrate of ferrous gluconate 2 Between 968.2849mg and 968.285mg and 968.28mg and 968.3mg；Between sodium molybdate 2 hydrate 4.85mg and 4.9mg； Between the 977.0014mg and 977 of the hydrate of copper gluconate 2, the 240.732265mg of the hydrate of manganese gluconate 2 with Between 240.732mg and 240.73mg and 240.7mg, or weight between sodium iodide 14.989mg and 15mg be equal effect or Can mutual equivalent substitution；Other or other components can be by that analogy.

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：Zinc gluconate or zinc gluconate hydrate or Portugal Grape saccharic acid zinc dihydrate or the hydrate 4547.1mg of zinc gluconate 3 (with zinc gluconate anhydride weight calculation amount), glucose 2 hydrate 968.28mg of sour ferrous iron, the hydrate 5.33mg of chromium chloride 6, the hydrate 4.85mg of sodium molybdate 2, copper gluconate 2 are hydrated Thing 977mg, the hydrate 99mg of manganese chloride 4, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorb Alcohol or lysine or Lysine Acetate or arginine or acetic arginine or taurine or glycine or L-aminobutanedioic acid OR gate winter ammonia Sour sodium or citric acid or sodium citrate or gluconic acid or sodium gluconate or mannitol or lactitol or xylitol or erythrose One or more 10-330g in alcohol or its hydrate or their pharmaceutically acceptable salt；In said one unit dose or In the said composition of unit formulation or unit volume containing above-mentioned each main ingredient component weight number or parts by weight 0.20~4 Times；Said composition can be with pharmaceutically acceptable auxiliary material or excipient composition injection.

, can be according to the quantitative relation between the molecular weight of individual component in itself or quality, in decimal point position in above-mentioned composition 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, its In, between the 4547.10397mg and 4547.104mg and 4547.1mg and 4547mg of zinc gluconate；The water of ferrous gluconate 2 Between compound 968.2849mg and 968.285mg and 968.28mg and 968.3mg；The hydrate 4.85mg of sodium molybdate 2 and 4.9mg it Between；It is equal effect or can mutual equivalent substitution.

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：

Zinc gluconate hydrate (C₁₂H₂₂O₁₄Zn) 4547.1mg (in terms of zinc gluconate anhydride)

Hydrate (the FeCl of iron chloride 6₃·6H₂O) 0.54g

Hydrate (the Na of sodium molybdate 2₂MoO₄·2H₂O) 4.85mg

The hydrate of chromium chloride 6 (CrCl36H2O) 5.33mg

Hydrate (the CuCl of copper chloride 2₂·2H₂O) 340mg

Hydrate (the MnCl of manganese chloride 4₂·4H₂O) 99mg

Sodium fluoride (NaF) 210mg

Sodium selenite pentahydrate (Na₂SeO₃·5H₂O) 10.5mg

KI (KI) 16.6mg

Sorbierite (C₆H₁₄O₆) 300g

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 0.20~4 times of parts by weight；Said composition can inject with pharmaceutically acceptable auxiliary material or excipient composition Agent.

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)2869.48mg、 The hydrate 968.28mg of ferrous gluconate 2, the hydrate 4.85mg of sodium molybdate 2, the hydrate 5.33mg of chromium chloride 6, gluconic acid Copper 905.12mg, the hydrate 240.73mg of manganese gluconate 2 or the hydrate 99mg of manganese chloride 4, sodium fluoride 210mg, sodium selenite 5 Hydrate 10.5mg, KI 16.6mg；In the said composition of said one unit dose or unit formulation or unit volume 0.20~4 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 composition injection.

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：Zinc gluconate 4547.1mg, ferric citrate 979.68mg, the hydrate 4.85mg of sodium molybdate 2, the hydrate 5.33mg of chromium chloride 6, the hydrate 977mg of copper gluconate 2, grape The hydrate 240.73mg of the saccharic acid manganese 2 or hydrate 99mg of manganese chloride 4, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, iodine Change potassium 16.6mg；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 0.20~4 times of parts by weight；Said composition can be noted with pharmaceutically acceptable auxiliary material or excipient composition Penetrate agent.

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 hydrate of zinc gluconate 3 or zinc gluconate (with C₁₂H₂₂O₁₄Zn weight calculations amount) 4547.1mg, sodium gluconate iron 112.16mg (weight is in terms of iron), the hydrate of ammonium heptamolybdate 4 24.77mg or the hydrate 4.85mg of sodium molybdate 2, chromium gluconate 12.1mg or the hydrate 5.33mg of chromium chloride 6, copper gluconate The 2 hydrate 977mg or hydrate 62.95mg of manganese chloride 2 or the hydrate 99mg of manganese chloride 4, sodium fluoride 210mg, the water of sodium selenite 5 Compound 10.5mg, sodium iodide 14.99mg or KI 16.6mg；In said one unit dose or unit formulation or unit volume Said composition in the weight number containing above-mentioned each main ingredient component or 0.20~4 times of parts by weight；Said composition can be with pharmacy Upper acceptable auxiliary material or excipient composition injection.

The multi-microelement injecta and its preparation technology of the present invention：Method one, step 1, by lysine or arginine Or taurine or glycine or L-aminobutanedioic acid or citric acid or gluconic acid or sorbierite or mannitol or lactitol or xylitol Or antierythrite or its hydrate or the appropriate water for injection dissolving of their pharmaceutically acceptable salt or excipient, use pharmacy Upper acceptable pH adjusting agent is acidified；Step 2, by iron ion salt or ferrous ion pharmaceutically acceptable salt, manganese ion Pharmaceutically acceptable salt, copper ion pharmaceutically acceptable salt, chromium ion pharmaceutically acceptable salt are one by one with appropriate acid The water for injection dissolving of change；Step 3, the water for injection dissolving by the appropriate acidifying of the acceptable pharmaceutical salts of zinc ion；Step 4th, villiaumite is dissolved with appropriate water for injection；Step 5, by molybdic acid pharmaceutical salts, selenous acid pharmaceutical salts, KI or sodium iodide with And the pharmaceutical salts of iodide ion are dissolved with appropriate water for injection respectively；Step 6, by the solution of step 2 solution with step 4 respectively It is sufficiently mixed uniformly；Step 7, the solution of the solution of step 3 and step 1 mixed, then with the mixing of the solution of step 6, then Easily mixed with the solution of step 5；Step 8, with pharmaceutically acceptable pH adjusting agent adjust pH value between 3.0~5.5, Preferable ph adds activated carbon decolorizing between 3.5~4.5, filters decarburization, moisturizing constant volume, refined filtration, examines, filling, sealing, goes out Bacterium, pack, examine.Wherein, the upper acceptable pH adjusting agent of the injection water system medication of acidifying is acidified, and its pH generally exists Between 3.0-5.6.

Or method two, step 1, by lysine or arginine or taurine or glycine or L-aminobutanedioic acid or citric acid or Portugal Grape saccharic acid or sorbierite or mannitol or lactitol or xylitol or antierythrite or its hydrate or theirs is pharmaceutically acceptable Salt or excipient dissolved with appropriate water for injection, be acidified with pharmaceutically acceptable pH adjusting agent；Step 2, by manganese Ion pharmaceutically acceptable salt, copper ion pharmaceutically acceptable salt are dissolved with the water for injection of appropriate acidifying respectively；Step Rapid 3, the acceptable pharmaceutical salts of the zinc ion water for injection of appropriate acidifying is dissolved；Step 4, by iron ion salt or it is ferrous from Sub- pharmaceutically acceptable salt, chromium ion pharmaceutically acceptable salt are dissolved with the water for injection of appropriate acidifying respectively；Step 5th, villiaumite is dissolved with appropriate water for injection；Step 6, by molybdic acid pharmaceutical salts, selenous acid pharmaceutical salts respectively with appropriate injection Dissolved with water；Step 7, the pharmaceutical salts of KI or sodium iodide and iodide ion are dissolved with appropriate water for injection respectively；Step Rapid 8, the solution of step 2 is sufficiently mixed uniformly with the solution of step 1 respectively；Step 9, by the molten of the solution of step 3 and step 8 Liquid mixes；Step 10, solution of the solution of step 4 respectively successively with step 5 fully mixed, then with the solution of step 9 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 thereto, Mix, then with the pH value of pharmaceutically acceptable pH adjusting agent regulation solution between 3.0~5.5, preferable ph 3.5~ Between 4.5；Step 12, solution is added to activated carbon decolorizing, filter decarburization, or filtering with microporous membrane, or using retention average molecular Quality 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, and fill Dress, seal, sterilize, pack, examine.Wherein, the upper acceptable pH adjusting agent of the injection water system medication of acidifying is acidified, Its pH is generally between 3.0-5.6.

Its pH adjusting agent pharmaceutically received can contain 0-20.00 grams or more in every 1000ml parenteral solutions of the present invention, Used pH adjusting agent is calculated its weight or calculated according to data such as concentration or density with its active ingredient or molecular formula Corresponding volume is calculated with molar concentration (M) or equivalent concentration (N).Used pH adjusting agent is being made in form of an aqueous solutions It is added to during preparing agent in the solution of composition.(such as sodium hydroxide, lemon when using alkaline solution to adjust pH value The one or more of sour trisodium, sodium gluconate etc.), during regulation, 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 readjustment (for example, acetic acid, lactic acid, lemon Acid, gluconic acid solution), to control a suitable pH value, vice versa.

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..

Pharmaceutically acceptable antioxidant and stabilizer in the pharmaceutical compositions of the present invention can be sulfurous acid and its salt, It is bisulfites, pyrosulfite, dithionite, TGA and its pharmaceutical salts, thiolactic acid and its pharmaceutical salts, thio Dipropionic acid and salt, amino acid and its pharmaceutical salts；Tartaric acid, nitrate, acetic acid pharmaceutical salts, 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 sodium ethylene diamine tetracetate calcium 2 are hydrated Thing, the hydrate of sodium ethylene diamine tetracetate calcium 4), N- bis- (2- ethoxys) glycine, xylitol, sorbierite, mannitol, ox sulphur One or several kinds in acid, amino acid or its pharmaceutically acceptable salt etc.；The salt of above-mentioned substance selects it pharmaceutically Acceptable salt.

Pharmaceutically acceptable isotonic regulator can be glucose, fructose, xylitol, sorbierite, mannitol, conversion One or more in sugar, dextran, sodium lactate 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 (I) (Ministry of Public Health's medicine mark Accurate (two) the 5th) with reference to the program preparation of the method for embodiment 4), 1 group of embodiment, 4 groups of embodiment, 6 groups of embodiment and embodiment 13 groups.Administering mode is intraperitoneal injection, and dosage is 0.2ml respectively, gives vehicle control group 0.2ml grapes respectively Sugared 5% parenteral solution, (control group is molten for the multi-microelement injecta control group solution in primary standard control group intraperitoneal injection table 1 Liquid pH value is 2.5) 0.2ml, and after embodiment solution 0.2ml is injected intraperitoneally in remaining each group, mouse produces in 15min after observation administration The number that writhing response occurs.

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 2.3 times of embodiment 1,4.1 times of 4 groups of embodiment, reality respectively Apply 6 groups of example 5.9 times, 4.5 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 original national standard medicine composition injection control group of table 1.

Zinc chloride (ZnCl₂)1360mg
	Iron chloride (FeCl₃·6H₂O)540mg
Copper chloride (CuCl₂·2H₂O)340mg
	Chromium chloride (CrCl36H2O) 5.33mg
Manganese chloride (MnCl₂·2H₂O)99mg
	Sodium fluoride (NaF) 210mg
Sodium selenite (Na₂SeO₃·5H₂O)10.5mg
	Sodium molybdate (Na₂MoO₄·2H₂O)4.85mg
KI (KI) 16.6mg
	Sorbierite (C₆H₁₄O₆)300g
Appropriate water for injection
	Full dose 1000ml

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, the new composition provided, most chlorions are removed, reduces hyperchloremia Incidence, and expand adaptation population, for example embodiment 4 or embodiment 5 or embodiment 6 etc.；2nd, it is beneficial to containing salt acid composition The treatment of autism children, to it is with self-closing disease but require supplementation with trace element pharmaceutical composition patient, there is provided One safer and more effective or more selection, perhaps this more current pharmacy or clinical ignore or have no promotion；3rd, for The patient for occurring or easily occurring acid poisoning provides new selection, or reduces potential adverse reaction.4th, of the invention composition Toxicity is reduced, and serious toxicity reaction can be reduced compared with the composition of copper chloride, manganese chloride etc. with zinc chloride in the prior art Incidence；5th, composition of the invention, can reduce the stimulation of intravenously administrable compared with the composition of zinc chloride in the prior art etc. Property incidence；6th, after but falling the acid chlorization zinc that dosage is big in stock blend, relative to the preparation of primary standard, composition is contributed to note Penetrate the overall reduction of agent acidity so that mixed in clinical medicine disposal process with other present or future listing medicines When preparing parenteral solution, the pH value difference between different pharmaceutical preparation is reduced, being advantageous to the stability after solution is prepared and clinic makes The security and validity of used time.7th, the pH value to be kept relative stability in composition solution pH value and storage is improved, improves and uses The security of medicine, improve compliance of the patient to medicine.The 8th, the preparation of different size or the composition of lower unit dose are provided, So that Clinical practice is convenient, waste etc. is reduced.

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 Product has more new adaptation population or more preferable specific aim and more preferable clinical safety etc. on Clinical practice；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 is included well known to a person skilled in the art any examples of such carriers suitable for specific administration mode,

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 small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 1

Prescription：Zinc gluconate hydrate (C₁₂H₂₂O₁₄Zn) 4547.1mg (in terms of zinc gluconate anhydride)

Hydrate (the FeCl of iron chloride 6₃·6H₂O) 0.54g

Hydrate (the Na of sodium molybdate 2₂MoO₄·2H₂O) 4.85mg

The hydrate of chromium chloride 6 (CrCl36H2O) 5.33mg

Hydrate (the CuCl of copper chloride 2₂·2H₂O)340mg

Hydrate (the MnCl of manganese chloride 4₂·4H₂O) 99mg

Sodium fluoride (NaF) 210mg

Sodium selenite pentahydrate (Na₂SeO₃·5H₂O) 10.5mg

KI (KI) 16.6mg

Sorbierite (C₆H₁₄O₆) 300g

Sodium gluconate 5g

2M gluconic acid solutions 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, use the sodium gluconate of recipe quantity, sorbierite The water for injection stirring and dissolving of proper amount of fresh, pH value is acidified to 3.2 with gluconic acid solution；Step 2, by the water of iron chloride 6 Compound, the hydrate of chromium chloride 6, the hydrate of copper chloride 2, the hydrate of manganese chloride 4 are acidified fresh note with gluconic acid solution respectively Dissolving of blunging is penetrated, solution is kept clarification；Step 3, the appropriate injection of zinc gluconate hydrate acidifying are water-soluble Solution, solution is set to keep clarification；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by the hydrate of sodium molybdate 2, Asia The hydrate of sodium selenate 5, KI are respectively with appropriate water for injection stirring and dissolving；Step 6, by the solution of step 3 and step 1 Solution 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 Even, then the solution with step 5 easily mixes；Step 8, adjusted with 2M gluconic acid solutions and 2M sodium lactate solutions pH value to 3.1, 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 phase To 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%, reference Method determines the Acceleration study sheet of 6 months in multi-microelement injecta (I) (the Sanitation Ministry medicine standard (two) the 5th) Each micro- content in the pharmaceutical composition of invention, find in the range of the 90-110% of the labelled amount of this prescription； Solution keeps clear and bright, and the pH value for determining solution is 3.1.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 2

Prescription：The hydrate 4547.1mg of zinc gluconate 3 (with zinc gluconate anhydride weight calculation amount), iron chloride 6 are hydrated Thing 0.54g, the hydrate 4.85mg of sodium molybdate 2, the hydrate 5.33mg of chromium chloride 6, the hydrate 340mg of copper chloride 2, the water of manganese chloride 4 Compound 99mg, sodium fluoride 210mg, the hydrate 10.5mg 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, adds 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 iron chloride 6 hydrates, the hydrate of chromium chloride 6, the hydrate of copper chloride 2, the hydrate of manganese chloride 4 are acidified appropriate with gluconic acid solution respectively Water for injection stirring and dissolving, make solution keep clarification；The injection of step 3, the hydrate of zinc gluconate 3 acidifying fresh amount Dissolved with water；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by the hydrate of sodium molybdate 2, the water of sodium selenite 5 Compound, KI use the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6, the solution by the solution of step 3 and step 1 Mix；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, so The solution with step 5 easily mixes afterwards；Step 8, adjusted with 2M gluconic acid solutions and 2M sodium gluconate solutions 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 phase To molecular mass 6000-20000 ultrafiltration membrance filter, 10ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 3

Prescription：The hydrate 4547.1mg of zinc gluconate 3 (with zinc gluconate anhydride weight calculation amount), iron chloride 6 are hydrated Thing 0.54g, the hydrate 4.85mg of sodium molybdate 2, the hydrate 5.33mg of chromium chloride 6, the hydrate 340mg of copper chloride 2, the water of manganese chloride 4 Compound 99mg, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, taurine 30g, sorbierite 20g, Glycine 20g, gluconic acid 20g, sodium gluconate 10g, 2M gluconic acid solution and 2M sodium lactate solutions are appropriate, 5M hydroxides Appropriate sodium solution, 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, 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 hydrate of zinc gluconate 3 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 the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, 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, 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 small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 4

Prescription：Zinc gluconate (C₁₂H₂₂O₁₄Zn) 4547.1mg, the hydrate 968.28mg of ferrous gluconate 2, chromium chloride 6 hydrate 5.33mg, the hydrate 4.85mg of sodium molybdate 2, the hydrate 977mg of copper gluconate 2, the hydrate of manganese gluconate 2 240.73mg, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorbierite 300g, 3M gluconic 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, by the sorbierite proper amount of fresh of recipe quantity Water for injection stirring and dissolving, gluconic acid solution is acidified pH value to 4.0；Step 2, by the hydrate of ferrous gluconate 2, chlorination The hydrate of chromium 6, the hydrate of copper gluconate 2, the hydrate of manganese gluconate 2 are acidified fresh injection with gluconic acid solution respectively Blunge dissolving；The appropriate water for injection that step 3, zinc gluconate are acidified with gluconic acid solution dissolves；Step 4, incite somebody to action Sodium fluoride is dissolved with fresh water for injection；Step 5, the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI used respectively The water for injection stirring and dissolving of proper amount of fresh；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, by step 2 Solution be sufficiently mixed uniformly with the solution of step 4 successively, then mixed with the solution of step 6, then the solution with step 5 holds Easily mix；Step 8, with 3M gluconic acid solutions and 2M sodium gluconate solutions pH value is adjusted to 4.0, benefit injects water to complete Amount, stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, using retention relative molecular mass 8000-20000 Ultrafiltration membrance filter, 5ml/ branch embeddings, 121 DEG C of 15min sterilizing, 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%, reference Method determines the Acceleration study sheet of 6 months in multi-microelement injecta (I) (the Sanitation Ministry medicine standard (two) the 5th) Each micro- content in the pharmaceutical composition of inventive embodiments, find this prescription labelled amount 90-110% model In enclosing；Solution keeps clear and bright, and the pH value for determining solution is 4.0.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 5

Prescription：The hydrate 4547.1mg of zinc gluconate 3 (with zinc gluconate anhydride weight calculation amount), ferrous gluconate 2 hydrate 968.28mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 4.85mg of sodium molybdate 2, the hydrate of copper gluconate 2 977mg, the hydrate 240.73mg of manganese gluconate 2, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorbierite 300g, 2M gluconic acid solution and 2M 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 proper amount of fresh of recipe quantity Water for injection stirring and dissolving, with the pH value of gluconic acid solution souring soln to 4.0；Step 2, ferrous gluconate 2 is hydrated Thing, the hydrate of chromium chloride 6, the hydrate of copper gluconate 2, the hydrate of manganese gluconate 2 are acidified new 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 Water dissolves；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, the hydrate of sodium molybdate 2, sodium selenite 5 be hydrated Thing, KI use the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6, the solution of step 3 and the solution of step 1 mixed It is even；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 Easily mixed with the solution of step 5；Step 8, adjusted with 2M gluconic acid solutions and 2M sodium gluconate solutions pH value to 4.3, 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 phase To molecular mass 10000-20000 ultrafiltration membrance filter, it is seen that after foreign matter and pH value inspection, 10ml/ branch embeddings, 121 DEG C of 15min Sterilizing, is produced.

Take appropriate above-mentioned sample lucifuge to be placed in 30 DEG C, placed 6 months in the environment of relative humidity 75% ± 5%, reference Method determines the Acceleration study sheet of 6 months in multi-microelement injecta (I) (the Sanitation Ministry medicine standard (two) the 5th) Each micro- content in the pharmaceutical composition of invention, find in the range of the 90-110% of the labelled amount of this prescription； Solution keeps clear and bright, and the pH value for determining solution is 4.3.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 6

Prescription：The hydrate 4547.1mg of zinc gluconate 3 (with zinc gluconate anhydride weight calculation amount), ferrous gluconate 2 hydrate 968.28mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 4.85mg of sodium molybdate 2, the hydrate of copper gluconate 2 977mg, the hydrate 240.73mg of manganese gluconate 2, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorbierite 20g, glycine 10g, gluconic acid 20g, sodium gluconate 20g, 2M gluconic acid solution and 2M glucose Appropriate acid sodium solution, 5M sodium hydroxide solutions are appropriate, appropriate water for injection, and 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 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 4.0 jointly；Step 2, by the hydrate of ferrous gluconate 2, the hydrate of chromium chloride 6, gluconic acid The hydrate of copper 2, the hydrate of manganese gluconate 2 are acidified fresh water for injection stirring and dissolving with gluconic acid solution respectively；Step 3rd, the appropriate water for injection that the hydrate of zinc gluconate 3 is acidified with gluconic acid solution is dissolved；Step 4, by sodium fluoride with new Fresh water for injection dissolving；Step 5, by the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI respectively with 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 It is sufficiently mixed uniformly with the solution of step 4, then is mixed with the solution of step 6, then the solution with step 5 easily mixes；Step Rapid 8, pH value is adjusted to 4.3 with 2M gluconic acid solutions and 2M sodium gluconate solutions, benefit adds to the full amount of water for injection, and stirring is equal Even and 0.22 μm of miillpore filter 20min of circulating filtration；Then, with retention relative molecular mass 10000-30000 milipore filter mistake Filter, after visible foreign matters and pH value check, by 10ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 7

Prescription：The hydrate 4547.1mg of zinc gluconate 3 (with zinc gluconate anhydride weight calculation amount), ferrous gluconate 2 hydrate 968.28mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 4.85mg of sodium molybdate 2, the hydrate of copper gluconate 2 977mg, the hydrate 240.73mg of manganese gluconate 2, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, xylitol 10g, glycine 20g, gluconic acid 30g, sodium gluconate 20g, 2M gluconic acid solution and 2M glucose Appropriate acid sodium solution, 5M sodium hydroxide solutions are appropriate, appropriate water for injection, and add to the full amount of water for injection 1000ml

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 the hydrate of ferrous gluconate 2, the hydrate of chromium chloride 6, gluconic acid The hydrate of copper 2, the hydrate of manganese gluconate 2 are acidified fresh water for injection stirring and dissolving with gluconic acid solution respectively；Step 3rd, the appropriate water for injection that the hydrate of zinc gluconate 3 is acidified with gluconic acid solution is dissolved；Step 4, by sodium fluoride with new Fresh water for injection dissolving；Step 5, by the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI respectively with 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 It is sufficiently mixed uniformly with the solution of step 4, then is mixed with the solution of step 6, then the solution with step 5 easily mixes；Step Rapid 8, pH value is adjusted to 4.3 with 2M gluconic acid solutions and 2M sodium gluconate solutions, benefit adds to the full amount of water for injection, and stirring is equal Even and 0.22 μm of miillpore filter 20min of circulating filtration；Then, then through 0.22 μm of filtering with microporous membrane, through visible foreign matters and pH value After inspection, by 2ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 8

Prescription：Zinc gluconate (C₁₂H₂₂O₁₄Zn) 4547.1mg, the hydrate 968.28mg of ferrous gluconate 2, sodium molybdate 2 hydrate 4.85mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 977mg of copper gluconate 2, the hydrate of manganese gluconate 2 240.73mg, sodium fluoride 210mg, the hydrate 10.5mg 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 the hydrate of ferrous gluconate 2, The hydrate of chromium chloride 6, the hydrate of copper gluconate 2, the hydrate of manganese gluconate 2 are acidified fresh with gluconic acid solution respectively Water for injection stirring and dissolving；Step 3, zinc gluconate are dissolved with the appropriate water for injection being acidified with gluconic acid solution；Step Rapid 4, sodium fluoride is dissolved with water for injection；Step 5, the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI used respectively The water for injection stirring and dissolving of proper amount of fresh；Step 6, the solution of the solution of step 3 and step 1 mixed；Step 7, by step 2 Solution be sufficiently mixed uniformly with the solution of step 4 successively, then mixed with the solution of step 6, then the solution with step 5 holds Easily mix；Step 8, with 4M 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 5000-10000 Ultrafiltration membrance filter, 15ml/ branch embeddings, 121 DEG C of 15min sterilizing, 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%, reference Method determines the Acceleration study sheet of 6 months in multi-microelement injecta (I) (the Sanitation Ministry medicine standard (two) the 5th) Each micro- content in the pharmaceutical composition of invention, find in the range of the 90-110% of the labelled amount of this prescription； Solution keeps clear and bright, and the pH value for determining solution still maintains 4.2.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 9

Prescription：Zinc gluconate 4547.1mg, the hydrate 968.28mg of ferrous gluconate 2, the hydrate of sodium molybdate 2 4.85mg, the hydrate 977mg of copper gluconate 2, the hydrate 5.33mg of chromium chloride 6, the hydrate 240.73mg of manganese gluconate 2, Sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorbierite 300g, taurine 2g, glycine 10g, 3M gluconic acid solutions 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 2 hydrates of sour ferrous iron, the hydrate of chromium chloride 6, the hydrate of copper gluconate 2, the hydrate of manganese gluconate 2 use gluconic acid respectively Solution is acidified fresh water for injection stirring and dissolving；Step 3, zinc gluconate is acidified fresh amount with gluconic acid solution Water for injection dissolves；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by the hydrate of sodium molybdate 2, selenous acid The hydrate of sodium 5, KI use the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6, by the solution of step 3 and step 1 Solution 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 Even, then the solution with step 5 easily mixes；Step 8, with 3M gluconic acid solutions and 2M sodium gluconate solutions adjust pH Value is to 4.2, and 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 cut Relative molecular mass 5000-10000 ultrafiltration membrance filter is stayed, 20ml/ branch embeddings, 121 DEG C of 15min sterilizings, is produced.

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

Prescription：Zinc gluconate 4547.1mg, the hydrate 968.28mg of ferrous gluconate 2, the hydrate of sodium molybdate 2 4.85mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 977mg of copper gluconate 2, the hydrate 240.73mg of manganese gluconate 2, Sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorbierite 300g, glycine 2g, 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 is weighed or prepared by recipe quantity, step 1, the sorbierite of recipe quantity, gluconic acid is used and fitted Fresh water for injection stirring and dissolving is measured, with the pH value of gluconic acid solution and sodium hydroxide solution solution regulation solution to 4.0； Step 2, by the hydrate of ferrous gluconate 2, the hydrate of chromium chloride 6, the hydrate of copper gluconate 2, the hydrate of manganese gluconate 2 The water for injection stirring and dissolving of fresh amount is acidified with gluconic acid solution respectively；Step 3, zinc gluconate acidifying are fresh suitable The water for injection dissolving of amount；Step 4, sodium fluoride dissolved with fresh water for injection；Step 5, by the hydrate of sodium molybdate 2, Asia The hydrate of sodium selenate 5, KI use the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6, solution and step by step 3 Rapid 1 solution mixes；Step 7, the solution of step 2 is sufficiently mixed uniformly with the solution of step 4 successively, then it is molten with step 6 Liquid mixes, and then the solution with step 5 easily mixes；Step 8, adjusted with 3M gluconic acid solutions and 2M sodium gluconate solutions PH value is saved to 4.0, benefit adds to the full amount of water for injection, and stir simultaneously 0.22 μm of miillpore filter 20min of circulating filtration；Then, adopt With retention relative molecular mass 5000-10000 ultrafiltration membrance filter, 40ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 11

Prescription：Zinc gluconate (C₁₂H₂₂O₁₄Zn) 4547.1mg, the hydrate 968.28mg of ferrous gluconate 2, sodium molybdate 2 hydrate 4.85mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 977mg of copper gluconate 2, the hydrate of manganese gluconate 2 240.73mg, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorbierite 300g, 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 proper amount of fresh of recipe quantity Water for injection stirring and dissolving, above-mentioned solution ph is acidified to 4.0 with gluconic acid solution；Step 2, by the water of ferrous gluconate 2 Compound, the hydrate of chromium chloride 6, the hydrate of copper gluconate 2, the hydrate of manganese gluconate 2 are acidified with gluconic acid solution respectively The water for injection stirring and dissolving of fresh amount；Step 3, the water for injection dissolving by zinc gluconate acidifying fresh amount；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；Mixed again 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, by 10ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 12

The hydrate 4547.1mg (weight is in terms of anhydride) of zinc gluconate 3, the hydrate of ferrous gluconate 2 968.28mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 4.85mg of sodium molybdate 2, the hydrate 977mg of copper gluconate 2, chlorination Hydrate (the MnCl of manganese 4₂·4H₂O) 99mg, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorb Alcohol 300g, 4M gluconic acid solution and 4M 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 proper amount of fresh of recipe quantity Water for injection stirring and dissolving, solution is acidified pH value to 4.0 with gluconic acid solution；Step 2, ferrous gluconate 2 is hydrated Thing, the hydrate of chromium chloride 6, the hydrate of copper gluconate 2, the hydrate of manganese gluconate 2 are acidified new with gluconic acid solution respectively Fresh appropriate water for injection stirring and dissolving；Step 3, the zinc gluconate water for injection of acidifying fresh amount dissolve；Step 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 distinguish With the water for injection stirring and dissolving of proper amount of fresh；Step 6, the solution of the solution of step 3 and step 1 mixed, step 7, will step Rapid 2 solution is sufficiently mixed uniformly with the solution of step 4 successively；The solution with step 6 mixes again, then molten with step 5 Liquid easily mixes；Step 8, with 3M gluconic acid solutions and 2M sodium gluconate solutions pH value is adjusted to 4.2, add water for injection 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, it is seen that after inspection of foreign substance is qualified, 5ml/ branch embeddings, 121 DEG C of 15min sterilizings, produce.

With reference to the method measure present invention in multi-microelement injecta (I) (the Sanitation Ministry medicine standard (two) the 5th) Pharmaceutical composition in each micro- content, find in the range of the 90-110% of the labelled amount of this prescription.

The preparation of the small hydro-acupuncture preparation of the various trace elements of embodiment 13

Prescription：The hydrate 4547.1mg (weight is in terms of anhydride) of zinc gluconate 3, the hydrate of ferrous gluconate 2 988.28mg, the hydrate 5.05mg of sodium molybdate 2, the hydrate 5.0mg of chromium chloride 6, the hydrate 306mg of copper chloride 2, manganese gluconate It is 250mg, sodium fluoride 200mg, the hydrate 11.0mg of sodium selenite 5, KI 17.3mg, sorbierite 100g, taurine 30g, sweet Propylhomoserin 10g, sodium gluconate 15g, 3M gluconic acid solution are appropriate, 3M lactic acid solutions and 3M sodium lactate solutions are appropriate, injection 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, glycine, ox sulphur Acid, the water for injection stirring and dissolving of sodium gluconate proper amount of fresh, solution is acidified pH value extremely with 3M gluconic acid solutions 3.8；Step 2, by the hydrate of ferrous gluconate 2, the hydrate of chromium chloride 6, the hydrate of copper chloride 2, the hydrate of manganese gluconate 2 Fresh appropriate water for injection stirring and dissolving is acidified with gluconic acid solution respectively；Step 3, the hydrate Portugal of zinc gluconate 3 Grape sugar acid solution is acidified fresh appropriate water for injection dissolving；Step 4, sodium fluoride dissolved with fresh water for injection；Step The 5th, the hydrate of sodium molybdate 2, the hydrate of sodium selenite 5, KI are used to the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6th, the solution of the solution of step 3 and step 1 is mixed, step 7, be sufficiently mixed solution of the solution of step 2 successively with step 4 Uniformly；The solution with step 6 mixes again, and then the solution with step 5 easily mixes；Step 8, with 3M lactic acid solutions and lactic acid Sodium solution adjusts pH value to 3.8, and 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 6000-20000 ultrafiltration membrance filter, by 2ml/ branch embeddings, 121 DEG C of 15min sterilize, Produce.

The preparation of the small hydro-acupuncture preparation of the various trace elements of embodiment 14

Prescription：The hydrate 2186.84mg of zinc acetate 2, the hydrate 968.28mg of ferrous gluconate 2, chromium gluconate 12.75mg (weight is in terms of anhydride), the hydrate 4.85mg of sodium molybdate 2, copper gluconate 905.12mg, manganese gluconate 222.71mg, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorbierite 200g, glycine 10g, Sodium gluconate 10g, 3M gluconic acid solution and 1M sodium gluconate solutions are appropriate, appropriate water for injection, is injected 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 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 small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 15

Prescription：White vitriol (ZnSO₄·7H₂O) 2869.48mg, the hydrate 968.28mg of ferrous gluconate 2, molybdic acid The hydrate 4.85mg of sodium 2, the hydrate 5.33mg of chromium chloride 6, copper gluconate 905.12mg, the hydrate of manganese gluconate 2 240.73mg, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg, sorbierite 100g, mannitol 2g, Glycine 10g, sodium gluconate 10g, 4M gluconic acid solution and 4M sodium gluconate solutions are appropriate, appropriate water for injection, add Water for injection 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, The hydrate of ferrous gluconate 2, the hydrate of chromium chloride 6, copper gluconate, the hydrate of manganese gluconate 2 are used into glucose respectively Acid solution is acidified the water for injection stirring and dissolving of fresh amount；Step 3, white vitriol is acidified with gluconic acid solution it is suitable Measure water for injection dissolving；Step 4, sodium fluoride dissolved with water for injection；Step 5, by the hydrate of sodium molybdate 2, the water of sodium selenite 5 Compound, KI use the water for injection stirring and dissolving of proper amount of fresh respectively；Step 6, the solution by the solution of step 3 and step 1 Mix, step 7, be sufficiently mixed the solution of step 2 uniformly with the solution of step 4 successively；The solution with step 6 mixes again, so The solution with step 5 easily mixes afterwards；Step 8, adjusted with 3M gluconic acid solutions and 1M sodium gluconate solutions pH value to 3.6, 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 phase To molecular mass 5000-10000 ultrafiltration membrance filter, 3ml/ branch embeddings, 115 DEG C of 30min sterilizings, produce.

The preparation of the small hydro-acupuncture preparation of the various trace elements of embodiment 16

Prescription：The hydrate 4577.81mg of zinc gluconate 3, the hydrate 1065.11mg of ferrous gluconate 2, sodium molybdate 2 Hydrate 5.34mg, the hydrate 4.80mg of chromium chloride 6, the hydrate 1074.7mg of copper gluconate 2, the hydrate of manganese gluconate 2 216.66mg, sodium fluoride 231mg, the hydrate 9.45mg of sodium selenite 5, KI 18.26mg, sorbierite 270g, 3M glucose 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 proper amount of fresh of recipe quantity Water for injection stirring and dissolving, gluconic acid solution is acidified pH value to 4.0；Step 2, by the hydrate of ferrous gluconate 2, chlorination The hydrate of chromium 6, the hydrate of copper gluconate 2, the hydrate of manganese gluconate 2 are acidified fresh amount with gluconic acid solution respectively 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 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；Mixed again 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 4.5, 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, 15ml/ 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%, reference Method determines each micro member in the present embodiment in multi-microelement injecta (I) (the Sanitation Ministry medicine standard (two) the 5th) The content of element, find in the range of the 90-110% of the labelled amount of this prescription；Solution keeps clear and bright, determines the pH value of solution For 4.4.

The preparation of the small hydro-acupuncture preparation of the various trace elements of embodiment 17

Prescription：The hydrate 5595.1mg of zinc gluconate 3, the hydrate 871.46mg of ferrous gluconate 2, the water of sodium molybdate 2 Compound 4.36mg, the hydrate 5.86mg of chromium chloride 6, the hydrate 879.3mg of copper gluconate 2, the hydrate of manganese gluconate 2 264.81mg, sodium fluoride 189mg, the hydrate 11.55mg of sodium selenite 5, KI 14.94mg, sorbierite 330g, 3M glucose 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 proper amount of fresh of recipe quantity Water for injection stirring and dissolving, gluconic acid solution is acidified pH value to 4.0；Step 2, by the hydrate of manganese gluconate 2, glucose The sour hydrate of copper 2 water for injection of appropriate acidifying dissolves；Step 3, by the hydrate of zinc gluconate 3 with appropriate acidifying Water for injection dissolves；Step 4, by the hydrate of ferrous gluconate 2, the hydrate of chromium chloride 6 respectively with the injection of appropriate acidifying Dissolved with water；Step 5, sodium fluoride dissolved with appropriate water for injection；Step 6, by the hydrate of sodium molybdate 2, the water of sodium selenite 5 Compound is dissolved with appropriate water for injection respectively；Step 7, KI dissolved with appropriate water for injection；Step 8, by step 2 Solution be sufficiently mixed uniformly with the solution of step 1 respectively；Step 9, the solution of the solution of step 3 and step 8 mixed；Step 10th, solution of the solution of step 4 respectively successively with step 5 is fully mixed, then the solution with step 9 easily mixes；Step Rapid 11, the solution of step 6 and the solution of step 10 are fully mixed, then the solution of step 7 is added thereto, mixed, Ran Houyong 3M gluconic acid solutions and 2M sodium gluconates adjust pH value to 4.3, moisturizing constant volume；Step 12, by solution retention phase to point Protonatomic mass is 50,000 to 100,000 membrane filtration, then removes thermal source with the milipore filter of retention relative molecular mass 8000~30000, 0.22 μm of filtering with microporous membrane, 10ml/ branch embeddings are pressed after inspection, sealed, 121 DEG C of 15min sterilizings, packed, examine, produce.

With reference to side in multi-microelement injecta (I) (the Sanitation Ministry medicine standard (two) the 5th) national drug standards Each micro- content in the pharmaceutical composition of the method measure present invention, find this prescription labelled amount 90-110% In the range of.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 18

Prescription：Zinc gluconate (C₁₂H₂₂O₁₄Zn) 4547.1mg, sodium gluconate iron 112.16mg (weight is in terms of iron), The hydrate 24.77mg of ammonium heptamolybdate 4, chromium gluconate 12.1mg, the hydrate 977mg of copper gluconate 2, the hydrate of manganese chloride 2 62.95mg, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, sodium iodide 14.99mg, sorbierite 200g, glycine 30g, Arginine 5g, xylitol 10g, 3M gluconic acid solution and appropriate sodium gluconate solution, appropriate water for injection, add water for injection To full dose 2000ml

Preparation technology：Supplementary material, step 1, glycine, xylitol 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, gluconic acid solution is acidified pH value to 4.5；Step 2, by the water of manganese chloride 2 Compound, the hydrate of copper gluconate 2 water for injection (pH=4.5) of appropriate acidifying dissolve；Step 3, by zinc gluconate 3 The hydrate water for injection of appropriate acidifying dissolves；Step 4, sodium gluconate iron, chromium gluconate used into glucose respectively The water for injection (pH=4.5) of acid acidifying fresh amount and water for injection (pH=4) dissolving；Step 5, by sodium fluoride with appropriate Water for injection dissolves；Step 6, the hydrate of ammonium heptamolybdate 4, the hydrate of sodium selenite 5 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 3M gluconic acid solutions and 2M glucose Sour sodium adjusts pH value to 4.5, moisturizing constant volume；Step 12, solution is used to the super of retention relative molecular mass 20000~40000 Membrane filtration, then with 0.22 μm of filtering with microporous membrane, 10ml/ branch embeddings are pressed after inspection, seal, 121 DEG C of 15min sterilizings, packaging, Examine, produce.

The preparation of the small hydro-acupuncture preparation of various trace elements pharmaceutical composition of embodiment 19

Prescription：The hydrate 4547.1mg of zinc gluconate 3 (with zinc gluconate anhydride weight calculation amount), iron chloride 6 are hydrated Thing 0.54g, chromium gluconate 12.1mg, the hydrate 4.85mg of sodium molybdate 2, the hydrate 977mg of copper gluconate 2, gluconic acid The hydrate 240.73mg of manganese 2, sodium fluoride 210mg, sodium hydrogen selenite 6.03mg, KI 16.6mg, sorbierite 10g, lactitol 10g, antierythrite 50g, glycine 20g, lysine 2g, gluconic acid 20g, sodium gluconate 20g, 2M gluconic acid solution and 2M sodium gluconate solutions are appropriate, appropriate water for injection, and 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, lysine, gluconic acid, the water for injection stirring and dissolving of sodium gluconate and sorbierite proper amount of fresh, by glucose 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) dissolves；Step 3, the water for injection dissolving by the appropriate acidifying of the hydrate of zinc gluconate 3；Step Rapid 4, by the hydrate of iron chloride 6, chromium gluconate respectively with gluconic acid be acidified fresh amount water for injection (pH=3.0) and Water for injection (pH=3.2) dissolves；Step 5, sodium fluoride dissolved with appropriate water for injection；Step 6, sodium molybdate 2 is hydrated Thing, sodium hydrogen selenite are dissolved with appropriate water for injection respectively；Step 7, KI dissolved with appropriate water for injection；Step 8th, the solution of step 2 is sufficiently mixed uniformly with the solution of step 1 respectively successively；Step 9, by the solution of step 3 and step 8 Solution mixes；Step 10, solution of the solution of step 4 respectively successively with step 5 fully mixed, it is then molten with step 9 Liquid 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 adjust pH value to 4.5 with 3M gluconic acid solutions and 2M sodium gluconates, moisturizing constant volume；Step 12, will be molten Ultrafiltration membrance filter of the liquid with retention relative molecular mass 10000~30000, then through 0.22 μm of filtering with microporous membrane, after inspection By 10ml/ branch embeddings, sealing, 121 DEG C of 15min sterilizings, pack, examine, produce.

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

Prescription：Zinc gluconate 4547.1mg, ferric citrate 979.68mg, the hydrate 4.85mg of sodium molybdate 2, chromium chloride 6 hydrate 5.33mg, the hydrate 977mg of copper gluconate 2, the hydrate 240.73mg of manganese gluconate 2, sodium fluoride 210mg, Asia The hydrate 10.5mg of sodium selenate 5, KI 16.6mg, sorbierite 100g, glycine 20g, gluconic acid 20g, sodium gluconate 5g, 2M gluconic acid solution and appropriate sodium gluconate solution, 1M sodium hydroxide solutions be appropriate, appropriate water for injection, filling is penetrated With water to full dose 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 saccharic acid, sodium gluconate proper amount of fresh, gluconic acid solution is acidified pH value to 3.5；Step 2nd, the hydrate of manganese gluconate 2, the hydrate of copper gluconate 2 water for injection of appropriate acidifying are dissolved, clarifies holding； Step 3, the water for injection dissolving by the appropriate acidifying of the hydrate of zinc gluconate 3；Step 4, by ferric citrate, glucose The water for injection that sour chromium is acidified fresh amount with gluconic acid respectively dissolves, and clarifies holding；Step 5, by sodium fluoride with appropriate Water for injection dissolving；Step 6, the hydrate of sodium molybdate 2, sodium hydrogen selenite dissolved with appropriate water for injection respectively；Step 7th, KI is dissolved with appropriate water for injection；It is step 8, the solution of step 2 is fully mixed with the solution of step 1 respectively successively Close uniform；Step 9, the solution of the solution of step 3 and step 8 mixed；Step 10, by the solution of step 4 respectively successively with step Rapid 5 solution fully mixes, and then the solution with step 9 easily mixes；Step 11, by the solution of step 6 and step 10 Solution is fully mixed, then the solution of step 7 is added thereto, and is mixed, then with 2M gluconic acid solutions and 2M sodium gluconates PH value is adjusted to 4.0, 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.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. the pharmaceutical composition of the various trace elements of injection, it is characterised in that：One unit dose or unit formulation or The ratio between the molal quantity of main ingredient component or molfraction are in the said composition of unit volume：Iron content (Fe) is 1.8~2.2 μm of ol/ Ml, zinc (Zn) are 9.0~11.0 μm of ol/ml, manganese (Mn) is 0.45~0.55 μm of ol/ml, copper (Cu) is 1.8~2.2 μm of ol/ Ml, selenium (Se) they are 0.032~0.048 μm of ol/ml, molybdenum (Mo) is 0.016~0.024 μm of ol/ml, chromium (Cr) be 0.016~ 0.024 μm of ol/ml, iodine (I) are 0.08~0.12 μ/ml, fluorine (F) should be 4.5~5.5 μm of ol/ml；In said one unit dose 0.025~20 times of molal quantity containing above-mentioned each main ingredient component in amount or the said composition of unit formulation or unit volume；Should Composition and pharmaceutically acceptable auxiliary material composition 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, L-ASPARTIC ACID ferrous iron, DL- L-aminobutanedioic acids ferrous iron, ferrous sulfate, iron ammonium sulfate, ferrous lactate, citric acid Ferrous or their hydrate, or L-aminobutanedioic acid iron, ferric sulfate, iron chloride, sodium gluconate iron, ferric lactate, ironic citrate, lemon One or more in lemon acid iron ammonium, 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 be selected from copper chloride, copper sulphate, copper gluconate, lactobionic acid copper, copper citrate, copper lactate or Pfansteihl copper, copper acetate, L-ASPARTIC ACID manganese, DL- L-aminobutanedioic acids manganese or or their hydrate or bivalent cupric ion pharmaceutically acceptable salt in one Kind is a variety of；

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

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

Molybdenum is selected from sodium molybdate or its molybdic acid sodium hydrate, the ammonium molybdate or pharmaceutically acceptable salt of ammonium molybdate hydrate or molybdic acid In one or more；

Chromium is selected from chromium chloride, chromium sulfate, chromium gluconate, chromium citrate, chromium acetylacetonate, Chromic lactate, chromic acetate or their water One or more in compound or trivalent chromic ion pharmaceutically acceptable salt.

2. the pharmaceutical composition of the various trace elements of injection, it is characterised in that：One unit dose or unit formulation or The ratio between the molal quantity of main ingredient component or molfraction are in the said composition of unit volume：Iron content (Fe) is 1.8~2.2 μm of ol/ Ml, zinc (Zn) are 9.0~11.0 μm of ol/ml, manganese (Mn) is 0.45~0.55 μm of ol/ml, copper (Cu) is 1.8~2.2 μm of ol/ Ml, selenium (Se) they are 0.032~0.048 μm of ol/ml, molybdenum (Mo) is 0.016~0.024 μm of ol/ml, chromium (Cr) be 0.016~ 0.024 μm of ol/ml, iodine (I) are 0.08~0.12 μ/ml, fluorine (F) should be 4.5~5.5 μm of ol/ml, lysine or acetic acid and rely ammonia Acid or arginine or acetic arginine or taurine or glycine or L-aminobutanedioic acid or Monosodium L-aspartate or citric acid or citric acid Sodium or gluconic acid or sodium gluconate or sorbierite or mannitol or lactitol or xylitol or antierythrite or its hydrate Or 0.02~0.35g/ml of one or more in their pharmaceutically acceptable salt；In said one unit dose or the system of unit 0.025~20 times of molal quantity containing above-mentioned each main ingredient component in the said composition of agent or unit volume；Said composition and medicine Acceptable auxiliary material or excipient composition injection on；

3. the pharmaceutical composition of the various trace elements according to claim 1,2, it is characterised in that：One unit dose or The ratio between the molal quantity of main ingredient component or molfraction are in the said composition of unit formulation or unit volume：It is 3.4 containing zinc (Zn) ~4.2mol/ml, manganese (Mn) are 0.014~0.022mol/ml, and copper (Cu) is 0.28~0.34mol/ml, and iodine (I) is 0.0063 ~0.0095mol/ml, fluorine (F) are 2.55~3.45mol/ml, and selenium (Se) is 0.020~0.030mol/ml；In said one 0.025~20 of molal quantity containing above-mentioned each main ingredient component in the said composition of unit dose or unit formulation or unit volume Times；Said composition and pharmaceutically acceptable auxiliary material or excipient composition injection；

Wherein, iron be selected from ferrous gluconate or its hydrate or ferrous gluconate dihydrate, L-ASPARTIC ACID it is ferrous, DL- L-aminobutanedioic acids ferrous iron, ferrous sulfate, iron ammonium sulfate, ferrous lactate, ferrous citrate or their hydrate, OR gate winter Propylhomoserin iron, ferric sulfate, iron chloride, the hydrate of iron chloride 6 (FeCl36H2O), sodium gluconate iron, ferric lactate, ironic citrate, One or more in ferric citrate, ferric acetate or its hydrate；

Zinc is selected from zinc sulfate, white vitriol, monohydrate zinc sulphate, zinc gluconate or zinc gluconate hydrate, gluconic acid Zinc (II) dihydrate, 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 3 hydrates, zinc acetate, the hydrate of zinc acetate 2, L-ASPARTIC ACID zinc, DL- L-aminobutanedioic acids zinc or one kind or several in its hydrate Kind；Copper is selected from copper chloride, the hydrate of copper chloride 2, copper sulphate, copper sulfate monohydrate, three brochanites, cupric sulfate pentahydrate, glucose Sour copper, the hydrate of copper gluconate 1, the hydrate (C of copper gluconate 2₁₂H₂₂O₁₄Cu ﹒ 2H₂O), lactobionic acid copper or lactobionic acid copper water Compound, 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, vinegar Sour copper or its hydrate of copper acetate 1 [(Ac)₂Cu ﹒ H₂O] in one or more；

Manganese is selected from manganese chloride or its hydrate [or the hydrate of manganese chloride 1 or the hydrate (MnCl of manganese chloride 2₂·2H₂) or manganese chloride O 4 hydrate (MnCl₂·4H₂O) or the hydrate of manganese chloride 5 or the hydrate of manganese chloride 6], manganese sulfate or, the hydrate of manganese sulfate 1, Portugal Grape saccharic acid manganese or manganese gluconate hydrate, lactobionic acid manganese or lactobionic acid manganese hydrate, manganese citrate or the manganese of citric acid three or lemon Lemon acid manganese hydrate, manganese lactate or Pfansteihl manganese or its hydrate, manganese acetate or the hydrate of manganese acetate 4, L-ASPARTIC ACID manganese, One or more in 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 sodium selenite, Asia Hydrate (the Na of sodium selenate 5₂SeO₃·5H₂O), the one or more in sodium hydrogen selenite or the acceptable pharmaceutical salts of selenous acid；Iodine One or more 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 is selected from chromium chloride, the hydrate of chromium chloride 6, chromium sulfate, the hydrate of chromium sulfate 6, chromium gluconate or chromium gluconate water Compound, chromium citrate or chromium citrate hydrate, Chromic lactate or Pfansteihl chromium or its hydrate, chromium acetylacetonate, chromic acetate or The one or more of its hydrate；

4. the pharmaceutical composition of the various trace elements according to claim 1-3, it is characterised in that：The present invention's is a variety of micro- The medicine composition injection of secondary element, main ingredient component in a unit dose or the said composition of unit formulation or unit volume Weight number or the ratio between parts by weight be：Zinc gluconate or zinc gluconate hydrate, zinc gluconate dihydrate or Portugal The hydrate 4547.1mg of grape saccharic acid zinc 3 (with zinc gluconate anhydride weight calculation amount)；Ferrous gluconate or ferrous gluconate 2 Hydrate 968.28mg (with the hydrated basis weight of ferrous gluconate 2)；The hydrate 5.33mg of chromium chloride 6；The hydrate of sodium molybdate 2 4.85mg；Copper gluconate or the hydrate 977mg of the hydrate of copper gluconate 1 or copper gluconate 2 are (with the water of copper gluconate 2 Compound weight calculation amount)；Manganese gluconate or the hydrate 240.73mg of manganese gluconate 2 (with the hydrated basis weight of manganese gluconate 2)； Sodium fluoride 210mg；Sodium selenite or the hydrate of sodium selenite 5 or sodium hydrogen selenite 10.5mg (are counted weight with the hydrate of sodium selenite 5 Amount), KI 16.6mg or sodium iodide 14.989mg；In said one unit dose or this of unit formulation or unit volume group Weight number containing above-mentioned each main ingredient component or 0.20~4 times of parts by weight in compound；Said composition can be with can pharmaceutically connect The auxiliary material or excipient received are prepared into injection；

5. the pharmaceutical composition of the various trace elements according to claim 1-3, it is characterised in that：The present invention's is a variety of micro- The medicine composition injection of secondary element, main ingredient component in a unit dose or the said composition of unit formulation or unit volume Weight number or the ratio between parts by weight be：

Hydrate (the FeCl of iron chloride 6₃·6H₂O)0.54g

Hydrate (the Na of sodium molybdate 2₂MoO₄·2H₂O)4.85mg

The hydrate of chromium chloride 6 (CrCl36H2O) 5.33mg

Hydrate (the CuCl of copper chloride 2₂·2H₂O)340mg

Hydrate (the MnCl of manganese chloride 4₂·4H₂O)99mg

Sodium fluoride (NaF) 210mg

Sodium selenite pentahydrate (Na₂SeO₃·5H₂O)10.5mg

KI (KI) 16.6mg

Sorbierite (C₆H₁₄O₆)300g

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 0.20~4 times；Said composition can be with pharmaceutically acceptable auxiliary material or excipient composition injection.

6. the pharmaceutical composition of the various trace elements according to claim 1-3, it is characterised in that：The present invention's is a variety of micro- The medicine composition injection of secondary element, main ingredient component in a unit dose or the said composition of unit formulation or unit volume Weight number or the ratio between parts by weight be：White vitriol 2869.48mg, the hydrate 968.28mg of ferrous gluconate 2, molybdic acid The hydrate 4.85mg of sodium 2, the hydrate 5.33mg of chromium chloride 6, copper gluconate 905.12mg, the hydrate of manganese gluconate 2 240.73mg, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg；In said one unit dose or In the said composition of unit formulation or unit volume containing above-mentioned each main ingredient component weight number or parts by weight 0.20~4 Times；Said composition can be with pharmaceutically acceptable auxiliary material or excipient composition injection.

7. the pharmaceutical composition of the various trace elements according to claim 1-3, it is characterised in that：The present invention's is a variety of micro- The medicine composition injection of secondary element, main ingredient component in a unit dose or the said composition of unit formulation or unit volume Weight number or the ratio between parts by weight be：Zinc gluconate 4547.1mg, ferric citrate 979.68mg, the hydrate of sodium molybdate 2 4.85mg, the hydrate 5.33mg of chromium chloride 6, the hydrate 977mg of copper gluconate 2, the hydrate 240.73mg of manganese gluconate 2, Sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, KI 16.6mg；In said one unit dose or unit formulation or Weight number containing above-mentioned each main ingredient component or 0.20~4 times of parts by weight in the said composition of unit volume；Said composition Can be with pharmaceutically acceptable auxiliary material or excipient composition injection.

8. the pharmaceutical composition of the various trace elements according to claim 1-3, it is characterised in that：The present invention's is a variety of micro- The medicine composition injection of secondary element, main ingredient component in a unit dose or the said composition of unit formulation or unit volume Weight number or the ratio between parts by weight be：The hydrate of zinc gluconate 3 or zinc gluconate are (with C₁₂H₂₂O₁₄Zn weight calculations amount) 4547.1mg, sodium gluconate iron 112.16mg (weight is in terms of iron), the hydrate 24.77mg of ammonium heptamolybdate 4 or sodium molybdate 2 are hydrated Thing 4.85mg, chromium gluconate 12.1mg or the hydrate 5.33mg of chromium chloride 6, the hydrate 977mg of copper gluconate 2 or manganese chloride The 2 hydrate 62.95mg or hydrate 99mg of manganese chloride 4, sodium fluoride 210mg, the hydrate 10.5mg of sodium selenite 5, sodium iodide 14.99mg or KI 16.6mg；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.

9. the pharmaceutical composition of the various trace elements according to claim 1-3, it is characterised in that：Its preparation method selects From：Method one, step 1, by lysine or arginine or taurine or glycine or L-aminobutanedioic acid or citric acid or gluconic acid Or sorbierite or mannitol or lactitol or xylitol or antierythrite or its hydrate or their pharmaceutically acceptable salt or Excipient is dissolved with appropriate water for injection, is acidified with pharmaceutically acceptable pH adjusting agent；Step 2, by iron ion salt Or ferrous ion pharmaceutically acceptable salt, manganese ion pharmaceutically acceptable salt, copper ion pharmaceutically acceptable salt, chromium from Sub- pharmaceutically acceptable salt is dissolved with the water for injection of appropriate acidifying one by one；Step 3, by the acceptable pharmaceutical salts of zinc ion Dissolved with the water for injection 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 and iodide ion are dissolved with appropriate water for injection respectively；Step 6th, the solution of step 2 is sufficiently mixed uniformly with the solution of step 4 respectively；Step 7, the solution by the solution of step 3 and step 1 Mix, then with being mixed with the solution of step 6, then the solution with step 5 easily mixes；Step 8, with pharmaceutically acceptable PH adjusting agent adjusts pH value between 3.0~5.5, and preferable ph adds activated carbon decolorizing between 3.5~4.5, filters decarburization, 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, by lysine or arginine or taurine or glycine or L-aminobutanedioic acid or citric acid or glucose Acid or sorbierite or mannitol or lactitol or xylitol or antierythrite or its hydrate or their pharmaceutically acceptable salt Or excipient is dissolved with appropriate water for injection, is acidified with pharmaceutically acceptable pH adjusting agent；Step 2, by manganese ion Pharmaceutically acceptable salt, copper ion pharmaceutically acceptable salt are dissolved with the water for injection of appropriate acidifying respectively；Step 3, The acceptable pharmaceutical salts of the zinc ion water for injection of appropriate acidifying is dissolved；Step 4, by iron ion salt or ferrous ion medicine Acceptable salt, chromium ion pharmaceutically acceptable salt are dissolved with the water for injection of appropriate acidifying respectively on；Step 5, incite somebody to action Villiaumite is dissolved with appropriate water for injection；Step 6, by molybdic acid pharmaceutical salts, selenous acid pharmaceutical salts respectively with appropriate water for injection Dissolving；Step 7, the pharmaceutical salts of KI or sodium iodide and iodide ion are dissolved with appropriate water for injection respectively；Step 8, The solution of step 2 is sufficiently mixed uniformly with the solution of step 1 respectively；Step 9, the solution of step 3 and the solution of step 8 mixed It is even；Step 10, solution of the solution of step 4 respectively successively with step 5 fully mixed, it is then easy with the solution of step 9 Mix；Step 11, the solution of step 6 and the solution of step 10 fully mixed, then the solution of step 7 is added thereto, mixed, Then with pharmaceutically acceptable pH adjusting agent adjust solution pH value between 3.0~5.5, preferable ph 3.5~4.5 it Between；Step 12, solution adds to activated carbon decolorizing, filters decarburization, or filtering with microporous membrane, or use retain relative molecular mass for 50000 to 300,000 membrane filtration, or above-mentioned filter method are used in mixed way, it is preferred to use and 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, filling, Sealing, sterilize, pack, examine.Wherein, the upper acceptable pH adjusting agent of the injection water system medication of acidifying is acidified, its PH is generally between 3.0-5.6.

10. the preparation method of the pharmaceutical composition of various trace elements according to claim 9, it is characterised in that：The group Compound and pharmaceutically acceptable auxiliary material or excipient form injection pH value between 3.0-5.0, and pH value is preferably in 3.5-4.5 Between.

11. the pharmaceutical composition of various trace elements according to claims 1 to 8, it is characterised in that：Its purposes is： Prepare prevention or treatment people and the multi-microelement injecta of mammal zinc, manganese, copper, selenium, fluorine, iodine deficiency and its syndrome Application in medicine.