CN1517085A - Multi-microelement injecta and its preparation method and application - Google Patents
Multi-microelement injecta and its preparation method and application Download PDFInfo
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- CN1517085A CN1517085A CNA031127126A CN03112712A CN1517085A CN 1517085 A CN1517085 A CN 1517085A CN A031127126 A CNA031127126 A CN A031127126A CN 03112712 A CN03112712 A CN 03112712A CN 1517085 A CN1517085 A CN 1517085A
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Abstract
An injecta for supplying multiple microelement to human body contains Cr, Cu, Fe, Mn, Mo, Se, Zn, I, F, sorbitol, hydrochloric acid and the water for injection. It is prepared through dissolving sorbitol in said water, adding hydrochloric acid to said water and dissolving iron chloride in it, respectively dissolving zinc chloride, manganese chloride, copper chloride, sodium selenite, sodium molybdate and potassium iodide in said water and adding them to said sorbitol solution, mixing with the solution of hydrochloric acid, respectively dissolving chromium chloride and sodium fluoride in said water and slowly adding them to resultant mixture, and regulating.
Description
Technical field
The invention belongs to one kind of multiple micro-element injections and its preparation method and application thereof.
Background technology
Although human body every day, they were very essential to homergy and the function of keeping human body to the requirement of trace element pettiness extremely.Trace element mainly contains two kinds of existence forms in human body: a kind of is to form metal complex with protein, nucleic acid (RNA) and adenosine triphosphate (ATP) etc.; Another is to combine with the active site of enzyme to form various enzymes, hormone or vitamin, as iron content, copper, zinc, manganese and selenic hundreds of enzyme, the thyroxin that contains iodine, ferruginous cytochrome etc., can make metal-organic double compound produce various unique biological effect, physiological function and biochemical reaction produce tremendous influence to the human life activity.The oxidation of sugar and fat in the vital movement, the generation of water is all finished under the catalysis of the cytochrome of enzyme and iron content or copper.Each trace element all has its special function, shortage or unfavorable to health above limiting the quantity of.Healthy people can absorb from food every day, if but patient at morbid state or for a long time can only be during as energy and nutrition with intravenous hyperalimentation, will cause the shortage of trace element and influence the health and the normal physiological function of human body.
Summary of the invention
The purpose of this invention is to provide one kind of multiple micro-element injections and its preparation method and application thereof, in order to satisfy the basic or medium needs of per day for adults to chromium, copper, ferrum, manganese, molybdenum, selenium, zinc, fluorine and iodine.Because of the gravid woman slightly increases the needs of trace element, so this product also is applicable to the gravid woman.
Its main technical schemes be contain chromium (Cr) 0.016-0.024umol/ml, copper (Cu) 1.8-2.2umol/ml, ferrum (Fe) 1.8-2.2umol/ml, manganese (Mn) 0.45-0.55umol/ml, molybdenum (Mo) 0.016-0.024umol/ml, selenium (Se) 0.032-0.048umol/ml, zinc (Zn) 9.0-11.0umol/ml, iodine (I) 0.08-0.12umol/ml, fluorine (F) 4.5-5.5umol/ml, sorbitol 0.27-0.33g/ml in this product, hydrochloric acid is an amount of, all the other are water for injection.Be to contain in this product of every 10ml: Chlorizate chromium (CrCl
36H
2O) 42.6-64.0ug, copper chloride (CuCl
22H
2O) 3.06-3.74mg, iron chloride (FeCl
36H
2O) 4.86-5.94mg, manganese chloride (MnCl
24H
2O) 0.89-1.09mg, sodium molybdate (Na
2MoO
42H
2O) 38.8-58.2ug, sodium selenite (Na
2SeO
35H
2O) 84-126ug, zinc chloride (ZnCl
2) 12.24-14.96mg, potassium iodide (KI) 132.8-199.2ug, sodium fluoride (NaF) 1.89-2.31mg, sorbitol 2.7-3.3g, hydrochloric acid is an amount of, all the other are water for injection.
The manufacture method of one kind of multiple micro-element injections is characterized in that:
A, under agitation sorbitol 270-330g/L is dissolved in 450-550g/L, 78-90 ℃ the water for injection;
B, with iron chloride (FeCl
36H
2O) 491-601mg/L is dissolved in 5-6ml and is added with in advance in the water for injection of 10-12ul1M hydrochloric acid, with zinc chloride (ZnCl
2) 1.224-1.496g/L, manganese chloride (MnCl
24H
2O) 89.0-109mg/L, copper chloride (CuCl
22H
2O) 306-374mg/L, sodium selenite (Na
2SeO
35H
2O) 8.4-12.6mg/L, sodium molybdate (Na
2MoO
42H
2O) 3.90-5.87mg/L, potassium iodide (KI) 15.9-24.0mg/L are dissolved in respectively in the 5-7ml water for injection, and above-mentioned each electrolyte solution joined in the sorbitol solution, under agitation the hydrochloric acid solution of 1.8-2.1ml1M is joined in sorbitol/electrolyte solution then;
C, with Chlorizate chromium (CrCl
36H
2O) 4.27-6.40mg/L and sodium fluoride (NaF) 189-231mg/L is dissolved in respectively in the 10-12ml water for injection, and slowly joins in sorbitol/electrolyte solution;
D, be 2.0-2.6 when regulating pH20 ℃ with 1M hydrochloric acid;
E, be 1L (1.1Kg) with the volume-adjustment of medicinal liquid with water for injection;
F, medicinal liquid is filtered in the aseptic receiving tank through 0.22 micron;
G, medicinal liquid poured in the 10ml sterilization ampoule on automatic filling machine and seal, the ampoule that embedding is good keeps in Dark Place;
H, the use ampoule Sterilization Kettle product that fill is good are sterilized, and sterilising temp 120-122 ℃, time 16-22 minute;
I, to the ampoule leak test that dyes after the sterilization, the ne-leakage person promptly gets this product.Notice that the product after sterilization and the leak detection must keep in Dark Place.
The described preparing tank of II is a kind of preparing tank with mixing plant; In the described receiving tank polytetrafluorethylecoatings coatings is arranged.
The using method of one kind of multiple micro-element injections, it is characterized in that under the guaranteed prerequisite of compatibility, can be under aseptic condition this product of 10ml be joined infusion in Amino Acid Compound Injection or the glucose injection 500ml, but must in 24 hours, finish using.
Scientist has carried out years of researches to physiological function, internal metabolism and the patient changes in demand to trace element behind disease, wound, burn and surgical operation of trace element both at home and abroad.In " outside the clinical intestinal and enteral nutrition " book of chief editors such as Jiang Zhuming, this has been carried out very detailed argumentation.By discovering:
The immunoreation of a, body is the network adjustment of a series of complexity, is subjected to influence of various factors, also is subjected to the influence of trace element.Lack in the body of essential trace element ferrum, zinc, copper, selenium, manganese, iodine etc., can cause that body fluid, cellularity and specificity or non-specific body's immunity are incomplete, the sickness rate of organism infection and malignant tumor is increased.
B, some endemic diseases are relevant with the shortage of certain trace element, are exactly because in the food due to the iodine deficiency as endemic goiter.
The trace elements absorbed obstacle can take place or excessively lose in c, patient under morbid state, behind severe trauma, burn and surgical operation to the increase in demand of trace element.
Losing of trace element can take place in d, a large amount of or life-time service amino acid injection or diuretic.
Therefore be very essential for the additional various trace elements of the patient of patient behind disease, wound, burn and the surgical operation and row vein nutrition.Our company is according to the suggestion of AAN and developed the injection that contains chromium, copper, ferrum, manganese, molybdenum, selenium, zinc, fluorine and nine kinds of trace element of iodine on the basis that a large amount of patients are studied, and commodity are called Anda U.S. (English name is Addamel N).This product is the present vein compound trace element preparation that uses of domestic unique suitable adult and anemia of pregnant woman, and can replenish nine kinds of trace element of needed by human every day one (10ml), reduces the trouble of injecting respectively and the chance of pollution.Show through clinical experiment itself and other nutritional preparation is used simultaneously, can satisfy the requirement that adult patients and anemia of pregnant woman increase the basic needs and the moderate strength of chromium, copper, ferrum, manganese, molybdenum, selenium, zinc, fluorine and nine kinds of trace element of iodine; And can avoid row parenteral nutrition patient that chromium, molybdenum, selenic shortage take place.
The various trace elements injection is a kind of solution type injection agent that contains nine kinds of trace element, sorbitol and waters for injection, and the effect of each composition is as follows in the product:
Chlorizate chromium (CrCl
36H
2O): human body trace elements necessary chromium is provided.The major function of chromium is the metabolism that participates in body sugar and fat, participates in activating insulin.
Copper chloride (CuCl
22H
2O): human body trace elements necessary copper is provided.Copper participates in the metabolism of hemopoietic and ferrum, influence the formation of collagen and osseous tissue, and copper is the constituent of some copper enzymes.
Iron chloride (FeCl
36H
2O): human body trace elements necessary ferrum is provided.Ferrum is the constituent of hemoglobin, Myoglobin and various cytochrome, participates in growth promoter and energy metabolism, if the human body iron deficiency will influence immunologic function.
Manganese chloride (MnCl
24H
2O): human body trace elements necessary manganese is provided.Manganese is the constituent of plurality of enzymes, participates in energy and lipid metabolism.
Sodium molybdate (Na
2MoO
42H
2O): human body trace elements necessary molybdenum is provided.Molybdenum is the important composition composition of xanthine oxidase, aldehyde oxidase, participates in the transmission of endocellular electricity, catalysis human body purine oxidative metabolism.
Sodium selenite (Na
2SeO
35H
2O): human body trace elements necessary selenium is provided.Selenium participates in the composition of glutathione peroxidase, avoids cell membrane to be damaged by peroxide.
Zinc chloride (ZnCl
2): human body trace elements necessary zinc is provided.Zinc participates in the synthetic of plurality of enzymes and hormone, influences the activity of the zinc dependence enzyme more than 80 kinds, accounts for critical role in Tissue respiration, organism metabolism and antioxidation; Zinc can be grown in acceleration of growth, can make wound tissue's regeneration, accelerating wound healing and human body immunity improving ability and slow down aging.
Potassium iodide (KI): human body trace elements necessary iodine is provided.Iodine is the essential composition of thyroxin (T3, T4), and iodine promotes protein synthesis, regulates effects such as energy metabolism and acceleration of growth growth by the thyroxine performance.
Sodium fluoride (NaF): human body trace elements necessary fluorine is provided.Fluorine is unique the upper and lower teeth not meeting properly tooth prevalence and alleviate the nutrient of the upper and lower teeth not meeting properly tooth disease feelings of reducing, and can quicken skeleton and form, promote growth.
Sorbitol: increase product stability, prevent that precipitation from generating.
Hydrochloric acid: regulate the pH value of product, increase stability.
Water for injection: carrier and solvent.
In the R﹠D process of product, we find:
A, the pH value of product is transferred to 2.0-2.6, solution is colourless or yellowish clear and bright solution, and solution flavescence when pH value is between 3-4 has precipitation to generate when pH is 4, therefore transfers between the 2.0-2.6 for the stability that the guarantees product pH value with finished product;
B, in product, add the stability that sorbitol can improve product;
C, iodine is run off when the sterilization, can provide the iodine of capacity, when feeding intake excessive 20% for guaranteeing finished product because of iodine and ferrum exist in solution simultaneously;
Although d, iron chloride easily are dissolved in water, it sees photo-labile, it is dissolved in to feed intake in the acid solution again can improves its stability;
E, use 78-90 ℃ water for injection to help the dissolving of sorbitol and various trace element;
Solution was alkalescence after f, sodium fluoride were dissolved in water, and Chlorizate chromium dissolves in water slowly and is the catalyst of chemical reaction, for the solution that guarantees these two kinds of raw materials of product stability can only in the end feed intake;
G, potassium iodide see that light easily decomposes, for the stability that guarantees product needs lucifuge in preparation process.
Because of the osmotic pressure of this product higher (being 1900mOsm/KgH2O) and pH value are lower, the direct injection human body can not tolerate, and not diluted can not be used.For safe and reliable medication is provided to extensive patients, our company proves through a large amount of research experiments: under the guaranteed prerequisite of compatibility, can be under aseptic condition this product of 10ml be joined infusion in Amino Acid Compound Injection or the glucose injection 500ml, but must in 24 hours, finish using.
The specific embodiment
Example one
Iron chloride (FeCl
36H
2O): 540mg, zinc chloride (ZnCl
2) 1.36g, manganese chloride (MnCl
24H
2O) 99mg, copper chloride (CuCl
22H
2O) 340mg, sodium selenite (Na
2SeO
35H
2O) 10.5mg, sodium molybdate (Na
2MoO
42H
2O) 4.88mg, potassium iodide (KI) 19.9mg, Chlorizate chromium (CrCl
36H
2O) 5.33mg, sodium fluoride (NaF) 210mg, sorbitol 300g, hydrochloric acid is an amount of, water for injection 797g.
Under agitation sorbitol 300g is dissolved in 500g, 78-90 ℃ the water for injection.
With iron chloride (FeCl
36H
2O) 540mg is dissolved in 6ml and is added with in advance in the water for injection of 11ul1M hydrochloric acid, with zinc chloride (ZnCl
2) 1.36g, manganese chloride (MnCl
24H
2O) 99mg, copper chloride (CuCl
2.2H
2O) 340mg, sodium selenite (Na
2SeO
35H
2O) 10.5mg, sodium molybdate (Na
2MoO
42H
2O) 4.88mg, potassium iodide (KI) 19.9mg are dissolved in respectively in the 6ml water for injection, and above-mentioned each electrolyte solution is joined in the sorbitol solution, under agitation the hydrochloric acid solution of 2ml1M are joined in sorbitol/electrolyte solution then.
With Chlorizate chromium (CrCl
36H
2O) 5.33mg and sodium fluoride (NaF) 210mg is dissolved in respectively in the 11ml water for injection, and slowly joins in sorbitol/electrolyte solution.
After pH when regulating 20 ℃ with 1M hydrochloric acid is 2.0-2.6, be 1.1Kg with the volume-adjustment of medicinal liquid with water for injection.
Medicinal liquid is filtered in the aseptic receiving tank in fill district through 0.22 micron.
Use the filter and the glass container of sterilization on automatic filling machine, to be filled in the 10ml sterilization ampoule, and seal.The ampoule that fill is good keeps in Dark Place.
Use the ampoule Sterilization Kettle product that fill is good to sterilize 121 ℃ of sterilising temps, time 16-22 minute; To the ampoule leak test that dyes after the sterilization, the ne-leakage person promptly gets this product.Notice that the product after sterilization and the leak detection must keep in Dark Place.
Product appearance: almost colourless clear and bright solution; Assay: chromium (Cr) 0.020umol/ml, copper (Cu) 2.0umol/ml, ferrum (Fe) 1.9umol/ml, manganese (Mn) 0.49umol/ml, molybdenum (Mo) 0.021umol/ml, selenium (Se) 0.039umol/ml, zinc (Zn) 10.1umol/ml, iodine (I) 0.11umol/ml, fluorine (F) 5.0umol/ml, sorbitol 0.30g/ml; PH:2.2; Osmotic pressure: 1900mOsm/KgH2O.
After keeping in Dark Place 24 months, room temperature (0-25 ℃) rechecks product appearance: almost colourless clear and bright solution; Assay: chromium (Cr) 0.021umol/ml, copper (Cu) 2.0umol/ml, ferrum (Fe) 1.9umol/ml, manganese (Mn) 0.49umol/ml, molybdenum (Mo) 0.021umol/ml, selenium (Se) 0.037umol/ml, zinc (Zn) 10.2umol/ml, iodine (I) 0.10umol/ml, fluorine (F) 4.8umol/ml, sorbitol 0.31g/ml; PH:2.2; Osmotic pressure: 1900mOsm/KgH2O.
Example two
Iron chloride (FeCl
36H
2O): 572mg, zinc chloride (ZnCl
2) 1.43g, manganese chloride (MnCl
24H
2O) 104mg, copper chloride (CuCl
22H
2O) 357mg, sodium selenite (Na
2SeO
35H
2O) 11.6mg, sodium molybdate (Na
2MoO
42H
2O) 5.38mg, potassium iodide (KI) 22.0mg, Chlorizate chromium (CrCl
36H
2O) 5.87mg, sodium fluoride (NaF) 220mg, sorbitol 315g, hydrochloric acid is an amount of, water for injection 782g.
Under agitation sorbitol 315g is dissolved in 500g, 78-90 ℃ the water for injection.
With iron chloride (FeCl
36H
2O) 572mg is dissolved in 6ml and is added with in advance in the water for injection of 11ul1M hydrochloric acid, with zinc chloride (ZnCl
2) 1.43g, manganese chloride (MnCl
24H
2O) 104mg, copper chloride (CuCl
22H
2O) 357mg, sodium selenite (Na
2SeO
35H
2O) 11.6mg, sodium molybdate (Na
2MoO
42H
2O) 5.38mg, potassium iodide (KI) 22.0mg are dissolved in respectively in the 6ml water for injection, and above-mentioned each electrolyte solution is joined in the sorbitol solution, under agitation the hydrochloric acid solution of 2ml1M are joined in sorbitol/electrolyte solution then.
With Chlorizate chromium (CrCl
36H
2O) 5.87mg and sodium fluoride (NaF) 220mg is dissolved in respectively in the 11ml water for injection, and slowly joins in sorbitol/electrolyte solution.
After pH when regulating 20 ℃ with 1M hydrochloric acid is 2.0-2.6, be 1.1Kg with the volume-adjustment of medicinal liquid with water for injection.
Medicinal liquid is filtered in the aseptic receiving tank in fill district through 0.22 micron.
Use the filter and the glass container of sterilization on automatic filling machine, to be filled in the 10ml sterilization ampoule, and seal.The ampoule that fill is good keeps in Dark Place.
Use the ampoule Sterilization Kettle product that fill is good to sterilize 121 ℃ of sterilising temps, time 16-22 minute; To the ampoule leak test that dyes after the sterilization, the ne-leakage person promptly gets this product.Notice that the product after sterilization and the leak detection must keep in Dark Place.
Product appearance: almost colourless clear and bright solution; Assay: chromium (Cr) 0.022umol/ml, copper (Cu) 2.1umol/ml, ferrum (Fe) 2.1umol/ml, manganese (Mn) 0.52umol/ml, molybdenum (Mo) 0.023umol/ml, selenium (Se) 0.044umol/ml, zinc (Zn) 10.6umol/ml, iodine (I) 0.11umol/ml, fluorine (F) 5.3umol/ml, sorbitol 0.315g/ml; PH:2.4; Osmotic pressure: 1901mOsm/KgH2O.
After keeping in Dark Place 24 months, room temperature (0-25 ℃) rechecks product appearance: almost colourless clear and bright solution; Assay: chromium (Cr) 0.022umol/ml, copper (Cu) 2.1umol/ml, ferrum (Fe) 2.0umol/ml, manganese (Mn) 0.52umol/ml, molybdenum (Mo) 0.022umol/ml, selenium (Se) 0.043umol/ml, zinc (Zn) 10.5umol/ml, iodine (I) 0.10umol/ml, fluorine (F) 5.2umol/ml, sorbitol 0.320g/ml; PH:2.4; Osmotic pressure: 1901mOsm/KgH2O.
Example three
Iron chloride (FeCl
36H
2O): 601mg, zinc chloride (ZnCl
2) 1.496g, manganese chloride (MnCl
24H
2O) 109mg, copper chloride (CuCl
22H
2O) 374mg, sodium selenite (Na
2SeO
35H
2O) 12.6mg, sodium molybdate (Na
2MoO
42H
2O) 5.87mg, potassium iodide (KI) 24.0mg, chromium oxide (CrCl
36H
2O) 6.4mg, sodium fluoride (NaF) 231mg, sorbitol 330g, hydrochloric acid is an amount of, water for injection 767g.
Under agitation sorbitol 330g is dissolved in 550978-90 ℃ the water for injection.
With iron chloride (FeCl
36H
2O) 601mg is dissolved in 6ml and is added with in advance in the water for injection of 12u11M hydrochloric acid, with zinc chloride (ZnCl
2) 1.496gg, manganese chloride (MnCl
24H
2O) 109mg, copper chloride (CuCl
22H
2O) 374mg, sodium selenite (Na
2SeO
35H
2O) 12.6mg, sodium molybdate (Na
2MoO
42H
2O) 5.87mg, potassium iodide (KI) 24.0mg are dissolved in respectively in the 7ml water for injection, and above-mentioned each electrolyte solution is joined in the sorbitol solution, under agitation the hydrochloric acid solution of 2.1ml1M are joined in sorbitol/electrolyte solution then.
With Chlorizate chromium (CrCl
36H
2O) 6.4mg and sodium fluoride (NaF) 231mg is dissolved in respectively in the 12ml water for injection, and slowly joins in sorbitol/electrolyte solution.
Be to be 1.1Kg with water for injection with the volume-adjustment of medicinal liquid behind the 2.0-2.6 when regulating pH20 ℃ with 1M hydrochloric acid.
Medicinal liquid is filtered in the aseptic receiving tank in fill district through 0.22 micron.
Use the filter and the glass container of sterilization on automatic filling machine, to be filled in the 10ml sterilization ampoule, and seal.The ampoule that fill is good keeps in Dark Place.
Use the ampoule Sterilization Kettle product that fill is good to sterilize 121 ℃ of sterilising temps, time 16-22 minute; To the ampoule leak test that dyes after the sterilization, the ne-leakage person promptly gets this product.Notice that the product after sterilization and the leak detection must keep in Dark Place.
Product appearance: almost colourless clear and bright solution; Assay: chromium (Cr) 0.024umol/ml, copper (Cu) 2.2umol/ml, ferrum (Fe) 2.2umol/ml, manganese (Mn) 0.55umol/ml, molybdenum (Mo) 0.024umol/ml, selenium (Se) 0.048umol/ml, zinc (Zn) 11umol/ml, iodine (I) 0.12umol/ml, fluorine (F) 5.5umol/ml, sorbitol 0.33g/ml; PH:2.5; Osmotic pressure: 1903mOsm/KgH2O.
After keeping in Dark Place 24 months, room temperature (0-25 ℃) rechecks product appearance: yellowish clear and bright solution; Assay: chromium (Cr) 0.023umol/ml, copper (Cu) 2.2umol/ml, ferrum (Fe) 2.1umol/ml, manganese (Mn) 0.54umol/ml, molybdenum (Mo) 0.024umol/ml, selenium (Se) 0.046umol/ml, zinc (Zn) 10.9umol/ml, iodine (I) 0.11umol/ml, fluorine (F) 5.4umol/ml, sorbitol 0.33g/ml; PH:2.6; Osmotic pressure: 1902mOsm/KgH2O.
Discussion of results: because the increase of inventory, various determination of trace elements results all reach or the upper limit of the recipe quantity that is near the mark in product, thus this to fill a prescription be the upper limit that reality is implemented prescription.
Example four
Iron chloride (FeCl
36H
2O): 518mg, zinc chloride (ZnCl
2) 1.29g, manganese chloride (MnCl
24H
2O) 94mg, copper chloride (CuCl
22H
2O) 323mg, sodium selenite (Na
2SeO
35H
2O) 9.5mg, sodium molybdate (Na
2MoO
42H
2O) 4.40mg, potassium iodide (KI) 18.0mg, Chlorizate chromium (CrCl
36H
2O) 4.8mg, sodium fluoride (NaF) 200mg, sorbitol 285g, hydrochloric acid is an amount of, water for injection 812g.
Under agitation sorbitol 285g is dissolved in 500g, 78-90 ℃ the water for injection.
With iron chloride (FeCl
36H
2O) 518mg is dissolved in 6ml and is added with in advance in the water for injection of 11ul1M hydrochloric acid, with zinc chloride (ZnCl
2) 1.29g, manganese chloride (MnCl
24H
2O) 94mg, copper chloride (CuCl
22H
2O) 323mg, sodium selenite (Na
2SeO
35H
2O) 9.5mg, sodium molybdate (Na
2MoO
42H
2O) 4.40mg, potassium iodide (KI) 18.0mg are dissolved in respectively in the 6ml water for injection, and above-mentioned each electrolyte solution is joined in the sorbitol solution, under agitation the hydrochloric acid solution of 2ml1M are joined in sorbitol/electrolyte solution then.
With Chlorizate chromium (CrCl
36H
2O) 4.8mg and sodium fluoride (NaF) 200mg is dissolved in respectively in the 11ml water for injection, and slowly joins in sorbitol/electrolyte solution.
After pH when regulating 20 ℃ with 1M hydrochloric acid is 2.0-2.6, be 1.1Kg with the volume-adjustment of medicinal liquid with water for injection.
Medicinal liquid is filtered in the aseptic receiving tank in fill district through 0.22 micron.
Use the filter and the glass container of sterilization on automatic filling machine, to be filled in the 10ml sterilization ampoule, and seal.The ampoule that fill is good keeps in Dark Place.
Use the ampoule Sterilization Kettle product that fill is good to sterilize 121 ℃ of sterilising temps, time 16-22 minute; To the ampoule leak test that dyes after the sterilization, the ne-leakage person promptly gets this product.Notice that the product after sterilization and the leak detection must keep in Dark Place.
Product appearance: almost colourless clear and bright solution; Assay: chromium (Cr) 0.018umol/ml, copper (Cu) 1.9umol/ml, ferrum (Fe) 1.9umol/ml, manganese (Mn) 0.48umol/ml, molybdenum (Mo) 0.019umol/ml, selenium (Se) 0.036umol/ml, zinc (Zn) 9.6umol/ml, iodine (I) 0.10umol/ml, fluorine (F) 4.8umol/ml, sorbitol 0.285g/ml; PH:2.3; Osmotic pressure: 1899mOsm/KgH2O.
After keeping in Dark Place 24 months, room temperature (0-25 ℃) rechecks product appearance: almost colourless clear and bright solution; Assay: chromium (Cr) 0.019umol/ml, copper (Cu) 1.9umol/ml, ferrum (Fe) 1.9umol/ml, manganese (Mn) 0.47umol/ml, molybdenum (Mo) 0.019umol/ml, selenium (Se) 0.035umol/ml, zinc (Zn) 9.6umol/ml, iodine (I) 0.09umol/ml, fluorine (F) 4.7umol/ml, sorbitol 0.285g/ml; PH:2.2; Osmotic pressure: 1899mOsm/KgH2O.
Example five
Iron chloride (FeCl
36H
2O): 491mg, zinc chloride (ZnCl
2) 1.224g, manganese chloride (MnCl
24H
2O) 89mg, copper chloride (CuCl
22H
2O) 306mg, sodium selenite (Na
2SeO
35H
2O) 8.4mg, sodium molybdate (Na
2MoO
42H
2O) 3.90mg, potassium iodide (KI) 15.9mg, Chlorizate chromium (CrCl
36H
2O) 4.27mg, sodium fluoride (NaF) 189mg, sorbitol 270g, hydrochloric acid is an amount of, water for injection 827g.
Under agitation sorbitol 270g is dissolved in 450g, 78-90 ℃ the water for injection.
With iron chloride (FeCl
36H
2O) 491mg is dissolved in 6ml and is added with in advance in the water for injection of 10ul1M hydrochloric acid, with zinc chloride (ZnCl
2) 1.224g, manganese chloride (MnCl
24H
2O) 89mg, copper chloride (CuCl
22H
2O) 306mg, sodium selenite (Na
2SeO
35H
2O) 8.4mg, sodium molybdate (Na
2MoO
42H
2O) 3.90mg, potassium iodide (KI) 15.9mg are dissolved in respectively in the 6ml water for injection, and above-mentioned each electrolyte solution is joined in the sorbitol solution, under agitation the hydrochloric acid solution of 2ml1M are joined in sorbitol/electrolyte solution then.
With Chlorizate chromium (CrCl
36H
2O) 4.27mg and sodium fluoride (NaF) 189mg is dissolved in respectively in the 10ml water for injection, and slowly joins in sorbitol/electrolyte solution.
Be to be 1.1Kg with water for injection with the volume-adjustment of medicinal liquid behind the 2.0-2.6 when regulating pH20 ℃ with 1M hydrochloric acid.
Medicinal liquid is filtered in the aseptic receiving tank in fill district through 0.22 micron.
Use the filter and the glass container of sterilization on automatic filling machine, to be filled in the 10ml sterilization ampoule, and seal.The ampoule that fill is good keeps in Dark Place.
Use the ampoule Sterilization Kettle product that fill is good to sterilize 121 ℃ of sterilising temps, time 16-22 minute; To the ampoule leak test that dyes after the sterilization, the ne-leakage person promptly gets this product.Notice that the product after sterilization and the leak detection must keep in Dark Place.
Product appearance: colourless clear and bright solution; Assay: chromium (Cr) 0.016umol/ml, copper (Cu) 1.8umol/ml, ferrum (Fe) 1.9umol/ml, manganese (Mn) 0.46umol/ml, molybdenum (Mo) 0.017umol/ml, selenium (Se) 0.033umol/ml, zinc (Zn) 9.1umol/ml, iodine (I) 0.09umol/ml, fluorine (F) 4.6umol/ml, sorbitol 0.27g/ml; PH:2.2; Osmotic pressure: 1898mOsm/KgH2O.After keeping in Dark Place 24 months, room temperature (0-25 ℃) rechecks product appearance: almost colourless clear and bright solution; Assay: chromium (Cr) 0.016umol/ml, copper (Cu) 1.8umol/ml, ferrum (Fe) 1.8umol/ml, manganese (Mn) 0.45umol/ml, molybdenum (Mo) 0.016umol/ml, selenium (Se) 0.032umol/ml, zinc (Zn) 9.0umol/ml, iodine (I) 0.08umol/ml, fluorine (F) 4.5umol/ml, sorbitol 0.27g/ml; PH:2.1; Osmotic pressure: 1897mOsm/KgH2O.
Discussion of results: because the reduction of inventory, various determination of trace elements results all reach or the lower limit of the recipe quantity that is near the mark in product, thus this to fill a prescription be the lower limit that reality is implemented prescription.
Claims (7)
1, injection various trace elements injection, it is characterized in that containing in this product chromium 0.016-0.024ummol/ml, copper 1.8-2.2ummol/ml, ferrum 1.8-2.2ummol/ml, manganese 0.45-0.55ummol/ml, molybdenum 0.01 6-0.024ummol/ml, selenium 0.032-0.048ummol/ml, zinc 9.0-11.0ummol/ml, iodine 0.08-0.12ummol/ml, fluorine 4.5-5.5ummol/ml, sorbitol 0.27-0.33g/ml, hydrochloric acid is an amount of, all the other are water for injection; Contain in perhaps every this product of 10ml: Chlorizate chromium (CrCl
36H
2O) 42.6-64.0ug, copper chloride (CuCl
22H
2O) 3.06-3.74mg, iron chloride (FeCl
36H
2O) 4.86-5.94mg, manganese chloride (MnCl
24H
2O) 0.89-1.09mg, sodium molybdate (Na
2MoO
42H
2O) 38.8-58.2ug, Monohydrated selenium dioxide (Na
2SeO
35H
2O) 84-126ug, zinc chloride (ZnCl
2) 12.24-14.96mg, potassium iodide (KI) 132.8-199.2ug, sodium fluoride (NaF) 1.89-2.31mg, sorbitol 2.7-3.3g, hydrochloric acid is an amount of, all the other are water for injection.
2, the manufacture method of one kind of multiple micro-element injections is characterized in that:
A, under agitation sorbitol 270-330g/L is dissolved in 450-550g/L, 78-90 ℃ the water for injection;
B, with iron chloride (FeCl
36H
2O) 491-601mg/L is dissolved in 5-6ml and is added with in advance in the water for injection of 10-12ul1M hydrochloric acid, with zinc chloride (ZnCl
2) 1.224-1.496g/L, manganese chloride (MnCl
2.4H
2O) 89.0-109mg/L, copper chloride (CuCl
22H
2O) 306-374mg/L, sodium selenite (Na
2SeO
35H
2O) 8.4-12.6mg/L, sodium molybdate (Na
2MoO
42H
2O) 3.90-5.87mg/L, potassium iodide (KI) 15.9-24.0mg/L are dissolved in respectively in the 5-7ml water for injection, and above-mentioned each electrolyte solution joined in the sorbitol solution, under agitation the hydrochloric acid solution of 1.8-2.1ml1M is joined in sorbitol/electrolyte solution then;
C, with Chlorizate chromium (CrCl
36H
2O) 4.27-6.4mg/L and sodium fluoride (NaF) 189-231mg/L is dissolved in respectively in the 10-12ml water for injection, and slowly joins in sorbitol/electrolyte solution;
D, be 2.0-2.6 when regulating pH20 ℃ with hydrochloric acid;
3, method according to claim 2, it is characterized in that e, again the medicinal liquid after will handling through the d operation through 0.22 micron membrane filtration to the aseptic receiving tank in fill district.
4, method according to claim 3 is characterized in that through after the processing of e operation, carries out f, the filter that uses sterilization and glass container again and is filled on automatic filling machine in the 10ml sterilization ampoule, and seal; The ampoule that fill is good keeps in Dark Place;
5, method according to claim 4 is characterized in that carrying out g again, using the ampoule Sterilization Kettle product that fill is good to sterilize 121 ℃ of sterilising temps, time 16-22 minute through after the processing of f operation; To the ampoule leak test that dyes after the sterilization, the ne-leakage person promptly gets this product.Notice that the product after sterilization and the leak detection must keep in Dark Place.
6, method according to claim 2 is characterized in that preparing tank is a kind of preparing tank with mixing plant.
7, the using method of various trace elements injection, it is characterized in that under the guaranteed prerequisite of compatibility, can be under aseptic condition this product of 10ml be joined infusion in Amino Acid Compound Injection or the glucose injection 500ml, but must in 24 hours, finish using.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031127126A CN1517085A (en) | 2003-01-15 | 2003-01-15 | Multi-microelement injecta and its preparation method and application |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031127126A CN1517085A (en) | 2003-01-15 | 2003-01-15 | Multi-microelement injecta and its preparation method and application |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1517085A true CN1517085A (en) | 2004-08-04 |
Family
ID=34283632
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031127126A Pending CN1517085A (en) | 2003-01-15 | 2003-01-15 | Multi-microelement injecta and its preparation method and application |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1517085A (en) |
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| CN1330315C (en) * | 2005-08-25 | 2007-08-08 | 天津市轩宏医药技术有限公司 | Freeze dry formulation of microelement and method for preparing the same |
| CN102526103A (en) * | 2010-12-07 | 2012-07-04 | 西藏海思科药业集团股份有限公司 | Multi-trace element injection and preparation method thereof |
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| CN107693539A (en) * | 2016-08-09 | 2018-02-16 | 刘力 | The medical composition and its use of various trace elements |
| CN108498541A (en) * | 2018-06-05 | 2018-09-07 | 百正药业股份有限公司 | The preparation method of one kind of multiple micro-element injections |
| CN113023752A (en) * | 2021-03-11 | 2021-06-25 | 合肥市未来药物开发有限公司 | Potassium iodide and preparation method and application thereof |
| CN113332237A (en) * | 2021-04-30 | 2021-09-03 | 北京诺康达医药科技股份有限公司 | Selenium-containing injection and preparation method thereof |
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