CN103565811B - Compound vitamin lyophilized preparation for injection and its preparation method - Google Patents
Compound vitamin lyophilized preparation for injection and its preparation method Download PDFInfo
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- CN103565811B CN103565811B CN201210248472.XA CN201210248472A CN103565811B CN 103565811 B CN103565811 B CN 103565811B CN 201210248472 A CN201210248472 A CN 201210248472A CN 103565811 B CN103565811 B CN 103565811B
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Abstract
The invention relates to a compound vitamin lyophilized preparation for injection and its preparation method. According to the invention, a scientific prescription and preparation process are utilized to make the prepared compound vitamin lyophilized preparation for injection have the advantages of high stability, low impurity content and the like.
Description
Technical field
The present invention relates to pharmaceutical field, be specifically related to a kind of composite vitamin for injection lyophilized formulations and preparation method thereof.
Background technology
Parenteral alimentation is made up of carbohydrate, aminoacid, fat milk, electrolyte, vitamin, trace element and the required nutritional factors of water seven large body, directly inputs the injection of body in the mode of periphery or central vein intubate.Seven large nutritional factorss have been mixed in proportion very important meaning, can play to critical patient the effect that maintains, extends and save life, the patient of normal feed or superelevation metabolism be played and correct negative nitrogen balance, promote wound healing, put on weight and improve the effect of survival rate.
Water soluble vitamins comprises vitamin C and vitamin B group, is to maintain the necessary nutrient substance of normal physiological activity, participates in the homergy of tissue and cell; Meanwhile, water soluble vitamins is in body, to be difficult to one group of compound synthetic and that store, must from food, obtain by quantitative timing.Although normal human's demand is very micro-, Deficiency of Intake just can cause various diseases.It is global nutritional problem that water soluble vitamins lacks.Vitimin supplement is the important content of parenteral alimentation, is also the important component part of intravenous nutrition.
Vitamin B
1(thiamine hydrochloride) exists with sequestered in human plasma, in liver, become pyrophosphate by pyrophosphorylation, i.e. cocarboxylase (TPP).Tricarboxylic acid cycle in the aerobic oxidation metabolic process of TPP involved in sugar in human body.In the time of Vitamin B1 deficiency, cocarboxylase cannot form, thereby tricarboxylic acid cycle is obstructed, and carbohydrate metabolism can not normally be carried out.Vitamin B
1easily excrete, do not pile up intoxicating phenomenon.Only, in the time of intravenous injection, occasionally there are medicine heat and anaphylaxis.
Vitamin B
2(riboflavin) is one of composition of respiratory chain, is the coenzyme of the flavo-enzyme such as flavin adenine (FAD) and flavin mononucleotide (FMN) (FMN), participates in the transmission of hydrogen in biological oxidation process.If there is no vitamin B
2, biological oxidation process can not be carried out smoothly.Vitamin B
2the also somatic normal growth of participant.Use vitamin B
2the normal yellow of discharging is urinated, but has no adverse reaction.
Vitamin C (ascorbic acid) is easily oxidized, participates in the transmission of hydrogen, participates in organism redox reaction, in Cellular respiration process, plays an important role.Vitamin C is also participated in the synthetic of lysine and proline hydroxylase, and these enzymes are to maintain the necessary material of collagen fiber normal configuration, therefore the C that is deficient in vitamin can cause vitamin C deficiency.Vitamin C also has antagonism radical damage, improves body's immunity, check melanin nucleus formation, and participates in iron metabolism, has the effect of protection hemoglobin.
1985, Fuso Pharmaceuticals Industries, Ltd. of Japan has developed compound vitamin (3) injection, be mainly used in vitamin supply, cannot fully absorb by food at a large amount of vitimin supplement of needs time, use, as wasting diseases, gravid woman, nursing women.
Compared with injection, sterile freeze-drying preparation has good stability, transports the advantages such as more convenient.But the prescription of composite vitamin for injection lyophilized formulations, especially freeze-dry process, be that can sterile freeze-drying preparation finally form, with and the important factor in order of quality good or not.Developing the composite vitamin for injection lyophilized formulations that stability is high, impurity content is low is to need those skilled in the art to put forth effort the technical problem solving.
Summary of the invention
The invention provides a kind of composite vitamin for injection lyophilized formulations and preparation method thereof.Completing in process of the present invention, inventor finds that different freeze-drying curves is huge to the quality influence of this product; In addition, even if choose optimized freeze-drying curve, in the present invention, the different order of addition of each component of lyophilized formulations in layoutprocedure also can produce different impacts to final product quality.Inventor, by the collocation method of different lyophilizing parameters and lyophilized formulations has been carried out to a large amount of research and experiments, has finally completed the present invention.Composite vitamin for injection lyophilized formulations of the present invention has advantages of that stability is high, impurity content is low.
Particularly, the present invention relates to a kind of composite vitamin for injection lyophilized formulations, its prescription is as follows:
The invention still further relates to a kind of preparation method of composite vitamin for injection lyophilized formulations, and the composite vitamin for injection lyophilized formulations that utilizes the method to prepare, described method is as follows:
1), after calcium disodium edetate 0.5g is dissolved in water, 0.22um filters;
2) in filtrate, add 60% amount water for injection;
3) add vitamin C 200g, with sodium bicarbonate adjusting pH value to 5.0;
4) add successively glycine 300g, vitamin B
110g and in the riboflavin sodium phosphate 5g of riboflavin, regulates pH value to 5.0 with sodium bicarbonate;
5) 0.22um filters;
6) water for injection adds to 3000ml, and 0.22um filters, with 1000 bottles of the amount fills of 3ml/ bottle;
7) lyophilization.
Wherein, step 7) lyophilization step as follows:
A) pre-freeze: goods cartonning, treat that sample temperature is down to-40 DEG C, be warming up to-15 DEG C～-20 DEG C, preferably 40～50 DEG C/h of heating rates, more preferably 40 DEG C/h, make sample temperature be down to-45 DEG C following after, be incubated 3 hours;
B) evacuation: pre-freeze is finished, starts condenser refrigeration, is down to below-50 DEG C, opens vacuum pump, makes freeze drying box vacuum be less than 0.15mba;
C) dry for the first time: after vacuum meets the requirements, start electrical heating, control and heat up, preferably 10～20 DEG C/h of heating rates, more preferably 10 DEG C/h, in-32 DEG C sublime up into sample below, watermark disappears, and is incubated 1～2 hour;
D) dry for the second time: control and be warming up to 30 DEG C, preferably 8～10 DEG C/h of heating rates,, are incubated 6 hours by more preferably 8 DEG C/h;
E) tamponade, air inlet outlet, rolls mouth with aluminium-plastic combined cover.
In addition, the invention still further relates to described composite vitamin for injection lyophilized formulations and treat and/or prevent the purposes in avitaminosis in preparation.
The present invention, by rational material addition sequence, has avoided influencing each other between various vitamin, has increased the stability of product.The change (seeing embodiment 9～10) of material addition sequence in composite vitamin for injection lyophilized formulations prescription of the present invention, (seeing embodiment 11) obviously raises the impurity content that makes preparation of the present invention.Meanwhile, lyophilization step is on the impact of formulation products quality of the present invention also highly significant.The preferred freeze-drying curve of the present invention (seeing embodiment 2～4) can make product appearance smooth, color even is consistent, residual moisture content is qualified, good stability, can long term storage, make effectiveness and the safety of medicine obtain sound assurance, particularly the prescription of embodiment 3 and preparation technology have obtained optimum product.
Detailed description of the invention
Following embodiment, only for further illustrating the present invention, should not be interpreted as any limitation of the invention.
All medicines and the reagent that the present invention relates to are commercial.
Embodiment 1 composite vitamin for injection lyophilized formulations
Prescription:
Preparation technology: get calcium disodium edetate 0.5g, 100 times of water gagings that add about calcium disodium edetate dissolve, 60 DEG C of stirrings of active carbon of solubilization dosage 0.05% 15 minutes, filter carbon removal, with 0.22 μ m membrane filtration, add the water for injection of total amount 60%, measure vitamin C by prescription and add dissolving, gradation adds appropriate sodium bicarbonate, makes the pH value of solution maintain 5.0.To the greatest extent not when gassing, add glycine, vitamin B1 and riboflavin sodium phosphate by recipe quantity until the carbon dioxide ease of solution, be stirred to dissolve, with manganese hydrogen sodium regulating solution pH value to 5.0 left and right, add the needle-use activated carbon of 0.05% (w/v), stir, leave standstill the de-charcoal of coarse filtration after 15 minutes, benefit injects water to enough, checks now pH value and the content of product, qualified after, after 0.22 μ m filters, every bottle of about 3ml of fill, adds half plug, lyophilization:
A) pre-freeze: goods cartonning, treat that sample temperature is down to-40 DEG C, be warming up to-10 DEG C (heating rate is 50 DEG C/h), start compressor, make sample temperature be down to-45 DEG C following after, be incubated 3 hours;
B) evacuation: pre-freeze is finished, starts condenser refrigeration, is down to below-50 DEG C, opens vacuum pump, makes freeze drying box vacuum be less than 0.15mba;
C) dry for the first time: after vacuum meets the requirements, start electrical heating, control and heat up (heating rate is 10 DEG C/h), in-32 DEG C sublime up into sample below, watermark disappears, and is incubated 2 hours;
D) dry for the second time: to control and be warming up to 30 DEG C (heating rate is 10 DEG C/h), be incubated 6 hours;
E) tamponade, air inlet outlet, rolls mouth with aluminium-plastic combined cover.
Embodiment 2 composite vitamin for injection lyophilized formulations
Preparation technology outside prescription and lyophilization is with embodiment 1, and difference is in lyophilization step:
A) pre-freeze: goods cartonning, treat that sample temperature is down to-40 DEG C, be warming up to-15 DEG C (heating rate is 50 DEG C/h), start compressor, make sample temperature be down to-45 DEG C following after, be incubated 3 hours;
B) evacuation: pre-freeze is finished, starts condenser refrigeration, is down to below-50 DEG C, opens vacuum pump, makes freeze drying box vacuum be less than 0.15mba;
C) dry for the first time: after vacuum meets the requirements, start electrical heating, control and heat up (heating rate is 10 DEG C/h), in-32 DEG C sublime up into sample below, watermark disappears, and is incubated 2 hours;
D) dry for the second time: to control and be warming up to 30 DEG C (heating rate is 10 DEG C/h), be incubated 6 hours;
E) tamponade, air inlet outlet, rolls mouth with aluminium-plastic combined cover.
Embodiment 3 composite vitamin for injection lyophilized formulations
Preparation technology outside prescription and lyophilization is with embodiment 1, and difference is in lyophilization step:
A) pre-freeze: goods cartonning, treat that sample temperature is down to-40 DEG C, be warming up to-20 DEG C (heating rate is 40 DEG C/h), start compressor, make sample temperature be down to-45 DEG C following after, be incubated 3 hours;
B) evacuation: pre-freeze is finished, starts condenser refrigeration, is down to below-50 DEG C, opens vacuum pump, makes freeze drying box vacuum be less than 0.15mba;
C) dry for the first time: after vacuum meets the requirements, start electrical heating, control and heat up (heating rate is 10 DEG C/h), in-32 DEG C sublime up into sample below, watermark disappears, and is incubated 2 hours;
D) dry for the second time: to control and be warming up to 30 DEG C (heating rate is 8 DEG C/h), be incubated 6 hours;
E) tamponade, air inlet outlet, rolls mouth with aluminium-plastic combined cover.
Embodiment 4 composite vitamin for injection lyophilized formulations
Preparation technology outside prescription and lyophilization is with embodiment 1, and difference is in lyophilization step:
A) pre-freeze: goods cartonning, treat that sample temperature is down to-40 DEG C, be warming up to-20 DEG C (heating rate is 40 DEG C/h), start compressor, make sample temperature be down to-45 DEG C following after, be incubated 3 hours;
B) evacuation: pre-freeze is finished, starts condenser refrigeration, is down to below-50 DEG C, opens vacuum pump, makes freeze drying box vacuum be less than 0.15mba;
C) dry for the first time: after vacuum meets the requirements, start electrical heating, control and heat up (heating rate is 20 DEG C/h), in-32 DEG C sublime up into sample below, watermark disappears, and is incubated 2 hours;
D) dry for the second time: to control and be warming up to 30 DEG C (heating rate is 10 DEG C/h), be incubated 6 hours;
E) tamponade, air inlet outlet, rolls mouth with aluminium-plastic combined cover.
Embodiment 5 composite vitamin for injection lyophilized formulations (reference examples)
Preparation technology outside prescription and lyophilization is with embodiment 2, and difference is that lyophilization step heating rate a) is 50 DEG C/h, and step heating rate c) is 20 DEG C/h, steps d) heating rate be 10 DEG C/h.
Embodiment 6 composite vitamin for injection lyophilized formulations (reference examples)
Preparation technology outside prescription and lyophilization is with embodiment 3, and difference is that lyophilization step heating rate a) is 50 DEG C/h, and step heating rate c) is 10 DEG C/h, steps d) heating rate be 8 DEG C/h.
Embodiment 7 composite vitamin for injection lyophilized formulations (reference examples)
Preparation technology outside prescription and lyophilization is with embodiment 4, and difference is that lyophilization step heating rate a) is 40 DEG C/h, and step heating rate c) is 10 DEG C/h, steps d) heating rate be 8 DEG C/h.
Embodiment 8 composite vitamin for injection lyophilized formulations (reference examples)
Preparation technology outside prescription and lyophilization is with embodiment 3, and difference is that lyophilization step heating rate a) is 45 DEG C/h, and step heating rate c) is 10 DEG C/h, steps d) heating rate be 8 DEG C/h.
Embodiment 9 composite vitamin for injection lyophilized formulations (reference examples)
Prescription: with embodiment 1.
Preparation technology: get calcium disodium edetate 0.5g, add approximately 100 times of water dissolutioies, 60 DEG C of stirrings of active carbon of solubilization dosage 0.05% 15 minutes, filter carbon removal, with 0.22 μ m membrane filtration, add 60% water for injection, add glycine, vitamin B1 and riboflavin sodium phosphate by recipe quantity, be stirred to dissolve, measure vitamin C by prescription and add dissolving, gradation adds appropriate sodium bicarbonate, makes the pH value of solution maintain 5.0.Until the carbon dioxide ease of solution to the greatest extent not when gassing, with manganese hydrogen sodium regulating solution pH value to 5.0 left and right, add the needle-use activated carbon of 0.05% (w/v), stir, leave standstill the de-charcoal of coarse filtration after 15 minutes, benefit injects water to enough, checks pH value and the content of intermediate, qualified after, after 0.22 μ m sterilizing filter membrane fine straining, every bottle of about 3ml of fill, adds half plug, lyophilization (lyophilization step is with embodiment 2).
Embodiment 10 composite vitamin for injection lyophilized formulations (reference examples)
Prescription: with embodiment 1.
Preparation technology: measure glycine, vitamin B1 and riboflavin sodium phosphate by prescription, add water and be stirred to dissolve, add calcium disodium edetate 0.5g, be stirred to dissolve, 60 DEG C of stirrings of active carbon of solubilization dosage 0.05% 15 minutes, filter carbon removal, with 0.22 μ m membrane filtration, add 60% water for injection, measure vitamin C by prescription and add dissolving, gradation adds appropriate sodium bicarbonate, makes the pH value of solution maintain 5.0.Until the carbon dioxide ease of solution to the greatest extent not when gassing, with manganese hydrogen sodium regulating solution pH value to 5.0 left and right, add the needle-use activated carbon of 0.05% (w/v), stir, leave standstill the de-charcoal of coarse filtration after 15 minutes, benefit injects water to enough, checks pH value and the content of intermediate, qualified after, after 0.22 μ m filters, every bottle of about 3ml of fill, adds half plug, lyophilization (lyophilization step is with embodiment 3).
The stability experiment of the composite vitamin for injection lyophilized formulations of embodiment 11 embodiment 1～10 preparations
Declare quality standard according to composite vitamin for injection (3), the composite vitamin for injection lyophilized formulations of embodiment 1～10 preparation is detected, result is as follows:
Table 1 stability experiment result (0 month)
Table 2 stability experiment result (6 months, temperature: 40 DEG C, humidity 75%)
Claims (6)
1. a composite vitamin for injection lyophilized formulations, its prescription is as follows:
Vitamin B1 10g,
In the riboflavin sodium phosphate 5g of riboflavin,
Vitamin C 200g,
Sodium bicarbonate is appropriate, pH 5.0,
Glycine 300g,
Calcium disodium edetate 0.5g,
Water for injection adds to 3000ml,
Make 1000 bottles;
It is prepared as follows:
1), after calcium disodium edetate 0.5g is dissolved in water, 0.22 μ m filters,
2) in filtrate, add 60% amount water for injection,
3) add vitamin C 200g, with sodium bicarbonate adjusting pH value to 5.0,
4) add successively glycine 300g, vitamin B
110g and in the riboflavin sodium phosphate 5g of riboflavin, regulates pH value to 5.0 with sodium bicarbonate,
5) 0.22 μ m filters,
6) water for injection adds to 3000ml, and 0.22 μ m filters, with 1000 bottles of the amount fills of 3ml/ bottle,
7) lyophilization;
Wherein, the lyophilization step of step 7) is as follows:
A) pre-freeze: goods cartonning, treat that sample temperature is down to-40 DEG C, be warming up to-15 DEG C～-20 DEG C, keep 30 minutes, cooling make sample temperature be down to-45 DEG C following after, be incubated 3 hours,
B) evacuation: pre-freeze is finished, starts condenser refrigeration, is down to below-50 DEG C, opens vacuum pump, makes freeze drying box vacuum be less than 0.15mba,
It is c) dry for the first time: after vacuum meets the requirements, start electrical heating, control and heat up, in-32 DEG C sublime up into sample below, watermark disappears, and is incubated 1～2 hour,
D) dry for the second time: control and be warming up to 30 DEG C, be incubated 6 hours,
E) tamponade, air inlet outlet, rolls mouth with aluminium-plastic combined cover.。
2. composite vitamin for injection lyophilized formulations according to claim 1, wherein the heating rate of step a) is 50 DEG C/h, and the heating rate of step c) is 10 DEG C/h, and the heating rate of step d) is 10 DEG C/h.
3. composite vitamin for injection lyophilized formulations according to claim 1, wherein the heating rate of step a) is 40 DEG C/h, and the heating rate of step c) is 10 DEG C/h, and the heating rate of step d) is 8 DEG C/h.
4. composite vitamin for injection lyophilized formulations according to claim 1, wherein the heating rate of step a) is 40 DEG C/h, and the heating rate of step c) is 20 DEG C/h, and the heating rate of step d) is 10 DEG C/h.
5. composite vitamin for injection lyophilized formulations according to claim 1, wherein the heating rate of step a) is 50 DEG C/h, and the heating rate of step c) is 20 DEG C/h, and the heating rate of step d) is 10 DEG C/h.
6. composite vitamin for injection lyophilized formulations according to claim 1, wherein the heating rate of step a) is 50 DEG C/h, and the heating rate of step c) is 10 DEG C/h, and the heating rate of step d) is 8 DEG C/h.
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| CN104490902B (en) * | 2014-12-30 | 2018-04-27 | 李迪 | A kind of composite vitamin for injection freeze drying powder injection composition and preparation method thereof |
| CN109364082A (en) * | 2018-06-08 | 2019-02-22 | 河北爱尔海泰制药有限公司 | A kind of high stability composite vitamin for injection lyophilized preparation composition |
| CN108815166A (en) * | 2018-08-16 | 2018-11-16 | 济南康和医药科技有限公司 | A kind of Compound vitamine injection and preparation method thereof |
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| CN101623293A (en) * | 2009-08-20 | 2010-01-13 | 北京普瑞博思投资有限公司 | Medical composition for injection |
| CN102552294A (en) * | 2012-01-10 | 2012-07-11 | 辽宁海思科制药有限公司 | Compound vitamin (3) freeze-dried powder injection for injection and preparation method and analysis method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101623293A (en) * | 2009-08-20 | 2010-01-13 | 北京普瑞博思投资有限公司 | Medical composition for injection |
| CN102552294A (en) * | 2012-01-10 | 2012-07-11 | 辽宁海思科制药有限公司 | Compound vitamin (3) freeze-dried powder injection for injection and preparation method and analysis method thereof |
Non-Patent Citations (2)
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| 易建勇.注射用十二种复合维生素的冻干曲线研究.《今日药学》.2010,第20卷(第3期),25-27. |
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