Compound vitamin medicine composition for injection and preparation method of compound vitamin medicine composition

A technology for compound vitamins and vitamins, applied in the directions of drug combinations, active ingredients of heterocyclic compounds, and freeze-dried delivery, etc., can solve the problems of large fluctuations in pH value and temperature, decline in product quality and stability, and accelerated decomposition of vitamin C, etc. Achieving the effect of less impurity content, avoiding degradation and impurity generation, and avoiding degradation

Inactive Publication Date: 2015-05-13
王大光
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Third, aqueous injection preparations have certain limitations in transportation and storage conditions
The above-mentioned patent directly uses sodium hydroxide to adjust the pH value of the solution containing vitamin C, resulting in large fluctuations in the pH value and temperature of the local solution, and sodium hydroxide al

Method used

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  • Compound vitamin medicine composition for injection and preparation method of compound vitamin medicine composition
  • Compound vitamin medicine composition for injection and preparation method of compound vitamin medicine composition
  • Compound vitamin medicine composition for injection and preparation method of compound vitamin medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] 1. Prescription:

[0031]

[0032]

[0033] Two. Method

[0034] Weigh 120g vitamin C and 90g vitamin C sodium, add to 2500ml water for injection, stir to dissolve; add 300g glycine and 0.5g calcium sodium edetate, stir to dissolve, then add 10g vitamin B1 and 6.355g riboflavin Sodium phosphate (5 g in terms of riboflavin) was stirred and dissolved, and the pH value of the solution was about 4.0; adding activated carbon for needles with a weight to volume ratio of 0.05%, filtered after stirring for 30 minutes, and then added 500 ml of water for injection to 3000 ml; It is filtered through a microporous membrane, filled into 1000 preparation units, and freeze-dried to obtain the product.

[0035] The freeze-drying operation is as follows: the product is put into the freeze-drying box, pre-frozen to below -40°C, crystallized and heated to -12°C, then cooled to below -40°C, heated to 40°C after vacuuming, kept at this temperature for 8 hours, frozen dry end.

Embodiment 2

[0037] 1. Prescription:

[0038]

[0039] Two. Preparation method:

[0040] Weigh 63.8g vitamin C and 153.3g vitamin C sodium, add to 2700ml water for injection, stir to dissolve; add 300g glycine and 0.5g edetate calcium sodium, stir to dissolve, then add 10g vitamin B1 and 6.355g core Sodium flavin phosphate (5 g in terms of riboflavin) was stirred and dissolved; the pH value of the solution was about 4.5; adding gac for needles with a weight to volume ratio of 0.05%, filtered after stirring for 30 minutes, and then added 300 ml of water for injection to 3000 ml; Filter through a 0.22 μm microporous membrane, fill into 1000 preparation units, and freeze-dry to obtain the product.

[0041] The freeze-drying operation is as follows: the product is put into the freeze-drying box, pre-frozen to below -40°C, crystallized and heated to -12°C, then cooled to below -40°C, heated to 40°C after vacuuming, kept at this temperature for 8 hours, frozen dry end.

Embodiment 3

[0043] 1. Prescription:

[0044]

[0045] Two. Preparation method:

[0046] Weigh 25.7g vitamin C and 195.6g vitamin C sodium, add to 1800ml water for injection, stir to dissolve; add 300g glycine and 0.5g edetate calcium sodium, stir to dissolve, then add 10g vitamin B1 and 6.355g core Sodium flavin phosphate (5g in terms of riboflavin) was stirred and dissolved; the pH value of the solution was about 5.0; adding gac for needles with a weight to volume ratio of 0.05%, filtered after stirring for 30 minutes, and then added 1200ml water for injection to 3000ml; Filter through a 0.22 μm microporous membrane, fill into 1000 preparation units, and freeze-dry to obtain the product.

[0047] The freeze-drying operation is as follows: the product is put into the freeze-drying box, pre-frozen to below -40°C, crystallized and heated to -12°C, then cooled to below -40°C, heated to 40°C after vacuuming, kept at this temperature for 8 hours, frozen dry end.

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PUM

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Abstract

The invention discloses a compound vitamin medicine composition for injection and a preparation method of the compound vitamin medicine composition and belongs to the field of pharmacy. The compound vitamin medicine composition for injection in unit preparation comprises the following active ingredients: 110 mg of vitamin B, 5 mg of riboflavin sodium phosphate calculated by riboflavin and 200 mg of vitamin C. The composition has the advantages that pH (potential of hydrogen) is stable, the degradation of vitamin C is reduced, the stability of the active ingredients is improved, a preparation technology is simple, the production time is shortened, the safety is high, and the composition is suitable for mass production.

Description

technical field [0001] The invention relates to a compound vitamin pharmaceutical composition for injection and a preparation method thereof, belonging to the field of pharmacy. Background technique [0002] The compound vitamin injection provides intravenous nutritional supplements to improve the nutritional status of the patient's whole body and prolong the patient's life. It is used for the supplement when some vitamins cannot be fully taken in through food, such as wasting disease, pregnant women, breastfeeding women, etc.; it is used for those who cannot eat for more than seven days due to disease or surgical factors, or the amount of food intake cannot maintain the body Patients who require further treatment or surgery and short bowel disease. With the improvement of people's living standards, the clinical application of total parenteral nutrition is becoming more and more extensive, and the market potential is huge. [0003] Based on the needs of the market and pati...

Claims

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Application Information

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IPC IPC(8): A61K31/675A61K9/19A61K47/22A61P3/02A61K31/51A61K31/375
Inventor 王大光刘文辉李雪明
Owner 王大光
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