Compound vitamin lyophilized powder injection composition for injection and preparation method thereof

A technology for compound vitamins and freeze-dried powder injections, which is applied in freeze-dried delivery, drug combination, active ingredients of heterocyclic compounds, etc. It can solve the problems of affecting product stability and quality, increasing the pH value of local solutions, and increasing vitamin C degradation, etc. problem, achieve the effect of reducing the risk of medication, making the preparation steps simple and easy, and reducing degradation

Active Publication Date: 2015-04-08
北京柏雅联合药物研究所有限公司
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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
Since vitamin C is very sensitive to pH and temperature, it is more unstable in the solution, so the change of local solution pH will lead to the degradation of vitamin C, generate related substances or impurities, and affect the stability and quality of the final product
However, in the prior art, adding a pH adjuster to a solution containing vitamin C will inevitably increase the pH of the local solution. Even if the dispersion of the active ingredient is accelerated by nitrogen filling and rapid stirring, the occurrence of active ingredients cannot be avoided. degradation
And different pH adjusters may also have other problems, such as sodium hydro

Method used

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  • Compound vitamin lyophilized powder injection composition for injection and preparation method thereof
  • Compound vitamin lyophilized powder injection composition for injection and preparation method thereof
  • Compound vitamin lyophilized powder injection composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 1. Prescription:

[0033]

[0034] Two. Method

[0035] Weigh 200g vitamin C and mix with 73.5g sodium bicarbonate, add to 1800ml 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 nuclear yellow Phosphate Sodium Phosphate (5g in terms of riboflavin) was stirred and dissolved; adding activated carbon 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; filtered through a 0.22 μm microporous membrane, It is filled into 1000 preparation units and freeze-dried to obtain the product.

Embodiment 2

[0037] 1. Prescription:

[0038]

[0039]

[0040] Two. Preparation method:

[0041] Weigh 200g vitamin C and mix with 69g sodium bicarbonate, add to 2700ml 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; adding activated carbon 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; filtered through a 0.22 μm microporous membrane, poured Pack into 1000 preparation units, freeze-dry, and obtain immediately.

Embodiment 3

[0043] 1. Prescription:

[0044]

[0045] Two. Preparation method:

[0046] Weigh 200g vitamin C and mix with 93g sodium bicarbonate, add to 2000ml 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 (calculated as riboflavin 5g) was stirred and dissolved; adding activated carbon for needles with a weight-to-volume ratio of 0.05%, filtered after stirring for 30 minutes, and then added 1000ml water for injection to 3000ml; filtered through a 0.22 μm microporous membrane, poured Pack into 1000 preparation units, freeze-dry, and obtain immediately.

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PUM

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Abstract

The invention discloses a compound vitamin lyophilized powder injection composition for injection and a preparation method thereof, and belongs to the field of pharmacy. Unit preparation is prepared from 10mg of vitamin B1 serving as an active ingredient, 5mg of riboflavin sodium phosphate based on riboflavin and 200mg of vitamin C. The composition has the advantages of simple preparation process, short production time and high production efficiency, and the prepared product has controllable quality and excellent stability.

Description

technical field [0001] The invention relates to a compound vitamin freeze-dried powder composition for injection and a preparation method thereof, belonging to the field of pharmacy. Background technique [0002] Compound vitamins for injection are sterile freeze-dried preparations made of vitamin B1, riboflavin sodium phosphate, vitamin C and pharmaceutical excipients, and belong to vitamin medicines. [0003] Compound vitamin injection is used for vitamin supplementation, that is, it is used when a large amount of vitamin supplements are required but cannot be fully ingested through food (such as wasting diseases, pregnant women, and lactating women). Many diseases are accompanied by the deficiency of vitamin B1, vitamin B2, and vitamin C, and patients need targeted supplementation during treatment, such as neuralgia, neuritis, muscle atrophy, digestive organ disorders, oral organ inflammation, skin inflammation, retinopathy Wait. Patients who cannot adequately take in v...

Claims

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Application Information

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IPC IPC(8): A61K31/675A61K9/19A61P3/02A61K31/51A61K31/375
CPCA61K9/0019A61K9/19A61K31/375A61K31/51A61K31/675A61K2300/00
Inventor 李迪陈曼刘坤
Owner 北京柏雅联合药物研究所有限公司
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