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Bacteriostat-free water-soluble vitamin freeze-dried preparation for injection

A technology for water-soluble vitamins and freeze-dried preparations, which can be used in medical preparations containing active ingredients, freeze-dried delivery, organic active ingredients, etc., and can solve the problems of inducing allergic reactions, reducing the incidence and severity of clinical adverse reactions, etc. Achieve the effect of eliminating the storage process and preventing recontamination

Active Publication Date: 2007-08-01
费森尤斯卡比华瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although it will not cause systemic poisoning reaction at the above concentration, there is still the possibility of inducing allergic reaction. Therefore, on the premise of reaching the product sterility standard, reducing the amount of bacteriostatic agent used as much as possible will improve the safety of the product. Reducing the incidence and severity of clinical adverse reactions has an obvious positive effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Accurately weigh the following raw materials: thiamine nitrate 3.1mg, riboflavin sodium phosphate 4.9mg, nicotinamide 40mg, pyridoxine hydrochloride 4.9mg, sodium pantothenate 16.5mg, vitamin C sodium 113mg, biotin 60μg, folic acid 0.4mg, vitamin B 12 5.0μg, glycine 300mg, disodium edetate 0.5mg.

[0033] Add the above-mentioned raw materials one by one into water for injection not exceeding 60°C, stir to dissolve, and adjust the total weight with water for injection; the dissolution process should be protected from light, and always protected by sterile filtered nitrogen; the final pH of the liquid is 5.6- 6.1;

[0034] The liquid medicine is sterile filtered to the receiving tank and protected with nitrogen;

[0035] Fill the sterile-filtered medicinal liquid into cleaned and sterilized vials within 12 hours with an automatic filling machine, and the filling volume of each vial is 2ml; stopper the upper half of the vial;

[0036] Immediately after filling, freeze-d...

Embodiment 2

[0041] Accurately weigh the following raw materials: 2.79mg of thiamine nitrate, 4.41mg of riboflavin sodium phosphate, 36mg of nicotinamide, 4.41mg of pyridoxine hydrochloride, 14.85mg of sodium pantothenate, 101.7mg of sodium vitamin C, 54μg of biotin, 0.36mg of folic acid, Vitamin B 12 4.5μg, glycine 270mg, edetate disodium 0.45mg; processing method is the same as above

Embodiment 3

[0043] Accurately weigh the following raw materials: 3.41 mg of thiamine nitrate, 5.39 mg of riboflavin sodium phosphate, 44 mg of nicotinamide, 5.39 mg of pyridoxine hydrochloride, 18.15 mg of sodium pantothenate, 124.3 mg of sodium vitamin C, 66 μg of biotin, 0.44 mg of folic acid, Vitamin B 12 5.5μg, 330mg glycine, 0.55mg disodium edetate; the treatment method is the same as above.

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PUM

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Abstract

Disclosed is an water soluble vitamin freeze-drying preparation containing no bacteria inhibitor, wherein each bottle of the preparation comprises constituents of aneurine mononitrate 2.79-3.41mg, riboflavin sodium phosphate 4.41-5.39mg, nicotinamide 36-44mg, chlorhydric pyridoxine 4.41-5.39mg, sodium pantothenate 14.85-18.15mg, vitamin C sodium 101.7-124.3mg, biotin 54-66mug, folic acid 0.36-0.44mg, vitamin B12 4.5-5.5mug, glycine 270-330mg, and dium ethylenediamine tetraacetate 0.45-0.55mg.

Description

technical field [0001] The invention belongs to a product for injection, in particular to a freeze-dried preparation of water-soluble vitamins for injection. Background technique [0002] Water-soluble vitamins are important nutrients necessary for human life, most of which have the function of coenzymes or as part of coenzymes, and are necessary cofactors for various metabolic reactions. Since water-soluble vitamins cannot be synthesized in the body and have no reserves, it is necessary to ingest an appropriate amount of water-soluble vitamins from the outside world every day to maintain the normal function of the body and ensure human health. [0003] Our company has listed products Shui Le Vita  It is the earliest freeze-dried preparation containing 9 kinds of water-soluble vitamins used clinically in China. As one of the indispensable components of parenteral nutrition, it is used to meet the daily physiological needs of adults and children for water-soluble vitamins. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/714A61K9/19A61P3/02A61K31/519A61K31/525A61K31/455A61K31/4415A61K31/4188A61K31/375A61K31/198A61K31/197
Inventor 马涛
Owner 费森尤斯卡比华瑞制药有限公司
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