Control method for anti-oxidation of vitamin C injection

A control method and vitamin technology, which are applied in the preparation of test samples, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. C instability and other problems, to achieve the effect of improving the process production efficiency, reducing the probability, and improving the qualified rate of finished products

Inactive Publication Date: 2019-11-05
新乡市常乐制药有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, vitamin C is very unstable in aqueous solution. Vitamin C is prone to oxidation reaction in the presence of oxygen, and light, heat, alkali and metal ions, especially iron ions and copper ions, can accelerate the oxidation reaction. Occurrence will cause vitamin C to lose its efficacy; at the same time, the internal aliphatic ring in the vitamin C molecule can be hydrolyzed and further reacted to form furfural, resulting in oxidative polymerization and a yellow color
However, the structure of vitamin C cannot be changed in production, and the oxidation and hydrolysis reactions can only be inhibited by improving the process.

Method used

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  • Control method for anti-oxidation of vitamin C injection
  • Control method for anti-oxidation of vitamin C injection

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Effect test

Embodiment 1

[0027] A method for controlling the anti-oxidation of vitamin C injection, the production process of vitamin C injection comprises the following steps: (1) quality control of raw material vitamin C and auxiliary materials, detection of furfural and Ca in raw material vitamin C 2+ content; detection of Ca in each excipient 2+ , Fe 3+ 、Cu 2+ and the content of sulfate; (2) the cleaning and drying of borosilicate ampoules: use circulating water, detergent, circulating water, clean compressed air, degraded water, clean compressed air, water for injection, and clean compressed air to carry out ampoules Cleaning, and then dry and sterilize the ampoule bottle; wherein, the filter element of the circulating water equipment is replaced every two weeks; (3) Preparation: includes the following steps: S1: Add water for injection of 2 / 3 of the preparation amount into the dispensing tank, The temperature was controlled at 32°C, and nitrogen gas with a purity of 99.99% was passed through t...

Embodiment 2

[0029] A method for controlling the anti-oxidation of vitamin C injection, the production process of vitamin C injection comprises the following steps: (1) quality control of raw material vitamin C and auxiliary materials, detection of furfural and Ca in raw material vitamin C 2+ content; detection of Ca in each excipient 2+ , Fe 3+ 、Cu 2+ and the content of sulfate; (2) the cleaning and drying of borosilicate ampoules: use circulating water, detergent, circulating water, clean compressed air, degraded water, clean compressed air, water for injection, and clean compressed air to carry out ampoules Cleaning, and then dry and sterilize the ampoule bottle; wherein, the filter element of the circulating water equipment is replaced every two weeks; (3) Preparation: includes the following steps: S1: Add water for injection of 2 / 3 of the preparation amount into the dispensing tank, The temperature was controlled at 32°C, and nitrogen gas with a purity of 99.99% was passed through t...

Embodiment 3

[0031] A method for controlling the anti-oxidation of vitamin C injection, the production process of vitamin C injection comprises the following steps: (1) quality control of raw material vitamin C and auxiliary materials, detection of furfural and Ca in raw material vitamin C 2+ content; detection of Ca in each excipient 2+ , Fe 3+ 、Cu 2+ and the content of sulfate; (2) the cleaning and drying of borosilicate ampoules: use circulating water, detergent, circulating water, clean compressed air, degraded water, clean compressed air, water for injection, and clean compressed air to carry out ampoules Cleaning, and then dry and sterilize the ampoule bottle; wherein, the filter element of the circulating water equipment is replaced every two weeks; (3) Preparation: includes the following steps: S1: Add water for injection of 2 / 3 of the preparation amount into the dispensing tank, The temperature was controlled at 32°C, and nitrogen gas with a purity of 99.99% was passed through t...

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Abstract

The invention relates to the technical field of vitamin C injections, and specifically provides a control method for anti-oxidation of a vitamin C injection. The method comprises the following steps:(1) quality control of the raw material medicine vitamin C and auxiliary materials; (2) cleaning and drying of ampoule bottles; (3) preparation: the raw material vitamin C and auxiliary materials areadded according to the prescription dosage to prepare a liquid medicine; (4) fine filtration: filtration is performed through a 0.22 micron microporous membrane cartridge filter; (5) potting; (6) sterilization: the sterilization condition is 100 DEG C and 9 min. After sterilization, spray equipment is turned on to cool the ampoule bottles. The raw material is strictly controlled, and the process is adjusted and optimized. After the vitamin C injection produced by the above control method is detected through an acceleration test and a long-term stability test, various properties all meet the standard requirements, stability of the product is improved, and production efficiency of the optimized process and qualified rate of the finished product are both obviously improved.

Description

technical field [0001] The invention relates to the technical field of vitamin C injection, in particular to a method for controlling oxidation prevention of vitamin C injection. Background technique [0002] Vitamin C, also known as ascorbic acid, is a water-soluble vitamin that can promote the biosynthesis of collagen, facilitate faster healing of tissue wounds, improve the metabolism of fats and lipids, especially cholesterol, prevent cardiovascular diseases, and enhance the body's ability to respond to the outside world. Environmental resilience and immunity. [0003] However, vitamin C is very unstable in aqueous solution. Vitamin C is prone to oxidation reaction in the presence of oxygen, and light, heat, alkali and metal ions, especially iron ions and copper ions, can accelerate the oxidation reaction. Occurrence will cause vitamin C to lose its efficacy; at the same time, the internal aliphatic ring in the vitamin C molecule can be hydrolyzed and further reacted to ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K47/02A61K31/375A61P3/02G01N33/15G01N1/38G01N1/34
CPCA61K9/08A61K9/0019A61K47/183A61K47/02A61K31/375A61P3/02G01N33/15G01N1/38G01N1/34
Inventor 李东红万向新董明江
Owner 新乡市常乐制药有限责任公司
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