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A kind of production technology of vitamin C for injection

A production process and technology of vitamins, applied in the field of medicine, can solve problems such as complex preparation process of vitamin C injection, hidden dangers of medical personnel's operation safety, difficulty in product quality assurance, etc., and achieve long-term storage, effective product quality, and low cost. Effect

Active Publication Date: 2019-11-26
HEBEI TIANCHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, vitamin C is unstable in aqueous solution and is easily oxidized into dehydroascorbic acid. Therefore, alkaline auxiliary materials such as sodium carbonate are usually added when producing vitamin injections, and some complexing agents are also added. Due to the large number of auxiliary materials, This will easily cause the preparation process of vitamin C injection to be complicated, and in the storage process, due to the strong reduction of the dienol in the vitamin C injection, it is easy to be accelerated by oxygen, light, heat, alkali metal ions and other factors to accelerate its oxidation reaction. , product quality is difficult to guarantee
In clinical use of vitamin C powder injection, a certain amount of water for injection needs to be added to dissolve the vitamin, and the enol group in vitamin C will react with sodium carbonate to produce a large amount of CO 2 Gas, causing the pressure in the airtight bottle to increase, and sometimes even an explosion, which brings safety hazards to the operation of medical staff
[0004] The important raw material of vitamin C for injection is sterile vitamin C. However, in the existing production process of sterile vitamin C, a large number of preparations are often required to ensure its purity. Using a large number of preparations will inevitably lead to complex processes, high costs, and low returns. and other shortcomings

Method used

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  • A kind of production technology of vitamin C for injection
  • A kind of production technology of vitamin C for injection
  • A kind of production technology of vitamin C for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A production process of vitamin C for injection, comprising the steps of:

[0030] 1), Weighing: Weigh vitamin C and anhydrous sodium carbonate, and its weight ratio is 3.5:1;

[0031] 2), total mixing: Pour the weighed vitamin C and anhydrous sodium carbonate into a three-dimensional mixer under the condition of 100-level laminar flow for mixing, the rotating speed is 4 revolutions / min, and the time is 175min to obtain the mixed total material;

[0032] 3) Subpackaging: subpackage the obtained mixed total material into low borosilicate glass control injection bottles under the condition of class 100 laminar flow;

[0033] 4) Vacuuming: Vacuumize the low borosilicate glass control injection bottle containing the mixture of vitamin C and anhydrous sodium carbonate, the pressure is -0.085MPaMPa, the time is 3 seconds, and then the rubber stopper is sealed to obtain the finished product for injection. Vitamin C, the limit of vitamin C-related substances in low borosilicat...

Embodiment 2

[0042] A production process of vitamin C for injection, comprising the steps of:

[0043] 1), Weighing: Weigh vitamin C and anhydrous sodium carbonate, and its weight ratio is 4.5:1;

[0044] 2), total mixing: Pour the weighed vitamin C and anhydrous sodium carbonate into a three-dimensional mixer under the condition of 100-level laminar flow for mixing, the rotating speed is 6 revolutions / min, and the time is 185min to obtain the mixed total material;

[0045] 3) Subpackaging: subpackage the obtained mixed total material into low borosilicate glass control injection bottles under the condition of class 100 laminar flow;

[0046] 4) Vacuuming: Vacuumize the low borosilicate glass control injection bottle containing the mixture of vitamin C and anhydrous sodium carbonate, the pressure is -0.090MPa, the time is 3 seconds, and then the rubber stopper is sealed to obtain the finished product for injection. Vitamin C, the limit of vitamin C-related substances in low borosilicate g...

Embodiment 3

[0055] A production process of vitamin C for injection, comprising the steps of:

[0056] 1), Weighing: Weigh vitamin C and anhydrous sodium carbonate, the weight ratio is 4:1;

[0057] 2), total mixing: pour the weighed vitamin C and anhydrous sodium carbonate into a three-dimensional mixer under the condition of 100-level laminar flow for mixing, the rotating speed is 5 revolutions / min, and the time is 180min to obtain the mixed total material;

[0058] 3) Subpackaging: subpackage the obtained mixed total material into low borosilicate glass control injection bottles under the condition of class 100 laminar flow;

[0059] 4) Vacuuming: Vacuumize the low borosilicate glass control injection bottle containing the mixture of vitamin C and anhydrous sodium carbonate, the pressure is -0.088MPa, the time is 4 seconds, and then the rubber stopper is sealed to obtain the finished product for injection. Vitamin C, the limit of vitamin C-related substances in low borosilicate glass c...

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PUM

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Abstract

The invention provides a kind of vitamin C for injection, including weighing, total mixing, sub-packaging and vacuumizing; meanwhile, it also provides a production and preparation process of sterile vitamin C, including weighing, dissolving, decarburization, crystallization, washing and smash. The vitamin C for injection provided by the invention has a simple production process, low cost and easy operation, and the obtained vitamin C for injection has high stability, good purity, convenient use, and is beneficial to clinical application. The preparation process of the sterile vitamin C is convenient, can effectively remove impurities in the vitamin C raw material, and has no solvent residue, and the obtained sterile vitamin C has good yield, stable properties and high purity.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a production process of vitamin C, in particular to a production process of vitamin C for injection. Background technique [0002] Vitamin C, also known as ascorbic acid, is an acidic polyhydroxy compound containing 6 carbon atoms. In organisms, vitamin C is an antioxidant that protects the body from the threat of free radicals. Vitamin C is also a coenzyme. The most widely known is that a lack of vitamin C causes scurvy. [0003] At present, the vitamin C sold on the market is mostly vitamin C injection or vitamin powder injection. However, vitamin C is unstable in aqueous solution and is easily oxidized into dehydroascorbic acid. Therefore, alkaline auxiliary materials such as sodium carbonate are usually added when producing vitamin injections, and some complexing agents are also added. Due to the large number of auxiliary materials, This will easily cause the preparation proc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/02A61K31/375A61P3/02
CPCA61K9/0019A61K9/08A61K31/375A61K47/02
Inventor 王振刚
Owner HEBEI TIANCHENG PHARMA