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Control method for oxidation prevention of vitamin C tablet

A control method and vitamin technology, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pill delivery, etc. It can solve the problems of shortened shelf life, exposed tablets, and high production costs.

Inactive Publication Date: 2019-11-08
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

However, the nature of vitamin C is extremely unstable, because the enol structure in vitamin C is easily oxidized, especially after contact with oxygen, light source, heat source, and other excipients in vitamin tablets, it will be automatically oxidized to generate dehydroascorbic acid, while dehydrogenation Ascorbic acid will continue to hydrolyze, making vitamin C lose its therapeutic effect
[0003] Studies have shown that the process of wet granulation and tabletting will accelerate the process of vitamin C oxidation, making vitamin C tablets dark gray and shortening the shelf life. Therefore, wet granulation and tabletting should be abandoned in the production process of vitamin C tablets method, and in the tableting process, magnesium stearate is often added as a lubricant, but magnesium stearate will affect the stability of vitamin C
And to the improvement aspect of vitamin C tablet stability, the method that adopts at present mainly contains: (1) vitamin C is coated with coating material or β-cyclodextrin etc.; (2) preparation of derivatives of vitamin C, such as sodium vitamin C phosphate, the method has complicated synthesis process, harsh conditions, and higher production cost

Method used

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  • Control method for oxidation prevention of vitamin C tablet
  • Control method for oxidation prevention of vitamin C tablet

Examples

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preparation example Construction

[0018] The preparation method of vitamin C microcapsules comprises the following steps: (1) Weighing a certain amount of polyglycerol fatty acid ester and hardened vegetable oil into water, heating and stirring in a water bath at 45° C. for 8 minutes, so that the polyglyceryl fatty acid ester and hardened vegetable oil Evenly dispersed, wherein, the ratio of polyglycerol fatty acid ester, hardened vegetable oil and water is 1:1:(15-20)(W / V), and the wall material solution is obtained; (2) Weigh 40-50 parts of vitamin C , 0.05-2 parts of citric acid, 0.05-2 parts of malic acid, 0.05-0.1 part of cyclohexanediaminetetraacetic acid, and quickly add it to water, and stir to obtain a core material solution; (3) according to the core material solution and The mass ratio of the wall material solution is 1:(5-15). Add the core material solution into the wall material solution, stir and mix evenly, and emulsify at a speed of 2200r / min for 3min; (4) emulsify the solution in step 3 Vitami...

Embodiment 1

[0021] A method for controlling oxidation resistance of vitamin C tablets. The production process of vitamin C tablets includes the following steps: S1: preparing vitamin C microcapsules; S2: weighing the following raw materials in parts by weight: 70 parts of vitamin C microcapsules, ring 0.002 part of hexanediaminetetraacetic acid, 8 parts of pregelatinized starch, 15 parts of lactose-starch complex, 0.0.5 part of histidine, 0.05 part of lysine and 1 part of benzoic acid, and crush each raw material for 60 Mesh sieve; S3: mix all the sieved raw materials evenly to obtain a mixed material; S4: directly compress the mixed material under a certain tabletting environment. Raw materials and process parameter control: the weight ratio of lactose and starch in the lactose-starch compound is 1:0.175, the water mass ratio of the mixed material in step S3 is 6%, and the bulk density of the mixed material is 0.35g / ml; The sheet environment is: a humidity range of 20% RH, and a temperat...

Embodiment 2

[0025] A method for controlling oxidation resistance of vitamin C tablets. The production process of vitamin C tablets includes the following steps: S1: preparing vitamin C microcapsules; S2: weighing the following raw materials in parts by weight: 85 parts of vitamin C microcapsules, cyclohexane 0.15 parts of diaminetetraacetic acid, 10 parts of pregelatinized starch, 25 parts of lactose-starch complex, 0.1 part of histidine, 0.1 part of lysine, 1 part of citric acid, and 0.1 part of malic acid. Crushing through a 60-mesh sieve; S3: mixing all the sieved raw materials evenly to obtain a mixed material; S4: directly compressing the mixed material under a certain tabletting environment. Raw materials and process parameter control: the weight ratio of lactose and starch in the lactose-starch compound is 1:0.175, the water mass ratio of the mixed material in step S3 is 5%, and the bulk density of the mixed material is 0.65g / ml; The sheet environment is: the humidity range is 40RH...

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Abstract

The invention relates to the technical field of vitamin C tablets and particularly provides a control method for oxidation prevention of a vitamin C tablet. A production process of the vitamin C tablet comprises the following steps that S1, vitamin C microcapsules are prepared; S2, 70-85 parts of the vitamin C microcapsules and a certain quantity of auxiliary materials are weighed, and all the rawmaterials are crushed to be sieved by a 60-mesh sieve; S3, all the raw materials are mixed evenly to obtain a mixed material; and S4, the mixed material is subjected to direct pressing forming undera certain tabletting environment. The auxiliary materials include cyclohexanediamine tetraacetic acid, pregelatinized starch, a lactose-starch complex, histidine, lysine and medically acceptable organic acid or inorganic acid. The vitamin C microcapsules are treated and then subjected to direct tabletting treatment, oxidation of a vitamin C in the wet granulation process is avoided, the other auxiliary materials are added to further inhibit oxidation of the vitamin C, and the stability of the vitamin C tablet is improved.

Description

technical field [0001] The invention relates to the technical field of vitamin C tablets, in particular to a method for controlling oxidation resistance of vitamin C tablets. Background technique [0002] Vitamin C, also known as ascorbic acid, is one of the vitamins that the human body needs more. If there is a lack of vitamin C, the human body is prone to scurvy, and vitamin C cannot be synthesized in the human body, so it needs to rely on food supply. Vitamin C tablets are a commonly used drug for supplementing vitamin C, which can be used to prevent and treat scurvy, and assist in the treatment of various acute and chronic infectious diseases and purpura. However, the nature of vitamin C is extremely unstable, because the enol structure in vitamin C is easily oxidized, especially after contact with oxygen, light source, heat source, and other excipients in vitamin tablets, it will be automatically oxidized to generate dehydroascorbic acid, while dehydrogenation Ascorbic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/18A61K47/36A61K47/26A61K47/12A61K31/375A61P3/02A61P31/00A61P7/04
CPCA61K9/2013A61K9/2018A61K9/2059A61K9/2081A61K9/2095A61K31/375A61P3/02A61P7/04A61P31/00
Inventor 李东红朱晓飞李荷梅
Owner 新乡市常乐制药有限责任公司
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