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A kind of preparation method of aseptic vitamin C composition and its product and application

A vitamin and composition technology, which is applied in the field of preparation of vitamin C composition, can solve problems such as difficult extraction, increased production cost, and many control conditions, so as to reduce process links and material costs, avoid degradation problems, and reduce production costs. Effect

Active Publication Date: 2016-01-20
HAIKOU PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are also defects in the use of such products, that is, a certain amount of water for injection needs to be added to dissolve during clinical application, and the enol group in vitamin C will react with sodium carbonate to generate a large amount of CO 2 Gas, causing the pressure in the airtight bottle to increase, it is difficult to extract it into the syringe, and sometimes there is even a danger of breaking the bottle, thus affecting the safety of clinical medication
[0008] In addition, the existing production process still has the problem of low yields of components such as sterile vitamin C and sterile vitamin C sodium, and it is difficult to achieve both purity and yield, and its production process is relatively complicated and there are many control conditions, so Increase the production cost and cannot meet the needs of large-scale production
At the same time, the storage performance of vitamin C powder injection in the marketed products still needs to be further improved

Method used

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  • A kind of preparation method of aseptic vitamin C composition and its product and application
  • A kind of preparation method of aseptic vitamin C composition and its product and application
  • A kind of preparation method of aseptic vitamin C composition and its product and application

Examples

Experimental program
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Effect test

Embodiment 1

[0053] This example is used to illustrate the preparation method of the sterile vitamin C composition of the present invention.

[0054] Add 1 kg of sodium vitamin C to 1 kg of water for injection, then add 10 g of cysteine, 50 g of calcium edetate, and 30 g of activated carbon for needles, and stir at 50±5°C for 20 minutes. Use a 0.22μm filter membrane for sterilizing filtration, inject the filtrate into a sterile crystallization tank, add 3kg of sterile ethanol solution while stirring, and lower the temperature to -4~0°C at a rate of 5°C per hour. In the process, the size of the formed crystals can be appropriately controlled to be 300-500 μm, and then kept at this temperature for 6 hours. Centrifuge and dehydrate the crystallization solution under sterile conditions, wash the crystals with a small amount (about 500g) of acetone, and then send them into a vacuum drying oven for vacuum drying (temperature is 40±2°C, vacuum degree is 0.06-0.08MPa)4 Hours, make its moisture co...

Embodiment 2

[0059] This example is used to illustrate the preparation method of the sterile vitamin C composition of the present invention.

[0060] Add 1 kg of sodium vitamin C to 1.8 kg of water for injection, then add 50 g of cysteine, 20 g of calcium edetate, and 50 g of activated carbon for needles, and stir at 45±5°C for 20 minutes. Use a 0.22 μm filter membrane for sterile filtration, inject the filtrate into a sterile crystallization tank, add 600 g of sterile isopropanol solution while stirring, and lower the temperature to -4 to 0 °C at a rate of 3 °C per hour. During this process, the size of the formed crystals can be appropriately controlled to be 300-500 μm, and then kept at this temperature for 7 hours. Centrifuge and dehydrate the crystallization liquid under sterile conditions, wash the crystals with isopropanol, and then send them into a vacuum drying oven for vacuum drying (temperature is 40±2°C, vacuum degree is 0.06-0.08MPa) for 6 hours. The water content is less tha...

Embodiment 3

[0065] This example is used to illustrate the preparation method of the sterile vitamin C composition of the present invention.

[0066] Add 1 kg of sodium vitamin C to 3 kg of water for injection, then add 20 g of cysteine, 40 g of calcium edetate, and 100 g of activated carbon for needles, and stir for 25 minutes at 55±5°C. Use a 0.22 μm filter membrane for sterile filtration, inject the filtrate into a sterile crystallization tank, add 600 g of sterile isopropanol solution while stirring, and lower the temperature to -4 to 0 °C at a rate of 5 °C per hour. During this process, the size of the formed crystals can be properly controlled to be 300-500 μm, and then kept at this temperature for 8 hours. Centrifuge and dehydrate the crystallization solution under sterile conditions, wash the crystals with isopropanol, and then send them into a vacuum drying oven for vacuum drying (temperature is 40±5°C, vacuum degree is 0.06-0.08MPa) for 8 hours. The water content is less than 0....

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Abstract

The invention provides a preparation of aseptic vitamin C composition, which comprises the steps of: preparing aseptic vitamin C sodium, preparing aseptic vitamin C and mixing the preparing aseptic vitamin C sodium and the aseptic vitamin C for preparing the composition, wherein in the preparation process of the aseptic vitamin C sodium comprises the steps of: adding antioxidant, complexing agent and activated carbon into the aqueous solution of the vitamin C sodium, and the like. The invention provides the aseptic vitamin C composition, and the application of the aseptic vitamin C composition in preparation of vitamin C powder injection.

Description

technical field [0001] The invention relates to a preparation method of a vitamin C composition, in particular to a preparation method of a sterile vitamin C composition, a sterile vitamin C composition and an application thereof. Background technique [0002] Vitamin C is a vitamin drug, also known as ascorbic acid, and its chemical name is L-threose-2, 3, 4, 5, 6 pentahydroxy-2-hexenoic acid-4-lactone. The most remarkable feature of the molecule is its Strong reducibility, its enolate chemical structure makes it extremely unstable, easily affected by metal ions, light, heat, humidity and strong extrusion, etc., it will be destroyed and hydrogen (H) atoms will be released. Crystalline vitamin C is quite stable in a dry environment, but it is easy to oxidize and degrade in complex environments such as solution or alkaline, especially when it encounters air, metal elements or light, almost all the active ingredients of vitamin C are lost. Degradation products include L-dehyd...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/375A61K9/14A61P3/02C07D307/62
Inventor 张志兰曾祎华沙莹陈义弘
Owner HAIKOU PHARMA FACTORY
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