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Production process of unstable chemical injection

A technology of stabilizers and substances, applied in the production process of unstable compound injections, which can solve problems such as product precipitation, turbidity, and decomposition of adenosine triphosphate

Inactive Publication Date: 2012-07-11
刘小清
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the mass production process of these injections, the use of general heat sterilization methods will cause the decomposition of adenosine triphosphate, and the product will appear undesired precipitation or turbidity

Method used

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  • Production process of unstable chemical injection
  • Production process of unstable chemical injection
  • Production process of unstable chemical injection

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0017] Preparation Example 1: Injection stock solution containing adenosine triphosphate disodium sodium chloride:

[0018]

[0019]

[0020] Take by weighing a certain amount of guanidine carbonate and dissolve it in an appropriate amount of water for injection, add disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, adenosine triphosphate disodium successively and fully stir to dissolve, add 0.05% (mg / ml) weight of Use activated carbon for needles, stir thoroughly, decarbonize by coarse filtration, and add water to 100ml. Sterilize with circulating steam at 120°C for 30 minutes. Cool, dilute to 1000ml with sterile water for injection, filter through a 0.22μm membrane filter, pressurize the filtrate for 20min under a pressure of 300MPa, pack it in a can, and seal it with a sterilized aluminum cap; pack it to obtain adenosine triphosphate disodium chloride injection liquid finished product.

preparation example 2

[0021] Preparation Example 2: Injection stock solution containing adenosine triphosphate disodium sodium chloride:

[0022]

[0023] Weigh a certain amount of Tween-80 and dissolve it in an appropriate amount of water for injection, add disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, and adenosine triphosphate disodium in sequence to dissolve, and add 0.05% (mg / ml) by volume Activated carbon was used for the weight of the needle, and after stirring thoroughly, the coarse filter was used to decarbonize, and water was added to 100ml. Sterilize with circulating steam at 120°C for 30 minutes. Cool, dilute to 1000ml with sterile water for injection, filter through a 0.22μm membrane filter, pressurize the filtrate for 20min under a pressure of 300MPa, pack it in a can, and seal it with a sterilized aluminum cap; pack it to obtain adenosine triphosphate disodium chloride injection liquid finished product.

preparation example 3

[0024] Preparation example 3: the stabilizer in embodiment 1 or 2 is replaced with the same content of propylene glycol.

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Abstract

The invention relates to a sterilization process of injection products and in particular relates to a sterilization method of adenosine triphosphate disodium-sodium chloride injections. The method comprises the steps as follows: preparing a stock solution of injection in which the content of adenosine triphosphate salt is more than 1% (by weight) and performing wet-process heating on the stock solution of injection for an effective time period; diluting the stock solution of injection to desired concentration and filtering with a filter membrane; and sterilizing the filtered dilution under high pressure (250 MPa to 450 MPa). The method can not only guarantee the activity of adenosine triphosphate in the sterilized injection product but also control the sterility assurance level below 10-6.

Description

technical field [0001] The invention relates to a sterilization process of an unstable compound injection, in particular to a sterilization process of adenosine triphosphate disodium sodium chloride injection. Background technique [0002] There are many medical and economic benefits of sterile pharmaceutical products, and there is a medical need for sterile pharmaceutical preparations because the use of non-sterile preparations would expose patients to the risk of unnecessary secondary infections caused by contamination caused by microorganisms that are at least resistant to pharmaceutical preparations. Furthermore, even if the contaminant is harmless, its growth can still result in the loss of the active drug itself, possibly accompanied by toxic by-products. Economically, the shelf life of contaminated pharmaceuticals will be shortened, requiring increased production costs to replace contaminated products more frequently. [0003] There is a need for a method of prepari...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/02A61L2/07A61K31/7076A61K9/08A61K47/10A61K47/12A61K47/16A61K47/22A61K47/34
Inventor 刘小清
Owner 刘小清
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