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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 the problems of adenosine triphosphate decomposition, turbidity, product precipitation, etc.

Inactive Publication Date: 2013-11-06
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 disodium triphosphate and sodium chloride component:

[0018]

[0019]

[0020] Weigh 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, and disodium adenosine triphosphate in sequence to dissolve it, and add 0.05% (mg / ml) weight by volume Activated carbon is used for needles, after fully stirring, coarse filter and decarbonize, add water to 100ml. Sterilize with live steam at 120°C for 30 minutes. Cool, dilute with sterile water for injection to 1000ml, filter with 0.22μm filter membrane, press the filtrate under 300MPa pressure, pressurize for 20min, canned, cover the sterilized aluminum cap; package, get adenosine disodium triphosphate sodium chloride injection Liquid finished product.

preparation example 2

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

[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 disodium triphosphate in sequence to dissolve it and add 0.05% by volume (mg / ml) The weight of activated carbon for needles, after fully stirring, coarse filtration and decarbonization, add water to 100ml. Sterilize with live steam at 120°C for 30 minutes. Cool, dilute with sterile water for injection to 1000ml, filter with 0.22μm filter membrane, press the filtrate under 300MPa pressure, pressurize for 20min, canned, cover the sterilized aluminum cap; package, get adenosine disodium triphosphate sodium chloride injection Liquid finished product.

preparation example 3

[0024] Preparation Example 3: Replace the stabilizer in Example 1 or 2 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 unstable compound injection, in particular to a sterilization process of adenosine disodium triphosphate and sodium chloride injection. Background technique [0002] Sterile pharmaceutical products have many benefits in medicine and economy. Sterile pharmaceutical preparations are required in medicine. This is because the use of non-sterile preparations will expose patients to unnecessary risks of secondary infections. Such infections are caused by contamination. At least caused by microorganisms that are resistant to pharmaceutical preparations. In addition, even if the pollutant is harmless, its growth will still cause the loss of the active drug itself, and may be accompanied by toxic by-products. Economically, the shelf life of contaminated drugs will be shortened, which requires increased production costs to replace contaminated products more frequently. [0003] There is a need for a method of prepar...

Claims

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Application Information

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Patent Type & Authority Patents(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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