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Method for removing bacterial endotoxin of use water refining raw medicine

A technology of bacterial endotoxin and raw material medicine, applied in the direction of organic chemistry, etc., to achieve the effect of stable product performance

Inactive Publication Date: 2018-08-03
ANHUI HAIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Therefore, when such raw materials are used as raw materials for injection drugs, bacterial endotoxins should be checked and controlled, but there are no relevant patents or literature reports to control or remove the bacterial endotoxins contained in them by effective methods.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] 1. During the operation, add 1.0kg of crude ganciclovir, 10kg of purified water and 100g of activated carbon into the reaction kettle, heat up and reflux for decolorization for 1 hour, press filter into the crystallization kettle while it is hot, cool to 5-10°C, and stir for 2 hours. The wet product of ganciclovir is obtained by centrifugation. The wet product does not stay, and directly enters the preheating oven. The oven is heated to 50 degrees in advance to inhibit the growth of bacteria. After the material enters, the temperature is raised to 80 degrees and dried for 2 hours. The finished product is 0.92kg.

[0017] 2. Detection and analysis of endotoxin content detection method: Limulus reagent method, in accordance with "Pharmacopoeia of the People's Republic of China" 2015 Edition Three Appendix ⅫE "Bacterial Endotoxin Inspection Method (Gel Limit Test)"

[0018] 3. The ganciclovir crude product containing bacterial endotoxin content before the treatment of the ...

Embodiment 2

[0021] 1. During the operation, add 5.0kg of crude ganciclovir, 55kg of purified water and 750g of activated carbon into the reaction kettle, raise the temperature and reflux for decolorization for 2 hours, press filter into the crystallization kettle while it is hot, cool to 5-10°C, and stir for 3 hours. The wet product of ganciclovir is obtained by centrifugation. The wet product does not stay, and directly enters the preheating oven. The oven is heated to 60 degrees in advance to inhibit the growth of bacteria. After the material enters, the temperature is raised to 100 degrees and dried for 2 hours. Get finished product 4.74kg.

[0022] 2. Detection and analysis of endotoxin content detection method: Limulus reagent method, in accordance with "Pharmacopoeia of the People's Republic of China" 2015 Edition Three Appendix ⅫE "Bacterial Endotoxin Inspection Method (Gel Limit Test)"

[0023] 3. The ganciclovir crude product containing bacterial endotoxin content before the trea...

Embodiment 3

[0026] 1. During the operation, add 2.0kg of acyclovir crude product, 22kg of purified water and 300g of activated carbon into the reaction kettle, raise the temperature and reflux for decolorization for 2 hours, press filter into the crystallization kettle while it is hot, cool to 5-10°C, and stir for 2 hours. The wet product of aciclovir is obtained by centrifugation. The wet product does not stay, and directly enters the preheating oven. The oven is heated to 50 degrees in advance to inhibit the growth of bacteria. After the material enters, the temperature is raised to 90 degrees and dried for 3 hours. Get finished product 1.80kg.

[0027] 2. Detection and analysis of endotoxin content detection method: Limulus reagent method, in accordance with "Pharmacopoeia of the People's Republic of China" 2015 Edition Three Appendix ⅫE "Bacterial Endotoxin Inspection Method (Gel Limit Test)"

[0028] 3. The bacterial endotoxin content of the acyclovir crude product before the treatme...

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Abstract

The invention discloses a method for removing bacterial endotoxin of use water refining raw medicine. The method comprises the following steps of adding raw medicine coarse products, pure water and active carbon into a reaction kettle; raising the temperature; performing backflow stirring; performing press filtering on the materials into a crystallization kettle when the materials are still hot; performing cooling and centrifugation to obtain the raw medicine wet product after bacterial endotoxin removal; performing drying at 80 to 110 DEG C; performing crushing and mixing to obtain finished product raw medicine. The method has the advantages that the operation is simple; the cost is low; on the promise of ensuring other quality, the bacterial endotoxin removal effect is obvious; the content can reach the national index standard; the product performance among batches is stable; the method is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of purification of pharmaceutical raw materials, and relates to a method for removing bacterial endotoxins of crude drugs refined with water. Background technique [0002] In the refining process of raw materials, it is inevitable to use water as a solvent for purification. In the production process of the final product, the raw material medicine refined with water is prone to bacteria growth, and after the bacteria growth is dried, the bacteria will die and become bacterial endotoxins, which will affect the product quality. In the actual production operation of workers, bacterial toxins will be produced if they are left overnight after centrifugation and then dried. If the workers do not carry out follow-up treatment in time after the operation, product contamination will occur. Since there are many possible causes of bacterial toxins, it takes a lot of money to check the causes Some manufacturers do not p...

Claims

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Application Information

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IPC IPC(8): C07D473/18
CPCC07D473/18
Inventor 张小顺
Owner ANHUI HAIKANG PHARMA
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