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Pharmaceutical composition capable of improving safety of compound andrographis injection

A technology of compound Andrographis paniculata paniculata and its composition, which is applied in the field of medicine, can solve the problems of polysorbate 80 being prone to rancidity, accelerating the pH value of the liquid medicine, and the drop of the pH value of the solution, and achieves the effect of improving safety, good safety, and high dosage

Inactive Publication Date: 2017-01-25
CHENGDU XIANXIANXIAN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the traditional Chinese medicine injection itself still has the problem that the pH value of the solution drops significantly during the sterilization and storage process, and polysorbate 80 (Tween 80) is prone to rancidity, which accelerates the drop of the pH value of the liquid medicine.

Method used

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  • Pharmaceutical composition capable of improving safety of compound andrographis injection
  • Pharmaceutical composition capable of improving safety of compound andrographis injection
  • Pharmaceutical composition capable of improving safety of compound andrographis injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027] Preparation method: decoct Andrographis paniculata and Coptis chinensis with water twice, each time for 2 hours, combine the decoction, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.27-1.30 (80°C), let it cool, add ethanol to make the ethanol content be 65%, stand overnight, filter, the filtrate is decompressed to recover ethanol and concentrate to a relative density of 1.30 (80°C), add 3 times the amount of water, stir well, refrigerate for 48 hours, filter, and the filtrate is concentrated to a relative density under reduced pressure About 1.15 (80°C), the liquid medicine is for later use; Radix isatidis is decocted twice with water, 1 hour each time, the decoction is combined, filtered, and the filtrate is concentrated to a relative density of 1.25-1.30 (80°C), let cool, and add ethanol Make the ethanol content 65%, let it stand overnight, filter, and concentrate the filtrate under reduced pressure to a relative den...

Embodiment 2

[0029]

[0030] Preparation method: decoct Andrographis paniculata and Coptis chinensis with water twice, each time for 2 hours, combine the decoction, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.27-1.30 (80°C), let it cool, add ethanol to make the ethanol content be 65%, stand overnight, filter, the filtrate is decompressed to recover ethanol and concentrate to a relative density of 1.30 (80°C), add 3 times the amount of water, stir well, refrigerate for 48 hours, filter, and the filtrate is concentrated to a relative density under reduced pressure About 1.15 (80°C), the liquid medicine is for later use; Radix isatidis is decocted twice with water, 1 hour each time, the decoction is combined, filtered, and the filtrate is concentrated to a relative density of 1.25-1.30 (80°C), let cool, and add ethanol Make the ethanol content 65%, let it stand overnight, filter, and concentrate the filtrate under reduced pressure to a relative den...

Embodiment 3

[0032]

[0033]Preparation method: decoct Andrographis paniculata and Coptis chinensis with water twice, each time for 2 hours, combine the decoction, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.27-1.30 (80°C), let it cool, add ethanol to make the ethanol content be 65%, stand overnight, filter, the filtrate is decompressed to recover ethanol and concentrate to a relative density of 1.30 (80°C), add 3 times the amount of water, stir well, refrigerate for 48 hours, filter, and the filtrate is concentrated to a relative density under reduced pressure About 1.15 (80°C), the liquid medicine is for later use; Radix isatidis is decocted twice with water, 1 hour each time, the decoction is combined, filtered, and the filtrate is concentrated to a relative density of 1.25-1.30 (80°C), let cool, and add ethanol Make the ethanol content 65%, let it stand overnight, filter, and concentrate the filtrate under reduced pressure to a relative dens...

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Abstract

The invention discloses a pharmaceutical composition capable of improving the safety of a compound andrographis injection. The pharmaceutical composition is a pharmaceutical composition for injection, prepared from andrographis extract, coptis chinensis extract, radix isatidis extract and hexafluorobutyl methacrylate. According to the invention, a cosolvent, polysorbate 80, which has potential safety hazards and influences the product quality in the compound andrographis injection is replaced with a cosolvent with better safety and more obvious solubilizing effect, the hexafluorobutyl methacrylate is higher in safety than the polysorbate 80 and is low in usage amount, the probability and risk of causing adverse reactions of the drug can be reduced, and the clinical medication safety is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for improving the safety of compound Andrographis paniculata injection. Background technique [0002] The standard of compound Andrographis paniculata injection is recorded in the drug standard issued by the Ministry of Health (preparation of traditional Chinese medicine). It has the effects of promoting blood circulation and promoting menstrual flow, dispelling blood stasis and relieving pain. It is clinically used to treat dysmenorrhea, amenorrhea, injury from tumbling, rheumatic arthralgia, etc. [0003] Compound Andrographis Radix Injection has been widely used clinically in my country for many years, and its clinical efficacy has been well received by both doctors and patients. However, in recent years, reports of adverse reactions in the clinical application of traditional Chinese medicine injections have become more and more seri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/14A61K47/26A61K36/718A61P15/00A61P29/00
CPCA61K9/08A61K36/19A61K36/195A61K36/315A61K36/718A61K47/14A61K47/26A61K2300/00
Inventor 付裕
Owner CHENGDU XIANXIANXIAN BIOTECH CO LTD
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