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Pharmaceutical composition capable of improving safety of compound radix polygoni multiflori injection

A technology of Polygonum multiflorum and its composition, which is applied in the field of medicine, can solve the problems of accelerating the pH value of the liquid medicine, the easy rancidity of polysorbate 80, and the decrease of the pH value of the solution, and achieve the effects of improving safety, low dosage, and good safety

Inactive Publication Date: 2016-09-07
成都市斯贝佳科技有限公司
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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 radix polygoni multiflori injection
  • Pharmaceutical composition capable of improving safety of compound radix polygoni multiflori injection
  • Pharmaceutical composition capable of improving safety of compound radix polygoni multiflori injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016]

[0017] Preparation method: boil Polygonum Polygoni Multiflori and Peppermint 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 so that the ethanol content is 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; decoct malang twice with water, 1 hour each time, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.25-1.30 (80°C), let it cool, and add ethanol Make the ethanol content 65%, let it stand overnight, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.20 (80°C), a...

Embodiment 2

[0019]

[0020] Preparation method: boil Polygonum Polygoni Multiflori and Peppermint 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 so that the ethanol content is 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; decoct malang twice with water, 1 hour each time, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.25-1.30 (80°C), let it cool, and add ethanol Make the ethanol content 65%, let it stand overnight, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.20 (80°C), a...

Embodiment 3

[0022]

[0023]

[0024]Preparation method: boil Polygonum Polygoni Multiflori and Peppermint 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 so that the ethanol content is 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; decoct malang twice with water, 1 hour each time, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.25-1.30 (80°C), let it cool, and add ethanol Make the ethanol content 65%, let it stand overnight, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.2...

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Abstract

The invention discloses a pharmaceutical composition capable of improving safety of a compound radix polygoni multiflori injection. The pharmaceutical composition is characterized in that the pharmaceutical composition for injection is mainly prepared from a radix polygoni multiflori extract, a herba menthae extract, an Indian kalimeris herb extract and polyglycerol dodecahydroxyl stearate, each 100 ml of solution contains the radix polygoni multiflori extract containing 10-35 g of radix polygoni multiflori, the herba menthae extract containing 20-75 g of herba menthae and the Indian kalimeris herb extract containing 10-35 g of Indian kalimeris herb, and the dosage ratio of radix polygoni multiflori to herba menthae to Indian kalimeris herb is 1:2:1. According to the pharmaceutical composition capable of improving the safety of the compound radix polygoni multiflori injection, cosolvent which is good in safety and obvious in solubilization assisting effect is adopted to replace the cosolvent polysorbate 80 which has potential safety hazards and affects the product quality in the compound radix polygoni multiflori injection, the safety of polyglycerol dodecahydroxyl stearate is higher than that of polysorbate 80, the dosage of polyglycerol dodecahydroxyl stearate is lower than that of polysorbate 80, probability and risks of adverse reactions of drugs are reduced, and the safety of clinical medication is improved.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition for improving the safety of compound Polygonum multiflorum injection. Background technique [0002] The standard of Compound Polygonum Polygoni Multiflori 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 Polygonum multiflorum 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 m...

Claims

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Application Information

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IPC IPC(8): A61K36/704A61K9/08A61K9/19A61K47/34A61P15/00A61P29/00
CPCA61K36/534A61K9/0019A61K9/08A61K9/19A61K36/28A61K36/704A61K47/14A61K2236/331A61K2236/39A61K2236/53A61K2300/00
Inventor 杨素坤
Owner 成都市斯贝佳科技有限公司
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