Pharmaceutical composition capable of improving safety of compound rhizoma polygonati injection

A composition and injection technology, applied in the field of medicine, can solve the problems of pH drop of solution, accelerated pH value of medicinal solution, easy rancidity of polysorbate 80, etc., and achieve high dosage, improved safety, and good effects of safety.

Inactive Publication Date: 2016-08-24
CHENGDU YISHENGKE BIOTECH
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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 rhizoma polygonati injection
  • Pharmaceutical composition capable of improving safety of compound rhizoma polygonati injection
  • Pharmaceutical composition capable of improving safety of compound rhizoma polygonati injection

Examples

Experimental program
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Effect test

Embodiment 1

[0016]

[0017] Preparation method: boil sealwort and Atractylodes macrocephala 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; add platycodon grandiflorum and decoct twice, 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 (...

Embodiment 2

[0019]

[0020]

[0021] Preparation method: boil sealwort and Atractylodes macrocephala 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; add platycodon grandiflorum and decoct twice, 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 densi...

Embodiment 3

[0023]

[0024]

[0025]Preparation method: boil sealwort and Atractylodes macrocephala 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; add platycodon grandiflorum and decoct twice, 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 densit...

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Abstract

The invention discloses a pharmaceutical composition capable of improving the safety of a compound rhizoma polygonati injection. The pharmaceutical composition is characterized in that the pharmaceutical composition is an injection pharmaceutical composition prepared from a rhizoma polygonati extract, a bighead atractylodes rhizome extract, a platycodon root extract and glycerin polyoxyethylene ether hydroxystearate, wherein each 100ml solution contains 15 to 45g of rhizoma polygonati extract prepared from rhizoma polygonati, 10 to 10g of bighead atractylodes rhizome extract prepared from bighead atractylodes rhizome and 5 to 15g of platycodon root extract prepared from platycodon root, and the dosage ratio of the rhizoma polygonati to the bighead atractylodes rhizome to the platycodon root is 3 to 2 to 1. According to the pharmaceutical composition disclosed by the invention, a cosolvent which has better safety and more obvious solubilization effect is adopted to substitute a cosolvent polysorbate 80, which has potential safety hazards and affects the product quality, in the compound rhizoma polygonati injection, and the glycerin polyoxyethylene ether hydroxystearate has higher safety and lower dosage than those of the polysorbate 80, such that the probability and risk of adverse reactions of the pharmaceutical composition are reduced, and the safety of the 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 Polygonatum Injection. Background technique [0002] The standard of Compound Rhizoma Polygonatum 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 Polygonatum 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 serious, which has affecte...

Claims

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Application Information

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IPC IPC(8): A61K36/8969A61K9/08A61K9/19A61K47/34A61P15/00A61P19/00A61P29/00
CPCA61K36/8969A61K9/0019A61K9/08A61K9/19A61K36/284A61K36/346A61K47/14A61K2236/331A61K2236/39A61K2236/51A61K2236/55A61K2300/00
Inventor 张蛟
Owner CHENGDU YISHENGKE BIOTECH
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