Preparing method for pharmaceutical composition capable of improving safety of compound ginkgo biloba injection

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

Inactive Publication Date: 2016-08-31
CHENGDU YICHUANGSI BIOLOGICAL SCI & TECH
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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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  • Preparing method for pharmaceutical composition capable of improving safety of compound ginkgo biloba injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Ginkgo biloba 100g

[0015] Dipyridamole 100g

[0016] Polysorbate 100g

[0017] Solutol HS-15 ® 2.0g

[0018] Preparation method: decoct ginkgo biloba and dipyridamole 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 containing The amount of ethanol is 65%, stand overnight, filter, the filtrate is decompressed to recover ethanol and concentrated 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 under reduced pressure When the relative density is about 1.15 (80°C), the medicinal liquid is used for later use; polysorbate is decocted twice, each time for 1 hour, and the decoction is combined, filtered, and the filtrate is concentrated to a relative density of 1.25-1.30 (80°C). Let it cool, add ethanol to make the etha...

Embodiment 2

[0020] Ginkgo biloba 100g

[0021] Dipyridamole 100g

[0022] Polysorbate 100g

[0023] Solutol HS-15 ® 1.0g

[0024] Tween-80 1.0

[0025] Preparation method: decoct ginkgo biloba and dipyridamole 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 containing The amount of ethanol is 65%, stand overnight, filter, the filtrate is decompressed to recover ethanol and concentrated 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 under reduced pressure When the relative density is about 1.15 (80°C), the medicinal liquid is used for later use; polysorbate is decocted twice, each time for 1 hour, and the decoction is combined, filtered, and the filtrate is concentrated to a relative density of 1.25-1.30 (80°C). Let it cool, add e...

Embodiment 3

[0027] Ginkgo biloba 100g

[0028] Dipyridamole 100g

[0029] Polysorbate 100g

[0030] Solutol HS-15 ® 2.0g

[0031]Preparation method: decoct ginkgo biloba and dipyridamole 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 containing The amount of ethanol is 65%, stand overnight, filter, the filtrate is decompressed to recover ethanol and concentrated 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 under reduced pressure When the relative density is about 1.15 (80°C), the medicinal liquid is used for later use; polysorbate is decocted twice, each time for 1 hour, and the decoction is combined, filtered, and the filtrate is concentrated to a relative density of 1.25-1.30 (80°C). Let it cool, add ethanol to make the ethan...

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Abstract

The invention discloses a preparing method for pharmaceutical composition capable of improving safety of compound ginkgo biloba injection. The pharmaceutical composition is mainly prepared from ginkgo biloba extract, dipyridamole extract, polysorbate extract and polyethylene glycol-12-hydroxyl stearate and is applied to injection. A cosolvent of polysorbate 80 which has safety hazard and can affect product quality in the compound ginkgo biloba injection is replaced by a cosolvent which is better in safety and more obvious in hydrotropy effect. The safety of the polyethylene glycol-12-hydroxyl stearate is higher than that of the polysorbate 80, the using amount of the polyethylene glycol-12-hydroxyl stearate is lower, the probability and the risk of untoward effects of medicine are reduced, and the safety of clinical medication is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a pharmaceutical composition for improving the safety of compound ginkgo injection. Background technique [0002] The standards of Compound Ginkgo Injection are recorded in the Drug Standards issued by the Ministry of Health (prescriptions of traditional Chinese medicines). 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 Ginkgo 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 a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16A61K9/08A61K47/34A61P15/00A61P29/00A61K31/519A61K31/765
CPCA61K36/16A61K9/0019A61K9/08A61K31/519A61K31/765A61K47/14A61K2236/331A61K2236/39A61K2300/00
Inventor 周洁
Owner CHENGDU YICHUANGSI BIOLOGICAL SCI & TECH
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