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Safe medicine composition for compound gastrodin injection and preparation method of safe medicine composition

A gastrodin injection, safety technology, applied in the field of medicine, can solve problems such as polysorbate 80 is prone to rancidity, the pH value of the solution drops, and accelerates the pH value of the liquid medicine, so as to achieve improved safety, high dosage, and good safety Effect

Inactive Publication Date: 2015-12-02
CHENGDU AIBIKE 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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Gastrodin 100g

[0013] Chuanxiong 100g

[0014] Safflower 100g

[0015] Solutol HS-15 ? 2.0g

[0016] Preparation method: decoct gastrodin and Chuanxiong with water twice, 2 hours each time, 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 reduce the ethanol content 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 to relative density under reduced pressure The density is about 1.15 (80°C), and the medicinal liquid is used for later use; the safflower 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, Add ethanol to make the ethanol content 65%, let stan...

Embodiment 2

[0018] Gastrodin 100g

[0019] Chuanxiong 100g

[0020] Safflower 100g

[0021] Solutol HS-15 ? 1.0g

[0022] Tween-801.0

[0023] Preparation method: decoct gastrodin and Chuanxiong with water twice, 2 hours each time, 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 reduce the ethanol content 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 to relative density under reduced pressure The density is about 1.15 (80°C), and the medicinal liquid is used for later use; the safflower 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, Add ethanol to make the ethanol...

Embodiment 3

[0025] Gastrodin 100g

[0026] Chuanxiong 100g

[0027] Safflower 100g

[0028] Solutol HS-15 ? 2.0g

[0029] Preparation method: decoct gastrodin and Chuanxiong with water twice, 2 hours each time, 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 reduce the ethanol content 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 to relative density under reduced pressure The density is about 1.15 (80°C), and the medicinal liquid is used for later use; the safflower 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, Add ethanol to make the ethanol content 65%, let stan...

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Abstract

The invention discloses a safe medicine composition for a compound gastrodin injection and a preparation method of the safe medicine composition. The safe medicine composition used for injection is mainly prepared from a gastrodin extract, a Szechuan lovage rhizome extract, a carthamus tinctorius extract and 12-hydroxystearic acid-polyethylene glycol. The safe medicine composition has the advantages that a solubilizing agent with higher safety and a more obvious solubilizing effect is utilized for replacing polysorbate 80 in the conventional compound gastrodin injection; polysorbate 80 has a potential safety hazard and affects the quality of the conventional compound gastrodin injection, 12-hydroxystearic acid-polyethylene glycol has higher safety than polysorbate 80, and the dose of 12-hydroxystearic acid-polyethylene glycol is lower than that of polysorbate 80, so that the possibility and risk of an adverse medicine reaction 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 gastrodin injection. Background technique [0002] The standard of compound gastrodin injection is recorded in the drug standard issued by the Ministry of Health (preparation of traditional Chinese medicine). The raw materials are gastrodin, Chuanxiong, and safflower, which belong to traditional Chinese medicine injection. 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 gastrodin 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 reaction...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K36/286A61K47/14A61K47/26A61P15/00A61P29/00
Inventor 何金蓉周洁
Owner CHENGDU AIBIKE BIOTECH
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