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Preparation method of pharmaceutical composition for improving safety of compound radix codonopsis injection solution

A technology for injection and safety, which is applied in the field of medicine, can solve the problems of solution pH drop, polysorbate 80 is easy to rancid, and accelerates the pH value of liquid medicine, etc., and achieves high dosage, improved safety, and good safety effects

Inactive Publication Date: 2017-02-01
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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  • Preparation method of pharmaceutical composition for improving safety of compound radix codonopsis injection solution
  • Preparation method of pharmaceutical composition for improving safety of compound radix codonopsis injection solution
  • Preparation method of pharmaceutical composition for improving safety of compound radix codonopsis injection solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027] Preparation method: decoct Codonopsis pilosula and summer without adding 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 reduce the ethanol content 65%, stand overnight, filter, the filtrate recovers ethanol under reduced pressure and concentrates to a relative density of 1.30 (80°C), adds 3 times the amount of water, stirs thoroughly, refrigerates for 48 hours, filters, and concentrates the filtrate to relative density under reduced pressure. The density is about 1.15 (80°C), and the liquid medicine is ready for use; Aescinus 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), and left to cool , add ethanol so that the ethanol content is 65%, let it stand overnight, filter, the filtrate is concentrated under red...

Embodiment 2

[0029]

[0030] Preparation method: decoct Codonopsis pilosula and summer without adding 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 reduce the ethanol content 65%, stand overnight, filter, the filtrate recovers ethanol under reduced pressure and concentrates to a relative density of 1.30 (80°C), adds 3 times the amount of water, stirs thoroughly, refrigerates for 48 hours, filters, and concentrates the filtrate to relative density under reduced pressure. The density is about 1.15 (80°C), and the liquid medicine is ready for use; Aescinus 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), and left to cool , add ethanol so that the ethanol content is 65%, let it stand overnight, filter, the filtrate is concentrated under red...

Embodiment 3

[0032]

[0033]Preparation method: decoct Codonopsis pilosula and summer without adding 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 reduce the ethanol content 65%, stand overnight, filter, the filtrate recovers ethanol under reduced pressure and concentrates to a relative density of 1.30 (80°C), adds 3 times the amount of water, stirs thoroughly, refrigerates for 48 hours, filters, and concentrates the filtrate to relative density under reduced pressure. The density is about 1.15 (80°C), and the liquid medicine is ready for use; Aescinus 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), and left to cool , add ethanol so that the ethanol content is 65%, let it stand overnight, filter, the filtrate is concentrated under redu...

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Abstract

The invention discloses a preparation method of a pharmaceutical composition for improving the safety of a compound radix codonopsis injection solution. The pharmaceutical composition is a pharmaceutical composition for injection, which is mainly prepared from radix codonopsis extract, rhizoma corydalis decumbentis extract, scandent schefflera root extract and tert-butyl peroxyacetate. According to the preparation method provided by the invention, a co-solvent, which has better safety and more obvious auxiliary dissolving effect, is used for replacing a co-solvent polysorbate 80 which has potential safety hazards on the compound radix codonopsis injection solution and influences product quality, the safety of the tert-butyl peroxyacetate is higher than that of the polysorbate 80 and the use amount of the tert-butyl peroxyacetate is lower; the probability and risks of untoward effects caused by medicines 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 Codonopsis Codonopsis injection. Background technique [0002] The standard of compound Codonopsis injection is recorded in the drug standard issued by the Ministry of Health (Chinese medicine prescription preparation), and the raw materials are Codonopsis Codonopsis, Xiawu, and Aescin, 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 Codonopsis 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/66A61K47/14A61K9/08A61K9/19A61P15/00A61P29/00
CPCA61K36/344A61K9/0019A61K9/08A61K9/19A61K36/25A61K36/66A61K47/14A61K2236/331A61K2236/39A61K2236/51A61K2236/53A61K2300/00
Inventor 付裕
Owner CHENGDU XIANXIANXIAN BIOTECH CO LTD
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