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Preparation method of drug composition for improving safety of compound crocus sativus injection

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

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 drug composition for improving safety of compound crocus sativus injection
  • Preparation method of drug composition for improving safety of compound crocus sativus injection
  • Preparation method of drug composition for improving safety of compound crocus sativus injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027] Preparation method: add water to decoct saffron and holly hair 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 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 medicinal liquid is used for later use; Fangji 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 so that the ethanol content is 65%, let stand overnight, filter, the filtrate is concentrated under reduced pressure to a relativ...

Embodiment 2

[0029]

[0030] Preparation method: add water to decoct saffron and holly hair 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 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 medicinal liquid is used for later use; Fangji 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 so that the ethanol content is 65%, let stand overnight, filter, the filtrate is concentrated under reduced pressure to a relativ...

Embodiment 3

[0032]

[0033] Preparation method: add water to decoct saffron and holly hair 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 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 medicinal liquid is used for later use; Fangji 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 so that the ethanol content is 65%, let stand overnight, filter, the filtrate is concentrated under reduced pressure to a relative ...

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Abstract

This invention discloses a preparation method of a drug composition for improving the safety of a compound crocus sativus injection. The drug composition for injection is mainly prepared from a crocus sativus extract, a pubescent Holly root extract, a radix stephaniae tetrandrae extract and butyl phthalyl butyl glycolate. A cosolvent good in safety and obvious in solubilizing-aiding effect is adopted to replace a cosolvent polysorbate 80 having potential safety hazard and affecting the product quality existing in the compound crocus sativus injection, the safety of the butyl phthalyl butyl glycolate is higher than that of the polysorbate 80, the usage amount of the butyl phthalyl butyl glycolate is lower, the probability and risk of adverse reaction 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 method for preparing a drug composition for improving the safety of compound saffron injection. Background technique [0002] The standard of compound saffron injection is recorded in the drug standard issued by the Ministry of Health (Chinese medicine prescription preparation), and the raw materials are saffron, Maodongqing and Fangji, which belong to the 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 saffron 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 clinic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/88A61K9/08A61K47/14A61P15/00A61P29/00
CPCA61K36/88A61K9/0019A61K9/08A61K36/185A61K36/59A61K47/14A61K2236/331A61K2236/39A61K2236/53A61K2300/00
Inventor 付裕
Owner CHENGDU XIANXIANXIAN BIOTECH CO LTD
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