Preparation method of pharmaceutical composition for improving safety of compound polygonatum rhizome injection

A technology for injection and safety, which is applied in the field of medicine, can solve problems such as the drop of solution pH value, accelerate the pH value of liquid medicine, and the easy rancidity of polysorbate 80, and achieve high dosage, improved safety, and good safety effects

Inactive Publication Date: 2017-03-29
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 polygonatum rhizome injection
  • Preparation method of pharmaceutical composition for improving safety of compound polygonatum rhizome injection
  • Preparation method of pharmaceutical composition for improving safety of compound polygonatum rhizome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027] Preparation method: boil sealwort and medlar 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 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 used for later use; the bellflower 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 relat...

Embodiment 2

[0029]

[0030] Preparation method: boil sealwort and medlar 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 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 used for later use; the bellflower 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%, stand overnight, filter, the filtrate is concentrated under reduced pressure to a relative den...

Embodiment 3

[0032]

[0033]Preparation method: boil sealwort and medlar 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 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 used for later use; the bellflower 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 relati...

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Abstract

The invention discloses a preparation method of a pharmaceutical composition for improving the safety of a compound polygonatum rhizome injection. The pharmaceutical composition is mainly prepared from polygonatum rhizome extract, wolfberry extract, balloonflower root extract, and polyvinyl acetate, and is used for injection. A safer cosolvent, which has a better dissolving assistant effect, is used to replace the cosolvent (polysorbate 80) in a compound polygonatum rhizome injection, polysorbate 80 is not safe and affects the product quality, polyvinyl acetate is safer, compared with polysorbate 80, the using amount of polyvinyl acetate is less, thus the happening rate and risk of adverse reactions are both reduced, and the clinical safety 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 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 ser...

Claims

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Application Information

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IPC IPC(8): A61K36/8969A61K9/08A61K47/26A61K47/32A61K47/14A61P15/00A61P29/00
CPCA61K36/8969A61K9/0019A61K9/08A61K36/346A61K36/815A61K47/14A61K47/26A61K47/32A61K2236/331A61K2236/39A61K2236/51A61K2236/53A61K2300/00
Inventor付裕
OwnerCHENGDU XIANXIANXIAN BIOTECH CO LTD