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Pharmaceutical composition capable of improving safety of compound smilax glabra injection

A technology of Smilax smilax and its composition, which is applied in the field of pharmaceutical compositions for improving the safety of compound Smilax smilax injection, can solve the problems of solution pH drop, polysorbate 80 is prone to rancidity, and accelerate the pH value of medicinal solution, etc. Low, improve safety, good safety effect

Inactive Publication Date: 2016-08-31
成都市斯贝佳科技有限公司
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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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  • Pharmaceutical composition capable of improving safety of compound smilax glabra injection
  • Pharmaceutical composition capable of improving safety of compound smilax glabra injection
  • Pharmaceutical composition capable of improving safety of compound smilax glabra injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016]

[0017]

[0018] Preparation method: Smilax smilax and schisandra are decocted twice with water, 2 hours each time, combined decoction, filtered, and the filtrate is concentrated under reduced pressure to a relative density of 1.27-1.30 (80°C), let it cool, and 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 liquid medicine is for later use; decoct the dodder with water twice, 1 hour each time, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.25-1.30 (80°C), let it cool, add Ethanol so that the ethanol content is 65%, let stand overnight, filter, the filtrate is concentrated under reduced pressure t...

Embodiment 2

[0020]

[0021]

[0022] Preparation method: Smilax smilax and schisandra are decocted twice with water, 2 hours each time, combined decoction, filtered, and the filtrate is concentrated under reduced pressure to a relative density of 1.27-1.30 (80°C), let it cool, and 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 liquid medicine is for later use; decoct the dodder with water twice, 1 hour each time, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.25-1.30 (80°C), let it cool, add Ethanol so that the ethanol content is 65%, let stand overnight, filter, the filtrate is concentrated under reduced pressure t...

Embodiment 3

[0024]

[0025]Preparation method: Smilax smilax and schisandra are decocted twice with water, 2 hours each time, combined decoction, filtered, and the filtrate is concentrated under reduced pressure to a relative density of 1.27-1.30 (80°C), let it cool, and 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 liquid medicine is for later use; decoct the dodder with water twice, 1 hour each time, combine the decoction, filter, and concentrate the filtrate to a relative density of 1.25-1.30 (80°C), let it 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

The invention discloses a pharmaceutical composition capable of improving the safety of a compound smilax glabra injection. The pharmaceutical composition is characterized by being mainly prepared from a smilax glabra extract, a fructus shisandrae extract, a semen cuscutae extract and polyethylene glycol stearate, wherein each 100ml of solution contains 20-75g of smilax glabra extract of a smilax glabra material, 20-75g of the fructus shisandrae extract of a fructus shisandrae material and 10-35g of semen cuscutae extract of a semen cuscutae material, wherein the dosage ratio of smilax glabra to fructus shisandrae to semen cuscutae is 2 to 2 to 1. A cosolvent polysorbate 80 which has a potential safety hazard and affects the product quality in the compound smilax glabra injection is replaced with the cosolvent which is better in safety and more obvious in solubilizing effect; the polyethylene glycol stearate is higher than the polysorbate 80 in safety and lower than the polysorbate 80 in dosage; the probability and risk of an adverse effect of the medicine are reduced; and the clinical medication safety is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for improving the safety of compound Smilax smilax injection. Background technique [0002] The standard of Compound Smilax Smilax Injection is recorded in the Drug Standards issued by the Ministry of Health (Chinese Medicine Prescriptions). 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 Smilax Injection has been widely used clinically for many years in my country, 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 affected the development of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/896A61K36/90A61K9/08A61K9/14A61K9/19A61K47/14A61P29/00A61P15/00
CPCA61K36/90A61K9/0019A61K9/08A61K9/14A61K9/19A61K36/39A61K36/57A61K36/79A61K36/896A61K47/14A61K2300/00
Inventor 杨素坤
Owner 成都市斯贝佳科技有限公司
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