Quality inspection method of traditional Chinese medicine composition twenty-five-ingredient lung disease preparation

Abstract

The invention discloses a quality inspection method of a traditional Chinese medicine composition twenty-five-ingredient lung disease capsule and a preparation thereof. On the basis of the primary standard, high-performance liquid chromatography (HPLC) is additionally used to perform limit test to aconitine in the twenty-five-ingredient lung disease capsule, and simultaneously the high-performance liquid chromatography (HPLC) is adopted to perform quantitative detection to active ingredients of hydroxysafflor yellow A, swertiamarin and cholic acid, as well as differentiation to fructus terminaliae billericae, sandalwood, kummel, Baxiaga and licorice root. The method improves the product quality, and ensures that the preparation can guarantee the drug use safety and the effectiveness while curing diseases.

Description

technical field [0001] The invention relates to a quality detection method of a traditional Chinese medicine composition preparation, in particular to a quality detection method of a Chinese medicine composition twenty-five-flavor lung disease preparation. Background technique [0002] Twenty-five Flavors of Lung Disease Capsule was first recorded in the "Supplement to the Secrets of Tibetan Medicine" written by Sangjie Gyatso. It has a history of clinical application for nearly 300 years and is a good medicine for treating lung diseases in Tibetan medicine. It is recorded in the national standard part of the local standard of Chinese patent medicine, standard number: WS-11380 (ZD-1380)-2002. Twenty-five flavors of lung disease capsules are composed of 25 herbs such as sandalwood, hanging wood, travertine, safflower, grape, licorice, iron rod hammer, bangga, myrobalan, hairy myrobalan, emblica, and bezoar. Eliminates heat and inflammation, relieves lungs and resolves phlegm...

AI Technical Summary

Problems solved by technology

Tiebendhammer and Bangga in Ershiwuweifeibing Capsules contain aconitine and other alkaloids, which have high pharmacological activity and medicinal value, but also have strong toxicity

Although the toxic components are significantly reduced after processing, the safety of medicinal use cannot be guaranteed.

The original quality standard of Ershiwuweifeibing Capsules included the TLC identification of oleanactone, oleanolic acid, cholic acid and oleanolic acid, and the content determination items of glycyrrhizic acid. Aconitine is subject to limit inspection, which makes the preparation a potential safety hazard

In order to prevent the potential safety hazards of this type of preparation, ensure the safety and effectiveness of medication for patients, and ensure that the new quality inspection is more accurate and reliable, the original standard needs to be improved

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