Chinese medicine and mass control method of preparations thereof

Abstract

The invention relates to a quality control method for Turpinia arguta Seem leaf and a preparation containing the Turpinia arguta Seem leaves. The invention is the quality control method which applies gallic acid, apigenin-7-0-neohesperidin glycosidase, apigenin-7-0-2'-rhamnose rue glycosidase, apigenin-7-0- Beta -D-glucoside and apigenin, etc., as the indexes of the quality control. The method can effectively control the quality of the medicine and the preparation containing the medicine, so that the invention is positive in assuring the safety, effectiveness and controllable quality on the medicine.

Description

technical field [0001] The invention relates to a method for quality control of round leaves and preparations containing the round leaves of Shanxiang, especially with gallic acid, apigenin-7-O-neohesperidoside, apigenin-7-O-2'-rhamnosyl ruta Glycosides, apigenin-7-O-β-D glucoside and apigenin are quality control methods for quality control indicators. Background technique [0002] Turpinia arguta Seem. is the fresh or dried leaf of Turpinia arguta Seem., which is distributed in Jiangxi, Fujian, Guangxi, Guangdong, Hunan, Taiwan and other provinces. , clinically used for the treatment of pharyngitis, acute tonsillitis, and sore throat. As a herbal medicine for treating acute throat diseases, Shanxiang round leaves have a long history of folk application in Anyuan County, Jiangxi Province, and have significant curative effects on throat, oral cavity and other diseases. The patent (application number 200610200362.0) shows that it has the effect of treating viral colds , the ...

AI Technical Summary

Problems solved by technology

After searching the basic drug database of the State Food and Drug Administration, the products on the market include Shanxiang Yuan Tablets, Shanxiang Yuan Granules, Shanxiang Yuan Buccal Tablets, etc. The method mostly adopts the quality control method identified by thin-layer chromatography of the reference medicinal material TLC (Ministry of Health of the People's Republic of China, Drug Standards of the Ministry of Health, Traditional Chinese Medicine Prescription Volume 17: 18; Eleven volumes: 18), in addition to its ursolic acid content determination and thin-layer chromatography identification and the spectrophotometric method with rutin as a contrast to measure the total flavonoids content (Mao Youchang, etc., TLC scanning method is used to determine the content of ursolic acid in the round leaves of Shanxiang). Content, Modern Applied Pharmacy, 1997, 14(3): 7; Luo Xiantang et al., Determination of the content of flavonoids in the flavonoids by UV method, Chinese Medicine Research, 2002, 18(5): 48), the above methods are difficult to comprehensively react And control the quality of medicinal materials and preparations, only use ursolic acid components to control the quality of medicinal materials and preparations. The extraction process, the extraction rate of fat-soluble components such as ursolic acid is very low, which cannot truly reflect the quality of medicinal materials and preparations, and it is difficult to ensure the safety, effectiveness and quality control of the drug, and the efficacy of traditional Chinese medicine is the result of the comprehensive synergy of multiple components , controlling the quality index of a single component cannot fully reflect the clinical pharmacological effect; the quality control method using the reference medicinal material can only be qualitative, but not quantitative, and the application of the method is limited due to the complexity of the components in the compound preparation; the spectrophotometric method is used to determine the total flavonoids The method has false positive results, large component interference, and no specificity

[0003] The round leaves of Shanxiang are generally harvested when the leaves are lush in summer and autumn. However, due to the influence of short-term interests, many medicinal materials that have not reached the appropriate harvesting season are harvested in advance or mixed with other leaf impurities. In addition, due to the influence of the drug preparation process, such as the specific parameter defects of the preparation process, even if some intermediate quality indicators are used to detect, but due to the incompleteness and imperfection of quality control indicators, still It will cause the content of the active ingredients to decrease, which will affect the safety and effectiveness of the drug.

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