Study On The Quality Evaluation System Of The Compound Danshen Tablets

OBJECTIVE: Through a series of test means, such as microscopic identification,routine inspection, and the active ingredient content inspection etc., the research of qualitycontrol and standardization was carried on different manufac-turers of Compound Danshen Tablets by multi-component, multi-target, multi-level andmulti-angle stuty. We compared the quality of Compound Danshen Tablets between the dif-ferent manufacturers and different batches. We explored and established a comprehensivequality evaluation system of Compound Danshen Tablets, which is consistent with the cha-racteristics of proprietary Chinese medicines, scientific and standard with a strong corre-lation between quality and effects.METHODS: Using character identification analysis, microscopic identification ana-lysis, TLC analysis, UV quantitative analysis, HPLC quantitative analysis, principal com-ponent analysis, water examination, determination of extractives, weight variation analysisand dissolution testing from Compound Danshen Tablets, a series of components were stu-died and compared systematically.RESULTS:1.The microstructure characterization of borneol was added to perfect themicroscopic characteristics of Compound Danshen Tablets in2010edition "Chinese Phar-macopoeia".2.Established the TLC method of Sal B from Compound Danshen Tablets, tofill the2010edition "Chinese Pharmacopoeia" non-Sal B blank under the thin-layer chro- matography identification. Added the TLC identification standard of ginsenoside Rg1, gin-senoside Rb1and notoginsenoside R1by fluorescence examination(365nm), to improve thefluorescent examination method of saponins under the thin-layer chromatography identifi-cation from Compound Danshen Tablets.3.Examined the content of Sal B and tanshinoneⅡAof Compound Danshen Tablets between the different manufacturers and differentbatches, to find that all the samples were consistent with the content limit in2010edition"Chinese Pharmacopoeia". At the same time, we examined the content of ginsenoside Rg1,ginsenoside Rb1and notoginsenoside R1of Compound Danshen Tablets between thedifferent manufacturers and different batches, to find that the content difference was smallbetween the same manufacturers in different batches, but the content difference was greatbetween the different manufacturers.4.Analyzed the importance of extract determination,demonstrated the significance to introduce extract tset into routine inspection item of thetraditional chinese medicine preparation as the representative of Compound Danshen Tab-lets.5.A comprehensive evaluation was given about the quality of eight manufacturers byprincipal component analysis.CONCLUSION: Through the comprehensive comparison of the effective ingredientcontent by principal component analysis, investigated disintegration time and extract data,to find the quality of samples from Beijing Tong Ren Tang was best; Ji Nan Hong Ji Tang,An Hui Hua Tuo, Guang Zhou Bai Yun Shan was better; Beijing Bei Wei Yao Ye was worst.According to the experimental results, based on the2010edition "Chinese Pharmacopoeia",we perfected the quality control method and evaluation system of the Compound DanshenTablets, and the results provided a scientific basis for the further study.