Study On Quality Standard Of Three Kinds Of Compound Chinese Medicine Granules

Objective:To establish the quality standard of Weileshu Granule, Compound Shanzha Granule and Compound Yinchen Granule. Methods:1.Weileshu Granule: The chief components of the preparation, Rhizoma corydalis, Inula japonica, Hawthorn, Magnolia officinalis were identified by TLC qualitatively. The content of Tetrahydropalmatine in Rhizoma corydalis was determined by HPLC.2.Compound Shanzha Granule: The chief components of the preparation, Crataegi Fructus and Cassiae Semen were identified by TLC. The contents of Autrantio-obtusin and Chrysophanol in Cassiae Semen were determined by HPLC.3.Compound Yinchen Granule: The chief components of the preparation, Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei, Licorice were identified by TLC qualitatively. The content of Baicalin in Radix Scutellariae was determined by HPLC.4.Compound Yinchen Granule was analyzed with the<Estimating System of Similarity of 2004 A Version>(the National Pharmacopoeia Committee) on the Chinese Medicine Fingerprint Chromatogram. Results:1.Weileshu Granule: In the identification, the sample displayed the same spots which were clear and with high resolution as the reference substance did in the Chromatography, while interference was not observed in the negative control. In the determination, the contents showed good linear in the range of 5.05~65.65μg·ml-1 for Tetrahydropalmatine, the RSD of precision, repeatability and recovery were less than 3%.2.Compound Shanzha Granule: In the identification, the sample displayed the same spots which were clear and with high resolution as the reference substance did in the Chromatography, while interference was not observed in the negative control. In the determination, the contents showed good linear in the range of 3.57~35.70μg·ml-1 for Autrantio-obtusin and 5.20~52.00μg·ml-1 for Chrysophanol, the RSD of precision, repeatability and recovery were less than 3%.3.Compound Yinchen Granule: In the identification, the sample displayed the same spots which were clear and with high resolution as the reference substance did in the Chromatography, while interference was not observed in the negative control. In the determination, the contents showed good linear in the range of 4.16~103.90μg·ml-1 for Baicalin, the RSD of precision, repeatability and recovery were less than 3%.4.The fingerprint of Compound Yinchen Granule was established by HPLC and 22 common peaks were found and their source were determined. Some of the common peaks, composition were confirmed by reference substance contrast method. The similarities of 10 batches samples were over 0.9. Conclusions:The quality control method three kinds of compound Chinese medicine granules were established. These analysis methods are specific, repeatable and simple, and can be used for quality control of three kinds of Chinese medicine granules.