Studies On Quality Control Methods Of Yangxinshi Pian And Its Manufacturing Process

Yangxinshi Pian (YXSP) is a traditional Chinese medicine preparation consisted of over ten kinds of different medicinal herbs, including Astragali Radix (Astragalus Membranaceus), Codonopsis Radix (Codonopsis Pilosula), Puerariae Radix (Puerariae Lobata) and so on. It has the effect of supporting healthy energy, benefiting qi for activating blood circulation, and is clinically used to treat coronary diseases, angina pectoris, myocardial infarction, hyperlipidemia and hyperglycemia. Currently, the drug standard of YXSP in the 2010 edition of Chinese Pharmacopoeia focuses only on the content of Astragaloside IV, and does not involve other active ingredients such flavonoids and alkaloids. On the other hand, effective quality control methods on key production processes such as extraction, concentration and alcohol precipitation are also ignored. In this thesis, Near-infrared Spectroscopy (NIRS) and traditional Chinese medicine fingerprint analysis coupled with multi-ingredients quantitative analysis have been investigated to improve the quality control methods of YXSP both on preparation and production process. The main research achievements are as follows:(1) NIRS was employed to establish quantitative models for determining puerarin, salvianolic acid B, icariin and total flavonoids in YXSP water extract of nine medicine herbs. The results showed that the method could rapidly and accurately monitor key parameters during the extraction process of YXSP.(2) NIRS was applied to monitor the concentration process of YXSP by rapid determination of four key parameters including puerarin, salvianolic acid B, icariin and relative density, and quantitative models for these four indicators were established. The method is helpful to judge the end point of concentration process.(3) NIRS was applied in detecting four key parameters including puerarin, salvianolic acid B, icariin and relative density during YXSP alcohol precipitation. The results showed that the established method is applicable in YXSP manufacturing process, and is beneficial for optimization of alcohol precipitation.(4) A simple and reliable method of high performance liquid chromatography with diode array detection (HPLC-DAD) was developed for fingerprint analysis and simultaneous determination of six compounds including puerarin, salvianolic acid B, berberine hydrochloride, palmatine chloride, dehydrocorydaline and icariin in YXSP. Four kinds of similarities were applied to evaluate the similarities of different batches of YXSP. The results showed that the developed method was an efficient tool for quality consistency evaluation of YXSP.