Study On The Quality Standard Of Bawei Shenxiang Pills

Bawei Chenxiang pills is famous prescription of traditional Tibetan medicine, which was recorded in the Tibetan classical masterpiece "The Four Medical Tantras"(AD 773-783), and now it has been officially recorded in the Ministry of Health, the first book of Tibetan pharmaceutical standards. Its prescriptions composed of the Aquilariae lignum resinatum, Myristicae semen, Choerospondiatis fructus, Chebulae fructus, Olibanum, Aucklandiae radix, Gossampini flos, Calciosinti 8 herbs. The prescription has been used as the common drug treatment of coronary heart disease and other cardiovascular diseases, clinical applications. Although this prescription has been applied in clinical application for over a thousand years, the further development of its clinical applications has been hindered because of its material basis and pharmacological effect mechanism of action is not clear. In addition, the current standard only defines Bawei Chenxiang pills microscopic identification, TLC identification of Aquilariae lignum resinatum. Without enough representation and lack of prescription quality control indicators and quantitative criteria, it is difficult to ensure the stability of the product quality as well as safety and efficacy of medication. Furthermore, the current commercially available Bawei Chenxiang pills has different packaging materials, which contains polyethylene packaging bottle for pharmaceutical packaging, PTP aluminum foil, PVC solid medicinal hard pieces, etc. And there are two periods of validity for Bawei Chenxiang pills: 42 months and 36 months. Since the physical basis is not clear, we still need to study if the differences in commercially available drug packaging materials and the periods of validity can ensure the safety of the medication in application.Our main purpose of this study is:firstly, to improve the existing quality standards, and to improve the quality of medicines controllability and uniformity of Bawei Chenxiang pills. Secondly, through preliminary stability studies, to explore the changes in pharmaceutical representative component, and then provid a scientific basis for drug packaging materials selection and Validity of the formulation. At last, we want to establish HPLC fingerprint of Bawei Chenxiang pills's conponets thus to give scientific supports to the quality control of the medicine.In this study, we created qualitative identification methods of Choerospondiatis fructus, Chebulae fructus, Olibanum and Aucklandiae radix by TLC, as well as HPLC quantitative methods of gallic acid, Costunolide, dehydrocostuslactone and Dehydrodiisoeugenol, which greatly improved the existing quality standards. Stability test results shows that the material basis of drugs affected by external conditions. So we should select the appropriate packaging material and formulate a reasonable validity period. The establishment of the whole party fingerprint, is the first try to explore the material basis of Bawei Chenxiang pills. It provided a method for the overall quality control of Bawei Chenxiang pills, as well as new method for further pharmacological efficacy mechanism research. This study brought us a new idea to further develop Bawei Chenxiang pills and helped us laid the foundation for the basic clarifying of its material composition and its mechanism of action.