South Of Schisandra Quality Standards And Liver Capsule

AIM:(1) To establish a HPLC method for the determination of deoxyschizandrin and schisantherrin A in Fructus schisandrae sphenantherae and improve its quality standard. (2) To establish the HPLC fingerprint spectrum and determine four lignans of Fructus schisandrae sphenantherae and Fructus schisandrae chinensis, and this method can be used for their quality control. (3) To complete the production process and quality standards of ganbao capsule. Methods:(1) The condition of HPLC was optimized, and the peaks of deoxyschizandrin and schisantherrin A reach a ideal baseline separation. (2) Similarity evaluation system for chromatographic fingerprint of TCM (2004 AB) was used in data analysis on fingerprints of Fructus schisandrae sphenantherae and Fructus schisandrae chinensis, and four components of lignans were determined. (3) The extraction rate of the active .ingredient as the index was used to study on extraction and formulations forming process by orthogonal test. In order to develop quality standards of ganbao capsule, the main active ingredient content was detected by HPLC method. Results:(1) A method was established that can determine deoxyschizandrin and schisantherrin A, and the method was simple, accurate, feasible and reproducible. According to actual determined results, recommend that take the total contents of deoxyschizandrin and schisantherrin A as the indicator of determination of content and no less than 0.30% in Chinese Pharmacopoeia. (2) The HPLC fingerprint of Fructus schisandrae sphenantherae and Fructus schisandrae chinensis were established.25 common peaks were pointed out from the HPLC fingerprint of Fructus schisandrae sphenantherae and 24 common peaks were pointed out from the HPLC fingerprint of Fructus schisandrae chinensis; Fructus schisandrae chinensis in different batch were of high similarity in HPLC fingerprint chromatogram, but their similarities were less than 0.30, comparing with the HPLC fingerprint chromatogram of Fructus schisandrae sphenantherae. (3) The extraction process of Fructus schisandrae sphenantherae and scutellaria radix were identified and molding process of ganbao capsule identified too; Three batches of pilot test and pilot scale test completed; The methods of identification of TLC and HPLC determination were established, An effective quality control standards developed too. Conclusion:The standard of Fructus schisandrae sphenantherae was improved. This method was simple and reliable. The HPLC fingerprint and contents of the main lignans can be used for their quality control; The production technology of ganbao capsule was practical and feasible. The methods of identification of TLC and HPLC determination were established that can effectively control the quality of the ganbao capsule. The study laid the foundation for the development and application of Fructus schisandrae sphenantherae.