Shu Gan Ping Wei Pills Quality Standard, Fingerprint And Pharmacokinetic Study

According to the principles of "Principal, Adjuvant, Auxilary and Conductant ingredirnts "of traditional Chinese medicine, the complex prescription of the traditional Chinese medine was concidered a kind of traditional preparation. The validity of the complex prescription of the traditional Chinese medine is proved in the clinical research. And the medication of it is accepted widely. So, establishing the quality control method of the Chinese medicine prescripition is extremely important.In this dissertation, Shugan Pingwei Pills(SGPW Pills) were selected as the object of study. SGPW Pills are about to be written in the pharmacopoeia of China, which were recorded in the Ministry of Health's drug standard catalogue of China. First, on the current principle of the pharmacopoeia of China, the new quality control standards of SGPW Pills were improved on the basis of their previous standard. The assay method of SGPW Pills were set up by HPLC, and then the HPLC fingerprint and pharmacokinetic study are set up.1. The elevation of the quality control standard of the SGPW PillsThe microscopical identified methods of Magnolia officinalis Rehd.et Wils, Pinellia ternata(Thunb.) Breit and Glycyrrhiza uralensis Fisch were revised, the TLC methods of Atractylodes lancea (Thunb.) DC, Magnolia officinalis Rehd.et Wils, Glycyrrhiza uralensis Fisch, Citrus aurantium L and Citrus reticulata Blanco were established, and the assaying method of the Magnolol and Honokiol in the complex prescription was set up by HPLC. The quality of the complex prescription was controlled fully by above-mentioned identification and determination.2. The HPLC fingerprint study of the SGPW PillsThe HPLC fingerprint of the SGPW Pills was established by HPLC, which expressed some correlated information of five kinds of medical material. The main chromatographic peaks were confirmed by comparing and analyzing the relative retention time of the SGPW pills and medical material. The penetrating quality control method was established by contrasting different batches of sample.3. The pharmacokinetic study of the SGPW PillsThe pharmacokinetics method of the SGPW Pills was established by HPLC-MS. Magnolol was the indicator of determination, and the absorbed situation of SGPW Pills in the body was observed. The test proved that the absorption and distribution of Magnolol were fast in the body, which reached the peak plasma concentration.around one hour. The absorbed situation of drug was comprehended by comparing AUC, Cmax and other pharmacokinetic parameters.