Quality Control Of The Traditional Chinese Medicine Fuzhengpingxiao Capsule By Modern Analytical Techniques

Chinese medicine prescription is a kind of Biotech drugs which made of appropriate medicinal odour and dosage, according to the "traassistant and guide" of principles of formulating prescription under the theory of traditional Chinese medicine by the ancient Chinese medicine doctors. The validity of the Chinese Medicine Prescription is proved in the clinical research. Now, Chinese medicine prescription is already widely accepted. Establishing the quality control method of the Chinese medicine prescripition is extremely important.Liver cancer is one of the most common malignant tumors in China with high morbidity and mortality. There are many strategies for liver tumor in clinical treatment, such as surgical treatment, interventional therapy, gene therapy and so on. Each strategy has its own advantages and disadvantages. In improving symptoms and survival of patients, Chinese medicine treatment plays an important role. In the guideline of TCM syndrome differentiation and clinical experience, Fuzhengpingxiao capsule is made of twenty-eight Chinese herbal medicines. It has been used for many years with good therapeutic effect. Because of its complicated components, there is not a systematic research for this medicine. According to Military Preparation Standard, it is necessary to qualitation and quantitation for as least one third components in a Chinese Medicine Prescription. We did a series of deeply and systematic research for Fuzhengpingxiao capsule.HPLC-TOF/MS was used the identification of constituents in Fuzhengpingxiao capsule. According to the professional databases and related literature, the database of constituents in Fuzhengpingxiao capsule was established. The mass response of capsule extraction was evaluated in both positive and negative ionization mode. After searching against the formula database established by ourselves,266 compounds were identified by HPLC-TOF/MS, and each constituent was indicated its resource herb medicine. The research characterized the chemical substance of Fuzhengpingxiao capsule and provided the instruction for its quality control.Based on the identification of constituents in Fuzhengpingxiao capsule by HPLC-TOF/MS, typical compounds in principal drug(Radix Astragali, Fructus Evodiae,Radix Scrophulariae,Spica Prunellae,Radix et Rhizoma Gentianae,Semen Persicae), ministerial drug(Bulbus Fritillariae Thunbergii), adjunctive drug(Radix Paeoniae Alba), meaaenger drug(Radix et Rhizoma Glycyrrhize) were selected to be quantitated. The extract conditions were optimized. A HPLC-(+)ESI/MS method for quantitation of amygdalin(Semen Persicae), paeoniflorin(Radix Paeoniae Alba), peimine(Bulbus Fritillariae Thunbergii), astragaloside IV(Radix Astragali), rutaecarpine(Fructus Evodiae), and a HPLC-(-)ESI/MS method for gentiopicroside(Radix et Rhizoma Gentianae), liquiritin(Radix et Rhizoma Glycyrrhize), rosmarinic acid(Spica Prunellae), harpagoside(Radix Scrophulariae) were established. The methods were successfully applied on determination of 9 compounds in 3 batches of Fuzhengpingxiao capsule. There were helpful in quality control of Fuzhengpingxiao capsule.GC-MS were used for the rapid identification of volatile components in Fuzhengpingxiao capsule.73 compounds were identified by GC-MS after searching against the formula database supplied by GC-MS instrument.48 compounds were indicated their resource herb medicine. The Fuzhengpingxiao capsule was also oral administrated to SD rats for investigate the migration components in serum.16 compounds were identified by HPLC-TOF/MS and database. It was only a preliminary study and provided hints to the possible medicinal composition of uzhengpingxiao capsule.