The Study On Preparation Process Andquality Standard Of Zhongfeng Keli

Objective: Zhongfeng Keli prescription sources of Traditional Chinese medicine preparation "Zhongfeng Gao" of Traditional Chinese Medicine Hospital of Gansu Province, is the hospital physician Xia Yongchao based on the ancient "Foshou San", according to syndrome differentiation and treatment principles of treatment, combined with clinical experience screeninparticipation. But the patient appeared many disadvantages, so the study considers the improvement for traditional Chinese medicine Keli, using the modern pharmaceutical technology, according to the difference of the effective components of Chinese herbal medicine prescription and its physicochemical properties, screening the best extraction process of Zhongfeng Keli and its preparation method, establishing the initial method of quality standard of this preparation.Methods: Through the orthogonal designed experiments optimizated the optimum extraction process of Zhongfeng Keli. The representative in the preparation of ferulic acid and paeoniflorin were investigated according to HPLC method, screening granular appearance, loose degree, liquidity best medicinal materials and molding process. Quality standard methods of Zhongfeng Keli finally be worked, the plant herbs were identified by TLC, then detecting the content of ferulic acid and paeoniflorin, and the preliminary stability tests of the preparation were studied finally.Results: The optimum extraction process for the prescription ratio weighing medicine, Angelica sinensis, Rhizome chuanxiong, the root of red-rooted salvia, notopterygium root refluxing 1.5h with 6 times amount of 70% ethanol, filtered and condensed into dry extract. Dregs and Radix Astragali, Radix paeoniae rubra, Liquiritia glycyrrhiza refluxing 1.5h with 8 times amount of water,extracted 3 times, filtered and condensed into dry extract, the merger of the two extraction of dry ointment. Microcrystalline cellulose and dextrin(microcrystalline cellulose : dextrin = 4:1) used as accessories was 19%, with 45% ethanol as binder, 15 mesh sieve extrusion granulating medicine. Content standards for each bag of grain weight 8.0g, equivalent to 10.3g of crude drugs, ferulic acid is more than or equal to 0.0998mg/bag, paeoniflorin is more than or equal to 1.2051mg/bag. Instructions for the preliminary stability tests of the preparation in high humidity conditions of instability and storage relative humidity should be control in critical relative humidity below 68% shall be packaged storage, accelerated stability test, microbial inspection are qualified. The preparation should be sealed and stored in a cool dry place, tentatively valid for 2 years.Conclusion: Under the guidance of TCM theory, the effective parts of the Zhongfeng Keli respectively by alcohol extraction and water extraction method to extract the active principle, screened the type and amount of excipients, the results of the study indicate that the preparation process is reasonable and feasible, the quality is controllable. The TLC method is specific, quantitative determination method is simple, reproducible. The quality standard scheme can effectively control the quality of the preparation. The prospects for the development of Zhongfeng Keli, this paper carried out on Zhongfeng Keli dosage form secondary development, quality standard and stability study of test is now applying for a patent of the extraction method, has laid a solid foundation for the further research and development.