Improve Preparation Process And Study Quality Control Of Bilingqutong Granule

Objective: BILINGQUTONG Granula is originate from Mr. Wang Zhengyu, abundant experience of First Affiliated Hospital of Anhui Medical University,It has an dfficacy with clearing away heat and toxic materials,clearing damp and promoting blood circulation to remove blood atasis. It has significant clinical effects on patients having intermittent swelling and pain associated with rheumatoid arthritis in gout acute phase. This study targets to enhance the extraction process and the particle formulation of BILINGQUTONG Granula, to compare the quality difference under old and new techniques, andto research product quality control method under the new techniques, in order to determine the best extraction and formulation techniques of this medicine and to further improve the quality control methods.Methods: 1.Use water extraction method on BILINGQUTONG Granula, adopt L9(34) orthogonal design method to evaluate the amount of water, boiling period and boiling times. Byevaluating three factors including hederagenin,oleanolic acid,ferulic acid, berberine hydrochloride and the yield of extraction as the detective index.analyzing the total scores to select the best water extraction techniques. 2.Ratio of accessories was investigated by taking moisture absorption percentage as index;Optimum molding technologh was screened by taking shaping rate of granule as index. 3.Radix Clematidis、Radix Angelica Sinensi、Cortex Phellodendr、Rhizoma Poltgoni Cuspidat、Rhizoma Dioscoreae Septemlobae were identified by thin layer chromatography. 4.According to the addenda general rule of the granula in the 2010 part I of Chinese Pharmacopoeia,a series of quality studies about Compound BILINGQUTONG granula performed as: moisture content,content uniformity,disintegration time,microbial limit. 5.Use ultra performance liquid chromatography(UPLC) method to evaluate the content of hederagenin, oleanolic acid, ferulic acid and berberine hydrochloridein ofthe granula. 6.Use ultra performance liquid chromatography(UPLC) method to establish the signalement fingerprint.and control the totality composition quality of the BILINGQUTONG granula.Results: 1.The best water extraction process was add 8 times amount of water and boiling 3 times with 1 hour for each time. 2.To select the Lactose and β- Cyclodextrinas as adjuvant material,with 80% alcohol to make gtanule and to dry under 60℃. 3.TLC spots were clear the method is a simple,accurate,and no negative interference. 4.Every preparing check was up to the general rule of Granula in Chinese Pharmacopoeia 2010 edition. 5.Establish the method for the determination of hederagenin, oleanolic acid, ferulic acid and berberine hydrochloride. The method is simple, specific and reproducible. 6. Based on fingerprints research under ultra high-performance liquid chromatography(UPLC) on ten batches of preparation, we select the best peak conditions, establish the common mode among different preparation batches, and evaluate the similarity. Control the quality of the preparation by the combination of qualitative and quantitative methods.Conclusion: The study conducts a comprehensive and rational optimization and feasibility validation of the preparation of BILINGQUTONG Granula.The improved quality control method is simple, specific and reproducible, and enables the effective and comprehensive qualitycontrol.