Studies On The Preparation Technology And Quality Standard Of Xiaozheng Granules

Objective: To prepare and evaluate the Traditional Chinese Medicine named Xiaozheng Granules used to treat Endometriosis, and then, study on its preparation process,quality standard, and preliminary stability research, providing experimental basis for new drug research.Methods: The subject is studied through orthogonal test to study the optimum extraction process of Xiaozheng Granules, including the volatile oil extraction and inclusion process, alcohol extraction, and water extraction. By investigating the ratio of raw and auxiliary materials, hygroscopicity and molding rate, optimizing the best molding process, and three batches of granules were prepared. Establish the thin layer chromatography of Xiaozheng Granules for qualitative identification, including zedoary,Cyperus Rotundus L, cassia, peach kernel, zhejiang fritillary and so on; the content determination of naringin which is the main effective component of the formula were done by High performance liquid chromatography, establish standard for quality control and investigate the systematically methodology for the determination method.Results: The optimum extraction process and molding process were confirmed, and to establish the thin layer chromatography of the main drug preparations and content determination method. The methods are simple and convenient, stable and controllable.Conclusion: Studies show that preparation of Xiaozheng Granules were simple, safety,stability and feasible. These methods of qualitative and quantitative are simple, specific.The quality standards of the drug preparations are stable and controllable, which provide quality assurance for clinical application and has a broad market prospect.