Studies On Preparation Technology And Quality Standard Of Heshenluo Granules

Objective: To prepare and evaluate the Traditional Chinese Medicine named Heshenluo Granules used to treat Chronic renal failure, and then, study on its preparation process, quality standard, and preliminary stability research, providing experimental basis for new drug research in the future.Methods: Use L9(34) orthogonal test to study the optimum extraction process,confirming the best extraction conditions, including the alcohol extraction, volatile oil extraction and inclusion process, and water extraction. By investigating the flowability and moldability, optimize the molding process to get the optimum. Establish the TLC identification methods of Heshenluo Granules for qualitative and quantitative identification;the content determination of epimedium glycoside which is the main effective component of the formula were done by high performance liquid chromatography(HPLC), and investigate the systematically methodology for the determination method.Results: The optimum extraction process and molding process were confirmed, and three batches of granules were prepared. The TLC identification methods were established,and the spots were clear, with strong specificity. The experiment method of the content determination is simple, strong specificity and good reproducibility. According to the determination results of three groups of samples, the content limit of epimedium glycoside were preliminary set. The epimedium glycoside of this product is tentatively not less than7.7 mg/bag.Conclusion: Studies show that preparation of Heshenluo Granules are simple,reasonable and practicable. TLC and determination method are simple, specific. The quality standards of the preparation are stable and controllable, according with the request of the modernization of Chinese medicine, and has a broad market prospect.