Pharmaceutical Study Of Conggui Yishen Granules

Objective: To preparate and evaluate the Traditional Chinese Medicine named Conggui Yishen Granules used to remedy Diabeticnephropathy, and then, study on its preparation process, quality standard and preliminary stability. Methods: Pharmaceutical indicators was used as an indicator to screen the preparation route. Study on the extraction, concentration, drying and molding process by single factor experiment and orthogonal experiment. And investigate the stability of the preparation. Qualitative identification of three Herbs were made by TLC; Echinacoside and Verbascoside, Morroniside and Loganin were measured respectively by HPLC. Samples were retained in room temperature and elevated temperature for preliminary stability test. Results: The best preparation process was: take all the herbs except Hordeum vulgare, extracting by water heating backflow with 10 times quantity for 2 hours and 8 times quantity for 2 hours, collecting distillation in the meantime, the combined filtrates was concentrated and the relative density was 1.10~1.15(60?), reserving it; paeonol is collected by distillation and preparated to paeonol-?-cyclodextrin, reserving it; crushing Hordeum vulgare into powder, reserving it; Mix the above dry matter with concentrated combined filtrates, and add starch and sucralose to 1000 g, spray drying, blending, packaging. The spots of the test solutions of the same color as the reference substance are in the corresponding position without interference. The content of Echinacoside and Verbascoside was no less than 2.25mg/g and the content of Morroniside and Loganin was no less than 1.12mg/g. Conclusion: The preparation process of the Conggui Yishen Granules was steady, the quality of the Granules can be controlled and the determination methods can be reproduced.