Study On Technology And Quality Standard Of Qidi Tongshen Tablets

Diabetic Nephropathy(DN), whice is known as diabetic glomerulosclerosis, is one of the Diabetes Mellitus(DM) major microvascular complications whose major clinical manifestations is proteinuria, edema, renal insufficiency, hypertension and so on.Qidi Tongshen Tablet is composed by seven herbs, including Astragalus menbranceus, Rehmanniae, Leech, Rhubarb, Bile Arisaema, Artemisia anomala and Lycopus lucidusin. According to the theory of TCM collateral disease and combined with modern medical analysis on the etiology and pathology of DN, the prescription is summarized from years of clinical practice.Its main function is supplementing qi and nourishing yin, resolving blood stasis and expelling phlegm, expelling masses to dredge collaterals. And clinically for the treatment of DN.This topic is mainly on the study of the preparation technology and the quality standard of the Qidi Tongshen Tablets guided by the traditional Chinese medicine theory.The preparation process:Firstly, the extraction solvent filtering: According to the physicochemical properties of medicine and the solvent used in the reported,the results showed that all medicine in prescription were extracted by water apart from rhubarb whice was crushed.Secondly, preferred process: The content of astragaloside IV and catalpol were used as index to evaluate the technologies based on orthogonal design, in which 3 factors considered were the extraction times, extraction time and volume of water. And the experimental results were analyzed by square-error. Considering cost savings and environmental protection, the extraction process which prefer and verify was ascertained as follows: water extracts three times, first extracts two hours with 11 times the amount of water, and the second, third times each extracts 1.5 hours with 9 times the amount of water.Finally, molding process: According to the spray drying conditions and tablets molding process, the spray drying conditions and adhesives ethanol concentration were determined. And according to the tableting granules moisture, the amount of lubricant was determined. After the 3 batch of pilot test, the results showed that the process is stable and feasible.The quality standard study:The TLC method was established for rehmannia and rhubarb. Heavy metals and microbiological examination were conducted. The Astragaloside IV contented in Astragalus menbranceus, was determined by HPLC, and its methodology was studied. The results showed that the method was simple and has good reproducibility, therefore it can be used to control the quality of Qidi Tongshen Tablet.