Preparation Process And Quality Control Research Of Tangshen Qingdu Granule

This preparation is guided by the theory of dialectical treatment of traditional Chinese medicine,which was used in the nephrology department clinical of Teaching Hospital of Chengdu University of TCM for twenty years,the prescription composed of Radix Scutellariae,Arctii Fructus,Lonicera similis,Taraxaci herba and Siegesbeckia herba,the effect of treating diabetic nephrotic toxic heat syndrome is remarkable,so it is to be developed as a hospital preparation.In this paper,the modern instrument analysis method is used to develop the preparation process of the granules and to establish a more complete quality control method.This subject provides the experimental basis for the development of the modern Chinese medicine preparation with safe and effective quality and controllable quality.In the study of extraction technology,the content of 7 components of chlorogenic acid,caffeic acid,baicalin,arctiin,wogonoside,baicalein,wogonin and ratio of extraction were selected as evaluation indexes,the weighted coefficient in eight synthetic evaluation indexes was determined by mixed weight of AHP-CRITIC.The water extraction process was optimized by orthogonal test,the parameters as follows:adding 7 times of water,decocting for 3 times,40min each time.In the purification process,the single factor test was used to select the purification process with the retention rate of 7 index components and the impurity removal rate as the evaluation index,the parameters were as follows:the concentration of the whole water extract was concentrated to the concentration of 0.75 g.mL^-1,and then centrifugal 20min（8000 r/min）.In the study of molding process,the relative density of thick paste was approximately determined to be 1.25¹.30 by observing the state of paste,then vacuum drying,and the dry paste was pulverized into fine powder.We select the type and proportion of excipients based on the comprehensive score of particle forming rate,solubility rate,moisture absorption rate and repose angle,that is:adding dextrin（extract powder:dextrin is 1:1）and 0.4%steviin were mixed,75%ethanol was used as wetting agent to make particles.In the study of quality standard,according to the corresponding requirements under the Pharmacopoeia granules,the finished products were checked and all the parameters were in accordance with the regulations.The qualitative identification method of Radix Scutellariae and Arctii Fructus was highly reproducible.HPLC method was used to determine the content of baicalin and arctium in the three batches of samples,the content of baicalin and Arctium were limited and the draft standard of quality standard for Tangshen Qingdu granule was formulated.In the study of fingerprint,the fingerprints of 10 batches of extract solution,intermediate and finished product of Tangshen Qingdu granules were created,their respective control fingerprints were generated,their common peaks were calibrated,and the similarity evaluation was carried out.7 common peaks were identified by the mixed control products.The fingerprints of water extract solution of single flavor medicinal herbs and lack of herbs negative were compared with all control fingerprints.Finding all the common peaks could be traced back to the raw materials,and the exclusive common peaks of the five drugs were determined.Using fingerprint with multi-index composition quantitative analysis for Tangshen Qingdu granular could provide a quality monitoring technology and quality evaluation system,to realize the whole process monitoring of the extract solution-intermediate-finished product,and narrowing the differences between the finished product batch.