Study On Preparation Technology And Quality Standard Of Yishen Huisheng Granules

Objective: To prepare of Yishen Huisheng granules with Clinical experience protocol of Yishen Huisheng decoction,and to complete the study of preparation technology,quality standard and stability test.The Study is carried out to ensure the better and more convenient service for the patients with the scientific and reasonable preparation process with stable and controllable quality.Methods:(1)Through orthogonal test,the optimum extraction parameters were selected by taking the yield of extract and the content of loganin as the evaluation index,and the concentration process parameters were investigated.(2)According to the nature of the drug,This study select the type and dosage of auxiliary materials,the concentration of wetting agent,the drying temperature and other indicators,such as the degree of granulation difficulty,particle molding rate and so on,so as to optimize the molding process parameters;The critical relative humidity of particles was investigated to provide a basis for the control of production environment.(3)Qualitative identification of every medicinal materials in the prescription by TLC;Astragaloside IV and loganin were determined by HPLC,and formulated the content limit of the preparation,then established the quality standard initially.(4)The stability of three batches of Yishen Huisheng granules were investigated by factor test,accelerated test and long-term test.Result:(1)The optimum extraction process for: prescriptions,add water for two times,with 10 times water for the first time as solvent,decocting for 2 hours,with 8 times water for the second time,decocting for 1 hour,merging of filtrates;Evaporated under reduced pressure to the clear paste with the relative density of 1.35 ~ 1.40.(2)The molding process for: dextrin is used as the excipient,and the proportion is 1.5:1 ~ 2:1.The soft material is made by adding 90% ethanol,Were obtained for granulation with ethanol and drying at70℃.(3)The study of quality standard: The main spots of Astragali,Cornel and Glycyrrhiza uralensis on TLC plates were clear without the interference.The contents of astragaloside IV and loganin were determined by high performance liquid chromatography(HPLC).(4)In the stability test,the results showed that the properties,identification,inspection(granularity,moisture,solubility),determination of the content and microbial limit of the three batches of samples were all in accordance with the regulations,the Yishen Huisheng Granules was stable.Conclusion: The preparation technology of Yishen Huisheng granules is feasible,the method of quality control is scientific and reasonable,which provides an effective basis for the quality control of Yishen Huisheng granules.