Study On Preparation And Quality Of Quickly Disintegrating Tablets Based On Classic Mingfang Baihu Decoction

Baihu Decoction is derived from Zhang Zhongjing’s Treatise on Febrile Diseases,which has the effects of clearing heat and relieving fire and solving evil.Clinically used for Yangming,gas division heat Sheng certificate.This project develops the new dosage form of the avalanche tablets,to determine the preparation process and the quality control method,and the internal pharmacokinetics of the rapid avalanche tablets was also studied.In the extraction process research,the semi-bionic extraction process was optimized by the uniform design method.Taking artificial gastric liquid and artificial intestinal liquid as the solvent,we studied the content and ointment rate of new mangoside and glyrrhizidine as the index.Determine the optimal process of 7.5 times amount of artificial gastric fluid extract 2.5 h,5.5 times amount of artificial intestinal fluid extract 4 h.Under this condition,the extraction process is stable and operable and can be used for production.In the preparation process of avalanche tablets,single-factor test and star-point design response surface method were optimized.Best prescription of 20%cream,23%L-HPC,48%lactose,65%ethanol right,wet legal grains,7%low substituted hydroxypropyl cellulose and 2%magnesium stearate mixed with pressure of 20-30 N/cm2.This process is simple and has good reproducibility can be used for industrial production.In the study of quality control method,appearance characteristics,sheet weight difference,hardness,brittle fragmentation,disintegration time limit,content determination and other quality evaluation items were established,and the preparation stability was preliminarily investigated through influencing factors.The anche sheet is pale yellow,uniform color and complete surface;sheet weight difference within 1%;hardness range between 20-30 N/cm2,completely disintegrated within 20 s;new mango side content not less than 226.80 μg/g,glyrrhizoside not less than 53.76μg/g.The stability results showed a significant decrease in content at 75%high humidity,and basically no change in various indicators under high temperature and 4500 xL strong light irradiation.The proposed method can effectively control the quality of the avalanche sheet.The avalanche film is highly hygroscopic and needs to be dry and moisture-proof.In the pharmacokinetic study,white tiger was tablets and determined the pharmacokinetics parameters of new mango side in rabbits.The AUC(0-t)of mangiferin was 4879.381μg/mL*min,Tmax was 60 min,T1/2 was 68.73 min,MRT(0-t)was 108.071 min,Cmax was 46.530 μg/L.