Preparation And Evaluation Of Huang Qi Sheng Mai Fast Released Preparations

In this study,Huang Qi Sheng Mai(HQSM)extract was used as the material.HQSM extract powder was prepared through optimizing the excipient types and content by a simplified method.HQSM effervescent tablets were prepared based on an isolation of acid-alkali granulating method.HQSM high porosity tablets were prepared based on a vacuum drying method.These HQSM fast released preparations were evaluated.Study presented was listed as follows:Part1: Preformulation study of HQSM fast released preparations.The density,water content and viscosity of HQSM extract were determined.The endothelial cells protection of HQSM extract related ingredients were investigated.The content of active ingredients was simultaneously determined by high performance liquid chromatography(HPLC).It was demonstrated that the ingredients in extract had obvious endothelial cytoprotection activity.Protocatechuic acid,lobetyolin and schizandrin could be simultaneously determined by HPLC.Part2: Preparation and evaluation of HQSM extract powder.Aggregative index of HQSM extract powder was developed through moisture absorption,fluxility,appearance and solubility to optiminze the excipient types and content.The optimized excipient was mannitol,mannitol: extract was 3:1.Moisture absorption of the extract powder within 24 hours was 4.47±0.04%,the angle of repose was 38.96±1.81 ° and the dissolution time was 15±1 s.Part3: Preparation and evaluation of HQSM effervescent tablets.Response surface design was used to optimize the formulation and process,gas production volume and dissolution time was used as index.The optimized HQSM effervescent tablets had 17.95% tartaric acid,14.70% sodium bicarbonate and moderate PVP/ethyl alcohol solution(6.96%,w/v).The dissolution time was 99.0±1.6 s and gas production volume was 1.04±0.05 mL.Part4: Preparation and evaluation of HQSM high porosity tablets.The influence of excipient types and content,compression degree,vacuum degree on expansivity and dissolution time was studied.The optimized HQSM porosity tablets used mannitol as excipient,and mannitol: extract was 3:1.The thickness of the tablets before drying was about 5.25 mm,the vacuum degree was 0.01 atm.The expansivity of the optimized HQSM porosity tablets was 128.6 ± 13.8% and the dissolution time was 4.0±1.0 s.