活血通脉软胶囊的制备及其溶出度评价  

Preparation of Huoxuetongmai Soft Capsules and its dissolution investigation

作　　者：孔令提[1] 代龙[2] 

机构地区：[1]蚌埠医学院第一附属医院药剂科,安徽蚌埠233000 [2]山东中医药大学药学院,山东济南250355

出　　处：《药学研究》2014年第11期647-650,共4页Journal of Pharmaceutical Research

摘　　要：目的采用湿法超微粉碎技术制备活血通脉软胶囊内容物,对其溶出度进行评价。方法以物料粒度、物料稳定性作考察指标,采用单因素考察法分别对不同分散介质、介质用量、粉碎时间、粉碎温度等工艺参数进行筛选;以多肽含量作溶出度考察指标,比较所制软胶囊与市售活血通脉硬胶囊体外溶出情况。结果软胶囊内容物的最佳湿法超微粉碎工艺为:药粉中加入3.8倍量含8%丙二醇的PEG400,于超微粉碎机中40℃粉碎30 min,出料,即得。软胶囊和硬胶囊在60 min时溶出率分别为75.74%和29.57%。结论湿法超微粉碎所制软胶囊溶出速率和程度显著高于市售硬胶囊,提示其具有更好的生物利用度,具有广阔的应用前景。Objective To prepare Huoxuetongmai Soft Capsules with wet ultrafine grinding technology,and evaluate its dissolution. MetHods Using particle size and material stability as evaluation indexes,different dispersion medium,medium dosage,grinding time and grinding temperature were studied by single factor method. The dissolution of soft capsules was comparing with commercially capsules using polypeptide content as indicator. Results The optimal process was：PEG400, which containing 8% propylene glycol,was added to the power of whitmania pigra at the ratio of 3. 8：1,and then ultrafine grinding under 40 ℃ for 30 min. The dissolution rate in 60 min of soft capsules and commercially capsule was 75. 74% and 29. 57%,respectively. CoNclusioN The dissolution of soft capsules was significantly higher than commercially available capsules,suggesting that it had better bioavailability and broad application prospects.

关 键 词：活血通脉软胶囊 湿法超微粉碎 水蛭 溶出度 

分 类 号：R944.5[医药卫生—药剂学]