CAJ | 학술논문

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。
목적：채용습법초미분쇄기술제비활혈통맥연효낭내용물，대기용출도진행평개。방법이물료립도、물료은정성작고찰지표，채용단인소고찰법분별대불동분산개질、개질용량、분쇄시간、분쇄온도등공예삼수진행사선；이다태함량작용출도고찰지표，비교소제연효낭여시수활혈통맥경효낭체외용출정황。결과연효낭내용물적최가습법초미분쇄공예위：약분중가입3.8배량함8%병이순적PEG400，우초미분쇄궤중40℃분쇄30 min，출료，즉득。연효낭화경효낭재60 min시용출솔분별위75.74%화29.57%。결론습법초미분쇄소제연효낭용출속솔화정도현저고우시수경효낭，제시기구유경호적생물이용도，구유엄활적응용전경。
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.