赖诺普利聚乙烯醇微粒的制备及其质量评价

Preparation and Quality Evaluation of Lisinopril Polyvinyl Alcohol Particles

目的:制备赖诺普利聚乙烯醇微粒并评价其质量。方法:以聚乙烯醇为载体,采用喷雾干燥法制备赖诺普利聚乙烯醇微粒。考察制剂的形态、粒径、跨度、载药量、包封率和体外溶出度。结果:所制赖诺普利聚乙烯醇微粒为近球形,表面有孔,平均粒径为17.29μm,跨度为0.88,载药量为31.40%,包封率为94.20%,30min时体外累积溶出百分率达90%以上。结论:该制剂制备工艺简单,重复性好,质量检测指标合格。

OBJECTIVE： To prepare lisinopril-loaded polyvinyl alcohol （PVA） particles （LIS-PVA-P） and establish its quality control method. METHODS： LIS-PVA-P was prepared by spray-drying process with PVA as carrier. The preparation was detect- ed in terms of morphology, particle size, span, drug-loading capacity, encapsulation and in vitro dissolution. RESULTS： The preparation assumed sphere with porous surface. The average particle size was 17.29μm while drug-loading capacity 31.40%, encapsulation 94.20%, Span was 0.88, 90% of the drug loads were released within 30 min. CONCLUSION： The preparation process is simple, good in repeatability and qualified in quality.