盐酸维拉帕米缓释微球的制备及其质量评价

Preparation and quality evaluation of Vera Pammy hydrochloride sustained release microspheres

目的:制备维拉帕米缓释微球,并对其进行质量评价。方法:采用低温喷雾干燥法制备盐酸维拉帕米缓释微球,评价内容包括:微球的粒径及其分布、微球含药量、载药量和包封率、收率以及不同pH值下的释放速率。结果:成功制备了盐酸维拉帕米缓释微球,平均收率为28.97%,所得微球55%以上的粒径在3.0~5.0μm,载药量为26.11%,包封率为76.40%。结论:微球的体外累积释放度完全符合Higuchi方程,初步证实该微球的释放属于骨架溶蚀性过程。

Objectives： Preparation of Vera Pammy microspheres and to evaluate its quality, evaluation content includes： the release rate of morphology, particle size and its distribution, drug content, drug loading and encapsulation efficiency, and yield under different PH conditions.Results： Verapamil hydroehloride sustained-release mierospheres were prepared successfully, the yield was 28.97%, more than 85% of the diameter of the microspheres in 3.0~5.0nm, the drug loading was 26.11%. The entrapment efficiency was 76.40%, and the accumulative release rate of microspheres in vitro with the Higuchi equation, initially confirmed that the microspheres reached skeleton dissolution requirements.