阿奇霉素微囊的制备与质量控制

目的:制备阿奇霉素微囊,并建立其质量控制方法。方法:以明胶为囊材,阿奇霉素为主药制备微囊。采用紫外分光光度法于482nm波长处测定阿奇霉素的含量,同时考察微囊的形态、粒径、载药量、包封率等指标。结果:所制微囊呈圆形,粒径均匀,平均体积径为100.96μm,平均载药量为23.8%,平均包封率为(68.72±0.89)%。阿奇霉素检测浓度的线性范围为7.5～52.5mg·L-1,平均回收率为(99.5±1.02)%,RSD=1.03%。结论:该制剂制备工艺可行,含量测定方法简便、可靠。

Preparation and Quality Control of Azithromycin Microcapsules

OBJECTIVE： To prepare Azithromycin microcapsules and to establish its quality control method. METHODS： Azithromycin microcapsules were prepared with gelatin as the coating material and azithromycin as main component. The content of azithromycin was determined by UV spectrophotometry at 482 nm wavelength. The morphology, average diameter, drug-loading rate and encapsulation coefficency of Azithromycin microcapsules were investigated. RESULTS： Azithromycin microcapsules assumed as round shape and uniform particle size distribution with average volume diameter of 100.96 ？m. The mean drug-loading rate was 23.8% and mean encapsulation coefficency was （68.72±0.89）%. The linear range of azithromycin was 7.5～52.5 mg·L-1 with mean recovery of （99.5±1.02）% （RSD=1.03%）. CONCLUSION： Preparation method is practical. Content determination method is simple and reliable.