美速静胶囊的制备及其成型工艺考察

Study on Preparation and Forming Technology of Meisujing Capsule

目的:对原美速静胶囊工艺进行改进,制定质量控制方法,考察成型工艺。方法:采用熔融法将聚乙二醇(PEG)4000与褪黑素制成固体分散体,粉碎后加入辅料制成胶囊。采用高效液相色谱法测定褪黑素的含量,考察美速静胶囊的含量均匀度和溶出度,并测定内容物的堆密度、休止角、临界相对湿度。结果:褪黑素检测浓度在4～24μg·mL-1范围内与其峰面积积分值线性关系良好(r=0.9998),平均回收率为99.6%(RSD=0.64%)。美速静胶囊的含量均匀度均<15.0,10min内溶出约90%。粉末堆密度为0.66g·mL-1,休止角为23.8°,临界相对湿度为60%。结论:建立的美速静胶囊制备工艺可行,且质量可控。

OBJECTIVE：To improve preparation process of Meisujing capsules,to establish its quality control method and to investigate forming technology.METHODS：Meisujing capsule was prepared using the excipient and Melatonin solid dispersion which was prepared by hot melting method using melatonin and PEG 4000.The content uniformity was studied,and the content and dissolution rate of melatonin in Meisujing capsule were measured by HPLC.The bulk density,angle of repose and critical relative humidity（CRH） were investigated.RESULTS：The linear range of melatonin was 4～24 μg·mL-1（r=0.999 8） with an average recovery of 99.6%（RSD=0.64%）.The content uniformity of melatonin in 3 batches of Meisujing capsule was lower than 15.0.The dissolution rate was nearly 90% in 10 min.Its bulk density was 0.66 g·mL-1,the angle of repose was 23.8°,and CRH was 60%.CONCLUSION：Established technology of Meisujing capsule is feasible and controllable in quality.