肠溶淀粉空心胶囊在酮洛芬胶囊剂中的应用

The Application of Enteric Starch Hollow Capsules in Ketoprofen

考察肠溶淀粉空心胶囊在酮洛芬胶囊剂中的应用。用肠溶淀粉空心胶囊装填酮洛芬制备酮洛芬肠溶淀粉胶囊剂,以市售酮洛芬肠溶胶囊剂为对照。将酮洛芬胶囊剂分别置于高温(40℃)、高湿RH(75±5)%条件下5 d和10 d,采用高效液相色谱法测定酮洛芬放置前后的含量变化,紫外分光光度法测定放置前后酮洛芬溶出度变化,同时观察胶囊剂外观、色泽等性状变化。结果显示影响因素实验后,胶囊剂外观、色泽等性状均无明显变化,含量测定值在94%~98%,变化均小于5%。在模拟胃液中,2 h后胶囊外观完整,酮洛芬溶出度均小于0.9%;在模拟肠液中,药物溶出度在86%~92%。肠溶淀粉空心胶囊与酮洛芬相容性良好,测定的主要指标符合《中国药典》2015版酮洛芬肠溶胶囊项中的规定。

To investigate the application of enteric starch hollow capsules in ketoprofen,the ketoprofen filled with enteric starch hollow capsules to prepare ketoprofen enteric capsules,and compared with commercial ketoprofen enteric capsules.The ketoprofen capsules samples were placed under conditions of high temperature of 40 ℃ and high humidity of（75 ± 5） % for 5 d and 10 d,respectively.A high performance liquid chromatography（HPLC） method was used to analyze the content of ketoprofen,the dissolution was determined by UV spectrophotometry（UVS）.The appearance,color and other traits were observed before and after placement.There were no obvious differences in appearance,color and other traits of ketoprofen enteric capsules before and after the experiment.The contents of ketoprofen enteric capsules were in the range of 94% ~ 98%,and the contents change was less than 5%.In the simulated gastric juice,the appearance of the ketoprofen enteric capsules was complete,and the dissolution was less than 0.9% after 2 h.In the simulated intestinal fluid and the dissolution of ketoprofen was 86% ~ 92%.There is good compatibility between ketoprofen and enteric starch hollow capsules,the main indicators satisfy the quality standard of ketoprofen enteric capsules in the Chinese Pharmacopoeia 2015 edition.