新型羟丙基淀粉空心胶囊在阿莫西林中的应用

摘要

Objective:To investigate the compatibility of vacant capsule from Hydroxypropyl Starch and Amoxicillin .Methods:The capsules were placed in the conditions of (4 000 ±500 Lx) light, 40 ℃and RH 75 ±5%for 5 and 10 days, respectively.The con-tent of Amoxicillin and related substances were analyzed by HPLC.The appearance , color and other drug traits were observed before and after placement.Results:After high temperature , high humidity and light test , the maximum impurity peak area and the total im-purity content increased , but the contents of Amoxicillin and related substances were in line with the standard requirements .Conclu-sion:The vacant capsule from Hydroxypropyl Starch has a good compatibility with Amoxicillin and substitute gelatin capsules is feasi -ble.%目的：考察新型羟丙基淀粉空心胶囊与阿莫西林的相容性。方法：分别在强光（4000±500 Lx）、高温（40℃）、高湿（相对湿度75％±5％）的条件下放置5 d和10 d，采用高效液相色谱法检查阿莫西林含量及有关物质在放置前后的变化，同时观察外观、色泽等药物性状的变化。结果：经高温、高湿、光照试验后，最大杂质峰面积和总杂质量虽有所增加，但有关物质检查及阿莫西林含量均符合标准规定。结论：自制羟丙基淀粉空心胶囊与阿莫西林有较好相容性，可替代明胶胶囊使用。