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目的:考察羟丙基淀粉胶囊对螺内酯胶囊主药含量的影响。方法:分别在强光(4 000 Lx±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样品放置前后含量改变,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,测得标示含量值均在93.45%~100.37%之间,符合标准规定(93.0%~107.0%)。结论:羟丙基淀粉空心胶囊与螺内酯相容性较好。
Objective: To investigate the effect of hydroxypropyl starch capsules on the content of spironolactone capsules. Methods: The samples were exposed to high light (4 000 Lx ± 500 Lx), high temperature (40 ℃) and high humidity (relative humidity 75% ± 5%) for 5 d and 10 d, respectively. Before and after the content change, while observing the appearance, color and other changes in drug traits. Results: After high temperature, high humidity, light test, the measured content values were between 93.45% and 100.37%, in line with the standard requirements (93.0% ~ 107.0%). Conclusion: Hydroxypropyl starch hollow capsules have good compatibility with spironolactone.