大豆磷脂胶丸稳定性的初步观察

Preliminary observations on the stability of phospholipid capsules

目的：研究大豆磷脂胶丸的稳定性。方法：进行影响因素试验、加速试验、室温留样考察及低温留样考察，考察本品的外观、崩解时限、乙醇溶液的颜色、含量及降解产物等，并与０时的数据、图谱进行比较。结果：本品６０℃放置胶丸变形、破碎、内容物色泽加深，第１０天时有降解；４０℃，ＲＨ７５％放置１，２，３个月均有降解、内容物色泽加深，３个月时崩解时限延长。结论：本品对高温、高湿度均不稳定，其它考察条件稳定。

OBJECTIVE: The stability of phospholipid capsules was preliminarily studied. METHOD: The appearance,disintegration time,color of alcohol solution,content and degradation products were observed and analyzed under the test of influencing factors,accelerating test,inspecting test at room temperature and low temperarure,respectively. And the results were compared with those at 0 hour. RESULTS: Under 60, the capsules became deformed and broken.The color of the content became dark.The degradation products appeared at the tenth day.Under 40 with RH 75%,degradation products appeared.The color of content became dark in the first month,the second month and the third month, respectively.disintegration time was prolonged in the third month. CONCLUSION: The phospholipid capsules were unstable at high temperature and high hAuthor umidity, but stable under other inspecting conditions.