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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: To study the stability of soybean phospholipid capsules. Methods: The influencing factors test, accelerated test, sample retention at room temperature and sample retention at low temperature were investigated. The appearance, disintegration time, color, content and degradation products of ethanol solution were investigated and compared with the data at 0 o’clock Compare Results: The product was deformed and crushed at 60 ℃, the color of the product was deepened, and it degraded on the 10th day. At 40 ℃, RH75% Disintegration time extension. Conclusion: This product is not stable to high temperature and high humidity, other conditions are stable.