目的：考察玉红膏在加速试验与长期试验条件下制剂随时间变化的规律,为生产及新药申报提供必要的试验数据,同时通过试验建立制剂有效期。方法参照我国现行中药稳定性试验指导原则,选择影响因素试验与长期试验条件,以β,β'-二甲基丙烯酰阿卡宁含量为定量指标,结合稳定性重点考察项目评价其稳定性,用统计学方法推断其有效期预测值。结果本品在高温[(30±2)℃,RH 45%±5%]、高湿[(25±2)℃,RH 75%±5%]、强光[(4500±500)Lx,(25±2)℃,RH 45%±5%]条件下放置10 d,其性状、外观、含量均符合规定,25℃条件下玉红膏有效期为41.216个月。结论目前生产条件下,玉红膏稳定性良好。%Objective To investigate the variation of the preparation time of Yuhong Ointment under conditions of accelerated test and long-term test;To provide the necessary data for the production and new medicine application, and establish the period of validity. Methods Referring to the current guiding principles of TCM stability test, the conditions of affecting factors in trial test and long-term test were decided:β,β'-dimethylacrylshikonin content was set as quantitative indicators, combined with the key items of stability test to evaluate the stability;its validity predictive value was deduced by using statistical methods. Results In the conditions of high temperature (30 ± 2 ℃, RH 45% ± 5%), high humidity (25 ± 2 ℃, RH 75% ± 5%), and hard light (4500 ± 500 Lx, 25 ± 2 ℃, RH 45%± 5%) for 10 days, the traits, appearance and content were in line with requirements. The validity of Yuhong Ointment under 25 ℃ conditions was 41.216 months. Conclusion Under current production conditions, the stability of Yuhong Ointment is good.
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