Stability Testing and Statistical Analysis of Validity of Yuhong Ointment / 中国中医药信息杂志

ABSTRACT

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 decidedβ,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.