DOI：10.3969/j.issn.1005-5304.2015.07.026
中图分类号：R283.5 文献标识码：A 文章编号：1005-5304（2015）07-0092-04
Stability Testing and Statistical Analysis of Validity of Yuhong Ointment XIAO Zheng-guo， LIU Xiao-shuan， LI Xi-xiang， ZHENG-Hui， SONG Wei， PAN Cong-ze （Gansu Province Hospital of Traditional Chinese Medicine， Lanzhou 730050， China）
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 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.
Key words：Yuhong Ointment；stability；β，β'-dimethylacrylshikonin
基金项目：甘肃省自然科学研究基金计划（1208RJZA135）
宜水煎服用，可参照2010年版《中华人民共和国药典》：“去壳，去油用，多入丸散服。”秦皮乙素主要具有抗菌抗炎和抑制酪氨酸酶活性作用[7]，且千金子打碎后水煎溶出较好，因此，临床使用千金子抗菌、抗炎时可打碎入煎剂服用。
