目的:建立农吉利碱凝胶剂质量标准,并进行初步稳定性考察。方法:通过含量测定、体外透皮试验、初步稳定性考察对农吉利碱凝胶剂进行综合评价。结果:农吉利碱在1.6μg/mL~102.4μg/mL的浓度范围内线性关系良好,平均回收率为100.75%,RSD为0.82%(n=6)。结论:建立的质量评价方法专属性良好,准确可靠,能有效控制农吉利碱凝胶剂的质量。
Objective:To establish quality standards of monocrotaline gel and conduct preliminary stability test. Methods:Comprehensive evaluation on monocrotaline gel was underwent through content determination ,diadermic test and prelimi-nary stability test. Result:Monocrotaline had good linearity in the range of 1.6 μg/mL~102.4 μg/mL. The average recovery rate was 100.75% and RSD was 0.82%(n=6). Conclusion:The method of quality evaluation established is specific,accu-rate and reliable,and can effectively control the quality of monocrotaline gel.