桂枝茯苓透皮贴剂主要成分含量及释放度测定

Determination of content determination and in vitro release of Guizhi Fuling transdermal patch

目的:测定桂枝茯苓透皮贴中芍药苷、肉桂酸、丹皮酚的含量及释放度。方法:建立HPLC法测定贴剂中肉桂酸、芍药苷和丹皮酚含量;按照《中国药典》2015年版四部溶出度与释放度测定法第四法测定贴剂的体外释放性能。结果:建立了同时测定桂枝茯苓贴中3种成分的液相色谱法。芍药苷、肉桂酸和丹皮酚的线性范围分别为16.08~144.72μg·mL-1,0.32~2.91μg·mL-1和8~72μg·mL-1。精密度、重复性、24 h稳定性、加样回收率良好。建立了桂枝茯苓贴剂体外释放度测定方法,贴剂释药曲线符合Higuchi方程。结论:建立的含量和释放度测定方法简便、准确,可用于桂枝茯苓透皮贴剂的质量控制。

OBJECTIVE To determine the content and release rate of paeoniflorin,cinnamic acid and paeonol in Guizhi Fuling transdermal patch.METHODS HPLC method was established to determine the content of cinnamic acid,paeoniflorin and paeonol in transdermalpatche,and the in vitro release property of the patch was determined according to the dissolution and release methodⅣdescribed in Chinese Pharmacopoeia(Edition 2015,VolumeⅣ).RESULTS An HPLC method for simultaneous determination of three constituents in Guizhi Fuling patch was established.The linear correlation of paeoniflorin,cinnamic acid and paeonol were observed in the range of 16.08-144.72μg·mL-1,0.32-2.91μg·mL-1 and 8-72μg·mL-1.The precision,repeatability,stability within 24 h and recovery rate of sample addition were proved to be favorable.A method for determination of release rate of Guizhi Fuling patch was established and the release rate profiles followed the Higuchi equation.CONCLUSION The established HPLC method for the determination of the contentand the release property of cinnamic acid,paeoniflorin and paeonolwere accurate,precise and stable,which can be used for quality control of patch.