小儿清热宣肺贴膏指标成分含量测定方法的建立及体外透皮特性研究  

To explore the determination method of index component content in Xiao’er Qingre Xuanfei Plaster and its transdermal property in vitro

作　　者：宗时宇 苏雅琼 王苗[3] 李晔[1] 张红[1] 王保安 毛鹏 王春柳[1] ZONG Shi-yu;SU Ya-qiong;WANG Miao;LI Ye;ZHANG Hong;WANG Bao-an;MAO Peng;WAQNG Chun-liu(Shaanxi Provincial Academy of Traditional Chinese Medicine,Xi’an 710003,China;Northwest University,Xi’an 710069,China;Shaanxi University of Chinese Medicine,Xianyang 712046,China;Shaanxi Momentum Qixuehe Pharmaceutical Co.,Ltd.Xianyang 712000,China)

机构地区：[1]陕西省中医药研究院,陕西西安710003 [2]西北大学,陕西西安710069 [3]陕西中医药大学,陕西咸阳712046 [4]陕西摩美得气血和制药有限公司,陕西咸阳712000

出　　处：《时珍国医国药》2025年第1期82-87,共6页Lishizhen Medicine and Materia Medica Research

基　　金：陕西省重点研发计划一般项目(2024SF-YBXM-530);陕西省自然科学基础研究计划项目一般项目-青年项目(2023-JC-QN-0973);陕西省中青年优秀骨干人才计划(2023-ZQNY-007)。

摘　　要：目的建立小儿清热宣肺贴膏中指标成分的含量测定方法,并研究其体外透皮特性。方法采用HPLC同时测定小儿清热宣肺贴膏中栀子苷和苦杏仁苷的含量。采用Franz扩散池法,以离体SD大鼠和巴马小型猪皮肤为体外透皮模型,20%乙醇生理盐水为接收液,研究小儿清热宣肺贴膏中指标成分的透皮行为。结果小儿清热宣肺贴膏中栀子苷和苦杏仁苷的含量分别为21.40 mg·g^(-1)和3.49 mg·g^(-1)。体外透皮实验,12 h时,栀子苷和苦杏仁苷在大鼠皮肤的累积透皮率分别为23.31%和25.64%,皮肤中滞留率分别为0.46%和0.53%;在小型猪皮肤的累积透皮率分别为4.13%和7.41%,皮肤中滞留率分别为0.47%和0.53%。指标成分的体外透皮过程符合零级动力学方程。结论建立的HPLC含量测定方法稳定、可靠,适用于小儿清热宣肺贴膏的质量控制;该贴膏在两种动物皮肤的透过性存在种属间差异大,SD大鼠皮肤的透过性明显高于巴马小型猪皮肤,其指标成分的释放主要以扩散为主,皮肤角质层是其主要限速因素。Objective To develop a method for determining the content of index components in Xiao’er Qingre Xuanfei Plaster(XQXP),and investigate its transdermal property in vitro.Methods HPLC was used to determine the contents of geniposide and amygdalin in XQXP.Franz diffusion cells were used to conduct the transdermal behavior of the index components in XQXP using isolated skin of SD rats and Bama miniature pigs as the transdermal model in vitro,and 20%ethanol saline as the receiving solution.Results The contents of geniposide and amygdalin in XQXP were 21.40 mg·g^(-1)and 3.49 mg·g^(-1)respectively.In vitro transdermal experiment,at 12 h,the cumulative transdermal rates of gardenoside and amygdalin in rats skin were 23.31%and 25.64%respectively,and the reten⁃tion rates in skin were 0.46%and 0.53%respectively.And in the skin of miniature pigs,the cumulative transdermal rates were 4.13%and 7.41%respectively,and the retention rates in skin were 0.47%and 0.53%respectively.The transdermal process in vitro of the index components conformed to the zero-order kinetic equation.Conclusion Being stable and reliable,the HPLC method is suitable for the quality control of XQXP.The skin permeability of SD rats was significantly higher than that of Bama miniature pigs.The release of index components was mainly diffusion-based,and the cuticle was the main rate-limiting factor.

关 键 词：小儿清热宣肺贴膏 栀子苷 苦杏仁苷 透皮特性 

分 类 号：R283[医药卫生—中药学]