六味地黄凝胶体外透皮特性与皮肤刺激性评价研究  

In Vitro Transdermal Characteristics and Skin Irritation Evaluation of Liuwei Dihuang Gel

作　　者：梅佳华 刘云宽 邰先桃 林柳任 王厚融 蔡俊飞 马云淑 MEI Jiahua;LIU Yunkuan;TAI Xiantao;LIN Liuren;WANG Hourong;CAI Junfei;MA Yunshu(Yunnan Key Laboratory of Southern Medicinal Utilization,Yunnan University of Chinese Medicine,Kunming 650500,China;The Key Laboratory of External Drug Delivery System and Preparation Technology in University of Yunnan Province,Yunnan Key Laboratory of Dai and Yi medicines,Engineering Research Center for Medicine and Food Homologous Beverage of Yunnan Province,Kunming 650500,China)

机构地区：[1]云南中医药大学暨云南省南药可持续利用研究重点实验室,昆明650500 [2]云南省高校外用给药系统与制剂技术研究重点实验室,云南省傣医药与彝医药重点实验室,云南省药食同源饮片工程中心,昆明650500

出　　处：《中国药学杂志》2025年第1期66-70,共5页Chinese Pharmaceutical Journal

基　　金：云南省科技计划项目-中医联合重点项目资助(2017FF117-006);云南省科技厅重点研发计划资助(202103AC100005);云南省科技厅重大科技专项资助(202102AA310027);云南省科技厅社会发展专项-重点研发计划项目资助(202303AC100025);云南省生物医药专项-重大科技专项计划资助(202302AA310031);云南省教育厅科学研究基金项目资助(2024Y379)。

摘　　要：目的研究六味地黄凝胶的体外透皮特性,并考察其皮肤刺激性。方法采用立式Franz扩散池进行体外透皮试验,以大鼠皮肤作为透过屏障,对六味地黄凝胶进行大鼠体外皮肤渗透实验,采用高效液相色谱法(HPLC)测定接受介质中马钱苷、莫诺苷和丹皮酚的浓度,计算累积渗透量及透过率,考察六味地黄凝胶的体外透皮特性;并观察六味地黄凝胶单次或多次涂抹于豚鼠完整及破损皮肤处后的刺激情况。结果六味地黄凝胶在12 h内莫诺苷、马钱苷、丹皮酚的累积透过量分别为246.56,298.47,369.89μg·cm^(-2),累积渗透率分别为19.67%,21.55%,39.18%,且六味地黄凝胶对豚鼠完整皮肤及破损皮肤均无刺激性。结论六味地黄凝胶透皮性能良好,各指标成分体外透皮过程均符合Higuchi动力学方程,对豚鼠皮肤无刺激性,皮肤外用安全可靠,具有临床应用潜力。OBJECTIVE To study the in vitro transdermal characteristics of Liuwei Dihuang gel and evaluate the safety of skin medication.METHODS The improved vertical Franz diffusion cell method was used for in vitro transdermal experimental and the skin of rat was used as the permeation barrier.The cumulative permeation amount and rate of morroniside,loganin,and paeonol in the receiving medium were determined by HPLC,to investigate the in vitro transdermal characteristics of Liuwei Dihuang gel.The skin irritation was observed after single or multiple application of Liuwei Dihuang gel on intact and damaged skin of guinea pig.RESULTS The cumulative permeation amount of morroniside,loganin and paeonol within 12 h were 246.56,298.47 and 369.89μg·cm^(-2),and the cumulative permeation rate were 19.67%,21.55%and 39.18%,respectively.Liuwei Dihuang gel is not irritating to both intact and damaged skin of guinea pigs.CONCLUSION The in vitro transdermal performance of Liuwei Dihuang gel is good.The in vitro transdermal process conforms to the Higuchi kinetic equation.It has no irritation effect on the skin of guinea pigs.It is safe and reliable for skin external use and has good linical application potential.

关 键 词：六味地黄凝胶 高效液相色谱法 体外透皮特性 皮肤刺激性 

分 类 号：R944[医药卫生—药剂学]