复方利多卡因乳膏体外透皮吸收实验

Percutaneous Absorption of the Compound Lidocaine Cream in Vitro

目的比较复方利多卡因乳膏实验制剂和市售参比制剂的透皮吸收效果,并考察复方利多卡因乳膏实验品存放不同时间的透皮吸收能力。方法以Franz扩散池和体外大鼠皮肤进行体外渗透实验,采用高效液相色谱法同时测定利多卡因和丙胺卡因的药物浓度,计算累积透皮吸收量,评价制剂的体外透皮吸收效果。结果两组制剂8 h内不同时段透皮吸收累积量差异无统计学意义。有效期内不同存放时间实验制剂各批的透皮吸收累积量和释药速率差异无统计学意义。结论实验制剂和参比制剂的透皮吸收能力一致,在有效期内,不同存放时间的实验制剂透皮吸收能力基本一致。

Objective To compare the percutaneous absorbency of the compound lidocaine cream between the lab made and commercially available one during different periods of storage. Methods The permeation of the cream was studied on rat skin with Franz diffusing cell. Lidocaine and prilocaine was quantified by HPLC. The percutaneous absorbency in vitro was evaluated by transdermal absorption accumulation of lidocaine and prilocaine. Results There were no significant difference in the transdermal absorption accumulation between the test cream and the reference one （ P〉0.05 ）. And no significant difference was found in the transdermal absorption and drug release whenever within the expiry date （ P 〉 0.05 ）. Conclusion The pereutaneous absorbency of the test cream is consistent with the reference cream, and which is stable during storing within the period of validity.