复方利多卡因乳膏体外透皮研究  

In Vitro Percutaneous Characteristics of Compound Lidocaine Cream

作　　者：贺亚静[1,2] 武学鑫 周洁[1,2] 沈腾[2] 贺吉香[1] 

机构地区：[1]山东中医药大学药学院,山东济南250355 [2]复旦大学药学院药剂学教研室,上海201203 [3]山东宏济堂制药集团有限公司,山东济南250355

出　　处：《中国药业》2015年第15期19-21,共3页China Pharmaceuticals

摘　　要：目的研究复方利多卡因乳膏体外透皮规律,并与国外上市产品（商品名Emla）比较离体透皮效果的一致性。方法建立高效液相色谱（HPLC）法测定乳膏透皮接受液中利多卡因和丙胺卡因的质量浓度;以改良Franz扩散池和离体大鼠腹部皮肤进行体外透皮试验。结果利多卡因和丙胺卡因质量浓度分别在0.224～16.8μg/m L和0.192～14.414μg/m L范围内与峰面积的线性关系良好;两药HPLC法测定的准确度和精密度符合要求。利多卡因和丙胺卡因的透皮符合零级动力学方程,利多卡因的供试药和对照药的流通量分别为（274.6±30.25）μg/（cm2·h）、（266.4±21.56）μg/（cm2·h）;丙胺卡因的供试药和对照药的流通量分别为（314.2±31.08）μg/（cm2·h）、（309.4±23.08）μg/（cm2·h）,均无显著性差异（P〉0.05）。结论供试药和对照药的体外透皮规律一致。Objective To investigate in vitro percutaneous characteristics of compound lidocaine cream, and the consistenty of in - vitrope-rcutaneous with the Emla cream. Methods The concentration of lidocaine and prilocaine in receptor fluid was quantified by HPLC. The in - vitro percutaneous experiments of compound lidocaine cream through rat abdomen skin were perfromed by modified Franz′s cell. Results There were good linear relationship between the peak area and concentration in the range of 0. 224 - 16. 8 μg / mL for lidocaine, andin the range of 0. 192 - 14. 414 μg / mL for prilocaine. The accuracy and precision could meet the require-ments. Percutaneous characteristicsof lidocaine and prilocaine accord with zero order kinetics equation. The flux oflidocainefor test and control creamis （274. 6 ± 30. 25） μg / （cm2·h）and （266. 4 ± 21. 56 ）μg / （cm2·h）, and the flux ofprilocainefor test and control creamis （314. 2 ± 31. 08）μg / （cm2·h） and （309. 4 ± 23. 08） μg / （cm2 ·h） There were no significant difference（ P〉 0. 05） by t - test statis-tics. Conclusion In vitropercutaneous patternare consistent for test and control compound lidocaine creams.

关 键 词：利多卡因 丙胺卡因 高效液相色谱法 体外透皮试验 

分 类 号：R969.1[医药卫生—药理学] R965[医药卫生—药学]