CAJ | 학술논문

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 / mL 和0.192~14.414μg / mL 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。
목적：연구복방리다잡인유고체외투피규률，병여국외상시산품(상품명 Emla)비교리체투피효과적일치성。방법건립고효액상색보（HPLC）법측정유고투피접수액중리다잡인화병알잡인적질량농도；이개량 Franz 확산지화리체대서복부피부진행체외투피시험。결과리다잡인화병알잡인질량농도분별재0.224~16.8μg / mL 화0.192~14.414μg / mL 범위내여봉면적적선성관계량호；량약 HPLC법측정적준학도화정밀도부합요구。리다잡인화병알잡인적투피부합령급동역학방정，리다잡인적공시약화대조약적류통량분별위（274.6±30.25）μg /（cm2·h）、（266.4±21.56）μg /（cm2·h）；병알잡인적공시약화대조약적류통량분별위（314.2±31.08）μg /（cm2·h）、（309.4±23.08）μg /（cm2·h），균무현저성차이（ P >0.05）。결론공시약화대조약적체외투피규률일치。
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.