复方盐酸利多卡因温敏凝胶的制备和含量测定

目的：制备复方盐酸利多卡因温敏凝胶，并建立其含量测定方法。方法：将盐酸利多卡因和盐酸罗哌卡因组成复方，制成温敏凝胶，用HPLC法同时测定其中盐酸利多卡因和盐酸罗哌卡因的含量。色谱柱：Athena C18-WP柱（200 mm×4.6 mm，5 μm）；流动相：乙腈-0.02 mol/L磷酸二氢钠-三乙胺（48∶52∶0.15，用磷酸调节pH值至3.15）；检测波长：220 nm；流速：1.0 ml/min。结果：复方盐酸利多卡因温敏凝胶为无色澄明液体，相变温度为32 ℃。盐酸利多卡因的线性回归方程为A=3.97×104c＋2.44×104（r=0.999 9），线性范围5.04~80.64 μg/ml；盐酸罗哌卡因的线性回归方程为A=3.93×104c＋1.21×103（r=0.999 9），线性范围2.03~32.48 μg/ml。HPLC法的精密度和准确度良好。凝胶中盐酸利多卡因和盐酸罗哌卡因的含量分别为标示量的 （97.89±1.32）%和（99.61±1.97）%（n=3）。结论：复方盐酸利多卡因温敏凝胶质量可控，是一种值得开发的新制剂。

Preparation and contents determination of the compound lidocaine hydrochloride thermosensitive gel

Objective： To prepare compound lidocaine hydrochloride thermosensitive gel and establish a method for contents determination. Methods： The thermosensitive gel containing lidocaine hydrochloride and ropivacaine hydrochloride was prepared. A HPLC method was established for simultaneous determination of the contents of lidocaine hydrochloride and ropiva caine hydrochloride. The HPLC method was applied on a Athena C18- WP analytical column（200 mm×4.6 mm,5 μm） ,with the mobile phase consisting of aeetonitrile 0.02 mol/L sodium dihydrogen phosphate-triethylamine （48 ： 52 ： 0. 15, pH value was adjusted to 3. 15 by phosphoric acid）. The detection wavelength was 220 nm. The flow rate was 1.0 ml/min. Results： Compound lidocaine hydrochloride thermosensitive gel is transparent colorless liquid with phase-transition temperature of 32 C. Lidocaine hydrochloride presented good linearity in the range of 5.04-80.64 tag/ml （A = 3.97 × 10^4 c＋ 2.44× 10^4 , r= 0. 999 9）. Ropiva caine hydrochloride presented good linearity in the range of 2.03-34.28μg/ml（A=3.93× 104c＋1.21× 10^3,r=0. 999 9）. The precision and accuracy of the method were all good. The contents of lidocaine hydroehloride and ropivaeaine hydrochloride were （97.89±1. 32）% and （99.61± 1.97）% （n=3） of the labelled contents. Conclusion： Compound lidocaine hydrochloride thermosensitive gel is worth further development and its quality can be controlled by HPLC method.