复方消伤痛喷膜剂的制备与质量控制

制备复方消伤痛喷膜剂，建立其质量控制方法。方法：以壳聚糖盐酸盐、聚乙烯吡咯烷酮（PVP）为成膜材料，羟丙基甲基纤维素（HPMC）为成膜辅助剂，制备复方消伤痛喷膜剂；采用HPLC法同时测定利多卡因和莫匹罗星的含量。色谱柱为Hypersi]ODS2色谱柱（250mm×4．6mm，5μm）；流动相为0．5％磷酸二氢铵-甲醇（40：60）（用氢氧化钠调节pH至6．0±0．5）；检测波长为222nm；流速：1．0ml·min^-1；柱温：30qC；进样量：20μl。结果：复方消伤痛喷膜剂成膜性良好。含量测定中利多卡因在25．0～400．0肛g·ml“范围内线性关系良好（r=0．9997），平均回收率为100．14％，RSD为1．2l％（n=9）；莫匹罗星在25．0～400.0μg·ml^-1范围内线性关系良好（r=0．9999），平均回收率为101.13％，RSD为0.57％（n=9）。

Preparation and Quality Control of Compound Xiaoshangtong Spray Films

To prepare compound Xiaoshangtong spray films and establish an HPLC method for quality control. Meth- otis： Chitosan hydrochloride and PVP as the main film- forming materials, and HPMC as the film -forming assitant agent, the com- pound Xiaoshangtong spray films were prepared. Lidocaine and mupirocin were simultaneously determined by HPLC. A Hypersil ODS2 column（250 mm×4.6 mm, 5μm）was used. The mobile phase was composed of 0.5% ammonium dihydrogen phosphate- methanol （40： 60, adjusting pH to 6.0±0.5 with sodium hydroxide）. The flow rate of mobile phase was 1.0 ml·min^-1 and the temperature of the column was 30 ℃. The detection wavelength was 222nm and the injection volume was 20μl. Results： The linear range of lido- caine was 25.0 -400.0μg·ml^-1 （r =0.999 7） and the average recovery was 100. 14% （RSD = 1.21% ,n =9）. The linear range of mupirocin was 25.0 - 400.0μg·ml^-1 （ r = 0.999 9 ） and the average recovery was 101.13% （ RSD = 0.57% , n = 9 ）. Conelusion： The preparation process is reasonable. The established determination method is accurate and reliable, and suitable for the quality control of the Compound Xiaoshangtong spray films.