CAJ | 학술논문

目的：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Hypersil ODS2色谱柱(250 mm ×4.6 mm,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222 nm；流速：1.0 ml·min-1；柱温：30℃；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25.0~400.0μg·ml-1范围内线性关系良好(r=0.9997),平均回收率为100.14%,RSD为1.21%(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)。结论：本制剂工艺可行,建立的检测方法准确、可靠,可用于复方消伤痛喷膜剂的质量控制。
목적：제비복방소상통분막제,건립기질량공제방법。방법：이각취당염산염、취을희필각완동( PVP)위성막재료,간병기갑기섬유소( HPMC)위성막보조제,제비복방소상통분막제；채용HPLC법동시측정리다잡인화막필라성적함량。색보주위Hypersil ODS2색보주(250 mm ×4.6 mm,5μm)；류동상위0.5%린산이경안-갑순(40∶60)(용경양화납조절pH지6.0±0.5)；검측파장위222 nm；류속：1.0 ml·min-1；주온：30℃；진양량：20μl。결과：복방소상통분막제성막성량호。함량측정중리다잡인재25.0~400.0μg·ml-1범위내선성관계량호(r=0.9997),평균회수솔위100.14%,RSD위1.21%(n=9)；막필라성재25.0~400.0μg·ml-1범위내선성관계량호(r=0.9999),평균회수솔위101.13%,RSD위0.57%(n=9)。결론：본제제공예가행,건립적검측방법준학、가고,가용우복방소상통분막제적질량공제。
Objective:To prepare compound Xiaoshangtong spray films and establish an HPLC method for quality control. Meth-ods: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, 5 μm)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 20 μl. Results: The linear range of lido-caine was 25. 0-400. 0 μg·ml-1(r=0. 999 7) and the average recovery was 100. 14% (RSD=1. 21%,n=9). The linear range of mupirocin was 25.0-400.0 μg·ml-1(r=0.999 9)and the average recovery was 101.13%(RSD=0.57%,n=9). Conclusion:The preparation process is reasonable. The established determination method is accurate and reliable, and suitable for the quality con-trol of the compound Xiaoshangtong spray films.