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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=0.999 7),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=0.999 9),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。
OBJECTIVE: To prepare Compound Xiaoxuetong Spray Film Agent and establish its quality control method. Methods: Chitosan hydrochloride, polyvinylpyrrolidone (PVP) as film-forming material and hydroxypropyl methylcellulose (HPMC) Determination of lidocaine and mupirocin content. The chromatographic column was Hypersil ODS2 (250 mm × 4.6 mm, 5 μm); the mobile phase consisted of 0.5% ammonium dihydrogen phosphate-methanol (40:60) (adjusted to pH 6.0 ± 0.5 with sodium hydroxide); the detection wavelength was 222 nm; flow rate: 1.0 ml · min-1; column temperature: 30 ° C; injection volume: 20 μl. Results: Compound Xiaoxuongong filming good filming. The content of lidocaine in the range of 25.0 ~ 400.0μg · ml-1 was good (r = 0.999 7), the average recovery was 100.14%, RSD was 1.21% (n = 9) The average recovery was 101.13% and the RSD was 0.57% (n = 9) in the range of ~ 400.0μg · ml-1. Conclusion: The preparation process is feasible, the established detection method is accurate and reliable, and it can be used for quality control of compound Xiaoxuongyong spray-filming agent.