盐酸芦氟沙星膜剂含量测定及体外透皮效果研究  

Content Determination of Rufloxacin Hydrochloride in Rufloxacin Hydrochloride Film and Its Transdermal Effect in Vitro

作　　者：金伟华 蒲志强 陈华 于波涛 余志军 JIN Weihua;PU Zhiqiang;CHEN Hua;YU Botao;YU Zhijun(Department of Pharmacy,The General Hospital of Western Theater Command of Chinese People's Liberation Army,Chengdu,Sichuan,China 610083;School of Pharmacy,Southwest Medical University,Luzhou,Sichuan,China 646000)

机构地区：[1]中国人民解放军西部战区总医院药剂科,四川成都610083 [2]西南医科大学药学院,四川泸州646000

出　　处：《中国药业》2021年第21期59-62,共4页China Pharmaceuticals

摘　　要：目的建立测定盐酸芦氟沙星膜剂中盐酸芦氟沙星含量的高效液相色谱法,并考察其体外透皮效果。方法以聚乙烯醇17-88制备膜剂。色谱柱为Eclipse XDB-C18柱(150 mm×4.6 mm,5μm),流动相为枸橼酸溶液-乙腈(88∶12,V/V),流速为1.0 mL/min,检测波长为254 nm,柱温为30℃,进样量为10μL。以昆明种小鼠为模型进行体外透皮试验。结果制备的盐酸芦氟沙星膜剂的溶化时限检查结果符合药典规定,在15 min内全部溶化。盐酸芦氟沙星质量浓度在0.015~0.150 mg/mL范围内与峰面积线性关系良好(r=0.999 9, n=5);检测限为0.000 23 mg/mL,定量限为0.000 78 mg/mL;精密度、稳定性、重复性试验的RSD均小于2.0%;平均回收率为101.13%, RSD为0.96%(n=9)。24 h体外透皮试验累积透过率为69.15%。结论该膜剂制备工艺可行,含量测定方法准确可靠,体外透皮效果良好。Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of rufloxacin hydrochloride in Rufloxacin Hydrochloride Film and to investigate its transdermal effect in vitro.Methods The film was prepared by polyvinyl alcohol 17-88.The chromatographic column was Eclipse XDB-C18 column(150 mm×4.6 mm,5μm),the mobile phase was citric acid solution-acetonitrile(88:12,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 254 nm,the column temperature was 3018,and the injection volume was 10μL.In vitro transdermal test was carried out by using Kunming mice as the model.Results The result of the dissolution time limit test of the prepared Rufloxacin Hydrochloride Film was in accordance with the requirement of the Chinese Pharmacopoeia,and all prepared Rufloxacin Hydrochloride Film dissolved within 15 min.The mass concentration of rufloxacin hydrochloride showed a good linear relationship in the range of 0.015-0.150 mg/mL(r=0.9999,n=5).The limit of detection(LOD)and the limit of quantitation(LOQ)were 0.00023 mg/mL,and 0.00078 mg/mL,respectively.The RSDs of precision,stability and repeatability tests were less than 2.0%.The average recovery of rufloxacin hydrochloride was 101.13%with an RSD of0.96%(n=9).The cumulative penetration rate of in vitro transdermal test within 24 h was 69.15%.Conclusion The preparation process of the film is feasible,the content determination method is accurate and reliable,and the transdermal effect in vitro is good.

关 键 词：盐酸芦氟沙星 膜剂 含量测定 体外透皮试验 

分 类 号：R927.2[医药卫生—药学] R978.1