奥硝唑口腔溃疡液配制及质量控制  

Preparation and quality control of ornidazole aphthae liquor

作　　者：邱新峰[1] 

机构地区：[1]安徽省安庆市立医院,安徽安庆246003

出　　处：《安徽医药》2005年第12期892-893,共2页Anhui Medical and Pharmaceutical Journal

摘　　要：目的研究奥硝唑口腔溃疡液的制备并对其质量进行控制.方法以奥硝唑为主药制成口腔溃疡液,用高效液相色谱法测定制剂的含量.色谱柱为C18(4.6 mm×250 mm,5 μm),流动相为甲醇-水(30∶ 70),流速1.0 ml·min-1,检测波长318 nm,柱温25℃.并建立制剂的其它质控指标.结果奥硝唑在0.04～0.40μg范围内峰面积与浓度呈良好的线性关系(r=0.9999),平均回收率为99.76%,RSD为0.47%(n=5).结论该制剂配制简单,质量可控.Aim To study the preparation and quality control method for ornidazole Aphthae liquor. Methods To prepare an aphthae liquor of ornidazole and to determine the drug content by HPLC. A kromasil C18 （4.6 mm×250 mm,5 μm） column was used. The mobile phase consisted of methanol-water（30： 70）. Flow rate was 1.0 ml· min^-1. The detection wavelength was at 318nm,column temperature was 25℃. The method for its other quality control was established. Results The absorption spectrums and the contrations have good liner relationship in the range of O. 04～O. 4 μg（r = O. 9999）. The average recovery and RSD were 99.76% and O. 47% （ n = 5）. Conclusion The ornidazole aphthae liquor can be prepared easily. The method of quality control is reliable.

关 键 词：奥硝唑 口腔溃疡液 制备 高效液相色谱法 质量控制 制剂配制 平均回收率 检测波长 质控指标 线性关系 

分 类 号：TQ463.53[化学工程—制药化工]