氯甲搽剂的质量控制与疗效观察

Quality control and clinical effects observation of Lujia liniment

目的研究氯甲搽剂质量控制方法,评价临床疗效。方法用紫外分光光度法测定甲硝唑或氯霉素含量;疗效采用碧宁凝胶进行对照。结果甲硝唑在10.3～82.0μg/ml范围内线性关系良好,r=0.999 8,甲硝唑和氯霉素的回收率分别为99.92%和99.85%,RSD为0.369%和0.484%。氯甲搽剂疗效与对照组比较,具有统计学意义（P〈0.01）。结论氯甲搽剂制剂质量控制方法快速,疗效确切。

Objective To establish the quality control and evaluate the therapeutic effects of Lujia liniment. Methods UV-spectrophotometry was used to determine the content of Metronidazole and Chloramphenicol. The therapeutic effects were compared with Bining gel. Results The linearity was good in the concentration rang of 10. 3-82.0 μg/ml of Metronidazole,r=0. 999 8,the average recovery rate was 99.92% and 99.85% ,the relative standard deviation（RSD） was 0. 369% and 0. 484%, respectively. The therapeutic effects were difference in statistics（P〈0.01）. Conclusion This preparation is reliable in quality control and satisfactory in therapeutic efficacy.