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目的:研制复方奥硝唑口腔溃疡膜剂,建立质量控制方法,观察其临床疗效。方法:以聚乙烯醇,羧甲基纤维素钠等为辅料制备复方奥硝唑口腔溃疡膜剂,采用分光光度法测定主药奥硝唑的含量,测定波长为316 nm。结果:奥硝唑在6.0～18.0μg·ml~(-1)范围内呈良好线性关系(r=0.999 7),平均回收率为100.19%,(RSD=0.66%,n=5)。治疗各型口腔溃疡患者517例,总有效率为98.2%。结论:该膜剂制备方法简便易行,质量可控,疗效确切,适于医院使用。
Objective: To develop compound ornidazole oral ulcer film, to establish quality control methods and observe its clinical efficacy. Methods: Compound ornidazole oral ulcer films were prepared with polyvinyl alcohol and sodium carboxymethyl cellulose as the excipients. The content of ornidazole was determined by spectrophotometry with the wavelength of 316 nm. RESULTS: Oronidazole showed a good linearity (r = 0.999 7) in the range of 6.0 ~ 18.0 μg · ml -1 with an average recovery of 100.19% (RSD = 0.66%, n = 5). Treatment of 517 cases of various types of oral ulcer patients, the total effective rate was 98.2%. Conclusion: The preparation method of the film is simple and easy to use, the quality is controllable and the curative effect is exact. It is suitable for hospital use.