复方奥硝唑口腔溃疡膜剂的制备及疗效观察

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316nm。结果：奥硝唑在6．0～18．0μg·ml-1范围内呈良好线性关系（r=0．9997），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。

Preparation and Curative Effect of Compound Ornidazole Oral Ulcer Film on Canker Sore

Objective： To prepare the compound ornidazole oral ulcer film, to estabilish a method for quality control and observe its clinical effect. Method ： The polyvinyl alcohol, sodinum carboxymethyl cellulose et al were used as exeipients. Main drug ornidazole content was determined by ultraviolet spectrophotometry with detecting wavelength at 316 nm. Result： The linear range of ornidazole was 6.0-18.0 μg.ml - 1 （ r = 0. 999 7 ）, the average recoverise of ornidazole was 100. 19% （ RSD = 0. 66%, n = 5 ）. The total efficency was 98. 2% in 517 samples. Conelttsion： The preparing method is simple , quality control is reasonable ,the therapy is efficient and the preparation is available for hospital.