复方水杨酸雷夫奴尔酊的制备及质量控制方法

Preparation and investigation on the quality control of the compound salicylic acid and ethacridine lactate tincture

目的研究复方水杨酸雷夫奴尔酊的制备工艺及质量控制方法。方法制备时根据方中成分的不同性质分别溶解后混合，采用酸碱滴定法测定水杨酸和苯甲酸的含量；采用紫外分光光度法测定雷夫奴尔的含量。结果雷夫奴尔溶于质量分数为75％的乙醇所得溶液，在362nm处有最大吸光度，在5-30mg·L^-1内质量浓度与吸光度值线性关系良好，雷夫奴尔含量测定平均回收率为100．2％，RSD为1．2％（n=9）。结论复方水杨酸雷夫奴尔酊的制备工艺合理，质量可控。

Objective To study the preparation formulation and quality control methods of the compound salicylic acid and ethacridine lactate tincture. Methods Salicylic acid, benzoic acid and ethacridine lactate were dissolved separately on the basis of their different solubilities during the preparation, then they were mixed. The contents of salicylic acid and benzoic acid were determined by acid base titration. The content of ethacridine lactate was determined by ultraviolet spectrometry. Results The wave-length of maximum absorption of ethacridine lactate was 362 nm. The calibration curve was linear in the range of 5 - 30 mg·L^-1 （ r = 0. 999 7） for ethacridine lactate. The mean recovery of the content of ethacridine lactate was 100.2 %, RSD = 1.2 % （n = 9）. Conclusions The preparation formulation of the compound salicylic acid and ethacridine lactate tincture is reasonable and the quality of the tincture is under control.