水杨酸氯霉素醇溶液的质量控制  

Quality control of preparation of salicylic acid and chloramphenicol alcoholic solution

作　　者：赵子瑞[1] 张迅[1] 张佳莉[1] 董敏[1] 李云兰[1] 

机构地区：[1]山西医科大学药学院,太原030001

出　　处：《中国药物与临床》2013年第4期413-415,I0001,共4页Chinese Remedies & Clinics

基　　金：国家自然科学基金(30772682);山西省回国留学人员科研资助项目(2010-54)

摘　　要：目的建立水杨酸氯霉素醇溶液的质量控制方法。方法采用酸碱滴定法测定水杨酸的含量,化学法鉴别其中的水杨酸和氯霉素,装量差异应符合涂剂项下有关的各项规定。结果 3批样品化学鉴别均呈阳性反应,阴性对照不干扰测定。水杨酸含量测定线性范围为80.0～402.5mg,回归方程为y=15.0803x+1.2704,r=0.9996,平均回收率为99.6%,RSD为0.4%(n=6)。结论本法简便灵敏,重复性好,专属性强,能有效控制水杨酸氯霉素醇溶液的质量。Objective To establish a methodology for quality control of preparation of salicylic acid and chlo- ramphenicol alcoholic solution. Methods The acid-base titration was employed to determine the content of salicylic acid, and miscellaneous chemical methods were applied to identify salicylic acid and ehloramphenieol. The difference in volume conformed to relevant regulations. Results The three batches of samples tested positively without interfe- rence on the negative control. Determination of salicylic acid yielded a linear range of 80-402.5 mg, the regression e- quation of y=15.0803x＋1.2704 （r=0.9996）, with the average recovery of 99.6% and RSD of 0.4% （n=6）. Conclusion Owing to high sensitivity repeatability and specificity, the aforementioned methodology may effectively secure the quality of salicylic acid and chloramphenicol alcoholic solution.

关 键 词：质量控制 水杨酸 氯霉素 

分 类 号：R927[医药卫生—药学]