复方洗必泰漱口液的制备及质量控制

Preparation and quality control of compound Xibitai Gargle

目的：制备复方洗必泰漱口液并建立其质量控制方法。方法：以醋酸洗必泰和替硝唑为主药制备漱口液，采用双波长分光光度法测定主药含量。结果：醋酸洗必泰和替硝唑检测浓度线性范围分别为7．3～20．3μg／ml和6．8～20．6μg／ml，平均回收率分别为100．22％和100．40％，相对标准差分别为1．39％和1．22％。结论：本制剂制备方法简便，含量测定准确，质量稳定可控。

Objective： To prepare a compound Xibitai gargle and to establish a quality control method for the gargle. Methods： Xibitai and tinidazole, principal components of the gargle, were quantitatively determined by a dual - wave length spectrophotomettic method. Results ： The linear ranges for the concentration of xibitai and Tinidazole were 7.3 - 20.3 μg/ml and 6.8 - 20.6 μg/ml respectively. The average recoveries of Xibitai and Tinidazole were 100. 22% （ RSD of 1.39% ） and 100. 40% （ RSD of 1.22% ） respectively. Conclusion ： The gargle is easy to be prepared and has a reliable and stable quality control method.