金银花替硝唑含漱液的制备及其质量控制

Preparation and Quality Control of Lonicera japonica and Tinidazole Gargle

目的:制备金银花替硝唑含漱液并建立其质量控制方法。方法:以替硝唑、金银花和氯化钠为主药制备含漱液;采用紫外分光光度法(318nm波长)和沉淀吸附滴定法分别测定替硝唑和氯化钠的含量,薄层色谱法鉴别金银花中的绿原酸;考察制剂放置6个月的稳定性。结果:替硝唑检测浓度线性范围为6.08～18.24μg·mL-(1r=0.9998);替硝唑和氯化钠的平均回收率分别为99.81%和99.47%,RSD分别为0.87%和0.70%;制剂放置6个月各指标无明显变化。结论:本制剂制备方法简便易行,质量稳定、可控。

OBJECTIVE： To prepare Lonicera japonica （L.japonica） and tinidazole gargle,and to establish quality control method.METHODS： Tinidazole,L.japonica and sodium chloride were used as the main components to prepare gargle.UV spectrophotometry （318 nm wavelength） and precipitation absorption titration were used to determine the concentration of tinidazole and sodium chloride.TLC was used to identify chlorogenic acid in L.japonica.The stability of preparation within 6 months was investigated.RESULTS： The linear range of tinidazole was 6.08～18.24 μg·mL-1 （r=0.999 8）.The average recoveries of tinidazole and sodium chloride were 99.81% （RSD=0.87%） and 99.47% （RSD=0.70%）.The index of preparation had no significant change within 6 months.CONCLUSION： The method is simple and feasible.The gargle is stable and controllable in quality.