复方冰连软膏的质量控制

Quality Control of Compound Binglian Ointment

目的：建立复方冰连软膏的质量控制方法。方法：采用理化鉴别和薄层色谱法对方中磺胺嘧啶银：磺胺嘧啶锌、冰片和白芍、黄连进行定性鉴别；采用HPLC法测定环丙沙星的含量，色谱柱为Welch materials C18（250mm×4．6mm，5μm）柱，流动相为乙腈-0．025mol·L^-1磷酸（用三乙胺调节pH至3．0）（16：84），流速为1．0ml·min^-1，检测波长为278nm，柱温为室温；进样量为20μl。结果：理化鉴别和薄层色谱法结果理想，阴性样品无干扰；在4．080—20．400μg·ml^-1的浓度范围内，环丙沙星进样量与峰面积值的线性关系良好（r=0．9995），平均加样回收率为100．40％（RSD=1．71％，n=6）。结论：该方法操作简便，专属性好，准确可靠，可用于复方冰连软膏的质量控制。

Objective： To establish a method for the quality control of compound Binglian ointment. Methods： Silver sulfadiazine, zinc sulfadiazine and borneo1 were identified by physicochemical identification methods, and Radix Paeoniae Alba and Rh/zoma Coptidis were identified by TLC. Ciprofloxacin was determined by HPLC on a Welch materials C18 （250mm×4.6mm,5μm） column with the mobile phase of acetonitrile-0.025 mol · L^-1 phosphate （ adjusting pH to 3 with triethylamine） （ 16： 84）, the flow rate was 1.0 ml · min^- 1, the detection wavelength was 278nm, the column temperature was ambient and the injection volume was 20 μl. Results： The results of physicochemical identification and TLC were promising without negative interference. The linear range between the ciprofloxacin concentration and peak area was 4. 080-20.400μg · ml ^- 1 （ r = 0.999 5 ） with the average recovery of 100.40% （ RSD = 1.71% , n = 6）. Conclusion： The method is simple, specific, accurate and reliable, and can be used in the quality control of compound Binglian ointment.