丹皮酚软膏中主成分及其抑菌剂羟苯乙酯的含量测定研究  

Study on the Determination of Main Components and Bacteriostatic Agent Ethylparaben in Paeonol Ointments

作　　者：陈玲玲 曹桂萍 周会芹 谢斌 丁爱华 支荣荣 葛玉松 CHEN Lingling;CAO Guiping;ZHOU Huiqin;XIE Bin;DING Aihua;ZHI Rongrong;GE Yusong(Yancheng Food and Drug Supervision and Testing Center,Yancheng 224055,China;Department of Pharmacy,Yancheng Hospital of Traditional Chinese Medicine,Yancheng 224000,China)

机构地区：[1]盐城市食品药品监督检验中心,盐城224055 [2]盐城市中医院药剂科,盐城224000

出　　处：《药学与临床研究》2023年第1期57-59,65,共4页Pharmaceutical and Clinical Research

摘　　要：目的:建立同时测定丹皮酚软膏中主成分丹皮酚、丁香酚及抑菌剂羟苯乙酯含量的HPLC法。方法:采用C_(18)色谱柱(250 mm×4.6 mm,5μm),以甲醇-乙腈-水(35∶15∶50)为流动相,等度洗脱,检测波长为210 nm,流速为1.0 mL·min^(-1),柱温为30℃。结果:丹皮酚、丁香酚及羟苯乙酯的线性范围分别为9.74~77.94、1.55~12.36、0.21~1.65μg·mL^(-1),平均回收率分别为98.97%、99.87%、99.04%,RSD分别为0.92%、0.08%、0.90%。4家生产企业的10批丹皮酚软膏中丁香酚含量存在明显差异。结论:该方法操作简便、专属性好,可用于丹皮酚软膏主药及抑菌剂的质量控制。Objective:To establish a HPLC method for simultaneously determining paeonol,eugenol and ethyl paraben in paeonol ointments.Methods:The analysis was performed on a C_(18)column (250 mm×4.6 mm,5μm) with a mobile phase consisting of methanol-acetonitrile-water (35∶15∶50) for isocratic elution The detection wavelength was set at 210 nm.The flow rate was 1.0 mL·min^(-1)and the column temperature was 30°C.Results:The paeonol,eugenol and ethylparaben showed good linearity at 9.74-77.94,1.55-12.36 and 0.21-1.65μg·mL^(-1),and the average recoveries were 98.97%(RSD 0.92%),99.87%(RSD0.08%) and 99.04%(RSD 0.90%),respectively.There were obvious differences in the contents of eugenol in 10 batches of paeonol ointments from four manufacturers.Conclusion:The method was simple and specific,which could be applied to the quality control of the main components and bacteriostatic agent in paeonol ointments.

关 键 词：丹皮酚软膏 丹皮酚 丁香酚 羟苯乙酯 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]