四季感冒片和胶囊中含量测定方法的研究  

Research on content determination method of Siji Ganmao Tablet and Capsule

作　　者：汪冰 徐兴燕 薛菲 林永强 WANG Bing;XU Xingyan;XUE Fei;LIN Yongqiang(Shandong Provincial Institute for Food and Drug Control,Jinan 250101,China)

机构地区：[1]山东省食品药品检验研究院,济南250101

出　　处：《中国药品标准》2021年第3期242-246,共5页Drug Standards of China

基　　金：国家药典委员会国家药品标准提高课题(WX-17-19和WX-17-20)。

摘　　要：目的:建立HPLC法同时测定四季感冒片(薄膜衣片、糖衣片)和四季感冒胶囊系列制剂中连翘苷和5-O-甲基维斯阿米醇苷的含量。方法:采用Agilent ZORBAX SB–C_(18)色谱柱(4.6 mm×250 mm, 5μm),以乙腈(A)–水(B)为流动相,梯度洗脱(0~5 min, 15%A,5~28 min, 15%A→29%A,28~35 min, 29%A),柱温和流速分别为35℃和1.0 mL·min^(-1),波长切换[0~25 min,在254 nm波长下检测5-O-甲基维斯阿米醇苷;25~35 min,在205 nm波长下检测连翘苷]。结果:应用所建立的方法对样品进行定量分析,结果连翘苷和5-O-甲基维斯阿米醇苷浓度分别在0.008 1~0.202 8 mg·mL^(-1)(r=1.000 0)、0.004 2~0.105 7 mg·mL^(-1)(r=0.999 9)范围内呈良好的线性关系,薄膜衣片、糖衣片和胶囊的平均加样回收率,连翘苷分别为101.7%、100.4%、99.1%(RSD为0.88%、1.01%、1.22%,n=6),5-O-甲基维斯阿米醇苷分别为99.0%、100.1%、98.2%(RSD为1.08%、0.66%、0.82%,n=6)。结论:建立的方法能同时测定四季感冒系列制剂中连翘苷和5-O-甲基维斯阿米醇苷的含量,节约样品,操作简便,重现性好,结果准确可靠,可用于四季感冒系列制剂的质量控制和质量评价。Objective:To establish an HPLC method for determination of Phillyrin and 5-O-methylvisammioside in Compound Siji Ganmao Tablet and Capsule.Methods:The test was performed in Agilent ZORBAX SB-C 18 column(4.6 mm×250 mm,5μm)under the gradient elution of acetonitrile and water.The gradient program of acetonitrile(A)-water(B)was as follow:0-5 min,15%A;5-28 min,15%A→29%A;28-35 min,29%A.The column temperature was 35℃and the flow rate was 1.0 mL·min^(-1).The detection wavelengths were set as 254 nm for 5-O-methylvisammioside in 0-25 min,and 205 nm for Phillyrin in 25-35 min.Results:The linear ranges of Phillyrin and 5-O-methylvisammioside fell into 0.0081-0.2028 mg·mL^(-1)(r=1.0000)and 0.0042-0.1057 mg·mL^(-1)(r=0.9999)respectively.The average spiked recoveries of Phillyrin in film-coated tablet,sugar-coated tablet and capsule were 101.7%,100.4%and 99.1%with RSD as 0.88%,1.01%and 1.22%(n=6)respectively;and the spiked recoveries of 5-O-methylvisammioside in film-coated tablet,sugar-coated tablet and capsule were 99.0%,100.1%and 98.2%with RSD as 1.08%,0.66%and 0.82%(n=6)respectively.Conclusion:The established method is economical,simple and accurate.It can determine Phillyrin and 5-O-methylvisammioside in Siji Ganmao preparations simultaneously,and can be used for the quality control of Siji Ganmao Tablet and Capsule.

关 键 词：四季感冒片 四季感冒胶囊 5-O-甲基维斯阿米醇苷 连翘苷 HPLC法 

分 类 号：R921.2[医药卫生—药学]