基于多成分测定的小儿咳喘灵口服液的质量评价  

Quality evaluation of Xiaoer Kechuanling oral liquid based on multi-component determination

作　　者：钱叶飞 陆林玲 张华锋 蔡雪萍 QIAN Ye-fei;LU Lin-ling;ZHANG Hua-feng;CAI Xue-ping(Suzhou Institute for Drug Control,Suzhou Jiangsu 215104)

机构地区：[1]苏州市药品检验检测研究中心,江苏苏州215104

出　　处：《中南药学》2021年第2期276-281,共6页Central South Pharmacy

基　　金：苏州市科技计划项目(项目编号:SYS2018103)。

摘　　要：目的建立UPLC测定方法对市售小儿咳喘灵口服液的整体质量进行评估,以期完善小儿咳喘灵口服液质量标准。方法采用Waters Acquity UPLC色谱仪,选用Waters HSS T3(2.1 mm×100 mm,1.8μm)色谱柱,以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱,流速0.3 mL·min-1,检测波长237 nm[(R,S)-告依春、绿原酸、甘草苷和甘草酸]、207 nm(苦杏仁苷),柱温35℃。对来源于不同厂家的59批小儿咳喘灵口服液进行含量测定,并对质量特征进行统计学分析。结果5个主要成分在59批小儿咳喘灵口服液中均可检出,但含量差异较大。单因素方差分析结果显示,厂家3、4与其他厂家之间5种成分差异均具有统计学意义(P<0.05);差异主要集中在苦杏仁苷和甘草苷2个成分上。结论增加小儿咳喘灵口服液控制指标对于规范药品生产、提高药品品质具有重大意义。Objective To evaluate the overall quality of Xiaoer Kechuanling oral liquid collected from different manufacturers by established UPLC method to promote its quality control.Methods The separation was performed on a Waters Acquity UPLC HSS T3 column(2.1 mm×100 mm,1.8μm),and the column temperature was set at 35℃.The mobile phase was composed of acetonitrile and 0.1%phosphoric acid with gradient elution at a flow rate of 0.3 mL·min-1.The detection wavelength was set at 237 nm for(R,S)-goitrin,chlorogenic acid,liquiritin and glycyrrhetic acid while 207 nm for amygdalin.All 59 batches of Xiaoer Kechuanling oral liquid from different manufacturers were determined.Results The 5 main markers were detected in the 59 batches of Xiaoer Kechuanling oral liquid,but their contents were quite different.The one-way ANOVA showed significant differences between manufacturer 3,manufacturer 4 and other 3 manufacturers in 5 components(P<0.05).The differences were mainly in components of ablymarin and glycyrrhizin.Conclusion It is important to increase quality control markers of Xiaoer Kechuanling oral liquid to standarde production and improve quality level.

关 键 词：小儿咳喘灵口服液 定量测定 双波长-超高效液相色谱法 

分 类 号：R285[医药卫生—中药学]