清热止咳口服液质量标准及药效学研究  

Research on quality standards and pharmacological effects of Qingre Zhike oral liquid

作　　者：任荣[1] 陈冠[2] 李正翔[1] 

机构地区：[1]天津医科大学总医院,天津300052 [2]天津市医药科学研究所,天津300020

出　　处：《天津中医药》2015年第4期239-243,共5页Tianjin Journal of Traditional Chinese Medicine

基　　金：天津市卫生局科技基金项目(2012KY30)

摘　　要：[目的]建立清热止咳口服液的定性、定量测定方法,并建立质量标准。对清热止咳口服液进行药效学观察。[方法]采用薄层色谱法（TLC）对处方中瓜蒌皮、苦杏仁进行薄层鉴别;采用高效液相色谱法（HPLC）对处方中前胡中的白花前胡甲素、白花前胡乙素同时进行含量测定。采用氨水引咳法观察小鼠的咳嗽潜伏期和咳嗽次数。[结果]清热止咳口服液中瓜蒌皮、苦杏仁薄层色谱鉴别特征明显,专属性强;白花前胡甲素、白花前胡乙素分别在10.2～102.00 mg/L,3.96～39.60 mg/L范围内,呈良好的线性关系。白花前胡甲素、白花前胡乙素平均回收率分别为98.94%（RSD 1.39%）、99.74%（RSD 1.75%）。清热止咳口服液可以明显延长浓氨水引起的咳嗽潜伏期,减少咳嗽次数（P〈0.05）。[结论]该质量控制方法简便、准确、专属性强、重现性好,可用于清热止咳口服液质量控制。清热止咳口服液具有显著的止咳作用。[Objective] To establish quality standard and evaluate the pharmacodynamic effects of Qingre Zhike oral liquid. [Methods] TI,C method was used to identify Pericarpium Trichosanthis and Prunus Armeniaea in Qingre Zhike oral liquid. The contents of Praeruptorin A and Praeruptofin B were determined by HPLC. The cough settling effect was observed on the ammonia water induced cough model of mouse. [Results] Established TLC had clear spots without interference of the negative control sample. I,inear ranges of Praeruptorin A and Praeruptorin B were 10.20-- 102.00 μg/mL and 3.96--39.60 μg/mL, average recoveries were 98.94%（RSD 1.39%） and 99.74% （RSD 1.75%）, respectively. High dose and middle dose group of Qingre Zhike oral liquid couht produce a protective effect on the cough induced by ammonia （P〈0.05）. [Conclusion] The method is simple, rapid, reproducible and specific, and it can be used for the quality control of Qingre Zhike oral liquid. Qingre Zhike oral liquid has the anti-cough effect.

关 键 词：清热止咳口服液 质量标准 前胡 药效学 

分 类 号：R282.73[医药卫生—中药学]