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清热止咳口服液质量标准及药效学研究
任荣1, 陈冠2, 李正翔1
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
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着的止咳作用。
关键词:  清热止咳口服液  质量标准  前胡  药效学
DOI:10.11656/j.issn.1672-1519.2015.04.12
分类号:
基金项目:天津市卫生局科技基金项目(2012KY30).
Research on quality standards and pharmacological effects of Qingre Zhike oral liquid
REN Rong1, CHEN Guan2, LI Zheng-xiang1
1.General Hospital of Tianjin Medical University, Tianjin 300052, China;2.Tianjin Institute of Medical Sciences, Tianjin 300020, China
Abstract:
[Objective] To establish quality standard and evaluate the pharmacodynamic effects of Qingre Zhike oral liquid. [Methods] TLC method was used to identify Pericarpium Trichosanthis and Prunus Armeniaca in Qingre Zhike oral liquid. The contents of Praeruptorin A and Praeruptorin 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. Linear 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 could 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.
Key words:  Qingre Zhike oral liquid  quality standard  radix peucedani  pharmacological effect
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