定喘止嗽丸质量标准研究*
作者：裴 璐，姜 颖，沈立茹
单位：唐山市食品药品综合检验检测中心，河北 唐山 063000
引用：引用：裴璐，姜颖，沈立茹.定喘止嗽丸质量标准研究[J].中医药导报,2025,31(7):63-67.
DOI：10.13862/j.cn43-1446/r.2025.07.010
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摘要：目的：建立定喘止嗽丸中罂粟壳、麻黄的薄层鉴别及5种生物碱含量测定的方法，为提高质量标准、加强制剂质量控制提供依据。方法：对定喘止嗽丸中的罂粟壳、麻黄进行薄层色谱法鉴别；通过高效液相色谱法同时测定定喘止嗽丸中5种生物碱含量。色谱柱：Agilent Zorbax Eclipse Plus
C18（4.6 mm×150.0 mm，5.0 μm)，流动相：乙腈（A）-0.1%三乙胺溶液（用磷酸调节pH值至3.0）（B），梯度洗脱；流速：1.0 mL/min；柱温：30 ℃；进样量：10 μL；检测波长：210 nm。结果：罂粟壳、麻黄展开情况良好、斑点清晰、条带较为明显。吗啡、盐酸麻黄碱、盐酸伪麻黄碱、磷酸可待因、盐酸罂粟碱的线性浓度范围为14.41～288.20 μg/mL（r=0.999 7）、13.02～260.40 μg/mL（r=0.997 4）、7.36～147.20 μg/mL（r=0.995 7）、0.94～18.70 μg/mL（r=0.999 1）、4.03～80.62 μg/mL（r=0.999 9）；精密度、稳定性、重复性试验RSD值均<2.0%（n=6）；平均加样回收率分别为98.3%、97.7%、95.8%、93.4%、98.7%（n=6）。结论：本研究建立的方法操作简便、结果准确、重复性好，专属性强，可用于定喘止嗽丸的定性鉴别和含量测定，有效提高该制剂的质量控制标准。
关键词：定喘止嗽丸；薄层色谱法；定性鉴别；高效液相色谱法；含量测定；质量标准
Abstract：
Objective: To establish the method of thin layer
identification of Yingsuqiao (poppy husk) and Mahuang (ephedra) in Dingchuan
Zhisou pills and the content determination of 5 alkaloids in Dingchuan Zhisou
pills, to provide the basis for improving the quality standard and
strengthening the quality control of preparations. Methods: The Yinsuqiao
(poppy husk) and Mahuang (ephedra) in Dingchuan Zhisou pills were identified by
thin layer chromatography (TLC). The content of 5 alkaloids in Dingchuan Zhisou
pills was determined by high-performance liquid chromatography (HPLC).
Chromatographic column was Agilent Zorbax Eclipse Plus C18 (4.6 mm×150.0 mm,
5.0 μm). Mobile phase was acetonitrile (A)-0.1% triethylamine solution (pH
adjusted to 3.0 with phosphoric acid) (B), with gradient elution. Flow
rate was 1.0 mL/min, with column
temperature of 30 ℃. Sample size was 10 μL, and detection wavelength was 210 nm. Results: Yinsuqiao (poppy husk)
and Mahuang (ephedra) developed well, with clear spots and obvious bands. The
linear concentrations of morphine, ephedrine hydrochloride, pseudoephedrine
hydrochloride, codeine phosphate and papaverine hydrochloride ranged from 14.41
to 288.20 μg/mL (r=0.999 7)，13.02 to 260.40 μg/mL (r=0.997 4)，7.36 to 147.20 μg/mL (r=0.995 7), 0.94~18.70 μg/mL (r=0.999 1), and 4.03~80.62
μg/mL(r=0.999 9). Precision, stability, repeatability test RSD<2.0% (n=6).
The average recoveries were 98.3%, 97.7%, 95.8%, 93.4%, 98.7% (n=6).
Conclusions: The method established in this study is simple, accurate,
reproducible and specific, and it can be used for qualitative identification
and content determination of Dingchuan Zhisou pills. It can effectively improve
the quality control standard of this preparation.
Key words：Dingchuan Zhisou Pills; thin layer chromatography; identification; high-performance liquid chromatography; content determination; quality standard
发布时间：2026-01-06
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