Page 70 - 《中国药房》2022年13期

麝香壮骨膏中盐酸麻黄碱和盐酸伪麻黄碱的含量测定及质量评

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杨媛媛 ，张 楠 ，谢志民 ，胡 静 ，曲 彤 ，陶宏迅 ，陈志永 （1.西安市食品药品检验所，西安 710054；
2.陕西省中医药研究院中药研究所，西安 710061；3.江苏大学食品与生物工程学院，江苏 镇江 210031）
中图分类号 R917 文献标志码 A 文章编号 1001-0408（2022）13-1600-06
DOI 10.6039/j.issn.1001-0408.2022.13.11
摘 要 目的 建立麝香壮骨膏中盐酸麻黄碱和盐酸伪麻黄碱的含量测定方法，并对41家企业生产的222批次麝香壮骨膏的质量
进行评价。方法 采用高效液相色谱（HPLC）法进行测定：使用Shimadzu Shim-pack GIS-C18色谱柱进行分离，以乙腈-0.1％磷酸溶
液（3 ∶ 97，V/V）为流动相，流速为0.9 mL/min，柱温为30 ℃，检测波长为210 nm，进样量为10 μL。以222批次样品的含量数据为指
标，采用Hiplot生物医学数据可视化和分析平台绘制聚类热图。结果 方法学考察结果均符合2020年版《中国药典》（四部）通则要
求。41家企业生产的222批次样品中盐酸麻黄碱和盐酸伪麻黄碱的总含量在0.646～6.325 μg/cm 之间。聚类热图分析结果显示，
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41家企业生产的样品可被聚为3类。不同企业生产的样品中成分含量差异较大，且部分企业生产的不同批次样品也存在含量差
异较大的现象。若拟定本品限度为每1 cm 含盐酸麻黄碱和盐酸伪麻黄碱的总量不得低于1.00 μg，则222批次样品中有23批次不
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合格。结论 本研究所建麝香壮骨膏中盐酸麻黄碱、盐酸伪麻黄碱含量测定的方法准确、精密，可用于其质量控制。部分企业应优
化生产工艺，加强质量控制。
关键词 麝香壮骨膏；盐酸麻黄碱；盐酸伪麻黄碱；含量测定；质量评价

Content determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Shexiang
zhuanggu plaster and its quality evaluation
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YANG Yuanyuan ，ZHANG Nan ，XIE Zhimin ，HU Jing ，QU Tong ，TAO Hongxun ，CHEN Zhiyong（1. Xi’an
Institute for Food and Drug Control，Xi’an 710054，China；2. Institute of Chinese Medicine，Shaanxi Academy
of Traditional Chinese Medicine，Xi’an 710061，China；3. School of Food and Biological Engineering，Jiangsu
University，Jiangsu Zhenjiang 210031，China）
ABSTRACT OBJECTIVE To establish the method for the content determination of ephedrine hydrochloride and pseudoephedrine
hydrochloride in Shexiang zhuanggu plaster，and to evaluate the quality of 222 batches of Shexiang zhuanggu plaster from 41
manufacturers. METHODS HPLC method was established. The determination was performed on Shimadzu Shim-pack GIS-C18
column with mobile phase consisted of acetonitrile-0.1％ phosphoric acid（3 ∶ 97，V/V）at the flow rate of 0.9 mL/min. The column
temperature was set at 30 ℃，the detection wavelength was 210 nm，the sample size was 10 μL. Taking the content data of 222
batches of samples as index，the cluster heatmap was drawn by Hiplot biomedical data visualization and analysis platform.
RESULTS The results of the methodological investigation were in line with the requirements of the general principles stated in
2020 edition of Chinese Pharmacopoeia （part Ⅳ ）. The total contents of ephedrine hydrochloride and pseudoephedrine
hydrochloride in 222 batches of samples from 41 manufacturers were 0.646-6.325 μ g/cm . Results of cluster heatmap analysis
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showed that these samples of 41 manufacturers could be divided into 3 categories. The contents of components in samples from
different manufacturers varied greatly，and the contents of components in different batches of samples from the same manufacturers
also varied greatly. If the proposed limit of this product was that the total amount of ephedrine hydrochloride and pseudoephedrine
hydrochloride per 1 cm would not be less than 1.00 μg，23 of the 222 batches of samples were unqualified. CONCLUSIONS The
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established method for the content determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Shexiang
zhuanggu plaster is accurate and precise，and can be used for the quality control. Some manufacturers should pay attention to
optimizing production process and strengthening quality control.
Δ 基金项目 2021 年国家药品抽检中央补助地方经费项目
KEYWORDS Shexiang zhuanggu plaster； ephedrine
（No.111）
＊第一作者 主管药师，硕士。研究方向：中药质量控制。E-mail： hydrochloride； pseudoephedrine hydrochloride； content
yuan_0116@126.com determination；quality evaluation
# 通信作者 副研究员，博士。研究方向：中药质量控制与活性成
分。E-mail：chenzhiyong0612@sina.com

·1600 · China Pharmacy 2022 Vol. 33 No. 13 中国药房 2022年第33卷第13期