| 摘要: |
| 为了有效控制麻芩止咳可溶性粉的质量，本研究以麻黄中有效成分盐酸麻黄碱为指标，建立了测定麻芩止咳可溶性粉含量的高效液相色谱（HPLC）检测方法，并进行了含量测定的方法学考察。结果表明：样品的前处理方法为加热水溶解后，加入浓氨试液并用乙醚振摇提取，再加盐酸乙醇溶液后回收溶剂即可将样品中含有的盐酸麻黄碱进行有效的提取；液相色谱条件，以十八烷基硅烷键合硅胶为填充剂，流动相为乙腈-0.1%磷酸溶液（含0.1%三乙胺）（3:97），检测波长为205 nm，进样量为10μl。在该条件下，对缺麻黄的阴性制剂进行了空白干扰测定，结果显示阴性无干扰；盐酸麻黄碱在9.24～69.30 μg/ml线性关系良好，加样回收率平均值为99.59%，精密度、重复性、溶液稳定性、以及耐用性等均符合规定。说明建立的麻芩止咳可溶性粉HPLC检测方法准确可靠，可以用作麻芩止咳可溶性粉的质量控制，为该产品推广应用于临床提供了必要条件。 |
| 关键词: 麻芩止咳可溶性粉 高效液相色谱（HPLC） 盐酸麻黄碱 含量测定 |
| DOI： |
| 投稿时间：2025-02-07修订日期：2025-05-26 |
| 基金项目: |
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| Study on Quality Standard of Maqin cough soluble powder |
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| (Baoding jizhong pharmaceutical co.LTD) |
| Abstract: |
| In order to effectively control the quality of Maqin cough soluble powder, high performance liquid chromatography (HPLC) detection method for determining the content of Maqin cough soluble powder was established based on ephedrine hydrochloride, the effective component of Ephedra, as an indicator, and the methodological inspection of the content was carried out.The results showed that the pretreatment method of the sample was to add hot water to dissolve it, add concentrated ammonia test solution and shake it with ether, then add hydrochloric acid ethanol solution, and recover the solvent to effectively extract the ephedrine hydrochloride contained in the sample; HPLC conditions, use octadecylsilane-bonded silica gel as filler, the mobile phase is acetonitrile-0.1% phosphoric acid solution (containing 0.1% triethylamine)(3:97), the detection wavelength is 205 nm, and the injection volume is 10μl.Under these conditions, blank interference determination was carried out on the negative preparation lacking Ephedra, and the results showed that there was no interference in the negative; ephedrine hydrochloride had a good linear relationship between 9.24 and 69.30 μg/ml, and the average recovery rate of sample addition was 99.59%. The precision, repeatability, solution stability, and durability all met the requirements. This shows that the established HPLC detection method for Maqin cough soluble powder is accurate and reliable, and can be used for quality control of Maqin cough soluble powder, providing necessary conditions for the promotion and application of this product in clinical practice. |
| Key words: Maqin Cough Soluble Powder High Performance Liquid Chromatography (HPLC) Ephedrine hydrochloride Content determination |
