摘要
目的对咳喘宁质量标准进行完善和提高。方法采用显微鉴别法(光学显微镜和扫描电镜)对桔梗和石膏进行显微鉴别研究,采用薄层色谱法对甘草、百部进行鉴别研究,采用高效液相色谱法(HPLC)对罂粟壳、麻黄进行鉴别研究,采用HPLC测定吗啡、盐酸麻黄碱和盐酸伪麻黄碱的含量,色谱柱为菲罗门Durashell C_(18)(250 mm×4.6 mm,5μm),流动相为乙腈(A)-0.1%磷酸溶液(B)(4:96),流速1 ml/min,柱温30℃,检测波长为210 nm,进样量为10μl。结果显微鉴别结果表明,产品具有桔梗和石膏的特异性特征和元素组成;薄层色谱法结果表明鉴别色谱专属性良好,斑点清晰。吗啡、盐酸麻黄碱、盐酸伪麻黄碱分别在测定范围内线性关系良好,平均加样回收率为94.1%~99.3%,RSD均小于1.2%;14批咳喘宁中3个成分的含量分别在0.28~0.70,1.13~1.98,0.78~1.69 mg/g之间。结论该质量标准覆盖处方药味较全面,方法易于操作、准确度好,可以为咳喘宁质量标准的进一步修订和完善提供参考。
Objective To improve the quality standard of Kechuanning.Methods Platycodonis Radix and Gypsum Fibrosum were identified by microscopy(light microscope and scanning electron microscope),Glycyrrhizae Radix Et Rhizoma and Stemonae Radix were identified by thin layer chromatography(TLC),and Ephedrae Herba and Papa Veris Pericarpium were identified by high performance liquid chromatography(HPLC).The contents of morphine,ephedrine hydrochloride and pseudoephedrine hydrochloride were determined by HPLC on a Durashell C_(18) column(250 mm×4.6 mm,5μm),using acetonitrile(A)-0.1%phosphoric acid solution(B)(4:96)as mobile phase.The flow rate was 1 ml/min,the column temperature was 30℃,the detection wavelength was 210 nm,and the injection volume was 10μl.Results The microscopic identification results showed specific characteristics and elemental composition of Platycodonis Radix and Gypsum Fibrosum,and TLC results showed that the specificity was good and the spots were clear.The linear relationships of morphine,ephedrine hydrochloride and pseudoephedrine hydrochloride were good in the determination ranges,the average recoveries were 94.1%-99.3%,with RSDs less than 1.2%.The contents of 3 components in 14 batches of Kechuanning were 0.28-0.70,1.13-1.98 and 0.78-1.69 mg/g,respectively.Conclusion The quality standard covers the medicinal materials in the prescription more comprehensively.The method is easy to operate and has good accuracy,which can provide reference for further revision and improvement of the quality standard of Kechuanning.
作者
田京歌
张妤琳
倪倩
周娟娟
庞庆林
TIAN Jing-ge;ZHANG Yu-lin;NI Qian;ZHOU Juan-juan;PANG Qing-lin(Jiangsu Institute for Food and Drug Control,Nanjing 210019,China)
出处
《食品与药品》
2025年第1期56-62,共7页
Food and Drug
基金
中国药品监管科学行动计划第二批重点项目“中药有效性安全性评价及全过程质量控制研究”(编号:NMPAJGKX-2023-096)
江苏省药品监督管理局2023年药品监管科学科研计划项目(编号:202303)。
关键词
咳喘宁
扫描电镜
薄层色谱法
高效液相色谱法
质量标准
Kechuanning
scanning electron microscope
thin layer chromatography
HPLC
quality standard
作者简介
田京歌,副主任药师,硕士,研究方向:中药质量分析与控制,E-mail:723880752@qq.com;通信作者:庞庆林,副主任药师,硕士,研究方向:药物分析,E-mail:616966032@qq.com。
