摘要
目的:提升透骨灵橡胶膏的质量标准。方法:采用薄层色谱法对制剂中含乌头碱类成分的药材进行定性鉴别;运用气相色谱法对制剂中含挥发性成分的药材进行定量测定,色谱柱为PE Elite-WAX ETR毛细管柱(30 m×0.32 mm,0.25μm);检测器为氢火焰离子化检测器(FID);进样口温度230℃;检测器温度250℃;采用程序升温;载气流速1.0mL·min^(-1);分流比10∶1;进样量1μL。结果:苯甲酰乌头碱类的薄层色谱斑点清晰,分离度好,且阴性对照无干扰。樟脑、薄荷脑、异龙脑、龙脑的线性范围分别为3.305~105.765mg、5.621~179.878mg、2.048~65.537mg、3.399~108.763mg(R^(2)=1.0000,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%(n=6);平均加样回收率分别为93.5%,94.5%,94.0%,94.1%,RSD分别为2.2%,2.3%,2.3%,2.5%(n=6)。结论:本研究建立的方法专属性较强,适用于透骨灵橡胶膏的成分分析,可用于该制剂的质量控制。
Objective:To improve the quality standard of Touguling adhesive plasters.Methods:Medicinal materials containing aconitine components in the preparation were identified qualitatively by the thin-layer chromatography.Volatile component in the preparation was quantitatively determined by the gas chromatography,the chromatographic column was PE Elite-WAX ETR capillary column(30 m×0.32 mm,0.25μm)and FID was used as the detector;the inlet temperature was set at 220℃and the detector temperature was set at 250℃,the temperature was programmed;the split ratio was 10:1 and the volume of sample injection was 1μL.Results:The TLC spots of benzoylaconine、benzoylmesaconine and benzoylhypaconine were clear and well separated,and the negative control had no interference.The linearity of camphor,menthol,isoborneol and borneol were 3.305~105.765mg、5.621~179.878mg、2.048~65.537mg、3.399~108.763mg respectively(R^(2)=1.0000,n=6).The RSDs of precision,stability and reproducibility tests were all lower than 2.0%(n=6).The average recoveries were 93.5%,94.5%,94.0%,94.1%respectively,with the RSDs of 2.2%,2.3%,2.3%,2.5%respectively(n=6).Conclusion:The method established in this study is highly specific,which is suitable for the composition analysis of Touguling adhesive plasters,and can be used for the quality control of this preparation.
作者
王莉莉
李建飞
籍学伟
樊明月
Wang Li-li;Li Jian-fei;Ji Xue-wei;Fan Ming-yue(Inspection and Testing Office of Mentougou District Market Supervision and Administration,Beijing 102300,China;Perkinelmer Enterprise Management(Shanghai)Co.,LTD,Beijing 100020,China;Inner Mongolia Institute for Drug Control,Inner Mongolia key laboratory for standard research of the Chinese and Mongolian medicine,Hohhot 010020,China;Inner Mongolia Horqin Pharmaceutical Co.,LTD,Tongliao 028000,China)
出处
《北方药学》
2024年第5期8-11,共4页
Journal of North Pharmacy
