透骨灵橡胶膏质量标准研究  

Quality Standard of Touguling adhesive plasters

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)

机构地区：[1]北京市门头沟区市场监督管理检验检测所,北京102300 [2]珀金埃尔默企业管理(上海)有限公司,北京100020 [3]内蒙古自治区药品检验研究院,内蒙古自治区中蒙药标准研究重点实验室,内蒙古呼和浩特010020 [4]内蒙古科尔沁药业有限公司,内蒙古通辽028000

出　　处：《北方药学》2024年第5期8-11,共4页Journal of North Pharmacy

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.

关 键 词：透骨灵橡胶膏 薄层色谱法 气相色谱法 苯甲酰新乌头原碱 苯甲酰乌头原碱 苯甲酰次乌头原碱 樟脑 薄荷脑 异龙脑 龙脑 

分 类 号：R827[医药卫生—临床医学]