摘要
目的建立脑立清制剂中樟脑限量的检测方法。方法利用气相色谱(GC)法对脑立清样品进行测定,并采用气相色谱-质谱联用(GC-MS)法对检测到含樟脑的阳性样品再次进行验证。结果10家企业的72个生产批次样品中,樟脑占冰片药材比例超过0.50%,最高者可达1.78%。问题批次占全部批次的81.8%。结论所建立的方法准确可靠,专属性强,可用于脑立清制剂中樟脑限量的检查;同时也为含冰片原料制剂中樟脑限量检查提供参考。
Objective To establish an analysis method for the determination of camphor limit in Naoliqing preparations.Methods The samples were determined by GC and the positive samples were verified by GC-MS.Results In 72 batches of Naoliqing preparations from 10 enterprises,the proportion of camphor in borneol medicinal materials exceeds 0.50%,and the highest being 1.78%.Conclusion The proposed method method was specific,precise,reliable,and suitable for determination of camphor limit in Naoliqing preparations.At the same time,it also provides a reference for examining the limit of camphor from borneol in preparations.
作者
尹雪
焦阳
梅桂雪
徐兴燕
谭乐俊
林永强
YIN Xue;JIAO Yang;MEI Guixue;XU Xingyan;TAN Lejun;LIN Yongqiang(NMPA Key Laboratory for Quality Evaluation of Gelatin Products,Shandong Institute for Food and Drug Control,Jinan 250101,China)
出处
《药学研究》
CAS
2022年第11期717-720,共4页
Journal of Pharmaceutical Research
基金
山东省中药材和饮片标准制修订项目。
