白带净胶囊质量标准研究  

Study on BaiDaiJing capsules

作　　者：梅婕 闫海霞 傅欣彤 杜小伟 Mei Jie;Yan Haixia;Fu Xintong;Du Xiaowei(Beijing Institute for Drug Control(Beijing Center For vaccine Control);NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Patent Medicine(Traditional Chinese Patent Medicine);Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院(北京市疫苗检验中心) [2]国家药品监督管理局中成药质量评价重点实验室 [3]中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《首都食品与医药》2023年第9期113-116,共4页Capital Food Medicine

摘　　要：目的对白带净胶囊进行质量评价。方法采用薄层色谱法对儿茶进行鉴别,采用气相色谱法对樟脑进行限量检查;对龙脑、异龙脑进行含量测定。结果儿茶的薄层斑点清晰,分离度良好。气相色谱法:色谱柱采用Agilent J&W scientific DB-NOWAX(30m×0.25mm,0.5μm 123-7033)聚乙二醇毛细管柱;柱温为130℃;分流进样,分流比6∶1;FID检测器;进样口温度220℃;检测器温度230℃。樟脑在1.075×10^(-3)-5.374×10^(-2)μg范围内线性关系良好(γ=0.9997),平均回收率为98.68%,RSD=2.16%(n=6)。异龙脑、龙脑的线性范围分别为2.474×10^(-2)-1.237μg(γ=0.9997)、3.032×10^(-2)-1.516μg(γ=0.9998),异龙脑平均回收率为97.63%,RSD=2.05%(n=6),龙脑平均回收率为99.71%,RSD=2.53%。结论该方法能有效控制白带净胶囊质量,并对含樟脑成分阴道给药带来的不良反应加以限制。Objective To establish a method for the quality control of BaiDaiJing capsules.Methods Catechu was identified by thinlayer chromatography.And the limits of Camphor;Borneol and Isoborneol were determined simultaneously by gas chromatography.Results The thin layer of catechu is well spotted and well separated.Gas chromatography was used for the quantitative determination of borneol and isoborneol and the test of camphor.The chromatographic column adopts Agilent J&W scientific DB-NOWAX(30m×0.25mm,0.5μm 123-7033)polyethylene glycol capillary column;the column temperature was 130℃;split injection,with a split ratio of 6∶1;the detector was a FID;injection port temperature was 220℃;the detector temperature was 230℃.The linearity of camphor was good in the range of 1.075×10^(-3)to 5.374×10^(-2)μg(γ=0.9997)with a mean recovery of 98.68%and RSD=2.16%(n=6).The linear ranges were 2.474×10^(-2)to 1.237μg(γ=0.9997);3.032×10^(-2)to 1.516μg(γ=0.9998)for Isobrneol and borneol,respectively,with mean recoveries of 97.63%,RSD=2.05%(n=6)and 99.71%,RSD=2.53%.Conclusion The method is effective in controlling the quality of BaiDaiJing capsules,and limiting adverse effects associated with vaginal administration of camphor-containing ingredients.

关 键 词：气相色谱法 白带净胶囊 龙脑 异龙脑 樟脑 儿茶 

分 类 号：R927.1[医药卫生—药学]