冠心膏的质量标准研究  

Quality standard for Guanxin Plaster

作　　者：田永庆 

机构地区：[1]河北省沧州市药品检验所,河北沧州061001

出　　处：《中成药》2008年第2期216-219,共4页Chinese Traditional Patent Medicine

摘　　要：目的:建立冠心膏(丹参,川芎,乳香,等)的质量标准。方法:采用薄层色谱法鉴别冠心膏中的丹参、川芎和当归;采用GC法,以PEG-20M弹性石英毛细管色谱柱(30 m×0.53 mm×1μm);FID检测器,测定冠心膏中的樟脑、薄荷脑及冰片。结果:定性鉴别分离度好,专属性强;樟脑线性范围为进样量0.095μg^0.95μg,(r=0.999 7,n=5);平均回收率为99.6%(RSD=1.9%)。薄荷脑线性范围为进样量0.123μg^1.23μg(r=0.999 6,n=5);平均回收率为98.4%(RSD为2.0%)。冰片线性范围为进样量0.202μg^2.02μg(r=0.999 7,n=5),平均回收率为98.2%(RSD为3.8%)。结论:所建立的方法可靠、准确、专属性强,可以用于该制剂的质量控制。AIM： To establish the quality standard for Guanxin Plaster （Radix et Rhizoma Salviae miltiorrhizae, Rhizoma Chuanxiong , Olibanum , etc）. METHODS： Radix et Rhizoma Salviae miltiorrhizae ; Rhizoma Chuanxiong and Radix Angeliae pubescentis of Guanxin Plaster were identified by TLC. Camphor, menthol and borneolum syntheticum were cletermined by GC together. RESULTS： The characteristic identification by TLC was distinct and highly specific. Camphor showed a good liner relationship at a range of 0.095 μg - 0.95 μg, （ r = 0.999 7, n = 5 ）. Menthol showed a good linear relationship at a range of 0.123 μg - 1.23 μg, r = 0.999 6, n = 5 ）. Borneolum syntheticum showed a good liner relationship at a range of 0. 202 μg - 2.02 μg, （ r = 0.999 7, n = 5 ）. The average recoveries were 99.6% （ RSD = 1.9% ） for camphor, 98.4% （ RSD = 2.0% ） for menthol, 98.2% （ RSD = 3.8% ） for bomeolum syntheticum. CONCLUSION： The method is reliable,accurate and specific. It can be used for quality control of Guanxin Plaster.

关 键 词：冠心膏 质量标准 樟脑 冰片 薄荷脑 GC 含量测定 TLC 

分 类 号：R927.2[医药卫生—药学]