中国药业2016,Vol.25Issue(4):26-28,29,4.
肝素钠粗品及原料药中猪源性成分的聚合酶链式反应检测
Identification of Porcine Derived Materials in Heparin Sodium Crude Product and Drug Substance Samples by PCR
摘要
Abstract
Objective To develop a PCR method for the identification of porcine derived materials in heparin sodium samples. Methods DNA was extracted from heparin sodium samples prepared from crude product and drug substance. Then the DNA samples extracted were amplified with specific primers. PCR products were digested by enzyme and sequenced to verify the sequence identity. Results It was found that porcine derived materials were detected in crude products,and none detected in drug substances. But porcine derived materials were detected in 50 times dilutions of crude products and drug substances by PCR. PCR products amplified from porcine de-rived samples had 99. 2% homologies to that of gene in the Genbank. Conclusion It is feasible to use PCR to identify porcine de-rived materials in heparin sodium crude product and drug substance.关键词
肝素钠/猪源性成分/DNA片段/聚合酶链式反应扩增Key words
heparin sodium/porcine derived materials/DNA fragment/PCR amplifi-cation分类
药学引用本文复制引用
余燕,邓锋..肝素钠粗品及原料药中猪源性成分的聚合酶链式反应检测[J].中国药业,2016,25(4):26-28,29,4.基金项目
广东省医学科研基金项目,项目编号A2013158,B2014093。 ()