基于凝集活性检测的板蓝根颗粒质量生物测定方法研究  

Agglutinated activity bioassay method for the determination of antivirus potency of Banlangen granula

作　　者：唐慧英[1,2] 鄢丹[1] 张少锋[1,2] 李寒冰[1] 刘荣华[2] 肖小河[1] 

机构地区：[1]解放军中药研究所解放军第302医院,北京100039 [2]江西中医学院现代中药制剂教育部重点实验室,江西南昌330004

出　　处：《药学学报》2010年第4期479-483,共5页Acta Pharmaceutica Sinica

基　　金："重大新药创制"科技重大专项(2009ZX09502-022;2009ZX09308-005);国家杰出青年科学基金项目(30625042);国家自然科学基金项目(30873385)

摘　　要：建立可用于板蓝根颗粒质量生物测定的新方法。采用血红细胞凝集活性检测法,对20批板蓝根颗粒抗病毒活性进行生物测定,并以流感病毒神经氨酸酶(NA)抑制试验进行药效学验证。结果显示,所建立方法简便易行,重复性良好(RSD=2.0%);所有测试样品均为阳性反应(效价值U介于2～11之间),具有较好的适用性;血红细胞凝集活性测定结果与流感病毒NA抑制活性测定结果之间相关性良好(r2=0.8783)。结果表明,血红细胞凝集活性测定法具有与药效相关、重复性好、经济安全、专属灵敏等特点,可用于表征板蓝根颗粒质量生物活性信息,以补充和完善板蓝根颗粒现行质量控制标准。To establish a bioassay method and quality standard of Banlangen granula,agglutinated activity assay was used in the analysis of the traditional Chinese medicine,Banlangen granula. It showed that masculined effect could be picked up effectively and the products quality of different pharmaceutical factories and different batch numbers from the same factory could be revealed conveniently,accurately,quickly and directly with this method （valence value was between 2 and 11）. The established bioassay method had a good reproducibility with RSD = 2%. The dependablity of the activity of red cell agglutination and restrainting influenza virus NA was conspicuous （r^2 = 0.878 3）. In conclusion,this bioassay method is suitable to control and evaluate the quality of Banlangen granula. Thus the method may provide a simple and effective technique in supervising and examining the quality of other traditional Chinese medicine.

关 键 词：板蓝根颗粒 质量控制 生物测定 凝集活性 血红细胞 

分 类 号：R917[医药卫生—药物分析学]