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

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.