基于生物检定法的妇科千金片质量控制方法研究  

Study on quality control methods of Fukeqianjin tablets based on biological detection method

作　　者：谢晓华 

机构地区：[1]浙江省宁波市鄞州人民医院,宁波315040

出　　处：《药物分析杂志》2016年第11期1936-1940,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立妇科千金片的生物检定法并用于质量控制。方法:以妇科千金片处方中具有抗菌作用的2种药材单面针和穿心莲为指标,考察它们的单煎混合液对4种标准菌株(金黄色葡萄球菌、沙门氏菌、大肠杆菌和枯草芽孢杆菌)的抑菌作用;利用单面针和穿心莲对照药材单煎混合液对敏感菌的抑菌圈直径大小与质量浓度的对数建立标准曲线,并根据量效曲线测定不同批号妇科千金片的生物效价。结果:单面针和穿心莲对照药材单煎混合液对以上4种标准菌株均有较强的抑菌作用;当单面针和穿心莲对照药材单煎混合液相对生药的质量浓度在0.029~0.137 g·mL^(-1)范围内时,质量浓度的对数与反应效应呈线性关系,且相关性好(r=0.967 0)。结论:生物效价测定法可配合传统的分析方法对妇科千金片的质量进行有效控制。Objective： To establish a biological detection method for the quality control of Fukeqianjin tablets. Methods： With Zanthoxylum dissitum Hemsl. and Andrographis paniculata （ Burm. F. ） Nees in Fukeqianjin tablets as indexes, the antimicrobial activities of the single fried mixture of Zanthoxylum dissitum and Andrographis paniculata to 4 kinds of standard strains （ Staphylococcus aureus, Salmonella, Escherichia coli and Bacillus subtilis ） were inspected. The standard curve was established using the inhibition zone diameter of susceptible strains and logarithm of the concentration, and this test was also adopted to defermine the biological potency of different batches of Fukeqianjin tablets according to the dose-response curve. Results： The single fried mixture of Zanthoxylum dissitum and paniculata had strong anti-bacterial effect on the above four standard strains. There was a good linear relationship between logarithmic dose and response effect when the concentration was in the range of 0. 029-0.137 g. mL-1 （ r=0.967 0 ）. Conclusion： Combined with traditional analysis method, thebiological potency detection method can be used in the quality control of Fukeqianjin tablets.

关 键 词：妇科千金片 单面针 穿心莲 金黄色葡萄球菌 沙门氏菌 大肠杆菌 枯草芽孢杆菌 量效曲线 生物效价 质量控制 生物检定法 

分 类 号：R917[医药卫生—药物分析学]