基于生物检定法的扶正消积胶囊质量控制方法研究

Study on quality control methods of Fuzheng Xiaoji capsule based on biological detection method

目的建立扶正消积胶囊的生物检定法。方法以扶正消积胶囊处方中具有抗癌、抗菌作用的4种药材黄芪、蛇舌草、水红花子和生大黄为指标,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、大肠埃希菌和枯草芽孢杆菌）的抑菌作用;利用黄芪、蛇舌草、水红花子和生大黄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扶正消积胶囊的生物效价。结果黄芪、蛇舌草、水红花子和生大黄药材单煎混合液对4种标准菌株（金黄色葡萄球菌、沙门氏菌、大肠埃希菌和枯草芽孢杆菌）均有较强的抑菌作用;当黄芪、蛇舌草、水红花子和生大黄药材单煎混合液相对生药浓度在0.029~0.136 g/m L时,对数浓度与反应效应呈线性关系,且相关性好（r=0.9583）。结论生物效价测定法可配合传统的分析方法对扶正消积胶囊的质量进行有效控制。

Objective To establish biological detection method for Fuzheng Xiaoji capsule.MethodsTaken Radix astragali,Hedyotis diffusa Willd, Fructus Polygoni orientalis and rhubarb in Fuzheng Xiaoji capsule as targets, the antimicrobial activity of the single fried mixture of Radix astragali,Hedyotis diffusa Willd,Fructus Polygoni orientalis and rhubarb to 4 kinds of standard strains（Staphylococcus aureus, Salmonella, Escherichia coli and Bacillus subtilis） were inspected.The standard curve by susceptible strains of the inhibition zone diameter and logarithm of the concentration was established,and this test also determined the biological potency of different batches of Fuzheng Xiaoji capsule according to the dose-response curve.ResultsThe single fried mixture of Radix astragali,Hedyotis diffusa Willd, Fructus Polygoni orientalis and rhubarb have strong anti-bacterial effect to the above four standard strains.There was a good linear relationship between logarithmic dose and response effect when the concentration in the range of 0.029-0.136g/mL（r=0.9583）.ConclusionBiological potency detection method can be combined with traditional analysis methods to control the quality of Fuzheng Xiaoji capsule.