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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 bioassay for gynecological gold tablets and to use it for quality control. Methods: The two herbs with antibacterial activity in the prescription of gynecological Qianjin tablets were used as indexes to study the effects of single decoction mixture on four kinds of standard strains (Staphylococcus aureus, Salmonella, Escherichia coli and Bacillus subtilis) Antibacterial effect; the use of single-needle and Andrographis paniculata liquid mixture of sensitive bacteria inhibition zone diameter size and the logarithm of the concentration of the standard curve, and the determination of different batches of gynecological daughter gold tablets bioavailability price. Results: The single-stained needle and Andrographis paniculata mixture had a strong antibacterial effect on the above four standard strains. When the single-stalk and the andrographis panfructus contrast medium single Chinese herbal medicine relative concentration of crude drug was 0.029 ~ 0.137 g · ML -1, the logarithm of mass concentration showed a linear relationship with the response effect, and the correlation was good (r = 0.967 0). Conclusion: Bioequivalence assay can be used to control the quality of gynecology Qianjin tablets with the traditional analysis methods.