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目的:建立连翘及其制剂的生物检定法。方法:采用体外抑菌试验,选定连翘生物检定的适用菌株和剂量范围,建立标准曲线和药物对敏感菌株的量效曲线。构建适用于一剂量法的效应模式。结果:当连翘的质量浓度0.08~0.49g·mL-1时,连翘的对数剂量和抑菌效应呈线性关系,且相关性好;可以用反应效应来表示它们的浓度。结论:生物检定法作为连翘及其制剂的质量控制方法是可行的、合理的。
Objective: To establish a biological assay for forsythia and its preparations. Methods: In vitro antibacterial tests were used to determine the applicable strains and dose ranges of the Forsythia suspensa bioassay, and the standard curve and dose-response curve of the drug to sensitive strains were established. Construct an effect model that applies to a dose method. Results: When the mass concentration of Forsythia suspensa was 0.08~0.49g·mL-1, the logarithmic dose and antibacterial effect of Forsythia suspensa had a linear relationship, and the correlation was good; they could be expressed by the reaction effect. Conclusion: The biological assay is feasible and reasonable as a quality control method for Forsythia suspense and its preparations.