开发一种评价复方丹参滴丸生物活性一致性的方法。以HepG_2细胞系为生物检测器,在复方丹参滴丸处理24 h后,使用基因表达谱芯片和qRT-PCR筛选能够代表药物生物活性的mRNA作为指标基因,随后对不同批次药物指标基因的表达水平进行相似度评价,实现对药物生物活性一致性的评价。指标基因按照如下准则筛选:1调节倍数<0.67或>1.5;2与疗效具有潜在相关性;3广泛分布在细胞功能通路中;4具有剂量-效应依赖性。本研究共选择10个指标基因。以夹角余弦相似度计算,方法的日内精密度和日间精密度分别为0.4%和0.6%。测定6批复方丹参滴丸,相似度在0.992~0.999之间,1批复方丹参片的相似度为0.534。所建立的方法专属性强、准确可行,能够全面、客观地反应复方丹参滴丸的生物活性一致性。该方法也可用于其他复方中药生物活性一致性的评价工作中。 Development of a method for evaluating the bioactivity of compound Danshen dripping pills. Using HepG2 cell line as a biological detector, 24 h after treatment with compound Danshen dripping pills, gene expression microarray and qRT-PCR were used to screen the mRNA that can represent the biological activity of the drug as an indicator gene. Subsequently, Level similarity evaluation, to achieve the consistency of the evaluation of biological activity of the drug. The marker genes were screened for the following criteria: 1 Modulation multiple <0.67 or> 1.5; 2 Potential correlation with efficacy; 3 Widely distributed in cellular functional pathways; 4 Dose-effect dependent. This study selected a total of 10 indicator genes. The cosine similarity of included angle method was 0.4% and 0.6% respectively. Determination of 6 batches of compound Danshen dripping pills, similarities between 0.992 ~ 0.999, 1 batch of salvia miltiorrhiza tablet similarity of 0.534. The established method is specific, accurate and feasible, and can comprehensively and objectively reflect the biological activity consistency of compound Danshen dripping pills. The method can also be used for the evaluation of the biological activity of other compound Chinese medicines.