中文摘要：

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。

英文摘要：

The study is aimed to develop a method in evaluation of the bioactive consistency of cardiotonic pill（CP）. HepG_2 cell line was employed as a biological detector. After treated with CP for 24 h, gene chip and qRT-PCR were used to select m RNAs that can represent the bioactivity of CP. Then similarity between different batches of CP were calculated based on expression levels of marker genes to evaluate the bioactive consistency of CP. Marker genes were selected according to the criteria as follows： 1 fold change 0.67 or 1.5; 2 potential relevance to curative effects; 3 extensive involvement in the cellular functions and clustering analysis categories; 4 dose-dependent effect. A total of 10 genes were selected as bioactive markers of CP. Angular cosine was calculated to evaluate the similarity between two samples. The method was validated using intra-day precision and inter-day precision. Using angular cosine similarity, the intra-day and inter-day precision were 0.4% and 0.6%, respectively. The similarities of 6 batches of CDPs ranged from 0.992 to 0.999, and 1 batch of Compound Danshen Tablet was 0.534. The established method is specific and accurate, and provides comprehensive and objective evaluation of bioactive quality of CDPs. It can also benefit the bioactive consistency evaluation of other compounds in traditional Chinese medicines.