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目的:通过指纹图谱与生物活性测定相结合的方式科学评价通天口服液的质量。方法:采用HPLC建立通天口服液的指纹图谱,并对10批次通天口服液进行同步定量分析;以抗血小板聚集活性为生物活性指标,确定通天口服液中活性成分贡献度。结果:10批次的通天口服液相似度均>0.96,标示出19个共有峰,确认第6,7,8,10,11号峰分别为芍药苷,升麻素苷,甘草苷,5-O-甲基维斯阿米醇苷,洋川芎内酯Ⅰ,同步定量分析结果显示,10批通天口服液中以上5个成分含量差异较大;抗血小板聚集活性结果显示,洋川芎内酯Ⅰ>5-O-甲基维斯阿米醇苷>升麻素苷>芍药苷,洋川芎内酯Ⅰ为其主要活性成分(P<0.001)。结论:建立了与通天口服液药效相关的指纹图谱,确定了与抗血小板聚集活性相关的主要化学成分为洋川芎内酯Ⅰ,5-O-甲基维斯阿米醇苷及升麻素苷,为通天口服液的质量评价提供一种更合理的手段。
OBJECTIVE: To scientifically evaluate the quality of Tongtian Oral Liquid by means of a combination of fingerprinting and bioactivity determination. Methods: The fingerprint of Tongtian oral liquid was established by HPLC, and the simultaneous quantitative analysis of 10 batches of Tongtian oral liquid was carried out. The anti-platelet aggregation activity was the biological activity index to determine the contribution of active ingredients in Tongtian oral liquid. Results: The similarities of 10 lots of Tongtian oral liquid were all> 0.96, indicating 19 common peaks, confirming that the peaks of 6,7,8,10,11 were paeoniflorin, ciminoside, liquiritin, O-methylvishisainin and yangchongxionglactone I. The results of synchronous quantitative analysis showed that there were significant differences in the contents of the above five components among the 10 batches of Tongtian oral liquid. The results of anti-platelet aggregation showed that the content of yangchongxiong lactoneⅠ > 5-O-methyl-Vaisindolin> ciclopirox> paeoniflorin, and Yangchuanxiong Lactone I as its main active ingredient (P <0.001). Conclusion: The fingerprint of Tongtian oral liquid was established, and the main chemical components related to the anti-platelet aggregation activity were identified as I Chuanxiong Lactone Ⅰ, 5-O-methyl-Vaisalain and cinnarin Glycosides, TongTian oral liquid quality evaluation provides a more reasonable means.