鱼腥草注射液不良反应与甲基正壬酮含量的相关性

Study on the correlation between adverse reaction of Herba Houttuyniae injection and the content of 2-undecanone

目的:探讨鱼腥草注射液不良反应与甲基正壬酮含量的相关性。方法:以甲基正壬酮为含量指标,考察了贵阳三桥、安顺旧州2个产地鱼腥草原料药材于一个生长周期中每月含量的动态变化和2001、2002、2003年度各月份生产的10,50,100mL3个规格鱼腥草注射液成品的含量变化情况。通过查阅文献报道中的鱼腥草注射液不良反应事件,对有生产批号的鱼腥草注射液的季节分布情况进行研究,来浅析鱼腥草注射液不良反应发生的原因与甲基正壬酮含量的相关性及与季节的关系。结果:贵州不同产地鱼腥草原料中甲基正壬酮含量以8月份(夏季)为最高,不同年度、不同季节、不同规格鱼腥草注射液中甲基正壬酮含量的最高值和较高值也集中出现在夏/秋季节,鱼腥草注射液不良反应在春季生产的产品批次发生较多。结论:无论药材和注射液成品,甲基正壬酮含量均在夏/秋季较高,鱼腥草注射液中甲基正壬酮的含量与季节有关,而报道的不良反应成品的批号月份多发生在春季,故甲基正壬酮含量高低与其不良反应无关。

OBJECTIVE To explore the correlation between adverse reaction of Herba Houttuyniae injection and the content of 2-undecanone. METHODS To determine the content of 2-undeeanone in Herba Houttuyniae once a month in its growth cycle from the area of Sanqiao of Guiyang and Jiuzhou of Anshun, and to determine the content in Herba houttuyniae injection of lit, 50 and 100ml produced in years 2001, 2002, 2003. Consulting reference to make sure the season distribution of adverse reaction of Herba houttuyniae injection and to analyze the relation between the season of the adverse reaction the content of 2 unde canone. RESULTS The content of 2-undecanone of Herba Honttuyniae from all area of Guizhou was the highest in August （summer）. In general, the content of 2-Undecanone of Herba Houttuyniae is the highest or was higher in season summer and autumn in all year. But the adverse reaction of Herha Houttuyniae injection appeared usually in spring. CONCLUSION The content of 2-undecanone is higher in summer and autumn at both medicinal materials and injection. The content of 2 undecanone in Herba Houttuyniae injection is related to the season. The adverse reaction reported mostly happened in spring. The content of 2-undecanone has done nothing to the adverse reaction.