鱼腥草注射液原料药材资源与质量控制研究进展

鱼腥草注射液的原料药材只有一味鱼腥草,鱼腥草的品质直接影响鱼腥草注射液的质量。鱼腥草野外分布较广,资源丰富,但随着其需求量不断提高,野生资源逐渐减少,当前鱼腥草供应以人工种植为主。2006年鱼腥草注射液不良反应事件引发了公众对中药注射剂的广泛关注,影响深远。本文综述了鱼腥草的鉴定、资源分布、品种选育、栽培种植、化学成分分析、农药残留和重金属检测等方面,以期规范化原料药材的生产,为中医临床用药和企业药品生产提供安全有效的药材,为鱼腥草注射液完善质量标准和上市后再评价提供理论依据,同时对其他中药注射剂原料药材研究具有示范作用。

Research Progress on the Raw Material Resources and Quality Control of Houttuynia Cordata Injection

The raw material of Houttuynia cordata Injection is a single ingredient,H.cordata.The quality of H.cordata directly affects the quality of H.cordata injection.H.cordata is widely distributed in the wild with abundant resources.However,the wild resources of H.cordata have gradually declined with the increasing demand.At present,the supply of H.cordata is mainly from the agricultural planting.In 2006,the adverse events of H.cordata Injection aroused the public′s extensive attention with far-reaching influence on the traditional Chinese medicine injection.This paper summarizes the identification,resource distribution,breeding,cultivation,chemical composition analysis,determination of pesticide residue,and heavy metal elements of H.cordata,aiming to standardize the production of raw materials.It provides safe and effective medicinal materials for clinical medicine of traditional Chinese medicine and production of pharmaceuticals for enterprises,and provides theoretical basis for perfecting quality standards of Houttuynia cordata Injection and evaluation after market.Meanwhile,it plays a guiding role in researches on the raw materials of other traditional Chinese medicine injections.