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国家药品监督管理局日前对安徽亳州等地的中药材专业市场进行了监督抽验,结果显示:中药材抽验不合格率高达80%。人们为此颇感震惊,广大患者更是诚惶诚恐,然而笔者根据自己多年的中药监督抽验与药检实践经验,对此有自己的看法。 首先,我们从抽验不合格率的定义探讨一下其内涵。抽验不合格率是指药品抽验不合格品种数(批次)与总抽验品种数(批次)之比。从这个定义中我们不难发现,药品抽验不合格率与药品市场不合格率(质量情况)不属一个概念,或者说不表示一层意思,也正是这一概念
The State Drug Administration has recently conducted supervision and inspection on the professional markets of Chinese herbal medicines in places such as Anhui Province and other places. The results show that the rate of unqualified sampling of traditional Chinese medicinal materials is as high as 80%. People are shocked by this, and the majority of patients are sincere and fearful. However, the author has his own opinions based on his years of practical experience in Chinese medicine supervision and drug testing. First of all, we discuss the connotation from the definition of sampling failure rate. The sampling failure rate refers to the ratio of the number (batch) of unqualified products and the total number (batch) of total sampling. From this definition, it is not difficult to find that the failure rate of drug sampling and the failure rate of the drug market (quality situation) are not a concept, or that it does not mean one layer of meaning. It is also this concept.