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药品的有效期是指药品在一定的贮存条件下,能够保持药品质量的期限。有些稳定性较差的药品(特别是它的制剂),在贮存过程中,受空气、温度,湿度、日光等影响,药效降低,毒性增加,有的甚至不能供药用。为了保证用药安全有效,对这类药品必须规定有效期。药品的有效期应根据药品的稳定性不同,通过留样观察试验,积累数据,总结全国情况,合理制订。新产品、新制荆的有效期可通过稳定性试验和加速试验先暂行规定有效期,在留样考察充分积累数据后进行修订。
The expiration date of the drug refers to the period that the drug can maintain the quality of the drug under certain storage conditions. Some less stable drugs (especially its preparation), stored in the air, temperature, humidity, sunlight, etc., lower efficacy, increased toxicity, and some even can not be used for medicinal purposes. In order to ensure safe and effective medication, such drugs must be valid. Validity of the drug should be based on the stability of different drugs, through the sample observation test, the accumulation of data, summed up the national conditions, the rational formulation. The new product, the new system of Jing can be validated by the stability test and accelerated test tentatively set the validity period, after leaving a sample study to fully accumulate data after the amendment.