药品检验中结果偏离的原因与质量控制研究

Study on the Cause and Quality Control of the Result Deviation in Drug Inspection

为了对药品检验结果出现偏离的原因进行分析,并探讨如何进行质量控制,从该所2017年3月—2018年2月中的药品中随机抽取510份药品样品,其中,西药355份,中药155份,通过紫外分光光度法和高效液相色谱法对其进行检验,并观察分析检验结果。发现,检测的生化药样本数量占比≤1.5%,与中药材制剂样本数量占比≤2.0%的药品之间没有显著差异,无统计学意义(P>0.05)。所以要确保药品的质量,就应该采取科学合理的检验方法,同时进行质量控制,使误差尽可能小。

To analyze the reasons for the results deviation of drug inspection and discuss how to control the quality, 510 drug samples are randomly collected from March 2017 to February 2018 in the institute. Among them, 355 are western and 155 are Chinese medicines. The samples are tested by using ultraviolet spectrophotometry and HPLC, then observe and analyze the results. And there is no significant difference because the biochemical drugs in the sample number proportion is less than or equal to 1.5%, but the Chinese medicinal preparations in the sample proportion is less than or equal to 2.0%(P>0.05)in the all samples. So in order to ensure the quality of drugs, people should take scientific and reasonable inspection method and carry on the quality control at the same time to make the error as small as possible.