中药制剂质量控制因素研究

Study on the quality control factors of traditional Chinese medicine preparation

目的对中药制剂的质量控制因素进行研究分析。方法本实验对我院2013年2月~2017年3月间中药制剂的质量控制情况进行回顾性分析。根据中药制剂质量管理时间将其分成两组,其中2013年2月~2015年2月期间我院中药制剂未进行质量控制管理,将其设定为对照组(抽检次数n=240);于2015年3月~2017年3月期间我院中药制剂中进行质量控制管理,将其设定为研究组(抽检次数n=240)。对比不同组别中药制剂抽检不合格率指标。结果研究组中药制剂抽检不合格率明显低于对照组,指标组间比较差异有统计学意义(P<0.05),研究组中药制剂合格情况更优。结论明确中药制剂质量控制的影响因素,针对每一因素提出相应措施,对于提高中药制剂质量及合格率均具有重要意义。

Objective To study and analyze the quality control factors of traditional Chinese medicine preparation.Methods The quality control of Chinese medicine preparation from February 2013 to March 2017 in our hospital was analyzed retrospectively.According to quality management time of traditional Chinese medicine preparation,all them were divided into two groups.From February 2013 to February 2015,the quality control management of Chinese medicine preparations were not set up in the hospital as control group(sampling times n=240).From March 2015 to March 2017,the quality control management of Chinese medicine preparations in our hospital were set up as research group(sampling times n=240).The unqualified rates of different groups of Chinese medicine preparations were compared.Results The unqualified rate of the Chinese medicine preparations in the study group was significantly lower than that in the control group,and there was a statistically significant difference between the two groups(P<0.05).The quality of Chinese medicine preparation in the study group was better.Conclusion It is of great significance for improving the quality and qualified rate of traditional Chinese medicine to clarify the factors affecting the quality control of traditional Chinese medicine and put forward corresponding measures for each factor.