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目的主要了解黔南州州内与州外药品生产企业中成药的质量情况。方法收集我所2011年~2014年1168份中成药检验报告书。结果 4年来,中成药的不合格率保持波动趋势,2011~2014年不合格率分别为0.32%、1.68%、0.37%和2.46%,不合格率以州外药品生产企业为高,州内药品生产企业仍然保持良好的质量状态,没有不合格批次。结论进一步加强药品生产企业、经营企业和使用单位中成药的质量管理,严格质量管理体系,规范中成药贮存制度;监管部门应加强对企业的监督与指导,将不合格药品杜绝在萌芽状态,维护老百姓用药安全有效。
Objective To understand the quality of the proprietary Chinese medicines in Qiannan Prefecture and other state pharmaceutical manufacturers. Methods We collected 1168 proprietary Chinese medicine test reports from 2011 to 2014. Results In the past 4 years, the unqualified rate of proprietary Chinese medicines kept fluctuating. The unqualified rates in 2011-2014 were 0.32%, 1.68%, 0.37% and 2.46%, respectively. The unqualified rate was higher in non-state pharmaceutical manufacturers and the state pharmaceuticals Production enterprises still maintain good quality status, there are no unqualified batch. Conclusion To further strengthen the quality control and strict quality management system of proprietary Chinese medicines in drug manufacturing enterprises, enterprises and users, standardize the storage system of proprietary Chinese medicines; supervise and control departments should strengthen the supervision and guidance to enterprises, stop unqualified drugs in the bud and maintain People use safe and effective drug.