近5年医院制剂温通膏生产质量分析

Analysis on the Quality of the Hospital Preparation Wentong Ointment in the Past 5 Years

目的对中药制剂温通膏的生产质量进行回顾性分析。方法采用回顾性方法,对温通膏在近五年(2011—2015年)的生产工艺、检验结果、设备验证及再验证等进行统计分析。结果 2011—2015年度生产温通膏批次分别为6批、8批、5批、6批、5批,共30批次,生产温通膏共673633支,按现行法定标准检验,全部合格,稳定性良好,工艺稳定。结论通过评价发现,温通膏按现行标准检验总体质量良好,且工艺稳定。

Objective To evaluate the quality of Wentong ointment. Methods Using a retrospective method, the inspection results and technology validation ang revalidation ang equipment validation and revalidation of Wentong ointment in past five years was analyzed statistically. Results From 2011 to 2015, Wentong Ointment batch respectively was 6,8,5,6 and 5, a total of 673633 pieces. According to the current legal standard inspection, Wentong ointment was all qualified and good stability and process stability. Conclusion Through the evaluation, we found that the overall quality was good and process was stability of Wentong ointment.