基于多指标综合评价的心脑静片质量分析

Quality Analysis of Xinnaojing Tablets Based on Multi-Index Comprehensive Evaluation

目的通过多指标综合评价,对心脑静片的质量进行系统分析。方法对抽检样品进行标准检验,并建立多个检测方法进行多指标综合评价。结果标准检验全部抽样均合格,多指标综合评价探索性研究发现部分样品存在原料质量差、少投料或生产过程控制问题。结论多指标综合评价更能反映制剂真实质量,建议企业关注冰片、木香、钩藤等药材的质量,加强生产过程控制,以确保制剂安全有效。

OBJECTIVE To analyze the quality status of Xinnaojing Tablets by multi-index comprehensive evaluation.METHODS Samples were tested according to the statutory standards.Several new methods were established and adopted for multi-index comprehensive evaluation.RESULTS All samples were qualified in statutory tests.But quality defects were found in some samples by multi-index comprehensive exploratory studies.The main problems involved poor quality of raw materials,low feeding,or lack of process control.CONCLUSION Multi-index comprehensive evaluation is more capable of evaluating the real quality status of Xinnaojing Tables.To ensure the safety and effectiveness of the midication,manufacturers should pay attention to the quality of raw materials and process control,especially on Borneolum Syntheticum,Aucklandiae Radix,and Uncariae Ramulus Cum Uncis.