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 sam-ples 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 Xinnao-jing 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.
关键词
心脑静片/质量评价/国家药品抽检
Key words
Xinnaojing Tablet/quality evaluation/national drug sampling and inspection
维普
万方数据