摘要
目的:分析栀子金花丸的质量状况并发现潜在的风险,提供其国家标准提高的建议。方法:对抽取的40批栀子金花丸按标准检验,并对其安全性、真实性及指标成分含量进行探索性研究。结果与结论:按照《中国药典》2020年版检验,栀子金花丸的合格率为100%,通过研究该品种检测设置的项目,发现栀子金花丸的性状有较大差异,存在重金属超标的风险。建议加强栀子金花丸质量控制研究,为其质量监督提供参考。
Objective:To analyze the quality of Zhizi Jinhua pills and find the potential risks,and provide suggestions for improving the national standard.Methods:Forty batches of Zhizi Jinhua pills were tested according to the standard,and the safety,authenticity and content of index components were explored.Results and conclusion:According to the test of the Chinese Pharmacopoeia 2020,the qualified rate of Zhizi Jinhua pills was 100%.Through studying the test items set for this product,it was found that there are great differences in the properties of Zhizi Jinhua pills,and there was a risk of exceeding the standard of heavy metals.It is suggested to strengthen the quality control of Zhizi Jinhua pills and provide reference for its quality supervision.
作者
梁秀坤
崔帅
许学丽
王洪明
LIANG Xiukun;CUI Shuai;XU Xueli;WANG Hongming(Binzhou Inspection and Testing Center,Binzhou Key Laboratory of Chemical Drug R&D and Quality Control(preparation),Binzhou 256600,China)
出处
《中国药品标准》
CAS
2022年第6期638-642,共5页
Drug Standards of China
关键词
栀子金花丸
质量分析
性状
重金属
Zhizi Jinhua pills
quality analysis
character
heavy metal
