摘要
目的:对33批次保和丸进行质量分析并结合检验情况进行探索性研究。方法:根据《中国药典》2020年版一部、四部的方法,对保和丸进行全项化学检验,再依据《中国药典》2020年版一部连翘鉴别(2)对保和丸的鉴别(2)方法优化进行探索性研究。结果:33批次样品所检项目全部合格,依据连翘药材所进行的保和丸探索性研究也取得较为满意的结果。结论:各厂家保和丸质量均能满足《中国药典》的要求,能够保障人民群众用药安全有效。通过更大范围的充分调查研究,探索商榷药典中保和丸鉴别(2)是否要进行方法优化。
objective:Thirty-three batches of Baohe Pill were subjected to quality analysis and exploratory study based on the test results.Methods:According to the methods in Chinese Pharmacopoeia,2020 Edition,PartⅠandⅣ,the full-item chemical tests were conducted on Baohe Pill,and the exploratory study on the identification(2)method of Baohe Pill was conducted based on the method of Forsythia identification(2)in Chinese Pharmacopoeia,2020 Edition,PartⅠ.Results:All the tested items in the 33 batches of samples were qualified,and the exploratory study on Baohe Pill based on the Forsythia herb also yielded satisfactory results.Conclusion:The quality of Baohe Pill produced by various manufacturers can meet the requirements of Chinese Pharmacopoeia,ensuring the safe and effective use of drugs by the people.Through more extensive and thorough investigation,it is proposed to explore whether the identification(2)method of Baohe Pill in Chinese Pharmacopoeia needs to be optimized.
作者
王娜
郝丽霞
陈倩倩
邬丽琴
赵亚男
WANG Na;HAO Lixia;CHEN Qianqian;WU Liqin;ZHAO Yana(Bayannur Product Quality Measurement and Testing Center,Bayannur 015000,China)
出处
《中国药品标准》
2025年第4期439-443,共5页
Drug Standards of China
关键词
保和丸
质量分析
鉴别2探索性研究
Baohe pills
quality analysis
identification 2 Exploratory study