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作 者:钟艳 辛丽 吴喆 郭林峰 周云峰 ZHONG Yan;XIN Li;WU Zhe;GUO Linfeng;ZHOU Yunfeng(Wanzai County People's Hospital,Wanzai Jiangxi 336199,China;The Inspection and Testing Center of Yichun,Yichun Jiangxi 336099,China)
机构地区:[1]万载县人民医院,江西万载336199 [2]宜春市检验检测中心,江西宜春336099
出 处:《药品评价》2023年第2期155-158,共4页Drug Evaluation
摘 要:目的 建立消栓通络片中异性有机物的检查方法,同时考察该制剂中9种有机氯农药残留量水平。方法 消栓通络片用水装片后置于显微镜下观察异性有机物;采用气相色谱法对样品中9种有机氯农药进行检查,并拟定限量值。结果 20批次样品中8批次检出了除三七以外的植物组织特征玉米淀粉粒,提示个别企业可能擅自添加了玉米淀粉辅料;所有样品中9种有机氯农药残留量均低于限量值。结论 所建立的显微鉴别法可有效甄别消栓通络片中是否存在异性有机物,对有机氯农药残留量的考察有助于控制该制剂的整体质量。Objective To establish a method for the determination of heterotropic organics in xiaoshuan tongluo tablets,and investigate the levels of 9 kinds of organochlorine pesticide residues in the preparation.Methods Xiaoshuan tongluo tablets were loaded with water and placed under microscope to observe heterotropic organics.9 kinds of organochlorine pesticides in samples were examined by gas chromatography and their limited values were determined.Results Corn starch grains with plant tissue characteristics other than panax notoginseng were detected in 8 batches of 20 samples,suggesting that individual enterprises may have added corn starch excipient without authorization.The residues of 9 kinds of organochlorine pesticides in all samples were lower than the limit value.Conclusion The established microscopic identification method can effectively identify the presence of heterotropic organics in xiaoshuan tongluo tablets,and the investigation of organochlorine pesticide residues can help to control the overall quality of the preparation.
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