风寒咳嗽丸添加水稻源性成分检测方法的研究  

Study on the detection method of added rice-derived ingredients in Fenghan Kesou pills

作　　者：郭琳 王菲菲[1] 戴忠[1] 马双成[1] GUO lin;WANG Fei-fei;DAI Zhong;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2023年第12期2098-2104,共7页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用化学分析及基因检测等技术建立风寒咳嗽丸中水稻源性成分的检测方法,制定相应的新标准,以规范药品生产企业的非法行为,保障用药安全。方法:采用高效液相色谱法对不同来源的风寒咳嗽丸中的成分进行比对,并对其淀粉含量进行测定;采用PCR方法对不同来源的样品进行基因筛查,并优化样品前处理方法和DNA提取过程,对方法的检出限、精密度和重复性进行考察。结果:不同来源的样品指纹图谱明显不同,淀粉含量差异很大。PCR方法证明了问题样品掺入了水稻源性成分,该方法检测限为1 g·kg^(-1),精密度及重复性良好;实验结果表明2批次问题样品和1批次问题混合粉均掺入了水稻源性成分。结论:建立了风寒咳嗽丸中掺伪水稻源性成分的PCR检验检测标准,弥补了此类掺伪手段在监管中的漏洞。Objective: In order to regulate the illegal behavior of drug manufacturers and ensure the safety of drug use, chemical analysis and gene detection techniques were used to establish the detection method of rice components in Fenghan Kesou pills, and the corresponding new standards were established. Methods: The composition of Fenghan Kesou pills from different sources was compared by HPLC, and the content of starch was determined. PCR method was used to screen the genes of samples from different sources, and the sample pre-treatment method and DNA extraction process were optimized. The detection limit, precision and repeatability of the method were investigated. Results: The fingerprints of samples from different sources were obviously different, and the starch content varied a lot. PCR method proved that the samples were adulterated with rice-derived ingredients, and the detection limit of this method was 1 g·kg^(-1), with good precision and repeatability. The experimental results showed that the two batches of suspicious samples and one batch of suspicious mixed powder were mixed with rice-derived ingredients. Conclusion: The PCR detection standard of adulterated rice-derived ingredients in Fenghan Kesou pills is established to make up the loopholes in supervision of such adulterated means.

关 键 词：风寒咳嗽丸 水稻源性成分掺伪 PCR反应 药品监管 质量控制 

分 类 号：R917[医药卫生—药物分析学]