中成药DNA检测标准物质的制备及评价  

Preparation and Calibration of the Reference Material of Oryza sativa L. for DNA Test

作　　者：王菲菲[1] 任秀[1] 白继超 李静[1] 张聿梅[1] 崔生辉[1] 郑健[1] 马双成[1] WANG Fei-fei;REN Xiu;BAI Ji-chao;LI Jing;ZHANG Yu-mei;CUI Shang-hui;ZHENG Jian;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：《中国药学杂志》2022年第4期279-283,共5页Chinese Pharmaceutical Journal

摘　　要：目的 研究制备和评价DNA检测标准物质的方法,为促进聚合酶链式反应(PCR)检测方法在中成药检验中的应用提供保证。方法 以水稻源性DNA检测标准物质(水稻标准物质)为例,依据CNAS-GL03:2018《能力验证样品均匀性和稳定性评价指南》和CNAS-GL017:2018《标准物质/标准样品定值的一般原则和统计方法》的要求,随机抽取足够的样本,采用电泳检测方法对水稻DNA标准物质的上样量、均匀性、稳定性和光密度值等指标进行考察。结果 水稻DNA标准物质的提取效率良好,选用0.5 ng冻干样品上样量可满足试验要求,均匀性和稳定性符合规定。结论 本研究对此类标准物质的制备过程进行了系统的研究,成功制备了首个中成药DNA检测标准物质,为中药基因检测方法研究提供了技术参考。OBJECTIVE To prepare and calibrate the DNA test reference materials(RM) for the application of PCR methods in the control of traditional Chinese medicines. METHODS The rice RM for DNA test was produced as an example. According to the guidance on “Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing(CNAS-GL03:2018) ” and “Reference Materials-General and Statistical Principles for Certification(CNAS-GL017: 2018)”, adequate sample was selected at random, then evaluated the sample volume, homogeneity, stability and optical density value by the electrophoretic detection. RESULTS Good extraction efficiency was obtained with the RM for DNA test. The sample volume of 0.5 ng could meet the test requirements after lyophilization. The homogeneity and stability complied with the regulations. CONCLUSION Based on the systematic study on its preparation, the first RM for DNA test is rice successfully prepared. It provides a good technical reference for the future development of gene test in traditional Chinese medicine.

关 键 词：中成药 水稻DNA检测标准物质 上样量 均匀性 稳定性 光密度值 

分 类 号：R917[医药卫生—药物分析学]