中成药DNA检测标准物质的制备及评价

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...

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

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.