川贝母PCR-RFLP法鉴别检验能力验证活动分析

Analysis of the Proficiency Test of the Identification of Fritillariae Cirrhosae Bulbus by the Method of PCR-RFLP

目的:考察相关实验室执行《中华人民共和国药典》川贝母PCR-RFLP法鉴别检验项目的技术能力,促进分子生物学技术在中药检定中的广泛应用。方法:测试样品为粉末,对样品的均匀性和稳定性进行评价,样品种类分为阳性和阴性两种,采用随机单盲方式分配至参与能力验证的实验室。各实验室按照作业指导书进行检测,并以规定格式书写原始记录。检测结果与样品性质一致的实验室为满意。对各实验室的反馈结果进行汇总和分析。结果:最终报名参加的实验室总计50家,能力验证结果为满意的26家,占52%,不满意24家,占48%。其中3家试验室未按要求返回结果,判定为不满意。分别统计不同类型参加实验室的满意率,地市级食药检机构满意率最高,为70.6%。结论:总体满意率偏低,川贝母PCR-RFLP法鉴别检验项目的整体技术水平有待提高。

Objective: To evaluate the technical capability of relevant laboratories to perform the identification of Fritillariae Cirrhosae Bulbus by the method of PCR-RFLP method according to Chinese Pharmacopia 2015 edition and to promote the application of molecular biological technology in the field of TCM identification, a proficiency test of the identification of Fritillariae Cirrhosae Bulbus by the method of PCR-RFLP was organized by National Institutes for Food and Drug Control. Methods: Samples for testing were in the form of powder and the homogeneity and stability of the samples were examined. The samples were classified into two types, positive and negative, which was randomly and single blindly distributed to the laboratories participating in the proficiency test. The laboratories carried out the tests according to the instruction book as designed and records were made in the specific forms. The satisfied judgment was only made when the testing result was in accord with the nature of the sample(positive or negative). Finally, Results from different laboratories were collected and analyzed. Results: A total of 50 laboratories participated in the proficiency test, 26 laboratories were satisfied, accounting for 52%, 24 laboratories were unsatisfied, accounting for 48%. 3 laboratories failed to return the results as required and were considered to be unsatisfied. The laboratories affiliated to cities got the highest rate of the satisfaction, 70.6%. Conclusion: The overall ratio of the satisfied is low. The technical level of the identification of Fritillariae Cirrhosae Bulbus by the method of PCR-RFLP needs to be improved.