目的通过对2013年72批川贝母药材及饮片全国抽验情况,总结我国川贝母的质量问题,并探讨聚合酶链式反应-限制性内切酶长度多态性方法在检验中应注意的问题。方法参照《中国药典》2010年版一部标准方法,对所抽取的样品进行检验和研究,发现并探讨其质量问题和检测方法。结果抽验结果表明,市场上川贝母的不合格率为25.4%,聚合酶链式反应-限制性内切酶长度多态性方法在检验中对取样环节应予以明确规定。结论应进一步完善和提高标准,加强质量监管,并建立专项抽验的长效机制,保证中药材及饮片的质量和安全。
OBJECTIVE To analyze the quality of crude drug materials and decoction pieces of Fritillariae Cirrhosae Bulbus by the national wide quality surveillance of 72 batches of samples in 2013,and study the suitability of polymerase chain reaction-restriction enzymes length polymorphism( PCR-RFLP) tests.METHODS The samples from different origins were identified and detected according to the standard of Chinese Pharmacopoeia.RESULTS Seventeen batches of samples did not meet the requirements,resulting in a disqualification rate of 25.4%.CONCLUSION Further measures should be taken to improve the quality standard and strengthen the quality surveillance of Fritillariae Cirrhosae Bulbus and other species of Chinese material medica.