浅析非药典标准在使用时遇到的问题及建议

Problems and Suggestions on Use of Non-pharmacopoeia Standards

我国的药品标准包括《中国药典》各部及增补本、部颁标准和局颁标准组成的非药典标准。本文总结了使用非药典标准进行检验时遇到的常见问题,例如同一品种的药品质量标准不同、质量标准不够全面、标准中使用的方法落后等问题,并提出了建议,希望国家有关部门尽快规范药品的质量标准,建立统一、完善、科学的药品标准。

Our country’s pharmaceutical standards include Chinese Pharmacopoeia and supplementary books,the non-pharmacopoeia standards which consist of the standards issued by the Ministry and issued by the Bureau.The common problems encountered in the use of non-pharmacopoeia standards were summarized.For example,the quality standards of the same variety of drugs were different,the quality standards were not comprehensive enough,and the methods used in the standards were backward,and so on,some suggestions were put forward.It was hoped that relevant state departments will standardize the quality standards of drugs as soon as possible and establish unified,perfect and scientific drug standards.