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国家历来十分重视药品标准体系的建设,国家食品药品监督管理局成立以后,再次对地方药品标准进行整顿,除部分中药材和中药饮片还存在地方药品标准以外,全部实行国家药品标准管理,《中国药典》2005年版今年正式颁布实施, 新版药典有几个特点:其一,从采用的分析方法看,现代仪器得以大量应用;其二,片剂、胶囊剂、颗粒剂、口服液、注射剂、气雾剂、喷雾剂、茶剂、栓剂、凝胶剂等现代剂型已逐渐上升为主流剂型;其三,重点增加安全性控制指标,并围绕检验方法的专属性进行了大量的增修订工作,增加了检验方法的科学性、先进性与实用性。其四,新版药典又增加了三部生物制品,迈出了药品标准体系建设的新步伐。
The state has always attached great importance to the construction of a drug standard system. After the establishment of the State Food and Drug Administration, the local drug standards are once again rectified. Apart from some local drug standards, some Chinese herbal medicines and Chinese herbal cutlets are also subject to the implementation of the State Drug Standards Administration. Pharmacopoeia 2005 edition formally promulgated and implemented this year, the new Pharmacopoeia has several characteristics: First, from the analysis method used, modern instruments to a large number of applications; Second, tablets, capsules, granules, oral solution, injection, gas Modern dosage forms such as aerosol, spray, tea, suppository and gel have gradually risen into the mainstream dosage form. Thirdly, they focus on increasing the safety control index, and have done a lot of revisions and amendments around the specificity of the test method, increasing The test method of scientific, advanced and practical. Fourth, the new Pharmacopoeia has added three biological products, has taken a new step in the construction of the drug standard system.