药用磷酸质量标准对比分析及其标准提高研究

Comparison and Improvement of the Quality Standards for Pharmaceutical Phosphoric Acid

为提高我国药用磷酸的质量标准,确保用药安全.对国家标准(GB 3149-2004)、英国药典(BP 2013)、欧洲药典(EP 7.0)、美国药典(USP 35-NF30)4种药用磷酸质量标准各项指标检测方法和限度的对比分析,拟建立我国更加严格、符合实际的药用磷酸质量标准.结果表明:我国现行国家标准(GB 3149-2004)对药用磷酸的质量要求远低于3种国外药典的要求.按照拟定的药用磷酸质量标准要求,对上市药用磷酸进行质量分析,结果符合标准规定.表明我国药用磷酸具有良好的质量基础,提高我国药用磷酸的质量标准是可行的.

In order to improve the requirements of the national standard for pharmaceutical phosphoric acid of PRC and ensure the safe use of drugs, a comparative study was made of the test methods and limitation of all indicators for the quality standards of pharmaceutical phosphoric acid in four current standards, i. e. , the state standard of PRC （GB 3149-2004）, the British pharmacopeia （BP 2013）, the European pharmacopeia （EP 7.0） and the United States pharmacopeia （USP 35-NF30）. The results showed that the require- ments of the state standard of PRC （GB 3149-2004） on the quality of pharmaceutical phosphoric acid are far lower than those of the other three. Then the listed pharmaceutical phosphoric acid was analyzed according to the drafting standards, and the results met the requirements. It is thus concluded that the quality of pharmaceutical phosphoric acid in our country is good at present and that it is feasible to improve the requirements of our national standard for pharmaceutical phosphoric acid.