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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 quality standard of medicinal phosphoric acid in our country and ensure the safety of medication, the medicinal properties of four medicinal products (GB 3149-2004, BP 2013, EP 7.0, USP 35-NF30) Phosphoric acid quality standards for the detection of indicators and the limits of comparative analysis, to establish our more stringent, in line with the actual quality of the pharmaceutical phosphate.The results show that: China’s current national standards (GB 3149-2004) on the quality of pharmaceutical phosphate far Lower than the requirements of three kinds of foreign pharmacopoeia.According to the requirements of the proposed pharmaceutical phosphate quality standards, the quality analysis of the listed medicinal phosphoric acid, the results meet the standards.It shows that our pharmaceutical phosphate has a good quality foundation to improve our country of medicinal phosphoric acid Quality standards are feasible.