新型药物辅料聚苯乙烯磺酸钠的质量研究
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孙西洋，刘宏飞，张 姝，曹心珂，潘卫三
(沈阳药科大学 药学院，辽宁 沈阳 110016)
摘要：目的 对新型药物辅料聚苯乙烯磺酸钠进行质量研究。 方法 根据《美国药典》24版、《英国药典》2000版和《中华人民共和国药典》2005版二部的相关实验方法和质量标准，对聚苯乙烯磺酸钠的国外样品、国内市售品及自制合成品进行了质量评价。结果 国内市售品的粒径、含水量、钠离子含量、钾离子交换容量及1,2-二氯乙烷残留量均不符合药典要求，而国外样品与自制合成品的以上指标均符合药典要求，且三者钠盐特征性反应呈阳性，铵盐限度和重金属检查均符合药典要求。结论 国外样品、自制合成品可以作为药用辅料应用，而国内市售品不能作为药用辅料被应用。
关键词：药剂学； 聚苯乙烯磺酸钠；药用辅料；质量研究
中图分类号：R94 文献标识码：A
contents
Quality assessment of a new excipient-sodium polystyrene sulfonate
SUN Xi-yang, LIU Hong-fei, ZHANG Shu,CAO Xin-ke, PAN Wei-san
(School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract：Objective To study on the quality of a new excipient- sodium polystyrene sulfonate. Methods According to the methods and the standards provided in USP 24, BP 2000 and of CP 2005(Ⅱ), the quality of sodium polystyrene sulfonate obtained as the foreign sample,the domestic sample and the sample synthesized in the lab was assessed. Results The domestic sample was not accord with the regulations in particle size, water content, sodium content , potassium ion exchange capacity and the residual 1,2-dichloroethane content; while the foreign sample and the sample synthesized in the lab were conformed to the standards mentioned above. All of the three yielded the characteristic reaction of sodium salt, and the limit tests of ammonium salts and heavy metals were all up to the specifications. Conclusions The domestic sample could not be used as parmaceutical grade excipient while the foreign sample and the sample synthesized in the lab could.
Key words：pharmaceutics; sodium polystyrene sulfonate; pharmaceutical grade excipient; quality assessment
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