藻酸双酯钠(PSS)生物效价测定方法的研究  

Study on the bioassay methods of the biological potency of propylene glycol alginate sodium sulfate(PSS)

作　　者：辛萌[1] 何小溪[1] 李海花[1] 杨程[1] 李春霞[1] 管华诗[1] 

机构地区：[1]中国海洋大学海洋药物教育部重点实验室,山东省糖科学与糖工程重点实验室,医药学院

出　　处：《中国海洋药物》2014年第1期65-69,共5页Chinese Journal of Marine Drugs

基　　金：山东省科技发展计划(2011GSF11815);青岛市公共领域科技支撑计划项目(11-2-3-73-jh)资助

摘　　要：目的考察以肝素作为标准品，通过《中国药典》的兔血浆法、《欧洲药典》的活化部分凝血酶时间法和《美国药典》的羊血浆法测定藻酸双酯钠（PSS）生物效价的可行性。方法《中国药典》2010年版兔血浆法、《欧洲药典》6．0版羊血浆活化部分凝血酶时间法、《美国药典》XXXII版羊血浆法测定PSS的抗凝效价。结果肝素做标准品，《中国药典》兔血浆法及《欧洲药典》的羊血浆活化部分凝血酶时间法测定结果均未通过可靠性检验；采用《美国药典》羊血浆法测得不同批号的PSS生物效价在6～13U·mg^-1。结论由于抗凝机制的差异，当采用《中国药典》的兔血浆法、《欧洲药典》的活化部分凝血酶时间法和《美国药典》的羊血浆法进行PSS的效价测定时，肝素不合适作为标准品，应考虑建立能反映其自身凝血特性的标准品。Objective To study the applicability of three methods, the rabbit plasma method of Chinese Pharmacopeia, the activated partial thromboplastin time method of European Pharmacopeia, and the sheep plasma method of United States Pharmacopeia, for determination anticoagulant activity of propylene glycol alginate sodium sulfate （PSS） with heparin as a standard. Methods The rabbit plasma method of Chinese Pharmacopoeia （2010 edition）, the activated partial thromboplastin time method of European Pharmacopeia （6.0 edition） and the sheep plasma method of United States Pharmacopeia （XXXII edition） were utilized to determine the biological potency of PSS. Results The rabbit plasma method of Chinese Pharmacopeia and the sheep plasma method of European Pharmacopeia were out of line with quality requirements of pharmacopeia with heparin as a standard. The biological potency of PSS was 6 -13 U·mg^-1 assayed by the sheep plasma method of United States Pharmacopeia. Conclusion The three assay methods for biological potency of heparin were not applicable to PSS, which indicated that PSS should establish its own standards to reflect its coagulation characteristics.

关 键 词：藻酸双酯钠 兔血浆法 活化部分凝血酶时间法 羊血浆法 肝素 效价 

分 类 号：R92[医药卫生—药学]