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猪羊兔血浆应用于APTT法测定肝素钠效价的可行性分析

Feasibility study of porcine,sheep and rabbit plasma in heparin potency test by APTT

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【作者】 张媛刘倩吴彦霖贺庆高华

【Author】 ZHANG Yuan;LIU Qian;WU Yan-lin;HE Qing;GAO Hua;National Institutes for Food and Drug Control;

【机构】 中国食品药品检定研究院

【摘要】 目的:比较冻存猪、羊、兔血浆及新鲜兔血浆4种来源血浆试验系统是否适用于活化部分凝血活酶时间法(APTT法)测定肝素钠生物效价。方法:参考英国药典APTT方法,以血凝仪测定血浆凝固时间,考察不同来源血浆APTT法的线性范围、凝血时间重复性、测定肝素钠效价的可靠性、精密度以及冻存血浆复融后使用时间。结果:4种不同来源血浆APTT法均具有良好的线性关系(r>0.99),使用APTT法测定肝素钠生物效价均可通过可靠性检验且具有较好的精密度。结论:4种血浆均可用于APTT法测定肝素钠生物效价,且3种冻存血浆复融后均可在24 h内使用。

【Abstract】 Objective: To determine the feasibility of frozen porcine,sheep,rabbit plasma and fresh rabbit plasma in the test of heparin potency using activated partial thromboplastin time method( APTT method). Methods: Referring to APTT method in British Pharmacopoeia,the coagulation time was analyzed by coagulometer to study the linearity range,repeatability,reliability,precision of APTT,as well as the expiration time of frozen plasma. Results: There was a good linear relationship of APTT in all the 4 different plasma systems( r > 0. 99). The test of heparin potency by APTT method showed high reliability and precision. Conclusion: All of the 4 different plasma can be applied in APTT method to analyze the heparin potency. The 3 frozen plasma can be used after thawing within 24 hours.

  • 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2014年08期
  • 【分类号】R446.1
  • 【下载频次】131
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