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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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不同来源试验系应用于肝素生物效价测定法的差异考察___

Assay on differences of heparin on various plasma

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出版年·卷·期(页码):2010,30 (4):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

 
目的:通过比较不同来源的血浆作为试验系,应用于肝素生物效价测定法的差异,评价适用于肝素生物效价测定法的试验系。方法:参考英国药典(BP2008)以血凝仪测定活化部分凝血活酶时间(APTT)的方法,通过比较凝血时间和效价测定的回收率,对不同来源、不同处理方法的血浆应用于肝素生物效价测定法的优劣进行评价。结果:以新鲜兔血浆、新鲜绵羊血浆、冷冻绵羊血浆、新鲜猪血浆、冷冻猪血浆、新鲜大鼠血浆、冷冻人血浆为试验系分别进行肝素生物效价的测定,结果的可靠性检验均符合要求,线性回归显著(P<0.01),偏离平行、二次曲线、反向二次曲线均不显著(P>0.05);平均回收率(%,n=3)分别为99.41±1.02,100.47±3.48,100.71±0.89,100.12±1.51,102.40±0.22,100.84±1.06,103.02±1.37;平均可信限率(FL%,n=3)分别为2.63±0.21,5.03±1.33,4.90±0.37,9.56±1.95,4.04±0.79,10.69±4.18,4.92±2.41。结论:新鲜兔血浆和冷冻绵羊血浆应用于肝素生物效价测定法稳定性好,测得效价准确,精密性高,较其他来源血浆更适宜作为肝素生物效价测定法的试验系。
 

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To evaluate the best experimental system of the seven kinds of plasma for the assay of heparin. Methods: Coagulometer was used in the assay of activated partial thromboplastin time (APTT) as the British Pharmacopoeia (BP2008). Different plasma used in biological assay of heparin was evaluated by clotting time and the average recovery rate of heparin standard. Results: The reliability tests of the assays on fresh rabbit plasma, fresh sheep plasma, frozen sheep plasma, fresh pig plasma, frozen pig plasma, fresh rat plasma and frozen human plasma were all passed. The linear regression was significant (P<0.01). The parallel deviation, the conic curve and the reverse conic curve were not significant (P>0.05). The average recovery rates (%, n=3) of heparin on the seven kinds of plasma were 99.41±1.02, 100.47±3.48, 100.71±0.89, 100.94±0.71, 102.40±0.22, 100.84±1.06 and 101.55±3.16. The average FL% (%, n=3) were 2.63±0.21, 5.03±1.33, 4.90±0.37, 10.55±1.32, 4.04±0.79, 10.69±4.18, 7.81±0.35. Conclusion: Both the assays of heparin on fresh rabbit plasma and frozen sheep plasma are stable, accurate and precise. Fresh rabbit plasma and frozen sheep plasma are much better to be the experimental system of the biological assay of heparin than others.

-----参考文献:---------------------------------------------------------------------------------------
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