CAJ | 학술논문

目的：针对现行《中国药典》附录中使用的肝素生物测定法的血浆法方法学进行改进。方法：选用肝素钠国家标准品和肝素钠注射液1批，采用1∶1氯化钠注射液稀释的兔血浆，用血小板聚集凝血因子分析仪，按《中国药典》2010年版二部附录XⅡ B方法对肝素钠标准品和肝素钠注射液的凝结时间进行测定。结果：已知靶值的标准品效价的回收率为98.88%~101.86%，肝素钠注射液加样回收率为102.30%~103.60%。结论：该肝素测定方法操作简单，终点客观，重现性和准确性好，可信限满足要求，推荐使用该方法作为肝素生物效价测定方法。
목적：침대현행《중국약전》부록중사용적간소생물측정법적혈장법방법학진행개진。방법：선용간소납국가표준품화간소납주사액1비，채용1∶1록화납주사액희석적토혈장，용혈소판취집응혈인자분석의，안《중국약전》2010년판이부부록XⅡ B방법대간소납표준품화간소납주사액적응결시간진행측정。결과：이지파치적표준품효개적회수솔위98.88%~101.86%，간소납주사액가양회수솔위102.30%~103.60%。결론：해간소측정방법조작간단，종점객관，중현성화준학성호，가신한만족요구，추천사용해방법작위간소생물효개측정방법。
Objective:To improve the plasma method for biological assay of heparin based on China Pharmacopeia currently in effect.Methods:National standard compound of heparin and a batch of sodium heparin injection were chosen, and the coagulation time of the standard heparin and heparin injection was tested by platelet aggregation and coagulation analyzer using 1∶1 diluted rabbit plasma with sodium chloride injection, according to the method collected in appendix XII B of China Pharmacopeia Volume II (version 2010) .Results: Compared with the standard target potency, the recovery rate of the standard was in the range of 98.88%~101.86%, while the recovery rate of the sodium heparin injection was in the range of 102.3%~103.6%.Conclusion:This new method for heparin determination is easy to operate, with objective end-point high accuracy and repetitiveness, and the conifdence limits meet the requirement, we therefore suggest this new method as the improved method for biological assay of heparin.