CAJ | 학술논문

目的：以利巴韦林为研究对象，研制具有可溯源和量值传递功能的国家级计量有证标准物质，并建立有效定值分析方法。方法采用差示扫描量热法（ DSC）对利巴韦林纯度标准物质进行均匀性和稳定性检验；采用DSC和高效液相色谱（ HPLC）法中两种不同原理方法联合定值，建立不确定度评估的数学模型。结果利巴韦林纯度标准物质具有良好的均匀性和稳定性，纯度标准值和不确定度值为（99.5±0.4）％（k=2，P=0.95）。结论研制的利巴韦林纯度标准物质属国家一级有证计量标准物质（ GBW09587），该标准物质可作为量值溯源与量值传递的计量器具，其研究结果可为我国药品质量控制提供标准物质、物质标准与标准方法，实现与国际接轨目标。
목적：이리파위림위연구대상，연제구유가소원화량치전체공능적국가급계량유증표준물질，병건립유효정치분석방법。방법채용차시소묘량열법（ DSC）대리파위림순도표준물질진행균균성화은정성검험；채용DSC화고효액상색보（ HPLC）법중량충불동원리방법연합정치，건립불학정도평고적수학모형。결과리파위림순도표준물질구유량호적균균성화은정성，순도표준치화불학정도치위（99.5±0.4）％（k=2，P=0.95）。결론연제적리파위림순도표준물질속국가일급유증계량표준물질（ GBW09587），해표준물질가작위량치소원여량치전체적계량기구，기연구결과가위아국약품질량공제제공표준물질、물질표준여표준방법，실현여국제접궤목표。
Objective To develop the ribavirin purity certified reference material( CRM ) which has measurement traceability and high accuracy,and establish an effective method of evaluation. Methods The homogeneity and the stability were checked by differential scanning calorimetry(DSC). High performance liquid chromatography(HPLC)and DSC methods were used for purity determination of ribavirin. Results Ribavirin showed satisfactory homogeneity and stability. The certified value of ribavirin was 99. 5%with an uncertainty of 0. 4%(k=2,P=0. 95). Conclusion Ribavirin purity CRM obtained in this paper has been proven to be a national primary CRM with high accuracy and traceability,which can be used to validate analytical methods,improve the accuracy of measurement data,establish meteorological traceability of analytical results as well as control the quality of ribavirin in the pharmaceutical industry.