CAJ | 학술논문

目的：评价国内吡诺克辛钠滴眼液的质量现状，并对现行质量标准进行评价与完善。方法按照法定方法结合探索性研究进行样品检验，统计分析检验结果并对吡诺克辛钠滴眼液的质量现状进行评价。结果法定方法检验显示51批样品全部符合规定；通过探索性研究，建立了有关物质检查及渗透压摩尔浓度测定方法。结论吡诺克辛钠滴眼液按法定方法检验合格率100％。通过探索性研究建议提高质量标准，增加有关物质检查及渗透压摩尔浓度测定，以保证吡诺克辛钠滴眼液药品质量。
목적：평개국내필낙극신납적안액적질량현상，병대현행질량표준진행평개여완선。방법안조법정방법결합탐색성연구진행양품검험，통계분석검험결과병대필낙극신납적안액적질량현상진행평개。결과법정방법검험현시51비양품전부부합규정；통과탐색성연구，건립료유관물질검사급삼투압마이농도측정방법。결론필낙극신납적안액안법정방법검험합격솔100％。통과탐색성연구건의제고질량표준，증가유관물질검사급삼투압마이농도측정，이보증필낙극신납적안액약품질량。
Objective To evaluate the quality status and existing problems of Pirenoxine Sodium Eye Drops,and to eval-uate and improve the current quality standard. Methods The quality of Pirenoxine Sodium Eye Drops was evaluated by statis-tieal analysis using statutory testing methods combined with the exploratory researeh. Results The legal method showed that 51 batchs of samples were in conformity with the provisions;Through exploratory research,the related substances examination and the method of measurement the osmotic were established. Conclusion The legal method inspection qualified rate of Pirenoxine Sodium Eye Drops was 100%. Exploratory study suggested that improve the quality standards,and osmotic pressure molar concentration and increase the material inspection,to ensure that actos,sodium eye drops drug quality.