CAJ | 학술논문

目的：对注射用头孢他啶中吡啶的检测方法进行研究，为提高该药质量标准、临床配制使用、合理包装贮存及说明书修订等提供参考。方法采用高效液相色谱（HPLC）法，外标以吡啶含量为指标，进行检测方法的线性关系试验、精密度试验及稳定性试验；对样品进行1个月加速试验、影响因素试验，比较该条件下产品质量；对按产品使用说明书中的配制方法配制样品溶液进行稳定性试验，比较头孢他啶中吡啶在不同配制溶液中的含量变化。结果吡啶线性回归方程为Y=168580X-2451，R2=0.9998，在0.0552~0.6619μg内与峰面积线性关系良好；精密度试验吡啶色谱峰面积相对标准偏差（RSD）为0.29%；稳定性试验下，新旧吡啶对照溶液吡啶峰面积RSD为0.40%；影响因素试验，加速1个月试验注射用头孢他啶中吡啶含量均未超出含量限度（0.4%）；3种头孢他啶静脉注射溶液随时间的增加吡啶含量均有增加，避光下含量增加幅度略低于不避光，以生理盐水组增加幅度最小。结论通过试验建立了吡啶的HPLC标准工作曲线进行定量检测，其方法可靠，影响因素及加速试验可为该制剂包装贮存提供参考，3种稀释剂配置的注射液稳定性试验可为提高该药质量标准、临床合理配用、说明书的合理科学制定等提供参考。
목적：대주사용두포타정중필정적검측방법진행연구，위제고해약질량표준、림상배제사용、합리포장저존급설명서수정등제공삼고。방법채용고효액상색보（HPLC）법，외표이필정함량위지표，진행검측방법적선성관계시험、정밀도시험급은정성시험；대양품진행1개월가속시험、영향인소시험，비교해조건하산품질량；대안산품사용설명서중적배제방법배제양품용액진행은정성시험，비교두포타정중필정재불동배제용액중적함량변화。결과필정선성회귀방정위Y=168580X-2451，R2=0.9998，재0.0552~0.6619μg내여봉면적선성관계량호；정밀도시험필정색보봉면적상대표준편차（RSD）위0.29%；은정성시험하，신구필정대조용액필정봉면적RSD위0.40%；영향인소시험，가속1개월시험주사용두포타정중필정함량균미초출함량한도（0.4%）；3충두포타정정맥주사용액수시간적증가필정함량균유증가，피광하함량증가폭도략저우불피광，이생리염수조증가폭도최소。결론통과시험건립료필정적HPLC표준공작곡선진행정량검측，기방법가고，영향인소급가속시험가위해제제포장저존제공삼고，3충희석제배치적주사액은정성시험가위제고해약질량표준、림상합리배용、설명서적합이과학제정등제공삼고。
Objective To study the detection method of pyridine in Ceftazidime for Injection to provide reference for in-creasing its quality standard,clinical dispensing use,rational package and storage,and revision of instruction. Methods The HPLC was adopted and the external standard used the pyridine content as the indicator ,the linear relationship test,precision test and stability test for the detection method were conducted;the 1-month accelerated test and the affecting factors trial were con-ducted for comparing the quality of products under this condition;the sample solution prepared by adopting the methods in the product manual was performed the stability test for comparing the content change of pyridine in different prepared solutions. Re-sults The linear regression equation for pyridine was Y=168 580X-2 451,R2=0.999 8,there was a good linear relationship with peak area within the range of 0.055 2~0.661 9μg;the precision test showed that RSD of pyridine chromatographic peak area was 0.29%;in the stability test,pyridine peak area RSD of the old and new pyridine control solution was 0.40%;in the influence factor tests,the 1-month accelerated tests showed that the pyridine content did not exceed the content limits (0.4%);in three kinds of ceftazidime intravenous solution ,the pyridine content was increased with time ,the content increased range in avoiding light was slightly lower than that without avoiding light ,which in the physiological saline group had smallest increase. Conclusion The established HPLC standard curve of pyridine by tests can be used for the quantitative detection of pyridine;the method is reliable, the influencing factors and accelerated test can provide a reference for the packaging and storage of this preparation;the stability test of injection solution prepared by three kinds of diluents can provide reference for improvement of drug standards and quality control,reasonable clinical use and making reasonable scientific product manual and so on.