CAJ | 학술논문

目的：建立血栓通注射液指纹图谱及多成分定量快检的方法。方法采用填料粒度细、长度短的快速分析柱，用常规HPLC建立快检方法，进行方法学考察，并将测得结果与国标方法进行比较。结果指纹图谱方法的精密度、稳定性、重复性良好，测得相似度均符合标准；多成分定量的线性、检出限、定量限、精密度、稳定性、重复性和回收率良好，且定量检测结果与国标方法很接近，表明本方法准确可靠。结论建立的方法能用于血栓通注射液指纹图谱和多成分定量的快速测定、在实际工作中容易推广，不仅能提高检验效率，还可以减少有机溶剂用量。
목적：건립혈전통주사액지문도보급다성분정량쾌검적방법。방법채용전료립도세、장도단적쾌속분석주，용상규HPLC건립쾌검방법，진행방법학고찰，병장측득결과여국표방법진행비교。결과지문도보방법적정밀도、은정성、중복성량호，측득상사도균부합표준；다성분정량적선성、검출한、정량한、정밀도、은정성、중복성화회수솔량호，차정량검측결과여국표방법흔접근，표명본방법준학가고。결론건립적방법능용우혈전통주사액지문도보화다성분정량적쾌속측정、재실제공작중용역추엄，불부능제고검험효솔，환가이감소유궤용제용량。
Objective To establish a method of fingerprint and rapid multi-component determination for Xueshuantong injection. Methods Conventional HPLC was performed on a fast short analytical column with fine granularity, and the methodology was evaluated. The measured results were compared with the national standard method. Results The fingerprint showed good precision, stability and repeatability. The similarity was in line with the standards. The linearity, limit of detection, limit of quantification, precision, stability, repeatability and recovery test of the multi-component determination showed good results, and the quantitative results were very close to the national standard method. This method was accurate and reliable. Conclusion The method could be used for Xueshuantong injection′s fingerprint and rapid determination, which was easily applied in practical work. It could not only improve the inspection efficiency, but also reduce the use of organic solvents.