目的评估荧光免疫层析法试剂盒检测降钙素原的性能。方法参照美国临床实验室标准化协会(Clinical and Laboratory Standards Institute,CLSI)EP5-A和EP6-A文件方法,对荧光免疫层析法试剂盒(TEBSUN)检测降钙素原的精密度、线性、方法学...目的评估荧光免疫层析法试剂盒检测降钙素原的性能。方法参照美国临床实验室标准化协会(Clinical and Laboratory Standards Institute,CLSI)EP5-A和EP6-A文件方法,对荧光免疫层析法试剂盒(TEBSUN)检测降钙素原的精密度、线性、方法学比对、相对灵敏度和特异性进行评估。结果荧光免疫层析法试剂盒检测降钙素原精密度较好,低浓度和高浓度样本精密度的变异系数分别为8.3%和4.7%;线性验证试验结果显示,在试剂盒标示的检测范围内具有良好的线性梯度关系(r=0.9989);方法学比对结果显示,荧光免疫层析法试剂盒与梅里埃VIDAS酶联免疫荧光法分析系统的降钙素原试剂盒检测结果一致性良好(r=0.9770);在0.5和2.0 ng/ml两个浓度水平,荧光免疫层析法试剂盒相对于酶联免疫荧光法试剂盒的灵敏度和特异性均大于86%,与其测定结果的总体符合率为93.75%。结论荧光免疫层析法试剂盒检测降钙素原的精密度、线性、方法学比对、相对灵敏度和相对特异性等性能评价较好,适用于临床标本检测。展开更多
Carbamazepine(CBZ)is an anticonvulsant with very low water solubility,presenting as a white crystalline powder with poor mechanical properties and is hard to bend.To enhance CBZ's physicochemical properties,such a...Carbamazepine(CBZ)is an anticonvulsant with very low water solubility,presenting as a white crystalline powder with poor mechanical properties and is hard to bend.To enhance CBZ's physicochemical properties,such as water solubility and mechanical properties,we selected six cocrystal coformers(CCFs):nicotinamide(NIC),benzamide(BZM),salicylic acid(SCA),fumaric acid(FMA),trimesic acid(TMA),and hesperetin(HPE).Six CBZ cocrystals were successfully prepared using the solution method.Fourier transform infrared spectroscopy(FT-IR),powder X-ray diffraction(PXRD),differential scanning calorimetry(DSC),and single crystal X-ray diffraction(SCXRD)were used to characterize the crystal structures and gain comprehensive insights into the six cocrystals.The mechanical,fluorescence,and solubility properties of the six cocrystals were tested.The results reveal that most of the prepared cocrystals exhibit improved water solubility and mechanical properties when compared to CBZ.Among them,the dissolution rate of cocrystals excluded from CBZ-HPE has increased by an average of 3 or 4 times compared to CBZ,while CBZ-HPE exhibits superior mechanical properties.Moreover,all six cocrystals possess better fluorescence performance than CBZ.We thoroughly evaluated the mechanical properties of the cocrystals through both experimental and theoretical approaches.This work provides a new direction for studying drug cocrystals to improve the physicochemical properties of drugs.展开更多
基金National Natural Science Foundation of China(grant No.22068002 and 22178054)Training plan for academic and technical leaders of major disciplines in Jiangxi Province-Youth Talent Project(grant No.20212BCj23001)+1 种基金Jiangxi Provincial Natural Science Foundation(grant No.20224ACB213007,20212ACB203002,and 20232BBH80015)Jiangxi Province Key Laboratory of Synthetic Chemistry(grant No.JXSC202209).
文摘Carbamazepine(CBZ)is an anticonvulsant with very low water solubility,presenting as a white crystalline powder with poor mechanical properties and is hard to bend.To enhance CBZ's physicochemical properties,such as water solubility and mechanical properties,we selected six cocrystal coformers(CCFs):nicotinamide(NIC),benzamide(BZM),salicylic acid(SCA),fumaric acid(FMA),trimesic acid(TMA),and hesperetin(HPE).Six CBZ cocrystals were successfully prepared using the solution method.Fourier transform infrared spectroscopy(FT-IR),powder X-ray diffraction(PXRD),differential scanning calorimetry(DSC),and single crystal X-ray diffraction(SCXRD)were used to characterize the crystal structures and gain comprehensive insights into the six cocrystals.The mechanical,fluorescence,and solubility properties of the six cocrystals were tested.The results reveal that most of the prepared cocrystals exhibit improved water solubility and mechanical properties when compared to CBZ.Among them,the dissolution rate of cocrystals excluded from CBZ-HPE has increased by an average of 3 or 4 times compared to CBZ,while CBZ-HPE exhibits superior mechanical properties.Moreover,all six cocrystals possess better fluorescence performance than CBZ.We thoroughly evaluated the mechanical properties of the cocrystals through both experimental and theoretical approaches.This work provides a new direction for studying drug cocrystals to improve the physicochemical properties of drugs.
