目的:建立反相高效液相色谱法分离测定盐酸右美托咪定及其有关物质。方法:采用Welch Ultimate AQ C18(250 mm×4.6 mm,3μm)为色谱柱,柱温35℃;以乙腈-磷酸盐缓冲液为流动相,进行梯度洗脱;流速为1.0 m L·min^(-1);检测波长为22...目的:建立反相高效液相色谱法分离测定盐酸右美托咪定及其有关物质。方法:采用Welch Ultimate AQ C18(250 mm×4.6 mm,3μm)为色谱柱,柱温35℃;以乙腈-磷酸盐缓冲液为流动相,进行梯度洗脱;流速为1.0 m L·min^(-1);检测波长为220nm。结果:盐酸右美托咪定与各已知杂质及强制破坏产生的降解产物均分离良好;杂质A、B、C、D、E、F和G在各自的线性范围内质量浓度与峰面积呈良好的线性关系(r≥0.999 5,n=6),且校正因子(相对于盐酸右美托咪定)分别为1.73、1.55、0.98、1.45、0.92、0.98、1.04;上述杂质的平均回收率(n=9)分别为116.7%、100.4%、102.6%、92.0%、108.1%、109.0%、84.2%,RSD分别为2.0%、1.3%、1.8%、7.2%、1.4%、2.3%、2.1%;精密度试验RSD(n=6)分别为1.7%、0.55%、0.41%、1.8%、0.46%、0.76%、0.50%。经检测表明,3批终产品均未检出杂质,粗品中主要杂质为杂质C(同分异构体)和杂质F(C4,C5-二烷基化物)。结论:本法经方法学验证,可用于盐酸右美托咪定有关物质的检测。展开更多
Complement deficiencies are uncommon types of primary immunodeficiency. Necrotizing fasciitis is a rare complication in pregnancy characterized by soft tissue invasion and necrosis of the subcutaneous and other adjace...Complement deficiencies are uncommon types of primary immunodeficiency. Necrotizing fasciitis is a rare complication in pregnancy characterized by soft tissue invasion and necrosis of the subcutaneous and other adjacent tissues, leading to high mortality rates. We report a case of a 29-year-old pregnant woman with functional deficiency of the C4 complement component and short uterine cervix. Admitted at the hospital with preterm labor, she received multiple doses of immunoglobulin. After 8 weeks, she had a premature membrane rupture, and due to pelvic presentation she had a cesarean. The patient presented multiple obstetric complications, such as operative wound infection, endometritis, sepsis, necrotizing fasciitis and pelvic septic thrombophlebitis. She underwent multiple antimicrobial schemes, a hysterectomy and 4 extensive debridements of the abdominal wall because of significant necrosis. She stayed at the hospital for 101 days (32 of those in ICU in immediate postpartum). 41 days after cesarean, patient was discharged in good conditions. Our case emphasizes individual handling and high multiple doses of immunoglobulin for favorable outcome of the case.展开更多
文摘目的:建立反相高效液相色谱法分离测定盐酸右美托咪定及其有关物质。方法:采用Welch Ultimate AQ C18(250 mm×4.6 mm,3μm)为色谱柱,柱温35℃;以乙腈-磷酸盐缓冲液为流动相,进行梯度洗脱;流速为1.0 m L·min^(-1);检测波长为220nm。结果:盐酸右美托咪定与各已知杂质及强制破坏产生的降解产物均分离良好;杂质A、B、C、D、E、F和G在各自的线性范围内质量浓度与峰面积呈良好的线性关系(r≥0.999 5,n=6),且校正因子(相对于盐酸右美托咪定)分别为1.73、1.55、0.98、1.45、0.92、0.98、1.04;上述杂质的平均回收率(n=9)分别为116.7%、100.4%、102.6%、92.0%、108.1%、109.0%、84.2%,RSD分别为2.0%、1.3%、1.8%、7.2%、1.4%、2.3%、2.1%;精密度试验RSD(n=6)分别为1.7%、0.55%、0.41%、1.8%、0.46%、0.76%、0.50%。经检测表明,3批终产品均未检出杂质,粗品中主要杂质为杂质C(同分异构体)和杂质F(C4,C5-二烷基化物)。结论:本法经方法学验证,可用于盐酸右美托咪定有关物质的检测。
文摘Complement deficiencies are uncommon types of primary immunodeficiency. Necrotizing fasciitis is a rare complication in pregnancy characterized by soft tissue invasion and necrosis of the subcutaneous and other adjacent tissues, leading to high mortality rates. We report a case of a 29-year-old pregnant woman with functional deficiency of the C4 complement component and short uterine cervix. Admitted at the hospital with preterm labor, she received multiple doses of immunoglobulin. After 8 weeks, she had a premature membrane rupture, and due to pelvic presentation she had a cesarean. The patient presented multiple obstetric complications, such as operative wound infection, endometritis, sepsis, necrotizing fasciitis and pelvic septic thrombophlebitis. She underwent multiple antimicrobial schemes, a hysterectomy and 4 extensive debridements of the abdominal wall because of significant necrosis. She stayed at the hospital for 101 days (32 of those in ICU in immediate postpartum). 41 days after cesarean, patient was discharged in good conditions. Our case emphasizes individual handling and high multiple doses of immunoglobulin for favorable outcome of the case.
