目的建立盐酸小檗碱片微生物限度检查方法。方法以《中华人民共和国药典》2015年版四部通则1105、1106、1107具体规定作为检验依据,采用含0.1%聚山梨酯80的p H7.0无菌氯化钠-蛋白胨缓冲液作为稀释液和冲洗液,微生物计数采用平皿法、稀...目的建立盐酸小檗碱片微生物限度检查方法。方法以《中华人民共和国药典》2015年版四部通则1105、1106、1107具体规定作为检验依据,采用含0.1%聚山梨酯80的p H7.0无菌氯化钠-蛋白胨缓冲液作为稀释液和冲洗液,微生物计数采用平皿法、稀释法、薄膜过滤法、稀释-薄膜过滤联用法进行验证,控制菌检查采用常规法、稀释法(200 m L)进行验证。结果该品对金黄色葡萄球菌和枯草芽孢杆菌具有较强抑菌性,对白色念珠菌和黑曲霉具有一定抑制作用,对大肠埃希菌只有微弱抑菌作用;需氧菌总数测定取1∶100稀释级薄膜过滤冲洗、霉菌和酵母菌总数测定取1∶20稀释级薄膜过滤冲洗处理进行试验菌株回收试验,回收率均达到50%~200%,控制菌测定采用稀释法(200 m L)依法检查检出大肠埃希菌。结论该法对类似品种微生物限度检查方法的建立具有指导意义。展开更多
Analyzing polysorbate 20(PS20)composition and the impact of each component on stability and safety is crucial due to formulation variations and individual tolerance.The similar structures and polarities of PS20 compon...Analyzing polysorbate 20(PS20)composition and the impact of each component on stability and safety is crucial due to formulation variations and individual tolerance.The similar structures and polarities of PS20 components make accurate separation,identification,and quantification challenging.In this work,a high-resolution quantitative method was developed using single-dimensional high-performance liquid chromatography(HPLC)with charged aerosol detection(CAD)to separate 18 key components with multiple esters.The separated components were characterized by ultra-high-performance liquid chromatography-quadrupole time-of-flight mass spectrometry(UHPLC-Q-TOF-MS)with an identical gradient as the HPLC-CAD analysis.The polysorbate compound database and library were expanded over 7-time compared to the commercial database.The method investigated differences in PS20 samples from various origins and grades for different dosage forms to evaluate the composition-process relationship.UHPLC-Q-TOF-MS identified 1329 to 1511 compounds in 4 batches of PS20 from different sources.The method observed the impact of 4 degradation conditions on peak components,identifying stable components and their tendencies to change.HPLC-CAD and UHPLC-Q-TOF-MS results provided insights into fingerprint differences,distinguishing quasi products.展开更多
In this work, blank polylactic acid （PLA） nanoparticles with unstained surface were prepared by the nano-deposition method. On the basis of the preparation, the effect of surface modification on brain microvascular ...In this work, blank polylactic acid （PLA） nanoparticles with unstained surface were prepared by the nano-deposition method. On the basis of the preparation, the effect of surface modification on brain microvascular endothelial cells （BMECs） targeting was examined by in vivo experiments and fluorescence microscopy. The results showed that PLA nanoparticles are less toxic than PACA nanoparticles but their BMECs targeting is similar to PACA nanoparticles. The experiments suggest that drugs can he loaded onto the particles and become more stable through adsorption on the surface of PLA nanoparticles with high surface activity. The surface of PLA nanoparticles was obviously modified and the hydrophilicity was increased as well in the presence of non-ionic surfactants on PLA nanoparticles. As a targeting moiety, polysobate 80 （T-80） can facilitate BMECs targeting of PLA nanoparticles.展开更多
We investigated the hydroxyl and saponification values of 27 samples of Polysorbate 60 products that were commercially available worldwide. We observed that the values of most of the studied samples were not within th...We investigated the hydroxyl and saponification values of 27 samples of Polysorbate 60 products that were commercially available worldwide. We observed that the values of most of the studied samples were not within the range established at the Joint FAO/WHO Expert Committee on Food Additives (JECFA), while they did agree with the specifications described in the USA, the EU and Japan. We believe that purities of the new commercial Polysorbate 60 samples are higher than those of the older products which were available when the JECFA specifications were discussed (around 1973). The present study suggests that the hydroxyl and saponification values of the current JECFA specifications for Polysorbate 60 should be re-evaluated.展开更多
Acute hepatitis is a very rare, but potentially fatal, adverse effect of intravenous amiodarone. We present a case of an 88-year-old man with history of ischemic dilated cardiomyopathy and severely depressed left vent...Acute hepatitis is a very rare, but potentially fatal, adverse effect of intravenous amiodarone. We present a case of an 88-year-old man with history of ischemic dilated cardiomyopathy and severely depressed left ventricular function that was admitted to our coronary care unit with diagnosis of decompensated heart failure and non-sustained ventricular tachycardia. A few hours after the beginning of intravenous amiodarone he developed an acute hepatitis. There was a completely recovery within the next days after amiodarone withdrawn and other causes of acute hepatitis have been ruled out. This case highlights the need for close monitoring of hepatic function during amiodarone infusion in order to identify any potential hepatotoxicity and prevent a fatal outcome. Oral amiodarone is, apparently, a safe option in these patients.展开更多
文摘目的建立盐酸小檗碱片微生物限度检查方法。方法以《中华人民共和国药典》2015年版四部通则1105、1106、1107具体规定作为检验依据,采用含0.1%聚山梨酯80的p H7.0无菌氯化钠-蛋白胨缓冲液作为稀释液和冲洗液,微生物计数采用平皿法、稀释法、薄膜过滤法、稀释-薄膜过滤联用法进行验证,控制菌检查采用常规法、稀释法(200 m L)进行验证。结果该品对金黄色葡萄球菌和枯草芽孢杆菌具有较强抑菌性,对白色念珠菌和黑曲霉具有一定抑制作用,对大肠埃希菌只有微弱抑菌作用;需氧菌总数测定取1∶100稀释级薄膜过滤冲洗、霉菌和酵母菌总数测定取1∶20稀释级薄膜过滤冲洗处理进行试验菌株回收试验,回收率均达到50%~200%,控制菌测定采用稀释法(200 m L)依法检查检出大肠埃希菌。结论该法对类似品种微生物限度检查方法的建立具有指导意义。
基金financial support from the Science Research Program Project for Drug Regulation,Jiangsu Drug Administration,China(Grant No.:202207)the National Drug Standards Revision Project,China(Grant No.:2023Y41)+1 种基金the National Natural Science Foundation of China(Grant No.:22276080)the Foreign Expert Project,China(Grant No.:G2022014096L).
文摘Analyzing polysorbate 20(PS20)composition and the impact of each component on stability and safety is crucial due to formulation variations and individual tolerance.The similar structures and polarities of PS20 components make accurate separation,identification,and quantification challenging.In this work,a high-resolution quantitative method was developed using single-dimensional high-performance liquid chromatography(HPLC)with charged aerosol detection(CAD)to separate 18 key components with multiple esters.The separated components were characterized by ultra-high-performance liquid chromatography-quadrupole time-of-flight mass spectrometry(UHPLC-Q-TOF-MS)with an identical gradient as the HPLC-CAD analysis.The polysorbate compound database and library were expanded over 7-time compared to the commercial database.The method investigated differences in PS20 samples from various origins and grades for different dosage forms to evaluate the composition-process relationship.UHPLC-Q-TOF-MS identified 1329 to 1511 compounds in 4 batches of PS20 from different sources.The method observed the impact of 4 degradation conditions on peak components,identifying stable components and their tendencies to change.HPLC-CAD and UHPLC-Q-TOF-MS results provided insights into fingerprint differences,distinguishing quasi products.
文摘In this work, blank polylactic acid （PLA） nanoparticles with unstained surface were prepared by the nano-deposition method. On the basis of the preparation, the effect of surface modification on brain microvascular endothelial cells （BMECs） targeting was examined by in vivo experiments and fluorescence microscopy. The results showed that PLA nanoparticles are less toxic than PACA nanoparticles but their BMECs targeting is similar to PACA nanoparticles. The experiments suggest that drugs can he loaded onto the particles and become more stable through adsorption on the surface of PLA nanoparticles with high surface activity. The surface of PLA nanoparticles was obviously modified and the hydrophilicity was increased as well in the presence of non-ionic surfactants on PLA nanoparticles. As a targeting moiety, polysobate 80 （T-80） can facilitate BMECs targeting of PLA nanoparticles.
文摘We investigated the hydroxyl and saponification values of 27 samples of Polysorbate 60 products that were commercially available worldwide. We observed that the values of most of the studied samples were not within the range established at the Joint FAO/WHO Expert Committee on Food Additives (JECFA), while they did agree with the specifications described in the USA, the EU and Japan. We believe that purities of the new commercial Polysorbate 60 samples are higher than those of the older products which were available when the JECFA specifications were discussed (around 1973). The present study suggests that the hydroxyl and saponification values of the current JECFA specifications for Polysorbate 60 should be re-evaluated.
文摘Acute hepatitis is a very rare, but potentially fatal, adverse effect of intravenous amiodarone. We present a case of an 88-year-old man with history of ischemic dilated cardiomyopathy and severely depressed left ventricular function that was admitted to our coronary care unit with diagnosis of decompensated heart failure and non-sustained ventricular tachycardia. A few hours after the beginning of intravenous amiodarone he developed an acute hepatitis. There was a completely recovery within the next days after amiodarone withdrawn and other causes of acute hepatitis have been ruled out. This case highlights the need for close monitoring of hepatic function during amiodarone infusion in order to identify any potential hepatotoxicity and prevent a fatal outcome. Oral amiodarone is, apparently, a safe option in these patients.
