ABSTRACT
Research progress ofpolysorbate 80 was summarized,including standards,chemical composition and impurity test.Assay methods of polysorbate 80 in preparations were also summarized.In addition,characteristics of the current technologies were discussed.Compositions of polysorbate 80 could be detected directly by spectrophotometry,SEC-ELSD or LC-MS methods.In addition,they could be analyzed indirectly by determing the hydrolysates with HPLC-UV or GC methods.In recent years,remarkable progress has been achieved in chemical composition determination and impurity test ofpolysorbate 80.But assay method of the excipient in related drugs need further study,due to large difference between purities ofpolysorbate 80 raw materials.
ABSTRACT
Objective To study the toxic effect ofNiuhuang Zhenjing Pill on zebrafish embryo development.Methods Zebrafish embryo was used to investigate the development situation under stereo microscope at different drug concentration (40,200,400,800,1 200 tg/mL) including embryo teratogenic and lethal tests.Results No abnormal embryo development was found when the concentration was not greater than 200 μg/mL (Approximately equal to 30 times the normal adult dosage,exceeding the normal effective dose).While,there was toxicity to embryo development at the concentration greater than 200 tg/mL.The head and eyes of the embryo were smaller,and the pupils were colorless.Zebrafish embryonic heart malformation was observed,heart rate was weak,blood pool congestion happened and back blood flow was not smooth.The abdominal surface of the embryo was poor in transparency,the tail was twisted,the yolk sac elongation structure became thicker,the notochord became thin,there was no normal embryo movement,and the body length became shorter.After the withdrawal,the abnormal phenotype was not recovered,and severity of the abnormal phenotype was concentration-dependent.It was also observed that all embryos died within 1 d after fertilization at the concentration of 1 200 μg/mL.Conclusion The drug could influence the development of zebrafish embryos when the concentration was higher than 200 tg/mL.Its toxic effect occurs during embryonic organogenesis.And it mainly affects the development of embryonic nervous system,cardiovascular system and bone.
ABSTRACT
Research progress ofpolysorbate 80 was summarized,including standards,chemical composition and impurity test.Assay methods of polysorbate 80 in preparations were also summarized.In addition,characteristics of the current technologies were discussed.Compositions of polysorbate 80 could be detected directly by spectrophotometry,SEC-ELSD or LC-MS methods.In addition,they could be analyzed indirectly by determing the hydrolysates with HPLC-UV or GC methods.In recent years,remarkable progress has been achieved in chemical composition determination and impurity test ofpolysorbate 80.But assay method of the excipient in related drugs need further study,due to large difference between purities ofpolysorbate 80 raw materials.
ABSTRACT
Objective To study the toxic effect ofNiuhuang Zhenjing Pill on zebrafish embryo development.Methods Zebrafish embryo was used to investigate the development situation under stereo microscope at different drug concentration (40,200,400,800,1 200 tg/mL) including embryo teratogenic and lethal tests.Results No abnormal embryo development was found when the concentration was not greater than 200 μg/mL (Approximately equal to 30 times the normal adult dosage,exceeding the normal effective dose).While,there was toxicity to embryo development at the concentration greater than 200 tg/mL.The head and eyes of the embryo were smaller,and the pupils were colorless.Zebrafish embryonic heart malformation was observed,heart rate was weak,blood pool congestion happened and back blood flow was not smooth.The abdominal surface of the embryo was poor in transparency,the tail was twisted,the yolk sac elongation structure became thicker,the notochord became thin,there was no normal embryo movement,and the body length became shorter.After the withdrawal,the abnormal phenotype was not recovered,and severity of the abnormal phenotype was concentration-dependent.It was also observed that all embryos died within 1 d after fertilization at the concentration of 1 200 μg/mL.Conclusion The drug could influence the development of zebrafish embryos when the concentration was higher than 200 tg/mL.Its toxic effect occurs during embryonic organogenesis.And it mainly affects the development of embryonic nervous system,cardiovascular system and bone.