摘要
目的建立盐酸鲁拉西酮的含量测定方法,并对盐酸鲁拉西酮-莽草酸共无定形体系的稳定性进行研究。方法采用溶剂法(真空减压旋转蒸发法)制备得到3种摩尔比为1∶1,1∶2及2∶1的共无定形盐酸鲁拉西酮-莽草酸,采用熔点仪、偏光显微镜、HPLC、PXRD等方法对共无定形盐酸鲁拉西酮-莽草酸进行了理化性质的考察。结果制备的3种共无定形盐酸鲁拉西酮-莽草酸中以摩尔比为1∶2的共无定形最为稳定。结论通过提高莽草酸的比例,可以在一定程度上提高共无定形的稳定性。
OBJECTIVE To establish a method for the determination of lurasidone hydrochloride and to study the stability of the lurasidone hydrochloride-shikimic acid coamorphous system.METHODS Three kinds of coamorphous lurasidone hydrochloride-shikimic acid with molar ratios of 1∶1,1∶2 and 2∶1 were prepared by the solvent method(vacuum and reduced pressure rotary evaporation method),using melting point instrument and polarizing microscope.The physical and chemical properties of the coamorphous lurasidone hydrochloride-shikimic acid were investigated by methods such as HPLC and PXRD.RESULTS Among the three prepared coamorphous lurasidone-shikimic acid,the coamorphous one with a molar ratio of 1∶2 was the most stable.CONCLUSION By increasing the ratio of shikimic acid,the stability of the coamorphous form can be improved.
作者
卢山
邢天嫣
胡义
薛大权
李彬
肖学成
LU Shan;XING Tianyan;HU Yi;XUE Daquan;LI Bin;XIAO Xuecheng(School of Pharmacy,Hubei University of Chinese Medicine,Wuhan 430065,China)
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2021年第20期2505-2511,共7页
Chinese Journal of Modern Applied Pharmacy
关键词
盐酸鲁拉西酮
莽草酸
共无定形
稳定性
lurasidone hydrochloride
shikimic acid
coamorphous
stability
