| 引用本文: | 卢山,邢天嫣,胡义,薛大权,李彬,肖学成.共无定形盐酸鲁拉西酮-莽草酸的稳定性研究[J].中国现代应用药学,2021,38(20):2505-2511. |
| LU Shan,XING Tianyan,HU Yi,XUE Daquan,LI Bin,XIAO Xuecheng.Investigation on the Stability of Coamorphous Lurasidone Hydrochloride-shikimic Acid[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(20):2505-2511. |
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| 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。 |
| 关键词: 盐酸鲁拉西酮 莽草酸 共无定形 稳定性 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.20.005 |
| 分类号:R917.101 |
| 基金项目: |
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| Investigation on the Stability of Coamorphous Lurasidone Hydrochloride-shikimic Acid |
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LU Shan, XING Tianyan, HU Yi, XUE Daquan, LI Bin, XIAO Xuecheng
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School of Pharmacy, Hubei University of Chinese Medicine, Wuhan 430065, China
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| Abstract: |
| 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. |
| Key words: lurasidone hydrochloride shikimic acid coamorphous stability |
