米诺地尔乳酸盐的制备及质量评价  

Preparation and Quality Evaluation of Minoxidil Lactate

作　　者：柏翔 张帅 刘青锋 贺敦伟 施斌 BAI Xiang;ZHANG Shuai;LIU Qingfeng;HE Dunwei;SHI Bin(School of Medicine and Pharmacy,Ocean University of China,Qingdao 266003,China;HQ Pharma(Shanghai)Co.,Ltd.,Shanghai 201807,China)

机构地区：[1]中国海洋大学医药学院,山东青岛266003 [2]上海则正医药科技股份有限公司,上海201807

出　　处：《生物化工》2025年第1期75-79,共5页Biological Chemical Engineering

摘　　要：为改善米诺地尔溶解性差的问题,采用反溶剂法制备了米诺地尔乳酸盐——一种新盐型物质。利用粉末X-射线衍射、差示扫描量热、热重分析以及核磁共振氢谱法对该盐进行表征,并检测了该盐的溶解度、有关物质及体外透皮速率,且与米诺地尔进行了比较。结果表明,米诺地尔和乳酸以1∶1(摩尔比)成盐。米诺地尔乳酸盐在pH值为3.0和4.0条件下的溶解度高于米诺地尔;米诺地尔乳酸盐的固体稳定性优于米诺地尔;米诺地尔乳酸盐的24 h累积渗透量是米诺地尔的1.46倍。本研究制备的米诺地尔乳酸盐整体上优于米诺地尔,可为生发产品的开发提供更多的可能性。In order to improve the problem of poor solubility of minoxidil,minoxidil lactate,a new salt-type substance,is prepared by antisolvent method.The salt is characterized by powder X-ray diffraction,differential scanning heat,thermogravimetric analysis and nuclear magnetic resonance hydrogen spectroscopy.The solubility of the salt,the substances and the in vitro transdermal rate are tested and compared with minoxidil.The results show that minoxidil and lactate are salted in a molar ratio of 1∶1.The solubility of minoxidil lactate is higher than that of minoxidil at pH value 3.0 and 4.0,the solid stability of minoxidil lactate is better than that of minoxidil,and the 24 h cumulative permeability of minoxidil lactate is 1.46 times that of minoxidil.The minoxidil lactate prepared in this study is generally superior to minoxidil,which can provide more possibilities for the development of hair growth products.

关 键 词：米诺地尔乳酸盐 米诺地尔 乳酸 制备 质量评价 

分 类 号：R986[医药卫生—药品]