Roxin P, Karlsson A, Singh S K
Dept. of Pharmaceutical Analytical Chemistry, Pharmacia and Upjohn AB, Uppsala, Sweden.
Drug Dev Ind Pharm. 1998 Nov;24(11):1025-41. doi: 10.3109/03639049809089946.
Cellulose acetate phthalate (CAP) is a commonly used enteric coating polymer. CAP powder has been studied by various methods to determine characteristics that have an influence on its functionality. While some of the parameters are well known, such as free-acid content and substituent composition, new methods have been developed to examine them. Other characteristics, such as the molecular mass distribution, have not been reported earlier. Fourier transform infrared spectroscopy (FTIR), nuclear magnetic resonance (NMR), and thermal analysis have also been performed on fresh samples, as well as samples stored under various temperature and humidity conditions. Humidity is by far a more critical storage parameter than temperature, although the two act in conjunction; high humidity is more deleterious to the functionality of the polymer than high temperature. Functionality in this case is taken to be determined by the substituents and by the molecular mass distribution. Mass-average molecular mass of a number of batches of the polymer has been measured and ranges around 48 kg/mol with a degree of polydispersity of 1.6. A method to perform a rough estimation of the molecular mass of CAP has also been suggested based on knowledge of the substituent content. It may be possible to use the values of
醋酸纤维素邻苯二甲酸酯(CAP)是一种常用的肠溶包衣聚合物。人们已通过各种方法对CAP粉末进行了研究,以确定影响其功能的特性。虽然一些参数是众所周知的,如游离酸含量和取代基组成,但也已开发出新方法来检测它们。其他特性,如分子量分布,此前尚未见报道。还对新鲜样品以及在各种温度和湿度条件下储存的样品进行了傅里叶变换红外光谱(FTIR)、核磁共振(NMR)和热分析。湿度是迄今为止比温度更关键的储存参数,尽管二者相互作用;高湿度对聚合物功能的损害比高温更大。在这种情况下,功能被认为由取代基和分子量分布决定。已测量了多批该聚合物的质均分子量,其范围约为48 kg/mol,多分散度为1.6。还基于取代基含量的知识提出了一种对CAP分子量进行粗略估计的方法。对于相同粘度等级的任何其他批次的CAP,有可能使用此处获得的