阿胶颗粒薄膜包衣前后的理化性质研究  

Physicochemical properties of Ejiao Granules before and after film-coating

作　　者：田守生[1] 牛伟霞[1] 张淹[1] 张路[1] 王春艳[1] 

机构地区：[1]山东东阿阿胶股份有限公司国家胶类中药工程技术研究中心,山东东阿252201

出　　处：《现代药物与临床》2014年第3期248-250,共3页Drugs & Clinic

基　　金：国家重大新药创制科技重大专项(2011ZX09201-201-10)

摘　　要：目的通过对阿胶颗粒薄膜包衣前后的理化性质分析,为阿胶颗粒进行薄膜包衣的必要性、可行性提供理论依据。方法通过对阿胶颗粒进行薄膜包衣前后的溶化性、外观性状和吸湿性进行对比分析,探讨颗粒包衣前后理化性质的变化。结果薄膜包衣对阿胶的溶化性、外观性状的影响比较小,但不同薄膜衣对阿胶颗粒的吸湿性影响比较明显,其中薄膜包衣预混剂英依美防潮效果较好,在相对湿度75%条件下84 h的吸湿率为0.84%,而薄膜包衣羟丙基甲基纤维素(HPMC)的吸湿率为0.98%;两种包衣颗粒的临界相对湿度无明显差别,约在70%,但均比未包衣颗粒的临界相对湿度50%大。结论薄膜包衣预混剂英依美防潮效果较好,且不干扰阿胶颗粒的质量,车间环境的相对湿度控制在约60%可更好地保证产品质量。Objective To study the physicochemical properties of Ejiao Granules before and after coating, and to provide theoretical basis for the necessity and feasibility of film-coating. Methods By contrastive analysis of solubility, appearance, and hygroscopicity of Ejiao Granules before and after film-coating, the changes of physicochemical property were investigated. Results Film-coating had few effect on the solubility and appearance while various types of film-coating materials had obvious effect on hygroscopicity. The film coated premix Sirma had the better effects. The hygroscopicity rate of premix Sirma was 0.84% under the relative humidity of 75% for 84 h, and that of film coated hydroxypropyl methyl cellulose（HPMC） was 0.98%. There was no significant difference between the critical relative humidity of two kinds of coated Ejiao Granules which was about 70%. But they were higher than those of uncoated Ejiao Granules with the critical relative humidity of 50%. Conclusion The film coated premix Sirma has better moisture proofing effect and no difference on the quality of Ejiao Granules. And the 60% relative humidity of workshop environment would ensure the qualities of products.

关 键 词：阿胶颗粒 薄膜包衣 英依美 羟丙基甲基纤维素 理化性质 吸湿性 

分 类 号：R283.6[医药卫生—中药学] R286.0[医药卫生—中医学]