目的 通過對阿膠顆粒薄膜包衣前后的理化性質(zhì)分析，為阿膠顆粒進行薄膜包衣的必要性、可行性提供理論依據(jù)。方法 通過對阿膠顆粒進行薄膜包衣前后的溶化性、外觀性狀和吸濕性進行對比分析，探討顆粒包衣前后理化性質(zhì)的變化。結(jié)果 薄膜包衣對阿膠的溶化性、外觀性狀的影響比較小，但不同薄膜衣對阿膠顆粒的吸濕性影響比較明顯，其中薄膜包衣預(yù)混劑英依美防潮效果較好，在相對濕度75%條件下84 h的吸濕率為0.84%，而薄膜包衣羥丙基甲基纖維素（HPMC）的吸濕率為0.98%；兩種包衣顆粒的臨界相對濕度無明顯差別，約在70%，但均比未包衣顆粒的臨界相對濕度50%大。結(jié)論 薄膜包衣預(yù)混劑英依美防潮效果較好，且不干擾阿膠顆粒的質(zhì)量，車間環(huán)境的相對濕度控制在約60%可更好地保證產(chǎn)品質(zhì)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.

國家重大新藥創(chuàng)制科技重大專項（2011ZX09201-201-10）