粉剂中药物理化性质的研究及制剂特性评价。

T. Hanawa, K. Kawata, Rie Ueda, A. Ito, M. Ohkuma, S. Nakajima
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引用次数: 0

摘要

卡马西平(CBZ)片(Tegretol®片;采用x射线衍射、差示扫描量热法和傅里叶变换红外分光光度法对卡马西平的理化性质进行了研究。采用Teg-tab研磨法制备研磨样品。使用电动磨片机或玛瑙研钵和杵。研磨前后CBZ的结晶度没有变化。在电子磨片机制备的地面样品的红外光谱中,观察到一个峰移,表明CBZ与其辅料之间存在分子相互作用。与Tegretol®细颗粒或玛瑙臼杵研磨样品相比,电子研磨机研磨样品中CBZ的溶出速度更快。通过对磨样平均直径的测量,发现磨样溶解行为的差异是由于磨样的平均直径不同,即磨时间延长,磨样的平均直径越小,CBZ溶解越快。此外,还对地面样品的分配特性进行了评价。因此,我们观察到,地面样品的点胶特性可能在很大程度上取决于地面样品的微观特性,如体积密度、可压缩性和均匀性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Investigation of the Physicochemical Properties of Medicine in the Ground Tablets and the Evaluation for Dispensing Characteristics of Ground Tablets.
The effect of grinding of the carbamazepine (CBZ) tablets (Tegretol® tablet; Teg-tab.) on the physicochemical properties of carbamazepine was investigated using X-ray diffraction, differential scanning calorimetric and fourier transform infrared spectrophotometric measurements. The ground samples were prepared by grinding Teg-tab. using an electrical tablet grinder or an agate mortar and pestle. There were no changes in the crystallinity of CBZ before and after grinding. In the infrared spectra of the ground sample prepared by the electrical tablet grinder, a peak shift suggesting a molecular interaction between CBZ and its excipients were observed. The dissolution rates of CBZ from the ground samples prepared by using an electrical tablet grinder were faster than those of Tegretol® fine granules or the ground samples prepared using the agate mortar and pestle. According to the measurements of the mean diameters of the ground samples, the differences in the dissolution behavior of the ground samples were due to the mean diameter of the ground samples, namely, the smaller the mean diameter by the elongation of the grinding time, the faster the CBZ dissolved. Furthermore, the dispensing characteristics of the ground samples were evaluated. As a result, the dispensing characteristics of the ground samples were observed to possibly greatly depend upon the micromeritical properties of the ground samples, such as the bulk density, compressibility and uniformity.
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