Development of a new evaluation method for gelatin film sheets

Development of a new evaluation method for gelatin film sheets
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DOI:
10.1016/j.ijpharm.2013.11.012
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发表时间:
2014-01-30
影响因子:
5.8
通讯作者:
Nakashima, Kenichiro
Nakashima, Kenichiro
中科院分区:
医学2区
文献类型:
--
作者:
Kamiya, Seitaro;Nagae, Kazunori;Nakashima, Kenichiro

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在用旋转模法制备的软胶囊中,经常使用明胶薄膜片来形成壳。当使用明胶以外的材料时,膜片性能的检查是非常重要的。我们研究了明胶膜片的宽度与抗张强度之间的关系,以建立所需的明胶膜片的指标。制备明胶膜片后4min和15min的线性回归系数(R)分别为0.9858和0.9167。这些结果表明,随着明胶膜片宽度的增加,明胶的抗拉强度降低。随后,我们考察了时间与抗拉强度之间的关系。我们观察到了新的现象:明胶薄膜的拉伸强度随着时间的延长而增加,经历了两个阶段。第一相对应于4、8、15min的过相变点,第二相对应于15、30、60min的欠相变点。R值分别为0.9952(4、8、15min)和0.9494(15、30、60min)。(C)2014爱思唯尔B.V.保留所有权利。
Gelatin film sheets are often used to form the shell in soft capsules prepared using the rotary die method. Examination of the film sheet properties is extremely important when materials other than gelatin are used.We examined the relationship between the width and the tensile strength of the gelatin film sheet in order to establish the required indexes of the gelatin film sheets. The coefficients of correlation (R) of the linear regressions 4 and 15 min after preparation of the gelatin film sheets were 0.9858 and 0.9167, respectively. These results suggest that the tensile strength decreased when the width of the gelatin film sheet increased. Subsequently, we examined the relationship between time and the tensile strength. We observed new phenomenon: the tensile strength of the gelatin sheets increased with time, following two phases. The first phase corresponded to over phase transition point at 4, 8, and 15 min and the second phase corresponded to under transition point at 15, 30, and 60 min. The R values were 0.9952 (4, 8, 15 min) and 0.9494 (15, 30, 60 min). (C) 2014 Elsevier B.V. All rights reserved.