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一些应用于阿司匹林片剂的有色和无色水性薄膜包衣的粘附特性。

The adhesion characteristics of some pigmented and unpigmented aqueous-based film coatings applied to aspirin tablets.

作者信息

Okhamafe A O, York P

出版信息

J Pharm Pharmacol. 1985 Dec;37(12):849-53. doi: 10.1111/j.2042-7158.1985.tb04988.x.

Abstract

The adhesion of pigmented (with talc and titanium dioxide) and unpigmented aqueous-based films, derived from hydroxypropyl methylcellulose, to aspirin tablets and the effect of ageing on the measured adhesion have been assessed. The adhesion of hydroxypropyl methylcellulose film attained maximum values at polyethylene glycol 400 and polyvinyl alcohol levels of 10 and 20 wt%, respectively. Above these concentrations, adhesion decreased. For solid loaded films it is proposed that the effect of pigments on film adhesion is dependent on the balance between their influence on the internal stress of the film coating and the strength of the film-tablet interface. Adhesion was enhanced when a pigment increased the strength of the interface faster than it increased internal stress, and vice versa. A simple relation between the measured adhesion and the incidence of edge splitting of film-coated tablets was not observed. Generally, film adhesion fell when the tablets were aged at 37 degrees C and 75% r.h. as a result of swelling-induced stresses in the film and at the film tablet interface. The effect of ageing on the adhesion of the system plasticized with polyethylene glycol 400 was eased when the film was pigmented. Adhesion was largely unaffected with film-coated tablets stored in tightly closed bottles at 20 degrees C for five months.

摘要

对源自羟丙基甲基纤维素的色素沉着(含滑石粉和二氧化钛)及未色素沉着的水基薄膜与阿司匹林片剂的粘附情况,以及老化对所测粘附力的影响进行了评估。羟丙基甲基纤维素薄膜的粘附力在聚乙二醇400和聚乙烯醇含量分别为10 wt%和20 wt%时达到最大值。高于这些浓度时,粘附力下降。对于固体负载薄膜,有人提出颜料对薄膜粘附力的影响取决于其对薄膜包衣内应力的影响与薄膜 - 片剂界面强度之间的平衡。当一种颜料使界面强度增加的速度快于其增加内应力的速度时,粘附力增强,反之亦然。未观察到所测粘附力与薄膜包衣片剂边缘裂开发生率之间的简单关系。一般来说,当片剂在37摄氏度和75%相对湿度下老化时,由于薄膜及薄膜 - 片剂界面处的溶胀诱导应力,薄膜粘附力会下降。当薄膜有色素时,老化对用聚乙二醇400增塑的体系粘附力的影响会减轻。在20摄氏度下密闭保存五个月的薄膜包衣片剂,其粘附力基本不受影响。

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