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薄膜包衣硫酸锌片及湿度对片剂性质的影响

Film-coated zinc sulphate tablets and the effect of humidity on tablet properties.

作者信息

Gürsoy A, Akbuğa J

出版信息

Pharmazie. 1986 Aug;41(8):575-8.

PMID:3786379
Abstract

Preparation of film-coated zinc sulphate tablets and the effect of relative humidity and aging on the physical properties of these coated tablets were investigated in this study. Shellac; Eudragit E and L, hydroxypropyl methylcellulose (HPMC) and HPMC-Eudragit E mixture were used as film-forming materials. As zinc sulphate has efflorescent properties, the effect of humidity on the coated tablets was studied and physical stability tests were carried out. Coated tablets were kept in bottles and in open petri-dishes at different relative humidities (30, 55 and 85%) at room temperature over 12 weeks, and the weight loss, hardness, and disintegration times of these tablets were followed. Findings indicated that film-coated zinc sulphate tablets having good tablet quality can be prepared using the formulations (F-VI) HPMC-Eudragit E mixture and (F-III) Eudragit E as coating materials. Thus, the effect of relative humidity on tablet properties can be reduced.

摘要

本研究考察了薄膜包衣硫酸锌片的制备以及相对湿度和老化对这些包衣片物理性质的影响。使用虫胶、丙烯酸树脂E和L、羟丙基甲基纤维素(HPMC)以及HPMC-丙烯酸树脂E混合物作为成膜材料。由于硫酸锌具有风化特性,研究了湿度对包衣片的影响并进行了物理稳定性试验。将包衣片置于瓶中以及在室温下不同相对湿度(30%、55%和85%)的开放式培养皿中保存12周,跟踪这些片剂的失重、硬度和崩解时间。结果表明,使用配方(F-VI)HPMC-丙烯酸树脂E混合物和(F-III)丙烯酸树脂E作为包衣材料可制备出具有良好片剂质量的薄膜包衣硫酸锌片。因此,可降低相对湿度对片剂性质的影响。

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