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直接压片的量热法评估

[Calorimetric evaluation of directly compressed tablets].

作者信息

Rehula M, Lavická J, Musilová M

机构信息

Katedra farmaceutické technologie Farmaceutické fakulty Univerzity Karlovy, Hradec Králové.

出版信息

Ceska Slov Farm. 2001 Jan;50(1):35-7.

Abstract

The paper studies the effect of the type of the disintegrating substance and the lubricant on the destruction heat of tablet materials and tablets. Destruction heat was determined by means of isoperibolic calorimetry. Tablet materials and tablets contained Avicel PH 101 as the dry binder, 10% of Primojel, Ac-Di-Sol, or Polyplasdone XL as disintegrating substances, and 5% of magnesium strearate or sodium laurylsulfate as the lubricants. The sum of destruction heats of the individual auxiliary substances equalled the found values in tablet materials and tablets. In tablets, in contrast to tablet materials, values of destruction heat higher by 57.9% were found. In the disintegrating substances and lubricants tested, the found values of destruction heats were dependent on the values of destruction heats of the individual auxiliary substances. In the disintegrating substances, a linear dependence of the total destruction heat (CDT) on the destruction heat of the disintegrating substances (DTR) was found, given by the relationship CDT = 0.797.DTR + 17.666 with the correlation coefficient r = 0.986.

摘要

本文研究了崩解剂类型和润滑剂对片剂物料及片剂的热分解的影响。热分解通过等温量热法测定。片剂物料和片剂含有作为干黏合剂的微晶纤维素PH 101、10%的预胶化淀粉、乙酰化二淀粉磷酸酯或交联聚维酮作为崩解剂,以及5%的硬脂酸镁或十二烷基硫酸钠作为润滑剂。各辅料的热分解热总和与片剂物料及片剂中的测定值相等。与片剂物料相比,片剂中的热分解热数值高出57.9%。在所测试的崩解剂和润滑剂中,热分解热的测定值取决于各辅料的热分解热数值。在崩解剂中,发现总热分解热(CDT)与崩解剂热分解热(DTR)呈线性关系,关系式为CDT = 0.797·DTR + 17.666,相关系数r = 0.986。

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