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聚对硝酸甘油的吸附作用及单位剂量包装中模制硝酸甘油片剂的稳定性

Polymer sorption of nitroglycerin and stability of molded nitroglycerin tablets in unit-dose packaging.

作者信息

Pikal M J, Bibler D A, Rutherford B

出版信息

J Pharm Sci. 1977 Sep;66(9):1293-7. doi: 10.1002/jps.2600660922.

Abstract

The sorption of nitroglycerin by thermoplastic polymers and the stability of molded nitroglycerin tablets in strip packaging were studied. The polymers investigated varied greatly in their affinity for nitroglycerin, the order of decreasing affinity being: vinyls greater than low density polyethylene greater than ionomers greater than high density polyethylene. With the proper choice of packaging, molded nitroglycerin tablets stabilized with povidone maintained acceptable potency for up to 2 years at 26 degrees when strip packaged in unit doses. Chemical decomposition (hydrolysis) of nitroglycerin also was investigated. Povidone accelerated the decomposition of nitroglycerin; at high temperature, decomposition was a significant factor in tablet stability for tablets containing povidone.

摘要

研究了热塑性聚合物对硝酸甘油的吸附作用以及模制硝酸甘油片在条装包装中的稳定性。所研究的聚合物对硝酸甘油的亲和力差异很大,亲和力递减顺序为:乙烯基聚合物大于低密度聚乙烯大于离聚物大于高密度聚乙烯。通过适当选择包装,用聚维酮稳定化的模制硝酸甘油片在26摄氏度下以单位剂量条装包装时,可保持长达两年的可接受效力。还研究了硝酸甘油的化学分解(水解)。聚维酮加速了硝酸甘油的分解;在高温下,分解是含聚维酮片剂稳定性的一个重要因素。

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