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土霉素片制剂:湿混时间、粒径和批次变化对颗粒及片剂性质的影响

Oxytetracycline tablet formulations: the effect of wet mixing time, particle size and batch variation on granule and tablet properties.

作者信息

Chalmers A A, Elworthy P G

出版信息

J Pharm Pharmacol. 1976 Mar;28(3):239-43. doi: 10.1111/j.2042-7158.1976.tb04137.x.

Abstract

The wet mixing time has been shown to influence the properties of an oxytetracycline dihydrate tablet formulation, wet granulated with PVP solution. Increased time of wet mixing produced larger, stronger and more dense granules, which compressed into tablets with longer disintegration and dissolution times. Decreased drug particle size aggravated these trends. A decrease in drug particle size also produced larger, stronger and more dense granules. Above an oxytetracycline mean particle diameter of about 6 mum, the tablet dissolution was satisfactory. As the oxytetracycline particle size was decreased further, however, the distintegration and dissolution of the corresponding tablets was markedly slower.

摘要

已表明湿混时间会影响用聚乙烯吡咯烷酮(PVP)溶液进行湿法制粒的土霉素二水合物片剂配方的性质。延长湿混时间会产生更大、更强且更致密的颗粒,压制成的片剂崩解和溶解时间更长。药物粒径减小会加剧这些趋势。药物粒径减小也会产生更大、更强且更致密的颗粒。当土霉素平均粒径约为6微米以上时,片剂的溶解情况令人满意。然而,随着土霉素粒径进一步减小,相应片剂的崩解和溶解明显变慢。

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