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单剂量包装后储存条件对氧化镁片稳定性的影响

[Influence of Storage Conditions after One-dose Packaging on Stability of Magnesium Oxide Tablets].

作者信息

Sato Kayoko, Inaoka Natsuko, Kodama Yukinobu, Muro Takahiro, Nakamura Tadahiro, Sasaki Hitoshi, Kitahara Takashi

机构信息

Department of Hospital Pharmacy, Nagasaki University Hospital.

出版信息

Yakugaku Zasshi. 2018;138(11):1435-1441. doi: 10.1248/yakushi.18-00024.

Abstract

The intestinal motor function declines in the elderly. Many patients have constipation and ingest magnesium oxide for a prolonged period. One-dose packaging of drugs is adopted for many elderly patients to help them to avoid forgetting to take an increase in the number of oral drugs to be taken and improve convenience. Several studies on differences in stability among magnesium oxide preparations including generic drugs have been reported, but no study on the influence of the storage conditions after one-dose packaging on the properties of magnesium oxide tablets has been reported. Three types of magnesium oxide tablet were one-dose-packaged and stored for 12 weeks with and without a desiccant. The difference in hardness and weight significantly increased in all tablets stored without a desiccant. The disintegration time significantly extended in the tablets stored without a desiccant from 2 weeks after the initiation of storage and that of the B tablet markedly extended. However, all tablets passed the disintegration criteria of the disintegration test. The pH-area under the concentration-time curve significantly decreased in the tablets stored without a desiccant. It was suggested that when the one-dose-packaged magnesium oxide preparation is stored, it should be placed in a bag containing a desiccant.

摘要

老年人肠道运动功能下降。许多患者患有便秘且长期服用氧化镁。许多老年患者采用药品单剂量包装,以帮助他们避免忘记增加口服药物的服用数量并提高便利性。已经报道了几项关于包括仿制药在内的氧化镁制剂稳定性差异的研究,但尚未有关于单剂量包装后储存条件对氧化镁片剂性质影响的研究报道。将三种类型的氧化镁片剂进行单剂量包装,并在有或没有干燥剂的情况下储存12周。在没有干燥剂储存的所有片剂中,硬度和重量差异显著增加。在没有干燥剂储存的片剂中,从储存开始2周后崩解时间显著延长,B片剂的崩解时间明显延长。然而,所有片剂均通过了崩解试验的崩解标准。在没有干燥剂储存的片剂中,浓度-时间曲线下的pH面积显著降低。建议单剂量包装的氧化镁制剂储存时,应放置在装有干燥剂的袋子中。

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