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碳酸锂缓释片的制剂及体内外评价

Formulation and in vitro-in vivo evaluation of sustained-release lithium carbonate tablets.

作者信息

Ciftçi K, Capan Y, Oztürk O, Hincal A A

机构信息

Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Hacettepe, Ankara, Turkey.

出版信息

Pharm Res. 1990 Apr;7(4):359-63. doi: 10.1023/a:1015863204732.

Abstract

The release of lithium carbonate incorporated into polymethylmethacrylate, polyvinyl chloride, hydrogenated vegetable oil, and carbomer matrix tablets was studied in vitro. The formulation containing 10% carbomer showed a sustained-release profile comparable to that of a standard, commercially available, sustained-release preparation containing 400 mg lithium carbonate embedded in a composite material. In vivo the newly formulated and standard sustained-release lithium carbonate tablets were compared to an oral solution and conventional lithium carbonate tablets in 12 healthy subjects. These crossover studies showed that the sustained-release tablets produced a flatter serum concentration curve than the oral solution and conventional tablet, without loss of total bioavailability.

摘要

研究了聚甲基丙烯酸甲酯、聚氯乙烯、氢化植物油和卡波姆基质片剂中碳酸锂的体外释放情况。含10%卡波姆的制剂显示出与标准的、市售的、含有嵌入复合材料中400mg碳酸锂的缓释制剂相当的缓释曲线。在12名健康受试者体内,将新配制的缓释碳酸锂片剂和标准缓释碳酸锂片剂与口服溶液和传统碳酸锂片剂进行了比较。这些交叉研究表明,缓释片剂产生的血清浓度曲线比口服溶液和传统片剂更平缓,且总生物利用度未降低。

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