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Delivery of Hypericum perforatum (St. John's Wort) in tablet form

机译:片状贯叶金丝桃(圣约翰草)的交付

摘要

St. John's Wort has been indicated as a beneficial supplement to human diet. It has been traditionally provided as an extract, tincture, tea or capsule form, usually administered in amounts taken three times/day. It has been found that the manufacture of a tablet of this supplement material is a complex process, and that St. John's Wort extract is not amenable to wet tableting. A tablet which can be taken twice a day to provide a recommended supplemental level of St. John's Wort is described as comprising by weight of the tablet:;400 to 500 mg St. John's Wort extract as 57 to 75% by weight of the tablet,;1.0-5.0% by weight binder,;8-18% by weight dissolution regulator,;up to 30% by weight filler,;0.2 to 5.0% by weight glidant, and;0.5 to 2.5% by weight lubricant/glidant.;A process for manufacturing the tablet comprises the steps of;a) mixing components comprising:;400 to 500 mg St. John's Wort extract as 57 to 75% by weight of the tablet,;1.0-5.0% by weight binder,;8-18% by weight dissolution regulator,;up to 30% by weight filler,;and less than a final proportion of glidant and lubricant/glidant of 0.2 to 5.0% by weight glidant, and 0.5 to 2.5% by weight lubricant/glidant to form a slug,;b) breaking the slug down into particulates which can be subsequently compressed into a tablet,;c) adding sufficient glidant and/or lubricant glidant to form a composition with proportions of glidant and lubricant/glidant of 0.2 to 5.0% by weight glidant, and 0.5 to 2.5% by weight lubricant/glidant, and;d) compressing the composition to form a tablet.
机译:已表明圣约翰草是人类饮食的有益补充。传统上,它以提取物,tin剂,茶或胶囊的形式提供,通常以每天服用3次的量服用。已经发现制造这种补充材料的片剂是复杂的过程,并且圣约翰草提取物不适于湿压片。可以每天服用两次以提供建议的圣约翰草补充水平的片剂被描述为按片剂的重量计:400至500毫克圣约翰草提取物占片剂的57至75% ;;; 1.0-5.0重量%的粘合剂;; 8-18重量%的溶解调节剂;;至多30重量%的填料;; 0.2至5.0重量%的助流剂;和0.5至2.5重量%的润滑剂/助流剂。 ;该片剂的制造方法包括以下步骤:a)混合以下组分:400至500 mg圣约翰草提取物,占片剂的57至75%(重量); 1.0-5.0%(重量)粘合剂; 8 -18%(重量)的溶出调节剂,最多30%(重量)的填料,并且助流剂和润滑剂/助流剂的最终比例小于0.2-5.0%(重量)助流剂和0.5-2.5%(重量)的润滑剂/助流剂,形成团块; b)将团块分解成颗粒,随后可将其压缩成片剂; c)添加足够的助流剂和/或润滑剂助流剂以形成组合物助流剂和润滑剂/助流剂的比例为0.2-5.0重量%的助流剂和0.5-2.5重量%的润滑剂/助流剂,和; d)压缩组合物以形成片剂。

著录项

  • 公开/公告号US6607754B1

    专利类型

  • 公开/公告日2003-08-19

    原文格式PDF

  • 申请/专利权人 UPSHER-SMITH LABORATORIES INC.;

    申请/专利号US19970890705

  • 发明设计人 WILLIAM J. TOUREK;SAMUEL DAISY JR.;

    申请日1997-07-11

  • 分类号A01N650/00;A61K92/80;

  • 国家 US

  • 入库时间 2022-08-22 00:06:59

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