JP2011201830A - フロセミド製剤 - Google Patents
フロセミド製剤 Download PDFInfo
- Publication number
- JP2011201830A JP2011201830A JP2010072339A JP2010072339A JP2011201830A JP 2011201830 A JP2011201830 A JP 2011201830A JP 2010072339 A JP2010072339 A JP 2010072339A JP 2010072339 A JP2010072339 A JP 2010072339A JP 2011201830 A JP2011201830 A JP 2011201830A
- Authority
- JP
- Japan
- Prior art keywords
- furosemide
- coating
- tablet
- preparation
- solid preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- 229960003883 furosemide Drugs 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 33
- 239000011248 coating agent Substances 0.000 claims abstract description 28
- 239000007787 solid Substances 0.000 claims abstract description 20
- 238000000576 coating method Methods 0.000 claims abstract description 15
- 229910052751 metal Inorganic materials 0.000 claims abstract description 12
- 239000002184 metal Substances 0.000 claims abstract description 12
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- 239000003826 tablet Substances 0.000 claims description 27
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- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 4
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Abstract
【解決手段】 フロセミドを含有する固形製剤の表面を、水溶性高分子と酸化された金属を含有するコーティング剤で被覆してなるフロセミド製剤。
【選択図】 なし
Description
等の方法を適宜利用することができる。この被覆に当たっての、固形製剤とコーティング剤の使用割合は、固形製剤の具体的形態によっても相違するが、錠剤の場合、固形製剤100部に対し、コーティング剤を1ないし20部程度、好ましくは3ないし10部程度とすればよい。
フロセミド製剤(錠剤)の調製:
下記の製剤処方により、医薬組成物を調製し、これを流動層造粒機にて造粒を実施して、得られた顆粒を用い、打錠を使用して直径6.1mm、厚さ2.9mmおよび重さ90mgの素錠を調製した。得られた素錠に対し、下記組成のコーティング剤を、精製水に懸濁し、乾燥後の皮膜が1錠あたり7mgとなるようドリアコーター中で噴霧し、フィルムコーティング剤を調製した。
成 分 名 配合量(mg)
フロセミド 20.0
乳糖水和物 19.0
トウモロコシデンプン 19.5
結晶セルロース 18
軽質無水ケイ酸 0.9
部分アルファー化デンプン 9
アルファー化デンプン 1.8
軽質無水ケイ酸 0.9
ステアリン酸マグネシウム 0.9
計 90.0
成 分 名 配合量(mg)
ヒドロキシプロピルメチル 4.5
セルロース*1
マクロゴール6000 0.7
酸化チタン 1.8
カルナウバロウ 微 量
計 7
*1 粘度:6.0mPa/s
着色防止性試験(1):
実施例1により作成した素錠(直径6.1mm、厚さ2.9mm)およびそのフィルムコーティング錠並びにオイルプレスにより上記と同様の大きさの錠剤状に成型した原薬(フロセミド)について、次のようにして着色の有無を評価した。
温 度 25℃ 暗室
風 5.4m/sec
試験期間 1週間若しくは2週間
着色防止性試験(2):
着色が単にフィルムコーティングで隠されているだけであり、素錠は着色している可能性もあるので、試験例1で2週間送風を受けた後のフィルムコーティング錠について、内部の着色状況を調べた。
Claims (4)
- フロセミドを含有する固形製剤の表面を、水溶性高分子と酸化された金属を含有するコーティング剤で被覆してなるフロセミド製剤。
- 固形製剤が、錠剤、顆粒剤、細粒剤または散剤である請求項1記載のフロセミド製剤。
- 水溶性高分子がヒドロキシプロピルメチルセルロースである請求項1または2記載のフロセミド製剤。
- 酸化された金属が、酸化チタンである請求項1ないし3のいずれかの項記載のフロセミド製剤。
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JP2010072339A JP5744412B2 (ja) | 2010-03-26 | 2010-03-26 | フロセミド製剤 |
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US10550354B2 (en) | 2015-05-19 | 2020-02-04 | Ecolab Usa Inc. | Efficient surfactant system on plastic and all types of ware |
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