サン調剤薬局

滋賀県守山市にある『サン調剤薬局』のブログ

投稿時間 : 18時51分37秒

カテゴリー : 指定なし(ブログ)

ジャンル : 日記

明けましておめでとうございます。
滋賀県守山市サン調剤薬局西川でございます。
楽しみしていた年末年始の休みもあっという間に終わり、また、仕事を頑張りましょう!

去年まとめ忘れていた局内研修会の報告をさせて頂きます。

研修日時   平成29年8月1日火曜日13:30~14:00
研修タイトル 原薬メーカーとアルピニー事件報道
研修要旨
1、アセトアミノフェン製造で国内最大手の原薬メーカー山本化学工業が、自社で作ったアセトアミノフェンに
  安価な中国製アセトアミノフェンを無届けで混ぜて水増しし、製薬会社に出荷していた。
2、山本化学工業の出荷するアセトアミノフェンの原薬で作られているもの製品には以下などがある。
  アルピニー坐剤、カロナール細粒、カロナール錠、コカールDS、コカール錠。
3、医薬品が出来上がるまでの工程として、以下のようなものがある。
  化学原料→原料中間体→原薬→製剤バルク→最終製品
4、原薬とはその医薬品に含まれている有効成分で、高い品質と有効性が求められる医薬品同様に、
  厳しい法規制が求められている。
5、ジェネリック医薬品は生物学的同等性により同等であるが、以下のような違いはある。
  添加物の違い。
  製剤化ノウハウの違い。
  品質や純度の違い。
  約50%を輸入原薬に依存しており、過去に法令違反や粗悪品事例の報告もある。
6、国内のジェネリック医薬品メーカーで、原薬供給能力をもつのは以下の6社である。
  岩城製薬
  大原薬品工業
  ダイト
  東和薬品
  日医工
  陽進堂
7、薬事法改正後の2007年、厚生労働省と医薬品医療機器総合機構は共同開発(1社が全ての資料を
  提出すれば他の共同開発会社は実測値、安定性、生物学的同等性資料を省略してよい)を認め、それ
  以降、数多くのジェネリック医薬品メーカーの参入が可能となった。

前回局内研修会 DI変更2017年11月 http://blog.cabrain.net/CN112049/article/id/103819.html
局内研修会履歴 http://www.myph.jp/sun_pharm/pc/free2.html
薬局HP http://www.myph.jp/sun_pharm/pc/index.html
薬局スマホサイト http://sun-ph.jp/sumaho/  

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