JP2017137315A - 固形医薬品 - Google Patents
固形医薬品 Download PDFInfo
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- JP2017137315A JP2017137315A JP2017019114A JP2017019114A JP2017137315A JP 2017137315 A JP2017137315 A JP 2017137315A JP 2017019114 A JP2017019114 A JP 2017019114A JP 2017019114 A JP2017019114 A JP 2017019114A JP 2017137315 A JP2017137315 A JP 2017137315A
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Abstract
Description
後記の表1〜表6に示す組成の通り調製した生薬含有混合物を、目的の径を有する臼、杵を備えた圧縮成型機を用いて、3kN〜20kNの成型圧で圧縮成型して、目的とする固形医薬品を得た。生薬は、ケイヒ、カンゾウ、オンジを、生薬末またはエキス粉末としたものを用い、添加剤は日本薬局方の収載品を用いた。なお、表1〜表6において、各生薬として、生薬末を用いたものを「〜末」、エキス粉末を用いたものを「〜エキス末」と記載している(以下の表において同じ)。得られた固形医薬品は円柱状であった。
各実施例および比較例の固形医薬品において、無作為に選出した50個の状態を目視にて観察し、1個でも割れ,欠けのあるものを成型障害「あり」、割れ,欠けの固形医薬品が全くないものを成型障害「なし」として評価した。
硬度(kp)は、錠剤硬度計(PTB−311E、PHARMA TEST)を用いて、無作為に選出した10個についてそれぞれ破壊強度を測定し、得た値の平均を硬度とした。
摩損度(%)の測定は、日本薬局方に記載の「錠剤の摩損度試験法」に準じ、次のように実施した。すなわち、錠剤摩損度試験器(TFT−1200、富山産業社製)を用い、質量が6.5gを超える最小数を試験機内に入れ、25rpmで100回転し、回転前の固形医薬品の総質量に対する回転後の固形医薬品の総質量の減少量を摩損度として算出した。
摩損度(%)=(回転前総質量−回転後総質量)/回転前総質量×100
後記の表7および表8に示す組成の固形医薬品を調製した。目的の径を有する臼、杵を備えた圧縮成型機を用いて、3kN〜20kNの成型圧で圧縮成型して、目的とする固形医薬品を得た。得られた固形医薬品は円柱状である。つぎに、これらの固形医薬品を、収容部が幅20mmおよび長さ70mmのスティック状のアルミラミネート包材に、封入した。封入した固形医薬品の個数は表7および表8に示す通りである。
各実施例および比較例の固形医薬品について、アルミラミネート包材から口内への移動させやすさを、最も口内へ移動させやすい(包材から出しやすい)と感じる場合を8点、全く感じられない場合を0点とする8点満点で各被験者がそれぞれ採点し、その平均点が、0点から2.0点以下を×、2.0点より大きく4.0点以下を△、4.0点より大きく6.0点以下を○、6.0点より大きく8.0点以下を◎として評価した。
アルミラミネート包材から口内へ入った各実施例および比較例の固形医薬品について、口内の飲み込みやすい位置に到達させやすいか否かを、最も到達させやすい(口内へ入れやすい)と感じる場合を8点、全く感じられない場合を0点とする8点満点で各被験者がそれぞれ採点し、その平均点が、0点から2.0点以下を×、2.0点より大きく4.0点以下を△、4.0点より大きく6.0点以下を○、6.0点より大きく8.0点以下を◎として評価した。
各実施例および比較例の固形医薬品が、食道を通過しやすいか否かを、最も通過しやすい(飲み込みやすい)と感じる場合を8点、全く感じられない場合を0点とする8点満点で各被験者がそれぞれ採点し、その平均点が、0点から2.0点以下を×、2.0点より大きく4.0点以下を△、4.0点より大きく6.0点以下を○、6.0点より大きく8.0点以下を◎として評価した。
各実施例および比較例の固形医薬品について、アルミラミネート包材から口内へ投入し、飲みこむまでの一連の行為についての総合評価であり、上記3項目(包材からの出しやすさ、口内への入れやすさ、飲みこみやすさ)の平均点が、0点から2.0点以下を×、2.0点より大きく4.0点以下を△、4.0点より大きく6.0点以下を○、6.0点より大きく8.0点以下を◎として評価した。
後記の表9に示す組成の固形医薬品を調製した。目的の径を有する臼、杵を備えた圧縮成型機を用いて、3kN〜20kNの成型圧で圧縮成型して、最大径が4.0mmおよび10.0mmの固形医薬品を得た。得られた固形医薬品は、それぞれ円柱状である。上記固形医薬品のうち、最大径が4.0mmの固形医薬品を実施例とし、最大径が10.0mmの固形医薬品をそれに対応する比較例とした。つぎに、これらの固形医薬品を、収容部が幅20mmおよび長さ70mmのスティック状のアルミラミネート包材に封入した。封入した固形医薬品の個数は表9に示す通りであり、いずれも比較例は1個である。実施例の個数は、対応する比較例1個の質量と同程度の質量になるように設定した。また、生薬は、ケイヒ、オンジ、カンゾウ、ゲンチアナ、ゲンノショウコ、センブリ、ウワウルシ、ショウキョウを、生薬末またはエキス粉末としたものを用い、添加剤は日本薬局方の収載品を用いた。
[式1]味の改善率(%)={1-(実施例の平均値/対応する比較例の平均値)}×100
後記の表10に示す組成の固形医薬品を調製した。目的の径を有する臼、杵を備えた圧縮成型機を用いて、3kN〜20kNの成型圧で圧縮成型して、最大径が4.0mmまたは10.0mmの固形医薬品を得た。得られた固形医薬品は円柱状である。つぎに、これらの固形医薬品を、収容部が幅20mmおよび長さ70mmのスティック状のアルミラミネート包材に封入した。封入した固形医薬品の個数は、試験例1が1個、試験例2が1個、試験例3が2個とした。
各試験例の固形医薬品について、アルミラミネート包材から口内へ投入した後、舌上で喉方向へ移動しやすいか否かを、最も移動しやすいと感じる場合を8点、全く感じられない場合を0点とする8点満点で各被験者がそれぞれ採点し、その平均点が、0点から2.0点以下を×、2.0点より大きく4.0点以下を△、4.0点より大きく6.0点以下を○、6.0点より大きく8.0点以下を◎として評価した。
下記の表11〜13に示す材料を用いて、本発明の固形医薬品(製剤例1〜18)を調製した。なお、製剤例1〜18の材料としては、日本薬局方の収載品を用いた。また、その硬度は、5kNの成型圧で成型したときの値である。
W 最大径
Claims (6)
- 生薬を有する固形医薬品であって、最大径が2.5〜9.0mmであることを特徴とする固形医薬品。
- 生薬を固形医薬品全体に対して、総量として1質量%以上含有する請求項1記載の固形医薬品。
- さらに添加剤を有する請求項1または2記載の固形医薬品。
- 生薬が、植物の根、樹皮、葉、根茎、地上茎、花、全草、果実、果皮、種子および樹脂からなる群から選ばれた少なくとも一つを用いるものであり、生薬末およびエキス粉末の少なくとも一方の形態で配合されたものである請求項1〜3記載のいずれか一項に記載の固形医薬品。
- 固形医薬品の硬度が、1.0〜10.0kpである請求項1〜4のいずれか一項に記載の固形医薬品。
- 生薬の総量1質量部に対して、添加剤を総量として0.001〜20質量部含有する請求項1〜5のいずれか一項に記載の固形医薬品。
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JP2012001474A (ja) * | 2010-06-16 | 2012-01-05 | Asahi Kasei Chemicals Corp | エキス末配合錠剤 |
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JP2015168643A (ja) * | 2014-03-06 | 2015-09-28 | 静岡県公立大学法人 | 生薬粉末を高含有する口腔内崩壊錠およびその製造方法 |
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JP2012001474A (ja) * | 2010-06-16 | 2012-01-05 | Asahi Kasei Chemicals Corp | エキス末配合錠剤 |
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JP2015168643A (ja) * | 2014-03-06 | 2015-09-28 | 静岡県公立大学法人 | 生薬粉末を高含有する口腔内崩壊錠およびその製造方法 |
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