JP6062168B2 - 生薬由来成分を含有する製剤及びその製造方法 - Google Patents
生薬由来成分を含有する製剤及びその製造方法 Download PDFInfo
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- JP6062168B2 JP6062168B2 JP2012146981A JP2012146981A JP6062168B2 JP 6062168 B2 JP6062168 B2 JP 6062168B2 JP 2012146981 A JP2012146981 A JP 2012146981A JP 2012146981 A JP2012146981 A JP 2012146981A JP 6062168 B2 JP6062168 B2 JP 6062168B2
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- extract
- adsorbent
- herbal
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- 235000019154 vitamin C Nutrition 0.000 description 1
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- 235000021260 warm beverage Nutrition 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
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Description
本発明の固形製剤(又は医薬組成物)は、活性成分として少なくとも生薬由来成分を含んでいればよく、活性成分は生薬由来成分単独で形成してもよく、生薬由来成分と他の活性成分(非生薬活性成分)とを組み合わせてもよい。他の活性成分は生理活性成分であってもよく薬理活性成分であってもよい。
本発明では、前記吸着剤として、吸着能の高い第1の吸着剤と、第1の吸着剤よりも吸着能の低い第2の吸着剤とを用いる。このような吸着剤を組み合わせて用いると、多量の生薬エキスまたは漢方エキスを用いた製剤であっても、少量の吸着剤で製剤のケーキングを防止できる。しかも、吸着能の高い第1の吸着剤を多量に用いると、外観変化(着色または変色)を生じる場合があるが、そのような場合であっても、第1の吸着剤と第2の吸着剤とを組み合わせることにより、外観変化を有効に防止できる。
本発明の組成物は、さらに、担体(結合剤、賦形剤、崩壊剤から選択された少なくとも1つの成分)を含有していてもよい。
本発明の製剤(医薬組成物)の形態は特に制限されず、種々の固形製剤(経口固形製剤)、例えば、散剤、顆粒剤(細粒又は顆粒剤)、丸剤、錠剤、カプセル剤、チュアブル錠などであってもよい。前記組成物は、通常、造粒物(散剤、粒剤)又は錠剤の形態である場合が多く、粒剤には、細粒剤及び顆粒剤が含まれる。
本発明では、少なくとも生薬エキスまたは漢方エキスを含む活性成分を、吸着剤(第1及び第2の吸着剤)を用いて湿式製粒することにより、本発明の固形製剤を製造することができる。この方法では、少なくとも生薬エキスまたは漢方エキス(例えば、少なくとも軟エキスを含む活性成分)を吸着剤に吸着させて造粒すればよく、通常、担体(例えば、賦形剤、崩壊剤及び結合剤から選択された少なくとも一種)を含む製剤成分(造粒成分)と併用して造粒する場合が多い。湿式造粒では、練合造粒法、押出造粒法などが利用できる。本発明では、生薬エキスまたは漢方エキスを用いるため、練合造粒法、流動層造粒法を利用するのが有利である。これらの方法は慣用の方法で行うことができる。造粒物は、通常、乾燥及び整粒される。また、この造粒物と担体との混合物を打錠することにより錠剤を得ることもできる。
[実施例1]
バーチカルグラニュレーター(FM−VG−25:パウレック製)に、表1の実施例1に示す割合で、ヒドロキシプロピルセルロース(HPC−L)、結晶セルロース、クロスポビドン、軽質無水ケイ酸(サイリシア320、有限会社ワイ・ケイ・エフ)及びケイ酸カルシウム(フローライトRE、エーザイフードケミカル)を仕込み、攪拌しながら、ナンテンジツエキス(アルプス薬品工業株式会社製)、キキョウエキス(日本粉末薬品株式会社製)、ショウキョウエキス(日本粉末薬品株式会社製)、チンピエキス(日本粉末薬品株式会社製)、水200mLに溶解したアセスルファムカリウム、スクラロースを添加し、粉末状態になるまで練合した。造粒してパワーミル(昭和化学、P−7型、パンチングサイズ:1.0mmφ)で整粒後、得られた粉末にステアリン酸マグネシウム、ジンジャーオイルを添加し、均一に混合して散剤とした。なお、軽質無水ケイ酸(サイリシア320)の吸着能は、約3ml/gであり、ケイ酸カルシウム(フローライトRE)の吸着能は、約5ml/gである。また、本実施例で用いたナンテンジツエキスの原生薬質量換算比(カタログ値)は、エキス:原生薬=1:5.5であり、キキョウエキスの原生薬質量換算比(カタログ値)は、エキス:原生薬=1:4であり、ショウキョウエキスの原生薬質量換算比(カタログ値)は、エキス:原生薬=1:10.3であり、チンピエキスの原生薬質量換算比(カタログ値)は、エキス:原生薬=1:5である。
[実施例2]
表1の実施例2に示す原料を用いる以外、実施例1と同様の方法で散剤を得た(表1の実施例2参照)。
[比較例1]
ケイ酸カルシウムを添加することなく、実施例1と同様の方法で散剤を得た(表1の比較例1参照)。
[比較例2]
軽質無水ケイ酸を添加することなく、実施例1と同様の方法で散剤を得た(表1の比較例2参照)。
[実施例3]
バーチカルグラニュレーターに、ヒドロキシプロピルセルロース、結晶セルロース、クロスポビドン、軽質無水ケイ酸及びケイ酸カルシウムとともにアセトアミノフェンを仕込むこと以外は、表1の実施例3に示す原料を用いて実施例1と同様の方法で散剤を得た(表1の実施例3参照)。
−:ケーキングなし(流動性良好)
+:ケーキングあり(振動を与えるとほぐれる)
++:ケーキングあり(振動を与えてもほぐれない)
Claims (10)
- 生薬エキスまたは漢方エキスと吸着剤とを含む固形製剤であって、前記吸着剤が、ケイ酸カルシウムである第1の吸着剤と、軽質無水ケイ酸である第2の吸着剤とを含み、
散剤、細粒剤及び顆粒剤から選択された少なくとも一種である固形製剤。 - 第1の吸着剤と第2の吸着剤との割合が、前者/後者=20/80〜90/10(質量比)である請求項1記載の固形製剤。
- 生薬エキスまたは漢方エキスが軟エキスである、請求項1または2記載の固形製剤。
- 生薬エキスが、ナンテンジツエキス、キキョウエキス、ショウキョウエキス、及びチンピエキスから選択された少なくとも一種の軟エキスである請求項1〜3のいずれかに記載の固形製剤。
- 生薬エキスまたは漢方エキスが水分含有量20〜40質量%の軟エキスである請求項1〜4のいずれかに記載の固形製剤。
- 生薬エキスまたは漢方エキス100質量部に対して吸着剤の総量が10〜45質量部である請求項1〜5のいずれかに記載の固形製剤。
- さらに解熱鎮痛剤を含む請求項1〜6のいずれかに記載の固形製剤。
- さらに、結合剤、賦形剤、崩壊剤および矯味剤から選択された少なくとも1つの成分を含有する請求項1〜7のいずれかに記載の固形製剤。
- ケイ酸カルシウムである第1の吸着剤と、軽質無水ケイ酸である第2の吸着剤とを含む吸着剤と、生薬エキスまたは漢方エキスとを湿式造粒し、散剤、細粒剤及び顆粒剤から選択された固形製剤を製造する方法。
- 生薬エキスまたは漢方エキスを、ケイ酸カルシウムである第1の吸着剤と、軽質無水ケイ酸である第2の吸着剤とを含む吸着剤に吸着させて湿式造粒し、散剤、細粒剤及び顆粒剤から選択された造粒物のケーキング及び/又は変色を防止する方法。
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