JP6887456B2 - 白色化剤として界面活性剤又は界面活性剤と塩を含有する皮膜形成性組成物 - Google Patents
白色化剤として界面活性剤又は界面活性剤と塩を含有する皮膜形成性組成物 Download PDFInfo
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- JP6887456B2 JP6887456B2 JP2019036083A JP2019036083A JP6887456B2 JP 6887456 B2 JP6887456 B2 JP 6887456B2 JP 2019036083 A JP2019036083 A JP 2019036083A JP 2019036083 A JP2019036083 A JP 2019036083A JP 6887456 B2 JP6887456 B2 JP 6887456B2
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Description
これらの塩は、1種あるいは2種以上を組み合わせて使用することができ、添加量に応じて白色度を変化させることができる。
5)ポリオキシプロピレン(5)グリコールとコハク酸ナトリウム、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールと炭酸水素ナトリウム(重曹)、ショ糖モノラウリン酸エステルとリンゴ酸ナトリウム、ショ糖モノラウリン酸エステルと炭酸カリウム、ショ糖モノラウリン酸エステルとリン酸水素二カリウム、ショ糖モノラウリン酸エステルとリン酸二水素カリウム、ショ糖モノラウリン酸エステルとリン酸水素二ナトリウム、ショ糖モノラウリン酸エステルとリン酸二水素ナトリウム、ショ糖モノラウリン酸エステルと炭酸水素ナトリウム(重曹)、ショ糖モノラウリン酸エステルとクエン酸ナトリウム、ショ糖モノラウリン酸エステルとコハク酸ナトリウム、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコールとリンゴ酸ナトリウム、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコールとコハク酸ナトリウム、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコールとクエン酸ナトリウム、ショ糖パルミチン酸エステルとリンゴ酸ナトリウム、ショ糖パルミチン酸エステルとコハク酸ナトリウム、マクロゴール4000とリンゴ酸ナトリウム、ポリソルベート80とリンゴ酸ナトリウム、キラヤサポニンとコハク酸ナトリウム、ゼラチンの場合は、ショ糖モノラウリン酸エステルとポリリン酸ナトリウム、ショ糖モノラウリン酸エステルとリン酸水素二ナトリウム、ショ糖モノラウリン酸エステルと無水ピロリン酸ナトリウム、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールとポリリン酸ナトリウム、キラヤサポニンとポリリン酸ナトリウム、キラヤサポニンと無水ピロリン酸ナトリウム、プルランの場合は、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールのみあるいは、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールと炭酸水素ナトリウム(重曹)などの組み合わせが挙げられる。
ポリオキシプロピレン(5)グリコールとリンゴ酸ナトリウム、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールとクエン酸ナトリウム、ショ糖モノラウリン酸エステルとリンゴ酸ナトリウム、ショ糖モノラウリン酸エステルとクエン酸ナトリウム、ショ糖モノラウリン酸エステルとリン酸水素二カリウム、ショ糖モノラウリン酸エステルとリン酸水素二ナトリウム、ショ糖モノラウリン酸エステルとリン酸二水素ナトリウム、ショ糖モノラウリン酸エステルと炭酸カリウム、ショ糖モノラウリン酸エステルとリン酸二水素カリウム、ショ糖モノラウリン酸エステルと炭酸水素ナトリウム(重曹)、ショ糖モノラウリン酸エステルとコハク酸ナトリウム、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコールとリンゴ酸ナトリウム、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコールとコハク酸ナトリウム、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコールとクエン酸ナトリウム、ショ糖パルミチン酸エステルとリンゴ酸ナトリウム、ショ糖パルミチン酸エステルとコハク酸ナトリウム、マクロゴール4000とリンゴ酸ナトリウム、ポリソルベート80とリンゴ酸ナトリウム、キラヤサポニンとコハク酸ナトリウム、ゼラチンの場合は、ショ糖モノラウリン酸エステルとポリリン酸ナトリウム、ショ糖モノラウリン酸エステルとリン酸水素二ナトリウム、ショ糖モノラウリン酸エステルと無水ピロリン酸ナトリウム、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールとポリリン酸ナトリウム、キラヤサポニンとポリリン酸ナトリウム、キラヤサポニンと無水ピロリン酸ナトリウム、プルランの場合は、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールである。
各種の皮膜形成性の高分子及び界面活性剤又は界面活性剤と塩を含む被検試料を調製し、皮膜形成時の白色化について試験を行った。
白色割合:◎100〜90%、〇90〜80%、△80〜70%、□70%以下 ●0%
白色濃さ:◎真白、〇白、△透け感あり、□ぼんやりと白い ●透明
A:常温ゲルを、105℃オーブンで加熱したガラス板上(105℃オーブンから出して直ぐ)に流す。直ちに60℃オーブンで15分乾燥。
B:常温ゲルを、105℃オーブンで加熱したガラス板上(放射温度計で約70℃になったとき)に流す。直ちに60℃オーブンで15分乾燥。
C:室内で自然乾燥
約20%のヒドロキシプロピルメチルセルロース溶液に、ヒドロキシプロピルメチルセルロース100重量部に対して2.5重量部のリンゴ酸ナトリウム及び2.5重量部のポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールを含む水溶液を添加し、皮膜形成性水溶液を調製した。この溶液を約105℃に熱したガラス板上に流し、60℃で15分間加熱したところ白色の皮膜が形成された。
約20%のヒドロキシプロピルメチルセルロース(HPMC2906とHPMC2910の混合HPMC)溶液に、ヒドロキシプロピルメチルセルロース100重量部に対して2.5重量部のリン酸水素二カリウム及び2.5重量部のショ糖モノラウリン酸エステルを含む水溶液を添加し、皮膜形成性水溶液を調製した。この溶液を約105℃に熱したガラス板上に流し、60℃で15分間加熱したところ白色の皮膜が形成された。
上記の方法において添加する塩を、リン酸水素二ナトリウム、リン酸二水素ナトリウム、炭酸カリウム、リン酸二水素カリウム、炭酸水素ナトリウムに代えてそれぞれ同様の皮膜を形成した。
これらの皮膜の白色割合、白色濃さの評価はいずれも◎であった。
約22%のプルラン溶液に、プルラン100重量部に対して2.5重量部のポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールを含む水溶液を添加し皮膜形成性水溶液を調製した。この溶液を、離型剤を塗布した約60℃に加熱したガラス板上に流し、室温で乾燥したところ、白色の皮膜が形成した。
約34%のゼラチン溶液に、ゼラチン100重量部に対して5重量部のポリリン酸ナトリウム及び5重量部のショ糖モノラウリン酸エステルを含む水溶液を添加し皮膜形成性水溶液を調製した。この溶液を、離型剤を塗布し約60℃に加熱したガラス板上に流し、室温で乾燥したところ、白色の皮膜が形成された。
実施例1に準じた方法で作製した白色皮膜について遮蔽効果を評価した。
被験試料は厚み100±10μmのフィルム片とし、分光光度計にて波長1100nm〜190nmの透過率を測定した。この結果、白色皮膜の形成により光透過率が減少し、遮蔽効果があることを確認した。
図1は、約20%のヒドロキシプロピルメチルセルロース溶液にヒドロキシプロピルメチルセルロース100重量部に対して2.5重量部のリンゴ酸ナトリウム及び2.5重量部のポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールを含む水溶液を添加し、約105℃に熱したガラス板上に流し、60℃で15分加熱して形成した白色皮膜、約20%のヒドロキシプロピルメチルセルロース溶液を約105℃に熱したガラス板上に流し、60℃で15分間加熱して形成した皮膜及び上記の製法において白色化剤を使用しない皮膜の透過率を測定したものである。酸化チタンを遮光剤に用いた一般コントロール品としては、約20%のヒドロキシプロピルメチルセルロース溶液にヒドロキシプロピルメチルセルロース100重量部に対して2重量部の酸化チタンを含む懸濁液を添加し、約105℃に熱したガラス板上に流し、60℃で15分加熱して形成した白色皮膜を用いた。
図2は、約20%のヒドロキシプロピルメチルセルロース溶液にヒドロキシプロピルメチルセルロース100重量部に対して2.5重量部のリンゴ酸ナトリウム及び2.5重量部のショ糖モノラウリン酸エステルを含む水溶液を添加し、約105℃に熱したガラス板上に流し、60℃で15分加熱して形成した白色皮膜及び上記の製法において白色化剤を使用しない皮膜の透過率を測定したものである。酸化チタンを遮光剤に用いた一般コントロール品としては、約20%のヒドロキシプロピルメチルセルロース溶液にヒドロキシプロピルメチルセルロース100重量部に対して2重量部の酸化チタンを含む懸濁液を添加し、約105℃に熱したガラス板上に流し、60℃で15分加熱して形成した白色皮膜を用いた。
約20%のヒドロキシプロピルメチルセルロース溶液に、ヒドロキシプロピルメチルセルロース100重量部に対して1.25重量部のリンゴ酸ナトリウム及び1.25重量部のポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールを含む水溶液を添加し、皮膜形成性水溶液を調製した。この溶液を約105℃に熱したガラス板上に流し、60℃で15分間加熱したところ白色の皮膜が形成された。この白色皮膜について、水への溶解性を評価した。試験検体は厚み100±10μmのフィルム片を披験試料とし、試験方法は日本薬局方の溶出試験法よりパドル法に準じ、下記条件にてヒドロキシプロピルメチルセルロースの溶出を評価した。
試験液:イオン交換水、試験液量:400mL、
試験液温度:37±0.5℃
パドル回転数:50rpm
この結果、溶出試験開始後の溶出率が向上していることを確認した(図3)。
約20%のヒドロキシプロピルメチルセルロース溶液に、ヒドロキシプロピルメチルセルロース(HPMC2910とHPMC2208の混合物)100重量部に対して1.25重量部のリンゴ酸ナトリウム、5重量部のショ糖モノラウリン酸エステル及び1重量部の黄色5号を含む水溶液を添加し、皮膜形成性水溶液を調製した。この溶液を約105℃に熱したガラス板上(放射温度計で70℃になったとき)に流し、60℃で15分間加熱し着色皮膜を作製した。約34%のゼラチン溶液に、ゼラチン100重量部に対して5重量部のポリリン酸ナトリウム、5重量部のショ糖モノラウリン酸エステル及び1重量部のクチナシ赤色素を含む水溶液を添加し、皮膜形成性水溶液を調整した。この溶液を、離型剤を塗布した約60℃に加熱したガラス板上に流し、室温で乾燥し着色皮膜を作製した。約34%のゼラチン溶液に、ゼラチン100重量部に対して5重量部のポリリン酸ナトリウム、5重量部のショ糖モノラウリン酸エステル及び1重量部のクチナシ青色素を含む水溶液を添加し、皮膜形成性水溶液を調整した。この溶液を、離型剤を塗布した約60℃に加熱したガラス板上に流し、室温で乾燥し着色皮膜を作製した。約34%のゼラチン溶液に、ゼラチン100重量部に対して5重量部のポリリン酸ナトリウム、5重量部のショ糖モノラウリン酸エステル及び1重量部の緑色色素(クチナシ青色素とベニバナ色素の混合色素)を含む水溶液を添加し、皮膜形成性水溶液を調整した。この溶液を、離型剤を塗布した約60℃に加熱したガラス板上に流し、室温で乾燥し着色皮膜を作製した。
また、約22%のプルラン溶液に、プルラン100重量部に対して2.5重量部のポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール及び1重量部のクチナシ赤色素を含む水溶液を添加し皮膜形成性水溶液を調製した。この溶液を、離型剤を塗布した約60℃に加熱したガラス板上に流し、室温で乾燥し着色皮膜を作製した。いずれも、不透明な着色皮膜が作製されることを確認した。
Claims (15)
- 皮膜形成性高分子成分と、界面活性剤または界面活性剤および水溶性の塩類からなる白色化剤を含む白色皮膜であって、
前記皮膜は白色顔料を含まず、
皮膜形成性高分子成分はセルロース誘導体、ゼラチン又はプルランから選択される1種を含み、
皮膜形成性高分子成分がセルロース誘導体である場合は、界面活性剤および水溶性の塩類からなる白色化剤を含み、ゼラチンまたはプルランである場合は、界面活性剤または界面活性剤および水溶性の塩類からなる白色化剤を含み、
前記界面活性剤が、多価アルコール脂肪酸エステル、ポリプロピレングリコール、ポリアルキレンオキサイド誘導体、およびアルキル硫酸エステル塩及びサポニンから選択されることを特徴とする、前記皮膜。 - 多価アルコールの脂肪酸エステルが、ショ糖脂肪酸エステル、ソルビタン脂肪酸エステル、グリセリン脂肪酸エステル、ポリオキシソルビタン脂肪酸エステルであり、ポリアルキレンオキサイド誘導体がポリオキシエチレンポリオキシプロピレングリコール、ポリオキシエチレンアルキルエーテル、ポリオキシエチレン脂肪酸エステル、サポニンがトリテルペノイドサポニン又はステロイドサポニンである請求項1に記載の皮膜。
- 界面活性剤が、ポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ポリオキシエチレン(160)ポリオキシプロピレン(30)グリコール、ショ糖モノラウリン酸エステル、ショ糖パルミチン酸エステル、ソルビタンモノラウリン酸エステル、ポリソルベート80及びラウリル硫酸ナトリウム、キラヤサポニン、人参サポニン、大豆サポニン、エンジュサポニン、茶種子サポニン、ビートサポニン、ユッカサポニン、グリチルリチンからなる群から選択される請求項1又は2に記載の皮膜。
- 乾燥重量として合計100重量部の皮膜形成性高分子成分に対し、界面活性剤の合計が0.5〜30重量部の範囲で、白色度が調節された請求項1〜3のいずれか1項に記載の皮膜。
- 乾燥重量として合計100重量部の皮膜形成性高分子成分に対し、界面活性剤の合計が0.7〜30重量部の範囲で、白色度が調節された請求項1〜4のいずれか1項に記載の皮膜。
- 乾燥重量として合計100重量部の皮膜形成性高分子成分に対し、界面活性剤の合計が1.0〜30重量部の範囲で、白色度が調節された請求項1〜4のいずれか1項に記載の皮膜。
- 乾燥重量として合計100重量部の皮膜形成性高分子成分に対し、界面活性剤の合計が0.5〜15重量部の範囲で、白色度が調節された請求項1〜4のいずれか1項に記載の皮膜。
- 添加する水溶性の塩類がナトリウム塩及び/又はカリウム塩及び/又はアンモニウム塩である請求項1〜7のいずれか1項に記載の皮膜。
- 乾燥重量として合計100重量部の皮膜形成性高分子成分に対し、添加する水溶性の塩類がリンゴ酸ナトリウム、コハク酸ナトリウム、クエン酸ナトリウム、ポリリン酸ナトリウム、炭酸水素ナトリウム、リン酸水素二カリウム、リン酸水素二ナトリウム、リン酸二水素ナトリウム、炭酸カリウム、リン酸二水素カリウム、ピロリン酸ナトリウムから選択される塩の1種又はそれ以上であり、その合計が0.5〜30重量部の範囲で白色度を変更し得る請求項1〜8のいずれか1項に記載の皮膜。
- 染料或いは顔料を加えて白以外に着色した請求項1〜9のいずれか1項に記載の皮膜。
- 請求項1〜10のいずれか1項に記載の皮膜からなる経口送達に適したカプセル。
- 医薬または健康食品を充填するものである請求項11に記載のカプセル。
- 請求項11又は12に記載のカプセルであって、
前記皮膜形成性高分子成分と界面活性剤の組み合わせが、ヒドロキシプロピルメチルセルロース(HPMC)とショ糖モノラウリン酸エステル、ヒドロキシプロピルメチルセルロース(HPMC)とポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ヒドロキシプロピルメチルセルロース(HPMC)とポリオキシエチレン(160)ポリオキシプロピレン(30)グリコール、ヒドロキシプロピルメチルセルロース(HPMC)とショ糖パルミチン酸エステル、ヒドロキシプロピルメチルセルロース(HPMC)とポリソルベート80、ヒドロキシプロピルメチルセルロース(HPMC)とサポニン(キラヤサポニン、人参サポニン、大豆サポニン、エンジュサポニン、茶種子サポニン、ビートサポニン、ユッカサポニン、グリチルリチン)、ゼラチンとショ糖モノラウリン酸エステル、ゼラチンとポリオキシエチレン(105)ポリオキシプロピレン(5)グリコール、ゼラチンとサポニン(キラヤサポニン、人参サポニン、大豆サポニン、エンジュサポニン、茶種子サポニン、ビートサポニン、ユッカサポニン、グリチルリチン)、又はプルランとポリオキシエチレン(105)ポリオキシプロピレン(5)グリコールである、カプセル。 - 水に溶解した皮膜形成性高分子成分と、界面活性剤または界面活性剤および水溶性の塩類からなる白色化剤を含む、請求項1〜10のいずれか1項に記載の皮膜を形成する皮膜形成性組成物。
- 皮膜形成性高分子成分を用いる白色皮膜又は経口送達に適した白色カプセルの製造において、白色顔料を使用せず、白色化剤として界面活性剤または界面活性剤および水溶性の塩類を使用する方法であって、
皮膜形成性高分子成分がセルロース誘導体、ゼラチン又はプルランから選択される1種を含み、
セルロース誘導体には、界面活性剤および水溶性の塩類からなる白色化剤を、
ゼラチン又はプルランには界面活性剤または界面活性剤および水溶性の塩類からなる白色化剤を使用し、
前記界面活性剤が、多価アルコール脂肪酸エステル、ポリプロピレングリコール、ポリアルキレンオキサイド誘導体、およびアルキル硫酸エステル塩およびサポニンから選択されることを特徴とする、前記方法。
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- 2019-07-03 CN CN201980045102.6A patent/CN112384206A/zh active Pending
- 2019-07-03 KR KR1020217003387A patent/KR20210028674A/ko not_active Application Discontinuation
- 2019-07-03 CA CA3105600A patent/CA3105600A1/en active Pending
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US20240058225A1 (en) | 2024-02-22 |
CA3105600A1 (en) | 2020-01-09 |
CN112384206A (zh) | 2021-02-19 |
EP3785708A1 (en) | 2021-03-03 |
EP3785708A4 (en) | 2021-07-07 |
WO2020009142A1 (ja) | 2020-01-09 |
US20210275404A1 (en) | 2021-09-09 |
KR20210028674A (ko) | 2021-03-12 |
JP2020019761A (ja) | 2020-02-06 |
BR112020027028A2 (pt) | 2021-06-15 |
US11801205B2 (en) | 2023-10-31 |
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