JP2016027039A - 局所粘膜用水性組成物 - Google Patents
局所粘膜用水性組成物 Download PDFInfo
- Publication number
- JP2016027039A JP2016027039A JP2015133527A JP2015133527A JP2016027039A JP 2016027039 A JP2016027039 A JP 2016027039A JP 2015133527 A JP2015133527 A JP 2015133527A JP 2015133527 A JP2015133527 A JP 2015133527A JP 2016027039 A JP2016027039 A JP 2016027039A
- Authority
- JP
- Japan
- Prior art keywords
- aqueous composition
- mucosa
- acid
- oil
- present
- 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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Abstract
【解決手段】(A)レバミピド、レバミピド誘導体、及びその塩からなる群より選択される少なくとも1種、並びに(B)油性成分を含有する、局所粘膜用水性組成物を調製する。
【選択図】図1
Description
充血除去剤:例えば、塩酸テトラヒドロゾリン、塩酸ナファゾリン、硫酸ナファゾリン、塩酸エピネフリン、塩酸エフェドリン、塩酸メチルエフェドリン等。
殺菌剤:例えば、アクリノール、セチルピリジニウム、塩酸クロルヘキシジン、グルコン酸クロルヘキシジン、塩酸ポリヘキサメチレンビグアニド等。
ビタミン類:例えば、フラビンアデニンジヌクレオチドナトリウム、塩酸ピリドキシン、シアノコバラミン、パンテノール、パントテン酸カルシウム等。
アミノ酸類:例えば、アミノエチルスルホン酸、コンドロイチン硫酸ナトリウム等。
消炎剤:例えば、グリチルレチン酸、サリチル酸メチル、サリチル酸グリコール、アズレンスルホン酸、アラントイン、トラネキサム酸、ベルベリン、リゾチーム、グリチルリチン酸ニカリウム、インドメタシン、プラノプロフェン、イブプロフェン、イブプロフェンピコノール、ブフェキサマク、フルフェナム酸ブチル、ベンダザック、ピロキシカム、ケトプロフェン、フェルビナク等。
収斂剤:例えば、亜鉛華、乳酸亜鉛、硫酸亜鉛等。
その他:例えば、メチル硫酸ネオスチグミン、ヒアルロン酸ナトリウム、スルファメトキサゾール、スルファメトキサゾールナトリウム、紫根、セイヨウトチノキ、及びこれらの塩等。
増粘剤:例えば、ヒドロキシエチルセルロース、ヒドロキシプロピルメチルセルロース、メチルセルロース、アルギン酸、コンドロイチン硫酸ナトリウム、ヒアルロン酸ナトリウム等。
糖アルコール類:例えば、キシリトール、ソルビトール、マンニトール等。これらはd体、l体又はdl体のいずれでもよい。
糖類:例えば、グルコース、シクロデキストリン等。
等張化剤:亜硫酸水素ナトリウム、亜硫酸ナトリウム、塩化カリウム、塩化カルシウム、塩化ナトリウム、塩化マグネシウム等。
pH調節剤:例えば、水酸化カリウム、水酸化カルシウム、水酸化マグネシウム、硫酸、ポリリン酸、プロピオン酸、シュウ酸、グルコン酸、フマル酸、乳酸、酒石酸、リンゴ酸、コハク酸、グルコノラクトン、酢酸アンモニウム等。
安定化剤:例えば、ナトリウムホルムアルデヒドスルホキシレート(ロンガリット)、亜硫酸水素ナトリウム、亜硫酸ナトリウム、ピロ亜硫酸ナトリウム、モノステアリン酸アルミニウム、モノステアリン酸グリセリン等。
キレート剤:例えば、エチレンジアミン二酢酸(EDDA)、エチレンジアミン三酢酸、エチレンジアミン四酢酸(エデト酸、EDTA)、N−(2−ヒドロキシエチル)エチレンジアミン三酢酸(HEDTA)、ジエチレントリアミン五酢酸(DTPA)等。
防腐剤、又は抗菌剤:例えば、安息香酸ナトリウム、エタノール、グルコン酸クロルヘキシジン、クロロブタノール、ソルビン酸、ソルビン酸カリウム、デヒドロ酢酸ナトリウム、パラオキシ安息香酸メチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル、硫酸オキシキノリン、フェネチルアルコール、ベンジルアルコール、ビグアニド化合物(具体的には、塩酸ポリヘキサメチレンビグアニド等)、グローキル(ローディア社製 商品名)等。
なお、表1〜4における各成分量の単位は、w/v%である。
10容量%ウシ胎児血清(MP BIOMEDICALS社製)を添加したDMEM培地(Gibco社製)に懸濁したラット好塩基球(性)白血病細胞株(RBL−2H3)を、1×105 cells/cm2 の密度で、96ウェルマイクロタイタープレート(コーニング社製)に播種し、37℃、5%CO2下で24時間培養した。その後、培養上清を吸引除去し、表1に示す濃度となるよう被験物質を溶解したPIPES緩衝液を1ウェル当たり0.1mLずつ添加し、1時間、37℃、5%CO2下でインキュベートした。PIPES緩衝液は、0.1w/v%ウシ血清アルブミン(シグマ社製)を添加したPIPES緩衝液(119mM NaCl、7.4mM KCl、5.6mM グルコース、0.85mM MgCl2、25mM PIPES, 1mg/mL BSA、4.0mM CaCl2、pH7.2)を用いた。ウェル中の試験液を吸引除去し、PIPES緩衝液0.1mLを添加した後に吸引除去した(洗浄操作)。その後1mM A23187(カルシマイシン:シグマ社製)を0.2mLずつ各ウェルに添加し、更に30分間、37℃、5%CO2下でインキュベートした。各ウェルの上清を回収し、ヒスタミンの含有量をELISAキット(Oxford Biochemical Research社製)を用いて定量した。
(式1)ヒスタミン遊離抑制率(%)
=100−(各サンプルのヒスタミン遊離量/比較例1のヒスタミン遊離量×100)
(実施例3〜5)
表2に示す組成の眼粘膜用水性組成物を常法に従って調製した。具体的には、各成分を100mL容量ガラスバイアルに量り取り、必要量の精製水を添加した。加温しながら攪拌し、室温にて最終pHを調節して均一な製剤を得た。ここで、レバミピドとしては、日本薬局方適合のレバミピドを用いた。
表2に示す組成の眼粘膜用水性組成物を、実施例3と同様に調製した。
(式2)濁度相対値(%)=[(各眼粘膜用水性組成物の濁度)/(基準となる比較例(比較例4)の濁度)]×100
(実施例6、7)
表3に示す組成の眼粘膜用水性組成物を、実施例3と同様に調製した。
表3に示す組成の眼粘膜用水性組成物を、比較例4と同様に調製した。
50cm離れた場所から観察し、結晶が20個以上確認できる ×
50cm離れた場所から観察し、結晶が10〜20個確認できる △
50cm離れた場所から観察し、結晶が1〜10個確認できる ○
50cm離れた場所から観察し、結晶が確認できない ◎
その結果を表3に併せて示す。
(実施例8、9)
表4に示す組成の眼粘膜用水性組成物(点眼剤)を、実施例3と同様に調製した。
表4に示す組成の眼粘膜用水性組成物(点眼剤)を、比較例4と同様に調製した。
(式3)動的接触角(前進角)改善率(%)={1−(実施例の動的接触角の平均値/対応する比較例の動的接触角の平均値)}×100
対応する比較例とは、(A)成分を含有しないこと以外は対応する実施例と同じ組成の水性組成物を意味する。具体的には、実施例8については比較例6、実施例9については比較例7である。
下記表5〜表8に記載の処方で、点眼剤(製剤例1〜19、22〜28)、口腔用スプレー剤(製剤例20)、含嗽液(製剤例21)が調製され、表中に記載の容器に収容される。表5〜表8の製剤例中、塩酸及び水酸化ナトリウムはpH調整に用いられ、局所粘膜用水性組成物が表5〜表8に記載のpHとなるように加えられる。精製水は各液剤の全量が100mLとなるよう加えられる。
Claims (6)
- (A)レバミピド、レバミピド誘導体、及びそれらの塩からなる群より選択される少なくとも1種、並びに
(B)油性成分
を含有する、局所粘膜用水性組成物。 - さらに、界面活性剤を含有する、請求項1記載の局所粘膜用水性組成物。
- さらに、緩衝剤を含有する、請求項1又は2記載の局所粘膜用水性組成物。
- さらに、溶解補助剤を含有する、請求項1〜3のいずれか1項記載の局所粘膜用水性組成物。
- 眼粘膜用である、請求項1〜4のいずれか1項記載の局所粘膜用水性組成物。
- 局所粘膜用水性組成物中に、
(A)レバミピド、レバミピド誘導体、及びそれらの塩からなる群より選択される少なくとも1種、並びに
(B)油性成分を共存させることを含む、該局所粘膜用水性組成物にヒスタミン遊離抑制作用を付与する方法。
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JP2019518433A (ja) * | 2016-04-27 | 2019-07-04 | ソシエテ・デクスプロワタシオン・デ・プロデュイ・プール・レ・アンデュストリー・シミック・セピックSociete D’Exploitation De Produits Pour Les Industries Chimiques Seppic | 組成物の筋損傷および筋疲労を予防する能力を評価する方法;食品補助剤および医薬品 |
KR20190093551A (ko) * | 2016-12-08 | 2019-08-09 | 라이온 가부시키가이샤 | 안과용 조성물 및 그 제조 방법 |
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JP2019518433A (ja) * | 2016-04-27 | 2019-07-04 | ソシエテ・デクスプロワタシオン・デ・プロデュイ・プール・レ・アンデュストリー・シミック・セピックSociete D’Exploitation De Produits Pour Les Industries Chimiques Seppic | 組成物の筋損傷および筋疲労を予防する能力を評価する方法;食品補助剤および医薬品 |
KR20190093551A (ko) * | 2016-12-08 | 2019-08-09 | 라이온 가부시키가이샤 | 안과용 조성물 및 그 제조 방법 |
JPWO2018105681A1 (ja) * | 2016-12-08 | 2019-12-12 | ライオン株式会社 | 眼科用組成物及びその製造方法 |
JP2022001595A (ja) * | 2016-12-08 | 2022-01-06 | ライオン株式会社 | 眼科用組成物及びその製造方法 |
KR102497952B1 (ko) * | 2016-12-08 | 2023-02-09 | 라이온 가부시키가이샤 | 안과용 조성물 및 그 제조 방법 |
JP7388418B2 (ja) | 2016-12-08 | 2023-11-29 | ライオン株式会社 | 眼科用組成物及びその製造方法 |
JP2019214525A (ja) * | 2018-06-12 | 2019-12-19 | ライオン株式会社 | 水性眼科用組成物 |
JP7139703B2 (ja) | 2018-06-12 | 2022-09-21 | ライオン株式会社 | 水性眼科用組成物 |
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JP7379913B2 (ja) | 2019-08-07 | 2023-11-15 | ライオン株式会社 | ソフトコンタクトレンズ用眼科組成物及び眼科用製品 |
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