JP2011213667A - 医薬用組成物 - Google Patents
医薬用組成物 Download PDFInfo
- Publication number
- JP2011213667A JP2011213667A JP2010084103A JP2010084103A JP2011213667A JP 2011213667 A JP2011213667 A JP 2011213667A JP 2010084103 A JP2010084103 A JP 2010084103A JP 2010084103 A JP2010084103 A JP 2010084103A JP 2011213667 A JP2011213667 A JP 2011213667A
- Authority
- JP
- Japan
- Prior art keywords
- eye
- pharmaceutical composition
- berberine
- vitamin
- sodium
- 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
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 40
- 208000003464 asthenopia Diseases 0.000 claims abstract description 38
- 150000003839 salts Chemical class 0.000 claims abstract description 26
- YBHILYKTIRIUTE-UHFFFAOYSA-N berberine Chemical compound C1=C2CC[N+]3=CC4=C(OC)C(OC)=CC=C4C=C3C2=CC2=C1OCO2 YBHILYKTIRIUTE-UHFFFAOYSA-N 0.000 claims abstract description 24
- QISXPYZVZJBNDM-UHFFFAOYSA-N berberine Natural products COc1ccc2C=C3N(Cc2c1OC)C=Cc4cc5OCOc5cc34 QISXPYZVZJBNDM-UHFFFAOYSA-N 0.000 claims abstract description 24
- 229940093265 berberine Drugs 0.000 claims abstract description 24
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- AGVAZMGAQJOSFJ-WZHZPDAFSA-M cobalt(2+);[(2r,3s,4r,5s)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2r)-1-[3-[(1r,2r,3r,4z,7s,9z,12s,13s,14z,17s,18s,19r)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2 Chemical compound [Co+2].N#[C-].[N-]([C@@H]1[C@H](CC(N)=O)[C@@]2(C)CCC(=O)NC[C@@H](C)OP(O)(=O)O[C@H]3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)\C2=C(C)/C([C@H](C\2(C)C)CCC(N)=O)=N/C/2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O AGVAZMGAQJOSFJ-WZHZPDAFSA-M 0.000 claims abstract description 18
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Abstract
【解決手段】ビタミンB12と、ベルベリン及び/又はその塩とを含有することを特徴とする医薬用組成物。
【選択図】なし
Description
上記医薬用組成物は、25℃における粘度が1〜60cpであることが好ましい。
上記医薬用組成物は、眼科用剤であることが好ましい。また、上記医薬用組成物は、眼精疲労改善剤であることが好ましい。
本発明において、ビタミンB12はコリン環の中にコバルトイオンを含む構造を持つ水溶性ビタミンである。ビタミンB12としては、コバルトイオンに対する配位子の種類により、シアノコバラミン、ヒドロキソコバラミン、アデノシルコバラミン、メチルコバラミン、アココバラミン、ニトリトコバラミン、スルフィトコバラミン等が存在することが知られているが、本発明では、いずれの形態をも用いることができる。また、これら化合物の有機塩又は無機塩もビタミンB12として用いることができる(以下、これらを合わせて「ビタミンB12類」とも称する)。なかでも、眼精疲労改善効果に優れるという点から、シアノコバラミン、メチルコバラミン(メコバラミン)、酢酸ヒドロキソコバラミン、塩酸ヒドロキソコバラミンが好ましい。これらのビタミンB12類は、単独で用いてもよく、2種以上を併用してもよい。
本発明の医薬用組成物は、その剤形は特に限定されないが、例えば、液剤、ゲル剤、軟膏剤(油脂性軟膏、乳剤性軟膏、水溶性軟膏)、散剤、顆粒剤、錠剤などがあげられ、用途に応じて適宜選択され得る。
本発明において、医薬用組成物の粘度は、実施例にも記載しているとおり、B型粘度計であるデジタル粘度計(型名:DV−II+、ブルックフィールド社製)を用い、スピンドルはULAを用いて、回転数6〜30rpm、液温25℃の条件で行った。
試験例1 眼精疲労度の評価(1)
(医薬用組成物(洗眼薬)の調製)
表1に示す処方に従い、各成分を滅菌精製水に溶解し、実施例1〜3及び比較例1〜3の医薬用組成物を調製した。pHは6.0に調整した。実施例1は、実施例2の組成にHPMC(ヒドロキシプロピルメチルセルロース)(信越化学工業株式会社製「メトローズ60SH−4000」)を適量加え、粘度が3cpとなるように調製した。
調製した洗眼薬の眼精疲労改善効果を以下の測定機器、測定指標、方法、判定基準により評価した。
測定機器:
調節微動解析装置MF−1(株式会社ライト製作所製)
測定指標:
眼精疲労度をHFC(High Frequency Component)で評価する(HFC値が大きいほど疲労度が高いことを示す)。なお、焦点距離40cmの値を採用する。
方法:
(1)被験者の眼精疲労度を測定する(初期値)。
(2)眼精疲労負荷をかける(15分間のVDT作業)。
(3)各組成物5mLを用い、洗眼を行う。
(4)被験者の眼精疲労度を測定する(洗眼後の測定値)。
洗眼に使用する洗眼カップは、「アイボン」(小林製薬株式会社製)に付属の洗眼カップを使用した。なお、(3)で洗眼を行わない場合の評価も行う(無処置)。
判定基準:
無処置時(VDT作業後無処置での測定値/初期値)×100と、各組成物使用時(各組成物の洗眼後の測定値/初期値)×100との差を算出し、眼精疲労改善効果を求める。
比較例3の眼精疲労改善効果の値を100%(基準)とし、これに対する各例の値(相対的改善効果(%))を算出した。
医薬用組成物(洗眼薬及び点眼薬)の調製
(洗眼薬の調製)
実施例4〜14は、表1の実施例2の組成にHPMC(ヒドロキシプロピルメチルセルロース)(信越化学工業株式会社製「メトローズ60SH−4000」)を適量加え、表2に記載の粘度となるように調製した。また、比較例4および5は、実施例5において、それぞれシアノコバラミン又は塩化ベルベリンを配合しない以外は同様に調製した。
(点眼薬の調製)
表2に記載の成分(シアノコバラミンおよび塩化ベルベリン)を10倍濃度とした以外は、上記洗眼薬と同様に調製した。
調製した洗眼薬及び点眼薬の眼精疲労改善効果について、眼精疲労の自覚症状のあるパネラー10名がそれぞれ点眼(1回使用量:2滴)と洗眼(1回使用量:5mL)を、3時間おきに3回行い、以下の方法、判定基準により評価した。
方法:
各組成物を使用(点眼又は洗眼)した後の眼精疲労改善度合いを使用前と比較し、下記5段階でそれぞれ評価する。
5点:改善した。
4点:やや改善した。
3点:どちらともいえない。
2点:あまり改善しなかった。
1点:改善しなかった。
判定基準:
点眼及び洗眼のそれぞれについて10人の合計点を算出し、下記基準で判定する。
◎:41〜50点
○:31〜40点
△:30点以下
表3〜11に示す処方に従い、常法により、医薬用組成物(洗眼薬)を調製し(pHは6.0に調整した)、無菌環境下、ろ過滅菌処理し、洗浄滅菌済みの透明容器(ポリエチレンテレフタレート)に充填し、製造した。
また、表3〜9に示す処方におけるビタミンB12類およびベルベリン類の配合量を10倍量とした医薬組成物(点眼薬)を調製し、無菌環境下、ろ過滅菌処理し、洗浄滅菌済みの透明容器(ポリエチレンテレフタレート)に充填し、製造した。
Claims (4)
- ビタミンB12と、ベルベリン及び/又はその塩とを含有することを特徴とする医薬用組成物。
- 25℃における粘度が1〜60cpである請求項1記載の医薬用組成物。
- 眼科用剤である請求項1又は2記載の医薬用組成物。
- 眼精疲労改善剤である請求項1〜3のいずれかに記載の医薬用組成物。
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JP2020196670A (ja) * | 2019-05-31 | 2020-12-10 | 小林製薬株式会社 | 水性組成物 |
JP2020196671A (ja) * | 2019-05-31 | 2020-12-10 | 小林製薬株式会社 | ビタミンb12類の光安定化方法 |
CN115350201A (zh) * | 2021-08-26 | 2022-11-18 | 南京纽邦生物科技有限公司 | 小檗碱及其衍生物与维生素b12的组合 |
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JP2020196670A (ja) * | 2019-05-31 | 2020-12-10 | 小林製薬株式会社 | 水性組成物 |
JP2020196671A (ja) * | 2019-05-31 | 2020-12-10 | 小林製薬株式会社 | ビタミンb12類の光安定化方法 |
JP7270465B2 (ja) | 2019-05-31 | 2023-05-10 | 小林製薬株式会社 | ビタミンb12類の光安定化方法 |
JP7368108B2 (ja) | 2019-05-31 | 2023-10-24 | 小林製薬株式会社 | 水性組成物 |
CN115350201A (zh) * | 2021-08-26 | 2022-11-18 | 南京纽邦生物科技有限公司 | 小檗碱及其衍生物与维生素b12的组合 |
US20230067847A1 (en) * | 2021-08-26 | 2023-03-02 | Nanjing Nutrabuilding Bio-Tech Co., Ltd. | Combination of berberine and derivatives thereof, and vitamin b12 |
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