JP2015113341A5 - - Google Patents
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- Publication number
- JP2015113341A5 JP2015113341A5 JP2014063175A JP2014063175A JP2015113341A5 JP 2015113341 A5 JP2015113341 A5 JP 2015113341A5 JP 2014063175 A JP2014063175 A JP 2014063175A JP 2014063175 A JP2014063175 A JP 2014063175A JP 2015113341 A5 JP2015113341 A5 JP 2015113341A5
- Authority
- JP
- Japan
- Prior art keywords
- luliconazole
- amount
- mass
- following formula
- represented
- 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
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- YTAOBBFIOAEMLL-REQDGWNSSA-N Luliconazole Chemical compound ClC1=CC(Cl)=CC=C1[C@H](CS\1)SC/1=C(\C#N)N1C=NC=C1 YTAOBBFIOAEMLL-REQDGWNSSA-N 0.000 claims 5
- 229960000570 luliconazole Drugs 0.000 claims 5
- WVDDGKGOMKODPV-UHFFFAOYSA-N benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 229920001451 Polypropylene glycol Polymers 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 150000001408 amides Chemical class 0.000 claims 1
- 235000019445 benzyl alcohol Nutrition 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
Claims (1)
医薬製剤全量に対して、１）１〜１０質量％のルリコナゾール、２）１〜３０質量％のベンジルアルコール及び二塩基酸エステル、３）１５〜４０質量％のポリプロピレングリコールを含有させる工程、及び、
苛酷条件（６０℃３週間）での保存による、下記式（２）に示されるルリコナゾールのＳＥ体の生成量、下記式（３）に示されるルリコナゾールのＺ体の生成量、及び下記式（１）に示されるルリコナゾールのアミド体の生成量が、ルリコナゾールの配合量に対してそれぞれ０．５質量％以下であることを確認し、医薬製剤として採用する工程を含む、
医薬製剤の鑑別方法。
1) 1 to 10% by mass of luliconazole, 2) 1 to 30% by mass of benzyl alcohol and dibasic acid ester, 3) 15 to 40% by mass of polypropylene glycol based on the total amount of the pharmaceutical preparation, and
The amount of production of SE form of luliconazole represented by the following formula (2), the amount of Z form of luriconazole represented by the following formula (3), and the following formula (1) by storage under severe conditions (60 ° C. for 3 weeks) the amount of amide of luliconazole shown in) is confirmed to be 0.5 wt% or less respectively amount of luliconazole, comprising the step of employing as a pharmaceutical preparation,
A method for distinguishing pharmaceutical preparations .
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2014063175A JP5926756B2 (en) | 2014-03-26 | 2014-03-26 | Evaluation method and index substance of preparation containing luliconazole |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2014063175A JP5926756B2 (en) | 2014-03-26 | 2014-03-26 | Evaluation method and index substance of preparation containing luliconazole |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013256584A Division JP5587488B1 (en) | 2013-12-12 | 2013-12-12 | Evaluation method and index substance of preparation containing luliconazole |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2015113341A JP2015113341A (en) | 2015-06-22 |
| JP2015113341A5 true JP2015113341A5 (en) | 2016-04-21 |
| JP5926756B2 JP5926756B2 (en) | 2016-05-25 |
Family
ID=53527472
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014063175A Active JP5926756B2 (en) | 2014-03-26 | 2014-03-26 | Evaluation method and index substance of preparation containing luliconazole |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP5926756B2 (en) |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HUE029707T2 (en) * | 2007-08-27 | 2017-03-28 | Nihon Nohyaku Co Ltd | Agent for fungal dermatitis |
| JP5345937B2 (en) * | 2007-09-05 | 2013-11-20 | 株式会社ポーラファルマ | Antifungal composition |
| JP5460797B1 (en) * | 2012-09-14 | 2014-04-02 | 株式会社ポーラファルマ | Amide derivatives and their use as stability indicators |
-
2014
- 2014-03-26 JP JP2014063175A patent/JP5926756B2/en active Active
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