JP2009102310A - External cream preparation for skin - Google Patents
External cream preparation for skin Download PDFInfo
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- JP2009102310A JP2009102310A JP2008249329A JP2008249329A JP2009102310A JP 2009102310 A JP2009102310 A JP 2009102310A JP 2008249329 A JP2008249329 A JP 2008249329A JP 2008249329 A JP2008249329 A JP 2008249329A JP 2009102310 A JP2009102310 A JP 2009102310A
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- irritation
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- 238000002360 preparation method Methods 0.000 title abstract description 14
- 229960000699 terbinafine hydrochloride Drugs 0.000 claims abstract description 28
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- 239000007788 liquid Substances 0.000 claims abstract description 15
- 239000007787 solid Substances 0.000 claims abstract description 15
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- BGRXBNZMPMGLQI-UHFFFAOYSA-N 2-octyldodecyl tetradecanoate Chemical compound CCCCCCCCCCCCCC(=O)OCC(CCCCCCCC)CCCCCCCCCC BGRXBNZMPMGLQI-UHFFFAOYSA-N 0.000 claims abstract description 9
- 229940073665 octyldodecyl myristate Drugs 0.000 claims abstract description 9
- 229940116364 hard fat Drugs 0.000 claims abstract description 6
- NCLNAHJFXIKYBY-UHFFFAOYSA-N 2-hexyldecyl 16-methylheptadecanoate Chemical compound CCCCCCCCC(CCCCCC)COC(=O)CCCCCCCCCCCCCCC(C)C NCLNAHJFXIKYBY-UHFFFAOYSA-N 0.000 claims abstract description 5
- DOMXUEMWDBAQBQ-WEVVVXLNSA-N terbinafine Chemical compound C1=CC=C2C(CN(C\C=C\C#CC(C)(C)C)C)=CC=CC2=C1 DOMXUEMWDBAQBQ-WEVVVXLNSA-N 0.000 claims abstract 8
- 230000007794 irritation Effects 0.000 claims description 17
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- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 238000000034 method Methods 0.000 claims description 2
- 150000003626 triacylglycerols Chemical class 0.000 claims 1
- 206010040880 Skin irritation Diseases 0.000 abstract description 10
- 231100000475 skin irritation Toxicity 0.000 abstract description 10
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- 230000035945 sensitivity Effects 0.000 abstract description 2
- 239000002085 irritant Substances 0.000 abstract 1
- BWMISRWJRUSYEX-SZKNIZGXSA-N terbinafine hydrochloride Chemical compound Cl.C1=CC=C2C(CN(C\C=C\C#CC(C)(C)C)C)=CC=CC2=C1 BWMISRWJRUSYEX-SZKNIZGXSA-N 0.000 description 22
- 230000000052 comparative effect Effects 0.000 description 9
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- NOOLISFMXDJSKH-KXUCPTDWSA-N (-)-Menthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O NOOLISFMXDJSKH-KXUCPTDWSA-N 0.000 description 3
- 229940121363 anti-inflammatory agent Drugs 0.000 description 3
- 239000002260 anti-inflammatory agent Substances 0.000 description 3
- 239000003429 antifungal agent Substances 0.000 description 3
- 238000013329 compounding Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- XMAYWYJOQHXEEK-ZEQKJWHPSA-N (2S,4R)-ketoconazole Chemical compound C1CN(C(=O)C)CCN1C(C=C1)=CC=C1OC[C@H]1O[C@](CN2C=NC=C2)(C=2C(=CC(Cl)=CC=2)Cl)OC1 XMAYWYJOQHXEEK-ZEQKJWHPSA-N 0.000 description 2
- MPDGHEJMBKOTSU-YKLVYJNSSA-N 18beta-glycyrrhetic acid Chemical compound C([C@H]1C2=CC(=O)[C@H]34)[C@@](C)(C(O)=O)CC[C@]1(C)CC[C@@]2(C)[C@]4(C)CC[C@@H]1[C@]3(C)CC[C@H](O)C1(C)C MPDGHEJMBKOTSU-YKLVYJNSSA-N 0.000 description 2
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 2
- 206010015150 Erythema Diseases 0.000 description 2
- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 description 2
- 206010030113 Oedema Diseases 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
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- 230000015572 biosynthetic process Effects 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 231100000321 erythema Toxicity 0.000 description 2
- 239000003925 fat Substances 0.000 description 2
- 229960004194 lidocaine Drugs 0.000 description 2
- 239000003589 local anesthetic agent Substances 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 201000009862 superficial mycosis Diseases 0.000 description 2
- 201000004647 tinea pedis Diseases 0.000 description 2
- 229940100611 topical cream Drugs 0.000 description 2
- DSSYKIVIOFKYAU-XCBNKYQSSA-N (R)-camphor Chemical compound C1C[C@@]2(C)C(=O)C[C@@H]1C2(C)C DSSYKIVIOFKYAU-XCBNKYQSSA-N 0.000 description 1
- -1 2-hexyldecyl Chemical group 0.000 description 1
- 206010017533 Fungal infection Diseases 0.000 description 1
- 241000237858 Gastropoda Species 0.000 description 1
- MPDGHEJMBKOTSU-UHFFFAOYSA-N Glycyrrhetinsaeure Natural products C12C(=O)C=C3C4CC(C)(C(O)=O)CCC4(C)CCC3(C)C1(C)CCC1C2(C)CCC(O)C1(C)C MPDGHEJMBKOTSU-UHFFFAOYSA-N 0.000 description 1
- BIVBRWYINDPWKA-VLQRKCJKSA-L Glycyrrhizinate dipotassium Chemical compound [K+].[K+].O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C([O-])=O)[C@@H]1O[C@H](C([O-])=O)[C@@H](O)[C@H](O)[C@H]1O BIVBRWYINDPWKA-VLQRKCJKSA-L 0.000 description 1
- VTAJIXDZFCRWBR-UHFFFAOYSA-N Licoricesaponin B2 Natural products C1C(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2)C(O)=O)C)(C)CC2)(C)C2C(C)(C)CC1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O VTAJIXDZFCRWBR-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 229960001747 cinchocaine Drugs 0.000 description 1
- PUFQVTATUTYEAL-UHFFFAOYSA-N cinchocaine Chemical compound C1=CC=CC2=NC(OCCCC)=CC(C(=O)NCCN(CC)CC)=C21 PUFQVTATUTYEAL-UHFFFAOYSA-N 0.000 description 1
- 239000013065 commercial product Substances 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 229940101029 dipotassium glycyrrhizinate Drugs 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
- 229960003720 enoxolone Drugs 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 208000024386 fungal infectious disease Diseases 0.000 description 1
- LPLVUJXQOOQHMX-UHFFFAOYSA-N glycyrrhetinic acid glycoside Natural products C1CC(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2=O)C(O)=O)C)(C)CC2)(C)C2C(C)(C)C1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O LPLVUJXQOOQHMX-UHFFFAOYSA-N 0.000 description 1
- 229960004949 glycyrrhizic acid Drugs 0.000 description 1
- UYRUBYNTXSDKQT-UHFFFAOYSA-N glycyrrhizic acid Natural products CC1(C)C(CCC2(C)C1CCC3(C)C2C(=O)C=C4C5CC(C)(CCC5(C)CCC34C)C(=O)O)OC6OC(C(O)C(O)C6OC7OC(O)C(O)C(O)C7C(=O)O)C(=O)O UYRUBYNTXSDKQT-UHFFFAOYSA-N 0.000 description 1
- 239000001685 glycyrrhizic acid Substances 0.000 description 1
- 235000019410 glycyrrhizin Nutrition 0.000 description 1
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 description 1
- NFLGAXVYCFJBMK-UHFFFAOYSA-N isomenthone Natural products CC(C)C1CCC(C)CC1=O NFLGAXVYCFJBMK-UHFFFAOYSA-N 0.000 description 1
- 229960004125 ketoconazole Drugs 0.000 description 1
- 230000007721 medicinal effect Effects 0.000 description 1
- 229940064438 nizoral Drugs 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229960004919 procaine Drugs 0.000 description 1
- MFDFERRIHVXMIY-UHFFFAOYSA-N procaine Chemical compound CCN(CC)CCOC(=O)C1=CC=C(N)C=C1 MFDFERRIHVXMIY-UHFFFAOYSA-N 0.000 description 1
- 239000002884 skin cream Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
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Abstract
Description
本発明は、皮膚外用クリーム剤に関し、詳しくは塩酸テルビナフィンの刺激を低減させた皮膚外用クリーム剤である。 The present invention relates to a cream for external use of skin, and in particular, is a cream for external use of skin with reduced irritation of terbinafine hydrochloride.
近年、医薬品や化粧品等の外用剤の安全性に対する生活者の関心は高く、より低刺激な製品の開発が望まれており、低刺激を謳った製品も多数上市されている。このことは、抗真菌外用クリーム剤についても同様であり、より低刺激のクリーム剤が望まれている。 In recent years, consumers are highly interested in the safety of external preparations such as pharmaceuticals and cosmetics, and development of products with lower irritation is desired. Many products with less irritation have been put on the market. This is the same for the antifungal topical cream, and a cream with less irritation is desired.
抗真菌外用クリーム剤の適用疾患である水虫は、完治するまで継続して塗布を続けることが必要であり、継続使用のためには薬剤の使用感が重要である。 The athlete's foot, which is a disease for which an antifungal topical cream is applied, needs to be continuously applied until it is completely cured, and the feeling of use of the drug is important for continued use.
塩酸テルビナフィンは現在汎用されている抗真菌剤の一つであり、種々真菌症に有用であるため、浅在性真菌症などの外用抗真菌クリーム剤として、広く用いられている。 Terbinafine hydrochloride is one of the currently used antifungal agents and is widely used as an antifungal cream for external use such as superficial mycosis because it is useful for various mycosis.
従来、塩酸テルビナフィンを配合した抗真菌医薬組成物において、ハードファット及びミリスチン酸オクチルドデシルなどが配合可能な成分として列記記載されている例（特許文献１参照）はあるが塩酸テルビナフィンの刺激低減効果については何ら開示も示唆もされていない。 Conventionally, in an antifungal pharmaceutical composition containing terbinafine hydrochloride, there are examples (see Patent Document 1) listed as hard fats, octyldodecyl myristate, and the like that can be added, but the effect of terbinafine hydrochloride on reducing the irritation Is not disclosed or suggested.
また、抗真菌剤であるケトコナゾールを配合した医療用医薬品（ニゾラールクリーム：登録商標）では添加物としてハードファットが配合されている。さらにミリスチン酸オクチルドデシルは抗真菌剤に配合されている例が多数ある。しかしながら、塩酸テルビナフィンを配合した製剤にそれらの成分が同時に配合されたことはない。 In addition, a hard fat is added as an additive in an ethical drug (Nizoral Cream: registered trademark) containing ketoconazole which is an antifungal agent. In addition, there are many examples where octyldodecyl myristate is blended in antifungal agents. However, these components have never been blended in a formulation blended with terbinafine hydrochloride.
本発明者らは、市販されている塩酸テルビナフィン含有クリーム剤は、皮膚刺激のポテンシャルが比較的高く、肌の感受性の高い人では、皮膚刺激の懸念があることを見出した。 The present inventors have found that commercially available terbinafine hydrochloride-containing creams have a relatively high potential for skin irritation, and there is a concern about skin irritation in people with high skin sensitivity.
本発明の目的は、塩酸テルビナフィンを含有した、より低刺激な外用クリーム剤を提供することにある。 An object of the present invention is to provide a less irritating cream for external use containing terbinafine hydrochloride.
本発明者らは、課題を解決するために種々検討した結果、塩酸テルビナフィンを配合したクリーム剤に、低極性液体エステル油及び固形トリグリセリドを同時に配合することにより、塩酸テルビナフィンの皮膚刺激が低減されることを見出し、本発明を完成した。 As a result of various studies to solve the problems, the present inventors have reduced the skin irritation of terbinafine hydrochloride by simultaneously blending a low polar liquid ester oil and solid triglyceride into a cream formulated with terbinafine hydrochloride. As a result, the present invention has been completed.
すなわち本発明は、
（１）塩酸テルビナフィン、低極性液体エステル油及び固形トリグリセリドを配合することを特徴とする外用クリーム剤、
（２）固形トリグリセリドがハードファットである（１）記載の外用クリーム剤、
（３）低極性液体エステル油がミリスチン酸オクチルドデシル及びイソステアリン酸２−ヘキシルデシルから選ばれる１種又は２種である（１）又は（２）に記載の外用クリーム剤、
（４）塩酸テルビナフィンの配合量が外用クリーム剤全体の０．２〜２質量％である（１）〜（３）のいずれかに記載の外用クリーム剤、
（５）低極性液体エステル油及び固形トリグリセリドを含有する塩酸テルビナフィンの刺激低減剤、
（６）塩酸テルビナフィン配合外用クリーム剤において、低極性液体エステル油及び固形トリグリセリドを配合してクリーム剤を製造することを特徴とする塩酸テルビナフィンの刺激を低減する方法、である。
That is, the present invention
(1) A cream for external use comprising terbinafine hydrochloride, a low polar liquid ester oil and solid triglyceride,
(2) The external cream according to (1), wherein the solid triglyceride is hard fat,
(3) The external cream according to (1) or (2), wherein the low polar liquid ester oil is one or two selected from octyldodecyl myristate and 2-hexyldecyl isostearate,
(4) The external cream according to any one of (1) to (3), wherein the amount of terbinafine hydrochloride is 0.2 to 2% by mass of the total external cream,
(5) An agent for reducing irritation of terbinafine hydrochloride containing a low polarity liquid ester oil and solid triglyceride,
(6) A method for reducing irritation of terbinafine hydrochloride, characterized in that a cream agent is produced by blending low polar liquid ester oil and solid triglyceride in terbinafine hydrochloride external preparation cream.
本発明により塩酸テルビナフィンの刺激を抑制することができた。 According to the present invention, the stimulation of terbinafine hydrochloride could be suppressed.
本発明において、塩酸テルビナフィンの配合量は、外用クリーム剤全体の０．２〜２質量％であり、好ましくは０．５〜１．５質量％である。０．２質量％未満であると薬効が不十分になり、２質量％を超えて配合すると、安定に溶解した状態を保つのが難しくなるからである。 In this invention, the compounding quantity of terbinafine hydrochloride is 0.2-2 mass% of the whole external cream, Preferably it is 0.5-1.5 mass%. This is because if it is less than 0.2% by mass, the medicinal effect becomes insufficient, and if it exceeds 2% by mass, it is difficult to maintain a stable dissolved state.
本発明で低極性液体エステル油とは、ＩＯＢ値（Inorganic Organic Balance値）０．１未満である常温（２５℃）で液体のエステル油のことであるが、好ましいものとしてミリスチン酸オクチルドデシル及びイソステアリン酸２−ヘキシルデシルがあげられ、最も好ましいものとしてミリスチン酸オクチルドデシルをあげることができる。ここでいうＩＯＢ値は、文献[甲田善生，「有機概念図―基礎と応用」，三共出版（１９８４）]に基づいて、有機性値と無機性値を求め、無機性値／有機性値により求められる数値である。 In the present invention, the low polar liquid ester oil is an ester oil that is liquid at room temperature (25 ° C.) having an IOB value (Inorganic Organic Balance value) of less than 0.1, and octyldodecyl myristate and isostearin are preferred. The acid 2-hexyldecyl is exemplified, and octyldodecyl myristate is most preferable. The IOB value here is based on the literature [Yoshio Koda, “Organic Conceptual Diagram-Fundamentals and Applications”, Sankyo Publishing (1984)]. The organic value and the inorganic value are obtained from the inorganic value / organic value. This is the desired value.
本発明の低極性液体エステル油の配合量は製剤全体の２〜２０質量％であり、好ましくは３〜１０質量％である。低極性液体エステル油を過剰に配合すると、皮膚塗布時にべたつき、使用感が悪くなり、配合量が少ないと製剤が固くなり使用感が低下するからである。本発明では２種類以上の低極性液体エステル油を混合して用いることもできる。 The compounding quantity of the low polar liquid ester oil of this invention is 2-20 mass% of the whole preparation, Preferably it is 3-10 mass%. This is because when the low-polar liquid ester oil is excessively blended, it becomes sticky when applied to the skin and the feeling of use becomes worse, and when the blending amount is small, the preparation becomes hard and the feeling of use is lowered. In the present invention, two or more kinds of low polar liquid ester oils can be mixed and used.
本発明で固形トリグリセリドとは、飽和脂肪酸のトリグリセリドを主成分とする、常温（２５℃）において固体の油脂のことであるが、好ましいものとしてハードファットをあげることができる。 In the present invention, solid triglyceride is a fat or oil that is solid fatty acid triglyceride as a main component and is solid at room temperature (25 ° C.), and a hard fat is preferable.
本発明で固形トリグリセリドの配合量は、製剤全体の２〜１０質量％が好ましく、３〜７質量％がさらに好ましい。固形トリグリセリドを過剰に配合すると、製剤が固くなりすぎ使用感が悪くなり、配合量が少ないと刺激の低減効果が十分得られないからである。 In the present invention, the amount of the solid triglyceride is preferably 2 to 10% by mass, more preferably 3 to 7% by mass, based on the whole preparation. This is because if the solid triglyceride is added excessively, the preparation becomes too hard and the feeling of use becomes worse, and if the amount is too small, the effect of reducing irritation cannot be obtained sufficiently.
本発明の皮膚外用クリーム剤は、塩酸テルビナフィンの佐薬として、通常局所麻酔剤、抗炎症剤、清涼化剤からなる群から選択される２種以上の薬物を含有する。この佐薬を配合することにより、浅在性真菌症の症状をより緩和することができる。 The external skin cream of the present invention contains two or more drugs selected from the group consisting of a local anesthetic, an anti-inflammatory agent, and a refreshing agent as an adjuvant for terbinafine hydrochloride. By blending this adjuvant, the symptoms of superficial mycosis can be further alleviated.
局所麻酔剤としては、例えばリドカイン、ジブカイン、プロカイン及びそれらの塩があげられ、製剤上好ましくはリドカインが選択される。配合量は、効能の観点から、通常、製剤全体の０．１〜５質量％であり、好ましくは０．５〜３質量％である。 Examples of the local anesthetic include lidocaine, dibucaine, procaine and salts thereof, and lidocaine is preferably selected in terms of formulation. The blending amount is usually 0.1 to 5% by mass, preferably 0.5 to 3% by mass of the whole preparation from the viewpoint of efficacy.
抗炎症剤としては、例えばグリチルリチン酸、グリチルレチン酸及びそれらの塩が挙げられ、製剤上好ましくはグリチルリチン酸２カリウムが選択される。抗炎症剤の配合量は、効能の観点から、通常、製剤全体の０．０５〜２質量％であり、好ましくは０．１〜１質量％である。 Examples of the anti-inflammatory agent include glycyrrhizic acid, glycyrrhetinic acid, and salts thereof, and dipotassium glycyrrhizinate is preferably selected for formulation. From the viewpoint of efficacy, the compounding amount of the anti-inflammatory agent is usually 0.05 to 2% by mass, preferably 0.1 to 1% by mass, based on the whole preparation.
清涼化剤としては、例えばｌ-メントール、dl-カンフル、dl-メントールがあげられ、製剤上好ましくはｌ-メントールが選択される。配合量は、効能の観点から、通常、０．１〜５質量％であり、好ましくは０．５〜３質量％である。 Examples of the refreshing agent include l-menthol, dl-camphor, and dl-menthol, and l-menthol is preferably selected in terms of formulation. The blending amount is usually 0.1 to 5% by mass, preferably 0.5 to 3% by mass, from the viewpoint of efficacy.
本発明の組成物は、必要に応じて通常の添加剤、他の有効成分などを混合して常法により、後述の実施例のようなクリーム剤とすることができる。 The composition of the present invention can be made into creams as in the examples described later by mixing conventional additives, other active ingredients and the like as required, by a conventional method.
以下実施例および試験例により、本発明を詳細に説明する。
実施例
表１−１〜１−４に示した処方で、常法により実施例１〜１２及び比較例１〜５のクリーム剤を得た。
Hereinafter, the present invention will be described in detail by way of examples and test examples.
Examples Creams of Examples 1 to 12 and Comparative Examples 1 to 5 were obtained by a conventional method with the formulations shown in Tables 1-1 to 1-4.
試験例（製剤の局所刺激性試験）
（試験方法）
毛を刈ったウサギ背部皮膚に製剤０．１ｇを、１日１回所定の期間連続塗布し、各塗布の２４時間後に製剤をふき取り、皮膚変化を毎日観察した。判定は紅斑及び浮腫形成を以下の表に示したDraizeの判定基準に従い行った。紅斑及び浮腫形成の各スコアの合計を刺激スコアとした。
Test example (local irritation test of drug product)
(Test method)
0.1 g of the preparation was continuously applied once a day for a predetermined period once to the skin on the back of the rabbit whose hair was cut, and the preparation was wiped off 24 hours after each application, and skin changes were observed daily. Judgment was performed according to the Draize criteria shown in the table below for erythema and edema formation. The total score of erythema and edema formation was taken as the stimulation score.
試験例１
塩酸テルビナフィン１％含有市販品クリーム剤と比較例１を上記試験方法により試験した。期間は、１４日間観察した。
Test example 1
A commercial product cream containing 1% terbinafine hydrochloride and Comparative Example 1 were tested by the above test method. The period was observed for 14 days.
結果を図１に示した。 The results are shown in FIG.
図から明らかな通り、塩酸テルビナフィン１％含有市販品クリーム剤と比較例１のスコアに大きな違いは無かった。 As is clear from the figure, there was no significant difference between the scores of the commercial cream containing 1% terbinafine hydrochloride and Comparative Example 1.
試験例２
比較例１〜４を上記試験方法により試験した。期間は、１０日間観察した。
Test example 2
Comparative Examples 1 to 4 were tested by the above test method. The period was observed for 10 days.
結果を図２に示した。 The results are shown in FIG.
試験の結果、ミリスチン酸オクチルドデシルを配合した処方（比較例４）のスコアが他に比べてやや低かった。 As a result of the test, the score of the formulation (Comparative Example 4) containing octyldodecyl myristate was slightly lower than the others.
試験例３
比較例１及び５を上記試験方法により試験した。期間は、２８日間観察した。
Test example 3
Comparative Examples 1 and 5 were tested by the above test method. The period was observed for 28 days.
結果を図３に示した。 The results are shown in FIG.
試験の結果、比較例１及び５のスコアに違いは無かった。 As a result of the test, there was no difference in the scores of Comparative Examples 1 and 5.
試験例４
実施例２、比較例１及び比較例４を上記試験方法により試験した。期間は、２８日間観察した。
Test example 4
Example 2, Comparative Example 1 and Comparative Example 4 were tested by the above test method. The period was observed for 28 days.
結果を図４に示した。 The results are shown in FIG.
試験の結果、ミリスチン酸オクチルドデシルを配合することにより刺激が低減され、さらにハードファットを配合した本発明の処方にすることにより、さらに刺激を低減させることができることが明らかになった。 As a result of the test, it has been clarified that the irritation is reduced by adding octyldodecyl myristate, and the irritation can be further reduced by using the formulation of the present invention containing hard fat.
本発明により塩酸テルビナフィン含有クリーム剤の皮膚刺激が低減されたので、水虫、いんきんたむし、ぜにたむしなどの治療に用いる医薬品として利用可能である。 Since the skin irritation of the terbinafine hydrochloride-containing cream is reduced according to the present invention, it can be used as a pharmaceutical used for the treatment of athlete's foot, snails, and sores.
Claims (6)
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103386058A (en) * | 2013-07-02 | 2013-11-13 | 袁娟 | Medicament for treating tinea cruris and preparation method |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH09309827A (en) * | 1996-05-22 | 1997-12-02 | Pola Chem Ind Inc | Antifungal agent for external use |
| JP2004520408A (en) * | 2001-02-28 | 2004-07-08 | ネオファーム シーオーエルティディ | Multi-layered emulsion for stabilizing skin useful substances and base for skin external preparation for treating a wide range of skin diseases using the same |
| JP2005104924A (en) * | 2003-09-30 | 2005-04-21 | Kobayashi Pharmaceut Co Ltd | External pharmaceutical composition |
| JP2007008893A (en) * | 2005-07-01 | 2007-01-18 | Rohto Pharmaceut Co Ltd | Antimycotic medicinal composition |
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2008
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH09309827A (en) * | 1996-05-22 | 1997-12-02 | Pola Chem Ind Inc | Antifungal agent for external use |
| JP2004520408A (en) * | 2001-02-28 | 2004-07-08 | ネオファーム シーオーエルティディ | Multi-layered emulsion for stabilizing skin useful substances and base for skin external preparation for treating a wide range of skin diseases using the same |
| JP2005104924A (en) * | 2003-09-30 | 2005-04-21 | Kobayashi Pharmaceut Co Ltd | External pharmaceutical composition |
| JP2007008893A (en) * | 2005-07-01 | 2007-01-18 | Rohto Pharmaceut Co Ltd | Antimycotic medicinal composition |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103386058A (en) * | 2013-07-02 | 2013-11-13 | 袁娟 | Medicament for treating tinea cruris and preparation method |
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