JP2005306810A - Composition for ameliorating damaged skin - Google Patents
Composition for ameliorating damaged skin Download PDFInfo
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Abstract
Description
本発明は、経時的な製剤の稠度上昇が抑制された糖及びポビドンヨード(ポリビニルピロリドン−ヨード錯体、Poly((2−oxopyrrolidin−1−yl)ethylene)iodine)を含有する損傷皮膚修復用組成物に関する。 The present invention relates to a composition for repairing damaged skin, comprising a sugar and povidone iodine (polyvinylpyrrolidone-iodo complex, Poly ((2-oxopyrrolidin-1-yl) ethylene) iodine) in which the increase in the consistency of the preparation over time is suppressed. .
白糖等の糖は創傷治癒作用、肉芽形成作用を有することから、ポビドンヨードと混合して褥瘡や皮膚潰瘍等の損傷皮膚の治療用製剤として使用されている(例えば、特許文献1〜2、非特許文献1〜2)。
しかし、糖及びポビドンヨードを含有する損傷皮膚修復用組成物(以下、軟膏剤と記載することもある。)は、その大半を糖で占めるため、糖固有の性質である経時的に固くなる性質を有しており、医療現場でガーゼ等の上に展延して使用する場合には、固くなった軟膏剤を撹拌し柔らかくしてから使用する必要があり、医療関係者に煩雑な手間と時間が必要であった。
Since sugars such as sucrose have wound healing action and granulation action, they are mixed with povidone iodine and used as preparations for treating damaged skin such as pressure ulcers and skin ulcers (for example, Patent Documents 1 and 2, Non-Patent Documents) Literatures 1-2).
However, the composition for repairing damaged skin containing sugar and povidone iodine (hereinafter sometimes referred to as an ointment) occupies most of it with sugar, and therefore has a property of becoming harder with time, which is an inherent property of sugar. It is necessary to use it after spreading it on gauze etc. at the medical site and stirring it until it is softened. Was necessary.
この経時的に稠度が上昇し固くなる欠点を改善する方法として、平均粒径の異なる2種以上の粉末糖を配合する方法(特許文献3)、不揮発性溶剤及びヒドロキシ低級アルキルアミンを配合する方法(特許文献4)等が知られているが、未だ充分ではない。
糖及びポビドンヨードを含有する損傷皮膚修復用組成物の稠度を低下させる他の方法としては、高分子基剤の配合量を低減するか又はこれを配合しないことが考えられるが、いずれも経時的に製剤成分が分離してしまい好ましくない。
As a method of improving the defect that the consistency increases and hardens over time, a method of blending two or more powdered sugars having different average particle diameters (Patent Document 3), a method of blending a non-volatile solvent and a hydroxy lower alkylamine (Patent Document 4) and the like are known, but are not sufficient.
As another method for reducing the consistency of the composition for repairing damaged skin containing sugar and povidone iodine, it is conceivable to reduce the blending amount of the polymer base or not to blend it, but all of them are over time. The formulation components are separated, which is not preferable.
また、製剤の形態を散剤としたものは、粉であるため患部への使用が困難であり、更に飛散して周囲の汚れを引き起こしたりする。 Moreover, since the powder form of the preparation is a powder, it is difficult to use it on the affected part, and it is further scattered to cause surrounding dirt.
そこで、経時的に稠度が上昇せず固くならない糖及びポビドンヨードを含有する損傷皮膚修復用組成物の開発が求められている。
本発明の目的は、経時的な稠度の上昇が抑制された糖及びポビドンヨードを含有する損傷皮膚修復用組成物を提供することにある。 An object of the present invention is to provide a composition for repairing damaged skin, which contains sugar and povidone iodine whose increase in consistency over time is suppressed.
本発明者らは、以上の点を考慮して鋭意検討を行った結果、全く意外にも糖、ポビドンヨード及び水を含有する系に一定量の炭化水素系油剤を配合することにより、経時的な稠度の上昇が抑制され、かつ安定性の良好な糖及びポビドンヨードを含有する損傷皮膚修復用組成物が得られることを見出し、本発明を完成した。 As a result of intensive studies in view of the above points, the inventors of the present invention unexpectedly blended a certain amount of a hydrocarbon-based oil into a system containing sugar, povidone iodine and water over time. The present inventors have found that a composition for repairing damaged skin containing sugar and povidone iodine, which suppresses the increase in consistency and has good stability, can be obtained.
すなわち、本発明は糖50〜90重量%、ポビドンヨード0.5〜10重量%、水0.1〜20重量%及び炭化水素系油剤1〜15重量%を含有することを特徴とする損傷皮膚修復用組成物を提供するものである。 That is, the present invention contains 50 to 90% by weight of sugar, 0.5 to 10% by weight of povidone iodine, 0.1 to 20% by weight of water and 1 to 15% by weight of a hydrocarbon-based oil agent, The composition for use is provided.
本発明の糖及びポビドンヨードを含有する損傷皮膚修復用組成物は、経時的な稠度の上昇が抑制され、使用が容易であって、更に製剤が軟らかく、深い傷口、肉芽面等への適用性に優れる。 The composition for repairing damaged skin containing the sugar and povidone iodine of the present invention is suppressed in the increase in consistency over time, is easy to use, has a softer formulation, and is applicable to deep wounds, granulation surfaces, etc. Excellent.
本発明に用いる糖は、非還元糖又は還元糖であって、例えば白糖(精製白糖も含む)、グルコース、蜂蜜、糖蜜等が挙げられ、特に白糖が好ましい。 The sugar used in the present invention is a non-reducing sugar or a reducing sugar, and examples thereof include sucrose (including purified sucrose), glucose, honey, molasses, and the like, and sucrose is particularly preferable.
本発明において糖の配合量は、製剤全量に対して50〜90重量%で、好ましくは60〜80重量%であり、特に好ましくは70重量%である。 In the present invention, the amount of sugar is 50 to 90% by weight, preferably 60 to 80% by weight, particularly preferably 70% by weight, based on the total amount of the preparation.
本発明においてポビドンヨードの配合量は、製剤全量に対して0.5〜10重量%で、好ましくは1〜7重量%であり、特に好ましくは2〜6重量%である。 In the present invention, the compounding amount of povidone iodine is 0.5 to 10% by weight, preferably 1 to 7% by weight, particularly preferably 2 to 6% by weight, based on the total amount of the preparation.
本発明において水の配合量は、製剤全量に対して0.1〜20重量%で、好ましくは0.3〜15重量%であり、特に好ましくは0.5〜12重量%である。 In the present invention, the amount of water is 0.1 to 20% by weight, preferably 0.3 to 15% by weight, particularly preferably 0.5 to 12% by weight, based on the total amount of the preparation.
本発明に用いる炭化水素系油剤は、炭素と水素からなる化合物又はそれらの混合物である。
炭化水素系油剤としては、例えば流動パラフィン、パラフィン、マイクロクリスタリンワックス、白色ワセリン、黄色ワセリン、オゾケライト、セレシン、ポリエチレン、α−オレフィンオリゴマー、ポリブテン、スクワラン、スクワレン、リモネン、テレビン油等が挙げられる。
市販品としてはスクワラン(岸本特殊肝油工業所(株))、白色ワセリン、流パラCARNANATION J72(以上、Crompton社)等がある。
The hydrocarbon-based oil used in the present invention is a compound composed of carbon and hydrogen or a mixture thereof.
Examples of the hydrocarbon oil include liquid paraffin, paraffin, microcrystalline wax, white petrolatum, yellow petrolatum, ozokerite, ceresin, polyethylene, α-olefin oligomer, polybutene, squalane, squalene, limonene, and turpentine oil.
Commercially available products include squalane (Kishimoto Special Liver Oil Industry Co., Ltd.), white petrolatum, flow para-CARNA NATION J72 (above, Crompton).
炭化水素系油剤としては、スクワラン及び白色ワセリンが好ましい。 As the hydrocarbon oil, squalane and white petrolatum are preferable.
本発明において、炭化水素系油剤は1種又は2種以上を組み合せて使用することができ、配合量は、製剤全量に対し1〜15重量%で、好ましくは2〜13重量%、より好ましくは3〜12重量%、特に好ましくは5〜10重量%である。炭化水素系油剤が1重量%未満では充分な稠度安定化効果が得られず、15重量%を超えると製剤の外観安定性が悪くなるため好ましくない。 In the present invention, the hydrocarbon oil can be used alone or in combination of two or more, and the blending amount is 1 to 15% by weight, preferably 2 to 13% by weight, more preferably based on the total amount of the preparation. It is 3 to 12% by weight, particularly preferably 5 to 10% by weight. If the amount of the hydrocarbon oil is less than 1% by weight, a sufficient consistency stabilizing effect cannot be obtained, and if it exceeds 15% by weight, the appearance stability of the preparation is deteriorated.
本発明の損傷皮膚修復用組成物のpHは、糖及びポビドンヨードの安定性の点から3.5〜6が好ましい。なお、pHは、例えば損傷皮膚修復用組成物1重量部に水9重量部を加えてよく振り混ぜてから、pHメーター(例えば、堀場製作所:F−24)で25℃で測定する。 The pH of the damaged skin repair composition of the present invention is preferably 3.5 to 6 from the viewpoint of the stability of sugar and povidone iodine. In addition, pH is measured at 25 degreeC with a pH meter (for example, Horiba: F-24), for example, after adding 9 weight part of water to 1 weight part of the composition for repairing damaged skin and shaking well.
pHの調節は、塩酸、クエン酸、水酸化ナトリウム等の酸、塩基を使用して行うが、製剤をpH緩衝系としてもよく、例えば乳酸緩衝液、クエン酸緩衝液、リン酸緩衝液等を使用してもよい。 The pH is adjusted using acids and bases such as hydrochloric acid, citric acid, sodium hydroxide, etc., but the preparation may be a pH buffer system, for example, lactate buffer, citrate buffer, phosphate buffer etc. May be used.
本発明の損傷皮膚修復用組成物には、これらの成分以外にも本発明の効果を妨げない限り、他の薬剤や医薬品の添加物として許容される各種任意成分を、例えば可溶化剤、界面活性剤、増粘剤等を所望に応じて、適宜その必要量を添加することが可能である。 In addition to these components, the composition for repairing damaged skin of the present invention contains various optional components that are acceptable as additives for other drugs and pharmaceuticals, for example, solubilizers, interfaces, etc. The necessary amount of activator, thickener and the like can be appropriately added as desired.
他の薬剤としては、bFGF、EGF、HGF、IGF等の成長因子や絹フィブロイン等のタンパク質等が挙げられる。 Examples of other drugs include growth factors such as bFGF, EGF, HGF, and IGF, and proteins such as silk fibroin.
可溶化剤としては、ヨウ化カリウム、ヨウ化ナトリウム、グリセリン、ポリエチレングリコール(マクロゴール)400、ポリエチレングリコール(マクロゴール)1500、ポリエチレングリコール(マクロゴール)4000、ポリエチレングリコール(マクロゴール)6000、ポリプロピレングリコール、プロピレングリコール、ジプロピレングリコール等が挙げられる。 As the solubilizer, potassium iodide, sodium iodide, glycerin, polyethylene glycol (macrogol) 400, polyethylene glycol (macrogol) 1500, polyethylene glycol (macrogol) 4000, polyethylene glycol (macrogol) 6000, polypropylene glycol , Propylene glycol, dipropylene glycol and the like.
界面活性剤としては、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、ポリオキシエチレン(120)ポリオキシプロピレン(40)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、ポリオキシエチレン(196)ポリオキシプロピレン(67)グリコール、ポリオキシエチレン(20)ポリオキシプロピレン(20)グリコール、ポリオキシエチレン(200)ポリオキシプロピレン(70)グリコール、ポリオキシエチレン(3)ポリオキシプロピレン(17)グリコール、ポリオキシエチレン(42)ポリオキシプロピレン(67)グリコール、ポリオキシエチレン(54)ポリオキシプロピレン(39)グリコール、ポリオキシエチレン硬化ヒマシ油、ポリソルベート、モノステアリン酸ソルビタン等が挙げられる。 Surfactants include polyoxyethylene (105) polyoxypropylene (5) glycol, polyoxyethylene (120) polyoxypropylene (40) glycol, polyoxyethylene (160) polyoxypropylene (30) glycol, polyoxyethylene Ethylene (196) polyoxypropylene (67) glycol, polyoxyethylene (20) polyoxypropylene (20) glycol, polyoxyethylene (200) polyoxypropylene (70) glycol, polyoxyethylene (3) polyoxypropylene ( 17) Glycol, polyoxyethylene (42) polyoxypropylene (67) glycol, polyoxyethylene (54) polyoxypropylene (39) glycol, polyoxyethylene hydrogenated castor oil, polysorbate Sorbitan monostearate, and the like.
増粘剤としては、プルラン、カルボキシメチルセルロースナトリウム、アルギン酸ナトリウム、ポビドン、カルボキシビニルポリマー、メチルセルロース、寒天、ゼラチン等が挙げられる。 Examples of the thickener include pullulan, sodium carboxymethylcellulose, sodium alginate, povidone, carboxyvinyl polymer, methylcellulose, agar, gelatin and the like.
本発明の損傷皮膚修復用組成物は、例えば前記成分を混合し、必要により加熱して均一になるまで撹拌することにより、軟膏状とすることにより製造される。 The composition for repairing damaged skin of the present invention is produced, for example, by mixing the above-mentioned components and heating them as necessary to stir until uniform, thereby forming an ointment.
本発明の損傷皮膚修復用組成物は、適宜ガーゼ等に展延して患部に付着させることにより用いるのが好ましい。また吸水性に優れているため滲出液を吸い取る等優れた効果を有する。 The composition for repairing damaged skin of the present invention is preferably used by appropriately spreading on gauze or the like and attaching it to the affected area. Moreover, since it is excellent in water absorption, it has excellent effects such as sucking out exudate.
以下、実施例を用いて本発明を具体的に説明するが、本発明はこれら実施例に限定されるものではない。 EXAMPLES Hereinafter, although this invention is demonstrated concretely using an Example, this invention is not limited to these Examples.
実施例1 軟膏剤の製造
本発明品1:精製水9.52g、水酸化ナトリウム0.08g、ヨウ化カリウム0.7g、クエン酸0.1g、プルラン0.2g、濃グリセリン1g、1,3−ブチレングリコール1g、プロピレングリコール1g、白糖70g、ポビドンヨード3gを加えよく練合した。次にスクワラン(スクワラン:岸本特殊肝油工業所(株))5gを加えよく練合し、更に、マクロゴール300 1g、マクロゴール400 8.3g、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1.1gを加熱溶解し加えよく練合した後、均一になるまで撹拌して軟膏剤(本発明品1)を製造した。
Example 1 Production of Ointment Product of the Invention 1: 9.52 g of purified water, 0.08 g of sodium hydroxide, 0.7 g of potassium iodide, 0.1 g of citric acid, 0.2 g of pullulan, 1 g of concentrated glycerin, 1, 3 -1 g of butylene glycol, 1 g of propylene glycol, 70 g of sucrose and 3 g of povidone iodine were added and kneaded well. Next, 5 g of squalane (Squalane: Kishimoto Special Liver Oil Industry Co., Ltd.) was added and kneaded well, and further, Macrogol 300 1 g, Macrogol 400 8.3 g, polyoxyethylene (160) polyoxypropylene (30) glycol After 1.1 g was dissolved by heating and kneaded well, the mixture was stirred until uniform to produce an ointment (Product 1 of the present invention).
本発明品2:本発明品1のスクワランに代えて白色ワセリン(白色ワセリン:Crompton社)を用いて本発明品2を製造した。 Invention product 2: Invention product 2 was produced using white petrolatum (white petrolatum: Crompton) instead of the squalane of the invention product 1.
比較品1:精製水9.5172g、水酸化ナトリウム0.0828g、ヨウ化カリウム0.7g、クエン酸0.1g、プルラン0.2g、濃グリセリン1g、1,3−ブチレングリコール1g、プロピレングリコール1g、白糖70g、ポビドンヨード3gを加えよく練合した。次に、マクロゴール300 1g、マクロゴール400 11.3g、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1.1gを加熱溶解し加えよく練合した後、均一になるまで撹拌して軟膏剤(比較品1)を製造した。 Comparative Product 1: 9.5172 g of purified water, 0.0828 g of sodium hydroxide, 0.7 g of potassium iodide, 0.1 g of citric acid, 0.2 g of pullulan, 1 g of concentrated glycerin, 1 g of 1,3-butylene glycol, 1 g of propylene glycol Then, 70 g of white sugar and 3 g of povidone iodine were added and kneaded well. Next, 1 g of Macrogol 300, 11.3 g of Macrogol 400, and 1.1 g of polyoxyethylene (160) polyoxypropylene (30) glycol were heated and dissolved, kneaded well, and stirred until uniform to ointment. An agent (Comparative product 1) was produced.
製造した軟膏剤約30gを軟質ガラス瓶(プラスチィック中栓・金属フタ・4号規格(JIS)瓶)に気密充填した状態で室温条件下で保存し、経時的な稠度、攪拌性及び展延性の変化を調べた。結果を表1に示す。 About 30 g of the produced ointment is stored in a soft glass bottle (plastic inner stopper, metal lid, No. 4 standard (JIS) bottle) in an airtight state at room temperature, and changes in consistency, agitation and spreadability over time I investigated. The results are shown in Table 1.
(pH)
製造直後の軟膏剤1gを採取し水9gとよく混合した後、25℃でpHメーター(F−24:堀場製作所)で測定した。
(PH)
1 g of the ointment immediately after production was collected and mixed well with 9 g of water, and then measured with a pH meter (F-24: Horiba Seisakusho) at 25 ° C.
(稠度)
製造直後と室温条件下で3箇月保存したときの稠度を測定した。
テクスチャーアナライザー(TA−XT2i:Stable Micro Systems)を用いて、1cmφの球を1mm/sの速度で2cm侵入させ、その侵入時の最大の負荷(g)を測定した。
(Consistency)
The consistency was measured immediately after production and when stored for 3 months under room temperature conditions.
Using a texture analyzer (TA-XT2i: Stable Micro Systems), a 1 cmφ sphere was allowed to penetrate 2 cm at a speed of 1 mm / s, and the maximum load (g) at the time of penetration was measured.
(攪拌性)
製造直後と室温条件下で3箇月保存したときの攪拌性を検討した。
攪拌性については、軟膏剤を木ベラで攪拌し、次の4段階で官能評価した。
◎:非常に攪拌しやすく、極めて使いやすい。
○:攪拌しやすく、使いやすい。
△:攪拌しにくいが、使用に耐えられなくはない。
×:非常に攪拌しにくく、使用に耐えられない。
(Stirability)
Stirability was examined immediately after production and when stored for 3 months at room temperature.
Regarding the stirring ability, the ointment was stirred with a wooden spatula and subjected to sensory evaluation in the following four stages.
A: Very easy to stir and extremely easy to use.
○: Easy to stir and use.
Δ: It is difficult to stir, but it cannot be used.
X: It is very difficult to stir and cannot be used.
(展延性)
製造直後及び室温条件下で3箇月保存したときの展延性を検討した。
展延性については、攪拌した軟膏剤を木ベラでガーゼに展延し、次の4段階で官能評価した。
◎:非常に展延しやすく、極めて使いやすい。
○:展延しやすく、使いやすい。
△:展延しにくいが、使用に耐えられなくはない。
×:非常に展延しにくく、使用に耐えられない。
(Extensibility)
The spreadability was examined immediately after production and when stored for 3 months under room temperature conditions.
For spreadability, the stirred ointment was spread on a gauze with a wooden spatula and subjected to sensory evaluation in the following four stages.
A: Very easy to spread and extremely easy to use.
○: Easy to spread and use.
(Triangle | delta): Although it is hard to spread, it does not have to endure use.
X: It is very difficult to spread and cannot be used.
本発明品1〜2は、室温で3箇月保存した後でも稠度の上昇が抑制され、攪拌性や展延性も良好で、極めて使用し易かった。一方、白糖、ポビドンヨード及び水を含有し、スクワラン及び白色ワセリンを含有しない軟膏剤(比較品1)は、室温で3箇月保存後の時点で稠度が著しく上昇し、攪拌性も悪くなった。
なお、本発明品中の白糖(高速液体クロマトグラフ法)及び有効ヨウ素(滴定法)についても室温3箇月保存後も安定であった。
The inventive products 1 and 2 were extremely easy to use because the increase in consistency was suppressed even after being stored at room temperature for 3 months, and the stirrability and spreadability were good. On the other hand, the ointment (Comparative Product 1) containing sucrose, povidone iodine and water, and not containing squalane and white petrolatum, had a markedly increased consistency and poor agitation at the point of storage for 3 months at room temperature.
The sucrose (high performance liquid chromatographic method) and effective iodine (titration method) in the product of the present invention were also stable after storage at room temperature for 3 months.
Claims (4)
The composition for repairing damaged skin according to any one of claims 1 to 3, wherein the pH is 3.5 to 6.
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JP2007277135A (en) * | 2006-04-05 | 2007-10-25 | Mie Univ | External preparation for wound treatment |
ITBA20130047A1 (en) * | 2013-06-07 | 2014-12-08 | Simone Tenerelli | COMPOSITION FOR THE PROTECTION AND HEALING OF DECUBITUS, VASCULAR AND DIABETIC ULCERS. |
WO2015198196A1 (en) * | 2014-06-26 | 2015-12-30 | Tenerelli Simone | Improved pharmaceutical composition for the protection and healing of pressure ulcers, diabetic ulcers and vascular ulcers |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6310731A (en) * | 1986-03-12 | 1988-01-18 | Kowa Co | Stable reparative pharmaceutical for damaged skin |
JPH11228439A (en) * | 1998-02-05 | 1999-08-24 | Noevir Co Ltd | Preparation for external use for skin |
JP2002241287A (en) * | 2001-02-20 | 2002-08-28 | Iwaki Seiyaku Co Ltd | Cutaneous ulcer-curing composition |
JP2002255723A (en) * | 2001-02-27 | 2002-09-11 | Kansai Koso Kk | Method for producing viscous cosmetic or medicinal agent containing lysozyme chloride |
JP2004051551A (en) * | 2002-07-19 | 2004-02-19 | Noevir Co Ltd | Skin preparation for external use |
-
2004
- 2004-04-23 JP JP2004128442A patent/JP4559111B2/en not_active Expired - Fee Related
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6310731A (en) * | 1986-03-12 | 1988-01-18 | Kowa Co | Stable reparative pharmaceutical for damaged skin |
JPH11228439A (en) * | 1998-02-05 | 1999-08-24 | Noevir Co Ltd | Preparation for external use for skin |
JP2002241287A (en) * | 2001-02-20 | 2002-08-28 | Iwaki Seiyaku Co Ltd | Cutaneous ulcer-curing composition |
JP2002255723A (en) * | 2001-02-27 | 2002-09-11 | Kansai Koso Kk | Method for producing viscous cosmetic or medicinal agent containing lysozyme chloride |
JP2004051551A (en) * | 2002-07-19 | 2004-02-19 | Noevir Co Ltd | Skin preparation for external use |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2007277135A (en) * | 2006-04-05 | 2007-10-25 | Mie Univ | External preparation for wound treatment |
ITBA20130047A1 (en) * | 2013-06-07 | 2014-12-08 | Simone Tenerelli | COMPOSITION FOR THE PROTECTION AND HEALING OF DECUBITUS, VASCULAR AND DIABETIC ULCERS. |
WO2015198196A1 (en) * | 2014-06-26 | 2015-12-30 | Tenerelli Simone | Improved pharmaceutical composition for the protection and healing of pressure ulcers, diabetic ulcers and vascular ulcers |
Also Published As
Publication number | Publication date |
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JP4559111B2 (en) | 2010-10-06 |
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