JP7362140B2 - Chinese herbal medicine topical patch for treating gouty joint pain and its preparation method - Google Patents

Chinese herbal medicine topical patch for treating gouty joint pain and its preparation method Download PDF

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JP7362140B2
JP7362140B2 JP2021171163A JP2021171163A JP7362140B2 JP 7362140 B2 JP7362140 B2 JP 7362140B2 JP 2021171163 A JP2021171163 A JP 2021171163A JP 2021171163 A JP2021171163 A JP 2021171163A JP 7362140 B2 JP7362140 B2 JP 7362140B2
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洪斌 邱
佳新 鄭
瑾 蘇
朝宇 宋
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Jiamusi University
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/756Phellodendron, e.g. corktree
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/19Acanthaceae (Acanthus family)
    • A61K36/195Strobilanthes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284Atractylodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A61K36/315Isatis, e.g. Dyer's woad
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/42Cucurbitaceae (Cucumber family)
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    • AHUMAN NECESSITIES
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/51Gentianaceae (Gentian family)
    • A61K36/515Gentiana
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704Polygonum, e.g. knotweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/708Rheum (rhubarb)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/716Clematis (leather flower)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/85Verbenaceae (Verbena family)
    • A61K36/855Clerodendrum, e.g. glorybower
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/06Antigout agents, e.g. antihyperuricemic or uricosuric agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Description

本発明は漢方薬の分野に属し、具体的には、痛風性関節痛を治療する漢方薬外用貼付剤及びその調製方法に関する。 The present invention belongs to the field of Chinese herbal medicine, and specifically relates to a Chinese herbal medicine topical patch for treating gouty arthralgia and a method for preparing the same.

痛風(gout)とは、高尿酸血症、尿酸塩沈着と密接に関連する代謝疾患である。高尿酸血症は、プリン代謝障害による代謝異常症状群である。急性痛風性関節炎(acute gouty arthritis、AGA)は、体内の血中尿酸の増加による尿酸塩の沈着が原因で、局所組織の損傷及び炎症性反応を引き起こし、腎臓に関与することが多く、慢性間質性腎炎や腎結石形成を引き起こす。急性痛風性関節炎は、男性の発病率が女性より高く、下肢関節に発生することが多く、関節及び周辺組織は、赤く腫れ、熱を持ち、痛みを伴い、夜間に悪化し、痛みは耐えられず、再発しやすく、患者の活動が不便になり、かつ頭痛、発熱、白血球の上昇などの症状を伴う。近年、生活レベルの向上およびライフスタイルの変化に伴い、高脂肪、高タンパクの食事によるプリン及びタンパクの摂取が増加し、中国及び世界の痛風発病率は上昇する傾向があり、且つ若年化する傾向にある。「2017年中国痛風現状報告白書」では、中国の痛風患者は800万人を超え、AGAは痛風病の一般的な臨床症状であることが記載されている。 Gout is a metabolic disease closely associated with hyperuricemia and urate deposition. Hyperuricemia is a group of metabolic symptoms caused by purine metabolism disorder. Acute gouty arthritis (AGA) is caused by urate deposition due to increased blood uric acid in the body, causing local tissue damage and an inflammatory response, often involving the kidneys, and causing chronic It causes nephritis and kidney stone formation. Acute gouty arthritis has a higher incidence in men than in women, and it often occurs in the joints of the lower extremities.The joints and surrounding tissues are red, swollen, warm, and painful.It worsens at night, and the pain is unbearable. The disease is likely to recur, making it inconvenient for the patient to carry out activities, and is accompanied by symptoms such as headache, fever, and elevated white blood cell count. In recent years, as living standards have improved and lifestyles have changed, the intake of purines and proteins from high-fat, high-protein diets has increased, and the incidence of gout in China and the world has tended to rise and become younger. It is in. The 2017 China Gout Status Report White Paper states that there are over 8 million gout patients in China and that AGA is a common clinical symptom of gout disease.

漢方医学における痛風病に関する最も古い記録は、関節病変に対する認識であり、痛風発病時の関節症状と病因に応じて、漢方医学の臨床診断は「痺症」「痛痺」「歴節」などのカテゴリーに分類される。「痛風」は先天的な体弱に外邪が加わり、痰湿が経絡や関節に滞留して発病すると考えられる。文献によると、古代の医学者は痛風病に対する認識は関節の病変、即ち、急性痛風性関節炎に限られていた。現代の診断技術の発展に伴い、現代中国医学診断は、中国医学の伝統理論と現代医学理論に基づいて高尿酸血症を新たに認識して紹介し、高尿酸血症が
に属するという理論を提唱し、血液レオロジー異常、および循環障害などはいずれも血濁とも言えると考えられる。
The oldest record of gout disease in Chinese medicine is the recognition of joint lesions, and depending on the joint symptoms and etiology at the time of onset of gout, the clinical diagnosis in Chinese medicine is divided into categories such as "paralysis,""pain and numbness," and "hikkitsu." are categorized. Gout is thought to develop when external illness is added to congenital physical weakness, causing phlegm to accumulate in the meridians and joints. According to literature, the recognition of gout disease by ancient medical scientists was limited to joint lesions, ie, acute gouty arthritis. With the development of modern diagnostic technology, modern Chinese medical diagnosis has newly recognized and introduced hyperuricemia based on the traditional theory of Chinese medicine and modern medical theory, and
He proposed the theory that blood rheology abnormalities and circulatory disorders can be considered to be hemoturbidity.

現在、臨床的に一般的な痛風病予防薬物は化学薬品を主とし、血中尿酸レベルの低下、消炎鎮痛をそれぞれの目的としている。例えば、コルヒチン、糖質コルチコイドなどは、作用が明確で、薬効が迅速であり、急性期臨床症状を緩和することができるが、胃腸管反応、消化管出血、肝臓腎臓機能損害、物質代謝障害などの異なる程度の安全リスクが存在し、かつ休薬した後に症状の繰り返しが発生しやすい。 Currently, clinically common drugs for preventing gout disease are mainly chemical drugs, and their respective purposes are to lower blood uric acid levels and to provide anti-inflammatory and analgesic effects. For example, colchicine, glucocorticoids, etc. have clear action, rapid efficacy, and can alleviate acute clinical symptoms, but they also cause gastrointestinal reactions, gastrointestinal bleeding, liver and kidney function damage, and substance metabolic disorders. There are different degrees of safety risks, and recurrence of symptoms is likely to occur after drug withdrawal.

上記の技術的問題に対して、本発明は、痛風性関節痛を治療する漢方薬外用貼付剤及びその調製方法を提供する。胃腸管を介した経口投与の方式を経ずに、漢方薬の外用貼付により、初回通過効果および胃腸管不良反応を回避し、患部に直接作用し、安全性が高く、操作が簡単であり、患者の適応性が良い。
上記の技術的目的を実現するために、本発明は以下の技術的解決策を提供する。
バッキング材、薬物、基質、粘着防止層を含む痛風性関節痛を治療する漢方薬外用貼付剤。
ただし、薬物は、質量部で、黄柏30~35部、
20~25部、腫節風30~35部、蒼朮20~25部、威霊仙30~35部、大黄20~25部、大青葉20~25部、天花粉15~20部、氷片(ボルネオール)5~7.5部を含む。
To address the above technical problems, the present invention provides a Chinese herbal medicine topical patch for treating gouty arthralgia and a method for preparing the same. The topical patching of Chinese herbal medicine avoids the first-pass effect and adverse gastrointestinal reactions, acts directly on the affected area, has high safety, is easy to operate, and is safe for patients, without going through the method of oral administration through the gastrointestinal tract. Good adaptability.
In order to realize the above technical objectives, the present invention provides the following technical solutions.
A Chinese herbal medicine topical patch for treating gouty joint pain, including a backing material, drug, matrix, and anti-adhesive layer.
However, the drug is 30 to 35 parts by mass,
20-25 parts, Tushufu 30-35 parts, Cangzhuang 20-25 parts, Wei Lingxian 30-35 parts, Rhubarb 20-25 parts, Rhubarb 20-25 parts, Celestial Pollen 15-20 parts, Ice Piece (Borneol) Contains 5 to 7.5 parts.

さらに、前記氷片は、アゾン、ユーカリ油、オレイン酸、メントールのいずれか1種に置換することができる。 Furthermore, the ice pieces can be replaced with any one of azone, eucalyptus oil, oleic acid, and menthol.

さらに、前記バッキング材は、不織布又はナイロン布から選択することができる。 Furthermore, the backing material can be selected from non-woven fabrics or nylon fabrics.

さらに、質量百分率で、前記基質は85~92%であり、前記薬物は8~15%である。 Further, in weight percentage, the substrate is 85-92% and the drug is 8-15%.

本発明はさらに、以下のステップを含むことを特徴とする痛風性関節痛を治療する漢方薬外用貼付剤の調製方法を提供する。
各原料を粉砕した後に、回転数180~200r/minの条件で30~42min基質と混合し、脱泡し、そしてバッキング材に塗布し、50℃で2h乾燥させ、表面を粘着防止層を被覆し、痛風性関節痛を治療する漢方薬外用貼付剤を得る。
The present invention further provides a method for preparing a Chinese herbal medicine topical patch for treating gouty arthralgia, which is characterized by comprising the following steps.
After pulverizing each raw material, it is mixed with the substrate for 30 to 42 minutes at a rotation speed of 180 to 200 r/min, defoamed, and applied to the backing material, dried at 50°C for 2 hours, and the surface is coated with an anti-adhesive layer. Then, a Chinese herbal medicine patch for topical use to treat gouty joint pain is obtained.

さらに、前記原料は100~120メッシュの微粉末に粉砕される。 Furthermore, the raw material is ground into a fine powder of 100-120 mesh.

さらに、前記基質の調製方法は、骨格材料を水に浸漬し、膨潤現象が現れた後、溶解するまで加熱し、さらに保湿剤を加え、50~55℃で1h混合することにより、基質を得る。 Furthermore, the method for preparing the substrate includes immersing the skeleton material in water, heating it until it dissolves after a swelling phenomenon appears, and then adding a humectant and mixing at 50 to 55°C for 1 hour to obtain the substrate. .

さらに、前記骨格材料は、ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウムを混合したものであり、前記保湿剤は、グリセリンとポリエチレングリコール400を混合したものであり、前記骨格材料と前記保湿剤の質量比は(11~12):(5~8)である。 Furthermore, the framework material is a mixture of gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, and sodium carboxymethyl cellulose, and the humectant is a mixture of glycerin and polyethylene glycol 400, and the framework material and The mass ratio of the humectant is (11-12):(5-8).

またさらに、前記ゼラチンは、寒天およびアラビアガム粉末のいずれか一種を選択することができる。 Furthermore, the gelatin can be selected from agar and gum arabic powder.

またさらに、前記カルボマーは、934、940、941仕様のいずれか一種を選択することができる。 Furthermore, the carbomer can be selected from any one of specifications 934, 940, and 941.

またさらに、前記ポリビニルピロリドンは、ポリビニルアルコールを選択することができる。 Furthermore, polyvinyl alcohol can be selected as the polyvinylpyrrolidone.

またさらに、前記ポリアクリル酸ナトリウムは、ポリアクリル酸又はポリエチレングリコールを選択することができる。 Furthermore, the sodium polyacrylate can be selected from polyacrylic acid or polyethylene glycol.

またさらに、前記カルボキシメチルセルロースナトリウムは、カルボキシメチルセルロース、メチルセルロースナトリウム、セルロース誘導体のいずれか一種を選択することができる。 Furthermore, the carboxymethyl cellulose sodium can be selected from any one of carboxymethyl cellulose, methyl cellulose sodium, and cellulose derivatives.

またさらに、前記保湿剤は、アゾン、ユーカリ油、オレイン酸、メントールのいずれか一種を選択することができる。 Furthermore, the humectant can be selected from any one of azone, eucalyptus oil, oleic acid, and menthol.

さらに、前記ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウム、グリセリン、ポリエチレングリコール400の質量比は(3~5):(6~8):(6~8):(10~12):(0.7~0.9):(7~9):(9~11)である。 Furthermore, the mass ratio of gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, sodium carboxymethylcellulose, glycerin, and polyethylene glycol 400 is (3-5):(6-8):(6-8):(10-12 ):(0.7-0.9):(7-9):(9-11).

さらに、前記ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウム、グリセリン、ポリエチレングリコール400の質量比は4:7:7:11:0.8:8:10である。 Furthermore, the mass ratio of gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, sodium carboxymethylcellulose, glycerin, and polyethylene glycol 400 is 4:7:7:11:0.8:8:10.

本発明の基質成分を置換した後の用量も、上記の配合比と同じ粘度になるように、適宜調整する必要がある。 The dosage after replacing the substrate component of the present invention also needs to be adjusted appropriately so that the viscosity is the same as the above-mentioned compounding ratio.

本発明で採用される漢方薬処方については『中国薬典』(2020版)を参照されたい。 For the Chinese herbal medicine prescription adopted in the present invention, please refer to "Chinese Pharmacy Dictionary" (2020 edition).

黄柏は、ミカン科植物黄樹皮の乾燥樹皮である。[性味と帰経]苦、寒。[機能と主治]清熱燥湿、瀉火除蒸、解毒療瘡。蒸熱瀉痢、黄疸尿赤、脚気痿躄、骨蒸労熱、瘡瘍腫毒、湿疹湿瘡に用いられる。 Huangbai is the dried yellow bark of a Rutaceae plant. [Characteristic taste and pathogenesis] Bitterness, coldness. [Function and treatment] Cleansing, heating, drying, and dehumidifying, detoxifying and treating acne. It is used to treat steam fever diarrhea, jaundice and red urine, beriberi, bone steam fever, ulcers, and eczema and eczema.

秦ぎょうは、リンドウ科植物秦ぎょう、粗茎秦ぎょう又は小秦ぎょうの乾燥根である。[性味と帰経]辛、苦、平。帰経:胃、肝、胆。[機能と主治]去風湿、清湿熱、止痺痛、清虚熱。風湿痺痛、中風半身不遂、筋脈拘攣、骨節酸痛、湿熱黄疸、骨蒸潮熱、小児疳積発熱に用いられる。 Qin-gyo is the dried root of Gentianaceae plant Qin-gyou, coarse stem Qin-gyou or small Qin-gyou. [Characteristic taste and origin] Spicy, bitter, flat. Meridian: Stomach, liver, bile. [Function and treatment] Gynecosis, dampness and heat, numbness and pain, and weakness and fever. It is used for wind and damp numbness pain, paralysis and hemiplegia, muscle spasm, bone acid pain, damp heat jaundice, bone steam fever, and childhood phlegm fever.

腫節風は、センリョウ科植物の乾燥全草である。[性味と帰経]苦、辛、平。[機能と主治]清熱涼血、活血消斑、去風通絡。血熱発斑発疹、風湿痺痛、跌打損傷に用いられる。 Tugenkaze is the dried whole plant of a plant in the family Amenaceae. [Characteristic taste and pathogenesis] Bitterness, spicyness, and flatness. [Function and treatment] Cool and cool blood, exfoliation of live blood, gout and gout. It is used for hemorrhagic rashes, wind damp numbness pain, and crush injuries.

蒼朮は、キンポウゲ科植物茅蒼朮又は北蒼朮の乾燥根茎である。[性味と帰経]辛、苦、温。帰経:脾、胃、肝。[機能と主治]燥湿健脾、去風散寒、明目。湿阻中焦、
泄瀉、水腫、脚気痿躄、風湿痺痛、風寒感冒、夜盲、眼目昏渋に用いられる。
Soshu is the dried rhizome of Soshu or Hokusoshu, a plant belonging to the Ranunculaceae family. [Taste and meridian] Spicy, bitter, warm. Meridian: spleen, stomach, liver. [Function and main treatment] Dry, wet and healthy spleen, wind and cold, clear eyes. humid embolism,
It is used to treat defecation, dropsy, beriberi, numbness and pain of wind, cold and cold, night blindness, and stupor of the eyes.

威霊仙は、キンポウゲ科植物威霊仙、綿団鉄線蓮又は東北鉄線蓮の乾燥根と根茎である。[性味と帰経]辛、咸、温。帰経:膀胱。[機能と主治]去風湿、通経絡。風湿痺痛、肢体麻木、経脈拘攣、屈伸不利に用いられる。 Weilingxian is the dried roots and rhizomes of the Ranunculaceae plant Weilingxian, the cotton tangle lotus, or the Tohoku railway lotus. [Sexual taste and origin] Spicy, spicy, warm. Return: Bladder. [Function and main treatment] Leaves and humidity, meridians. It is used for wind and damp numbness, limb paralysis, meridian spasm, and disadvantages in bending and stretching.

大黄は、タデ科植物掌葉大黄、唐古特大黄又は薬用大黄の乾燥根和根茎である。[性味と帰経]苦、寒。帰経:脾、胃、大腸、肝、心包。[機能と主治]瀉下攻撃、清熱瀉火、涼血解毒、
利湿退黄。実熱積滞便秘、血熱吐衄、目赤咽腫、癰腫疔瘡、跌打損傷、黄疸尿赤;外治やけどに用いられる。大青葉は、アブラナ科植物ホソバタイセイの乾燥葉である。[性味と帰経]苦、寒。帰経:心、胃。[機能と主治]清熱解毒、涼血消斑。温病高熱、神昏、発斑発疹、おたふく風邪、喉痺、丹毒、癰腫に用いられる。
Rhubarb is the dried rhizome of palmate rhubarb, Tanggutoku rhubarb, or medicinal rhubarb, a plant belonging to the Polygonaceae family. [Characteristic taste and pathogenesis] Bitterness, coldness. Meridians: spleen, stomach, large intestine, liver, heart capsule. [Function and management] Cathartic attack, clear heat purification, cool blood detoxification,
Humid and yellow. It is used for constipation caused by accumulation of heat, blood fever vomit, erythropharyma of the eye, carbuncle acne, crush injury, jaundice and red urine; external treatment for burns. Dai-Aoba is the dried leaf of the Brassica plant. [Characteristic taste and pathogenesis] Bitterness, coldness. Return to sutra: heart, stomach. [Function and treatment] Clear heat detoxification, cool blood exfoliation. It is used to treat high fever, fainting, macular rash, mumps, throat numbness, erysipelas, and carbuncles.

天花粉は、
又は双辺か楼の乾燥根である。[性味と帰経]甘、微苦、微寒。帰経:肺、胃。[機能と主治]清熱瀉火、生津止渇、消腫排膿。熱病煩渇、肺熱燥咳、内熱消渇、瘡瘍中毒に用いられる。本発明の薬用メカニズム:
Heavenly pollen is
Or the dry roots of Fuangen or Lou. [Taste and origin] Sweet, slightly bitter, slightly cold. Return: lungs, stomach. [Function and treatment] Clearing heat, quenching thirst, extinguishing swelling and draining pus. It is used for fever and thirst, lung fever and dry cough, internal fever, and ulcer poisoning. Medicinal mechanism of the invention:

元.朱震亨「丹溪心法痛風六十三」曰く:「遍身骨節疼痛、昼静夜劇、如虎噛之状、名曰白虎歴節風」「大率有痰、風熱、風湿、血虚」、痛風の発病は風湿熱、
であることが多く、威霊仙の味は辛、咸、温であり、腫節風の味は苦、辛、平であり、リウマチを除去し、経絡の通りを改善することができ、ともに君薬であり、黄柏は苦、寒であり、秦ぎょうは辛、苦、平であり、大黄は苦、寒であり、三薬は清湿熱、止痺痛、
の作用を有し臣薬であり、君薬と配合して去風、清熱、止痛の効果を奏し、蒼朮の味は辛、苦、温であり、君臣薬が苦寒すぎることを防止し、去湿散寒を助けて佐薬であり、天花粉は甘、微苦、微寒であり、氷片とともに消腫療瘡して使薬であり、諸薬が皮膚を通して痛みに到達し、全体の配合から見ると、去風通絡、除痺止痛の効果を有する。
Yuan. Zhu Zhenheng's ``Sixty-Three Gout Methods'' says: ``All over the body joint pain, day and night play, like a tiger biting, famous white tiger history festival'' ``large amount of phlegm, wind fever, wind dampness, blood deficiency.'' , the onset of gout is due to wind damp heat,
The taste of Wei Ling Immortal is spicy, spicy, and warm, and the taste of Tushu is bitter, spicy, and flat, and it can eliminate rheumatism and improve the meridian passage, and both Huangbai is bitterness and coldness, Qingyo is spicy, bitterness, and flatness; Rhubarb is bitterness and coldness;
It is a vassal medicine with the action of lord medicine, and when combined with lord medicine, it has the effect of eliminating wind, clearing fever, and pain relief. It is a medicine that helps with dampness and coldness, and celestial pollen is sweet, slightly bitter, and has a slight coldness, and it is used together with ice chips to treat swelling, and the various medicines reach the pain through the skin and improve the overall composition. Viewed from above, it has the effect of eliminating gout and eliminating numbness and pain.

従来技術に比べて、本発明の有益な効果は、
本発明の貼付剤を使用する時に患部に直接貼り、作用が緩和で持続的であり、腫れと痛みを軽減する効果が顕著であり、痛風による関節痛を効果的に予防又は緩和して痛風による結節を改善することができ、使用しやすく、患者の適応性が良く、刺激がなく、複数回の投薬に適する。そして、経口薬の口当たりが良くない欠陥を回避する。同時に、基質の稠度が適切であるため、皮膚表面に貼られた体感が清涼であり、局所的な赤、腫、熱、痛の症状を緩和でき、添加された経皮促進剤類成分は薬物の浸透をより加速でき、即効性の目的を達成する。基質の調製過程において、各成分の比率、加熱温度、撹拌速度、混合時間、脱泡程度はいずれも基質の稠度と薬物放出性能に影響を与えることが可能であり、各影響要因を互いに配合し、最終的に対応する効果を有する産物を製造する必要がある。
Compared to the prior art, the beneficial effects of the present invention are:
When using the patch of the present invention, it is applied directly to the affected area, and its action is soothing and lasting, and the effect of reducing swelling and pain is remarkable, and it can effectively prevent or alleviate joint pain caused by gout. Can improve nodules, easy to use, good patient adaptability, no irritation, suitable for multiple doses. and avoid the unpalatable defects of oral drugs. At the same time, the consistency of the matrix is appropriate, so it feels refreshing when applied to the skin surface, and can relieve local symptoms of redness, swelling, heat, and pain, and the added transdermal enhancer ingredients are The penetration of the product can be accelerated and the purpose of immediate effect can be achieved. In the preparation process of the matrix, the ratio of each component, heating temperature, stirring speed, mixing time, and degree of defoaming can all affect the consistency and drug release performance of the matrix, and each influencing factor can be combined with each other. , it is necessary to finally produce a product with the corresponding effect.

本発明の様々な例示的な実施形態を詳細に説明するが、この詳細な説明は本発明を制限するものではなく、本発明の特定な方面、特性、および実施形態に対するより詳細な説明と理解すべきである。 Various exemplary embodiments of the invention will be described in detail, but this detailed description is not intended to limit the invention, but rather to provide a more detailed description and understanding of particular aspects, features, and embodiments of the invention. Should.

本発明に記載されている専門用語は単に特別な実施形態を説明するためのものであり、本発明を制限するものではない。また、本発明の数値範囲について、この範囲の上限と下限の間の各中間値も具体的に開示されているものと理解すべきである。すべての記述値又は記述範囲内の中間値及びすべての他の記述値又は前記範囲内の中間値の間の小さい範囲はいずれも本発明に含まれる。これらの小さい範囲の上限と下限は独立して範囲内に含まれるか排除されてもよい。 The terminology described in the present invention is merely for describing particular embodiments and is not intended to limit the invention. It should also be understood that for the numerical ranges of the present invention, each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range and any smaller range between any other stated value or intermediate value within said range are included in the invention. The upper and lower limits of these smaller ranges may be independently included or excluded within the range.

特に記載のない限り、本文で使用されるすべての技術および科学用語は、当業者が通常に理解できるのと同じ意味を有する。本発明では好ましい方法および材料のみを説明しているが、本発明の実施又は測定において本文の記載と類似又は同等の任意の方法および材料を使用してもよい。本明細書で言及されたすべての文献は、前記文献に関連する方法及び/又は材料を開示、説明するために、引用により組み込まれる。組み込まれた文献との間に矛盾が生じた場合、本明細書の内容が優先される。 Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Although only preferred methods and materials are described in the invention, any methods and materials similar or equivalent to those described herein may be used in the practice or measurement of the invention. All documents mentioned herein are incorporated by reference to disclose and describe the methods and/or materials to which they relate. In the event of a conflict with incorporated documents, the present specification will control.

本発明の範囲又は精神から逸脱することなく、本発明の明細書の発明を実施するための形態を様々に改善、変更することができ、これは当業者にとって自明である。本発明の明細書によって得られる他の実施形態は当業者にとって自明である。本願明細書および実施例は例示的なものである。 It will be obvious to those skilled in the art that various improvements and changes can be made to the mode of carrying out the invention described herein without departing from the scope or spirit of the invention. Other embodiments will be apparent to those skilled in the art given the present specification. The specification and examples are exemplary.

本文で使用される「含む」、「有する」、「含有」などは、いずれもオープンな用語であり、つまり含むがこれらに限られない意味である。 As used herein, the terms "comprising," "having," "containing," and the like are open terms, meaning including but not limited to.

本発明で調製された痛風性関節痛を治療する漢方薬外用貼付剤は、10×8cmのバッキング材あたり、薬物と基質全重量が18.0±0.5gである。 The Chinese herbal medicine topical patch for treating gouty arthralgia prepared according to the present invention has a total weight of drug and substrate of 18.0±0.5 g per 10×8 cm 2 of backing material.

本発明で調製されたサンプルは、『中国薬典』(2020年版)四部通則「0122パッチ剤」の項目に準拠しており、耐熱性、賦形性、含有量の均一度などを測定したところ、いずれも標準要求を満たし、刺激性実験およびアレルギー性実験は皮膚に刺激性とアレルギー性がないことを示している。 The sample prepared according to the present invention complies with the section ``0122 Patch agent'' of Part 4 of the "Chinese Pharmacopoeia" (2020 edition), and was measured for heat resistance, formability, content uniformity, etc. , all meet standard requirements, and irritation and allergy experiments show that it is not irritating or allergic to the skin.

[実施例1]
(1)原料の選択:
黄柏33部、秦ぎょう23部、腫節風32部、蒼朮22部、威霊仙32部、大黄22部、大青葉23部、天花粉18部、氷片6部。
(2)秤量された原料をそれぞれ粉砕し、110メッシュの篩にかけ、薬物の微粉末を得た。
(3)重量百分率で、ゼラチン:カルボマー:ポリビニルピロリドン:ポリアクリル酸ナトリウム:カルボキシメチルセルロースナトリウム:グリセリン:ポリエチレングリコール400=4:7:7:11:0.8:8:10となるように基質を調製した。
(4)基質の製法:ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウムを水に浸漬し、膨潤させ、溶解するまで加熱し、さらにグリセリンとポリエチレングリコール400を加え、53℃で1h混合し、基質を得た。
(5)薬物の微粉末と基質を回転数190r/minの条件で36min混合し、脱泡し、そして不織布に塗布し、裁断し、50℃で2h乾燥させ、表面を粘着防止層で被覆し、痛風性関節痛を治療する漢方薬外用貼付剤を得た。
前記基質は88%を占め、前記薬物は12%を占めた。
[Example 1]
(1) Selection of raw materials:
33 parts of Huangbai, 23 parts of Qin Gyeong, 32 parts of Tushuanfu, 22 parts of Cangzhuang, 32 parts of Wei Lingxian, 22 parts of Rhubarb, 23 parts of Great Green Leaves, 18 parts of Heavenly Pollen, and 6 parts of Ice Pieces.
(2) Each of the weighed raw materials was ground and passed through a 110 mesh sieve to obtain a fine drug powder.
(3) Add the substrate so that the weight percentage is gelatin: carbomer: polyvinylpyrrolidone: sodium polyacrylate: sodium carboxymethyl cellulose: glycerin: polyethylene glycol 400 = 4:7:7:11:0.8:8:10. Prepared.
(4) Substrate manufacturing method: Gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, and sodium carboxymethylcellulose are immersed in water, swelled, and heated until dissolved, then added with glycerin and polyethylene glycol 400, and heated at 53°C for 1 hour. The mixture was mixed to obtain a substrate.
(5) Fine drug powder and substrate were mixed at a rotational speed of 190 r/min for 36 min, defoamed, applied to a nonwoven fabric, cut, dried at 50°C for 2 hours, and covered the surface with an anti-adhesive layer. We obtained a topical Chinese herbal medicine patch for treating gouty joint pain.
The substrate accounted for 88% and the drug accounted for 12%.

[実施例2]
(1)原料の選択:
黄柏35部、秦ぎょう25部、腫節風30部、蒼朮20部、威霊仙35部、大黄25部、大青葉20部、天花粉15部、氷片5部。
(2)秤量された原料をそれぞれ粉砕し、120メッシュの篩にかけ、混合し、薬物の微粉末を得た。
(3)重量百分率で、ゼラチン:カルボマー:ポリビニルピロリドン:ポリアクリル酸ナトリウム:カルボキシメチルセルロースナトリウム:グリセリン:ポリエチレングリコール400=4:6:7:10:0.8:7:11となるように基質を調製した。
(4)基質の製法:ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウムを水に浸漬し、膨潤させ、溶解するまで加熱し、さらにグリセリンとポリエチレングリコール400を加え、50℃で1h混合し、基質を得た。
(5)薬物の微粉末と基質を回転数180r/minの条件で42min混合し、脱泡し、そして不織布に塗布し、裁断し、50℃で2h乾燥させ、表面を粘着防止層で被覆し、痛風性関節痛を治療する漢方薬外用貼付剤を得た。
前記基質は85%を占め、前記薬物は15%であった。
[Example 2]
(1) Selection of raw materials:
35 parts of Huangbao, 25 parts of Qin Gyeong, 30 parts of Tuanjifu, 20 parts of Cangzhuang, 35 parts of Wei Lingxian, 25 parts of Rhubarb, 20 parts of Great Green Leaves, 15 parts of Heavenly Pollen, and 5 parts of Ice Pieces.
(2) The weighed raw materials were each ground, passed through a 120-mesh sieve, and mixed to obtain a fine drug powder.
(3) Add the substrate so that the weight percentage is gelatin: carbomer: polyvinylpyrrolidone: sodium polyacrylate: sodium carboxymethyl cellulose: glycerin: polyethylene glycol 400 = 4:6:7:10:0.8:7:11. Prepared.
(4) Substrate manufacturing method: Gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, and sodium carboxymethylcellulose are immersed in water, swollen, and heated until dissolved, then added with glycerin and polyethylene glycol 400, and heated at 50°C for 1 hour. The mixture was mixed to obtain a substrate.
(5) The fine powder of the drug and the substrate were mixed at a rotation speed of 180 r/min for 42 min, defoamed, applied to a nonwoven fabric, cut, dried at 50°C for 2 hours, and the surface was coated with an anti-adhesive layer. We obtained a topical Chinese herbal medicine patch for treating gouty joint pain.
The substrate accounted for 85% and the drug 15%.

[実施例3]
(1)原料の選択:
黄柏30部、秦ぎょう20部、腫節風35部、蒼朮25部、威霊仙30部、大黄20部、大青葉25部、天花粉20部、氷片7.5部。
(2)秤量された原料をそれぞれ粉砕し、100メッシュの篩にかけ、混合し、薬物の微粉末を得た。
(3)重量百分率で、ゼラチン:カルボマー:ポリビニルピロリドン:ポリアクリル酸ナトリウム:カルボキシメチルセルロースナトリウム:グリセリン:ポリエチレングリコール400=3:7:7:11:0.8:9:10となるように基質を調製した。
(4)基質の製法:ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウムを水に浸漬し、膨潤させ、溶解するまで加熱し、さらにグリセリンとポリエチレングリコール400を加え、55℃で1h混合し、基質を得た。
(5)薬物の微粉末と基質を回転数190r/minの条件で36min混合し、脱泡し、そしてナイロン布に塗布し、裁断し、50℃で2h乾燥させ、表面を粘着防止層で被覆し、痛風性関節痛を治療する漢方薬外用貼付剤を得た。
前記基質は92%を占め、前記薬物は8%を占めた。
[Example 3]
(1) Selection of raw materials:
30 parts of huangbai, 20 parts of chinensis, 35 parts of Tuanjifu, 25 parts of Cangzhuang, 30 parts of Wei Lingxian, 20 parts of Rhubarb, 25 parts of Big Green Leaves, 20 parts of Celestial Pollen, and 7.5 parts of Ice Pieces.
(2) The weighed raw materials were each ground, passed through a 100-mesh sieve, and mixed to obtain a fine drug powder.
(3) Add the substrate so that the weight percentage is gelatin: carbomer: polyvinylpyrrolidone: sodium polyacrylate: sodium carboxymethyl cellulose: glycerin: polyethylene glycol 400 = 3:7:7:11:0.8:9:10. Prepared.
(4) Substrate manufacturing method: Soak gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, and sodium carboxymethylcellulose in water, swell, and heat until dissolved, then add glycerin and polyethylene glycol 400, and heat at 55°C for 1 hour. The mixture was mixed to obtain a substrate.
(5) Mix the fine drug powder and the substrate at a rotational speed of 190 r/min for 36 min, defoaming, apply to nylon cloth, cut, dry at 50°C for 2 hours, and cover the surface with an anti-adhesive layer. We obtained a Chinese herbal medicine patch for topical use to treat gouty joint pain.
The substrate accounted for 92% and the drug accounted for 8%.

[実施例4]
(1)原料の選択:
黄柏33部、秦ぎょう21部、腫節風30部、蒼朮24部、威霊仙34部、大黄21部、大青葉22部、天花粉19部、ユーカリ油5.5部。
(2)秤量された原料をそれぞれ粉砕し、110メッシュの篩にかけ、混合し、薬物の微粉末を得た。
(3)重量百分率で、寒天:カルボマー:ポリビニルピロリドン:ポリアクリル酸ナトリウム:カルボキシメチルセルロースナトリウム:プロピレングリコール=5:6:7:10:0.8:17となるように基質を調製した。
(4)基質の製法:ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウムを水に浸漬し、膨潤させ、溶解するまで加熱し、さらにプロピレングリコールを加え、53℃で1h混合し、基質を得た。
(5)薬物の微粉末と基質を回転数190r/minの条件で36min混合し、脱泡し、そして不織布に塗布し、裁断し、50℃で2h乾燥させ、表面を粘着防止層で被覆し、痛風性関節痛を治療する漢方薬外用貼付剤を得た。
前記基質は90%を占め、前記薬物は10%であった。
[Example 4]
(1) Selection of raw materials:
33 parts of Huangbao, 21 parts of Qin Zhuang, 30 parts of Tuanjianfu, 24 parts of Cangzhuang, 34 parts of Wei Lingxian, 21 parts of Rhubarb, 22 parts of Big Green Leaves, 19 parts of Celestial Pollen, and 5.5 parts of Eucalyptus oil.
(2) The weighed raw materials were each ground, passed through a 110-mesh sieve, and mixed to obtain a fine drug powder.
(3) A substrate was prepared so that the weight percentage of agar: carbomer: polyvinylpyrrolidone: sodium polyacrylate: sodium carboxymethyl cellulose: propylene glycol was 5:6:7:10:0.8:17.
(4) Substrate manufacturing method: gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, and sodium carboxymethylcellulose are immersed in water, allowed to swell, heated until dissolved, further added with propylene glycol, and mixed at 53°C for 1 hour. Obtained the substrate.
(5) Fine drug powder and substrate were mixed at a rotational speed of 190 r/min for 36 min, defoamed, applied to a nonwoven fabric, cut, dried at 50°C for 2 hours, and covered the surface with an anti-adhesive layer. We obtained a topical Chinese herbal medicine patch for treating gouty joint pain.
The substrate accounted for 90% and the drug 10%.

[比較例1]
原料を粉砕し、80メッシュの篩にかけたこと以外は、実施例1と同様である。
[Comparative example 1]
The procedure was the same as in Example 1 except that the raw materials were crushed and passed through an 80 mesh sieve.

[比較例2]
薬物の微粉末と基質を回転数100r/minの条件で混合したこと以外は、実施例1と同様である。
[Comparative example 2]
The procedure was the same as in Example 1 except that the fine powder of the drug and the substrate were mixed at a rotational speed of 100 r/min.

[比較例3]
薬物の微粉末と基質の混合時間を20minにしたこと以外は、実施例1と同様である。
[Comparative example 3]
The procedure was the same as in Example 1 except that the mixing time of the fine drug powder and the substrate was 20 min.

[比較例4]
前記基質が95%を占め、前記薬物が5%であること以外は、実施例1と同様である。
[Comparative example 4]
Same as Example 1 except that the substrate accounts for 95% and the drug accounts for 5%.

[比較例6]
前記基質が80%を占め、前記薬物が20%であること以外は、実施例1と同様である。
調製された漢方薬外用貼付剤は粘度が高すぎて、貼付効果及び体感が良くない。
[Comparative example 6]
Same as Example 1 except that the substrate accounts for 80% and the drug accounts for 20%.
The viscosity of the prepared Chinese herbal medicine patch for external use is too high, and the application effect and sensation are not good.

[比較例7]
ステップ(4)の加熱温度が72℃であること以外は、実施例1と同様である。
加熱時間が長すぎるため、基質材料の粘度が変化し、調製された漢方薬外用貼付剤の効果が弱くなる。
[Comparative example 7]
It is the same as Example 1 except that the heating temperature in step (4) is 72°C.
Because the heating time is too long, the viscosity of the matrix material changes, which weakens the effectiveness of the prepared Chinese herbal medicine topical patch.

一、臨床治療効果の観察:
本発明の貼付剤(実施例1~4)と対照グループの貼付剤(比較例1~7)及び薬局で販売されている痛風性関節痛の漢方薬外用貼付剤(対照グループ)の痛風性関節痛に対する治療効果を観察検証した。
痛風性関節炎患者1100例を選択し、ランダムに11グループに分け、各グループ100例である。各グループの年齢、性別、疾患過程、関節痛の程度に統計学的差異はなかった(p>0.05)。
治療方法:
貼付剤を関節に直接貼り、1日1回貼り、1クールは12日である。
判定標準:
1、治癒:関節痛感がなくなるかほぼなくなり、関節活動が正常に戻り、関節腫脹現象がない。
2、有効:関節痛感が好転し、関節活動が軽く制限され、軽度の関節腫脹現象を伴う。
3、無効:関節痛感が明らかに改善されず、ひいては重くなり、関節活動が制限され、活動が難しく、深刻な関節腫脹現象を伴う。
1. Observation of clinical treatment effects:
Gouty arthralgia of the patch of the present invention (Examples 1 to 4), the control group patch (Comparative Examples 1 to 7), and the Chinese herbal medicine patch for gouty arthralgia sold at pharmacies (control group) The therapeutic effect was observed and verified.
1100 patients with gouty arthritis were selected and randomly divided into 11 groups, each group having 100 patients. There were no statistical differences in age, gender, disease course, or degree of joint pain in each group (p>0.05).
Method of treatment:
The patch is applied directly to the joint once a day, and one course lasts 12 days.
Judgment standard:
1. Healing: joint pain disappears or almost disappears, joint activity returns to normal, and there is no joint swelling phenomenon.
2. Effective: joint pain sensation improves, joint activity is slightly restricted, accompanied by mild joint swelling phenomenon.
3. Ineffective: joint pain sensation is not obviously improved, even becomes heavy, joint activity is restricted, activity is difficult, and severe joint swelling phenomenon occurs.

試験の結果:
12日間の治療後、各試験グループの臨床治療効果の統計結果を表1に示す。
上記の患者の治療前後の血液、尿、便のルーチン検査、肝臓と腎臓の機能及び心電図に異常は見られなかった。後の再診時に本発明の調製された貼付剤で治療を受けた痛風は、痛風による関節痛及び結節が見られなかった。
Test results:
After 12 days of treatment, the statistical results of clinical treatment effects for each test group are shown in Table 1.
No abnormalities were found in routine blood, urine, and stool tests, liver and kidney functions, and electrocardiograms of the above patients before and after treatment. At the subsequent re-examination, joint pain and nodules due to gout were not observed in the patients with gout treated with the patch prepared according to the present invention.

表1からわかるように、12日間の治療を経て、本発明の貼付剤を使用した患者は基本的に治癒したが、本発明の調製方法で調製されていない貼付剤である比較例1~7の有効率は基本的に90%以下であり、本発明の痛風性関節痛を治療する貼付剤は、本発明の具体的な調製方法に従って処理され後に効果がより良くなる。薬局で販売されている貼付剤で12日間の治療を経ても効果は明らかに良くなかった。 As can be seen from Table 1, after 12 days of treatment, the patients using the patch of the present invention were basically cured, but Comparative Examples 1 to 7, which are patches not prepared by the preparation method of the present invention. The effectiveness rate of is basically less than 90%, and the patch for treating gouty arthralgia of the present invention becomes more effective after being processed according to the specific preparation method of the present invention. Even after 12 days of treatment with a patch sold at a pharmacy, the effect was clearly not good.

二、現在、臨床的には、痛風性関節炎の患者は一般的にイブプロフェンを投与して治療されている。本発明で調製された貼付剤の効果を検証するために、以下の検証を行った。
急性痛風性関節炎患者(すべて男性)70例を選択し、ランダムに対照グループ(イブプロフェンのみを投与する)と治療グループ(イブプロフェンを投与する同時に実施例1で調製された貼付剤を使用する)に分け、各グループ35例とした。治療時間は12日間であり、患者の治療前後の実験室指標[赤血球沈降率(ESR)、血中尿酸(UA)、-反応性タンパク質(CRP)]、中国医学症状評価、関節腫脹及び活動度などの評価、患者疼痛反応及び不良反応状況を観察した。
2.Currently, clinically, patients with gouty arthritis are generally treated with ibuprofen. In order to verify the effects of the patch prepared according to the present invention, the following verification was performed.
Seventy patients with acute gouty arthritis (all male) were selected and randomly divided into a control group (administering ibuprofen only) and a treatment group (administering ibuprofen and using the patch prepared in Example 1 at the same time). There were 35 patients in each group. The treatment time was 12 days, and the patient's laboratory indicators [erythrocyte sedimentation rate (ESR), blood uric acid (UA), -reactive protein (CRP)], Chinese medicine symptom evaluation, joint swelling and activity level before and after treatment were evaluated. The patient's pain response and poor response status were observed.

結果は以下のことを示している。
1)治療後、2グループの患者のESR、UA、CRPレベルはいずれも治療前より低く(p<0.05)、グループ間の差異は統計学的な意味はなかった。
2)中国医学症状の評価比較において、治療グループは対照グループより低かった(p<0.05)。
3)関節腫脹及び活動度評価は、グループ間の差異に統計学的な意味はなかった。
4)関節痛が完全に緩和する時間は、治療グループの方が対照グループの方よりも短かった(p<0.05)。
5)2グループの患者の治療前後の血液、尿、便のルーチン検査、肝臓と腎臓の機能及び心電図に異常は見られなかった。
以上の臨床治療結果より、イブプロフェンを併用して急性痛風性関節炎を治療する時、患者の臨床症状を顕著に改善し、疾患過程を短縮することができ、本発明の調製された漢方薬外用貼付剤が痛風性関節痛の治療に良好な治療効果を有することを示し、薬物を経口服用したくない場合、本発明の貼付剤を選択でき、同様に治療作用を有する。又は、経口薬と併用する場合、疾患過程を短縮し、苦痛を軽減し、患者の選択範囲を広げられる。
The results show that:
1) After treatment, the ESR, UA, and CRP levels of patients in the two groups were all lower than before treatment (p<0.05), and the differences between the groups were not statistically significant.
2) In comparing the evaluation of Chinese medicine symptoms, the treatment group was lower than the control group (p<0.05).
3) There was no statistical significance in the differences between groups in joint swelling and activity evaluation.
4) The time for complete relief of joint pain was shorter in the treatment group than in the control group (p<0.05).
5) No abnormalities were found in routine blood, urine, and stool tests, liver and kidney functions, and electrocardiograms before and after treatment of patients in the two groups.
From the above clinical treatment results, when treating acute gouty arthritis in combination with ibuprofen, the clinical symptoms of patients can be significantly improved and the disease process can be shortened, and the prepared Chinese herbal medicine patch of the present invention can be used for topical use. has shown to have a good therapeutic effect in treating gouty arthralgia, and if you do not want to take the drug orally, you can choose the patch of the present invention, which also has a therapeutic effect. Alternatively, when used in combination with oral medications, they can shorten the disease process, reduce suffering, and expand patient options.

ケース:
王さん、女45歳、痛風性関節痛3年間、四肢関節痛、行動が不便であり、非常に苦痛であった。本発明の貼付剤を6日間使用した後に腫脹がなくなり、痛みが軽減され、また6日間治療した後、正常に戻り、患者は臨床的に治愈した。
Case:
Ms. Wang, 45 years old, had suffered from gouty arthralgia for 3 years, which made her movements inconvenient and extremely painful. After using the patch of the present invention for 6 days, the swelling disappeared and the pain was relieved, and after 6 days of treatment, the patient returned to normal and was clinically cured.

李さん、男、38歳、急性痛風1年間、西洋薬物を服用しても顕著な治療効果がなかった。本発明の貼付剤を使用して1日1回貼り、3日間後に痛みが緩和され、継続して9日間使用した後、症状が明らかに改善され、痛みがほぼなくなり、継続して1か月使用し、症状がなくなった。 Mr. Lee, 38 years old, had been suffering from acute gout for a year, and even after taking Western drugs, there was no significant treatment effect. The patch of the present invention was applied once a day, and the pain was alleviated after 3 days, and after 9 days of continuous use, the symptoms were clearly improved and the pain almost disappeared, and continued for 1 month. I used it and my symptoms disappeared.

銭さん、男58歳、骨関節炎5年間、四肢関節痛、歩くことができなかった。本発明の貼付剤を12日間使用した後に痛みがなくなり、継続して治療1クール治療した後に行動が自由になった。 Mr. Qian, 58 years old, had suffered from osteoarthritis for 5 years and had joint pain in his limbs and was unable to walk. After using the patch of the present invention for 12 days, the patient had no pain and became able to move freely after one course of treatment.

以上は単に本発明の好ましい実施例であり、本発明を制限するものではない。本発明の精神と原則内で行われたすべての修正、均等な置換および改善などは、いずれも本発明の保護範囲内に含まれる。 The above are merely preferred embodiments of the invention and are not intended to limit the invention. All modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention are included within the protection scope of the present invention.

Claims (5)

痛風性関節痛を治療する漢方薬外用貼付剤の調製方法であって、
前記漢方薬外用貼付剤は、バッキング材、薬物、基質及び粘着防止層を含み、
前記薬物は、原料として、質量部で、黄柏30~35部、秦ぎょう20~25部、腫節風30~35部、蒼朮20~25部、威霊仙30~35部、大黄20~25部、大青葉20~25部、天花粉15~20部、氷片5~7.5部を含み、
質量百分率で、前記基質は85~92%であり、前記薬物は8~15%であり、
前記痛風性関節痛を治療する漢方薬外用貼付剤の調製方法は、
各原料を粉砕した後に、回転数180~200r/minの条件で30~42min、基質と混合し、脱泡し、そしてバッキング材に塗布し、50℃で2h乾燥させ、表面を粘着防止層で被覆し、痛風性関節痛を治療する漢方薬外用貼付剤を得るステップを含み、
前記基質の調製方法は、骨格材料を水に浸漬し、膨潤現象が現れた後、溶解するまで加熱し、さらに保湿剤を加え、50~55℃で1h混合することにより、基質を得る方法であることを特徴とする痛風性関節痛を治療する漢方薬外用貼付剤の調製方法。
A method for preparing a Chinese herbal medicine topical patch for treating gouty joint pain, the method comprising:
The Chinese herbal medicine topical patch includes a backing material, a drug, a substrate, and an anti-adhesion layer,
The drug contains, as raw materials, 30 to 35 parts of Huangbai, 20 to 25 parts of Qin Yang, 30 to 35 parts of Tuanjiang, 20 to 25 parts of Cangzhu, 30 to 35 parts of Wei Lingxian, and 20 to 25 parts of Rhubarb. Contains 20 to 25 parts of large green leaves, 15 to 20 parts of heavenly pollen, and 5 to 7.5 parts of ice chips.
In mass percentage, the substrate is 85-92% and the drug is 8-15%;
The method for preparing the Chinese herbal medicine topical patch for treating gouty arthralgia is as follows :
After pulverizing each raw material, it is mixed with the substrate for 30 to 42 minutes at a rotation speed of 180 to 200 r/min, defoamed, and applied to a backing material, dried at 50°C for 2 hours, and the surface is coated with an anti-adhesive layer. and obtaining a Chinese herbal medicine topical patch for treating gouty joint pain;
The method for preparing the substrate is to obtain the substrate by immersing the skeleton material in water, heating it until it dissolves after a swelling phenomenon appears, adding a humectant, and mixing at 50 to 55°C for 1 hour. A method for preparing a Chinese herbal medicine topical patch for treating gouty arthralgia, characterized by the following.
前記原料は100~120メッシュの微粉末に粉砕されることを特徴とする請求項1に記載の痛風性関節痛を治療する漢方薬外用貼付剤の調製方法。 The method for preparing a Chinese herbal medicine topical patch for treating gouty arthralgia according to claim 1, wherein the raw material is pulverized into a fine powder of 100 to 120 mesh. 前記骨格材料は、ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウムを混合したものであり、前記保湿剤は、グリセリンとポリエチレングリコール400を混合したものであり、前記骨格材料と前記保湿剤の質量比は(11~12):(5~8)であることを特徴とする請求項1に記載の痛風性関節痛を治療する漢方薬外用貼付剤の調製方法。 The framework material is a mixture of gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, and sodium carboxymethylcellulose, and the moisturizer is a mixture of glycerin and polyethylene glycol 400, and the framework material and the moisturizer The method for preparing a Chinese herbal medicine topical patch for treating gouty arthralgia according to claim 1, wherein the mass ratio of the agents is (11-12):(5-8). 前記ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウム、グリセリン、ポリエチレングリコール400の質量比は(3~5):(6~8):(6~8):(10~12):(0.7~0.9):(7~9):(9~11)であることを特徴とする請求項3に記載の痛風性関節痛を治療する漢方薬外用貼付剤の調製方法。 The mass ratio of gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, sodium carboxymethylcellulose, glycerin, and polyethylene glycol 400 is (3-5):(6-8):(6-8):(10-12): (0.7-0.9):(7-9):(9-11) The method for preparing a Chinese herbal medicine topical patch for treating gouty arthralgia according to claim 3. 前記ゼラチン、カルボマー、ポリビニルピロリドン、ポリアクリル酸ナトリウム、カルボキシメチルセルロースナトリウム、グリセリン、ポリエチレングリコール400の質量比は4:7:7:11:0.8:8:10であることを特徴とする請求項3に記載の痛風性関節痛を治療する漢方薬外用貼付剤の調製方法。 Claim characterized in that the mass ratio of gelatin, carbomer, polyvinylpyrrolidone, sodium polyacrylate, sodium carboxymethylcellulose, glycerin, and polyethylene glycol 400 is 4:7:7:11:0.8:8:10. 3. The method for preparing a Chinese herbal medicine topical patch for treating gouty arthralgia according to 3.
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