TW200942270A - Chinese medicine composition for treatment of wounds or bedsore, and method for producing preparation thereof - Google Patents

Chinese medicine composition for treatment of wounds or bedsore, and method for producing preparation thereof Download PDF

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TW200942270A
TW200942270A TW97148693A TW97148693A TW200942270A TW 200942270 A TW200942270 A TW 200942270A TW 97148693 A TW97148693 A TW 97148693A TW 97148693 A TW97148693 A TW 97148693A TW 200942270 A TW200942270 A TW 200942270A
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Taiwan
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chinese medicine
aconite
acne
peony
trauma
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TW97148693A
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Chinese (zh)
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Ming-Jen Chuang
Hitoshi Nagaoka
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Ming-Jen Chuang
Hitoshi Nagaoka
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Priority to TW97148693A priority Critical patent/TW200942270A/en
Publication of TW200942270A publication Critical patent/TW200942270A/en

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Abstract

This invention provides a Chinese medicine composition and a topical paste-like preparation for use in the treatment of bedsore or intractable wounds due to trauma or diseases. Namely, the present invention provides a topical Chinese medicine composition for use in the treatment of traumatic wounds or bedsores, comprising Chinese medicines such as dried ginger, Aconiti Lateralis Preparata Radix(Fu zi or baked Fu Zi), cinnamomum(Cassia cinnamon) etc. as active ingredients. The preferred formulation thereof; in addition to the above ingredients, further contains Bunge pricklyash Peel, or together with Fructus Evodiae, or additionally together with Paeoniae radix and Cortex Magnoliae Offininalis, or further together with Olibanum, Myrrha, or furthermore together with Catechu. Another preferred formulation for the topical Chinese medicine compostion further contains lyophilized mycelia extract of Flammulina velutipes in addition to the aforesaid ingredients. The topical Chinese medicine compostion according to the present invention is an ointment preparation prepared by pulverizing the Chinese medicines in the above formulation and mixing the pulverized medicines with fat (for example, lard) with stirring to form a paste.

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200942270 * 六、發明說明: .【發明所屬之技術領域】 本發明係關於中藥組成物。本發明又關於用於治療褥 瘡及其他因外傷或疾病造成傷口難以癒合之外用膏狀製 劑。 【先前技術】 褥瘡為臨床醫療上常見之徵候,好發於行動不便、長 年臥病在床的病患。造成褥瘡的原因係因局部皮膚及其下 〇方軟組織長時間相壓迫*缺氧,結果導致細胞組織壞死。 發生褥瘡的原因說明於下: 局部性因素: 1. 表皮的垂直壓力:當外界壓力大於局部皮下組織内之微 血管血壓時,局部血液循環受到阻礙,使細胞處於缺氧 狀態。若缺氧狀態持續過久,細胞就會死亡而造成皮 膚、或皮下組織及肌肉潰爛。 ❹受壓迫的地方往往是身體骨頭最突出的部位,例如薦 骨、體骨、坐骨脊、足跟、足踝、肩胛骨及手财等處。 2. 表皮的剪應力:當患者躺著或坐著時,薦骨處之皮膚 被繃緊產生一股水平方向的切力,而施加壓力於 古 膚的血管,導致皮膚的缺氧及壞死。 、'、’ 3. 局部的外傷及感染:在不慎擦傷或挫傷而導致感染的 情況’組織對缺氧的对受力降低,若長期臥床,由ς承 受壓力及剪應力,將會發生褥瘡。 、 4.局部的溫度:由於局部组織之溫度降低,細胞代謝率降 320866 4 200942270 低且對缺氧的财受性降低。 • 5.局部的濕度··皮膚浸潤過度時,組織會較為鬆軟而脆 弱,局部透氣不良及因大小便失禁而經常穿著紙尿褲會 使局部常呈溫暖狀態。 全身性因素: 1. 年齡:因老化而使皮膚失去彈性及血液循環變差,故而 減低組識對缺氧的耐受力。. 2. s養不良.因長期的營養不良,組織的修復停滞、對缺 氧的耐受力以及對感染的抵抗力下降。 3. 貧血.發生貧血時,血液輸送氧氣的能力降低,血液循 環受到阻礙時易造成組織的缺氧。 4·心理因素:因久病臥床造成求生意志減弱,使免疫能力 降低。 從中醫之觀點,其致病機轉可由黃帝内經之《靈樞. 癱疽篇》(非專利文獻1)中說明: 〇 『寒邪客於經絡之中則血泣,血泣則不通,不通則衛 氣歸之,不得復反,故癰腫。寒氣化為熱,熱盛則腐肉, 肉腐則為膿’膿不瀉則爛筋,筋爛則傷骨,骨傷則髓.消, 不當骨空’不得洩瀉,血枯空虛’則筋骨肌肉不相榮,經 脈敗漏,熏于五臟,臟傷故死矣。』 目前’ 一般用以治療傷口之藥物多為碘酊劑、敷料、 外傷·燒燙傷用軟膏或外用藥,且該等軟膏及外敷藥之功 效大多止於消毒殺菌。 然而如上所述·,褥瘡的成因與單純外傷的成因有極大 320866 200942270 k 差異。 - 就治療褥瘡等難以癒合之傷口的藥劑而言,對於可同 時具備:細菌感染之清除、壞死組織之再生、以及其他疾 病所致之傷口癒合不良之改善功能等的藥劑,至今尚未開 發出確具功效的配方法。 關於治療褥瘡及外傷之中藥,有下列文獻: (1) 外科證治全生集(非專利文獻2)、 (2) 外科正宗(非專利文獻3)、 〇 (3)醫宗金鑑(非專利文獻4)。 上開文獻中, (1) 之文獻提及藉由陽和解凝膏治療潰爛、陰疽、凍瘡。 (2) 之文獻提及藉由生肌玉紅膏在癰疽、發背(背部腫塊), 各種潰爛、棒毒等之瘡中形成膿,而可於棑膿時進行治療。 (3) 之文獻提及依據廯盡生肌之治療癱疽的方法。 經查上開文獻所提及之中藥配方,不是偏於理論,就 U 是實際之療效不彰,且今多數患者已先用碘酊劑等外甩殺 菌消毒劑等藥品處理傷口,更增加醫療上的困難度。 [非專利文獻1]:黃帝内經之《靈樞.·癱疽篇》 [非專利文獻2]:外科証治全生集 [非專利文獻3]:外科正宗 [非專利文獻4]:醫宗金鑑 【發明内容】 如上所述,從辨證論治之角度可視褥瘡為一寒證、虛 證、勞證、痿證、血淤,故治則大法為寒者溫之、虛者補 6 320866 200942270 之、勞者溫之、治痿者獨取陽明、再以活血化瘀之法佐之 清朝錢塘吳師機所著《理鑰駢文》有云:「内治之法即為外 治之法」,其理一致。 本發明人係根據上述之原理而專心致志開發出治療 瘡的有效膏劑。 ’、傅 本發明之治療外傷、褥瘡用之中藥組成物,以及治療 外傷、褥瘡用之中藥膏劑,其特徵係包括下述[1:]至^ 以及[33]之項目。 ❹[1]一種治療外傷或褥瘡用之中藥組成物,其特徵為:含有 乾量、附子(或炮附子)、以及肉桂作為有效成分。 本發明中,亦可使用鹽附子、加工附子等取代附 附子經減毒而成之炮附子 . 3 [2] 如[1]之治療外傷或褥瘡用之中藥組成物,其中,作 有效成分之乾4、时(或_子)與_之混合重量比 4 : 2 . 1 〇 ❹ [3] 如[1]虹2]之轉外傷或褥 物 各有效成麵粉狀。 ⑽具1 卜傷或褥瘡用之中藥膏劑,其特徵為:含有[ [5] 一種治;成物以及適量之油脂劑。 乾蔓、附子(或=、用肉之广^ [6] 如[5]之治療外 底以及蜀椒作為有效成分。 有效成分之乾薹、附或用之中藥組成物,其中,作 量比為4 : 1 : 1 、 5 寸子)、肉桂與蜀椒之混合 * 1 〇 320866 7 200942270 之中藥組成物,其中, [7]如[5]或[6]之治療外傷或褥瘡用 各有效成分為粉狀。 療=療用之中藥㈣,其待徵為:含有[5] 至[7」中任1之中藥組成物以及適 [9] 一種治療外傷或褥瘡用 物,曰姓外 . τ樂組成物,其特徵為.含有 ^量、附子(或炮附子)、肉桂、蜀椒以及吳茱萸作為有效 成分。 [10] 如⑻之治療外傷或褥瘡用之中藥組成物,其中,作為 有效成分之乾Ϊ、附子(或_子)、肉桂、輯與吳莱笑 之混合重量比為4: 1 : 1 : 1 : i。 [11] 如[9]或[1G]之治療外傷或褥瘡用之巾藥組成物,其 中,各有效成分為粉狀。 [12] 一種治療外傷或褥瘡用之中藥㈣,其特徵為:含有 [9]至[1.1]中任一項之中藥組成物以及適量之 油脂劑。 [13] —種治療外傷或褥瘡用之中藥組成物,其特徵為:含 Q有乾董.、附子(或炮附子)、肉桂、蜀椒、吳茱萸以及芍藥 作為有效成分。 [14] 如[13]之治療外傷或褥瘡用之中藥組成物,其中,作 為有效成分之乾薑、附子(或炮附子)、肉桂、蜀椒、吳茱 萸與芍藥之混合重量比為4: 1 : 1 : 1 : 1 :丄。 [15] 如[13]或[14]之治療外傷或褥瘡用之中藥組成物,其 中,各有效成分為粉狀。 [16] —種治療外傷或褥瘡用之中藥軟膏,其特徵為:含有 [13]至[15]中任一項之中藥組成物以及適量之油脂劑。 8 320866 200942270 • [ 17 ] —種治療外傷或褥瘡用之中藥組成物,其特徵為:含 - 有乾薑、附子(或炮附子)、肉桂、蜀椒、吳茱萸、芍藥以 及厚朴作為有效成分。 [18] 如[17]之治療外傷或褥瘡用之中藥組成物,其中,作 為有效成分之乾薑、附子(或炮附子)、肉桂、蜀椒、吳茱 萸、芍藥與厚朴之混合重量比為4: 1 : 1 : 1 : 1 : 1 : 1。 [19] 如[17]或[18]之治療外傷或褥瘡用之中藥組成物’其 中,各有效成分為粉狀。 〇 [20]—種治療外傷或褥瘡用之中藥膏劑’其特徵為:含有 [17 ]至[19 ]中任一項之中藥組成物以及遶量之油脂劑。 [21 ] —種治療外傷或褥瘡用之中藥組成物,其特徵為:含 有乾薑、附子(或炮附子)、肉桂、蜀椒、吳茱萸、芍藥、 厚朴、乳香以及沒藥作為有效成分。 [22]如[21]之治療外傷或褥瘡用之中藥組成物,其中,作 為有效成分之乾薑、附子(或炮附子)、肉桂、蜀椒、吳茱 Q 萸、芍藥、厚朴、乳香與沒藥之混合重量比為4 : 1 : 1:1 : 1 : 1 : 1 ; 1 〇 [23]如[21]或[22]之治療外傷或褥瘡用之中藥組成物,其 中,各有效成分為粉狀。 [24]-種治療外傷或褥瘡用之中藥膏劑,其特徼人 [21]至[23]巾任-項之㈣組成物以及適量之油:· 3 ===或褥瘡用之中藥組成物,其特:為: 有乾薑附子(或炮附子)、肉桂、蜀椒、 越 厚朴、乳香、沒藥以及兒茶作為有效成分。I与樂 320866 9 200942270 • [26]如[25]之治療外傷或褥瘡用之中藥組成物,其中,作 -為有巧分之乾*、附子(或炮时)、賴、_、吳茱 萸、苟藥、厚朴、乳香、沒藥與兒茶之混合重量比為4: !: 1 : 1 : 1 : 1 : 1 : 1 小 [27]如[25]或[26]之治療外傷或褥瘡用之中藥組成物,其 中’各有效成分為粉狀。 [28卜種士療外傷或褥瘡用之中藥膏劑,其特徵為:含有 [27]之中藥組成物以及適量之油脂劑。 〇 [29]如[1]至[3]、[5]至[7]、[9:U[11]、[13 至⑽、叫至⑽、[25]至[27]中任一項之治療外傷或 得瘡用之中樂组成物,其另含有金針兹菌菌絲體萃取物作 為有效成分。 [30] 如[29]之治療外傷或褥瘡用之中藥組成鵪,其中,金 针蒜菌菌絲體萃取物之含量,相對於其他作為有效成分之 乾薑、附子(或炮附子)、肉桂、萄椒、吳菜楚、爷藥、厚 〇朴、乳香、沒藥以及兒茶的總含量1重量份,為0 〇1至 0.27重量份,以0·02至重量份為佳。 ♦ [31] 如[29]或[3G]之治療外傷或褥瘡用之中藥組成物,其 中,有效成分為粉狀。 、 [32] -種治療外傷或褥瘡之中藥膏劑,其特徵為··含有㈣ 至[31]中任一項之中藥組成物以及適量之油脂劑。 [33] 如⑷、[8]、[12]、⑽、⑽、⑽、_中任一 項之治療外傷或褥瘡用之中藥組成物或膏劑,其中,油脂 劑為豬油。 320866 10 200942270 本發月之冶療外傷、褥瘡用中藥組成物,以及治療外 傷褥瘡用之令藥膏劑,其主要功效包含:增加病患之免 疫力’「亦即「扶正氣」;不僅有效地控制感染亦可去腐生肌, 亦即袪邪氣」’使推陳致新,並與傷口相容而快速吸收滲 出液’又可保持濕潤狀態。 口此本發明提供一種外用中藥膏劑,適用在治療傷 口癒合不良之情況。 ' 本發明之外用中藥膏劑尤其在治療褥瘡上最為有效。 本,明之中藥膏劑包含乾薑、附子(或炮附子)、肉桂, 蜀椒吳茱楚、与藥、厚朴、乳香、沒藥及兒茶等中藥材。 再配入金針兹菌菌絲體萃取物,則效果更佳。 乾薑為薑科薑屬植物薑 之根的乾燥品。具有溫中散寒,止血,回陽通脈的效果, 且具有鎮痛、抗缺氧、抗炎的藥理作用。 附子為毛莨科烏頭屬植物烏頭Uconii⑽ 0 如化3虹)的侧根(子根).。具有回.陽救逆,散 寒除濕的效果,且具有抗心肌缺血缺氧、抗血栓形成、抗 炎使Τ淋巴細胞轉化率增加之免疫功能提升的藥理作 用。炮附子係附子經減毒加工者。 肉桂為樟科樟屬植物肉桂(挪⑽⑽⑵a presi) 的樹,、’盈乾燥加工者。具有補火助陽,散寒止痛,溫經通 脈的效果’且財抗潰瘍、抗炎、抗菌、預防老化的藥理 作用。肉桂亦可以桂枝代用。 【實施方式】 11 320866 200942270 以下為選自上述中藥中之較佳配方,其中數值表示重 y 量份(parts by weight) ° 配方1為:乾薑4、附子(或炮附子)2、肉桂卜. 配方1,為:乾薑4、附子(或炮附子)2、肉桂卜 菇菌菌絲體萃取物0. 27。 .虫可 ο 卜配方2為:乾薑4、附子(或炮附子)卜肉桂卜蜀椒 配方2’為:砮望/ 卜金針兹菌菌絲體萃取物^或炮附子)卜肉桂卜蜀椒 配方3為·•參曾 1、吳茱萸1。 附子(或炮附子)丨、肉桂1、蜀椒 配方3’為:參曾/ 1、吳茱萸卜金針益詰附子(或炮附子)卜肉桂卜蜀椒 *針盛菌菌絲體萃取物0.27。 配方4為··私兹 ο 卜吳茱萸1、爷=。附子(或炮附子M、肉桂卜苟椒 :配方4’為·•妒菫 卜吳茱萸1、爷藥1丄附子(或炮附子M、肉桂1、萄椒 配方5為:|:墓:針兹菌菌絲體萃取物0.27。. 1、吳茱萸1μ附子(或炮附子M、肉桂1、_ ,勺樂厚朴1。 配方5為:參當λ i、吳茱萸b 4子(或炮附子)卜肉桂1、_ 配方β為:舍 金針菇菌菌絲體萃取物〇. 27。 卜吳茱萸1、4厂附子(或炮附子)卜肉桂卜蜀椒 配方6,為厚朴】、如^ 乙、附子(或炮附子)卜肉桂1、萄椒 320866 12 200942270 1兴茱们、爷藥卜厚朴卜乳香Γ、沒藥卜 « 菌絲體萃取物0. 27。 ι针#菌 、本㈣之中藥㈣’鱗上述中藥材依上述配 後混合並磨碎成粉狀後,添加辅劑妥加攪拌而成。° 上述中藥材可為生鮮型或乾燥麼。然 而以乾燥型為宜。 質 >昆入 〇 品質聲燥之程度並無特別限制,然過度乾燥時,將會影響 可使^辅劑可為礦物系油脂或動植物系油脂。另外亦 =系油:方面,除了地壤、凡士林以外,列 如.源自石油資源之碳原子數15以上的石 刊舉 動物系油脂方面,例如_ ^糸歹° 黃油、紹油、鳕魚肝油、深海鮫油等’。5 ’可列舉如蛋 0 ;動物脂肪而言,可列舉如牛油、豬油、羊油等 植物系油鹿方面’就植物油而言,可舉:由:。 等乾性油;麻油等半乾性油;撖 ·葵化油 就植物脂肪而言,可列汽 '由等不乾性油。 本發明中,該等椰油、木壤等。 礦物系油脂以凡士林馬輕-膏狀物者為佳。 油為較佳。較佳。動植物油脂以牛油、豬 、依本發明中藥外用膏劑之用途,可 ^ 脂或乳液(emulsion)類材料。 、其他醫藥用油 經發明人之實驗證實, 貝豬油之效果最為優異。 320866 13 200942270 _ 將上述輔劑(例如豬油)與上述磨成粉狀之中藥製劑混 1 合攪拌即可製成軟膏等製劑。為調整軟膏之黏度,可混Z 適當之黏度調整劑。另外,為令使用者易於接受,可摻入 適當之除臭劑或芳香劑。 上述之金針菇菌菌絲體萃取物可於上述之中藥材在磨 碎成粉狀後’與輔劑同時添加並樣拌混合。或於上述膏狀 製劑製成後,添加上述金針菇菌菌絲體萃取物並加以攪拌 混合。 : ’ ◎ 本發明之膏藥之作用範圍係涵蓋:皮(皮膚)、脈(神 經、血管、經脈>、肉(皮下脂肪)、筋(肌肉)、骨(骨髓) 等。 本發明之膏狀製劑具有下述優點: •對深度潰爛之作用: > 褥瘡治療最困難之處在於壞死組織(necr〇tic tissue,此為中醫學所謂之「陰疽」)的去除,而本發明 〇 之膏藥有解寒凝之功效,故可去死肌而終止潰爛”此為 是否具有療效之關鍵。 促進肉芽組織(graniQati〇n tissue)的新生: 本發明之膏藥有促進新肌的生成之功效。 •滲出液的抑制: 褥瘡㊉見的大量參出液(exudafe) ’亦即黃水瘡(傳 染性膿痂瘡),其病原體大多為金黃色葡萄球菌。 本發明之膏藥所含有之活性成分,具有增強吞嚏細 胞的吞噬作用並提高身體的免疫功能,對多種病原體具 14 伽866 200942270 " 有抑制作用。 1 •保持濕潤狀態: 本發明之膏藥對於上述滲出液的過度浸潤 (infiltrates)具有抑制作用,同時可使該經清除滲出液 之組織保持濕潤狀態以利於傷口的復原。 本發明之膏藥在上述褥瘡的各階段處均可適用。 接著,說明前述金針益菌菌絲體萃取物之製造方法。 首先將蔗渣所成之固體培養基與水,較佳是純水,適 ^ 當地混合後滅菌,加以冷卻’然後接種金針蒜(尺 種菌。 又’該蔗渣培養基中除了米糠外,視需要可添加磷、 鐵等礦物質類;花生之表皮、糖米等。 韻搾汁後之S渣中因含有g絲體之營養_糖類及 蛋白質,可直接作為固體培養基,但是,於中添加上 述之米糠時,對80重量份之篇潰而言,通常係添加1〇至 〇 20重量份之米糖。 金針菇菌可使用公知者。 繼之,將接種金針難g後之隨騎基移至溫产 渥度經,節且照光度亦經調節之培養室内,使菌_= 如是使金針菇種菌增殖期間,於接種金針菇曰 .宜在溫度14至阶及座度超過谓之條件下 ^ 述溫度及渔度75至㈣之條件下,最好是於上 度80至95%之條件下之培養室内培養,培養之:二 常為2至6個月之間,最好是2至3個月之間4 續時間 门心間,期望能 320866 15 200942270 菌絲體增殖。 由於金針菇種菌之作用,培養基中之认 後被分解成水及二氧化碳,培養基内部水分:為=夺最 因此,上賴度如果設定在7舰下 ^ ^ :,多,結果會使培養基縮小,而無法 本發财’顧體於賴培養基中蔓延 Φ200942270 * VI. Description of the invention: [Technical field to which the invention pertains] The present invention relates to a composition of a traditional Chinese medicine. The present invention is further directed to a cream formulation for treating acne and other wounds that are difficult to heal due to trauma or disease. [Prior Art] Acne is a common symptom in clinical medicine, and it occurs in patients who have mobility problems and are sick in bed for many years. The cause of acne is due to the long-term phase pressure of the local skin and the soft tissue of the lower jaw, which results in necrosis of the tissue. The causes of acne are described below: Local factors: 1. Vertical pressure of the epidermis: When the external pressure is greater than the microvascular blood pressure in the local subcutaneous tissue, the local blood circulation is hindered, leaving the cells in an oxygen-deficient state. If the hypoxic state persists for too long, the cells will die and cause skin, or subcutaneous tissue and muscle ulceration. The most oppressed areas are often the most prominent parts of the body's bones, such as sacral bones, body bones, ischial ridges, heels, athlete's foot, shoulder blades and hand wealth. 2. Shear stress of the epidermis: When the patient is lying or sitting, the skin of the sacrum is tightened to produce a horizontal shear force, which exerts pressure on the blood vessels of the ancient skin, resulting in hypoxia and necrosis of the skin. , ', ' 3. Local trauma and infection: In the case of inadvertent abrasion or contusion, the infection will be reduced. If the bed is in bed for a long time, hemorrhoids will occur due to pressure and shear stress. . 4. Local temperature: Due to the decrease of the temperature of the local tissue, the cell metabolic rate drops 320866 4 200942270 and the financial tolerance to hypoxia is reduced. • 5. Local humidity • When the skin is excessively infiltrated, the tissue will be soft and fragile. Poor local ventilation and frequent diapers due to incontinence will make the part often warm. Systemic factors: 1. Age: The skin loses its elasticity and blood circulation deteriorates due to aging, thus reducing the tolerance of the group to hypoxia. 2. s Poor nutrition. Due to long-term malnutrition, tissue repair stagnation, tolerance to hypoxia, and resistance to infection. 3. Anemia. When anemia occurs, the ability of the blood to deliver oxygen is reduced, and when the blood circulation is hindered, it is likely to cause hypoxia in the tissue. 4. Psychological factors: The long-term illness in bed causes the will to survive, and the immunity is reduced. From the point of view of traditional Chinese medicine, the pathogenesis of the disease can be explained by the Yellow Emperor's "Lingshu. 瘫疽篇" (Non-Patent Document 1): 〇 "The cold sorcerer is crying in the meridian, the blood is crying, If you don't get it, then you can't revert it, so it's swollen. The cold gas is turned into heat, the hot is the carrion, the meat rot is the pus, the pus does not diarrhea, the ribs are broken, the gluten is broken, the bone is injured, the bone is damaged, the bones are empty, the blood is empty, and the bones are empty. The muscles are not honorable, the meridians are lost, and they are smoked in the five internal organs. At present, most of the drugs commonly used to treat wounds are iodine preparations, dressings, traumas, burns or ointments, and the effects of these ointments and external preparations are mostly sterilized. However, as mentioned above, the cause of acne and the cause of simple trauma are greatly different between 320866 and 200942270 k. - For the treatment of wounds that are difficult to heal, such as acne, the drug that can simultaneously have the following functions: clearance of bacterial infection, regeneration of necrotic tissue, and improvement of wound healing caused by other diseases has not yet been developed. Effective method of distribution. For the treatment of acne and traumatic Chinese medicine, the following documents are available: (1) Surgical treatment of the whole life collection (Non-Patent Document 2), (2) Surgical authenticity (Non-Patent Document 3), 〇 (3) Medical Archives Patent Document 4). In the literature above, (1) the literature mentions the treatment of ulceration, pubic lice, and frostbite by Yanghe Jiegel. (2) The literature mentions that the pus can be formed in the sores of the sputum, the back of the hair (back mass), various ulcers, rods and the like by the myogenic jade red cream, and can be treated at the time of pus. (3) The literature refers to methods for treating sputum based on sputum. After examining the Chinese medicine formula mentioned in the literature, it is not biased by theory, but U is the actual curative effect, and most patients have treated the wound with iodine and other external disinfectant and other drugs, and increased medical treatment. The difficulty. [Non-Patent Document 1]: "Lingshu.." in the Yellow Emperor's Internal Classics [Non-Patent Document 2]: Surgical Treatment of the Whole Set [Non-Patent Document 3]: Surgical Orthodox [Non-Patent Document 4]: Medical Zong Jinjian [Invention content] As mentioned above, from the perspective of syndrome differentiation and treatment, hemorrhoids can be regarded as a cold syndrome, deficiency syndrome, labor syndrome, phlegm syndrome, blood stasis, and therefore the rule of law is that the cold is warm and the virtual is supplemented by 6 320866 200942270 The laborer Wen Zhizhi, the ruler who took Yangming alone, and then the method of activating blood and removing blood stasis, the Qing Dynasty Qiantang Wu Shiji wrote "The Key to the Law": "The law of internal treatment is the law of external treatment." Consistent. The present inventors have devoted themselves to the development of an effective ointment for treating sores in accordance with the above principles. The invention relates to a composition for treating trauma, acne, and a medicinal ointment for treating trauma and acne, which are characterized by the following items [1:] to ^ and [33]. ❹ [1] A traditional Chinese medicine composition for treating trauma or acne, which comprises: a dry amount, an aconite (or an aconite), and cinnamon as an active ingredient. In the present invention, salt aconite, processing aconite, etc. may be used instead of the aconite which has been attenuated by the attachment. 3 [2] The composition of a traditional Chinese medicine for treating trauma or acne according to [1], wherein, as an active ingredient Dry 4, time (or _ child) and _ mix weight ratio 4 : 2 . 1 〇❹ [3] such as [1] rainbow 2] of the trauma or booty each effective into a flour. (10) A traditional Chinese medicine ointment with 1 bruise or acne, which is characterized by containing [[5] a treatment; a finished product and an appropriate amount of a fat agent. Dried vines, aconites (or =, with the wide range of meat ^ [6] such as [5] treatment of the outsole and pepper as an active ingredient. The active ingredients of the cognac, attached or use of traditional Chinese medicine composition, of which the ratio is 4 : 1 : 1 , 5 inch ) , mixed with cinnamon and scallions * 1 〇 320866 7 200942270 Traditional Chinese medicine composition , [7] such as [5] or [6] for the treatment of trauma or acne with active ingredients Powdery. Treatment = Chinese medicine (4), which is to be levied as: Containing any of the Chinese herbal medicines of [5] to [7" and suitable [9] A treatment for trauma or hemorrhoids, surnamed outside. It is characterized by containing a quantity, an aconite (or an aconite), a cinnamon, a pepper and an anthraquinone as an active ingredient. [10] The composition of traditional Chinese medicine for treating trauma or acne according to (8), wherein the weight ratio of cognac, aconite (or _), cinnamon, and Wu Laixiao as an active ingredient is 4:1 : 1 : 1 : i. [11] A composition for treating trauma or acne according to [9] or [1G], wherein each active ingredient is in the form of a powder. [12] A traditional Chinese medicine for treating trauma or acne (4), which comprises the composition of a traditional Chinese medicine according to any one of [9] to [1.1] and an appropriate amount of a fainting agent. [13] A traditional Chinese medicine composition for treating trauma or acne, which is characterized in that it contains Q, dried dong, aconite (or medicinal aconite), cinnamon, peony, peony and peony as active ingredients. [14] The composition of traditional Chinese medicine for treating trauma or acne according to [13], wherein the weight ratio of dried ginger, aconite (or artillery aconite), cinnamon, peony, sage and peony as an active ingredient is 4:1: 1 : 1 : 1 : Hey. [15] The composition of a traditional Chinese medicine for treating trauma or acne according to [13] or [14], wherein each active ingredient is in the form of a powder. [16] A traditional Chinese medicine ointment for treating trauma or acne, which comprises the composition of the Chinese medicine according to any one of [13] to [15] and an appropriate amount of the oil agent. 8 320866 200942270 • [ 17 ] A traditional Chinese medicine composition for the treatment of trauma or hemorrhoids, characterized by: - with ginger, aconite (or medicinal aconite), cinnamon, peony, peony, peony and magnolia as active ingredients. [18] The composition of traditional Chinese medicine for treating trauma or hemorrhoids according to [17], wherein the weight ratio of dried ginger, aconite (or medicinal aconite), cinnamon, peony, peony, peony and magnolia as an active ingredient is 4 : 1 : 1 : 1 : 1 : 1 : 1. [19] The composition of a traditional Chinese medicine for treating trauma or acne according to [17] or [18], wherein each active ingredient is in the form of a powder. 〇 [20] A traditional Chinese medicine ointment for treating trauma or acne, characterized in that it comprises a composition of a traditional Chinese medicine according to any one of [17] to [19] and a lubricating agent for winding. [21] A traditional Chinese medicine composition for treating trauma or acne, which is characterized by containing ginger, aconite (or aconite), cinnamon, peony, peony, peony, magnolia, frankincense and myrrh as active ingredients. [22] The composition of a traditional Chinese medicine for treating trauma or acne according to [21], wherein, as an active ingredient, dried ginger, aconite (or aconite), cinnamon, amaranth, scorpion, scorpion, peony, magnolia, frankincense and The weight ratio of myrrh is 4:1 : 1:1 : 1 : 1 : 1 ; 1 〇 [23] such as [21] or [22] for the treatment of trauma or acne with traditional Chinese medicine composition, wherein each active ingredient It is powdery. [24]---------------------------------- , its special: for: There are dried ginger aconite (or gun aconite), cinnamon, pepper, the more koji, frankincense, myrrh and catechu as an active ingredient. I and Le 320866 9 200942270 • [26] [25] for the treatment of trauma or acne with Chinese medicine composition, which, for the sake of the coincidence *, aconite (or gun time), Lai, _, Wu Hao, The weight ratio of peony, magnolia, frankincense, myrrh and catechu is 4: !: 1 : 1 : 1 : 1 : 1 : 1 small [27] such as [25] or [26] for the treatment of trauma or hemorrhoids The composition of the traditional Chinese medicine, wherein 'the active ingredients are in the form of powder. [28] A traditional Chinese medicine ointment for trauma or hemorrhoids, characterized by containing a composition of Chinese medicine [27] and an appropriate amount of oil agent. 〇[29] such as [1] to [3], [5] to [7], [9: U [11], [13 to (10), to (10), [25] to [27] A composition for treating trauma or sore, which additionally contains a strain of Mycelium of Mycelium as an active ingredient. [30] Such as [29] for the treatment of trauma or hemorrhoids with traditional Chinese medicine composition, of which, the content of the extract of A. sinensis mycelium, relative to other active ingredients of dried ginger, aconite (or artemisia), cinnamon, The total content of the pepper, the medicinal herbs, the medicinal herbs, the thick sage, the frankincense, the myrrh, and the catechu is 1 part by weight, preferably 0 〇1 to 0.27 parts by weight, preferably 0. 02 parts by weight. ♦ [31] For example, [29] or [3G] is a traditional Chinese medicine composition for treating trauma or acne, wherein the active ingredient is powder. [32] The invention relates to a medicine for treating trauma or acne, which is characterized in that the composition of the traditional Chinese medicine of any one of (4) to [31] and an appropriate amount of the oil agent are contained. [33] A composition or ointment for treating trauma or acne according to any one of (4), [8], [12], (10), (10), (10), _, wherein the oil agent is lard. 320866 10 200942270 This month's treatment of trauma, acne with traditional Chinese medicine composition, and the treatment of traumatic acne with ointment, its main effects include: increase the patient's immunity '" is also "righteous"; not only effective Controlling the infection can also go to the saprophytic muscles, which means that the cockroaches are "to make the new and new, and compatible with the wound and quickly absorb the exudate" and keep it moist. The present invention provides a topical Chinese medicine ointment suitable for treating a wound healing condition. The external Chinese medicine ointment of the present invention is most effective in treating acne. Ben, Mingzhong Chinese medicine ointment contains dried ginger, aconite (or medicinal aconite), cinnamon, peony pepper Wu Chuchu, medicine, magnolia, frankincense, myrrh and catechu and other Chinese herbal medicines. The effect is better when it is added to the A. faecalis mycelium extract. Dried ginger is a dried product of the root of ginger ginger. It has the effects of warming and dispelling cold, stopping bleeding, and returning to the yang, and has pharmacological effects of analgesia, anti-hypoxia and anti-inflammatory. The aconite is the lateral root (sub-root) of the Aconitum Uconii (10) 0 (3). It has the effect of returning to the sun, reversing the cold and dehumidifying, and has the pharmacological effect of enhancing the immune function of anti-myocardial ischemia and hypoxia, anti-thrombosis and anti-inflammatory to increase the lymphocyte transformation rate. The aconite attached to the aconite is attenuated. Cinnamon is a tree of the genus Cinnamomum (10) (10) (2) a presi, and is a dry processing processor. It has the effect of supplementing the fire and helping the yang, dispelling cold and relieving pain, and warming the blood circulation. The anti-cancer, anti-inflammatory, anti-bacterial and anti-aging pharmacological effects. Cinnamon can also be used for cassia twigs. [Embodiment] 11 320866 200942270 The following is a preferred formulation selected from the above traditional Chinese medicines, wherein the numerical value indicates parts by weight ° Formula 1 is: dried ginger 4, aconite (or artillery aconite) 2, cinnamon b Formulation 1, for: dried ginger 4, aconite (or gun aconite) 2, mycorrhizal mycelium extract 0. 27.虫可ο 卜 Formula 2 is: dried ginger 4, aconite (or gun aconite), cinnamon, chopped pepper, formula 2':: 砮望 / 金金菌菌菌提取物^ or gun aconite) 3 is ·········1, Wu茱萸1. Aconite (or gun aconite) 丨, cinnamon, 蜀 pepper Formula 3': 参曾 / 1, Wu 茱萸 金 金 金 诘 诘 ( ( 或 或 或 或 或 或 或 或 或 或 或 或 或 或 或 或 * * * * * * * * * * * * * * * * * * * * * Recipe 4 is ······················· Aconite (or Aconite M, Cinnamon Bud: Formula 4' is ···················································· Mycelium extract 0.27.. 1. Wusong 1μ aconite (or gun aconite M, cinnamon 1, _, spoon Le Houpu 1. Formula 5 is: λ λ i, Wu 茱萸 b 4 (or gun aconite) Cinnamon 1, _ Formulation β is: Mycelium of Mycorrhiza sinensis mycelium extract. 27. Bu Wuzhen 1, 4 plant aconite (or gun aconite) Bu Cinnamon Bucchi formula 6, for Magnolia, such as ^ B, aconite ( Or gun aconite) Bu Cinnamon 1, Bell Pepper 320866 12 200942270 1 Xing Yi, the medicinal medicine Bu Houpu Bu milk fragrant sputum, myrrh] « Mycelium extract 0. 27. ι needle #菌,本(四)中药(四)' scale The above-mentioned Chinese medicinal materials are mixed and ground into powder after the above-mentioned mixing, and then added with an auxiliary agent and stirred. ° The above Chinese medicinal materials can be fresh or dry. However, it is preferable to use a dry type. The degree of quality sound is not particularly limited, but when it is excessively dried, it will affect the minerals or animal and plant fats. Also = oil: in addition to the soil, Vaseline, such as the petroleum resources from the number of carbon atoms more than 15 stone publication animal oils, such as _ ^ 糸歹 ° butter, Shao oil, cod liver oil, The deep sea oyster sauce, etc. '5' can be exemplified as egg 0; for animal fat, for example, botanical oil deer such as butter, lard, and sheep oil, in terms of vegetable oil, it can be mentioned as: Oil; semi-drying oil such as sesame oil; 撖·Kinghua oil, in terms of vegetable fat, can be listed as a non-drying oil. In the present invention, such coconut oil, woody soil, etc. Mineral oils and fats are Vaseline horse light- Preferably, the oil is preferred. The animal and vegetable fats and oils are used for the use of butter, pig, and the external plaster of the traditional Chinese medicine according to the present invention, and may be used as a fat or emulsion material. The experiment of human has confirmed that the effect of shell lard is the best. 320866 13 200942270 _ The above auxiliary agent (such as lard) is mixed with the above-mentioned ground powdered Chinese medicine preparation and stirred to prepare an ointment and the like. Viscosity, can be mixed with Z appropriate viscosity modifier In addition, in order to make the user easy to accept, a suitable deodorant or fragrance may be incorporated. The above-mentioned mycelium extract of Flammulina velutipes may be added simultaneously with the adjuvant after the above-mentioned Chinese medicine is ground into a powder. The mixture of the above-mentioned cream preparations is added, and the above-mentioned mycelium extract of Flammulina velutipes is added and stirred and mixed. : ' ◎ The scope of the plaster of the present invention covers: skin (skin), vein (neural) , blood vessels, meridians>, meat (subcutaneous fat), tendons (muscles), bones (bone marrow), etc. The paste preparation of the present invention has the following advantages: • Effect on deep ulceration: > The most difficult place for acne treatment It is the removal of necrotic tissue (this is the so-called "shadow" of traditional Chinese medicine), and the plaster of the present invention has the effect of relieving cold and condensing, so it can kill the muscle and terminate the ulceration. This is the key to whether it has curative effect. . Promoting the regeneration of granulation tissue (graniQati〇n tissue): The plaster of the present invention has the effect of promoting the formation of new muscles. • Inhibition of exudate: A large amount of exudfe (exudafe), which is a yellow sore (transfective purulent acne), whose pathogens are mostly Staphylococcus aureus. The active ingredient contained in the plaster of the invention has the function of enhancing the phagocytosis of the swallowing cells and improving the immune function of the body, and has an inhibitory effect on various pathogens. 1 • Maintaining a wet state: The plaster of the present invention has an inhibitory effect on the infiltrates of the above exudate, and at the same time, the tissue excreted by the exudate is kept moist to facilitate recovery of the wound. The plaster of the present invention is applicable at each stage of the above-mentioned acne. Next, a method of producing the above-mentioned extract of Mycorrhiza mycelium mycelium will be described. First, the solid medium made of bagasse is mixed with water, preferably pure water, and then sterilized and cooled. Then, the golden needle garlic is inoculated (the inoculum. In addition to the rice bran in the bagasse medium, phosphorus may be added as needed. Minerals such as iron; the skin of peanuts, sugar rice, etc. The S-slag after the juice is extracted from the nutrient-glycoside and protein of g-filament, which can be directly used as a solid medium, but when the above-mentioned rice bran is added For 80 parts by weight of the crucible, usually 1 to 20 parts by weight of rice sugar is added. The Flammulina velutipes can be used by a well-known person. Then, after the inoculation of the golden needle is difficult, the riding base is moved to the warm production. The temperature, the degree of illumination and the illuminance are also adjusted in the culture room, so that the bacteria _= If the Flammulina velutipes breeding period is proliferating, inoculation of Flammulina velutipes. The temperature and the degree of fishing should be determined under the conditions of temperature 14 to the order and the degree of seating exceeding the prevailing conditions. Under the conditions of 75 to (4), it is best to culture in a culture room under the condition of 80 to 95% of the upper culture. The culture is usually between 2 and 6 months, preferably between 2 and 3 months. Continued time between the door, expectation 320866 15 200942270 bacteria Body proliferation. Due to the action of Flammulina velutipes, the medium is decomposed into water and carbon dioxide, and the internal moisture of the medium is the most. If the temperature is set to 7 ^ ^ :, the result will be the medium. Shrinking, but not able to make a fortune

Q 實體正要產生之前後時期進行·基材的 作,且宜將通過12mesh之_的部 、之解束麵 下。又,_舰基材培養基 ^為30重量㈣ 產生之前後時期進行,但亦可在子‘俨:於子實體正要 進行。 在子“相當成長後之時期 固態培養基雄持在3〇至5π°γ ·τγ 體培養基中添加-種以上選自水、纖維』上=束後之固 萄糠苷酶、半纖維素酶、幾皙醢、’、、’’、、蛋白酶、葡 酵素。戍丁質酶、澱粉酶及果膠酶等之 所添加之酵素宜為纖維素酶。 解束=二:=2:2子類之純水’在& 添加後成為含顏之齡物。41至1Qkg’較佳3至响, 接著,由該含有$渣之混合物 萃取物。如是萃取金針兹菌菌絲體時,宜將二;= 320866 16 200942270 - 混合物使用如附有變速裝置之齒輪果等使之循環,在固體 . 培養基中施以粉碎以及擂潰作用,使約有70重量%以上之 蔗渣纖維通過12mesh之網篩。 當能夠通過12lQesh網篩之量未滿70重量%時,固體培 養基中之有效成分之萃取則不夠充分,纖維素未充分軟化 之部分增多,所得之固形殘渣將無法充分有效地利用作為 飼料、食料或肥料。 含有蔗渣之混合物的粉碎或擂溃可在維持該混合物之 ^溫度於30至50°C下實施,亦可於溫度由上述之溫度開始 緩慢上昇之情況下實施,較好是溫度在上昇之同時而實施。 水溫維持在30°C以上,較好是3.5°C以上,此時當室溫 之空氣噴人含有紐之混合物中時,空氣泡因被急驟加孰 而破裂,對蔗渣纖維產生衝擊,可有效地促進有效成分的' 萃:取。 繼之,將如是處理後之含有蔗渣之混合物進一步加熱 0至95°C ’較佳加熱至75至90tl·程度的溫度,維持此溫^ 數十分鐘,使該混合物中之酵素失活,同時對該混合 行滅菌’而得金針菇菌菌絲體萃取物。 如是將該混合物中之酵素加熱使之失活並予以滅菌, 以防止金針菇菌菌絲體萃取物的變質。 所侍金針菇菌菌絲體萃取物亦可視需要,使用50至 120廳h,較好是6〇至1〇〇mesh左右之濾布進行過遽。 如此製得之金針菇菌菌絲體萃取物含有 新的抗腫瘤成分;pr〇flamin)。 種 320866 17 200942270 此萃取物可濃縮後使用,亦可冷凍乾燥成粉末後使 •用,亦可進一步經由例如精製水、酒精等稀釋後使用,可 添加於醫藥品(例如:異位性皮膚炎治療劑、抗黴菌劑、面 皰治療劑、免疫活性化劑、愛滋病治療劑、制癌劑等)以及 化妝品(皮膚保濕用化妝品等)中使用。 以下係藉由製造例、實施例更具體說明本發明之治療 外傷、褥瘡用之藥組成物,以及治療外傷、褥瘡用之中藥 膏藥。 〇製造例1: 將下列之中藥材依下列配方調配後,混合、粉碎並加 以均勻攪拌: 乾薑150g、附子(或炮附子)37. 5g、肉桂37. 5g,蜀椒 37. 5g、吳茱萸 37. 5g、苟藥 37. 5g、厚朴 37· 5g、乳香 37. 5g、 沒藥 37· 5g、兒茶 37. 5g (共 487. 5g)。 磨碎係使用欣鎮企業有限公司製造之氣流式超微粉碎 Q機(台灣專利121630號),磨碎至可通過120 mesh之網篩 之程度(微粉碎)。粉碎後,然後再與2400g豬油混合攪拌 成膏狀’而製得軟膏狀製劑(中藥軟膏1 : 2887. 5g)。 製造例2 : 依據與上述製造例1相同的處方,將所製造之中藥材 (共487. 5g)後,混合及粉碎成粉狀,添加經冷凍乾燥之金 針菇菌菌絲體萃取物粉末l〇g並加以均勻攪拌,再與24〇〇g 豬油混合攪拌成膏狀,而製得軟膏狀製劑(中藥軟膏2 : 2897. 5g) 〇 320866 18 200942270 查貞复絲體培養萃取物(F, Υ. Μ)<調製方法: • 使由90重量份蔗渣與1〇重量份米糠所組成之固體格 養基含適量之純水後,接種金針菇(尺reJ肘ipes)種菌f 靜置在已調節溫度與溼度之培養室内,使菌絲體繁殖。 菌絲體在培養基中繁殖蔓延後,解束蔗渣基材之纖維 素’使通過12 mesh之網篩的部分為24重量%以下。而經 解束之1.0kg培養基中添加3. 5kg純水,一面使溫度維持 在40°C而一面添加2 〇g纖維素酶,成為含有培養基之混 合物。 接著’將該含有培養基之混合物以附有變速裝置之齒 輪泵2之循環,在齒輪部分中施以200分鐘左右的粉碎以 及擂潰作用,使固體培養基約有8Q重量%蔗渣纖維通過12 mesh之網篩。 含有培養基之混合物的粉碎與擂潰係在使該混合物4 溫度缓缓上昇之條件下進行。 0 接著將含有培養基之混合物再進行加熱至並方 置30分鐘。藉由机的加熱使酵素喪失活性並得以滅菌 成今==有培,之混合物以6〇 ^之遽布過_ 成十蒜菌菌絲體萃取液,經遭縮後,進行 , 到金針蒜菌菌絲體萃取物之經冷凌乾燥粉 6'、’ 明之 I ^ «r-ι ' (F. V· M)之併用你f : (= 使用含有金針__體培養萃取物( 療劑,對絲效果進行檢討之結果,發現相較於 菌菌絲體拉養萃取名 320866 19 200942270 曰後才可生成新肌者,使用本發明之含有金針菇菌菌絲體 •培養萃取物(F.V.M)之褥瘡治療劑者會更促進新肌的生成。 在金針4读囷絲體培養萃取物.(F.V.M)本身所且有之 抗腫瘤作用、免疫活化作用以及消除疲勞作用之相乘效果 下,應可提升身體的抵抗力。 特別是低濃度的金針菇菌菌絲體萃取物,因刺激交感 神經而得以消除疲勞。 ◎ (2)含有金針菇菌菌絲體培養萃取物(F· V M)之褥瘡製劑 (例如:製造例2之中藥軟膏2)具有金針菇菌菌絲體培養 萃取物(F· V. M)本身所具有之抗腫瘤作用、免疫活化作用以 及消除疲勞作用。 再者,金針菇菌菌絲體培養萃取物(F. vj|)具有對皮膚 的保濕作用’經由使用該褥瘡治療劑之洽療即可促進皮膚 的新肌生成’由於保濕作用而使皮膚提前形成新肌。. 本發明之含有金針菇菌菌絲體培養萃取物(F. v m)2 〇褥瘡治療劑(亦即,中藥軟膏或中藥軟膏2)(無),在促進 對創傷皮膚之治療作用上,相對於(乙)未處置(對創傷皮膚 未施行處置之情況)者,在傷口癒合後的張力強度(tensile strength)方面呈現顯著性高值,具有促進癒合之作用。 本發明之中藥軟膏2,相較於為一般市售的褥瘡治療 劑之「b-FGF」(褥瘡治療劑,科研製藥(股)製造;通稱 「trafermin」),顯示強而有力的促進癒合之作用,在皮 膚創傷上具有優異之癒合效果(試驗例H)。 在患有遺傳性糖尿病之小鼠(db/db小鼠)背部形成創 20 320866 200942270 -傷的部位上塗抹本發日4之中藥軟膏2後,挪定其創傷部位 面積,由其結果判定中藥軟膏2具有促進癒合之作用。而 且,創傷部位面積對麵過時間之曲線下面積(A[JC :肛的 under curve)亦呈現顯著性低值’判定具有從=a 用(試驗例12)。 口又作 本發明之膏藥係依照下述說明使用〇 首先將療口以無菌生理食鹽水清洗 捲蔣亭 藥適量地塗敷在不織布上並覆蓋紗布,再數喊=棒將膏 〇 如和較深,_接將膏藥(依瘡口之*在療口上。 量使用)塗敷於瘡口再敷上紗布,每日 ^小、深度,酌 數次,換藥時須謹慎小心,不使傷口 (傷口之情況更換 時保持濕潤狀態,忌用碘酒消毒。之新生薄膜破裂,同 保存方法:須置於陰涼處,、;陽光直拉 時请放置冰箱冷藏,保存之有效、筏照射,長期存放 [實施例]^ 限為一年。 0 實驗例、1 ; 病歷1:陳χ,52歲,為腦出血H 年9月28日發現薦部有褥瘡,傷管’長期臥床1 2〇〇7 潰瘍侵犯至真皮層,屬丑度褥瘡口(面積)約10cmx5cm, 使用製造例1之褥瘡奢劍皮 1〇日傷口已癒合。如第日更換一次,至同年10月 實驗例2 : 圖(A)至⑻所示。 病歷2,趙X,66歲,為腦 有褥瘡,傷口約3cmx2 者’長期臥床’薦部 至皮下脂肪層,屬m度褥 320S66 21 200942270 ‘ 瘡,病程已有1個月,傷口癒合不良,2007年9月29日 , 起使用製造例1之褥瘡膏劑治療,至同年10月10日傷口 癒合良好。如第2圖(A)至(D)所示。 實驗例3 : 病歷3,鄭X,34歲,患者有高血壓、下肢靜脈栓塞病 史,2007年5月5曰來院就診,左足跟部因外傷導致蜂窩 性組織炎,病程已有1個月,傷口至皮下脂肪層,傷口約 10cmx4cm ° @ 使用製造例1製造之褥瘡膏劑,每日換藥一次,同年 7月20曰傷口已癒合。如第3圖(A)及(B)所示。 實驗例4 : 病歷4,王X,21歲,2007年3月初因車禍引起右小 腿外傷,經鏠合後傷口癒合不良,引發蜂窩性組織炎。 傷口約6cmx4cm,傷口至肌肉層,屬IV度褥瘡。同年4 .月12日起使用製造例1之褥瘡膏劑,每日更换一次,至同 ❹年6月29日傷口癒合。如第4圖所示。 實驗例5 : 病歷5,彭X,54歲,為腦出血及糖尿病患者,長期臥 床,臀部褥瘡,傷口至肌肉層,傷口約10cmx5cm,屬IV度 褥瘡。 背部亦有褥瘡,傷口至皮下脂肪,傷口約5cmx3cm, 屬]Π度褥瘡,病程已有2個月。 2007年6月起使用製造例1之褥瘡膏劑治療,每曰更 換一次,同年7月17日傷口已癒合。如第5圖(A)及(B) 22 320866 200942270 - 所示。 • 實驗例6 : 病歷6,許X,76歲,行動不便,長期坐輪椅、馱床, 背部褥瘡,皮膚發紅破皮,傷口至表皮層,屬I度褥瘡, 病程已有1個月,2007年10月1日起使用製造例1之褥 瘡膏劑,每日更換1次,至同年10月7日傷口已癒合。如 第6圖(A)至(E)所示。 實驗例7卜 ❹ 病歷7,劉X,64歲,為乳癌及直腸癌患者,小腸人工 肛門造口,腹部多處傷口癒合不良,化膿。 傷口至真皮層,多為1至2cmxl至2cm,屬Π度褥瘡, 病程已有數個月。 2007年9月起使用製造例1之褥瘡膏劑治療,至同年 10月5日停止化膿,傷口已癒合。如第7圖(A)至(F)所示。 實驗例8 : q 病歷8,張X,79歲,為糖尿病患者,左拇趾色黑壞死, 第二趾關節處紅腫化膿疼痛,病程已有數個月。 2007年7月起使用製造例1之褥瘡膏劑,每日更換1 至2次,至同年8月3日化膿紅腫改善。如第8圖所示。 實驗例9 : 病歷9,魏X,76歲,為腦出血患者,長期跃床,坐骨 部發生褥瘡,傷口至真皮層,傷口約2cmx2cm,病程已有1 個月,2007年8月10日起使用製造例1之褥瘡膏劑治療, 至同年9月21日傷口癒合。 23 320866 200942270 ' 實驗例ίο: • 病歷10,鄭X,77歲,為肺結核患者,長期臥床,左 肩頭褥瘡,皮膚紅腫破皮。 傷口至表皮層,傷口約2cmx2cm,屬I度褥瘡,病程 已有2個月,2〇〇7年7月13日起使用製造例1之褥瘡膏 劑,至同年8月初傷口癒合。 實驗例11 : 本發H中膏2對大鼠虔膚割傷模剞的治療實驗 ® 1·〈概要〉 將12週齡Crl : CD(SD系)大鼠之皮膚割傷模型以製造 例2所得中藥軟膏(亦可稱為「中藥軟膏2」)處置,進行 促進癒合作用之實驗,其結果如以下之表1以及第9圖表 示,(甲)未處置群、(乙)本發明之中藥軟膏2處置群、以 及(丙)「b-FGF」(褥瘡治療劑,科研製藥(股)製造;通稱 「trafermin」)處置群之傷口癒合後張力強度之平均值及 〇標準誤差分別為(曱)143±8g、(乙)289±31g、(丙)2〇5±1如。 相較於(甲)未處置群者,(乙)本發明之中藥軟膏2處 置群以及⑷「b—FGF」處置群之傷口癒合後張力強度的 增加率分別為102.1%以及43.4%。The Q entity is about to produce the substrate in the previous period, and it is better to pass the 12m _ part of the unwinding surface. Also, the _ ship base medium ^ is 30 weight (four) produced before and after the period, but it can also be carried out in the child 俨: in the fruiting body. In the period of "the period of considerable growth, the solid medium is added to the medium of 3 〇 to 5π ° γ · τ γ, and more than one kind selected from water and fiber" = glucosidase, hemicellulase, Several enzymes, ',, '', protease, and grape enzymes. The enzyme added by chymase, amylase and pectinase should be cellulase. Unconstrained = two: = 2: 2 subclass The pure water 'in the & is added to become the age of the skin. 41 to 1Qkg' is preferably 3 to ring, and then, the mixture containing the residue containing slag. If it is extracted from the mycelium of A. niger, it is preferable to be two; = 320866 16 200942270 - The mixture is circulated using gears such as a gearbox, and comminuted and collapsed in a solid medium to allow approximately 70% by weight of the bagasse fibers to pass through a 12 mesh screen. When the amount of the 12 l Qesh mesh sieve is less than 70% by weight, the extraction of the active ingredient in the solid medium is insufficient, and the portion of the cellulose which is not sufficiently softened is increased, and the obtained solid residue cannot be fully and effectively utilized as feed, foodstuff or Fertilizer. Containing bagasse The pulverization or mashing of the mixture can be carried out at a temperature at which the mixture is maintained at 30 to 50 ° C, or at a temperature at which the temperature starts to rise slowly, preferably while the temperature is rising. The water temperature is maintained at 30 ° C or higher, preferably 3.5 ° C or higher. At this time, when the room temperature air is sprayed with the mixture containing the New Zealand, the air bubbles are broken by being rapidly twisted, and the bagasse fibers are impacted. Effectively promote the 'extraction of the active ingredient: take. Then, if the treated bagasse-containing mixture is further heated to 0 to 95 ° C, it is preferably heated to a temperature of 75 to 90 tl · to maintain the temperature for tens of minutes The enzyme in the mixture is inactivated and the mixture is sterilized to obtain the mycelium extract of Flammulina velutipes. If the enzyme in the mixture is heated to inactivate and sterilize, the mycelium of Flammulina velutipes is prevented. Deterioration of the extract. The mycelium extract of Flammulina velutipes can also be used as a filter cloth of 50 to 120 halls h, preferably 6 to 1 〇〇mesh, as needed. Silk body extraction Contains a new anti-tumor component; pr〇flamin). 320866 17 200942270 This extract can be used after concentration, or can be freeze-dried into a powder for use, or further diluted with, for example, purified water, alcohol, etc. It is added to pharmaceuticals (for example, atopic dermatitis therapeutic agents, antifungal agents, vesicle therapeutic agents, immunostimulating agents, AIDS therapeutic agents, carcinostatic agents, etc.) and cosmetics (skin moisturizing cosmetics, etc.). The composition for treating trauma, acne, and the intermediate medicine for treating trauma and acne according to the present invention will be more specifically described by way of production examples and examples. 〇Production Example 1: After the following Chinese medicinal materials are formulated according to the following formula, Mixing, pulverizing, and evenly stirring: 150 g of dried ginger, aconite (or medicinal aconite) 37. 5 g, cinnamon 37. 5 g, 蜀 pepper 37. 5 g, 茱萸 茱萸 37. 5 g, peony 37. 5 g, magnolia 37 · 5 g, frankincense 37克。 (5. 5g, 487. 5g). The grinding system was carried out using a gas flow type ultrafine pulverization Q machine (Taiwan Patent No. 121630) manufactured by Xinzhen Enterprise Co., Ltd., and was ground to a degree that it could pass through a mesh of 120 mesh (fine pulverization). After pulverization, it was mixed with 2400 g of lard and stirred into a paste to prepare an ointment preparation (Chinese Herbal Ointment 1: 2887. 5g). Production Example 2: According to the same prescription as in the above Production Example 1, the prepared Chinese herbal medicine (total 487.5 g) was mixed and pulverized into powder, and the freeze-dried Flammulina velutipes mycelium extract powder was added. g, and evenly stirred, and then mixed with 24 〇〇g lard to form a paste, and the ointment preparation (Chinese medicine ointment 2: 2897. 5g) 〇320866 18 200942270 贞 贞 贞 培养 培养 培养 培养Υ. Μ)<Preparation method: • After a suitable amount of pure water is composed of 90 parts by weight of bagasse and 1 part by weight of rice bran, the inoculum is inoculated with Flammulina velutipes (foot reJ elbipe). Adjust the temperature and humidity in the culture chamber to make the mycelium multiply. After the mycelium propagated in the medium, the cellulose of the bagasse substrate was unwound, and the portion passing through the mesh of 12 mesh was 24% by weight or less. To the 1.0 kg medium which was unwound, 3.5 kg of pure water was added, and 2 〇g of cellulase was added while maintaining the temperature at 40 ° C to obtain a mixture containing the medium. Then, the mixture containing the medium is circulated and crushed in the gear portion for about 200 minutes in a cycle of the gear pump 2 with the shifting device, so that the solid medium has about 8Q% by weight of the bagasse fibers passing through the 12 mesh. Mesh screen. The pulverization and mashing of the mixture containing the medium is carried out under the condition that the temperature of the mixture 4 is gradually increased. 0 The mixture containing the medium was then heated and incubated for 30 minutes. The enzyme is deactivated by the heating of the machine and sterilized into a current == cultivating mixture, and the mixture is pulverized by 6 〇 ^ _ into the mycelium mycelium extract, after being contracted, to the golden needle garlic The mycelium extract is cold-dried dry powder 6', 'Mingzhi I ^ «r-ι ' (F. V· M) and used by you f : (= using gold needle __ body culture extract (therapeutic agent) As a result of reviewing the silk effect, it was found that the new muscle was produced compared to the mycelium extracting name 320866 19 200942270, and the mycelium-containing mycelium culture extract (FVM) of the present invention was used. The acne treatment agent will promote the formation of new muscles. Under the effect of the anti-tumor effect, immune activation and anti-fatigue effect of the gold needle 4 reading 囷 silk body culture extract (FVM), It can improve the body's resistance. Especially the low concentration of Flammulina velutipes mycelium extract can eliminate fatigue by stimulating the sympathetic nerve. ◎ (2) Acne preparation containing Flammulina mycelium mycelium culture extract (F·VM) (Example: Manufacturing Example 2 Chinese Medicine Ointment 2) has Flammulina velutipes The silk culture extract (F·V. M) itself has anti-tumor effect, immune activation and fatigue elimination. Furthermore, the Flammulina mycelium culture extract (F. vj|) has moisturizing effect on the skin. The action 'promotes the new muscle formation of the skin through the use of the acne treatment agent' to form a new muscle in advance due to the moisturizing effect. The present invention contains the Flammulina mycelium mycelium culture extract (F. vm) 2 Acne therapeutic agent (ie, traditional Chinese medicine ointment or traditional Chinese medicine ointment 2) (none), in promoting the therapeutic effect on wounded skin, relative to (b) untreated (when the wounded skin is not treated), in the wound The tensile strength after healing exhibits a high value and promotes healing. The Chinese medicine ointment 2 of the present invention is compared with the "b-FGF" (acne treatment agent) which is a commercially available acne therapeutic agent. , research and pharmaceutical (stock) manufacturing; commonly known as "trafermin"), showing a strong and effective healing effect, excellent healing effect on skin wounds (test case H). Diabetic mice (db/db mice) formed a wound on the back 20 320866 200942270 - After applying the traditional Chinese medicine ointment 2 on the wounded area, the area of the wound was determined, and the result was that the Chinese medicine ointment 2 promoted healing. Moreover, the area under the curve of the area of the wound site opposite to the time (A[JC: the under curve of the anus) also showed a significant low value' judgment with the use of =a (Test Example 12). The plaster is used according to the following instructions. First, the therapeutic mouth is cleaned with a sterile physiological saline solution. The Jiang Ting medicine is applied to the non-woven fabric and covered with gauze, and then the shouting = stick will paste the cream and the deeper. (According to the sore mouth * on the treatment mouth. Apply the amount to the sore mouth and apply gauze. Daily, small, deep, and several times. Care must be taken when changing the dressing. Do not make the wound (when the condition of the wound is changed, keep it moist, avoid iodine disinfection.) New film rupture, the same preservation method: must be placed in a cool place,; when the sun is straight, please put it in the refrigerator, save it effectively, sputum irradiation, long-term storage [Example] ^ limited to one year. 0 Experimental example, 1; Medical record 1: Chen Wei, 52 years old, for cerebral hemorrhage on September 28, found that there is hemorrhoids in the recommendation department, the injury tube 'long-term bed rest 1 2〇〇7 ulcer invasion to the dermis, is the ugly degree of hemorrhoids (area) about 10cmx5cm The wound of the hemorrhoids of the manufacturing case 1 was healed on the 1st day. If it is replaced on the first day, it will be as shown in the next year, October 2: Figure (A) to (8). Medical record 2, Zhao X, 66 years old, There are hemorrhoids in the brain, and the wound is about 3cmx2. The 'long-term bed' recommendation to the subcutaneous fat layer is a m degree 褥320S66 21 200942270 ' Sore, the disease has been cured for 1 month, the wound healing is poor, September 29, 2007, used to manufacture In the case of the hemorrhoids cream of Example 1, the wound healed well on October 10 of the same year. 2 Figures (A) to (D). Experimental Example 3: Medical record 3, Zheng X, 34 years old, patient with hypertension, lower extremity venous thrombosis, May 5, 2007, came to the hospital for treatment, left heel due to trauma Causes cellulitis, the disease has been 1 month, the wound to the subcutaneous fat layer, the wound is about 10cmx4cm ° @ Use the hemorrhoids ointment made in Manufacturing Example 1, change the dressing once a day, the wound has healed on July 20 of the same year. 3 (A) and (B). Experimental Example 4: Medical record 4, Wang X, 21 years old, in the beginning of March 2007, the right calf was injured due to a car accident, and the wound healing was poor after the healing, which caused cellulitis. The wound is about 6cmx4cm, and the wound is to the muscle layer, which is a grade IV hemorrhoid. The same year, from the 12th of the same year, the hemorrhoids cream of the manufacturing example 1 was used, and the wound was healed once a day until the wound on June 29 of the same year. As shown in Fig. 4 Experimental Example 5: Medical record 5, Peng X, 54 years old, for cerebral hemorrhage and diabetes, long-term bed rest, hip sore, wound to muscle layer, wound about 10cmx5cm, is a grade IV hemorrhoid. Hemorrhoids on the back, wound to the skin Fat, wound about 5cmx3cm, belongs to] hemorrhoids, the course of disease has been 2 months. 20 Since June 2007, the hemorrhoids cream of the manufacturing example 1 was used, and each time the sputum was replaced, the wound was healed on July 17, the same year, as shown in Fig. 5 (A) and (B) 22 320866 200942270 - Example 6 : Medical record 6, X, 76 years old, inconvenient to move, long-term wheelchair, trampoline, back hemorrhoids, red skin and skin, wound to the epidermis, is a degree of hemorrhoids, the disease has been 1 month, October 2007 The hemorrhoid ointment of the manufacturing example 1 was used from the 1st, and was changed once a day until the wound was healed on October 7 of the same year. As shown in Figure 6 (A) to (E). Experimental example 7 Bu 病 Medical record 7, Liu X, 64 years old, for breast cancer and rectal cancer patients, small intestine artificial anal stoma, multiple wound healing in the abdomen, suppuration. The wound to the dermis, mostly 1 to 2 cm x 1 to 2 cm, is a acne acne, and the course of disease has been several months. Since September 2007, the hemorrhoids cream of the manufacturing example 1 was used for treatment. On October 5 of the same year, the suppuration was stopped and the wound was healed. As shown in Figure 7 (A) to (F). Experimental Example 8: q Medical record 8, X, 79 years old, is a diabetic patient, the left thumb is black and necrotic, the second toe joint is red and swollen, and the course of disease has been several months. In July 2007, the hemorrhoids ointment of the manufacturing example 1 was used, and the daily replacement was performed 1 to 2 times, and on August 3 of the same year, the purulent redness was improved. As shown in Figure 8. Experimental Example 9: Medical record 9, Wei X, 76 years old, for patients with cerebral hemorrhage, long-term hop bed, hemorrhoids in the ischial bone, wound to the dermis, wound about 2cmx2cm, the course of disease has been 1 month, from August 10, 2007 The hemorrhoids of the manufacturing example 1 were used for treatment, and the wounds healed on September 21 of the same year. 23 320866 200942270 'Experimental case ίο: • Medical record 10, Zheng X, 77 years old, is a tuberculosis patient, prolonged bed rest, hemorrhoids on the left shoulder, redness and swelling of the skin. The wound to the epidermis, the wound is about 2cmx2cm, it is a degree of acne, and the course of disease has been 2 months. The hemorrhoids cream of the manufacturing example 1 was used from July 13, 2007 to the wound healing in the early August of the same year. Experimental Example 11: Treatment experiment of the cream of the skin of the rat 2 in the rat skin: 1. Summary of the 12-week-old Crl: CD (SD) rat skin wound model The obtained traditional Chinese medicine ointment (also referred to as "Chinese medicine ointment 2") is treated to promote healing. The results are shown in Table 1 and Figure 9 below. (A) Untreated group, (B) Chinese medicine of the present invention The average value of the tension strength after wound healing of the ointment 2 treatment group and (c) "b-FGF" (acne treatment agent, scientific research pharmaceutical (share); commonly known as "trafermin") treatment group is (曱) ) 143 ± 8g, (B) 289 ± 31g, (C) 2 〇 5 ± 1 such as. Compared with (a) untreated group, (b) the Chinese medicine ointment 2 in the present invention and (4) the "b-FGF" treatment group had an increase rate of tensile strength after wound healing of 102.1% and 43.4%, respectively.

本發明之中藥軟膏2處置群以及「卜FGF」(褥瘡户療 劑,科研製藥(股)製造,·通稱「trafermin」)處置群:傷 口癒合後之張力強度,相較於未處置群者,呈現顯著性古 值,暗示具有促進癒合作用。並可知相較於「b_FGF 群’本發明之中藥軟貪2處置群更加促進對皮膚創傷的療 320866 24 200942270 效(參照表1、第9圖)。 由上述之結果,製造例2所得本發明之中藥軟膏( 軟膏2)處置群呈示超出市售之褥瘡治療劑的卜卿的促進The treatment group of the Chinese medicine ointment 2 of the present invention and the treatment group of "Bu FGF" (a acne treatment agent, a scientific research pharmaceutical (share), commonly known as "trafermin") treatment group: the tensile strength after wound healing, compared with the untreated group, Significant ancient values are presented, suggesting a promoting healing effect. It is also known that the "b_FGF group" of the present invention is more effective in promoting the treatment of skin wounds (see Table 1, Figure 9). From the above results, the present invention obtained in Production Example 2 The Chinese medicine ointment (Ointment 2) disposal group presents the promotion of Bu Qing beyond the commercially available acne treatment agent

瘡合作用’而可註實本發明之中藥軟膏2對皮膚創 合具有優異效果。 J 以下’結合實驗過程而詳加說明。 2·&lt;實驗概要&gt; 發明之中藥軟膏 外 (i)(i-a)受驗物質:由製造例2而得之本 〇 (巾藥軟I* 2)。 (巧)比較用對照物質:「FiMast(註冊商標)加叩咖」 (簡稱「b-FGF」;褥瘡治療劑,科研製藥(股)製造;通稱 「trafermin」)。 (ii)實驗系:大鼠(SPF)、Crl : CDCSD)。 (ill)實驗:對於由製造例2而得本發明之中藥軟膏(中藥 軟膏2)賴錢合的促進作㈣使用錢皮膚割傷模型而 0 進行實驗。 (iv) 實驗期間= 2008年2月26日至2008年6月u日 (v) 實驗施行日:取得實驗用動物(大鼠)並分組,在割傷製 作(2008年3月Π日)後,於20〇8年3月17日開始藥劑 的投與’直到2008年3月20曰停止投與。張力測定係於 2008年3月21日進行。 (VI)取得實驗用動物(大鼠)之首日(取得當天)之體重範圍 為325g至403g。取得之動物在檢疫·馴化飼養期間的一般 狀態與體重變化並無異常。 320866 25 200942270 ' (vii)溼度:在40. 0至70. 0%之溼度下飼養(雖有在極短時 , 間内超出此範圍的情形,卻不影響實驗成績)。 3. 〈序言〉 使用12週齡Crl : CD(SD系)大鼠之皮膚割傷模型,以 製造例2所得中藥軟膏對促進癒合作用之影響進行實驗。 4. 〈受驗物質等〉 4· 1. (a)受驗物質以及比較用對照物質 受驗物質:由製造例2而得本發明之中藥軟膏(中藥軟膏 ❸2)。 比較用對照物質:「Fiblast(註冊商標)Spray250」(簡稱 「b-FGF」;褥齋治療劑’科研製藥(股)製造;通稱 「trafermin」;批號:G71183)。 5. 〈投與檢體〉 5. 1 (a)調製法 (比較用對照物質) ❹受驗物質:直接使用於實驗。 比較用對照物質.係使用瓶(250 # g)中所附之溶解液 (2. 5mL/支)全量使之溶解成為濃度〇, 01w/v/%者。 6. 〈試驗系〉 (6-1)實驗用動物以及該飼養條件 實驗中使用藥效藥理實驗一般所使用之動物種,其係 系統維持明確之雄性Crl : CD(SD)(SPF ; CHARLES RIVER LABORATORIES JAPAN) 〇 於2008年3月5日取得i〇週齡之實驗用動物42隻。 26 320866 200942270 ' 取得當天之體重範圍為325至403g。該等先設定5天的檢 ' 疫期再有7天的馴化期。在該期間進行1日3次之體重測 定(使用之電子天平:PM2000、PG2002-S ;梅特勒__托利多 (股)(Mettler Toledo International Inc.)製造)以及 1 曰1次的一般狀態之觀察,於實驗中使用未觀察到異常者。 動物係於維持有設定溫度:23t:(實測值:20.5至 24.7°〇、設定溼度55%(實測值:29.4%至74.9%)、.明暗各 12小時、換氣次數:12次/小時(經濾網除菌之新鮮空氣) 〇 之飼養室中養育。每週進行2次以上之拖盤與水瓶的替換。 飼料係將固形飼料(CRF-1 ;批號:0711〇5、曰本東方 酵母工業(股)製造)放入飼料盒中使其自由攝食。 飲料水係將自來水裝入水瓶中使其自由攝取。 (6-2)分組法以及個體辨識法 分組係在投藥當天進行’將體重以電腦分出層別後, 藉由隨機抽樣法任意分成3組,每組1〇隻,並使各組動物 ◎之分散以及平均體重幾乎相同。分組後剩餘的動物皆於麻 醉下致死。 (6-3)投藥 投藥路徑係依臨床適用路徑進行經皮投與。 投與係依照實驗設備中所使用的一般方法,受驗物質 (第2纟且)係使用聚丙烯材料製成之注射筒依照由預先測定 之比重而得的容積塗佈20〇mg(〇.2mL)在創傷部位上。使用 微量吸管將比較用對照物質(第3組)〇.2mL滴在創傷部位 27 320866 200942270 才又藥次數係1天一次連續4天。 投藥在上午實施’創傷製作日以及Michel缝合夾的拆 除曰係各個個體在作業結束後即刻進行。 (6-4)群組之組成、投藥量以及動物的使用隻數 第1組(未施行處置者有1〇隻):無塗佈(處置)。 第2組(施行本發明之中藥軟膏2處置者有1()隻):塗佈 200mg(0.2mL) » 乃第3組(施行b-FGF處置者有1〇隻):塗佈〇.—。 ν 7.〈實驗方法〉 (7-1)皮膚之割傷製作 在才又藥4天以戊巴比妥鋼(pent〇barbHai Sodium Salt .「Nembutal」(註冊商標)注射液;4〇mg/〇 8mL/kg、 i,P)麻醉後’以_刀歸動物背部之毛^背部皮膚以 酒精棉消錢’料科手彻红帽上城3 4cm之傷 口(當天為割傷製作日)。在割傷部位之中央部以及由中央 〇部至頭部側以及尾部侧之lcm位置(共3處)以缝合器 (Michel staples:大型3· 〇xl4mm,·夏目製作所製造)缝合。 (7-2)創傷癒合效果之評估 於割傷製作的第4天之投藥前,在乙鲢的麻醉下去除 Michel夾。於割傷製作的第5天測量(使用之電子天平: PG-2002-G ;梅特勒_托利多(股))體重,以乙醚過量麻醉 致死後,將創傷部之周圍皮膚剝離。製作以剑傷部為中心 之長方形皮膚片(約2cmx3Cin),將皮膚片於距離邊端0.5cm 之位置固定’以創傷癒合測定用張力試驗儀(TK-251 ; 28 320866 200942270 ' Uni com(股))測定傷口癒合後之耐張力強度(割傷裂開所需 . 負重)。 而且,由割傷製作的第2天至第5天為止,每天1次 在上午進行一般狀態的觀察。 8. &lt;綜合統計學上之方法以及結果&gt; 求出各組傷口癒合後之耐張力強度以及體重的平均值 士標準誤差。亦求出各組傷口癒合後之平均耐張力強度對未 處置群者的增加率。 統計學上之解析係對於傷口癒合後之耐張力強度進行 2組間之比較。亦即,經jr檢定進行等分散性之檢驗,由 於為不等性分散而進行Aspin-Welch之1:檢驗。另外’對 比之群組間(第1組vs第2至3組)係如下述。顯著性差異 (significance level)係將未滿5%視為顯著性,而各表示 為未滿5%(p〈0. 05)以及未滿ι%(ρ〈〇. 〇丨)。 (群組間比較) Q 以第1組對第2至3組作比較。. 9. &lt;實驗成績〉 對由大鼠製作的皮膚割傷模型進行促進癒合作用之檢 讨,並將其結果至不於表1與第9圖 未處置之傷口癒合後的耐張力強度為143±8g。 使用由製造例2所得本發明之中藥軟膏(中藥軟膏2) 對皮膚割傷模型進行治療時,傷口癒合後的耐張力強度為 289±31g,可斷定相較於未處置群者,傷口癒合後的耐張力 強度顯者地增加。並且,對未處置群之傷口癒合後的耐張 29 320866 200942270 '力強度的增加率為102. 1%。 • b-FGF群之傷口癒合後的耐張力強度為2〇5±l9g,可斷 定相較於未處置群者,傷口癒合後的耐張力強度顯著地增 加。並且,對未處置群之傷口癒合後的耐張力強度的增加 率為43.4% 〇 1〇. &lt;結論;&gt; 將12週齡Crl:CD(SD系)大鼠之皮膚割傷模型以本發 明之中藥軟膏2進行促進癒合作用之實驗,其結果係(甲) ^ 未處置群、(乙)本發明之中藥軟膏2處置群、以及(丙) 「b-FGF」處置群的傷口癒合後耐張力強度之平均值及標準 誤差分別為(曱)143±8g、(乙)289±31宮、(丙)205±19忌。 相對於(甲)未處置群者,(乙)由製造例2所得之中藥 軟膏處置群以及(丙)b-FGF處置群之傷口癒合後耐張力強 度的增加率分別為(乙)1〇2. 1%以及(丙)43. 4%。 (乙)由製造例2所得之中藥軟膏處置群以及(丙)b_F(JF ◎處置群之傷口癒合後耐張力強度,與(曱)未處置群相較, 呈現顯著性高值,表示有促進癒合之作用。而且,相較於 (丙)b-FGF處置群者,(乙)由.製造例2所得之中藥軟膏處 置群對皮膚更有促進割傷癒合之效果。 從以上結果可知’相較於為市售褥瘡治療劑之b_FGF, 由裝反例2所传本發明之中藥軟膏呈現更強的促進癒合作 用,顯示出由製造例2所得本發明之中藥軟膏的效用。 320866 30 200942270The soy cream can be used to embody the excellent effect of skin ointment 2 of the present invention on skin creation. J The following is described in detail in conjunction with the experimental procedure. 2·&lt;Experimental Summary&gt; Inventive Herbal Ointment (i) (i-a) Test substance: The original product obtained in Production Example 2 (Wool soft I* 2). (Qiao) Comparative control substance: "FiMast (registered trademark) plus 叩 」" (abbreviated as "b-FGF"; acne treatment agent, research and pharmaceutical (stock) manufacturing; commonly known as "trafermin"). (ii) Experimental system: rat (SPF), Crl: CDCSD). (ill) Experiment: For the promotion of the Chinese medicine ointment (Chinese medicine ointment 2) of the present invention by the production example 2, the experiment was carried out using the money skin cut model. (iv) Experimental period = February 26, 2008 to June 2008 (v) Experimental implementation day: Animals (rats) were obtained and grouped, after the cuts were made (the next day of March 2008) The drug was administered on March 17, 20, 2008, and it was not until March 20, 2008. Tension measurement was conducted on March 21, 2008. (VI) The first day of the animal (rat) obtained (the day of acquisition) was in the range of 325 g to 403 g. There was no abnormality in the general state and weight change of the animals obtained during quarantine and domestication. 320866 25 200942270 ' (vii) Humidity: Raised at a humidity of 40. 0 to 70. 0% (although it is outside the range in a very short time, it does not affect the experimental results). 3. Preface The experiment was carried out using the skin cut model of a 12-week-old Crl:CD (SD) rat to promote the healing effect of the traditional Chinese medicine ointment obtained in Example 2. 4. <Subject substance, etc.> 4. (a) Test substance and comparative control substance Test substance: The traditional Chinese medicine ointment (Chinese medicine ointment ❸ 2) of the present invention was obtained. Comparative control substance: "Fiblast (registered trademark) Spray 250" (abbreviated as "b-FGF"; 褥 治疗 therapeutic agent' research and pharmaceutical (stock) manufacturing; commonly known as "trafermin"; batch number: G71183). 5. <Publication of the specimen> 5. 1 (a) Modulation method (Comparative substance for comparison) ❹ Test substance: It is used directly in the experiment. The comparative control substance was dissolved in the total amount of the solution (2.5 mL/branch) attached to the bottle (250 #g) to a concentration of 〇, 01 w/v/%. 6. <Testing System> (6-1) Experimental animals and animal species used in pharmacological experiments in the feeding condition experiment, the system maintains a clear male Crl: CD (SD) (SPF; CHARLES RIVER LABORATORIES JAPAN) On March 5, 2008, 42 experimental animals were obtained. 26 320866 200942270 ' The weight range for the day is 325 to 403g. These first set 5 days of inspection 'the epidemic period has another 7 days of domestication. During this period, the body weight was measured three times a day (the electronic balance used: PM2000, PG2002-S; manufactured by Mettler Toledo International Inc.) and the general state of 1 曰1 times. Observed, no abnormalities were observed in the experiment. The animal system maintains a set temperature: 23t: (measured value: 20.5 to 24.7° 〇, set humidity 55% (measured value: 29.4% to 74.9%), 12 hours for light and dark, and 12 times for air exchange/hour ( Breeding fresh air through the filter) Raise in the breeding room. Replace the tray and water bottle twice a week. The feed system will be solid feed (CRF-1; batch number: 0711〇5, Sakamoto Oriental yeast) Industrial (stock) manufacturing) Put it into the feed box to make it free to eat. The beverage water system puts the tap water into the water bottle for free ingestion. (6-2) Grouping method and individual identification method grouping is carried out on the day of administration. After dividing the layers by computer, they were randomly divided into 3 groups by random sampling method, and each group was 1 ,, and the dispersion and average body weight of each group of animals were almost the same. The remaining animals after grouping were killed under anesthesia. 6-3) The route of administration and administration is transdermally administered according to the clinical application route. The administration method is based on the general method used in the experimental equipment, and the test substance (the second one) is a syringe made of polypropylene material. According to the pre-measured specific gravity Apply 20 〇mg (〇.2mL) to the wound site. Use a micropipette to compare the control substance (Group 3) 〇.2mL to the wound site. 27 320866 200942270 Only the number of times of the drug is 1 day for 4 consecutive days. In the morning, the implementation of the 'wound production day and the removal of the Michel suture clips were carried out immediately after the end of the work. (6-4) The composition of the group, the dosage and the use of the animals were only the first group (not implemented) There are 1 处置 ) : : : : : : : : 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第-FGF disposer has 1 ) only): Coated 〇.-. ν 7. <Experimental method> (7-1) Skin cuts are made in a pentabarbital steel (pent〇barbHai Sodium) Salt . "Nembutal" (registered trademark) injection; 4 〇 mg / 〇 8mL / kg, i, P) after anesthesia 'to the back of the animal's hair _ knife back skin with alcohol cotton to eliminate money' material hand red Hat on the city 3 4cm wound (the day is the day of the cut injury). At the center of the cut site and from the central crotch to the head side and tail The lcm position of the side (3 places in total) was sutured with a stapler (Michel staples: large 3·〇xl4mm, manufactured by Natsume Sangyo Co., Ltd.) (7-2) Evaluation of wound healing effect before the fourth day of the cut production Remove the Michel clip under the anesthesia of acetaminophen. Measure on the 5th day of the cut (electronic balance used: PG-2002-G; METTLER TOLEDO), and anesthetize with ether. The skin around the wound is peeled off. A rectangular skin piece (about 2 cm x 3 Cin) centered on the sword wound is prepared, and the skin piece is fixed at a position of 0.5 cm from the side end. The tensile tester for the wound healing test (TK-251) 28 320866 200942270 'Uni com(stock)) Determines the tensile strength after wound healing (required for cut splitting. Load). Further, from the second day to the fifth day of the cut, the general state was observed once a day in the morning. 8. &lt;Comprehensive statistical method and result&gt; The mean value of the tensile strength and body weight after wound healing in each group was determined. The increase rate of the average tensile strength after healing of each group to the untreated group was also determined. Statistical analysis was performed on the comparison of the two groups between the tensile strength after wound healing. That is, the test of equal dispersion is performed by the jr test, and the Aspin-Welch 1: test is performed for the dispersion of inequality. In addition, the comparison between groups (Group 1 vs. Groups 2 to 3) is as follows. The significance level is considered to be less than 5%, and each is expressed as less than 5% (p < 0.05) and less than ι % (ρ < 〇. 〇丨). (comparison between groups) Q Compare the first group to the second to third groups. 9. &lt;Experimental results> A review of the healing effect of the skin cut model made by rats, and the results are not to the tensile strength after untreated wounds in Tables 1 and 9 143 ± 8g. When the skin cut model was treated with the traditional Chinese medicine ointment (Chinese medicine ointment 2) obtained in Production Example 2, the tensile strength after wound healing was 289 ± 31 g, which can be judged that after wound healing, compared with the untreated group The tensile strength is significantly increased. Furthermore, the rate of increase in the strength of the wounds after healing of the wounds of the untreated group was 202.1866 200942270. • The tensile strength after wound healing of the b-FGF group was 2〇5±l9g, and it was concluded that the tensile strength after wound healing was significantly increased compared with the untreated group. Further, the rate of increase in the tensile strength after wound healing in the untreated group was 43.4% &1〇. &lt;Conclusion;&gt; The skin cut model of a 12-week-old Crl:CD (SD) rat was used as the present In the invention, the ointment 2 was subjected to an experiment for promoting healing, and the result was (A) untreated group, (b) the Chinese medicine ointment 2 treatment group of the present invention, and (c) after the wound healing of the "b-FGF" treatment group. The average value and standard error of the tensile strength are (曱) 143±8g, (B) 289±31, and (C) 205±19. With respect to (a) untreated group, (b) the increase rate of the tensile strength after wound healing of the Chinese medicine ointment treatment group obtained in Production Example 2 and the (c) b-FGF treatment group was (B) 1〇2 1% and (C) 43.4%. (b) The traditional Chinese medicine ointment treatment group obtained in Production Example 2 and (c) b_F (JF ◎ treatment group, the tensile strength after wound healing, compared with the (曱) untreated group, showed a significant high value, indicating that there is promotion The effect of healing. Moreover, compared with the (c) b-FGF treatment group, (b) the Chinese medicine ointment treatment group obtained in the production example 2 has an effect of promoting wound healing on the skin. Compared with the b_FGF which is a commercially available acne therapeutic agent, the traditional Chinese medicine ointment of the present invention which was transmitted by the reversed Example 2 exhibited a stronger promoting healing effect, and showed the utility of the traditional Chinese medicine ointment obtained by the production example 2. 320866 30 200942270

I -_ II 表 __I ο ac.sponoA.s-s-slM^yq'alsuf-cWIXaJOaaanB^^laoaiasl^KiJOO.g.sspomasMnqwJolip^uTr .7032 樂【_|^韧鹚#【#_^^1 V葙(2和誕濂Φ )蘅碟-40¾醵.¾ 體重(g) [Body weight(g)] 最终曰 Final day *n -H 9 m •H S 422 ± 4 首曰 Initial day 429 ± 4 430 ± 4 430 ί 4 想 R Ξ ^ % Jg- S 1| 々&gt;1 D 雄 1增加率(%) lncmuscrrale(4/i) 1 102.1@ 43.4@ um War A ·τι!«ΐ— Actunl value (g) do -H jj im i 3i *· 205 ± 19 * fil frmVI «Vkvtlmt trt* 劑量 [Dose] _藥劑Drug /-N _ .¾ 彰I W 象 # 對照奴 Cojatroi — 0 1 1 Im i ;5 i s 3 m m WGF 02 Φ f\K * lkWI ΩΙ· fiiattSfi^Bnflir fllffikr* 。铤^毋滅(10.1-|'芒8)度¾破牵(5齋-δ3?® 趄电靱运獬逑杯«*ϊ省濂4^琛溆4*滅越取食餐要*部寒xlii^—dlolsy每 •dno&amp;falmoauqlapu/nhood i {δβικί ρ^βνβ,ϋπτι# 31 320866 200942270 ' 實驗例12 : ' 本發明之中藥敕膏2對治療患有遺傳性糖尿病的小鼠 (db/db小鼠)之皮膚創傷模型的癒合效果實驗 1.&lt;實驗概要〉 (1-1)受驗物質:由製造例2所得本發明之中藥軟膏(中藥 軟膏2)。 (卜2)實驗系:小鼠(SPF)、BKS.Cg-+Leprdb/+Leprdb/Jc:l。 U-3)實驗目的:製作患有遺傳性糖尿病小鼠(db/db小鼠) ^ 之皮膚創傷,進行由製造例2所得之本發明中藥軟膏對創 傷癒合有無促進作用之實驗。 (1-4)實驗期間:2008年2月26日開始至2008年7月7 日結束。 (1-5)實驗日期:首先取得實驗用動物(患有遺傳性糖尿病 的小鼠;db/db小鼠),分組後製作創傷模型(2008年4月 9日),然後進行藥劑(受驗物質)的投與,於2008年4月9 q 日開始並於2Q08年4月29日結束。 (1-6)取得實驗用動物首日(取得當天)之體重範圍為42.0 g至45. 4g。所取得之動物在檢疫•馴化飼養期間的一般狀 態與體重變化並無異常。 (1-7)3-甲基-1-丁醇(批號:WKG6715)。 2.〈概要〉 在12週齡患有遺傳性糖尿病的小鼠(db/db小鼠)之背 部作成創傷部並以製造例2所得本發明之中藥軟膏(中藥 軟膏2)每曰塗佈1次,每2天測定1次創傷部位面積,調 32 320866 200942270 ' 查中藥軟膏2之促進癒合作用。 • 由其結果發現,本發明之中藥軟f 2在投藥的第3天 呈現顯著性高值,而在第n、13、15、17天以及第19中 呈現顯著性低值,因而斷定有促進癒合之作用。 而且,創傷部位面積對經過時間之曲線下面積(重) 亦呈現顯著性低值,判定具有促進癒合之作用。 +為市售褥療治療劑之「b-FGF」(轉瘡治療劑,科研製 藥(股)製造;通稱「traferminj ),在投與第9、u、13、 15、17、19天以及第21天時,呈現顯著性低值,厦亦呈 現顯著性低值,判定具有促進癒合之作用。 由上述可知,本發明之中藥軟膏2對北施小鼠之傷 口具有促進創傷癒合之作用。 3.〈序言&gt; ^ . 在實施例11所示之大鼠背部割傷實驗(本發明之中藥 軟膏2對大鼠皮膚割傷模型之治療實驗)中,本發明之中藥 Q軟膏2對傷口具有促進癒合之作用。' 更且,為了調查是否有創傷癒合效果,而使用12週舻 患”糖尿病的小鼠Wb/db小鼠)之Μ㈣·二 ,背部形成之創傷部上使用本發明之中藥軟膏2以防水透 氣敷料(Tegaderm)進行封閉性投與(註丨),每天i次且 每2天測定創傷部位面積2次,以調查中藥軟膏2是否具 有促進癒合的作用。 ' (註1)「中藥軟膏2以防水透氣敷料進行封閉性投與」如 下述,係使該創傷部位受到包覆的方式而在小鼠背部^創 320866 33 200942270 傷部位敷貼通氣性密封材『Tegaderm』(其可防止水或病菌 彳X入創傷部位並具有水蒸氣與氧氣之通過性,可維持皮膚 呼吸且可長期敷貼之由聚胺酯所製的薄膜;3M公司製造), 然後將充填有中藥款膏2之注射筒(在b-FGF投與時,為注 射針)抵壓該膜片並使其貫穿,即稱為在創傷部位投與中藥 軟膏2(在b-FGF投與時,為b-FGF)者。 4.〈受驗物質等〉 4. 1受驗物質、比較用對照物質以及介質 ^ Ο-a)受驗物質:由「製造例2」所得本發明之中藥軟膏(中 藥軟膏2)。 (卜b)比較用對照物質:「Fiblast(註冊商標)Spray25〇」 (難治性皮膚潰瘍治療藥,科研製藥(股)製造;批號: G71183)。 (1-c)介質之生理食鹽水(批號:K7E83 ;大塚製藥工廠(股) 製造)。 q 4. 2試藥:3-曱基-1-丁醇(批號:WKG6715 ;和光純藥工業 (股))、2, 2, 2-三溴乙醇(批號:Df&gt;H794Q ;和光純藥工業 (股))、注射用水(批號:7C75N ;大塚製藥工廠(股))。 5. 〈投與檢體〉 5.1調製法 5. 1.1比較用對照物質之調製原液 比較用對照物質:以添加1瓶所附溶解液(2.5mL/支) 之全量進行溶解以使濃度成為〇· Olw/v/%者作為調製原液 5. 1.2受驗物質以及比較用對照物質 32〇866 34 200942270 文驗物質.直接使用中藥軟膏2作為受驗物質。 比較用對照物質:在調製原液中添加5倍之生理舍鹽水使 濃度稀釋為0. 〇〇2w/v/%。 5. 1. 3 麻醉(阿佛丁: Avertin) 在3-甲基-1-丁醇2乩中添加2,2, 2-三溴乙醇3运,於 37C左右之溫浴中保持溫度3〇分鐘使之溶解。完全溶解 〇I -_ II Table __I ο ac.sponoA.ss-slM^yq'alsuf-cWIXaJOaaanB^^laoaiasl^KiJOO.g.sspomasMnqwJolip^uTr .7032 Music [_|^韧鹚#[#_^^1 V葙(2 and birthday Φ) 蘅碟-403⁄4醵.3⁄4 Weight (g) [Body weight(g)] Final 曰Final day *n -H 9 m •HS 422 ± 4 First 曰Initial day 429 ± 4 430 ± 4 430 ί 4 Think R Ξ ^ % Jg- S 1| 々&gt;1 D Male 1 increase rate (%) lncmuscrrale(4/i) 1 102.1@ 43.4@ um War A ·τι!«ΐ— Actunl value (g) Do -H jj im i 3i *· 205 ± 19 * fil frmVI «Vkvtlmt trt* dose [Dose] _ medicament Drug /-N _ .3⁄4 彰 IW 象# Control slave Cojatroi — 0 1 1 Im i ;5 is 3 mm WGF 02 Φ f\K * lkWI ΩΙ· fiiattSfi^Bnflir fllffikr*.铤^毋灭(10.1-|'Mang 8) degree 3⁄4 broken pull (5 fast-δ3?® 趄 靱 獬逑 « « « « « « « « « « « « * * * * * * * * * * * * * * * * * * * * * * Xlii^—dlolsy per•dno&amp;falmoauqlapu/nhood i {δβικί ρ^βνβ,ϋπτι# 31 320866 200942270 'Experimental Example 12: 'The Chinese herbal medicine ointment 2 for treating mice with hereditary diabetes (db/db Healing effect test of skin wound model of mouse) 1. &lt;Experimental summary> (1-1) Test substance: The traditional Chinese medicine ointment (Chinese medicine ointment 2) obtained in Production Example 2 (b) Mouse (SPF), BKS.Cg-+Leprdb/+Leprdb/Jc: 1. U-3) Experimental purpose: To make a skin wound with hereditary diabetic mice (db/db mice) ^ The experiment of the traditional Chinese medicine ointment of the present invention obtained in Example 2 has a promoting effect on wound healing. (1-4) Experimental period: starting from February 26, 2008 to July 7, 2008. (1-5) Experiment date: First, experimental animals (mice with hereditary diabetes; db/db mice) were obtained, and a wound model was prepared after grouping (April 9, 2008), and then the drug was administered. The contribution of the substance began on April 9th, 2008 and ended on April 29, 2Q08. (1) The weight of the first day of the day of the animal (the day of the acquisition) was 42.0 g to 45.4 g. There was no abnormality in the general state and body weight of the animals obtained during quarantine and domestication. (1-7) 3-methyl-1-butanol (batch number: WKG6715). 2. <Summary> A wound portion was prepared on the back of a 12-week-old mouse (db/db mouse) having hereditary diabetes, and the traditional Chinese medicine ointment (Chinese medicine ointment 2) obtained in Production Example 2 was coated 1 per sputum. Secondly, the area of the wound site was measured once every 2 days, and the effect of promoting the healing of the Chinese medicine ointment 2 was adjusted to 32 320866 200942270. • As a result, it was found that the soft medicine f 2 of the present invention exhibited a significant high value on the third day of administration, and a significant low value on the nth, thirteenth, fifteenth, and seventeenth and the ninth, and thus it was confirmed that there was promotion. The role of healing. Moreover, the area of the wound site to the area under the curve of the elapsed time (weight) also showed a significant low value, and it was judged to have the effect of promoting healing. + "b-FGF" (a manufacturing agent for the treatment of acne, a research and pharmaceutical company); it is called "traferminj", and it is administered on the 9th, u, 13, 15, 17th, 19th and the At 21 days, it showed a significant low value, and Xiamen also showed a significant low value, which was judged to have a promoting healing effect. From the above, it can be seen that the traditional Chinese medicine ointment 2 has the effect of promoting wound healing in the wound of Beishi mice. <Preamble> ^ In the rat back cut test shown in Example 11 (the therapeutic experiment of the Chinese medicine ointment 2 on the rat skin cut model in the present invention), the Chinese medicine Q ointment 2 of the present invention has a wound on the wound Promote the role of healing. 'Moreover, in order to investigate whether there is a wound healing effect, use 12 weeks of "diabetic mouse Wb / db mice" (four) · two, the use of the traditional Chinese medicine on the wound formed on the back The ointment 2 was sealed with a waterproof breathable dressing (Tegaderm), and the area of the wound site was measured twice a day and every 2 days to investigate whether the traditional Chinese medicine ointment 2 has an effect of promoting healing. ' (Note 1) "Chinese medicine ointment 2 is applied in a closed manner with a waterproof and breathable dressing". As described below, the wound site is covered by a method of applying a ventilating sealant to the back of the mouse at 320866 33 200942270. "Tegaderm" (which prevents water or pathogens from entering the wound site and has a passability of water vapor and oxygen, can maintain skin respiration and can be applied for a long time by a film made of polyurethane; manufactured by 3M Company), and then will be filled The syringe of Chinese medicine paste 2 (in the case of b-FGF administration, the injection needle) presses the membrane and penetrates it, which is called administering the traditional Chinese medicine ointment 2 at the wound site (when b-FGF is administered) , for b-FGF). 4. <Subject substance, etc.> 4. 1 Test substance, comparative control substance and medium ^ Ο-a) Test substance: The traditional Chinese medicine ointment (Chinese medicine ointment 2) obtained from "Production Example 2". (b) Comparative control substance: "Fiblast (registered trademark) Spray 25" (refractory dermatological therapeutic drug, scientific research pharmaceutical (stock) manufacturing; batch number: G71183). (1-c) Physiological saline solution of medium (batch number: K7E83; manufactured by Otsuka Pharmaceutical Factory Co., Ltd.). q 4. 2 reagent: 3-mercapto-1-butanol (batch number: WKG6715; Wako Pure Chemical Industries Co., Ltd.), 2, 2, 2-tribromoethanol (batch number: Df> H794Q; Wako Pure Chemical Industries (share)), water for injection (batch number: 7C75N; Otsuka Pharmaceutical Factory (share)). 5. <Administration of the sample> 5.1 Modulation method 5. 1.1 Comparison of the preparation solution for the control substance. Comparison of the control substance: Dissolve by adding the entire amount of the attached solution (2.5 mL/piece) to make the concentration become 〇· Olw/v/% as the preparation stock solution 5. 1.2 Test substance and comparative control substance 32〇866 34 200942270 Test substance. Directly use traditional Chinese medicine ointment 2 as the test substance. For comparison, a control substance was added: 5 times the physiological saline solution was added to the prepared stock solution to dilute the concentration to 0. 〇〇 2w/v/%. 5. 1. 3 Anesthesia (Avertin: Avertin) Add 2,2,2-tribromoethanol to 3-methyl-1-butanol 2, and maintain the temperature in a warm bath at 37 °C. Dissolve it in minutes. Completely dissolved

Q 後’將0. 5mL之該溶液加入4〇mL注射用水中使其上下混合。 6.〈實驗系〉 6. 1實驗動物以及飼養條件 實驗中使用一般藥效藥理實驗中所使用之動物種,其 係系統維捧明確之雄性BKS. Cg_+Leprdb/+Leprdb/Jcl (SiyP,日本克莉亞(Clea_japan)(股))β 隹於2008年3月日取得l〇週齡之該實驗用動物4〇 又取得當天之體重範圍為42. 0至45. 4g。該等動物設定 先有5天的檢疫期再有8天的馴化期。在該期間進行3次 之趙重測定(使用之電子天平:PG2002一s、PB3〇〇2 ;梅特勒 、托#】多(股)(Mettier Toledo International Inc.)製造) 以及1曰1次的一般狀態之觀察,於實驗中使用無異常者。 將動物於維持設定溫度:23。(:(實測值:22. 9 $ 23.7。。、 ^义)、設定溼度55%(實測值:51.3至57. 5%)、明暗各 +時、換氣次數:12次/小時(經濾網除菌之新鮮空氣) 之,%室中養育。 工、 、、每週進行2次以上之塑膠製拖盤與水瓶的替換。每 週進行1次以上之飼料盒替換。 320866 35 200942270 飼料係將固形飼料(CRF-l ;批號:071105、〇8〇1{)7 曰本東方酵母工業(股)製造)放入飼料盒中使其自由攝食 飲料水係將自來水裝入水瓶中使其自由攝取。 6. 2分組法以及個體辨識法 分組係在投藥當天進行;將體重以電腦分出層別後, 藉由隨機抽樣法在投藥當天任意分成3組,每組1〇隻,』 ❹ ❹ 使各組動物之平均體重以及分散幾乎相同(另外,分^德动 餘的動物皆予致死)。 6. 3投藥 射針= 的投與係使用第3組卜聊投與所制之咖, 藥軟膏2之I:?製造),而且,作為軟膏劑之第2組的4 性(用後即丢二:=果二216注射針之聚丙婦製之- 等注射針:匕積;泰爾茂(股)製造)。在驾 針(或左射涛)中充填各投與藥劑c檢體φ Ml 入覆蓋創傷部位之聚鮮後,穿刺注After Q, 0.5 ml of this solution was added to 4 mL of water for injection and mixed up and down. 6. <Experimental Department> 6. 1 Experimental animals and feeding conditions The animal species used in the general pharmacodynamic experiment were used in the experiment, and the system was well-established with male BKS. Cg_+Leprdb/+Leprdb/Jcl (SiyP, Japanese Celia (Clea_japan) (share) β 隹 取得 隹 隹 3 3 3 3 该 该 该 该 该 该 该 该 该 该 该 该 该 该 该 该 该 该 该 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 These animals are set up for a five-day quarantine period and an eight-day acclimation period. Three times of measurement in this period (electronic balance used: PG2002-s, PB3〇〇2; METTLER, 托#) (Mettier Toledo International Inc.) and 1曰1 Observed in the general state, no abnormalities were used in the experiment. The animals were maintained at the set temperature: 23. (: (measured value: 22. 9 $ 23.7., ^ meaning), set humidity 55% (measured value: 51.3 to 57. 5%), light and dark each +, gas exchange times: 12 times / hour (filtered The fresh air of the net is sterilized by the net, and the room is raised in the room. The plastic tray and the water bottle are replaced twice a week, and the feed box is replaced more than once a week. 320866 35 200942270 The solid feed (CRF-l; lot number: 071105, 〇8〇1{) 7 曰 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方 东方Ingestion. 6. 2 grouping method and individual identification method grouping is carried out on the day of drug administration; after dividing the body weight by computer, it can be arbitrarily divided into 3 groups on the day of administration by random sampling method, each group is only 1,, ❹ ❹ The average body weight and dispersion of the animals in the group were almost the same (in addition, the animals that were divided into two groups were lethal). 6. 3 The dosage of the injection needle = the use of the third group of Buddy to cast the prepared coffee, the ointment 2 of the I:?), and as the second group of the ointment 4 (after use) Lost two: = fruit two 216 injection needle of polypropylene women's system - and other injection needles: hoarding; Terumo (stock) manufacturing). After the needle (or left shot) is filled with each dose of the drug c specimen φ Ml into the covered wound site, the puncture injection

公司製造),Μ 名稱:TegadH 投藥錢佈iQML(Q.imL)藥劑。 数保1天1次,連續21天。 痕跡至下午2點之間實施,創傷製作曰^ 6.4群組之、_ 1 體之作⑽束後立即實施。 第1电、投藥量以及動物的使用隻數 、、且(未鈿行處置者有10隻盔佈 第2組(施行本發明之中華㈣佈(處置)。 隻)··塗佈瘡治療劑)處置者有10 '且(施仃b’F處置者有10隻):塗佈i〇〇#L。 320866 36 200942270 — 7.〈實驗方法&gt; ’ 7 · 1皮膚創傷之製作 在分叙前3天,以電鬚刀剃掉實驗用動物背部之毛, 並以除毛膏去毛。分組後,在『阿佛T(Avertin)』之麻醉 下[杈與液里·體重(g)x〇. 02+0· 〇5mL;投藥路徑:腹腔内], 將以背部正中線為軸之皮膚以眼科手姻剪除去I.—之 皮膚,製成皮膚創傷(創傷製作首曰)。 ^ 然、後’將該皮膚創傷部位以氧氣與水蒸氣之通過性優 異之聚胺酯膜材『Tegaderm』(商品名稱;3M公司製造)覆 f 0 JDZL. 7. 2皮膚創傷部位面積之測定 在投與第 1、3、5、7、9、11、13、15、17、19 天以 及第21天每天1次對創傷部位輪廓進行追跡,並將該面積 以求積儀(Super PLANIX β ; TAMAYA測量系統(股))測定。 皮膚創傷部位判斷為「已痊癒」之動物不再進行追跡, Q 並使該創傷部位面積設為0。 將投藥第1天(當天)之面積設為1〇〇%,求出各投藥曰 之面積率,從投藥天數依下式求出創傷部位面積對經過時 間之曲線下面積(AUC)。 AUC=(a+k)+2(b+c+d+e+f+g+h+i+j) a:投藥第1天之面積率、 b:投藥第3天之面積率、 c:投藥第5天之面積率、 d:投藥第7天之面積率、 320866 37 200942270 e ··投藥第9天之面積率、 • f :投藥第11天之面積率、 g :投藥第13天之面積率、 h :投藥第15天之面積率、 i :投藥第17天之面積率、 j :投藥第19天之面積率、 k :投藥第21天之面積率。 7. 3 —般狀態 D 包含是否死亡之一般狀態,在每日上午投藥之前觀察 1次。 7.4體重測定 體重係在創傷製作的第1、7、14天以及第21天(在投 藥日之投與前測定)測定(使用之電子天平:PG2002-S ;梅 特勒-托利多(股)製造)。 7. 5照片拍攝 p 在創傷製作的第1、7、14以及第21天拍攝全例之照 片(在投藥曰之投與前拍攝)。 8. 統計學上之方法 體重、由創傷製作的第1天至第21天之創傷部位面 積、以及創傷部位面積對經過時間之曲線下面積(AUC)係求 算每組之平均值:h標準誤差。 顧著性差異之檢定在未處置對照群與各投藥群間進 行,係將未滿5%視為顯著性,而各表示為未滿5%(p〈0. 05) 以及未滿1%(ρ&lt;0. 01)。檢定方法係在Bartlett檢定後, 38 320866 200942270 &quot; 等分散時使用Dunnett檢定,而在不等分散時使用非參數 • (nonparametric test)之 Steel 檢定。檢定中,使用 SAS 前臨床包裝版本 5. 〇(SAS Institute Japan)。 9.實驗成績 9. 1 一般狀態 任一組在投藥期間之一般狀態均無異常。 9. 2體重 將結果呈示於第1〇圖與表2。 ^ 在未處置群中,投與第1天(當天)之平均體重為 45.4±〇.5g,但經過投藥期間而逐漸減少’在投藥第21天 時成為 38. 5±1. 5g 〇 在製造例2所得本發明之中藥軟膏投與群中,投與第 1天(當天)之平均體重為45· 4±0.4g,但經過投藥期間而逐 漸減少,在投藥第21天時成為35.1:1:0. 8g。相較於未處置 群’在投藥第14天之後的測定日中雖呈現低值,但在任竟 0 之測定日中均未觀察到顯著性差異。&quot; 在b-FGF處置群中,投與第1天之平均體重為 45. 3±0. 4g ’但經過投藥斯間而逐漸減少’在投藥第21天 時成為38. 3土〇· 9g。相較於未處置群,幾乎呈現相同的體 重變化,而未觀察到顯著性差異。 9. 3皮膚創傷部位面積、以及創傷部位面積對經過時間之 曲線下面積(AUC) 將結果呈示於第11、12圖與表3。 在未處置群中,創傷製作第1天(製作創傷之當天)之 320866 39 200942270 平均面積為255. 3±6. 7mm2。該面積至創傷製作第15天為止 •係以固定之值變動,而從創傷製作第15天起,創傷面積雖 日益漸小,但在創傷製作苐21夭之創傷面積率尚有 62. 4±5· 8%。而且,在全例中看不出痊癒的跡象。此仙c之 平均為 1885. 1±44. lmm2。 在製造例2所得本發明之中藥軟膏投與群中,創傷製 作第1天之平均面積為258. 8±9. lmm2。 該面積率至創傷製作第7天(由第1天數至第7天)為 止,相較於製作時之創傷面積增大,且在創傷製作第14天 之後,創傷部位之周圍有發炎現象。 然而’創傷面積雖隨著天數而變小,但在創傷製作第 21天之創傷面積率尚有43. 7±5. 5%。 而且’在本發明之中藥軟膏2處置群中,全例中看不 出「皮膚創傷已痊癒」.的跡象。此之平均為 1472. 9+55. 1mm2 ° 0 相較於未處置群,本發明之中藥軟膏2之處置群中, 面積率在投藥的第3天呈現顯著性高值,而在第n、&amp; 15、17天以及第19天呈現顯著性低值。且服 性低值。顯著 ,在b-FGF處置群中,創傷製作第1天(製作創傷之當天) 之平均面積為245. 7±6. 4mra2。創傷面積隨著創傷製作後之 天數而變小,且在創傷製作第21天之創傷面積率僅有 1. 2±〇K。並且,1〇例中之6例已痊癒。此之平均為 1135. 5±33. 3mm2。相較於未處置群,b_FGF處置群中,面積 320866 40 200942270 - 率在投藥的第9、11、13、15、17天以及第19天呈現顯著 * 性低值。且AUC亦呈現顯著性低值。 10. &lt;結論&gt; 在12週齡患有遺傳性糖尿病的小鼠(db/db小鼠)之背 部作成創傷部並以製造例2所得本發明之中藥軟膏(中藥 軟膏2)進行1天1次之塗佈,每2天測定創傷部位面積1 次,調查此中藥軟膏2之促進癒合的作用。 由其結果發現,製造例2所得本發明之中藥軟膏(中藥 0 軟膏2)在投藥的第3天呈現顯著性高值,而在第11、13、 15、17天以及第19天中呈現顯著性低值,因而斷定有促 進癒合之作用。 而且,創傷部位面積對經過時間之曲線下面積(AUC) 亦呈現顯著性低值,判定具有促進癒合之作用。然而,此 次使用之製造例2所得本發明之中藥軟膏(中藥軟膏2)在 投藥的第14天之後,由於體重低於未處置群者,且背部皮 q 膚之創傷部位周圍有發炎的跡象,因此在在投藥的第17天 之後,創傷部位面積的縮小停滯。 此原因雖然尚未明瞭,但由於該檢體(藥劑)為軟膏 劑,故在此次的封閉式投與方法中,不易被皮膚所吸收, 而有檢體殘留在聚胺酯膜材『Tegaderm』中之情形。因此, 判斷每天的連續投藥將使動物增加負擔且承受壓力,進而 影響到使體重減輕以及使創傷部位面積縮小停滯。 然而,實驗例11中所示大鼠皮膚割傷實驗中,為市售 褥瘡治療劑之「b-FGF」具有更強的促進癒合之作用,顯示 41 320866 200942270 ' 出由製造例2所得本發明之中藥軟膏的效用。 • 並且,即使在此次患有遺傳性糖尿病的小鼠(db/db小 鼠)中之皮膚創傷之療效上亦顯示出促進癒合之作用。 經由上述可知,由製造例2所得本發明之中藥軟膏(中 藥軟膏2)經由連日密閉性投與,雖不易由皮膚所吸收,但 對db/db小鼠之皮膚創傷具有促進癒合之作用。 0 0 42 320866 200942270' [表 2] &quot;--gg^^J^BSq^ ~ u } t_g14 aojm qp/qpplsvlM'BAlsI^^O ^ospwuoosTJl esaumuJeslai^tuwM. #礆wlfn^剌離φ【·ιί _刼&gt;(1 ,f'qp/qp)1七堞竣黎杯,¥葙2和#濂午)盔愈4.2崦00 s (»4 5 41 -Η -« -Η fn ^ ^ ηMade by the company), Μ Name: TegadH Pharmacy Qianbu iQML (Q.imL) Pharmacy. The number is guaranteed once a day for 21 consecutive days. The traces were carried out between 2 pm and the wounds were made 曰^ 6.4 group, _ 1 body (10) bundles were implemented immediately. The first electricity, the dose, and the use of the animal are only counted, and (there are 10 helmets in the second group (the Chinese (four) cloth (disposal).) The disposer has 10 ' and 10 (the Shi B'F disposer has 10): coated i〇〇#L. 320866 36 200942270 — 7. <Experimental method> '7 · 1 Skin wound preparation Three days before the resection, the hair of the back of the experimental animal was shaved with a whisker and the hair was removed with a hair removal cream. After grouping, under the anesthesia of "Avertin" [杈 and liquid, body weight (g) x 〇. 02+0· 〇 5mL; administration route: intra-abdominal], will be centered on the back midline The skin is removed by eye ophthalmology to remove the skin of I.—to make a skin wound (the first wound of the wound). ^ 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然 然Tracing the contour of the wound site once a day on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21, and using the area as a product (Super PLANIX β ; TAMAYA Measurement system (unit)) measurement. Animals judged to have "healed" in the skin wound site are no longer traced, and Q is made to have the area of the wound site set to zero. The area on the first day (day) of the administration was set to 1%, and the area ratio of each administration 求出 was determined, and the area under the curve (AUC) of the wound site area versus elapsed time was obtained from the number of administration days according to the following formula. AUC=(a+k)+2(b+c+d+e+f+g+h+i+j) a: area ratio on the first day of administration, b: area ratio on the third day of administration, c: Area ratio on the 5th day of administration, d: Area ratio on the 7th day of administration, 320866 37 200942270 e · Area ratio on the 9th day of administration, • f: Area ratio on the 11th day of administration, g: Day 13 on administration Area ratio, h: area ratio on the 15th day of administration, i: area ratio on the 17th day of administration, j: area ratio on the 19th day of administration, k: area ratio on the 21st day of administration. 7. 3 General state D Contains the general state of death, observed 1 time before daily dosing. 7.4 Body weight determination Body weight is determined on days 1, 7, 14 and 21 of the wound production (measured prior to administration on the dosing date) (electronic balance used: PG2002-S; METTLER TOLEDO) Manufacturing). 7. 5Photographing p Take the photo of the whole case on the 1st, 7th, 14th and 21st day of the trauma production (take the shot before the administration). 8. Statistical Methods Body weight, area of the wound site from day 1 to day 21, and area of the wound site to the area under the curve of the elapsed time (AUC). Average of each group: h standard error. The determination of sexual differences between the untreated control group and each drug-administered group is considered to be less than 5%, and each is expressed as less than 5% (p<0.05) and less than 1% ( ρ&lt;0. 01). The verification method is based on the Bartlett test, 38 320866 200942270 &quot; etc., using the Dunnett test for dispersion, and the non-parametric test for non-parametric test. In the test, use SAS Pre-Clinical Packing Version 5. S (SAS Institute Japan). 9. Experimental results 9. 1 General status There is no abnormality in the general state of any group during the administration period. 9. 2 Weight The results are presented in Figure 1 and Table 2. ^ In the untreated group, the average body weight on the first day (the day) was 45.4 ± 〇. 5g, but gradually decreased during the administration period. 'On the 21st day of administration, it became 38.5 ± 1. 5g 〇 Manufactured In the administration group of the traditional Chinese medicine ointment obtained in Example 2, the average body weight on the first day (the day) was 45·4±0.4 g, but gradually decreased during the administration period, and became 35.1:1 on the 21st day of administration. : 0. 8g. Although the value was lower than that of the untreated group 'on the measurement day after the 14th day of administration, no significant difference was observed in the measurement day of any of 0 days. &quot; In the b-FGF treatment group, the average body weight on the first day of administration was 45. 3±0. 4g 'but gradually decreased after administration of the drug'. On the 21st day of administration, it became 38. 3 soil〇·9g . Almost the same body weight change was observed compared to the untreated group, and no significant difference was observed. 9. 3 The area of the wound site of the skin and the area under the curve of the time of the wound site (AUC) are shown in Figures 11, 12 and 3. In the untreated group, the average area of the first day of the wound production (the day of the wounding) was 320.563, 2009, and the average area was 255.3 ± 6. 7 mm 2 . The area was changed to a fixed value on the 15th day of the wound production, and the wound area was gradually reduced from the 15th day of the wound production, but the wound area ratio of the wound preparation was still 62. 4± 5.8%. Moreover, there is no sign of recovery in the full case. The average of this c is 1885. 1±44. lmm2.至1. lmm2。 The average area of the wound on the first day of the wound production was 258.0 ± 9. lmm2. The area ratio was on the 7th day of the wound production (from the first day to the 7th day), and the area of the wound was increased as compared with the production, and after the 14th day of the wound production, there was inflammation around the wound site. However, the wound area was reduced by the number of days, but the wound area ratio of the 21st day of wound production was 43.7 ± 5.5%. Further, in the treatment group of the ointment 2 of the present invention, the "skin wound has healed" is not seen in the whole example. The average of this is 1472. 9+55. 1mm2 ° 0 Compared with the untreated group, the area ratio of the drug ointment 2 of the present invention shows a significant high value on the third day of administration, and in the nth, &amp; 15, 17 days and 19th day showed a significant low value. And the service is low.至4. 4mra2。 The average area of the wound on the first day of the wound production (the day of the wound) was 244.7±6. 4mra2. The wound area became smaller as the number of days after the wound was made, and the wound area ratio on the 21st day of wound production was only 1. 2 ± 〇K. Also, 6 of the 1 cases have recovered. The average is 1135. 5±33. 3mm2. Compared with the untreated group, the area of the b_FGF treatment group, the area of 320866 40 200942270 - showed a significant low value on the 9th, 11th, 13th, 15th, 17th and 19th days of administration. And AUC also showed a significant low value. 10. &lt;Conclusion&gt; A wound portion was formed on the back of a 12-week-old mouse (db/db mouse) having hereditary diabetes, and the traditional Chinese medicine ointment (Chinese medicine ointment 2) obtained in Production Example 2 was subjected to one day. One coat was applied, and the area of the wound site was measured once every two days to investigate the effect of the Chinese herbal ointment 2 on promoting healing. From the results, it was found that the traditional Chinese medicine ointment (Chinese medicine 0 ointment 2) obtained in Production Example 2 exhibited a remarkable high value on the third day of administration, and was remarkable on the 11th, 13th, 15th, 17th, and 19th days. The low value of sex is thus determined to promote healing. Moreover, the area under the curve of the wound site (AUC) also showed a significant low value, which was judged to have a promoting healing effect. However, the traditional Chinese medicine ointment (Chinese medicine ointment 2) obtained in Production Example 2 used this time, after the 14th day of administration, has a lower body weight than the untreated group, and there is an indication of inflammation around the wound portion of the back skin. Therefore, after the 17th day of administration, the reduction in the area of the wound site was stagnant. Although the reason for this is not clear, the sample (agent) is an ointment, so in the closed-type administration method, it is not easily absorbed by the skin, and the sample remains in the polyurethane film "Tegaderm". situation. Therefore, judging the daily continuous administration of the drug will increase the burden on the animal and withstand the stress, which in turn will affect the weight loss and the reduction of the wound site area. However, in the rat skin cut test shown in Experimental Example 11, the "b-FGF" which is a commercially available acne therapeutic agent has a stronger effect of promoting healing, and shows that the present invention obtained by Production Example 2 is shown in 41 320866 200942270' The utility of traditional Chinese medicine ointment. • Moreover, even in the efficacy of skin wounds in mice with hereditary diabetes (db/db mice), it has been shown to promote healing. As described above, the traditional Chinese medicine ointment (Traditional Chinese Medicine Ointment 2) of the present invention obtained in Production Example 2 was administered by the daily sealing, and was not easily absorbed by the skin, but had an effect of promoting healing of the skin wound of db/db mice. 0 0 42 320866 200942270' [Table 2] &quot;--gg^^J^BSq^ ~ u } t_g14 aojm qp/qpplsvlM'BAlsI^^O ^ospwuoosTJl esaumuJeslai^tuwM. #礆wlfn^剌从φ[·ιί _刼&gt;(1 ,f'qp/qp)1七堞竣黎杯, ¥葙2 and #濂午) 头盔愈4.2崦00 s (»4 5 41 -Η -« -Η fn ^ ^ η

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碱B硃彰 ios^Q 趄幽鞑碡嘲(dnoJ3 10.14-&gt;§3)璁餒*矣銻要:00艺W瞵+ι(ω)^贫屮碳¥砟 baew ^paes J εα« ^§5ΑΜ»« «οζ ri-w ^ ^ I gq g^qjws^p IP·808 43 320866 200942270' [表 3] §Λ si ts f 3^$ s-«rl i 3 Ϊ9·ί 5 3 + 6= 5 3 iF-o: sec ^ s ir? Λ- 5W i 5 ^ 2t sz-f 屮* SNt-ϊ Is S27 « 9 5 屮--t5? ο ο 蜣該Φ嬸銮^f_f_^w2 ,【、qp/qp)^七墚呦邀趄餘«-te'f-iiz如挺镰-fr-w-s^4co^ zswitb^4 giau ,l§Alkali B Zhu Zhang ios^Q 趄 鞑碡 鞑碡 (dnoJ3 10.14-&gt;§3)璁馁*矣锑要:00艺W瞵+ι(ω)^Barren carbon¥砟baew ^paes J εα« ^ §5ΑΜ»« «οζ ri-w ^ ^ I gq g^qjws^p IP·808 43 320866 200942270' [Table 3] §Λ si ts f 3^$ s-«rl i 3 Ϊ9·ί 5 3 + 6 = 5 3 iF-o: sec ^ s ir? Λ- 5W i 5 ^ 2t sz-f 屮* SNt-ϊ Is S27 « 9 5 屮--t5? ο ο 蜣The Φ婶銮^f_f_^w2 ,【 , qp/qp)^七墚呦 invites more «-te'f-iiz such as 镰-fr-ws^4co^ zswitb^4 giau , l§

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^oiQ -4 t fggs i S5 i g? o? ^f^vr^ri^oi^iri^etriwi ψ\^oiQ -4 t fggs i S5 i g? o? ^f^vr^ri^oi^iri^etriwi ψ\

«3S =F1 ,£'5 •+lm -Hm «6Ί5 •Hti «m ^ β·ιβ •Mn2 ·«i *s2 Ξ] 4i -if -« *»«·« -H&gt;if ·«·♦&lt; Ή -tf •n •Oa g ?|S|iSiiS3| ΛΦΙΓ· 玄a frpi 一 frpil X*MI 1.11 3--¾¾ 3*pt &gt;vf»s.言1 (X )齋矣.il(w 赛《 钽荦s*f««?-tt! S18-li^ee{ &amp;B6 (s日s&gt;#«w趄费串 gs ss ^so^. (¾¾ 。寒^墙碟翊(&amp;23^扫1103)逋&amp;:*食鎵英:^ ΛΙ0·0Μ**)Μ·¥ 铤 &quot; f ^δ§?1§ (赛vsi錄电&gt;5?啻瓚璩*無《钽爺傘fsMV隼W瞵'+lw%fel·嫦迆吨 d»0&amp; ^§8 *€8§ ^1V9S« .^5.£ 1 &amp;s» lfw« §slx • ^us^s^§s&lt; ΰ3^ _ yg^lrps gmfMoy gnpA qaig 44 320866 Ο Ο 200942270 [產業上之巧利用性] -般在褥瘡等的處置方法上,傷,若㈣腐肉,_ 移除影響傷讀合的壞死組鐵,稱為傷。清創術(為外科醫 師使用II械去除或使用特定祕㈣狀製劑軟化壞死組 織)’傷口壞死組織經清理後,正常情况下自己才能長出新 生組織。 然而,患者對於傷π處置所隨之而來的痛楚與精㈣ 力,往往讀貞荷,有時在d對斥進而 傷口的癒合。 本發明之膏藥由塗敷初期至復原為止, 制病菌等之抗生素等會帶來副作用之藥#j,而僅 發明之膏藥塗敷(期間數次替換紗布、涤遽 只^ ^ , 太双^之乎段,不僅 可有效地去除壞死、、且織、且可促進新肌的生成。 本發明之中藥軟膏並具有抑制參出液之作用, 使傷口保持濕、潤狀態以利於傷口的復原。. 、 因此,不會帶給患者身體的痛楚以及精神上的負荷, 且避免動手術等所▼來的經濟壓力,並可縮短復原的時°日 因此,對於患者本身與其家屬’本發明之中藥軟膏無 論在復原性、精神性、身體性、經濟性以及時間性方面均 為優異之配方。 雖然本發明以乾薑、附子(或炮附子)、肉桂,蜀板、 吳茱萸、芍藥、厚朴、乳香、沒藥、兒茶等十種中藥材, 以及金針菇菌菌絲體萃取物為有效成分,惟其配方可依實 際症狀加以調整。 320866 200942270 ' 根據發明人從中藥理論推衍,得到上述十種中藥材 • 中,乾薑、附子(或炮附子)與肉桂為不可或缺之成分之見 解,更專心致志反覆研究之結果而達到本發明之外傷、褥 瘡之治療用中藥組成物,以及外傷、褥瘡之治療用中藥軟 膏,遂而完成本發明。 本發明之製劑的組合係包括下述者: 較佳之配方可為「乾薑、附子(或炮附子)、肉桂、蜀 椒之組合」,以及「乾薑、附子(或炮附子)、肉桂、蜀椒、 ^ 金針益菌菌絲體萃取物之組合」。 更佳之配方可為「乾薑、附子(或炮附子)、肉桂、蜀 椒、吳茱萸之組合,以及乾薑、附子(或炮附子)、肉桂、 蜀椒、吳茱11、金針菇菌菌絲體萃取物之組合」。 又更佳之配方可為「乾薑、附子(或炮附子)、肉桂、 蜀椒、吳茱萸、芍藥之組合,以及乾薑、附子(或炮附子)、 肉桂、蜀椒、吳茱萸、苟藥、金針蒜菌菌絲體萃取物之組 〇合」。 另更佳之配方可為「乾薑、附子(或炮附子)、肉桂、 蜀椒、吳茱萸、芍藥、厚朴之組合,以及乾薑、附子(或炮 附子)、肉桂、蜀椒、吳茱萸、芍藥、厚朴、金針菇菌菌絲 體萃取物之組合」。 再更佳之配方可為「乾薑、附子(或炮附子)、肉桂、 蜀椒、吳茱爽、芍藥、厚朴、乳香、沒藥之組合,以及乾 薑、附子(或炮附子)、肉桂、蜀椒、吳茱萸、芍藥、厚朴、 乳香、沒藥、金針菇菌菌絲體萃取物之組合」。 46 320866 200942270 - 最佳之配方可為「乾#、附子(或_子)、肉桂、蜀 *椒、吳茱萸、苟藥、厚朴、乳香、沒藥、兒茶之組合,以 及乾薑、附子(或炮附子)、肉桂、蜀椒、吳茱萸、与藥、 厚朴、乳香、沒藥、兒茶、金針菇菌菌絲體萃取物之組合」。 【圖式簡單說明】 第1圖(A)係呈示實驗例】所示薦部之#瘡傷口至疮疲 為止之過程中的第1張照片。^ 帛1 ®⑻係呈示實驗例丨所讀部之褥瘡傷口至疾瘡 ^為止之過程中延續第i圖(幻的第2張照片。 第1圖(C)係呈示實驗例〗所示薦部之褥療傷口至痊瘡 為止之過程中延續第丨圖(幻的第3張照片。 第1 ®(D)係呈示實驗例丨所示薦部之褥瘡傷口至減 為止之過程中延續第丨圖(〇的第4張照片。 第2圖(A)係呈示實驗例2所示薦部之褥瘡傷口至疮癒 為止之過程中的第1張照片。 0 第2圖(B)係呈示實驗例2所示薦部之搏療傷口至疾癒 為止之過程中延續第1圖(A)的第2張照片。 第2圖(C)係呈示實驗例2所示薦部之褥瘡傷口至疮瘡 為止之過程中延續第1圖(B)的第3張照片。 第2圖(D)係呈示實驗例2所示薦部之褥瘡傷口至疾癒 為止之過程中延續第1圖(C)的第4張照片。 、第m(A)係呈示實驗例3所示左足跟部發生蜂寫性組 織炎之傷口至痊癒為止之過程的第丨張照片。 第3圖(B)係呈示實驗例3所示左足跟部發生蜂寫性組 320866 47 200942270 ' 織炎之傷口至痊癒為止之過程中延續第3圖(A)的第2張照 *片。 第4圖係呈示實驗例4所示右小腿發生蜂窩性組織炎 之傷口至痊癒為止之照片。 第5圖(A)係呈示實驗例5所示臀部之褥瘡傷口在痊癒 狀態之照片。 第5圖(B)係呈示實驗例5所示背部之褥瘡傷口在痊癒 狀態之照片。 ® 第6圖(A)係呈示實驗例6所示背部之褥瘡傷口至痊癒 為止之過程中的第1張照片。 第6圖(B)係呈示實驗例6所示背部之褥瘡傷口至痊癒 為止之過程中延續第6圖(A)的第2張照片。 第6圖(C)係呈示實驗例6所示背部之褥瘡傷口至痊癒 為止之過程中延續第6圖(B)的第3張照片。 第6圖(D)係呈示實驗例6所示背部之褥瘡傷口至痊癒 Q 為止之過程中延續第6圖(C)的第4張照片。 第6圖(E)係呈示實驗例6所示背部之褥瘡傷口至痊癒 為止之過程中延續第6圖(D)的第5張照片。 第7圖(A)係呈示實驗例7所示腹部之褥瘡傷口至痊癒 為止之過程中的第1張照片。 第7圖(B)係呈示實驗例7所示腹部之褥瘡傷口至痊癒 為止之過程中延續第7圖(A)的第2張照片。 第7圖(C)係呈示實驗例7所示腹部之褥瘡傷口至痊癒 為止之過程中延續第7圖(B)的第3張照片。 48 320866 200942270 第7圖(D)係呈示實驗例7所示腹部之褥瘡傷口至痊癒 為止之過程中延續第7圖(C)的第4張照片。 第7圖(E)係呈示實驗例7所示腹部之褥瘡傷口至痊癒 為止之過程中延續第7圖(D)的第5張照片。 第7圖(F)係呈示實驗例7所示腹部之褥瘡傷口至痊癒 為止之過程中延續第7圖(E)的第6張照片。 第8圖係呈示實驗例8所示左拇趾之第二趾關節處的 傷口獲得改善之照片。 第9圖係實驗例11所示,由製造例2所得本發明之中 藥軟膏(中藥軟膏 2 ; Chinese medicine of bedsore-2)對 小鼠皮膚割傷模型進行治療時所呈現傷口癒合後的耐張力 強度(tensile strength(g)) ° 另外,第9圖中同時呈示未處置群(對照組;control group)之傷口癒合後的财張力強度,以及使用「b-FGF」進 行治療時之傷口癒合後的耐張力強度。 第ίΟ圖係呈示實驗例12中對db/db小鼠的投藥天數 (days of administration)與體重(body weight(g))之關 係圖表。 第10圖中,「〇與實線」表示對照組,「•與虛線」表 示投與本發明之中藥軟膏2的情形,「△與實線」表示投與 「b-FGF」的情形。 第11圖係呈示本發明之實驗例12中對db/db小鼠的 投藥天數(days of administration)與創傷面積變化率 (change of wound lesion area(%))之關係圖表0 49 320866 200942270 ' 另外,第11圖中同時呈示未處置群(對照組;control ' group)之對db/db小鼠的投藥天數與創傷面積變化率之關 係,以及藥劑「b-FGF」投與群之對db/db小鼠的投藥天數 與創傷面積變化率之關係。 第11圖中,「〇與實線」表示對照組,「•與虛線」表 示投與本發明之中藥軟膏2的情形,「△與實線」表示投與 「b-FGF」的情形。 第12圖係實驗例12所示,由製造例2所得本發明之 ^ 中藥軟膏(中藥軟膏 2 ; Chinese medicine of bedsore-2) 對db/db小鼠投與後並以AUC(mm2)表示其痊癒效果。 亦併列對照組以及「b-FGF」之投與情形。 【主要元件符號說明】 無 50 320866«3S =F1 ,£'5 •+lm -Hm «6Ί5 •Hti «m ^ β·ιβ •Mn2 ·«i *s2 Ξ] 4i -if -« *»«·« -H&gt;if ·«·♦ &lt; Ή -tf •n •Oa g ?|S|iSiiS3| ΛΦΙΓ· Xuan a frpi a frpil X*MI 1.11 3--3⁄43⁄4 3*pt &gt;vf»s.言1 (X)斋矣.il( w赛" 钽荦s*f««?-tt! S18-li^ee{ &B6 (s day s&gt;#«w趄费串gs ss ^so^. (3⁄43⁄4. 寒^墙碟翊(&amp ; 23^Sweep 1103)逋&:*Food Gallium:^ ΛΙ0·0Μ**)Μ·¥ 铤&quot; f ^δ§?1§ (赛vsi录电&gt;5?啻瓒璩*没有Grandfather umbrella fsMV隼W瞵'+lw%fel·嫦迤 tons d»0&amp; ^§8 *€8§ ^1V9S« .^5.£ 1 &s» lfw« §slx • ^us^s^ §s&lt; ΰ3^ _ yg^lrps gmfMoy gnpA qaig 44 320866 Ο Ο 200942270 [Industry use] - Generally, in the treatment of hemorrhoids, injury, if (four) carrion, _ remove the necrosis affecting the injury Group iron, called injury. Debridement (for the surgeon to use II to remove or use a specific secret (four) preparation to soften the necrotic tissue) 'When the wound necrotic tissue is cleaned, it is normal to grow new tissue. However, the patient For the injury π disposal The pain and the fineness (4) force, often read the sputum, sometimes in the d repulsion and the healing of the wound. The plaster of the present invention from the initial stage of application to the restoration, the antibiotics such as pathogenic bacteria and the like may cause side effects of the drug #j, However, only the plaster of the invention is applied (the gauze is replaced several times, the polyester is only ^^, and the pair is too double, which can effectively remove necrosis, weave, and promote the formation of new muscles. The ointment also has the function of inhibiting the exudate, keeping the wound in a wet and moist state to facilitate the recovery of the wound. Therefore, it does not bring pain and mental load to the patient's body, and avoids surgery and the like. Economic pressure, and can shorten the time of recovery. Therefore, for the patient itself and his family, the herbal ointment of the present invention is excellent in terms of restorativeness, mentality, physicality, economy, and time. Ten kinds of Chinese herbal medicines such as dried ginger, aconite (or medicinal aconite), cinnamon, medlar, Wusong, peony, magnolia, frankincense, myrrh, catechu, and the extract of mycoplasma mycelium are effective. Points, but the formula can be adjusted according to the actual symptoms. 320866 200942270 ' According to the inventor's theory of traditional Chinese medicine, the above ten kinds of Chinese herbal medicines are obtained. Among them, dried ginger, aconite (or artemisia) and cinnamon are indispensable components. The present invention has been accomplished by focusing on the results of repeated studies and achieving the therapeutic Chinese medicine composition for trauma, hemorrhoids, and the traditional Chinese medicine ointment for trauma and hemorrhoids. The combination of the preparation of the present invention includes the following: The preferred formula may be "dry ginger, aconite (or artemisia), cinnamon, and pepper combination", and "dry ginger, aconite (or artemisia), cinnamon, and pepper. , ^ Combination of Mycorrhizal Mycelium Extracts. A better formula can be a combination of "Ginger, Aconite (or Aconite), Cinnamon, Amaranth, and Evodia, as well as dried ginger, aconite (or aconite), cinnamon, pepper, Wujing 11, and Flammulina mycelium extract. Combination." A better formula can be "dry ginger, aconite (or artemisia), cinnamon, peony, sorghum, peony, and dried ginger, aconite (or artemisia), cinnamon, peony, peony, peony, Acerola A combination of mycelium extracts." Another better formula can be "dry ginger, aconite (or cannon), cinnamon, peony, sorghum, peony, magnolia combination, as well as dried ginger, aconite (or artemisia), cinnamon, peony, peony, peony, thick Combination of Park and Flammulina mycelium extracts. A better formula can be "Dried Ginger, Aconite (or Aconite), Cinnamon, Amaranth, Wushuang Shuang, Peony, Magnolia, Frankincense, Myrrh, and Dried Ginger, Aconite (or Aconite), Cinnamon, Pepper, Combination of Wusong, Peony, Magnolia, Frankincense, Myrrh, and Flammulina Mycelium Extract. 46 320866 200942270 - The best formula can be "dry #, aconite (or _ child), cinnamon, 蜀 * pepper, 茱萸 茱萸, peony, magnolia, frankincense, myrrh, catechu, and dried ginger, aconite (or gun aconite), cinnamon, pepper, Wusong, and medicine, Magnolia, frankincense, myrrh, catechu, Flammulina velutipes mycelium extract combination. [Simplified description of the drawings] Fig. 1(A) shows the first photograph of the process of the sore wound to the soreness of the recommended part of the experimental example. ^ 帛1 ® (8) is the first picture of the illusion (the second picture of the illusion is shown in the process of the acne wound to the sore after the reading of the experimental part). Figure 1 (C) shows the experimental example In the process of treating the wound to the acne, the continuation of the third picture (the third picture of the illusion. The first │ (D) shows the acne wound of the recommended part of the experimental 丨 continuation of the third Figure (4th photo of 〇. Fig. 2(A) shows the first picture of the acne wound of the recommended part of the experimental example 2 until the sore. 0 Fig. 2 (B) shows the experiment The second photo of Figure 1 (A) is continued during the healing of the wound in the recommended part of Example 2. Figure 2 (C) shows the acne wound to the sore shown in the experimental example 2 The third picture of Fig. 1(B) is continued during the sore process. Fig. 2(D) shows the acne wound of the recommended part of the experimental example 2 until the recovery (Fig. 1) The fourth photo. The m (A) shows the third photo of the process from the wound of the bee-like tissue inflammation to the healing of the left heel in Experimental Example 3. Figure 3 (B) Presenting the left heel of the experimental example 3, the bee writing group 320866 47 200942270 'The second photo of the 3rd figure (A) is continued during the process of healing the wound of the inflammatory inflammation. Fig. 4 shows the experimental example 4 shows the photo of the wound of the cellulitis of the right lower leg until it is cured. Fig. 5(A) shows the photograph of the hemorrhoid wound of the buttocks shown in the experimental example 5 in the state of healing. Fig. 5 (B) shows the experiment Photograph of the hemorrhoid wound on the back shown in Example 5 in the state of healing. ® Figure 6 (A) shows the first photograph of the back of the hemorrhoid wound as shown in Experimental Example 6 until the recovery. Figure 6 (B) The second photograph of Fig. 6 (A) is shown in the process of presenting the acne wound on the back of the experiment example 6 to the recovery. Fig. 6 (C) shows the acne wound of the back shown in the experimental example 6 until it is cured. In the process, the third photograph of Fig. 6(B) is continued. Fig. 6(D) shows the fourth step of Fig. 6(C) in the process of showing the hemorrhoid wound on the back of the experiment example 6 to the healing Q. Photograph. Fig. 6(E) shows the process of the hemorrhoid wound on the back shown in Experimental Example 6 until it is cured. The fifth photograph of Fig. 6(D) is continued. Fig. 7(A) shows the first photograph of the acne wound of the abdomen shown in Experimental Example 7 until it is cured. Fig. 7(B) shows The second photograph of Fig. 7(A) is continued during the process of the hemorrhoid wound of the abdomen as shown in the experimental example 7. Fig. 7(C) shows the process of the hemorrhoid wound of the abdomen shown in the experimental example 7 until healed. The third photo of Figure 7 (B) is continued. 48 320866 200942270 Figure 7 (D) shows the fourth part of Figure 7 (C) in the process of the hemorrhoid wound of the abdomen shown in Experimental Example 7 Fig. 7(E) shows the fifth photograph of Fig. 7(D) in the course of the hemorrhoid wound of the abdomen shown in Experimental Example 7 until healed. Fig. 7(F) is a sixth photograph showing the continuation of Fig. 7(E) in the course of the hemorrhoid wound of the abdomen shown in Experimental Example 7 until healed. Fig. 8 is a photograph showing the improvement of the wound at the second toe joint of the left thumb as shown in Experimental Example 8. Fig. 9 is a graph showing the tensile strength after wound healing in the treatment of a mouse skin cut model by the Chinese medicine ointment (Chinese medicine of bedsore-2) of the present invention obtained in Production Example 2, as shown in Experimental Example 11. Strength (gile strength (g)) ° In addition, in Figure 9, the unstressed group (control group; control group) showed the strength of the wound after healing, and the wound healing after treatment with "b-FGF" Tensile strength. The figure is a graph showing the relationship between days of administration and body weight (g) in db/db mice in Experimental Example 12. In Fig. 10, "〇 and solid line" indicate a control group, "• and dashed line" indicate the case where the Chinese medicine ointment 2 of the present invention is administered, and "△ and solid line" indicate the case of administration of "b-FGF". Figure 11 is a graph showing the relationship between days of administration and change of wound lesion area (%) in db/db mice in Experimental Example 12 of the present invention. 0 49 320866 200942270 ' In Fig. 11, the relationship between the number of days of administration of the untreated group (control group; control 'group) and the rate of change of wound area in the db/db mice, and the pair of drugs "b-FGF" administered to the group db/ The relationship between the number of days of administration of db mice and the rate of change of wound area. In Fig. 11, "〇 and solid lines" indicate a control group, "• and broken lines" indicate the case where the Chinese medicine ointment 2 of the present invention is administered, and "△ and solid lines" indicate the case where "b-FGF" is administered. Fig. 12 is a view showing the experimental example 12, the medicinal ointment of the present invention (Chinese medicine of bedsore-2) obtained in Production Example 2 was administered to db/db mice and expressed in AUC (mm2). Healing effect. The control group and the investment situation of "b-FGF" were also included. [Main component symbol description] None 50 320866

Claims (1)

200942270 ' 七、申請專利範圍: .1· -種治療外傷或褥瘡用之中藥組成物,其特徵為:含有 乾薑^附子(或炮附子)以及肉桂作為有效成分。 2·如申請專利範圍第1項之治療外傷或褥瘡用之中藥組 成物’其中’作為有效成分之乾薑、附子(或炮附子) 與肉桂之混合重量比為4: 2 : 1。 3.=:=^: = 2,_或褥瘡用. Ο 4. 一種治療外傷戈裾容 成分為粉狀。 申請專利範=之中藥膏劑,其特徵為;含❼ 乾薑、附子用之中藥組成物,其特徵為:含# 6如申請^子)、肉桂以及蜀椒作為有效成分 第5項之治療外傷或褥奢用之中藥組 〇 肉桂與蜀椒之混合重量比為4:1·· 1:1。 8. ㈣第5項或第6項之治療外傷或搏瘡用之 中絲成物’射,各有效成分為粉狀。 之中藥膏劑,其特徵為:含有如 量之油=圍弟5至7項中任一項之中藥組成物以及追 療外傷或褥瘡用之中藥組成物,其特徵為:含有 八附子(或炮附子)、肉桂、蜀誠及吳茱萸作為有 效成分。 320866 51 9. 200942270 ' 10.如申請專利範圍第9項之治療外傷或褥瘡用之中藥組 成物,其中,作為有效成分之乾薑、附子(或炮附子)、 肉桂、蜀椒與吳茱焚之混合重量比為4 : 1 : 1 : 1 : 1。 11. 如申請專利範圍第9項或第10項之治療外傷或褥瘡用 之中藥組成物,其中,各有效成分為粉狀。 12. —種治療外傷或褥瘡用之中藥膏劑,其特徵為:含有如 申請專利範圍第9至Π項中任一項之中藥組成物以及 適量之油脂劑。 . 0 13. —種治療外傷或褥瘡用之中藥組成物,其特徵為:含有 乾薑、附子(或炮附子)、肉桂、蜀椒、吳茱萸以及芍藥 作為有效成分。 14.如申請專利範圍第13項之治療外傷或褥瘡用之中藥組 成物,其中,作為有效成分之乾薑、附子(或炮附子)、 肉桂、蜀椒、吳茱萸與芍藥之混合重量比為4 : 1 ·· 1 : 1:1:1。 Q 15.如申請專利範圍第13項或第14項之治療外傷或褥瘡用 之中藥組成物,其中,各有效成分為粉狀。 16. —種治療外傷或褥瘡用之中藥膏劑,其特徵為:含有如 申請專利範圍第13至15項中任一項之中藥組成物以及 適量之油脂劑。 17. —種治療外傷或褥瘡用之中藥組成物,其特徵為:含有 乾薑、附子(或炮附子)、+肉桂、蜀椒、吳茱萸、芍藥以 及厚朴作為有效成分。 18. 如申請專利範圍第17項之治療外傷或褥瘡用之中藥組 52 320866 200942270 ' 成物,其中,作為有效成分之乾薑、附子(或炮附子)、 肉桂、蜀椒、吳茱萸、芍藥與厚朴之混合重量比為4: 1:1:1:1:1:1° 19. 如申請專利範圍第17項或第18項之治療外傷或褥瘡用 之中藥組成物,其中,各有效成分為粉狀。 20. —種治療外傷或褥瘡用之中藥膏劑,其特徵為:含有如 申請專利範圍第17至19項中任一項之中藥組成物以及 適量之油脂劑。 &amp; 21. —種治療外傷或褥瘡用之中藥組成物,其特徵為:含有 乾薑、附子(或炮附子)、肉桂、蜀椒、吳茱萸、芍藥、 厚朴、乳香以及沒藥作為有效成分。 22.如申請專利範圍第21項之治療外傷或褥瘡用之中藥組 成物,其中,作為有效成分之乾薑、附子(或炮附子)、 肉桂、蜀椒、吳茱萸、芍藥、厚朴、乳香與沒藥之混合 重量比為 4 : 1 : 1 : 1 : 1 : i: 1 : 1 : 1。 Q 23.如申請專利範圍第21項或第22項之治療外傷或褥瘡用 之中藥組成物,其中,各有效成分為粉狀。 24. —種治療外傷或褥瘡用之中藥膏劑,其特徵為:含有如 申請專利範圍第21至23項中任一項之中藥組成物以及 適量之油脂劑。 25. —種治療外傷或褥瘡用之中藥組成物,其特徵為:含有 乾薑、附子(或炮附子)、肉桂、蜀椒、吳茱萸、芍藥、 厚朴、乳香、沒藥以及兒茶作為有效成分。 26. 如申請專利範圍第25項之治療外傷或褥瘡用之中藥組 53 320866 200942270 成物’其中’作為有效成分之乾薑、附子(或炮附子)、 肉桂、蜀椒、吳茱萸、芍藥、厚朴、乳香、沒藥與兒茶 之混合重量比為4 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1。 27·如申請專利範圍第25項或第26項之治療外傷或褥瘡用 之中:組成物’其中,各有效成分為粉狀。 28. —種治療外傷或褥瘡用之中藥膏劑,其特徵為:含有如200942270 ' VII. Patent application scope: .1· - A traditional Chinese medicine composition for treating trauma or acne, which is characterized by containing dry ginger ^ aconite (or artillery aconite) and cinnamon as an active ingredient. 2. The weight ratio of dried ginger, aconite (or medicinal aconite) to cinnamon, which is the active ingredient of the traditional Chinese medicine composition for treating trauma or acne according to item 1 of the patent application, is 4:2:1. 3.=:=^: = 2, _ or acne. Ο 4. A treatment for traumatic sputum is a powdery component. Patent application: Chinese medicine ointment, which is characterized by: a traditional Chinese medicine composition containing ❼ dried ginger and aconite, characterized by: containing #6 such as application ^), cinnamon and peony as the active ingredient of the fifth item of treatment for trauma or In the extravagant Chinese medicine group, the mixture ratio of cinnamon to chopped pepper is 4:1·· 1:1. 8. (4) The fifth or sixth item of the treatment of trauma or pneumococcal ammunition, the active ingredients are powdered. The traditional Chinese medicine ointment is characterized in that it comprises a Chinese medicine composition such as a quantity of oil = a mixture of 5 to 7 of the divine brothers, and a traditional Chinese medicine composition for the treatment of trauma or hemorrhoids, which is characterized in that it contains eight aconites (or cannons). Aconite), cinnamon, devout and sage are the active ingredients. 320866 51 9. 200942270 ' 10. For the treatment of trauma or acne with Chinese medicine composition according to item 9 of the patent application, among them, dried ginger, aconite (or artemisia), cinnamon, pepper and Wusong are used as active ingredients. The mixing weight ratio is 4 : 1 : 1 : 1 : 1. 11. The pharmaceutical composition for treating trauma or acne according to claim 9 or 10, wherein each active ingredient is in the form of a powder. 12. A medicinal ointment for treating trauma or acne, which comprises the composition of a medicinal composition according to any one of claims 9 to 3, and an appropriate amount of a fascia. 0 13. A traditional Chinese medicine composition for treating trauma or acne, which is characterized by containing dried ginger, aconite (or medicinal aconite), cinnamon, peony, peony and peony as active ingredients. 14. The pharmaceutical composition for treating trauma or acne according to claim 13 of the patent application, wherein the weight ratio of dried ginger, aconite (or medicinal aconite), cinnamon, peony, sage and peony as an active ingredient is 4: 1 ·· 1 : 1:1:1. Q 15. A pharmaceutical composition for treating trauma or acne according to claim 13 or 14, wherein each active ingredient is in the form of a powder. A medicinal ointment for treating trauma or acne, which comprises a medicinal composition according to any one of claims 13 to 15 and an appropriate amount of emollient. 17. A traditional Chinese medicine composition for treating trauma or acne, which comprises: dried ginger, aconite (or medicinal aconite), + cinnamon, peony pepper, peony root, peony and magnolia as active ingredients. 18. For the treatment of trauma or acne, the Chinese medicine group 52 320866 200942270 ', the active ingredient of dried ginger, aconite (or artemisia), cinnamon, peony, peony, peony and thick The weight ratio of Park's mixture is 4:1:1:1:1:1:1. 19. For the treatment of trauma or acne, according to Article 17 or Item 18 of the patent application, wherein the active ingredients are Powdery. 20. A medicinal ointment for treating trauma or acne, which comprises a medicinal composition according to any one of claims 17 to 19, and an appropriate amount of emollient. &amp; 21. A traditional Chinese medicine composition for treating trauma or acne, which comprises: dried ginger, aconite (or medicinal aconite), cinnamon, peony, sorghum, peony, magnolia, frankincense, and myrrh as an active ingredient. 22. The composition of a traditional Chinese medicine for treating trauma or acne according to the scope of claim 21, wherein, as an active ingredient, dried ginger, aconite (or aconite), cinnamon, peony, peony, peony, magnolia, frankincense and no The mixture weight ratio of the medicine is 4 : 1 : 1 : 1 : 1 : i: 1 : 1 : 1. Q 23. A pharmaceutical composition for treating trauma or acne according to claim 21 or 22, wherein each active ingredient is in the form of a powder. 24. A medicinal ointment for treating trauma or acne, which comprises a medicinal composition according to any one of claims 21 to 23 and an appropriate amount of emollient. 25. A traditional Chinese medicine composition for treating trauma or acne, which is characterized by containing dried ginger, aconite (or medicinal aconite), cinnamon, peony, peony, peony, magnolia, frankincense, myrrh and catechu as active ingredients. . 26. For the treatment of trauma or acne in the 25th paragraph of the patent application section 53 320866 200942270 The compound 'in which' as the active ingredient of dried ginger, aconite (or artemisia), cinnamon, peony, peony, peony, magnolia The mixture ratio of frankincense, myrrh and catechu is 4 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1. 27. In the treatment of trauma or acne according to claim 25 or 26 of the patent application: Composition 'wherein, each active ingredient is in powder form. 28. A traditional Chinese medicine ointment for treating trauma or acne, characterized by: Ο 申响專利乾圍第27項之中藥組成物以及適量之油脂 劑。 29.如申請專利範圍第1至3項、5至7項、9至11項、1 至15項、17至19項、21至23項、25至27項中任一 項之/口療外傷或褥療用之中藥組成物,其中,另含有益 針蒜_絲體萃取物作為有效成分。 3〇.如申請專利範圍f29項之治療外傷賴瘡用之中藥組 成物’其巾’金他® g絲體萃取物之含量,相對於其 他作為有效成分之乾薑、附子U炮附子&gt;、_、_、 =茱m厚朴、㈣、沒藥以及兒茶的總含量] 重量份,為〇.〇1至0.27重量份。 礼如申請專利範圍第29項或第3〇項之治療外 之中藥組成物,其中,料絲為粉狀、。卜傷或碍瘡用 32.:種治療外傷或褥瘡用之中藥膏劑 申請專利顧第29_項惊—項之巾含有如 適量之油脂劑。 樂、'且成物 320^55 54申 Apply for the 27th Chinese medicine composition of the patent dry circumference and the appropriate amount of grease. 29. If the patent application scopes 1 to 3, 5 to 7, 9 to 11, 1 to 15, 17 to 19, 21 to 23, 25 to 27 / oral trauma Or a traditional Chinese medicine composition for treatment, in which an extract of yam-shrimp-filament extract is additionally contained as an active ingredient. 3〇. For example, the content of the traditional Chinese medicine composition for the treatment of traumatic diarrhea in the patent scope f29 is 'the content of the towel' Jinta® g filament extract, compared to other dried ginger and aconite U cannon as an active ingredient&gt; , _, _, = 茱m magnolia, (four), myrrh and total content of catechu] by weight, 〇.〇1 to 0.27 parts by weight. For example, the therapeutic composition of the external Chinese medicine is in the 29th or the third aspect of the patent application, wherein the filament is powdery. Bu wound or sore used 32.: A kind of traditional Chinese medicine ointment for treating trauma or hemorrhoids. Applying for a patent, the 29th item of the item - the towel of the item contains a proper amount of oil agent. Music, 'and products 320^55 54
TW97148693A 2007-12-14 2008-12-12 Chinese medicine composition for treatment of wounds or bedsore, and method for producing preparation thereof TW200942270A (en)

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CN102526314A (en) * 2012-01-10 2012-07-04 刘军报 Medicament for treating inguinal hernia and preparation method for medicament
CN102526317B (en) * 2012-01-13 2013-09-04 张爱华 Chinese medicine applying agent for treating bedsore
CN103989807B (en) * 2014-05-30 2016-05-25 薛洁 A kind of external-applied ointment for the treatment of bedsore
CN104435273B (en) * 2014-12-22 2017-11-21 王林青 A kind of Chinese medicine for treating empyrosis and preparation method thereof
CN107050237A (en) * 2017-01-10 2017-08-18 利川市民族中医院 A kind of plaster of external application for curing bedsore
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