TWI232112B - Process of preparing porcine dressing - Google Patents

Process of preparing porcine dressing Download PDF

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Publication number
TWI232112B
TWI232112B TW88117733A TW88117733A TWI232112B TW I232112 B TWI232112 B TW I232112B TW 88117733 A TW88117733 A TW 88117733A TW 88117733 A TW88117733 A TW 88117733A TW I232112 B TWI232112 B TW I232112B
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Taiwan
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dressing
skin
pigskin
pig skin
hair
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TW88117733A
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Chinese (zh)
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Hong-Chi Chang
Ying-Ru Lee
Mei-Yun Chen
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Pig Res Inst Taiwan
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Abstract

This invention related to a process of preparing dressing from healthy adult porcine skin. Firstly, raw porcine hide has to be cleaned and subdermal fat tissue has to be removed. Then, the hairs and hair roots were cut and scraped completely. The clean surface was treated with heptane, octane or nonane, and disinfectant before skin grafting. Then, the skin-grafts were put into a sterilizing solution composing of sodium hypochlorite or hydrogen peroxide and irradiated with Co-60. This is a simple, effective and low-cost process that can be produce a porcine dressing for further fabrication into medical devices.

Description

1232112 _案號881Π733_年月曰 修正_ 五、發明說明(1) (一)、發^明背景 : 豬皮作為生物敷料已有二十餘年的歷史,一般皆認為 豬皮敷料對傷口的癒合有正面幫助,能降低水份、電解質 及蛋白質的流失,減少病患傷口的疼痛,而且擁有完整皮 膚結構之豬皮敷料,更能防止外來細菌的侵入。美國是最 早有此類商品的國家,如G e n e t i c公司所生產之豬皮敷料; 而日本也有商社生產類似的產品,如大鵬株式會社出產的 乾燥豬皮敷料。但這些產品均有毛根殘留,致使敷料粘著 性差,且對傷口易產生粘結,並會刺激病患傷口引起疼痛 〇 國内醫藥用豬皮敷料的來源分為兩種:國内醫院(燒 燙傷中心)自行製作及仰賴產品進口。國内手工製作之豬 皮敷料需工繁瑣,品質不一,無法大量生產。國外產品則 價格昂貴,重大傷亡事件時,如金門士兵燒燙傷事件等, 才緊急進口 ,根本緩不濟急。 有關醫藥用豬皮敷料,國外已用之有年。國内臺灣養 豬科學研究所在民國7 5年亦曾提出有關豬皮敷料的發明專 利(公告號1 1 5 9 7 2 ),中國大陸也有相關的專利(CN 1 0 6 0 6 1 1 A )。而就臺灣養豬科學研究所在民國7 5年所提之 專利,此專利方法所製作的敷料,雖能維持豬皮基本結構 (完整角質層、上皮層及真皮層),並進入臨床實驗研究 (41st General Scientific Meeting, Surgical Association, R e p u b 1 i c o f C h i n a ),但所製得成品仍會 殘留毛根,且不易大量生產供應病患。中國大陸的專利,1232112 _Case No. 881Π733_ Year and month revision_ V. Description of the invention (1) (1), development background: Pigskin has been used as a biological dressing for more than 20 years. Generally, pigskin dressings are considered to heal wounds With positive help, it can reduce the loss of water, electrolytes and proteins, reduce the pain of patients' wounds, and the pigskin dressing with a complete skin structure can prevent the invasion of foreign bacteria. The United States is the earliest country to have such products, such as pig skin dressings produced by the company, and Japanese companies have similar products, such as dry pig skin dressings made by Dapeng Co., Ltd. However, these products have hair root residues, which results in poor adhesion of the dressing, and it is easy to cause sticking to the wound, and can irritate the patient's wound and cause pain. There are two sources of domestic pig skin dressings for domestic medicine: Scald Center) make and rely on imported products. Domestic handmade pigskin dressings are cumbersome and of varying quality and cannot be mass produced. Foreign products are expensive, and they were imported urgently in the event of major casualties, such as the burns and burns of Golden Gate soldiers. Regarding medicinal pigskin dressing, it has been used abroad for several years. The domestic Taiwan Pig Research Institute also proposed an invention patent on pig skin dressing in the Republic of China in 1975 (Announcement No. 1 1 5 9 7 2), and China also has related patents (CN 1 0 6 0 6 1 1 A ). As for the patent filed by the Taiwan Pig Research Institute in 1975, the dressing made by this patent method can maintain the basic structure of pigskin (complete cuticle, epithelium and dermis) and enter clinical experimental research. (41st General Scientific Meeting, Surgical Association, Repub 1 icof C hina), but the finished product will still have hairy roots, and it is not easy to mass produce and supply patients. Patents in mainland China,

1232112 _案號881Π733_年月日__ 五、發明說明(2) 則是利用化學方法(硫化鈉與氫氧化鈣等水溶液)去除豬 皮上的毛根,並強化豬皮之硬度,增加片皮的次數;此法 製作簡便,但是用硫化鈉溶液處理豬皮需要極高pH值(pH >11),取下之豬皮需要大量清水清洗以降低p Η值,而且 硫化鈉溶液為強氧化劑,會破壞豬皮膠原蛋白之原始結構 及上表皮層,減低豬皮敷料抵抗外來細菌侵入的功效° 有鑑於此,我們發明一種新鮮豬皮敷料的改良製作方 法,此法成本低廉,且所得之敷料成品無藥劑及毛根殘 留,並可保留完整全皮層結構。本方法有利於敷料產品在 國内大量生產製造,以方便供應國人使用。1232112 _Case No. 881Π733_ 年月 日 __ V. Description of the invention (2) The chemical method (aqueous solution of sodium sulfide and calcium hydroxide) is used to remove hair roots from pig skin, strengthen the hardness of pig skin, and increase the skin This method is simple to make, but treating pigskin with sodium sulfide solution requires extremely high pH (pH > 11). The removed pigskin needs a lot of water to wash to reduce p Η value, and the sodium sulfide solution is a strong oxidant. Will destroy the original structure and upper epidermal layer of pigskin collagen, reduce the effectiveness of pigskin dressings against the invasion of foreign bacteria. In view of this, we have invented an improved manufacturing method of fresh pigskin dressings, which is low cost and the resulting The finished dressing is free of medicaments and hair roots, and can retain a complete full cortex structure. This method is beneficial to the mass production of dressing products in China, so as to facilitate the use of people in the country of supply.

C二)、發明之詳細說明: 1 、發明方法步驟說明 (1 )、前處理 (a) 取新鮮外觀正常、無皮膚病及外傷之成 豬豬皮,清洗乾淨並去除皮下脂肪、肌 肉組織後固定於取皮床上,並以電剪剪 去長毛。 (b) 以庚烷、辛烷或壬烧刷洗原料豬皮表 面,再用刀片將皮上的毛剃除。C) Detailed description of the invention: 1. Description of the method steps of the invention (1), pre-treatment (a) Take pig skins that are fresh and normal in appearance, without skin diseases and trauma, and clean and remove subcutaneous fat and muscle tissue. Fix it on the leather bed and cut off the long hair with electric scissors. (b) Scrub the surface of the raw pork skin with heptane, octane, or octane, and then shave the hair off with a razor blade.

(c )均勻喷灑含碘離子或含銀離子或四級銨 之液態制菌劑於豬皮表面上,再刮去表 面殘留之毛根。 (d )取皮前,於豬皮表面喷上7 5 % 酒精水溶(c) Spray the liquid bacteriostatic agent containing iodine ions or silver ions or quaternary ammonium uniformly on the surface of pig skin, and then scrape off the remaining hair roots on the surface. (d) Spray 75% alcohol-soluble water on the surface of pigskin before taking the skin

第6頁 1232112 _案號881Π733_年月日__ 五、發明說明(3) 液,待乾後,噴上已滅菌之液態石臘。 (2 )、取皮 (a )將取皮機(Z i ra m e r)之刻度盤調整為適當 厚度(8 / 1 Ο Ο 0〜3 Ο / 1 Ο Ο 0英吋)及寬度(2 〜4英对),進行取皮。 (b)取下豬皮先用無菌水沖洗至無血水為止 ,再浸泡於含(Κ Ο 1〜1 %wt次氯酸鈉 (NaCIO)水溶液或0. 1%〜5%wt雙氧水 (H202 ) 2 0〜1 2 0分鐘。以無菌水沖洗,至 豬皮無異味。Page 6 1232112 _Case No. 881Π733_ Year Month Date__ V. Description of the invention (3) Liquid, after drying, spray with sterilized liquid paraffin. (2) Take the skin (a) Adjust the scale of the skin picker (Z i ra mer) to an appropriate thickness (8/1 Ο Ο 0 ~ 3 Ο / 1 Ο Ο 0 inch) and width (2 to 4 British pair), to take the skin. (b) Remove the pigskin, rinse it with sterile water until it is bloodless, and soak it in a solution containing (Κ Ο 1〜1% wt sodium hypochlorite (NaCIO) or 0.1% ~ 5% wt hydrogen peroxide (H202) 2 0 ~ 120 minutes. Rinse with sterile water until the pigskin has no odor.

(3 )、包裝 將豬皮敷料浸於1 5 %甘油,2〜6小時。再將豬 皮敷料網狀面向下放置於無菌紗布上,將紗 布平整捲起,放置於已滅菌離心管内密封, 再用鈷6 0射線(2 5 K G y,3〜5小時)照射滅菌, 需置於-2 0〜-3 0 °C之冰箱中保存。 2、本發明方法所製得之生物敷料具以下的優點:(3) Packaging The pig skin dressing was immersed in 15% glycerol for 2 to 6 hours. The pigskin dressing was placed on the sterile gauze with the mesh facing down, rolled up flatly, placed in a sterilized centrifuge tube, sealed, and irradiated with cobalt 60 rays (2 5 KG y, 3 to 5 hours) for sterilization. Store in a refrigerator at -20 to -30 ° C. 2. The biological dressing prepared by the method of the present invention has the following advantages:

(1 )本發明方法所製得之豬皮敷料具結構完整之全 皮層,包含完整的角質層、上皮層及真皮層, 能降低水份、電解質及蛋白質的流失,並防止 外來細菌的侵入。 (2 )本發明方法所製得之豬皮敷料不殘留毛根,降 低傷口黏結現象,減輕病患疼痛。 (3 )本發明方法只用到少量藥劑,及大量之無菌水(1) The pig skin dressing prepared by the method of the present invention has a complete structural cortex, including a complete cuticle, epithelium and dermis, which can reduce the loss of water, electrolytes and proteins, and prevent the invasion of foreign bacteria. (2) The pigskin dressing prepared by the method of the present invention does not leave hair roots, reduces the phenomenon of wound adhesion, and reduces the pain of patients. (3) The method of the present invention uses only a small amount of medicine and a large amount of sterile water

第7頁 1232112 _案號88 Π 7733_年月曰 修正_ 五、發明說明(4) 沖洗,成品幾乎無藥劑殘留。 (4 )本發明所製成之生物敷料,天然結構未受傷害 ,可保持良好貼附性。 (5 )本發明方法製程簡單,可視醫療狀況,生產不 同厚度的豬皮敷料。 (6 )本發明屬於醫療器材中暫時性生物敷料之製作 方法,成品可用於燒、燙、創傷傷口包紮及覆 蓋。 (三)、圖式詳細說明 * 第一圖、原料豬皮全皮層組織結構切片圖。新鮮外觀正 常、無皮膚病及外傷之豬皮,經組織切片後,進行Η&Ε染 色之情形。此圖為組織切片放大20Χ時,可明顯看出豬皮 全皮層之完整結構,A :角質層;Β :上皮層;C :真皮層; I):脂肪層;E :毛囊組織。 第二圖、厚度0.01 6吋豬皮敷料全皮層組織結構切片圖。 經本發明之製造方法所得之新鮮豬皮敷料,經組織切片 後,進行H&E染色之情形。此圖為組織切片放大4 0X時,可 明顯看出豬皮敷料仍保留完整之全皮層結構,A :角質層; B ··上皮層;C :真皮層。 第三圖、厚度0 . 0 3 0吋豬皮敷料全皮層組織結構切片圖。 經本發明之製造方法所得之新鮮豬皮敷料,經組織切片 後,進行Η&E染色的情形。此圖為組織切片放大40X時,可 明顯看出豬皮敷料仍保留完整之全皮層結構,A :角質層;Page 7 1232112 _ Case No. 88 Π 7733_ Year Month Amendment _ V. Description of the invention (4) Rinse, the finished product has almost no drug residue. (4) The biological dressing made by the present invention has no damage to the natural structure and can maintain good adhesion. (5) The method of the present invention has a simple process and can produce pigskin dressings of different thicknesses depending on the medical conditions. (6) The present invention belongs to a method for manufacturing a temporary biological dressing in medical equipment. The finished product can be used for burns, burns, and wound dressing and covering. (3) Detailed description of the diagram * The first picture is a slice of the whole cortex tissue structure of raw pig skin. Pig skin with normal fresh appearance, without skin disease and trauma, was stained with Η & E after tissue sectioning. This picture shows the complete structure of the whole cortex of pig skin when the tissue section is enlarged by 20 ×, A: cuticle; B: epithelial layer; C: dermal layer; I): fat layer; E: hair follicle tissue. The second figure is a slice of the whole cortex tissue structure of 0.01 6 inch thick pigskin dressing. The fresh pig skin dressing obtained by the manufacturing method of the present invention is subjected to H & E staining after tissue sectioning. This picture shows that when the tissue section is enlarged at 40X, it can be clearly seen that the pigskin dressing still retains the complete full cortex structure, A: cuticle; B. epithelium; C: dermis. The third figure is a section of the whole cortex tissue structure of a pig skin dressing with a thickness of 0.030 inches. In the case where the fresh pigskin dressing obtained by the manufacturing method of the present invention is subjected to tissue slicing, Η & E staining is performed. This picture shows that when the tissue section is enlarged by 40X, it can be clearly seen that the pigskin dressing still retains the complete full cortex structure, A: cuticle;

1232112 _案號88117733_年月曰 修正_ 五、發明說明(5) B:上皮層;C:真皮層。 (四)、實施例· 首先將新鮮外觀正常、無皮膚病及外傷之豬皮原料5 其組織結構如圖一之切片圖所示。經前處理清洗乾淨,去 除多餘的脂肪及肌肉組織,固定於取皮床上,以電剪剪掉 長毛。以直鏈辛烷(C8H18)刷洗豬皮表面,溶去豬皮表面油 脂後,將使毛根豎立,再用刀片以先逆毛、順毛方向將皮 上的毛剃除。再喷灑P 〇 v i d ο n e I 〇 d i n e於豬皮上,以逆毛 、順毛方向刮去表面殘留之毛根。取皮前,先喷上7 5 % 酒 精水溶液,待乾後,喷上已滅菌之液態石臘。 將取皮機之刻度盤調整為〇 . 〇 1 6吋、寬4吋,進行取 皮。取下豬皮先用無菌水沖洗至無血水。再浸泡於 0. 0 5wt%次氯酸鈉(NaC 10)水溶液30分鐘,以去除豬皮的腥 味,而後再以無菌水沖洗,至豬皮無異味°圖二及圖三為 本發明所得之豬皮敷料之組織切片圖,由切片中可看出其 結構十分完整。 將豬皮敷料浸於1 5 %甘油,2〜6小時。再將豬皮敷料網 狀面向下放置於無菌紗布上,將紗布平整捲起,放置於已 滅菌之50 n]L離心管内密封,再用鈷60射線(25 KGy,3〜5小 時)照射滅菌。成品置於-2 0〜-3 0 °C之冰箱中保存。 本發明所製得之豬皮敷料不殘留藥劑、毛根,具結構 完整的全皮層,適合燒、烫及創傷傷口覆蓋及包紮使用。1232112 _ Case No. 88117733_ Year Month Amendment _ V. Description of the invention (5) B: epithelial layer; C: dermal layer. (IV) Example: Firstly, the fresh pig skin raw material 5 with normal appearance, no skin disease and trauma, and its tissue structure is shown in the section diagram of Fig. 1. After cleaning, remove excess fat and muscle tissue, fix it on the leather bed, and cut off long hair with electric scissors. Brush the surface of pigskin with straight chain octane (C8H18), after dissolving the grease on the surface of pigskin, the roots will be erected, and then the hairs on the skin will be shaved off with a razor in the direction opposite to the hair. Then spray P o v i d o n e I o o d i n e on the pigskin, scrape the hair roots on the surface in the direction of reverse hair and along the hair. Spray the 75% alcoholic alcohol solution before taking the skin. After drying, spray the sterilized liquid paraffin. Adjust the scale of the peeling machine to 0.016 inches and 4 inches wide for peeling. Remove the pigskin and rinse it with sterile water until it is bloodless. Soak in 0.05% by weight sodium hypochlorite (NaC 10) aqueous solution for 30 minutes to remove the fishy smell of pigskin, and then rinse with sterile water until the pigskin has no odor. Figure 2 and Figure 3 are pig skins obtained according to the present invention The tissue section of the dressing can be seen from the section and its structure is very complete. Soak the pigskin dressing in 15% glycerol for 2-6 hours. The pigskin dressing was placed on the sterile gauze with the mesh facing down, rolled up flatly, placed in a sterilized 50 n] L centrifuge tube, sealed, and irradiated with cobalt 60 rays (25 KGy, 3 ~ 5 hours) . The finished product is stored in a refrigerator at -20 to -30 ° C. The pig skin dressing prepared by the present invention does not have any residual medicine and hair roots, and has a complete skin layer with a complete structure, which is suitable for burn, burn, and wound wound covering and dressing.

1232112 案號 88117733 年_月 曰 修正 圖式簡单說明 第一圖、豬皮全皮層之完整結構。 第二圖、0. 0 1 6吋之豬皮敷料全皮層之詳細結構 第三圖、0 . 0 3 0吋之豬皮敷料全皮層之詳細結構 參1232112 Case No. 88117733 _ Month Revision Amendment of the drawing briefly The first picture, the complete structure of the entire cortex of pigskin. The second picture, the detailed structure of the whole skin layer of a pig skin dressing of 0.016 inches The third picture, the detailed structure of the whole skin layer of a pig skin dressing of 0.016 inches

第10頁Page 10

Claims (1)

1232112 /-l· ^ !,古参丨 案號 88Π773ί 年 月 申請專利範圍1232112 / -l · ^!, Gu Shen 丨 Case No. 88Π773ί Scope of patent application 一種新鮮豬皮敷料之製造方法,包括下列步騾: (1) 取新鮮外觀正常、無皮膚病及外傷之豬皮,經清洗 ,去除脂肪、月II肉组織及毛; (2) 以庚烷、辛烷或壬烷去除豬皮表面油脂後,將豎立 之毛揋众刃片剃除,再喷灑制菌劑於豬皮表靣,再 以刀片將殘餘之毛根副除; (3 )緒皮再經酒精消毒後,赁上液態石龎,以取皮機取 下所需靣積及厚度的表層豬皮,以無g水沖洗至無 血水 ;A method for manufacturing a fresh pig skin dressing, comprising the following steps: (1) taking fresh pig skin with normal appearance, without skin disease and trauma, and washing it to remove fat, moon II meat tissue and hair; (2) geng After removing the grease on the surface of pigskin with alkane, octane or nonane, shave the razor blades of upright hair, and then spray the bactericide on the surface of pig skin, and then remove the remaining hair root with a blade; (3) After the ulcer is sterilized with alcohol, it is rented with liquid stone trowel to remove the surface layer of pig skin with the required volume and thickness using a skin machine, and rinsed with g-free water to blood-free water; (4) 取下之豬皮浸泡於(KOI〜l%wt次氯酸鈉(NaCIO)水 溶液或0,1¾〜5%wt雙氧水(fi2 02 )中20〜120分鐘後, 再以無菌水沖洗至豬皮無異味; (5) 所得之豬皮敷斜再經無議包裝及鈷60射線照射滅g 呈.如專利申請範圍第]項之製造方法,其中之制議劑可為 含碘離子制菌劑,含銀離子制議劑或西級銨之液態制菌 ........... ' 一種由申請專利範圍第1項製法製得之豬皮敷料,其係 無毛根殘留並保持全皮層完整結構及無菌污染之豬皮敷 料。(4) Soak the removed pig skin in (KOI ~ 1% wt sodium hypochlorite (NaCIO) aqueous solution or 0,1¾ ~ 5% wt hydrogen peroxide (fi2 02) for 20 ~ 120 minutes, then rinse with sterile water until the pig skin is free. Peculiar smell; (5) the obtained pigskin is obliquely packaged and then irradiated with cobalt 60 rays to eliminate g. The manufacturing method such as the scope of the patent application] item, wherein the proposed agent may be an iodine-containing bacteriostatic agent, Liquid bactericidal preparation containing silver ion inhibitor or western ammonium ... '' A pigskin dressing made by the first method of patent application, which has no hairy roots and remains whole Cortical complete structure and sterile contaminated pigskin dressing. 第11頁Page 11
TW88117733A 1999-10-08 1999-10-08 Process of preparing porcine dressing TWI232112B (en)

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