本文選題：中藥海綿敷料 + 創(chuàng)面愈合�。� 參考：《南方醫(yī)科大學》2016年碩士論文

【摘要】：研究背景：由于人口老齡化加劇,交通運輸業(yè)迅速發(fā)展,車禍等創(chuàng)傷事故發(fā)生率不斷增加,使得皮膚傷口這一問題越來越成為世界范圍內(nèi)非常嚴重的健康問題與負擔。近年來,國內(nèi)外在傷口愈合方面也提出了很多新的治療理論、方法和技術(shù)。1974年誕生了全球第一塊密閉性敷料安舒妥,提出濕性愈合的理論,并逐漸被廣泛接受。近50年來,國內(nèi)大量關(guān)于創(chuàng)面的基礎(chǔ)研究和臨床治療證實了濕潤環(huán)境有利于傷口的愈合,新型保濕敷料也不斷進入醫(yī)療市場。但新型敷料存在功能單一、缺乏復合治療功能、制備工藝復雜、價格昂貴、市場普及慢等缺點,且國內(nèi)市場上的新型敷料主要來自歐美行業(yè)巨頭,本土企業(yè)的產(chǎn)品很少。中藥敷料在治療傷口修復方面獨具特色,能主動促進創(chuàng)面愈合,防止瘢痕增生,適合于各類急慢性傷口的治療護理,且來源簡單、安全、副作用小,費用不高,能提高傷口護理水平,降低醫(yī)療服務(wù)成本,提高醫(yī)院工作效率。然而,中藥敷料也存在不能維持密閉、微濕潤的環(huán)境、使用不便等不足,其安全性問題也一直備受關(guān)注。醫(yī)用敷料質(zhì)量的好壞直接關(guān)系到患者的生命安全,發(fā)達國家從20世紀60年代就開始對醫(yī)用敷料進行安全性監(jiān)測。1976年,美國食品藥物管理局(FDA)開始管理醫(yī)用敷料,并實行售前審批制度,建立了一系列生物和質(zhì)量評價標準。我國從70年代后期開始研究醫(yī)用敷料的生物學評價,中國醫(yī)療器械注冊的相關(guān)規(guī)定要求醫(yī)用敷料正式進入市場前,在完成加工性能、外形設(shè)計等程序后,必須對其進行物理和化學性能評價,生物學評價、制定產(chǎn)品質(zhì)量標準等,但是與發(fā)達國家相比還是有一定差距。如由于中藥敷料成分復雜,且制劑形式多樣,國家尚未建立統(tǒng)一化的中藥敷料評價標準,制約著其產(chǎn)業(yè)化發(fā)展。因此,中藥敷料的研究存在一些不足,研發(fā)體系存在著缺陷,需要進一步完善。本課題組在總結(jié)中草藥和民間廣為流傳使用的傷科驗方基礎(chǔ)上,依據(jù)中藥組方原則,選取功效不同的中草藥創(chuàng)制出傷科驗方“三七復方”。全驗方由三七、紫珠草、白芨、兒茶、雞矢藤、兩面針、虎杖等9味中草藥組成,具有良好的止血、抗菌、消腫、鎮(zhèn)痛等作用,但原劑型存在使用不便、容易污染傷口等不足。本課題組己對該傷科驗方進行改革,將該中藥傷科驗方的特色與新型保濕敷料的優(yōu)勢結(jié)合起來,研制開發(fā)出一種能夠提供一個濕性愈合的環(huán)境,快速吸收滲出液,促進肉芽生長,減少感染,主動促進創(chuàng)面愈合的中藥復合海綿敷料,即三紫創(chuàng)愈海綿敷料,適用于各類機械性或創(chuàng)傷性傷口、慢性感染傷口、糖尿病足潰瘍等急慢性傷口。然而,其安全性和藥效有待證實,質(zhì)量有待評價。為此,我們對三紫創(chuàng)愈海綿敷料進行藥效學和質(zhì)量分析研究,確保海綿敷料安全有效、穩(wěn)定可控,為醫(yī)用敷料的注冊審批提供重要科研資料,為進一步擴大生產(chǎn)提供科學的依據(jù)。研究目的：1.驗證三紫創(chuàng)愈海綿敷料對大鼠創(chuàng)面修復的影響,探討其治療機理。2.評價三紫創(chuàng)愈海綿敷料的物理性能。3.鑒別三紫創(chuàng)愈海綿敷料中藥材三七、虎杖。研究方法：1.三紫創(chuàng)愈海綿敷料的藥效學研究本研究采用大鼠背部小面積皮膚切除傷模型,將大鼠隨機分為3組,陰性對照組10只,陽性對照組10只,實驗組10只。大鼠取俯臥位,脫去大鼠背部毛發(fā),用3%的戊巴比妥鈉腹腔注射麻醉,碘伏及70%乙醇常規(guī)消毒皮膚后,用利刀于大鼠背部左右對稱制作2個直徑為2cm的圓形全層缺損創(chuàng)面,醋酸洗必泰溶液充分清洗消毒創(chuàng)面。實驗組用自制的三紫創(chuàng)愈海綿敷料覆蓋創(chuàng)面,陽性對照組用空白海綿基質(zhì)覆蓋創(chuàng)面,陰性對照組用凡士林紗布覆蓋創(chuàng)面,三組外層均用無菌紗布敷料包扎。前三天每日換藥一次,三天后隔一天換藥,一周后隔兩天換藥。每次換藥時,觀察三組大鼠性情和行為等生活情況以及創(chuàng)面大體情況,包括精神狀況、攝食及飲水情況、活動情況、創(chuàng)面滲出、出血、感染跡象、肉芽組織生長情況,并選定創(chuàng)面面積、炎癥積分、病理學情況作為修復指標。治療后第3d、7d、14d,數(shù)碼相機拍照,利用Image J軟件測定刻度尺像素比例,測出創(chuàng)面面積,計算創(chuàng)面愈合率；治療后第3d、7d測創(chuàng)面炎癥積分,計算炎癥積分值并進行統(tǒng)計學分析；于治療后第3d、7d、14d隨機抽取6只大鼠(每組2只)過量麻醉處死,立即切取創(chuàng)面皮膚,4%的多聚甲酵固定,用H.E染色,觀察炎細胞浸潤及壞死、纖維細胞及毛細血管增生、膠原纖維等情況,進行形態(tài)學描述。2.三紫創(chuàng)愈海綿敷料的質(zhì)量研究本研究應(yīng)用文獻回顧的方法,參照《中國藥典》2010版的相關(guān)要求及中國醫(yī)療器械注冊的相關(guān)規(guī)定標準,咨詢中藥制劑學、護理學的臨床及教學一線專家,采用薄層色譜法對三紫創(chuàng)愈海綿敷料進行定性鑒別,鑒別海綿敷料中人參皂苷Rb1、人參皂苷Rg1、虎杖苷。將對照品溶液、供試品溶液、陰性溶液點于同一薄層板上,在展開容器內(nèi)用展開劑展開,使試樣溶液所含成分分離,所得色譜圖進行對比,進行制劑的鑒別。同時選取透氣率、吸水率、保濕性、抗撕強度、重量差異、耐熱性、耐寒性等7個指標作為海綿敷料的評價指標。為了驗證工藝條件合理性,進行了三批三紫創(chuàng)愈海綿敷料的研究。研究結(jié)果：1.大鼠飲食和活動情況麻醉清醒后,各組大鼠均精神不佳,無任何主動活動及飲食；治療后第3d,實驗組和陽性對照組大鼠精神狀態(tài)、主動活動、飲食均接近正常,陰性對照組有少量活動及飲食,精神狀態(tài)好轉(zhuǎn)；治療后第7d、14d組各大鼠精神狀態(tài)、主動活動、飲食均正常,組間無明顯差別。各組均未見實驗性的大鼠死亡。2.大鼠傷口愈合情況創(chuàng)面愈合率比較,治療后第3天,實驗組創(chuàng)面愈合率為(40.22±0.05)%,陽性對照組創(chuàng)面愈合率為(38.33±0.1)%,高于陰性對照組創(chuàng)面愈合率(22.02±0.03)%,比較有顯著性差異(P0.05)；治療后第7天,實驗組創(chuàng)面愈合率為(71.32±0.08)%,高于陽性對照組創(chuàng)面愈合率(60.66±0.09)%和陰性對照組創(chuàng)面愈合率(50.01±0.10)%,比較有顯著性差異(P0.05)；治療后第14天,實驗組創(chuàng)面愈合率為(90.44±0.07)%,高于陽性對照組創(chuàng)面愈合率(81.03±0.04)%和陰性對照組創(chuàng)面愈合率(71.65±0.10)%,比較有顯著性差異(P0.05)。三紫創(chuàng)愈海綿敷料能縮小創(chuàng)面面積,縮短創(chuàng)面的愈合時間,提高創(chuàng)面愈合率。病理學觀察,與對照組相比,治療后第3d,實驗組較早出現(xiàn)毛細血管,成纖維細胞開始增殖。治療后第7d,實驗照組創(chuàng)面纖維增生明顯,膠原纖維明顯多于對照組。治療后第14d,與對照組相比實驗組膠原纖維增生明顯,與術(shù)后第7d相比沒有明顯改變,傷口未見異物組織,沒有組織破壞和壞死現(xiàn)象。三紫創(chuàng)愈海綿敷料能促進毛細血管和膠原纖維的生長。炎癥積分比較,治療后第3天,實驗組創(chuàng)面炎癥積分為(3.20±0.42)分,低于陽性對照組創(chuàng)面炎癥積分(4.18±0.60)分和陰性對照組創(chuàng)面炎癥積分(5.67±0.50)分,比較有顯著性差異(P0.05)；治療后第7天,實驗組創(chuàng)面炎癥積分為(1.70±0.48)分,低于陽性對照組創(chuàng)面炎癥積分(2.55±0.52)分和陰性對照組創(chuàng)面炎癥積分(3.89±0.33)分,比較有顯著性差異(P0.05)。三紫創(chuàng)愈海綿敷料能減少創(chuàng)面滲液的過多分泌。3.三紫創(chuàng)愈海綿敷料的質(zhì)量評價實驗結(jié)果顯示三紫創(chuàng)愈海綿敷料的平均透氣率為80.86%,故本品透氣率暫定為不低于78%；平均保濕率為38.11%,保濕率暫定為不低于35%；平均吸水率為11.15倍,吸水率暫定為不低于10倍；平均抗撕強度為131.59g/cm3,抗撕強度標準暫定為不小于130g/cm3；最大片重差異為3.5%,最小片重差異為3.4%,重量差異限度在平均重量的±5%以內(nèi),符合藥典評價標準。于冰箱中貯存后,敷料未見明顯分層現(xiàn)象；放置烘箱后,敷料表面無滲油現(xiàn)象,有光澤。三紫創(chuàng)愈海綿敷料具有良好的透氣率、吸水率和保濕性,耐熱、耐寒、賦形性良好,抗撕強度高,重量差異差別小。薄層色譜鑒別三紫創(chuàng)愈海綿敷料中三七及虎杖的分離度好,樣品色譜中,在與對照品色譜相應(yīng)的位置上有相同顏色的斑點,且陰性無干擾。結(jié)論：1.通過對三紫創(chuàng)愈海綿敷料主要藥效學的研究表明,三紫創(chuàng)愈海綿敷料具有快速止血、抗炎抑菌、活血化瘀等作用,能吸收傷口過多的滲出物,防止感染,為創(chuàng)面愈合創(chuàng)造良好的微環(huán)境,促進創(chuàng)面血管新生,促進肉芽組織生長,加速創(chuàng)面的愈合,并能減少瘢痕的產(chǎn)生,減少后遺癥,降低死亡率。三紫創(chuàng)愈海綿敷料作為創(chuàng)面敷料具有安全可靠性。2.三紫創(chuàng)愈海綿敷料具有良好的透氣率、吸水率和保濕性,耐熱、耐寒性良好,抗撕強度高,重量差異限度在5%的標準范圍內(nèi)。薄層色譜法鑒別人參皂苷Rg1、人參皂苷Rb1、虎杖苷,操作方法簡便、快捷、準確、可靠、重復性好,可以作為三紫創(chuàng)愈海綿敷料的定性鑒別方法,為后期產(chǎn)品敷料產(chǎn)業(yè)化擴大生產(chǎn)提供了實驗依據(jù)。
[Abstract]:Background: as the aging of the population, the rapid development of traffic and transportation, and the increasing incidence of accidents, such as traffic accidents, the problem of skin wound has become a very serious health problem and burden in the world. In recent years, many new theories, methods and methods have been put forward in the field of wound healing at home and abroad. Technology.1974 was born in.1974, the first closed dressing in the world, and put forward the theory of wet healing and was gradually accepted. In the past 50 years, a large number of basic research and clinical treatment of the wound have proved that the moist environment is beneficial to the healing of the wound, and the new moisturizing dressing has also entered the medical market. However, the new dressing has a good work. Single, lack of compound treatment function, complex preparation process, high price, slow market popularization, and the new dressings on the domestic market are mainly from the European and American industry giants, and the local enterprises have few products. The traditional Chinese medicine dressing has the unique features in the treatment of wound repair. It can actively promote wound healing and prevent scar hyperplasia, suitable for various kinds of wound. The treatment and nursing of acute and chronic wounds, with simple sources, safety, small side effects and low cost, can improve the level of wound care, reduce the cost of medical service and improve the efficiency of hospital work. However, the traditional Chinese medicine dressings have also been unable to maintain the closed, micro humid environment and use inadequacy, and the safety problems have been paid much attention to. The quality is directly related to the safety of the patient's life. The developed countries began to monitor the safety of medical dressings in 1960s for.1976 years. The US Food and Drug Administration (FDA) began to manage medical dressings and implemented the pre sale examination and approval system, and established a series of raw materials and quality evaluation standards. China began in the late 70s. The biological evaluation of medical dressings is studied. The relevant regulations of medical instruments registration in China require medical dressings to enter the market formally. After completing the processing performance and shape design procedures, the medical dressings must be evaluated in physical and chemical properties, biological evaluation, and product quality standards, but there is still a certain difference compared with the developed countries. For example, because of the complex composition of traditional Chinese medicine dressing and the variety of preparation forms, the country has not established a unified standard for evaluation of traditional Chinese medicine dressing, which restricts the development of its industrialization. Therefore, there are some deficiencies in the research of traditional Chinese medicine dressings. There are defects in the R & D system and need further improvement. On the basis of Department of Traumatology test, according to the principle of prescription of traditional Chinese medicine, select the Chinese herbal medicine of different efficacy of Chinese herbal medicine "37 compound". The whole prescription is composed of 9 herbs, including 37, the herb, the Bletilla striata, the catechu, the chicken Yato, the two needles and the Polygonum cuspidatum, which have good hemostatic, antibacterial, swelling and analgesic effects, but the original dosage forms are inconvenient and easy to use We have made a reform in this department of Traumatology, combined the characteristics of the Department of Traumatology laboratory prescription with the advantages of the new moisturizing dressing, and developed a kind of traditional Chinese medicine that can provide a wet healing environment, quickly absorb exudative fluid, promote the growth of granulation, reduce infection and promote wound healing. Sponge dressing, which is three purple wound healing sponges, is suitable for all kinds of mechanical or traumatic wounds, chronic infection wounds, diabetic foot ulcers and other acute and chronic wounds. However, its safety and efficacy need to be confirmed and the quality needs to be evaluated. Therefore, we study the pharmacodynamics and quality analysis of three purple healing sponge compress to ensure the sponge dressing. It is safe, effective, stable and controllable to provide important scientific data for the registration and approval of medical dressings, and provide scientific basis for further expansion of production. 1. the purpose of this study is to verify the effect of three purple wound healing sponges on the wound healing of rats, and to explore the therapeutic mechanism of.2. for the evaluation of the physical properties of the three purple healing sponges for the identification of the three purple Chuang Yu sea. Chinese herbal medicine 37, Radix Polygonum cuspidatum. Research methods: 1. three the pharmacodynamic study of three purple healing sponges. This study adopted a small area skin excision model on the back of rats. The rats were randomly divided into 3 groups, 10 negative control group, 10 positive control group and 10 experimental group. The rats were prone position, removed the back hair of rats, and 3% pentobarbital sodium. After intraperitoneal injection of anaesthesia, iodophor and 70% ethanol in the routine disinfection of the skin, 2 round full layer defect wounds with diameter of 2cm were made with a sharp knife on the back of the rat, and the surface of the wound was fully cleaned by chlorhexidine acetate solution. The experimental group covered the wound with a self-made three purple healing spongy dressing, and the positive control group covered the wound with a blank sponge matrix. The negative control group covered the wound with vaseline gauze. The outer layer of the three groups was bandaged with sterile gauze dressing. The first three days, the medicine was changed one day, after three days, the medicine was changed one day, and the other two days after the other was changed. Every change of medicine, the sex and behavior of the three groups of rats and the large body condition, including mental condition, feeding and drinking water, were observed. Activities, wound exudation, bleeding, infection signs, granulation tissue growth, and selected wound area, inflammation integral, pathological condition as repair index. After treatment, 3D, 7d, 14d, digital camera were photographed, Image J software was used to measure scale pixel ratio, surface area of wound surface was measured, wound healing rate was calculated, and 3D, 7d measurement of wound surface after treatment. After the treatment, 6 rats (2 rats in each group) were randomly selected to die at 3D, 7d, and 14d after the treatment. The wound skin was immediately cut and 4% of the polymethylene was fixed. H.E staining was used to observe the infiltration and necrosis of the inflammatory cells, fibrous cells and capillary hyperplasia, collagen fibers and other conditions. Study on the quality of.2. three purple Chuang Yu sponge dressing, the method of literature review, reference to the related requirements of Chinese Pharmacopoeia >2010 and the relevant standards of Chinese medical instruments registration, consulting Chinese medicine preparation, nursing clinical and teaching frontline experts, using TLC to determine three purple healing sponges. Identifying the ginsenoside Rb1, ginsenoside Rg1 and polygonin in the spongy dressing, the control solution, the test solution, the negative solution on the same thin plate, the expansion agent in the unfolding container, the component of the sample solution separated, the chromatogram comparison, the identification of the preparation, and the selection of air permeability and water absorption. 7 indexes such as moisture, tear strength, weight difference, heat resistance and cold resistance were used as evaluation indexes of sponge dressing. In order to verify the rationality of the process conditions, three batches of three purple wound dressing were studied. The results were as follows: after the diet and activity situation of the 1. rats were awake, the rats in each group were inactive, without any active activity and Diet: the mental state of the rats in 3D, the experimental group and the positive control group, the active activity, the diet were all close to normal, the negative control group had a small amount of activity and diet, and the mental state was improved. After treatment, the mental state, active activity and diet were normal in group 7d and 14d, and there was no significant difference between the groups. No experimental rats were dead. The healing rate of wound healing in.2. rats was compared. The wound healing rate in the experimental group was (40.22 + 0.05)% after treatment and the wound healing rate in the positive control group was (38.33 + 0.1)%, which was higher than that of the negative control group (22.02 + 0.03)% (22.02 + 0.03), with a significant difference (P0.05), and the wound healing rate of the experimental group was (71.32 + 0.08)% after the treatment at the seventh day after treatment. The wound healing rate (60.66 + 0.09)% and the negative control group were (50.01 + 0.10)%, compared with the negative control group (P0.05). The wound healing rate in the experimental group was (90.44 + 0.07)% after fourteenth days after treatment, which was higher than that in the positive control group (81.03 + 0.04)% and the negative control group (71.65 + 0.10)%, compared with the negative control group (71.65 + 0.10)%. Significant difference (P0.05). Three purple wound healing sponger dressing can reduce wound area, shorten the wound healing time, improve wound healing rate. Pathological observation, compared with the control group, after treatment 3D, the experimental group earlier appeared capillary, fibroblasts began to proliferate. After treatment, 7d, experimental group of wound fiber hyperplasia, collagen fiber bright More than the control group. After treatment, 14d, compared with the control group, the collagen fibers proliferated obviously, and there was no significant change compared with the postoperative 7d. No tissue, tissue destruction and necrosis were not found in the wound. Three purple wound healing sponger dressing could promote the growth of capillary and collagen fibers. The score of inflammation was compared, and the experiment was third days after treatment. The score of inflammation in the wound of the group was (3.20 + 0.42), which was lower than that of the positive control group (4.18 + 0.60) and the score of inflammation (5.67 + 0.50) in the negative control group (5.67 + 0.50). The score of the wound inflammation in the experimental group was (1.70 + 0.48) after seventh days after the treatment, which was lower than that of the positive control group (2.55 + 0.52). The score of wound inflammation (3.89 + 0.33) in the negative control group was 3.89 + 0.33, and there was a significant difference (P0.05). The experimental results showed that the average air permeability of three purple wound dressing was 80.86%, so the permeability rate of this product was not less than 78%. The average moisture retention rate is 38.11%, the moisture retention rate is not less than 35%, the average water absorption rate is 11.15 times, the water absorption rate is not less than 10 times, the average anti tearing strength is 131.59g/cm3, the tearing strength standard is not less than less than 130g/cm3, the maximum slice weight difference is 3.5%, the minimum slice weight difference is 3.4%, the weight difference limit is within the average weight of + 5%, According to the standard of Pharmacopoeia evaluation. After storage in the refrigerator, there is no obvious stratification in the dressing. After placing the oven, the surface of the dressings has no seepage and luster. The three purple wound dressing has good air permeability, water absorption and moisture retention, heat resistance, cold resistance, good shape, high tear strength, and small difference in weight difference. TLC identification of three purple The separation degree of 37 and the Polygonum cuspidatum was good in Chuang Yue sponge dressing. In the sample chromatography, there was the same color spot in the corresponding position of the control substance and negative and no interference. Conclusion: 1. through the study of the main pharmacodynamics of three purple healing sponges, the three purple wound healing spongy compress has rapid hemostasis, anti-inflammatory and bacteriostasis, blood activating and removing stasis. It can absorb the excessive exudation of the wound, prevent the infection, create a good microenvironment for the wound healing, promote the angiogenesis of the wound, promote the growth of the granulation tissue, accelerate the healing of the wound, reduce the production of scar, reduce the sequelae and reduce the death rate. The three purple wound healing sponger dressing has the safety and reliability of the wound dressing with the safety and reliability of three purple. Chuang Yu sponge dressing has good air permeability, water absorption and moisture retention, good heat resistance, good cold resistance, high tearing strength and weight difference limit in the standard range of 5%. TLC identification of ginsenoside Rg1, ginsenoside Rb1 and Polygonum Polygonum are simple, quick, accurate, reliable, reproducible, and can be used as three purple healing sponges. The qualitative identification method provides an experimental basis for the industrialization of the product dressings and the expansion of production in the later stage.
【學位授予單位】：南方醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2016
【分類號】：R285

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