背景:RT-Q膜为乳酸-透明质酸新型共聚物,其既有透明质酸的多种生物功能、良好的柔韧性、生物相容性,又具有聚乳酸的易加工性及遇水成膜性.目的:考察RT-Q膜对颈外静脉出血大鼠模型的止血效果,评估在肌肉组织局部使用后的组织相容性.设计:随机对照动物实验. 单位:四川大学华西药学院药理教研室,生药教研室. 材料:选用雄性Wistar大鼠130只,鼠龄6周,体质量170~210 g.其中80只用于止血效果的评价,另外50只用于生物相容性实验.实验过程中对动物的处置符合动物伦理学标准.实验目的物成分为DL-乳酸-透明质酸、α-氰基丙烯酸酯、丙酮(溶剂)、氟利昂(抛射剂)的RT-Q气雾剂和成分为丙酮与氟利昂(抛射剂)的附加剂气雾剂均由四川大学华西药学院药剂教研室提供(批号均为20050311).α-氰基丙烯酸酯医用胶由北京瞬康医用胶科技发展有限公司生产(批号20050930).方法:①止血实验:随机将80只大鼠分为4组:RT-Q膜组、氰基丙烯酸酯胶组、附加剂组及阴性对照组,每组20只.动物麻醉后于分离的一侧颈外静脉剪一约0.6 cm切口使其出血,并立即以消毒纱布擦拭创面,纱布移开瞬间迅速喷RT-Q气雾剂1次,或附加剂气雾剂1次,或α-氰基丙烯酸酯医用胶0.15 mL,而后覆上纱布,阴性对照组则擦拭创面后直接覆上纱布让其自然止血,记录止血时间,计算出血量(止血后纱布重量-使用前重量).②局部组织相容性实验:随机将大鼠50只大鼠分为A、B两组.A组30只,采用同体左右侧自身对比法,即麻醉大鼠并行后肢外侧肌肉横切术,拉开肌层,左侧喷附加剂气雾剂1次,右侧喷RT-Q膜气雾剂1次.B组20只,在两后肢外侧造成与A组相同的伤口,不给药.分别于术后1~7,15,23,30 d,取创口处标本,苏木精-伊红染色,光镜下做病理组织学检查.观察膜对伤口愈合的影响、自身降解情况及对周围组织是否产生毒性反应.主要观察指标: 止血实验:止血时间, 出血量;局部组织相容性实验:伤口愈合, 生物降解, 对周围组织的毒性. 结果: 大鼠130只均进入结果分析. RT-Q膜的局部组织相容性:病理组织学检查结果显示,RT-Q膜对伤口愈合既无促进也无延迟性影响,形成的膜于术后15 d开始降解,三四周完全吸收,对周围组织无毒性影响.RT-Q膜的局部止血作用:RT-Q膜组应用后的止血时间和出血量比阴性对照组和附加剂组明显减少(P < 0.01),RT-Q膜组与瞬康医用胶组间比较,差异无显著性意义 (P > 0.05). 结论:RT-Q医用生物膜的局部止血效果显著,与α-氰基丙烯酸酯医用胶相当;同时具有局部组织相容性好的特点.
揹景:RT-Q膜為乳痠-透明質痠新型共聚物,其既有透明質痠的多種生物功能、良好的柔韌性、生物相容性,又具有聚乳痠的易加工性及遇水成膜性.目的:攷察RT-Q膜對頸外靜脈齣血大鼠模型的止血效果,評估在肌肉組織跼部使用後的組織相容性.設計:隨機對照動物實驗. 單位:四川大學華西藥學院藥理教研室,生藥教研室. 材料:選用雄性Wistar大鼠130隻,鼠齡6週,體質量170~210 g.其中80隻用于止血效果的評價,另外50隻用于生物相容性實驗.實驗過程中對動物的處置符閤動物倫理學標準.實驗目的物成分為DL-乳痠-透明質痠、α-氰基丙烯痠酯、丙酮(溶劑)、氟利昂(拋射劑)的RT-Q氣霧劑和成分為丙酮與氟利昂(拋射劑)的附加劑氣霧劑均由四川大學華西藥學院藥劑教研室提供(批號均為20050311).α-氰基丙烯痠酯醫用膠由北京瞬康醫用膠科技髮展有限公司生產(批號20050930).方法:①止血實驗:隨機將80隻大鼠分為4組:RT-Q膜組、氰基丙烯痠酯膠組、附加劑組及陰性對照組,每組20隻.動物痳醉後于分離的一側頸外靜脈剪一約0.6 cm切口使其齣血,併立即以消毒紗佈抆拭創麵,紗佈移開瞬間迅速噴RT-Q氣霧劑1次,或附加劑氣霧劑1次,或α-氰基丙烯痠酯醫用膠0.15 mL,而後覆上紗佈,陰性對照組則抆拭創麵後直接覆上紗佈讓其自然止血,記錄止血時間,計算齣血量(止血後紗佈重量-使用前重量).②跼部組織相容性實驗:隨機將大鼠50隻大鼠分為A、B兩組.A組30隻,採用同體左右側自身對比法,即痳醉大鼠併行後肢外側肌肉橫切術,拉開肌層,左側噴附加劑氣霧劑1次,右側噴RT-Q膜氣霧劑1次.B組20隻,在兩後肢外側造成與A組相同的傷口,不給藥.分彆于術後1~7,15,23,30 d,取創口處標本,囌木精-伊紅染色,光鏡下做病理組織學檢查.觀察膜對傷口愈閤的影響、自身降解情況及對週圍組織是否產生毒性反應.主要觀察指標: 止血實驗:止血時間, 齣血量;跼部組織相容性實驗:傷口愈閤, 生物降解, 對週圍組織的毒性. 結果: 大鼠130隻均進入結果分析. RT-Q膜的跼部組織相容性:病理組織學檢查結果顯示,RT-Q膜對傷口愈閤既無促進也無延遲性影響,形成的膜于術後15 d開始降解,三四週完全吸收,對週圍組織無毒性影響.RT-Q膜的跼部止血作用:RT-Q膜組應用後的止血時間和齣血量比陰性對照組和附加劑組明顯減少(P < 0.01),RT-Q膜組與瞬康醫用膠組間比較,差異無顯著性意義 (P > 0.05). 結論:RT-Q醫用生物膜的跼部止血效果顯著,與α-氰基丙烯痠酯醫用膠相噹;同時具有跼部組織相容性好的特點.
배경:RT-Q막위유산-투명질산신형공취물,기기유투명질산적다충생물공능、량호적유인성、생물상용성,우구유취유산적역가공성급우수성막성.목적:고찰RT-Q막대경외정맥출혈대서모형적지혈효과,평고재기육조직국부사용후적조직상용성.설계:수궤대조동물실험. 단위:사천대학화서약학원약리교연실,생약교연실. 재료:선용웅성Wistar대서130지,서령6주,체질량170~210 g.기중80지용우지혈효과적평개,령외50지용우생물상용성실험.실험과정중대동물적처치부합동물윤리학표준.실험목적물성분위DL-유산-투명질산、α-청기병희산지、병동(용제)、불리앙(포사제)적RT-Q기무제화성분위병동여불리앙(포사제)적부가제기무제균유사천대학화서약학원약제교연실제공(비호균위20050311).α-청기병희산지의용효유북경순강의용효과기발전유한공사생산(비호20050930).방법:①지혈실험:수궤장80지대서분위4조:RT-Q막조、청기병희산지효조、부가제조급음성대조조,매조20지.동물마취후우분리적일측경외정맥전일약0.6 cm절구사기출혈,병립즉이소독사포찰식창면,사포이개순간신속분RT-Q기무제1차,혹부가제기무제1차,혹α-청기병희산지의용효0.15 mL,이후복상사포,음성대조조칙찰식창면후직접복상사포양기자연지혈,기록지혈시간,계산출혈량(지혈후사포중량-사용전중량).②국부조직상용성실험:수궤장대서50지대서분위A、B량조.A조30지,채용동체좌우측자신대비법,즉마취대서병행후지외측기육횡절술,랍개기층,좌측분부가제기무제1차,우측분RT-Q막기무제1차.B조20지,재량후지외측조성여A조상동적상구,불급약.분별우술후1~7,15,23,30 d,취창구처표본,소목정-이홍염색,광경하주병리조직학검사.관찰막대상구유합적영향、자신강해정황급대주위조직시부산생독성반응.주요관찰지표: 지혈실험:지혈시간, 출혈량;국부조직상용성실험:상구유합, 생물강해, 대주위조직적독성. 결과: 대서130지균진입결과분석. RT-Q막적국부조직상용성:병리조직학검사결과현시,RT-Q막대상구유합기무촉진야무연지성영향,형성적막우술후15 d개시강해,삼사주완전흡수,대주위조직무독성영향.RT-Q막적국부지혈작용:RT-Q막조응용후적지혈시간화출혈량비음성대조조화부가제조명현감소(P < 0.01),RT-Q막조여순강의용효조간비교,차이무현저성의의 (P > 0.05). 결론:RT-Q의용생물막적국부지혈효과현저,여α-청기병희산지의용효상당;동시구유국부조직상용성호적특점.
BACKGROUND: RT-Q medical biomembrane, the novel copolymer synthesized from lactic acid and hyaluronic acid, not only possesses the advantages of hyaluronic acid, such as multiple biological functions, excellent flexibility and biocompatibility, but also has the merits of polylactic acid fragments to be easily processed and transformed to membrane when encountering water. OBJECTIVE: To investigate the hemostatic effect of RT-Q medical biomembrane in rat external jugular vein hemorrhage model, and to evaluate its histocompatibility by locally applying it to rat muscle. DESIGN: Randomized controlled animal trial.SETTING: Department of Pharmacology, Department of Pharmacognosy, West China School of Pharmacy, Sichuan University.MATERIALS: 130 male Wistar rats aged 6 weeks, weighing 170-210 g, were selected. Eighty rats were used for evaluation of hemostatic effect, and the other fifty were used in biocompatibility experiment. Animal intervention met the animal ethical standard. RT-Q aerosol composed of DL-lactic acid and hyaluronic acid, α-cyanoacrylate, acetone (solvent), freon (propellant) and excipient aerosol composed of acetone and freon (propellant) (Batch number 20050311) were provided by Department of Pharmaceutics, West China School of Pharmacy, Sichuan University.α-cyanoacrylate medical adhesive(SUNCON medical adhesive) (Batch number 20050930) was produced by Beijing Suncon Medical Adhesive Science and Technology Development Co., Ltd. METHODS: Haemostatic effect: Eighty male rats were randomly divided into four groups, served as RT-Q, SUNCON (positive control), excipient group and non-treatment group (negative control), twenty in each group. After anesthesia was induced, external jugular vein of rats was exposed, and an approximately 0.6 cm incision was made to create hemorrhage. The bleeding areas were blotted by antiseptic gauze. After removing the gauze, the bleeding surfaces were immediately treated with RT-Q aerosol in the RT-Q group, excipient aerosol in the excipient group, 0.15 mL SUNCON medical adhesive in the SUNCON group, or no agent in non-treatment group, respectively. Then, injury surfaces were covered by gauze. In the non-treatment group, bleeding was left to naturally stop. Bleeding time and blood loss (gauze weight after hemostasia - that before hemostasia) were determined. Local histocompatibility: Rats were divided into A and B groups. Incision was made in rat post-leg muscle after anesthesia was induced. Left bleeding surfaces were treated with excipient aerosol, and right bleeding surfaces were treated with RT-Q aerosol in group A (n=30). The same incision as the group A was made, but no intervention was performed in the group B (n=20). Tissues were possessed and HE-stained for pathological observation under light microscope at days 1, 2, 3, 4, 5, 6, 7, 15, 23, 30 after the surgery. Effect of biomembrane on wound healing, degradation and toxicity to tissues surrounding injuries were observed. MAIN OUTCOME MEASURES: Bleeding time and blood loss in hemostatic experiment; wound healing, biodegradation and toxicity to tissues surrounding injuries in local histocompatibility experiment. RESULTS: 130 rats were involved in the result analysis. Histopathologic examination showed RT-Q membrane had no effect of promoting or delaying wound healing. Membrane formed by RT-Q aerosol began to degrade on the 15th day, absorbed completely during 3-4 weeks, and had no toxicity to surrounding tissues. Bleeding time and blood loss were reduced in the RT-Q group than in the non-treatment group and the excipient group (P < 0.01). There was no significant difference between the RT-Q group and the SUNCON group (P > 0.05).CONCLUSION: RT-Q medical biomembrane as α-cyanoacrylate medical adhesive has significant hemostatic effects on topical bleeding, and possesses good histocompatibility.
