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題 名 | 快得寧水分散性粒劑對天竺鼠皮膚過敏反應之評估=Evaluation of Dermal Sensitization of Oxine Copper in Guinea Pigs |
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作 者 | 吳偉嘉; 楊俊宏; 黃振聲; 蔡三福; | 書刊名 | 植物保護學會會刊 |
卷 期 | 49:2 2007.06[民96.06] |
頁 次 | 頁153-165 |
分類號 | 433.85 |
關鍵詞 | 快得寧水分散性粒劑; 皮膚過敏性; 天竺鼠; Oxine copper; Dermal sensitization; Guinea pig; |
語 文 | 中文(Chinese) |
中文摘要 | 對於各種新配製或新合成藥劑進行皮膚過敏性安全評估,是保障藥劑操作者或使用者安全之重要參考資料。因此本試驗以國際公認之Buehler Test皮膚貼覆測試方法,評估由國內自行配製之80%快得寧(oxine-copper)水分散性粒劑(W.G., water dispersible granule)對天竺鼠之皮膚過敏反應,實驗分為實驗1與實驗2。實驗1目的為篩選及確認藥劑的刺激濃度後進行實驗2。實驗2以未稀釋之80%快得寧水分散性粒劑分別於第1、2及3週進行致敏試驗、第4週為停藥期、第5及第6週進行激發試驗。試驗並以2,4-二硝基氯苯(2,4-dinitro-1-chlorobenzene, DNCB)為陽性藥劑。試驗分析項目包括皮膚紅腫程度、血液學、血清生化分析及病理組織判讀。試驗顯示由國內自行配製之快得寧水分散性粒劑於各週藥劑處理後第24及48小時之結果,對天竺鼠左腰窩部皮膚並無明顯紅腫反應。而DNCB陽性藥劑處理後皮膚出現中至強度之紅斑及浮腫並於48小時後形成痂皮等皮膚病變。血液學檢查於處理快得寧水分散性粒劑後對天竺鼠之紅血球總數、血球容積比及血色素等與對照組相較無明顯差異(P>0.05)。且白血球分類計數(WBC differential count)亦顯示,快得寧水分散性粒劑對天竺鼠之淋巴球、嗜中性球及嗜伊紅性球等比例上與對照相較亦無明顯差異(P>0.05)。但DNCB藥劑處理組則對天竺鼠之淋巴球比例上與對照相較有明顯上升趨勢。血清生化檢測顯示,快得寧水分散性粒劑及DNCB處理組對天竺鼠之鹼性磷酸酶(alkaline phosphatase, ALP)、丙胺酸轉胺酶(alanine aminotransferase, ALT)、天門冬安酸轉胺酶(aspartate aminotransferase, AST)、總膽紅素(total bilirubin)、血中尿素氮(blood urea nitrogen, BUN)、膽固醇(cholesterol)、總蛋白(total protein)及鈣離子(calcium)等與對照相較均無顯著性差異。組織病理觀察結果,顯示快得寧水分散性粒劑除於皮膚組織有嗜伊紅性球浸潤(infiltration)外,並無明顯皮膚病變。但DNCB處理組則可導致明顯接觸性過敏性皮膚炎,皮膚病變區呈現過度角化(hyperkeratosis)及棘皮層增厚(acanthosis),真皮層局部出血並伴有淋巴球、嗜伊紅性球(eosinophils)及少數肥胖細胞(mast cells)浸潤於病兆區,同時病變區出現慢性炎症修補反應,可見纖維芽細胞(fibroblasts)及結締組織增生等變化。綜合以上結果,顯示由國內自行配製之80%快得寧水分散性粒劑對天竺鼠不具皮膚過敏反應。 |
英文摘要 | This study is aimed to evaluate the dermal sensitization of various new formulated or synthesized compound and provide the important information for people who handle these chemicals or other users. Experiments were carried out according to the internationally approved Buehler test, using skin patch method in guinea pigs to evaluate the dermal sensitization of domestically formulated 80% Oxine copper. Studies were performed by experiment I and experiment II. Experiment I were applied to select and confirm irritant concentrations for the Experiment II. Experiment II, undiluted 80% Oxine copper was used at the 1st, 2nd and 3rd week of the induction phase. There was no chemical applied at the 4th week and the challenge phase was performed at the 5th and 6th week. The dermal sensitizing chemical, 2,4-dinitro-1-chlorobenzene (DNCB), was used as the positive control. The test items included in this study were skin erythema and edema reaction, hematology analysis, serum biochemical analysis and histopathologic observations. The domestically formulated Oxine copper applied to the left waist skin of guinea pig did not show obvious erythema or edema reaction at 24th and 48th hour at every test weeks, whereas the DNCB positive control exhibited pathological changes of moderate to severe erythema, edema and eschar at 48th hour. The hematological data did not indicate any significant change in total red blood count, hematocrit or hemoglobin in Oxine copper treated group compared with the blank control group (P>0.05). The leukocyte differential count also did not show significant difference in lymphocytes, neutrophils or eosinophils in Oxine copper treated group compared with the blank control group (P>0.05). However, there was a significant increase in lymphocytes in DNCB group compared with blank control group. The serum biochemical assay showed no significant changes in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea nitrogen (BUN), cholesterol, total protein and calcium in both Oxine copper treated and DNCB groups. Histopathlogical observations revealed no obvious skin pathological changes except for an increase in eosinophils in Oxine copper treated group. However, DNCB caused obvious contact hypersensitivity dermatitis, with hyperkeratosis and acanthosis. There was also hemorrhage in the dermis accompanied by infiltration of lymphocytes, eosinophils and few mast cells in lesion areas. Chronic repair inflammation reaction such as fibroblasts and connective tissue proliferation also occurred in these areas. The comprehensive tests carried out in this study showed no significant dermal sensitization reaction of domestically formulated 80% Oxine copper in guinea pigs. |
本系統中英文摘要資訊取自各篇刊載內容。