可吸收性手術縫合線材質鑑定及功能性試驗方法探討

Research and Discussion of Material identification and Performance test method for Absorbable surgical suture

許祐寧(You-Ning Hsu) ； 勞寬(Kuan Lao) ； 黃守潔(Shou-Chieh Huang) ； 陳玉盆(Yu-Pen Chen) ； 周秀冠(Hsiu-Kuan Chou) ； 陳惠芳(Hwei-Fang Cheng)

《食品藥物研究年報》 6期 (2015/12) Pp. 229-241

摘要

為保障國人之健康安全並因應偽劣醫材查緝檢驗需要，本計畫依食藥署99年9月30日之公告「可吸收性縫合線臨床前測試基準」，建立可吸收性手術縫合線材質成分鑑定與功能性試驗方法。功能性試驗係參考美國藥典與歐洲藥典之方法，利用萬能試驗機進行可吸收性縫合線張力強度及縫合針與線間張力強度試驗。材質成分鑑定則利用熱裂解儀搭配氣相層析質譜儀(Pyrolyzer-GC/MS)，建立聚乳酸、聚乙醇酸、聚乙醇乳酸、聚對二氧六環酮、聚己內酯、聚亞丙基碳酸酯及聚三甲基碳酸酯等7種可吸收高分子材料最佳化熱釋放氣體質譜分析(EGA-MS)條件、方法及資料庫。應用所建立之方法檢測6件市售產品，每件產品選擇2-3項不同尺寸之檢體，共計17組。功能性試驗結果中，縫合線張力強度部分有1組檢體不符合美國及歐洲藥典要求，縫合針與線間張力強度部分則均符合上述藥典要求。在材質鑑定方面，鑑別市售可吸收性手術縫合線6件，結果均符合產品原查驗登記之材質規格。本計畫所建立之方法將提供各界檢驗可吸收性手術縫合線材質成分鑑定與功能性試驗方法之參考。

關鍵字

可吸收性縫合線 ； 功能性試驗 ； 熱裂解氣相層析質譜儀

並列摘要

In order to assure the quality of absorbable surgical sutures in markets, two product tests, an analysis of material composition and a physical performance test, were established in this report. Between April 2014 and November 2014, 17 samples of 2 to 3 specifications from 6 suture products were collected from supplies in Taiwan. The physical performance of the samples was tested according to the guidance document “Guidance for pre-clinical testing of absorbable surgical suture” published by the Taiwan FDA, USP＜37＞, and EP (8.0). The tensile strength of the suture and the suture-needle attachment were examined using a tensilometer, while the material composition was analyzed using a pyrolysis-GC/MS. All samples passed the test of needle-suture attachment, while 1 out of the 17 samples failed to meet the criteria for suture tensile strength. All 6 products examined fulfilled the regulatory requirements for the material composition of the surgical sutures. In this study, the method using EGA-MS in the analysis of suture material was established and the analytic references for 7 high molecular polymers, including Polylactic acid (PLA), Polyglycolic acid (PGA), Poly lactic-co-glycolic acid (PLGA), Polydioxanone (PDS), Polycaprolactone (PCL), Polypropylene carbonate (PPC), and Polytrimethylene carbonate (PTMC) were given. The method and the references reported here can be adopted in the industrial testing of the absorbable surgical sutures.

並列關鍵字

absorbable surgical suture ； performance test ； pyrolyzer-GC/MS