使用檸檬酸三丁酯、乙醯檸檬酸三丁酯及超分支聚酯提升組織調理材黏彈性質穩定性

Abstract

組織調理材（tissue conditioner）常用於義齒暫時墊底以舒緩因義齒（denture）不密合口腔黏膜引起的不適感，而目前臨床使用上最大問題是組織調理材所含之酯類增塑劑及乙醇會釋出導致材料黏彈性質（viscoelasticity）快速喪失。 為延長組織調理材黏彈性的維持時間及減少生物毒性成份的使用，本研究以適用於食品及醫療器材的無毒環保增塑劑—檸檬酸三丁酯（tributyl citrate, TBC）及乙醯檸檬酸三丁酯（acetyl tributyl citrate, ATBC）取代市售產品常使用的三種酯類增塑劑—鄰苯二甲酸乙醇酸丁酯（butyl phthalyl butyl glycolate, BPBG）、鄰苯二甲酸二丁酯（dibutyl phthalate, DBP）、苯甲酸芐酯（benzyl benzoate, BB），另亦將ATBC及TBC兩組加入10% TAH進行比較。希望藉由添加分子量較大(Mn=1306 g．mol-1, Mw=4245 g．mol-1)之超分支聚酯（hyperbranched polyester）以減少增塑劑於口內的釋出進而減少組織調理材料黏彈性質的喪失。本研究亦將三種市售組織調理材（Shofu、GC、Densply）加入比較黏彈性質穩定性。為符合臨床使用需求，第二部分實驗將乙醇加入增塑劑中，並測其膠化時間，求得各組樣品之膠化時間符合臨床需求之增塑劑所需最少乙醇量。 藉由流變儀（Rheometer）、紫外光/可見光光譜儀（UV-vis Spectroscopy）、接觸角（Contact angle）及電子天平（Electronic balance）分析各種不同增塑劑成分的組織調理材隨浸泡於37℃水中時間增加其黏彈性質、增塑劑釋出量、表面親水性、材料重量改變、材料吸水性及材料溶解性。 結果顯示，組織調理材使用ATBC作為增塑劑的黏彈性穩定度較使用TBC、BPBG、DBP及BB為增塑劑高，且ATBC釋出量為所有組別中最低。而將環保增塑劑（ATBC、TBC）的組別加入10% TAH後，發現接觸角減少、親水性增加。組織調理材使用液劑為78.3%ATBC、8.7%TAH和13%乙醇之複數剪切模數（G*）的百分比變化量為所有組別中最小。故本研究認為78.3%ATBC、8.7%TAH和13%乙醇為適用於長時間使用之組織調理材。

Tissue conditioners are often used in edentulous patients to treat lesions of the alveolar mucosa caused by ill-fitted dentures. The main problem in clinical use is the rapid loss of viscoelasticity due to the leaching of ester plasticizer and ethanol into the oral environment. In this study, butyl phthalyl butyl glycolate (BPBG), dibutyl phthalate (DBP) and benzyl benzoate (BB), which are commonly used in commercial products, were replaced by tributyl citrate (TBC) and acetyl tributyl citrate (ATBC), which are non-toxic and often used in food packing and medical appliances, to extend the life span of tissue conditioners and reduce the use of biological toxic ingredients. 10% of hyperbranched polyester TAH with large molecular weight (Mn=1306 g．mol-1, Mw=4245 g．mol-1) was added to TBC and ATBC respectively to reduce the release of plasticizer into the oral cavity and the loss of viscoelastic property. The viscoelasticity of commercial products (Shofu, GC, and Densply) was also measured. In order to meet the clinical requirements, we added different percentages of ethanol to plasticizers and measured the gelation time in the second part of the experiment. The purpose is to determine the least ethanol which is able to meet the clinical working time. The viscoelasticity, leaching of plasticizer, hydrophilicity, weight change, water absorption, and solubility were evaluated using rheometer, UV-vis spectroscopy, contact angle, and electronic balance. The results showed that the viscoelasticity stability of tissue conditioners using ATBC as plasticizer was better than that of those using TBC, BPBG, DBP and BB as plasticizer. In addition, the leaching of ATBC was the least. The contact angle decreased and hydrophilicity increased after adding 10% TAH to ATBC. The changes in the percentage of complex modulus (G*) with time for the tissue conditioner using ATBC 78.3%, TAH 8.7% and ethanol 13% as plasticizer was the smallest of all the groups. Therefore, in this study, ATBC 78.3%, TAH 8.7% and ethanol 13%is the most suitable combination for tissue conditioners.