Insulin mucoadhesive buccal films (MBF) are a noninvasive insulin delivery system that offers an advantageous alternative route of administration to subcutaneous injection. One major concern in the formulation of insulin MBF is the preservation of an insulin secondary structure in the presence of the other film components. Buccal films were formulated using chitosan, glycerin, and L-arginine. The MBF-forming solutions (MBF-FS) and the films (MBF) were examined for their chemical and structural stability and for their in vivo activity. Enzyme-Linked Immunosorbent Assay (ELISA) of the insulin-loaded MBF showed that each individualized unit dose was at least loaded with 80% of the insulin theoretical dose. Results of Synchrotron Radiation Circular Dichroism (SRCD) measurements revealed that MBF-FS retained the α-helices and β–sheets conformations of insulin. Fourier transform infrared (FTIR)-microspectroscopy (FTIR-MS) examination of insulin MBF revealed the protective action of L-arginine on insulin structure by interacting with chitosan and minimizing the formation of an unordered structure and β-strand. A blood glucose-lowering effect of insulin MBF was observed in comparison with subcutaneous (S.C) injection using a rat model. As a result; chitosan-based MBFs were formulated and characterized using SRCD and FTIR-MS techniques. Furthermore, the results of in vivo testing suggested the MBFs as a promising delivery system for insulin.

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胰岛素黏膜粘膜颊膜的表征：光谱分析和体内评价

胰岛素粘膜粘膜颊膜（MBF）是一种非侵入性胰岛素输送系统，可为皮下注射提供有利的替代给药途径。胰岛素MBF制剂中的一个主要关注是在其他膜成分存在下胰岛素二级结构的保存。使用壳聚糖，甘油和L-精氨酸配制颊膜。检查了MBF形成溶液（MBF-FS）和薄膜（MBF）的化学和结构稳定性以及体内活性。载有胰岛素的MBF的酶联免疫吸附测定（ELISA）表明，每个单独的单位剂量至少载有80％的胰岛素理论剂量。同步辐射圆二色性（SRCD）的测量结果表明，MBF-FS保留了胰岛素的α-螺旋和β-折叠结构。胰岛素MBF的傅里叶变换红外（FTIR）-显微光谱（FTIR-MS）检查显示，L-精氨酸通过与壳聚糖相互作用并最小化无序结构和β链的形成对胰岛素结构的保护作用。与使用大鼠模型的皮下（SC）注射相比，观察到了胰岛素MBF的降血糖作用。结果是; 使用SRCD和FTIR-MS技术配制并表征了基于壳聚糖的MBF。此外，体内测试的结果表明，MBFs是有希望的胰岛素输送系统。胰岛素MBF的傅里叶变换红外（FTIR）-显微光谱（FTIR-MS）检查显示，L-精氨酸通过与壳聚糖相互作用并最小化无序结构和β链的形成对胰岛素结构的保护作用。与使用大鼠模型的皮下（SC）注射相比，观察到了胰岛素MBF的降血糖作用。结果是; 使用SRCD和FTIR-MS技术配制并表征了基于壳聚糖的MBF。此外，体内测试的结果表明，MBFs是有希望的胰岛素输送系统。胰岛素MBF的傅里叶变换红外（FTIR）-显微光谱（FTIR-MS）检查显示，L-精氨酸通过与壳聚糖相互作用并最小化无序结构和β链的形成对胰岛素结构的保护作用。与使用大鼠模型的皮下（SC）注射相比，观察到了胰岛素MBF的降血糖作用。结果是; 使用SRCD和FTIR-MS技术配制并表征了基于壳聚糖的MBF。此外，体内测试的结果表明，MBFs是有希望的胰岛素输送系统。结果是; 使用SRCD和FTIR-MS技术配制并表征了基于壳聚糖的MBF。此外，体内测试的结果表明，MBFs是有希望的胰岛素输送系统。结果是; 使用SRCD和FTIR-MS技术配制并表征了基于壳聚糖的MBF。此外，体内测试的结果表明，MBFs是有希望的胰岛素输送系统。