Formulation development and Evaluation of Hydrophobic Base Containing Herbal extracts for Oral Ulcers

This research study tended to develop hydrophobic base with suitable gelling agents containing mangostin and/or asiaticoside for the relief of oral lichen planus and apthous ulcer. Hydrophobic base with good physical appearance was prepared from melting process of plyethylene polymer (PE) and mineral oil at about 80 degree Celsius. PE polymer in mineral oil was found to precipitate as small crystallites surrounded by long fibrous amorphous filaments which intermesh and produce a sponge-like structure resulting in a three dimentional lattice responsible for stable gel structure. Among various percentages of PE in this study, it was found that the appropriate amount of PE polymer in hydroiphobic base was 4.5 percent. From rheogram at various temperatures, hydrophobic base exhibits psuedoplastic behavior. Activation energy calculated from modified Arrhenius’s equation was about 12.45 kj/mol. Gelatin, xanthan gum, pectin, sodium evaluated for suitable gelling agent in hydrophobic base. Chitosan salts prepared by spray-drying process with suitable conditions were fine yellowish powder with round shape. Among these gelling agents mixed with hydrophobic base, SCMC, pectin, chitosan glutamate molecular weight 227000, butylated hydroxytoluene (BHT) and active ingredient (either mangostin or asiaticoside_ was suitable. From photoxidation study the result revealed that the percent contents of both mangostin and asiaticoside in formulation using BHT as antioxidant were slightly changed with in acceptablelimit. In addition, after 4 months of stability study at 30 degree Celsius the percent contents of mangostin and asiaticoside in formulation seem to be unchanged at various storage time intervals

本研究旨在开发含有倒捻子素（mangostin）和/或积雪草苷（asiaticoside）的适宜胶凝剂疏水基质，用于缓解口腔扁平苔藓（oral lichen planus）与阿弗他溃疡（apthous ulcer）。通过将聚乙烯聚合物（PE）与矿物油在约80℃下熔融制备得到外观良好的疏水基质。研究发现，矿物油中的PE聚合物会析出为微小微晶，其周围环绕着相互交织的长纤维状无定形丝状体，进而形成海绵状结构，该结构构成了稳定凝胶所需的三维网状骨架。在本研究设置的多种PE添加比例中，疏水基质中PE聚合物的适宜用量为4.5%。通过不同温度下的流变图谱可知，该疏水基质呈现假塑性（pseudoplastic）流变行为。基于修正阿伦尼乌斯（Arrhenius）方程计算得到的活化能约为12.45千焦每摩尔（kJ/mol）。本研究对明胶、黄原胶、果胶等胶凝剂在疏水基质中的适配性进行了考察。通过适宜条件下的喷雾干燥法制备得到的壳聚糖盐为淡黄色球形细粉。在与疏水基质复配的各类胶凝剂中，羧甲基纤维素钠（SCMC）、果胶、分子量为227000的谷氨酸壳聚糖、二叔丁基对甲酚（BHT）以及活性成分（倒捻子素或积雪草苷）均为适宜的复配组分。光氧化试验结果显示，以BHT作为抗氧剂的制剂中，倒捻子素与积雪草苷的含量变化幅度极小，处于可接受范围内。此外，在30℃条件下进行4个月的稳定性试验后，制剂中倒捻子素与积雪草苷的含量在各存储时间节点均未出现明显变化。