肉桂油论文：肉桂油微乳的制备及质量评价.doc

肉桂油论文：肉桂油微乳的制备及质量评价【中文摘要】本研究采用转相乳化法制备肉桂油微乳,并对其理化性质、稳定性等进行考察,建立血浆中肉桂醛的HPLC分析方法,研究肉桂油微乳体外释放情况。主要研究及结果如下：1.肉桂油微乳的制备通过转相乳化法制备微乳,考察了不同油相、表面活性剂、助表面活性剂之间配比的变化对微乳形成能力的影响。根据微乳伪三元相图区域面积大小,表面活性剂复合及高温实验对微乳配方进行优化。考察所制备微乳的形态、粒径和理化性质。结果表明：制备出的肉桂油微乳配方是EL-40/Tween80/无水乙醇/IPP/肉桂油蒸馏水(EL-40/Tween80=2、Km=2。所制备的微乳稳定,透射电镜下呈圆球形,分布均匀,平均粒径为32.0nm,基本理化参数分别为：电导率111s/cm,黏度105mpa.s,折光率1.415nd,pH值5.24,离心加速后稳定性好。2. HPLC法检测肉桂油微乳中肉桂醛含量肉桂醛浓度在28.8100.8g/mL范围内与色谱峰面积线性关系良好(R2=0.9999),平均回收率为101.29%,RSD为1.45%。该方法可靠,重现性好。3.肉桂油微乳稳定性考察分别在4、30、室温(25)条件下对肉桂油微乳进行留样稳定性实验,光照条件下进行光稳定性实验。4条件下,肉桂油微乳呈白色固体,加热融化后,仍为澄清、透明、均一体系,微乳中肉桂醛含量缓慢降低,第6个月时,肉桂醛含量平均损失25.5%。30条件下,0至第5个月,微乳外观几乎无变化,第6个月出现微量悬浮物,肉桂醛含量平均损失60.5%。室温(25)条件下,0至第5个月,微乳外观几乎无变化,第6个月出现微量悬浮物,肉桂醛含量平均损失53.6%。光照实验结果：第10天,肉桂油外观无明显变化,肉桂醛含量损失16.4%。以上结果表明：肉桂油微乳对光、热较敏感,肉桂油微乳应低温避光贮存。4. HPLC法检测羊血浆中肉桂醛的含量用甲醇来沉淀羊血浆中的蛋白质,空白羊血浆中在肉桂醛出峰处,无色谱峰干扰,实验专属性好,肉桂醛血浆浓度在216g/mL4500g/mL浓度范围内线性关系良好(R2=0.9995),提取回收率和方法回收率符合要求。5.肉桂油微乳体外释放考察配制pH值为6.8的人工肠液,研究肉桂油微乳体外释放情况。温度控制在370.5,放入摇床中,转速控制在100r/min,于0.5,1,2,4,6,8小时分别取4mL样检测肉桂醛含量。结果表明：肉桂油微乳体外释放符合Retger-peppas方程模型(R2=0.93978)。【英文摘要】In this research, the microemulsion of cinnamon oil was prepared by the method of pHase inversion emulsification. The quality stability and physicochemical property of cinnamon oil microemulsion were studied, the analytical method of cinnamicaldehyde in plasma were established. Investigate delivering situations of Cinnamon oil microemulsion in vitro. The main results were as follows:1. Preparation of cinnamon oil microemulsion.The thesis investigates the interaction among oils, surfactants and co-surfactants. According to the size of the microemulsion as the index, the optimum formulation was investigated by using titration to prepare the Pseudo-ternary phase diagram, testing the size of distribution and physicochemical property of cinnamon oil microemulsion. The results showed that the cinnamon oil microemulsion delivery could be prepared using EL-40/Tween80/dehyrated ethanol/IPP/cinnamon oil/Water(Km=2、EL-40/Tween80=2).The average diameter of cinnamon oil microemulsion was 32.0 nm, Its basic character parameter such as refractive indexes, pH, conductivity, viscosity were 1.415nd,5.24, 111us/cm,105mpa.s,respectively. The centrifugal acceleration experiment certify that microemulsion have a good stability.2. Established the HPLC method for determining the content of cinnamicaldehyde in cinnamon oil microemulsion.The calibration curve was linear in the range of 28.8100.8g/mL (R2= 0.9999). The mean recovery was 101.29% and RSD was 1.45%. The formulation is reasonable and the method is accurate.3. The stability quality evaluation of cinnamon oil microemulsionResearch stability of cinnamon oil microemulsion was at 4, room temperature, 30and under light. At the temperature of 4, cinnamon oil microemulsion is white solid, it turns to be clear, transparent, uniform system when heat it. The content of cinnamicaldehyde is decrease slowly. The content of cinnamicaldehyde averagely declined 25.2%. At the temperature of 30, the appearance of cinnamon oil microemulsion was kept well between zero and the fifth months, there are a few of trace suspended solids at the sixth month. The content of cinnamicaldehyde averagely declined 60.5%. At the room temperature, the appearance of cinnamon oil microemulsion was kept well between 0 and the fifth month, there are a few of trace suspended solids at the sixth month.The content of cinnamicaldehyde averagely declined 53.6%. Illumination experimental results, the appearance of cinnamon oil microemulsion was kept well at the tenth day, The content of cinnamicaldehyde averagely declined 16.4%. These results suggested that cinnamon oil microemulsion should be store at low temperature and away from light.4. Established the HPLC method for determining the content of cinnamicaldehyde in sheep plasmaMethanol was usd to precipitate the plasma protein. At the time of cinnamicaldehydes chromatogram peaks, there are no other chromatogram peaks in the blank plasmas chromatogram. The experimental specificity is good. The calibration curve was linear in the range of 216g/mL4500g/mL (R2= 0.9995). Extraction recovery and methods recovery are meeting the requirement of experiment.5. Investigated the delivering situations of Cinnamon oil microemulsion in vitroPreparation artificial intestinal liquid (6.8 pH) for the research. Investigate delivering situations of Cinnamon oil microemulsion in vitro. Put the samples in table concentrator,controlling temperature in 370.5, speed at100r/min.Taking 4mL samples respectively (0.5 hours,1 hours,2 hours,4 hours,6 hours and 8 hours) to investigate the content of cinnamaldehyde. The results showed that the release of cinnamon oil microemulsion in vitro matched with Retger-perpas equation model. (R2=0.93978)【关键词】肉桂油 肉桂醛 微乳 高效液相色谱 血浆【英文关键词】Cinnamon oil cinnamicaldehyde microemulsion High Performance Liquid Chromatography plasma【目录】肉桂油微乳的制备及质量评价摘要4-6ABSTRACT6-7第1章 引言13-261.1 肉桂的研究进展13-141.1.1 肉桂中药化学成分141.2 肉桂油研究进展14-191.2.1 对血液和心血管系统的作用14-151.2.2 对消化系统的作用151.2.3 对机体免疫功能的作用15-161.2.4 抗菌作用16-171.2.5 降血糖作用171.2.6 抗肿瘤作用17-181.2.7 镇痛和平喘作用18-191.2.8 抗氧化作用191.2.9 其他作用191.3 微乳的研究进展19-241.3.1 微乳形成机制19-201.3.2 微乳结构类型201.3.3 微乳在药物制剂中的应用20-241.4 研究价值及意义24-26第2章 肉桂油微乳的制备26-432.1 材料与仪器262.1.1 实验材料262.1.2 实验仪器262.2 实验方法26-302.2.1 微乳配方的初步筛选26-282.2.2 伪三元相图的绘制28-292.2.3 微乳配方优化设计292.2.4 肉桂油微乳外观及类型鉴别292.2.5 肉桂油微乳理化性质及其粒径测定292.2.6 肉桂油微乳的形态观察292.2.7 肉桂油微乳的破乳29-302.3 结果与分析30-412.3.1 微乳配方初步筛选结果30-362.3.2 微乳配方优化设计36-382.3.3 肉桂油微乳类型鉴别38-392.3.4 肉桂油微乳理化性质及其粒径测定39-402.3.5 肉桂油微乳的形态观察402.3.6 肉桂油微乳的破乳40-412.4 讨论41-422.5 小结42-43第3章 肉桂油微乳的稳定性考察43-673.1 材料与仪器433.1.1 实验材料433.1.2 实验仪器433.2 HPLC法检测肉桂油微乳中肉桂醛含量及方法学实验43-453.2.1 色谱条件43-443.2.2 溶液制备443.2.3 方法专属性考察443.2.4 线性关系考察443.2.5 精密度实验443.2.6 稳定性实验44-453.2.7 加样回收率实验453.2.8 样品含量测定453.2.9 肉桂油微乳包封率测定453.3 肉桂油微乳的稳定性考察45-463.3.1 强光照射实验453.3.2 恒温加速实验45-463.3.3 留样观察实验463.3.4 不同贮存温度下肉桂油微乳各项理化性质变化463.4 结果与分析46-653.4.1 方法专属性考察46-473.4.2 线性关系考察47-483.4.3 精密度实验结果483.4.4 稳定性实验结果48-493.4.5 加样回收率实验结果493.4.6 样品含量测定结果49-503.4.7 肉桂油微乳包封率实验结果50-513.4.8 强光照射实验结果51-533.4.9 恒温加速实验结果53-563.4.10 留样观察实验结果56-613.4.11 不同贮存温度下肉桂油微乳各项理化性质变化结果61-653.5 讨论65-663.6 小结66-67第4章 肉桂醛血浆HPLC分析方法的建立