补骨脂治疗白癜风透皮制剂的药学研究药物分析学专业论文.docxVIP

0．171％。在稳定性研究中，加速试验和长期试验的结果表明，补骨脂凝胶中的补 0．171％。在稳定性研究中，加速试验和长期试验的结果表明，补骨脂凝胶中的补 骨脂素的含量无明显的变化，其余各项指标也相对稳定。但在加速试验中，三个 月后凝胶的色泽稍变暗，提示高温对凝胶的色泽有一定的影响。 用化学脱色法制备实验性白癜风动物模型，以8一甲氧基补骨脂素酊剂为阳性 对照，分别用低，中，高剂量补骨脂凝胶进行治疗，考察其对实验性白癜风皮肤 黑色素分布、胆碱酯酶与酪氨酸酶活性的影响。结果表明，补骨脂凝胶对实验性 白癜风有良好的治疗作用，与模型对照组比较，对皮肤黑色素分布影响显著，对 胆碱酯酶和酪氨酸酶活性的影响差异显著(PO．05)；高，中，低剂量组间无明 显差异(PO．05)。 最后，通过急性毒性试验和皮肤刺激性试验评估补骨脂凝胶的安全性，初步 结果表明，补骨脂凝胶具有较高安全性，在等于或高于临床拟用剂量时并无急性 毒性和皮肤刺激性。 本论文对补骨脂的透皮制剂进行了药学研究，结果证实了产品质量的可控 性、有效性和安全性，为治疗白癜风透皮新制剂的开发提供了数据。 关键词： 补骨脂；补骨脂素：自癜风； 标准提取物；透皮制剂 II ]Title：Pharmic ] Title：Pharmic Study on Transdermal Preparations of Fructus Psoraleae for Vitiligo Speciality：Pharmaceutical Analysis Name：Huang Fangfang Supervisor：Prof．Yang Depo AB STRACT Fructus Psoraleae，which is proved to be good for treating vitiligo，is widely used in clinic．However,there are only some liquid topical preparations available． These kinds of preparations are discommodious，and the preparation procedure is loose，which is bad for the quality,effect and clinical use of the preparation．In order to develop new choice for vitiligo，transdermal preparations of Fructus Psoraleae were studied． At first，the preparation technology of the standardized extract from Fructus Psoraleae was studied．The method of cold maceration and crystallization was chosen， and single factor test was employed tO optimize the extraction technique．The optimal technique was simple and steady．The productivity was 0．66％and the content of psoralen in the standardized extract was about 85％．The quality of the standardized extract was studied，and the items included properties，examination，identification and determination．Stress test，accelerated test and long—term test were done to prove the stability of the extract．The results indicated good quality and stability of the standardized extract． During the research of transdermal preparations，some new excipients，such as carpopol and SQE一21，were used．The formulas of the transdermal preparations were optimized with the methods of single fa