柳烯酸制剂工艺和质量研究.pdf

柳烯酸制剂工艺和质量研究 摘 要 手足癣是常见而又顽固的皮肤疾病，通过接触传染，患病率高，再感染率高。如果 不治疗可能会引起其他并发疾病，影响人们的工作与生活。目前国内外治疗手足癣类疾 病的西药类制剂主要有化学类制剂和广谱抗真菌制剂。其中广谱抗真菌制剂，临床上有 滥用的风险，且副作用较大。临床上患者多选择外用化学类抗真菌制剂治疗。通过分析 发现，目前国内化学类抗真菌制剂，缺少不同类型化学机构成分的复方制剂。因此我们 认为有必要改进现有制剂，以新颖配方、新型增效剂和给药形式来提高制剂的质量水平。 经调查发现国外“AFAKIN ”产品较为突出，以此立题进行处方研究，经过对原处方的拆 解和重组，确定了以十一烯酸和水杨酸为复方组分，以二乙醇胺为增效剂的新处方，将 其命名为柳烯酸溶液。 通过药效学的实验、质量的研究和稳定性的考察，证实了仿制出的柳烯酸溶液比 “AFAKIN ”效果更佳。依据前期的质量研究和稳定性研究结果，严格遵守工艺要求，在 GMP 车间连续生产三批柳烯酸溶液喷雾剂（每批 10000 瓶）。经 QA 部门的验证和 QC 部门的检验，生产工艺和产品质量均符合要求。 关键词： 柳烯酸，抗真菌剂，十一烯酸、水杨酸，复方制剂，质量研究，工艺研究 I Salicylic Acid and Undecylenici Acid Solution Quality research and Preparation technology Abstract Tinea pedis is common and stubborn skin disease, spread through contact, high prevalence rate, and the high infection rate. If not treated can cause other disease, affecting peoples work and life. Western medicine agents at home and abroad to treat tinea diseases mainly include chemical agents and broad-spectrum antifungal agent. The broad-spectrum antifungal agents, there is the risk of abuse clinically, and side effects. Patients choose external chemical class of antifungal agents in the treatment of. Through the analysis, the domestic chemical class of antifungal agents, the lack of compound preparation of different types of chemical mechanism components. So we think it is necessary to improve the existing preparation, new formulation, new synergistic agent and dosage form to improve quality level of preparation. The survey found that the AFAKIN products is more prominent, this topic for research on prescription, the original prescription after dismantling and reorganization, the u