磷酸咯萘啶胶囊的质量研究-制药工程专业论文.docxVIP

万方数据 万方数据 摘 要 疟疾是由蚊子传播疟原虫并寄生于人体引起的一种传染性寄生虫病。磷酸咯 萘啶是一种治疗抗疟药物，通过竞争性与血红素结合，抑制疟原虫的生长发育和 增殖。本文对磷酸咯萘啶胶囊的处方和质量标准进行研究，为新药研究提供依据。 根据原辅料的理化性质和特点，设计了磷酸咯萘啶胶囊的 12 个处方。通过 颗粒的成型、外观、休止角、溶出度等评价，磷酸咯萘啶胶囊为硬胶囊剂，规格 为 0.1g，每粒含磷酸咯萘啶（以咯萘啶计）的标示量为 90.0%～110.0%，其内容 物为黄色至桔黄色颗粒。适宜处方组成是（每 1000 粒磷酸咯萘啶胶囊）：磷酸 咯萘啶（以咯萘啶计）100g，淀粉 88g，蔗糖 7g，10%的淀粉浆 80g，硬脂酸镁 0.01g。处方合理，工艺简便可行。 磷酸咯萘啶胶囊对高温（60℃）及强光（4500lx±500lx）稳定，对高湿（75% ±5%）敏感。经过加速试验和稳定性试验，外观、装量限度差异、溶出度、水分、 微生物限度、有关物质和含量等在 24 个月内均未见明显变化。贮藏条件定为在 遮光、密封条件下保存，有效期定为两年。解决了现有制剂生物利用度低、给药 途径少的缺点，具有很好的市场效应，为生产企业创造较好的经济效益和社会效 益。 关键词：磷酸咯萘啶胶囊，处方，工艺，稳定性 Abstract Malaria is a kind of infectious parasitic diseases caused by the spreading of plasmodium parasite on human body through mosquitoes. Malaridine phosphate is a kind of antimalarial drug, which can combine with hemoglobin through competition to restrain the growth and proliferation of the plasmodium. In this article, we studied prescription and quality standard of malaridine phosphate capsule, provided gist for the research of the new drug. According to the physicochemical property and feature of the original auxiliary materials, we designed eight prescriptions with the malaridine phosphate capsule. Through the shape, the appearance, the angle of repose, the dissolution and the evaluation of particle, malaridine phosphate capsules was evaluated as hard capsule. Its specification is 0.1g, the labeled amount of every malaridine phosphate particle (calculated with malaridine ) is 90.0% ~ 110.0%, the color of its content is from yellow to aurantium. The suitable formulation of prescription (1000 grains malaridine phosphate capsules) :100 g malaridine phosphate (calculated with malaridine ), 88 g starch, 7g sucrose, 80g 10% starch slurry, 0.01g magnesium stearate. The prescription is reasonable, simple and feasible. Malaridine phosphate capsule is stable in high temperature (60 ℃) and hard light (4500 lx±500 lx), but it is sensitive in high humidity (75%±5%). Through the accelerated test and the stability tes