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目的卵泡刺激素(FSH)已成为治疗不孕不育不可或缺的常规药物。笔者通过回顾卵泡刺激素制剂的发展历程,为今后新型卵泡刺激素制剂的开发提供宝贵的经验与教训,也可为其他基因药物的开发提供借鉴。方法回顾卵泡刺激素制剂的发展历程,对目前所用常规卵泡刺激素制剂生产及质量控制作概述,讨论并分析各制剂的质量问题。结果与结论安全、有效的卵泡刺激素制剂的开发与应用,充满了来自疗效、安全性以及病人顺应性等各种挑战。动物源性卵泡刺激素的低疗效及免疫源性,人垂体来源卵泡刺激素的安全性,尿源性卵泡刺激素的低纯度等产品质量问题的出现,促进了卵泡刺激素生产工艺的改革,和质量控制技术的完善。重组基因技术的出现,使得具备高纯度、高批间一致性等优点的重组卵泡刺激素得以上市,卵泡刺激素制剂产品走向安全、有效、质量可控,长效卵泡刺激素则进一步改善了病人的用药顺应性。
The purpose of follicle stimulating hormone (FSH) has become an indispensable treatment of infertility conventional drugs. By reviewing the development of follicle stimulating hormone preparations, the author provides valuable experience and lessons for the future development of new follicle stimulating hormone preparations, as well as reference for the development of other gene drugs. Methods The development history of follicle stimulating hormone preparations was reviewed. The production and quality control of the conventional follicle stimulating hormone preparations used at present were summarized. The quality problems of the preparations were discussed and analyzed. RESULTS AND CONCLUSIONS The development and application of a safe and effective follicle stimulating hormone formulation is full of challenges from efficacy, safety and patient compliance. The low efficacy and immunogenicity of animal-derived follicle-stimulating hormone, the safety of follicle-derived follicle-stimulating hormone in human pituitary gland and the low purity of urinary follicle-stimulating hormone and other products have promoted the reform of follicle-stimulating hormone production process, And quality control technology improvement. With the advent of recombinant gene technology, the recombinant follicle stimulating hormone with the advantages of high purity, high batch consistency and the like can be marketed. The follicle stimulating hormone preparations are safer, more effective and the quality controllable, and the long-term follicle stimulating hormone further improves the patients The medication compliance.