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目的:阐述肽与蛋白质激素类药物的质量标准与质控,以及国内外研究进展,为肽与蛋白质激素类药物新产品的研制,老产品的质量提高提供参考。方法:阅读国内外相关的文献资料,进行整理,分析归纳和综合评价。结果:激素类药物临床主要用于治疗糖尿病,侏儒症,低血糖症,心力衰竭,骨质疏松症,高血钙症,自身免疫性疾病,以及性功能不全引起的各种病症等等。各国药典收载的肽与蛋白质激素类原料药标准有32个,制剂标准有30个。结论:提取的天然激素的质控重点是生物效价与常规安全性;化学和生物合成的激素类药物的质控重点是理化性质鉴别、纯度分析、杂质及外源污染物检查、含量测定或生物活性分析。我国的激素类药物应着眼于提高产品质量,降低生产成本,瞄准国际市场,研制和开发具有竞争力的品种。
OBJECTIVE: To elucidate the quality standards and quality control of peptides and protein hormones, as well as the research progress at home and abroad, to provide reference for the development of new products of peptides and protein hormones and the improvement of the quality of old products. Methods: Read the relevant literature at home and abroad, to organize, analyze and summarize and evaluate. Results: Hormones were mainly used to treat diabetes, dwarfism, hypoglycemia, heart failure, osteoporosis, hypercalcemia, autoimmune diseases, various diseases caused by sexual dysfunction and so on. Pharmacopoeia of countries containing peptides and protein hormones API standard has 32, 30 formulations standards. Conclusion: The quality control of extracted natural hormones focuses on biological potency and routine safety. Quality control of chemical and biosynthetic hormonal drugs focuses on the identification of physical and chemical properties, purity analysis, examination of impurities and exogenous contaminants, determination of content or Bioactivity analysis. Hormonal drugs in China should focus on improving product quality, reduce production costs, targeting the international market, research and development of competitive varieties.