| 程速远,胡莹莹,李怡君,寇雅真,赛文博.重组人生长激素比活要求及其对临床用药剂量影响的考量[J].中国药事,2021,35(5):595-599 |
| 重组人生长激素比活要求及其对临床用药剂量影响的考量 |
| On the Specific Activity of Recombinant Human Growth Hormone and Its Influence on Clinical Dosage |
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| DOI：10.16153/j.1002-7777.2021.05.015 |
| 中文关键词: 重组人生长激素 比活 制剂规格 生物学活性 临床用量 |
| 英文关键词: recombinant human growth hormone specific activity preparation specification bioactivity clinical dosage |
| 基金项目: |
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| 中文摘要: |
| 目的：规范重组人生长激素制剂的比活，确保临床用药的安全有效。方法：针对国内企业存在的问题，例如比活不统一，通过对重组人生长激素比活3.0 IU·mg-1的历史回溯、各国药典规定的梳理以及比活对临床用法用量和疗效影响的分析，建议规范重组人生长激素制剂的比活规格。结果与结论：在有关物质及其生物活性研究较为充分的基础上，建议重组人生长激素比活统一为3.0 IU·mg-1，以确保临床使用的安全性和有效性。 |
| 英文摘要: |
| Objective: To standardize the specific activity of recombinant human growth hormone preparation for the safety and effectiveness of clinical medication. Methods: In the view of the existing problems in domestic enterprises, such as the inconsistency of specific activity, the specification of rhGH specific activity was standarized by reviewing the history of rhGH specific activity 3.0 IU · mg-1, combing the regulations of pharmacopoeia in various countries, as well as analyzing the influence of specific activity on clinical usage, dosage and curative effect. Results and Conclusion: On the basis of sufficient research on related substances and their biological activities, the specific activity is recommended as 3.0 IU · mg-1 to ensure the safety and effectiveness of clinical use. |
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