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Objective: To analyze the related substances produced in new production process of somatostatin, and the stability of raw materials and preparation was studied. Methods: The related substances were separated, collected, characterized and analyzed by high performance liquid chromatography, preparative liquid chromatography and ultra performance liquid chromatography-time-of-flight mass spectrometry tandem system. In addition, the stability of somatostatin and its preparation was studied under high temperature, light, oxidation and acidolysis destruction conditions. Conclusion: Based on the stability study combined with the production process of somatostatin and its preparation, somatostatin will produce new impurities in the new production process. This study provides a basis for revising pharmacopoeia standards.

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目的:对生长抑素在新生产工艺下产生的有关物质进行分析,并对原料及制剂进行稳定性研究。方法:通过HPLC、制备液相色谱以及超高效液相色谱-飞行时间质谱串联系统等设备对有关物质进行分离、收集、定性及结构解析。此外,对生长抑素及制剂通过高温、光照、氧化以及酸解破坏实验进行了稳定性研究。结论:通过稳定性研究,结合生长抑素及其制剂的生产工艺可知,生长抑素在新的生产工艺过程中会产生新的工艺杂质。本研究为药典标准修订提供了依据。

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梁成罡,男,研究员,主要从事激素及生物技术药物质量控制研究。联系电话:(010)53851638,E-mail:
张慧,女,主任药师,主要从事重组激素类药物质量控制研究。联系电话:(010)53851640,E-mail:
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张伟,男,副主任药师,主要从事化药、生化药以及重组激素类药物质量控制研究。联系电话:(010)53851619,E-mail:

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张伟,男,副主任药师,主要从事化药、生化药以及重组激素类药物质量控制研究。联系电话:(010)53851619,E-mail:

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生长抑素在新生产工艺过程中的有关物质分析及稳定性研究
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张伟 , 张慧 , 梁成罡
中国新药杂志 | 实验研究 2023,32(1): 80-85
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中国新药杂志 | 实验研究 2023, 32(1): 80-85
生长抑素在新生产工艺过程中的有关物质分析及稳定性研究
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张伟 , 张慧 , 梁成罡
作者信息
  • 中国食品药品检定研究院激素室,国家药品监督管理局化学药品质量研究与评价重点实验室,北京 102629
  • 张伟,男,副主任药师,主要从事化药、生化药以及重组激素类药物质量控制研究。联系电话:(010)53851619,E-mail:

通讯作者:

梁成罡,男,研究员,主要从事激素及生物技术药物质量控制研究。联系电话:(010)53851638,E-mail:
张慧,女,主任药师,主要从事重组激素类药物质量控制研究。联系电话:(010)53851640,E-mail:
Analysis of related substances and stability study of somatostatin in new production process
Wei ZHANG , Hui ZHANG , Cheng-gang LIANG
Affiliations
  • Division of Hormone, National Institutes for Food and Drug Control, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China
出版时间: 2023-01-15
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目的:对生长抑素在新生产工艺下产生的有关物质进行分析,并对原料及制剂进行稳定性研究。方法:通过HPLC、制备液相色谱以及超高效液相色谱-飞行时间质谱串联系统等设备对有关物质进行分离、收集、定性及结构解析。此外,对生长抑素及制剂通过高温、光照、氧化以及酸解破坏实验进行了稳定性研究。结论:通过稳定性研究,结合生长抑素及其制剂的生产工艺可知,生长抑素在新的生产工艺过程中会产生新的工艺杂质。本研究为药典标准修订提供了依据。

生长抑素  /  新生产工艺  /  有关物质  /  稳定性

Objective: To analyze the related substances produced in new production process of somatostatin, and the stability of raw materials and preparation was studied. Methods: The related substances were separated, collected, characterized and analyzed by high performance liquid chromatography, preparative liquid chromatography and ultra performance liquid chromatography-time-of-flight mass spectrometry tandem system. In addition, the stability of somatostatin and its preparation was studied under high temperature, light, oxidation and acidolysis destruction conditions. Conclusion: Based on the stability study combined with the production process of somatostatin and its preparation, somatostatin will produce new impurities in the new production process. This study provides a basis for revising pharmacopoeia standards.

somatostatin  /  new production process  /  related substances  /  stability
张伟, 张慧, 梁成罡. 生长抑素在新生产工艺过程中的有关物质分析及稳定性研究. 中国新药杂志, 2023 , 32 (1) : 80 -85 .
Wei ZHANG, Hui ZHANG, Cheng-gang LIANG. Analysis of related substances and stability study of somatostatin in new production process[J]. Chinese Journal of New Drugs, 2023 , 32 (1) : 80 -85 .
  • 国家药典委员会药品标准制修订研究课题(2020H012)
2023年第32卷第1期
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  • 首发时间:2026-03-06
  • 出版时间:2023-01-15
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  • 录用日期:2022-07-08
基金
国家药典委员会药品标准制修订研究课题(2020H012)
作者信息
    中国食品药品检定研究院激素室,国家药品监督管理局化学药品质量研究与评价重点实验室,北京 102629

通讯作者:

梁成罡,男,研究员,主要从事激素及生物技术药物质量控制研究。联系电话:(010)53851638,E-mail:
张慧,女,主任药师,主要从事重组激素类药物质量控制研究。联系电话:(010)53851640,E-mail:
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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