摘  要利拉鲁肽在治疗2型糖尿病方面具有独特优势。利拉鲁肽药品的研发至关重要，杂质研究是药品研究的关键部分。为了提取利拉鲁肽中C杂质,为C杂质的分析提供样品，本实验主要通过原料老化方法制备C杂质,即考察其在酸性、碱性、过氧化氢以及不同温度条件下C杂质与主成分的分离情况，并通过高效液相色谱仪进行检测分析。结果显示，不同温度处理实验中，25℃温度处理时，C杂质含量最高，第9天时，C杂质峰面积比为19.703％。利用强碱处理时，C杂质分离迅速，10 min时即发生了分离，C杂质峰面积比为0.552%，30 min时含量最高，C杂质峰面积比达到1.091%，随后又有下降的趋势。利用强酸处理时，无法降解出C杂质。利用过氧化氢氧化处理时，C杂质降解速度较慢且含量较低，24h时C杂质峰面积比为1.069%。通过本实验的研究，可为利拉鲁肽等药品的生产、包装、贮存和有效期的确定等提供一定的依据，同时也可为此类多肽药品的不良反应提供相关参考。69164

该论文有图8幅，表1个，参考文献17篇。 

毕业论文关键词：利拉鲁肽  老化处理  C杂质  高效液相色谱

Analysis of impurity C during the production of Liraglutide

Abstract

Liraglutide has a unique advantage in the treatment of type 2 diabetes.The discovery of Liragiutide is very essential and impurity research is an important aspect of drug research. In order to extract the impurity C of Liraglutide, provide the samples for the impurity analysis , this experiment was prepared by aging the raw material to extract the impurities C, that is, considering its acidic, alkaline, hydrogen peroxide, different temperature conditions and the main impurity C separation of components, and analyzed by high-performance liquid chromatography. The results showed that different temperature experiment, the temperature 25 ℃ treatment, C impurity content of the highest, the ninth day, C impurity peak area ratio of 19.703%. The use of alkali treatment, C impurity separation quickly, 10 min That is when the separation occurred, C impurity peak area ratio of 0.552 percent, the highest content at 30 min, C impurity peak area ratio of 1.091 percent, followed by another decline. The use of strong acid treatment, can not degrade the C impurities. The use of hydrogen peroxide treatment, C impurities degrade slower and lower levels, C impurity peak area ratio of 1.069% at 24h.By studying this experiment may provide some basis for the production, packaging, storage and determine the validity of medicines and the like, but also to provide relevant data to adverse drug reactions. 

.

Key words:  Liraglutide  Aging treatment  Impurity C  HPLC.

目   录

摘  要 I

Abstract II

目   录 III

图清单 III

表清单 IV

1 绪论 1

2 材料与方法 2

2.1仪器 2

2.2试药 2

2.3溶液的制备 2

2.4老化处理方法 3

  2.4.1 酸处理 3

  2.4.2 碱处理 3

  2.4.3氧化处理 3

  2.4.4 热处理 3

2.5 杂质检测方法 4