注射用门冬氨酸鸟氨酸含量方法学研究

论文总字数：15809字

摘 要

注射用门冬氨酸鸟氨酸在临床主要用于治疗因急、慢性肝病如肝硬化、脂肪肝、肝炎所致的高血氨症，特别适用于因为肝脏疾患引起的中枢神经系统症状的解除及肝昏迷的抢救。本品可提供尿素和谷氨酰胺合成的底物.谷氨酰胺是氨的解毒的产物，同时也是氨的储存和运输形式；在生理和病理的条件下，尿素合成及谷氨酰胺的合成会受到鸟氨酸、门冬氨酸和其他二羧基化合物的影响。

本文对注射用门冬氨酸鸟氨酸含量方法学研究，主要包括以下内容：系统适用性考察、进样精密度、溶液稳定性、回收率试验、精密度、耐用性等实验的考察。在本研究中，主要采用高效液相色谱法来测定。本法采用氨基键合硅胶为填充剂的色谱柱；以乙腈：0.05mol/L磷酸二氢钾溶液（54:46）为流动相；柱温为25℃； 流速为每分钟1.0ml；检测波长为210nm；根据《中国药典》验证该方法， 发现各峰分离度均大于1.5符合要求，理论塔板数5547。RCD%均小于2，符合常规的质量要求。说明含量测定方法简便、准确、专属性强，重现性好。

关键词：门冬氨酸鸟氨酸；溶液稳定性；精密度；高效液相色谱；含量方法学；

Validation method for the determination of the ornithine Aspartate Injection

Abstract

Ornithine Aspartate for Injection is mainly used in the clinical treatment for acute and chronic liver disease such as Cirrhosis, fatty liver and hepatitis caused by high blood ammonia disease, especially for the liver disease caused by the relief of central nervous system symptoms and hepatic coma.This product can provide Substrates for urea and glutamine synthesis. Glutamine is not only the product of ammonia detoxification, but also the storage and transport form of ammonia; Under the condition of physiology and pathology,Ornithine aspartate, and two other carbonyl compounds will affect the synthesis of urea and glutamine.

In this paper, the research of content methodology about Ornithine Aspartate for Injection,the main contents are as follows:the investigation of the applicability of the system, the precision of injection, the stability of the solution, the experiment of the recovery, the precision and the durability, etc..In this study is mainly use HPLC, This method uses the chromatographic column filled with amino bonded silica gel,and with acetonitrile: 0.05 mol / L potassium dihydrogen phosphate (54:46) as mobile phase;the column temperature was 25, the flow rate was 1.0ml at a flow rate of, and the detection wavelength was 210nm.According to the Chinese Pharmacopoeia, the method was verified, and the peak separation degree was higher than 1.5, and the number of theoretical tower was 5547. RCD% are less than 2, consistent with the quality of the conventional requirements.It means the content of the method is simple, accurate, specificity and reproducibility.

Key words: Ornithine aspartate；The stability of solution；precision content；High performance liquid chromatography；The content of the methodology；

目录

第一章 绪论

1.1课题背景 1

1.1.1肝病病学分析 1

1.1.2肝脑疾病治疗及药物市场概况 1

1.2 门冬氨酸鸟氨酸 2

1.2.1 门冬氨酸鸟氨酸简介 2

1.2.2 临床应用 3

1.2.2.1 治疗肝性脑病 3

1.2.2.2 治疗慢性乙型肝炎 3

1.2.2.3 肝癌病人术中及术后的治疗 3

1.2.2.4 其他 3

1.2.3 药代动力学 3

1.2.4 药理毒性 3

第二章 实验材料及色谱条件 5

2.1 实验仪器 5

2.2 实验试药剂 5

2.3 色谱条件 5

第三章 实验方法与结果 6

3.1方法摸索 6

3.2 拟定方法 7

3.3 系统适用性考察 7

3.4 进样精密度 7

3.5 溶液稳定性 8

3.6 回收率试验 8

3.7 重复性试验 9

3.8 中间精密度 9

3.9 耐用性试验 10

3.9.1 不同流速考察 10

3.9.2不同波长考察 11

3.9.3不同色谱柱考察 11

3.9.4 不同流动相比例考察 11

3.9.5不同pH值 12

3.9.6不同柱温考察 12

3.10注射用门冬氨酸鸟氨酸含量方法学验证结果 13

第四章 结论与展望 14

参考文献 15

致谢 16

附件 17

第一章 绪论

1.1课题背景

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