论文总字数：20288字

摘 要

盐酸法舒地尔（Fasudil hydrochloride）是一种具有广泛药理作用的新型药物，用于改善和预防蛛网膜下腔出血术后的脑血管痉挛及引起的脑缺血症状，促进神经再生。是迄今唯一可用于临床治疗的Rho激酶抑制剂，具有广泛的临床应用前景。

盐酸法舒地尔注射液的制备及其质量研究主要以含量测定为指标，通过处方筛选从而优化制备工艺；用高效液相色谱法对所制备的盐酸法舒地尔注射液的质量进行检测，并进行初步的稳定性研究。结果表明，优选得到的工艺处方稳定，产品符合质量标准。

对用高效液相色谱法测定注射液含量所用的各种分离因素进行考察并确定了测定的条件，色谱条件：色谱柱：Agilent Zorbax SB-C8（250mm×4.6mm，5μm）；柱温为30℃；流动相为 0.05mol/L磷酸盐缓冲液（取磷酸二氢铵11.5g，加水2000mL使溶解）-乙腈（85：15）；流速为1.0mL/min；检测波长为220nm。实验结果验证，盐酸法舒地尔含量测定方法简单、快捷、经济、高效、准确；制备的盐酸法舒地尔注射液比较稳定，适合大批量生产。

关键词：盐酸法舒地尔；高效液相色谱；注射液；稳定性；质量研究

Preparation and Quality Study of Fasudil Hydrochloride Injection

Abstract

Fasudil hydrochloride is a novel drug with a wide range of pharmacological effects. It is used to improve and prevent cerebral vasospasm and cerebral ischemia caused by subarachnoid hemorrhage and promote nerve regeneration. It is the only Rho kinase inhibitor that can be used for clinical treatment so far and has a wide range of clinical application prospects.

The preparation of Fasudil hydrochloride injection and its quality research are mainly based on the determination of the content, through the prescription screening to optimize the preparation process; the quality of the prepared fasudil hydrochloride injection is tested by high performance liquid chromatography. And conduct a preliminary stability study. The results show that the preferred process recipe is stable and the product meets quality standards.

The separation factors used for the determination of the content of the injection by high performance liquid chromatography were examined and the conditions for the determination were determined. The chromatographic conditions were as follows: Column: Agilent Zorbax SB-C8 (250 mm×4.6 mm, 5 μm); column temperature was 30 ℃; The mobile phase was a 0.05 mol/L phosphate buffer solution (ammonium dihydrogen phosphate 11.5 g, dissolved in 2000 mL water)-acetonitrile (85:15); flow rate 1.0 mL/min; detection wavelength was 220 nm. The experimental results show that the determination of fasudil hydrochloride is simple, rapid, economical, efficient, and accurate. The prepared Fasudil hydrochloride injection is stable and suitable for mass production.

Keywords:Fasudil hydrochloride；HPLC；Injection；stability；Quality research

目录

摘要 I

Abstract II

第一章 绪论 1

1.1. 盐酸法舒地尔的基本信息 1

1.1.1. 药品名称 1

1.1.2. 结构 1

1.1.3. 理化性质 1

1.2. 盐酸法舒地尔的分析方法 2

1.3. 选题依据与研究内容 2

1.3.1. 选题依据 2

1.3.2. 研究内容 2

1.4. 本章小结 3

第二章 盐酸法舒地尔注射液的制备 4

2.1. 处方的确定 4

2.2. 规格的确定： 4

2.3. pH值及包装的确定 4

2.4. 活性炭用量筛选： 4

2.5. 盐酸法舒地尔注射液的制备 5

2.6. 三批次样品的检验结果 6

第三章 盐酸法舒地尔注射液的含量方法学研究 7

3.1. 方法选择 7

3.2. 测定条件 7

3.3. 测定方法 7

3.4. 方法验证 8

3.4.1. 专属性试验 8

3.4.2. 定量限 10

3.4.3. 线性和范围 10

3.4.4. 准确度实验 11

3.4.5. 精密度实验 11

3.4.6. 系统适用性 12

3.4.7. 溶液稳定性 13

3.4.8. 耐用性 13

3.5. 样品测定 16

第四章 盐酸法舒地尔注射液的初步稳定性研究 17

4.1. 样品情况汇总 17

4.1.1. 自制样品情况汇总 17

4.1.2. 参比制剂情况汇总 17

4.2. 研究内容及结果 17

4.3. 稳定性数据 18

4.3.1. 参比制剂影响因素试验 18

4.3.2. 自制样品影响因素试验 18

第五章 结论 20

致谢 21

参考文献 22

绪论

盐酸法舒地尔的基本信息

药品名称

中文名：盐酸法舒地尔

英文名：Fasudil Hydrochloride

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