阿托伐他汀钙片制备工艺及质量控制 -药学专业

摘要

本文旨在深入探讨阿托伐他汀钙片的制备工艺及其质量控制策略。阿托伐他汀钙片作为一种重要的调脂药物，广泛应用于高脂血症的治疗，其制备工艺的精细程度及质量控制水平直接关系到药品的疗效与安全性。本文首先概述了阿托伐他汀钙片的定义、作用机制、临床应用及剂型选择的重要性。随后，详细阐述了阿托伐他汀钙片的制备工艺，包括原料与辅料的选择与处理、制剂工艺流程的设计与优化，为生产高质量药品提供了技术基础。在质量控制方面，本文系统分析了国家药品质量标准与法规要求，探讨了微生物限度、无菌检查、物理化学性质控制等关键质量控制标准，并介绍了高效液相色谱法、光谱分析技术及质谱技术在质量控制中的应用，以及稳定性研究的必要性和方法。最后，提出了建立质量追踪与追溯体系、实施工艺参数实时监控与控制、制定严格供应商评估与管理程序等质量控制策略，以确保阿托伐他汀钙片的质量稳定与可靠。本研究对于提升阿托伐他汀钙片的生产工艺水平及质量控制能力具有重要意义。

关键词：阿托伐他汀钙片;制备工艺;质量控制;高效液相色谱法;稳定性研究

Abstract

The purpose of this paper is to discuss the preparation technology and quality control strategy of atorvastatin calcium tablets. Atorvastatin calcium tablets, as an important lipid-regulating drug, are widely used in the treatment of hyperlipidemia. The precision and quality control of the preparation process are directly related to the efficacy and safety of the drug. In this paper, the definition, mechanism of action, clinical application and the importance of dosage form selection of atorvastatin calcium tablets were summarized. Then, the preparation process of atorvastatin calcium tablets, including the selection and treatment of raw materials and auxiliary materials, the design and optimization of preparation process flow, provides a technical basis for the production of high quality drugs. In terms of quality control, this paper systematically analyzed the national drug quality standards and regulatory requirements, discussed the microbial limit, sterility inspection, physical and chemical property control and other key quality control standards, and introduced the application of high performance liquid chromatography, spectral analysis technology and mass spectrometry technology in quality control, as well as the necessity and method of stability research. Finally, quality control strategies such as establishing quality tracking and tracing system, implementing real-time monitoring and control of process parameters, and formulating strict supplier evaluation and management procedures were proposed to ensure the stable and reliable quality of atorvastatin calcium tablets. This study is of great significance for improving the production technology level and quality control ability of atorvastatin calcium tablets.

Keywords：Atorvastatin calcium tablets; Preparation process; Quality control; High performance liquid chromatography; Stability study

第一章绪论 1

1.1 研究背景 1

1.2 研究目的及意义 1

第二章阿托伐他汀钙片概述 2

2.1 阿托伐他汀钙片的定义与作用 2

2.2 药品的临床应用与重要性 2

2.3 阿托伐他汀钙片的剂型选择 2

第三章阿托伐他汀钙片制备工艺 4

3.1 原料选择与处理 4

3.2 辅料选择与配比 4

3.3 制剂工艺流程 5