Study on production technology of hydroxycamptothecin lyophilized powder needle
羟基喜树碱冻干粉针生产工艺研究

摘要

本文主要针对羟基喜树碱冻干粉针生产工艺进行研究。在文章进行研究的过程中，针对羟基喜树碱进行了简要介绍，主要介绍了羟基喜树碱的主要作用和研究现状。同时，在当前社会发展背景下，也正在加紧对羟基喜树碱冻干粉针的生产工艺研究。本文在结合文献资料和相关实践经验后，提出了羟基喜树碱冻干粉针制备工艺、质量标准以及稳定性研究措施。在本文进行研究的过程中，发现了羟基喜树碱冻干粉的化学性质不够稳定。研究中发现，通过工艺优化能够提升羟基喜树碱冻干粉的稳定性，工艺流程主要冻干粉针剂的制备工艺研究及药学质量稳定性研究等。而最后的研究过程中发现，羟基喜树碱冻干粉会受到光照强度、高温的性质影响。在以上两种条件下，高温对羟基喜树碱冻干粉的形状和相对含量均有影响，而光照强度对羟基喜树碱冻干粉的影响仅为相对含量，因此判断温度是羟基喜树碱冻干粉的主要影响物质。如，在高温情况下，羟基喜树碱冻干粉的理化性质从塌陷转为稀松，并且相对含量呈下降趋势。因此，根据本文研究可知，在羟基喜树碱冻干粉生产的过程中，要求对温度因素进行实际的控制，防治温度过高对羟基喜树碱冻干粉的性质造成影响。

Abstract

The production technology of hydroxycamptothecin freeze-dried powder for injection was studied in this paper. In the course of the research, the main function and research status of hydroxycamptothecin were introduced briefly. At the same time, in the current social development background, is also stepping up the hydroxycamptothecin freeze-dried powder production process research. In this paper, the preparation technology, quality standard and stability research measures of hydroxycamptothecin freeze-dried powder for injection were put forward. In the course of this study, it was found that the chemical property of hydroxycamptothecin freeze-dried powder was not stable enough. It was found that the stability of hydroxycamptothecin lyophilized powder could be improved by optimizing the process, which included preparation of coating, dissolution process, pharmacokinetic test and drug property study. Finally, it was found that the properties of hydroxycamptothecin freeze-dried powder were affected by light intensity and high temperature. Under the above two conditions, the shape and relative content of hydroxycamptothecin freeze-dried powder were affected by high temperature, while the effect of light intensity on the relative content of hydroxycamptothecin freeze-dried powder was only relative, therefore, judging temperature is the main.