论文部分内容阅读
在50%葡萄糖注射剂(20ml)生产中,中间体的质量对产品最终质量起着决定性作用。提高中间体的分析质量是提高产品质量的关键。采用“分析质量管理”是提高分析质量的一种科学管理方法。我们对50%葡萄糖注射剂中间体的含量分析,建立了全面的质量管理。具体过程是,按药典方法,采用正确无误的操作,得到大量的分析数据。对数据进行分析、整理,并用管理图记录分析结果的精密度和准确度。对以后的含量分析结果,用该图直观地进行考察,从而判断分析结果的准确性和可靠性。采用这种方法,可以及时发现生产过程中的异常现象,并找出原因,采取必要措施,以保证生产顺利进行。现将实验情况介绍如下。
The quality of the intermediates plays a decisive role in the final quality of the product in the production of 50% glucose injections (20 ml). Improve the quality of intermediates is the key to improving product quality. Adopting “Analysis Quality Management ” is a scientific management method to improve the quality of analysis. We analyzed the content of 50% glucose injection intermediates and established a comprehensive quality management. The specific process is, according to Pharmacopoeia method, the use of correct operation, a large number of analytical data. Data analysis, sorting, and management charts recorded the results of the precision and accuracy. The content analysis results for the future, with the chart intuitive investigation, in order to determine the accuracy of the analysis results and reliability. Using this method, we can find out the anomalies in the production process in time and find out the reasons and take the necessary measures to ensure the smooth production. Now the experimental conditions are as follows.