化学药品制剂处方工艺变更研究技术要求及案例分析

Technical Requirements and Case Analysis of Prescription Process Change Research of Chemical Drug Preparation

目的:研究化学药品制剂处方工艺变更技术要求及案例分析。方法:试验组采用制剂处方变更,参照组在试验组的基础上采用制剂生产工艺变更,两组对比分析。结果:试验组研究符合度显著高于参照组研究符合度;试验组对两种不同处方变更研究程度高于参照组;试验组在工艺变更的研究与验证强弱高低情况优于参照组。结论:研究结果不能支持制剂生产工艺变更的合理性,所以,不能批准制剂生产工艺变更。

Objective： To study the technical requirements and case analysis of the prescription process change of chemical drug preparation. Methods： The formulation of prescription was changed in the experimental group, and for the reference group, the production process was changed on the basis of the experimental groups, and the two groups were compared and analyzed. Results： The research conformity of the experimental group was signifcantly higher than that of the reference group, and the degree of research of two different prescriptions for the experimental groups was higher than that of the reference group. For the research and validation of process change, the experimental group is superior to the reference group. Conclusion： The research results can’t support the rationality of the preparation production process change, therefore, the preparation production process change can’t be approved.