Method for evaluating stability of cefoperazone sodium leechdom

Abstract

The invention provides an evaluating method of stableness of cefoperazone sodium medicine; the crystal analysis is preceded by powder X-ray diffraction technology, the diffraction characteristic parameters which express the different crystal sample is selected as the quantizing index, the different crystal samples can be partied into different monoids by the statistical analysis. Based on the above, different sample monoids are associated with its stability to build the correlation relationship of the diffraction characteristic parameters and the stability, so the evaluation of stability can be rapidly realized with the diffraction characteristic parameters. The method is quick, convenient and accurate, it compensates for the disadvantages of traditional method, can do quick evaluation for the stability of the cefoperazone sodium medicine, and can be used to guide the company to produce the production and improve the process.

Description

technical field

[0001] The present invention relates to a method for quickly evaluating the stability of cefoperazone sodium drug, in particular, it relates to a crystallinity analysis using powder X-ray diffraction technology, and establishes the correlation between diffraction characteristic parameters and stability, so as to realize the diffraction of samples Characteristic parameters quickly evaluate its stability. Background technique

[0002] Stability is one of the important indicators for evaluating the quality of drugs, and a major criterion for measuring the safety and effectiveness of drugs. "Chinese Pharmacopoeia" (Version 2, 2005) Appendix XIXC "Guiding Principles for Stability Testing of APIs and Pharmaceutical Preparations" and "International Technical Requirements for ICH Drug Registration" (Quality Part) "Stability Testing of New APIs and Preparations ICH Tripartite The Harmonized Guiding Principles elaborates and stipulates the purpose, basic requirements,...