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Method for evaluating stability of cefoperazone sodium leechdom

A technology of cefoperazone sodium and evaluation method, which is applied in the preparation of test samples, material analysis using radiation diffraction, etc., can solve the problems of long test period, time-consuming and labor-intensive, heavy workload, etc., and achieve the effect of rapid evaluation

Active Publication Date: 2007-05-30
NAT INST FOR FOOD & DRUG CONTROL +1
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Problems solved by technology

[0008] The purpose of the present invention is to provide a fast and accurate drug stability evaluation method to overcome the shortcomings of traditional evaluation methods such as long test period, heavy workload, time-consuming and laborious, and at the same time guide the improvement of cefoperazone sodium drug production process

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Embodiment Construction

[0030] The following examples can further clearly understand the present invention, but the following examples do not limit the present invention.

[0031] 1. Current status of cefoperazone sodium

[0032] In 2000, the Antibiotics Office of China National Institute for the Control of Pharmaceutical and Biological Products conducted a key random inspection on it. The samples for this random inspection come from 28 production enterprises, distributed in 17 provinces, municipalities, and autonomous regions. The total number of batches is 112, of which 72 batches are directly drawn by the production enterprises, accounting for 64.3% of the total number of batches; 40 batches are from the circulation field Withdrawal, 35.7%. According to the 1995 edition of the Chinese Pharmacopoeia, the extracted samples were tested, and the results were as follows:

[0033] 1. The total pass rate of this random inspection is 88.4%; 13 batches of samples do not meet the requirements, and the fai...

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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,...

Claims

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Application Information

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IPC IPC(8): G01N23/20G01N1/28
Inventor 胡昌勤薛晶李建文侯秉章邬华丽杨利红
Owner NAT INST FOR FOOD & DRUG CONTROL
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