Method for detecting related substances in azithromycin for injection

Abstract

The invention relates to the field of a drug, and in particular relates to a method for detecting related substances in azithromycin for injection. The method comprises the steps of: diluting an azithromycin B reference substance into a solution by sodium chloride injection, orderly carrying out an abnormal toxicity control method test on the solution according to the ascending order of the injection amount, and setting the injection amount in a previous test of the test to be injection amount extreme of the azithromycin B until a mice death result appears in a retest of the test of the azithromycin B injection amount; measuring the injection extremes of azithromycin Gx and erythrocin A iminoether according to the same method; carrying out quantitative analysis on the content C of three substances and the azithromycin in the drug to be tested; calculating according to each maximal dosage and formula to obtain the impurity extremes W1, W2 and W3 of three related substances; if the content of one related substance is not more than W1, not more than W2 and not more than W3, judging that the content of the related substance of the drug achieves the safety level, or else, judging that the content does not achieve the safety level. The target of quantitative evaluation is achieved by the method.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a method for checking related substances in azithromycin for injection. Background technique [0002] The inspection of related substances in azithromycin for injection is an important index to evaluate its safety. Related substances in azithromycin for injection mainly refer to azithromycin B and azithromycin G x , Erythromycin A, imide ether, etc. [0003] In related technologies, the inspection of related substances in azithromycin for injection is performed by thin-layer chromatography (TLC): the test product (azithromycin for injection) and the control solution are respectively spotted on a silica gel G thin-layer plate, and by comparing the two The number and color of spots can be used to judge whether the content of related substances has reached a safe level. Various inspection methods only slightly change the type and concentration of the control solution, and the principles ...

AI Technical Summary

Problems solved by technology

[0005] It can be seen from the above that the inspection methods in related technologies can only achieve the purpose of semi-quantitative evaluation of the content of related substances, and cannot achieve quantitative evaluation, so more scientific research cannot be carried out, such as the analysis of the reasons that affect the safety of injections, etc.

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