Microbial limit detection method for azithromycin dry suspension

Abstract

The invention belongs to the technical field of microbial limit detection, and discloses a microbial limit detection method of an azithromycin dry suspension, which is characterized in that aerobic bacteria detection is carried out by adopting a membrane filtration method (low-speed filtration) based on a prepared neutralizer-free test solution; based on the prepared neutralizer-free test solution, carrying out mould and yeast detection by adopting a plate method; based on the prepared neutralizer-free test solution, a membrane filtration method (low-speed filtration) and a dilution method are combined for detection of control bacteria. The concentration of each test bacterium suspension is less than or equal to 10 < 4 > cfu/ml and less than or equal to 10 < 2 > cfu/ml. The invention discloses a microbiological limit test method without centrifugation and a neutralizing agent. A microbial limit test method of the azithromycin dry suspension is established, and reference is provided for controlling the quality of related drugs; the test result that the filtering speed of the flushing fluid directly affects the applicability of the microbial limit method is determined, and a basis is provided for improvement of microbial limit test conditions.

Description

technical field [0001] The invention belongs to the technical field of microbial limit detection, in particular to a microbial limit detection method of azithromycin dry suspension. Background technique [0002] At present, azithromycin is an aza compound and belongs to a macrolide antibiotic. The dosage forms recorded in the "Chinese Pharmacopoeia" include dry suspension, tablet, capsule, granule and injection. Among them, the dry suspension is a variety that has been included since the 2000 edition of the Pharmacopoeia. The dosage form has the characteristics of easy swallowing, easy dose distribution, less irritation to the gastrointestinal tract, and easy absorption. Azithromycin has strong antibacterial activity against a variety of Gram-positive and negative bacteria, especially against Haemophilus influenzae. Due to its bacteriostatic properties, in the published articles on the microbial limits of various dosage forms of azithromycin, the supernatant after centrifug...

AI Technical Summary

Problems solved by technology

Compared with the previous version of the Pharmacopoeia, the centrifugal precipitation method is deleted, which can more truly reflect the microbial contamination of the drug, but it also brings certain difficulties to the microbial limit method for confirming strong bacteriostatic drugs

When exploring the applicability test of microbial limit aerobic bacteria and control bacteria method of azithromycin dry suspension, it is found that the membrane filtration method is used, and the filtration speed affects the applicability test result of the microbial limit method, but the pharmacopoeia does not clearly stipulate the filtration speed

[0003] Through the above analysis, the existing problems and defects of the prior art are: the detection accuracy of the existing limit detection method is not high: the Pharmacopoeia has made clear regulations on important factors such as the filter membrane and flushing volume of the membrane filtration method, but the filtration speed is not the same. not specified

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