Microbial limit detection method of miconazole nitrate suppository

Abstract

The invention discloses a microbial limit detection method of miconazole nitrate suppository. The method comprises dissolving sample with sodium chloride-peptone buffer solution (pH 7.0) containing 10 vol% polysorbate 80 (Tween 80), adding 20ml of isopropyl myristate, and washing with aqueous solution containing 0.1 vol% polysorbate 80 and 0.1 wt% peptone. Membrane filtration method is adopted for bacteria, mildew, yeast, Staphyloccocus aureus and Monilia albican, with recovery rate all above 70%. Culture medium dilution method is adopted to detect Pseudomonas Aeruginosa. The addition of isopropyl myristate can accelerate fat / water layer separation, shorten experiment time, stabilize flow rate, reduce test cost, and achieve strong operability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for checking the microbial limit of miconazole nitrate suppositories. Background technique [0002] Miconazole nitrate is a broad-spectrum antifungal drug, which has a strong inhibitory effect on the growth of various fungi, especially Candida, and has antibacterial effect on some Gram-positive bacteria. In the microbial limit inspection, because antibacterial drugs can inhibit the growth and reproduction of certain microorganisms, false negative results will appear in conventional inspections, but this does not mean that there are no microorganisms or even pathogenic microorganisms in the drug, and these microorganisms contaminated After the drug enters the human body, some microorganisms will revive and reproduce, endangering human health. [0003] The excipients used in the miconazole nitrate suppositories currently on the market generally fall into three categories...

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Problems solved by technology

[0008] 1. The organic solvent isopropyl myristate directly added in the preparation process of need testing solution destroys the living environment of bacteria, which is unfavorable for the growth of bacteria; Bacteria cause damage; pH7.0 sodium chloride-peptone buffer solution with 10% polysorbate 80 is used as diluent, and 0.1% peptone aqueous solution with 0.1% polysorbate 80 is used as washing solution; recovery rate is measured by membrane filtration method During the test, the sample is difficult to dissolve in the diluent, and the lipid-water layering speed is slow

It not only prolongs the test time, but also it is difficult to wash during the inspection of mold, yeast, and control bacteria (Staphylococcus aureus, Candida albicans). When the flushing volume is close to 200ml, membrane blockage often occurs, which makes the test impossible to continue

[0009] 2. In the verification process of bacteria, mold and yeast methods, some washing methods use 1000ml / membrane and 100ml / time washing method, the washing time is too long, the cost is high, and the washing process also causes damage to bacteria, which takes a long time Time washing may also lead to microbial contamination; in addition, because different manufacturers have adopted different excipients, for example, the excipients of some manufacturers are esters and EDTA, and the excipients can enhance the antibacterial strength of the sample, but the excipients The more excipients, the more difficult it is for the sample to dissolve, the amount of washing solution should fully take into account the influence of different excipients

[0010] 3. The verification method of control bacteria Staphylococcus aureus and Pseudomonas aeruginosa both adopt membrane filtration method, and the verification method of Candida albicans is lacking

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