Microbial limit detection method of miconazole nitrate suppository

A miconazole nitrate suppository and microbiological limit technology, applied in the field of medicine, can solve the problems of slow lipid-water layering, destroying the living environment of bacteria, prolonging the test time, etc.

CN102586393AInactive Publication Date: 2012-07-18SHAANXI INST FOR FOOD & DRUG CONTROL
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
Publication Date
2012-07-18
Estimated Expiration
Not applicable · inactive patent

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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.
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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...

Examples

Embodiment Construction

[0049] Concrete test process of the present invention is as follows:

[0050] 1 Instruments and materials

[0051] 1.1 Instrument

[0052] Water-proof electric heating constant temperature incubator Chongqing Four Experimental Instrument Factory production model: WGP-600

[0053] Biochemical incubator Shanghai Yiheng Technology Co., Ltd. production model: LRH-250

[0054] Mold incubator Chongqing Wanda production model: SHH-250JS

[0055] Biological safety cabinet Shanghai Lishen Scientific Instrument Co., Ltd. Production model: HF Safe 760s

[0056] 1.2 Medium

[0057] Nutrient agar medium batch number: 090912 produced by Beijing Sanyao Science and Technology Development Company

[0058] Rose Bengal Sodium Agar Medium Lot Number: 0911172 Produced by Beijing Sanyao Technology Development Company

[0059] Nutrient broth culture medium Batch number: 100310, produced by Beijing Sanyao Science and Technology Development Company

[0060] Improved Martin Medium Batch No.: 091...