Sterility testing method of antifungal pharmaceutical preparation

2014 
The invention relates to a sterility testing method of an antifungal pharmaceutical preparation, and in particular to a sterility testing method of an antifungal pharmaceutical caspofungin preparation. The sterility testing method disclosed by the invention comprises the following steps of: (1) preparing washing fluid: dissolving cyclodextrin or derivatives thereof by using water to obtain a solution, split-charging, and sterilizing at 121 DEG C for 15 min, thereby obtaining the washing fluid; (2) preparing a test solution: respectively and completely transferring the antifungal pharmaceutical preparation in 0.9% sterile sodium chloride solution, thereby obtaining the test solution; (3) filtering and washing a film: filtering the test solution obtained in the step (2) through a film, and washing the washing fluid obtained in the step (1) for many times; (4) testing: testing according to the sterility testing method in the appendix XIH in the second department of the Chinese Pharmacopoeia in 2012 edition, and taking aspergillus niger as positive control bacteria, wherein a fungal culture medium is an improved martin culture medium or a tryptone soya broth culture medium. The sterility testing method of the antifungal pharmaceutical preparation is accurate and reliable.
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