Sterile detection method of voriconazole for injection

Abstract

The invention relates to the technical field of drug detection, in particular to a sterile detection method of voriconazole for injection. Accordingt to the sterile detection method of voriconazole for injection, when a membrane filtration method is adopted to carry out sterile detection on voriconazole for injection, a sulfobutyl beta-cyclodextrin sodium solution with the concentration not higherthan 1% is adopted as a flushing fluid. According to the sterile detection method, the antibacterial activity of voriconazole can be remarkably reduced, the accuracy of the sterile detection result of voriconazole for injection is improved, meanwhile, the sample amount treated by each membrane during membrane filtration can be increased, and the detection cost of an enterprise is reduced.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a sterility detection method of voriconazole for injection. Background technique [0002] Voriconazole is a new type of triazole antifungal drug. Compared with fluconazole, voriconazole has a wider antibacterial spectrum and stronger antibacterial efficacy. It not only inhibits the growth of yeast, but also has the important characteristic of killing Aspergillus. In view of the strong antifungal effect of voriconazole, how to effectively remove its antifungal activity during sterility testing is critical. Therefore, it is necessary to find a suitable method to remove the antibacterial effect of voriconazole, so as to establish an effective sterility test suitable for the quality control of this drug. [0003] In the prior art, the membrane filtration method is often used to carry out sterility testing of voriconazole. The washing solution used in this method has pH7.0-sod...

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Problems solved by technology

[0003] In the prior art, the membrane filtration method is often used to carry out sterility testing of voriconazole. The washing solution used in this method has pH7.0-sodium chloride peptone buffer solution, 0.1% peptone solution and 0.9% sodium chloride solution, etc., but the above washing None of the solutions can remove the bacteriostasis of voriconazole very well, and then lead to inaccurate sterility test results. In order to improve the accuracy of the test results in the prior art, the sample concentration is reduced and the flushing volume is increased, but excessive flushing volume Reduce the detection rate. At the same time, too many filter membranes are used, which increases the testing cost of the enterprise. For example, for voriconazole for injection with a specification of 0.2 g / bottle, the sterility test volume of one batch of samples is 30 bottles (including 10 bottles of positive samples) ), but at least 5 sets of triple aseptic incubators are needed to completely remove its antibacterial properties, that is, each set of aseptic incubators can only process 6 bottles of samples, and the detection amount of each film is only 2 bottles, thus It can be seen that although the voriconazole sterility test process used in the prior art reduces the sample volume and increases the flushing volume, the accuracy of the test results can be improved to a certain extent, but the test cost is too high

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