Sterile detection method of voriconazole for injection

A voriconazole and detection method technology, which is applied in the field of sterility detection of voriconazole for injection, can solve the problems of reduced detection rate, excessive flushing volume, and high detection cost, so as to reduce antibacterial performance, save detection cost, and improve accuracy Effect

Pending Publication Date: 2020-10-30
LIVZON PHARM GRP INC
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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

Method used

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  • Sterile detection method of voriconazole for injection
  • Sterile detection method of voriconazole for injection
  • Sterile detection method of voriconazole for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0045] The specification of the voriconazole for injection detected in this embodiment is 0.2 g / bottle, and the batch number of the voriconazole is V190701.

[0046]Specifically, the sterility testing process of the voriconazole for injection is as follows:

[0047] 1 Preparation and counting of bacteria solution

[0048] Select bacteria powders containing six kinds of bacteria including Escherichia coli, Staphylococcus aureus, Clostridium sporogenes, Bacillus subtilis, Candida albicans and Aspergillus niger, the concentration of each bacteria powder is 110-1100cfu, before use First dissolve the corresponding bacterial powder with 1.1ml of the supporting solvent and mix well, so that the concentration of the bacteria is 100-1000cfu / ml. When using, add 0.1ml of the bacteria liquid, that is, the concentration of the added bacteria is 10-100cfu / 0.1ml. At the same time, take 0.1ml of Escherichia coli, Staphylococcus aureus, and Bacillus subtilis into tryptone soy agar medium, and...

Embodiment 2

[0062] Examples 2-3 were tested according to the sterility detection method provided in Example 1, the difference being that the batch numbers of voriconazole for injection used were different, specifically, the batch number of voriconazole used in Example 2 was V190801, and the batch number of voriconazole used in Example 3 was V190801. The batch number is V190802. The difference between Example 4 and Example 1 is that the batch numbers of voriconazole for injection used are different V200101, V191201, and V191202, and both the flushing solution and the dissolving solution are 0.1% sulfobutylbeta-cyclodextrin sodium solution. And the enumeration result of each bacterial species in the bacterium liquid prepared in embodiment 2-embodiment 4 sees the following table:

[0063]

[0064] The sterility test result of embodiment 2 is as follows:

[0065]

[0066] Note: "—" indicates clarification without growth; "+" indicates good growth. The test article grew aseptically wit...

Embodiment 3

[0067] The sterility test result of embodiment 3 is as follows:

[0068]

[0069] Note: "—" indicates clarification without growth; "+" indicates good growth. The test article grew aseptically within 14 days.

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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...

Claims

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Application Information

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IPC IPC(8): C12Q1/04
CPCC12Q1/04
Inventor 侯艳辉廖春花张润容黄滔付龙王皓
Owner LIVZON PHARM GRP INC
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