Norfloxacin composition

A technology of norfloxacin and composition, which is applied in the field of norfloxacin pharmaceutical composition, can solve problems such as unsatisfactory dissolution of norfloxacin preparations, achieves simple and operable prescription process, solves slow dissolution and improves dissolution. Effect

Inactive Publication Date: 2018-02-06
迪沙药业集团(天津)药物研究有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Purpose of the invention: to provide a simple and easy-to-implement method for industrialization to solve the problem of unsatisfactory dissolution of norfloxacin preparations

Method used

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  • Norfloxacin composition
  • Norfloxacin composition
  • Norfloxacin composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Press the prescription described in table 2, prepare 3 batches of norfloxacin capsules by the preparation method described in technical scheme part, each prescription prepares 10000 capsules.

[0041] Table 2

[0042]

[0043] The 60min cumulative dissolution amount and f2 value of the gained capsules are shown in Table 3, and the dissolution curve results are shown in the appendix image 3 .

[0044] table 3

[0045]

Embodiment 2

[0054] Select lactose as filler, prepare norfloxacin capsules according to the prescription described in table 6, and prepare 10000 capsules for each prescription.

[0055] Table 6

[0056]

[0057] Prepare 10,000 capsules according to the preparation method described in the technical scheme and the preparation method for mixing powder and directly filling capsules.

[0058] The 60min cumulative dissolution of the obtained capsule is 96.2%, compared with the reference preparation, its f2 value is 72, and the dissolution data curve results are shown in the attached Figure 4 .

Embodiment 3

[0067] To investigate whether different proportions of lactose in the formulation affect the dissolution of the preparation. The prescription is shown in Table 8, and 10,000 norfloxacin capsules are prepared for each prescription.

[0068] Table 8

[0069]

[0070] According to the preparation method of dry granulation described in the technical scheme, 10000 capsules were prepared respectively.

[0071] The 60min cumulative dissolution amount and f2 value of the gained capsules are shown in Table 9, and the dissolution curve results are shown in the appendix Figure 5 .

[0072] Table 9

[0073]

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Abstract

The invention relates to a norfloxacin composition and belongs to the technical field of pharmacy. According to the technical scheme provided by the invention, the norfloxacin composition is preparedfrom norfloxacin, lactose, cross-linked sodium carboxymethyl cellulose and other pharmaceutically acceptable auxiliary materials. The pharmaceutically acceptable auxiliary materials comprise a fillingagent and a lubricant and the granularity of the norfloxacin is distributed in a range that D90 is greater than or equal to 200mu m and less than or equal to 300mu m. The invention provides the stable norfloxacin composition with a dissolution behavior which is the same as that of an original research.

Description

technical field [0001] The invention relates to a norfloxacin pharmaceutical composition, which belongs to the technical field of pharmacy. Background technique [0002] Norfloxacin is a third-generation fluoroquinolone antibacterial drug, developed by Kyorin Corporation of Japan in 1978, first listed in Japan in 1984, and listed in the United States in 1986. Norfloxacin has a broad-spectrum antibacterial effect, especially for aerobic Gram-negative bacilli. It acts on the A subunit of bacterial DNA helicase, inhibits DNA synthesis and replication, and leads to bacterial death. [0003] Norfloxacin chemical name: 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid; molecular formula: C 16 h 18 FN 3 o 3 ; Molecular weight: 319.24; Its structural formula is: [0004] [0005] The chemical structure of norfloxacin has both amino and carboxyl groups, and the pH dependence of solubility exists, and there is an isoelectric point at pH6.7, so nor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/20A61K47/26A61K47/38A61K31/496A61P31/04
CPCA61K9/2095A61K9/2018A61K9/2054A61K9/4858A61K9/4866A61K31/496
Inventor 吴成杨邓若寒薛颖娜
Owner 迪沙药业集团(天津)药物研究有限公司
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