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Oral norfloxacin capsule and preparation method thereof

A technology for norfloxacin and capsules, which is applied to the field of norfloxacin oral capsules and their preparation, can solve the problems of slow dissolution rate and unattainable curative effect, and achieves the effects of stable quality, definite curative effect and simple production process.

Inactive Publication Date: 2019-04-16
WUHAN TONGJI MODERN PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Norfloxacin produced by Japan Kyorin Pharmaceutical Co., Ltd. is in the form of tablets. The dissolution rate and bioavailability of capsules currently on the market in China are very different. Norfloxacin dissolves easily in the dissolution medium of pH 6.8 and in water. Agglomerated into agglomerates, its dissolution rate is slow, resulting in the clinical efficacy of norfloxacin capsules used in clinical practice can not be consistent with the norfloxacin tablets of Japan Xinglin

Method used

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  • Oral norfloxacin capsule and preparation method thereof
  • Oral norfloxacin capsule and preparation method thereof
  • Oral norfloxacin capsule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0037] An oral capsule of norfloxacin of this embodiment includes norfloxacin, sodium starch glycolate and pharmaceutically acceptable excipients, wherein the mass ratio of norfloxacin to sodium starch glycolate is 23.8:1.

[0038] The contents of the capsule are composed as follows:

[0039]

[0040] Wherein: the particle size of the norfloxacin raw material is D50≤60μm, D90≤180μm; the particle size of the sodium starch glycolate is D50≤30μm, D90≤75μm.

[0041] The preparation method of the aforementioned norfloxacin oral capsule is as follows:

[0042] Sieve norfloxacin into particle size D50≤60μm, D90≤180μm, sodium starch glycolate to filter out particle size D50≤30μm, D90≤75μm, and then separate norfloxacin and sodium starch glycolate in a three-dimensional mixer Mix for 10 minutes, then add the prescribed amount of lactose, silicon dioxide, and magnesium stearate and mix for 5 minutes in a three-dimensional mixer; finally, fill in the 2# capsule shell at 278 mg / capsule to make 10...

Embodiment 2

[0044] An oral capsule of norfloxacin of this embodiment includes norfloxacin, sodium starch glycolate and pharmaceutically acceptable excipients, wherein the mass ratio of norfloxacin to sodium starch glycolate is 13.3:1.

[0045] The contents of the capsule are composed as follows:

[0046]

[0047] Wherein: the particle size of the norfloxacin raw material is D50≤60μm, D90≤180μm; the particle size of the sodium starch glycolate is D50≤30μm, D90≤75μm.

[0048] The preparation method of the aforementioned norfloxacin oral capsule is as follows:

[0049] Sieve norfloxacin into particle size D50≤60μm, D90≤180μm, sodium starch glycolate to filter out particle size D50≤30μm, D90≤75μm, and then separate norfloxacin and sodium starch glycolate in a three-dimensional mixer Mix for 10 minutes, then add the prescribed amount of lactose, silicon dioxide, and magnesium stearate, mix for 5 minutes in a three-dimensional mixer, and finally fill in the 2# capsule shell at 260 mg / capsule to make 10...

Embodiment 3

[0051] An oral capsule of norfloxacin of this embodiment includes norfloxacin, sodium starch glycolate and pharmaceutically acceptable excipients, wherein the mass ratio of norfloxacin to sodium starch glycolate is 16.6:1.

[0052] The contents of the capsule are composed as follows:

[0053]

[0054] Wherein: the particle size of the norfloxacin raw material is D50≤60μm, D90≤180μm; the particle size of the sodium starch glycolate is D50≤30μm, D90≤75μm.

[0055] The preparation method of the aforementioned norfloxacin oral capsule is as follows:

[0056] Sieve norfloxacin into particle size D50≤60μm, D90≤180μm, sodium starch glycolate to filter out particle size D50≤30μm, D90≤75μm, and then separate norfloxacin and sodium starch glycolate in a three-dimensional mixer Mix for 10 minutes, then add the prescribed amount of lactose, silicon dioxide, and magnesium stearate, mix for 5 minutes in a three-dimensional mixer, and finally fill in the 2# capsule shell at 259 mg / capsule to make 10...

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Abstract

The invention relates to an oral norfloxacin capsule and a preparation method thereof and belongs to the field of pharmaceutical preparations. The oral norfloxacin capsule contains norfloxacin, sodiumcarboxymethyl starch and a pharmaceutically acceptable auxiliary material, wherein the mass ratio of the norfloxacin to the sodium carboxymethyl starch is 10-30 to 1. A norfloxacin raw material has the particle diameter D50 of 100 microns or below, and D90 of 240 microns or below, preferably D50 of 60 microns or below and D90 of 180 microns or below. The particle size of the sodium carboxymethylstarch is D50 of 40 microns or below and D90 of 120 microns or below, preferably D50 of 30 microns or below and D90 of 75 microns or below. The key process for the preparation of the contents is thatnorfloxacin and sodium carboxymethyl starch are premixed and then are mixed with other pharmaceutically acceptable auxiliary materials. The norfloxacin-containing capsule is consistent with norfloxacin tablet reference preparations produced by Japan Xinglin joint-stock company on the market at present in in-vitro dissolution.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations. More specifically, the invention relates to a norfloxacin oral capsule and a preparation method thereof. Background technique [0002] Norfloxacin is a third-generation quinolone antibacterial drug. In 1984, Norfloxacin capsules developed by Japan Xinglin Pharmaceutical Co., Ltd. were first marketed in Japan, and the marketed dosage form was tablets. It is suitable for urinary tract infections, gonorrhea, prostatitis, intestinal infections and typhoid fever and other salmonella infections caused by sensitive bacteria. Has a broad-spectrum antibacterial effect. It mainly acts on the A subunit of bacterial DNA helicase to inhibit DNA synthesis and replication and cause bacterial death. [0003] The basic information of Norfloxacin is as follows: [0004] Chemical name: 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid [0005] Molecular formula: C 16 H 18 FN 3 O 3 ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/36A61K31/496A61P31/04
CPCA61K9/4866A61K31/496A61P31/04
Inventor 李亦武
Owner WUHAN TONGJI MODERN PHARMA TECH CO LTD
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