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Norfloxacin capsule and preparation method thereof

A technology for norfloxacin and capsules, which is applied to the field of norfloxacin capsules and their preparation, can solve the problems of differences in dissolution rate and bioavailability, slow dissolution rate, unattainable curative effect, etc., so as to ensure product stability and continuous The effect of production, guarantee possibility

Active Publication Date: 2020-04-07
北京鑫开元医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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

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  • Norfloxacin capsule and preparation method thereof
  • Norfloxacin capsule and preparation method thereof
  • Norfloxacin capsule and preparation method thereof

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preparation example Construction

[0036] On the other hand, the present invention also provides a method for preparing norfloxacin capsules, which includes the following steps:

[0037] In step S10, the raw material norfloxacin is crushed and passed through a screen to obtain the raw material norfloxacin meeting the particle size requirements;

[0038] Step S20, respectively pass the filler, disintegrant and binder through the first mesh screen to obtain filler, disintegrant and binder meeting the particle size requirements;

[0039] Step S30: Weigh the raw material norfloxacin, fillers, disintegrants and binders that meet the particle size requirements according to the batch amount and mix them evenly in a three-dimensional mixer to obtain a mixture;

[0040] Step S40, adding the mixed material to a dry granulator to obtain broken dry particles;

[0041] Step S50, sizing the broken dry particles through a second mesh screen to obtain dry particles;

[0042] In step S60, the lubricant is weighed according to the batch am...

Embodiment 1

[0052] Based on the preparation of 140mg per capsule, norfloxacin capsules include the following ingredients by mass percentage:

[0053]

[0054] The preparation process is a dry granulation process and includes the following steps:

[0055] S1: First crush the raw material norfloxacin, sieving, and collect the part that meets the required particle size d90=30-35;

[0056] S2: Pass the microcrystalline cellulose, sodium carboxymethyl starch and pregelatinized starch through a 60 mesh screen to obtain microcrystalline cellulose, sodium carboxymethyl starch and pregelatinized starch that meet the particle size requirements;

[0057] S3: Weigh the aforementioned raw materials norfloxacin, microcrystalline cellulose, sodium carboxymethyl starch, and pregelatinized starch that meet the particle size requirements according to the batch amount and mix them evenly in a three-dimensional mixer to obtain a mixture;

[0058] S4: Put the above mixture into the dry granulator, set the feeding frequ...

Embodiment 2

[0067] Based on the preparation of 140mg per capsule, norfloxacin capsules include the following ingredients by mass percentage:

[0068]

[0069] The preparation process is a dry granulation process and includes the following steps:

[0070] S1: First crush the raw material norfloxacin, sieving, and collect the part meeting the required particle size d90 = 20-25 microns;

[0071] S2: Pass the microcrystalline cellulose, sodium carboxymethyl starch and pregelatinized starch through a 60 mesh screen to obtain microcrystalline cellulose, sodium carboxymethyl starch and pregelatinized starch that meet the particle size requirements;

[0072] S3: Weigh the aforementioned raw materials norfloxacin, microcrystalline cellulose, sodium carboxymethyl starch, and pregelatinized starch that meet the particle size requirements according to the batch amount and mix them evenly in a three-dimensional mixer to obtain a mixture;

[0073] S4: Put the above mixture into the dry granulator, set the feedin...

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Abstract

The invention, which belongs to the field of medicines, particularly relates to a norfloxacin capsule and a preparation method thereof. The preparation method of the norfloxacin capsule comprises thefollowing steps: crushing norfloxacin serving as a raw material and performing sieving, and collecting parts meeting the required particle size; respectively screening a filler, a disintegrating agentand an adhesive by using a sieving net; weighing the raw materials of norfloxacin, the filler, the disintegrating agent and the adhesive according to the batch feeding amount, and uniformly mixing the raw materials in a three-dimensional mixer; adding the mixed material into a dry type granulator to obtain crushed dry particles; sieving the crushed dry particles by a sieve and carrying out granulating to obtain dry particles; weighing a lubricant, and then uniformly mixing the dry particles and the lubricant in the three-dimensional mixer to obtain particles; and filling the particles to obtain the norfloxacin capsule. According to the invention, particles with good fluidity are obtained by adopting a dry granulation process through novel prescription composition; and a lubricant is added, so that the stability of the product and the possibility of continuous production can be ensured.

Description

Technical field [0001] The invention belongs to the field of medicine, and specifically relates to a norfloxacin 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] At present, the domestic preparations of norfloxacin are mainly injections, oral tablets and oral hard capsules. The common specification of oral hard capsules is 100mg. Norfloxacin is absorbed quickly but not completely when taken orally on...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/496A61K47/12A61K47/38A61P31/04
CPCA61K9/4858A61K9/4866A61K31/496A61P31/04
Inventor 霍志强赵婷陈华吕永磊谭丽鹤霍燕戴信敏
Owner 北京鑫开元医药科技有限公司