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Preparation method of ciprofloxacin hydrochloride tablets

A technology of ciprofloxacin hydrochloride and tablet compression, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas. It can solve the problems of large differences in dissolution rate and stickiness, and achieve different Small size, smooth drug release, good quality effect

Inactive Publication Date: 2018-02-09
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide a preparation method of ciprofloxacin hydrochloride tablets, which solves the problems of splits, sticky punches, and large differences in dissolution rate. The process is simple, easy to implement, and suitable for large-scale production.

Method used

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  • Preparation method of ciprofloxacin hydrochloride tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Prescription composition:

[0025] Ciprofloxacin hydrochloride 588g, lactose 40g, starch 60g, crospovidone 7g, magnesium stearate 3g; the lactose is Foremost315 / 316 type.

[0026] The preparation method of described ciprofloxacin hydrochloride tablet is as follows:

[0027] (1) Ciprofloxacin hydrochloride is passed through an 80-mesh sieve, and lactose, starch, crospovidone and magnesium stearate are passed through an 80-mesh sieve respectively;

[0028] (2) take by weighing ciprofloxacin hydrochloride, lactose, starch, crospovidone, magnesium stearate;

[0029] (3) Add ciprofloxacin hydrochloride, lactose, starch, and crospovidone into the mixer, and mix for 25 minutes at a speed of 8 rpm;

[0030] (4) Magnesium stearate was added to the mixer, and mixed for 5 minutes at a rotating speed of 8 rpm;

[0031] (5) The mixture is directly compressed into tablets, and the average hardness of the tablets is 60N.

Embodiment 2

[0033] Prescription composition:

[0034] Ciprofloxacin hydrochloride 588g, starch 60g, lactose 40g, microcrystalline cellulose 50g, crospovidone 12g, magnesium stearate 4g; starch is compressible starch, lactose is Foremost 315 / 316 type, microcrystalline Cellulose is PH102 type.

[0035] The preparation method of described ciprofloxacin hydrochloride tablet is as follows:

[0036] (1) Ciprofloxacin hydrochloride is passed through a 100-mesh sieve, and starch, lactose, microcrystalline cellulose, crospovidone, and magnesium stearate are passed through a 100-mesh sieve respectively;

[0037] (2) Take by weighing ciprofloxacin hydrochloride, starch, lactose, microcrystalline cellulose, crospovidone, magnesium stearate;

[0038] (3) Add ciprofloxacin hydrochloride, starch, lactose, microcrystalline cellulose, and crospovidone into the mixer, and mix for 25 minutes at a speed of 8 rpm;

[0039] (4) Magnesium stearate was added to the mixer, and mixed for 5 minutes at a rotating...

Embodiment 3

[0042] Prescription composition:

[0043] Ciprofloxacin hydrochloride 588g, starch 100g, lactose 50g, microcrystalline cellulose 50g, crospovidone 15g, magnesium stearate 5g; starch is compressible starch, lactose is Foremost 315 / 316 type, microcrystalline Cellulose is PH102 type.

[0044] The preparation method of described ciprofloxacin hydrochloride tablet is as follows:

[0045] (1) Ciprofloxacin hydrochloride is passed through a 120-mesh sieve, and starch, lactose, microcrystalline cellulose, crospovidone, and magnesium stearate are passed through a 120-mesh sieve respectively;

[0046] (2) Take by weighing ciprofloxacin hydrochloride, starch, lactose, microcrystalline cellulose, crospovidone, magnesium stearate;

[0047] (3) Add ciprofloxacin hydrochloride, starch, lactose, microcrystalline cellulose, and crospovidone into the mixer, and mix for 25 minutes at a speed of 8 rpm;

[0048] (4) Magnesium stearate was added to the mixer, and mixed for 5 minutes at a rotatin...

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Abstract

The invention relates to a preparation method of ciprofloxacin hydrochloride tablets, belonging to the technical field of pharmaceutical preparations. According to the preparation method of the ciprofloxacin hydrochloride tablets, ciprofloxacin hydrochloride is taken as a main material, a filling agent, a disintegrating agent and a lubricating agent are taken as auxiliary materials, and the ciprofloxacin hydrochloride tablets are prepared by adopting a direct powder compression process; the filling agent is a mixture of starch and one or two of lactose or microcrystalline cellulose; the disintegrating agent is one or two of crospovidone or low-substituted hydroxypropyl cellulose. The preparation method provided by the invention solves the problems of tablet cracking, sticking and picking,great dissolubility difference and the like, and is simple in technology, easy to implement and suitable for large-scale production.

Description

technical field [0001] The invention relates to a preparation method of ciprofloxacin hydrochloride tablets, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Ciprofloxacin Hydrochloride Tablets is a third-generation quinolone antibacterial drug with strong bactericidal power, wide antibacterial spectrum and good clinical effect. It is currently a commonly used drug in large and medium-sized hospitals. However, there are many domestic manufacturers, and there are significant differences in dissolution rate between different manufacturers and different batches of the same manufacturer, especially the dissolution rate difference between the preparation units at the 5min and 10min sampling points [For details, see: Chinese Journal of New Drugs, 3(3 ): 51-54; Tianjin Pharmacy, 1996, 8(2): 64-66; China Pharmaceutical Industry Journal, 1997, 28(7): 308; Modern Medicine and Health, 2011, 27(7): 1095-1096]. [0003] Because ciprofloxacin...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/36A61K47/26A61K47/38A61K31/496A61P31/04
CPCA61K9/2018A61K9/2027A61K9/2054A61K9/2059A61K9/2095A61K31/496
Inventor 黄京山陈传永陈德仁邵伟
Owner REYOUNG PHARMA
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