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Ciprofloxacin hydrochloride oral solid preparation and preparation process thereof

A technology of ciprofloxacin hydrochloride and solid preparation, applied in the directions of pharmaceutical formulation and drug delivery, can solve the problems of inconsistent drug efficacy, influence drug efficacy, large difference in pH of gastrointestinal tract, etc., so as to ensure drug safety and improve biological efficiency. The effect of the degree of utilization and the simple preparation process

Inactive Publication Date: 2014-12-10
赵明亮
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

"Because ciprofloxacin hydrochloride is absorbed in the gastrointestinal tract, the alkaline environment of the small intestine causes some ciprofloxacin hydrochloride to precipitate and crystallize, which cannot be absorbed by the human body, which affects the efficacy of the drug, and at the same time, it is easy to form urinary stones
In addition, the pH of the gastrointestinal tract varies greatly between different patients. Therefore, for patients with different alkaline gastrointestinal tracts, taking this drug may easily cause differences in absorption in the body, resulting in inconsistent drug effects for patients with the same condition.

Method used

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  • Ciprofloxacin hydrochloride oral solid preparation and preparation process thereof
  • Ciprofloxacin hydrochloride oral solid preparation and preparation process thereof
  • Ciprofloxacin hydrochloride oral solid preparation and preparation process thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0018]

[0019] Preparation Process:

[0020] (1) Prescription quantity Weigh ciprofloxacin hydrochloride and hydroxypropyl methylcellulose, add to 2000ml water, 100r / min electric stirring, stirring for 2h, obtain a clear and transparent solution, spray this solution into the spray through a peristaltic pump In the dryer, the spray temperature is set to 70°C, and the spray-dried fine powder is collected to obtain a dispersion;

[0021] (2) Take the above-mentioned dispersion in proportion, and put the multi-sport mixer with the crospovidone and sodium stearate fumarate of the prescribed amount, mix for 10min, measure the semi-finished product content, then carry out on the automatic capsule filling machine Filling at a filling speed of 800 capsules / min to obtain ciprofloxacin hydrochloride capsules, which are inner-wrapped on an aluminum-plastic packaging machine, and the heating temperature of the inner-wrapped blister board is 110° C., and finally the outer packaging is r...

Embodiment 2

[0023]

[0024] Preparation Process:

[0025] (1) Prescription quantity Weigh ciprofloxacin hydrochloride and hydroxypropyl methylcellulose, add to 2500ml water, 150r / min electric stirring, stirring for 1.5h, obtain clear and transparent solution, spray this solution into the In the spray dryer, the spray temperature is set to 75°C, and the spray-dried fine powder is collected to obtain a dispersion;

[0026] (2) Take the above-mentioned dispersion in proportion, put the multi-sport mixer with the sodium carboxymethyl starch and magnesium stearate of the prescribed amount, mix for 15min, measure the semi-finished product content, then fill on the automatic capsule filling machine, fill The speed is 700 capsules / min to obtain ciprofloxacin hydrochloride capsules, which are inner-wrapped on an aluminum-plastic packaging machine, and the heating temperature of the inner-wrapped blister board is 105° C., and finally the outer packaging is ready.

Embodiment 3

[0028]

[0029] Preparation Process:

[0030] (1) Prescription quantity Weigh ciprofloxacin hydrochloride and hydroxypropyl methylcellulose, add them to 2200ml of water, 200r / min electric stirring, stirring for 1h, obtain a clear and transparent solution, and spray this solution into the spray through a peristaltic pump In the dryer, the spray temperature is set to 65°C, and the spray-dried fine powder is collected to obtain a dispersion;

[0031] (2) Take the above-mentioned dispersion in proportion, put in a multi-motion mixer with the sodium carboxymethyl starch and magnesium stearate of the prescribed amount, mix for 20min, measure the semi-finished product content, then fill on the automatic capsule filling machine, fill The speed is 650 capsules / min to obtain ciprofloxacin hydrochloride capsules, which are inner-wrapped on an aluminum-plastic packaging machine, and the heating temperature of the inner-wrapped blister board is 105° C., and finally the outer packaging i...

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Abstract

The invention relates to a ciprofloxacin hydrochloride oral solid preparation and a preparation process thereof. The oral solid preparation contains ciprofloxacin hydrochloride, hydroxypropyl methyl cellulose, a disintegrating agent and a lubricant. The preparation process comprises the following steps: dissolving the ciprofloxacin hydrochloride and the hydroxypropyl methyl cellulose in water and carrying out spray drying so as to obtain a dispersion body; evenly mixing the dispersion body with the disintegrating agent and the lubricant; filling the obtained mixture in a capsule shell or pressing the obtained mixture to form a tablet. The oral solid preparation is stable under an alkaline condition, and can be used for effectively avoiding the problem that the ciprofloxacin hydrochloride is separated out in an alkaline intestinal environment.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a solid oral preparation containing ciprofloxacin hydrochloride and a preparation process thereof. Background technique [0002] Ciprofloxacin Hydrochloride (Ciprofloxacin Hydrochloride) is a third-generation quinolone antibacterial drug. By acting on the A subunit of bacterial DNA helicase, it inhibits DNA synthesis and replication and leads to bacterial death. It has a broad-spectrum antibacterial effect and good bactericidal effect. The antibacterial activity against all bacteria is 2-4 times stronger than that of norfloxacin and enoxacin. Antibacterial effect. In particular, it has high antibacterial activity against aerobic Gram-negative bacilli, and has good antibacterial effect on the following bacteria in vitro: most bacteria of the Enterobacteriaceae family, including Citrobacter, cloacae, Enterobacter aerogenes, Escherichia coli, Klebsi...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/496A61K47/38
Inventor 赵明亮
Owner 赵明亮
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