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Dispersible tablet of prulifloxacin and preparation method thereof

A technology of prulifloxacin and dispersible tablets, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve problems such as intestinal stimulation, many impurities, and not very rigorous , to achieve the effect of high bioavailability, high stability and high dissolution rate

Active Publication Date: 2014-08-20
JUMPCAN PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The provided prulifloxacin uses talcum powder as a lubricant. However, talc powder has certain pharmacological effects, and it is not very strict to be used as a pharmaceutical excipient, and the dispersible tablet has poor stability and more impurities
In addition, talcum powder has been proven to have an irritating effect on the intestinal tract, which further affects the safety of the drug

Method used

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  • Dispersible tablet of prulifloxacin and preparation method thereof
  • Dispersible tablet of prulifloxacin and preparation method thereof
  • Dispersible tablet of prulifloxacin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Precision weighing:

[0033] Prulifloxacin 120g

[0034] Microcrystalline Cellulose - 101 260g

[0035] Low-substituted hydroxypropyl cellulose 24g

[0036] Aspartame 24g

[0037] PVP 30 13g

[0038] Magnesium Stearate 5g

[0039] (1) Pass microcrystalline cellulose-101, low-substituted hydroxypropyl cellulose, and aspartame through an 80-mesh sieve for use; prulifloxacin is crushed and passed through a 150-mesh sieve for use, and weigh the PVPk 30 , dissolved in medicinal ethanol to make a solution with a mass volume ratio of 10% (g / 100ml);

[0040] (2) Weigh the pulverized prulifloxacin, microcrystalline cellulose and 15g of low-substituted hydroxypropyl cellulose and mix them in a wet mixing granulator with a stirring speed of 100r / min and a mixing time of 5 to 7 minutes; add 0.3L10% PVPk 30 Ethanol solution, mixed and stirred for 10 to 15 minutes, and after discharging, it was made into wet granules by a swinging granulator;

[0041] (3) Dry the prepared w...

Embodiment 2

[0044] Precision weighing:

[0045] Prulifloxacin 160g

[0046] Microcrystalline Cellulose - 101 320g

[0047] Low-substituted hydroxypropyl cellulose 40g

[0048] Aspartame 40g

[0049] PVP 30 22g

[0050] Magnesium Stearate 6g

[0051] (1) Pass microcrystalline cellulose-101, low-substituted hydroxypropyl cellulose, and aspartame through an 80-mesh sieve for use; prulifloxacin is crushed and passed through a 150-mesh sieve for use, and weigh the PVPk 30 , dissolved in medicinal ethanol to make a solution with a mass volume ratio of 10% (g / 100ml);

[0052] (2) Weigh the pulverized prulifloxacin, microcrystalline cellulose and 25g of low-substituted hydroxypropyl cellulose and mix them in a wet mixing granulator, the stirring speed is 100r / min, and the mixing time is 5-7 minutes; add 0.4L10% PVPk 30 Ethanol solution, mixed and stirred for 10 to 15 minutes, and after discharging, it was made into wet granules by a swinging granulator;

[0053] (3) Dry the prepared wet...

Embodiment 3

[0056] Precision weighing:

[0057] Prulifloxacin 132g

[0058] Microcrystalline Cellulose - 101 290g

[0059] Low-substituted hydroxypropyl cellulose 32g

[0060] Aspartame 27g

[0061] PVP 30 17g

[0062] Magnesium Stearate 5.3g

[0063] (1) Pass microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and aspartame through an 80-mesh sieve for later use; prulifloxacin is crushed through a 150-mesh sieve for later use, and weigh the PVPk 30 , dissolved in medicinal ethanol to make a solution with a mass volume ratio of 10% (g / 100ml);

[0064] (2) Weigh the pulverized prulifloxacin, microcrystalline cellulose and 20g of low-substituted hydroxypropyl cellulose and mix them in a wet mixing granulator with a stirring speed of 100r / min and a mixing time of 5 to 7 minutes; add 0.35L10% PVPk 30 Ethanol solution, mixed and stirred for 10 to 15 minutes, and after discharging, it was made into wet granules by a swinging granulator;

[0065] (3) Dry the prepared w...

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PUM

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Abstract

The invention provides a dispersible tablet containing an antibacterial agent prulifloxacin and a preparation method thereof. The preparation is composed of: prulifloxacin, microcrystalline cellulose-101, low-substituted hydroxypropyl cellulose, aspartame, Magnesium stearate, PVPk30; Its weight ratio is: prulifloxacin 120-160 parts, microcrystalline cellulose-101 260-320 parts, low-substituted hyprolose 24-40 parts, aspartame 24- 30 parts, PVPk3013-22 parts, magnesium stearate 5-6 parts. The dispersible tablet prepared by the invention greatly improves the dissolution rate after taking, improves the bioavailability, improves the compliance of patients, and is especially suitable for patients who have difficulty in swallowing solids.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a new pharmaceutical preparation containing an antibacterial agent prulifloxacin, in particular to a dispersible tablet of prulifloxacin and a preparation method thereof. Background technique [0002] Infectious disease is the most common clinical disease, involving almost all clinical specialties, and it is also one of the most common causes of patient death. According to the report of the World Health Organization in 1997, the number of deaths from infectious diseases was as high as 33.3% of the total number of deaths from various causes. In my country, due to the large rural population and the still backward medical insurance system, the main diseases that endanger people's health are still infectious diseases caused by various pathogenic bacteria, and are also the main cause of disability and death. [0003] Fluoroquinolones (fluoroquinolones) are rapidly developed...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/496A61K47/38A61P31/04
Inventor 曹龙祥董自波杭夏清邵建国
Owner JUMPCAN PHARMA GRP
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