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Troxipide dispersible tablet and preparation method thereof

A technology for traxipide and dispersible tablets, applied in the field of medicine, can solve the problems of long disintegration time and single taking method, and achieve the effects of short disintegration time, high bioavailability and good dispersion uniformity

Active Publication Date: 2013-12-04
NEW FOUNDER HLDG DEV LLC +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing dosage forms on the market in China are only tablets and capsules. These two dosage forms take a long time to disintegrate and take a single method

Method used

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  • Troxipide dispersible tablet and preparation method thereof
  • Troxipide dispersible tablet and preparation method thereof
  • Troxipide dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1. The selection of disintegrating agent

[0017] Select PVPP (cross-linked polyvinylpyrrolidone), CMS-Na (sodium carboxymethyl starch), LS-HPC (low-substituted hydroxypropyl cellulose) as disintegrants, the dosage is 15%, each before and after granulation Add half, then detect the appearance and pink uniformity of the tablet, the results are shown in Table 1.

[0018] Table 1. Preliminary selection of disintegrants

[0019]

[0020] For the four prepared tablets, the disintegrating agent LS-HPC added in prescription 3 had almost no disintegration effect; when disintegrating in prescription 2, the surface layer disintegrated faster, while the inside was more difficult to disintegrate, but the tablet The appearance of the formulation is the best; the disintegrating agent added in prescription 1 has a greater effect, but the appearance is loose and there are cracks; the appearance and dispersion uniformity of prescription 4 all meet the requirements, which ...

Embodiment 2

[0021] Example 2. Selection of Adhesive

[0022] Based on the selection of filler MCC (microcrystalline cellulose) and disintegrant PVPP (cross-linked polyvinylpyrrolidone), CMS-Na (sodium carboxymethyl starch), the concentration of the binder is investigated, and the dispersion uniformity is the main Index, Tablet Appearance Compressibility as the secondary index to select the best formulation. The results are shown in Table 2.

[0023] Table 2. Choice of Binder Concentration

[0024]

[0025] Note: Measuring method for dispersion uniformity (s): Take 2 tablets of the test product, place in 100ml water at 20°C±1°C, shake, and record the total disintegration time.

[0026] It can be seen from Table 2 that considering the tablet dispersion uniformity, appearance and compressibility, the most preferred 2% PVPk30 aqueous solution is the binder.

Embodiment 3

[0027] Embodiment 3. the preparation of troxipide dispersible tablet A

[0028] Prescription: Traxipide 100g

[0029] Microcrystalline Cellulose 120g

[0030] Sodium carboxymethyl starch 10g

[0031] Cross-linked polyvinylpyrrolidone 30g

[0032] Magnesium Stearate 1.3g

[0033] Micronized silica gel 1.3g

[0034] Get the prescription amount of troxipide, microcrystalline cellulose, cross-linked polyvinylpyrrolidone and sodium starch glycolate, sieve and mix evenly, use 60mL of 1% PVPk30 aqueous solution (concentration unit is g / mL, that is, 1g PVPk30 is dissolved in 100mL of water (the same below) made of soft materials, granulated with 20-mesh nylon sieve, dried at 70°C for 2 hours, granulated with 24-mesh nylon sieve, then added with micropowder silica gel and magnesium stearate, mixed evenly, measured content, pressed into tablets, after passing the inspection Package.

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Abstract

The invention discloses a troxipide dispersible tablet and a preparation method thereof. The troxipide dispersible tablet contains 30-40% by weight of troxipide and 10-30% by weight of sodium carboxymethyl starch and / or cross-linked polyvinyl pyrrolidone serving as a disintegrating agent, and can further contain an adhesive, a filling agent, a sweetening agent, a lubricant and other pharmaceutical auxiliary materials. The dispersible tablet has the characteristics of short disintegration time, good dispersion uniformity, rapidness in medicament dissolution, rapidness in absorption, high bioavailability and convenience for administration.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a troxipide dispersible tablet and a preparation method thereof. Background technique [0002] Gastric ulcer is a common disease with high morbidity and long course in the population. Its pathogenesis is mainly caused by the imbalance between ulcer-causing factors and anti-ulcer factors. In the past, too much emphasis was placed on the attacking effect of gastric acid and pepsin, but in recent years, anti-ulcer factors such as the gastric mucosal barrier, cytoprotective factors, and local blood circulation of the gastric mucosa have begun to be emphasized. [0003] Troxipide, the chemical name is (±) 3,4,5-trimethoxy-N-3-azacyclohexyl formamide, it is a novel defense factor enhancer developed by Japan Kyorin Pharmaceutical Co., Ltd., its The curative effect is definite, the side effect is mild, the anti-gastritis and gastric ulcer effect is high, and there is no obvious toxic side effect...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4462A61P1/04
Inventor 赵洪武唐凤
Owner NEW FOUNDER HLDG DEV LLC
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