Troxipide dispersible tablet and preparation method thereof

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

Active Publication Date: 2012-05-23
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] Example 1. Selection of disintegrant

[0017] Choose 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, and then check the appearance and pink uniformity of the tablets. The results are shown in Table 1.

[0018] Table 1. Preliminary selection of disintegrants

[0019]

[0020] For the four tablets prepared, the disintegrant LS-HPC in prescription 3 has almost no disintegration effect; when prescription 2 disintegrates, the surface layer disintegrates faster, and the inner layer is more difficult to disintegrate, but the tablet The appearance of the agent is the best; the disintegrant 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 meet the requirements, which is the better solution.

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 (carboxymethyl starch sodium), the concentration of the binder was investigated, and the dispersion uniformity was the main Index, tablet appearance compressibility is a secondary index to choose the best prescription. The results are shown in Table 2.

[0023] Table 2. Selection of binder concentration

[0024]

[0025] Note: Dispersion uniformity (s) measurement method: Take 2 pieces of the test product, place them in 100ml water at 20℃±1℃, shake, and record the total disintegration time.

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

Embodiment 3

[0027] Example 3. Preparation of Trixipide Dispersible Tablets A

[0028] Prescription: Trixipide 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] Take the prescription amount of trexipide, microcrystalline cellulose, cross-linked polyvinylpyrrolidone and sodium carboxymethyl starch, sieving and mixing, and use 60mL of 1% PVPk30 aqueous solution (concentration unit is g / mL, that is, 1g PVPk30 is dissolved in 100mL water, the same below) make soft material, granulate with 20 mesh nylon sieve, dry for 2h at 70℃, granulate with 24 mesh nylon sieve, then add micronized silica gel and magnesium stearate and mix well, determine content, press tablet, and pass 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, and particularly relates to trixipide dispersible tablets and a preparation method thereof. Background technique [0002] Gastric ulcer is a common disease with high incidence 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 effects of gastric acid and pepsin. Only in recent years has it begun to pay attention to anti-ulcer factors such as gastric mucosal barrier, cytoprotective factors, and local blood circulation of gastric mucosa. [0003] Trixipide, whose chemical name is (±)3,4,5-trimethoxy-N-3-azacyclohexylcarboxamide, is a new type of defensive factor enhancer developed by Japan Xinglin Pharmaceutical Co., Ltd. The curative effect is definite, the side effect is slight, it has high anti-gastritis and gastric ulcer effect, and has no obvious side effects, es...

Claims

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Application Information

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