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Medicine tablets for treating dyspepsia and preparing method of medicine tablets

A technology for indigestion and tablets, which is applied to the digestive system, drug combination, pill delivery, etc., can solve the problem of poor fluidity of acotiamide hydrochloride capsules, poor dissolution of acotiamide hydrochloride capsules, and increased water content. and other problems to achieve the effect of improving safety and effectiveness, good fluidity, and reduced hygroscopicity

Inactive Publication Date: 2017-12-15
甘宜玲
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Random selection of drug ingredients may also lead to poor dissolution of acotiamide hydrochloride capsules, increase in related substances, increase in water content, etc., or even failure to form granules
[0007] The present invention aims to overcome the problems of poor fluidity, low dissolution rate, obvious weight difference and hygroscopicity of the existing acotiamide hydrochloride capsules, and the obtained acotiamide hydrochloride capsules have high stability, good fluidity and low loading capacity. Low, high dissolution rate, and the test found that its hygroscopicity is significantly reduced, greatly improving the safety and effectiveness of medication

Method used

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  • Medicine tablets for treating dyspepsia and preparing method of medicine tablets
  • Medicine tablets for treating dyspepsia and preparing method of medicine tablets
  • Medicine tablets for treating dyspepsia and preparing method of medicine tablets

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0056] Experimental Example 1: Lubricant Type Screening Test

[0057] In this test, the lubricant described in the present invention is investigated to investigate the influence of the lubricant type on the dissolution rate of the product. Tablets were prepared by the preparation method of the present invention, and only part of the experimental data is listed here; the screening results are shown in Table 1.

[0058] Table 1 Results of screening experiments for lubricant types

[0059]

[0060] As can be seen from this, lubricants have a great influence on the dissolution rate of acotiamide hydrochloride tablets, commonly used lubricants such as magnesium stearate, talcum powder, micropowder silica gel, silicon dioxide, sodium stearyl fumarate , sodium lauryl sulfate, polyethylene glycol, glyceryl behenate, etc., the dissolution rate of acotiamide hydrochloride tablets obtained from them is relatively low.

[0061]

[0062]

experiment example 3

[0063] Experimental Example 3: Performance Testing

[0064] The comparison of the performance of acotiamide hydrochloride tablets prepared according to the prescription provided by the invention and the preparation method and the performance of prior art acotiamide hydrochloride tablets is shown in Table 3:

experiment example 4

[0085] Experimental Example 4: Accelerated Test

[0086] Get the samples of Examples 1 and 2 of the present invention and place them for 6 months at a temperature of 40°C ± 2°C and a relative humidity of 75% ± 5%. Take a sample at the end of the 1st, 2nd, 3rd, and 6th months respectively. Sex key investigation items are measured. The test results are shown in Table 4.

[0087] Table 4 Accelerated test results

[0088]

[0089]

[0090] Carry out identical experiment to other embodiment of the present invention, obtain the result similar to embodiment 1, 2 of the present invention; As can be seen from the experimental result, the product of embodiment of the present invention is 75% ± 75% ± 2 ℃ at temperature 40 ℃ ± 2 ℃, relative humidity. Under the condition of 5%, it has high stability in terms of dissolution rate, related substances, and crystal form.

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Abstract

The invention relates to the technical field of medicine, in particular to medicine tablets for treating dyspepsia and a preparing method of the medicine tablets. The medicine tablets comprise acotiamide hydrochloride, inositol, saccharose, calcium carboxymethylcellulose, and magnesium lauryl sulfate. According to the preparing method, the tablets are prepared through a method of pressing powder into the tablets. The preparing method is simple, through the mutual synergic effect, the stability, mobility and are improved, the dissolution rate of acotiamide hydrochloride is increased, hygroscopicity is lowered, and the safe use and long-term storage of clinic drugs are facilitated.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical tablet for treating dyspepsia and a preparation method thereof. Background technique [0002] Acotiamide hydrochloride, jointly developed by Japan's Zeli Shinyaku Co., Ltd. and Anstelles Pharmaceuticals, was the first to be listed in Japan on June 6, 2013. The trade name is Chemical name: N-[2-(diisopropylamino)ethyl]-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]-4-thiazolecarboxamide hydrochloride compound, molecular formula: C21H30N4O5S HCl 3H2O; molecular weight: 541.06, and its structure is as shown in formula (I): [0003] [0004] Acotiamide Tablets is a new muscarinic M1, M2 antagonist, adenosine A1 receptor antagonist, suitable for postprandial fullness, epigastric flatulence, and early satiety caused by functional dyspepsia. The Ministry of Health, Labor and Welfare of Japan approved the listing of acotiamide tablets in Japan in March 2013. ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/426A61K47/38A61K47/20A61K47/26A61K47/10A61P1/14
CPCA61K9/2013A61K9/2018A61K9/2054A61K9/2095A61K31/426
Inventor 甘宜玲
Owner 甘宜玲
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