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

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

Example Embodiment

[0056] Experimental example 1: Lubricant type screening test

[0057] This test examines the lubricants of the present invention to investigate the influence of lubricant types on product dissolution. Using the preparation method of the present invention to prepare tablets, only part of the experimental data is listed here; the screening results are shown in Table 1.

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

[0059]

[0060] It can be seen that lubricants have a great influence on the dissolution of acotiamide hydrochloride tablets. Commonly used lubricants are magnesium stearate, talc, micronized silica gel, silicon dioxide, and sodium stearyl fumarate. , Sodium lauryl sulfate, polyethylene glycol, glyceryl behenate, etc., which give acotiamide hydrochloride tablets with low dissolution.

[0061]

[0062]

Example Embodiment

[0063] Experimental example 3: Performance detection

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

Example Embodiment

[0085] Experimental example 4: accelerated test

[0086] Take 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%. Samples will be taken at the end of the first, second, third, and sixth month. The key survey items are determined. The test results are shown in Table 4.

[0087] Table 4 Accelerated test results

[0088]

[0089]

[0090] The same experiment was performed on other embodiments of the present invention, and results similar to those of the embodiments 1 and 2 of the present invention were obtained; from the experimental results, it can be seen that the product of the embodiment of the present invention has a temperature of 40°C±2°C and a relative humidity of 75%± Under the condition of 5%, it has high stability in terms of dissolution, 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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