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Acotiamide hydrochloride composite capsule

A technology of acotiamide hydrochloride and a composition, applied in the field of pharmaceutical preparations, can solve the problems of poor fluidity of acotiamide hydrochloride capsules, no further prompts, obvious differences in filling amount and the like

Inactive Publication Date: 2017-12-22
甘宜玲
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Invention patent CN104523686A proposes that the possible reason for the low solubility of acotiamide hydrochloride is that its own solubility is small, and it tends to become viscous when mixed with water, so that the solvent cannot enter the interior of the material, so that the dissolution method changes from dissolution to erosion, which greatly reduces the solubility of the raw material and dissolution rate
However, how to obtain a better dissolution rate through a suitable prescription and process, improve its fluidity and loading difference, reduce its moisture content, and further improve its stability, the prior art does not give further hints, in view of this, especially proposed this invention
[0008] The present invention aims to overcome the problems of poor fluidity, low dissolution rate, obvious difference in filling capacity and hygroscopicity of the existing acotiamide hydrochloride capsules, and the obtained acotiamide hydrochloride capsules have high stability, good fluidity and low filling capacity. The difference is low, the dissolution rate is high, and the test found that its hygroscopicity is significantly reduced, which greatly improves the safety and effectiveness of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0051] Experimental Example 1: Prescription Screening Experiment

[0052]

[0053]

[0054] Since acotiamide hydrochloride is easy to absorb moisture and is unstable to heat and humidity, the dry granulation method is preferred to prevent the influence of the temperature of the water agent on the raw and auxiliary materials. The specific preparation method is as follows: crush the raw and auxiliary materials separately, pass through a 80-mesh sieve, and mix evenly Send it to a dry granulator for granulation, 18-mesh granulation, and capsule filling.

[0055] There are too many screening experimental data, and only some important experimental data are listed here. Due to the poor fluidity of acotiamide hydrochloride and starch, the loading capacity is poorly controlled, which brings inconvenience to production. The inventor found through a large number of experimental screenings that sodium alginate was used as a disintegrating agent, and glyceryl behenate was added as a...

experiment example 2

[0056] Experimental Example 2: Screening experiment of dosage of glyceryl behenate and sodium alginate

[0057] This experimental example is used as a dosage screening experiment of glyceryl behenate and sodium alginate when preparing acotiamide hydrochloride capsules to control the weight percentage of each raw material: acotiamide hydrochloride 25%-30%, micro 30%-35% of crystalline cellulose, 22%-26% of starch, and 0.1%-0.3% of tyrosine, on the basis of which the weight percent content of glyceryl behenate and sodium alginate is adjusted.

[0058] The amount of disintegrating agent sodium alginate has a great influence on the disintegration time and dissolution rate, and if the amount is too small, it cannot meet the requirements of disintegration and dissolution. Sodium alginate aqueous solution is a viscous disintegrating agent, the larger the dosage, the slower the disintegration and dissolution rate. Therefore, the inventors selected 14%-18% by weight after a large numb...

experiment example 3

[0064] Experimental Example 3: Performance Testing

[0065] According to the prescription provided by the present invention and the comparison of the performance of the acotiamide hydrochloride capsules prepared by the preparation method and the performance of the prior art acotiamide hydrochloride capsules are shown in Table 3:

[0066] Table 3 performance test results

[0067]

[0068] As can be seen from the above table, the acotiamide hydrochloride capsules of the present invention have high dissolution rate, good fluidity, low loading difference, significantly reduced hygroscopicity, and its performance is significantly better than that of the existing preparation acotiamide hydrochloride.

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Abstract

The invention relates to the field of pharmaceutical preparations, and particularly discloses an acotiamide hydrochloride composite capsule. The acotiamide hydrochloride composite capsule is prepared from acotiamide hydrochloride, microcrystal cellulose, starch, tyrosine, sodium alginate and glyceryl behenate. The acotiamide hydrochloride composite capsule preferably selects the acotiamide hydrochloride, microcrystal cellulose, starch, tyrosine, sodium alginate and glyceryl behenate as the composition of the acotiamide hydrochloride, and the synergistic effect can improve the stability, mobility and dissolution rate of the acotiamide hydrochloride, can reduce the moisture absorption performance and can facilitate the safe application and long-term storage of clinical drugs.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an acotiamide hydrochloride composition capsule. 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] Alteicosamide Hydrochloride Tablets is the world's first drug for the treatment of functional dyspepsia. It mainly works by inhibiting acetylcholinesterase, which can promote gastric motility, improve gastric accommodation disorders, and enhance gastric fundus expansion. However, since alteicosamide hydrochloride tablet is an insoluble drug, it is sl...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/38A61K47/36A61K47/18A61K47/14A61K31/426A61P1/14
CPCA61K9/4858A61K9/4866A61K31/426
Inventor 甘宜玲
Owner 甘宜玲
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