Preparation method for acotiamide hydrochloride composition capsule

The technology of acotiamide hydrochloride and composition is applied in the field of preparation of acotiamide hydrochloride composition capsules, and can solve the problems of poor stability, easy moisture absorption of acotiamide hydrochloride capsules, low dissolution rate, etc.

Inactive Publication Date: 2018-01-05
甘宜玲
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The present invention aims to explore the preparation method of wet granulation, overcome technical problems such as easy moisture absorption, low dissolution rate and poor stability of acotiamide hydrochloride capsules obtained by the existing wet granulation method, and o

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  • Preparation method for acotiamide hydrochloride composition capsule
  • Preparation method for acotiamide hydrochloride composition capsule
  • Preparation method for acotiamide hydrochloride composition capsule

Examples

Experimental program
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preparation example Construction

[0038] The preparation method of acotiamide hydrochloride capsules:

[0039] (1) Raw material preparation: Acotiamide hydrochloride, microcrystalline cellulose, starch, tyrosine, sodium alginate are mixed and pulverized, passed through an 80-mesh sieve first, and then repeatedly passed through a 100-mesh sieve twice; the hypromellose Prepare a 5% solution and use it as an adhesive for subsequent use;

[0040] (2) Granulation: Add the pulverized and sieved material into a wet granulator and mix evenly, the mixing speed is 400-600 rpm, and the mixing time is 5-6 minutes; then add 5% hypromellose Solution-made soft material, granulated with 18-mesh sieve, dried at 50°C for 40 minutes, granulated with 20-mesh sieve.

[0041] (3) Total mixing: place the sized granules and glyceryl behenate in a three-dimensional mixer and mix evenly, the mixing speed is 10-15 rpm, and the mixing time is 8-10 minutes;

[0042] (4) Capsule filling.

[0043] experiment method:

[0044] 1. Liquidit...

experiment example 1

[0065] Experimental Example 1: Prescription Screening Experiment

[0066]

[0067]

[0068] 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.

[0069] 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

[0071] Experimental Example 2: Screening experiment of dosage of glyceryl behenate and sodium alginate

[0072] 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.

[0073] 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 its dosage,

[0074] The slower the disintegration and dissolution rate. Therefore, the inventors selected 14%-18% by weight after a ...

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Abstract

The invention relates to the field of pharmaceutical preparations, and particularly discloses a preparation method for an acotiamide hydrochloride composition capsule. The preparation method includesthe steps of adding acotiamide hydrochloride, microcrystalline cellulose, starch, tyrosine, sodium alginate and glyceryl behenate into 5% of hydroxypropyl methylcellulose solution, conducting capsulation after wet granulation, and obtaining the acotiamide hydrochloride composition capsule. The preparation method is simple, and solves the technical problem that the acotiamide hydrochloride composition capsule obtained by the existing technology of wet granulation is easily-hygroscopic, not high in dissolution rate, poor in stability and the like; therefore, the prepared capsule is not easy to absorb moisture and agglomerate, and has high fluidity and a high dissolution rate, which is beneficial to the safe use and long-term storage of clinical drugs.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of acotiamide hydrochloride composition capsules. 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] Functional Dyspepsia (FD) refers to a group of clinical syndromes originating from the gastroduodenal region, characterized by postprandial fullness discomfort, early satiety, epigastric pain or burning sensation in the upper abdomen. Functional gastrointestinal disorders category. This disease is clinical common disease and fr...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/426A61P1/14
Inventor 甘宜玲
Owner 甘宜玲
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