Acotiamide hydrochloride sustained-release pellet and preparation method thereof

A technology of acotiamide hydrochloride and sustained-release pellets, which is applied in the field of medicine, can solve the problems of high incidence of adverse reactions, large fluctuations in blood drug concentration, and many times of taking drugs, and achieve small differences in individual bioavailability and reduce Dosing frequency and effect of improving bioavailability

Inactive Publication Date: 2016-04-13
BEIJING COLLAB PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After taking the medicine, acotiamide hydrochloride dissolves quickly in the body, resulting in large fluctuations in the blood concentration of the drug in the body, a high incidence of adverse reactions, and many times of taking the medicine, resulting in poor compliance

Method used

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  • Acotiamide hydrochloride sustained-release pellet and preparation method thereof
  • Acotiamide hydrochloride sustained-release pellet and preparation method thereof
  • Acotiamide hydrochloride sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] formula:

[0065] Ball core: acotiamide hydrochloride 2g, microcrystalline cellulose 80g, lactose 18g, hypromellose 3g.

[0066] Coating ingredients: EudragitNE30D5g, PEG60001g, triethyl citrate 0.2g, talc powder 0.5g, titanium dioxide 0.1g.

[0067] Preparation method: take acotiamide hydrochloride, microcrystalline cellulose, and lactose, pass through a 100-mesh sieve, mix evenly, add hypromellose to make a soft material, and then move the soft material into an extrusion machine to extrude into a high-quality Density strips, and finally in the centrifugal spheroidization machine, the strips are broken into granules and rounded to make pellets, which are coated with coating ingredients and finally packed into bags. Get the prepared acotiamide hydrochloride sustained-release assay pellets with a diameter of ≤2.5mm.

[0068] Get the prepared acotiamide hydrochloride sustained-release pellets, measure the release curve in water, 0.1M hydrochloric acid solution, pH4.0 ca...

Embodiment 2

[0071] formula:

[0072] Ball core: acotiamide hydrochloride 10g, microcrystalline cellulose 70g, lactose 18g, hypromellose 4g.

[0073] Coating ingredients: Eudragit NE30D 5g, PEG60001g, triethyl citrate 0.2g, talc powder 1g, titanium dioxide 0.1g.

[0074] Preparation method: Take acotiamide hydrochloride, microcrystalline cellulose, and lactose and pass through a 100-mesh sieve, mix evenly, and use hypromellose solution as a binder in a centrifugal coating granulator to make pellets , coat the pellets with coating ingredients, and finally pack into capsules. Get the prepared acotiamide hydrochloride sustained-release assay pellets with a diameter of ≤2.5mm.

[0075] Get the prepared acotiamide hydrochloride sustained-release pellets, measure the release curve in water, 0.1M hydrochloric acid solution, pH4.0 carbonate buffer, pH6.8 phosphate buffer respectively, the results are shown in figure 2 .

[0076] The results showed that the prepared acotiamide hydrochloride su...

Embodiment 3

[0078] formula:

[0079] Ball core: 20g of acotiamide hydrochloride, 70g of microcrystalline cellulose, 10g of lactose, 4g of hypromellose. Coating ingredients: 7 g of ethyl cellulose, 300.5 g of povidone K, 0.3 g of triethyl citrate, 0.8 g of talc, and 0.2 g of titanium dioxide.

[0080] Preparation method: take acotiamide hydrochloride, microcrystalline cellulose, and lactose, pass through a 100-mesh sieve, mix evenly, add hypromellose to make a soft material, and then move the soft material into an extrusion machine to extrude into a high-quality Density strips, and finally in the centrifugal spheroidization machine, the strips are broken into granules and rounded to make pellets, which are coated with coating ingredients, and finally loaded into capsules. Get the prepared acotiamide hydrochloride sustained-release assay pellets with a diameter of ≤2.5mm.

[0081] Get the prepared acotiamide hydrochloride sustained-release pellets, measure the release curve in water, 0.1M...

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Abstract

The invention belongs to the field of medicine, and discloses an acotiamide hydrochloride sustained-release pellet and a preparation method thereof. The acotiamide hydrochloride sustained-release pellet consists of the following components in parts by weight: 2-50 parts of acotiamide hydrochloride, 20-95 parts of a thinner, 1-10 parts of a binding agent, 1-30 parts of a sustained-release material, 0-5 parts of a pore-forming agent, 0-5 parts of a plasticizer, 0-20 parts of an anti-sticking agent and 0-5 parts of a light-screening agent. By mixing the thinner, the binding agent, the sustained-release material and the acotiamide hydrochloride according to certain proportions, a drug release rate can be effectively regulated, and the acotiamide hydrochloride can be slowly released in vivo so as to generate a stable blood concentration and to avoid adverse reactions caused by relatively great fluctuation of the blood concentration in vivo in the case that the acotiamide hydrochloride dissolves rapidly in vivo. The preparation method of the acotiamide hydrochloride sustained-release pellet is simple to operate, low in production cost and high in efficiency, and the preparation method is applicable to the industrial production of the acotiamide hydrochloride sustained-release pellets.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to acotiamide hydrochloride sustained-release pellets and a preparation method thereof. Background technique [0002] Functional dyspepsia (FD), also known as dyspepsia, refers to a group of patients with discomfort symptoms such as upper abdominal pain, upper abdominal distension, early satiety, belching, loss of appetite, nausea, and vomiting, and the organic diseases causing the above symptoms are excluded after examination. clinical syndrome. Symptoms are persistent or recurrent, with a duration of more than one month or accumulated for more than twelve weeks in the past twelve months. FD is the most common functional gastrointestinal disease clinically. According to the statistics of hospital patients in western countries, FD patients account for 2-3% of the total number of medical patients and account for 20-40% of digestive system diseases. According to domestic statist...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/426A61P1/14A61P1/08
CPCA61K31/426A61K9/0002A61K9/1652A61K9/5073
Inventor 张良军邱敦有邹德超方胜王珂赵大龙
Owner BEIJING COLLAB PHARMA
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