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Metoprolol tartrate sustained release tablet and preparation method thereof

A technology for metoprolol tartrate and torolol sustained-release tablets, which can be used in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as sticking and impacting production, etc. , to achieve the effect of strong hygroscopicity, improved stability and good fluidity

Inactive Publication Date: 2013-11-27
SHANGHAI SINE PROMOD PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the high solubility of metoprolol tartrate in water, which can reach 1.5g / mL in actual measurement, most of the traditional wet granulation uses starch, dextrin or starch dextrin as the binder dissolved in purified water. It is easy to cause sticking during tablet compression, which seriously affects production

Method used

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  • Metoprolol tartrate sustained release tablet and preparation method thereof
  • Metoprolol tartrate sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Preparation: Put metoprolol tartrate and hypromellose E50 in a KJZ-10 fast stirring granulator, stir rapidly for 5 minutes to mix evenly, add 220g of 80% ethanol solution and stir rapidly for 5 minutes to make a soft material; then YK -160 oscillating granulator 20 mesh sieve granulation, as drug-containing granules; mix lactose and hypromellose K4M evenly, 80% ethanol solution 440g, the same method as the soft material, granulate, as blank granules; drug-containing granules and Blank granules were dried in a CT-C-F hot air circulation oven at 60±5°C for 7 hours, passed through a YK-160 oscillating granulator with a 20-mesh sieve for granulation, added silicon dioxide and magnesium stearate, mixed evenly, and ZP33 rotary tabletting Machine, Φ8.5mm round concave punching tablet, the film coating powder (stomach-soluble type) purchased from Shanghai Colorcon Coating Technology Co., Ltd. is added to the stirred 30% ethanol solution to make film coating powder (Stoma...

Embodiment 2

[0031] Preparation: Put metoprolol tartrate and hypromellose E50 in a KJZ-10 fast stirring granulator, stir rapidly for 5 minutes to mix evenly, add 230g of 80% ethanol solution, and stir rapidly for 5 minutes to make a soft material; then YK-160 oscillating granulator 20 mesh sieve granules, as drug-containing granules; mix lactose and hypromellose K4M evenly, 80% ethanol solution 430g, the same method as the soft material, granulate, as blank granules; drug-containing granules and blank granules were dried in a CT-C-F hot air circulation oven at 60±5°C for 7 hours, passed through a YK-160 swinging granulator with a 20-mesh sieve for granulation, added silicon dioxide and magnesium stearate and mixed evenly, and ZP33 rotary press Tablet machine, Φ8.5mm round concave punched tablets, film coating powder (stomach-soluble type) purchased from Shanghai Colorcon Coating Technology Co., Ltd., added to the stirred 30% ethanol solution to make film coating powder (Stomach-solu...

Embodiment 3

31g

[0037] Preparation: Put metoprolol tartrate and hypromellose E50 in a KJZ-10 fast stirring granulator, stir quickly for 5 minutes to mix evenly, add 200g of 80% ethanol solution and stir quickly for 5 minutes to make a soft material; YK- Granulate with a 20-mesh sieve in a 160 swinging granulator, and use it as a drug-containing granule; mix lactose and hypromellose K4M evenly, add 460g of 80% ethanol solution, and use the same method as the soft material, granulate, and use it as a blank granule; the drug-containing granule and blank The granules were dried in a CT-C-F hot air circulation oven at 60±5°C for 7 hours, passed through a YK-160 swinging granulator with a 20-mesh sieve for granulation, added silicon dioxide and magnesium stearate and mixed evenly, and ZP33 rotary tablet press , Φ8.5mm round concave punched tablet, film coating powder (gastric dissolving type) purchased from Shanghai Colorcon Coating Technology Co., Ltd., added to the stirred 30% ethan...

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Abstract

The invention provides a metoprolol tartrate sustained release tablet. The metoprolol tartrate sustained release tablet is prepared from the following components in percentage by mass: 100 of metoprolol tartrate, 60-80 of retardant, 20-40 of filling agent, 2-10 of lubricating agent, 50-90 of adhesive and 2.5-4 of film coating powder. Aiming at the problem that adhesive brewing is easily caused in production because the metoprolol tartrate is easy to dissolve in water, the invention provides a two-step granulation method comprising the steps of respectively preparing medicine contained granules and blank granules, drying the medicine contained granules and the blank granules, totally mixing the medicine contained granules and the blank granules and tabletting, so that the problem of adhesive brewing in tabletting is solved. In addition, the metoprolol tartrate is strong in moisture absorption property and bitter in taste, and a coating layer can be used for improving the stability of the metoprolol tartrate and masking the bitter taste of the metoprolol tartrate. The metoprolol tartrate sustained release tablet has the advantages that the components of the auxiliary materials are simple, the operation is convenient, the prepared granules are good in flowability, strong in adhesive resistance and incapable of causing adhesive brewing during tabletting, and the coating layer can be used for improving the stability of a drug and masking the bitter tastes of active ingredients and has no affect to the release rate of the tablet. The metoprolol tartrate sustained release tablet is suitable for industrial production and relatively high in application value.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to sustained-release preparations, in particular to a metoprolol sustained-release tablet and a preparation method thereof. Background technique [0002] Metoprolol tartrate, whose chemical name is 1-isopropylamino-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L(+)-tartrate, is a cardiotoxic highly selective beta 1 Receptor blocker, structural formula is as follows: [0003] [0004] Metoprolol tartrate as selective beta 1 Blockers have a relatively selective effect on the heart and are used to treat hypertension, angina pectoris, myocardial infarction, hypertrophic cardiomyopathy, aortic dissection, arrhythmia, hyperthyroidism, and cardiac neurosis. For the treatment of heart failure. Studies have shown that metoprolol can effectively treat hypertension, and long-term use can significantly reduce the risk of death in patients with heart failure. It is one of the first choices of ant...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/138A61K47/38A61K47/10A61P9/12A61P9/10A61P9/00A61P9/06A61P5/16A61P9/04A61P25/00
Inventor 于垂亮孙蓉肖志勇梅锦平
Owner SHANGHAI SINE PROMOD PHARMA
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