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A kind of trimetazidine hydrochloride osmotic pump controlled-release tablet and preparation method thereof

A controlled-release technology of trimetazidine hydrochloride and osmotic pumps, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc., which can solve the problem of unfavorable drug effects, short duration, and taking before bedtime The drug is in the body in the early morning, the risk of cardiovascular disease is high and the risk is unfavorable, so as to achieve the effect of reducing production cost and reducing the impact

Active Publication Date: 2015-08-19
HEFEI LIFEON PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If there is a hysteresis phenomenon in the sustained-release preparation, it means that the patient cannot get the drug supplement in the body in time after taking the medicine, which is not good for the drug effect; on the other hand, if the sustained-release preparation cannot continuously control the release of the drug, or the release time is too short , the drugs taken before going to bed have been completely eliminated in the body in the morning, which is also unfavorable for controlling the high risk of cardiovascular disease in the morning

Method used

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  • A kind of trimetazidine hydrochloride osmotic pump controlled-release tablet and preparation method thereof
  • A kind of trimetazidine hydrochloride osmotic pump controlled-release tablet and preparation method thereof
  • A kind of trimetazidine hydrochloride osmotic pump controlled-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] composition Dosage (mg) trimetazidine hydrochloride 35 microcrystalline cellulose 30 Polyethylene oxide (5 million) 5 Sodium chloride 45 lactose 45 dextrin 30 Povidone K30 10 Magnesium stearate 1

[0042] composition Dosage (mg) Cellulose acetate 20 Dibutyl phthalate 0.2 PEG-1500 4 acetone Appropriate amount

[0043] Preparation:

[0044] (1) After mixing the raw and auxiliary materials, moisten with absolute ethanol, granulate with 30 mesh, dry at 40°C, control the water content below 3%, and sieve with 24 mesh for granulation. Add the prescribed amount of magnesium stearate, and press the tablet with a shallow concave of φ8mm to obtain the osmotic pump tablet core.

[0045] (2) Coating liquid configuration: Take a certain amount of acetone, add cellulose acetate and PEG-1500 into the acetone solution, stir to dissolve; add plasticizer, stir and mix well. The soli...

Embodiment 2

[0050] composition Dosage (mg) trimetazidine hydrochloride 35 microcrystalline cellulose 80 Hydroxypropyl Methyl Cellulose (K100M) 20 Sodium chloride 30 dextrin 25 Povidone K30 10 Magnesium stearate 1

[0051] composition Dosage (mg) Cellulose acetate 20 Dibutyl phthalate 0.2 PEG-1500 4 acetone Appropriate amount

[0052] Preparation method: same as the preparation method in Example 1, and the coating weight gain is the same as that of Example 1.

Embodiment 3

[0054] composition Dosage (mg) trimetazidine hydrochloride 35 microcrystalline cellulose 40 Polyethylene oxide (5 million) 5 Hydroxypropyl Methyl Cellulose (K100M) 15 Sodium chloride 25 Mannitol 20 dextrin 80 Povidone K30 10 Magnesium stearate 1

[0055] composition Dosage (mg) Cellulose acetate 20 PEG-6000 5 acetone Appropriate amount

[0056] Preparation method: the same preparation method as in Example 1, using φ8.5mm shallow concave tablet compression, and the weight gain of the coating is the same as in Example 1.

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Abstract

The invention discloses a trimetazidine hydrochloride osmotic pump controlled-release tablet and a preparation method thereof, which is a single-chamber osmotic pump controlled-release preparation, comprising a single-layer tablet core, an insoluble semipermeable film coat and small holes for drug release. The present invention can effectively improve drug hysteresis and drug release terminal residues by screening and optimizing the combination of fillers, adjust drug release rate and controlled release time, and reach a certain blood drug concentration in a relatively short period of time, forming a stable and constant rate release, and realizing rapid drug release. The purpose of drug controlled release design is to achieve effective, stable drug release and reduce side effects.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a trimetazidine hydrochloride osmotic pump controlled-release tablet and a preparation method thereof. Background technique [0002] Oral osmotic pump controlled-release technology has been used for more than 30 years since the first product was launched in the 1980s. It uses the osmotic pressure from the drug system to provide drug release power. Compared with the matrix type and the reservoir It is one of the most promising controlled-release technologies. One, it is especially suitable for the treatment of chronic cardiovascular and cerebrovascular diseases. [0003] Among all kinds of osmotic pump technologies, single-chamber osmotic pumps (also known as primary osmotic pumps or basic osmotic pumps, elementary osmotic pumps, EOP) have the simplest structure and preparation process: the conventional tablet preparation process is used to compress the drug-containing ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/44A61K31/495A61K47/38A61P9/10
Inventor 季俊虬高美华陈军夏军何杰
Owner HEFEI LIFEON PHARMA
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