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Prostacyclin analogue sustained release preparation

A technology for sustained-release preparations and analogues, which is applied in the field of sustained-release preparations of prostacyclin analogues, can solve the problems of unstable physical and chemical properties of the main drug, improve medication compliance, overcome different tablet hardness and dissolution curve. stable effect

Active Publication Date: 2017-06-13
BEIJING TIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the present invention solves the problem of extremely unstable physical and chemical properties of the main drug itself, and provides a safer, more stable, and more durable oral sustained-release preparation of prostaglandin analogues

Method used

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  • Prostacyclin analogue sustained release preparation
  • Prostacyclin analogue sustained release preparation
  • Prostacyclin analogue sustained release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] formula:

[0031]

[0032] Remarks: *Solvent, removed during preparation.

[0033] Preparation:

[0034] (1) Dissolve beraprost sodium and glutamic acid in purified water for later use;

[0035] (2) Put ethyl cellulose and lactose in a wet granulator, use the solution in (1) as a wetting agent for wet granulation, add the wetting agent by spraying, and control the stirring during the granulation process Paddle speed 150~250 r / min, cutter speed 2000~2500 r / min, liquid spray speed 7.5~12.5g / min;

[0036] (3) After the granules are dried, pass through a 30-mesh sieve for sizing, add magnesium stearate for blending, and compress into tablets.

Embodiment 2

[0038] formula:

[0039]

[0040] Remarks: *Solvent, removed during preparation.

[0041] Preparation:

[0042] (1) Dissolve beraprost sodium and aspartic acid in purified water for later use;

[0043] (2) Put ethyl cellulose, microcrystalline cellulose and lactose in a wet granulator, use the solution in (1) as a wetting agent for wet granulation, add the wetting agent by spraying, and prepare During the granulation process, the speed of the stirring paddle is controlled at 150~250 r / min, the speed of the cutter is at 2000~2500 r / min, and the spraying speed is 7.5~12.5g / min;

[0044] (3) After the granules are dried, pass through a 30-mesh sieve for sizing, add magnesium stearate for blending, and compress into tablets.

Embodiment 3

[0046] formula:

[0047]

[0048] Preparation:

[0049] (1) Mix Beraprost Sodium, Glycine, Lactose and Glyceryl Behenate evenly in equal amounts, and dry granulate with a dry granulator. ~45 r / min, to produce large pieces of particles with suitable hardness;

[0050](2) Pass the above granules through a 30-mesh sieve, weigh them, calculate the amount of magnesium stearate to be added, mix them, and compress them into tablets.

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Abstract

The invention relates to a prostacyclin analogue sustained release preparation, which belongs to a trace sustained release preparation technology. The prostacyclin analogue sustained release preparation contains a prostaglandin analogue, a sustained release material, a lubricating agent and other pharmaceutically accepted additives. A process comprises various simple and convenient granulation processes, including wet granulation, and the sustained release preparation which contains uniform content of main drugs and is released sustainably and stably in vitro is obtained by controlling critical process parameters. According to the prostacyclin analogue sustained release preparation, no organic solvent is used from the composition of the formula to the whole process preparation process; therefore, the prostacyclin analogue sustained release preparation is more environment-friendly and is suitable for wider crowds. Meanwhile, according to the prostacyclin analogue sustained release preparation, the problem that the physicochemical property of the main drugs is extremely unstable is solved, so that a patient can use the preparation more safely and more reliably.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a sustained-release preparation of prostacyclin analogs, which contains active ingredients of prostacyclin analogs and can control stable and sustained drug release. Background technique [0002] Prostacyclin analogues are the earliest class of drugs targeted for the treatment of pulmonary arterial hypertension (PAH), which has changed the poor prognosis of patients with pulmonary arterial hypertension as a milestone. These include intravenous epoprostenol, subcutaneous treprostinil, inhaled iloprost, and oral beraprost. [0003] At present, except for beraprost, which is administered orally, other prostacyclin drugs need intravenous injection or subcutaneous injection or nebulized inhalation. As far as the mode of administration is concerned, oral administration is the most convenient, but due to factors such as its absorption, blood concentration steady-state time, h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/5578A61K31/5585A61K47/10A61K47/38A61K47/32A61K47/36A61K47/14A61K47/18A61P11/00A61P9/12
CPCA61K9/2013A61K9/2027A61K9/2031A61K9/205A61K9/2054A61K31/5578A61K31/5585
Inventor 赵焰平朱朝露吴昀蒲晓蕾卢迪刘亚男
Owner BEIJING TIDE PHARMA
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