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A nifedipine sustained-release tablet composition

A technology for nifedipine and nifedipine, which is applied in the field of nifedipine sustained-release tablet composition and preparation thereof, can solve the problems of unstable particle size, unstable dissolution and the like, so as to ensure effective durability and better pharmacoeconomics , the effect of ensuring safety

Active Publication Date: 2019-01-11
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the actual preparation work, it was found that the particle size of nifedipine sustained-release tablets needs to be strictly controlled, and the instability of particle size will lead to the instability of dissolution

Method used

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  • A nifedipine sustained-release tablet composition
  • A nifedipine sustained-release tablet composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Nifedipine 20g (D90 is 105.5μm), lactose 40g, corn starch 5g, Tween-80 5g, microcrystalline cellulose 8g, magnesium stearate 1g, film coating premix (Colorcon, the model is 295F620084 , the ingredients are hypromellose, macrogol 4000, titanium dioxide, ferric oxide) 4g. Prepare 1000 tablets according to the preparation method described in the technical scheme part of the description.

Embodiment 2

[0029] Example 2 Nifedipine 20g (D90 is 105.5μm), lactose 44g, corn starch 5g, Tween-80 7g, microcrystalline cellulose 8g, magnesium stearate 1g, film coating premix (Colorcon, The model is 295F620084, and the ingredients are hypromellose, macrogol 4000, titanium dioxide, iron sesquioxide) 4g. Prepare 1000 tablets according to the preparation method described in the technical scheme part of the description.

Embodiment 3

[0030] Example 3 Nifedipine 20g (D90 is 105.5μm), lactose 36g, corn starch 5g, Tween-80 6g, microcrystalline cellulose 12g, magnesium stearate 1g, film coating premix (Colorcon, The model is 295F620084, and the ingredients are hypromellose, macrogol 4000, titanium dioxide, iron sesquioxide) 4g. Prepare 1000 tablets according to the preparation method described in the technical scheme part of the description.

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Abstract

The invention relates to a nifedipine sustained-release tablet composition and a preparation method thereof. The nifedipine sustained-release tablet composition of the invention comprises nifedipine,tween-80, lactose, microcrystalline cellulose, corn starch, and that D90 of nifedipine is 95-135 [mu] m, the mass ratio of lactose to nifedipine is 1.8: 1-2.2: 1, the dosage of Tween is 6-9%. As thattechnical scheme of the invention is reasonably adjust in composition, the process and equipment limit caused by the grinding fineness are avoided, and the tablet composition with low Cmax than the reference preparation and high AUC than the reference preparation is prepared.

Description

technical field [0001] The invention relates to a nifedipine slow-release tablet composition and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Hypertension is a common disease in our country, which requires life-long medication, which has a great impact on the life and health of the people and the cost of living. Nifedipine is an old drug of dipines for the treatment of hypertension. It has a huge market and good antihypertensive effect in my country. Its slow-release preparation can stably control the blood pressure of the human body and reduce blood pressure fluctuations of patients, so it has a broad market prospect. [0003] Nifedipine sustained-release tablets mostly use sustained-release matrix materials to achieve the sustained-release effect of nifedipine, but the original Bayer company patent (US526446) discloses that the insoluble characteristics of nifedipine can be used, and the specif...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4422A61K47/26A61K47/38A61P9/12
CPCA61K9/2018A61K9/2054A61K9/2866A61K31/4422A61P9/12
Inventor 金栋霞候铁强白莉高永吉
Owner DISHA PHARMA GRP
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