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Prednisone oral pulsatile tablet and preparation method thereof

The technology of pulse and prednisone is applied in the field of oral prednisone pulse preparation and its preparation, which can solve the problems of short action time and large fluctuation of blood drug concentration, and achieve the effects of reducing the therapeutic effect and solving the low curative effect.

Inactive Publication Date: 2015-06-24
INCREASEPHARM TIANJIN INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the short action time of prednisone, ordinary tablets generally need to be taken several times a day (3 to 4 times), and the blood concentration fluctuates greatly.

Method used

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  • Prednisone oral pulsatile tablet and preparation method thereof
  • Prednisone oral pulsatile tablet and preparation method thereof
  • Prednisone oral pulsatile tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Chip core (10000 pieces):

[0043]

[0044] The raw and auxiliary materials used are passed through 80 mesh sieves, and the prescription amount of prednisone, PVPP, cross-linked CMC-Na, sorbitol, pregelatinized starch and MCC are mixed evenly, and the prescription amount of SiO2 is added according to the method of equal addition. Mix in a multi-sport mixer for 30 minutes, then add the prescribed amount of magnesium stearate and mix for 10 minutes to obtain the mixed material, punch the uniformly mixed material with a shallow arc of 5.0 mm, and press with a single-punch tablet machine to obtain the required tablet core. The tablet core weighs about 125mg and has a hardness of 2.8kg±0.5kg.

[0045] Dissolve HPMC in 60% ethanol to make a coating solution, and prepare a 5% HPMC alcohol solution to obtain a swelling layer coating solution; place the tablet core in the coating pan, and adjust the angle of the tumbling coating pan to 30° °, the speed is 25~35 / min, ...

Embodiment 2

[0049] Chip core (10000 pieces):

[0050]

[0051] Pass the raw and auxiliary materials used through 80 mesh sieve, and mix the prescribed amount of prednisone, L-HPC, cross-linked CMC-Na, mannitol, lactose and MCC according to the method of equal addition, and then add the prescribed amount of SiO 2 , placed in a multi-sport mixer and mixed for 30 minutes, then added the prescribed amount of talcum powder and mixed for 10 minutes to obtain the mixed material, punched the uniformly mixed material with a shallow arc of 5.0 mm, and pressed it with a single-punch tablet machine to obtain the required tablet core. The tablet core weighs about 125mg and has a hardness of 2.1kg±0.5kg.

[0052] Dissolve HPMC in 60% ethanol to make a coating solution, and prepare a 5% HPMC alcohol solution to obtain a swelling layer coating solution; place the tablet core in the coating pan, and adjust the angle of the tumbling coating pan to 30° °, the speed is 25~35 / min, add the coating solution...

Embodiment 3

[0055] Chip core (10000 pieces):

[0056]

[0057]

[0058] Pass the used raw and auxiliary materials through 80 mesh sieves, and mix the prescribed amount of prednisone, PVPP, cross-linked CMC-Na, mannitol, lactose and MCC according to the method of equal addition, and then add the prescribed amount of SiO 2 , placed in a multi-sport mixer and mixed for 30 minutes, then added the prescribed amount of magnesium stearate and mixed for 10 minutes to obtain the mixed material, punched the uniformly mixed material with a shallow arc of 5.0mm, and pressed it with a single-punch tablet machine to obtain the desired tablet core. The tablet core weighs about 125mg and has a hardness of 2.5kg±0.5kg.

[0059] Dissolve HPMC in 60% ethanol to make a coating solution, and prepare a 5% HPMC alcohol solution to obtain a swelling layer coating solution; place the tablet core in the coating pan, and adjust the angle of the tumbling coating pan to 30° °, the speed is 25~35 / min, add the ...

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Abstract

The invention discloses a prednisone oral pulsatile tablet and a preparation method thereof. The oral pulsatile tablet comprises a rapid-release tablet core, a swelling coating layer and a controlled-release film coating layer, wherein the rapid-release tablet core is composed of a main medicine and pharmaceutically acceptable auxiliary materials, the main medicine is pulsatile, the dosage specification is 1-20mg per tablet metered by pulsatile, and the tablet core weight is 120-220mg; the swelling coating layer is composed of hydroxypropyl methylcellulose, and the coating weight increment relative to the weight of the rapid-release tablet core is 1-20%; the controlled-release film coating layer is composed of a water-insoluble film coating material which is insoluble under different pH values and other pharmaceutically acceptable auxiliary materials, and the coating weight increment relative to the total weight of the rapid-release tablet core and the swelling coating layer is 1-15%. According to the prednisone oral pulsatile tablet and the preparation method thereof disclosed by the invention, the tablet core is prepared by a direct powder tableting process, the swelling coating layer and the controlled-release layer are prepared by a film coating method, the preparation is stable, and the process is simple and practicable, and high in reproducibility.

Description

technical field [0001] The invention relates to a prednisone oral pulse preparation for treating rheumatoid arthritis joint morning stiffness and a preparation method thereof, that is, according to the circadian rhythm of the onset of the disease, an appropriate drug release time lag is selected, and the explosive release is completely released after the time lag. Prescription composition and preparation method of pulse preparation of medicine. Background technique [0002] A large number of studies have confirmed that slow-acting antirheumatic drugs (DMARDs) can delay the joint destruction of rheumatoid arthritis (RA). It can effectively control the disease and prevent joint destruction, which is especially beneficial for patients with early RA. [0003] Prednisone is an adrenal corticosteroid. Mainly used for allergic and inflammatory diseases. It is the most important drug in the treatment of autoimmune diseases such as rheumatism. Its chemical name is 17α,21-dihydrox...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/36A61K31/573A61P19/02A61P29/00
Inventor 龚莉王鹏易佳李桂龙王婧斯王广明陈奇王莹莹王颖
Owner INCREASEPHARM TIANJIN INST CO LTD
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