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Prednisone pulse release tablet

A pulsed release, prednisone technology, applied in the directions of organic active ingredients, non-central analgesics, pharmaceutical formulations, etc., to achieve the effect of convenient and feasible medication, symptom relief, and easy large-scale industrial production

Inactive Publication Date: 2015-04-29
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Currently listed prednisone API products are mainly prednisone and its acetates, hydroprednisolone (prednisolone) and its acetates, methylprednisolone and its acetates, preparations Varieties include tablets, injections, creams and eye drops, etc. There is no pulse preparation of prednisone on the market in China

Method used

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Experimental program
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Effect test

Embodiment 1

[0033] Prednisone

[0034]Preparation process: After the above-mentioned prednisone and auxiliary materials are fully mixed, the powder is directly compressed into tablets to obtain immediate-release tablet cores.

[0035] Controlled Release Coating Formulation

[0036] HPMC E50 (Colorcon)

[0037] Preparation process: Fill 150mg of HPMC E50 cup body material into a 9mm shallow concave die, press lightly to form a cup body layer; then, place the immediate-release tablet core in the center of the cup body layer, press lightly to make the tablet core and cup body part Flat; finally add 80mg of top layer material (30% mannitol 70% HPMC E50), and carry out direct powder compression to get final product.

Embodiment 2

[0039] Prednisone

[0040] Preparation process: After the above-mentioned prednisone and auxiliary materials are fully mixed, the powder is directly compressed into tablets to obtain immediate-release tablet cores.

[0041] Controlled Release Coating Formulation

[0042] HPMC E50 (Colorcon)

[0043] Preparation process: 150mg of cup material (10% HPMC E6, 90% HPMC E50) is filled into a 9mm shallow concave die, and lightly pressed to form a cup layer; then, the immediate-release tablet core is placed in the center of the cup layer, Gently press to make the tablet core and the cup part flush; finally add 80 mg of top layer material (30% mannitol, 70% HPMC E50), and carry out direct powder compression to get final product.

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Abstract

The invention discloses a prednisone pulse release tablet and a preparation method thereof. The prednisone pulse release tablet consists of a fast-release tablet core and a controlled-release coating layer, wherein the optimized coating weight gain rate of the controlled-release coating layer, relative to that of the fast-release tablet core, is 350-390%; the fast-release tablet core consists of drugs and an inner layer auxiliary material, wherein the drugs are prednisone and acetate thereof, the dose specification of the drugs is 1-5mg per tablet on the basis of prednisone; and the controlled-release coating layer consists of a coating framework material and a pore forming agent, wherein the coating framework material is a composition of hypromellose and ethyl cellulose, and the pore forming agent is mannitol. The prednisone pulse release tablet disclosed by the invention can ensure that the drug release time lag is adjusted between 2-9 hours by changing a prescription process, and the drug release time lag is preferably 4-8 hours according to specific needs of time pathology treatment performed clinically. The prescription of the prednisone pulse release tablet disclosed by the invention is not complex in composition, the preparation process adopts a simple and feasible powder direct tabletting method and a coating pressing method, and is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to prednisone pulse release tablets. Background technique [0002] Prednisone is an adrenal corticosteroid drug that has rapid, powerful and non-specific anti-inflammatory effects, and is effective for various inflammations. In the early stage of inflammation, it can inhibit the dilation of capillaries, reduce exudation and edema, inhibit the infiltration and phagocytosis of white blood cells, and reduce the symptoms of inflammation. In the later stage of inflammation, it can inhibit the proliferation of capillaries and fibroblasts, delay the formation of granulation tissue, thereby reducing the sequelae of inflammation such as scars and adhesions. At the same time, prednisone can inhibit the phagocytosis and processing of antigens by macrophages and promote the disintegration and destruction of lymphocytes, which can play a certain role in immunosuppression. Clinically,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/573A61K47/38A61P29/00
Inventor 蒋曙光黄铃
Owner CHINA PHARM UNIV
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