Oral prednisone time-selecting release preparation and preparation method thereof

A technology of prednisone and preparations, which is applied in the field of oral prednisone timed-release preparations and preparation thereof, timed-release oral solid preparations and preparation fields thereof, and can solve the problem of easily causing diabetes, peptic ulcer and Cushing-like syndrome Symptoms, disturbing the normal secretion of corticosteroids, fast release rate of normal release dosage forms, etc., to achieve the effect of facilitating long-term treatment, reducing adverse reactions, and convenient oral administration

Inactive Publication Date: 2014-04-02
ZHONGSHUAI PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Listed at home and abroad, prednisone is an oral regular-release tablet, and its specifications are: 1mg, 2.5mg, 5mg, 10mg and 20mg. Taking it at night requires a large dose, which disturbs the normal secretion of corticosteroids, and has relatively large toxic and side effects. Medication violates the principle of chronopharmacology, and the release rate of the regular-release dosage form is too fast, which can easily cause diabetes, peptic ulcer and Cushing's syndrome-like symptoms, concurrent and aggravated infection; to achieve the desired effect, it is necessary to take the medicine in the early morning, which is not suitable for patients Medication habits, inconvenience to patients

Method used

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  • Oral prednisone time-selecting release preparation and preparation method thereof
  • Oral prednisone time-selecting release preparation and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0041] The oral prednisone timing release preparation of the present invention is expanded by 25 times according to the original and auxiliary material composition formula, expressed in parts by weight. The oral prednisone timing release preparation is composed of 100g prednisone, 300g glyceryl behenate and hydroxypropyl Composition of 100g cellulose.

[0042] The preparation method of the oral prednisone selective release preparation of the present invention, the detailed steps of the preparation method are as follows:

[0043] a. Weigh prednisone, glyceryl behenate and hydroxypropyl cellulose according to the raw and auxiliary material composition of the above-mentioned oral prednisone timing release preparation, first place the prednisone in a mixing mixer and mix evenly; turn on the low temperature refrigeration The temperature is controlled at 4~15℃. After 10 minutes, the prednisone raw material after stirring and cooling is put into the trough of the dry granulator. The verti...

Embodiment 2

[0046] Embodiment 2: It is basically the same as embodiment 1, except that:

[0047] The oral prednisone timing release formulation of the present invention is expanded by 25 times according to the original and auxiliary material composition formula, expressed in parts by weight. The oral prednisone timing release formulation is composed of prednisone 25g, glyceryl behenate 500g and hydroxypropyl Composition of 300g cellulose.

[0048] The preparation method of the oral prednisone selective release preparation of the present invention differs from Example 1 in:

[0049] In step b: adding the weighed hydroxypropyl cellulose to 10000 ml of ethanol with a concentration of 85% by mass to dissolve it until it is clear.

Embodiment 3

[0050] Embodiment 3: It is basically the same as Embodiment 1, except that:

[0051] The oral prednisone timing release preparation of the present invention is expanded by 25 times according to the original and auxiliary material composition formula, expressed in parts by weight. The oral prednisone timing release preparation is composed of prednisone 125g, glyceryl behenate 750g and hydroxypropyl Composition of 500g cellulose.

[0052] The preparation method of the oral prednisone selective release preparation of the present invention differs from Example 1 in:

[0053] In step b: adding the weighed hydroxypropyl cellulose to 9000ml ethanol with a concentration of 90% by mass to dissolve it until it is clear.

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Abstract

The invention discloses an oral prednisone time-selecting release preparation and a preparation method thereof. The oral prednisone time-selecting release preparation provided by the invention mainly consists of 0.3-5 parts of prednisone and derivatives thereof, 10-50 parts of glyceryl behenate and 3-30 parts of hydroxypropyl cellulose, and can further contain a disintegrating agent and other pharmaceutically acceptable excipients. The preparation method is as below: extruding tablet cores or granules containing the drug according to the formula by a tablet press or a dry granulator; and coating the tablet cores or particles containing the drug by a coating pan or a fluidized bed to attach the coating film to the tablet cores or particles containing the drug, so as to obtain the oral prednisone time-selecting release preparation. The oral prednisone time-selecting release preparation provided by the invention can achieve a good balance between the biological rhythm of the patients and the curative effects, and is safer, more convenient and effective compared with a traditional preparation. The oral prednisone time-selecting release preparation is prepared by an extrusion-coating process, which is simple for operation, and the obtained time-selecting release preparation has the advantages of drug stability and high reproducibility.

Description

technical field [0001] The present invention relates to the preparation method of pharmaceutical preparations in the field of pharmacy, in particular to a time-selected release oral solid preparation with prednisone and its derivatives as the main agent and its preparation method, that is, to an oral prednisone time-release Formulations and methods for their preparation. Background technique [0002] Prednisone is an adrenal corticosteroid drug mainly used for allergic and inflammatory diseases. It is a commonly used oral glucocorticoid clinically, and it is the most important drug in the treatment of systemic lupus erythematosus, rheumatism, nephrotic syndrome and other autoimmune diseases; it is also a drug in some malignant tumor chemotherapy regimens such as tumors and leukemia. Has a good therapeutic effect. The chemical name is 17α,21-dihydroxypregna-1,4diene-3,11,20-trione. Molecular formula is C 21 h 26 o 5 , the molecular weight is 358.43, and the structural f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/573A61K47/38A61K47/14A61K9/16A61K9/36A61K9/48A61P37/02A61P35/00A61P35/02A61P37/08A61P29/00
Inventor 孙卫东任逢晓邬向东
Owner ZHONGSHUAI PHARMA SCI & TECH CO LTD
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