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Phosphodiesterase-4 inhibitor apremilast composition and quality detection method

A technology of Apos and content, applied in the field of medicine, can solve the problem that the exact mechanism cannot be finally confirmed

Pending Publication Date: 2021-02-02
HANGZHOU ZHUYANGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the occurrence of this disease is related to virus (such as HIV virus) and fungal (such as Malassezia) infection, the exact mechanism has not been confirmed yet.

Method used

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  • Phosphodiesterase-4 inhibitor apremilast composition and quality detection method
  • Phosphodiesterase-4 inhibitor apremilast composition and quality detection method
  • Phosphodiesterase-4 inhibitor apremilast composition and quality detection method

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0122] Preparation example 1, prepare the plain tablet of Apremilast

[0123] Prescription: 10 parts by weight of Apremilast, 60 parts by weight of lactose monohydrate, 26.25 parts by weight of microcrystalline cellulose, 3 parts by weight of croscarmellose sodium (internal addition: external addition = 2:1), stearin Magnesium acid 0.75 parts by weight.

[0124] Preparation method:

[0125] (i) Apremilast, lactose, microcrystalline cellulose, and croscarmellose sodium are mixed uniformly, and the granules are prepared by dry method using pressing roller equipment;

[0126] (ii) add surplus croscarmellose sodium to the granule obtained in step (i), mix uniformly, then add magnesium stearate and mix uniformly;

[0127] (iii) Compressing the mixed granules obtained in step (ii) on a tablet machine to obtain tablets in the form of plain tablets.

[0128] The term "internal addition" is added before the granules are made to prepare tablets, that is, the croscarmellose sodium p...

preparation example 2

[0129] Preparation example 2, prepare the plain tablet of Apremilast

[0130] Prescription: 10 parts by weight of Apremilast, 62 parts by weight of lactose monohydrate, 22 parts by weight of microcrystalline cellulose, 3.5 parts by weight of croscarmellose sodium (internal addition: external addition = 2:1), stearin Magnesium acid 0.9 parts by weight.

[0131] Preparation method:

[0132] (i) Apremilast, lactose, microcrystalline cellulose, and croscarmellose sodium are mixed uniformly, and the granules are prepared by dry method using pressing roller equipment;

[0133] (ii) add surplus croscarmellose sodium to the granule obtained in step (i), mix uniformly, then add magnesium stearate and mix uniformly;

[0134] (iii) Compressing the mixed granules obtained in step (ii) on a tablet machine to obtain tablets in the form of plain tablets.

preparation example 3

[0135] Preparation example 3, prepare the plain tablet of Apremilast

[0136] Prescription: 10 parts by weight of Apremilast, 55 parts by weight of lactose monohydrate, 28 parts by weight of microcrystalline cellulose, 2.5 parts by weight of croscarmellose sodium (internal addition: external addition = 2:1), stearin Magnesium acid 0.6 parts by weight.

[0137] Preparation method:

[0138] (i) Apremilast, lactose, microcrystalline cellulose, and croscarmellose sodium are mixed uniformly, and the granules are prepared by dry method using pressing roller equipment;

[0139] (ii) add surplus croscarmellose sodium to the granule obtained in step (i), mix uniformly, then add magnesium stearate and mix uniformly;

[0140] (iii) Compressing the mixed granules obtained in step (ii) on a tablet machine to obtain tablets in the form of plain tablets.

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Abstract

The invention relates to a phosphodiesterase 4 inhibitor apremilast composition and a quality detection method. The apremilast composition is a tablet, comprises lactose, magnesium stearate and otherauxiliary materials, and is used for treating adult patients suffering from active psoriatic arthritis, adult patients suffering from moderate-to-severe plaque psoriasis and suitable for phototherapyor systemic therapy, and adult oral ulcer patients related to Bessel's disease. The quality detection method comprises the step of determining the content of the enantiomer in the tablet, and comprises the following operations: by using a chiral chromatographic column and using n-hexane, isopropanol and the like as mobile phases, in a high performance liquid chromatography system, injecting 5 [mu]l of a system applicable solution into a liquid chromatograph, wherein the peak appearance sequence is enantiomer peaks and apremilast peaks successively, and the separation degree between two peaks is not less than 1.5, and precisely measuring 5 [mu]l of the test solution, injecting the test solution into a liquid chromatograph, recording a chromatogram, and calculating the content of the enantiomer according to an area normalization method if enantiomer peaks exist in the chromatogram of the test solution. The compositions and methods of the present invention exhibit excellent technical effects as described in the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a selective phosphodiesterase-4 inhibitor that can be administered orally, in particular to a selective phosphodiesterase-4 inhibitor with apremilast as an active substance The oral pharmaceutical composition, especially relates to the quality detection method of the oral pharmaceutical composition of the selective phosphodiesterase-4 inhibitor. The pharmaceutical composition can be used for the treatment of adult patients with active psoriatic arthritis, adult patients with moderate to severe plaque psoriasis suitable for phototherapy or systemic therapy, and adult patients with oral ulcers related to Behche's disease. This quality detection method has excellent performance for the unique formulations of the present invention. Background technique [0002] Psoriasis, commonly known as psoriasis, is a chronic inflammatory skin disease with a long course of disease and a tendency ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74A61K9/36A61K9/32A61K31/4035A61P17/06
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74A61K31/4035A61K9/2866A61K9/2853A61K9/284A61K9/2054A61P17/06G01N2030/324
Inventor 马雯霞葛勇张群何海珍吴倩倩谢红瑜戚兰君
Owner HANGZHOU ZHUYANGXIN PHARMA
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