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Indobufen pharmaceutical composition and its quality control method

A technology of indobufen and its composition, which is applied in the field of medical technology, and can solve problems such as low dissolution rate and slow drug speed

Active Publication Date: 2020-05-08
HANGZHOU ZHONGMEI HUADONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Indobufen is known to have an extremely low dissolution rate under acidic conditions, which is related to the solubility of the drug substance, and this property is detrimental to the drug's retention in the stomach, which usually lasts up to 2 hours, especially when it needs to be taken orally after a meal Under the circumstances, the drug enters the duodenum and small intestine more slowly

Method used

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  • Indobufen pharmaceutical composition and its quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0119] Embodiment 1: Preparation of indobufen tablets

[0120] prescription:

[0121] Indobufen 200mg,

[0122] Lactose 40mg,

[0123] Microcrystalline Cellulose 25mg,

[0124] Croscarmellose sodium (disintegrant) 10mg,

[0125] Polyvinylpyrrolidone (binder) 5 mg,

[0126] Micropowder silica gel (flow aid) 2mg,

[0127] Magnesium stearate (lubricant) 2mg.

[0128] Preparation method:

[0129] (1) After mixing indobufen and sugar diluent, carry out pretreatment together (spray into water accounting for 10w / w% of the weight of the powder material and seal it for 18 hours); the rest of the solid materials are respectively pulverized into 80-mesh powder;

[0130] (2) Mix the pretreatment mixture obtained in step (1) with a cellulose diluent and a disintegrant accounting for 40% of the total amount;

[0131] (3) Add a binder solution (mixed with water to a concentration of 4w / v%) in advance with a solvent in the mixed material obtained in step (2), and prepare wet granules...

Embodiment 2

[0133] Embodiment 2: preparation of indobufen tablets

[0134] prescription:

[0135] Indobufen 200mg,

[0136] Lactose 30mg,

[0137] Microcrystalline Cellulose 40mg,

[0138] Crospovidone (disintegrant) 5mg,

[0139] Polyvinylpyrrolidone (binder) 8 mg,

[0140] Micropowder silica gel (flow aid) 1mg,

[0141] Magnesium stearate (lubricant) 5mg.

[0142] Preparation method:

[0143] (1) After mixing indobufen and carbohydrate diluent, carry out pretreatment together (spray into water accounting for 9w / w% of powder material weight and seal and let stand for 16 hours); the remaining solid materials are respectively crushed into 80-mesh powder;

[0144] (2) Mix the pretreatment mixture obtained in step (1) with the cellulose diluent and the disintegrant accounting for 60% of the total amount;

[0145] (3) Add a binder solution (prepared to 5w / v% concentration with 40% ethanol solution) in the mixed material obtained in step (2) with a solvent in advance, and prepare we...

Embodiment 3

[0147] Embodiment 3: Preparation of indobufen tablets

[0148] prescription:

[0149] Indobufen 200mg,

[0150] Lactose (anhydrous lactose) 50mg,

[0151] Microcrystalline Cellulose 15mg,

[0152] Sodium starch glycolate (disintegrant) 15mg,

[0153] Hypromellose (binder) 3mg,

[0154] Talc powder (glidant) 5mg,

[0155] Stearic acid (lubricant) 1mg.

[0156] Preparation method:

[0157] (1) After mixing indobufen and carbohydrate diluent, carry out pretreatment together (spray into water accounting for 8w / w% of the weight of the powder material and seal it for 20 hours); the remaining solid materials are respectively pulverized into 80-mesh powder;

[0158] (2) Mix the pretreatment mixture obtained in step (1) with the cellulose diluent and the disintegrant accounting for 50% of the total amount;

[0159] (3) Add the binder solution (mixed to 3w / v% concentration with 70% ethanol solution) in the mixed material obtained in step (2) with a solvent in advance, and pre...

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Abstract

The invention relates to an indobufen pharmaceutical composition and a quality control method thereof. Specifically, the indobufen pharmaceutical composition of the present invention includes: 200 parts by weight of indobufen, 30-50 parts by weight of sugar diluent, 15-40 parts by weight of cellulose diluent, 5-15 parts by weight of disintegrant 3-8 parts by weight of binder, 1-5 parts by weight of glidant, and 1-5 parts by weight of lubricant. The sugar diluent is selected from the group consisting of mannitol, sucrose, lactose, fructose, glucose, sorbitol, hydrates thereof, and combinations thereof. The invention also relates to the preparation method of the composition, its quality control method and pharmaceutical application. The indobufen pharmaceutical composition of the present invention can be used for arteriosclerotic ischemic cardiovascular disease, ischemic cerebrovascular disease and peripheral arterial disease, dyslipidemia, venous thrombosis and diabetes, and can be used for preventing thrombosis during extracorporeal circulation operation Formed, the pharmaceutical composition exhibits excellent effects as described in the instructions.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a medicine that can be used for the prevention of arteriosclerotic ischemic cardiovascular disease, ischemic cerebrovascular disease and peripheral arterial disease, dyslipidemia, venous thrombosis, diabetes and cardiopulmonary bypass surgery. The indobufen pharmaceutical composition of thrombosis, particularly relates to a kind of indobufen tablet pharmaceutical composition with excellent pharmaceutical properties, and the present invention also relates to the preparation of this indobufen pharmaceutical composition with excellent pharmaceutical properties Methods of preparation, and their quality control methods. Background technique [0002] Indobufen pharmaceutical composition related to the present invention, its active ingredient is indobufen, Indobufen, Chinese chemical name: (±) 2-[4-(1-oxo-2-isoindolinyl) Phenyl]butyric acid, or (±)2-[4-(1-oxo-2-isoindolinyl)phenyl]butyr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/404A61K47/26A61K47/38A61P9/10A61P7/02A61P3/10A61P3/06G01N21/33
CPCA61K9/2018A61K9/2054A61K9/2072A61K9/2077A61K9/2095A61K31/404G01N21/33
Inventor 韩敏刘玉艳周屹峰张洪记
Owner HANGZHOU ZHONGMEI HUADONG PHARMA
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