Medicinal compound composition of irbesartan and hydrochlorothiazide and preparation method thereof

A technology of hydrochlorothiazide and composition, which is applied in the field of pharmaceutical compound composition of irbesartan and hydrochlorothiazide and its preparation, which can solve the problems of low dissolution rate and achieve good stability

Inactive Publication Date: 2014-03-26
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The dissolution rate of the irbesartan-hydrochlorothiazide compound preparation disclosed in the above-mentioned prior art is low, and the dissolution rate will become lower after being placed under high temperature conditions, so further research is still needed to improve its dissolution rate and ensure its stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Preparation of Irbesartan Hydrochlorothiazide Coated Tablets

[0028] Component Unit (g)

[0029] Hydrochlorothiazide 25

[0030] Irbesartan 300

[0031] Lactose 87.5

[0032] Microcrystalline Cellulose 53

[0033] Croscarmellose Sodium 25

[0034] Micronized silica gel 2

[0035] Magnesium Stearate 2.5

[0036] Methylcellulose 5

[0037] Makes 1000 pieces

[0038] Weigh the prescribed amount of methyl cellulose and make it into a 5% aqueous solution of methyl cellulose; weigh the prescribed amount of hydrochlorothiazide, irbesartan, lactose, and microcrystalline cellulose and mix evenly, then add part (10g) to cross-link Sodium carboxymethylcellulose, mix well, add 5% methylcellulose aqueous solution, granulate, dry, granulate, then add the remaining amount of croscarmellose sodium and prescription amount of micropowder silica gel, stearic acid Magnesium, mixed evenly, compressed into tablets and coated.

Embodiment 2

[0039] Example 2 Preparation of Irbesartan Hydrochlorothiazide Granules

[0040] Component Unit (g)

[0041] Hydrochlorothiazide 25

[0042] Irbesartan 300

[0043] Lactose 90

[0044] Microcrystalline Cellulose 55

[0045] Croscarmellose Sodium 25

[0046] Gelatin 5

[0047] Packed into 1000 bags

[0048] Weigh the prescribed amount of gelatin and configure it into a 5% gelatin aqueous solution; weigh the prescribed amount of hydrochlorothiazide, irbesartan, lactose, microcrystalline cellulose, and croscarmellose sodium and mix evenly, add 5% gelatin Aqueous solution, granulation, drying, granulation, and then packaging to obtain granules.

Embodiment 3

[0049] Example 3 Preparation of Irbesartan Hydrochlorothiazide Capsules

[0050]Component Unit (g)

[0051] Hydrochlorothiazide 25

[0052] Irbesartan 300

[0053] Lactose 83

[0054] Microcrystalline Cellulose 52

[0055] Croscarmellose Sodium 25

[0056] Polyethylene glycol 4000 15

[0057] Packing 1000 capsules

[0058] Weigh the prescribed amount of polyethylene glycol 4000 and configure it into a 15% aqueous solution of polyethylene glycol 4000; weigh the prescribed amount of hydrochlorothiazide, irbesartan, lactose, microcrystalline cellulose, and croscarmellose sodium Mix evenly, add 15% polyethylene glycol 4000 aqueous solution, granulate, dry, granulate, pack into capsules, and obtain.

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PUM

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Abstract

The invention discloses a compound composition of irbesartan and hydrochlorothiazide. The composition can be made into granules, capsules, tablets and coated tablets. By screening and adopting a specific adhesive, the dissolution rate of the active ingredient irbesartan can exceed 94%, and the dissolution rate of hydrochlorothiazide can exceed 96%; after the composition is placed for 10 days at a high temperature of 60 DEG C, the dissolution rates of the two active ingredients are basically kept unchanged; and therefore, the composition has good stability and can meet the needs of clinical medication.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a medicinal compound composition and a preparation method thereof, in particular to a medicinal compound composition of irbesartan and hydrochlorothiazide and a preparation method thereof. Background technique [0002] In recent years, due to the rapid development of social economy and changes in people's lifestyles, the prevalence of hypertension in my country has been on the rise. According to the 2004 survey on the status quo of nutrition and health of Chinese residents, the prevalence of hypertension among residents aged 18 and above in my country is 18.8%, and it is estimated that the number of patients nationwide exceeds 160 million. , the number of patients increased by about 70 million. In many countries around the world, the proportion of adults suffering from high blood pressure is as high as 15%-25%, and high blood pressure is the leading cause of death and disability i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/549A61P9/12A61K31/4184
Inventor 申磊姚振江刘贵池
Owner 石药集团中诺药业(石家庄)有限公司
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