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Irbesartan hydrochlorothiazide composite preparation and preparation method thereof

A compound preparation, hydrochlorothiazide technology, applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pill delivery, etc., can solve the problem of high cost, achieve dissolution guarantee, improve mixing effect, and reduce material cost Effect

Active Publication Date: 2020-03-24
瀚晖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The main purpose of the present invention is to provide a compound preparation of irbesartan hydrochlorothiazide and its preparation method, to solve the problem of high cost of the compound preparation of irbesartan hydrochlorothiazide in the prior art

Method used

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  • Irbesartan hydrochlorothiazide composite preparation and preparation method thereof
  • Irbesartan hydrochlorothiazide composite preparation and preparation method thereof
  • Irbesartan hydrochlorothiazide composite preparation and preparation method thereof

Examples

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preparation example Construction

[0028] In one embodiment, the above-mentioned preparation method includes: step S1, adding the prescribed amount of irbesartan, the prescribed amount of hydrochlorothiazide, the prescribed amount of microcrystalline cellulose, the prescribed amount of lactose monohydrate, and part of the prescribed amount of colloidal Silicon dioxide is mixed with croscarmellose sodium of part prescription quantity to obtain the first mixture, preferably part of the prescription quantity of colloidal silicon dioxide is 40-60% of the total amount of colloidal silicon dioxide, preferably part of the prescription The amount of croscarmellose sodium is 40~60% of the croscarmellose sodium total amount; step S2, prepares the aqueous solution of hypromellose; step S3, mixes the aqueous solution of 40~50 ℃ with The first mixture is mixed and granulated to obtain wet granules; Step S4, the wet granules are dried to obtain the first dry granules; Step S5, the remaining prescription amount of colloidal si...

Embodiment 6

[0068] Microcrystalline cellulose 102 was used to replace the microcrystalline cellulose in Example 1, and the rest were the same as in Example 1.

Embodiment 7

[0070] Adopt hypromellose E6 to replace the hypromellose E5 of embodiment 1, all the other are the same as embodiment 1.

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Abstract

The invention provides a compound preparation of irbesartan hydrochlorothiazide and a preparation method thereof. The composite preparation comprises a tablet core, which includes the following ingredients (by weight): 150.0 parts of irbesartan, 12.5 parts of hydrochlorothiazide, 24.0-29.0 parts of microcrystalline cellulose, 10.0-17.0 parts of lactose monohydrate, 15.0-19.5 parts of croscarmellose sodium, 12.0-18.0 parts of hydroxypropyl methylcellulose, 8.0-11.0 parts of colloidal silicon dioxide and 7.0-9.0 parts of magnesium stearate. Compared with the equivalent weight of irbesartan and hydrochlorothiazide, microcrystalline cellulose and lactose monohydrate are also used as fillers in the tablet core of theinvention, and the sum of maximum total weights of microcrystalline cellulose and lactose monohydrate is less than 50, thus greatly reducing the amount of the fillers and lowering the material cost of the composite preparation; moreover, a proper amount of hydroxypropyl methylcellulose ensures the dissolution of the effective components.

Description

technical field [0001] The invention relates to the technical field of preparation of irbesartan-hydrochlorothiazide compound preparations, in particular to a compound preparation of irbesartan-hydrochlorothiazide and a preparation method thereof. Background technique [0002] Hypertension is the most common cardiovascular disease and a major public health problem worldwide. Irbesartan, namely 2-n-butyl-4-spirocyclopentane-1-[(2-(tetrazol-5-yl)biphenyl-4-yl)methyl]-2-imidazole Lin-5-one is a high-efficiency long-acting angiotensin II receptor antagonist, especially for the treatment of cardiovascular diseases such as hypertension and heart failure. Hydrochlorothiazide is a diuretic antihypertensive drug that causes activation of the sympathetic nervous system and the renin-angiotensin system, counteracts the antihypertensive effect, and lowers blood potassium levels. The combination of irbesartan and hydrochlorothiazide has a synergistic effect in the treatment of hyperten...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/26A61K9/28A61K31/549A61K31/4184A61P9/12
CPCA61K9/2018A61K9/2054A61K9/2095A61K9/28A61K31/4184A61K31/549A61P9/12A61K2300/00
Inventor 杜加秋陆常辉蔡邱华钱昌海邵婷婷
Owner 瀚晖制药有限公司
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