Compound antihypertensive pharmaceutical composition and preparation method thereof

A technology of composition and medicine, which is applied in the field of compound antihypertensive pharmaceutical composition and its preparation, the pharmaceutical composition of alisartan medoxomil and/or its salt and indapamide and its preparation field, which can solve the problem that the equivalence cannot be achieved and other issues, to achieve the effect of reducing treatment costs, ensuring safety and effectiveness, and maintaining blood drug concentration

Active Publication Date: 2022-04-12
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The study found that there is an interaction between alisartan medoxomil and indapamide, and the bioequivalence of the combined drug cannot be achieved. In order to solve this technical problem, it is very important to find a preparation scheme that is suitable for clinical use, and further research is needed to develop

Method used

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  • Compound antihypertensive pharmaceutical composition and preparation method thereof
  • Compound antihypertensive pharmaceutical composition and preparation method thereof
  • Compound antihypertensive pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Calculate and weigh each component of the corresponding prescription amount, and then prepare the alisartan medoxomil indapamide preparation according to the following preparation process, and the specific prescription composition is as follows.

[0037]

[0038] Concrete preparation process is as follows:

[0039](1), Alisartan medoxomil and polyvinylpyrrolidone weighing prescription quantity are dissolved in appropriate methylene chloride, dehydrated alcohol, are made into medicine solution, and the crospovidone of prescription quantity is placed in fluidized bed, The drug solution is sprayed into the fluidized bed for spray granulation and drying, and then the prescribed amount of lactose, microcrystalline cellulose, crospovidone and stearic acid are added for mixing to obtain the total mixed granules of alisartan medoxomil.

[0040] (2), add the prescription amount of povidone to absolute ethanol and purified water, stir until completely dissolved, add the prescr...

Embodiment 2

[0044] prescription

[0045]

[0046] preparation:

[0047] (1), dissolving alisartan medoxomil and polyvinylpyrrolidone in an appropriate amount of dichloromethane and absolute ethanol to make a drug solution, place the copovidone in the prescribed amount in a fluidized bed, and spray it into The drug solution is subjected to fluidized-bed spray granulation and drying, and then the prescription amount of lactose, pregelatinized starch, carboxymethyl starch sodium and magnesium stearate are added for mixing to obtain the allisartan medoxomil granules.

[0048] (2) After mixing the prescribed amount of indapamide, hypromellose and calcium hydrogen phosphate, add them into a dry granulator to compress large tablets, and then crush the granules to obtain granules, and then mix them with the added stearin acid and hydrogenated castor oil are mixed together, and the tablets are compressed and coated to obtain indapamide sustained-release tablet cores.

[0049] (3), the alisart...

Embodiment 3

[0052] prescription

[0053]

[0054] Preparation: (1), dissolving alisartan medoxomil and copovidone in an appropriate amount of dichloromethane and absolute ethanol to make a drug solution, and placing the prescribed amount of crospovidone in a fluidized bed , spray the drug solution, carry out fluidized bed spray granulation and drying, and then add lactose monohydrate, mannitol, crospovidone and magnesium stearate in the prescribed amount for mixing to obtain allisartan medoxomil granules.

[0055] (2), mix the prescription amount of indapamide, hypromellose and calcium hydrogen phosphate with additional silicon dioxide and stearic acid, and carry out tablet coating to obtain indapamide sustained-release tablets core.

[0056] (3), the alisartan medoxomil blended granules weighing the prescription amount are the outer layer, and the indapamide sustained-release tablet is the tablet core to compress and pack the chip;

[0057] (4) Chip coating: Add the film coating pre...

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and relates to a compound antihypertensive pharmaceutical composition and a preparation method thereof, in particular to a pharmaceutical composition of allisartan medoxomil and/or salt thereof and indapamide and a preparation method thereof.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a compound antihypertensive pharmaceutical composition and a preparation method thereof, in particular to a pharmaceutical composition of alisartan medoxomil and / or its salt and indapamide and a preparation method thereof. Background technique [0002] Allisartan Isoproxil, chemical name: 2-butyl-4-chloro-1-[2'-(1H-tetrazol-5-yl)-1,1'-biphenyl-methyl]- Imidazole-5-carboxylic acid, 1-[(isopropoxy)-carbonyloxy]-methyl ester, trade name: Xinlitan, is a new type of angiotensin Ⅱ receptor antagonist. Chinese patent CN200680000397.8 discloses the structural formula of the allisartan medoxomil compound. The allisartan medoxomil is less toxic and has a better antihypertensive effect than similar products (such as losartan). Its antihypertensive effect. Chinese patents CN106188012A, CN104610232A, CN109320501A, CN109694369A, CN105232489A, and CN107441497A respectively s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/22A61K47/32A61K47/38A61K31/4178A61K31/404A61P9/12
Inventor 蔡燕霞叶冠豪
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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