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Azilsartan medoxomil tablets and preparation method thereof

A azilsartan medoxomil tablet and a technology for azilsartan medoxomil are applied in the field of azilsartan medoxomil tablet and its preparation, and can solve the problem of low bioavailability, drug leakage, liposome easily broken, etc. question

Active Publication Date: 2015-04-08
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The closed structure of liposomes can protect the active ingredients of drugs to a certain extent, but liposomes are easily broken during the preparation process, resulting in drug leakage, low drug encapsulation efficiency, and low bioavailability

Method used

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  • Azilsartan medoxomil tablets and preparation method thereof
  • Azilsartan medoxomil tablets and preparation method thereof
  • Azilsartan medoxomil tablets and preparation method thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0017] The present invention also provides a method for preparing azilsartan medoxomil tablets, which comprises the following steps:

[0018] 1) Grind the active ingredients, fillers and organic acid carrier materials with a sand mill for 2-3 hours, so that the drugs are evenly dispersed in the carrier materials;

[0019] 2) Add disintegrant and lubricant to the above-mentioned mixed powder and mix well;

[0020] 3) Adopt high-speed rotary tablet press to adjust parameters for direct powder compression;

[0021] 4) Whole piece, check piece weight and packaging.

[0022] In the azilsartan medoxomil tablet prepared by the present invention, the highly dispersed active ingredients help the rapid dissolution of the drug and increase the solubility of the insoluble drug, and the acidic microenvironment generated by the organic acid carrier material helps to maintain the stability of the drug; Direct compression can effectively avoid the neutral water environment during the preparation proce...

specific Embodiment approach

[0023] In order to enable those skilled in the art to better understand the technical solutions of the present invention, some non-limiting embodiments are further disclosed below to further describe the present invention in detail.

[0024] The reagents used in the present invention can be purchased from the market or can be prepared by the method described in the present invention.

Embodiment 1

[0026] prescription:

[0027] Make up

Content

Azilsartan medoxomil potassium salt

20 servings

Pregelatinized starch

40 servings

Citrate

30 servings

Sodium Carboxymethyl Starch

5 servings

Talc

5 servings

[0028] Preparation Process:

[0029] Add azilsartan medoxomil potassium salt, pregelatinized starch and citric acid into the sand mill according to the prescription amount, adjust the grinding time for 3 hours to obtain a uniformly mixed drug powder; crush the sodium carboxymethyl starch and talc Pass through a 30-mesh sieve, add to the aforementioned drug powder, mix thoroughly, and finally add the mixture to a high-speed rotary tablet press for direct powder compression. Whole piece, check appearance, measure piece weight, and pack.

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Abstract

The invention provides azilsartan medoxomil tablets which comprise 10-35 parts of azilsartan medoxomil, 20-70 parts of a filling agent, 10-40 parts of an organic acid carrier material, 1-15 parts of a disintegrating agent and 5-15 parts of a lubricating agent, wherein the organic acid carrier material refers to citric acid or fumaric acid. According to the azilsartan medoxomil tablets prepared by the invention, the active ingredients which are highly dispersed in the carrier material contribute to rapidly dissolving the medicines and improving the dissolubility of insoluble drugs, and the acidic microenvironment generated by the organic acid carrier material contributes to maintaining the drug stability; and moreover, direct powder tabletting is adopted, so that a neutral water environment in the preparation process can be effectively avoided. The preparation drug is high in bioavailability, stable in quality and simple in preparation.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an azilsartan medoxomil tablet and a preparation method thereof. Background technique [0002] Azilsartan medoxomil (Azilsartan medoxomil) exists in the form of potassium salt in pharmaceutical preparations, with the structure as formula (I). Azilsartan medoxomil is unstable in a neutral pH environment, is almost insoluble in water, and has poor permeability. It belongs to category IV in the BCS classification. [0003] [0004] Azilsartan medoxomil is a prodrug of Azilsartan, a type of blood pressure lowering drug developed by Takeda Pharmaceutical Company of Japan. Azilsartan medoxomil is an angiotensin II receptor inhibitor, which blocks angiotensin II The activity of receptors achieves the effect of lowering blood pressure, which can not only control blood pressure well, but also reduce the risk of concurrent cardiovascular disease and diabetes. The product was approved ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4245A61K47/12A61P9/12A61P3/10A61P9/00
Inventor 王建军赵锋
Owner SUNSHINE LAKE PHARM CO LTD
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