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Irbesartan self-emulsifying soft capsule and preparation method thereof

A self-emulsifying and emulsifier technology, used in capsule delivery, emulsion delivery, cardiovascular system diseases, etc., can solve the problems of poor stability and low bioavailability, achieve stable properties, simple preparation process, and reduce the first pass. effect of effect

Inactive Publication Date: 2017-12-15
ZHENGZHOU TAIFENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the deficiencies of existing preparations, the object of the present invention is to provide a self-emulsifying soft capsule of irbesartan and a preparation method thereof, so as to solve the technical problems of poor stability and low bioavailability of existing irbesartan oral tablets

Method used

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  • Irbesartan self-emulsifying soft capsule and preparation method thereof
  • Irbesartan self-emulsifying soft capsule and preparation method thereof
  • Irbesartan self-emulsifying soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment l

[0033] A kind of irbesartan self-emulsifying soft capsule, the specification is 1000 grains, and the ratio of each raw material is as shown in the following table:

[0034]

[0035] The specific preparation method is as follows:

[0036] 1) Content preparation: Precisely weigh polyoxyethylene hydrogenated castor oil and PEG600 according to the weight ratio, mix evenly, add to the prescribed amount of medium-chain triglycerides, vortex and mix evenly, add irbesartan, and sonicate until The drug is completely dissolved to obtain a self-emulsion;

[0037] 2) Preparation of soft capsule glue: in parts by weight, add 35 parts of glycerin and 95 parts of water into the glue tank, heat to 40-70 degrees Celsius, add 100 parts of gelatin and heat to 70-90 degrees Celsius, stir for 30-40 Minutes, stand for 30-50 minutes, sieve and filter, the screen size is 120-140 mesh, and the glue is kept in a liquid storage tank at 55 degrees Celsius for later use;

[0038] 3) Preparation of so...

Embodiment 2

[0042] A kind of irbesartan self-emulsifying soft capsule, the specification is 1000 grains, and the ratio of each raw material is as shown in the following table:

[0043]

[0044] Preparation method: same as the preparation method in Example 1.

Embodiment 3

[0046] A kind of irbesartan self-emulsifying soft capsule, the specification is 1000 grains, and the ratio of each raw material is as shown in the following table:

[0047]

[0048] Preparation method: same as the preparation method in Example 1.

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Abstract

The invention belongs to the technical field of medicinal preparations, and concretely relates to an irbesartan self-emulsifying solution. The irbesartan self-emulsifying solution comprises 20-40 wt% of irbesartan, 25-50 wt% of an oil phase, 10-50 wt% of an emulsifier and 5-20 wt% of a co-emulsifier. The invention also discloses a preparation method of an irbesartan self-emulsifying soft capsule. The preparation method comprises the following steps: synthesizing the irbesartan self-emulsifying solution from the irbesartan, the emulsifier, the co-emulsifier and the oil phase according to a certain ratio, and processing the self-emulsifying solution through a device to prepare the soft capsule. The above medicine is dissolved in the oil phase, the obtained solution is orally taken and then self-emulsifies in bodies to form a micro-emulsion with the particle size of about 200 nm, so the in-vitro dissolubility and the in-vivo absorption of the irbesartan are remarkably improved, and the in-vivo bioavailability is improved. The medicine can be taken at an integral grain after being processed to prepare the soft capsule, and the content of the soft capsule also can be taken out and is diluted with water to form a solution to be sent in order to improve the medicine taking compliance of old people and difficult swallowing patients.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an irbesartan self-emulsifying liquid, a self-emulsifying soft capsule and a preparation method thereof. Background technique [0002] Irbesartan (English name: Irbesartan) is an angiotensin Ⅱ (Angiotensin Ⅱ, Ang Ⅱ) receptor inhibitor, which can inhibit the conversion of Ang Ⅰ to Ang Ⅱ, and can specifically antagonize the angiotensin converting enzyme 1 receptor (AT1). The antagonism of AT1 is obviously better than that of AT. By selectively blocking the combination of Ang II and AT1 receptors, it inhibits vasoconstriction and the release of aldosterone, resulting in a powerful antihypertensive effect. Irbesartan is mainly used clinically for the treatment of hypertension. It does not inhibit angiotensin-converting enzyme (ACE), renin, and other hormone receptors while lowering blood pressure, nor does it inhibit ions related to blood pressure reg...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/4184A61K9/48A61P9/12
CPCA61K9/1075A61K9/4825A61K31/4184A61K47/12A61K47/14
Inventor 沙薇常新义李婷朱新科
Owner ZHENGZHOU TAIFENG PHARMA CO LTD
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