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Candesartan cilexetil self-microemulsion soft capsule and preparation method thereof

A technology of candesartan cilexetil and self-microemulsification, which is applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve problems such as strong hepatic and intestinal first-pass effects, low bioavailability, and long dissolution time problem, achieve the effect of overcoming capsule shell degeneration, high bioavailability, and reducing disparity

Inactive Publication Date: 2012-04-25
HUBEI UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] One of the purposes of the present invention is to overcome the long dissolution time limit, low dissolution rate, poor absorption, strong intestinal first-pass effect, short half-life, and low bioavailability of candesartan cilexetil in the prior art. etc. Insufficiency, thereby provide a kind of candesartan cilexetil self-microemulsifying soft capsule for oral administration, it has the characteristics of good solubility and high bioavailability, and can improve the curative effect of medicine

Method used

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  • Candesartan cilexetil self-microemulsion soft capsule and preparation method thereof
  • Candesartan cilexetil self-microemulsion soft capsule and preparation method thereof
  • Candesartan cilexetil self-microemulsion soft capsule and preparation method thereof

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Embodiment 1

[0034] The preparation of embodiment 1 candesartan cilexetil self-microemulsified soft capsule

[0035] A kind of preparation method of candesartan cilexetil self-microemulsifying soft capsule of the present invention adopts the following process steps: its component ratio is calculated in parts by weight:

[0036] Preparation of the shell fluid:

[0037] Weigh 100 parts of gelatin of prescription quantity, put 18 parts of glycerin; 20 parts of sorbitol; After filtration (70-80 mesh), vacuum defoaming: vacuum degree -0.06~-0.1MPa, holding temperature: 60°C-80°C, the capsule shell liquid is obtained, and the rotational viscosity of the capsule shell liquid is greater than 240mPa.s. Bucket, spare.

[0038] Preparation of content solution:

[0039] Take 1 part of candesartan cilexetil of prescription quantity; 20 parts of polyethylene glycol 400; 10 parts of ethyl acetate; 80 parts of polyoxyethylene hydrogenated castor oil, will candesartan cilexetil, co-emulsifier, oil phase, ...

Embodiment 2

[0050] The preparation of embodiment 2 candesartan cilexetil self-microemulsified soft capsules

[0051] A kind of preparation method of candesartan cilexetil self-microemulsifying soft capsule of the present invention adopts the following process steps: its component ratio is calculated in parts by weight:

[0052] Preparation of the shell fluid:

[0053] Weigh 120 parts of gelatin in the prescribed amount; add 25 parts of glycerin; 25 parts of sorbitol; Finally (70-80 mesh) filtration, vacuum defoaming: vacuum degree -0.06~-0.1MPa, holding temperature: 60°C-80°C, remember the capsule shell liquid, the rotational viscosity of the shell liquid is greater than 240mPa.s, load the material Bucket, spare.

[0054] Preparation of content solution:

[0055] Take by weighing 2 parts of candesartan cilexetil of recipe quantity; 30 parts of polyethylene glycol 400; 20 parts of ethyl acetate; 90 parts of polyoxyethylene hydrogenated castor oil, will candesartan cilexetil, co-emulsifi...

Embodiment 3

[0066] The preparation of embodiment 3 candesartan cilexetil self-microemulsified soft capsules

[0067] A kind of preparation method of candesartan cilexetil self-microemulsifying soft capsule of the present invention adopts the following process steps: its component ratio is calculated in parts by weight:

[0068] Preparation of the shell fluid:

[0069] Weigh 130 parts of gelatin in the prescribed amount; place 30 parts of glycerin; 30 parts of sorbitol; Finally (70-80 mesh) filtration, vacuum defoaming: vacuum degree -0.06~-0.1MPa, holding temperature: 60°C-80°C, remember the capsule shell liquid, the rotational viscosity of the shell liquid is greater than 240mPa.s, load the material Bucket, spare.

[0070] Preparation of content solution:

[0071] Take by weighing 2 parts of candesartan cilexetil of prescription quantity; 40040 parts of polyethylene glycol; 30 parts of ethyl acetate; 100 parts of polyoxyethylene hydrogenated castor oil, with candesartan cilexetil, co-...

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Abstract

The invention relates to a candesartan cilexetil self-microemulsion soft capsule and a preparation method thereof. The soft capsule comprises capsule liquid and content medicine liquid. The preparation method is as follows: 100-130 parts of gelatin is arranged in mixing solution for swelling, wherein the mixing solution is formed by 18-30 parts of glycerol, 20-30 parts of sorbic alcohol and 100-120 parts of water; then 0.1-0.3 part of ethylparaben is added, heating is carried out until the gelatin is dissolved, the mixture is stirred uniformly and is filtered, and vacuum defoaming and heat insulation are carried out, thus obtaining the capsule liquid; 1-2 parts of candesartan cilexetil, 20-40 parts of assistant emulsifiers, 10-30 parts of oil phase and 80-100 parts of emulsifiers are mixed uniformly, and then the mixture is heated and stirred until the uniform and transparent content solution is formed; and the prepared capsule liquid and the prepared content solution the weight percentage ratio of which is 4:3 are moulded and pressed into soft capsules by rotating a mould press, and then drying and surface treatment are carried out on the soft capsules, thus obtaining the finished products. In the invention, the bioavailability of the candesartan cilexetil is improved, and the preparation method is simple relatively, the production is easy, thus the application prospect is wide.

Description

technical field [0001] The invention belongs to the technical field of western medicine preparations, and in particular relates to a candesartan cilexetil self-microemulsified soft capsule and a preparation method thereof. Background technique [0002] Hypertension is the most common cardiovascular disease in the world, and it is also one of the biggest epidemics. It often causes complications in the heart, brain, kidney and other organs, and seriously endangers human health. Hypertensive disease is a systemic disease characterized by elevated arterial blood pressure accompanied by functional or organic changes in the heart, blood vessels, brain, and kidneys. In my country, the main direct complication of hypertension is cerebrovascular disease, especially cerebral hemorrhage. In addition, high blood pressure can also lead to various lesions of the heart, brain, kidney and blood vessels, and serious complications that threaten life and health such as left ventricular hypert...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/4184A61K47/34A61K47/42A61P9/12A61K47/10
Inventor 刘明星李蓉蓉
Owner HUBEI UNIV OF TECH
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