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Ursodeoxycholic acid preparation for covering bitter taste by adopting lipid net-shaped inclusion technology
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A technology of ursodeoxycholic acid and adhesive, which is applied in the field of ursodeoxycholic acid preparation and its preparation, and achieves the effects of long validity period, easy industrial production, and improved taste
Inactive Publication Date: 2019-06-21
HEFEI IND PHARMA INST CO LTD +1
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[0004] The purpose of the present invention is to solve the problem of the bitter taste of oral ursodeoxycholic acid, and propose a method for preparing taste-masked ursodeoxycholic acid using lipid network inclusion technology, through taste-masking carrier and ursodeoxycholic acid drug lipid Obtain fine powder after inclusion, and then prepare solid preparation with other pharmaceutical excipients
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[0015] Preparation process: Micronize ursodeoxycholic acid, weigh ursodeoxycholic acid, glyceryl sorbate, polyethylene glycol, lactose, and carmellose sodium according to the prescription amount and mix them in a high-speed mixing granulator for 10 minutes. Add water or 40% ethanol to granulate for 3 minutes, collect and dry at 60°C for 30 minutes to measure the moisture content to be less than 2%, pass through a 30-60 mesh sieve, add the remaining auxiliary materials and mix for 10 minutes to obtain the product.
[0018] Preparation process: micronize ursodeoxycholic acid, weigh ursodeoxycholic acid, glyceryl sorbate, poloxamer, lactose, and carmellose sodium according to the prescription amount and mix them in a high-speed mixing granulator for 10 minutes. Add water or 40% ethanol to granulate for 3 minutes, collect the material with an extrusion granulator, use a 0.5mm screen, dry at 60°C for 30 minutes after spheronization, measure the moisture content to be less than 2%, pass through a 30-60 mesh sieve, add the remaining auxiliary materials and mix for 10 minutes, that is have to.
[0021] Preparation process: Micronize ursodeoxycholic acid, weigh glyceryl monostearate, pass polyvinylpyrrolidone through 80 mesh sieve, add 50ml of chloroform to dissolve, add ursodeoxycholic acid, stir for 30min, spray dry (60°C ) to obtain a taste-masking powder, and fully mix the prepared taste-masking powder with other auxiliary materials to obtain a dry suspension of ursodeoxycholic acid.
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Abstract
The invention relates to the field of pharmaceutical preparations, in particular to an ursodeoxycholic acid preparation for covering bitter taste by adopting a lipid net-shaped inclusion technology and a preparation method of the ursodeoxycholic acid preparation. The preparation method comprises the following steps: mixing ursodeoxycholic acid with a lipid carrier material and a release regulator,directly drying or granulating, and then drying to obtain taste maskingpowder, and mixing the obtained taste maskingpowder with common pharmaceutical auxiliary materials to prepare the solid preparation. The lipid-coated ursodeoxycholic acid preparation tastes good.
Description
technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a ursodeoxycholic acid preparation and a preparation method thereof which uses lipid network inclusion technology to maskbitter taste. Background technique [0002] Ursodeoxycholic acid, whose chemical name is 3α, 7β-dihydroxy-5β-cholestane-24-acid, is currently FDA-approved for primary cholestatic cirrhosis, primary sclerosing cholangitis, etc. It is the drug of choice for cholestatic liver disease. There are many products on the market, but ursodeoxycholic acid tastes extremely bitter, which limits its development. [0003] Oral dosage forms of drugs are convenient and low-cost, and are currently the most common way of drug delivery. However, many drugs have unbearable bad taste, which is greatly restricted in the development and clinical use of dosage forms. With the continuous improvement of people's living standards, people's requirements for the quality of medic...
Claims
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Application Information
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