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Ezetimibe tablets

A technology of ezetimibe and parts by weight, applied in the field of pharmaceuticals, can solve the problems of large release differences, human organ and tissue damage, side effects, etc., to reduce dissolution differences, reduce absorption fluctuations, and improve safety. Effect

Inactive Publication Date: 2016-01-06
WUXI FORTUNE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, the release of ezetimibe tablets in the prior art varies greatly in gastric juice, and the absorption fluctuations in the body are relatively large. The drug effect of ezetimibe tablets in the human body cannot be released continuously and stably. If the dissolution of ezetimibe tablets is too fast, it will cause damage to human organs and tissues, and has certain side effects in pharmacology

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021]

[0022]

[0023] Measure according to the method under the two appendices of Chinese Pharmacopoeia version in 2010, paddle method, temperature is 37 ℃, and rotating speed is 50 rev / mins, and dissolution medium is in the 0.1M hydrochloric acid solution that contains 0.45% sodium lauryl sulfate in 500ml, uses The ultraviolet detector detects under the wavelength 233nm, obtains the dissolution measurement result in the embodiment one, as shown in specific reference table 1, and forms as follows figure 1 The dissolution profile is shown.

[0024] time (min)

[0025] Table 1: Example 1 dissolution test results

Embodiment 2

[0027]

[0028] Measure according to the method under the two appendices of Chinese Pharmacopoeia version in 2010, paddle method, temperature is 37 ℃, and rotating speed is 50 rev / mins, and dissolution medium is in the 0.1M hydrochloric acid solution that contains 0.45% sodium lauryl sulfate in 500ml, uses The ultraviolet detector detects under the wavelength 233nm, obtains the dissolution measurement result in the embodiment one, as shown in the specific reference table 2, and forms as follows figure 2 The dissolution profile is shown.

[0029] time (min)

[0030] Table 2: Dissolution test result of embodiment two

Embodiment 3

[0032]

[0033] Measure according to the method under the two appendices of Chinese Pharmacopoeia version in 2010, paddle method, temperature is 37 ℃, and rotating speed is 50 rev / mins, and dissolution medium is in the 0.1M hydrochloric acid solution that contains 0.45% sodium lauryl sulfate in 500ml, uses The ultraviolet detector detects under the wavelength 233nm, obtains the dissolution measurement result in the embodiment one, as shown in the specific reference table 3, and forms as follows image 3 The dissolution profile is shown.

[0034] time (min)

[0035] Table 3: Example 3 dissolution test results

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Abstract

The invention provides ezetimibe tablets. The ezetimibe tablets are prepared from the following components in parts by weight: 100g to 200g of ezetimibe, 600g to 1200g of lactose, 50g to 100g of microcrystalline cellulose PH101, 50g to 100g of cross-linked sodium carboxymethylcellulose, 1g to 2g of lauryl sodium sulfate, 2g to 4g of polyvinylpyrrolidone k30, 0.5g to 1g of magnesium stearate and 40g to 80g of a wetting agent. The ezetimibe tablets disclosed by the invention can be used for effectively reducing the fluctuation of the dissolution rate of the ezetimibe tablets and the dissolution difference is reduced; the safety of the ezetimibe tablets in a drug application process is improved and the fluctuation of internal absorption of the ezetimibe tablets is reduced.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to an ezetimibe tablet. Background technique [0002] Ezetimibe is authorized by Schering-Plough to produce chemical name 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4 (S)-(4-hydroxyphenyl)-2-azetidin (azetidin) ketone, the chemical structural formula is: [0003] [0004] Ezetimibe is a white crystalline powder, easily soluble in ethanol, methanol and acetone, almost insoluble in water, with a melting point of about 160°C and stable at room temperature. The clinical main drug of Ezetimibe Tablets is used for primary hypercholesterolemia. This product is used as an adjuvant therapy other than diet control. It can be used alone or in combination with HMG-CoA reductase inhibitors such as statins to treat cholesterolemia. It can lower total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), only protein B (ApoB), or as an adjunct to other lipid-low...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/397A61K47/38A61K47/26A61K47/20A61K47/12A61P3/06
Inventor 虞佳媛李勇张惠芳徐建国张莹王涛王庆林
Owner WUXI FORTUNE PHARMA
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