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Dispersant tablet containing hypolipidemic component and its prepn process

A technology of dispersible tablets and effective doses, applied in the field of oral pharmaceutical preparations, can solve the problems of sticking and punching, disintegration time limit overtime, and no solution is found to clearly teach.

Active Publication Date: 2007-01-03
江苏万高药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, for the insurmountable obstacles such as sticky impact and disintegration time limit overtime in its actual operation, no clear teaching of related solutions has been found in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Embodiment 1: prescription (calculated in single tablet)

[0072] Component Content (mg / tablet)

[0073] Bezafibrate 200mg

[0074] Lactose 150mg

[0075] Calcium Sulfate 200mg

[0076] Sodium carboxymethyl starch 50mg

[0077] Hypromellose 30mg

[0078] Tween-80 10mg

[0079] Micronized silica gel 15mg

[0080] Magnesium Stearate 5mg

[0081] Aspartame 10mg

[0082] 5% povidone K30 in 95% ethanol solution (adhesive) appropriate amount

[0083] Total tablet weight 670mg

[0084] Process:

[0085] Take the raw material of bezafibrate, pulverize it, pass through a 120-mesh sieve, and set aside.

[0086] According to the prescription amount, weigh bezafibrate, lactose, hydroxypropyl cellulose, calcium sulfate, aspartame and 2 / 3 of the prescription amount of sodium carboxymethyl starch and pass through a 100 mesh sieve to mix evenly, pour the adhesive and Soft materials made of Tween-80, granulated through a 40-mesh sieve, dried at 55°C, granulated with a ...

Embodiment 2

[0087] Embodiment 2: prescription (calculated in single tablet)

[0088] Component Content (mg / tablet)

[0089] Bezafibrate 400mg

[0090] Lactose 50mg

[0091] Microcrystalline Cellulose 150mg

[0092] Low-substituted hydroxypropyl cellulose 45mg

[0093] Micronized silica gel 20mg

[0094] Talc powder 10mg

[0095] Stevia 5mg

[0096] 8% povidone K30 in 90% ethanol solution (adhesive) appropriate amount

[0097] Total tablet weight 680mg

[0098] Process:

[0099] The raw material of bezafibrate is taken, micronized, and set aside.

[0100] According to the prescription amount, weigh bezafibrate, lactose, microcrystalline cellulose, stevioside and 2 / 3 of low-substituted hydroxypropyl cellulose, pass through a 100-mesh sieve and mix evenly, pour into the soft material made of adhesive, pass through 20 Mesh sieve granulation, dry at 50°C, granulate with 20 mesh, add micropowder silica gel, talcum powder and remaining low-substituted hydroxypropyl cellulose t...

Embodiment 3

[0101] Embodiment 3: Prescription (calculated in single tablet)

[0102] Component Content (mg / tablet)

[0103] Bezafibrate 300mg

[0104] Mannitol 100mg

[0105] Microcrystalline Cellulose 50mg

[0106] Carboxymethyl Starch Sodium 40mg

[0107] Croscarmellose Sodium 20mg

[0108] Sodium Lauryl Sulfate 10mg

[0109] Micronized silica gel 20mg

[0110] Talc powder 10mg

[0111] Protein sugar 10mg

[0112] 3% hypromellose in 95% ethanol solution (adhesive) appropriate amount

[0113] Total tablet weight 560mg

[0114] Process:

[0115] Take the raw material of bezafibrate, pulverize it, pass through a 180-mesh sieve, and set aside.

[0116] According to the prescription amount, weigh bezafibrate, mannitol, microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and protein sugar, pass through a 100-mesh sieve and mix evenly, pour into the soft material made of adhesive, Pass through a 18-mesh sieve to granulate, dry at 60°C, granulate with a...

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PUM

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Abstract

The present invention relates to orally taken medicine preparation containing benzafibrate, and is especially dispersant tablet of benzafibrate with enhanced effect. The dispersant tablet of benzafibrate has fast acting, enhanced active component and easy taking.

Description

technical field [0001] The present invention relates to pharmaceutical oral preparations containing bezafibrate, in particular to a dispersible tablet form for enhancing the beneficial effect of bezafibrate. Background technique [0002] Bezafibrate is a blood lipid regulating drug derived from clofibrate, which can reduce blood low-density lipoprotein and cholesterol. The mechanism is to strengthen the clearance of receptor-bound low-density lipoprotein. [0003] Those skilled in the art know that solid preparations need to go through the process of disintegration, dissolution, and absorption, which is very unfavorable for the effectiveness of insoluble drugs, while oral liquids cannot be accurately divided into doses, and are inconvenient and unstable to carry. Unfortunately, bezafibrate is a drug with poor water solubility, and its dissolution in the digestive tract will be limited, which will further affect the absorption of the active ingredients of bezafibrate by patie...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/192A61K47/38A61P3/06
Inventor 姚俊华
Owner 江苏万高药业股份有限公司
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