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High-dissolution oral bifendate capsule and preparation method thereof

A bifendate and capsule technology, which is applied in the field of medicine, can solve the problems of low bioavailability and poor absorption effect, and achieve the effects of simple preparation method, stable product and improved bioavailability

Inactive Publication Date: 2009-10-07
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to prepare a kind of oral solid preparation of bifendate with high dissolution rate for the problems of poor absorption effect and low bioavailability of oral preparations of bifendate in the above existing dosage forms, so as to improve bioavailability , to reduce the dosage, thereby reducing the purpose of toxic and side effects

Method used

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  • High-dissolution oral bifendate capsule and preparation method thereof
  • High-dissolution oral bifendate capsule and preparation method thereof
  • High-dissolution oral bifendate capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] (1) Preparation of bifendate solid dispersion: with acrylic resin No. IV as the carrier, pre-mix the two for 5 minutes according to the ratio of medicine and carrier 1:4, and set the temperature in the four zones of the melt extruder to 180°C, after equilibrating for 20 minutes, add the physical mixture into the feeding funnel, disperse through the melt extruder at a speed of 180rpm, melt and extrude, and cool at room temperature to obtain a solid dispersion of biphenyl diester, which is crushed through a 100-mesh sieve to obtain Powdered bifendate solid dispersion.

[0019] (2) Preparation of high-dissolution bifendate oral capsules: get 5g of bifendate solid dispersion powder, add glidant 1g micropowder silica gel, after 4g sorbitol mix evenly, fill in No. 2 capsules (100 grain).

[0020] The dissolution results show that the dissolution rate of bifendate in the solid dispersion can reach more than 90%, and the dissolution rate of the high-dissolution bifendate oral ...

Embodiment 2

[0022] (1) Preparation of bifendate solid dispersion: take S-630 as the carrier, pre-mix the two for 5 minutes according to the ratio of drug and carrier 1:5, and set the temperature in the first zone of the melt extruder to 100°C, and the other three zones are set at 180°C. After equilibrating for 20 minutes, add the physical mixture into the feeding funnel, disperse it with a melt extruder at a speed of 180rpm, melt and extrude it, and obtain a solid dispersion of biphenyl diester after cooling at room temperature body, which was pulverized through a 100-mesh sieve to obtain a powdery bifendate solid dispersion.

[0023] (2) Preparation of high-dissolution bifendate oral capsules: take 8.5 g of bifendate solid dispersion powder, add glidant corn starch 1 g, sorbitol 0.5 g, mix well, and fill in No. 2 capsules (100 capsules).

[0024] The dissolution results show that the dissolution rate of bifendate in the solid dispersion can reach more than 80%, and the dissolution rate ...

Embodiment 3

[0026] (1) Preparation of bifendate solid dispersion: take PVP:PEG6000=9:1 as the carrier, pre-mix the two for 5 minutes according to the ratio of medicine and carrier 1:3, and uniformly heat the temperature in the four zones of the melt extruder Set at 180°C, after equilibrating for 20 minutes, add the physical mixture into the feeding funnel, disperse it in a melt extruder at a speed of 180rpm, melt and extrude it, and obtain a solid dispersion of biphenyl diester after cooling at room temperature, crushed over 80 After the mesh sieve, the powdery bifendate solid dispersion was obtained.

[0027] (2) Preparation of high-dissolution bifendate oral capsules: get 4g of bifendate solid dispersion powder, add glidant talc powder 1g, after mixing 5g of lactose, fill in No. 2 capsules (100 capsules ).

[0028] The dissolution results show that the dissolution rate of bifendate in the solid dispersion can reach more than 80%, and the dissolution rate of the high-dissolution bifenda...

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Abstract

The invention discloses a high-dissolution oral bifendate capsule and a preparation method thereof, which belong to the technical field of medicines. The high-dissolution oral bifendate capsule is prepared by 10 of bifendate, 20-80 of hydrophilic carrier auxiliary material, 10-20 of flow aid, 0-50 of filling agent, and the like according to the weight percentage. The preparation method of the high-dissolution oral bifendate capsule comprises the following steps: a bifendate bulk drug is mixed with a hydrophilic carrier, and the high-dissolution solid dispersion is prepared by a melt-extrusion technology; and the obtained solid dispersion is crushed and sieved and then is mixed with a proper mount of the auxiliary material and then is filled in capsules to be prepared into high-dissolution oral bifendate capsules. The drug in the solid dispersion exists in the polymeric carrier in an abnormal crystal form, the dissolution rate is remarkably improved compared with that of the bulk drug, and the bioavailability of the drug can be improved, therefore, the dosage of administration and the untoward reaction of the drug can be reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a high-dissolution bifendate capsule and a preparation method thereof. Background technique [0002] Bifendate (bifendate) is a synthetic analogue of Schisandra C, which is commonly used in the treatment of chronic and persistent hepatitis. Animal experiments have proved that bifendate can significantly reduce the content of serum alanine aminotransferase (SGPT) caused by various chemical poisons such as carbon tetrachloride and thioacetamide, and can alleviate the pathological changes of the liver at the same time, without obvious toxicity effect. Bifendate as a drug for liver diseases has been recorded in the Chinese Pharmacopoeia, and the dosage forms currently on the market include ordinary tablets and dropping pills. Studies have shown that bifendate has poor water solubility, little damage in the gastrointestinal tract after oral administration, poor absorption, and 70% is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/357A61K47/32A61K47/34A61K47/36A61K47/38A61P1/16A61J3/07A61K47/10
Inventor 唐星李慧
Owner SHENYANG PHARMA UNIVERSITY
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