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A kind of double-coated silibinin sustained-release pellets and preparation method thereof

A technology of silibinin and sustained-release pellets, which is applied in the direction of medical preparations of non-active ingredients, pharmaceutical formulas, and the digestive system, and can solve problems such as increasing bioavailability in vivo, poor patient compliance, and no sustained-release effect , to achieve the effect of improving relative bioavailability, reducing the number of medications, and easy operation

Active Publication Date: 2017-09-26
JIANGSU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above-mentioned preparations are common preparations, which simply increase the dissolution of the drug and thus increase the bioavailability in the body, but have no sustained-release effect, and the patient's compliance is poor, and there are no products on the market that have a good sustained-release effect and are highly praised by the industry. Oral sustained-release formulation of silibinin

Method used

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  • A kind of double-coated silibinin sustained-release pellets and preparation method thereof
  • A kind of double-coated silibinin sustained-release pellets and preparation method thereof
  • A kind of double-coated silibinin sustained-release pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Weigh 100g of blank pellets and place them in a Mini-250 extrusion spheronization fluidized coating machine, and preheat for 30 minutes.

[0043] Weigh 4g silybin and 8g PVP K respectively 30 , 12g PEG400, 16g Tween 80, add to 200mL of 50% ethanol water and magnetically stir until it is clear and uniform, add 1.2g of talc, magnetically stir, and set the coating parameters of the solid dispersion layer: the coating speed is 800rpm, the air inlet speed is 25Hz, The wind speed is 18Hz, and the spraying speed of the coating spray gun is 1mL·min -1 , The air inlet temperature is 45°C, the material temperature is 40°C, the coating is carried out, after the coating is completed, take it out, and dry it in a vacuum drying oven at 50°C for 2h to obtain silibinin solid dispersion pellets. The obtained silybin solid dispersion pellets were observed under electron microscope, and the results were as follows Figure 5 ; Measure the dissolution curve of silybin solid dispersion pellets i...

Embodiment 2

[0046] Weigh 100g of blank pellets and place them in a Mini-250 extrusion spheronization fluidized coating machine, and preheat for 30 minutes.

[0047] Weigh 6g silybin and 3g PVP K respectively 30 , 6g F68, 6g Tween 80, add to 150mL 60% ethanol water and magnetically stir until it is clear and uniform, add 2g magnesium stearate, magnetically stir, and set the coating parameters of the solid dispersion layer: the coating speed is 800rpm, the air inlet speed is 25Hz , The wind speed is 18Hz, and the spraying speed of the coating spray gun is 1mL·min -1 , The inlet air temperature is 45℃, and the material temperature is 40℃. Carry out the coating, take it out after the coating is completed, and dry it in a vacuum drying oven at 50°C for 12 hours to obtain silybin solid dispersion pellets. The test results are as in Example 1.

[0048] Take 100g of the silybin solid dispersion pellets prepared above, weigh 5g EC, 4g dibutyl phthalate, 3g PEG6000 respectively, add to 150mL pure ethan...

Embodiment 3

[0050] Weigh 100g of blank pellets and place them in a Mini-250 extrusion spheronization fluidized coating machine, and preheat for 30 minutes.

[0051] Weigh 8g silybin and 40g PVP K respectively 25 , 15g F68, 30g PEG400, 15g Tween 80, 2g soybean phospholipid, add to 200mL 75% ethanol water and magnetically stir until clear, add 6.4g talc, magnetically stir, set the solid dispersion layer coating parameters: the coating speed is 800rpm , The air inlet speed is 25Hz, the air outlet speed is 18Hz, the spraying speed of the coating spray gun is 1mL·min -1 , The inlet air temperature is 45℃, and the material temperature is 40℃. Carry out the coating, take it out after the coating is completed, and dry it in a vacuum drying oven at 50°C for 12 hours to obtain silybin solid dispersion pellets. The test results are as in Example 1.

[0052] Take 100g of the silybin solid dispersion pellets prepared above, weigh 10g EC, 2g micronized silica gel, and 3gPEG6000 respectively, add them to 15...

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Abstract

The invention relates to a silibinin slow release micropill with double layers of coatings. The silibinin slow release micropill is formed by a hollow pill core outside which the double layers of coatings are wrapped, wherein the first layer of coating forms a silibinin solid dispersion micropill and comprises silibinin, a solid dispersion carrier, a solubilizer and a sticky-resisting agent which are wrapped outside the hollow pill core so as to form the silibinin slow release micropill; the second layer of coating is formed outside the silibinin slow release micropill and comprises a slow release material, a lubricant and a plasticizer which are wrapped outside the silibinin slow release micropill so as to form silibinin slow release micropill with double layers of coatings. The silibinin slow release micropill provided by the invention is simple and convenient in preparation method, high in industrialized potential, stable in medicine release after being taken orally and high in bioavailability, and has a certain slow release effect.

Description

Technical field [0001] The invention relates to an oral solid sustained-release pellet preparation of insoluble drugs and a preparation method thereof, in particular to an oral sustained-release silybin oral sustained-release pellet preparation and a preparation method thereof. Background technique [0002] Compositae plant Silybum marinaum (L) Gaenrt has been a good liver-protecting drug since ancient times. Silymarin is the general term for effective mixtures extracted from Silybum marianum. Silibinin (SLB) is its main active ingredient. Silybin has a variety of pharmacological activities in pharmacology, including liver protection, antioxidant, anti-inflammatory, anti-cancer and myocardial protection. Significantly maintains liver cells, maintains liver function, and reduces blood lipids. It is mainly used clinically to treat liver poisoning, cirrhosis, acute and chronic hepatitis, etc. It is currently recognized as a hepatoprotective drug with significant curative effect. [...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/48A61K31/357A61K47/32A61K47/10A61K47/38A61P1/16
Inventor 余江南黄治民朱源徐希明曹霞
Owner JIANGSU UNIV
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