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Targeted positioning type film coating premix and preparation method thereof

A film-coating, positioning-type technology, applied in the directions of pharmaceutical formulations, inactive medical preparations, inorganic inactive ingredients, etc., can solve the problems of decreased drug treatment effect, drug disintegration, etc. dosage, the effect of reducing dissolution

Active Publication Date: 2020-11-13
BEIJING YINGMAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, acrylic resin is a commonly used film coating material. Utilizing the pH dependence of acrylic resin, it can be kept intact in acidic gastric juice, but it will quickly form salt, dissolve swelling and release drugs in intestinal juice with higher pH. However, the traditional film coating and has good targeting, so that the drug will disintegrate before reaching the intended administration site, resulting in a decrease in the therapeutic effect of the drug

Method used

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  • Targeted positioning type film coating premix and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1: A targeted positioning type film coating premix is ​​prepared by the following method:

[0037]S1. Weigh 50kg of polyacrylic acid resin III, 22kg of Eudragit RS100, 10kg of talcum powder anti-sticking agent, 15kg of plasticizer, 2kg of Tween-80, 10kg of purified water, 3kg of ethanol with a volume fraction of 95%, and 1kg of color lake ; Wherein, plasticizer is made up of 5kg triethyl citrate and 10kg polyethylene glycol 6000;

[0038] S2. Take the polyacrylic resin III weighed in S1, Eudragit RS100, talcum powder, plasticizer, Tween-80, add water and ethanol with a volume fraction of 95% as a solvent, and use it at a speed of 2500r / min , mixed and stirred for 0.9h to obtain a blend;

[0039] S3, drying the blend solution at a temperature of 40° C. for 4.5 hours until the moisture content is ≤8%, to obtain a blend;

[0040] S4. Add color lake to the blend, pre-mix for 0.8h at a speed of 800r / min to obtain a premix; grind the premix for 5h at a speed of 3000...

Embodiment 2

[0041] Example 2: A targeted positioning type film coating premix is ​​prepared by the following method:

[0042] S1. Weigh 45kg of polyacrylic acid resin III, 20kg of Eudragit RS100, 8kg of magnesium stearate anti-sticking agent, 12kg of plasticizer, 1kg of Tween-80, 10kg of purified water, 3kg of ethanol with a volume fraction of 95%, and 0.5 kg color lake; Wherein, plasticizer is made up of 4kg triethyl citrate and 8kg polyethylene glycol 6000;

[0043] S2. Take the polyacrylic resin III weighed in S1, Eudragit RS100, magnesium stearate, plasticizer, Tween-80, add water and ethanol with a volume fraction of 95% as a solvent, and use it at 2000r / min Speed, mixed and stirred for 0.8h to obtain a blend;

[0044] S3, drying the blend solution at a temperature of 35° C. for 5 hours until the moisture content is ≤8%, to obtain a blend;

[0045] S4. Add color lake to the blend, and pre-mix for 0.5h at a speed of 500r / min to obtain a premix; grind the premix for 4h at a speed of ...

Embodiment 3

[0046] Example 3: A targeted positioning type film coating premix is ​​prepared by the following method:

[0047] S1. Weigh 55kg of polyacrylic resin III, 25kg of Eudragit RS100, 12kg of talcum powder anti-sticking agent, 18kg of plasticizer, 2kg of Tween-80, 10kg of purified water, 3kg of ethanol with a volume fraction of 95%, and 1kg of color lake ; Wherein, plasticizer is made up of 6kg triethyl citrate and 12kg polyethylene glycol 6000;

[0048] S2. Take the polyacrylic resin III weighed in S1, Eudragit RS100, talcum powder, plasticizer, Tween-80, add water and ethanol with a volume fraction of 95% as a solvent, and use it at a speed of 3000r / min , mixed and stirred for 1h to obtain a blend;

[0049] S3, drying the blend solution at a temperature of 45° C. for 4 hours until the moisture content is ≤8%, to obtain a blend;

[0050] S4. Add color lake to the blend, and pre-mix for 1 hour at a speed of 1000r / min to obtain a premix; grind the premix for 6 hours at a speed of ...

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Abstract

The invention relates to the field of medicine coating materials, and particularly discloses a targeted positioning type film coating premix. The targeted positioning type film coating premix is prepared from the following raw materials in parts by weight: 45 to 55 parts of polyacrylic resin III, 20 to 25 parts of Eudragit RS100, 8 to 12 parts of an anti-sticking agent, 12 to 18 parts of a plasticizer, 1 to 3 parts of tween-80 and 0.5 to 2 parts of a coloring agent, the preparation method comprises the following steps: S1, weighing: weighing the raw materials in proportion for later use; and S2, taking the weighed raw materials, taking water and ethanol as solvents, mixing, drying, premixing, grinding, sieving, and mixing again to obtain the targeted positioning type film coating premix. The targeted positioning type film coating premix disclosed by the invention can be used for coating medicines and has the advantages of targeted positioning and sustained and controlled release.

Description

technical field [0001] This application relates to the field of drug coating materials, more specifically, it relates to a targeted positioning type coating premix and its preparation method. Background technique [0002] Coating is to coat sugar or other film-forming materials on the outer surface of the solid drug preparation in specific equipment according to a specific process, so that it becomes a multifunctional protective layer that closely adheres to the surface of the material after drying, and the drug passes through After the coating treatment, the drug can be protected from moisture, light, taste, disintegration, and drug dissolution. Coating generally includes sugar coating, film coating and press coating, and film coating is a new type of coating technology. Through the spray coating process, the polymer solution or dispersion is evenly coated on the surface of the solid preparation to form A plastic film layer with a certain thickness and strength, which has ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/32A61K47/26A61K47/10A61K47/02A61K47/14
CPCA61K47/32A61K47/26A61K47/10A61K47/02A61K47/14
Inventor 陈佩英
Owner BEIJING YINGMAO PHARMA
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