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Orally delivered intestinal site-specific drug release film coating premixed auxiliary material and preparation method thereof

A technology of film coating and premixing auxiliary materials, which is applied in the directions of pharmaceutical formulations, drug delivery, and medical preparations with non-active ingredients, etc., can solve the problems of low production efficiency, high production cost, and difficult operation in the coating process.

Active Publication Date: 2014-07-16
CHENGDU KETE COATING TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After searching, there are many studies on small intestine targeted drug release technology, but a comprehensive analysis of the existing technology found the following defects: 1. Most of the main components are selected from abroad, the price is expensive, the production cost is high, and domestic pharmaceutical companies are not easy to accept; 2. The pH value corresponding to the disintegration of the coated tablet is too

Method used

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  • Orally delivered intestinal site-specific drug release film coating premixed auxiliary material and preparation method thereof
  • Orally delivered intestinal site-specific drug release film coating premixed auxiliary material and preparation method thereof
  • Orally delivered intestinal site-specific drug release film coating premixed auxiliary material and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Embodiment 1: A premixed auxiliary material for oral administration of enteric localized drug release film coating, when the pH value of the intestinal tract is 5.0, the localized drug release film coating premixed auxiliary material consists of the following raw materials in parts by weight:

[0056] Polyacrylic resin Ⅱ: 54; Polyacrylic resin Ⅲ: 3;

[0057] Triethyl citrate: 20; Titanium dioxide: 1;

[0058] Talc: 8; Sodium Palmitate: 2;

[0059] Wherein, the viscosity of the polyacrylic resin II is 18 mPa·s, and the viscosity of the polyacrylic resin III is 17 mPa·s.

[0060] The preparation method of the above-mentioned oral administration enteric localized drug release film coating premixed auxiliary material comprises the following steps:

[0061] S1. Weighing: Accurately weigh each raw material according to the above ratio, and set aside;

[0062] S2. Premixing: Put the above-mentioned weighed raw materials into a ziplock bag and mix for 5 minutes;

[0063] S3...

Embodiment 2

[0066] Embodiment 2: A premixed auxiliary material for oral administration of enteric localized drug release film coating, when the pH value of the intestinal tract is 5.8, the localized drug release film coating premixed auxiliary material consists of the following raw materials in parts by weight:

[0067]

[0068] Wherein, the viscosity of the polyacrylic resin II is 18 mPa·s, and the viscosity of the polyacrylic resin III is 17 mPa·s.

[0069] The preparation method of the above-mentioned oral administration enteric localized drug release film coating premixed auxiliary material comprises the following steps:

[0070] S1. Weighing: Accurately weigh each raw material according to the above ratio, and set aside;

[0071] S2. Premixing: put the above-mentioned weighed raw materials into a ziplock bag and mix for 10 minutes;

[0072] S3. Pulverization: put the premixed raw materials into an ultrafine pulverizer and grind them for 150 minutes, and pass the ground raw materi...

Embodiment 3

[0075] Embodiment 3: A premixed auxiliary material for oral administration of enteric localized drug release film coating. When the pH value of the intestinal tract is 6.8, the localized drug release film coating premixed auxiliary material consists of the following raw materials in parts by weight:

[0076] Polyacrylic resin Ⅱ: 44; Polyacrylic resin Ⅲ: 13;

[0077] Triethyl citrate: 25; Tartrazine: 3;

[0078] Talc: 13; Sodium Palmitate: 2;

[0079] Wherein, the viscosity of the polyacrylic resin II is 18 mPa·s, and the viscosity of the polyacrylic resin III is 26 mPa·s.

[0080] The preparation method of the above-mentioned oral administration enteric localized drug release film coating premixed auxiliary material comprises the following steps:

[0081] S1. Weighing: Accurately weigh each raw material according to the above ratio, and set aside;

[0082] S2. Premixing: Put the above-mentioned weighed raw materials into a ziplock bag and mix for 6 minutes;

[0083] S3. Pu...

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Abstract

The invention discloses an orally delivered intestinal site-specific drug release film coating premixed auxiliary material. According to the pH value of the intestinal tract, the film coating premixed auxiliary material is prepared from the following raw materials in parts by weight: 1-54 parts of polyacrylic resin II, 3-55 parts of polyacrylic resin III, 20-25 parts of triethyl citrate, 1-5 parts of pigments, 8-25 parts of talcum powder and 1-3 parts of sodium palmitate, wherein the viscosity of polyacrylic resin II is 16-20mPa.s, and the viscosity of polyacrylic resin III is 17-26mPa.s. The orally delivered intestinal site-specific drug release film coating premixed auxiliary material disclosed by the invention has the advantages of low cost, accurate site-specific drug release according to different pH values of the intestinal tract, good disintegrating release property and less increment in weight of coating. Accurate site-specific drug release in the intestinal tract is realized, and the film coating premixed auxiliary material has important meaning for fully and efficiently utilizing drugs and quickly and efficiently treating diseases in the intestinal tract. The preparation method is simple in operation, convenient in preparation, low in required equipment cost and suitable for industrialized production on a large scale.

Description

technical field [0001] The present invention relates to a film-coated premixed auxiliary material and a preparation method thereof, and more specifically relates to a film-coated premixed auxiliary material for oral administration and enteric localized drug release and a preparation method thereof. Background technique [0002] Intestinal-targeted drug delivery system is a new type of drug delivery system that has attracted much attention in recent years. It is based on a full understanding of the physiological functions of the gastrointestinal tract, through specific prescription design and technological means, to selectively deliver drugs to the stomach. A specific part of the intestinal tract releases drugs in an immediate, sustained or pulsed manner to achieve a specific therapeutic purpose. Intestinal-targeted drug delivery system is of great significance for overcoming the insufficiency of the drug itself or improving the therapeutic index of the drug: (1) Intestinal-t...

Claims

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Application Information

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IPC IPC(8): A61K47/32A61K9/30
Inventor 宴新连
Owner CHENGDU KETE COATING TECH
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