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Aqueous enteric film coating premixed agent and preparation method thereof

A technology of film coating and premix, which is applied in the field of medicine, can solve the problems of film coating, such as unsatisfactory enteric solubility, water solubility, unsatisfactory enteric effect, and inability to be used in actual clinical production, etc., to achieve high toughness and strength , low cost, low moisture absorption effect

Active Publication Date: 2016-08-10
连云港万泰医药辅料技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the enteric property of the film coating prepared by this application is not ideal, and cannot be used in actual clinical production
[0010] In addition, there are many water-based gastric-soluble film-coating premixes disclosed in the prior art, while enteric-soluble film-coating premixes use alcohol as a solvent, and the water-soluble and enteric-coating effects are not ideal.

Method used

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  • Aqueous enteric film coating premixed agent and preparation method thereof
  • Aqueous enteric film coating premixed agent and preparation method thereof
  • Aqueous enteric film coating premixed agent and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0036] A water-based enteric film coating premix, which includes the following components: polyacrylic acid resin I 56g, polyethylene glycol 6000 15g, talcum powder 19g, titanium dioxide 5g, sodium lauryl sulfate 1.5g, saturated carbonic acid Sodium hydrogen solution 3.5g.

[0037] The preparation method of this premix is ​​specifically as follows:

[0038] Put polyacrylic acid resin Ⅰ, titanium dioxide, sodium lauryl sulfate and saturated sodium bicarbonate solution together into a ball mill mixer, mix for 2 hours, transfer to a double cone mixer, add polyethylene glycol 6000, talc powder, and then mixed for 1 hour, that is.

[0039]Among them, polyacrylic resin I is made of the following raw materials in weight ratio: methacrylic acid 100; ethyl acrylate 22; butyl acrylate 78; potassium persulfate or ammonium persulfate 0.496; 10 0.041; sodium lauryl sulfate 1.121; polysorbate 80 3.940; purified water 482.

[0040] The steps of its preparation method are as follows: (1) A...

Embodiment 2

[0042] A water-based enteric film coating premix, which includes the following components: polyacrylic acid resin I 56g, polyethylene glycol 6000 15g, talcum powder 19g, titanium dioxide 5g, sodium lauryl sulfate 1.5g, saturated carbonic acid Sodium hydrogen solution 3.5g.

[0043] The preparation method of this premix is ​​specifically as follows:

[0044] (1) Pulverize polyacrylic resin I, polyethylene glycol 6000, polysorbate 60, titanium dioxide and sodium lauryl sulfate, pass through an 80-mesh sieve, and pour it into purified water together with saturated sodium bicarbonate solution, at 60°C Stir for 1 h to obtain a suspension;

[0045] (2) The suspension in step (1) is granulated by spray granulation, wherein the air inlet temperature is 100°C, the air outlet temperature is 60°C, and the liquid flow rate is 90g / min;

[0046] (3) The particles obtained in step (2) are pulverized and passed through a 40-mesh sieve to obtain a premix.

[0047] Wherein, polyacrylic resin...

Embodiment 3

[0049] A water-based enteric film coating premix, which includes the following components: polyacrylic acid resin I 56g, polyethylene glycol 6000 15g, acetyl triethyl citrate 4g, povidone K90 16g, lemon yellow starch 3g, Sodium lauryl sulfate 1.5g, polysorbate 80 2.6g, 3M sodium hydroxide solution 1.9g.

[0050] The preparation method of this premix is ​​specifically as follows:

[0051] (1) Pulverize polyacrylic resin I, polyethylene glycol 6000, acetyl triethyl citrate, povidone K90, lemon yellow lake, sodium lauryl sulfate, polysorbate 80 and pass through a 100-mesh sieve, then Pour into purified water together with sodium hydroxide solution, and stir at 40°C for 2 hours to obtain a suspension;

[0052] (2) The suspension in step (1) is granulated by spray granulation, wherein the air inlet temperature is 100°C, the air outlet temperature is 60°C, and the liquid flow rate is 90g / min;

[0053] (3) The particles obtained in step (2) are pulverized and passed through a 40-me...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to an aqueous enteric film coating premixed agent and a preparation method thereof. The aqueous enteric film coating premixed agent comprises the following components in percentage by weight: 45-65% of polyacrylic resin I, 9-19% of a plasticizer, 16-26% of an anti-sticking agent, 2-15% of a colorant, 0.8-2.5% of a surfactant and 2.6-4.7% of other additives. The preparation method of the premixed agent comprises the following steps: (1) crushing the polyacrylic resin I, the plasticizer, the anti-sticking agent, the colorant, the surfactant and the other additives, screening, and stirring in pure water so as to obtain suspension; (2) granulating the suspension of the step (1) by using a spraying granulation method; (3) crushing granules obtained in the step (2), and screening, thereby obtaining the premixed agent. A coating agent prepared from the premixed agent provided by the invention is good in stability and low in moisture absorption rate.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an aqueous enteric film coating premix and a preparation method thereof. Background technique [0002] With the improvement of the level of pharmaceutical preparations, the continuous application of new pharmaceutical excipients and new technologies, the coating of pharmaceuticals has also undergone the evolution from sugar coating to film coating. Film coating is a coating technology developed in the early 1950s. Due to its advantages of good stability, short coating time, less weight gain, and good moisture resistance, it has gradually replaced sugar coating. In recent years, with the emergence of various new polymers and the advent of novel coating equipment, it has been popularized and developed. [0003] The film coating premix is ​​to use various excipients with excellent properties together to organically combine the advantages of various raw materials and pa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/34A61K47/32A61K47/20A61K47/26A61K47/14A61K47/04A61K9/34A61K31/616
CPCA61K9/2846A61K31/616A61K47/02A61K47/14A61K47/20A61K47/26A61K47/32A61K47/34
Inventor 张绍国
Owner 连云港万泰医药辅料技术有限公司
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