Film coating agent for extract medicament solid preparation and preparation method thereof

A technology of film coating agent and solid preparation, which can be used in pharmaceutical formulations, medical preparations with inactive ingredients, inactive ingredients of oil/fat/wax, etc. High production efficiency, strong flexibility, and the effect of reducing moisture absorption

Active Publication Date: 2012-07-18
TIANJIN BOKELIN MEDICINE PACKAGING TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, acrylic resin is brittle, and the coating film often produces tiny cracks, which reduces the moisture-proof effect.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A kind of film coating agent for the solid preparation of extract class medicine, its component and the weight of each component are:

[0029] 50 grams of hydroxypropyl methylcellulose;

[0030] 30 grams of diethyl phthalate;

[0031] Stearic acid 20 grams.

[0032] The steps of the above-mentioned preparation method for the film coating agent of extract class medicine solid preparation are:

[0033] (1) Take by weighing 50 grams of hydroxypropyl methylcellulose, 30 grams of diethyl phthalate, and 20 grams of stearic acid;

[0034] (2) Add the weighed hydroxypropyl methylcellulose, diethyl phthalate, and stearic acid into a high-speed shearing machine, and mix the materials evenly at a speed of 350 rpm to obtain a coating agent The finished product has high production efficiency and low energy consumption.

[0035] In this embodiment, no coloring agent is used, a transparent film can be formed, and the original appearance characteristics of the product can be reflec...

Embodiment 2

[0038] A kind of film coating agent for the solid preparation of extract class medicine, its component and the weight of each component are:

[0039] 30 grams of hydroxypropyl methylcellulose;

[0040] Polyethylene glycol 5 grams;

[0041] 30 grams of stearic acid;

[0042] 35 grams of titanium dioxide.

[0043] The steps of the above-mentioned preparation method for the film coating agent of extract class medicine solid preparation are:

[0044] (1) Take by weighing 30 grams of hydroxypropyl methylcellulose, 5 grams of polyethylene glycol, 30 grams of stearic acid, and 35 grams of titanium dioxide;

[0045] (2) The hydroxypropyl methylcellulose, polyethylene glycol, stearic acid, titanium dioxide that weighed are added in the high-speed shearing machine, make material mix evenly with the speed of 500 rev / mins;

[0046] (3) Increase the speed of the high-speed shearing machine to 900 rpm, the particle size of the titanium dioxide is 10-20 μm, the colorant is fully disperse...

Embodiment 3

[0049] A kind of film coating agent for the solid preparation of extract class medicine, its component and the weight of each component are:

[0050] 60 grams of hydroxypropyl methylcellulose;

[0051] castor oil 15 grams;

[0052] Stearic acid 2 grams;

[0053] Color lake 23 grams.

[0054] The steps of the above-mentioned preparation method for the film coating agent of extract class medicine solid preparation are:

[0055] (1) Take by weighing 60 grams of hydroxypropyl methylcellulose, 15 grams of castor oil, 2 grams of stearic acid, and 23 grams of color lake;

[0056] (2) the hydroxypropyl methylcellulose, castor oil, stearic acid, color lake that weighed are added in the high-speed shearing machine, make material mix evenly with the speed of 500 rev / mins;

[0057](3) The speed of the high-speed shearing machine is increased to 1000 rpm, the particle size of the color lake is 1-10 μm, the colorant is fully dispersed, and a finished coating agent with uniform color is ...

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Abstract

The invention relates to a film coating agent for an extract medicament solid preparation, which comprises the following components in parts by weight: 30-60 parts of hydroxypropyl methyl cellulose, 5-30 parts of plasticizer and 2-30 parts of stearic acid. The invention also relates to a preparation method of the film coating agent, which comprises the following steps of: (1) weighing the hydroxypropyl methyl cellulose, the plasticizer and the stearic acid in parts by weight; and (2) adding the hydroxypropyl methyl cellulose, the plasticizer and the stearic acid into a high-speed shearing machine and uniformly mixing the materials at the speed of 350-600 rpm to prepare a coating agent finished product. The coating agent is safe and non-toxic, and can form a hydrophobic molecular layer onthe surface of a medicament for inhibiting the adsorption and osmosis of steam on the surface of a coating film, thereby reducing the moisture absorbing rate of a medicament coating tablet and preventing the damping and hardening of the medicament and medicament efficiency loss; meanwhile, the coating film has strong flexibility, and the coating quality is stable; and the preparation method has the outstanding advantages of high production efficiency, low energy consumption, favorable application performance of coating agent finished products, and the like.

Description

technical field [0001] The invention belongs to the field of coating agents, in particular to a film coating agent for solid preparations of medicinal extracts and a preparation method thereof. Background technique [0002] Many products in traditional Chinese medicine tablets are extract tablets, which contain many ingredients that are easy to absorb moisture. They are easy to soften and absorb moisture under the influence of heat and humidity, resulting in deformation of the tablet core, hardening of the drug, and inability to completely disintegrate, affecting the efficacy of the drug; moreover, moisture absorption can also Cause agglomeration, fluidity reduction, deliquescence, crystal form change, etc. of the preparation, and then cause color change, content reduction or compatibility change between components; after moisture absorption, the preparation is more likely to be oxidized, hydrolyzed, and mildewed, making the physical stability of the preparation , chemical s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/38A61K47/12A61K47/44
Inventor 赵永建邵广川王鹏宇
Owner TIANJIN BOKELIN MEDICINE PACKAGING TECH
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