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Cellulose rhodophyta polysaccharide film coating premix and solution preparation method thereof

A red algae polysaccharide and film coating technology, which is applied in pharmaceutical formulations, drug delivery, etc., can solve problems such as slow disintegration speed, surface abrasion of finished products, poor gloss, etc., and achieves easy GMP management, good moisture-proof and oxygen-proof, The effect of simple preparation method

Inactive Publication Date: 2013-02-06
GUANGXI NANNING HUIRUN BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But on the whole, the development of this technology in our country is still relatively slow, and there are still many problems in its application. For example, due to the complexity of the ingredients of Chinese patent medicines, compared with Western medicine tablets, Chinese patent medicines have a strong selectivity for film coating powder. The same film coating powder and its technical parameters are often only suitable for one or several Chinese patent medicine tablets
Because of this, most of the research work of film coating material manufacturers in my country is to provide "tailor-made" technical services for pharmaceutical companies. Although the application formula research level has a certain international competitiveness, there is no such thing as the development of new film materials. progress
In addition, commercially available film coating materials have problems such as slow disintegration speed, poor moisture-proof effect, poor gloss, and many organic components in solvents. Waste of raw materials also makes the operating environment worse
[0004] Most of the existing various film coating premixes, due to the unreasonable selection of polymers or the unreasonable composition ratio, after being prepared into coating slurry, some of them have too low viscosity, resulting in the coating film of the solid pharmaceutical preparation coating finished product Adhesion to the drug core is poor, resulting in surface wear of the finished product, cracking or peeling of the film edge; some of the viscosity is too high, and it is easy to form larger mist droplets during the coating process, which is difficult to evenly distribute on the drug surface. Aggregation on the surface of the drug is more likely to cause adhesion, and the density of the coating film is also poor, resulting in many air bubbles; when the coating slurry is too difficult, it may also cause rough and wrinkled surface of the coating layer of the final film-coated product; For drug core tablets with notches or markings on the coating surface, if the composition of the coating premix is ​​unreasonable, then the mechanical parameters of the coating film will not meet the requirements, such as too high elastic coefficient, poor film strength, viscosity, etc. In the drying process of the coating film, a high pull-back force is generated, which pulls the surface of the coating film from the scratches, and the film retracts, resulting in bridging phenomenon, which makes the scratches on the drug surface disappear or the markings are not correct. clear

Method used

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  • Cellulose rhodophyta polysaccharide film coating premix and solution preparation method thereof
  • Cellulose rhodophyta polysaccharide film coating premix and solution preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Weigh 1.5kg of red seaweed polysaccharide (K-carrageenan 1kg, iota-carrageenan 0.5kg), cellulose derivatives (hypromellose) 8.5kg, and mix them with a two-dimensional mixer for 25min until they are uniform to obtain Film-coating premix; add an ethanol solution 18 times the weight of the film-coating premix (the weight ratio of ethanol to water is 1:5) into the liquid preparation tank, raise the temperature to 85°C, and then add the film-coating premix while stirring Coating premix, stir for 30 minutes until uniform, then lower the temperature to 45°C, and place at a constant temperature for 30 minutes to obtain a gastric-soluble colorless transparent cellulose red algae polysaccharide film coating solution.

Embodiment 2

[0029] Weigh 1.5kg of red seaweed polysaccharide (K-carrageenan 1kg, iota-carrageenan 0.5kg), cellulose derivatives 8.5kg (ethyl cellulose 2.5kg, hypromellose 6kg), and use two-dimensional mixing Mix by machine for 35 minutes until uniform, and prepare the film coating premix; add an ethanol solution 16 times the weight of the film coating premix (the weight ratio of ethanol to water is 1:7) into the liquid preparation tank, and heat up to 90°C , then add the film coating premix while stirring, stir for 30 minutes until uniform, then lower the temperature to 45°C, and place it at a constant temperature for 30 minutes to obtain the enteric-coated colorless transparent cellulose red algae polysaccharide film coating solution.

Embodiment 3

[0031] Weigh 1.1kg of raw material red algal polysaccharide (0.8kg of K-carrageenan, 0.3kg of iota-carrageenan), 8.9kg of cellulose derivatives (1.6kg of ethyl cellulose, 1.3kg of sodium carboxymethyl cellulose, hypromellose Cellulose 6kg), mixed with a three-dimensional mixer for 35min until uniform, to obtain a film coating premix; add an ethanol solution 23 times the weight of the film coating premix in the liquid preparation tank (the weight ratio of ethanol and water is 3:20), raise the temperature to 90°C, then add the film coating premix while stirring, stir for 30 minutes until uniform, then lower the temperature to 45°C, and place it at a constant temperature for 30 minutes to obtain the enteric-coated colorless transparent cellulose red algae polysaccharide Film coating solution.

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Abstract

The invention discloses a cellulose rhodophyta polysaccharide film coating premix, comprising the following materials in parts by weight: 0.3-26 parts of rhodophyta polysaccharide, 70-99 parts of cellulose derivatives and 0-10 parts of adjuvant ingredients. The invention further discloses a solution preparation method for the film coating premix, comprising the steps of: uniformly mixing the materials to obtain the film coating premix; adding a solvent the weight of which is 14-28 times of the weight of the film coating premix in a container, heating to 85-95 DEG C, then adding the film coating premix while mixing, mixing for 10-60 minutes till the solution is even, subsequently cooling to 40-58 DEG C, and setting for 10-60 minutes at the constant temperature to obtain the cellulose rhodophyta polysaccharide film coating solution. The cellulose rhodophyta polysaccharide film coating premix and the solution preparation method thereof are green, environment-friendly, safe and reliable, and are simple in production; the coating solution is stable, the coating appearance and performance are excellent, and the moisture resistance and oxygen isolation effect are good; and the premix and the solution preparation method thereof can be widely used for coating of tablets, pills and the like, and have broad market prospect.

Description

technical field [0001] The invention relates to a novel film coating material, in particular to a cellulose red algae polysaccharide film coating premix and a liquid preparation method thereof. Background technique [0002] Film coating is a new type of coating technology developed by western countries in the early 1950s, and it has experienced more than half a century of development. The polymer solution or dispersion is evenly coated on the surface of solid preparations such as tablets, capsules, pellets, and granules to form a plastic film layer with a thickness of several microns. This process is called film coating. It is film coating, and the material used for coating is called coating material. With the development of science and technology, film coating gradually replaces sugar coating. Compared with sugar coating, in addition to the effects of light-proof, moisture-proof, taste-masking, and wear-resistant, it also has the characteristics of good quality, less weig...

Claims

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Application Information

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IPC IPC(8): A61K47/38A61K47/36A61K9/36
Inventor 朱桂波张蔚
Owner GUANGXI NANNING HUIRUN BIO TECH