Gastric soluble compound seaweed polysaccharide film coating premix and liquid preparation method adopting same

A seaweed polysaccharide and film coating technology, applied in pharmaceutical formulations, drug delivery and other directions, can solve the problems of difficult to evenly distribute drug surface, peeling, poor film strength, etc., achieve green, safe and novel price, easy GMP management, and increase the choice. Effect

Inactive Publication Date: 2012-07-18
BEIJING IMPERIAL ISLAND MARINE BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Most of the existing gastric-soluble film coating premixes are unreasonable in the selection of polymers or compositional ratios. After the coating slurry is prepared, the viscosity of some is too low, resulting in the coating of solid pharmaceutical preparations. The adhesion between the coating film and the drug core is poor, and the surface of the finished product is worn, and the edge of the film is cracked or peeled off. On the surface of the drug, there is a lot of aggregation on the surface of the drug, resulting in adhesion. At the same time, the density of the coating film is also poor, resulting in a lot of air bubbles; Wrinkled skin, etc.; when coating drug core tablets with nicks or marks on the coating surface, if the composition of the coating premix is ​​unreasonable, the mechanical parameters of the coating film will be unreasonable, such as excessively high elastic coefficient, poor film strength, Poor adhesion, etc., during the drying process of the coating film, a high pullback force is generated, the surface of the coating film is pulled up from the score, and the film retracts, resulting in bridging phenomenon, which makes the score on the surface of the drug disappear or mark don't know

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Stomach-soluble colorless and transparent compound seaweed polysaccharide film coating premix and preparation method

[0035] Composition: Seaweed polysaccharide gum 0.3kg, hypromellose 9kg, soluble starch 0.7kg. (component ratio 3:90:7)

[0036] The above-mentioned mixture by weight was mixed with a SYH type three-dimensional motion mixer for 25 minutes to prepare a film coating premix. Take 8 times of compound seaweed polysaccharide film coating premix water and 2 times of compound seaweed polysaccharide film coating premix ethanol, add it to the liquid preparation tank and raise the temperature to 55°C. After reaching the temperature, add the premix while stirring. After stirring for 25 minutes, Lower the temperature to 45°C, and place at a constant temperature for 30 minutes; the stomach-soluble colorless and transparent compound seaweed polysaccharide film coating solution is obtained.

Embodiment 2

[0037] Example 2 Composition and solution preparation method of stomach-soluble yellow-green compound seaweed polysaccharide film coating premix

[0038] Composition: seaweed polysaccharide gum 0.5kg, hypromellose 8.5kg, glycerin 0.5kg, lemon yellow starch 0.2kg, apple green starch 0.3kg (component ratio 5:85:5:5)

[0039]The above-mentioned mixture by weight was mixed with a SYH type three-dimensional motion mixer for 30 minutes to prepare a film coating premix. Take 10 times of compound seaweed polysaccharide film coating premixed water and 5 times of compound seaweed polysaccharide film coating premixed amount of ethanol and add it to the liquid preparation tank and raise the temperature to 85°C. After reaching the temperature, add the premix while stirring. After stirring for 30 minutes, Lower the temperature to 45°C, and place at a constant temperature for 30 minutes; the stomach-soluble yellow-green compound seaweed polysaccharide film coating solution is obtained.

Embodiment 3

[0040] Example 3 Composition and liquid preparation method of stomach-soluble colorless and transparent compound seaweed polysaccharide film coating premix

[0041] Composition: seaweed polysaccharide gum 0.8kg, hydroxymethylcellulose sodium 9kg, carboxymethyl starch sodium 0.6kg, ethyl cellulose 1.6kg (component ratio 6.7:75:5:13.3, no plasticizer and auxiliary ingredients )

[0042] The above-mentioned mixture by weight was mixed with a SYH type three-dimensional motion mixer for 30 minutes to prepare a film coating premix. Take 15 times of compound seaweed polysaccharide film coating premixed water and 5 times of compound seaweed polysaccharide film coating premixed amount of ethanol and add it to the liquid preparation tank and raise the temperature to 90°C. After reaching the temperature, add the premix while stirring. After stirring for 30 minutes, Lower the temperature to 43°C, and place at a constant temperature for 25 minutes; the stomach-soluble colorless and transp...

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PUM

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Abstract

The invention provides a gastric soluble compound seaweed polysaccharide film coating premix and a liquid preparation method adopting the same. The premix comprises the following raw materials in parts by weight: 0.5-25 parts of seaweed polysaccharide gum, 75-98 parts of plant and dietary fibers, 0-5 parts of plasticizing agent and 0-5 parts of other auxiliary components. The specific liquid preparation method comprises the following step: heating a solvent with weight being 8-25 times that of the raw materials to a temperature above 55 DEG C, adding a raw material mixed in advance while stirring after reaching the temperature, stirring the materials until the materials are uniform, then reducing the temperature to 43-55 DEG C and keeping the constant temperature for 10-40 minutes, thus obtaining film coating liquid. The premix and the liquid preparation method have the following beneficial effects: the main raw material used by the premix is the safe and cheap natural polymer material-seaweed polysaccharide gum; the obtained coating has good applicability; and various indexes conform to the specifications in the current version of Pharmacopeia of the People's Republic of China after the coating is used.

Description

technical field [0001] The invention relates to a novel film coating material, in particular to a gastric-soluble compound seaweed polysaccharide film coating premix, and further provides a liquid preparation method for the premix. Background technique [0002] Film coating is to uniformly spray a layer of relatively stable polymer coating material on the surface of the tablet core by spraying to form a plastic film layer with a thickness of several microns. [0003] 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. my country started relatively late, and it was not until the mid-1990s that the "hotness" of film coating technology gradually appeared and began to be widely used in Chinese patent medicine preparations. With the development of science and technology, film coating gradually replaces sugar coating. Compared with sugar coating, it not only has the fun...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36
Inventor 唐连德冯国平张涛施凤英周玉坤霍晓丹
Owner BEIJING IMPERIAL ISLAND MARINE BIOLOGICAL TECH
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