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Solid preparation film coating agent and preparation method thereof

A technology of film coating agent and solid preparation, which is applied in the direction of pharmaceutical formulations and medical preparations with non-active ingredients, etc. It can solve the problems of label bridging, no film coating agent found, low tensile strength, etc., and achieve good mechanical properties. Performance and moisture resistance, good coating effect, low moisture absorption effect

Active Publication Date: 2009-02-11
TIANJIN BOKELIN MEDICINE PACKAGING TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The coating agent prepared by hydroxypropyl methylcellulose alone has good tensile strength, but the flexibility of the formed film is poor, and the coating film is prone to deformation, label bridging and other problems; and the moisture resistance is not strong, which is not suitable for absorbing Moisture extract tablets cannot effectively block the entry of water, resulting in high moisture absorption rate of the drug and changes in ingredients, affecting the efficacy of the drug
Polyvinyl alcohol resin has strong ductility and flexibility, and has a good effect of isolating moisture, but has low tensile strength and poor protection for the tablet core.
[0008] And in the patent and scientific literature, it is not found that hydroxypropyl methylcellulose and polyvinyl alcohol resin are used in combination to form a solid preparation film coating agent

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Recipe 1

[0032] The mass ratio of each component of the formula is: 5% of hydroxypropyl methylcellulose, 60% of polyvinyl alcohol resin, 5% of polyethylene glycol 6000, 18% of titanium dioxide, and 12% of color lake.

[0033] The water vapor transmission rate data compared with the film coating agent formulation using hydroxypropyl methylcellulose alone are as follows:

[0034] Recipe 1 HPMC formula Water vapor permeability (μg / cm 2 / h) 1.42 3.11

[0035] After adding polyvinyl alcohol resin to hydroxypropyl methylcellulose, the water vapor permeability of the coating film decreased, indicating that the moisture-proof performance of the film was significantly improved. This is because the addition of polyvinyl alcohol resin caused hydroxypropyl methylcellulose Increase in crystallinity and change in film structure. It shows that the hydroxypropyl methylcellulose formulation with polyvinyl alcohol resin has enhanced the moisture barrier prope...

Embodiment 2

[0040] Recipe 2

[0041] The mass ratio of each component of the formula is: 65% of hydroxypropyl methylcellulose, 7% of polyvinyl alcohol resin, 10% of polyethylene glycol 400, 11% of talcum powder, 5% of titanium dioxide, and 2% of iron oxide.

[0042] The water vapor permeability data are as follows:

[0043] Recipe 2 HPMC formula Water vapor permeability (μg / cm 2 / h) 2.18 3.11

[0044] At the same time, the film performance data comparison between the formula 2 using polyvinyl alcohol resin and the HPMC formula is shown in the following table:

[0045] Recipe 2 HPMC formula Tensile strengthN / cm 2 15.3 18.6 strain% 2.1 1.5 Elastic Modulus 4.4 7.9

[0046] The formula with high content of hydroxypropyl methylcellulose has lower flexibility than the formula with high content of polyvinyl alcohol resin, but it has better tensile strength and can protect the tablet core better against external impact.

Embodiment 3

[0048] Recipe 3

[0049] After the formula is optimized, the mass ratio of each component is: 25% of hydroxypropyl methylcellulose, 45% of polyvinyl alcohol resin, 5% of polyethylene glycol 6000, 15% of titanium dioxide, and 10% of color lake.

[0050] The water vapor permeability data are as follows:

[0051] Recipe 3 HPMC formula Water vapor permeability (μg / cm 2 / h) 1.63 3.11

[0052] At the same time, the performance data comparison between formula 3 using polyvinyl alcohol resin and HPMC formula film is shown in the following table:

[0053] Recipe 3 HPMC formula Tensile strengthN / cm 2 12.9 18.6 strain% 3.6 1.5 Elastic Modulus 3.8 7.9

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PUM

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Abstract

The invention relates to a solid preparation film coating agent which mainly contains hydroxypropyl methyl cellulose and polyvinyl alcohol resins, and can also contain polyethylene glycol and a colorant according to demands. The film coating agent can effectively reduce the permeability of water vapor and improve the tolerance capacity of coated substances to the environment.

Description

technical field [0001] The invention relates to a film coating agent, in particular to a film coating agent for solid preparations. Background technique [0002] Film coating agents are usually composed of film-forming agents, plasticizers, colorants, etc., and are coated on the surface of solid preparations by spraying to form a film of a certain thickness, which can be used in solid pharmaceutical preparations, food processing, candy and crop seeds The coating can improve the taste, protect against moisture, improve product stability and bright and pleasing to the eye. Since the 1960s, the film coating process mainly uses hydroxypropyl methylcellulose as the film-forming material. Hydroxypropyl methylcellulose is soluble in aqueous media and organic solvent systems of general film coating agents, and has a wide range of applications, convenient operation, and relatively easy coating process. It is the main film-forming material. Hydroxypropyl methylcellulose is a water-s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/38
Inventor 邵广川赵永建王岳辉
Owner TIANJIN BOKELIN MEDICINE PACKAGING TECH