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Film coating agent used for exudative solid preparation and method for preparing same

A film coating agent and solid preparation technology, which is applied in the directions of pharmaceutical formulations, drug delivery, and medical preparations with inactive ingredients, etc. high sex effect

Active Publication Date: 2009-11-04
TIANJIN BOKELIN MEDICINE PACKAGING TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, if no plasticizer is used, the performance of the coating film will decrease, which is reflected in the phenomenon that the coating film has edges and cracks after coating, and bridging occurs at the label of the tablet.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 is a commonly used formulation of a common drug film coating agent containing HPMC, and 2 to 7 are formulations containing HPC described in the present invention and acting on drugs that are prone to exudation. To carry out performance testing on it, the testing method adopted is as follows:

[0024] 1. The evaluation of the film performance is determined by the known film tensile test: prepare the film, cut it into a dumbbell shape, and use a tensile tester to measure the tensile strength, strain, elastic modulus and other data of the sample, wherein:

[0025] Tensile strength: The maximum stress per unit area when the film breaks. Describe the ability of the film to resist external forces.

[0026] Strain: The proportion by which a film increases in length before breaking. An increase in strain indicates good flexibility and ductility of the material.

[0027] Modulus of Elasticity: The ratio of stress to strain, which is an indicator of membrane stiffnes...

Embodiment 2

[0037] Recipe 2

[0038] The weight of each component of the formula is: 60 grams of HPMC, 5 grams of HPC, 5 grams of plasticizer polyethylene glycol, and 30 grams of color lake.

[0039] Prepare coating agent finished product by the method in embodiment 1, carry out film performance measurement, its measurement result is shown in Table 2:

[0040] Table 2: Determination results of formula 2

[0041] Formulation 1 (HPMC)

[0042] Compared with the common formula in Example 1, the plasticizer content of formula 2 is reduced, and part of HPC is added, and the coating agent finished product is tested for film performance, and its film performance data is close to formula 1 with high plasticizer content (data are shown in table 1), indicating that HPC plays a role in enhancing the flexibility of the coating film; the coated drug of formula 2 is placed in a constant temperature and humidity box for observation, and due to the reduction of plasticizer, the drug exudatio...

Embodiment 3

[0044] Recipe 3

[0045] The weight of each component of the formula is: 35 grams of HPMC, 25 grams of HPC, 2.5 grams of plasticizer polyethylene glycol, and 37.5 grams of titanium dioxide.

[0046] Prepare coating agent finished product by the method in embodiment 1, carry out membrane performance measurement, its measurement result is shown in Table 3:

[0047] Table 3: Determination results of formula 3

[0048] Formulation 1 (HPMC)

[0049] Formulation 3 uses HPMC and HPC to form a composite film-forming material, and the film performance data of the finished coating agent is slightly better than that of formulation 1, indicating that the content of HPC has a significant impact on the flexibility of the coating film; Put it in the box and observe, a small amount of black components ooze out after 2-3 days, and it is more obvious after 4-5 days. The oozing time is basically the same as that of formula 2, but the oozing degree is lighter than that of formula 2. ...

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PUM

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Abstract

The invention relates to a film coating agent used for an exudative solid preparation, including hydroxypropyl methylcellulose and hydroxy propyl cellulose, wherein the content of the hydroxypropyl methylcellulose ranges from 10 to 60 according to parts by weight, and the content of the hydroxy propyl cellulose ranges from 5 to 45 according to parts by weight. The invention adopts the technical scheme that HPC and HPMC are combined to form a composite film-forming material so as to prepare the coating agent. As the flexibility and the ductibility of HPC are far superior to HPMC, the flexibility of the coating film is improved after HPC is added to the formula; therefore, plasticiser can be partially or completely replaced, the structure of the coating film can be much more compact, the porosity can be greatly reduced, water can be prevented from entering a medicine, and components of the medicine can also be prevented from seeping from pores; and furthermore, the compatibility of HPC and HPMC is good, and the coating film thereof also has good flexibility, thereby avoiding the problems of coating film breakage, bridging, etc.

Description

technical field [0001] The invention belongs to the technical field of drug coating agents, in particular to a film coating agent for easily oozing drug solid preparations and a preparation method thereof. Background technique [0002] Polymer film-forming polymers and their additives, dissolved or dispersed, are evenly sprayed on the surface of solid pharmaceutical preparations to form a plastic film layer with a certain thickness and strength, which can be used in pharmaceutical tablets, pills, food processing, candy And the coating of crop seeds can improve the taste, protect against moisture, improve product stability and bright and pleasing to the eye. [0003] Hydroxypropylmethylcellulose (HPMC) is a widely used film-forming material for film coating. HPMC is a part of methyl and part of hydroxypropyl ether of cellulose, which has good film-forming properties. This type of semi-synthetic cellulose polymer has intermolecular forces such as van der Waals force between ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K47/38A61K47/02
Inventor 赵永建邵广川王磊
Owner TIANJIN BOKELIN MEDICINE PACKAGING TECH