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Preparation method of film coating pre-mixing agent and uses thereof

A technology of film coating and premix, which is applied in application, medical preparations of non-active ingredients, pharmaceutical formulas, etc., can solve the problems of poor density of the coating film, rough surface, peeling off, etc., and achieve good stability, Easy to prepare and easy to use

Active Publication Date: 2009-03-11
BEIJING YINGMAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Most of the existing various film coating premixes have low viscosity after being formulated into a coating solution due to the unreasonable selection or composition ratio of the polymers, resulting in the coating of solid pharmaceutical preparations after coating. The adhesion between the film and the drug element tablet is poor, and the surface of the finished product is worn, and the edge of the film is cracked or peeled off; some of the viscosity is too high, and it is easy to form larger droplets during the coating process, which is difficult to evenly distribute on the drug The surface of the plain tablet will cause adhesion, and the density of the coating film is also poor, resulting in a lot of air bubbles, which can also cause the surface after coating to be rough and uneven, and sometimes bridging will occur, making the scratches on the surface of the drug disappear or The logo is not clear

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: White series (stomach-soluble type) is prepared into about 10000g

[0025] prescription:

[0026] Titanium dioxide 1000g

[0027] Talc powder 500g

[0028] Polyethylene glycol 6000 1000g

[0029] Povidone K30 500g

[0030] Hypromellose 7000g

[0031] Glyceryl Triacetate 30g

[0032] Purified water 225g

[0033] Ethanol 675g

[0034] Preparation method:

[0035] Mix the prescription amount of titanium dioxide, talcum powder, polyethylene glycol 6000, povidone K30, hypromellose, triacetin, purified water and ethanol for 1 hour, dry at 40°C for 5 hours, and take the intermediate for detection. After passing the test, transfer it to a grinder for grinding for 5 hours, sieve, take the intermediate for testing, and pack the semi-finished product after passing the test.

Embodiment 2

[0036] Embodiment 2: red line (stomach-soluble type) is prepared into about 10000g

[0037] prescription:

[0038] Titanium dioxide 400g

[0039] Talc powder 500g

[0040] Polyethylene glycol 6000 1000g

[0041] Povidone K30 500g

[0042] Hypromellose 7000g

[0043] Glyceryl Triacetate 30g

[0044] Purified water 225g

[0045] Ethanol 675g

[0046] Appropriate amount of pigment

[0047] Carmine 600g

[0048] Preparation method:

[0049] Mix the prescription amount of titanium dioxide, talcum powder, polyethylene glycol 6000, povidone K30, hypromellose, triacetin, purified water and ethanol for 1 hour, dry at 40°C for 5 hours, and take the intermediate for detection. After passing the test, add the color lake according to the prescription, mix for 0.5 hours, transfer to a grinder and grind for 5 hours, sieve, take the intermediate for testing, add an appropriate amount of pigment for adjustment, and mix for 1 hour. After the semi-finished product passes the inspection...

Embodiment 3

[0050] Embodiment 3: green system (stomach-soluble type) is prepared into about 10000g

[0051] prescription:

[0052] Titanium dioxide 600g

[0053] Talc powder 500g

[0054] Polyethylene glycol 6000 1000g

[0055] Povidone K30 500g

[0056] Hypromellose 7000g

[0057] Glyceryl Triacetate 30g

[0058] Purified water 225g

[0059] Ethanol 675g

[0060] Appropriate amount of pigment

[0061]Fruit Green Aluminum Lake 400g

[0062] Preparation method:

[0063] Mix the prescription amount of titanium dioxide, talcum powder, polyethylene glycol 6000, povidone K30, hypromellose, triacetin, purified water and ethanol for 1 hour, dry at 40°C for 5 hours, and take the intermediate for detection. After passing the test, add fruit green aluminum lake according to the prescription, mix for 0.5 hours, transfer to a grinder and grind for 5 hours, sieve, take the intermediate for testing, add appropriate amount of pigment for adjustment, and mix for 1 hour. After the semi-finished ...

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PUM

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Abstract

The invention discloses a method for preparing film coating premix and the application thereof. The film coating premix comprises the following components: cellulose derivative or acrylic derivative, povidone K30, polyethylene glycol 6000, glyceryl triacetate and talcum powders. The film coating premix has low cost and simple and controllable preparation method, and is suitable for scale production; the film coating premix also comprises titanium dioxide, pigment and color lake; a coating level and a drug tablet have firm and tight combination, uniform thickness and uniform and smooth coloring. The film coating premix with various colors can be obtained by different ratioes of the titanium dioxide, the pigment and the color lake to better satisfy various needs for solid drug preparation film coating, and meanwhile, the invention also discloses the preparation method for the solid drug preparation film coating and the application thereof.

Description

technical field [0001] The invention relates to a preparation method and application of a film coating premix used for medicine and food. Background technique [0002] Film coating is to uniformly spray a layer of relatively stable polymer material on the surface of solid pharmaceutical preparations by spraying to form a plastic film layer with a thickness of several microns. [0003] The film coating technology used in the pharmaceutical industry is a production process in which tablets are wrapped with a small amount of safe, non-toxic, and physically and chemically stable polymer materials. The safety of these polymer coating materials has long been widely recognized by countries all over the world. Since the 1950s, with the rapid development of the polymer material industry, the film coating technology in the pharmaceutical industry has gradually matured and been widely used in the production of preparations. In developed countries, film-coated tablets have basically re...

Claims

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Application Information

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IPC IPC(8): A61K47/38A61K47/32A61K47/34A61K47/02A61K9/32A61K9/36A23P1/08A23P20/18A61K47/10A61K47/14
Inventor 胡晓晓
Owner BEIJING YINGMAO PHARMA
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