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Stomach dissolved film coating pre-mix dose and preparing method thereof

A film coating and premix technology, which is applied in pharmaceutical formulations, drug delivery and other directions, can solve the problems of complex manufacturing process and increased tablet core weight, and achieves reduced permeability, low permeability, and improved moisture-proof effect. Effect

Inactive Publication Date: 2008-06-18
AILEYI MEDICINE MATERIAL SCI & TECH TIANJIN CITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compared with the film coating premix, the manufacturing process of sugar-coated tablets (the main auxiliary ingredient is talcum powder which has been eliminated abroad) is complicated, which can often increase the weight of the tablet core by 50% to 100%. It takes 16 hours. Because it contains a lot of talcum powder and sugar, there are certain restrictions on people who take it, especially for diabetics. [1-2][9-11]

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Example 1 Stomach-soluble iron red film coating premix

[0012] 1. Prescription composition:

[0013] Hydroxypropyl Methyl Cellulose 70%

[0014] Glyceryl Triacetate 4%

[0015] Tween-80 0.1%

[0016] Polyvinyl alcohol 1%

[0017] Talc 10.5%

[0018] Silica 0.1%

[0019] Titanium dioxide 6.8%

[0020] Yellow Iron Oxide 1.6%

[0021] High Concentration Carmine Aluminum Lake 5.9%

[0022] 2. Preparation method: Put the hydroxypropyl methylcellulose and polyvinyl alcohol in the stated ratio in a super mixer and mix at 50°C for 5 minutes at low speed, then add triacetin and Tween-80 and mix at high speed for 20 minutes , out of the material, to obtain a dispersion medium. Then add the dispersion medium, talcum powder, silicon dioxide, titanium dioxide, yellow iron oxide, and high-concentration carmine aluminum lake into the super mixer for high-speed dispersion for 30 minutes, and the finished product is obtained after the discharge is sieved.

Embodiment 2

[0023] Example 2 Stomach-soluble iron red film coating premix

[0024] 1. Prescription composition:

[0025] Hydroxypropyl Methyl Cellulose 10%

[0026] Glyceryl Triacetate 10%

[0027] Tween-80 0.3%

[0028] Polyvinyl alcohol 40%

[0029] Macrogol 600 04%

[0030] Talc 14.4%

[0031] Silica 0.4%

[0032] Titanium dioxide 6.8%

[0033] Yellow Iron Oxide 5%

[0034] Black Iron Oxide 1.2%

[0035] High Concentration Carmine Aluminum Lake 7.9%

[0036] 2. Preparation method: Put the hydroxypropyl methylcellulose and polyvinyl alcohol in the above proportion in a super mixer and mix at 55°C for 5 minutes at low speed, then add triacetin and Tween-80 and mix at high speed for 20 minutes , out of the material, to obtain a dispersion medium. Then add the dispersion medium, talcum powder, silicon dioxide, titanium dioxide, yellow iron oxide, black iron oxide, and high-concentration carmine aluminum lake into the super mixer for high-speed dispersion for 30 minutes, add poly...

Embodiment 3

[0037] Example 3 Gastro-soluble light yellow film coating premix

[0038] 1. Prescription composition:

[0039] Hydroxypropyl Methyl Cellulose 40%

[0040] Macrogol 400 20%

[0041] Tween-80 0.1%

[0042] Polyvinyl alcohol 7.4%

[0043] Acrylic II 0.2%

[0044] Sodium pyrophosphate 0.4%

[0045] Macrogol 4000 1%

[0046] Talc 14.5%

[0047] Silica 0.4%

[0048]Titanium dioxide 15%

[0049] Low concentrated lemon yellow aluminum lake 1%

[0050] 2. Preparation method: put the hydroxypropyl methylcellulose, polyvinyl alcohol and acrylic resin II in the stated ratio in a super mixer and mix at a low speed of 45°C for 5 minutes, then add polyethylene glycol 400 and Tween- Mix at a high speed of 80 for 20 minutes, and discharge to obtain a dispersion medium. Then add the dispersion medium, talcum powder, silicon dioxide, titanium dioxide, and low-concentration tartrazine aluminum lake into the super mixer for high-speed dispersion for 30 minutes, add polyethylene glycol ...

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Abstract

The invention relates to a gastric-juice-soluble film-coating premix and the preparation method. The components include film-forming material (principal film-forming material and non-principal film-forming material), plasticizer, antisticking agent, surfactant and unorganic colorant. The preparation method of the gastric-juice-soluble film-coat premix is that: principle film-forming material is put into a super-mixer whose temperature is between 20 to 80 DEG C to mix at a low speed for 5minutes,and then after the plasticizer and the surfactant being added, to mix at a high speed for 20 minutes to get dispersive medium; then the dispersive medium, the lubricant and the unorganic colorant are added into the super-mixer to be dispersed at a high speed for 30 minutes; then the non-principal film-forming material and the plasticizer are added to mix at a low speed for 5 minutes; the finished product can be got after being screened. The gastric-juice-soluble film-coat premix which adopts complete hydrosolvent system is of moderate viscosity, so that good suspending state can be maintained; relatively low permeability can ensure the stability of the preparation; with improved production efficiency, improved moistureproof effect of the traditional Chinese medicine, more delicate coat and brighter color, the invention can better meet the requirements of the solid medicine for the film-coating.

Description

technical field [0001] The invention relates to a film coating premix and a preparation method of the film coating premix. technical background [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. [1-2] . Film coating agents are usually made of film-forming materials, plasticizers, anti-sticking agents, surfactants and inorganic colorants through a simple physical mixing manufacturing process [2] In this way, the film-coated tablet not only has the functions of moisture-proof, light-proof, taste-masking, wear-resistant, mildew-resistant, and easy to disintegrate, but also greatly improves the dissolution rate, bioavailability and validity period of the drug, expanding the The countries and regions where the drug can be sold have strongly promoted the export of drugs [3-5] The weight gain of the coating is on...

Claims

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Application Information

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IPC IPC(8): A61K47/38A61K9/36
Inventor 孟静马炤军王闻宇李序会陈文兵王然张志刚侯琦
Owner AILEYI MEDICINE MATERIAL SCI & TECH TIANJIN CITY
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