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Moisture-proof preparation method for solvent-free solid preparation

A solid preparation and solvent-free technology, which is applied in the field of moisture-proof preparation of solid preparations of traditional Chinese medicine, can solve the problems of difficult technical operation, long operation time, and many coating materials, so as to improve the compliance of production personnel and facilitate industrial production. The effect of short operating time

Active Publication Date: 2012-06-20
SHENYANG DONGXIN PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method is simple, but because the hygroscopic extract powder is still exposed to the air, a large amount of excipients is required to meet the moisture-proof requirements; (2) Gao Aiqin’s patent for moisture-proof coating of Xiaojianzhong capsules is granulated by one-step granulation Fluidized bed coating with HPMC or acrylic resin is used to prevent moisture. The fluidized bed coating technology adopted in this patent has the characteristics of difficult technical operation, long operation time, easy agglomeration during the coating process, and the sphericity of the coating particles has a great impact on the coating. (3) Jiangyin Tianjiang Pharmaceutical Co., Ltd. has applied for a patent on the moisture-proof coating process of traditional Chinese medicine formula granules. The preparation method is to fully mix traditional Chinese medicine formula In a quality emulsifier, stir for 15-20 min at 75-80 °C and 180-210 r / min to make moisture-proof coating formula granules
This patent adopts hot-melt coating technology. Since the surface of traditional Chinese medicine particles is not round and the drug is directly mixed with auxiliary materials, relatively more coating materials are required. The thickness of the coating layer of the obtained product is not uniform, and the moisture-proof effect is not significant enough. Does not dissolve rapidly at room temperature

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The composition of raw material medicine is as follows: Guizhi Fuling spherical granules 500g; magnesium stearate 15g; stearic acid 25g.

[0027] The preparation process is as follows: (1) Preparation of spherical granules of Guizhi Fuling: Weigh 500g of Guizhi Fuling extract powder, prepare a soft material with 50% (v / v) ethanol as a binder, and place the soft material in an extruder with an aperture of 1.0mm at 30rmp Extruded under conditions, the strip-shaped extrudate was first spheronized at 20rmp for 2min in a spheronizer, and then spheronized at 40rmp for 10min. The pellets were dried in an oven at 40°C for 12 hours, then sieved, and the particle size was between 16-24 mesh.

[0028] ⑵Preparation of Cinnamon Twig Poria Moisture-proof Pellets: Pass the prescribed amount of stearic acid through an 80-mesh sieve, and mix well. Weigh the prescription amount of Guizhi Poria cocos spherical granules and magnesium stearate into the coating pan, use the traditional ...

Embodiment 2

[0030] The composition of raw material medicine is as follows: Guizhi Poria spherical granules 500g; PEG6000 1g; stearic acid 24g; magnesium stearate 15g.

[0031] The preparation process is as follows: (1) Preparation of spherical granules of Guizhi Fuling: Weigh 500g of Guizhi Fuling extract powder, prepare a soft material with 40% (v / v) ethanol as a binder, put the soft material in an extruder and extrude it at 30rmp The strip-shaped extrudate was first spheronized at 20rmp for 2min in a spheronizer, and then spheronized at 40rmp for 10min. The pellets were dried in an oven at 30°C for 12 hours, then sieved, and the particle size was between 16-24 mesh.

[0032] (2) Preparation of Guizhi Fuling Moisture-proof Pellets: Pass stearic acid and PEG6000 according to prescription through 80-mesh sieve, and mix well. Weigh the prescription amount of Guizhi Poria cocos spherical granules and magnesium stearate into the coating pan, use the traditional coating pan to prepare moi...

Embodiment 3

[0034] The composition of raw material medicine is as follows: Guizhi Fuling spherical granules 500g; full water moisture-proof film coating material Opadry AMB 25g.

[0035] Preparation Process: (1) Preparation of spherical granules of Guizhi Fuling: Weigh 500g of Guizhi Fuling extract powder, prepare a soft material with 60% (v / v) ethanol as a binder, put the soft material in an extruder and extrude it at 30rmp The strip-shaped extrudate was first spheronized at 20rmp for 2min in a spheronizer, and then spheronized at 40rmp for 10min. The pellets were dried in an oven at 40°C for 10 hours, then sieved, and the particle size was between 16-24 mesh.

[0036]⑵Preparation of Guizhi Fuling moisture-proof pellets: Prepare Opadry AMB into 10% water coating solution, stir evenly at room temperature; weigh the prescription amount of Guizhi Fuling spherical granules and place them in the coating device, and start the fluidized bed according to the following parameters Coating: te...

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Abstract

The invention relates to a moisture-proof preparation method for a traditional Chinese medicine solid preparation, in particular to a moisture-proof preparation method for solvent-free solid preparation of an easy moisture-absorption traditional Chinese medicine extract powder. The moisture-proof preparation method for the solvent-free solid preparation comprises the following steps: firstly, preparing traditional Chinese medicine extract spherical particles by the extrusion spheronization technology; then, evenly mixing 1-10% of water-proof coating material and 0-1% of hydrophilic coating material; carrying out hot-melting coating on the traditional Chinese medicine extract spherical particles by a traditional coating pan; in the coating process and when the coating process ends, adding 0-5% of lubricating agent to prevent particles from bonding; and cooling to obtain the solvent-free solid preparation after the coating process is finished. The moisture-proof preparation method has the outstanding advantages of solvent-free operation, wide applicability and the like and is suitable for preventing moisture for easily-hydrolyzed medicine, the compliance of production personnel is improved, and the environment is protected.

Description

technical field [0001] The invention relates to a moisture-proof preparation method of a traditional Chinese medicine solid preparation, in particular to a moisture-proof preparation method of a solvent-free solid preparation of traditional Chinese medicine extract powder which is easy to absorb moisture. Background technique [0002] Most of the solid preparations of traditional Chinese medicine are extracted by water or ethanol in the preparation process. However, the solid preparations of traditional Chinese medicine prepared by this method are rich in substances that are highly hygroscopic such as sugars, resins, and tannins, resulting in softening and appearance in a short period of time. The color becomes darker, agglomerated, fluidity decreases, and even mildew occurs, which seriously affects the quality and curative effect of the drug, and brings great difficulties to the production and storage of the drug. Therefore, the problem of moisture absorption of solid prep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/00
Inventor 唐星何海冰张宇
Owner SHENYANG DONGXIN PHARMA CO LTD
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