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Method for granulating easily oxidized raw materials

A technology that is easy to oxidize and raw materials is applied in the direction of plant raw materials, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of product quality risk and unsatisfactory control of the stability of the finished product content of uniform preparations and other issues to achieve the effect of reducing product risk, uncomplicated production equipment, and avoiding deterioration

Inactive Publication Date: 2015-05-06
GUIZHOU JINGFENG INJECTION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, most of the easily oxidized raw materials of solid preparations in the industry are added during tableting or coating. This addition method has problems with uniform content and content stability control of finished preparations, which puts the product at risk of quality.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Vitamin C Yinqiao tablets (sugar-coated tablets): add an appropriate amount of 20L of purified water and 1kg of hydroxypropyl methylcellulose into a 50L stainless steel slurry (liquid) tank, start stirring; then close the liquid (material) port and continue stirring for 40 Minutes, ready for use; receive 100kg of vitamin C raw materials and pour them into the wet granulator, turn on the wet granulator and spray into the stirred mixed solution to granulate; after granulation is completed, discharge the material, and dry the granulated wet granules at 40°C Get dry granules for later use. Dry particles are stored at an intermediate station for sampling.

[0018] Sampling plan: Use a long-handled spoon to take an average of 3 samples each according to the storage time of the drug for 1 day, 3 days, 5 days, 10 days, 15 days, 30 days, 60 days, and 90 days.

[0019] The number of items measured after the completion: a total of 24 points of sampling materials (sample 1-sample ...

Embodiment 2

[0021] Vitamin C Yinqiao tablets (film-coated tablets): add an appropriate amount of 10L of purified water and 0.5kg of hydroxypropyl methylcellulose into a 50L stainless steel slurry (liquid) tank, start stirring; then close the liquid (material) port and continue to stir for pre-treatment Dissolve for 35 minutes and wait for use; receive 50kg of vitamin C raw materials and pour them into the wet granulator, turn on the wet granulator and spray into the stirred mixed solution to granulate; after granulation is completed, discharge the granulated wet granules 42 ℃ drying to obtain dry particles, set aside. Dry particles are stored at an intermediate station for sampling.

[0022] Sampling plan: Use a long-handled spoon to take an average of 3 samples each according to the storage time of the drug for 1 day, 3 days, 5 days, 10 days, 15 days, 30 days, 60 days, and 90 days.

[0023] The number of items measured after the completion: a total of 24 points of sampling materials (sa...

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PUM

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Abstract

The invention relates to a method for granulating easily oxidized raw materials. The method comprises the following steps: adding a proper amount of purified water and hydroxypropyl methyl cellulose with the corresponding ratio into a dosing tank, and starting stirring; closing the feeding hole, continuously stirring at the rotating speed being less than 90 revolution per minute, pre-dissolving for 30-60 minutes, uniformly stirring, fully dissolving, and stopping stirring for later use; then pouring a corresponding amount of easily oxidized raw materials into a wet type granulator, starting the wet type granulator, spraying the stirred solution for granulating, coating the surfaces of the easily oxidized raw materials with the stirred solution grains by using an adhesive so as to generate particles; and finally, drying the particles of the easily oxidized raw materials at low temperature for later use. The grains prepared by the method are oxidation resistant, so that the easily oxidized raw materials are long in storage time after being unpacked to be used, the condition that the materials are oxidized to go bad in the production process can be avoided, the production process is controllable, and the product quality is improved; and moreover, the risk existing in the product quality is greatly lowered, meanwhile, the production cost is reduced, and the method is particularly suitable for industrial production.

Description

Technical field: [0001] The invention relates to a granulation method of easily oxidizable raw materials, in particular to a granulation method of easily oxidizable raw materials such as vitamin C. Background technique: [0002] Granulation of pharmaceutical materials is a relatively common production process in the pharmaceutical industry, and the content of solid preparation raw materials decreases from time to time during the granulation process. How to ensure that the raw materials do not degrade during the production process is very important for the quality of the product, especially for some compound preparations. For solid preparations such as vitamin C Yinqiao tablets, whether the quality can be guaranteed is particularly critical. [0003] At present, most oxidizable raw materials for solid preparations in the industry are added during tablet compression or coating. This method of addition has problems with uniform content and content stability control of finished ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/38A61K9/16A61K31/375A61K36/899
Inventor 叶湘武周德林余渊周燕
Owner GUIZHOU JINGFENG INJECTION