Method for preparing small-volume fat-soluble vitamin freeze-dried powder injection and its preparation device

A technology for fat-soluble vitamins and freeze-dried powder injections, which can be used in freeze-dried transportation, powder transportation, and pharmaceutical formulations. It can solve problems such as increased filling volume, low product output, and poor water solubility, and achieve reduced packaging Volume, improve product quality, reduce cost effect

Active Publication Date: 2016-03-02
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The currently commercially available fat-soluble vitamin (I) (specification: VA0.69mgVD210ugVE6.4mgVK10.20mg) freeze-dried powder injection is filled with 10ml brown control vials, so there is a large volume of the inner packaging container, resulting in the product output of each batch of production Low shortcoming, because the water-solubility of fat-soluble vitamin (I) itself is not good, thereby needs just dissolving with a large amount of solvents in the preparation process, so that make fat-soluble vitamin (I) lyophilized powder injection
The original preparation process did not use ultrasonic solubilization and the preparation temperature was low. The temperature is generally 20°C to 25°C during concentrated preparation, and the amount of water added (300 times the water of the main ingredient) causes the fat-soluble vitamins to precipitate, thus Increased filling volume leads to unsatisfactory solubility of the product, reduced output, increased energy consumption for freeze-drying with more moisture, and increased packaging and transportation costs
[0003] Currently commercially available fat-soluble vitamin (II) (specification: VA0.99mgVD 2 5ugVE9.1mgVK 1 0.15mg) freeze-dried powder injection is filled with 10ml control vials, so there is a large volume of inner packaging container, which causes the shortcoming of low yield of products produced in each batch. Because the water solubility of fat-soluble vitamin (II) itself is not good, so In the preparation process, a large amount of solvent is required to be dissolved in order to make fat-soluble vitamin (II) freeze-dried powder injection
The original preparation process did not use ultrasonic solubilization and the preparation temperature was low. The temperature is generally 20°C to 25°C during concentrated preparation, and the amount of water added (300 times the water of the main ingredient) causes the fat-soluble vitamins to precipitate, thus Increased filling volume leads to unsatisfactory solubility of the product, reduced output, increased energy consumption for freeze-drying with more moisture, and increased packaging and transportation costs

Method used

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  • Method for preparing small-volume fat-soluble vitamin freeze-dried powder injection and its preparation device
  • Method for preparing small-volume fat-soluble vitamin freeze-dried powder injection and its preparation device
  • Method for preparing small-volume fat-soluble vitamin freeze-dried powder injection and its preparation device

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Embodiment 1

[0029]

[0030] The preparation method of the small-volume fat-soluble vitamin freeze-dried powder injection is to weigh the prescribed amount of water for injection into the dispensing tank 3, turn on the stirring, and lower the temperature to 30℃-35℃, and release about 4% of the added amount of water for injection as dilution Water, spare. Add the prescribed amount of mannitol, stir to dissolve, and control the temperature at 30°C-35°C. The top and bottom of the tank are protected by nitrogen at the same time; this solution is considered as a liquid. Weigh the prescribed amount of Tween-80 and VE, and add them to stainless steel container 2 in turn, and then put the stainless steel bucket in the ultrasonic pool 1, turn on the ultrasonic, turn on the stirring, and ensure that the water temperature in the ultrasonic is 30-35°C, and stir. The whole process is protected by a hose with nitrogen. The solution is counted as liquid b, and vitamin K1, vitamin A, and vitamin D2 are add...

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Abstract

The invention belongs to the technical field of freeze-dried powder injection preparation, and relates to a small-size fat-soluble vitamin freeze-dried powder injection, a preparation method and a production device thereof. The small-size fat-soluble vitamin freeze-dried powder injection is filled in a 7-ml tubular penicillin bottle; the product specification of the fat-soluble vitamin freeze-dried powder injection is fat-soluble vitamin I or II; the preparation method comprises the following steps: adding VA, VD2, VE, VK1, and a solvent into a container, stirring till dissolving to obtain a B solution; adding injection water into a preparation tank, cooling, weighing a vehicle, adding the vehicle for dissolution to obtain an A solution; adding the B solution into the A solution, uniformly stirring; weighing active carbon, adding the active carbon to perform adsorption for 30 min, performing filtration, fine filtration, filling the solution into a 7-ml tubular penicillin bottle, performing freeze-drying, tamping, and cover rolling to obtain the product. According to the invention, the package size is reduced; thus the yield is effectively increased; the package cost and the transport cost are reduced; and the freeze-drying and evaporation energy consumption is greatly reduced.

Description

Technical field [0001] The invention relates to a method for preparing a small-volume fat-soluble vitamin freeze-dried powder injection and a preparation device thereof, and belongs to the field of freeze-dried powder injection and a preparation method and equipment thereof. Background technique [0002] The currently marketed fat-soluble vitamin (I) (specification: VA0.69mgVD210ugVE6.4mgVK10.20mg) freeze-dried powder injection is filled with 10ml brown controlled vials, which has a large inner packaging container, resulting in the production of each batch of products The disadvantage of low is that the fat-soluble vitamin (I) itself has poor water solubility, so a large amount of solvent is needed to dissolve it in the preparation process to make the fat-soluble vitamin (I) freeze-dried powder. The original preparation process did not use ultrasonic solubilization and the preparation temperature was relatively low. The temperature during concentrated preparation was generally be...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/592A61P3/02A61K31/355A61K31/122A61K31/07
Inventor 何茂群苗得足张光明白先杰司吉晖张国明
Owner REYOUNG PHARMA
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