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

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...

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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

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