Small-volume levocarnitine freeze-dried powder injection and its preparation method and production device

Abstract

The invention belongs to the technical field of freeze-dried powder injection preparation, and relates to a small-size levocarnitine freeze-dried powder injection, a preparation method and a production device thereof; the injection is characterized in that the levocarnitine freeze-dried powder injection is filled in a 15-ml tubular penicillin bottle, and the levocarnitine content in the levocarnitine freeze-dried powder injection is 1 g. Compared with the prior art, the invention has the beneficial effects of effectively increased yield, reduced energy consumption, reduced package size, and thus reduced packaging and transport cost; the filling amount is reduced to be only 6-7 ml; the freeze-drying and evaporation energy consumption is greatly reduced; and the cost is further reduced.

Description

technical field [0001] The invention belongs to the technical field of preparation of freeze-dried powder injection, and relates to a small-volume levocarnitine freeze-dried powder injection, a preparation method and a production device thereof. Background technique [0002] Currently commercially available levocarnitine freeze-dried powder injections are filled in 20ml vials, so the volume of the inner packaging container is large, and the area occupied by each bottle in the freeze-drying box is large, resulting in low output of each batch of products. Due to the addition of auxiliary material mannitol in the formulation of levocarnitine freeze-dried powder injection, a large amount of solvent is needed to dissolve mannitol in the preparation process so as to make levocarnitine freeze-dried powder injection. The original preparation process did not control the preparation temperature, and the temperature is generally between 20°C and 25°C during concentrated preparation. Th...

AI Technical Summary

Problems solved by technology

[0002] Currently commercially available levocarnitine freeze-dried powder injections are filled in 20ml vials, so the volume of the inner packaging container is large, and the area occupied by each bottle in the freeze-drying box is large, resulting in low output of each batch of products. Due to the addition of mannitol as an excipient in the formulation of levocarnitine freeze-dried powder injection, a large amount of solvent is needed to dissolve mannitol in the preparation process so as to make levocarnitine freeze-dried powder injection

The original preparation process did not control the preparation temperature, and the temperature is generally between 20°C and 25°C during concentrated preparation. Therefore, it is necessary to add 12.5 times the water of the excipient (mannitol) in the prescription to dissolve it, thereby increasing the filling volume. In order to ensure the sublimation rate of water during the freeze-drying process, 20ml vials are used for filling, resulting in a decrease in the output of each batch, increased energy consumption due to more moisture in freeze-drying, and increased packaging and transportation costs.

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