Small-volume asarin freeze-dried powder injection, preparation method and producing apparatus thereof

Abstract

The invention relates to a small-volume asarin freeze-dried powder injection, a preparation method and a producing apparatus thereof. A 7ml tube-made penicillin bottle is filled with the small-volume asarin freeze-dried powder injection with a volume under a water mark position being 2.0ml. The preparation method includes following steps: 1. stir-dissolving asarin in a solvent with stirring fully to obtain a concentrated liquid, and performing stir-dissolving to obtain a B solution; 2. mixing water for injection with an excipient with a temperature being controlled to be at 20-25 DEG C until the solutes are all dissolved to obtain an A solution; 3. slowly adding the B solution into the A solution with stirring uniformly with assistance of ultrasonic; 4. adding activated charcoal with stirring to perform adsorption; 5. adding residual water for injection in a preparation amount and mixing the residual water for injection with the concentrated liquid to obtain a diluted liquid and performing temperature maintenance; and 6. filling the 7ml tube-made penicillin bottle with the diluted liquid, performing a freeze-drying process, pressing a plug onto the penicillin bottle and rolling a cover onto the penicillin bottle. The preparation method can improve product quality, can effectively increase productivity and reduce energy consumption, and can reduce package volume, thereby reducing costs in packaging and transportation. The preparation method can greatly reduce energy consumption during freeze-drying evaporation and further reduce the cost.

Description

technical field [0001] The invention belongs to the field of freeze-dried powder injection, and in particular relates to a small-volume asarone freeze-dried powder injection, a preparation method and a production device thereof. Background technique [0002] Currently commercially available asarone (specification: 8mg) freeze-dried powder injection is filled with 10ml control vials, which has the disadvantage that the volume of the inner packaging container is large and the output of each batch of products is low. The water solubility is not good, so a large amount of solvent is needed to be dissolved in the preparation process so as to make asarone freeze-dried powder injection. The original preparation process did not use ultrasonic solubilization, and the amount of solvent used in the concentrated preparation was increased, and the amount of water added was also large (100 times the water of the main drug), resulting in the precipitation of asarone, which increased the fi...

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Problems solved by technology

[0002] Currently commercially available asarone (specification: 8mg) freeze-dried powder injection is filled with 10ml control vials, which has the disadvantage that the volume of the inner packaging container is large and the output of each batch of products is low. The water solubility is not good, so a large amount of solvent is needed to dissolve in the preparation process, so as to make asarone freeze-dried powder injection

The original preparation process did not use ultrasonic solubilization, and the amount of solvent used in the concentrated preparation was increased, and the amount of water added was also large (100 times the water of the main drug), resulting in the precipitation of asarone, which increased the filling volume and resulted in the product Unsatisfactory solubility, reduced yield, increased energy consumption for lyophilization, increased packaging and transportation costs

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