Interferon spray for lung administration and its prepn process
A technology for pulmonary drug delivery and interferon, which can be used in pharmaceutical formulations, aerosol delivery, medical preparations containing active ingredients, etc. To achieve the effect of convenient medication, large dosage, high chemical stability and microbial stability
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[0051] Example 1
[0052] This example describes a method for preparing highly active interferon spray-dried powder by adding lecithin as an active protective agent.
[0053] Used as a liquid phase for spray drying, its composition is: citric acid 0.38mg / ml, disodium hydrogen phosphate 3.8mg / ml, soybean lecithin 1.34mg / ml, lactose 66.7mg / ml, each milliliter of emulsion contains interferon α-2b is about 40,000 international units, and the pH of the solution is measured to be 7.05. The obtained emulsion is spray-dried with Buchi minispray dryer B-191 (the same below, not mentioned again), and the spray conditions are as follows:
[0054] Solution temperature 6℃-8℃
[0055] Inlet temperature 110℃
[0056] Outlet temperature 70℃-80℃
[0057] Nozzle air flow rate 500l / h
[0058] Spray speed 1.8ml / min
[0059] Once the solution is sprayed, the inlet temperature is lowered, and the outlet temperature is maintained at about 60°C-70°C for about 10 minutes, and the interferon spra...
Example Embodiment
[0062] Example 2
[0063] This example describes a method for preparing highly active interferon spray-dried powder by adding HPCD as an active protective agent.
[0064] The liquid phase used for spray drying is composed of: citric acid 0.076mg / ml, sodium citrate 1.8mg / ml, disodium hydrogen phosphate 0.76mg / ml, HPCD 0.67mg / ml, lactose 66.7mg / ml, Each milliliter of solution contains about 200,000 international units of interferon alpha-2a, and the pH of the solution is measured to be 6.92.
[0065] The spray conditions are as follows:
[0066] Solution temperature 4℃-6℃
[0067] Inlet temperature 110℃
[0068] Outlet temperature 60℃-70℃
[0069] Nozzle nitrogen flow rate 570l / h
[0070] Spray speed 2.1ml / min
[0071] Gun Condensing System On
[0072] Once the solution is sprayed, the inlet temperature is lowered, and the outlet temperature is maintained at about 60°C-70°C for about 10 minutes, and the interferon spray-dried powder is subjected to secondary drying to fur...
Example Embodiment
[0075] Example 3
[0076] This example describes a method for preparing highly active interferon spray-dried powder using lysine as a stabilizer.
[0077] Used as a liquid phase for spray drying, its composition is: citric acid 0.38mg / ml, disodium hydrogen phosphate 3.8mg / ml, lysine 0.67mg / ml, lactose 66.7mg / ml, each milliliter of emulsion contains interferon α-2a is about 40,000 international units, and the pH of the solution is measured to be 6.81.
[0078] The spray conditions are as follows:
[0079] Solution temperature 7℃-9℃
[0080] Inlet temperature 110℃
[0081] Outlet temperature 60℃-70℃
[0082] Nozzle air flow rate 500l / h
[0083] Spray speed 1.8ml / min
[0084] Once the solution is sprayed, the inlet temperature is lowered, and the outlet temperature is maintained at about 60°C-70°C for about 10 minutes, and the interferon spray-dried powder is subjected to secondary drying to further reduce the water content.
[0085] Spray-dried powder form: see image 3 ...
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