Dry suspension and its preparation process
A technology of dry suspension and suspending agent, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. The problems of long drying time and large fluctuation of loading amount can shorten the preparation process time, have a good taste and improve production efficiency.
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[0031] The preparation method of the dry suspension of the present invention comprises the following steps: 1. Sieve the excipient with a particle size of 30 to 65 mesh, and dry it at 60°C in Chongqing Yongsheng Experimental Instrument Factory, model CS101-3E electric blast drying oven Two, emulsify the defoamer and surfactant of conventional dosage in Fluko, model FA25 emulsifying machine, make emulsion; %, disintegrating agent 0-12.0%, conventional doses of flavoring agents, coloring agents, and buffer salts are placed in an appropriate amount of water, and stirred with an EYELA, model Z-2100 electric mixer for 1-4 hours to obtain a suspending medium; 4. 1. Add 0.1% to 35.0% of the active ingredient of the drug and the emulsion into the suspending medium, and stir evenly with an EYELA, model Z-2100 electric mixer to obtain a drug suspension; 5. Mix the excipients by 29.0% to 99.3 % placed in Germany GLATT company, model GPCG 1.1 fluidized bed, spray drug suspension on it, af...
Embodiment 1
[0034] Example 1, preparing 200 bags of cefaclor dry suspension, specification: cefaclor 125mg / bag, the components are:
[0035]
[0036] Preparation process: 1. Sieve 40-60 mesh sucrose as excipient, and dry at 60°C. 2. Dissolve sodium lauryl sulfate in purified water 10 times the amount of simethicone, then add simethicone, and stir for 2 minutes with a mixer to obtain silicon emulsion. 3. Put xanthan gum, methylcellulose, and 25g of sucrose in a beaker, mix these three materials evenly, add 200ml of purified water, stir with an electric mixer for 1 hour to fully dissolve, then add the active ingredient of cefaclor, Silicone emulsion, stir well. 4. 575g of sucrose excipient granules are placed in the fluidized bed, and the drug suspension is sprayed. 5. After applying the medicine, spray the pigment solution evenly on the surface of the granule and dry it. 6. Add the strawberry powder essence to the granules, mix well, and you get it.
[0037] Wherein, fluidized bed G...
Embodiment 2
[0061] Example 2, preparation of clarithromycin dry suspension, specification: clarithromycin 125mg / bag, the components are:
[0062]
[0063] Preparation process: 1. Sieve 40-60 mesh sucrose as excipient, and dry at 60°C. 2. Put carbomer, stevioside, compressible starch, and sodium saccharin in 300 mL of purified water, stir for 3 hours with an electric mixer, then add clarithromycin, and stir evenly. 3. Put the sucrose excipient in the fluidized bed, spray the drug suspension, and dry it to obtain the product. 4. Spray orange liquid essence at low temperature.
[0064] Fluidized bed Glat preparation parameters:
[0065] (1) Heating: Put 40-60 mesh sucrose as excipient into the fluidized bed.
[0066]Air flow 70m 3 / h
[0067] Inlet air temperature (Air temp) 70℃
[0068] Dry to a material temperature (product temp) of 50°C,
[0069] (2) Spraying: start spraying when the material temperature reaches 50°C.
[0070] Air flow 60m 3 / h
[0071] Inlet air temperature ...
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