Fluorofenidone solid dispersoid and preparation thereof
A technology of solid dispersion and flufenidone, which is applied in the field of medicine, can solve problems affecting the stable absorption of drugs, low dissolution rate, and affecting drug bioavailability, etc.
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Embodiment 1
[0079] The solid dispersion of fluorofenidone in this embodiment includes fluorofenidone, poloxamer, ethylene glycol and a polymer matrix PEG4000, and the weight ratio of the four is 1:0.2:0.2:5.
[0080] The preparation method is the melting method: first heat PEG4000 at 90°C to melt, then mix fluorofenidone, poloxamer and ethylene glycol, and add to PEG4000, and then quickly cool down to 35°C within 20 minutes to cool and solidify , And finally freeze-dried into powder.
[0081] Solubility test: Take an excess of the solid dispersion of fluorofenidone into a stoppered Erlenmeyer flask, add 100ml of purified water, and shake at 25°C and 37°C for 48 hours. Take the supernatant, filter and dilute, and detect the concentration of fluorofenidone. , Make three copies of each sample in parallel. After testing, the solubility of fluorofenidone solid dispersion at 25°C is 51.2±1.66mg / ml, and the solubility at 37°C is 63.1±1.79mg / ml. The solubility of fluorofenidone bulk drug in water is ...
Embodiment 2
[0083] The preparation process is the same as in Example 1, except that the solid dispersion of flufenidone includes flufenidone, Tween-80 and PVP10000, and the weight ratio of the three is 1:0.1:4.
[0084] The solubility test method is the same as in Example 1. The solubility of the fluorofenidone solid dispersion at 25°C is 53.5±1.58 mg / ml, and the solubility at 37°C is 78.5±1.62 mg / ml.
Embodiment 3
[0086] The preparation process is the same as in Example 1, except that the solid dispersion of fluorofenidone includes fluorofenidone, polyoxyethylene castor oil, glycerol and xanthan gum, and each weight ratio is 1:0.5:0.5:10.
[0087] The solubility test method is the same as in Example 1. The solubility of the fluorofenidone solid dispersion at 25°C is 48.7±1.98 mg / ml, and the solubility at 37°C is 61.4±1.83 mg / ml.
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