Fasudil hydrochloride compound and preparation method and medicine composition thereof
A technology of fasudil hydrochloride and its compound, which is applied in the direction of drug combination, organic chemical method, drug delivery, etc., can solve the problems of low binding strength, difference in solubility of crystalline drugs, and easy hydration of the surface between particles, and achieve low attraction Effects of wetness, improved stability, good absorption characteristics and bioavailability
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Embodiment 1
[0045] [embodiment 1] fasudil hydrochloride compound
[0046] 1) Prepare mixed solution A by mixing dimethylformamide and water at a volume ratio of 1:4;
[0047] 2) get fasudil hydrochloride crude drug, add the mixed solution A prepared in step 1), wherein the volume of the mixed solution A and the mass ratio of fasudil hydrochloride crude drug are 7ml: 1g, stir to make all After dissolving, add 0.1% g / ml activated carbon to the obtained solution to decolorize and filter to obtain a clear solution;
[0048] 3) Methyl isobutyl ketone and isopropanol are prepared into a mixed solution B at a volume ratio of 1:3.5;
[0049] 4) At room temperature, add mixed solution B to the clear solution obtained in step 2) under an ultrasonic field with a power of 0.6KW, wherein the amount of mixed solution B added is 7 times the volume of mixed solution A, and turn off the ultrasonic wave after adding field, lowered the temperature to 3° C., allowed to stand for 2 hours, crystals were prec...
preparation Embodiment 1
[0058] [Preparation Example 1] Fasudil Hydrochloride Injection
[0059] prescription:
[0060]
[0061] Preparation:
[0062] Get the water for injection of about 85% of the total preparation amount, add the fasudil hydrochloride dihydrate 30g (calculated as fasudil hydrochloride), 16g sodium chloride and 10mL benzyl alcohol that embodiment 1 makes under the protection of nitrogen and stir Dissolve, adjust the pH value to 6.0 with 0.1mol / L sodium hydroxide solution, add activated carbon with a total volume of 0.08% (g / mL), stir and adsorb for 10 minutes, filter for decarbonization, add water for injection to 2000mL, stir evenly, and pass through 0.22μm Fine filtration with a filter membrane, filled with nitrogen for potting, and sterilized with damp heat at 121° C. for 20 minutes to obtain the Fasudil Hydrochloride Injection.
preparation Embodiment 2
[0063] [Preparation Example 2] Fasudil Hydrochloride Water Injection
[0064] Get the fasudil hydrochloride dihydrate 2g (calculated as fasudil hydrochloride) that embodiment 2 makes, add the water for injection of 800ml, stir and make dissolving completely, adjust with the sodium hydroxide of 0.1mol / l and hydrochloric acid solution pH to 6.0, then add water for injection to 1000ml. Add 0.5 g of activated carbon, stir for 15 min to decarbonize and filter, and the resulting filtrate is sterilized by fine filtration with a 0.22 μm microporous membrane. After passing the intermediate inspection, it was filled and sealed in a 2ml ordinary ampoule, and sterilized at 121°C for 15 minutes to obtain fasudil hydrochloride aqueous injection.
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