A kind of cyclic adenosine monophosphate compound and its pharmaceutical composition of cyclic adenosine monophosphate meglumine
A cyclic adenosine phosphate compound and the technology of the cyclic adenosine phosphate compound are applied in the field of medicine and can solve the problems of poor stability, unstable insoluble particles and the like, and achieve the effect of improving stability
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Embodiment 1
[0064] Example 1 Preparation of cyclic adenosine monophosphate compound
[0065] 1. Add cyclic adenosine monophosphate raw materials into pyridine at a weight ratio of 1:3, raise the temperature to 62°C, and stir at 120 rpm to dissolve.
[0066] 2. Cool down to 58°C, and at a stirring speed of 100 rpm, slowly and uniformly add 3 times pyridine in step 1 with a volume ratio of 7:3 to the solution in step 1 while stirring at a speed of 50ml / min. A mixed solution of ethanol and ether, stop stirring after adding the mixed solution, cool down to 2°C at a rate of 0.6°C / min, let stand to grow crystals for 8 hours, and filter.
[0067] 3. Wash the filter cake obtained by filtering in 2 twice with 2 times the weight of ethanol, and dry at 60° C. for 6 hours to obtain the cyclic adenosine monophosphate compound.
[0068] X-ray powder diffraction pattern see attached figure 1 , the characteristic peaks in the spectrum at 2θ±0.2° are 5.8°, 6.9°, 7.6°, 11.3°, 16.5°, 19.2°, 21.7°, 22.6°, ...
Embodiment 2
[0069] Example 2 Preparation of cyclic adenosine monophosphate compound
[0070] 1. Add cyclic adenosine monophosphate raw materials into pyridine at a weight ratio of 1:3, raise the temperature to 67°C, and stir at 150 rpm to dissolve.
[0071] 2. Cool down to 60°C, and at a stirring speed of 120 rpm, slowly and uniformly add 4 times the weight of pyridine in step 1 with a volume ratio of 7:3 to the solution in step 1 while stirring at a speed of 60ml / min. A mixed solution of ethanol and ether, stop stirring after adding the mixed solution, cool down to 4°C at a rate of 0.8°C / min, let stand to grow crystals for 8 hours, and filter.
[0072] 3. Wash the filter cake obtained by filtering in 2 twice with 2 times the weight of ethanol, and dry at 5° C. for 6 hours to obtain the cyclic adenosine monophosphate compound.
[0073] The X-ray powder diffraction pattern is consistent with Example 1. Content: 99.97%. Melting point: 262~265℃, water solubility 92.8mg / ml.
Embodiment 3
[0074] Example 3 Preparation of cyclic adenosine monophosphate injection, specification: 2ml: 20mg.
[0075] prescription:
[0076] Cyclic adenosine monophosphate compound: 20g
[0077] L-malic acid: 1g
[0079] Add water for injection to 2000ml
[0080] ________________________
[0081] Make 1000 pieces
[0082] The preparation method is:
[0083] 1. Add water for injection to 1600ml, adjust the water temperature to 50°C, add the prescribed amount of cyclic adenosine monophosphate compound, L-malic acid, and sodium tartrate to dissolve, cool down to 22°C and adjust the pH to 5.8 with sodium hydroxide.
[0084] 2. Add water for injection to 2000ml, stir evenly, filter with a 0.22 μm filter membrane, fill according to the specifications, melt seal, sterilize with damp heat at 121°C for 15 minutes, pack after passing the inspection, and prepare the active ingredient as the ring of the present invention. Adenosine Phosphate Compound Injection...
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