Hesperetin and isonicotinamide eutectic, and preparation method, composition and application thereof
A technology of isonicotinamide and hesperetin, applied in the field of medicine, can solve the problems of not seeing the co-crystal of hesperetin and isonicotinamide, similarity or conflict, etc., and achieve the advantages of good safety medicine, significant solubility and solubility The effect of speed advantage
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Embodiment 1
[0060] Hesperetin and isonicotinamide co-crystal preparation method 1
[0061] Take an appropriate amount of hesperetin and isonicotinamide, the molar ratio of the two is 1:1, add the sample into a suitable container by solvent suspension method at room temperature, add an appropriate amount of organic solvent, stir for an appropriate time at room temperature, and mix the obtained mixture The suspension solvent was evaporated to dryness, filtered to dry naturally or filtered to vacuum-dried, and the conditions and parameters were shown in Table 3. Carry out powder X-ray diffraction analysis to it, its diffraction pattern and figure 1 Consistent, indicating that the obtained sample is a co-crystal of hesperetin and isonicotinamide.
[0062] Table 3 Hesperetin and isonicotinamide co-crystal preparation method 1 specific example
[0063]
Embodiment 2
[0065] Dissolution and release characteristics of hesperetin and isonicotinamide cocrystal in vitro
[0066] The solubility characteristics of hesperetin and isonicotinamide co-crystal and hesperetin API in pure water, pH 4.5 and pH 6.8 were investigated. The experiment was carried out with reference to the "Technical Guidelines for Dissolution Test of Ordinary Oral Solid Preparations". Dissolution percentage adopts high performance liquid phase method, and external standard method calculates its dissolution percentage content. Take time as the abscissa, and the dissolution percentage as the ordinate to draw the dissolution curve respectively ( Figure 6 ). The data are shown in Table 4.
[0067] Detection conditions: detection system: Aligent 1200, chromatographic column: Agilent Eclipse XDB-C18 (4.6 × 150mm, 5μm); mobile phase: methanol-water (70:30, v / v); flow rate: 1mL min -1 ; Column temperature: 30°C; Detection wavelength: Hesperetin: 280nm; Injection volume: 10 μl. ...
Embodiment 3
[0072] Stability advantage of hesperetin and isonicotinamide co-crystal
[0073] High temperature test: put the sample of hesperetin and isonicotinamide co-crystal in an open clean watch glass, place it at 60°C for 10 days, and take samples on the 0th day, the 5th day and the 10th day. Powder X-ray diffraction analysis was performed on the samples obtained at the above sampling points, and the results showed that the co-crystal of hesperetin and isonicotinamide was stable under the test of high temperature influencing factors.
[0074] High humidity test: put the sample of hesperetin and isonicotinamide co-crystal in an open clean surface dish, place it at 25°C for 10 days at a relative humidity of 90%±5%, and test it on the 0th day, the 5th day and Samples were taken on day 10. Powder X-ray diffraction analysis was performed on the samples obtained at the above sampling points, and the results showed that the co-crystal of hesperetin and isonicotinamide was stable under high...
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