Sodium valproate crystal form as well as preparation method and application thereof
A technology of sodium valproate and crystal form, which is applied in the field of providing new crystal form II of sodium valproate, which can solve the problems of poor resolubility and reduce the hygroscopicity of sodium valproate, achieve low water content and shorten the dissolution time , good clinical effect
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Embodiment 1
[0027] Embodiment 1 The preparation method of sodium valproate crystal form II of the present invention
[0028] Weigh 10 g of sodium valproate, add 66.6 ml of purified water, freeze at -40°C for 18 hours, start the freeze dryer, and dry in vacuum without heating the shelf during the entire drying process to obtain sodium valproate in crystal form II. During the whole drying process, the temperature of the shelf is not raised, that is, the temperature remains constant during the drying process, which ensures a high repeatability of the production method.
[0029] The P-XRD pattern of Form II is shown in figure 1 , see the DSC spectrum figure 2 .
[0030] Wherein, in the X-ray diffraction pattern, there are characteristic absorption peaks at (2θ)=6.40°, 7.22°, 7.40°, 17.05°, 18.25°, 18.98°, 19.27°±0.1° (also can be expressed as 6.40°±0.1°, 7.22°±0.1°, 7.40°±0.1°, 17.05°±0.1°, 18.25°±0.1°, 18.98°±0.1°, 19.27°±0.1°).
[0031] In the present invention, the sodium valproate ra...
Embodiment 2
[0032] Embodiment 2 The preparation method of pharmaceutical composition of the present invention
[0033] Under aseptic conditions, after the sodium valproate crystal form II was prepared by using Example 1, the crystal form II was put into a glass bottle and sealed to obtain the powder injection of sodium valproate crystal form II.
[0034] The beneficial effects of the present invention will be specifically described below through test examples.
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