Sodium valproate crystal form as well as preparation method and application thereof
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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
Active Publication Date: 2012-07-25
SICHUAN CREDIT CHEMWERTH PHARMACEUTICAL CO LTD
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Problems solved by technology
In this invention, sodium valproate crystal form III has good solubility, which solves the problem of poor resolubility of existing sodium valproate powder injections, but this patent does not involve research on the hygroscopicity of sodium valproate
[0009] At present, there is no relevant report on reducing the hygroscopicity of sodium valproate by changing the crystal form of sodium valproate
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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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Abstract
The invention discloses a sodium valproate crystal form II as well as a preparation method and application thereof, wherein characteristic absorption peaks appear at diffraction angles of (2theta)=6.3-6.5 DEG, 7.12-7.32 DEG, 7,3-7.5 DEG, 16.95-17.15 DEG, 18.15-18.35 DEG, 18.88-19.08 DEG and 19.17-19.37 DEG in a powder x-ray diffraction pattern of the crystal. The sodium valproate crystal form II provided by the invention has the advantages that the hygroscopicity is significantly reduced and lower water content of the product is guaranteed to ensure that the quality of the sodium valproate is more stable in storage period; while the hygroscopicity is reduced, the dissolution time of the product is significantly shortened and the dissolvability of the product is improved to ensure that the curative effect and very good safety of the sodium valproate are guaranteed in clinical application, the injection pain is also significantly relieved, compliance of patients is increased during treatment and very good clinical effect of the treatment is obtained.
Description
technical field [0001] The invention provides a new crystal form II of sodium valproate, which belongs to the field of medicine. Background technique [0002] Sodium valproate is a first-line broad-spectrum antiepileptic drug. The chemical structural formula is as follows: [0003] [0004] The chemical name of sodium valproate is 2-sodium valproate, molecular formula: C 8 h 15 NaO 2 , with a molecular weight of 166.2, is a white, odorless, crystalline water-soluble powder. It is a better antiepileptic drug and is suitable for various epilepsy (petit mal seizures, focal epilepsy, psychomotor seizures and mixed seizures) and Prevention and treatment of personality and behavioral disorders caused by epilepsy [Chinese Journal of Pharmaceutical Industry 1999, 30(9): 389-390], which can be prepared into oral preparations and injection preparations. At present, the specifications of oral preparations include tablet: 100mg, 200mg, syrup: 5ml: 200mg, 500mg. Sodium valproate...
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Patent Type & Authority Applications(China)
IPC IPC(8): C07C53/128C07C51/43A61K31/19A61P25/08
Inventor 傅霖李文婕陈刚陈功政万树伦
Owner SICHUAN CREDIT CHEMWERTH PHARMACEUTICAL CO LTD
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