New crystalline form of hydrochloric acid Ivabradine and preparation method thereof
A technology of ivabradine hydrochloride and ivabradine, which is applied in the field of new crystal forms of ivabradine hydrochloride and its preparation, and can solve problems not described in detail
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Embodiment 1
[0014] Embodiment 1: Ivabradine hydrochloride in W-crystalline form
[0015] 1.0 g of ivabradine hydrochloride was added to 30 mL of acetone and 2 mL of methanol for dissolution under reflux, and the filtrate was allowed to stand for crystallization. Then pump and filter, and wash the filter cake with a small amount of acetone. The filter cake was vacuum dried at 85°C to constant weight. A 0.85 g sample of crystal form W was obtained. The melting point is 196.5-197.7°C.
[0016] The powder X-ray diffraction pattern is shown in Figure (1).
[0017]
[0018]
Embodiment 2
[0019] Embodiment 2: pharmaceutical composition
[0020] For the preparation of 1000 tablets, wherein each tablet contains 5 mg of ivabradine base, using the following formula 5.39 g of the compound of Example 1, 60.0 g of lactose, 20.0 g of microcrystalline cellulose, and 1.0 mg of magnesium stearate g, 13.61 g of starch, prepared by a conventional tablet preparation process.
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