Diquafosol sodium composition, preparation and preparation method of diquafosol sodium composition
A technology of diquafosol and its composition, which is applied in the field of pharmaceutical preparations, can solve the problems of increasing calcium ion concentration, low bioavailability, and poor patient compliance, and achieve the goals of reducing the number of administrations, simplifying the preparation process, and increasing compliance Effect
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Embodiment 1
[0026] Example 1: Take an appropriate amount of water, weigh 0.4g of polycarbophil and add it, use a high-shear device at 5000rpm / min, cut for 30min, make swelling and dispersion complete, and set aside (solution A); Appropriate amount of water, weigh 0.005g disodium edetate, add it, stir to dissolve completely; then weigh 0.035g boric acid, add it, stir to dissolve completely; then weigh 1.25g mannitol, add it, stir to dissolve completely; then weigh 1.5g diquafosol sodium and add it and stir to dissolve completely; then weigh 0.05g poloxamer and add it, stir to dissolve completely; finally add 0.3g hypromellose to add it, use The high-shear equipment is set at 5000rpm / min, and sheared for 15min to make it swell completely and form a homogeneous system (solution B); add solution B to solution A, stir to mix evenly, filter, and filter with 1mol / L NaOH solution to In the mixed solution, adjust the pH value to 6.0~8.0, then add water to filter it, weigh it to the full amount, an...
Embodiment 3
[0027] Example 3: Take an appropriate amount of water, weigh 0.4g polycarbophil and add it, use a high-shear device at 5000rpm / min, cut for 30min, make swelling and dispersion complete, and set aside (solution A); take another Appropriate amount of water, weigh 0.005g disodium edetate, add it, stir to dissolve completely; then weigh 0.05g boric acid, add it, stir to dissolve completely; then weigh 1.65g mannitol, add it, stir to dissolve complete; then weigh 0.45g diquafosol sodium and add it, stir to dissolve completely; then weigh 0.05g poloxamer and add it, stir to dissolve completely; finally add 0.3g hypromellose and add it, Use high-shear equipment at 5000rpm / min, cut for 15min, make it swell completely, and form a homogeneous system (solution B); add solution B to solution A, stir to mix evenly, filter, and filter with 1mol / L NaOH solution Put it into the mixed solution, adjust the pH value to 6.0~8.0, then add water to filter it, weigh it to the full amount, and store ...
Embodiment 4
[0028] Example 4: Take an appropriate amount of water, weigh 0.4g of polycarbophil and add it, use a high-shear device at 5000rpm / min, cut for 30min, make swelling and dispersion complete, and set aside (solution A); take another Appropriate amount of water, weigh 0.005g disodium edetate, add it, stir to dissolve completely; then weigh 0.035g boric acid, add it, stir to dissolve completely; then weigh 0.3g mannitol, add it, stir to dissolve completely; then weigh 9g of diquafosol sodium and add it, stir to dissolve completely; The high-shear equipment is set at 5000rpm / min, and sheared for 15min to make it swell completely and form a homogeneous system (solution B); add solution B to solution A, stir to mix evenly, filter, and filter with 1mol / L NaOH solution to In the mixed solution, adjust the pH value to 6.0~8.0, then add water to filter it, weigh it to the full amount, and store it at room temperature.
[0029]Example 4: Take an appropriate amount of water, weigh 0.4g of ...
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