Entecavir solid dispersion, pharmaceutical composition, method for preparing entecavir solid dispersion and pharmaceutical application of entecavir solid dispersion
A solid dispersion, entecavir technology, applied in the field of solid dispersion of entecavir, can solve the problem of organic solvent residues, affecting the quality and safety of entecavir drugs, solid dispersion solubility, dissolution rate and stability can not achieve maximum drug absorption and Use and other problems to achieve the effect of guaranteed quality, good stability and improved water solubility
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Embodiment 1
[0027] Example 1. Solid dispersion and preparation of entecavir and lactose (1:500)
[0028] Dissolve 1g of entecavir and 500g of lactose in 1000ml of water, heat to 70°C while stirring. After mixing evenly, it becomes a clear and transparent solution. Freeze-dry for 24 hours to remove water, then dry, cool to 20°C and pulverize, pass through an 80-mesh sieve , the obtained product is solid dispersion of entecavir and lactose.
[0029] Tablet preparation
[0030] The solid dispersion prepared above is mixed with the following pharmaceutical excipients in proportion to prepare tablets:
[0031]
[0032] According to the conventional tablet preparation process, it is compressed into tablets, and each tablet contains 5 mg of entecavir.
Embodiment 2
[0033] Example 2. Solid dispersion and preparation of entecavir and lactose (1:100)
[0034] Dissolve 1g of entecavir and 100g of lactose in 1000ml of water, heat it to 80°C while stirring, and get a clear and transparent solution after mixing evenly, remove the water by spray drying, then dry, cool to 10°C and pulverize, pass through an 80-mesh sieve to obtain The product is entecavir and lactose solid dispersion.
[0035] Preparation of granules
[0036] The solid dispersion prepared above is mixed with the following pharmaceutical excipients in proportion to prepare granules:
[0037]
[0038] According to the conventional preparation process of granules, the granules are prepared, dried and granulated.
Embodiment 3
[0039] Example 3. Solid dispersion and preparation of entecavir and lactose (1:250)
[0040] Dissolve 1g of entecavir and 250g of lactose in 1000ml of water, heat it to 85°C while stirring, and get a clear and transparent solution after mixing evenly, remove the water by spray drying, then dry, cool to 22°C and pulverize, pass through a 80-mesh sieve to obtain The product is entecavir and lactose solid dispersion.
[0041] Preparation of capsules
[0042] The solid dispersion prepared above is mixed with the following pharmaceutical excipients in proportion to prepare capsules:
[0043]
[0044] According to the conventional preparation process of capsules, it is compressed into tablets, and each capsule contains 1 mg of entecavir.
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