Enteric soluble preparation of Alun phosphorate and its preparing method
A technology of alendronate and enteric-coated preparations, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., and can solve problems such as peptic ulcers, increased dosage, and poor patient compliance. , to reduce adverse reactions and eliminate irritation
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Embodiment 1
[0050] Component Weight Weight %
[0051] (1) Core material
[0052] Alendronate Sodium 13.3g (Containing Alendronate 10g) 5%
[0053]Lactose 172.9g 65%
[0054] Hypromellose 47.88g 18%
[0055] Povidone 13.3g 5%
[0056] 95% ethanol appropriate amount
[0057] Talc 2.66g 1%
[0058] Makes 1000 pieces
[0059] (2) Coating solution
[0060] Ethylcellulose 15.96g 6%
[0061] 95% ethanol 500ml
[0062] Weigh the alendronate sodium, diluent, and part of the disintegrant through the 80-mesh sieve according to the prescription amount, mix well, add an appropriate amount of 10% povidone, granulate, dry the remaining part of the disintegrant and dry The granules are mixed evenly, and the semi-finished product is qualified after the inspection, adding a lubricant, and then pressed into tablets after mixing.
[0063] The prepared plain tablet is weighed and placed in a coating pan, while spraying the coating solution and blowing hot air to obtain an enteric-coated tablet.
Embodiment 2
[0065] Component Weight Weight %
[0066] (1) Core material
[0067] Alendronate Sodium 93.1g (Alendronate 70g) 18.62%
[0068] Microcrystalline Cellulose 229.4g 45.88%
[0069] Hypromellose 35g 7%
[0070] Sodium starch glycolate 35g 7%
[0071] Talc 7.5g 1.5%
[0072] Povidone 30g 6%
[0073] 95% ethanol appropriate amount
[0074] Makes 1000 pieces
[0075] (2) Coating solution:
[0076] Polyacrylic resin No. II 40g 8%
[0077] Polyacrylic resin No. III 10g 2%
[0078] Macrogol 6000 20g 4%
[0079] 95% ethanol 1000ml
[0080] Take the prescribed amount of alendronate sodium, pass through a 100-mesh sieve for 3 times, add diluent and disintegrant, mix well, add appropriate amount of wetting agent or binder to granulate, dry, add lubricant after the semi-finished product is qualified, mix Press evenly.
[0081] Weigh the prepared plain tablets and place them in a coating pan, spray the coating liquid and blow hot air while blowing to obtain enteric-coated tablets...
Embodiment 3
[0083] Component Weight Weight %
[0084] (1) Core material:
[0085] Alendronate Sodium 39.9g (Containing Alendronate 30g) 13.3%
[0086] Microcrystalline Cellulose 150g 50%
[0087] Hypromellose 30g 10%
[0088] Povidone 21g 7%
[0089] 95% ethanol appropriate amount
[0090] Makes 1000 capsules
[0091] (2) Coating solution:
[0092] Polyacrylic resin No. II 48g 16%
[0093] Macrogol 1000 5.1g 1.7%
[0094] Macrogol 6000 6g 2%
[0095] 95% ethanol 1000ml
[0096] The granules prepared according to the preparation method are weighed and placed in a coating pan or a fluidized fluidized bed, while spraying the coating solution and blowing hot air to obtain enteric-coated granules.
[0097] Enteric-coated granules are filled into capsules to obtain alendronate sodium enteric-coated capsules.
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