Esomeprazole magnesium contained enteric-coated tablet and preparation method thereof
A technology of esomeprazole magnesium and esomeprazole, which is applied in the field of pharmaceutical preparations, can solve the problems of destructive changes in chemical structure, discoloration and polymerization, poor stability of esomeprazole magnesium, etc., and achieve uniform coating , dense coating layer, ensuring safe and effective effect
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Embodiment 1
[0031] Tablet core prescription containing esomeprazole magnesium (specification: 20mg):
[0032] Esomeprazole magnesium (calculated as esomeprazole) 10.0 kg (in dry form)
[0033] Lactose 45.0 kg
[0035] 10% starch solution appropriate amount
[0036] Magnesium stearate 1.0 kg
[0037] A total of 500,000 pieces were made
[0038] Prescription of coating solution for intermediate isolation layer:
[0039] Hypromellose 12.0 kg
[0040] Titanium dioxide 2.5 kg
[0041] Polyethylene glycol-6000 1.2 kg
[0042] Sodium dihydrogen phosphate 0.8 kg
[0043] Purified water 120.0 kg
[0044] Enteric coating layer coating liquid prescription:
[0045] Eudragit L30D-55 40.0 kg
[0047] Polyethylene glycol-6000 1.2 kg
[0048] 0.1mol / L KOH solution Appropriate amount
[0049] Purified water 40.0 kg
[0050] Preparation: ...
Embodiment 2
[0065] Tablet core prescription containing esomeprazole magnesium (specification: 20mg):
[0066] Esomeprazole magnesium (calculated as esomeprazole) 10.0 kg (in dry form)
[0067] Mannitol 45.0 kg
[0069] 3% hypromellose solution appropriate amount
[0071] A total of 500,000 pieces were made
[0072] Prescription of coating solution for intermediate isolation layer:
[0073] Hypromellose 12.0 kg
[0074] Titanium dioxide 2.2 kg
[0075] Polyethylene glycol-6000 1.2 kg
[0076] Disodium hydrogen phosphate 1.0 kg
[0077] Purified water 120.0 kg
[0078] Enteric coating layer coating liquid prescription:
[0079] Eudragit L30D-55 42.0 kg
[0081] Polyethylene glycol-6000 1.2 kg
[0082] 0.5mol / L NaOH solution appropriate amount
[0083] Purified water 42.0 kg
[0084] Preparation: ...
Embodiment 3
[0099] Tablet core prescription containing esomeprazole magnesium (specification: 20mg):
[0100] Esomeprazole magnesium (calculated as esomeprazole) 10.0 kg (in dry form)
[0101] Mannitol 45.0 kg
[0102] Calcium carbonate 5.0 kg
[0103] 2% PVP-K30 solution appropriate amount
[0104] Micronized silica gel 1.2 kg
[0105] A total of 500,000 pieces were made
[0106] Prescription of coating solution for intermediate isolation layer:
[0107] Hypromellose 12.0 kg
[0108] Titanium dioxide 2.4 kg
[0109] Polyethylene glycol-6000 1.2 kg
[0110] Sodium phosphate 1.0 kg
[0111] Purified water 120.0 kg
[0112] Enteric coating layer coating liquid prescription:
[0113] Eudragit L30D-55 42.0 kg
[0114] Talc powder 3.5 kg
[0115] Polyethylene glycol-6000 1.2 kg
[0116] 0.5mol / L NaOH solution appropriate amount
[0117] Purified water 42.0 kg
[0118] Preparation:
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