Enteric dry suspension of rabeprazole and dextroisomer thereof, and preparation method thereof
A technology of rabeprazole and dry suspension, which is applied in the field of medicine, can solve problems such as difficulty in swallowing ordinary enteric-coated tablets, irritation of the gastrointestinal tract of raw and auxiliary materials, inconvenient division of doses, etc., and achieves good bioavailability, effective Fast-acting, easy-to-split dosage effect
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Embodiment 1
[0030] In the present embodiment, the enteric-coated dry suspension of rabeprazole and its dextrorotatory isomer consists of the following components by weight:
[0031] Sustained-release microspheres A: Rabeprazole sodium 10g, glyceryl behenate 442g, poloxamer 148g,
[0032] Coating solution A: hypromellose 10g, water 190g,
[0033] Coating solution B: Eudragit L100-5530g EVONIC), sodium hydroxide 0.4g (in the process of preparing the above-mentioned enteric coating polymer material powder into an aqueous dispersion, a small amount of alkali or organic base needs to be added to neutralize the carboxyl groups in the polymer to obtain a pH value of about 5.2 Latex dispersion), talcum powder 15g, triethyl citrate 3g, water 52g;
[0034] Microspheres C945g,
[0035] Flavoring agent: 973g sucrose, 2g apple essence,
[0036] Suspending agent: hydroxypropyl cellulose 60g, xanthan gum 20g.
[0037] The preparation method of the enteric-coated dry suspension of rabeprazole and i...
Embodiment 2
[0044] In the present embodiment, the enteric-coated dry suspension of rabeprazole and its dextrorotatory isomer consists of the following components by weight:
[0045] Sustained-release microspheres A: dex-rabeprazole sodium 10g, mixed fatty acid glycerides 442g, poloxamer 148g,
[0046] Coating solution A: hypromellose 10g, water 190g,
[0047] Coating solution B: HPMCP HP-556g (Shin-Etsu), talc powder 1.5g, diethyl phthalate 0.6g, ethanol 28g, water 64g;
[0048] Microsphere C818g,
[0049] Flavoring agent: sorbitol 1100g, sodium saccharin 2g,
[0050] Suspending agent: sodium carboxymethylcellulose 60g, gum arabic 20g.
[0051] The preparation method of the enteric-coated dry suspension of rabeprazole and its dextrorotatory isomer in the present embodiment comprises the following steps:
[0052] (1) Accurately take each component according to the parts by weight, mix dextro-rabeprazole sodium, mixed fatty acid glycerides, and poloxamer evenly, melt the mixture at 90°C t...
Embodiment 3
[0058] In the embodiment, the enteric-coated dry suspension of rabeprazole and its dextrorotatory isomer consists of the following components by weight:
[0059] Sustained-release microspheres A: dex-rabeprazole sodium 10g, polyethylene glycol 6000590g,
[0060] Coating solution A: hypromellose 10g, water 190g,
[0061] Coating Solution B: Eudragit L1006g EVONIC), talc powder 1.2g, triethyl citrate 0.6g, ethanol 92g;
[0062] Microsphere C810g,
[0063] Flavoring agent: mannitol 1120g, stevia essence 10g,
[0064] Suspending agent: hypromellose 60g.
[0065] The preparation method of the enteric-coated dry suspension of rabeprazole and its dextrorotatory isomer in the present embodiment comprises the following steps:
[0066] (1) Accurately take each component according to the parts by weight, mix the preferred rabeprazole sodium and polyethylene glycol 6000 evenly, melt the mixture at 80°C through twin-screw extrusion, and then spray and condense to make a particle size...
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