Osmotic pump controlled release tablet of losartan potassium and hydrochlorothiazide solid dispersion or inclusion compound
A solid dispersion, osmotic pump controlled release technology, applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, drug combinations, etc., can solve problems such as increasing technical complexity, achieve high application value, Improve bioavailability and reduce peak-to-valley fluctuations
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Embodiment 1
[0083] The losartan potassium hydrochlorothiazide osmotic pump controlled-release tablet is composed of a tablet core and a coating film wrapping the tablet core, and a drug release hole of 0.3-0.9 mm is punched in the center of the coating side.
[0084] The tablet core consists of the following components:
[0085] Losartan Potassium 50mg
[0086] Hydrochlorothiazide-urea solid dispersion 87.5 mg
[0087] Lactose 125 mg
[0088] Sucrose 187.5 mg
[0089] It also contains magnesium stearate accounting for 1% of the mass of the tablet core, and povidone in a dose sufficient to bind the above substances;
[0090] The mass ratio of hydrochlorothiazide to urea in the hydrochlorothiazide-urea solid dispersion is 1:6.
[0091] The used coating liquid of described coating accounts for 3~5% of tablet core weight, and each component ratio of coating liquid is:
[0092] 30 parts of cellulose acetate,
[0093] Polyethylene glycol-4000 1.2 parts,
[0094] 6 parts of diethyl ph...
Embodiment 2
[0111] The hydrochlorothiazide-urea solid dispersion in Example 1 was replaced with the hydrochlorothiazide-polyvidone solid dispersion, and the others were the same as in Example 1.
[0112] The preparation method of the hydrochlorothiazide-povidone solid dispersion is as follows: weigh hydrochlorothiazide, povidone and poloxamer 188, place them in a container, add 2~5ml / 10mg of hydrochlorothiazide dehydrated alcohol, 35~45°C Stir to dissolve completely, evaporate the solvent in a water bath at 75-85°C to obtain a dry solid, then dry it in a desiccator for 24 hours, pass through a 60-mesh sieve, and seal it for later use.
[0113] The test method of the release of the two active ingredients of the losartan potassium hydrochlorothiazide osmotic pump controlled-release tablet prepared by the present embodiment is the same as in Example 1, and the release curve recorded is as follows: figure 2 .
[0114]
Embodiment 3
[0116] The hydrochlorothiazide-urea solid dispersion in Example 1 is replaced with hydrochlorothiazide-hydroxypropyl-β-cyclodextrin inclusion compound, and its addition amount is 200mg, the hydrochlorothiazide-hydroxypropyl-β-cyclodextrin inclusion compound The preparation method is:
[0117] Weigh hydrochlorothiazide, place it in a container, add 0.1mol / LNaOH, stir electromagnetically until hydrochlorothiazide dissolves, add hydroxypropyl-β-cyclodextrin, the molar ratio of added hydroxypropyl-β-cyclodextrin to hydrochlorothiazide is 3:1, add 0.1mol / L HCL drop by drop under electromagnetic stirring at 38°C, adjust the pH value to 5-7, rotate the water in the above solution at 70°C, and vacuum dry at 60°C to obtain Hydrochlorothiazide-hydroxypropyl-β-cyclodextrin inclusion compound solid dispersion.
[0118] Others are the same as in Example 1.
[0119] The test method of the release of the two active ingredients of the losartan potassium hydrochlorothiazide osmotic pump cont...
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