Single-layer osmotic pump controlled-release tablet containing echinacoside and preparation method thereof
A single-layer osmotic pump, echinacoside technology, applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, osmotic transportation, etc., can solve problems such as controlled-release tablets without echinacoside, etc. Achieve the effects of improving bioavailability and drug safety, reducing dosing frequency and dosage, and enhancing compliance
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[0054] The present invention also provides a method for preparing the above-mentioned single-layer osmotic pump controlled-release tablet containing echinacoside, comprising: S1) mixing echinacoside and a cyclodextrin solubilizer in a solvent, and drying to obtain Echinacoside cyclodextrin chelate; S2) mixing and granulating the echinacoside cyclodextrin chelate, filler, osmotic pressure promoter and binder, and then mixing with lubricant evenly, Compressing the tablet to obtain the tablet core; S3) coating the tablet core and drilling holes with a laser to obtain a single-layer osmotic pump controlled-release tablet containing echinacoside.
[0055] The present invention has no special limitation on the sources of all raw materials, which can be commercially available.
[0056] Wherein, the echinacoside, cyclodextrin solubilizer, filling machine, osmotic pressure accelerator, adhesive and lubricant are all the same as above, and will not be repeated here.
[0057] Mix echina...
Embodiment 1
[0075] (1) Grind echinacoside, pass it through a 100-mesh sieve, weigh it according to the prescription amount, and mix it with β-cyclodextrin sulfobutyl ether sodium ethanol solution [50% (W / V)] at a ratio of 1:1, Stir evenly, filter, dry at 40°C for 2 hours, and pass through a 100-mesh sieve to obtain echinacoside-β-cyclodextrin sulfobutyl ether sodium chelate (ie ECH-(SBE)7m-β-CD,1 :1), spare.
[0076] (2) Take each auxiliary material according to the prescription ratio respectively, fully mix the raw material with 116 parts by weight of microcrystalline cellulose, 0 parts by weight of sodium chloride, and 4 parts by weight of povidone K30, add 85% ethanol to make a soft material, pass 24 Mesh Pharmacopoeia sieve granulation.
[0077] (3) Dry the wet granules at 55°C for 4 hours, then sieve the granules with a 20-mesh sieve, add 1 part by weight of magnesium stearate, mix evenly, and measure the content of the granules.
[0078] (4) Tablet pressing: set the speed of the t...
Embodiment 2
[0083] (1) Grind echinacoside, pass it through a 100-mesh sieve, weigh it according to the prescription amount, and mix it with β-cyclodextrin sulfobutyl ether sodium ethanol solution [50% (W / V)] at a ratio of 1:1, Stir evenly, filter, dry at 40°C for 2 hours, and pass through a 100-mesh sieve to obtain echinacoside-β-cyclodextrin sulfobutyl ether sodium chelate (ie ECH-(SBE)7m-β-CD,1 :1), spare.
[0084] (2) Take each auxiliary material according to the prescription ratio respectively, mix the raw material with 115 parts by weight of microcrystalline cellulose, 7.5 parts by weight of sodium chloride / sodium carbonate (2:1), 0.5 parts by weight of polyethylene oxide (PEO), 4 parts by weight of povidone K30 are fully mixed, added with soft material made of 85% ethanol, passed through a 24-mesh pharmacopoeia sieve and granulated.
[0085] (3) Dry the wet granules at 55°C for 4 hours, then sieve the granules with a 20-mesh sieve, add 1 part by weight of magnesium stearate, mix ev...
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