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Pentoxifylline sustained release tablets and preparation thereof

A technology of pentoxifylline and theobromine, which is applied in the field of sustained-release tablets, can solve the problems of poor stability and frequent medication, and achieve the effect of improving stability

Inactive Publication Date: 2008-08-13
沈阳双鼎制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the existing pentoxifylline enteric-coated tablets have the problems of poor stability and frequent administration

Method used

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  • Pentoxifylline sustained release tablets and preparation thereof
  • Pentoxifylline sustained release tablets and preparation thereof
  • Pentoxifylline sustained release tablets and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Pentoxifylline 100g

[0015] Hypromellose K4M 100g

[0016] PEG2000 20g

[0017] Lactose 10g

[0018] Magnesium Stearate 5g

[0019]

[0020] Makes 1000 pieces

[0021] Pass pentoxifylline, PEG2000, hypromellose K4M and lactose through a 40-mesh sieve, mix evenly, prepare a soft material with 5% povidone K30 (PVP K30) alcohol solution, and granulate with a 16-mesh sieve. The wet granules are dried at 40°C for 2 hours, sieved with a 14-mesh sieve, added with prescribed amount of magnesium stearate, mixed evenly, and then compressed into tablets.

[0022] Determination of release: get this product, according to release assay (Chinese Pharmacopoeia in 2005 edition two appendix X D first method), adopt the device of dissolution assay (Chinese Pharmacopoeia in 2005 edition two appendix X C) second method, with hydrochloric acid Solution (9 → 1000) 900ml is the solvent, the speed is 50 revolutions per minute, oper...

Embodiment 2

[0028] Pentoxifylline 200g

[0029] Hypromellose K4M 65g

[0030] Hypromellose K15M 40g

[0031] PEG4000 20g

[0032] Microcrystalline Cellulose 15g

[0033] Micronized silica gel 1g

[0034]

[0035] Makes 1000 pieces

[0036] Pass the pentoxifylline and the excipients in the prescription (except micronized silica gel) through a 60-mesh sieve, mix evenly, prepare a soft material with 5% povidone K30 (PVP K30) ethanol solution, and granulate with a 16-mesh sieve. The wet granules were dried at 40°C for 2 hours, sieved with a 14-mesh sieve, added the prescribed amount of micro-powdered silica gel, mixed evenly, and then pressed into tablets.

[0037] The released amount of each tablet of the sample in this example is 22.2%, 40.4%, 70.3% and 80.6% of the labeled amount at 2, 6, 12 hours and 16 hours respectively.

[0038] test results

[0039]

Embodiment 3

[0041] Pentoxifylline 400g

[0042] Hypromellose K4M 75g

[0043] Hypromellose K100M 20g

[0044] PEG6000 20g

[0045] Starch 10g

[0046] Talc powder 7g

[0047]

[0048] Makes 1000 pieces

[0049] Pass pentoxifylline and the auxiliary materials in the prescription (except talcum powder) through a 80-mesh sieve, mix evenly, prepare a soft material with 5% starch slurry, and granulate with a 16-mesh sieve. The wet granules were dried at 40°C for 2 hours, sieved with a 14-mesh sieve, added the prescribed amount of talcum powder, mixed evenly, and then pressed into tablets.

[0050] The released amount of each tablet of the sample in this example is 17.3%, 36.9%, 69.3% and 78.6% of the labeled amount at 2, 6, 12 hours and 16 hours respectively.

[0051] test results

[0052]

[0053]

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PUM

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Abstract

The invention relates to a slow release formulation of hexanone theobromine, which contains hexanone theobromine used as the active components and slow release materials, filling agents, stabilizing agents, lubricants and bonds all used as accessories; wherein, each of the slow release tablet contains hexanone theobromine for 100 to 800mg, the slow release materials at least contain hydroxypropyl methylcellulose. The medicine releasing is controlled by adding slow release materials hydroxypropyl methylcellulose and other slow release materials; simultaneously the stabilizing agents are added in order to elevate the stability of the hexanone theobromine in the slow release formulation.

Description

technical field [0001] The invention relates to a sustained-release tablet, in particular to a sustained-release tablet whose active ingredient is pentoxifylline. Background technique [0002] Pentoxifylline (PTX) is a methylpurine derivative, its chemical name is 3,7-dihydro-3,7-dimethyl-1-(5-oxyhexyl)-1H-purine-2, 6-diketone. Pentoxifylline has been used clinically for more than 20 years. It is a nonspecific peripheral vasodilator that dilates isolated canine basilar arteries. Intravenous injection can increase cerebral blood volume, reduce cerebral vascular resistance, and promote cerebral oxygen and glucose metabolism. This product can enhance the deformability of red blood cells in rats, reduce blood viscosity, and increase capillary flow. Oral administration inhibits laser-induced thrombosis in rat mesenteric arteries. It is mainly used for the improvement of cerebral circulation after ischemic cerebrovascular disease, and it can also be used for the treatment of ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/38A61K31/522A61P9/08A61P1/02A61P11/00A61P31/18A61P35/00A61P9/10A61P9/12
Inventor 马占芝王知斌郑锦辉赵鑫孟繁娜李桂艳
Owner 沈阳双鼎制药有限公司
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