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Felodipine controlled-release preparation

The technology of a preparation, lodipine, is applied in the field of felodipine controlled-release preparations, which can solve the problems of organ damage, frequent drug administration, and large blood pressure fluctuations, achieve stable blood drug concentration, reduce drug administration times, improve safety and effect of effectiveness

Inactive Publication Date: 2005-07-20
HEBEI MEDICAL UNIVERSITY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has been confirmed by scientific research that simple high blood pressure can cause damage to organs, but the damage caused by fluctuations in blood pressure is more serious.
In order to avoid the disadvantages of frequent doses of felodipine ordinary tablets and large fluctuations in blood pressure, people have developed felodipine sustained-release tablets
However, although sustained-release tablets reduce the number of times of taking, the fluctuation of blood drug concentration still cannot be controlled within the ideal range

Method used

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  • Felodipine controlled-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Chip core 1000 pieces

[0038] Felodipine 5g

[0039] Sodium chloride 80g

[0040] Starch 15g

[0041] Polyethylene glycol 10g

[0042] Magnesium stearate 0.5g

[0043] 5% starch paste appropriate amount

[0044] Coating solution (100ml)

[0045] Cellulose acetate 20g

[0046] Polyethylene glycol 0.5g

[0047] Appropriate amount of distilled water

[0048] The preparation method of this tablet is as follows:

[0049] 1, Felodipine is pulverized to 200 orders, sieves, adds starch and mixes;

[0050] II, sodium chloride, polyethylene glycol, magnesium stearate are pulverized to 100 orders respectively, sieve, mix with the mixture that I makes;

[0051] III, adding 5% starch paste to the mixture prepared by II to make soft material in an appropriate amount;

[0052] IV. Dried at 50-60°C, granulated and compressed into tablets; made into each tablet containing 5 mg of felodipine.

[0053] V. Coat the tablet prepared by IV, and punch a small hole of 10-900 μm on ...

Embodiment 2

[0060]Chip core 1000 pieces

[0061] Felodipine 10g

[0062] Sucrose 80g

[0063] Mannitol 15g

[0064] Polyethylene glycol 10g

[0065] Magnesium stearate 0.5g

[0066] 30% syrup appropriate amount

[0067] Coating liquid is the same as embodiment 1

[0068] The preparation method of this tablet is as follows:

[0069] 1, Felodipine is pulverized to 200 orders, sieves;

[0070] II, sucrose, mannitol, Polyethylene Glycol, magnesium stearate are pulverized to 100 orders respectively, sieve, mix with the felodipine that I makes;

[0071] III, adding 30% syrup to the mixture prepared by II to make soft material in an appropriate amount;

[0072] IV, 50~60 ℃ of drying, whole grain, tabletting, make the tablet that each contains 10mg felodipine.

[0073] V. Coat the tablet prepared by IV, and punch a small hole of 10-900 μm on one side of the tablet with a laser after passing the test.

[0074] The release situation of embodiment 2 felodipine is shown in Table 2:

[0075...

Embodiment 3

[0081] Chip core 1000 pieces

[0082] Felodipine 5g

[0083] Sodium chloride 80g

[0084] Polyethylene glycol 10g

[0085] Hypromellose 10g

[0086] Starch 15g

[0087] Magnesium stearate 0.5g

[0088] 5% starch paste appropriate amount

[0089] Coating liquid is the same as embodiment 1

[0090] The preparation method of this tablet is as follows:

[0091] 1, Felodipine is pulverized to 200 orders, sieves, adds starch and mixes;

[0092] II, sodium chloride is crushed to 100 mesh, sieved, mixed with the mixture prepared by I and polyethylene glycol, hypromellose, magnesium stearate;

[0093] III, adding 5% starch paste to the mixture prepared by II to make soft material in an appropriate amount;

[0094] IV. Dried at 50-60°C, granulated and compressed into tablets to make each tablet containing 5 mg of felodipine.

[0095] V. Coat the tablet prepared by IV, and punch a small hole of 10-900 μm on one side of the tablet with a laser after passing the test.

[0096] T...

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PUM

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Abstract

The present invention discloses a felodipine control-released preparation. It comprises core body and film. Said core body comprises feldodipine with effective therapeutic dose and physiologically-acceptable osmotic pressure regulating agent, osmotic accelerator and adhesive, and its film is made up by using semipermeable membrane material and pore-forming material.

Description

technical field [0001] The invention relates to a medical preparation, in particular to a felodipine controlled-release preparation. Background technique [0002] Felodipine (felodipine, fel) is a dihydropyridine calcium antagonist with high vascular selectivity, and has the effect of significantly lowering blood pressure and total peripheral boost. Healthy volunteers po Fel 10mg, qd, 4h peak drug concentration (C max )6.2 nmol -1 ~7.3 nmol -1 ; Bioavailability is 15% to 25%; Plasma protein binding rate is 99%; The pharmacokinetics in vivo belongs to a three-compartment model, starting with a rapid distribution period, t 1 / 2 6min; distribution volume 0.6Lkg -1 ; when redistributed t 1 / 2 1.5h; final volume of distribution is 10Lkg -1 , the distribution of these three phases is difficult to separate, and the entire distribution absorbs for more than 12 hours. Its therapeutic plasma concentration range is 5nmoIL -1 ~20 nmol -1 [0003] Felodipine has first-pass metabo...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4422A61P9/12
Inventor 曹德英季俊虬杜青高美华齐晓丹王静
Owner HEBEI MEDICAL UNIVERSITY
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