Timely released preparation and preparation thereof

Abstract

The invention discloses timed-release preparation consisting of a core tablet and a coating, which is characterized in that the coating contains retarder of stearate,. The invention also discloses a method for preparing the timed-release preparation; the coating of the timed-release preparation can be suppressed through direct powder sintering or wet granulation. The timed-release preparation of the invention can prohibit the rapid release of the preparation, obviously prolong the time delay and maintain comparatively better pulse effect. The wet granulation used for suppressing the coating adopted by the preparation method of the invention can reduce the consumption of framework material and decrease the viscosity during the granulation process so that the method is convenient for the granulation.

Description

technical field

[0001] The invention relates to a preparation and a preparation method thereof, in particular to a timed release preparation and a preparation method thereof. Background technique

[0002] Timed-release preparations refer to preparations that release rapidly after a certain time lag. For example, timed-release tablets, also known as single-pulse tablets, or pulse tablets for short, refer to tablets that can release medicine quickly after a certain time lag. The time-release preparation is composed of a drug-containing tablet core and a coating (time-lag coating layer), and the purpose of its time-release is achieved by relying on its coating (time-lag coating layer).

[0003] According to the preparation method, the current time-release preparations mainly contain two types: (1) liquid coating type, such as coating with an organic solution of ethyl cellulose or an aqueous dispersion of acrylic resin; (2) compression coating type, and It is called dry compre...

Examples

Embodiment 1

[0021] Tablet core prescription (total amount is 100mg):

[0022] %(W / W)

[0023] Isosorbide mononitrate 20

[0024] Microcrystalline Cellulose 20

[0025] Starch 46.2

[0026] Crospovidone 10

[0027] Povidone 2.8

[0028] Talc powder 1

[0029] Total 100

[0030] After mixing the above-mentioned first 4 ingredients, add 28 μl of 75% ethanol aqueous solution containing 10wt% povidone to make a soft material, sieve it, put it into an oven to dry at 50°C for 1 hour, add 1wt% talcum powder and mix for 3 minutes, Compressed into tablet cores.

[0031] Coating prescription (300mg in total):

[0032] %(W / W)

[0033] Hydroxypropyl Methyl Cellulose K100M 10

[0034] Acrylic resin RL 31.5

[0035] Povidone K30 18

[0036] Microcrystalline Cellulose 15

[0037] Lactose 22.5

[0038] Sodium stearate 2

[0039] Talc powder 1

[0040] Total 100

[0041] After uniformly mixing the first six auxiliary materials, granulate with 70...

Embodiment 2

[0043] Tablet core prescription (total amount is 100mg):

[0044] %(W / W)

[0045] Nitrindipine 10

[0046] Lactose 39.2

[0047] Mannitol 15

[0048] Sodium carboxymethyl starch 8

[0049] Microcrystalline Cellulose 25

[0050] Hydroxypropyl methylcellulose 1.8

[0051] Talc powder 1

[0052] Total 100

[0053] After mixing the aforementioned 5 ingredients, add 60 μl of 50% ethanol aqueous solution containing 3% hydroxypropyl methylcellulose to make a soft material, sieve it, dry it at 50°C for 1 hour, add 1 wt% talcum powder and mix for 3 minutes , pressed into tablet cores.

[0054] Coating prescription (300mg in total): % (W / W)

[0055] Hydroxypropyl Methyl Cellulose K15M 10

[0056] Povidone K30 18

[0057] Ethyl cellulose (0.01Pa.s) 30

[0058] Microcrystalline Cellulose 15

[0059] starch 23

[0060] Magnesium stearate 3

[0061] Talc powder 1

[0062] Total 100

[0063] After uniformly mixing the first six auxiliary materials, gran...

Embodiment 3

[0065] Tablet core prescription (total amount is 100mg):

[0066] %(W / W)

[0067] Salbutamol Sulfate 8

[0068] Starch 73.4

[0069] Sodium Carboxymethyl Cellulose 15

[0070] Povidone 2.6

[0071] Talc powder 1

[0072] Total 100

[0073] After mixing the above three ingredients, add 26 μl of 75% ethanol aqueous solution containing 10% povidone to make a soft material, sieve, dry at 50°C for 1 hour, add 1wt% talcum powder and mix for 3 minutes, and press into Chips.

[0074] Coating prescription (300mg in total): % (W / W)

[0075] Hydroxyethylcellulose (Natrosol HX) 6

[0076] Povidone K30 25

[0077] Ethyl cellulose (0.01Pa.s) 30

[0078] Microcrystalline Cellulose 12

[0079] Compressible starch 22

[0080] Zinc stearate 4

[0081] Talc powder 1

[0082] Total 100

[0083] After uniformly mixing the first six auxiliary materials, granulate with 70% ethanol aqueous solution, dry, granulate, and then mix with 1wt% talcum powder for 3 minu...

technical field

[0001] The invention relates to a preparation and a preparation method thereof, in particular to a timed release preparation and a preparation method thereof. Background technique

[0002] Timed-release preparations refer to preparations that release rapidly after a certain time lag. For example, timed-release tablets, also known as single-pulse tablets, or pulse tablets for short, refer to tablets that can release medicine quickly after a certain time lag. The time-release preparation is composed of a drug-containing tablet core and a coating (time-lag coating layer), and the purpose of its time-release is achieved by relying on its coating (time-lag coating layer).

[0003] According to the preparation method, the current time-release preparations mainly contain two types: (1) liquid coating type, such as coating with an organic solution of ethyl cellulose or an aqueous dispersion of acrylic resin; (2) compression coating type, and It is called dry compre...

Examples

Embodiment 1

[0021] Tablet core prescription (total amount is 100mg):

[0022] %(W / W)

[0023] Isosorbide mononitrate 20

[0024] Microcrystalline Cellulose 20

[0025] Starch 46.2

[0026] Crospovidone 10

[0027] Povidone 2.8

[0028] Talc powder 1

[0029] Total 100

[0030] After mixing the above-mentioned first 4 ingredients, add 28 μl of 75% ethanol aqueous solution containing 10wt% povidone to make a soft material, sieve it, put it into an oven to dry at 50°C for 1 hour, add 1wt% talcum powder and mix for 3 minutes, Compressed into tablet cores.

[0031] Coating prescription (300mg in total):

[0032] %(W / W)

[0033] Hydroxypropyl Methyl Cellulose K100M 10

[0034] Acrylic resin RL 31.5

[0035] Povidone K30 18

[0036] Microcrystalline Cellulose 15

[0037] Lactose 22.5

[0038] Sodium stearate 2

[0039] Talc powder 1

[0040] Total 100

[0041] After uniformly mixing the first six auxiliary materials, granulate with 70...

Embodiment 2

[0043] Tablet core prescription (total amount is 100mg):

[0044] %(W / W)

[0045] Nitrindipine 10

[0046] Lactose 39.2

[0047] Mannitol 15

[0048] Sodium carboxymethyl starch 8

[0049] Microcrystalline Cellulose 25

[0050] Hydroxypropyl methylcellulose 1.8

[0051] Talc powder 1

[0052] Total 100

[0053] After mixing the aforementioned 5 ingredients, add 60 μl of 50% ethanol aqueous solution containing 3% hydroxypropyl methylcellulose to make a soft material, sieve it, dry it at 50°C for 1 hour, add 1 wt% talcum powder and mix for 3 minutes , pressed into tablet cores.

[0054] Coating prescription (300mg in total): % (W / W)

[0055] Hydroxypropyl Methyl Cellulose K15M 10

[0056] Povidone K30 18

[0057] Ethyl cellulose (0.01Pa.s) 30

[0058] Microcrystalline Cellulose 15

[0059] starch 23

[0060] Magnesium stearate 3

[0061] Talc powder 1

[0062] Total 100

[0063] After uniformly mixing the first six auxiliary materials, gran...

Embodiment 3

[0065] Tablet core prescription (total amount is 100mg):

[0066] %(W / W)

[0067] Salbutamol Sulfate 8

[0068] Starch 73.4

[0069] Sodium Carboxymethyl Cellulose 15

[0070] Povidone 2.6

[0071] Talc powder 1

[0072] Total 100

[0073] After mixing the above three ingredients, add 26 μl of 75% ethanol aqueous solution containing 10% povidone to make a soft material, sieve, dry at 50°C for 1 hour, add 1wt% talcum powder and mix for 3 minutes, and press into Chips.

[0074] Coating prescription (300mg in total): % (W / W)

[0075] Hydroxyethylcellulose (Natrosol HX) 6

[0076] Povidone K30 25

[0077] Ethyl cellulose (0.01Pa.s) 30

[0078] Microcrystalline Cellulose 12

[0079] Compressible starch 22

[0080] Zinc stearate 4

[0081] Talc powder 1

[0082] Total 100

[0083] After uniformly mixing the first six auxiliary materials, granulate with 70% ethanol aqueous solution, dry, granulate, and then mix with 1wt% talcum powder for 3 minu...

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