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Punailuoer or delayed-release preparation of salt thereof and preparation method thereof

A delayed-release preparation, the technology of propranolol, which is applied in the field of delayed-release preparations of propranolol or its salts and its preparation, can solve problems such as the chronological rhythm of hypertension and angina pectoris without consideration

Inactive Publication Date: 2012-05-23
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Both sustained-release tablets and sustained-release capsules are on the market in my country, but these dosage forms only achieve the purpose of sustained release in the traditional sense, without considering the time rhythm of the onset of hypertensive angina pectoris, and without combining the rhythm of disease onset and therapeutic drugs The characteristics of chronopharmacology to achieve the purpose of timed drug release

Method used

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  • Punailuoer or delayed-release preparation of salt thereof and preparation method thereof
  • Punailuoer or delayed-release preparation of salt thereof and preparation method thereof
  • Punailuoer or delayed-release preparation of salt thereof and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Recipe 1:

[0059] Chip

[0060] Propranolol Hydrochloride 1.0g

[0061] Mannitol 2.5g

[0062] L-HPC 2.0g

[0063] Starch 0.5g

[0064] Magnesium stearate 0.1g

[0065] Sodium chloride 4.0g

[0066] 100 pieces

[0067] Take propranolol hydrochloride, mannitol, L-HPC, and sodium chloride to pass through 80-mesh sieve, and mix evenly; take starch, add 10mL of water to boil, let it cool to make starch slurry, add mixed raw and auxiliary materials to prepare soft material , granulated through a 16-mesh sieve, dried at 65°C for 4 hours, granulated with a 18-mesh sieve, mixed with magnesium stearate. Use a 5.0mm shallow arc punch as a die, and press on a tablet press (TDP single-punch tablet press) to obtain a tablet core. The tablet core weighs 101mg and has a hardness of 3.5±0.5kg.

[0068] coating layer

[0069] Hydroxymethylcellulose 0.45g

[0070] Carnauba Wax 0.60g

[0071] Talc p...

Embodiment 2

[0078] Recipe 2:

[0079] Chip

[0080] Propranolol Hydrochloride 1.0g

[0081] Starch 3.5g

[0082] PVPP 0.5g

[0083] Povidone k29 0.1g

[0084] Magnesium stearate 0.1g

[0085] Potassium chloride 5.0g

[0086] 100 pieces

[0087] Take propranolol hydrochloride, starch, PVPP, and potassium chloride to pass through a 80-mesh sieve, mix evenly, dissolve povidone k29 in 10 mL of ethanol, add the mixed raw and auxiliary materials to make a soft material, and pass through a 16-mesh sieve to granulate , dried at 65°C for 3 hours, granulated with 18 mesh, mixed with magnesium stearate. Use a 5.0mm shallow arc punch as a die, and press a tablet machine to obtain tablet cores. The tablet core weighs 102mg and has a hardness of 4.5±0.5kg.

[0088] coating layer

[0089] Hydroxyethylcellulose 1.43g

[0090] Ethylcellulose 1.07g

[0091] Glyceryl Monostearate 0.71g

[0092] Triethyl citrate 0.36g

[0093...

Embodiment 3

[0096] Recipe 3:

[0097] Chip

[0098] Propranolol Hydrochloride 1.0g

[0099] Microcrystalline Cellulose PH101 3.4g

[0100] Mannitol 0.1g

[0101] CCNa 0.5g

[0102] Povidone k29 0.1g

[0103] Micronized silica gel 0.1g

[0104] Sorbitol 5.0g

[0105] 100 pieces

[0106] Take propranolol hydrochloride, microcrystalline cellulose PH101, CCNa, povidone k29, micropowder silica gel, sorbitol, and mannitol and pass through 80-mesh sieve respectively, mix evenly, and use the method of powder direct compression, with a thickness of 5.0 mm. The arc punching is a punching die, and the tablet core is obtained. The tablet core weighs 102mg and has a hardness of 3.5±0.5kg.

[0107] coating layer

[0108] Polyethylene glycol 0.41g

[0109] Beeswax 0.30g

[0110] Ethyl cellulose 0.01g

[0111] Glyceryl monostearate 0.20g

[0112] Triacetin 0.10g

[0113]Mix polyethylene glycol, beeswax, glycerin monostearate, glycero...

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Abstract

The invention discloses a delayed-release preparation of propranolol for treating cardiovascular diseases such as abnormal heart rate, angina, myocardial infarction and the like or a salt thereof. The aim of the invention is to provide a drug preparation which meets the intentions of chrono-pharmacology and chrono-therapeutics and has the delayed and impulse drug-release effects and a method for preparing the same. The delayed-release preparation comprises: a tablet core containing the active component propranolol with effective treating dose or the salt thereof and other auxiliary materials and one or two coating layers which are coated in a coating pan by the rollover method or coated by the fluidization coating method or dry pressing coating method. The composition and the thickness ofthe coating layers decide the time lag of releasing the drug.

Description

technical field [0001] The invention relates to a delayed-release preparation of propranolol or its salt for treating arrhythmia, angina pectoris, myocardial infarction and other cardiovascular diseases and hypertension and a preparation method thereof. The delayed-release preparation comprises a tablet core (containing a therapeutically effective dose of active ingredient propranolol or its salt and adjuvants) and a coating layer, and its release feature is that after a period of time lag, a certain dose of The active ingredient propranolol or its salts have a so-called delayed and pulsed release effect. Background technique [0002] Propranolol hydrochloride (Propranolol), also known as propranolol, is a beta-receptor blocking drug. Its chemical name is: 1-isopropylamino-3-(1-naphthyloxy)-2-propanol hydrochloride, the structural formula is as follows, it is a white or off-white crystalline powder, odorless, slightly sweet taste After the bitter, the melting point of 162 ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K9/32A61K9/36A61K31/138A61K47/34A61K47/36A61K47/38A61P9/06A61P9/10A61K47/10
Inventor 李亚平顾王文陈伶俐
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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