Compound sustained-release pellet tablet containing nifedipine and atenolol and preparation thereof

A sustained-release micropill tablet and technology for sustained-release micropellet, which are applied in the field of nifedipine and atenolol compound sustained-release micropellet tablets and their preparation, can solve the problem of process stoppage, difficult control of drug release behavior, equipment damage, etc. problem, to achieve good mixing uniformity

Inactive Publication Date: 2008-09-10
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the composition, particle size, density and fluidity of powders and granules are far from those of drug-containing pellets, it is impossible to protect the uniformity of mixing in the process of industrial mass production. Due to the vibration of the hopper of the machine, the ingredients will also be seriously stratified, resulting in the uncontrollable content of the ingredients of the compound; at the same time, the normal tablet force may not be able to compress a high proportion of drug-containing pellets into tablets, resulting in process stoppage and equipment damage; There may also be different degrees of rupture or fusion of the drug-containing pellets between the tablets prepared by compression, and the drug release behavior is difficult to control

Method used

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  • Compound sustained-release pellet tablet containing nifedipine and atenolol and preparation thereof
  • Compound sustained-release pellet tablet containing nifedipine and atenolol and preparation thereof
  • Compound sustained-release pellet tablet containing nifedipine and atenolol and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Take by weighing 5g atenolol, 5g microcrystalline cellulose and 3g tartaric acid, mix homogeneously, use the 2% aqueous solution of povidone K30 as the soft material of binding agent system, extrude and spheronize and prepare atenolol containing pill core, sieve Take 30-40 mesh for later use.

[0052] Take above-mentioned 10g atenolol drug-containing pellet cores in the fluidized bed. Add 0.267g of talc powder and 0.002g of bright blue lake into 15ml of water, mix and stir to obtain a suspension, add 0.533g of methyl methacrylate: butyl acrylate 1:1.5 polymer, 15ml of water and 15ml of ethanol before use In the coating solution, adjust the wind speed, temperature and coating solution flow rate to ensure a good fluidized state, and the coating weight increases by about 8%, to prepare atenolol sustained-release pellets with a drug content of 35.6%.

[0053] Take by weighing 10g of nifedipine and 20g of polyethylene glycol 6000 to prepare a solid dispersion, take by weigh...

Embodiment 2

[0059] Take by weighing 5g atenolol, 5g microcrystalline cellulose and 3g tartaric acid, mix homogeneously, use the 2% aqueous solution of povidone K30 as binder system soft material, centrifugal granulation coating prepares atenolol containing pill core , sieve 30-40 mesh for later use.

[0060] Take the above-mentioned 10g atenolol-containing pill core in a centrifugal granulation coating machine. Add 0.833g of talcum powder and 0.002g of bright blue color lake into 15ml of water and mix and stir to obtain a suspension, which consists of 1.667g of methyl methacrylate: ethyl acrylate 1:2 polymer, 15ml of water and 15ml of ethanol before use In the coating solution, adjust the wind speed, temperature and coating solution flow rate, and the coating weight increases by about 25%, to prepare atenolol sustained-release pellets with a drug content of about 30.77%.

[0061] Take by weighing 10g of nifedipine and 20g of polyethylene glycol 4000 to prepare a solid dispersion, take by...

Embodiment 3

[0067] Take by weighing 5g atenolol, 10g microcrystalline cellulose and 3g tartaric acid, mix homogeneously, use the 2% aqueous solution of povidone K30 as binder system soft material, fluidized bed one-step preparation atenolol contains pill core, Sieve 30-40 mesh for later use.

[0068] Take above-mentioned 10g atenolol drug-containing pellet cores in the fluidized bed. Add 0.5g of talc powder and 0.002g of bright blue color lake into 15ml of water and mix and stir to obtain a suspension, add 1g of methyl methacrylate: butyl acrylate 1:2 polymer, 15ml of water and 15ml of ethanol before use In the coating liquid, adjust the wind speed, temperature and coating liquid flow rate to ensure a good fluidized state, and the weight of the coating is increased by about 15%, to prepare atenolol sustained-release pellets with a drug content of 24.15%.

[0069] Take by weighing 10g of nifedipine and 40g of polyethylene glycol 6000 to prepare a solid dispersion, take by weighing 10g of ...

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Abstract

The invention relates to the pharmaceutical preparation field, in particular to a compound controlled release pellet tablet of nifedipine and atenolol, and is characterized in that: controlled release pellet of nifedipine, controlled release pellet of atenolol and blank pellet are pelletized to obtain the compound controlled release pellet tablet of nifedipine and atenolol, wherein the controlled release pellet of nifedipine and the controlled release pellet of atenolol are respectively obtained from drug contained core coated with acrylic resin; the weight of coating of the controlled release pellet of nifedipine is added by 10 to 30 percent while the weight of coating of the controlled release pellet of atenolol by 8 to 25 percent; the blank pellet comprises microcrystaline cellulose and one of macrogol 6000, macrogol 4000 and stearic acid or the mixture of one or two of the macrogol 6000, the macrogol 4000 and the stearic acid, wherein the blank pellet takes up 50 to 70 percent of the total weight of the compound controlled release pellet tablet of nifedipine and atenolol.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a compound sustained-release pellet of nifedipine and atenolol and a preparation method thereof. Background technique [0002] Nifedipine (NF) is a calcium antagonist; Atenolol (AT) is a selective β1 receptor blocker. The combination of the two can enhance the efficacy and reduce the dosage , offset adverse reactions, and does not affect normal blood sugar and blood lipids. At present, the market and clinical practice are mostly single preparations of nifedipine or atenolol, which have problems such as inconvenient medication and uncoordinated drug release behavior. Compound preparations developed abroad are ordinary preparations or slow-release nifedipine mixed with quick-release atenolol and filled with capsules, such as Beta- Ethypharm's and Astra Zeneca's Chinese patent CN1915224 discloses a compound atenolol sustained-release tablet and a preparation method ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61K31/165A61P9/12A61P9/10
Inventor 朱家壁杨燕陈盛君
Owner CHINA PHARM UNIV
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