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Medicinal composition for preparing orally-taken sustained release preparation

A technology for sustained-release preparations and compositions, applied in the field of solid pharmaceutical compositions, can solve the problems of poor permeability, unsustainable release of ordinary preparations, and high solubility

Inactive Publication Date: 2017-08-22
JIANGSU YABANG AIPUSEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Amlodipine besylate, propranolol hydrochloride and salbutamol sulfate are all acid group-bound drugs, and their drugs dissolve in the gastric solution and mainly exist in the form of ions, and the inherent poor permeability in the lower part of the gastrointestinal tract leads to gastrointestinal These drugs dissolve quickly in water and have high solubility. These parameters make ordinary preparations unable to sustain release

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Example 1: Preparation of Waxy Matrix Sustained Release Tablets

[0013] Amlodipine besylate, propranolol hydrochloride or albuterol sulfate use carnauba wax as the skeleton material, polyethylene glycol 1500, polyethylene glycol 4000, polyethylene glycol 6000 as the skeleton pore-inducing agent (addition amount is generally 10~25%), the sustained-release tablets were prepared by melting method and solvent evaporation method. The pore-leading agent polyethylene glycol can increase the release rate of the sustained-release tablet, and the sustained-release prepared by the melting method releases faster than the one prepared by the solvent evaporation method. A zero-order drug release rate was observed during the first 7 hours of dissolution, depending on the amount of pore-leading agent added.

Embodiment 2

[0014] Example 2: Sustained-release tablets compressed with ethyl cellulose

[0015] Amlodipine besylate, propranolol hydrochloride or albuterol sulfate use ethyl cellulose as the skeleton material and hydroxypropyl methyl cellulose to make long-acting tablets, after oral administration, because ethyl cellulose is insoluble in the gastrointestinal tract The hydroxypropyl methylcellulose gradually dissolves, creating intricate pores in the tablet, and the drug slowly diffuses to the gastrointestinal fluid through the pores. By adjusting the dosage ratio of ethyl cellulose and hydroxypropyl methyl cellulose in the prescription, the in vitro dissolution rate test was carried out to screen out the best prescription.

Embodiment 3

[0016] Embodiment 3: co-manufacturing sustained-release tablets with acrylic methacrylate

[0017] After the polyethylene glycol 600 and ethyl cellulose are melted, pour them into the ceramic dish on the heating plate (the temperature is controlled at 75°C, 85°C and 90°C for 10 minutes respectively) and mix, add methacrylate resin , and stir for 10 minutes. Then, add amlodipine besylate, propranolol hydrochloride or albuterol sulfate under heat preservation and stir for another 10 minutes to make the medicines evenly distributed. The mixture was poured onto a glass plate while it was hot, cooled and kept at 0°C to allow it to condense. Each coagulated solid was transferred to a ceramic mortar and ground for 15 minutes, and the powder particles with a particle size of less than 420 μm were collected by sieving. It is compressed into two kinds of tablets with tablet hardness of 3.5 and 4.8kg / cm, and the uniformity difference of the whole batch of tablet weight and hardness is ...

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Abstract

The invention discloses a medicinal composition for preparing an orally-taken sustained-release preparation. Active ingredients of the medicinal composition comprises amlodipine besylate or propranolol hydrochloride or salbutamol sulfate. A sustained release polymer in the medicinal composition is a cellulose derivative, an acrylic acid or methylacrylic acid derivative, or a carbohydrate-based polymer and the like. The sustained release solid composition containing the amlodipine besylate, or the propranolol hydrochloride or the salbutamol sulfate can be prepared into preparation forms such as sustained-release watered pills, various skeleton sustained release preparations, coating sustained release preparations, sustained release capsules, sustained release medical membranes, resin drug sustained release preparations, liquid sustained release preparations.

Description

technical field [0001] The invention relates to a pharmaceutical composition for preparing oral sustained-release preparations, in particular to a solid pharmaceutical composition containing amlodipine besylate, propranolol hydrochloride or salbutamol sulfate as active ingredients. Background technique [0002] The sustained-release preparation can provide the human body with an appropriate blood drug concentration within a predetermined period as required, reduce the number of doses and obtain a good therapeutic effect. The important feature of sustained-release preparations is that the human body can maintain this blood concentration for a long time, instead of dropping rapidly like ordinary preparations, so that it can avoid the "bee valley" phenomenon that occurs when frequent administration of ordinary preparations, and make the drug The safety, efficacy and adaptability have been improved. Because the frequency of medication is reduced, it greatly facilitates patients...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4422A61K31/138A61K31/137A61K47/44A61K47/38A61K47/32A61K47/14
CPCA61K9/0002A61K9/2013A61K9/2027A61K9/2054A61K31/137A61K31/138A61K31/4422
Inventor 陈再新葛育红王勇军王淑娟朱峰
Owner JIANGSU YABANG AIPUSEN PHARMA
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