Preparation method of controlled-release drug

A technology for controlled release of drugs and active drugs, which is applied in the fields of pharmaceutical formulations, drug delivery, and active ingredients of heterocyclic compounds. It can solve the problems of difficult to achieve large-scale production promotion and application, and it is difficult to achieve osmotic pumps with ordinary equipment, so as to achieve easy scale Production and marketing, avoiding sudden release, safe and effective clinical application

Inactive Publication Date: 2017-12-08
山东则正医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent is a controlled-release preparation made by combining hot-melt extrusion technology and osmotic pump technology. Osmotic pump technology has strict requirements on the coating equipment of the preparation and the punching machine for drug release holes, and it is difficult for ordinary equipment to meet the requirements of osmotic pumps. The requirements of the osmotic pump preparations that meet the quality requirements have been prepared. Therefore, it is difficult to realize the popularization and application of osmotic pump controlled release in China at present.

Method used

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  • Preparation method of controlled-release drug
  • Preparation method of controlled-release drug
  • Preparation method of controlled-release drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The preparation of embodiment 1 theophylline controlled release tablet

[0039] (1) According to the components and consumption in Table 1, at first take theophylline bulk drug and ethyl cellulose, polyethylene glycol, hydroxypropyl methyl cellulose, hydrogenated oil, talcum powder, magnesium stearate;

[0040] (2) Add theophylline bulk drug, ethyl cellulose, hydroxypropyl methyl cellulose, hydrogenated oil, talcum powder, and magnesium stearate into a three-dimensional mixer and mix for 10 minutes, and take out the material;

[0041] (3) Take out the mixed materials and prepare for the hot-melt extrusion process. Set the temperature of the hot-melt extrusion equipment to 155~175°C and start hot-melting. Initially set the screw speed to 10rpm~30rpm. Accelerate according to the actual situation;

[0042] (4) Long strips are obtained after hot melt extrusion. During the extrusion process, the cutter on the hot melt extruder can be used, or a crushing and granulator can b...

Embodiment 2

[0049] Example 2 Preparation of Nifedipine Controlled-release Tablets

[0050] (1) According to the components and amounts in Table 2, first weigh nifedipine, ethylene-vinyl acetate copolymer, povidone, sodium carmellose, colloidal silicon dioxide and silicon dioxide.

[0051] (2) Nifedipine is mixed with colloidal silicon dioxide, and then mixed with ethylene-vinyl acetate copolymer, povidone, sodium carboxymethylcellulose, and silicon dioxide;

[0052] (3) Set the temperature range of the hot melt extruder to 170~180°C, set the initial screw speed to 10rpm, and then adjust it according to the extrusion state;

[0053] (4) The hot-melt extruded strip-shaped object is covered with a layer of ethyl cellulose powder on the surface of the extruded object after it has just exited the hot-melt extruder, and the hot-melt basic equipment is used to Cutter to crush the long sticks into short sticks with a length of 1 mm to 1.5 mm;

[0054] (5) Add lactose monohydrate and microcrysta...

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Abstract

The invention belongs to the field of pharmaceutical preparations, specially relates to a preparation method of a controlled-release drug, and particularly relates to theophylline and nifedipine controlled-release tablets prepared by using the method. The controlled-release drug is prepared by adopting combination of two techniques of hot melt extrusion and membrane controlling. Compared with the prior art, the method disclosed by the invention has the advantages that the drug is subjected to melting and solidification based on that the drug is preferably controlled to release at a zero level, the quality is uniform, and the phenomenon that burst release of other drugs in controlled-release dosage forms possibly occurs is avoided; for drugs with narrow therapeutic windows, clinical application is safer; organic solvents are not used, so that the security of mass production is good.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a controlled-release drug and a preparation method thereof, in particular to theophylline controlled-release tablets and nifedipine controlled-release tablets prepared by the method. Background technique [0002] Ordinary preparations generally need to be administered multiple times a day, so it often leads to missed doses, and some patients even change the dosage regimen without authorization, thus failing to achieve the expected therapeutic purpose. The drug loading of controlled-release preparations is higher than the single dose of traditional dosage forms, and can maintain effective blood drug concentration for a long time. Controlled release of drugs is an important trend in the future. It is especially suitable for patients with chronic diseases who take medicine for a long time, such as cardiovascular disease, angina pectoris, high blood pressure, asthma, etc. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/52A61K31/522A61K31/4422
CPCA61K9/0002A61K9/2081A61K9/5089A61K31/4422A61K31/522
Inventor 贺敦伟张志宏于风平王国骅李美晨
Owner 山东则正医药技术有限公司
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