Method for in vitro slow release performance evaluation of slow and controlled release preparation based on overflow principle

The overflow principle is used to simulate the drug absorption/metabolism process in the body, which solves the problem that the existing technology cannot accurately evaluate the release rate and effective drug release time of sustained and controlled release preparations, and achieves a more comprehensive evaluation of sustained release performance, which is suitable for macromolecular substances such as Protein release status.

CN105044013AInactive Publication Date: 2015-11-11CHONGQING UNIV OF TECH
4 Cites 15 Cited by

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
CHONGQING UNIV OF TECH
Filing Date
2015-08-07
Publication Date
2015-11-11
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

Existing technology cannot accurately simulate the in vivo environment, cannot effectively evaluate the drug release rate and effective drug release time of sustained and controlled release preparations, and has a greater impact on the release of macromolecular substances such as proteins.

Method used

An in vitro sustained-release performance evaluation method for sustained- and controlled-release preparations based on the overflow principle is adopted. A container with an upper outlet and a lower outlet is used as a release pool. The dissolution medium is added from the lower outlet through a peristaltic pump and the dissolved medium is taken away by the overflow from the upper outlet. Drugs, simulate the drug absorption/metabolism process in the body, measure the overflow drug concentration and flow rate, and calculate the sustained and controlled drug release rate and total release amount.

Benefits of technology

It achieves a more accurate evaluation of the drug release rate and effective drug release time of sustained- and controlled-release preparations, reflects the impact of body dissolution medium metabolism on drug release, provides a more comprehensive evaluation of sustained-release performance, is simple to operate, and has strong applicability.

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Abstract

The invention discloses a method for in vitro slow release performance evaluation of a slow and controlled release preparation based on the overflow principle. A container with an upper outlet and a lower outlet is adopted to serve as a release tank, a to-be-detected medicine and a dissolution medium are placed in the release tank, a stirring device is adopted in the release tank to perform stirring, and the dissolution medium is added from the lower outlet of the release tank through a peristaltic pump; the dissolution medium dissolved with the medicine is taken away through the overflow from the upper outlet so as to offset medicine absorption or metabolism, and the slow and controlled release speed of the medicine, the total medicine overflow quantity and the total release amount are calculated by measuring the concentration of the medicine contained in the dissolution medium flowing out, the volume of the release tank and the overflow quantity. According to the method, the releasing degree of the slow and controlled release medicine can be evaluated accurately, the effective medicine release time of the slow and controlled release preparation is evaluated, and slow release performances of the slow and controlled release preparation are evaluated comprehensively.
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Citation Information

Patent Citations

  • Double-layer sustained-release nifedipine tablet and preparation method thereof

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  • A solid-liquid-gas three-phase split-flow rumen simulated continuous fermentation system and method

    CN102286359A

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