As an aspect of the quality evaluation control of sustained-release preparations, the research on the mechanism of in vitro release has been paid more and more attention by researchers. From the nature, surface and internal morphological changes of sustained-release materials, the release process of sustained-release preparations was studied, and the sustained-release preparations were evaluated. In vitro release mechanism.
The strength and viscosity of the gel are closely related to the drug release mechanism. The texture analyzer method directly measures the gel layer of the matrix sheet taken out from the eluate by using a texture analyzer, and can accurately detect the phase transition interface of the glassy-rubbery state in the matrix sheet and the probe insertion and extraction skeleton. The resistance encountered in the sheet, thereby obtaining the strength and adhesion of the matrix sheet gel.
Studies have found that the release behavior of compound Danshen sustained-release tablets is related to the resistance and adhesion of gel sustained-release materials. When gel resistance and adhesion are large, the release of drugs is mainly based on dissolved release, gel. When the resistance and adhesion are small, the drug release is mainly based on dissolution and release. Therefore, the texture resistance and adhesion can be measured by a texture analyzer to study the formulation process of the sustained release preparation.
1 Sample preparation
Take a compound Danshen sustained-release tablets, according to the Chinese Pharmacopoeia 2005 edition two, Appendix XD release determination method. Place the sustained release tablet sample on the sample stage and set aside.
2 Instruments and test conditions
Instrument: Universal TA Texture Analyzer
Probe: P/4 cylindrical probe
Place the sustained-release sheet sample directly under the cylindrical probe, and then puncture the sustained-release sheet sample with a cylindrical probe. The test conditions are set :
Test mode: puncture
Speed ​​before test: 0.5mm/s
Test speed: 0.1mm/s
Speed ​​after test: 0.1mm/s
Trigger force: 5g
Target mode: distance 3mm
3 test results
The physical properties such as gel resistance and adhesion of the compound Danshen sustained-release tablets can be determined.
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