A kind of vancomycin nano liposome composition and preparation method thereof
A technology of nano-liposomes and vancomycin, which can be used in liposome delivery, drug delivery, and pharmaceutical formulations, and can solve problems such as phlebitis that cannot be prevented
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Embodiment 1
[0053] Embodiment 1 prepares vancomycin nano liposome
[0054] Accurately weigh 200 mg of egg yolk lecithin (Lipoid) and 100 mg of cholesterol (Sigma), dissolve them in 3 ml of absolute ethanol to form a clear solution; recover the ethanol under reduced pressure, and form a film on the container wall.
[0055] Inject 27ml of vancomycin hydrochloride solution (2mg / ml) prepared in 10mM, pH6.5 histidine buffer, containing 5% (w / w) glucose and a short peptide stabilizer (such as IKP), in which the short peptide stabilizes The molar ratio of drug to vancomycin was 1:1.
[0056] After the membrane material is dissolved, hydrate for 1h to 2h; under the condition of heating in a water bath at 37°C, continuously extrude the liposomes obtained by the above method through a high-pressure extruder with a pore size of 400nm-50nm to obtain nano-lipids with a particle size of ≤100nm body; carry out aseptic filtration under 100 grade laminar flow with 0.2 micron sterile filter, obtain vancom...
Embodiment 2
[0057] Embodiment 2 prepares vancomycin nano liposome
[0058] Accurately weigh 200 mg of soybean lecithin (Lipoid) and 100 mg of cholesterol (Sigma), dissolve them in 3 ml of isopropanol to form a clear solution; then slowly inject 27 ml of hydrochloric acid prepared in 37 °C water bath with 10 mM, pH 6.5 phosphate buffer Vancomycin solution (2.2mg / ml), containing 9% (w / w) sucrose and short peptide stabilizer in the solution, wherein the molar ratio of short peptide stabilizer and vancomycin is 1:1, to obtain liposome primary emulsion , hydrated for 1h-2h; under the condition of heating in a water bath at 37°C, use a high-pressure homogenizer to process the liposomes obtained by the above method to obtain nano-liposomes with a particle size of ≤100nm; Sterile filtration is carried out under laminar flow to obtain a vancomycin nano-liposome solution; the vancomycin nano-liposome solution is directly packaged into products for cryopreservation.
Embodiment 3
[0059] Embodiment 3 stability investigation
[0060] In the vancomycin hydrochloride solution (2mg / ml) that histidine buffer solution (containing 5% glucose) prepares, add different short peptide stabilizers to test, the mol ratio of short peptide stabilizer and vancomycin in the composition is 1:1.
[0061] Use HPLC to detect the stability of vancomycin in the composition, and the HPLC detection conditions are as follows:
[0062] Chromatographic column: SinoChrom ODS-BP column (250mm×4.6nm, 5μm)
[0063] Mobile phase: acetonitrile-0.0125mol / L potassium dihydrogen phosphate solution (10:90);
[0064] Flow rate: 1.0ml / L;
[0065] Detection wavelength: 280nm;
[0066] Injection volume: 20μL;
[0067] Column temperature: 35°C
[0068] According to the initial vancomycin content in each sample and the content at the time of sampling, the vancomycin degradation rate in the sample was calculated. Vancomycin degradation rate%=(1-vancomycin content at the time of sampling / init...
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