Nanoparticle containing hydrophobic drug and composition and application thereof
A technology for hydrophobic drugs and nanoparticles, which can be used in drug combinations, medical preparations containing active ingredients, and non-active ingredients of polymer compounds, which can solve problems such as poor water solubility of hydrophobic drugs.
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[0173] 23. The method for preparing a nanoparticle-containing composition according to embodiment 22, wherein the homogenization pressure is about 20000-30000 psi; further, the homogenization time is about 1-10 minutes.
[0174] 24. The method for preparing a nanoparticle-containing composition according to embodiment 22 or 23, wherein the mass ratio of immunoglobulin to hydrophobic drug is ≥5:1.
[0175] 25. The method of preparing a nanoparticle-containing composition according to any one of embodiments 22-24, wherein the concentration of the hydrophobic drug in the mixture of the oil phase and the water phase is about 1 mg / ml-50 mg / ml.
[0176] 26. The method for preparing a nanoparticle-containing composition according to any one of embodiments 22-25, wherein the aqueous phase comprises about 5-100 mg / ml anti-PD-L1 antibody, about 10-20 mM buffer, about 65 -90 mg / ml isotonicity adjusting agent and about 0.1-0.6 mg / ml surfactant, and pH is about 4.5-6.5.
[0177] 27. The m...
Embodiment 1
[0191] This example relates to anti-PD-L1 antibody and paclitaxel to form nanoparticles.
[0192] Mix chloroform and ethanol at a volume ratio of 9:1 to prepare a mixed solvent, weigh 639 mg of paclitaxel, and dissolve it in 3.6 ml of a mixed solvent of chloroform and ethanol to obtain an oil phase solution.
[0193] Prepare 43.92mg / ml anti-PD-L1 antibody aqueous phase solution: prepare anti-PD-L1 antibody stock solution with a mass volume concentration of 30mg / mL, and then concentrate by ultrafiltration to make the mass volume concentration of anti-PD-L1 antibody to 43.92mg / ml , to obtain an anti-PD-L1 antibody aqueous phase solution; wherein the anti-PD-L1 antibody stock solution is prepared as follows: the formula of the anti-PD-L1 antibody stock solution is: mass volume concentration 30mg / mL anti-PD-L1 antibody, Sucrose with a mass volume concentration of 80 mg / mL, polysorbate 80 with a mass volume concentration of 0.2 mg / ml, histidine with a molar concentration of 10 mM, ...
Embodiment 2
[0199] This example relates to the formation of nanoparticles of trastuzumab and paclitaxel.
[0200] Mix chloroform and ethanol at a volume ratio of 9:1 to prepare a mixed solvent, weigh 600 mg of paclitaxel, and dissolve it in 3.6 ml of a mixed solvent of chloroform and ethanol to obtain an oil phase solution.
[0201] Configure 116.4ml of trastuzumab aqueous phase solution: take trastuzumab freeze-dried powder, dissolve it in water, and prepare trastuzumab aqueous phase solution; wherein each single dose of trastuzumab in the vial is frozen The dry powder formula is: 150mg trastuzumab, 2.2mg L-histidine, 3.4mg L-histidine monohydrochloride, 0.6mg polysorbate 20, 136.2mg α, α-trehalose dihydrate, complex The pH value after dissolution is 6.0; the amino acid sequence of the light chain of trastuzumab is shown in SEQ ID NO.20, and the amino acid sequence of the heavy chain is shown in SEQ ID NO.19.
[0202]Put 116.4ml of trastuzumab aqueous phase solution in the rotor of a sh...
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