Anthracycline encapsulated with polysaccharide for use in treatment of tumours
An anthracycline and polysaccharide technology, applied in the field of new drug forms of polysaccharide-coated anthracycline
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Embodiment 1
[0045]Production of Polysaccharide Coated Anthracycline
[0046](a) Preparation of dextran-coated epirubicin (NPs_EPI)
[0047]According to the method of preparing nanoparticles from polysaccharides as described in patent PL221251 (see Examples 2 and 4 for details), dextran and dodecylamine hydrochloride with a molecular weight of 70kDa (degree of oxidation of 5-15%) are used, Preparation of dextran coated epirubicin. The degree of substitution of the aldehyde group produced by the winding agent dodecylamine in the dextran is 10-20%. The degree of substitution of aldehyde groups produced by epirubicin in dextran is 4-10%. The other generated aldehyde groups were replaced by alanine. Using NanoSight LM 10 (405nm laser) in an aqueous solution, the average particle size of the prepared nanoparticles is between 80 and 140nm (figure 1 A). The determined epirubicin content in the dry matter of the nanoparticles is 3.0-5%. The obtained nanoparticles were freeze-dried and stored in a sealed conta...
Embodiment 2
[0056]Cytotoxicity determination of polysaccharide-encapsulated anthracycline on cell lines (drug-bound nanoparticles)
[0057]The subject of this study is to determine the cytotoxicity of anthracyclines encapsulated with polysaccharides EPI, DAU, DOX, and IDA on cell lines. A quantitative method based on colorimetric technology (MTT) was used to assess toxicity [see item 203]. In this test, the amber dehydrogenase present in the cell converts soluble tetrazolium salt (3-4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide into reduced form. The reaction produces water-insoluble purple crystalline formazan. The number of crystals formed depends on the activity of the enzyme, so it is directly proportional to the number of living cells in the sample. Spectrophotometric measurement requires the use of organic solvents to dissolve the obtained crystals (isopropanol). The change in color intensity was measured by spectrophotometry at a wavelength of 570nm. The dilutions (9) of various...
Embodiment 3
[0087]Determination of the anti-tumor effect of polysaccharide coated anthracycline
[0088]A) Determination of the maximum tolerated dose (MTD) of dextran-coated epirubicin (NPs-EPI)
[0089]Using the acute oral toxicity-up and down method according to OECD method No. 425, the MTD measurement method was used to perform acute treatment on the polysaccharide-coated anthracycline in the form of dextran-coated epirubicin (NPs-EPI) produced in Example 1. For toxicity evaluation, the route of administration of the test material was changed.
[0090]Intravenous administration (iv; injection into the tail vein) is determined by the administration of epirubicin in the currently used form, that is, epirubicin hydrochloride (EPI) to patients, if the anti-tumor efficacy of NPs-EPI is If confirmed, NPs-EPI will be administered.
[0091]The acute toxicity assessment method used is an alternative method recommended by the OECD (OECD Method No. 425), which takes into account the purpose of improving animal we...
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