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Uricase lipid nanoparticle and preparation method thereof

A uricase lipid and nanoparticle technology, applied in the field of medicine, can solve the problems of short half-life, increased load, and high treatment cost

Inactive Publication Date: 2012-07-04
CHONGQING MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The current common prevention and treatment plan for hyperuricemia has the following defects: (1) allopurinol can block the production of uric acid, but it will increase the renal excretion of uric acid precursors (hypoxanthine and The load of xanthine, which is more insoluble than uric acid in urine), is worse for patients with high concentrations of blood xanthine associated with hyperuricemia; Ineffective; (3) Allopurinol and probenecid have obvious liver and kidney toxicity, and can easily cause allergic reactions
[0005] However, all natural UCs have inherent defects: (1) The pH value of the external environment has a great influence on the catalytic ability of UC
This leads to low activity of UC in vivo, large dose required for treatment, high treatment cost and low safety
(2) The half-life of circulation in the body is short
Although PEGylated UC has certain advantages over natural enzymes in prolonging the half-life of the enzyme, reducing immunogenicity and antigen reactivity, there are still some disadvantages: (1) it is still at pH 7.4 rather than the optimum pH value of UC (8.5~ 9.2) play a role, the UC activity is lower, and the activity after PEGylation is lower (retained specific activity is 10% to 40%)
(2) Even with the optimized Puricase, the bioavailability after intravenous injection is lower than that of natural enzymes (partially due to the large molecular weight of the enzyme-PEG polymer)
(4) PEGylated UC has high technical requirements, complicated process and high cost
[0009] After querying patents and literature, no one used alkaline (pH8-9) buffer pairs to construct a semi-permeable alkaline micro-reaction system mediating uricase

Method used

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  • Uricase lipid nanoparticle and preparation method thereof
  • Uricase lipid nanoparticle and preparation method thereof
  • Uricase lipid nanoparticle and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Formula: 0.8 parts of lecithin, 0.8 parts of cholesterol, 0.07 parts of DSPE-PEG2000, appropriate amount of uricase and bovine serum albumin (making the content in the prepared preparation 0.3U / ml, bovine serum albumin 0.05mg / ml), 50mM Tris buffer The liquid pH is 8. The preparation method is: dissolve the formula amount of lecithin and cholesterol in 10ml of ether, evaporate the chloroform under reduced pressure with a rotary evaporator, add 15ml of ether, add 50mmol / L boric acid-borax buffer solution containing UC and BSA, and ultrasonic in a water bath To form a uniform dispersion system with opalescence, continue to evaporate under reduced pressure until the gel collapses into a milky white opalescent uniform liquid, add an appropriate amount of boric acid buffer, continue to rotate under reduced pressure, and the resulting suspension is stored in the refrigerator for 4 After standing at ℃ for 24 hours, pass through a 0.22 μm microporous membrane to obtain the produ...

Embodiment 2

[0023] Formula: 1.5 parts of lecithin, 1 part of cholesterol, 0.05 part of DSPE-PEG5000, appropriate amount of uricase and bovine serum albumin (making the content in the prepared preparation 0.2U / ml, bovine serum albumin 0.08mg / ml), 10mM boric acid - Borax buffer (pH 8.5). The preparation method is: dissolve the formula amount of lecithin and cholesterol in 20ml of chloroform, evaporate the chloroform to dryness under reduced pressure with a rotary evaporator, add 30ml of ether, add 50mmol / L boric acid-borax buffer solution containing UC and BSA, and the rest of the operations are the same as in the examples 1.

Embodiment 3

[0025] Formula: 2 parts of lecithin, 2 parts of cholesterol, 0.05 part of DSPE-PEG2000, appropriate amount of uricase and bovine serum albumin (making the content in the prepared preparation 0.1U / ml, bovine serum albumin 0.1mg / ml), 100mMBicine buffer solution (pH 9). The preparation method is as follows: dissolve the formulated amount of lecithin and cholesterol in 30ml of ether, evaporate to dryness under reduced pressure with a rotary evaporator, add an appropriate amount of ether, add 100mmol / LBicine buffer solution containing UC and BSA, and the rest of the operations are the same as in Example 1.

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Abstract

The invention belongs to the technical field of medicinal preparation. The invention discloses a formula of an uricase lipid nanoparticle and a preparation method thereof. The content of the uricase is 0.1U / ml-1U / ml, and other materials are the medical auxiliary material or the additive of the lipid nanoparticle. The uricase lipid nanoparticle can be used for curing different diseases which are characterized in the increase of the level of the circulated uric acid, wherein the diseases comprise but are not limited to the hyperuricemia and the tumor disintegration syndrome.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to uricase lipid nanoparticles and a preparation method thereof. Background technique [0002] Purines generated during the decomposition of nucleic acids and nucleotides in cells are converted into uric acid under the action of xanthine oxidase. Uricase (Uricase, UC) can catalyze the oxidation of uric acid to produce hydrogen peroxide (H2O2) and allantoin (allantion), which are excreted from the body. However, due to the lack of UC in the human body, purine catabolism can only generate uric acid and excrete it through the kidneys. When uric acid production exceeds renal excretion, it will cause hyperuricemia (the concentration of uric acid in the blood is higher than 0.42mmol / L). Hyperuricemia can cause or exacerbate a variety of diseases: hyperuricemia caused by massive lysis of tumor cells during chemotherapy for malignant tumors can cause metabolic disorders, renal failure and even death...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K9/10A61K38/44A61K47/42A61P19/06
Inventor 张景勍王娜赵春景廖飞董志邱宗荫
Owner CHONGQING MEDICAL UNIVERSITY
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