Preparation method of compound for enhancing immune response

A compound and graft technology, applied in the field of compound preparation, can solve the problems of insufficient safety and efficacy data, large side effects, poor effect, etc., and achieve the effects of convenient pharmacy, easy absorption, and enhanced immune response.

Active Publication Date: 2018-11-06
XINFU BEIJING MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In August 2012, Hemispherx biopharmaceutical company submitted further original clinical research data, but it was rejected by the US Food and Drug Administration (FDA) due to insufficient safety and efficacy data
[0007] It can be seen that simple PIC cannot be used in animals above primates including humans, and the side effects of PICLC are largely denied by the US FDA. PIC 12 U was rejected by the US FDA because of its poor effect, and PICLC actually has strong side effects

Method used

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  • Preparation method of compound for enhancing immune response
  • Preparation method of compound for enhancing immune response
  • Preparation method of compound for enhancing immune response

Examples

Experimental program
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preparation example Construction

[0162] According to one aspect of the present invention, the present invention also relates to a method for preparing a compound for enhancing immune response, comprising:

[0163] contacting polyinosinocytes, at least one cationic stabilizer, and a soluble calcium salt in a liquid reaction system;

[0164] The cationic stabilizer is a water-soluble non-antibiotic amino compound with a molecular weight of ≤5kDa, or the water-soluble non-antibiotic amino compound mixed with polyethylene glycol monomethyl ether, polyethylene glycol, polyethyleneimine, folic acid, galactose One or more of the formed grafts.

[0165] In some embodiments, the polyinosinic acid is prepared by base pairing reaction of polycytidylic acid and polyinosinic acid.

[0166] In some embodiments, the molecular weight of the polycytidylic acid and polyinosinic acid is greater than 23,000 Daltons.

[0167] In some embodiments, the polycytidylic acid has a molecular weight ranging from 66,000 Daltons to 660,0...

Embodiment 1

[0194] The preparation of embodiment 1 pamica

[0195] 1. Preparation of Pamika Complex

[0196] 1. Prepare PBS solution (pH7.2):

[0197] 1.1 Prepare sodium chloride solution (0.85%, 1500ml): weigh 12.75g of sodium chloride, put it into a 2000ml measuring cylinder, and dilute to 1500ml with water;

[0198] 1.2 Prepare disodium hydrogen phosphate solution (0.006mol / L, 500ml): weigh disodium hydrogen phosphate 0.006×0.5×141.96=0.4259g, put it into a 500ml volumetric flask, and dilute to 500ml with 0.85% normal saline;

[0199] 1.3 Prepare sodium dihydrogen phosphate solution (0.006mol / L, 500ml): weigh sodium dihydrogen phosphate 0.006×0.5×137.99=0.4140g, put it into a 500ml volumetric flask, and dilute to 500ml with 0.85% normal saline;

[0200] 1.4 Prepare a PBS solution with a pH value of 7.2: take 273.6ml of "1.2 solution" + 126.4ml of "1.3 solution".

[0201] 2. Prepare PIC solution (2.0mg / ml, 100ml):

[0202] 2.1 Weigh PI 2.0mg / ml*100ml*【1.04 / (1.04+1)】 / 91.5% / (1-2.7%)=1...

Embodiment 2

[0282]Embodiment 2 Pamika combined with PEI increases the solubility test

[0283] Refer to the preparation method of "Pamica combined with PEG" (i.e. Example 1) for preparation. Precipitation occurs after increasing the amount of COS in Pamica, which affects the uniformity of its administration. After adding PEI, precipitation can be avoided and COS can be increased. The dosage can further enhance its immune effect.

[0284]

[0285] The test clearly showed that after pamicha combined with PEI, the solubility of COS in PIC increased from 1.6mg / ml to 6.4mg / ml, at least 4 times.

[0286] CN105396130A patent application literature discloses a "calcium dermamine adjuvant and a vaccine containing calcium dermamine adjuvant", and discloses that the non-antibiotic amino compound can be selected as chitosan.

[0287] In this comparative example, water-soluble chitosan (chitosan hydrochloride, referred to as CS) was used to replace the chitosan oligosaccharide in Example 1, so as ...

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Abstract

The invention relates to a novel compound and studies preparation and application of the compound. A preparation method of the compound comprises: enabling poly IC, at least one cationic stabilizing agent and soluble calcium salt to be in contact in a liquid reaction system, wherein the cationic stabilizing agent is a water soluble non-antibiotic amino compound, the molecular weight of the water soluble non-antibiotic amino compound is less than or equal to 5kDa, or the cationic stabilizing agent is a graft formed by the water soluble non-antibiotic amino compound and one or more of methoxy polyethylene glycol, polyethylene glycol, polyethyleneimine, folic acid and galactose. The viscosity and the molecular mass of the compound are moderate, the compound is used to make a drug conveniently, the chemical property of the compound is stable, and the compound is not easy to degrade after long-term storage, is safe to use, obviously strengthens the nonspecific immunoreaction of the body when used separately, fulfills the purposes of preventing and treating diseases, has better anti-tumor anti-virus antibacterial (superbacteria) effects when being used with other drugs, and is easy to beabsorbed by a patient.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a method for preparing a complex for enhancing immune response. Background technique [0002] Double-stranded RNA (dsRNA) adjuvants are generally considered to include PIC (polyriboinosinic-polyribocytoidylic acid), PICLC (PIC with poly-L-lysine andcarboxymethylcellulose), PIC 12 U(PIC with uridylic acid in specific interval, trade name Ampligen) and PICKCa((PIC-kanamycin-CaCl 2 ), which are ligands of various membrane recognition receptors (PRRs), enhance the immune response on the one hand, and make it possible to make preventive vaccines into therapeutic vaccines by changing the type of immunity on the other hand. [0003] PIC (polyinocyte) was developed by Merck in the 1960s. In mice, PIC is an inducer of IFN-α and has antiviral activity. PIC protects mice from lethal nasal and lung infections. However, due to the degradation of PIC by primate and human serum nucleases, the sta...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K47/26A61K47/02A61K31/713A61K45/06A61P37/04A61P35/00A61P31/12A61P31/04
CPCA61K31/713A61K39/39A61K45/06A61K47/02A61K47/26A61K2039/55561A61P31/04A61P31/12A61P35/00A61P37/04
Inventor 林海洋刘芳查力
Owner XINFU BEIJING MEDICAL TECH CO LTD
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