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Indocyanine green liposome as well as large-scale preparation method and application thereof

A technology for large-scale preparation of indocyanine green lipids, which can be applied in the directions of preparations and pharmaceutical formulations for in vivo tests, and can solve the problems of stability, encapsulation rate, and large-scale production of suspicious pharmaceutical potentials, and no indocyanine green lipids can be obtained. Plasmid preparations, inability to carry out industrial production, etc., to achieve the effects of improving safety and effectiveness, avoiding self-quenching, and low production costs

Pending Publication Date: 2022-04-12
SHENZHEN INST OF ADVANCED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The publication number in the prior art is that CN110960694B and CN103690486A disclose the synthetic method of indocyanine green liposome in two patents, but can't carry out industrialized production because the operation is loaded down with trivial details
Although the above studies clearly confirm the possibility of using liposomes to encapsulate IG, no liposomal formulations of IG are commercially available.
For example, many of these formulations have questionable pharmaceutical potential due to issues related to stability, entrapment, potential for scale-up, and cost of lipids used

Method used

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  • Indocyanine green liposome as well as large-scale preparation method and application thereof
  • Indocyanine green liposome as well as large-scale preparation method and application thereof
  • Indocyanine green liposome as well as large-scale preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] 1. Weighing appropriate amounts of DOPC and DSPE-PEG2000 (DOPC: DSPE-PEG2000 = 95: 5 mol / mol) were dissolved in trichloromethane, and the dispersion was evenly obtained to give a lipid solution.

[0034] 2. Weighing a quantitative ICG in 20-100 μLDMSO, then 2 mL of methanol, uniformly disperse the ICG solution.

[0035] 3. Mix the lipid solution from the ICG solution and ultrasound 1-2 min.

[0036] 4. Remove the organic solvent by rotating evaporation, forming a film.

[0037] 5. Dry vacuum for 2-4 hours.

[0038] 6. Add the appropriate amount of PBS buffer and oscillate completely dissolve the lipid indole crystal green film.

[0039] 7. The lipid indole chlorine was heated in hot water at 65 ° C and then cooled in liquid nitrogen, and the process was repeated 5 times.

[0040] 8. Turn on the high pressure homogeneous machine air pump, set to the appropriate pressure, open the homogeneous valve fill pressure; mount the sample-containing syringe, collect the samples; the...

Embodiment 2

[0045] The large-scale preparation method of hydrazine alkaline, including the following steps:

[0046] 1. Weigh the DOPC and DSPE-PEG2000, dissolved in trichloromethane, and the ratio of the substance of the lipid solution, the amount of the DOPC and DSPE-PEG2000 is 45: 1;

[0047] 2. Weigh ICG in DMSO, the mass ratio of ICG and DMSO is 0.01 mg / ml, add 0.5 ml of methanol, and uniformly disperse to obtain ICG solution;

[0048] 3. The lipid solution obtained in the above step 1 is mixed with the ICG solution obtained above, and the ultrasound treatment is carried out after 2 min, and the organic solvent is rotated and evaporated.

[0049] 4. The film obtained by the above-mentioned step 3 was vacuum dry for 4 h, and then 3 ml of PBS buffer was added, oscillated to obtain a lipid indole chlorine.

[0050] 5. The lipid indole chlorine liquid obtained by the above step 4 was placed in hot water at 30 ° C for 30 min, and was rapidly cooled in liquid nitrogen; 6. Repeat the above st...

Embodiment 3

[0054]The large-scale preparation method of hydrazine alkaline, including the following steps:

[0055] 1. We will weigh the DOPC and DSPE-PEG2000, dissolved in dichloromethane, and the ratio of the substance of the lipid solution, the amount of the DOPC and DSPE-PEG2000 is obtained is 5: 1;

[0056] 2. Weigh ICG in DMSO, the mass ratio of ICG and DMSO is 10 mg / ml, and 20 ml of methanol is added, and the ICG solution is evenly dispersed.

[0057] 3. The lipid solution obtained in the above step 1 is mixed with the ICG solution obtained above, and the ultrasound treatment is carried out after 2 min, and the organic solvent is rotated and evaporated.

[0058] 4. The film obtained by the above step 3 was vacuum drying for 2 h, and then 100 ml of PBS buffer was added, and the green solution of lipid hydrazine was obtained.

[0059] 5. The lipid indole chlorine-based green solution obtained in the above step 4 was placed in hot water at 90 ° C for 10 min, and was rapidly cooled in li...

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Abstract

The invention discloses indocyanine green lipidosome and a large-scale preparation method and application thereof, and belongs to the technical field of compound materials. The invention provides an indocyanine green liposome, which is obtained by synthesizing indocyanine green and embedding the indocyanine green into a lipid bilayer by using hydrophobic interaction of the indocyanine green and lipid micromolecules through a method of combining film hydration, freeze thawing and a high-pressure homogenizer. The invention also provides a large-scale preparation method and application of the indocyanine green liposome. The method disclosed by the invention is high in efficiency, good in liposome particle size uniformity and consistent in basic conditions for generating the liposome, so that the clinical safety and effectiveness of the liposome are improved. The production process disclosed by the invention is less in equipment investment, simple and convenient to operate, low in production cost and very suitable for industrial mass production. According to the invention, further clinical application of indocyanine green can be promoted, so that the clinical injection dose can be greatly reduced.

Description

Technical field [0001] The present invention belongs to the technical field of compound material, and more particularly to indole chlorine green liposomes and its large-scale preparation methods and applications. Background technique [0002] Indomethacine green (ICG) is currently numerously approved by the US Food Drug Administration (FDA) for clinical near-infrared fluorescence. It can not only check the liver function and liver effective blood flow, but also in real-time diagnosis of intraoperative disease. [0003] However, since ICG is very unstable in the aqueous solution, it is easy to remove rapidly in the blood circulation, and ICG is easily quenched in an aqueous solution to cause fluorescence quenching, thereby affecting its optical properties. And the indole cream is approved for clinical, but its side effects are also obvious, which may cause nausea, fever, shock, etc., so it is necessary to reduce the amount of indoleptic green. At this stage, the application of ind...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K49/00
Inventor 盛宗海郑海荣胡德红高笃阳
Owner SHENZHEN INST OF ADVANCED TECH
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