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Vagina gel preparation and preparation method thereof

A vaginal gel and preparation technology, applied in the field of vaginal gel preparation and its preparation, can solve the problems affecting the therapeutic effect of gene transfection and complex components, etc., and achieve the effect of flexible reagent formula, simple preparation process and good therapeutic effect

Active Publication Date: 2020-08-25
ZHUHAI SHU TONG MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the structural stability of gene delivery nanoparticles in these formulations is a great challenge
The composition of vaginal and cervical mucus is complex. If nanoparticles cannot maintain their structural stability in the formulation (such as decomposing into cationic polymers and genes), they are easily affected by proteins / enzymes, bacterial secretions, inorganic salts, etc. in the mucus after release It can no longer self-assemble into a gene-cationic polymer nanoparticle structure with high transfection efficiency, which will affect gene transfection and subsequent therapeutic effects

Method used

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  • Vagina gel preparation and preparation method thereof
  • Vagina gel preparation and preparation method thereof
  • Vagina gel preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Embodiment 1, the preparation of gel

[0076] 1. Synthesis of PBAE polymer

[0077] BDD, AP, and AMP were prepared into PBAE polymers as follows: first, BDD (stabilized with p-hydroxyanisole ether MEHQ) and AP were mixed in a molar ratio of 1:1, and placed on a magnetic stirring plate at 90 ° C under N 2 Stir under atmosphere for 36 hours, after the above reaction, dilute with dimethylformamide (DMF), wash with cold diethyl ether after precipitation. After removal of ether by vacuum drying, the intermediate product (i-PBAE) was dried at room temperature. Secondly, i-PBAE was dissolved in anhydrous DMF, reacted with 5 times molar amount of AMP at room temperature for 24 hours under stirring, and then the reaction product was precipitated in cold anhydrous diethyl ether. Finally, the final polymer (PBAE) was washed three times with diethyl ether, dried under vacuum for 48 hours, and stored at room temperature for future use.

[0078] The synthetic equation of PBAE poly...

Embodiment 2

[0100] Embodiment 2, mouse living experiment

[0101] We evaluated the vaginal retention ability of NPs-mMMT gel in Kunming mouse model by in vivo imaging technique. The fluorescent dye Ce-6 is mixed in by accounting for 1% mass ratio of the total mass of the composite nanoparticles when preparing the composite nanoparticles to obtain Ce-6-labeled NPs, and then prepare the Ce-6-labeled PBAE-plasmid composite according to the scheme of Example 1 Nanoparticle gel (NPs-mMMTgel). Then the free fluorescent dye Ce-6 and the PBAE-plasmid composite nanoparticle gel marked by Ce-6 were put into the mouse vagina respectively, and the test results were as follows: Figure 4 As shown, the signal of the free fluorescent dye (Ce-6) disappeared within a day. For mMMT gels, strong fluorescence can be found at day 3. These results indicate that mMMT gel has good vaginal retention ability, which can improve the action time of gene medicine in vagina.

Embodiment 3

[0102] Embodiment 3, pig experiment

[0103] (1) Comparison of transfection effects of different cationic polymers

[0104] In order to evaluate the transfection efficiency of our vaginal gel preparation, in the preparation process of the PBAE-plasmid composite nanoparticle, PEI-plasmid composite nanoparticle, PAMAM-plasmid composite nanoparticle of embodiment 1, according to the method for embodiment 2 in preparation When compounding nanoparticles, the plasmid (reporter gene) is a green fluorescent protein particle (Gep).

[0105] We chose large mammalian pigs as the experimental subjects because the pig genome is very close to that of humans, and the pigs were one-month-old ordinary domestic pigs.

[0106] During administration, each pig was given one of GFP-labeled PBAE-plasmid composite nanoparticles, PEI-plasmid composite nanoparticles, and PAMAM-plasmid composite nanoparticles, and the dosage was 2 mL, and the vaginal gel was uniformly It spreads over the vaginal surfa...

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Abstract

The invention relates a vagina gel preparation and a preparation method thereof. The vagina gel preparation comprises a carrier and a gene used for treatment. The vagina gel preparation also compriseshydrophilic high polymer material modified montmorillonite, and the carrier comprises a cationic polymer. The vagina gel preparation can favorably stabilize the structure of a nanoparticle, and has high transfection efficiency, a good treatment effect and high safety, and can be locally applied through the vagina. The vagina gel preparation has a simple preparation process and a flexible reagentformula.

Description

technical field [0001] The invention belongs to the field of gene therapy, and in particular relates to a vaginal gel preparation and a preparation method thereof. Background technique [0002] Genome editing has shown promising success in treating genetic diseases. However, one of the keys to the success of gene therapy is the genetically engineered delivery tool. Polymeric nanoparticles (NPs) have achieved efficient delivery of gene therapy due to nanosize, low toxicity, long cycle time, and good plasticity. [0003] Gene therapy can be delivered systemically or locally based on specific therapeutic goals and pharmacokinetics. The vagina has several features that facilitate the delivery of therapeutic molecules, including DNA, RNA and proteins. The vaginal route has an adequate blood supply, high contact area, and appropriate permeability to several substances, allowing systemic and localized drug delivery. It also avoids the hepatic first-pass effect and gastrointesti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K47/02A61K47/36A61K47/34A61K48/00A61P15/00A61P15/02A61P31/22A61P35/00
CPCA61K9/06A61K9/0034A61K47/02A61K47/36A61K47/34A61K48/005A61P15/00A61P15/02A61P31/22A61P35/00A61K47/38A61K47/12C12N15/87A61K48/0041A61K48/0075B82Y5/00
Inventor 不公告发明人
Owner ZHUHAI SHU TONG MEDICAL TECH CO LTD
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