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Finasteride nano-liposome, gel and preparation method thereof

A nano-liposome and finasteride technology, applied in the field of medicine, can solve the problems of destroying the patient's skin tissue, changing the skin structure, skin damage, etc., and achieve the effect of improving poor skin permeability, good reproducibility, and simple operation

Inactive Publication Date: 2017-02-01
CHANGSHA JINGYI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because finasteride is almost insoluble in water and has strong lipophilicity, it is easy to stay in the stratum corneum of the skin when it is made into external preparations, making it difficult for the drug concentration in the deep skin to reach the effective concentration. Commonly used chemical / physical penetration enhancement methods will change the skin structure Or cause irreversible damage to the skin, long-term use will destroy the patient's skin tissue
[0005] Therefore, it is necessary to develop a new dosage form to improve the poor skin permeability of finasteride

Method used

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  • Finasteride nano-liposome, gel and preparation method thereof
  • Finasteride nano-liposome, gel and preparation method thereof
  • Finasteride nano-liposome, gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0032] A finasteride nanoliposome, comprising the following raw materials (parts by weight) components, see Table 1:

[0033] Table 1 main drug and flexible lipid material prescription

[0034]

[0035] The preparation method is as follows:

[0036] (1) Soybean lecithin, cholesterol and finasteride are dissolved in absolute ethanol (the amount is based on the ability to dissolve the above-mentioned raw materials), and placed in an eggplant-shaped flask;

[0037] (2) Place the eggplant-shaped flask on a rotary evaporator, and remove absolute ethanol by rotary evaporation under reduced pressure in a constant temperature water bath at 37° C. to form a uniform lipid film on the wall of the bottle;

[0038] (3) Prepare a PBS solution of sodium deoxycholate, add the solution to the eggplant-shaped bottle that formed the film in step (2), in a water bath at 40°C, rotate at normal pressure, and hydrate for 60 minutes to prepare finasteride nano primary emulsion of liposomes;

[...

Embodiment 4

[0041] Physicochemical properties of the finasteride nanoliposomes prepared in the above examples 1-3.

[0042] The finasteride nanoliposome prepared by embodiment 1-3 is evaluated as follows:

[0043] (1) Average particle size and PDI:

[0044] Use a pipette gun to draw an appropriate amount of the flexible nanoliposome suspension of finasteride, add it to the quartz measuring cell, dilute it to 1mL with pure water, and measure the average particle size and polydispersity index of the sample with a laser scattering particle size analyzer (PDI).

[0045] (2) Determination of Encapsulation Efficiency:

[0046] The flexible nano-liposome and unencapsulated free drug were separated by ultrafiltration centrifugation, and the content was determined by high performance liquid chromatography. Precisely measure 500 μL of the flexible nanoliposome suspension of finasteride into a 50KD ultrafiltration tube, centrifuge at low speed for 15 minutes, take the entrapped flexible nanolipos...

Embodiment 5

[0053] In vitro transdermal permeability study of finasteride nanoliposome gel:

[0054] The finasteride nanoliposome of embodiment 1 is made into gel, and preparation method is as follows:

[0055] The preparation of gel base: take 10 parts by weight of carbomer as the base, 50 parts by weight of glycerol as a wetting agent, 1 part by weight of sodium benzoate as a preservative, 13.5 parts by weight of triethanolamine as a pH regulator, add 17.5 parts by weight of water, Stir to get the gel matrix;

[0056] To the above gel matrix, add Example 1 to prepare finasteride nanoliposomes, add an appropriate amount of water, and stir evenly to obtain finasteride nanoliposome gel (sample A).

[0057] Prepare finasteride flexible nano-liposome gel (sample A), finasteride common liposome gel (sample B, the flexible material of the present invention is not contained in this sample formulation) and finasteride common liposome gel respectively. Gel (sample C, the sample directly disperses...

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Abstract

The invention relates to a finasteride nano-liposome and a preparation method thereof. The finasteride nano-liposome comprises finasteride, phospholipids, a flexible material and a PBS solution, wherein the weight percentage of the finasteride accounting for the phospholipids is 2.5% to 10%, the weight percentage of the flexible material accounting for the phospholipids is 20% to 50%, and the weight percentage of the PBS solution accounting for the phospholipids is 2.5% to 10%. According to the finasteride nano-liposome, the disadvantage, such as poor percutaneous permeability, of the finasteride is improved, the phospholipids and the flexible material are taken as a carrier system, and the prepared finasteride nano-liposome is simple to operate and good in repeatability and prevents from using an organic solvent with large toxicity, drugs are delivered to skin deep layers by using high deformability and efficient permeability of the flexible nano-liposome, and a better therapeutic effect is exerted.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a finasteride nano liposome, a gel and a preparation method thereof. Background technique [0002] Androgenetic alopecia (AGA) is the most important type of pathological alopecia, and its pathological manifestations are progressive hair thinning, accompanied by hair follicle atrophy, and the distribution of alopecia mainly involves the top of the patient's head and the frontotemporal region. Epidemiological studies have shown that the total incidence of male androgenetic alopecia in my country exceeds 20%, and the prevalence increases steadily with age. The disease will cause psychological burden and stress for patients (especially young patients), and affect patients' society. Behavioral positivity. Androgenetic alopecia is related to the amount of androgen in the patient's body. The mechanism of hair loss is: testosterone is converted into dihydrotestosterone by 5α-reductase, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/58A61K47/24A61K47/28A61K47/26A61K47/22A61K9/06A61P17/14A61P5/28
CPCA61K9/127A61K9/06A61K31/58A61K47/22A61K47/24A61K47/26A61K47/28
Inventor 梁丰孙亚洲李果黄辉
Owner CHANGSHA JINGYI PHARM TECH CO LTD
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