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A kind of thymosin β-4 ethosome and its preparation process

A thymosin and ethosome technology, applied in the field of thymosin β-4 ethosome and its preparation process and application, to achieve the effects of prolonging the action time, reducing inactivation, and firming the membrane structure

Active Publication Date: 2021-03-02
山东源科生物科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The second object of the present invention is to provide the preparation method of the above-mentioned thymosin β-4 ethosome, the preparation method in the present invention solves the stability problem of the ethosome by adding anionic surfactant, the preparation cost is low, and the process is simple, good stability

Method used

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  • A kind of thymosin β-4 ethosome and its preparation process
  • A kind of thymosin β-4 ethosome and its preparation process
  • A kind of thymosin β-4 ethosome and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048]Example 1 Selection of Preparation Method

[0049]1.1 Alcohol phase injection

[0050]Add 1.5mg soy lecithin and 0.25mg cholesterol into 1mL absolute ethanol solution and place in the center. Dissolve 0.50mg thymosin β-4 in 1.75mL distilled water and place it in a pear-shaped bottle. Inject the alcohol phase mixed solution into the pear at 400uL / min. In the flask solution, hydrate for 15 minutes at 700r / min at 30°C. After cooling to room temperature, pass through a microporous membrane with a pore size of 450nm. After a certain treatment, the EE is 10±4%, and the alcohol solution appears turbid. The background of the TEM photo is messy, the size of the formed body is different, and most of them are cracked or sticky. The result is as attached.figure 1 Shown. 1.2 Water phase injection

[0051]Add 1.5mg of soybean lecithin and 0.25mg of cholesterol to 1mL of absolute ethanol solution and place in a pear-shaped bottle, dissolve 0.50mg of thymosin β-4 in 1.75mL of distilled water, and pour...

Embodiment 2

[0052]Example 2 Single factor test of ethanosome preparation

[0053]2.1 The amount of cholesterol

[0054]Add 1.5 mg of soybean phospholipids and different amounts of cholesterol to 1 mL of absolute ethanol solution and place them in a pear-shaped bottle, dissolve 0.50 mg of thymosin β-4 in 1.75 mL of distilled water, and pour the water-phase mixed solution at 400 uL / min into the pear-shaped bottle. In the bottle solution, hydrate for 15 minutes at 700r / min at 30°C. After cooling to room temperature, pass through a microporous membrane with a pore size of 450nm. After certain treatment, the EE is measured. The experimental results are shown in the following table:

[0055]The effect of cholesterol dosage on EE (n=3)

[0056]

[0057]The amount of cholesterol has a great influence on the EE of the alcohol body, especially when the cholesterol is not added, the alcohol body solution prepared can not show the light blue opalescence well, such asimage 3 As shown, the TEM picture shows that only a ver...

Embodiment 3

[0093]Example 3 Orthogonal design method to optimize the prescription

[0094]The results of the single-factor experiment in Example 2 show that the factors that have a greater impact on the alcohol body are: the amount of cholesterol (A), the amount of β-4 (B), the ethanol concentration (C), and the dripping rate (D). Orthogonal design L9(3^4) table is used as the parameter to evaluate each prescription. The following table is the result of factor level table and orthogonal design.

[0095]Orthogonal experiment factors and level table

[0096]

[0097]

[0098]Orthogonal experiment results

[0099]

[0100]Combining orthogonal experiment and single factor experiment to determine the final prescription and process: add 1.5mg soy phospholipid and 0.25mg cholesterol into 1mL absolute ethanol solution and place 0.75mg thymosin β-4 dissolved in 1.75mL distilled water in pear Pour the alcohol phase mixed solution into the pear-shaped bottle solution at a rate of 200 uL / min in the flask, hydrate at 700 r / min ...

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Abstract

The invention discloses a thymosin β-4 ethosome and a preparation method thereof. The specific composition of the thymosin β-4 ethosome comprises: thymosin β-4 0.022%-0.043%, phospholipid 0.054%-0.084% , cholesterol 0.018% ~ 0.028%, anionic surfactant 0.02% ~ 0.04%, ethanol 10.10% ~ 30.30%, the rest is distilled water; it has the effect of increasing the transdermal absorption of drugs and enhancing the repair of scarred skin by thymosin β‑4 technical effect. And the preparation method of thymosin β-4 ethosome in the present invention, utilizes the mode that adds anionic surfactant and cholesterol to solve the stability problem of thymosin β-4 ethosome, adopts the thymosin that this preparation method obtains The β‑4 ethosome has high encapsulation efficiency, good stability, simple process and good economic benefits. Correspondingly, the present invention also protects the application of the thymosin β-4 ethosome in the field of scar repair.

Description

Technical field[0001]The invention relates to the field of pharmaceutical preparations, in particular to a thymosin β-4 ethoxylate and its preparation process and application.Background technique[0002]Skin injury caused by various traumas, burns, surgery, radiation and other reasons is a common clinical disease with a high incidence. According to statistics, the global cost of trauma treatment reached 11.5 billion U.S. dollars in 2016. With current treatment methods, the formation rate of wounds after healing is as high as 62% (Caucasian) and 80% (non-white). These scars often bring long-term physical obstacles and psychological burdens to patients. It is of great research significance to develop pharmaceutical preparations that can accelerate wound healing, promote the regeneration of local wound hair follicles, sweat glands and other accessory organs, and help wound tissues to be double-repaired in terms of structure and function. At present, the local supplementation of exogenous...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/22A61K9/127A61K47/28A61P17/02
CPCA61K9/1277A61K38/2292A61K47/28A61P17/02
Inventor 林贵梅傅相蕾王慧
Owner 山东源科生物科技股份有限公司
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