Thymosin beta-4 ethosome, and preparation method thereof

A technology for thymosin and alcohol plastids, which is applied to thymosin beta-4 alcohol plastids and their preparation technology and application fields, to achieve the effects of prolonging action time, reducing inactivation and strengthening membrane structure

Active Publication Date: 2018-11-02
山东源科生物科技股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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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

Method used

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  • Thymosin beta-4 ethosome, and preparation method thereof
  • Thymosin beta-4 ethosome, and preparation method thereof
  • Thymosin beta-4 ethosome, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The selection of embodiment 1 preparation method

[0049] 1.1 Alcohol phase injection

[0050] Add 1.5mg soy lecithin and 0.25mg cholesterol into 1mL absolute ethanol solution, dissolve 0.50mg thymosin β-4 in 1.75mL distilled water and put it in a pear-shaped bottle, inject the mixed solution of alcohol phase into the pear at 400uL / min In the shaped bottle solution, hydration at 700r / min at 30°C for 15min, after cooling to room temperature, passing through a microporous membrane with a pore size of 450nm, after a certain treatment, the measured EE was 10±4%, and the appearance of the ethanol solution was turbid. The background of the TEM photo is messy, the size of the formed ethanol bodies is different, most of them are ruptured or adhered, and the results are as attached figure 1 shown. 1.2 Water phase injection

[0051] Add 1.5mg soy lecithin and 0.25mg cholesterol to 1mL absolute ethanol solution and put it in a pear-shaped bottle, dissolve 0.50mg thymosin β-4 in...

Embodiment 2

[0052] Embodiment 2 ethosome preparation single factor test

[0053] 2.1 The dosage of cholesterol

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

[0055] Effect of Cholesterol Dosage on EE (n=3)

[0056]

[0057] The amount of cholesterol has a great impact on the EE of ethosomes, especially when no cholesterol is added, the prepared ethosome solution cannot show light blue opalescence, such as image 3 As shown, the TEM pictures show that only a very small amount of ethosomes are formed and the sh...

Embodiment 3

[0093] Embodiment 3 Orthogonal Design Method Optimizing Prescription

[0094]The single factor experiment result shows in embodiment 2, the factor that has bigger influence to ethosome has: the consumption (A) of cholesterol, beta-4 consumption (B), ethanol concentration (C), drop rate (D), by Orthogonal design L9(3^4) table is used as the parameter of investigation to evaluate each prescription, the following table is the investigation result of factor level table and orthogonal design respectively.

[0095] Orthogonal experimental factors and level table

[0096]

[0097]

[0098] Orthogonal Experimental Results

[0099]

[0100] Combined with orthogonal test and single factor experiment to determine the final prescription and process: add 1.5mg soybean lecithin and 0.25mg cholesterol to 1mL absolute ethanol solution, put 0.75mg thymosin β-4 in 1.75mL distilled water and place in pear In the pear-shaped bottle, inject the alcohol-phase mixed solution into the pear...

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Abstract

The invention discloses a thymosin beta-4 ethosome, and a preparation method thereof. The thymosin beta-4 ethosome comprises 0.022 to 0.043% of thymosin beta-4, 0.054 to 0.084% of phosphatide, 0.018 to 0.028% of cholesterol, 0.02 to 0.04% of an anionic surfactant, 10.10 to 30.30% of ethanol, and the balance distilled water. The thymosin beta-4 ethosome is capable of improving medicine transdermalabsorption effect, and improving the restoration technical effect of thymosin beta-4 on scar skin. According to the preparation method, the anionic surfactant and cholesterol are added to solve a stability problem of thymosin beta-4 ethosome. The thymosin beta-4 ethosome prepared through the preparation method is high in encapsulation efficiency, and stability; the technology is simple; excellenteconomical benefit is achieved, and the invention also discloses applications of the thymosin beta-4 ethosome in the technical field of scar restoration.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a thymosin β-4 ethosome and its preparation process and application. Background technique [0002] Skin damage caused by various traumas, burns, operations, radiation and other reasons is a common clinical disease with a high incidence. According to statistics, the cost of global trauma treatment reached 11.5 billion US dollars in 2016. With the current treatment methods, the formation rate of wounds after healing is as high as 62% (Caucasians) and 80% (non-Caucasians), and 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 hair follicles, sweat glands and other accessory organs in wounds, and help wound tissues to be repaired in terms of structure and function. At present, local suppl...

Claims

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Application Information

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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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