A method for preparing a highly effective transdermal regeneration polysaccharide milk fat globule skin care emulsion

Abstract

The present invention relates to a method for preparing a polysaccharide milk fat globule skin care product emulsion with high efficiency in transdermal regeneration. The method for preparing the polysaccharide milk fat globule skin care product emulsion with high efficiency in transdermal regeneration comprises the following steps: (1) peeling and pulping aloe leaves to obtain gel; (2) subjecting the gel to low temperature stirring treatment and high temperature film evaporation treatment in sequence to obtain aloe primary extract; (3) treating the aloe primary extract and wheat germ oil in a double cone rotary reactor for 24 hours, and then removing the oil to obtain an oil-water biphilic aloe polysaccharide; (4) subjecting the oil-water biphilic aloe polysaccharide and water to high shear homogenization, and homogenizing with a homogenizer to fully blend the two to obtain a primary emulsion; (5) adding vegetable oil to the primary emulsion, and continuing to homogenize with a homogenizer to fully blend the components. The present invention can accelerate the transdermal absorption and penetration rate and accelerate wound regeneration and repair, and verifies the application prospects of the obtained microemulsion in cosmetics, medical devices and drug scenarios.

Description

Technical Field

[0001] The invention belongs to the technical field of skin care products, and particularly relates to a method for preparing a highly efficient transdermal regeneration polysaccharide milk fat globule skin care product emulsion. Background Art

[0002] Transdermal Drug Delivery Systems (TDDS) refer to a class of preparations that, after being administered through the skin, are absorbed by capillaries into the blood circulation to reach effective blood drug concentrations, produce systemic or local therapeutic effects, and thus achieve disease treatment and prevention. However, the efficacy of transdermal drug delivery is limited by the low permeability of the skin barrier, which hinders the effective delivery of many drugs, and its potential as an alternative to oral and subcutaneous administration has not yet been fully realized.

[0003] There are currently three main methods to improve the drug delivery effect of transdermal drug delivery systems:

[0004] One is through chemical methods, such as the use of penetration enhancers;

[0005] The second is through physical methods, including iontophoresis, ultrasound toner, microneedle technology, needle-free jet drug delivery, etc.;

[0006] The third is through pharmaceutical methods, such as making microemulsions, liposomes, ethosomes, transfersomes, etc.

[0007] These methods can overcome the limitations of the skin barrier to a certain extent and improve the drug delivery effect. However, they still have some disadvantages, including skin irritation, discomfort, drug stability issues and the need for professional operation.

[0008] In recent years, there has been an increasing number of studies on microemulsions (ME). Microemulsions are thermodynamically stable dispersion systems that are spontaneously formed by surfactants, co-surfactants, aqueous phases, and oil phases in appropriate proportions. Microemulsions have great advantages in transdermal drug delivery. At present, the surfactants commonly used in the preparation of microemulsions are mainly industrial preparations, such as alkyl alcohol amides, fatty alcohol polyoxyethylene ethers, alkylphenol polyoxyethylene ethers, etc. Although the above surfactants can increase drug solubility, due to their excessive irritation, long-term or high-concentration application may cause skin or mucosal damage. With the in-depth study of microemulsion technology, the development of efficient, stable and safe microemulsions has been the focus of research in recent years. Summary of the invention

[0009] In view of this, the purpose of the present invention is to propose a method for preparing a highly efficient transdermal regenerative polysaccharide milk fat globule skin care emulsion, the essence of which is to prepare a natural surfactant, and obtain an oil- and water-philic aloe polysaccharide through a series of treatments on aloe vera. The oil- and water-philic aloe polysaccharide can be homogenized with water phase and oil phase substances to form a microemulsion, and lipophilic and hydrophilic drugs can be dissolved (loaded) in the oil phase and water phase of the microemulsion to form a stable transdermal drug delivery system, thereby solving the technical problem of high irritation caused by the microemulsion prepared by the existing industrial surfactant when preparing the transdermal drug delivery system.

[0010] Therefore, the technical solution adopted in the present invention is as follows:

[0011] A natural surfactant is provided, which uses aloe as raw material, obtains polysaccharide primary extract through peeling, pulping, film evaporation and film peeling; and then pre-treats the polysaccharide primary extract with vegetable oil to obtain oil-water-philic aloe polysaccharide.

[0012] In the present invention, the aloe vera is preferably Aloe vera.

[0013] In the present invention, the added vegetable oil is wheat germ oil. The purpose of this process is to allow the obtained aloe polysaccharide primary extract to be hydroxy-modified so as to have lipophilic properties. Therefore, in addition to wheat germ oil, other vegetable oils or other substances that can be used to hydroxy-modify the aloe polysaccharide primary extract meet the requirements.

[0014] Specifically, the preparation method of the natural surfactant of the present invention comprises the following steps:

[0015] (1) peeling and pulping aloe leaves to obtain gel;

[0016] (2) The gel is subjected to low-temperature stirring treatment and high-temperature membrane evaporation treatment in sequence to obtain aloe vera primary extract;

[0017] (3) The aloe vera primary extract and the hydroxyl-modified vegetable oil are treated in a double cone rotary reactor for 24 hours at a temperature of 40-50°C. After the treatment, the oil is removed (the wheat germ oil precipitated from the upper layer of the mixture treated in the double cone rotary reactor is taken out, and then vacuum is applied to complete the oil removal operation) to obtain aloe vera polysaccharides that are both oil- and water-philic, i.e., natural surfactants.

[0018] Furthermore, in the present invention, the temperature of the low-temperature stirring treatment is 4-8°C, and the temperature of the high-temperature film evaporation treatment is 75-85°C.

[0019] A microemulsion is a highly efficient transdermal regeneration polysaccharide milk fat globule skin care product emulsion, comprising an aqueous phase, an oil phase and the above-mentioned oil-water biphilic aloe polysaccharide. The preparation method of the microemulsion comprises the following steps:

[0020] (1) High shear homogenization of aloe polysaccharide and water is performed by a homogenizer to fully blend the two to obtain a primary emulsion;

[0021] (2) Add vegetable oil to the primary emulsion and continue homogenizing to allow all components to fully blend to obtain a microemulsion.

[0022] In the above-mentioned preparation method of microemulsion, the volume ratio of the amphiphilic aloe polysaccharide to water is preferably 1:5, and the volume ratio of the primary emulsion to the vegetable oil is 1:4. During homogenization, the speed of the homogenizer is at least 4000 r / min.

[0023] The present invention performs Zeta potential analysis on the obtained microemulsion to confirm the charge distribution and particle size of the microsphere system, and verifies the invention through an in vitro transdermal absorption test on ex vivo skin and an animal model test on skin injury of Bama pigs with second-degree scalds that the invention can accelerate the transdermal absorption and penetration rate and accelerate wound regeneration and repair, thereby verifying the application prospects of the obtained microemulsion in cosmetics, medical devices and drugs.

[0024] The microemulsion of the present invention has obvious application advantages in the fields of cosmetics or therapeutic drugs, such as skin care products. After step (1) and step (2), hydrophilic and lipophilic drugs can be added to the primary emulsion and microemulsion respectively, and then homogenized again to obtain a microsphere drug delivery system. The loading amount of the hydrophilic drug and the lipophilic drug in the emulsion is 1 / 3 of the mass of the primary emulsion or microemulsion.

[0025] The advantages of the present invention are:

[0026] The present invention obtains a plant-derived biosurfactant from Aloe vera, and completes the preparation process of the microemulsion by controlling the feed ratio, high shear homogenization and other processes. Then, the invention is verified to accelerate the transdermal absorption and penetration rate and the wound regeneration and repair through Zeta potential analysis, ex vivo skin in vitro transdermal absorption test and Bama pig II degree scald skin injury animal model test, and the application prospects of the obtained microemulsion in cosmetics, medical devices and drug scenarios are verified. Compared with the existing microemulsion system prepared based on industrial surfactants, the present invention has the characteristics of safety and stability, and has typical microemulsion structural characteristics in the actual application scenario of the microemulsion. At the same time, through in vitro transdermal absorption experiments, samples from the ex vivo pig skin surface (including the stratum corneum), the inside of the skin, and the subcutaneous receiving fluid were collected, and the silicon element was determined by inductively coupled plasma mass spectrometry according to the Chinese Pharmacopoeia (2020 edition) 0412 to determine the in vitro transdermal absorption of the microemulsion. The results showed that the microemulsion of the present invention has the effect of significantly accelerating the transdermal absorption and penetration rate. At the same time, the animal model experiment of Bama pig II degree scald skin injury verified that the invention can significantly accelerate the wound regeneration and repair rate. It is suggested that the microemulsion has good commercial application prospects and value in cosmetics, medical devices and drug preparation processes. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 This is a flow chart for the preparation of oil-water amphiphilic aloe polysaccharide;

[0028] Figure 2 It is the Zeta potential analysis diagram of microemulsion;

[0029] Figure 3 is the particle size distribution of the microemulsion;

[0030] Figure 4 It is the result of skin PAS staining;

[0031] Figure 5 It is the result of Masson staining of the skin;

[0032] Figure 6 These are photos of skin recovery results of the blank control group, positive control group and microemulsion group in the regeneration and repair test;

[0033] Figure 7 Flow chart for the preparation of microsphere drug delivery system. DETAILED DESCRIPTION

[0034] In order to make the technical personnel in the field understand the present invention more clearly and intuitively, the present invention will be further described below in conjunction with the accompanying drawings. The experimental methods without specific conditions in the following examples are selected according to conventional methods and conditions, or according to the product instructions.

[0035] Example 1

[0036] A method for preparing a natural surfactant, which uses aloe vera leaves as raw materials, washes and peels them, and then stirs them at 4-8°C, evaporates them at 75-85°C, and removes the membrane to obtain an aloe primary extract;

[0037] The obtained primary extract is mixed with 1 times the weight of wheat germ oil, and the wheat germ oil is used to modify the primary extract of aloe vera to make it lipophilic. The mixture is treated in a double cone rotary vacuum reactor (model SCG-100) for 24 hours at a temperature of 40-50°C. The wheat germ oil chromatographically separated from the upper layer of the mixture is then taken out and vacuumed to remove oil, thereby obtaining an oil-water-philic aloe polysaccharide, i.e., a natural surfactant. The preparation process is as follows: Figure 1 shown.

[0038] Example 2

[0039] A microemulsion, which is also a highly efficient transdermal regeneration polysaccharide milk fat globule skin care emulsion, and its preparation method is as follows:

[0040] (1) The oil-water biphilic aloe polysaccharide obtained in Example 1 was subjected to high shear homogenization with 5 times the volume of water, and the speed of the homogenizer (model L5M-A) was 4000 r / min, so that the two were fully blended to obtain a primary emulsion;

[0041] (2) Add 4 times the volume of wheat germ oil to the primary emulsion. The purpose of adding wheat germ oil is to continue to maintain the oil-water amphiphilicity of aloe polysaccharide therein. Continue homogenizing at a homogenizer speed of 4000 r / min for 15 minutes to obtain a microemulsion.

[0042] Performance Verification:

[0043] The obtained microemulsion was subjected to Zeta potential analysis experiment, such as Figure 2 As shown, the Zeta potential of the microemulsion is evenly distributed. Figure 3 As shown, the obtained microemulsion was measured for particle size distribution by Zeta particle size / potential analysis (DLS) instrument (model: British-Malvern-Zetasizer Nano S90). The results showed that the particle size distribution of the microemulsion was about 640nm, indicating that the molecular particle size of the microemulsion was small and met the requirements for the particle size of the microemulsion. At the same time, after one month of standing, no significant changes were found in the performance of the microemulsion, proving that the colloidal beam system is highly stable.

[0044] The microemulsion prepared in Example 2 was subjected to an in vitro transdermal absorption experiment using an isolated pig skin model.

[0045] 1 Purpose of testing

[0046] Through in vitro transdermal absorption experiments, samples were collected from the surface of pig skin (including the stratum corneum), inside the skin, and in the subcutaneous receiving fluid, and the silicon element was determined by inductively coupled plasma mass spectrometry according to the 0412 General Rules of Part IV of the 2020 edition of the Chinese Pharmacopoeia to determine the in vitro transdermal absorption of the test samples. At the same time, PAS and Masson staining were performed on the skin after penetration to examine the changes in the stratum corneum, epidermis, and dermis of the skin.

[0047] 2 Method Introduction

[0048] Transdermal testing is to study the transport of chemical substances through the skin and their accumulation and absorption in different skin layers. Through transdermal testing, parameters such as the cumulative permeation amount, retention amount, and diffusion percentage of the product can be obtained, thereby evaluating the distribution and absorption in different skin structures.

[0049] 3 Test conditions

[0050] 3.1 Instruments

[0051] Drug transdermal diffusion tester: PYJ-12B, inductively coupled plasma mass spectrometer: Agilent 7900, microwave digestion instrument: MILESTONE MAXI-44eT, etc.

[0052] 3.2 Skin information

[0053] Bama miniature pig (male): Guangdong Mingzhu Biotechnology Co., Ltd.

[0054] 3.3 Reagents

[0055] Phosphate buffer solution PBS (pH7.2-7.4), nitric acid: UP grade, 3.3.4 hydrofluoric acid: GR, etc.

[0056] 3.4 Standards

[0057] Silicon standard solution: 1000 mg / L, internal standards (scandium, germanium, indium, rhodium, rhenium, bismuth): 1000 mg / L.

[0058] 4 Experimental Grouping

[0059] Table 1 Experimental groups

[0060]

[0061] 5 Test methods

[0062] 5.1 In vitro percutaneous absorption test procedure

[0063] 5.1.1 Preparation of ex vivo skin

[0064] Take the skin, wash it with clean water, absorb excess water with filter paper and set aside.

[0065] 5.1.2 Equipment preparation

[0066] Place the matching magnetic stirrer in an 8mL receiving tank, and fix the treated pigskin between the supply tank and the receiving tank. After fixation, add 8mL of normal saline to the receiving tank, exhaust all the air, and make the bottom of the pigskin in close contact with the receiving solution.

[0067] 5.1.3 Skin sampling

[0068] 0.2g of the test sample (the theoretical content of dimethyl silicone oil in the sample is 20mg / g, and the proportion of silicon in dimethyl silicone oil is 34.5%) is added to the surface of the pig skin and evenly applied. Three groups of parallel samples are set up for each sample. The samples are continuously stirred at a constant speed of 300r / min in a constant temperature water bath at (32±1)℃. At the same time, only dimethyl silicone oil is applied on the surface of the pig skin as a blank control.

[0069] The test sample is a microemulsion carrying dimethicone oil, that is, in the process of preparing the microemulsion, dimethicone oil is added to wheat germ oil and mixed thoroughly, and then added to the primary emulsion and homogenized to obtain the microemulsion.

[0070] 5.2 Sampling and sample preparation

[0071] 5.2.1 Subcutaneous treatment solution: Take 1 mL of receiving solution from the receiving pool at 4h, 8h, and 24h, respectively, and place it in a microwave digestion tank. At the same time, add the same volume of fresh receiving solution at the same temperature to the receiving pool. After each addition of receiving solution, it is necessary to exhaust the air bubbles. At the same time, the subcutaneous treatment solution obtained by applying only dimethyl silicone oil on the pig skin surface is used as a blank control.

[0072] 5.2.2 Skin treatment: After 24 hours of diffusion, remove the pig skin and rinse the skin surface with PBS to remove the residual drug on the skin. After 30 minutes of ultrasonic treatment, dilute to 10 ml to obtain the skin treatment solution. Then take 1 ml of the skin treatment solution into the microwave digestion tank for later use; in the same way, wash the pig skin with dimethyl silicone oil applied only on the pig skin surface to prepare a blank control.

[0073] 5.2.3 Treatment of the middle part of the skin: Use clean surgical scissors to cut the pigskin treated in 5.2.2 into pieces and place them in a microwave digestion tank for later use. In the same way, cut the pigskin with dimethyl silicone oil applied only on the surface of the pigskin into pieces and place them in a microwave digestion tank as a blank control.

[0074] 5.2.4 Digestion: Add 5 mL of nitric acid to each of the above microwave digestion vessels, and add 0.5 mL of hydrofluoric acid to the digestion vessel containing the skin. Cover the lid and digest in a microwave digestion instrument. After cooling, dilute to 50 mL for later use.

[0075] 5.3 Test specimens

[0076] 5.3.1 Instrument parameter setting

[0077] Table 2 Inductively coupled plasma mass spectrometer measurement parameters

[0078]

[0079] 5.3.2 Detection limit

[0080] Six groups of subcutaneous blank digestion solutions were measured separately, and the detection limit and quantification limit in the digestion solution were calculated according to the guidance principles for validation of analytical methods in Part IV 9101 of the 2020 edition of the Chinese Pharmacopoeia.

[0081] 5.3.3 Solution determination

[0082] PAS staining: After the penetration, the skin surface was cleaned separately, and the middle part of the effectively penetrated tissue was selected for PAS staining and then observed under a microscope. The internal standard solution, standard curve solution, and sample solution were injected into the inductively coupled plasma mass spectrometer respectively, and the signal response values ​​of the element to be measured and the internal standard element were determined. The concentration of the element to be measured in the digestion solution was obtained according to the standard curve.

[0083] 5.3.4 Qualitative testing

[0084] PAS staining: After the penetration is completed, the skin surface is cleaned separately, and the middle part of the effectively penetrated tissue is selected for PAS staining and microscopic observation.

[0085] Masson staining: After the penetration is completed, the skin surface is cleaned separately, and the middle part of the effectively penetrated tissue is selected for Masson staining and microscopic observation.

[0086] 6 Data Statistics and Calculation

[0087] 6.1 Cumulative Transmission

[0088] C=C n ×V+∑C i ×V0(i=1···n-1), where: C: cumulative permeate; V: receiving liquid volume in the receiving pool 8.0mL; V0: the volume of each sampling 1.0mL; C i : The concentration of the target substance in the receiving solution during the first to n-1 sampling; C n : The target concentration measured at the nth sampling point.

[0089] 6.2 Diffusion percentage (transmittance)

[0090] P=C / P0×100%, where: P: diffusion percentage; C: cumulative permeation volume in the receiving chamber at each time point; P0: initial sample loading volume in the diffusion chamber.

[0091] 6.3 Others

[0092] 6.3.1 Total permeation amount = cumulative permeation amount under the skin + retention amount in the skin;

[0093] 6.3.2 Non-penetration rate = non-penetration amount / sample amount*100%;

[0094] 6.3.3 Absorption percentage = retention amount / sample amount*100%;

[0095] 6.3.4 Recovery rate (%) = (total amount of penetration + amount not penetrated on the skin) × 100% ÷ theoretical silicon content;

[0096] 6.3.5 Theoretical silicon content (mg) = 20 × 34.5% × m; where: 20: The theoretical content of dimethyl silicone oil in the sample is 20 mg / g; m: dosage, g;

[0097] 6.3.6 Calculation of the detection limit (LOD) of Si in the digestion solution: LOD = 3SD / S;

[0098] Calculation of the limit of quantification (LOQ) of Si in the digestion solution: LOQ = 10SD / S;

[0099] Where: SD: standard deviation of the ratio of the CPS value of the element to be measured to the CPS value of the internal standard element; S: slope of the standard curve.

[0100] 7 Test results

[0101] 7.1 Linear range

[0102] Table 3 Linear regression equation

[0103]

[0104] 7.2 Detection Limit and Quantification Limit

[0105] Table 4 Detection limit and quantification limit

[0106]

[0107] 7.3 Results of Subcutaneous Cumulative Penetration and Permeability

[0108] Table 5 Subcutaneous cumulative permeation and permeation rate

[0109]

[0110] Note: If the subcutaneous digestion solution test result is less than the detection limit, the result is expressed as 0.

[0111] 7.4 Skin retention and absorption percentage

[0112] Table 6 Skin retention and absorption percentage

[0113]

[0114] 7.5 Results of determination of skin non-penetration volume and non-penetration rate

[0115] Table 7 Non-penetration amount and non-penetration rate on the skin

[0116]

[0117] 7.6 Non-penetration, absorption percentage and transmittance

[0118] Table 8 Non-penetration rate, absorption percentage and transmittance

[0119]

[0120] 7.7 Qualitative Results

[0121] 7.7.1 Skin PAS staining results Figure 4 shown.

[0122] 7.7.2 Skin Masson staining results Figure 5 shown.

[0123] 8 Results and Discussion

[0124] In this test, no silicon was detected in the receiving solution of the microemulsion sample after 4h, 8h, and 24h of penetration. After 24h of penetration, the skin absorption percentages were 34.44%, 34.75%, and 25.27%, respectively; and the non-penetration rates were 55.19%, 51.08%, and 70.62%, respectively. This shows that the microemulsion has the effect of significantly accelerating the transdermal absorption and penetration rate of substances (silicon).

[0125] In this experiment, the total recovery rates of the target analytes on, in, and under the skin were between 85.83% and 95.89%, which is within the reliable range.

[0126] Observation of PAS staining results: compared with the skin at 0h, the stratum corneum at 4h, 8h and 24h was softened, the stemness of the basal epidermal cells increased, and the collagen increased.

[0127] Observation of Masson staining results: Application for 24 hours can reconstruct the collagen microenvironment of the dermis and provide an extracellular material basis for cell regeneration.

[0128] 9 Conclusion

[0129] Under the test conditions, the microemulsion samples did not penetrate subcutaneously but were absorbed in the skin after 4h, 8h and 24h of penetration.

[0130] Regeneration and repair test of microemulsion using Bama pig II degree scald skin injury animal model

[0131] The specific method is as follows:

[0132] Modeling method: 24 miniature pigs, half male and half female, were placed on a constant temperature operating table. The scalding area (10 cm × 10 cm) was selected, and the area that did not need to be scalded was blocked with gauze or thermal insulation film. 40 layers of gauze of about 10 cm × 10 cm were prepared and immersed in hot water. When the water temperature was constant at above 95°C, they were taken out and immediately spread flat on the area to be scalded. The scalding time was 28 s (deep second-degree burn).

[0133] After the burn model was established, the rats were randomly divided into three groups: control group, positive control group (marketed drug name: Beifuxin, main ingredient: bovine basic fibroblast growth factor BFGF), and microemulsion group (number: AVBER). The groups and dosages are shown in Table 9.

[0134] Table 9 Groups and dosages for regeneration and repair test

[0135]

[0136] like Figure 6 As shown in the study, after 19 days of drug intervention, all wounds in the microemulsion group healed, and the morphology of damaged skin was close to normal skin. Compared with the control group and the positive drug group, the skin repair effect after microemulsion treatment was faster and better, the tissue integrity and orderliness were improved, the skin layers were clear, and it was closer to normal skin. This proves that microemulsion has the effect of significantly accelerating the regeneration and repair of damaged skin.

[0137] Example 3

[0138] The above performance tests on the microemulsion indicate that the microemulsion has good commercial application prospects and value in the preparation of cosmetics, medical devices and drugs.

[0139] Therefore, this embodiment proposes a microsphere drug delivery system, including a hydrophilic drug and / or a lipophilic drug, and a microemulsion. The preparation method is the same as the preparation method of the microemulsion, only the hydrophilic drug and / or the lipophilic drug are added to the primary emulsion and / or the microemulsion, respectively. The preparation process is as follows: Figure 7 shown.

[0140] In this embodiment, hydrophilic drugs can be selectively added to the primary emulsion, and lipophilic drugs can be selectively added to the microemulsion as needed. Of course, hydrophilic drugs can also be added to the primary emulsion and lipophilic drugs can be added to the microemulsion at the same time. The amount of each drug added is determined according to the solubility of the drug in the water phase or the oil phase and the dosage. For example, the loading amount of the hydrophilic drug and the lipophilic drug in the emulsion accounts for 1 / 3 of the mass of the primary emulsion or the microemulsion.

[0141] Finally, a sterilization step is included, in which the emulsion is filled and placed in a 121°C steam sterilization chamber for sterilization.

[0142] The above description of the embodiments is to facilitate the understanding and application of the present invention by those skilled in the art. It is obvious that those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the embodiments herein, and improvements and modifications made to the present invention by those skilled in the art based on the disclosure of the present invention should be within the scope of protection of the present invention.

Claims

1. A method for preparing a natural surfactant, characterized in that: The steps include: (1) peeling and pulping aloe leaves to obtain gel; (2) The gel is subjected to stirring treatment and film evaporation treatment in sequence, and the film is removed to obtain the primary extract of aloe vera; the temperature of the stirring treatment is 4-8°C, and the temperature of the film evaporation treatment is 75-85°C; (3) The aloe vera primary extract and wheat germ oil are treated in a double cone rotary reactor for 24 hours at a temperature of 40-50°C, and then deoiled to obtain an oil- and water-philic aloe polysaccharide, i.e., a natural surfactant.

2. A highly effective transdermal regeneration polysaccharide milk fat globule skin care emulsion, characterized in that: The invention comprises the oil-water amphiphilic aloe polysaccharide prepared by the preparation method according to claim 1.

3. The method for preparing a highly effective transdermal regeneration polysaccharide milk fat globule skin care emulsion according to claim 2, characterized in that: The steps include: (1) high shear homogenization of the aloe polysaccharide having both oil and water affinity and water, using a homogenizer to fully blend the two to obtain a primary emulsion; (2) Add vegetable oil to the primary emulsion and continue homogenizing with a homogenizer to fully blend the components to obtain a microemulsion.

4. The method for preparing a highly effective transdermal regeneration polysaccharide milk fat globule skin care emulsion as claimed in claim 3, characterized in that: The volume ratio of the oil-water biphilic aloe polysaccharide to water is 1:5, and the volume ratio of the primary emulsion to the vegetable oil is 1:

4.

5. The method for preparing a highly effective transdermal regeneration polysaccharide milk fat globule skin care emulsion as claimed in claim 3, characterized in that: During homogenization, the speed of the homogenizer is 4000 r / min.

6. Application of the highly effective transdermal regeneration polysaccharide milk fat globule skin care emulsion prepared by the preparation method according to any one of claims 3 to 5 in the manufacture of cosmetics and medicines.

7. A microsphere drug delivery system, characterized in that: The steps include: (1) high shear homogenization of the oil-water amphiphilic aloe polysaccharide obtained by the preparation method of claim 1 and water, and homogenization by a homogenizer to fully blend the two to obtain a primary emulsion; (2) Add vegetable oil to the primary emulsion and continue homogenizing with a homogenizer to fully blend the components to obtain a microemulsion; The hydrophilic drug and the lipophilic drug are added to the primary emulsion and the microemulsion after step (1) and / or step (2), respectively, and the mixture is homogenized again to obtain the product.

8. A microsphere drug delivery system as claimed in claim 7, characterized in that: The volume ratio of aloe polysaccharide to water of the oil-water biphilic is 1:5, and the volume ratio of primary emulsion to vegetable oil is 1:4; During homogenization, the speed of the homogenizer is 4000 r / min.

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