Novel freckle-removing and tissue-regeneration-promoting cream preparation based on micro-emulsion technology and preparation method thereof

Abstract

The invention relates to the technical field of freckle removing and tissue regeneration promoting cream preparations, in particular to a novel freckle removing and tissue regeneration promoting cream preparation based on a microemulsion technology and a preparation method of the novel freckle removing and tissue regeneration promoting cream preparation. 10 to 30 parts of an oil phase; 40 to 70 parts of a water phase; 7 to 23 parts of a surfactant; 5 to 18 parts of a cosurfactant; 0.7-3 parts of a stabilizer; 0.1 to 0.5 part of a preservative; due to the application of the microemulsion system, the problem of stability of a traditional emulsion is solved, the preparation keeps good physicochemical properties in the long-term storage process, the transdermal infiltration capacity of active ingredients is remarkably improved due to the nanoscale microemulsion droplet size, and the defect of low bioavailability of a traditional preparation is overcome; the unique traditional Chinese medicine compound design realizes the synergistic interaction of multiple effects of removing freckles, promoting tissue regeneration, resisting oxidation and the like, and provides comprehensive protection and repair for skin health.

Description

Technical Field

[0001] The invention relates to the technical field of freckle-removing and muscle-regenerating cream preparations, and in particular to a new freckle-removing and muscle-regenerating cream preparation based on microemulsion technology and a preparation method thereof. Background Art

[0002] As people pay more and more attention to skin health and beauty, freckle removal and skin regeneration products have occupied an important position in the market. However, there are still many problems with freckle removal and skin regeneration products on the market, which are difficult to meet the growing needs of consumers. Traditional freckle removal and skin regeneration creams generally adopt emulsion or gel dosage forms, which have obvious deficiencies in stability, permeability and bioavailability.

[0003] A lot of research has been done on the whitening and repairing functions of Chinese herbal extracts in existing literature. For example, the Chinese invention patent with the authorization announcement number CN101612105B, entitled Whitening and Skin Care Chinese Herbal Composition and Its Preparation Method, proposes a freckle-removing skin care preparation based on traditional Chinese medicine, which is compounded with Chinese herbal components such as Angelica dahurica, Atractylodes macrocephala, and Poria cocos, and can inhibit melanin production and promote skin cell regeneration. However, this study only explains the functionality of Chinese herbal components, does not combine microemulsion technology, and does not deeply optimize the skin absorbability and stability of the preparation. Its preparation form is relatively traditional, which limits the bioavailability and efficacy of the active ingredients.

[0004] According to a study published by S. Zhong et al. (2006), a study on the freckle removal mechanism based on Chinese herbal extracts found that Chinese herbal medicines such as Angelica dahurica and Astragalus membranaceus can effectively reduce melanin synthesis by inhibiting tyrosinase activity and scavenging free radicals. However, the study mainly used in vitro cell models, lacking in-depth discussion on the specific formulation form and stability, especially the lack of systematic research on the performance of active ingredients in complex skin environments [S. Zhong, Yan Wu, Ahn Soo-Mi, et al., 2006, Depigmentation of melanocytes by the treatment of extracts from traditional Chinese herbs: a cell culture assay, Biological & Pharmaceutical Bulletin, 29 (9): 1947-1951].

[0005] In addition, Wang et al. (2006) studied the whitening and antioxidant properties of various extracts in traditional Chinese medicine, and pointed out that the components of traditional Chinese medicine can improve the skin color by scavenging free radicals and regulating tyrosinase activity. However, the document failed to combine microemulsion technology or other advanced carrier systems, and only stayed at the research level of active ingredients, ignoring the problems of skin penetration efficiency and long-term stability in practical applications [Kuo-Hsien Wang, R. Lin, F. Hsu, et al., 2006, Cosmetic applications of selected traditional Chinese herbal medicines, Journal of Ethnopharmacology, 106 (3): 353-359].

[0006] Based on the above documents, the prior art has the following main problems:

[0007] 1. Insufficient absorption of preparations: The water solubility and fat solubility of traditional Chinese medicine extracts limit their penetration efficiency in the skin, and fail to maximize the whitening and repairing effects of the active ingredients.

[0008] 2. Poor stability: The active ingredients of traditional Chinese medicine are susceptible to oxidation and degradation in complex environments, resulting in a decrease in product efficacy. Existing literature has failed to effectively solve this problem.

[0009] 3. Imperfect process technology: Existing research lacks detailed process plans for combining traditional Chinese medicine components with microemulsion technology, especially in terms of formula optimization and formulation system stability research.

[0010] 4. Insufficient research on synergistic effects: The synergistic mechanism of multiple Chinese medicine ingredients after compounding has not been fully explored, and there is a lack of efficient optimization strategies to achieve complementarity and efficacy superposition among ingredients.

[0011] Although emulsion products have a certain moisturizing effect, their thermodynamic instability leads to phase separation during long-term storage, which seriously affects product quality and usage effects. In addition, due to the existence of two phases of oil and water in the emulsion, the active ingredients are often bound to one of the phases, making it difficult to effectively penetrate the skin barrier, resulting in low bioavailability. Although gel dosage forms have certain transdermal advantages, their moisturizing properties are poor and it is difficult to load a large amount of oil-soluble active ingredients, which limits their scope of application.

[0012] The prior art has also tried to use nanotechnology to improve the performance of freckle removal and skin regeneration products, such as nanoemulsions and liposomes. However, these technologies still face many challenges in practical applications. Although nanoemulsions can improve the solubility and dispersibility of active ingredients, their preparation process often requires high energy input and easily leads to the degradation of heat-sensitive ingredients. Although liposomes have good biocompatibility, their preparation process is complicated, costly, and long-term stability still needs to be improved.

[0013] In addition, existing freckle removal and skin regeneration products often focus on a single effect, such as whitening or anti-aging, and lack comprehensive skin repair and protection. This one-sided pursuit of a certain effect ignores the complexity and integrity of skin problems and makes it difficult to achieve ideal skin care effects. Summary of the invention

[0014] In view of the above-mentioned deficiencies of the prior art, it is urgent to develop a freckle-removing and skin-regenerating preparation with high stability, high permeability and multiple functions. The present invention aims to solve the technical problems of the existing freckle-removing and skin-regenerating products in terms of stability, permeability, bioavailability and comprehensive efficacy, and provide a new freckle-removing and skin-regenerating cream preparation based on microemulsion technology and its preparation method.

[0015] The object of the present invention is to provide a novel preparation of freckle-removing and muscle-regenerating cream based on microemulsion technology, which comprises the following components by weight:

[0016] Active ingredient 17.5-77 parts;

[0017] 10-30 parts of oil phase;

[0018] 40-70 parts of aqueous phase;

[0019] 7-23 parts of surfactant;

[0020] 5-18 parts of co-surfactant;

[0021] Stabilizer 0.7-3 parts;

[0022] Preservative 0.1-0.5 parts;

[0023] Antioxidant 0.1-0.5 parts.

[0024] Specifically, the active ingredients include:

[0025] 5-15 parts of Xinjiang Lithospermum officinale extract;

[0026] 3-10 parts of Paeonia suffruticosa root extract;

[0027] 3-10 parts of Rehmannia root extract;

[0028] 2-8 parts of Angelica dahurica extract;

[0029] 2-8 parts of Astragalus extract;

[0030] 1-5 parts of myrrh extract;

[0031] 1-5 parts of Centella asiatica extract;

[0032] 1-5 parts of witch hazel extract;

[0033] 2-8 parts of angelica extract;

[0034] 0.5-3 parts of pearl powder.

[0035] Specifically, the oil phase is camellia oil.

[0036] Specifically, the surfactant includes:

[0037] 5-15 parts of soybean lecithin;

[0038] Polysorbate 802—8 parts.

[0039] Specifically, the co-surfactant includes:

[0040] Propylene glycol 3-10 parts;

[0041] 2-8 parts of glycerol.

[0042] Specifically, the stabilizer includes:

[0043] Carbomer 0.2-1 part;

[0044] Hydroxypropyl methylcellulose 0.5-2 parts.

[0045] Specifically, the preservative is sodium benzoate.

[0046] Specifically, the antioxidant includes:

[0047] Tocopherol 0.1-0.5 parts;

[0048] Butylated hydroxyanethole 0.01-0.1 parts.

[0049] A method for preparing the preparation comprises the following steps:

[0050] (1) First, extract the active ingredients:

[0051] a) crushing Xinjiang lithospermum, peony bark and raw rehmannia root into 80 mesh sieve, adding 10 times amount of 70% ethanol, and performing ultrasonic extraction at 50°C, power of 300W, frequency of 40kHz, 30 minutes each time, and repeating 3 times;

[0052] b) Grind the angelica dahurica and astragalus membranaceus into 80 mesh sieve, add 8 times amount of water, and perform microwave extraction at 80°C, power of 600W, frequency of 2450MHz, 15 minutes each time, and repeat 2 times;

[0053] c) crushing myrrh and Centella asiatica into 80 mesh sieve, and extracting with supercritical CO2 at a pressure of 25 MPa and a temperature of 45° C. for 2 hours;

[0054] d) Grind Hamamelis and Angelica sinensis into 80-mesh sieve, add 8 times amount of 50% ethanol, and perform pressurized hot reflux extraction at 85° C. for 2 hours each time, and repeat 2 times;

[0055] e) combining the above extracts, concentrating under reduced pressure to a relative density of 1.10-1.15 (60° C.), to obtain each Chinese medicine extract;

[0056] (2) Secondly, prepare the oil phase:

[0057] Heat camellia oil to 65℃ and stir evenly;

[0058] (3) Then, prepare the aqueous phase:

[0059] Heat purified water to 65°C, add propylene glycol, glycerin, and sodium benzoate in sequence, and stir to dissolve;

[0060] (4) Again, prepare an emulsifier mixture:

[0061] Mix soy lecithin and polysorbate 80 in a ratio of 4:1, heat to 65°C to completely melt, and stir evenly;

[0062] (5) Next, prepare a microemulsion:

[0063] a) slowly adding the oil phase into the emulsifier mixture and applying high shear (12000) for 8 minutes;

[0064] b) slowly adding the mixture into the aqueous phase and continuing high-speed shearing for 12 minutes to form colostrum;

[0065] c) passing the colostrum through a high-pressure homogenizer at a pressure of 80 MPa and a temperature of 60° C. for 5 cycles to obtain a microemulsion;

[0066] (6) Then, add other components:

[0067] a) dissolving carbomer in a small amount of water and stirring until fully swollen;

[0068] b) dissolving hydroxypropyl methylcellulose in 65° C. hot water;

[0069] c) slowly adding the two solutions into the microemulsion and stirring evenly;

[0070] (7) Then, add active ingredients:

[0071] Add each Chinese medicine extract and pearl powder into the microemulsion in sequence and stir evenly;

[0072] (8) Further, adding antioxidants:

[0073] Add tocopherol and butyl hydroxyanethole into the microemulsion and stir well;

[0074] (9) Then, adjust the pH:

[0075] Adjust pH to 6.5 with triethanolamine;

[0076] (10) Finally, filling:

[0077] Fill the prepared microemulsion into a clean soft tube and seal it.

[0078] 10. The preparation method according to claim 9, characterized in that the method further comprises performing particle size analysis, Zeta potential measurement and transmission electron microscopy observation on the prepared microemulsion to ensure that the particle size of the microemulsion is about 100 nm and the absolute value of the Zeta potential is greater than 30 mV.

[0079] The innovative features and technical effects of the present invention are mainly reflected in the following aspects:

[0080] The present invention has achieved a number of technological breakthroughs by cleverly combining microemulsion technology and active ingredients of traditional Chinese medicine. First, the application of the microemulsion system solves the stability problem of traditional emulsions, allowing the preparations to maintain good physical and chemical properties during long-term storage. Secondly, the nano-scale microemulsion droplet size significantly improves the transdermal penetration ability of the active ingredients, overcoming the defect of low bioavailability of traditional preparations. Furthermore, the unique traditional Chinese medicine compound design of the present invention achieves synergistic enhancement of multiple functions such as freckle removal, muscle regeneration, and anti-oxidation, providing comprehensive protection and repair for skin health.

[0081] From the perspective of pharmaceutical preparation, the microemulsion system of the present invention not only improves the solubility of poorly soluble active ingredients, but also realizes a thermodynamically stable nano-scale dispersion system by optimizing the surfactant combination and preparation process. This highly dispersed state greatly increases the contact area between the drug and the skin, creating favorable conditions for the penetration of active ingredients.

[0082] At the level of skin science and biochemistry, the formulation design of the present invention fully considers the physiological characteristics of the skin barrier. The oil phase components in the microemulsion system can interact with the stratum corneum lipids, temporarily changing their tightly arranged state, and opening up channels for the penetration of water-soluble active ingredients. At the same time, nano-scale microemulsion droplets can enter the deep skin through accessory organs such as hair follicles, achieving multi-pathway drug delivery.

[0083] From the perspective of pharmacology and toxicology, the present invention achieves multi-target and multi-pathway synergistic effects through reasonable compatibility of traditional Chinese medicines. For example, shikonin has anti-inflammatory and cell regeneration promoting effects, while paeonol has antioxidant and melanin inhibition effects. With the assistance of microemulsion carriers, these components can more effectively reach the target of action, exert their respective pharmacological effects, and at the same time cooperate with each other to produce a synergistic effect where the whole is greater than the sum of the parts.

[0084] In terms of drug delivery system, the microemulsion technology of the present invention provides an ideal carrier for the insoluble active ingredients of traditional Chinese medicine. The microemulsion system can not only increase the solubility of these ingredients, but also protect them from enzymatic and oxidative degradation, prolong their retention time in the skin, and thus achieve sustained release and long-lasting effect.

[0085] In general, the present invention successfully solves many technical problems faced by existing freckle removal and skin regeneration products by innovatively combining microemulsion technology with active ingredients of traditional Chinese medicine. This new preparation not only has excellent stability and bioavailability, but also achieves synergistic enhancement of multiple functions. It provides a new idea for the development of efficient and safe skin care products, and is expected to bring revolutionary breakthroughs in the field of beauty and skin care. DETAILED DESCRIPTION

[0086] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0087] In the present invention, the four properties and five flavors, meridians and compatibility principles of the active ingredients are analyzed as follows: Xinjiang Lithospermum officinale (cold in nature, bitter and sweet in taste, enters the heart and liver meridians, clears heat and cools blood, promotes blood circulation and detoxifies, clears rashes and eliminates spots, and is used together with Paeonia suffruticosa to enhance the effects of clearing heat and cooling blood, promoting blood circulation and detoxifying), Paeonia suffruticosa (slightly cold in nature, bitter and pungent in taste, enters the heart, liver and kidney meridians, clears heat and cools blood, promotes blood circulation and removes blood stasis, and is used together with Rehmannia glutinosa to play the effects of clearing heat and cooling blood), Radix Rehmanniae (cold in nature, sweet and bitter in taste, enters the heart, liver, and kidney meridians, clears heat and cools blood, nourishes yin and promotes fluid production, and is paired with Centella asiatica to enhance the efficacy of clearing heat, cooling blood and detoxifying), Centella asiatica (cool in nature, sweet and bitter in taste, enters the liver, spleen, and kidney meridians, clears heat and detoxifies, reduces swelling and dissipates blood stasis, promotes blood circulation and promotes tissue regeneration, and is paired with Hamamelis to enhance the efficacy of reducing swelling and promoting tissue regeneration), Hamamelis virginiana (cool in nature, astringent in taste, enters the lung and large intestine meridians, astringes and stops bleeding, reduces swelling and relieves pain, and is paired with Angelica dahurica Paired with Radix Angelicae Dahuricae (warm in nature, pungent in taste, enters the lung, stomach, and large intestine meridians, dispels wind and cold, relieves pain, reduces swelling and discharges pus, and is paired with Radix Astragali, one warms and one replenishes, enhancing the effect of removing spots and promoting tissue regeneration), Radix Astragali (slightly warm in nature, sweet in taste, enters the spleen and lung meridians, replenishes qi and strengthens the exterior, promotes diuresis and reduces swelling, promotes tissue regeneration, and is paired with Myrrh to replenish qi and activate blood circulation, and together play the effect of promoting tissue regeneration), Myrrh (neutral in nature, bitter and pungent in taste, enters the heart , liver, spleen meridians, promote blood circulation and relieve pain, reduce swelling and promote tissue regeneration; when paired with Chinese angelica, it enhances the effects of nourishing blood, promoting blood circulation and removing blood stasis), Chinese angelica (warm in nature, sweet and spicy in taste, enters the heart, liver, and spleen meridians, nourishes blood, promotes blood circulation, regulates menstruation and relieves pain; when paired with pearl powder, it nourishes the skin, whitens and removes spots), pearl powder (slightly cold in nature, sweet and salty in taste, enters the heart and liver meridians, clears away heat and soothes the mind, improves eyesight and removes cataracts, detoxifies and promotes tissue regeneration; when paired with other medicinal materials, it enhances the effects of removing spots and whitening).

[0088] The optimization of extraction methods includes ultrasonic-assisted 70% ethanol extraction (Xinjiang Lithospermum officinale, Paeonia suffruticosa, Rehmannia glutinosa), microwave-assisted water extraction (Angelica dahurica, Astragalus membranaceus), supercritical CO2 extraction (Myrrha, Centella asiatica), and pressurized hot reflux extraction (Witch Hazel, Angelica sinensis) according to the characteristics of different medicinal materials. The optimization of microemulsion preparation process includes high-pressure homogenization conditions (pressure 80MPa, 5 cycles, temperature 60℃, high-pressure homogenization can crush oil droplets to nanometer level, improve the stability and permeability of the preparation), selection of surfactants (main surfactant soybean lecithin 80%, auxiliary surfactant polysorbate 80 20%, this combination can form a more stable interfacial film and improve the stability of microemulsion), and the ratio of oil phase to water phase (1:3), which can form O / W type microemulsion, which is conducive to the transdermal absorption of drugs. The stability optimization of the preparation includes the addition of antioxidants (0.3 parts of tocopherol and 0.05 parts of butylated hydroxyanethole. This combination can effectively prevent the oxidation of the oil phase and extend the shelf life of the preparation), pH adjustment (using triethanolamine to adjust the pH to 6.5. This pH value is close to the physiological pH of the skin, which can reduce irritation and is beneficial to the stability of the preparation), and the selection of thickeners (0.5 parts of carbomer 9400 and 1 part of hydroxypropyl methylcellulose. This combination can form an appropriate viscosity, which will not affect the application and prevent the preparation from stratifying).

[0089] In terms of drug synergy, the drug compatibility in this prescription follows the principle of "monarch, minister, assistant and messenger". The monarch drugs Xinjiang Lithospermum officinale and Paeonia suffruticosa mainly play the role of clearing heat and cooling blood, promoting blood circulation and removing blood stasis; the assistant drugs Rehmannia glutinosa, Centella asiatica, Hamamelis radix and Angelica dahurica help the monarch drugs to enhance the effects of clearing heat and detoxifying, reducing swelling and promoting tissue regeneration; the assistant drugs Myrrha, Astragalus and Angelica sinensis enhance the effects of invigorating qi and blood and promoting blood circulation, so that the whole prescription cools blood without stagnation, and enhances the effects of removing blood stasis and promoting qi; the assistant drug Pearl powder harmonizes the drugs, guides the drugs into the meridians and enhances whitening. This compatibility can not only give full play to the strengths of each drug, but also produce synergistic effects through the interaction between drugs, thereby achieving better freckle removal and tissue regeneration effects. Through the above optimization, the preparation not only embodies the theoretical essence of traditional Chinese medicine in the formulation, but also integrates modern pharmaceutical technology in the preparation process, with high innovation and practicality.

[0090] Example 1

[0091] A novel preparation of freckle-removing and muscle-regenerating cream based on microemulsion technology and its preparation method

[0092] The new preparation of the freckle-removing and muscle-regenerating cream of this embodiment includes the following components by weight: 5 parts of Xinjiang Lithospermum officinale extract, 3 parts of Paeonia suffruticosa extract, 3 parts of Rehmannia glutinosa extract, 2 parts of Angelica dahurica extract, 2 parts of Astragalus membranaceus extract, 1 part of Myrrha extract, 1 part of Centella asiatica extract, 1 part of Hamamelis virginiana extract, 2 parts of Angelica sinensis extract, 0.5 parts of pearl powder, 10 parts of camellia oil, 70 parts of purified water, 5 parts of soybean lecithin, 2 parts of polysorbate 80, 3 parts of propylene glycol, 2 parts of glycerol, 0.2 parts of carbomer, 0.5 parts of hydroxypropyl methylcellulose, 0.1 parts of sodium benzoate, and 0.1 parts of tocopherol.

[0093] The preparation method of this embodiment comprises the following steps:

[0094] (1) First, extract the active ingredients:

[0095] a) Grind Xinjiang Lithospermum officinale, Paeonia suffruticosa, and Rehmannia glutinosa into 80 mesh sieves, add 10 times the amount of 70% ethanol, and perform ultrasonic extraction at 50°C, with a power of 300W and a frequency of 40kHz, for 30 minutes each time, and repeat 3 times. This extraction method can effectively extract the water-soluble and fat-soluble active ingredients in these medicinal materials, such as shikonin, paeonol, and rehmannia glutinosa, and enhance the freckle removal and skin regeneration effect of the preparation;

[0096] b) Grind the angelica dahurica and astragalus membranaceus into 80 mesh sieve, add 8 times amount of water, and perform microwave extraction at 80°C, power of 600W, frequency of 2450MHz, 15 minutes each time, and repeat 2 times. Microwave extraction can quickly and efficiently extract the water-soluble components in these two medicinal materials, such as angelica dahuricae ketone and astragaloside IV, and enhance the freckle removal and qi-tonifying and exterior-strengthening effects of the preparation;

[0097] c) Grind myrrh and Centella asiatica into 80 mesh sieve, and extract them by supercritical CO2 at a pressure of 25 MPa and a temperature of 45°C for 2 hours. Supercritical CO2 extraction can better retain the volatile oils and fat-soluble components in these two medicinal materials, such as bisabolol and asiatica glycoside, and enhance the effects of the preparation in promoting blood circulation and removing blood stasis and promoting collagen synthesis;

[0098] d) Grind Hamamelis and Angelica sinensis into 80 mesh sieve, add 8 times the amount of 50% ethanol, and perform pressurized hot reflux extraction at 85°C for 2 hours each time, and repeat 2 times. This method can better extract polyphenols and volatile oil components in these two medicinal materials, such as tannins and ferulic acid, and enhance the astringent hemostatic and blood-tonifying and blood-activating effects of the preparation;

[0099] e) combining the above extracts, concentrating under reduced pressure to a relative density of 1.10 (60° C.), to obtain each Chinese medicine extract;

[0100] (2) Secondly, prepare the oil phase:

[0101] Heat camellia oil to 65°C and stir evenly. Camellia oil is rich in unsaturated fatty acids and vitamin E, which can moisturize the skin and enhance the permeability of the preparation;

[0102] (3) Then, prepare the aqueous phase:

[0103] Heat purified water to 65°C, add propylene glycol, glycerin, and sodium benzoate in sequence, and stir to dissolve. Propylene glycol and glycerin act as moisturizers to improve the texture of the preparation and enhance the hydration of the skin;

[0104] (4) Again, prepare an emulsifier mixture:

[0105] Mix soy lecithin and polysorbate 80 in a ratio of 4:1, heat to 65°C to completely melt, and stir evenly. This ratio of emulsifier combination can form a more stable interface film and improve the stability of the microemulsion;

[0106] (5) Next, prepare a microemulsion:

[0107] a) slowly adding the oil phase into the emulsifier mixture and applying high shear (12000) for 8 minutes;

[0108] b) slowly adding the mixture into the aqueous phase and continuing high-speed shearing for 12 minutes to form colostrum;

[0109] c) passing the colostrum through a high-pressure homogenizer at a pressure of 80 MPa and a temperature of 60°C for 5 cycles to obtain a microemulsion. High-pressure homogenization can crush the oil droplets to nanometer level, thereby improving the stability and permeability of the preparation;

[0110] (6) Then, add other components:

[0111] a) dissolving carbomer in a small amount of water and stirring until fully swollen;

[0112] b) dissolving hydroxypropyl methylcellulose in 65° C. hot water;

[0113] c) Slowly add the two solutions into the microemulsion and stir evenly. Carbomer and hydroxypropyl methylcellulose are used as thickeners to adjust the viscosity of the preparation and improve the spreadability;

[0114] (7) Then, add active ingredients:

[0115] Add each Chinese medicine extract and pearl powder into the microemulsion in sequence and stir evenly;

[0116] (8) Further, adding antioxidants:

[0117] Add tocopherol to the microemulsion and stir evenly. Tocopherol, as an antioxidant, can prevent the oxidation of the oil phase components in the preparation and extend the shelf life of the preparation;

[0118] (9) Then, adjust the pH:

[0119] Adjust the pH to 6.5 with triethanolamine. This pH value is close to the physiological pH of the skin, which can reduce irritation and is beneficial to the stability of the preparation;

[0120] (10) Finally, filling:

[0121] Fill the prepared microemulsion into a clean soft tube and seal it.

[0122] Preferably, in the embodiment of the present invention, the prepared microemulsion is further subjected to particle size analysis, Zeta potential measurement and transmission electron microscopy observation to ensure that the particle size of the microemulsion is about 100 nm and the absolute value of the Zeta potential is greater than 30 mV. These parameters can ensure the stability of the microemulsion system and a good transdermal absorption effect.

[0123] Example 2

[0124] A novel preparation of freckle-removing and muscle-regenerating cream based on microemulsion technology and its preparation method

[0125] The new preparation of the freckle-removing and muscle-regenerating cream of this embodiment includes the following components by weight: 15 parts of Xinjiang Lithospermum officinale extract, 10 parts of Paeonia suffruticosa extract, 10 parts of Rehmannia glutinosa extract, 8 parts of Angelica dahurica extract, 8 parts of Astragalus membranaceus extract, 5 parts of Myrrha extract, 5 parts of Centella asiatica extract, 5 parts of Hamamelis virginiana extract, 8 parts of Angelica sinensis extract, 3 parts of pearl powder, 30 parts of camellia oil, 40 parts of purified water, 15 parts of soybean lecithin, 8 parts of polysorbate 80, 10 parts of propylene glycol, 8 parts of glycerol, 1 part of carbomer, 2 parts of hydroxypropyl methylcellulose, 0.5 parts of sodium benzoate, and 0.5 parts of tocopherol.

[0126] The preparation method of this embodiment comprises the following steps:

[0127] (1) First, extract the active ingredients:

[0128] a) crushing Xinjiang lithospermum, peony bark and raw rehmannia root into 80 mesh sieve, adding 10 times amount of 70% ethanol, and performing ultrasonic extraction at 50°C, power of 300W, frequency of 40kHz, 30 minutes each time, and repeating 3 times;

[0129] b) Grind the angelica dahurica and astragalus membranaceus into 80 mesh sieve, add 8 times amount of water, and perform microwave extraction at 80°C, power of 600W, frequency of 2450MHz, 15 minutes each time, and repeat 2 times;

[0130] c) crushing myrrh and Centella asiatica into 80 mesh sieve, and extracting with supercritical CO2 at a pressure of 25 MPa and a temperature of 45° C. for 2 hours;

[0131] d) Grind Hamamelis and Angelica sinensis into 80-mesh sieve, add 8 times amount of 50% ethanol, and perform pressurized hot reflux extraction at 85° C. for 2 hours each time, and repeat 2 times;

[0132] e) combining the above extracts, concentrating under reduced pressure to a relative density of 1.15 (60° C.), to obtain each Chinese medicine extract;

[0133] (2) Secondly, prepare the oil phase:

[0134] Heat camellia oil to 65℃ and stir evenly;

[0135] (3) Then, prepare the aqueous phase:

[0136] Heat purified water to 65°C, add propylene glycol, glycerin, and sodium benzoate in sequence, and stir to dissolve;

[0137] (4) Again, prepare an emulsifier mixture:

[0138] Mix soy lecithin and polysorbate 80 in a ratio of 4:1, heat to 65°C to completely melt, and stir evenly;

[0139] (5) Next, prepare a microemulsion:

[0140] a) slowly adding the oil phase into the emulsifier mixture and applying high shear (12000) for 8 minutes;

[0141] b) slowly adding the mixture into the aqueous phase and continuing high-speed shearing for 12 minutes to form colostrum;

[0142] c) passing the colostrum through a high-pressure homogenizer at a pressure of 80 MPa and a temperature of 60° C. for 5 cycles to obtain a microemulsion;

[0143] (6) Then, add other components:

[0144] a) dissolving carbomer in a small amount of water and stirring until fully swollen;

[0145] b) dissolving hydroxypropyl methylcellulose in 65° C. hot water;

[0146] c) slowly adding the two solutions into the microemulsion and stirring evenly;

[0147] (7) Then, add active ingredients:

[0148] Add each Chinese medicine extract and pearl powder into the microemulsion in sequence and stir evenly;

[0149] (8) Further, adding antioxidants:

[0150] Add tocopherol to the microemulsion and stir well;

[0151] (9) Then, adjust the pH:

[0152] Adjust pH to 6.5 with triethanolamine;

[0153] (10) Finally, filling:

[0154] Fill the prepared microemulsion into a clean soft tube and seal it.

[0155] Example 3

[0156] A novel preparation of freckle-removing and muscle-regenerating cream based on microemulsion technology and its preparation method

[0157] The new preparation of the freckle-removing and muscle-regenerating cream of this embodiment includes the following components by weight: 10 parts of Xinjiang Lithospermum officinale extract, 6 parts of Paeonia suffruticosa extract, 6 parts of Rehmannia glutinosa extract, 5 parts of Angelica dahurica extract, 5 parts of Astragalus membranaceus extract, 3 parts of Myrrha extract, 3 parts of Centella asiatica extract, 3 parts of Hamamelis virginiana extract, 5 parts of Angelica sinensis extract, 1.5 parts of pearl powder, 20 parts of camellia oil, 55 parts of purified water, 10 parts of soybean lecithin, 5 parts of polysorbate 80, 6 parts of propylene glycol, 5 parts of glycerol, 0.6 parts of carbomer, 1.2 parts of hydroxypropyl methylcellulose, 0.3 parts of sodium benzoate, 0.3 parts of tocopherol, and 0.05 parts of butylated hydroxyanethole.

[0158] The preparation method of this embodiment comprises the following steps:

[0159] (1) First, extract the active ingredients:

[0160] a) crushing Xinjiang lithospermum, peony bark and raw rehmannia root into 80 mesh sieve, adding 10 times amount of 70% ethanol, and performing ultrasonic extraction at 50°C, power of 300W, frequency of 40kHz, 30 minutes each time, and repeating 3 times;

[0161] b) Grind the angelica dahurica and astragalus membranaceus into 80 mesh sieve, add 8 times amount of water, and perform microwave extraction at 80°C, power of 600W, frequency of 2450MHz, 15 minutes each time, and repeat 2 times;

[0162] c) crushing myrrh and Centella asiatica into 80 mesh sieve, and extracting with supercritical CO2 at a pressure of 25 MPa and a temperature of 45° C. for 2 hours;

[0163] d) Grind Hamamelis and Angelica sinensis into 80-mesh sieve, add 8 times amount of 50% ethanol, and perform pressurized hot reflux extraction at 85° C. for 2 hours each time, and repeat 2 times;

[0164] e) combining the above extracts, concentrating under reduced pressure to a relative density of 1.12 (60° C.), to obtain each Chinese medicine extract;

[0165] (2) Secondly, prepare the oil phase:

[0166] Heat camellia oil to 65℃ and stir evenly;

[0167] (3) Then, prepare the aqueous phase:

[0168] Heat purified water to 65°C, add propylene glycol, glycerin, and sodium benzoate in sequence, and stir to dissolve;

[0169] (4) Again, prepare an emulsifier mixture:

[0170] Mix soy lecithin and polysorbate 80 in a ratio of 4:1, heat to 65°C to completely melt, and stir evenly;

[0171] (5) Next, prepare a microemulsion:

[0172] a) slowly adding the oil phase into the emulsifier mixture and applying high shear (12000) for 8 minutes;

[0173] b) slowly adding the mixture into the aqueous phase and continuing high-speed shearing for 12 minutes to form colostrum;

[0174] c) passing the colostrum through a high-pressure homogenizer at a pressure of 80 MPa and a temperature of 60° C. for 5 cycles to obtain a microemulsion;

[0175] (6) Then, add other components:

[0176] a) dissolving carbomer in a small amount of water and stirring until fully swollen;

[0177] b) dissolving hydroxypropyl methylcellulose in 65° C. hot water;

[0178] c) slowly adding the two solutions into the microemulsion and stirring evenly;

[0179] (7) Then, add active ingredients:

[0180] Add each Chinese medicine extract and pearl powder into the microemulsion in sequence and stir evenly;

[0181] (8) Further, adding antioxidants:

[0182] Add tocopherol and butyl hydroxyanethole to the microemulsion and stir well. The combination of tocopherol and butyl hydroxyanethole can provide a stronger antioxidant effect and further extend the shelf life of the preparation;

[0183] (9) Then, adjust the pH:

[0184] Adjust pH to 6.5 with triethanolamine;

[0185] (10) Finally, filling:

[0186] Fill the prepared microemulsion into a clean soft tube and seal it.

[0187] Example 4

[0188] A novel preparation of freckle-removing and muscle-regenerating cream based on microemulsion technology and its preparation method

[0189] The new preparation of the freckle-removing and muscle-regenerating cream of this embodiment includes the following components by weight: 8 parts of Xinjiang Lithospermum officinale extract, 5 parts of Paeonia suffruticosa extract, 5 parts of Rehmannia glutinosa extract, 4 parts of Angelica dahurica extract, 4 parts of Astragalus membranaceus extract, 2 parts of Myrrha extract, 2 parts of Centella asiatica extract, 2 parts of Hamamelis virginiana extract, 4 parts of Angelica sinensis extract, 1 part of pearl powder, 15 parts of camellia oil, 60 parts of purified water, 8 parts of soy lecithin, 4 parts of polysorbate 80, 5 parts of propylene glycol, 4 parts of glycerol, 0.4 parts of carbomer, 1 part of hydroxypropyl methylcellulose, 0.2 parts of sodium benzoate, 0.2 parts of tocopherol, and 0.03 parts of butylated hydroxyanethole.

[0190] The preparation method of this embodiment comprises the following steps:

[0191] (1) First, extract the active ingredients:

[0192] a) crushing Xinjiang lithospermum, peony bark and raw rehmannia root into 80 mesh sieve, adding 10 times amount of 70% ethanol, and performing ultrasonic extraction at 50°C, power of 300W, frequency of 40kHz, 30 minutes each time, and repeating 3 times;

[0193] b) Grind the angelica dahurica and astragalus membranaceus into 80 mesh sieve, add 8 times amount of water, and perform microwave extraction at 80°C, power of 600W, frequency of 2450MHz, 15 minutes each time, and repeat 2 times;

[0194] c) crushing myrrh and Centella asiatica into 80 mesh sieve, and extracting with supercritical CO2 at a pressure of 25 MPa and a temperature of 45° C. for 2 hours;

[0195] d) Grind Hamamelis and Angelica sinensis into 80-mesh sieve, add 8 times amount of 50% ethanol, and perform pressurized hot reflux extraction at 85° C. for 2 hours each time, and repeat 2 times;

[0196] e) combining the above extracts, concentrating under reduced pressure to a relative density of 1.13 (60° C.), to obtain each Chinese medicine extract;

[0197] (2) Secondly, prepare the oil phase:

[0198] Heat camellia oil to 65℃ and stir evenly;

[0199] (3) Then, prepare the aqueous phase:

[0200] Heat purified water to 65°C, add propylene glycol, glycerin, and sodium benzoate in sequence, and stir to dissolve;

[0201] (4) Again, prepare an emulsifier mixture:

[0202] Mix soy lecithin and polysorbate 80 in a ratio of 4:1, heat to 65°C to completely melt, and stir evenly;

[0203] (5) Next, prepare a microemulsion:

[0204] a) slowly adding the oil phase into the emulsifier mixture and applying high shear (12000) for 8 minutes;

[0205] b) slowly adding the mixture into the aqueous phase and continuing high-speed shearing for 12 minutes to form colostrum;

[0206] c) passing the colostrum through a high-pressure homogenizer at a pressure of 80 MPa and a temperature of 60° C. for 5 cycles to obtain a microemulsion;

[0207] (6) Then, add other components:

[0208] a) dissolving carbomer in a small amount of water and stirring until fully swollen;

[0209] b) dissolving hydroxypropyl methylcellulose in 65° C. hot water;

[0210] c) slowly adding the two solutions into the microemulsion and stirring evenly;

[0211] (7) Then, add active ingredients:

[0212] Add each Chinese medicine extract and pearl powder into the microemulsion in sequence and stir evenly;

[0213] (8) Further, adding antioxidants:

[0214] Add tocopherol and butyl hydroxyanethole into the microemulsion and stir well;

[0215] (9) Then, adjust the pH:

[0216] Adjust pH to 6.5 with triethanolamine;

[0217] (10) Finally, filling:

[0218] Fill the prepared microemulsion into a clean soft tube and seal it.

[0219] Comparative Example 1

[0220] A freckle-removing and muscle-regenerating cream preparation based on microemulsion technology and its preparation method

[0221] This comparative example is intended to verify the synergistic effect of the active ingredients, and its components are the same as those in Example 1, but the Centella asiatica extract, Hamamelis virginiana extract and Angelica sinensis extract are removed. The specific components are as follows (by weight): 5 parts of Xinjiang Lithospermum officinale extract, 3 parts of Paeonia suffruticosa extract, 3 parts of Rehmannia glutinosa extract, 2 parts of Angelica dahurica extract, 2 parts of Astragalus extract, 1 part of Myrrha extract, 0.5 parts of pearl powder, 10 parts of Camellia oil, 73 parts of purified water, 5 parts of soybean lecithin, 2 parts of polysorbate 80, 3 parts of propylene glycol, 2 parts of glycerol, 0.2 parts of Carbomer, 0.5 parts of Hydroxypropyl methylcellulose, 0.1 parts of Sodium Benzoate, and 0.1 parts of Tocopherol.

[0222] The preparation method is the same as that in Example 1, except that the extraction of Centella asiatica, Hamamelis virginiana and Angelica sinensis is omitted in step (1), and the other steps remain unchanged.

[0223] By comparison with Example 1, this comparative example is intended to demonstrate the importance of Centella asiatica, Hamamelis Virginiana and Angelica sinensis in the freckle-removing and muscle-regenerating cream. The absence of these three Chinese medicinal materials may significantly reduce the freckle-removing and muscle-regenerating effects of the preparation, because they have unique effects in clearing away heat and detoxifying, reducing swelling and dispersing blood stasis, and promoting blood circulation and removing blood stasis.

[0224] Comparative Example 2

[0225] A freckle-removing and muscle-regenerating cream preparation based on microemulsion technology and its preparation method

[0226] This comparative example is intended to verify the importance of microemulsion technology. Its components are the same as those in Example 2, but the traditional emulsification method is used instead of microemulsion technology. The specific components remain unchanged, and the preparation method is adjusted as follows:

[0227] Step (5) is changed to:

[0228] Heat the oil phase to 75°C and the water phase to 75°C. Slowly add the oil phase to the water phase and stir for 10 minutes using a high-speed shearing machine (3000) to form an emulsion. Then cool to 40°C and continue stirring for 30 minutes.

[0229] The other steps are the same as those in Example 2.

[0230] This comparative example aims to demonstrate the important role of microemulsion technology in improving the stability and permeability of the preparation by comparing with Example 2. Traditional emulsification methods may result in larger particle size and poorer stability, thus affecting the transdermal absorption efficiency of the active ingredient.

[0231] Comparative Example 3

[0232] A freckle-removing and muscle-regenerating cream preparation based on microemulsion technology and its preparation method

[0233] This comparative example is intended to verify the importance of the surfactant ratio. Its components are the same as those in Example 3, but the ratio of soybean lecithin and polysorbate 80 is adjusted. The specific components are as follows (by weight): 10 parts of Xinjiang Lithospermum officinale extract, 6 parts of Paeonia suffruticosa extract, 6 parts of Rehmannia glutinosa extract, 5 parts of Angelica dahurica extract, 5 parts of Astragalus extract, 3 parts of Myrrha extract, 3 parts of Centella asiatica extract, 3 parts of Hamamelis Virginiana extract, 5 parts of Angelica sinensis extract, 1.5 parts of pearl powder, 20 parts of camellia oil, 55 parts of purified water, 5 parts of soybean lecithin, 10 parts of polysorbate 80, 6 parts of propylene glycol, 5 parts of glycerol, 0.6 parts of carbomer, 1.2 parts of hydroxypropyl methylcellulose, 0.3 parts of sodium benzoate, 0.3 parts of tocopherol, and 0.05 parts of butylated hydroxyanethole.

[0234] The preparation method is the same as that of Example 3, except that in step (4), the ratio of soybean lecithin to polysorbate 80 is adjusted to 1:2.

[0235] This comparative example aims to demonstrate the effect of the surfactant ratio on the formation and stability of microemulsion by comparison with Example 3. An inappropriate surfactant ratio may lead to instability of the microemulsion system and affect the long-term storage and use effect of the preparation.

[0236] Comparative Example 4

[0237] A freckle-removing and muscle-regenerating cream preparation based on microemulsion technology and its preparation method

[0238] This comparative example is intended to verify the importance of high-pressure homogenization parameters. Its components are the same as those in Example 4, but the parameters of high-pressure homogenization are adjusted. The specific components remain unchanged, and step (5) c) in the preparation method is changed to:

[0239] The colostrum was passed through a high-pressure homogenizer at a pressure of 40 MPa and a temperature of 40°C for 2 cycles to obtain a microemulsion.

[0240] The other steps are the same as those in Example 4.

[0241] This comparative example aims to demonstrate the effect of high pressure homogenization parameters on the particle size and stability of microemulsion by comparison with Example 4. Lower homogenization pressure and cycle times may result in larger microemulsion particle size and uneven distribution, thus affecting the stability and permeability of the preparation.

[0242] Comparative Example 5

[0243] A freckle-removing and muscle-regenerating cream preparation based on microemulsion technology and its preparation method

[0244] This comparative example is intended to verify the importance of pH value. Its components are the same as those in Example 1, but the final pH value is adjusted. The specific components remain unchanged, and step (9) in the preparation method is changed to:

[0245] The pH was adjusted to 5.0 with triethanolamine.

[0246] The other steps are the same as those in Example 1.

[0247] This comparative example is intended to demonstrate the effect of pH value on formulation stability and skin compatibility by comparison with Example 1. A lower pH value may cause instability of certain active ingredients and may irritate the skin, affecting comfort and safety of use.

[0248] Comparative Example 6

[0249] A freckle-removing and muscle-regenerating cream preparation based on microemulsion technology and its preparation method

[0250] This comparative example is intended to verify the importance of the antioxidant combination. Its components are the same as those in Example 2, but only tocopherol is used as an antioxidant and butylated hydroxyanethole is removed. The specific components are as follows (by weight): 15 parts of Xinjiang Lithospermum officinale extract, 10 parts of Paeonia suffruticosa extract, 10 parts of Rehmannia glutinosa extract, 8 parts of Angelica dahurica extract, 8 parts of Astragalus extract, 5 parts of Myrrha extract, 5 parts of Centella asiatica extract, 5 parts of Hamamelis Virginiana extract, 8 parts of Angelica sinensis extract, 3 parts of pearl powder, 30 parts of camellia oil, 40 parts of purified water, 15 parts of soybean lecithin, 8 parts of polysorbate 80, 10 parts of propylene glycol, 8 parts of glycerol, 1 part of carbomer, 2 parts of hydroxypropyl methylcellulose, 0.5 parts of sodium benzoate, and 0.5 parts of tocopherol.

[0251] The preparation method is the same as that of Example 2, except that the addition of butyl hydroxyanethole is removed in step (8).

[0252] This comparative example is intended to demonstrate the effect of the antioxidant combination on the long-term stability of the formulation by comparison with Example 2. The lack of synergistic antioxidants may cause the formulation to be more easily oxidized during storage, affecting its long-term stability and effectiveness.

[0253] In order to comprehensively evaluate the effectiveness and superiority of the present invention, a series of test experiments were designed to verify the core innovations of the present invention, including the application of microemulsion technology, the synergistic effect of active ingredients, the stability and bioavailability of the preparation, etc.

[0254] Experiment 1: Particle size analysis and stability test

[0255] Experimental purpose: To evaluate the particle size distribution and long-term stability of microemulsion formulations.

[0256] Experimental methods:

[0257] 1. The particle size distribution of each embodiment and comparative example was measured using a dynamic light scattering instrument (DLS).

[0258] 2. The samples were stored at 25°C, 4°C and 40°C for 6 months, and the particle size distribution and Zeta potential were measured once a month.

[0259] 3. The centrifugal stability of the preparation was evaluated by centrifugation test (4000, 30 min).

[0260] The experimental results are as follows:

[0261] Table 1. Initial particle size and stability data after 6 months for each example and comparative example

[0262]

[0263] Results analysis: Examples 1-4 exhibited excellent particle size distribution and long-term stability, with Example 1 performing best. Comparative Example 2 had a significantly larger particle size and poorer stability due to the lack of microemulsion technology. Comparative Examples 3 and 4 also had increased particle size and decreased stability due to the adjustment of surfactant ratios and homogenization parameters.

[0264] Experiment 2: In vitro transdermal absorption test

[0265] Purpose of the experiment: To evaluate the transdermal penetration ability of the active ingredients in the preparation.

[0266] Experimental methods:

[0267] 1. Franz diffusion cell and pig skin were used as skin models.

[0268] 2. Add 0.5 g of the preparation to the donor compartment and PBS buffer (pH 7.4) to the receptor compartment.

[0269] 3. Incubate at 37°C for 24 hours, sampling every 4 hours.

[0270] 4. The contents of shikonin and paeonol in the receptor fluid were determined using HPLC method.

[0271] Experimental results:

[0272] sample Shikonin Paeonol Example 1 42.5 38.2 Example 2 45.8 41.3 Example 3 44.2 39.7 Example 4 43.6 40.1 Comparative Example 1 35.1 32.4 Comparative Example 2 18.3 16.7 Comparative Example 3 28.6 25.9 Comparative Example 4 25.4 23.2 Comparative Example 5 40.2 36.8 Comparative Example 6 41.9 37.5

[0273] Results analysis: Examples 1-4 all showed excellent transdermal absorption effects, among which Example 2 had the best effect. Comparative Example 2 had significantly reduced transdermal absorption effects due to the lack of microemulsion technology. Comparative Examples 1, 3 and 4 also had inferior transdermal absorption effects to those of the Examples due to adjustments in formulation or process.

[0274] Experiment 3: Antioxidant activity test

[0275] Experimental purpose: To evaluate the antioxidant capacity of the preparation.

[0276] Experimental methods:

[0277] 1. Use DPPH free radical scavenging method.

[0278] 2. Dilute the preparation 100 times and react with DPPH solution for 30 minutes.

[0279] 3. Measure the absorbance at a wavelength of 517 nm using a UV spectrophotometer.

[0280] 4. Calculate the DPPH free radical scavenging rate.

[0281] Experimental results:

[0282]

[0283]

[0284] Results: Examples 1-4 all showed excellent antioxidant activity, with Example 2 having the best effect. Comparative Example 1 had significantly reduced antioxidant activity due to the lack of some active ingredients. Comparative Example 6 also had a reduced effect due to the lack of a synergistic antioxidant.

[0285] According to the above test results, Example 2 can be considered as the best example of the present invention. It not only exhibits excellent particle size distribution and long-term stability, but also has the best transdermal absorption effect and antioxidant activity.

[0286] The present invention demonstrates some unexpected technical effects:

[0287] 1. Ultra-high stability: Microemulsion technology combined with an optimized surfactant ratio ensures that the particle size of the preparation does not change by more than 5% during a 6-month storage period, which is much better than traditional emulsions. This high stability may be due to the fact that the microemulsion system forms a thermodynamically stable structure that effectively prevents phase separation.

[0288] 2. Synergistic effect: The unique combination of active ingredients not only improves transdermal absorption, but also significantly enhances antioxidant activity. This may be due to the synergistic effect between the active ingredients in different Chinese herbal extracts, for example, shikonin and paeonol may form a complex that enhances their ability to penetrate the skin barrier.

[0289] 3. The key role of pH adjustment: Experimental results show that adjusting the pH to about 6.5 not only improves the stability of the preparation, but also significantly enhances the transdermal absorption of the active ingredient. This may be because at this pH, the active ingredient is in the best ionized state, which is conducive to its transmembrane transmission.

[0290] 4. Long-term effect of the antioxidant system: By rationally combining tocopherol and butylated hydroxyanethole, the present invention realizes a long-term antioxidant protection system. This not only protects the active ingredients in the preparation, but also provides continuous antioxidant protection for the skin, helping to reduce the damage of free radicals to the skin.

[0291] 5. Optimization effect of microemulsion particle size: Experimental data show that when the microemulsion particle size is controlled at around 90nm, the transdermal absorption effect is optimal. This finding provides an important reference for the optimization of microemulsion preparations, suggesting that there is an optimal particle size range that can maximize the transdermal absorption of active ingredients while maintaining the stability of the preparation.

[0292] In general, the present invention realizes a freckle-removing and skin-regenerating cream with high stability and high bioavailability through microemulsion technology, a well-designed formula and an optimized preparation process. This preparation not only has excellent physical and chemical properties, but also exhibits significant biological activity, providing an important idea for the development of a new generation of efficient and safe skin care products.

[0293] The above description is only an embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent substitution, improvement, etc. made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A novel preparation of freckle-removing and muscle-regenerating cream based on microemulsion technology, characterized in that: By weight, it includes the following components: Active ingredient 17.5-77 parts; 10-30 parts of oil phase; 40-70 parts of aqueous phase; 7-23 parts of surfactant; 5-18 parts of co-surfactant; Stabilizer 0.7-3 parts; Preservative 0.1-0.5 parts; Antioxidant 0.1-0.5 parts.

2. The preparation according to claim 1, characterized in that The active ingredients include: 5-15 parts of Xinjiang Lithospermum officinale extract; 3-10 parts of Paeonia suffruticosa root extract; 3-10 parts of Rehmannia root extract; 2-8 parts of Angelica dahurica extract; 2-8 parts of Astragalus extract; 1-5 parts of myrrh extract; 1-5 parts of Centella asiatica extract; 1-5 parts of witch hazel extract; 2-8 parts of angelica extract; 0.5-3 parts of pearl powder.

3. The preparation according to claim 1, characterized in that The oil phase is camellia oil.

4. The preparation according to claim 1, characterized in that The surfactants include: 5-15 parts of soybean lecithin; Polysorbate 802—8 parts.

5. The preparation according to claim 1, characterized in that The co-surfactant comprises: Propylene glycol 3-10 parts; 2-8 parts of glycerol.

6. The preparation according to claim 1, characterized in that The stabilizer includes: Carbomer 0.2-1 part; Hydroxypropyl methylcellulose 0.5-2 parts.

7. The preparation according to claim 1, characterized in that The preservative is sodium benzoate.

8. The preparation according to claim 1, characterized in that The antioxidants include: Tocopherol 0.1-0.5 parts; Butylated hydroxyanethole 0.01-0.1 parts.

9. A method for preparing the preparation according to any one of claims 1 to 8, characterized in that: The following steps are involved: (1) First, extract the active ingredients: a) crushing Xinjiang lithospermum, peony bark and raw rehmannia into 80 mesh sieve, adding 10 times amount of 70% ethanol, and performing ultrasonic extraction at 50°C, power of 300W, frequency of 40kHz, 30 minutes each time, and repeating 3 times; b) Grind the angelica dahurica and astragalus membranaceus into 80 mesh sieve, add 8 times amount of water, and perform microwave extraction at 80°C, power of 600W, frequency of 2450MHz, 15 minutes each time, and repeat 2 times; c) Grinding myrrh and Centella asiatica into 80 mesh sieve, extracting with supercritical CO2 at a pressure of 25 MPa and a temperature of 45° C. for 2 hours; d) Grind Hamamelis and Angelica sinensis into 80-mesh sieve, add 8 times amount of 50% ethanol, and perform pressurized hot reflux extraction at 85° C. for 2 hours each time, and repeat 2 times; e) combining the above extracts, concentrating under reduced pressure to a relative density of 1.10-1.15 (60° C.), to obtain each Chinese medicine extract; (2) Secondly, prepare the oil phase: Heat camellia oil to 65℃ and stir evenly; (3) Then, prepare the aqueous phase: Heat purified water to 65°C, add propylene glycol, glycerin, and sodium benzoate in sequence, and stir to dissolve; (4) Again, prepare an emulsifier mixture: Mix soy lecithin and polysorbate 80 in a ratio of 4:1, heat to 65°C to completely melt, and stir evenly; (5) Next, prepare a microemulsion: a) slowly adding the oil phase into the emulsifier mixture and high shearing (12000) for 8 minutes; b) slowly adding the mixture into the aqueous phase and continuing high-speed shearing for 12 minutes to form colostrum; c) passing the colostrum through a high-pressure homogenizer at a pressure of 80 MPa and a temperature of 60° C. for 5 cycles to obtain a microemulsion; (6) Then, add other components: a) dissolving carbomer in a small amount of water and stirring until fully swollen; b) dissolving hydroxypropyl methylcellulose in 65° C. hot water; c) slowly adding the two solutions into the microemulsion and stirring evenly; (7) Then, add active ingredients: Add each Chinese medicine extract and pearl powder into the microemulsion in sequence and stir evenly; (8) Further, adding antioxidants: Add tocopherol and butyl hydroxyanethole into the microemulsion and stir well; (9) Then, adjust the pH: Adjust pH to 6.5 with triethanolamine; (10) Finally, filling: Fill the prepared microemulsion into a clean soft tube and seal it.

10. The preparation method according to claim 9, characterized in that: The method further comprises performing particle size analysis, Zeta potential measurement and transmission electron microscope observation on the prepared microemulsion to ensure that the particle size of the microemulsion is about 100 nm and the absolute value of the Zeta potential is greater than 30 mV.

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