A fascia knife lubricating composition with muscle relaxation effect and its preparation process

Abstract

This invention discloses a fascia knife lubricating composition with muscle relaxation effects and its preparation process, belonging to the field of external traditional Chinese medicine compositions and rehabilitation therapy technology. The composition comprises: sweet almond oil, dimethyl silicone oil, *Lycopodium clavatum* extract, *Clematis chinensis* extract, safflower extract, *Artemisia argyi* extract, azone, carbomer, vitamin E, an encapsulated cooling agent, and deionized water as the balance. The preparation process includes alcohol extraction of traditional Chinese medicine, volatile oil encapsulation, high-pressure homogenization emulsification, and gradient temperature-controlled maturation. After high-pressure homogenization, the oil droplet size of the composition is 100-200 nm, the viscosity at 25℃ is 15000-30000 mPa·s, and the thixotropic index is 3.0-6.0. It possesses both excellent lubrication properties and muscle-relaxing effects, exhibiting a significant physical-biological synergistic effect when used with a fascia knife.

Description

Technical Field

[0001] This invention belongs to the field of external Chinese medicine composition and rehabilitation therapy technology, specifically a fascia knife lubricating composition with muscle relaxation effect and its preparation process. Background Technology

[0002] Fascial knife technology is a soft tissue release therapy that combines traditional Chinese medicine scraping (gua sha) with modern rehabilitation medicine. It uses a stainless steel blade to apply mechanical stress to the fascia layer through directional sliding on the skin surface, thereby achieving the therapeutic goals of releasing fascial adhesions, relieving muscle tension, and promoting local metabolism. In recent years, with the rapid development of the sports rehabilitation and fitness industry, the application of fascial knives in professional rehabilitation institutions, fitness venues, and even home use has become increasingly widespread. During fascial knife operation, the choice of lubricating medium is crucial: insufficient lubrication will lead to skin pulling, redness, swelling, or even damage due to the high coefficient of friction between the blade and the skin, severely affecting the treatment experience and results; excessive lubrication or a medium with too high fluidity will prevent the blade from maintaining adequate contact with the skin, making it difficult for the operator to obtain accurate tactile feedback from the fascial nodules, affecting the precise transmission of treatment force. Simultaneously, the high-speed reciprocating sliding of the blade during fascial knife operation will continuously rub against the skin surface. If the lubricating medium does not have sufficient oil film strength and long-lasting film-forming ability, it will be unable to maintain a stable lubrication state throughout the operation, requiring repeated reapplication of the medium and affecting the continuity of treatment. Therefore, an ideal lubricant for a fascia knife should meet specific requirements in both physical lubrication properties and operational compatibility. However, there are currently no dedicated lubricant products on the market specifically designed and validated for fascia knife operation scenarios. In clinical practice, ordinary massage creams, silicone oils, or gua sha oils are often used as substitutes. These products have not been optimized for fascia knife operation in terms of key parameters such as viscosity, thixotropy, and coefficient of friction, resulting in problems such as poor lubrication, easy leakage, and poor user experience.

[0003] Several related products already exist in the prior art, but all have different shortcomings. A specially formulated health-promoting lubricant (Chinese patent application No. 201510899178.9, CN106852950A) discloses a specially formulated health-promoting lubricant composed of 80-90% base liquid, 0.1-10% mineral powder, 0.1-10% transdermal penetration enhancer, and 0.1-10% plant extract or traditional Chinese medicine, possessing both lubricating properties and health-promoting functions such as far-infrared radiation, magnetism, and negative ions. However, this product is a liquid dosage form, and due to insufficient viscosity, it easily flows and is lost during fascia knife operations, failing to form a continuous and stable lubricating protective film on the skin surface. Its function mainly comes from the physical effects of the mineral powder (far-infrared radiation, negative ions, etc.). Although it claims to improve microcirculation, the product formula does not contain traditional Chinese medicine ingredients for relieving muscle tension, thus its effect on alleviating muscle tension is limited, failing to meet the core requirement of simultaneously releasing fascia and relieving muscle tension during fascia knife operations. A herbal massage lotion for promoting blood circulation and unblocking meridians (Chinese Patent Application No. 201710515675.3, CN107157854A) discloses a herbal massage lotion for promoting blood circulation and unblocking meridians and its preparation method. The herbal ingredients include Ligusticum chuanxiong, frankincense, Salvia miltiorrhiza, Spatholobus suberectus, safflower, Sappanwood, Achyranthes bidentata, Lycopodium clavatum, and Acanthopanax senticosus, which can improve the nervous system and promote the smooth flow of qi and blood. This product uses polydimethylsiloxane as a lubricating ingredient and contains Lycopodium clavatum, safflower, and other herbal ingredients that promote blood circulation and unblock meridians, showing similarity to this invention in some components. However, this product is explicitly labeled as a "massage lotion," and its viscosity design and rheological properties are optimized entirely for human hand massage scenarios—the shear rate and pressure of human hand massage are far lower than those of fascia knife operations. Therefore, the viscosity and thixotropy of this product cannot adapt to the high-speed, high-pressure, and high-shear mechanical conditions of fascia knife operations. Furthermore, this product uses a water extraction method to prepare the herbal extract, resulting in limited extraction efficiency and transdermal absorption efficiency of the active ingredients, leading to a weaker therapeutic effect on deep fascia tissues. A massage drug for treating soft tissue injuries (Chinese patent application number 201210146540.X, CN102641338A) discloses a massage drug for treating soft tissue injuries, prepared using a reflux extraction process, which combines lubrication, muscle relaxation, anti-inflammatory, analgesic, and microcirculation-improving effects. This patent explicitly states that in the prior art, "talcum powder or water as a massage lubricating medium only has a lubricating effect and does not increase the therapeutic effect of massage." The inventive concept of this patent—combining lubrication with the therapeutic effects of traditional Chinese medicine—is quite similar to that of this invention. However, its traditional Chinese medicine formula focuses on the analgesic effects of Corydalis and Ligusticum chuanxiong, and does not include core traditional Chinese medicine combinations such as Lycopodium clavatum, Clematis armandii, Carthamus tinctorius, and Artemisia argyi, which are used to relax muscles and tendons. Furthermore, it does not involve the systematic optimization of lubrication parameters (viscosity, thixotropy, coefficient of friction) for the fascia knife operation scenario, nor does it employ any technical means to promote the transdermal targeted delivery of active ingredients of traditional Chinese medicine.

[0004] In summary, no existing fascia knife lubricant product simultaneously meets the following conditions: First, it possesses physical performance parameters such as viscosity, thixotropy, and coefficient of friction that match the mechanical characteristics of fascia knife operation (high shear rate, high pressure, high-speed reciprocating sliding); second, it contains traditional Chinese medicine ingredients scientifically formulated according to the principles of traditional Chinese medicine, which can provide physical lubrication and protection while effectively relaxing muscles; third, the transdermal absorption efficiency of the active ingredients of the traditional Chinese medicine is sufficiently high, enabling rapid penetration and action on deep fascia and muscle tissue within the limited time of fascia knife operation. Therefore, developing a lubricating composition and its preparation process specifically designed for fascia knife operation, possessing both excellent physical lubrication performance and significant muscle relaxation effects, and allowing for efficient transdermal delivery of active ingredients of traditional Chinese medicine to target tissues, has significant clinical value and broad market application prospects. Summary of the Invention

[0005] The purpose of this invention is to provide a fascia knife lubricating composition with muscle relaxation effects and its preparation process, overcoming the shortcomings of existing fascia knife lubricating products such as limited functionality, mismatch between lubrication performance and the mechanical conditions of fascia knife operation, low transdermal absorption efficiency of active ingredients from traditional Chinese medicine, and lack of a scientific system for optimizing physical performance parameters. Specifically, this invention aims to provide a lubricating composition through scientific formulation design and innovative preparation process, possessing both excellent physical lubrication performance and significant muscle relaxation effects; precise matching of key physical parameters (viscosity, thixotropic index, coefficient of friction) with the mechanical properties of fascia knife operation; and efficient delivery of active ingredients from traditional Chinese medicine to the fascia layer through the synergistic effect of nanoemulsion structure and transdermal enhancers. This significantly improves the efficacy, safety, and user experience of fascia knife operation, filling a technological gap in this field.

[0006] The complete technical solution of this invention has been described in detail in the claims, and is further summarized and supplemented here: (I) Formulation system of the composition and its scientific basis The fascia knife lubricating composition provided by this invention comprises sweet almond oil, dimethyl silicone oil, *Lycopodium clavatum* extract, *Clematis chinensis* extract, safflower extract, *Artemisia argyi* extract, azone, carbomer, vitamin E, an encapsulated cooling agent, and deionized water. The weight proportions of each component are as follows. The core feature of this formulation lies in the scientific ratio and synergistic mechanism of the components.

[0007] 1. Optimized Combination and Synergistic Mechanism of Basic Lubricating Components: This invention uses 60-70 parts of sweet almond oil and 10-15 parts of dimethyl silicone oil to form a basic lubricating system, wherein the mass ratio of sweet almond oil to dimethyl silicone oil is 4:1-7:1. Sweet almond oil is a natural plant oil obtained by cold pressing of the mature seeds of the sweet almond plant (Prunus armeniaca), a member of the Rosaceae family. Its fatty acid composition contains approximately 60%-70% oleic acid and 20%-30% linoleic acid, which is highly similar to the fatty acid composition of human sebum. Therefore, it has excellent skin compatibility and mildness, and long-term use will not cause skin irritation or allergic reactions. More importantly, sweet almond oil has a moderate stratum corneum penetration and softening effect—its oleic acid molecules can insert into the lipid bilayer of the stratum corneum, disrupting the orderly arrangement of lipid molecules, increasing the fluidity and permeability of the stratum corneum, thereby creating favorable conditions for the transdermal delivery of active ingredients from traditional Chinese medicine. Dimethyl silicone oil, a linear polydimethylsiloxane, is a chemically inert synthetic silicone oil with extremely low surface tension, excellent spreadability, and lubricity. It forms a continuous, hydrophobic, and highly flexible protective film on the skin surface. The film-forming effect of dimethyl silicone oil not only significantly reduces the coefficient of friction between the fascia knife and the skin, minimizing the risk of skin pulling and damage during the procedure, but also prevents the stratum corneum from curling or detaching under the mechanical pressure of the fascia knife, maintaining the structural integrity of the skin barrier. When sweet almond oil and dimethyl silicone oil are compounded in the specific ratio defined in this invention, the sweet almond oil molecules fill the micropores between the polymer chains of the dimethyl silicone oil, forming a continuous and uniform composite lubrication interface—dimethyl silicone oil provides the main framework and long-lasting lubrication protection, while sweet almond oil imparts moderate permeability and skin affinity to the interface. This "rigid-flexible" composite lubrication system gives the composition high lubrication efficiency, long-lasting oil film strength, good skin compatibility, and an auxiliary promoting effect on the transdermal delivery of traditional Chinese medicine components.

[0008] 2. Scientific Compatibility and Pharmacodynamic Basis of Four Chinese Medicines: The composition of the present invention contains 3-5 parts of Lycopodium clavatum extract, 2-3 parts of Speranskia tuberculata extract, 1-2 parts of Carthamus tinctorius extract, and 1-2 parts of Artemisia argyi extract. The four Chinese medicines are compatible according to the principle of monarch, minister, assistant, and guide in traditional Chinese medicine theory. Lycopodium clavatum is the dried whole herb of Lycopodium clavatum L., which is bitter, pungent, and warm in nature, and belongs to the liver, spleen, and kidney meridians. It has the effects of dispelling wind and dampness, relaxing tendons and activating collaterals, and is the monarch drug of this formula, mainly attacking the core pathogenesis such as muscle tension, fascia adhesion, and tendon vessels spasm targeted by fascia knife operation. Modern pharmacological research shows that Lycopodium clavatum contains rich triterpenoid saponin components (such as lycoclavanoside, etc.), which have definite anti-inflammatory, analgesic, and skeletal muscle relaxation activities, and can significantly promote local blood circulation. Speranskia tuberculata is the dried stem of Impatiens balsamina L., which is pungent, bitter, and warm in nature, and belongs to the liver and kidney meridians. It has the effects of dispelling wind and dampness, relaxing tendons and activating collaterals, promoting blood circulation to relieve pain; Carthamus tinctorius is the dried flower of Carthamus tinctorius L., which is pungent and warm in nature, and belongs to the heart and liver meridians. It has the effects of promoting blood circulation to dredge the meridian, dissipating stasis and relieving pain. The two together are minister drugs, assisting the monarch drug Lycopodium clavatum to enhance the effects of relaxing tendons and activating collaterals, promoting blood circulation to remove blood stasis - Speranskia tuberculata focuses on dispelling wind and dampness, dredging collaterals, and Carthamus tinctorius focuses on promoting blood circulation to remove blood stasis and improving microcirculation. The three drugs are combined, emphasizing both dispelling wind and promoting blood circulation, and simultaneously dredging collaterals and removing blood stasis. The main active components in Carthamus tinctorius, safflower yellow pigment and safflower glycoside compounds, have been confirmed by modern pharmacology to be able to significantly dilate blood vessels, improve microcirculation, inhibit platelet aggregation, and reduce blood viscosity, which is of great significance for relieving blood circulation disorders in the fascia knife operation area. Artemisia argyi is the dried leaf of Artemisia argyi Levl. & Vaniot, which is pungent, bitter, and warm in nature, and belongs to the liver, spleen, and kidney meridians. It has the effects of warming the meridian to stop bleeding, dispersing cold and relieving pain, and is the assistant and guide drug. Artemisia argyi plays a dual role in this formula: First, warming the meridian and dispelling cold, assisting the monarch and minister drugs to disperse the cold and damp evils between muscles and fascia; Second, Artemisia argyi is rich in volatile oils (the main components are eucalyptol, thujone, camphor, etc.), which have a local mild stimulating and warming effect, and can make the operation site produce a comfortable warm feeling, further enhancing the treatment experience. The four Chinese medicines act synergistically to achieve the combined effects of dispelling wind and cold, relaxing tendons and activating collaterals, promoting blood circulation to remove blood stasis, and warming the meridian to dredge collaterals, and effectively intervene at multiple levels and multiple targets for the pathological states such as muscle tension, fascia adhesion, and qi and blood stasis targeted by fascia knife operation.

[0009] 3. Selection and Dosage Optimization of Transdermal Transmission Enhancers and Thickeners: This invention selects azone (laurocapram) as the transdermal transmission enhancer, with a dosage of 0.5-1 part. Laurocapram is currently recognized as one of the most widely applicable and effective chemical transdermal transmission enhancers. Its mechanism of action involves reversibly inserting into the lipid bilayer of the stratum corneum, disrupting the tight and orderly arrangement of lipid molecules, increasing the fluidity and permeability of the lipid bilayer, thereby reducing the diffusion resistance of drug molecules through the stratum corneum. The unique advantage of laurocapram lies in its selectivity—it mainly acts on the intercellular lipids of the stratum corneum without significantly damaging active epidermal cells. The stratum corneum barrier function can be rapidly restored after discontinuation, thus exhibiting high safety. In this invention, laurocapram and sweet almond oil, a basic lubricating ingredient, form a synergistic penetration-enhancing effect: the moderate penetration of sweet almond oil pre-softens the stratum corneum, increasing its fluidity and creating more favorable conditions for the insertion and action of laurocapram; while the penetration-enhancing effect of laurocapram further improves the skin permeability of the active ingredients of traditional Chinese medicine, allowing more effective ingredients such as *Lycopodium clavatum* triterpenoid saponins and safflower yellow pigment to reach the dermis and fascia layers to exert their therapeutic effects. This invention uses carbomer as a thickener, with a dosage of 0.3-0.5 parts. Carbomer is a high molecular weight polymer crosslinked with acrylic acid and allyl sucrose or pentaerythritol allyl ether. After swelling in water, the carboxyl groups on its molecular chains ionize under alkaline conditions, generating electrostatic repulsion, causing the molecular chains to fully extend and entangle with each other, forming a three-dimensional network structure. This network structure endows the composition with two key properties: first, suitable viscosity, ensuring that the composition remains a paste-like consistency without dripping when at rest, facilitating application and retention at the treatment site; second, significant thixotropy—the property that viscosity decreases with increasing shear rate and recovers after shearing stops, which is crucial for fascia knife applications. Vitamin E, as an antioxidant, is used at a dosage of 0.5-1 part. Its function is to prevent the unsaturated fatty acids in sweet almond oil from oxidizing and becoming rancid during long-term storage, extending the product's shelf life. Simultaneously, vitamin E itself also moisturizes the skin and promotes skin repair.

[0010] 4. Innovative Introduction of Embedded Cooling Agent: This invention introduces 0.5-1.5 parts of an embedded cooling agent into the composition. This cooling agent is an inclusion complex formed by menthol and hydroxypropyl-β-cyclodextrin. Menthol is the main active ingredient in peppermint volatile oil, possessing cooling, antipruritic, mild analgesic, and local vasoconstrictive effects, and is widely used in topical preparations to enhance user comfort. However, menthol has strong volatility and chemical instability. Direct addition to the composition easily leads to volatilization loss during production, storage, and use, resulting in a significant decrease in cooling effect over time, and making it difficult to guarantee consistency between product batches. More importantly, free menthol releases a large amount of cooling sensation upon application. This "one-off burst" cooling effect is not only short-lived but also does not match the actual needs of fascia knife operation—pain and discomfort during operation mainly occur during the intensive scraping phase of the knife, rather than the instant of application. This invention employs inclusion technology to encapsulate menthol as a guest molecule within the hydrophobic cavity of the host molecule, hydroxypropyl-β-cyclodextrin. Hydroxypropyl-β-cyclodextrin is a hydroxypropylated derivative of β-cyclodextrin, possessing a cyclic barrel structure with an inner hydrophobic and an outer hydrophilic structure. Its hydrophobic cavity can accommodate menthol molecules to form a stable inclusion complex. After inclusion, the menthol molecules are effectively "shielded" within the cyclodextrin cavity, significantly reducing volatility and greatly enhancing chemical stability. More importantly, the encapsulation structure endows menthol with a unique "friction-triggered release" property. During normal storage and initial application, menthol is stably protected within the inclusion complex, resulting in almost no or only a very slight cooling sensation. When the composition is applied to the skin and the fascia knife operation begins, the high-speed reciprocating motion of the blade generates frictional heat locally, raising the skin temperature at the treatment site to approximately 37-40°C. Simultaneously, the shearing force applied by the blade mechanically disturbs the inclusion complex structure, weakening the binding effect of the hydroxypropyl-β-cyclodextrin cavity on the menthol. The menthol is gradually released from the inclusion complex, producing an immediate and continuous cooling sensation. This "on-demand release" mechanism achieves a dynamic match between the cooling sensation and the intensity of the fascia knife operation—the more intensive the operation and the more intense the friction, the greater the amount of menthol released and the stronger the cooling sensation, precisely relieving deep pressure pain and discomfort in that area, thereby significantly improving user comfort and compliance throughout the treatment process.

[0011] After high-pressure homogenization and gradient temperature-controlled curing, the composition of this invention possesses the following key physical parameters that have been rigorously tested and optimized. These parameters collectively constitute one of the core technical features of this invention: 1. Oil Droplet Size: The average droplet size in the composition is controlled within the range of 100-200 nm, preferably 120-180 nm. This size range is based on clear theoretical grounds and experimental support. Transdermal delivery theory studies have shown that emulsion particles larger than 500 nm mainly diffuse via the intercellular lipid pathway, resulting in low transdermal efficiency and limited delivery depth. While particles smaller than 50 nm have extremely high transdermal efficiency, they are difficult to prepare, costly, and may raise safety concerns. Nanoemulsions with a particle size between 100-200 nm can specifically penetrate deep into the skin via a "bypass" route through skin appendages such as hair follicles and sweat glands. The opening diameter of the hair follicle infundibulum is approximately 50-100 μm, while the inner diameter of the hair follicle canal is approximately 10-20 μm. Nanoscale oil droplets can smoothly enter the hair follicle canal and penetrate downwards into the dermis, thus bypassing the dense intercellular lipid barrier of the stratum corneum, a major rate-limiting step in transdermal delivery. Furthermore, the extremely high specific surface area of ​​nano-sized oil droplets (the surface area per unit volume is inversely proportional to the particle size) means a significant increase in the contact area between the active ingredients and the stratum corneum and hair follicle walls, further promoting the release and absorption of the traditional Chinese medicine components. This invention achieves efficient, safe, and targeted transdermal delivery by precisely controlling the oil droplet size to 100-200 nm through a high-pressure homogenization process.

[0012] 2. Viscosity: The viscosity of the composition at 25°C is controlled within the range of 15,000-30,000 mPa·s, preferably 18,000-25,000 mPa·s. This viscosity range is determined based on a systematic study of the actual operating conditions of the fascia knife. If the viscosity is too low (e.g., below 10,000 mPa·s), the composition is easily dissipated by gravity after application, making it difficult to remain stably on the operating site, resulting in discontinuous lubrication and protection, requiring frequent reapplication, and affecting the continuity and efficiency of treatment. If the viscosity is too high (e.g., above 35,000 mPa·s), the composition is difficult to apply evenly, resulting in excessive resistance during application, and the initial resistance during fascia knife sliding is too high, affecting the smoothness of operation and the precision of the feel. The viscosity range of 15,000-30,000 mPa·s lies precisely between the two unfavorable extremes mentioned above, allowing the composition to remain as a stable paste in a static state, which can be evenly applied and maintained on the operating site without flowing or being too viscous, thus avoiding affecting the application and feel of the operation.

[0013] 3. Thixotropic index: The thixotropic index of the composition is controlled within the range of 3.0-6.0, preferably 4.0-5.5. The thixotropic index is defined as the index of the composition at a shear rate of 1 s⁻¹. -1 The viscosity and shear rate at 10 s⁻¹ -1The ratio of viscosity to shear rate is an important indicator of the strength of thixotropy in non-Newtonian fluids. A higher thixotropic index indicates a greater decrease in viscosity with increasing shear rate, meaning a more pronounced "shear-thinning" effect. This invention selects a thixotropic index range of 3.0-6.0 based on analysis of the shear rate during fascia knife application: the shear rate of manually applied compositions is typically between 0.1 and 1 second. -1 At this level, the composition exhibits a high viscosity, facilitating application control and retention at the treatment site; the shear rate during fascia knife gliding can reach 10-100 s. -1 At this point, the viscosity of the composition decreases significantly due to the thixotropic effect, becoming smooth and easy to apply, greatly reducing the frictional resistance between the blade and the skin. Once the blade has passed and the shearing force has disappeared, the three-dimensional network structure of the composition rapidly recovers through hydrogen bonding and molecular chain entanglement, and the viscosity returns to its initial level within seconds, reverting to a paste-like consistency. This avoids the problems of dripping and staining clothing caused by excessively low viscosity. This dynamic rheological property—"paste-like when still, liquid-like when in motion, and rapid transition between stillness and motion"—perfectly matches the operational scenarios of the fascia knife of this invention.

[0014] 4. Coefficient of Friction: The coefficient of friction of the composition, measured under conditions of room temperature (25°C), normal load (2.0 N), and sliding speed (50 mm / s), is controlled within the range of 0.06-0.12, preferably 0.08-0.10. The coefficient of friction is a quantitative indicator directly reflecting the friction-reducing effect of the lubricating medium. If the coefficient of friction is too high (e.g., greater than 0.15), the friction between the fascia knife and the skin is excessive, increasing the operator's force burden and, more seriously, easily leading to tearing, damage, or even breakage of the stratum corneum, causing pain and discomfort to the patient. If the coefficient of friction is too low (e.g., less than 0.05), the fascia knife slips too much on the skin surface, preventing the operator from obtaining tactile feedback from pathological structures such as fascial nodules and cord-like adhesions, affecting the accuracy of diagnosis and the targeting of treatment. The coefficient of friction range of 0.08-0.10 is the "optimal operating window" determined by the experimental research of this invention—within this range, the skin can be effectively protected from frictional damage while ensuring that the operator obtains clear tactile feedback, achieving precise treatment.

[0015] (III) Key steps in the preparation process and their innovations 1. Extraction Process of Traditional Chinese Medicine: This invention uses 65%-75% ethanol as the extraction solvent and performs two reflux extractions. The choice of ethanol concentration takes into account the extraction efficiency of different polarity active ingredients, such as triterpenoid saponins in *Lycopodium clavatum* (easily soluble in high-concentration ethanol), safflower yellow pigment in *Carthamus tinctorius* (strongly water-soluble), and volatile oil in *Artemisia argyi* (alcohol-soluble). Reflux extraction can increase the extraction temperature and accelerate the mass transfer process, significantly shortening the extraction time and improving the extraction efficiency compared to cold maceration and percolation methods. The two extractions ensure the full dissolution of active ingredients in the raw materials of traditional Chinese medicine.

[0016] 2. Preparation of Encapsulated Cooling Agent: Inclusion complexes of menthol and hydroxypropyl-β-cyclodextrin were prepared using the saturated aqueous solution method. A high inclusion rate was ensured by controlling the mass ratio of menthol to hydroxypropyl-β-cyclodextrin to be 1:4-1:8, the inclusion temperature to be 40-60℃, and the inclusion time to be 1-3 hours. After inclusion, the inclusion complex was allowed to precipitate fully by low-temperature standing, followed by vacuum drying to remove residual moisture and free menthol, yielding a stable solid inclusion complex powder.

[0017] 3. High-Pressure Homogenization Process: In this invention, the primary emulsion is subjected to high-pressure homogenization at 50-80 MPa, 2-4 times, preferably 3 times at 60-70 MPa. High-pressure homogenization is the key process innovation of this invention. Its mechanism is as follows: Under high pressure, the primary emulsion passes through the tiny gap of the homogenization valve, undergoing intense shearing, high-speed impact, and cavitation effects caused by instantaneous pressure release. The combined effect of these three effects breaks the oil droplets from the micron level to the nanometer level (100-200 nm). High-pressure homogenization has multiple purposes and effects: (i) it forms stable oil-in-water nanoemulsions, significantly improving the physical and storage stability of the emulsion and preventing oil-water separation and oil droplet aggregation; (ii) it encapsulates water-soluble components (such as polysaccharides, some flavonoid glycosides, safflower yellow pigment, etc.) in the aqueous phase and dissolves lipid-soluble components (such as triterpenoid saponins and volatile oils) inside the oil droplets, forming a biphasic drug-carrying system, which improves the drug loading and stability of active ingredients with different polarities; (iii) the formation of nano-sized oil droplets creates particle size conditions for transdermal targeted delivery of active ingredients via skin appendages; (iv) the high specific surface area of ​​the nanoemulsion increases the contact area and release rate between lubricating and active ingredients and the skin, improving lubrication efficiency and the speed of drug efficacy. During homogenization, the temperature of the feed solution is controlled to not exceed 45°C by a cooling jacket, avoiding the damage of high temperature to the active ingredients of traditional Chinese medicine (especially heat-sensitive volatile oils and glycosides).

[0018] 4. Gradient Temperature Controlled Curing Process: The product after high-pressure homogenization is first cured at 35-40℃ for 4-8 hours (preferably at 38℃ for 6 hours), and then slowly cooled to room temperature at a cooling rate of 0.5-1.0℃ / min. This gradient temperature controlled curing process is another important technological innovation of this invention. In the higher temperature curing stage, the surfactant molecules (including carbomer molecules and some surface-active traditional Chinese medicine components such as saponins) at the oil-water interface in the composition gain sufficient thermal energy, resulting in a more compact and ordered arrangement at the interface. The oil-water interfacial tension gradually decreases and tends to equilibrium, and the emulsion system evolves towards a thermodynamically stable state. At the same time, the hydrogen bonds and hydrophobic interactions between carbomer molecular chains further develop and improve at a suitable temperature, resulting in a more uniform and robust three-dimensional network structure. In the subsequent slow cooling stage, the thixotropic network of the composition is stably formed under mild conditions of no external force interference and slow temperature changes, avoiding network structure defects and stress concentrations that may be caused by rapid cooling. After gradient temperature curing, the product's viscosity, thixotropy, and stability all reach their optimal state, and batch-to-batch consistency is effectively guaranteed.

[0019] Core Innovation Points (a) Optimization of the physical property parameters of the fascia knife: viscosity-thixotropic index-friction coefficient: Unlike existing technologies that only provide qualitative descriptions of lubrication effects (such as vague terms like "good lubricity," "good spreadability," and "suitable consistency"), this invention explicitly proposes that the composition should simultaneously meet the following quantitative indicators: viscosity of 15000-30000 mPa·s at 25°C, thixotropic index of 3.0-6.0, and coefficient of friction of 0.06-0.12 (preferably viscosity of 18000-25000 mPa·s, thixotropic index of 4.0-5.5, and coefficient of friction of 0.08-0.10). These three parameters correspond to three core performance dimensions of the composition: viscosity determines the rheological behavior of the medium during application and at rest, ensuring that the composition can be evenly applied and stably maintained at the application site without being lost due to gravity; thixotropic index determines the dynamic response characteristics of the medium under the sliding shearing of the fascia knife, ensuring dynamic adaptation of "instantly thinning into a smooth and easy-to-push consistency during operation, and quickly returning to a paste-like consistency without dripping after the knife passes over"; the coefficient of friction directly quantifies the friction-reducing efficiency of the medium, ensuring the best balance between effectively protecting the skin from friction damage and maintaining tactile feedback. The establishment of the three-dimensional parameter optimization system enables the composition of this invention to achieve a systematic and precise match with the mechanical conditions of fascia knife operation for the first time, overcoming the technical defects of selecting lubricating media based on experience and intuition in the prior art. In addition, this parameter system also provides an objective and reproducible evaluation basis for product quality control, standardized production, and the formulation of industry standards, which has important technological progress significance and industrial application value.

[0020] (II) High-pressure homogenization-induced nanoemulsion structure and its transdermal targeted delivery mechanism This invention innovatively introduces high-pressure homogenization technology into the preparation process of the fascia knife lubricating composition. Through high-pressure treatment at 50-80 MPa, the oil droplet size is precisely controlled within the range of 100-200 nm, forming a stable oil-in-water nanoemulsion. This nanoemulsion structure has the following three innovative effects: First, the specific surface area of ​​nano-sized oil droplets is tens of times larger than that of micron-sized oil droplets, significantly increasing the oil-water interface area per unit mass of the composition. This greatly enhances the contact area between the lubricating components and the active ingredients of traditional Chinese medicine and the stratum corneum and hair follicle walls, thereby accelerating the release and absorption of the active ingredients. Secondly, oil droplets with a particle size between 100-200 nm can specifically enter the deep layers of the skin through "bypass pathways" of skin appendages such as hair follicles and sweat glands. The size of the hair follicle infundibulum opening and hair follicle canal provides a natural channel for the entry of nano-oil droplets, allowing the lipid-soluble active ingredients of traditional Chinese medicine encapsulated in the droplets to bypass the dense intercellular lipid barrier of the stratum corneum, the main rate-limiting step in transdermal absorption, and be delivered directly to the dermis and even the fascia layer, achieving true "transdermal targeted delivery." Thirdly, the kinetic stability of the nanoemulsion is significantly better than that of conventional micron-sized emulsions. Due to Brownian motion, the oil droplets are able to overcome gravitational sedimentation and are not prone to aggregation and stratification, which greatly extends the storage stability and shelf life of the product. In vitro transdermal diffusion experiments have confirmed that the 24-hour cumulative penetration of ferulic acid, a representative active ingredient of traditional Chinese medicine in the composition of this invention, is more than 40% higher than that of conventional stirred emulsion products. This innovation successfully crosses over from the fields of cosmetics and pharmaceuticals to the specific product type of fascia knife lubricating medium, achieving significant technological progress.

[0021] (III) The systemic synergistic effect mechanism between physical lubrication function and the bioactivity of traditional Chinese medicine This invention, through meticulous formulation design, establishes and utilizes for the first time a synergistic mechanism between physical lubrication and the bioactivity of traditional Chinese medicine. Sweet almond oil, a basic lubricating component, not only provides lubrication but also acts as a natural transdermal softener. Its oleic and linoleic acids can insert into the lipid bilayer of the stratum corneum, increasing its fluidity and permeability. This reduces barrier resistance and creates favorable penetration conditions for the subsequent transdermal delivery of active ingredients from traditional Chinese medicine. The continuous protective film formed by dimethyl silicone oil effectively reduces frictional damage during fascia knife operation and prevents the stratum corneum from curling, detaching, or breaking under repeated mechanical pressure from the fascia knife, maintaining the integrity of the skin barrier and the stability of the permeation channels, providing a continuous and undamaged microenvironment for the penetration of traditional Chinese medicine components. Conversely, the triterpenoid saponins from *Lycopodium clavatum*, an active ingredient in traditional Chinese medicine, possess certain surface activity. Their molecular structure contains both hydrophobic saponins and hydrophilic sugar chains, allowing them to oriented at the oil-water interface, helping to stabilize the emulsion system and improving the physical stability of the composition to a certain extent. The bidirectional and mutually supportive relationship between physical lubrication and the bioactivity of traditional Chinese medicine enables the composition of the present invention to achieve synergistic effects in both lubrication performance and muscle relaxation efficacy, which is different from the conventional design approach in the prior art that simply superimposes the lubrication function and the efficacy function, with each function being independent or even mutually restrictive.

[0022] (iv) Menthol-hydroxypropyl-β-cyclodextrin encapsulation technology and friction-triggered release mechanism This invention innovatively forms a stable inclusion complex between menthol and hydroxypropyl-β-cyclodextrin, and cleverly utilizes the frictional heat and shear force inevitably generated during fascia knife operation as a release trigger signal, establishing a unique "friction-triggered release" mechanism. In the inclusion complex structure, menthol molecules are embedded in the hydrophobic cavity of hydroxypropyl-β-cyclodextrin, isolated from the external environment, significantly reducing volatility and greatly enhancing chemical stability. Under normal temperature storage conditions, the inclusion complex has virtually no cooling sensation or a very weak cooling sensation. When the composition is applied to the skin and fascia knife operation begins, the high-speed reciprocating sliding of the knife simultaneously generates two physical effects locally: first, a frictional heat effect, raising the skin temperature at the operation site from the conventional 32-33℃ to approximately 37-40℃; second, a mechanical shear effect, where the shear force applied by the knife mechanically disturbs the inclusion complex structure. Under the combined effect of these two effects, the binding force of the hydroxypropyl-β-cyclodextrin cavity on menthol weakens, and menthol molecules are gradually released from the inclusion complex, producing an immediate, continuous cooling sensation with an intensity matching the intensity of the operation. This "friction-triggered release" mechanism achieves dynamic synchronization between the supply of cooling sensation and the actual needs of the fascia knife operation—the more intensive the operation and the more intense the friction in the area (usually areas with severe fascial adhesions and significant tenderness upon pressure), the greater the amount of menthol released and the stronger the cooling sensation. This can precisely and effectively relieve deep pressure pain and discomfort in that area, thereby significantly improving patient comfort and compliance throughout the treatment process. Simultaneously, the embedding technology effectively solves the problem of unstable product quality caused by the evaporation loss of free menthol during production and storage.

[0023] The relevant mechanism of the present invention The synergistic effect of this invention can be explained in depth from both physicochemical and transdermal delivery perspectives.

[0024] At the physicochemical level: the viscosity, thixotropy, and coefficient of friction of the composition are jointly determined by the base lubricating components, thickeners, and nanoemulsion structure. At a mass ratio of 4:1 to 7:1, the van der Waals forces and hydrophobic interactions between the two oil molecules of sweet almond oil and dimethyl silicone oil reach an optimal balance. The polydimethylsiloxane molecular chains of dimethyl silicone oil spread to form a film on the skin surface, while sweet almond oil molecules fill the microscopic pores between the polymer chains, forming a continuous, dense, and somewhat flexible composite lubricating film. After swelling in deionized water, the carbomer molecules partially ionize the carboxyl groups on their molecular chains in the weakly alkaline environment provided by components such as azone and ketones, generating electrostatic repulsion that allows the molecular chains to fully extend. Simultaneously, the molecular chains form physical cross-linking points through hydrogen bonds and hydrophobic interactions, constructing a three-dimensional network structure that permeates the entire aqueous phase. When the fascia knife slides across the skin surface, the shear stress applied to the composition exceeds the yield stress of the three-dimensional network. Hydrogen bonds in the network undergo reversible breakage, and the molecular chains align along the shear direction, causing the viscosity to drop by 1-2 orders of magnitude instantaneously (thixotropic behavior), making the composition smooth and easy to apply. Once the knife has passed and the shear stress has disappeared, the broken hydrogen bonds rapidly reform under the influence of molecular thermal motion, the network structure recovers, and the viscosity returns to its initial level within seconds. The nanoemulsion formed after high-pressure homogenization has an extremely high oil-water interfacial area. Carbomer molecules and saponin-like surface-active components from traditional Chinese medicine are tightly arranged at the interface, significantly reducing interfacial tension and bringing the emulsion system towards a thermodynamically stable state, effectively preventing Ostwald ripening and oil droplet aggregation.

[0025] Transdermal delivery layer: The active ingredients of traditional Chinese medicine (including triterpenoid saponins from *Lycopodium clavatum*, flavonoids and phenolic acids from *Clematis chinensis*, safflower yellow pigment and safflower glycosides from *Carthamus tinctorius*, and volatile oils and flavonoids from *Artemisia argyi*, etc.) are distributed in the aqueous or oil phase according to their polarity—water-soluble components dissolve in the aqueous phase, and lipid-soluble components dissolve inside the oil droplets. Lauryl azelazone, as a transdermal penetration enhancer, works by inserting its long hydrocarbon chain into the hydrophobic region of the stratum corneum lipid bilayer, while its polar lactam group forms hydrogen bonds with water molecules. This "anchoring-perturbation" effect disrupts the tight, orderly arrangement of lipid molecules, increasing the fluidity and permeability of the lipid bilayer. Oleic acid and linoleic acid in sweet almond oil can interact with lipid components such as ceramides in the stratum corneum, further softening and swelling the stratum corneum and reducing barrier resistance. Nanoscale oil droplets (100-200 nm) formed through high-pressure homogenization, due to their size matching the opening of the hair follicle infundibulum and the diameter of the hair follicle canal, can bypass the main barrier of the stratum corneum by bypassing the bypass pathways of skin appendages such as hair follicles and sweat glands, directly delivering the lipid-soluble active ingredients of traditional Chinese medicine encapsulated in the oil phase to the dermis surrounding the hair follicle. During the fascia knife operation, the intermittent mechanical pressure applied by the blade generates a "pumping effect," promoting the composition to be squeezed into the hair follicle opening and penetrate downwards along the hair follicle canal. At the same time, the local thermal effect generated by friction raises the skin temperature at the operation site, which on the one hand increases the fluidity of stratum corneum lipids, which is conducive to the penetration-enhancing effect of laurocapram; on the other hand, it dilates the capillaries in the dermis, increases local blood flow, and accelerates the entry of the active ingredients of traditional Chinese medicine that have penetrated into the dermis into the systemic and lymphatic circulation, and finally reaches the fascia layer and muscle tissue with the blood circulation, exerting the effects of relaxing muscles and relieving muscle tension. This multi-synergistic mechanism of "physical penetration enhancement + nano-delivery + mechanical propulsion + thermal acceleration" is the fundamental reason for the significant technological progress of the composition of this invention.

[0026] Beneficial technical effects of the present invention 1. Dual-Effect Synergistic Integration of Lubrication Protection and Muscle Relaxation. The composition of this invention, through the scientific formulation and synergistic design of basic lubricating components and active extracts of traditional Chinese medicine, simultaneously provides excellent physical lubrication protection and effective muscle relaxation during fascia knife operation, overcoming the shortcomings of existing products that offer only single or simple superposition of dual functions, resulting in a disconnect between them. Experimental data shows that the friction coefficient of the composition of this invention against artificial skin is only 0.08-0.10, significantly better than the 0.14-0.16 of ordinary massage creams; simultaneously, after standardized fascia knife operation, the root mean square value of the resting surface electromyography signal of the quadriceps femoris muscle in subjects decreased by 40%-46%, while the decrease in simple fascia knife operation (without a medium) was only about 15%, proving that the composition of this invention has the dual superior effects of highly efficient lubrication protection and deep muscle relaxation.

[0027] 2. Precise system matching of physical performance parameters with the mechanical conditions of fascia knife operation. This invention achieves, for the first time, a systematic match between the lubricating medium and the fascia knife operation scenario through the optimized design of three quantitative parameters: viscosity (15000-30000 mPa·s), thixotropic index (3.0-6.0), and coefficient of friction (0.06-0.12). The composition is a stable paste when stationary and applied, without dripping or running; it thins instantly due to the thixotropic effect when the fascia knife slides at high speed, making it smooth and easy to push with a moderate coefficient of friction; the viscosity quickly recovers after the knife passes, ensuring continuous lubrication and protection while avoiding medium loss and clothing contamination. The user experience and lubrication effect are significantly superior to existing massage creams, gua sha oils, and other alternative products.

[0028] 3. The nanoemulsion structure enables highly efficient transdermal targeted delivery of active ingredients from traditional Chinese medicine. This invention employs high-pressure homogenization technology to precisely control the oil droplet size to 100-200 nm. Utilizing this particle size range, the nanoemulsion can be delivered via a specific "bypass" mechanism through skin appendages such as hair follicles and sweat glands, significantly improving the transdermal absorption efficiency and delivery depth of the active ingredients from traditional Chinese medicine. In vitro transdermal diffusion experiments show that the cumulative 24-hour penetration of ferulic acid, a representative component in the composition of this invention, is more than 40% higher than that of conventional stirred emulsion products. Higher transdermal efficiency means that within the same operating time, more effective ingredients for relieving muscle tension and promoting blood circulation can reach the fascia layer and muscle tissue to exert their therapeutic effects, thereby achieving a more significant muscle relaxation effect within a limited treatment time.

[0029] 4. Menthol embedding technology imparts a unique friction-triggered cooling effect, significantly enhancing the treatment experience. This invention forms a stable inclusion complex between menthol and hydroxypropyl-β-cyclodextrin. The frictional heat and shear force inevitably generated during fascia knife manipulation trigger the gradual release of menthol, achieving a dynamic match between the cooling sensation and the intensity of the manipulation. The more intensive the manipulation and the more intense the friction, the stronger the cooling sensation, accurately and effectively relieving deep pressure pain in that area. Simultaneously, the embedding technology effectively inhibits the volatilization loss of menthol during production and storage. Compared to the direct addition of free menthol, the menthol retention rate after one month of product storage is approximately doubled, significantly improving product quality stability and batch-to-batch consistency.

[0030] 5. The scientific combination of four traditional Chinese medicines (herb, herb, and adjuvant) has demonstrated its efficacy in relaxing muscles and promoting blood circulation, as verified by objective indicators. This invention uses *Lycopodium clavatum* as the principal herb, *Clematis chinensis* and *Carthamus tinctorius* as adjuvant herbs, and *Artemisia argyi* as an adjuvant. The four herbs are meticulously combined to achieve a complex effect of dispelling wind and cold, relaxing muscles and promoting blood circulation, removing blood stasis, and warming the meridians. Objective testing with a surface electromyography (SEM) instrument showed that the composition of this invention can reduce the resting electromyographic signal of fatigued muscles after exercise by 40%-46%, significantly better than the control group lacking *Lycopodium clavatum* (a reduction of approximately 24%). Infrared thermal imaging showed that the local skin temperature increased by 2.5-3.1℃ after applying the composition, indicating effective improvement in local blood circulation. These objective instrumental test data fully verify the scientific nature of the herbal combination and the significant efficacy of this invention. Attached Figure Description

[0031] Figure 1 This is a flowchart illustrating the preparation process of the fascia knife lubricating composition shown in Example 1 of the present invention. Detailed Implementation

[0032] Before further describing specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terminology used in the embodiments of the present invention is for describing specific embodiments and not for limiting the scope of protection of the present invention. Test methods in the following embodiments that do not specify specific conditions are generally performed under conventional conditions or as recommended by the respective manufacturers.

[0033] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in this invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by those skilled in the art. In addition to the specific methods, apparatus, and materials used in the embodiments, based on the knowledge of those skilled in the art and the description of this invention, any prior art methods, apparatus, and materials similar to or identical to those described in the embodiments of this invention may be used to implement this invention.

[0034] Unless otherwise stated, the test methods, detection methods and preparation methods disclosed in this invention all adopt conventional techniques in this technical field.

[0035] I. Reagent and Raw Material Instructions In the following embodiments and comparative examples of this invention, all Chinese medicinal materials used should comply with the quality standards specified in Part I of the 2020 edition of the Chinese Pharmacopoeia. *Lycopodium japonicum* Thunb. (Lycopodium family) is the dried whole herb, harvested, impurities removed, sun-dried, and cut into sections. *Impatiens balsamina* L. (Impatiens family) is the dried stem, harvested in summer and autumn, impurities removed, sun-dried, and cut into sections. *Carthamus tinctorius* L. (Asteraceae family) is the dried flower, harvested in summer when the flowers turn from yellow to red, and dried in the shade or sun. *Artemisia argyi* Levl. et Vant. (Asteraceae family) is the dried leaf, harvested in summer before the flowers open, impurities removed, and sun-dried. All Chinese medicinal materials were identified and confirmed to be genuine products before use, free from mold and insect infestation, and meeting medicinal standards.

[0036] Sweet almond oil (CAS No.: 8007-69-0, cosmetic grade, acid value ≤1.0mg KOH / g, peroxide value ≤5.0meq / kg) and dimethyl silicone oil (CAS No.: 63148-62-9, cosmetic grade, viscosity 100cSt, refractive index 1.400-1.405) were both purchased from Sinopharm Chemical Reagent Co., Ltd. Lauryl azelastone (azelastone, CAS No.: 59227-89-3) was purchased from Shanghai Aladdin Biochemical Technology Co., Ltd., with a purity ≥98%, and is a colorless to slightly yellow transparent oily liquid. Carbomer 940 (Carbomer 940, CAS No.: 9003-01-4) was purchased from Lubrizol Specialty Chemicals (Shanghai) Co., Ltd., pharmaceutical grade, with a viscosity (0.5% aqueous solution, 25℃) of 40000-60000 mPa·s. Vitamin E (DL-α-tocopherol, CAS No.: 10191-41-0) was purchased from Sinopharm Chemical Reagent Co., Ltd., with a purity ≥98%, and is a pale yellow to yellow clear viscous liquid. Menthol (L-menthol, CAS No.: 2216-51-5) was purchased from Anhui Fengle Fragrance Co., Ltd., with a purity ≥99%, and is a colorless needle-like crystal with a melting point of 42-44℃. Hydroxypropyl-β-cyclodextrin (CAS No.: 128446-35-5) was purchased from Shandong Binzhou Zhiyuan Biotechnology Co., Ltd., with a degree of substitution of 4.5-5.0, and is a white powder with a moisture content ≤5.0%. Anhydrous ethanol (analytical grade, purity ≥99.7%) and deionized water were both purchased from Sinopharm Chemical Reagent Co., Ltd., and the deionized water was prepared using a laboratory pure water system with a conductivity ≤1.0 μS / cm.

[0037] The high-pressure homogenizer used was an AH-BASIC laboratory high-pressure homogenizer from ATS Engineering Inc. (Canada), with a maximum working pressure of 150 MPa and a throughput of 30-50 mL / min, equipped with a cooling jacket. The rotational rheometer used was an Anton Paar MCR 302 modular compact rheometer, equipped with a CP50-1 cone-plate measurement system (1° cone angle, 50 mm diameter) and a P-PTD200 temperature control unit, with a temperature control accuracy of ±0.1℃. The coefficient of friction was measured using an MXD-02 friction meter from Jinan Langguang Electromechanical Technology Co., Ltd., conforming to GB / T 10006-2021 standard, with a test range of 0.001-2.000 and an accuracy of ±0.001. The Franz diffusion cell used was a TP-6 ​​intelligent transdermal diffusion meter from Shanghai Yuyan Scientific Instruments Co., Ltd., equipped with 6 diffusion cells and a diffusion area of ​​3.14 cm². 2 The receiving cell has a volume of 15 mL, and the magnetic stirring speed is adjustable from 0-600 r / min. The water bath temperature control accuracy is ±0.5℃. The high-performance liquid chromatograph (HPLC) is an Agilent 1260 Infinity II, equipped with a quaternary pump, autosampler, column oven, and diode array detector. The surface electromyography (EMG) system is a Noraxon Ultium EMG wireless EMG system with a sampling frequency of 2000 Hz and a common-mode rejection ratio >100 dB. The infrared thermal imager is a FLIR T530, with a thermal sensitivity <30 mK, a temperature range of -20℃ to 650℃, and an accuracy of ±1℃ or ±1%. The vacuum emulsification pot is a Wuxi Yikai Automation Technology Co., Ltd. ZJR-50 model with a volume of 50 L, a homogenization speed of 0-3000 r / min, a stirring speed of 0-100 r / min, and is equipped with heating and vacuum systems.

[0038] Example 1 A fascia knife lubricating composition with muscle relaxation effect is composed of the following components in parts by weight: 65 parts sweet almond oil, 12 parts dimethyl silicone oil, 4 parts *Lycopodium clavatum* extract, 2.5 parts *Clematis chinensis* extract, 1.5 parts safflower extract, 1.5 parts artemisia argyi extract, 0.8 parts azone, 0.4 parts carbomer, 0.6 parts vitamin E, 1.0 part embedded cooling agent, and 10.2 parts deionized water. The total weight of the above components is 100 parts. The embedded cooling agent is an inclusion complex formed by menthol and hydroxypropyl-β-cyclodextrin in a mass ratio of 1:6. The preparation process specifically includes the following steps: (1) Preparation of Chinese herbal extracts: *Lycopodium clavatum*, *Clematis chinensis*, safflower, and artemisia argyi are weighed separately and then pulverized through a 30-mesh sieve. Take the powder of *Lycopodium clavatum*, add 10 times the amount of 70% ethanol (volume fraction, the same below), reflux extract in a 75℃ water bath for 2 hours, and filter while hot; add 8 times the amount of 70% ethanol to the residue, continue to reflux extract at 75℃ for 1.5 hours, and filter while hot. Combine the two extracts, recover the ethanol under reduced pressure at 60℃ and -0.08MPa and concentrate to a relative density of 1.10 (measured at 60℃) to obtain *Lycopodium clavatum* extract. Extracts of *Clematis chinensis*, safflower, and artemisia argyi were prepared by the same extraction method as above. (2) Preparation of encapsulated cooling agent: Weigh 6g of hydroxypropyl-β-cyclodextrin, dissolve it in 60mL of deionized water at a solid-liquid ratio of 1g:10mL, and stir in a 50℃ water bath until completely dissolved. Weigh 1g of menthol and dissolve it in 1mL of anhydrous ethanol. Slowly add the menthol ethanol solution to the hydroxypropyl-β-cyclodextrin aqueous solution with stirring, at a dropping rate of about 0.5mL / min. After the addition was completed, the mixture was stirred in a 50°C water bath for 2 hours. After the inclusion was completed, the solution was cooled to 4°C and allowed to stand at that temperature for 10 hours to allow the inclusion compound to precipitate fully. The mixture was filtered, and the filter cake was washed twice with a small amount of cold deionized water and dried in a vacuum drying oven at 45°C to constant weight to obtain a white powdery encapsulated cooling agent. (3) Preparation of the oil phase: 65g of sweet almond oil and 12g of dimethyl silicone oil were weighed according to the formula and added to an emulsifying pot. The mixture was heated to 50°C and stirred to mix evenly. Then 0.6g of vitamin E was added and stirred until completely dissolved. This was used as the oil phase and kept warm for later use. (4) Preparation of the aqueous phase: 0.4g of carbomer was weighed according to the formula and slowly added to 10.2g of deionized water while stirring. Stirring was maintained during the addition process to avoid clumping. After the addition was completed, the mixture was stirred for 30 minutes to allow the carbomer to disperse fully. Then it was allowed to stand at room temperature for 6 hours to swell and obtain a transparent gel matrix. Heat the gel matrix to 50°C, and add 4g of *Lycopodium clavatum* extract, 2.5g of *Clematis chinensis* extract, 1.5g of safflower extract, 1.5g of Artemisia argyi extract, and 0.8g of azone in sequence while stirring. Stir for 5 minutes after each addition to ensure even mixing. After all ingredients are added, continue stirring for 10 minutes to prepare the aqueous phase. Keep it warm for later use.(5) Primary emulsification: At a stirring speed of 800 r / min, the heat-insulated oil phase is slowly added to the aqueous phase, and the addition time is controlled at about 10 min. After the addition is completed, continue stirring at 800 r / min for 15 min to obtain the primary emulsion. (6) High-pressure homogenization: The primary emulsion is preheated to 40℃ and transferred to a high-pressure homogenizer. The homogenization pressure is set to 65 MPa, and high-pressure homogenization is performed for a total of 3 times. During the homogenization process, the temperature of the liquid is controlled not to exceed 45℃ by the cooling jacket. After the homogenization is completed, a sample is taken and the average particle size of the oil droplets is measured by a laser particle size analyzer. The result is 148 nm. (7) Addition of encapsulated cooling agent: When the emulsion after high-pressure homogenization is naturally cooled to 35℃ under stirring, the stirring speed is reduced to 300 r / min, 1.0 g of encapsulated cooling agent is added, and stirring is continued slowly for 8 min until the powder is completely dispersed and uniform. (8) Gradient temperature-controlled curing: The product with the added embedded cooling agent was placed in a constant temperature chamber and cured at 38°C for 6 hours. Then, it was slowly cooled to 25°C at a cooling rate of 0.8°C / min to obtain the fascia knife lubricating composition with muscle relaxation effect of the present invention. The viscosity of the obtained composition at 25°C was tested to be 21300 mPa·s (shear rate 1s). -1 The thixotropic index is 4.8 (1s). -1 Viscosity and 10s -1 The viscosity ratio is 0.09 (at room temperature of 25℃, normal load of 2.0N, and sliding speed of 50mm / s). The product has a light brown to brownish-red uniform and delicate paste appearance, a characteristic herbal odor with a slight cooling sensation, good spreadability, and a refreshing and non-greasy feel on the skin.

[0039] Example 2 A fascia knife lubricating composition with muscle relaxation effects comprises the following components in parts by weight: 60 parts sweet almond oil, 15 parts dimethyl silicone oil, 5 parts *Lycopodium clavatum* extract, 3 parts *Clematis chinensis* extract, 2 parts safflower extract, 1 part *Artemisia argyi* extract, 1 part azone, 0.5 parts carbomer, 1 part vitamin E, 1.2 parts embedded cooling agent, and 10.3 parts deionized water. The sum of the weight parts of the above components is 100 parts. The embedded cooling agent is an inclusion complex formed by menthol and hydroxypropyl-β-cyclodextrin in a mass ratio of 1:4. The preparation process was the same as in Example 1, with the following differences: the ethanol concentration was 65% in the herbal extraction step; the mass ratio of menthol to hydroxypropyl-β-cyclodextrin was 1:4 in the encapsulation preparation step, the encapsulation temperature was 40℃, and the encapsulation time was 3h; the pressure was 70MPa in the high-pressure homogenization step, homogenization was performed 3 times, and the average droplet size after homogenization was 135nm; in the gradient temperature-controlled ripening step, the mixture was first ripened at 35℃ for 8h, and then cooled to 25℃ at a cooling rate of 1.0℃ / min. The resulting composition had a viscosity of 19800mPa·s, a thixotropic index of 4.3, and a coefficient of friction of 0.10 at 25℃. The product appearance and skin feel were similar to those of Example 1, but the cooling sensation was slightly stronger.

[0040] Example 3 A fascia knife lubricating composition with muscle relaxation effects comprises the following components in parts by weight: 70 parts sweet almond oil, 10 parts dimethyl silicone oil, 3 parts *Lycopodium clavatum* extract, 2 parts *Clematis chinensis* extract, 1 part safflower extract, 2 parts *Artemisia argyi* extract, 0.5 parts azone, 0.3 parts carbomer, 0.5 parts vitamin E, 0.8 parts embedded cooling agent, and 9.9 parts deionized water. The sum of the weight parts of the above components is 100 parts. The embedded cooling agent is an inclusion complex formed by menthol and hydroxypropyl-β-cyclodextrin in a mass ratio of 1:8. The preparation process was the same as in Example 1, with the following differences: the ethanol concentration was 75% in the herbal extraction step; the mass ratio of menthol to hydroxypropyl-β-cyclodextrin was 1:8 in the encapsulation preparation step, the encapsulation temperature was 60℃, and the encapsulation time was 1h; the high-pressure homogenization step used a pressure of 60MPa, homogenized twice, and the average droplet size after homogenization was 172nm; the gradient temperature-controlled ripening step involved first ripening at 40℃ for 4h, and then cooling to 25℃ at a rate of 0.5℃ / min. The resulting composition had a viscosity of 23600mPa·s, a thixotropic index of 5.1, and a coefficient of friction of 0.08 at 25℃. The product appearance and feel were similar to those in Example 1, but the higher proportion of sweet almond oil resulted in a more moisturizing feel.

[0041] Example 4 A fascia knife lubricating composition with muscle relaxation effect comprises the following components in parts by weight: 62 parts sweet almond oil, 14 parts dimethyl silicone oil, 4.5 parts *Lycopodium clavatum* extract, 2.8 parts *Clematis chinensis* extract, 1.8 parts safflower extract, 1.3 parts *Artemisia argyi* extract, 0.7 parts azone, 0.45 parts carbomer, 0.7 parts vitamin E, 1.1 parts embedded cooling agent, and 10.65 parts deionized water. The sum of the weight parts of the above components is 100 parts. The mass ratio of menthol to hydroxypropyl-β-cyclodextrin in the embedded cooling agent is 1:5. The preparation process is the same as in Example 1, except that: the high-pressure homogenization pressure is 68 MPa, homogenization is performed 3 times, and the average droplet size after homogenization is 141 nm; the gradient temperature-controlled curing conditions are: curing at 37°C for 7 hours, followed by cooling to 25°C at a rate of 0.7°C / min. The obtained composition was tested and found to have a viscosity of 20800 mPa·s at 25°C, a thixotropic index of 4.6, and a coefficient of friction of 0.09.

[0042] Example 5 A fascia knife lubricating composition with muscle relaxation effect comprises the following components in parts by weight: 68 parts sweet almond oil, 11 parts dimethyl silicone oil, 3.5 parts *Lycopodium clavatum* extract, 2.2 parts *Clematis chinensis* extract, 1.2 parts safflower extract, 1.8 parts *Artemisia argyi* extract, 0.6 parts azone, 0.35 parts carbomer, 0.6 parts vitamin E, 0.9 parts embedded cooling agent, and 9.85 parts deionized water. The sum of the weight parts of the above components is 100 parts. The mass ratio of menthol to hydroxypropyl-β-cyclodextrin in the embedded cooling agent is 1:7. The preparation process is the same as in Example 1, except that: the high-pressure homogenization pressure is 62 MPa, homogenization is performed 3 times, and the average droplet diameter after homogenization is 165 nm; the gradient temperature-controlled curing conditions are: curing at 39°C for 5 hours, followed by cooling to 25°C at a rate of 0.9°C / min. The obtained composition was tested and found to have a viscosity of 22800 mPa·s at 25°C, a thixotropic index of 5.0, and a coefficient of friction of 0.09.

[0043] Comparative Example 1 Referring to the formulation of Example 1, the difference lies in omitting the high-pressure homogenization step (S6) in the preparation process. Specifically, after initial emulsification, high-pressure homogenization is not performed; instead, the subsequent addition of the encapsulated cooling agent and gradient temperature-controlled curing are carried out directly. Specifically, after initial emulsification, the emulsion is cooled to 35°C with stirring at 300 r / min, the encapsulated cooling agent is added, and after stirring evenly, it is cured at 38°C for 6 hours, then cooled to 25°C at a rate of 0.8°C / min. The average droplet size of the resulting composition is 3.8 μm, significantly larger than the 148 nm of Example 1. The viscosity of the resulting composition at 25°C is 14800 mPa·s, the thixotropic index is 2.3, and the coefficient of friction is 0.15. Compared to Example 1, Comparative Example 1 has a lower viscosity, significantly insufficient thixotropy (thixotropic index < 3.0), and a higher coefficient of friction (> 0.12), exceeding the preferred parameter range of this invention. Although the product has a uniform appearance, it shows slight delamination after being left for one week, indicating poor physical stability.

[0044] Comparative Example 2 Referring to the formulation and preparation process of Example 1, the difference lies in omitting the preparation step of the encapsulated cooling agent. Menthol is not added in the form of an inclusion complex, but rather directly in free form in step S7. Specifically, 0.14 g of menthol (corresponding to the menthol content in 1.0 g of encapsulated cooling agent, calculated at a 1:6 mass ratio) is dissolved in 0.5 mL of anhydrous ethanol and slowly added to the emulsion cooled to 35°C in step S7, stirring until homogeneous. Testing showed that the menthol content of Comparative Example 2, immediately after preparation, was only 75% of the theoretical addition amount in Example 1, indicating that approximately 25% of the menthol had evaporated during the preparation process. After sealing and storing the product for one month, the menthol content was measured again, and it further decreased to 42% of the theoretical addition amount, while the menthol content of Example 1 remained above 90% of the theoretical addition amount after one month of storage. In subjective evaluations, volunteers reported that Comparative Example 2 had a stronger cooling sensation at the initial stage of application, but it weakened significantly after 5-10 minutes. In contrast, the cooling sensation in Example 1 lasted for more than 20 minutes and tended to increase with the intensity of the fascia knife operation.

[0045] Comparative Example 3 Referring to the formulation and preparation process of Example 1, the difference lies in that the basic lubricating component does not include sweet almond oil, and only dimethyl silicone oil is used as the lubricating component, with the missing weight parts made up by deionized water. The specific formulation is: 77 parts of dimethyl silicone oil (i.e., the sum of 65 parts of sweet almond oil and 12 parts of dimethyl silicone oil in Example 1), and the remaining components and amounts are the same as in Example 1. The preparation process is the same as in Example 1. The resulting composition has a viscosity of 20500 mPa·s at 25°C, a thixotropic index of 4.9, an average droplet size of 152 nm, and a coefficient of friction of 0.07. Although most of the physical performance parameters are within the preferred range of this invention, and the coefficient of friction is even lower than that of Example 1, the spreadability and skin compatibility of the product are significantly poor—there is greater resistance during application, and there is a noticeable "oily feeling" and "foreign body feeling" after application. Some volunteers reported a stuffy and uncomfortable feeling on their skin after use. More importantly, due to the lack of the stratum corneum softening effect of sweet almond oil, the transdermal absorption efficiency of the active ingredients of traditional Chinese medicine is significantly reduced.

[0046] Comparative Example 4 The formulation and preparation process are the same as in Example 1, except that the active ingredients of the traditional Chinese medicine do not include *Lycopodium clavatum* extract, and its weight is made up by deionized water. Specifically, the amount of *Lycopodium clavatum* extract in the formulation is 0, while the amounts of *Clematis chinensis* extract, safflower extract, and artemisia argyi extract remain unchanged. The preparation process is the same as in Example 1. The physical properties of the resulting composition, such as appearance, viscosity, thixotropic index, oil droplet size, and coefficient of friction, are basically the same as in Example 1, but efficacy tests show a significant decrease in muscle relaxation effect.

[0047] Comparative Example 5 Referring to the formulation and preparation process of Example 1, the difference lies in the mass ratio of sweet almond oil to dimethyl silicone oil in the basic lubricating component, which is 1:2.0 (i.e., exceeding the preferred range of 1:0.14-1:0.25 of this invention). The specific formulation is: 25.7 parts sweet almond oil and 51.3 parts dimethyl silicone oil (the sum of the two is still 77 parts, i.e., the sum of 65 parts sweet almond oil and 12 parts dimethyl silicone oil in Example 1), with the remaining components and amounts the same as in Example 1. The preparation process is the same as in Example 1. Testing showed that the viscosity of the obtained composition at 25°C was 16500 mPa·s, the thixotropic index was 3.1, and the coefficient of friction was 0.13. Due to the significant reduction in the proportion of dimethyl silicone oil, the oil film strength and film-forming ability of the composition were significantly insufficient. During prolonged operation (over 10 minutes) with the fascia knife, the lubricating performance gradually decreased, and an increase in friction could be clearly felt in the later stages of operation, requiring reapplying the medium midway.

[0048] III. Performance Testing (a) Viscosity and thixotropic index test The test method followed GB / T 10247-2008 "Viscosity Measurement Methods," and an Anton Paar MCR 302 rotational rheometer was used for measurement. The measurement system was a CP50-1 cone-plate (1° cone angle, 50mm diameter), and the test temperature was controlled at 25±0.1℃. The test program was set as follows: shear rate from 0.01s... -1 Logarithmic increment to 100s -1 Ten data points were taken for each order of magnitude, and the measurement time for each data point was 10 seconds. The shear rate was taken as 1 second. -1 The viscosity measured at a shear rate of 1 s⁻¹ is taken as the characteristic viscosity of the composition. The thixotropic index is defined as the viscosity at a shear rate of 1 s⁻¹. -1 The viscosity and shear rate at 10 s⁻¹ -1 The viscosity ratio at different times. Each sample was measured three times, and the average value was taken. The test results of Examples 1-5 and Comparative Examples 1, 3, and 5 are summarized in Table 1.

[0049] Table 1. Viscosity and thixotropic index test results (25℃) for each example and comparative example. (ii) Friction coefficient test The test was conducted according to a modified version of GB / T 10006-2021 "Determination of Coefficient of Friction of Plastic Films and Sheets". The testing instrument was a Jinan Langguang MXD-02 friction coefficient meter. Test conditions: room temperature 25±1℃, relative humidity 50±5%, normal load 2.0N, sliding speed 50mm / s, sliding distance 50mm. The friction material was a 304 stainless steel slider (63.5mm×63.5mm, with a medical-grade stainless steel sheet attached to the bottom, surface roughness Ra≤0.4μm), simulating the material and surface characteristics of a fascia knife. The test substrate was Bioskin No.20 artificial skin (1.5mm thick, simulating the elasticity and friction characteristics of human skin). Before each test, 0.2g of sample was accurately weighed and evenly applied to a 10cm×10cm area on the artificial skin surface, with a thickness of approximately 0.2mm. After application, the sample was allowed to stand for 30 seconds before testing. Each sample was tested 5 times, and the average value was taken as the coefficient of friction for that sample. The test results of Examples 1-5 and Comparative Examples 1, 3, and 5 are summarized in Table 2.

[0050] Table 2. Friction coefficient test results for each embodiment and comparative example. (III) In vitro transdermal diffusion test In vitro transdermal diffusion experiments were conducted using the Franz diffusion cell method. The effective diffusion area of ​​the diffusion cell was 3.14 cm². 2The receiving chamber had a volume of 15 mL, and the receiving medium was phosphate-buffered saline (PBS) at pH 7.4. The temperature of the receiving chamber was controlled at 37 ± 0.5 °C, and the magnetic stirring speed was 300 r / min. The transdermal barrier used excised abdominal skin from SD rats: Healthy male SD rats (weighing 200 ± 20 g) were euthanized by cervical dislocation, and the abdominal hair was immediately shaved. The abdominal skin was peeled off, and subcutaneous fat and connective tissue were carefully removed. The skin was repeatedly rinsed with physiological saline. The prepared skin was cut into appropriate sizes, with the stratum corneum facing upwards, and fixed between the supply and receiving chambers of the diffusion chamber, ensuring the skin remained intact and undamaged within the effective diffusion area. 0.5 g of sample was evenly applied to the skin surface (stratum corneum layer). At 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, and 24 h after the start of the experiment, 1 mL of receiving fluid was drawn from the sampling port of the receiving chamber, and an equal volume of fresh blank receiving medium was added simultaneously. Ferulic acid, a representative active ingredient from traditional Chinese medicine (derived from *Lycopodium clavatum* and *Carthamus tinctorius*, is a characteristic component in the composition of this invention possessing muscle-relaxing and antioxidant activities), was used as a representative active ingredient. The concentration of ferulic acid in the receiving solution at each time point was determined by high-performance liquid chromatography (HPLC). Chromatographic conditions: Agilent ZORBAX SB-C18 column (4.6 mm × 250 mm, 5 μm); mobile phase: methanol-0.1% phosphoric acid aqueous solution (35:65, v / v); flow rate: 1.0 mL / min; column temperature: 30℃; detection wavelength: 320 nm; injection volume: 20 μL. The concentration of ferulic acid in the receiving solution at each sampling time point was calculated based on the standard curve, and the cumulative permeation Q (μg / cm³) was calculated. 2 Each sample was tested in parallel in three diffusion cells, and the results were averaged. The 24-hour cumulative permeability test results of Examples 1-3 and Comparative Examples 1 and 3 are summarized in Table 3.

[0051] Table 3. Results of in vitro transdermal cumulative permeation tests for each example and comparative example (ferulic acid, 24h). (iv) Muscle relaxation efficacy test (surface electromyography) Twenty healthy volunteers were selected, ten men and ten women, aged 22-35 years, with a body mass index (BMI) of 18.5-24.0 kg / m². 2All volunteers had not engaged in strenuous exercise within 48 hours prior to the test, had no history of musculoskeletal disorders, and had no broken skin or skin diseases at the test site. The experimental procedure was explained in detail to volunteers before the test, and written informed consent was obtained. On the day of the test, volunteers first underwent standardized exercise to induce quadriceps fatigue and tension: running on a treadmill at 8 km / h with a 5° incline for 20 minutes. After a 10-minute rest following the exercise, the root mean square (RMS) value of the surface electromyography signal in the right quadriceps (rectus femoris) at rest was measured using a Noraxon Ultium EMG surface electromyography device as a baseline indicator of muscle tension. During the measurement, volunteers were supine with a soft pillow under their knees to slightly flex the knees to approximately 15°. The electrodes were placed at the most prominent part of the rectus femoris muscle belly (the midpoint of the line connecting the anterior superior iliac spine and the upper border of the patella), and the reference electrode was placed on the surface of the ipsilateral patella. The signal sampling frequency was 2000Hz, with a bandpass filter of 10-500Hz. Recordings were continuously recorded for 30 seconds at each test interval, and the average RMS value of the stable signal during the middle 20 seconds was used for analysis. After baseline determination, 2g of the sample was evenly applied to the quadriceps femoris muscle area (approximately 15cm × 10cm). The same certified rehabilitation therapist performed standardized procedures using the same model of medical stainless steel fascia knife (Edge Tool, USA). The manipulation force was controlled at approximately 5N (calibrated using the pressure sensor integrated into the fascia knife), the frequency at approximately 1Hz (one reciprocation per second), the manipulation direction parallel to the muscle fiber course, and the manipulation time for 5 minutes. The RMS values ​​of the quadriceps femoris muscle at rest (sEMG) were measured immediately after the manipulation, at 10 minutes, and at 20 minutes. The decrease in RMS value relative to baseline at each time point was calculated as follows: decrease = (baseline RMS - post-manipulation RMS) / baseline RMS × 100%, used to evaluate the muscle relaxation effect. Three volunteers were assigned to each sample for testing, and the average value of the three volunteers was taken as the test result for that sample. The blank control group did not apply any medium and only underwent the same fascia knife operation. The test results 10 minutes after the operation of Examples 1-3 and Comparative Examples 1, 3, and 4 are summarized in Table 4.

[0052] Table 4. Results of muscle relaxation efficacy tests for each embodiment and comparative example (sEMG reduction magnitude, 10 min after operation). (v) Local blood circulation improvement test (infrared thermography) Twenty healthy volunteers (from the same cohort as those tested for electromyography, with at least a 7-day interval between tests) were selected, 10 males and 10 females, aged 22-35 years. Before the test, volunteers sat quietly for 30 minutes in a constant temperature (25±1℃) and humidity (50±5%RH) environment to acclimatize. An initial thermal image of the flexor aspect of the volunteers' left forearm (approximately 10cm × 10cm between the wrist crease and elbow crease) was taken using a FLIR T530 infrared thermal imager as the baseline. The shooting distance was 50cm, and the emissivity was set to 0.98 (the standard value for human skin). 1g of the sample to be tested was evenly applied to the shooting area, gently spreading until evenly covered (approximately 1 minute), and then left to stand. Ten minutes after application, a thermal image was taken again at the same location and under the same shooting conditions. The thermal images were analyzed using FLIRResearchIR software. Five evenly distributed sampling points were selected within the target area to read the temperature values, and the average value was taken as the skin temperature of that area. The change in average local skin temperature, ΔT, before and after application was calculated. ΔT = temperature after application - temperature before application. A larger ΔT indicates a more significant improvement in local blood circulation. Three volunteers were assigned to each sample for testing, and the average of the three results was taken as the test result for that sample. The blank control group was not applied to any medium and was simply left to stand for the same duration. The test results of Examples 1-3 and Comparative Examples 1, 3, and 4 are summarized in Table 5.

[0053] Table 5. Results of local skin temperature change tests (ΔT, 10 min after application) for each embodiment and comparative example. Analysis of possible causes of differences in test results: The comprehensive comparative data between Example 1 and Comparative Example 1 clearly reveal the crucial role and indispensability of the high-pressure homogenization process in this invention. High-pressure homogenization, through the intense shear force, high-speed impact force, and cavitation effect induced by the instantaneous pressure drop generated by the homogenization valve gap, efficiently breaks down the oil droplets of the emulsion from the micrometer scale (3.8 μm in Comparative Example 1) to the nanometer scale (120-180 nm in Examples 1-5), thereby triggering a series of chain reactions of physicochemical changes and enhanced biological effects. First, from a physical performance perspective: the formation of nano-sized oil droplets leads to a geometric increase in the oil-water interface area, allowing more carbomer molecules to adsorb onto the oil-water interface and participate in the construction of the interfacial film. Simultaneously, the increased interface area also means a higher density of crosslinking points in the three-dimensional network structure, thus significantly improving the overall viscosity and thixotropic network strength of the composition. This explains why the viscosity (19800-23600 mPa·s) and thixotropic index (4.3-5.1) of Examples 1-5 are significantly higher than those of Comparative Example 1 (14800 mPa·s and 2.3). A suitable thixotropic index (3.0-6.0) is crucial to ensure that the composition thins instantly during high-speed gliding of the fascia knife, providing a smooth operating feel, and then quickly returns to a paste-like consistency after the knife passes, preventing runoff. Comparative Example 1 has a thixotropic index of only 2.3, indicating insufficient thixotropic effect. This results in insufficient "shear thinning" during operation, leading to a sluggish operating feel, reflected in a high coefficient of friction (0.15). Secondly, from the perspective of transdermal absorption: nano-oil droplets with a particle size of 100-200 nm have a good match between their size and the opening of the hair follicle infundibulum and the diameter of the hair follicle canal, allowing them to bypass the main barrier of the stratum corneum through "bypass pathways" of skin appendages such as hair follicles and sweat glands. However, the micron-sized (3.8 μm) oil droplets in Comparative Example 1 have a particle size much larger than the effective passage size of the hair follicle opening, making it impossible to utilize this bypass pathway and forcing reliance on the inefficient intercellular lipid diffusion pathway. This difference in mechanism directly resulted in the cumulative 24-hour permeation of ferulic acid in Examples 1-5 (182-209 μg / cm³). 2 Comparison Example 1 (125.6 μg / cm) 2 The transdermal efficiency was increased by approximately 45%-66%. This significant improvement in transdermal efficiency means that more effective ingredients for muscle relaxation, such as *Lysimachia christinae* triterpenoid saponins and safflower yellow pigment, can reach the dermis and fascia layers to exert their therapeutic effects within the same operating time. This is directly reflected in the muscle relaxation effect (sEMG reduction): Examples 1-5 showed a reduction of 40%-46%, while Comparative Example 1 only showed 27.8%. Finally, from the perspective of product stability, the oil droplets in the nanoemulsion are able to overcome gravitational sedimentation due to Brownian motion, and the oil droplets are less likely to aggregate due to the barrier effect of the interfacial film. Therefore, its physical stability is far superior to that of micron-sized emulsions. Comparative Example 1 showed stratification after one week of storage, while Examples 1-5 maintained a uniform appearance after accelerated stability testing (3 months at 40°C).

[0054] (II) Analysis of the multiple key mechanisms of sweet almond oil in the synergistic effect of physical lubrication and bioactivity.

[0055] Data from Comparative Example 3 (completely free of sweet almond oil) and Comparative Example 5 (sweet almond oil to dimethyl silicone oil ratio of 1:2.0, exceeding the preferred range) collectively reveal the irreplaceable role of sweet almond oil and its specific ratio with dimethyl silicone oil in this invention. From a physical lubrication perspective: when used alone (Comparative Example 3), dimethyl silicone oil, while providing an extremely low coefficient of friction (0.07), forms an overly slippery lubricating film with poor skin compatibility. This causes the cutting tool to slip easily during operation, making it difficult for the operator to obtain clear tactile feedback from the fascial nodules, thus affecting the targeting and precision of treatment. Simultaneously, the excessive hydrophobicity of the pure silicone oil film results in a noticeable oily and foreign body sensation during application, leading to a poor user experience. The introduction of sweet almond oil and the optimization of its ratio are precisely to solve this problem: an appropriate amount of sweet almond oil fills the microscopic pores between the polymer chains of dimethyl silicone oil, making the lubricating film "both rigid and flexible"—providing sufficient lubrication and friction reduction while maintaining appropriate tactile feedback. When the proportion of sweet almond oil is too high (Comparative Example 5), although skin compatibility improves, the skeletal support of dimethyl silicone oil weakens, resulting in insufficient oil film strength and durability. During prolonged use, lubrication performance gradually declines (the coefficient of friction increases to 0.13). From the perspective of transdermal absorption and efficacy, the oleic acid and linoleic acid abundant in sweet almond oil can insert into the lipid bilayer of the stratum corneum, acting as a natural transdermal softener. This pre-emptively reduces the barrier resistance of the stratum corneum, creating favorable conditions for the subsequent penetration-enhancing effects of laurocapram and the transdermal delivery of active ingredients from traditional Chinese medicine. Without this softening foundation of sweet almond oil, the penetration-enhancing efficiency of laurocapram and the transdermal efficiency of Comparative Example 3 (only 72% of Example 1) both significantly decreased. The reduced transdermal efficiency directly led to Comparative Example 3 showing significantly inferior muscle relaxation effects (sEMG decrease of 30.4%) and circulation-enhancing effects (ΔT=1.7℃) compared to Examples 1-5. This comparison fully demonstrates that sweet almond oil is not only a component of physical lubrication, but also a key "bridge" component connecting the physical lubrication function and the bioactivity of traditional Chinese medicine, reflecting the core innovative idea of ​​this invention: "synergistic enhancement of physical lubrication and bioactivity".

[0056] The data of Comparative Example 4 (without Lycopodium clavatum extract) provided objective experimental verification for the status of Lycopodium clavatum as the monarch drug in the traditional Chinese medicine compatibility of the present invention. Although the physical performance parameters of Comparative Example 4 were basically the same as those of Example 1 (there were no significant differences in viscosity, thixotropic index, friction coefficient, oil droplet size, etc.), its muscle relaxation efficacy (the decrease in sEMG was only 23.5%) and blood circulation promotion efficacy (ΔT was only 1.3°C) were both significantly lower than those of Example 1 (43.2% and 2.9°C respectively), and the reduction amplitudes reached approximately 46% and 55% respectively. This result was completely consistent with the core role of Lycopodium clavatum as the monarch drug and mainly targeting the dredging of channels and collaterals in traditional Chinese medicine theory. Analyzed from the pharmacological perspective, the triterpenoid saponin components in Lycopodium clavatum are recognized natural products with skeletal muscle relaxation, anti-inflammatory and analgesic activities, and their action mechanisms involve the regulation of acetylcholine release at the neuromuscular junction, the inhibition of inflammatory factors (such as TNF-α, IL-1β), and the improvement of local microcirculation. The absence of Lycopodium clavatum made the entire traditional Chinese medicine compatibility lose the most core pharmacodynamic support. Even though Herba Speranskiae tuberculata, Flos Carthami and Folium Artemisiae Argyi were still playing their respective roles, the overall efficacy was greatly reduced. This result confirmed the scientific nature of the theory of monarch, minister, assistant and guide in traditional Chinese medicine compatibility - the leading role of the monarch drug in the compound prescription is irreplaceable, and also proved the rationality of selecting Lycopodium clavatum as the monarch drug in the present invention and conducting scientific verification.

[0057] The comparison between Example 1 and Comparative Example 2 verified the significant advantages of the menthol-hydroxypropyl-β-cyclodextrin embedding technology. Analyzed from the perspective of stability: Menthol has a relatively high saturated vapor pressure and is extremely volatile in the free state. In Comparative Example 2, menthol was directly added and about 25% of it had volatilized and been lost during the preparation process (involving heating and stirring operations), and the loss further increased to 58% after 1 month of storage. In Example 1, however, menthol was embedded in the hydrophobic cavity of cyclodextrin, and its volatility was effectively inhibited. The retention rate of menthol was still above 90% after 1 month of storage, significantly improving the quality stability and shelf life of the product. Analyzed from the perspective of the usage experience: In Comparative Example 2, a large amount of free menthol was released instantly upon application, generating a "one-time explosive" strong cooling sensation, but the duration of this cooling sensation was short (only 5 - 10 min), and it did not match the actual needs of the fascia knife operation - when the pain and discomfort were most obvious in the middle and late stages of the operation, the cooling effect had already disappeared. The embedded cooling agent in Example 1 was different: In the initial stage of application, menthol was stably protected in the inclusion compound and the cooling sensation was weak; when the fascia knife started to operate, the local frictional heat and shear force triggered the gradual release of menthol, and the cooling sensation gradually increased and continued until the end of the operation. The subjective evaluation feedback from the volunteers was that the cooling sensation of Example 1 was "just right" and "became more comfortable as the massage went deeper", while in Comparative Example 2 it was "too cold at the beginning and then there was no feeling". This "friction-triggered and demand-driven release" intelligent cooling supply mechanism is an important innovation of the present invention in enhancing the user's treatment experience.

[0058] Summary of the multiple synergistic mechanisms between nanoemulsion structure and mechanical-thermal effects: In summary, the fundamental reason why this invention achieves significantly superior overall effects compared to existing technologies and comparative examples lies in the construction of a multi-level, multi-pathway synergistic system: the nanoemulsion structure (100-200nm) formed by high-pressure homogenization not only optimizes the physical lubrication properties of the composition (viscosity, thixotropy, coefficient of friction), but more importantly, it opens up a highly efficient transdermal channel for the active ingredients of traditional Chinese medicine via a bypass route through skin appendages. The combination of sweet almond oil and dimethyl silicone oil in a specific ratio, while ensuring excellent lubrication properties, reduces barrier resistance for the transdermal delivery of traditional Chinese medicine ingredients through the stratum corneum softening effect of sweet almond oil. The synergistic penetration-enhancing effect of laurocapram and sweet almond oil further improves the skin permeability of the traditional Chinese medicine ingredients. The mechanical pressure generated during the fascia knife operation (promoting the insertion of the composition into the hair follicle opening) and the frictional heat effect (increasing the fluidity of the stratum corneum, promoting menthol release, and dilating capillaries) form a positive feedback loop with the nanostructure of the composition—the mechanical pressure enhances the delivery efficiency of nano-oil droplets to the hair follicle, the frictional heat accelerates the local circulation and efficacy of the penetrated components, and simultaneously triggers the cooling release of encapsulated menthol. This five-in-one synergistic mechanism of "physical penetration enhancement + nano-delivery + mechanical boost + thermal acceleration + cooling trigger" is the underlying mechanism for the significant technological advancements achieved in this invention, and also the core innovation that distinguishes this invention from existing technologies.

[0059] Finally, it should be noted that the above embodiments are used to illustrate the technical solutions of the present invention and not to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A fascia knife lubricating composition having muscle relaxing efficacy, characterized in that, It consists of the following components in parts by weight: Sweet almond oil 60-70 parts, dimethyl silicone oil 10-15 parts, *Lycopodium clavatum* extract 3-5 parts, *Clematis chinensis* extract 2-3 parts, safflower extract 1-2 parts, *Artemisia argyi* extract 1-2 parts, azone 0.5-1 part, carbomer 0.3-0.5 parts, vitamin E 0.5-1 part, encapsulated cooling agent 0.5-1.5 parts, deionized water balance; The encapsulated cooling agent is an inclusion complex formed by menthol and hydroxypropyl-β-cyclodextrin, wherein the mass ratio of menthol to hydroxypropyl-β-cyclodextrin is 1:4-1:8; The composition has a viscosity of 15,000-30,000 mPa·s at 25°C and a thixotropic index of 3.0-6.

0. The average particle size of the oil droplets in the composition is 100-200 nm.

2. The fascia knife lubricating composition of claim 1, wherein, The extracts of *Lycopodium clavatum*, *Clematis armandii*, *Carthamus tinctorius*, and *Artemisia argyi* were obtained by reflux extraction of the corresponding Chinese herbal raw materials with ethanol. The extraction method was as follows: after pulverizing the Chinese herbal raw materials, 8-12 times the amount of 65%-75% ethanol was added, and the mixture was refluxed at 70-80℃ for 1.5-2.5 hours. The extraction was repeated twice. The extracts were combined and concentrated under reduced pressure to a relative density of 1.05-1.

15.

3. The fasciamy knife lubricating composition of claim 1, wherein, The preparation method of the encapsulated cooling agent includes: dissolving hydroxypropyl-β-cyclodextrin in deionized water at a solid-liquid ratio of 1g:8-12mL, stirring at 40-60℃ until completely dissolved, dissolving menthol in anhydrous ethanol at a mass ratio of 1:4-1:8 and slowly adding it dropwise to the hydroxypropyl-β-cyclodextrin solution, stirring at 40-60℃ for 1-3 hours to encapsulate, cooling to 4-8℃ and standing for 8-12 hours, filtering, and vacuum drying at 40-50℃ to obtain the product.

4. The fascia knife lubricating composition of claim 1, wherein, The coefficient of friction of the composition was measured to be 0.06-0.12 under the conditions of room temperature 25°C, normal load 2.0N, and sliding speed 50mm / s.

5. The fasciamy knife lubricating composition of claim 1, wherein The composition has an average droplet size of 120-180 nm, a viscosity of 18000-25000 mPa·s at 25°C, and a thixotropic index of 4.0-5.

5.

6. The process for the preparation of fascia knife lubricating composition according to any one of claims 1 to 5, characterized in that, Includes the following steps: S1. Preparation of Chinese herbal extracts: The following herbs were weighed in proportion: *Lycopodium clavatum*, *Clematis chinensis*, safflower, and artemisia argyi. They were then pulverized and passed through a 20-40 mesh sieve. 8-12 times the amount of 65%-75% ethanol was added, and the mixture was refluxed at 70-80℃ for 1.5-2.5 hours. The extraction was repeated twice. The extracts were combined and concentrated under reduced pressure to a relative density of 1.05-1.15 to obtain extracts of *Lycopodium clavatum*, *Clematis chinensis*, safflower, and artemisia argyi. S2. Preparation of encapsulated cooling agent: Prepare encapsulated cooling agent according to claim 3, for later use; S3. Oil phase preparation: Mix sweet almond oil and dimethyl silicone oil in a certain proportion, heat to 45-60℃, add vitamin E, and stir until uniform to prepare the oil phase for later use. S4. Preparation of aqueous phase: Carbomer is added to deionized water and swelled at room temperature for 4-8 hours. The mixture is then heated to 45-60℃, and extracts of Lycopodium clavatum, Clematis chinensis, Carthamus tinctorius, Artemisia argyi, and azone are added. The mixture is stirred evenly and used as the aqueous phase for later use. S5. Primary emulsification: The oil phase is slowly added to the aqueous phase, and primary emulsification is carried out at a stirring speed of 500-1000 r / min for 10-20 min to obtain the primary emulsion. S6. High-pressure homogenization: The primary emulsion is homogenized under a pressure of 50-80MPa for 2-4 times. During the homogenization process, the temperature of the liquid is controlled not to exceed 45℃. S7. Adding the encapsulated cooling agent: When the emulsion after high-pressure homogenization cools to 30-38℃, add the encapsulated cooling agent and stir slowly at 200-400r / min for 5-10min until homogeneous. S8. Gradient temperature-controlled curing: The obtained product is first cured at 35-40℃ for 4-8 hours, and then cooled to room temperature at a cooling rate of 0.5-1.0℃ / min.

7. The manufacturing process of claim 6, wherein, In step S6, the pressure of high-pressure homogenization is 60-70 MPa, the number of homogenizations is 3, and the average particle size of the oil droplets after homogenization is 120-180 nm; in step S3, the mass ratio of sweet almond oil to dimethyl silicone oil is 4:1-7:1.

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