Traditional Chinese medicine combined medicated oil for local fat reduction and preparation method thereof

Abstract

The application belongs to the technical field of external preparation of traditional Chinese medicine, and specifically discloses a traditional Chinese medicine combined oil for local fat reduction. The oil is composed of traditional Chinese medicine extracts and a transdermal penetration enhancer. The traditional Chinese medicine extracts are obtained by extracting 19 kinds of traditional Chinese medicine decoctions, i.e. Paederia scandens, caper, Coptis chinensis, Phellodendron amurense, Sparganium stoloniferum, Curcuma zedoaria, Rhei Radix et Rhizoma, Salvia miltiorrhiza, lotus leaf, hawthorn, Cassia obtusifolia, Ramulus Cinnamomi, Pericarpium Citri Reticulatae, Fructus Aurantii, Pericarpium Citri Reticulatae Viride, Poria cocos, Rhizoma Pinelliae and Rhizoma Anemarrhenae, with plant oil. The transdermal penetration enhancer is composed of ligustrazine and menthol. The mass percentage concentration of ligustrazine in the oil is 0.5% to 3.0%, and the mass percentage of menthol is 1.0% to 5.0%. The mass ratio of ligustrazine to menthol is 1:1 to 1:4. The oil is prepared by crushing the traditional Chinese medicine decoctions, adding plant oil, soaking at room temperature for 7 days, heating for extraction, and then adding ligustrazine and menthol before filtration. The oil has the characteristics of rapid effect, high transdermal absorption efficiency, and targeting phlegm-dampness and blood stasis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine external preparation technology, specifically relating to a traditional Chinese medicine external oil for localized fat reduction based on the synergistic effect of a traditional Chinese medicine composition and a transdermal penetration enhancer. This invention is particularly suitable for external fat reduction in areas such as the abdomen, thighs, and upper limbs caused by simple obesity and localized fat accumulation. Background Technology

[0002] Obesity is a significant risk factor for many metabolic diseases, with simple obesity accounting for the vast majority of obese individuals. Current treatments for obesity primarily include oral weight-loss medications, surgery, and various topical weight-loss products.

[0003] Oral weight-loss drugs have significant side effects. Most commercially available weight-loss drugs work by suppressing appetite, reducing intestinal fat absorption, or promoting metabolism, but they are often accompanied by adverse reactions such as gastrointestinal discomfort, palpitations, insomnia, and liver and kidney damage. Some patients discontinue treatment due to intolerance of these side effects. While surgical procedures (such as liposuction and gastric bypass) can achieve more direct fat reduction, they are high-risk, expensive, and may lead to complications such as loose skin and uneven skin texture. Therefore, they are not suitable as a routine weight-loss method.

[0004] Topical weight loss products have gained widespread attention due to their ease of use and relatively high safety. Currently, commercially available topical weight loss products mainly include heating patches, massage creams, and essential oils.

[0005] Du Lanbo (Du Lanbo. A topical Chinese herbal medicine with weight loss and lipid-lowering functions: CN102266414B[P]. 2015-06-03.) disclosed a topical Chinese herbal medicine using 6-20 parts rhubarb, 10-30 parts atractylodes macrocephala, 15-25 parts licorice, 18-26 parts bitter orange blossom, 10-30 parts fennel, 3-6 parts camphor, 5-10 parts ephedra, 5-10 parts cinnamon, 10-25 parts atractylodes lancea, and 10-30 parts angelica dahurica as raw materials. It exerts its spleen-strengthening and dampness-removing effects through transdermal absorption. This formula has the following shortcomings: the formula mainly uses pungent and warm dispersing herbs (ephedra, cinnamon, camphor, etc.), and its weight-loss mechanism mainly relies on sweating and local heat to promote water excretion, failing to exert a substantial effect on adipose tissue. Such products have a short duration of action, and weight easily recovers after discontinuation. Furthermore, the patent does not involve the design of transdermal absorption enhancers, and the fat-soluble components such as rhubarb free anthraquinone contained therein are difficult to effectively penetrate the stratum corneum of the skin to reach the subcutaneous fat layer.

[0006] Han Hongyan et al. (Henan University of Traditional Chinese Medicine (Han Hongyan, Li Hanwei, Dang Changlin, Xu Hongzhou, Guo Wei). A Traditional Chinese Medicine Acupoint Patch for Simple Obesity: CN105943773A[P]. 2016-09-28.) disclosed a traditional Chinese medicine acupoint patch for simple obesity, made from 15-30g of Atractylodes macrocephala, 6-18g of Pinellia ternata, 6-18g of Citrus reticulata peel, 6-18g of Atractylodes lancea, 6-18g of Alisma plantago-aquatica, 6-18g of Cinnamomum cassia, 6-18g of Plantago asiatica, 6-18g of Crataegus pinnatifida, 3-9g of Glycyrrhiza uralensis (processed), 0.07-0.14g of sodium benzoate, 5-10g of sodium carboxymethyl cellulose, and 0.7-1.4g of laurocapram. The drawback of this acupoint patch is that laurocapram, used as a chemically synthesized transdermal penetration enhancer, poses a risk of skin irritation and allergies with long-term external use. In addition, this acupoint patch is a solid patch with a fixed drug release area, making it unsuitable for use on areas with large fat deposits such as the waist, abdomen, and thighs.

[0007] Zhang Lijing et al. (Zhang Lijing, Shi Wanjun, Han Bangrong. A topical drug for weight loss: CN103432548A[P]. 2013-12-11.) disclosed a topical drug made from more than 50 kinds of traditional Chinese medicines, including Acanthopanax senticosus, rhubarb, Angelica pubescens, and Asarum heterotropoides, which exerts a weight loss effect by applying heat to the Shenque acupoint. This formula contains more than 50 kinds of herbs, making it complex and unfavorable for quality control and large-scale production. Due to the lack of transdermal penetration enhancers, the penetration-enhancing effect of the heat application method relies on continuous heating, which is inconvenient to operate and results in poor patient compliance.

[0008] Liu Weiguo (Henan Yangzi Aimei Slimming Service Chain Co., Ltd.). A traditional Chinese medicine that helps with weight loss and sub-health: CN110772619A[P]. On February 11, 2020, a traditional Chinese medicine formula for weight loss using hot compresses was disclosed. This formula is composed of 0.5-1 parts turmeric, 0.8-1.5 parts ginseng, 1.2-2 parts trichosanthes root, 0.5-1 part mung bean husk, 0.5-1 part angelica dahurica, 1.5-2 parts Euonymus alatus, 0.8-1.5 parts aconite, 0.5-0.8 parts stir-fried nardostachys jatamansi, 1.5-2 parts prepared rhubarb, 0.5-0.8 parts cassia seed, 2-3 parts angelica sinensis, 0.6-1 part chuanxiong rhizome, 1-1.5 parts safflower, 0.3-0.8 parts atractylodes lancea, 0.5-1 part angelica pubescens, 0.5-0.8 parts fennel, 0.3-0.5 parts galangal, and 0.5-1 parts eucommia bark. This formula uses a hot compress method for drug administration, and its mechanism of action remains at the physical level of generating heat and sweating, failing to achieve a systematic conditioning of the constitution characterized by the mutual binding of phlegm-damp-heat and blood stasis.

[0009] Guizhou Hongyu Pharmaceutical Co., Ltd. (Chai Li) (Guizhou Hongyu Pharmaceutical Co., Ltd. (Chai Li). Compound essential oil with body shaping function and its preparation method: CN102743304B[P]. 2013-10-30.) disclosed a compound essential oil containing cinnamon oil, artemisia capillaris oil, myrrh oil and camellia oil, which has the effect of body shaping. The shortcomings of this solution are: it only contains four essential oil components, lacks a systematic Chinese medicine formula for phlegm-damp-heat and blood stasis constitution, and does not involve the addition of transdermal penetration enhancers. The transdermal penetration capacity of essential oils themselves is limited, and their penetration-enhancing effect depends on the temporary disturbance of the stratum corneum of the skin by volatile components, making it difficult to achieve effective delivery of large molecular or water-soluble active ingredients.

[0010] Zhejiang University (Cheng Yiyu, Wang Yi, Zhang Yufeng) (Zhejiang University (Cheng Yiyu, Wang Yi, Zhang Yufeng). Compounds extracted from the traditional Chinese medicine Euonymus alatus and their uses: CN102827179B[P]. 2014-05-07.) disclosed a novel polyphenolic compound extracted from Euonymus alatus, which, as verified by 3T3-L1 cells, has the function of inhibiting adipocyte differentiation and inhibiting triglyceride production. However, this patent only involves the cellular-level verification of a single active ingredient, does not involve the development of compound topical preparations, and does not solve the problem of how the active ingredients of compound traditional Chinese medicine can be effectively absorbed transdermally and synergistically exert a fat-reducing effect.

[0011] Guangzhou Jindiya Biotechnology Co., Ltd. (Zhao Xinwei) (Guangzhou Jindiya Biotechnology Co., Ltd. (Zhao Xinwei). A multi-functional massage oil for external use, including ginseng, angelica, poria, hawthorn, and other medicinal herbs, as well as vegetable oil and magnetized water, for use in weight loss and body shaping. In this design, the active ingredients of the traditional Chinese medicine are added to the oil phase system in the form of water extracts. Because water-soluble components are difficult to disperse evenly in an oily matrix, the release and transdermal behavior of the active ingredients are uncertain during actual use. This patent does not involve the system design of transdermal absorption promoters.

[0012] The common technical challenges of the aforementioned existing technologies include the following aspects.

[0013] Firstly, the formulation of these products lacks a systematic coverage of the etiology and pathogenesis of obesity. From the perspective of Traditional Chinese Medicine (TCM), obesity is closely related to phlegm-dampness, damp-heat, and blood stasis, representing a complex pathological process involving multiple organs and stages. The inventor, through years of practice in TCM weight loss, has discovered that most patients with localized obesity do not simply suffer from "internal retention of dampness," but rather from a complex pathogenesis involving the intermingling of phlegm-damp-heat and blood stasis. Existing topical weight-loss products typically target only a single pathological stage (such as strengthening the spleen and eliminating dampness or promoting qi circulation and relieving stagnation), failing to form a systematic formulation covering five dimensions: clearing damp-heat, promoting blood circulation and removing blood stasis, reducing lipids and eliminating stagnation, warming and unblocking the meridians, and strengthening the spleen and resolving phlegm. This single-target approach results in a narrow range of product applications and poor long-term effects.

[0014] Secondly, the low transdermal absorption efficiency of active ingredients in traditional Chinese medicine (TCM) remains a long-standing technical challenge in the field of topical formulations. The stratum corneum of the skin is composed of dead keratinocytes and a lipid matrix rich in ceramides, cholesterol, and free fatty acids. Its dense "brick wall" structure forms a natural barrier against the transdermal absorption of exogenous compounds. The active ingredients in TCM compound formulas are mostly hydrophilic glycosides or macromolecular compounds, which generally have poor lipid solubility. Passive diffusion alone is insufficient to achieve effective therapeutic concentrations. Although some literature reports that chemical penetration enhancers such as laurocapram can improve transdermal efficiency, these enhancers pose risks of skin irritation and long-term safety. While naturally derived transdermal penetration enhancers (such as menthol, borneol, and ligustrazine) have relatively high safety profiles, their penetration-enhancing effects vary greatly among individuals and are subject to component selectivity. Not every combination of a natural penetration enhancer with any active ingredient in TCM will achieve the desired penetration-enhancing effect. How to achieve synergistic penetration enhancement of multiple active ingredients in a compound without using chemically synthesized penetration enhancers, using naturally derived penetration enhancers, is a long-standing technical problem in this field that has never been well solved.

[0015] Third, the synergistic matching between extracts from traditional Chinese medicine (TCM) compound preparations and transdermal penetration enhancers is uncertain. In existing technologies, the design of external TCM preparations typically considers the "selection and compatibility of effective components" and the "construction of a transdermal delivery system" as two relatively independent technical steps. Different active ingredients in TCM compound preparations (alkaloids, flavonoids, terpenes, anthraquinones, etc.) have different physicochemical properties, and their response behaviors to the same transdermal penetration enhancer also vary. This means that even if a transdermal penetration enhancer has a penetration-enhancing effect on a single component, its addition to the compound system may still result in a weakening or even loss of this effect due to interactions between components. When faced with a compound system containing multiple active ingredients with varying physicochemical properties, those skilled in the art lack universally applicable rules for selecting transdermal penetration enhancers and require extensive experimentation to verify their synergistic effectiveness. Existing literature does not present a technical solution for using a specific ratio of tetramethylpyrazine and menthol for transdermal penetration enhancement in external TCM compound preparations.

[0016] Fourth, the compatibility between plant oil matrices and the active ingredients of traditional Chinese medicine (TCM) is uncertain. Plant oils (such as olive oil and camellia oil) often act as matrix carriers in topical preparations, but different plant oils differ in fatty acid composition, polarity, and viscosity. These differences directly affect their solubility and release behavior of different TCM active ingredients. Olive oil, whose main component is triglycerides, may have insufficient solubility for moderately polar components (such as lotus leaf alkaloids and emodin), requiring experimental determination of suitable material-liquid ratios and extraction conditions. Although there are sporadic reports in the existing literature on topical TCM oils with plant oil as the matrix, none have conducted systematic experimental verification of the compatibility of different plant oil matrices.

[0017] Fifth, controlling the stability of topical Chinese medicine oils presents challenges. Chinese medicine extracts are complex systems containing multiple chemical components, and the plant oils, rich in unsaturated fatty acids, are prone to oxidative rancidity during storage. Tetramethylpyrazine is a nitrogen-containing heterocyclic alkaloid, and menthol is a monoterpene compound; the stability of both in plant oil systems is significantly affected by factors such as temperature, light, and oxygen. Maintaining their content depends on the complete dissolution of active ingredients during the extraction process and precise control of process conditions during subsequent additions.

[0018] In summary, existing topical weight-loss products have significant technical shortcomings in terms of systematic formulation, high efficiency of transdermal absorption, synergistic matching of compound ingredients and penetration enhancers, compatibility with plant oil matrices, and product stability. Therefore, it is necessary to develop a topical weight-loss medicated oil based on the traditional Chinese medicine theory of "phlegm-dampness-heat-blood stasis leading to obesity," incorporating a complete formula that clears damp-heat, invigorates blood circulation, removes blood stasis, lowers lipids and eliminates stagnation, warms and unblocks meridians, and strengthens the spleen and resolves phlegm, with ligustrazine and menthol synergistically promoting transdermal penetration. Summary of the Invention

[0019] This invention provides a traditional Chinese medicine combination oil for localized fat reduction and its preparation method, aiming to overcome the above-mentioned shortcomings of the prior art.

[0020] This invention's medicinal oil is guided by the traditional Chinese medicine theory of "phlegm, dampness, heat, and blood stasis leading to obesity." It uses Paederia scandens as the principal ingredient, Artemisia capillaris, Coptis chinensis, and Phellodendron chinense as assistant ingredients, and Sparganium stoloniferum, Curcuma zedoaria, Rheum palmatum (processed with wine), Salvia miltiorrhiza, Nelumbo nucifera leaf, Crataegus pinnatifida, Cassia tora seed, Cinnamomum cassia twig, Citrus reticulata peel, Citrus aurantium, Areca catechu peel, Poria cocos, Pinellia ternata (processed), Atractylodes macrocephala, and Angelica dahurica as adjuvant ingredients. After extraction with olive oil, ligustrazine and menthol are added as transdermal penetration enhancers to form a topical fat-reducing preparation with the synergistic effect of traditional Chinese medicine active ingredients and natural transdermal penetration enhancers.

[0021] The medicinal oil of this invention is composed of traditional Chinese medicine extracts and transdermal penetration enhancers. The traditional Chinese medicine extracts are obtained by extracting the following traditional Chinese medicine slices by weight using plant oil: 15-22 parts of Paederia scandens, 12-18 parts of Artemisia capillaris, 6-10 parts of Coptis chinensis, 6-10 parts of Phellodendron chinense, 5-10 parts of Sparganium stoloniferum, 5-10 parts of Curcuma zedoaria, 3-8 parts of Rheum palmatum (processed with wine), 10-15 parts of Salvia miltiorrhiza, 20-30 parts of Nelumbo nucifera leaf, 12-18 parts of Crataegus pinnatifida, 8-12 parts of Cassia tora seed, 3-7 parts of Cinnamomum cassia twig, 8-15 parts of Citrus reticulata peel, 5-10 parts of Citrus aurantium, 10-15 parts of Areca catechu peel, 12-18 parts of Poria cocos, 6-12 parts of Pinellia ternata (processed), 10-15 parts of Atractylodes macrocephala, and 6-10 parts of Angelica dahurica. The transdermal penetration enhancers are tetramethylpyrazine and menthol, with tetramethylpyrazine having a mass percentage concentration of 0.5% to 3.0% in the medicinal oil and menthol having a mass percentage concentration of 1.0% to 5.0% in the medicinal oil.

[0022] The formulation of the medicinal oil of this invention is based on the following traditional Chinese medicine theories.

[0023] Obesity is closely related to phlegm-dampness, damp-heat, and blood stasis. Excessive consumption of rich and fatty foods damages the spleen and stomach, leading to impaired digestion and the internal generation of dampness; dampness transforms into heat, resulting in damp-heat accumulation; damp-heat obstructs the flow of qi, causing qi stagnation and blood stasis; and the mutual binding of phlegm and blood stasis leads to the accumulation of fat and turbidity, resulting in obesity. Based on this, this invention divides eighteen traditional Chinese medicines into five functional groups: The formula for clearing damp-heat includes: Paederia scandens, Artemisia capillaris, Coptis chinensis, and Phellodendron chinense. Paederia scandens is sweet and sour in taste, neutral in nature, and enters the liver, spleen, stomach, and large intestine meridians. Its functions include promoting digestion, eliminating food stagnation, dispelling wind and dampness, and activating blood circulation and relieving pain. It is the chief herb in this formula for clearing damp-heat. Artemisia capillaris is bitter and slightly cold in nature, and enters the spleen, stomach, liver, and gallbladder meridians. It effectively clears damp-heat in the liver and gallbladder. Coptis chinensis and Phellodendron chinense are bitter, cold, and drying, directly clearing heat from the middle and lower burners. The combined effects of these four herbs in clearing damp-heat are mutually reinforcing.

[0024] The blood-activating and stasis-removing group consists of: Sparganium rhizome, Curcuma rhizome, Rhubarb (processed with wine), and Salvia miltiorrhiza. Sparganium rhizome and Curcuma rhizome are a pair of herbs that break up blood stasis, promote qi circulation, eliminate stagnation, and relieve pain; Rhubarb (processed with wine) activates blood circulation, removes blood stasis, and promotes metabolism; Salvia miltiorrhiza is bitter and slightly cold in nature, entering the heart and liver meridians, and functions to activate blood circulation, regulate menstruation, cool the blood, and eliminate carbuncles, making it a key herb for activating blood circulation and guiding the flow of qi. The four herbs combined work synergistically to break up blood stasis, promote qi circulation, activate blood circulation, and unblock the meridians.

[0025] The lipid-lowering and digestion-eliminating group consists of lotus leaf, hawthorn, and cassia seed. Lotus leaf promotes the upward movement of clear qi and downward movement of turbid qi, eliminates dampness and reduces fat; its lotus leaf alkaloid content can upregulate the activity of hormone-sensitive lipase in adipose tissue. Hawthorn aids digestion, resolves stagnation, dissipates blood stasis, and contains lipase that can directly break down fats. Cassia seed clears the liver, improves eyesight, and lubricates the intestines to relieve constipation. The three herbs combined work synergistically to lower lipids and eliminate digestion.

[0026] The meridian-warming group consists of cinnamon twig, dried tangerine peel, immature bitter orange peel, and areca peel. Cinnamon twig warms and unblocks the meridians; dried tangerine peel and immature bitter orange peel regulate qi and relieve chest congestion; areca peel regulates qi and promotes diuresis. The four herbs combined unblock the qi mechanism of the triple burner, providing meridian pathways for the movement of the other herbs.

[0027] The spleen-strengthening and phlegm-resolving group consists of Poria cocos, Pinellia ternata (processed), Atractylodes macrocephala, and Angelica dahurica. Poria cocos strengthens the spleen and eliminates dampness; Pinellia ternata dries dampness and resolves phlegm; Atractylodes macrocephala strengthens the spleen and replenishes qi; and Angelica dahurica dries dampness and relieves pain. The four herbs work together to strengthen the spleen, eliminate dampness, and resolve phlegm, addressing the root cause of obesity—spleen deficiency leading to phlegm production.

[0028] Transdermal penetration enhancement group: Tetramethylpyrazine and menthol. Tetramethylpyrazine is the main active alkaloid in the traditional Chinese medicine Ligusticum chuanxiong, and has a good transdermal penetration enhancing effect. Menthol is a classic natural transdermal penetration enhancer; a 3% concentration can significantly promote the transdermal absorption of various lipid-soluble drugs. The combined use of tetramethylpyrazine and menthol can synergistically promote drug transdermal absorption from two aspects: "opening lipid channels in the stratum corneum" and "dilating capillaries to improve microcirculation".

[0029] In the medicinal oil of the present invention, the mass percentage concentration of tetramethylpyrazine is 0.5% to 3.0%, preferably 1.0% to 2.0%, more preferably 1.2% to 1.8%. The mass percentage concentration of menthol is 1.0% to 5.0%, preferably 2.0% to 4.0%, more preferably 2.5% to 3.5%. The mass ratio of tetramethylpyrazine to menthol is 1:1 to 1:4, preferably 1:1.5 to 1:3.

[0030] In the medicinal oil of this invention, the vegetable oil is olive oil, and the ratio of medicinal herbs to vegetable oil is 1:3 to 1:6 (g / mL), preferably 1:4 to 1:5.

[0031] The key feature of this medicated oil is its direct action through the skin to the subcutaneous fat layer. Unlike oral medications, which require absorption through the gastrointestinal tract and first-pass metabolism in the liver, the active ingredients in this transdermal oil can directly reach the sites of fat accumulation, resulting in a short pathway of action and rapid onset of action. It can be applied directly to any area with fat accumulation, whether in the abdomen (middle burner), thighs (lower burner), or upper limbs (upper burner). The rhubarb and artemisia capillaris in the formula also have the effect of clearing damp-heat from the lower burner. Combined with massage of acupoints such as Tianshu, Zhongwan, and Daheng, it can further unblock the Qi mechanism of the middle burner and enhance the effects of removing dampness and lowering lipids.

[0032] This invention also provides a method for preparing the above-mentioned traditional Chinese medicine combination oil, comprising the following steps: Step 1: Weigh out the following ingredients according to their weight proportions: *Paederia scandens*, *Artemisia capillaris*, *Coptis chinensis*, *Phellodendron chinense*, *Sparganium stoloniferum*, *Curcuma zedoaria*, *Rheum palmatum* (processed with wine), *Salvia miltiorrhiza*, *Nelumbo nucifera* leaf, *Crataegus pinnatifida*, *Cassia tora* seed, *Cinnamomum cassia* twig, *Citrus reticulata* peel, *Areca catechu* peel, *Poria cocos*, *Pinellia ternata* (processed), *Atractylodes macrocephala*, and *Angelica dahurica*. Grind them into coarse powder. Add the coarse powder to olive oil and soak at room temperature for 7 days. Then heat at 40–50°C for 4–6 hours, shaking 1–2 times daily. After extraction, filter through gauze and collect the filtrate.

[0033] Step 2: Add ligustrazine and menthol to the filtrate, stir at 30-50℃ for 20-40 minutes to dissolve and disperse, then filter with gauze to obtain the herbal combination oil.

[0034] In the above preparation method, ligustrazine is obtained by extraction from ligustrazine slices. The extraction method is as follows: take ligustrazine slices, reflux extract with 70% to 80% ethanol (volume percentage) for 1.5 hours, combine the extracts, and recover the ethanol until there is no alcohol odor to obtain ligustrazine extract, which contains ligustrazine.

[0035] When using this medicated oil, the specific dosage depends on the size of the area being treated: approximately 5 mL for thin individuals (abdomen), approximately 10 mL for average-sized individuals, and approximately 20 mL for obese individuals (abdomen). Apply to areas of localized fat accumulation, such as the abdomen, thighs, or upper limbs, and massage using a fixed technique for 20 minutes. Use 1-2 times daily. Immediate reduction in local circumference can be observed within 15-30 minutes after application.

[0036] Beneficial effects

[0037] The medicinal oil of this invention has the following beneficial effects.

[0038] First, the formulation system is highly targeted. This invention targets the complex pathogenesis of obesity caused by the mutual accumulation of phlegm, dampness, heat, and blood stasis. It adopts the treatment method of "dispersing and purging, resolving blood stasis and lowering lipids, and strengthening the spleen and consolidating the foundation". The eighteen Chinese medicines are divided into five functional groups: clearing damp heat, promoting blood circulation and breaking up blood stasis, lowering lipids and eliminating accumulation, warming and unblocking the meridians, and strengthening the spleen and resolving phlegm. Each group performs its own function and works synergistically to form a systematic coverage of the etiology and pathogenesis of obesity.

[0039] Second, the route of administration is direct and the path of action is short. This invention is a topical preparation, and the active pharmaceutical ingredient acts directly on subcutaneous adipose tissue after transdermal penetration, avoiding the first-pass effect of the liver and gastrointestinal side effects of oral administration.

[0040] Third, the transdermal penetration enhancement design is reasonable. The combination of ligustrazine and menthol is based on the traditional Chinese medicine theory of "pungent and dispersing to unblock the meridians". One promotes blood circulation and unblocks the meridians, improving microcirculation, while the other is pungent and cool, penetrating and opening the pores. The two work together to help the medicine penetrate to the affected area.

[0041] Fourth, it has a high safety profile. This formula uses only commonly used Chinese herbs and does not contain any toxic ingredients. External application further reduces the risk of systemic adverse reactions. Attached Figure Description

[0042] Figure 1 Photograph of the abdominal circumference (100cm) before using the medicated oil of this invention.

[0043] Figure 2 Photograph of abdominal circumference at the navel after using the medicated oil of this invention (95cm).

[0044] Figure 3 Photograph of the forearm circumference (35cm) measured using the medicated oil of this invention.

[0045] Figure 4 Photographs showing arm circumference measurements after using the medicated oil of this invention.

[0046] Figure 5 Photograph of the abdominal circumference at the level of the navel before using the medicated oil of this invention (103cm).

[0047] Figure 6 Photograph of abdominal circumference at the navel after using the medicated oil of this invention (97cm). Detailed Implementation

[0048] To make the technical solution and beneficial effects of the present invention clearer, the following description, in conjunction with specific embodiments and related accompanying drawings, is provided. The related images are derived from the inventor's actual measurement records in clinical practice, all measured using a flexible measuring tape. Measurement sites include three locations: at the level of the navel, above the navel, and below the navel. The measurement positions and conditions were maintained before and after use. The accompanying drawings visually demonstrate the changes in local circumference after using the medicated oil of the present invention. The present invention will be further described in detail below. The embodiments described are only for explaining the present invention and do not constitute a limitation on the scope of protection of the present invention.

[0049] Example 1: Preparation of a combination of traditional Chinese medicine oils Weigh out 18g of *Paederia scandens*, 15g of *Artemisia capillaris*, 8g of *Coptis chinensis*, 8g of *Phellodendron chinense*, 8g of *Sparganium stoloniferum*, 8g of *Curcuma zedoaria*, 5g of rhubarb (processed with wine), 12g of *Salvia miltiorrhiza*, 25g of lotus leaf, 15g of hawthorn, 10g of cassia seed, 5g of cinnamon twig, 12g of dried tangerine peel, 8g of bitter orange peel, 12g of areca peel, 15g of *Poria cocos*, 9g of prepared *Pinellia ternata*, 12g of *Atractylodes macrocephala*, and 8g of *Angelica dahurica*, and grind them into coarse powder. Add the coarse powder to 500mL of olive oil and soak at room temperature for 7 days, then heat at 45℃ for 5 hours, shaking twice daily. After extraction, filter with gauze and collect the filtrate. Add 1.2g of ligustrazine and 0.9g of menthol (the mass ratio of ligustrazine to menthol is 4:3) to the filtrate, stir at 40℃ for 30 minutes to dissolve and disperse, and then filter with gauze to obtain the herbal combination oil.

[0050] Example 2: Preparation of Traditional Chinese Medicine Combination Oil (Different Proportions) Weigh out 18g of *Paederia scandens*, 15g of *Artemisia capillaris*, 8g of *Coptis chinensis*, 8g of *Phellodendron chinense*, 8g of *Sparganium stoloniferum*, 8g of *Curcuma zedoaria*, 5g of rhubarb (processed with wine), 12g of *Salvia miltiorrhiza*, 25g of lotus leaf, 15g of hawthorn, 10g of cassia seed, 5g of cinnamon twig, 12g of dried tangerine peel, 8g of bitter orange peel, 12g of areca peel, 15g of *Poria cocos*, 9g of prepared *Pinellia ternata*, 12g of *Atractylodes macrocephala*, and 8g of *Angelica dahurica*, and grind them into coarse powder. Add the coarse powder to 500mL of olive oil and soak at room temperature for 7 days, then heat at 45℃ for 5 hours, shaking twice daily. After extraction, filter with gauze and collect the filtrate. Add 1.5g of ligustrazine and 2.5g of menthol to the filtrate, stir at 40℃ for 30 minutes to dissolve and disperse, and then filter with gauze to obtain the herbal combination oil.

[0051] Example 3: Preparation of a combination of traditional Chinese medicine oils (pre-extraction of ligustrazine) Weigh 10g of Ligusticum chuanxiong slices and extract twice with 70% ethanol (100mL ethanol added each time, refluxed for 1.5 hours). Combine the extracts and recover the ethanol until no alcohol odor remains, obtaining Ligusticum chuanxiong extract (containing approximately 1.2g of ligustrazine). Weigh 18g of Paederia scandens, 15g of Artemisia capillaris, 8g of Coptis chinensis, 8g of Phellodendron chinense, 8g of Sparganium stoloniferum, 8g of Curcuma zedoaria, 5g of Rheum palmatum (processed with wine), 12g of Salvia miltiorrhiza, 25g of Nelumbo nucifera leaf, 15g of Crataegus pinnatifida, 10g of Cassia tora seed, 5g of Cinnamomum cassia twig, 12g of Citrus reticulata peel, 8g of Citrus aurantium, 12g of Areca catechu peel, 15g of Poria cocos, 9g of Pinellia ternata (processed), 12g of Atractylodes macrocephala, and 8g of Angelica dahurica, and grind them into coarse powder. Add the coarse powder to 500mL of olive oil and soak at room temperature for 7 days, then heat at 45℃ for 5 hours, shaking twice daily. After extraction, filter with gauze and collect the filtrate. Add the above-mentioned Ligusticum chuanxiong extract and 0.9g of menthol to the filtrate, stir at 40℃ for 30 minutes to dissolve and disperse, and then filter with gauze to obtain the Chinese herbal combination oil.

[0052] Example 4: Usage Method Example Take 5-20 mL of the medicated oil prepared in Example 1, depending on the degree of abdominal fat accumulation, and apply it to the abdomen (at the level of the navel, above the navel, and below the navel area). Massage for 20 minutes using massage techniques. The massage techniques mainly involve pushing, kneading, and pressing, focusing on the areas where acupoints such as Tianshu, Zhongwan, and Daheng are located. After the massage, the local skin is usually slightly red, and the softness of the subcutaneous tissue is improved. Use once daily; the number of consecutive uses depends on individual circumstances.

[0053] Typical use cases The following are some typical cases of using the medicinal oil of this invention. The relevant circumference data comes from the inventor's clinical practice and is a comparison measurement made with a soft measuring tape.

[0054] The user, Mr. Jiang, male, 40 years old, had an abdominal circumference (at the navel) of 106cm, accompanied by excessive appetite, abdominal distension after meals, and sticky stools. After using the product for 6 consecutive times, his abdominal circumference decreased to 100cm, a reduction of 6cm, and the abdominal distension after meals was significantly reduced, while his stools became formed and smooth.

[0055] User Wang, male, 30 years old, had an abdominal circumference (at the navel) of 100cm, accompanied by sticky stools, a pale and swollen tongue with a thick, greasy yellow coating. After using the product for 6 consecutive times, his abdominal circumference decreased to 95cm, a reduction of 5cm, his stools became formed, and his tongue coating turned thin and white.

[0056] User Ms. Chen, female, 25 years old, had an abdominal circumference (below the navel) of 93cm, accompanied by a pale and slippery tongue, a thin white coating, and loose, unformed stools. After using the product for 8 consecutive times, her abdominal circumference decreased to 85cm, a reduction of 8cm. The softness of her abdomen was significantly reduced, and her firmness improved. Her stools gradually became more formed.

[0057] The user, Ms. Liu, 31 years old, had an abdominal circumference (at the navel) of 92cm, accompanied by excessive sticky phlegm and a distended abdomen. After using the product for 8 consecutive times, her abdominal circumference decreased to 83cm, a reduction of 9cm, and her abdomen became noticeably flatter and firmer, with a significant reduction in excessive phlegm.

[0058] User Ms. Tang, female, 38 years old, had an abdominal circumference (below the navel) of 82cm, accompanied by a soft abdomen. After using the product 10 times consecutively, her abdominal circumference decreased to 78cm, a reduction of 4cm, and the softness of her abdomen lessened while her firmness increased.

[0059] User Huang, male, 28 years old, had a pre-meal weight of 88.1 kg, an abdominal circumference (at the navel) of 100.5 cm, and an upper arm circumference of 44 cm, accompanied by abdominal obesity and fat accumulation in the arms. After using this medicated oil 12 times, his pre-meal weight decreased to 84.6 kg, his abdominal circumference (at the navel) decreased to 94.5 cm, and his upper arm circumference (upper arm) decreased to 41 cm. His abdomen felt firmer, and his arms became less loose.

[0060] The user, Mr. He, male, 39 years old, had an abdominal circumference (at the navel) of 103cm, accompanied by sticky and difficult bowel movements, cloudy urine, and a red tongue with a yellow and greasy coating. After using the product 12 times consecutively, his abdominal circumference decreased to 97cm, a reduction of 6cm, his bowel movements became formed and smooth, his urine became clearer, and his tongue coating became thinner and whiter.

[0061] User Ms. Li, 27 years old, had an abdominal circumference (at the navel) of 78cm, accompanied by a soft abdomen, pale and swollen tongue with a white and greasy coating. After using the product for 9 consecutive times, her abdominal circumference decreased to 67cm, a reduction of 11cm, her tongue coating became thinner and whiter, and her abdomen became noticeably firmer and flatter.

[0062] User Ms. Li, 42 years old, had an abdominal circumference (at the navel) of 96cm, accompanied by sticky stools, a thick, yellow, greasy tongue coating, and a feeling of heaviness in her body. After using the product 17 times consecutively, her weight decreased from 77.7kg to 71.8kg, her abdominal circumference shrank to 88cm (a reduction of 8cm), her stools became formed, her tongue coating turned thin and white, and she felt noticeably lighter.

[0063] User Ms. Chen, female, 32 years old, had an abdominal circumference (at the navel) of 85cm and an arm circumference (above the arm) of 38cm, accompanied by fat accumulation in the abdomen and upper arms, fatigue upon waking, and sticky and unsatisfactory bowel movements. After using the product 17 times consecutively, her abdominal circumference decreased to 79.5cm and her arm circumference (above the arm) decreased to 33.5cm. Her abdominal firmness significantly improved, the looseness of her arms was significantly reduced, and she felt lighter and more agile, and her bowel movements became more formed and regular.

[0064] The above changes are consistent with the expected effects of clearing heat and dampness, promoting blood circulation and removing blood stasis, and strengthening the spleen and resolving phlegm in the formula of this invention. They are also consistent with the traditional efficacy records of each herb, such as chicken dung vine for digestion and eliminating food stagnation, artemisia capillaris for clearing heat and dampness, lotus leaf for raising clear qi and lowering lipids, poria cocos for strengthening the spleen and removing dampness, and cinnamon twig for warming and unblocking the meridians.

[0065] Example 5: Explanation of the Mechanism of Fat Reduction The fat-reducing effect of the medicinal oil of this invention is based on the synergistic effect of the known efficacy of each traditional Chinese medicine component. Lotus leaf alkaloids can upregulate the activity of hormone-sensitive lipases in adipose tissue, promoting the decomposition of triglycerides in adipocytes; rhubarb anthraquinones can inhibit the activity of glycerol-3-phosphate dehydrogenase, reducing the resynthesis of free fatty acids; and triterpenoids in Poria cocos can regulate mitochondrial function and promote β-oxidation of fatty acids. The fat-reducing effects of the above-mentioned medicinal materials are all recorded in traditional Chinese medicine literature. The addition of ligustrazine and menthol can assist transdermal absorption of the drug from two aspects: improving local microcirculation and opening the stratum corneum channels, allowing the above-mentioned active ingredients to better reach the subcutaneous fat layer. Based on the known pharmacological effects of the above-mentioned components and their synergistic delivery with the assistance of transdermal penetration enhancers, those skilled in the art can reasonably expect that the medicinal oil of this invention has a fat-reducing effect by promoting fat decomposition.

[0066] Example 6: Description of Vegetable Oil Matrix This invention uses plant oils as the extraction matrix and carrier for its medicinal oil. In practice, the inventors primarily use olive oil. Different plant oils differ in their fatty acid composition and polarity. Olive oil and camellia oil have better compatibility with the fat-soluble active ingredients of traditional Chinese medicine due to their unsaturated fatty acid composition, and their skin feel (spreadability, viscosity) is also superior to sesame oil and sunflower seed oil. Based on the above considerations and practical experience, this invention preferentially uses olive oil as the plant oil matrix.

[0067] Example 7: Stability Description This invention relates to a medicinal oil based on olive oil, with tetramethylpyrazine and menthol exhibiting good chemical stability within the oil system. Through long-term preparation and storage practices, the inventors observed that when this medicinal oil is stored in a sealed glass container away from light, its properties (appearance and odor) remain stable for a considerable period, without significant oxidative rancidity or stratification. Based on the general stability principles of plant oil matrices and the known stability characteristics of tetramethylpyrazine and menthol in oil systems, those skilled in the art can expect this medicinal oil to have a reasonable shelf life under normal storage conditions. Storage in a sealed, light-protected, and cool place is recommended.

[0068] Modification Instructions This invention's medicinal oil formula primarily clears damp-heat, with Phellodendron bark, Coptis chinensis, and Artemisia capillaris being bitter and cold in nature. For those with kidney deficiency or sensitivity to bitter and cold medications, the dosage of Phellodendron bark can be reduced or temporarily discontinued, while increasing the dosage of Poria cocos and Atractylodes macrocephala to strengthen the spleen, replenish qi, protect the stomach, and harmonize the middle jiao. Specifically, the dosage of Phellodendron bark is reduced from 8 parts to 3-5 parts, Poria cocos is increased to 18-22 parts, and Atractylodes macrocephala is increased to 15-20 parts. This modification maintains the original dampness-removing and lipid-lowering effects while also supporting the body's vital energy and avoiding the stomach-damaging effects of bitter and cold herbs.

[0069] If skin redness, burning sensation or other discomfort occurs during use, it is a normal reaction in a small number of people with sensitive constitutions. It usually subsides on its own after rest. Alternatively, you can temporarily stop using the product and take oral antihistamines (such as chlorpheniramine) for symptomatic treatment.

[0070] Precautions for use Due to individual differences, it is recommended to apply a small amount of the medicated oil to the skin behind the ear for a test before first use. Observe for 30 minutes and confirm that there is no allergic reaction such as redness, swelling, or itching before using it normally.

[0071] Industrial applicability

[0072] The traditional Chinese medicine combination oil and its preparation method provided by this invention have widely available raw materials, a simple preparation process, and are easy to operate, making them suitable for large-scale industrial production. The oil of this invention is convenient to use, highly safe, and has a rapid onset of action, making it suitable for widespread application in beauty salons, health centers, and homes, with promising market prospects and economic benefits.

Claims

1. A traditional Chinese medicine combination oil for localized fat reduction, characterized in that, Composed of traditional Chinese medicine extracts and transdermal penetration enhancers; The herbal extract is obtained by extracting the following parts by weight of prepared herbal pieces from vegetable oil: Chicken dung vine 15-22 parts, Artemisia capillaris 12-18 parts, Coptis chinensis 6-10 parts, Phellodendron chinense 6-10 parts, Sparganium rhizome 5-10 parts, Curcuma rhizome 5-10 parts, Rhubarb (processed with wine) 3-8 parts, Salvia miltiorrhiza root 10-15 parts Lotus leaf 20-30 parts, hawthorn 12-18 parts, cassia seed 8-12 parts Cinnamon twig 3-7 parts, dried tangerine peel 8-15 parts, immature bitter orange peel 5-10 parts, areca peel 10-15 parts Poria cocos 12-18 parts, Pinellia ternata 6-12 parts, Atractylodes macrocephala 10-15 parts, Angelica dahurica 6-10 parts; The transdermal penetration enhancer is tetramethylpyrazine and menthol, wherein the mass percentage concentration of tetramethylpyrazine in the medicinal oil is 0.5% to 3.0%, and the mass percentage concentration of menthol in the medicinal oil is 1.0% to 5.0%.

2. The traditional Chinese medicine combination oil according to claim 1, characterized in that, The weight proportions of the prepared Chinese herbal medicine pieces are as follows: Chicken dung vine 18 parts, Artemisia capillaris 15 parts, Coptis chinensis 8 parts, Phellodendron amurense 8 parts 8 parts of Sparganium rhizome, 8 parts of Curcuma rhizome, 5 parts of Rhubarb (processed with wine), and 12 parts of Salvia miltiorrhiza root. Lotus leaf 25 parts, hawthorn 15 parts, cassia seed 10 parts Cinnamon twig 5 parts, dried tangerine peel 12 parts, immature bitter orange peel 8 parts, areca peel 12 parts Poria cocos 15 parts, Pinellia ternata 9 parts, Atractylodes macrocephala 12 parts, Angelica dahurica 8 parts; The mass percentage concentration of ligustrazine in the medicinal oil is 1.0% to 2.0%, and the mass percentage concentration of menthol in the medicinal oil is 2.0% to 4.0%.

3. The traditional Chinese medicine combination oil according to claim 1 or 2, characterized in that, The mass ratio of ligustrazine to menthol is 1:1 to 1:

4.

4. The traditional Chinese medicine combination oil according to claim 1 or 2, characterized in that, The vegetable oil is camellia oil or olive oil, and the ratio of the medicinal herbs to the vegetable oil is 1:3 to 1:6 (g / mL).

5. The traditional Chinese medicine combination oil according to claim 1 or 2, characterized in that, The herbal extract was prepared by the following method: The Chinese herbal medicine slices in the specified weight proportions are crushed into coarse powder, added to vegetable oil, and extracted by soaking at 40-60℃ for 4-8 days. The mixture is then filtered and the filtrate is collected. The ligustrazine and menthol are added to the filtrate before filtration, and stirred at 30-50°C for 20-40 minutes to dissolve and disperse them, and then filtered to obtain the final product.

6. The traditional Chinese medicine combination oil according to claim 5, characterized in that, The immersion extraction temperature is 45–55°C, and the immersion extraction time is 5–7 days.

7. The traditional Chinese medicine combination oil according to claim 1 or 2, characterized in that, The herbal combination oil also contains the following components at a concentration of [mass percentage]: Tetramethylpyrazine 1.2%–1.8%, menthol 2.5%–3.5%.

8. The traditional Chinese medicine combination oil according to claim 1 or 2, characterized in that, The ligustrazine is obtained by extracting ligustrazine slices. The extraction method is as follows: take ligustrazine slices and reflux extract with ethanol of 60% to 80% (v / v) 1 to 3 times. Combine the extracts and recover the ethanol until there is no alcohol taste to obtain ligustrazine extract.

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