Traditional Chinese medicine acupoint patch for treating simple obesity, preparation method and application thereof

Abstract

The application discloses a Chinese medicine acupoint plaster for treating simple obesity, wherein a plaster ointment is made of vaseline and a Chinese medicine composition with the following components and weight parts: fried white Semen Raphani 3-9 parts, prepared Kansui 2-6 parts, honey bran fried Atractylodes 2-9 parts, cooked Aconiti Praeparata 2-6 parts, Cinnamomum 2-6 parts, Saussurea 2-6 parts and dried ginger 1-3 parts; the weight ratio of the Chinese medicine composition to vaseline is 4:3. In addition, the application further discloses a preparation method and application of the Chinese medicine acupoint plaster. The Chinese medicine acupoint plaster can obviously reduce the body mass index and body fat rate of patients with simple obesity, effectively reduce the fat area, and has a more remarkable effect on abdominal subcutaneous fat. The effective rate of the Chinese medicine acupoint plaster for treating simple obesity reaches 83.9% after continuous plastering for 12 weeks, can obviously reduce the fasting blood sugar level of patients, is safe and reliable, has no obvious adverse reactions, is convenient to continuously use, can prolong the treatment cycle, consolidate the curative effect, and is suitable for clinical promotion and use.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine acupoint patch and a preparation method thereof. The traditional Chinese medicine acupoint patch acts on acupoints of the human body to treat simple obesity of spleen deficiency and dampness obstruction syndrome. Background Art

[0002] Over the past decade, the global prevalence of obesity has increased at an alarming rate and is showing a rapid spread. With the improvement of people's living standards and the continuous changes in dietary structure, the proportion of obese people has continued to increase, and is gradually developing towards younger people. At this stage, obesity has become a major public health problem that seriously affects the physical and mental health of the Chinese people. According to the "Report on the Nutrition and Chronic Disease Status of Chinese Residents (2020)", the obesity rate of residents aged 18 and above in my country is 16.4%, among which the obesity rates of residents aged 18 to 44, 45 to 59, and 60 and above are 16.4%, 18.3% and 13.6% respectively, and the obesity rate of residents in my country is on the rise.

[0003] Obesity refers to excessive total body fat content and / or increased local fat content and abnormal distribution. It is a chronic metabolic disease caused by the combined effects of genetic and environmental factors. Obesity can lead to a higher risk of early death and increase overall mortality. Due to the mass effect of excess adipose tissue or its direct metabolic effects, it is also associated with the occurrence of various chronic diseases, including diabetes, stroke, coronary artery disease, hypertension, respiratory diseases, obstructive sleep apnea, osteoarthritis and gallstones. Obesity is even associated with the occurrence of various tumors. Multiple surveys and studies have shown that there are more than 200 comorbidities related to obesity. At the same time, even a small amount of weight loss can improve these comorbidities.

[0004] Simple obesity, also known as primary obesity, may be related to factors such as genetics, diet and exercise habits, and is a common clinical disease of abnormal fat metabolism, accounting for 95% of the total number of obesity. The current treatment methods for simple obesity mainly include diet control, exercise intervention, drugs and weight loss surgery. Diet and exercise play an important role in body weight management, but individual differences are obvious, and the specific methods are not clear, and it is often difficult to adhere to. Commonly used drugs such as non-central action weight loss drugs, amine compounds and anticonvulsant drugs combined with hypoglycemic drugs with weight loss effects often have adverse reactions in the digestive tract or are dose-dependent. Studies have found that surgery is proportional to the risk of obesity and its related complications. Due to its exact effect and few side effects, the prevention and treatment of obesity by traditional Chinese medicine has been the focus of attention and research in recent years. Existing studies have shown that the side effects of traditional Chinese medicine therapy for obesity are small, and weight loss and improved quality of life through traditional Chinese medicine therapy have gradually become a commonly used clinical therapy. However, oral administration of traditional Chinese medicine is often difficult to adhere to due to its bitter taste, and the efficacy is reduced when the drug is decomposed by the gastrointestinal tract and liver, resulting in a slow effect. Therefore, it is of great practical significance to seek an economical, safe, effective and long-term use of traditional Chinese medicine external therapy for weight loss treatment of obesity.

[0005] Traditional Chinese medicine acupoint sticking therapy is one of the external therapies of traditional Chinese medicine, based on the theory of traditional Chinese medicine, with the principle of overall concept and syndrome differentiation, according to the meridian property of drugs, syndrome differentiation and medication, sticking on the corresponding acupoints, stimulating the acupoints to dredge the meridians, regulate yin and yang, and make them absorb in the corresponding acupoints of the body, play the pharmacological role, with the double action of drugs and acupoints, which is the product of the ingenious combination of acupuncture and medicine. Acupoint sticking has the advantages of transdermal drug delivery, which can not only avoid the decomposition of drugs by digestive enzymes in the gastrointestinal tract and the first-pass effect of the liver caused by oral administration, but also provide a predictable and long-acting time by controlling the rate of drug delivery, maintain stable and long-lasting blood drug concentration, reduce drug toxicity and adverse reactions, reduce the frequency of drug administration, improve efficacy, and is economical, safe and simple. In southern China, patients with simple obesity are mostly of the type of spleen deficiency and dampness obstruction. In the pathogenesis of obesity, traditional Chinese medicine believes that obese people are mostly qi deficiency, spleen deficiency, and more damp and phlegm, with virtual and actual, and virtual and actual. In 'Four Diagnostics', 'People are fat and white, and their pulses are mostly weak and soft, or slippery, because of the shape of the gas virtual, more wet and phlegm.' Obese people have slippery and weak pulses, which is because of the accumulation of phlegm and dampness, although the external body type is strong, but the internal qi is virtual. According to the etiology and clinical syndrome of phlegm and dampness accumulation, the acupoint sticking of traditional Chinese medicine is made, which can effectively eliminate phlegm and dampness, and the drug nature enters the pores and channels, dredges the meridians, and removes the pathological state of phlegm and dampness obstruction of qi movement in obese patients, so as to actively treat simple obesity and prevent disease progression.

[0006] Research shows that the main pathological mechanism of simple obesity is the sustained chronic low inflammatory reaction state, which leads to the destruction of the balance of the body's immune response, and the traditional Chinese medicine theory also believes that obesity should be considered as an imbalance of the body, which belongs to the shape of the gas virtual, the absolute excess and the relative deficiency. Therefore, the focus of the treatment of simple obesity is not in the short-term weight loss, but in coordinating the functions of each system of the body, restoring the balance of the body, and long-term control of body weight. Although the western medicine and surgical treatment measures are effective, the adverse reactions are many, and the treatment cost is high. Oral administration of various types of Chinese and western medicines is basically accompanied by adverse reactions in the digestive tract or dose-dependent, and the sustained efficacy is poor, so seeking a method for treating and preventing simple obesity other than oral administration of drugs is the innovation point of the current research, and providing a kind of external use of traditional Chinese medicine preparation for treating simple obesity still needs to be solved. SUMMARY

[0007] To solve the above technical problems, the application provides a traditional Chinese medicine acupoint patch for treating simple obesity and a preparation method thereof, which is economical, safe, effective and suitable for long-term use. The traditional Chinese medicine acupoint patch is used for treatment by pre-prepared traditional Chinese medicinal materials acting on specific acupoints for a long time, which has long-lasting effect, mild drug effect and small side effects, is easy to adhere to long-term use, can correct the secretion disorder of adipose tissue, improve the effect of obesity, and has remarkable effect on treating simple obesity of spleen deficiency and dampness obstruction type.

[0008] To achieve the above purpose, the application provides a traditional Chinese medicine acupoint patch for treating simple obesity, and the ointment of the patch is prepared from petrolatum and the following raw medicinal materials in parts by weight: fried white radish seed 3-9 parts, prepared kansas 2-6 parts, honey bran fried atractylodes 2-9 parts, cooked aconite 2-6 parts, cinnamon 2-6 parts, safflower 2-6 parts, dried ginger 1-3 parts.

[0009] The weight ratio of the raw medicinal materials to petrolatum is 4:3.

[0010] The ointment of the above traditional Chinese medicine acupoint patch is prepared by the following method:

[0011] (1) The raw medicinal materials are crushed into 80 mesh fine powder for standby;

[0012] (2) The fine powder is mixed with medical grade white petrolatum in a weight ratio of 4:3 and uniformly mixed into a thick paste.

[0013] Stir-fried white mustard seeds: warm in nature and pungent in flavor, they enter the lung and stomach meridians, offering benefits such as warming the lungs, dispelling phlegm and promoting qi, relieving pain and reducing swelling. White mustard seeds primarily contain polysaccharides, volatile oils, fatty acids, alkaloids, and flavonoids. Sinapis albicans is found in the highest concentration in raw white mustard seeds and is non-irritating in itself. However, the allyl isothiocyanate produced by hydrolysis has a pungent, volatile aroma and excellent anti-inflammatory properties, but it is also highly irritating, and topical application can cause localized heating, redness, and blistering on the skin. Stir-frying white mustard seeds reduces the sinapine thiocyanate content, thus reducing skin irritation. White mustard seeds possess a strong pungent, warm, and stimulating property, which can rapidly promote drug penetration in topical formulations, making it easier for applied medications to be absorbed through the skin, resulting in more pronounced therapeutic effects. Modern research shows that acupoint application of white mustard seeds can increase immunoglobulin A (IgA) and IgG levels, reduce IgE levels, inhibit IgE-mediated allergic inflammation, regulate the balance of helper T cells (Th1 / Th2), and thus improve the body's immune status.

[0014] Processed gansui (Gansui) is cold in nature, bitter in taste, and toxic. It enters the lung, kidney, and large intestine meridians, and has the effects of dispelling fluid, eliminating swelling, and dispersing stagnation. It is commonly used to treat edema, pleural effusion, phlegm accumulation, qi reversal, cough, and asthma, as well as constipation. Gansui contains triterpenes, diterpenes, and steroidal compounds, with diterpenes and triterpenes being the primary compounds in gansui. They exhibit a wide range of pharmacological activities, including skin irritation and modulation of multidrug resistance. Clinical studies have shown that topical application of gansui can contract intestinal smooth muscle, promote intestinal peristalsis, and have a significant purgative effect. Animal experiments have confirmed that vinegar-prepared gansui extract has minimal nephrotoxicity in mice and exhibits a significant diuretic effect. Raw gansui has side effects such as skin irritation, toxicity, and purgative effects, so processed forms are often used clinically. Pharmacological studies have shown that vinegar-prepared gansui significantly reduces its toxic and side effects. Experiments on mice found that the median lethal dose (LD50) of raw gansui was 36.4g / kg, while that of vinegar-cured gansui was 65.3g / kg. Furthermore, vinegar-cured gansui significantly reduced the drug's intestinal irritation. Traditional Chinese medicine acupoint patches using vinegar-cured gansui have an average dosage far below the LD50, and have been clinically proven to be safe with no significant side effects.

[0015] Stir-fried Atractylodes macrocephala with honey bran: warm in nature, bitter and sweet in taste, it enters the spleen and stomach meridians, and has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. Atractylodes macrocephala contains medicinal ingredients such as volatile oils such as atractylodes ketone, diatractylodes lactone, atractylodes lactone (I-III), and atractylodes polysaccharides. Stir-frying Atractylodes macrocephala with bran can reduce its dryness, reduce gastrointestinal irritation, and enhance its spleen-strengthening function. Studies have shown that atractylodes polysaccharides can reduce inflammatory responses in rats, and atractylodes lactone I can enhance the body's ability to scavenge free radicals, inhibit inflammatory responses, and play a role in protecting the liver.

[0016] Cooked aconite root: Sweet in flavor, highly toxic and hot in nature, it enters the heart, spleen, and kidney meridians, and has the effects of restoring yang, replenishing fire and supporting yang, and dispelling cold and relieving pain. Ancient texts describe aconite root as "well-adapted to all meridians," capable of circulating throughout the body, ensuring the smooth flow of yang energy and thus better protecting against external pathogens. The processing of aconite root aims to reduce its toxicity without affecting its efficacy. In actual clinical applications and comparative toxicity tests on mice before and after processing, the results demonstrate that the use of processed aconite root, which has been attenuated, is safe and effective. The active ingredients of cooked aconite root are water-soluble alkaloids, such as monoester alkaloids and diester alkaloids. Research suggests that aconite root has anti-inflammatory and immune-enhancing properties. The finished product is then stir-fried to form cooked aconite root slices, which emphasize anti-thrombotic and analgesic properties.

[0017] Cinnamon bark: Pungent, sweet, and highly warming in nature, it enters the kidney, spleen, heart, and liver meridians, tonifying vital yang, warming the spleen and stomach, dispelling cold, and promoting blood circulation. Cinnamon's main chemical components include cinnamaldehyde, coumarin, cinnamic acid, cinnamyl alcohol, o-methoxycinnamaldehyde, and polysaccharides. Modern pharmacological research indicates that cinnamaldehyde, a major component of its volatile oil, possesses a wide range of pharmacological effects, including potent vasodilator, anti-gastric ulcer, antibacterial, and antioxidant properties. Activity tests have shown that cinnamon polysaccharides possess excellent antioxidant capacity and also exhibit inhibitory effects on α-amylase and α-glucosidase. Cinnamon polyphenols also possess excellent antioxidant and significant antibacterial properties.

[0018] Costus root: Mild in nature and bitter in taste, it promotes qi and spleen function, relieves pain, and aids digestion. Its components, costus esters and dehydrocostus lactone, relax smooth muscles and relieve spasms. Costus lactone has numerous benefits, including inhibiting bacterial growth, killing insects, stopping diarrhea, and inhibiting gastric cancer growth. Costus root is primarily used to treat gastrointestinal disorders such as spleen and stomach qi stagnation, diarrhea, and indigestion. Its decoction and volatile oil are also effective in promoting gastric emptying and intestinal motility.

[0019] Dried ginger: Pungent and warm in nature, it warms the middle and dispels cold, restores yang and unblocks the meridians, and warms the lungs and eliminates phlegm. Studies have shown that dried ginger is rich in volatile components such as α-zingiberene, β-sesquiphellandrene, α-curcumene, and pinene, exhibiting antioxidant, antibacterial, anti-inflammatory, and anti-tumor activities. Ginger powder and essential oil can increase serum total antioxidant capacity and reduce malondialdehyde levels. Dried ginger has the effect of opening muscle pores. The transdermal absorption-enhancing effect of processed ginger changes after it is dried, with dried ginger volatile oil exhibiting significantly greater transdermal absorption-enhancing effects than fresh ginger volatile oil.

[0020] Vaseline: A white, odorless, solid ointment, it's a common medication used in medical therapy. It doesn't cause any adverse effects or chemical reactions, but provides a protective, moisturizing effect on the skin. It can also effectively reduce local irritation caused by medications.

[0021] Preferably, the above-mentioned traditional Chinese medicine acupoint patch for treating simple obesity, wherein the weight parts of the raw materials are: 6-8 parts of fried white mustard seeds, 3-4 parts of processed kansui, 3-4 parts of fried atractylodes with honey bran, 3-4 parts of cooked aconite, 3-4 parts of cinnamon, 3-4 parts of costus root, and 1-3 parts of dried ginger.

[0022] More preferably, the above-mentioned traditional Chinese medicine acupoint patch for treating simple obesity, wherein the weight parts of the raw materials are: 8 parts of fried white mustard seeds, 4 parts of processed kansui, 4 parts of fried atractylodes with honey bran, 4 parts of cooked aconite, 4 parts of cinnamon bark, 4 parts of costus root, and 3 parts of dried ginger.

[0023] Preferably, the above-mentioned traditional Chinese medicine acupoint patch for treating simple obesity is prepared by powdering the raw medicine according to the weight ratio, sieving, fully mixing, adding medical-grade external white vaseline, mixing and forming round pills, and placing them on a blank desensitizing tape.

[0024] More preferably, the above-mentioned traditional Chinese medicine acupoint patch for treating simple obesity is prepared by powdering the raw medicine according to the weight ratio, sieving, fully mixing, adding medical-grade external white vaseline, mixing, and then cutting into 1cm×1cm×1cm cubic medicine blocks, and placing the medicine blocks on a blank desensitizing tape.

[0025] More preferably, the above-mentioned Chinese medicine acupoint patch for treating simple obesity is prepared by powdering the raw material according to the weight ratio, sieving, mixing thoroughly, adding medical grade external use white vaseline, mixing well, and filling into a 1 cm opening. 2 Each time you use the ointment, squeeze out a 1 cm long strip of ointment and place it on a blank desensitizing tape.

[0026] More preferably, the above-mentioned traditional Chinese medicine acupoint patch for treating simple obesity is prepared by powdering the raw materials according to the weight ratio, sieving, fully mixing, adding medical-grade external white vaseline, mixing and filling into an ointment box, and using a quantitative medicine spoon to scoop out an appropriate amount of ointment each time and place it on a blank desensitizing tape.

[0027] The present invention also provides application of the traditional Chinese medicine acupoint patch in treating simple obesity of spleen deficiency and dampness obstruction type.

[0028] Preferably, the Chinese herbal acupoint patch of the present invention is suitable for simple obesity of the spleen deficiency and dampness obstruction type. When used, it is applied alternately to the following two groups of acupoints: (1) Zhongwan and Tianshu; (2) Qihai and Zusanli. Each application lasts for 2 to 4 hours, 2 to 3 times a week, and a course of 12 weeks constitutes a course of treatment.

[0029] Zhongwan and Qihai belong to the Ren Meridian and are key acupoints for regulating the Chong and Ren meridians. Disharmony between the Chong and Ren meridians leads to a deficiency of vital energy in the internal organs, and the inability to transform dampness, which accumulates into phlegm. Qi deficiency and blood stagnation, which accumulate into blood stasis, can lead to the accumulation of phlegm and blood stasis over time, which can cause obesity. Tianshu and Zusanli belong to the Stomach Meridian of Foot-Yangming. The pathogenesis of obesity has been generally believed to be related to "phlegm and dampness" and "spleen deficiency," with "phlegm and dampness" being the symptoms and "spleen deficiency" being the root cause. Tianshu is a gathering point on the Large Intestine Meridian of Foot-Yangming, and Zhongyuan is a gathering point on the Stomach Meridian of Foot-Yangming. These two points work together to regulate the gastrointestinal tract and improve the pathological state of spleen and stomach dysfunction. Yangming is a meridian rich in qi and blood. Zhongyuan acupoint is not only good at treating the spleen and stomach and replenishing the acquired constitution, but it can also replenish the qi and blood of Yangming to benefit the Chong and Ren meridians, making it a key acupoint for replenishing the Chong and Ren meridians. The Suwen (Suwen) Six Micro-Aims Treatise states: "Above Tianshu, the Heavenly Qi governs; below Tianshu, the Earthly Qi governs. The interaction of Qi is the basis of human Qi, and all things flow from it." Tianshu acupoint regulates the intestines and viscera, bidirectionally regulating gastrointestinal function, and plays a key role in addressing the pathological condition of obesity characterized by a strong stomach and a weak spleen. The Difficult Classic (Nanjing) Sixty-Sixth Difficulty states: "The Qi below the navel and between the kidneys is the lifeblood of the human body and the root of the twelve meridians." The Qi between the kidneys is the Yuan Qi. The Qi Hai (Qi Hai) is the source of Yuan Qi, and it is excellent for nourishing Yuan Qi and strengthening the foundation, tonifying the kidneys and replenishing essence. Zusanli (Zusanli) is a He point on the Stomach Meridian of Foot-Yangming, also known as the Lower He point of the Stomach and Internal Organs. "He governs the internal organs," making it a key acupoint for treating digestive system diseases. Modern medical research also demonstrates that Zusanli has significant regulatory effects on multiple aspects of the human digestive and endocrine systems. For example, it bidirectionally regulates gastric motility and can alter the release of peripheral brain-gut peptides.

[0030] Compared with the prior art, the present invention has the following advantages and technical effects:

[0031] The Chinese herbal acupoint patch of the present invention uses stir-fried white mustard seeds as the main ingredient, which warms and dissolves cold phlegm, disperses lumps and reduces swelling. It can penetrate the skin and membranes and is particularly good at dissolving phlegm that has strayed from the meridians. Processed kansui, stir-fried white atractylodes with honey bran, and cooked aconite root are used as auxiliary ingredients, which can penetrate the middle jiao and enhance the effects of strengthening the spleen and promoting transportation, warming yang and expelling water. Traditional Chinese medicine believes that "the spleen is the source of phlegm," thus eliminating phlegm, fluid and dampness from the source. Cinnamon and costus root are used as adjuvants to warm the meridians, promote qi and blood circulation; dried ginger is used as an auxiliary ingredient to warm yang and dissolve fluid. Combined with cinnamon, it warms and unclogs the meridians, while combined with costus root, it promotes qi and opens the acupoints, stimulating the meridians and acupoints. It is more suitable for simple obesity of the spleen deficiency and dampness obstruction syndrome. The causes of simple obesity are often related to poor diet and lifestyle habits, insufficient or excessive physical activity, decreased physical function due to aging, or genetic factors. Traditional Chinese medicine believes that obesity is mostly caused by spleen and kidney qi deficiency, turbid phlegm, and internal retention of dampness. Although there are still other symptoms such as liver depression and spleen deficiency, gastrointestinal heat, etc. clinically, it is still mostly caused by spleen deficiency and dampness obstruction. The Chinese medicine acupoint patch of the present invention mainly selects warming yang and expectorant drugs, acts on the middle jiao spleen and stomach, can invigorate yang energy, warm and transform cold phlegm and dampness, and promote meridian circulation. Coordinate medical grade external use white vaseline to make acupoint plaster, can produce protection, moist local nursing effect to skin, can also effectively alleviate the stimulation of local drug production, easy to use, convenient and continuous use, can extend the treatment cycle, and consolidate the therapeutic effect.

[0032] Clinical trial results show that the Chinese herbal acupoint patch of the present invention can significantly reduce the BMI and body fat percentage of patients with simple obesity, effectively reduce fat area, and has a more significant effect on subcutaneous fat. Continuous application for 12 weeks has an efficacy of up to 83.9% in treating simple obesity, and can significantly reduce patients' fasting blood sugar levels. The Chinese herbal acupoint patch is economical, safe, effective, and suitable for long-term use. The Chinese herbal acupoint patch uses pre-prepared Chinese medicinal materials to act on specific acupoints for a long time for treatment. It has long-lasting efficacy, mild medicinal effect, and few side effects. It is easy to maintain long-term use, can correct the disorder of fat tissue distribution, reduce body mass index, thereby improving obesity, and has a significant effect in treating simple obesity of spleen deficiency and dampness obstruction type. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 Changes in BMI before and after treatment in the treatment group and the control group.

[0034] Figure 2 Changes in body fat percentage before and after treatment in the treatment group and the control group.

[0035] Figure 3 Differences in waist circumference, visceral and subcutaneous fat areas between the treatment group and the control group after treatment. DETAILED DESCRIPTION

[0036] Various exemplary embodiments of the present invention will now be described in detail. While the present invention has been described herein with reference to specific embodiments thereof, this should not be construed as limiting the scope of the present invention to the following examples. All techniques implemented based on the above-described teachings of the present invention fall within the scope of the present invention. Various modifications and variations may be made to the specific embodiments described herein without departing from the scope or spirit of the present invention. Therefore, the description and drawings should be regarded as illustrative rather than restrictive.

[0037] Example 1

[0038] Weigh 80 grams of stir-fried white mustard seeds, 40 grams of processed kansui, 40 grams of stir-fried atractylodes macrocephala with honey bran, 40 grams of cooked aconite root, 40 grams of cinnamon bark, 40 grams of costus root, and 30 grams of dried ginger. Mix the above-mentioned Chinese herbal medicine slices and grind them into 80-mesh fine powder. Mix the fine powder with medical-grade external-use white vaseline (232.5 grams) in a weight ratio of 4:3 and mix thoroughly into a thick paste to prepare a Chinese medicine acupuncture patch.

[0039] Example 2

[0040] Weigh 60 grams of stir-fried white mustard seeds, 30 grams of processed kansui, 60 grams of stir-fried atractylodes macrocephala with honey bran, 30 grams of cooked aconite root, 30 grams of cinnamon bark, 30 grams of costus root, and 20 grams of dried ginger. Mix the above-mentioned Chinese herbal medicine slices and grind them into 80-mesh fine powder. The fine powder is mixed with medical-grade external-use white vaseline (195 grams) in a weight ratio of 4:3 and mixed thoroughly into a thick paste to prepare a Chinese medicine acupoint patch.

[0041] Example 3

[0042] The Chinese medicine acupoint patch prepared in Example 2 was filled into a plaster box, and stored under light protection at 20°C or below after sealing. An appropriate amount of the plaster was scooped out with a quantitative spoon each time and placed on a blank desensitization adhesive plaster.

[0043] Example 4

[0044] The Chinese medicine acupoint patch prepared in Example 1 was molded and cut into 1 cm x 1 cm x 1 cm cubic blocks, and stored under light protection at 20°C or below after being wrapped with mulberry paper. In use, the mulberry paper was discarded, and the block was placed on a blank desensitization adhesive plaster.

[0045] Example 5

[0046] A patient, female, 32 years old, 158 cm in height, 70.7 kg in weight, 92 cm in waist circumference, and 106 cm in hip circumference, mainly engaged in mental work, denied a history of previous internal medicine diseases, denied a history of infectious diseases such as hepatitis and tuberculosis, denied a history of surgery and blood transfusion, had a normal delivery of 1 child, and had regular menstruation. The heart rate was 72 beats per minute, and the blood pressure was 120 / 70 mmHg. The BMI was 28.32, the waist-hip ratio was 0.87, and the patient complained of fatigue, heaviness of the limbs, normal appetite and defecation, pale and swollen tongue with tooth marks on the edge, thin and white and greasy fur, and fine and weak pulse. The blood routine, liver and kidney functions, and urine routine were normal, the cholesterol was 6.42 mmol / L, the triglyceride was 1.32 mmol / L, the low-density lipoprotein was 4.17 mmol / L, and the fasting blood glucose was 5.57 mmol / L. The patient was diagnosed with simple obesity by Western medicine, and with obesity by traditional Chinese medicine, and was of the spleen deficiency and dampness obstruction type. The Chinese medicine acupoint patch of Examples 2 and 3 was used for treatment, 2 times a week, and alternately applied on the Zhongwan and Tianshu points, and the Qihai and Zusanli points. Each patch lasted for 2-4 hours, and 12 weeks constituted a course of treatment. During the period, no other treatment drugs were taken, and only the Chinese medicine acupoint patch was used for continuous treatment for 12 weeks. After the treatment, the patient's weight was 60.2 kg, the waist circumference was 77 cm, the hip circumference was 96 cm, the BMI was 24.11, the waist-hip ratio was 0.8, the cholesterol was 5.62 mmol / L, the triglyceride was 0.76 mmol / L, the low-density lipoprotein was 3.68 mmol / L, and the fasting blood glucose was 4.79 mmol / L. The patient complained of no obvious fatigue, and the symptoms such as heaviness of the limbs were obviously improved. The tongue was pale red, the fur was thin and white, and the pulse was fine. The patient was clinically cured of simple obesity, the blood lipid and blood glucose indexes were lower than before, the traditional Chinese medicine syndrome was obviously improved, no adverse reactions were found during the treatment, and the use feedback was good.

[0047] Example 6 - Clinical efficacy observation of the Chinese medicine acupoint patch of the application in the treatment of simple obesity

[0048] 1. Case selection

[0049] 1.1 Diagnostic criteria

[0050] (1) Diagnostic criteria for simple obesity: Refer to the "Guidelines for the Prevention and Control of Overweight and Obesity in Adults in China" issued by the National Health Commission's Disease Prevention and Control Bureau in 2021. Simple obesity can be diagnosed if secondary obesity is excluded based on medical history, physical examination, laboratory tests, etc., and one or more of the following items are present: ① Body mass index (BMI) ≥ 28; ② Waist circumference: male ≥ 90 cm, female ≥ 85 cm.

[0051] (2) Diagnostic criteria for spleen deficiency and dampness obstruction type: formulated with reference to the "Diagnosis and Therapeutic Effect Evaluation Criteria for Simple Obesity" and "Traditional Chinese Medicine Internal Medicine".

[0052] Main symptoms: heaviness of limbs, abdominal distension, fatigue and weakness.

[0053] Secondary symptoms: loss of appetite, irregular bowel movements, and mild edema of the limbs.

[0054] Tongue and pulse: The tongue is pale and fat with teeth marks on the edges, the tongue coating is thin and greasy white, and the pulse is moist and fine.

[0055] The patient can be diagnosed if he or she has two of the above main symptoms plus one of the secondary symptoms, and his or her tongue and pulse match.

[0056] 1.2 Inclusion criteria

[0057] ① Meet the diagnostic criteria for simple obesity, with a BMI of 28 ≤ ≤ 40; ② Meet the criteria for the differentiation of spleen deficiency and dampness obstruction; ③ Age 18 to 50 years; ④ No weight loss measures other than lifestyle intervention have been used in the past 3 months; ⑤ The patient's vital signs are normal, he / she is aware of the research plan, agrees to cooperate with the trial, and signs a written informed consent.

[0058] 1.3 Exclusion criteria

[0059] ① Obesity caused by pathological or drug-related factors; ② Pregnant or lactating women; ③ Patients with liver, kidney, heart, or lung dysfunction, or coagulation dysfunction; ④ Patients with organic diseases; ⑤ Patients with severe allergies, allergies to known interventions in the study, or those with contraindications to their use; ⑥ Patients with mental illness or infectious diseases; ⑦ Patients with cognitive or communication impairments; ⑧ Patients currently participating in other clinical trials.

[0060] 1.4 Falling off and rejection standards

[0061] Patients who were lost to follow-up after enrollment or voluntarily withdrew due to adverse events or poor efficacy were treated as dropouts; patients who were mistakenly included or violated the protocol were excluded.

[0062] 2. Research Methods

[0063] Patients who met the inclusion criteria were randomly divided into the experimental group and the control group, and the observation study was conducted using a placebo-controlled trial design.

[0064] 3. Treatment options

[0065] All patients underwent lifestyle intervention, including: ① engaging in at least 30 minutes of moderate-intensity physical activity daily; ② dietary control, with total daily calorie intake controlled as follows: 125.5-146 kJ / kg standard body weight for light physical activity, 147-167 kJ / kg standard body weight for moderate physical activity, and ≥168 kJ / kg standard body weight for heavy physical activity. Vitamin and fiber intake were not restricted. Recommendations included: consuming more whole grains, vegetables, fruits, soy products, dairy products, fish, nuts, and drinking water (tea and coffee). Limiting the following: ① Salty, pickled, and smoked foods; ② High-salt foods; ③ High-sugar and sugar-added foods; ④ High-fat and fried foods; ⑤ Meat products; ⑥ Alcohol and sugary beverages. ⑦ Reduce dining out and ordering takeout [References: Endocrinology Branch of the Chinese Medical Association, Diabetes Branch of the Chinese Association of Traditional Chinese Medicine, Obesity and Diabetes Surgeons Committee of the Surgical Branch of the Chinese Medical Association, etc. Clinical-based multidisciplinary consensus on the diagnosis and treatment of obesity (2021 edition) [J]. Chinese Journal of Digestive Surgery, 2021, 20(11): 16.].

[0066] The control group and the treatment group received acupoint application treatment for 12 consecutive weeks, and a follow-up examination was conducted after the completion of all treatments.

[0067] Acupoint application method:

[0068] (1) The treatment group was given the Chinese medicine acupoint patches described in Examples 1 and 4, and the control group was given an acupoint patch with the same appearance as Example 3, made by mixing starch, pigment, a small amount of ginger powder and medical-grade external white vaseline.

[0069] (2) Acupoint selection: Zhongwan, Tianshu (bilaterally), Qihai, and Zusanli (bilaterally).

[0070] (3) Duration: Apply for 1 to 2 hours each time. Keep the application on until the skin feels hot, red, or blistering.

[0071] (4) Treatment course: Twice a week, apply to Zhongwan acupoint and bilateral Tianshu acupoints (first time), Qihai acupoint and bilateral Zusanli acupoints (second time). 4 weeks constitutes one course of treatment. A total of 3 courses of treatment.

[0072] (5) Treatment requirements: After treatment, do not eat seafood, beef or other irritating foods; after treatment, you can take more walks, jog, do Tai Chi, Ba Duan Jin or other relaxing exercises; in terms of diet, avoid overeating, cold drinks and snacks, do not eat too much for dinner, and eat until you are 50% to 60% full; do not take a bath on the day of treatment.

[0073] 4. Observation indicators

[0074] 4.1 Primary outcome measures

[0075] (1) Obesity index: Measure BMI, waist circumference (WC), waist-to-hip ratio (WHR) and fat percentage (F%). BMI = body mass (kg) ÷ [height (m)] 2 WC is the diameter measured midway between the lower edge of the ribs and the anterior superior iliac spine. WHR = WC (cm) ÷ hip circumference (cm). F% = (0.570 ÷ D - 4.142) × 100, where D is body density. The InBody tester (model: ioi353, Saiwei Hengkang Co., Ltd., National Medical Device Registration No. 201624022689) was used.

[0076] (2) TCM syndrome score: calculated once before and after treatment.

[0077] 4.2 Secondary Outcome Measures

[0078] (1) Blood lipid and blood glucose indicators: 2 mL of fasting cubital venous blood was drawn before and after treatment to test fasting blood glucose (FBG) and fasting blood lipids (serum cholesterol TC, triglycerides TG, low-density lipoprotein cholesterol LDL).

[0079] (2) Visceral fat area: Visceral fat area was calculated using the DUAL bioimpedance method before and after treatment using an Omron visceral fat detector (model: HDS-2000, National Medical Device Registration No. 2014-2211667).

[0080] 4.3 Safety indicators

[0081] (1) General physical examination items: respiration, heart rate, blood pressure, and pulse.

[0082] (2) Routine blood test, routine urine test, liver and kidney function test.

[0083] (3) Safety indicators should be monitored before and after treatment, and women should be screened for urine pregnancy before treatment.

[0084] 5. Efficacy evaluation criteria

[0085] Refer to the "Diagnosis and Therapeutic Efficacy Evaluation Criteria for Simple Obesity" to evaluate the therapeutic effect of simple obesity.

[0086] Clinical cure: weight loss reaches the standard weight, WC decreases ≥8cm, F% decreases ≤25% for men and ≤30% for women, and BMI <28; marked effect: weight loss ≥5kg, WC decreases 4cm≤<8cm, F% decreases ≥5% but does not reach the standard of recovery, and BMI decreases ≥4; effective: weight loss ≥3kg and <5kg, WC decreases 2cm≤<4cm, F% decreases 3%≤<5%, and BMI decreases 2≤<4; ineffective: the above indicators do not reach the effective standards after treatment, and the body weight may even increase.

[0087] 6. Statistical Methods

[0088] Basic information and data were entered using Excel spreadsheets, and statistical analysis was performed using SPSS 21.0 statistical software.

[0089] Normally distributed measurement data were expressed as mean ± standard deviation If the variances were homogeneous, the independent sample t-test was used for inter-group comparisons, and the paired sample t-test was used for intra-group comparisons. If the variances were unequal, the rank sum test was used for both inter-group and intra-group comparisons. For skewed variables, the median was used to represent the mean level, and the interquartile range (interquartile range) was used to represent the degree of dispersion, and the rank sum test was used. Enumeration data were expressed as frequencies or percentages, and inter-group comparisons were performed using the chi-squared test. A P value of less than 0.05 was considered statistically significant.

[0090] 7. Analysis and comparison of clinical efficacy data

[0091] General Information: 68 patients with simple obesity were admitted to the Department of Traditional Chinese Medicine Preventive Health Care, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, between March and August 2024 and were randomly divided into an experimental group and a control group. There were no statistically significant differences in age, gender, or BMI between the two groups (P>0.05), indicating that the two groups were comparable. There were no significant differences in obesity level, blood lipids, and blood sugar levels before enrollment between the treatment and control groups (P>0.05).

[0092] 7.1 Chinese herbal acupoint patches are effective in treating simple obesity

[0093] A total of 68 patients were enrolled. During the study, 6 patients were excluded because they did not use the acupoint patch treatment as required and were not included in the analysis. At the end of the treatment course, 31 patients in the treatment group had clinical recovery, 5 had marked effect, 16 had effective, and 5 had effective, for an overall effective rate of 83.9%. In the control group, 31 patients had clinical recovery, 0 had marked effect, 14 had effective, and 2 had effective, for an overall effective rate of 51.6%. The differences in the efficacy levels of the two groups after treatment were statistically significant (P < 0.05). See Table 1.

[0094] Table 1. Comparison of clinical efficacy between the treatment group and the control group (cases)

[0095]

[0096] Note: *P<0.05 compared with the control group.

[0097] 7.2 BMI significantly decreased after treatment with Chinese herbal acupoint patches

[0098] After 12 weeks of TCM acupoint patch treatment, the BMI of the treatment group was significantly reduced. The BMI of the treatment group after treatment was significantly different from that of the control group (#P<0.05), see Table 2 and Figure 1As shown. Furthermore, within-group comparisons before and after treatment showed a significant decrease in BMI in the treatment group (*P < 0.05). These results suggest that Chinese herbal acupoint patches can effectively reduce BMI in patients with simple obesity.

[0099] 7.3 Treatment with Chinese herbal acupoint patches significantly reduced body fat percentage

[0100] After 12 weeks of TCM acupoint patch treatment, the body fat percentage (F%) of the treatment group was significantly reduced. The intergroup comparison showed that the body fat percentage of the treatment group after treatment was significantly different from that of the control group (#P<0.05), see Table 2 and Figure 2 As shown. Furthermore, within-group comparisons before and after treatment showed a significant decrease in F% in the treatment group compared to before treatment (*P < 0.05). These results suggest that Chinese herbal acupoint patches can effectively reduce body fat percentage in patients with simple obesity.

[0101] 7.4 The area of ​​subcutaneous fat in the abdomen was significantly reduced after treatment with the Chinese herbal acupoint patch

[0102] After 12 weeks of TCM acupoint patch treatment, the abdominal subcutaneous fat area of ​​the treatment group was significantly reduced. The inter-group comparison showed that the abdominal subcutaneous fat area of ​​the treatment group after treatment was significantly different from that of the control group (#P<0.05), see Table 2 and Figure 3 As shown. Furthermore, within-group comparisons before and after treatment showed a significant decrease in abdominal subcutaneous fat area in the treatment group compared to before treatment (*P < 0.05). These results suggest that Chinese herbal acupoint patches can effectively reduce abdominal subcutaneous fat in patients with simple obesity.

[0103] 7.5 Treatment with Chinese herbal acupoint patches can reduce waist circumference and visceral fat area

[0104] After 12 weeks of TCM acupoint patch treatment, the waist circumference and visceral fat area of ​​the treatment group decreased. The waist circumference and visceral fat area of ​​the treatment group were significantly different from those of the control group (△P<0.1), see Table 2 and Figure 3 As shown in the figure, within-group comparisons before and after treatment showed a significant decrease in waist circumference and visceral fat area in the treatment group compared to before treatment (*P < 0.05). These results suggest that Chinese herbal acupoint patches can reduce waist circumference and visceral fat in patients with simple obesity.

[0105] Table 2. Comparison of changes in obesity indicators between the treatment group and the control group

[0106]

[0107] Note: There was a statistically significant difference between the group before and after treatment, *P < 0.05; there was a statistically significant difference between the treatment group and the control group, #P < 0.05, △P < 0.1.

[0108] 7.6 Chinese herbal acupoint patch therapy can lower fasting blood sugar

[0109] After 12 weeks of treatment with the TCM acupoint patch, the treatment group's fasting blood glucose levels decreased compared to their pre-treatment levels. A statistically significant difference in fasting blood glucose between the treatment group and the control group was observed (P < 0.05). No significant differences were observed in other blood lipid indicators (see Table 3). These results suggest that TCM acupoint patches can lower fasting blood glucose levels in patients with simple obesity.

[0110] Table 3. Comparison of changes in blood lipids and blood glucose indicators between the treatment group and the control group (unit: mmol / L)

[0111]

[0112] Note: There was statistically significant difference between the treatment group and the control group, #P<0.05.

Claims

1. A Chinese medicine acupoint patch for treating simple obesity, characterized in that: The ointment of the patch is prepared from vaseline and the following raw materials in parts by weight: 3-9 parts of fried white mustard seeds, 2-6 parts of processed kansui, 2-9 parts of fried atractylodes macrocephala with honey bran, 2-6 parts of cooked aconite root, 2-6 parts of cinnamon bark, 2-6 parts of costus root, and 1-3 parts of dried ginger. The weight ratio of the raw material drug to vaseline is 4:

3.

2. The Chinese medicine acupoint patch for treating simple obesity according to claim 1, characterized in that: The weight parts of the raw materials are as follows: 6-8 parts of fried white mustard seeds, 3-4 parts of processed kansui, 3-4 parts of fried atractylodes macrocephala with honey bran, 3-4 parts of cooked aconite root, 3-4 parts of cinnamon bark, 3-4 parts of costus root, and 1-3 parts of dried ginger.

3. The Chinese medicine acupoint patch for treating simple obesity according to claim 1, characterized in that: The weight parts of the raw materials are respectively: 8 parts of fried white mustard seeds, 4 parts of processed kansui, 4 parts of fried atractylodes macrocephala with honey bran, 4 parts of cooked aconite root, 4 parts of cinnamon bark, 4 parts of costus root, and 3 parts of dried ginger.

4. The Chinese medicine acupoint patch for treating simple obesity according to any one of claims 1 to 3, characterized in that: The vaseline is medical grade external use white vaseline.

5. The method for preparing the Chinese medicine acupoint patch for treating simple obesity according to any one of claims 1 to 4, characterized in that: The following steps are involved: (1) Grind the raw material into 80 mesh fine powder for later use; (2) Mix the fine powder and vaseline in a weight ratio of 4:3 and blend into a thick paste.

6. The method for preparing the Chinese medicine acupoint patch for treating simple obesity according to claim 5, characterized in that: The method further comprises the following steps: molding and cutting the medicine blocks into 1cm×1cm×1cm cubes, placing the medicine blocks on a blank desensitizing adhesive tape; or filling the medicine blocks into a 1cm opening. 2 Put the ointment into the ointment tube, squeeze out a 1cm long strip of ointment and place it on the blank desensitizing tape each time you use it; or fill it into the ointment box, use a quantitative medicine spoon to scoop out an appropriate amount of ointment each time and place it on the blank desensitizing tape.

7. Use of the traditional Chinese medicine acupoint patch according to any one of claims 1 to 4 in the preparation of a medicament for treating simple obesity.

8. The use according to claim 7, characterized in that The syndrome type of the simple obesity is spleen deficiency and dampness obstruction syndrome.

9. The use according to claim 8, characterized in that Apply the Chinese medicine acupoint patch to the acupoint, which is Zhongwan acupoint, Tianshu acupoint, Qihai acupoint or Zusanli acupoint.

10. The use according to claim 9, characterized in that Apply the Chinese medicine acupoint patch to the acupoint, each patch lasts for 2 to 4 hours, 2 to 3 times a week, and 12 weeks as a course of treatment.

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