Traditional Chinese medicine acupoint patch for treating simple obesity as well as preparation method and application of traditional Chinese medicine acupoint patch

Abstract

The invention discloses a traditional Chinese medicine acupoint patch for treating simple obesity. The ointment of the patch is prepared from vaseline and the following traditional Chinese medicine composition in parts by weight: 3-9 parts of fried semen brassicae, 2-6 parts of prepared euphorbia kansui, 2-9 parts of honey and bran fried rhizoma atractylodis macrocephalae, 2-6 parts of prepared radix aconiti lateralis praeparata, 2-6 parts of cinnamon, 2-6 parts of radix aucklandiae and 1-3 parts of rhizoma zingiberis. The weight ratio of the traditional Chinese medicine composition to the vaseline is 4: 3. In addition, the invention further discloses a preparation method and application of the traditional Chinese medicine acupoint patch. Through clinical verification, the traditional Chinese medicine acupoint patch can obviously reduce the body mass index and the body fat rate of a patient suffering from simple obesity, can effectively reduce the fat area, and has a more remarkable effect on abdominal subcutaneous fat. The effective rate of treating simple obesity after continuous application for 12 weeks is up to 83.9%, the fasting blood glucose level of a patient can be obviously reduced, and the traditional Chinese medicine composition is safe, reliable, free of obvious adverse reaction, convenient to continuously use, capable of prolonging the treatment cycle and consolidating the curative effect and suitable for clinical application and popularization.

Description

Technical Field

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

[0002] Over the past decade, the prevalence of obesity has increased at an alarming rate worldwide and is showing a trend of 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 Chinese residents 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 the overall mortality rate. 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. Many 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. It is a common disease of abnormal fat metabolism in clinical practice. It is the main population of obesity, accounting for 95% of the total number of obese people. At present, the main methods for treating simple obesity include diet control, exercise intervention, drugs and weight loss surgery. Diet and exercise play an important role in weight management, but there are obvious individual differences, and the specific methods are still unclear, and it is often difficult to adhere to them. Commonly used drugs such as non-central weight loss drugs, compound drugs composed of neuroamines and anticonvulsants, and hypoglycemic drugs with weight loss effects often have adverse gastrointestinal reactions or are dose-dependent. Studies have found that the efficacy of surgery for obesity and its related complications is proportional to the risk. Due to its advantages such as definite efficacy and few toxic and side effects, traditional Chinese medicine therapy for the prevention and treatment of obesity has been the focus of attention and research in recent years. Existing studies have shown that traditional Chinese medicine therapy has few side effects in the treatment of obesity. It has gradually become a common clinical therapy to lose weight and improve the quality of life through traditional Chinese medicine therapy. However, oral Chinese medicine is often difficult to adhere to because of its bitter taste, and the efficacy of the drug is weakened when it is decomposed by the stomach and liver, resulting in slow effect. Therefore, it is of great practical significance to seek an economical, safe, effective and long-term TCM external treatment method to reduce weight and treat obesity.

[0005] Chinese medicine acupoint application therapy is one of the external treatment methods of traditional Chinese medicine. It is based on the theory of traditional Chinese medicine, with the principle of holistic concept and syndrome differentiation and treatment. According to the meridian properties of the drug, the drug is used according to syndrome differentiation, and applied on the corresponding acupoints. By stimulating the acupoints to dredge the meridians and harmonize yin and yang, it is absorbed at the corresponding acupoints of the patient's body to play a pharmacological role. It has the dual effects of drugs and acupoints. It is a product of the ingenious combination of acupuncture and prescriptions. Acupoint application has the advantages of transdermal administration. It can not only avoid the decomposition of drugs by gastrointestinal digestive enzymes and the first-pass effect of the liver caused by oral administration, but also provide a predictable and longer action time by controlling the rate of drug delivery, maintain a stable and lasting blood drug concentration, reduce drug toxicity and adverse reactions, reduce the number of administrations, improve the efficacy, and is economical, safe, simple and easy. In southern my country, simple obesity patients are mostly spleen deficiency and dampness obstruction type. In the pathogenesis of obesity, traditional Chinese medicine believes that obese people are mostly qi deficiency, spleen deficiency, dampness and phlegm, and the underlying deficiency and superficial excess, and both deficiency and excess are seen. In the Four Diagnosis Explanation, it is said: "People who are fat and white have pulses that are often weak and moist, or slippery, because they are physically strong and have weak qi, and have a lot of dampness and phlegm." The pulses of obese people are often slippery and weak, because they have a lot of phlegm and dampness inside. Although they look strong, they are actually weak qi inside. According to the etiology of obesity caused by phlegm and dampness accumulation and the clinical syndrome type, the prescription and compatibility of Chinese medicine acupoint plaster can effectively eliminate phlegm and enter the skin from the pores, regulate the meridians, and dredge the pathological state of phlegm and dampness blocking the qi mechanism in obesity, so as to actively treat simple obesity and prevent the progression of the disease.

[0006] Studies have shown that the main pathological mechanism of simple obesity is a persistent chronic low-inflammatory response state, which leads to the destruction of the balance of the body's immune response. Traditional Chinese medicine theory also believes that obesity should be regarded as an imbalanced state of the body, belonging to the state of physical excess and qi deficiency, with absolute excess of physical form and relative deficiency of qi. Therefore, the focus of simple obesity treatment is not on reducing body weight in the short term, but on coordinating the functions of various body systems, restoring the body's balance state, and controlling body weight in the long term. Although Western medicine and surgical treatment measures are effective, they have many adverse reactions and high treatment costs. Oral Chinese and Western medicines are basically accompanied by adverse reactions to the digestive tract or are dose-dependent, and the sustainable efficacy is poor. Therefore, seeking methods other than oral drugs to treat and prevent simple obesity is an innovative point in current research. Providing an external Chinese medicine preparation for the treatment of simple obesity remains to be solved. Summary of the invention

[0007] In order to solve the above technical problems, the present invention proposes a 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 Chinese medicine acupoint patch is treated by pre-prepared Chinese medicinal materials acting on specific acupoints for a long time, and has a long-lasting curative effect, mild medicinal effect, and small side effects. It is easy to adhere to long-term use, can achieve the effect of correcting the secretion disorder of adipose tissue and improving obesity, and has a significant effect in treating simple obesity of spleen deficiency and dampness obstruction type.

[0008] In order to achieve the above object, the present invention provides a Chinese medicine acupoint patch for treating simple obesity. The ointment of the patch is prepared from vaseline and the following Chinese medicine composition 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, 2-6 parts of cinnamon bark, 2-6 parts of costusroot, and 1-3 parts of dried ginger;

[0009] The weight ratio of the traditional Chinese medicine composition to vaseline is 4:3.

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

[0011] (1) crushing the Chinese medicine composition into 80 mesh fine powder for standby use;

[0012] (2) The fine powder was mixed with medical grade external white vaseline in a weight ratio of 4:3 and blended into a thick paste.

[0013] Fried white mustard: warm in nature and pungent in taste, enters the lung and stomach meridians, and has the effects of warming the lungs, dispelling phlegm and promoting qi, relieving pain and reducing swelling. White mustard mainly contains polysaccharides, volatile oils, fatty acids, alkaloids, flavonoids and other ingredients. Among them, sinigrin has the highest content in raw white mustard, which itself has no irritating effect, while allyl isothiocyanate generated by hydrolysis has a spicy smell, is volatile, has a good anti-inflammatory effect, and is also highly irritating. External use can cause local heating, redness, and blistering of the skin. After the white mustard is fried, the content of sinapinic thiocyanate is reduced, and the irritation to the skin is also weakened. White mustard has a strong pungent and warm irritating nature, which can quickly promote the penetration of drugs in external prescriptions, making it easier to absorb and apply drugs through the skin, so that the therapeutic effect is more significant. Modern research shows that acupoint application of white mustard seeds can increase the levels of immunoglobulin A (IgA) and IgG, reduce the level of IgE, inhibit IgE-mediated allergic inflammation, regulate the balance of helper T cells (Th1 / Th2) cells, and thus improve the body's immune status.

[0014] Processed Gan Sui: cold in nature, bitter and toxic, it belongs to the lung, kidney and large intestine meridians, and has the effects of draining water, removing fluid, reducing swelling and dispersing stagnation. It is often used to treat edema, chest and abdominal effusion, phlegm and fluid accumulation, qi reversal, cough and asthma, and constipation. Gan Sui contains triterpenes, diterpenes and steroid compounds, among which diterpenes and triterpenes are the main compounds of Gan Sui, which have a wide range of pharmacological activities, such as skin irritation and regulation of multidrug resistance. Clinical studies have shown that external use of Gan Sui can contract intestinal smooth muscles, promote intestinal peristalsis, and has a significant laxative effect. Animal experiments have confirmed that vinegar-fried Gan Sui extract has little kidney toxicity to mice and shows a more obvious diuretic effect. Gan Sui raw products have side effects such as skin irritation, toxicity, and laxative, so its processed products are often used as medicine in clinical practice. Pharmacological experimental studies have shown that the toxic and side effects of Gan Sui are significantly reduced after being processed with vinegar. Experiments on mice have found that the median lethal dose of raw gansui is 36.4g / kg, while the median lethal dose of gansui roasted in vinegar is 65.3g / kg, and the drug's irritation to the intestines is significantly weakened after being roasted in vinegar. The Chinese medicine acupoint patch uses vinegar-roasted gansui, and the average dose used for external application is far lower than the above lethal dose, and it has been tested to be safe in clinical use, with no obvious 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, double atractylodes lactone, atractylodes lactone (I-III), and atractylodes polysaccharides. Stir-fried Atractylodes macrocephala with bran can reduce dryness, reduce gastrointestinal irritation, and enhance the function of strengthening the spleen. Studies have shown that atractylodes polysaccharides can reduce inflammatory responses in rats, and atractylodes lactone I can improve the body's ability to scavenge free radicals, inhibit inflammatory responses, and play a role in protecting the liver.

[0016] Cooked aconite: sweet in taste, hot in nature, toxic, enters the heart, spleen, and kidney meridians, and has the effects of restoring yang, replenishing fire and yang, and dispelling cold and relieving pain. Ancient books say that aconite is "good at traveling through all meridians" and can travel and circulate throughout the body to ensure the smooth flow of yang energy in the body, thereby better resisting external evil. The processing of aconite is to reduce its toxicity without affecting its efficacy. In actual clinical applications and using mice to conduct toxicity comparison tests before and after the processing of aconite, the results show that the use of aconite that has been attenuated after processing is safe and effective. The active ingredients of cooked aconite are water-soluble alkaloids such as monoester alkaloids and diester alkaloids. Studies have shown that aconite has anti-inflammatory and immunity-enhancing effects. The finished product is fried to become cooked aconite slices, which emphasizes anti-thrombotic and analgesic effects.

[0017] Cinnamon: spicy, sweet, hot in nature, it enters the kidney, spleen, heart, and liver meridians, and has the effects of replenishing yang, warming the spleen and stomach, removing cold accumulation, and unblocking blood vessels. The main chemical components of cinnamon are cinnamaldehyde, coumarin, cinnamic acid, cinnamyl alcohol, o-methoxycinnamaldehyde, polysaccharides, etc. Modern pharmacological studies have shown that cinnamaldehyde, the main component of volatile oil, has a wide range of pharmacological effects such as strong vasodilator, anti-gastric ulcer, antibacterial, and antioxidant. Activity tests show that cinnamon polysaccharides have good antioxidant capacity, and cinnamon polysaccharides also have inhibitory effects on α-amylase and α-glucosidase. Cinnamon polyphenols have good antioxidant effects and significant antibacterial effects.

[0018] Costus root: mild in nature, bitter in taste, has the effects of promoting qi and strengthening the spleen, relieving pain and digestion. Its components, costus alcohol and dehydrocostus lactone, have the effects of relaxing smooth muscles and relieving spasms. Costus lactone has many functions such as inhibiting bacterial growth, killing insects, stopping diarrhea, and inhibiting the growth of gastric cancer. Costus root is mainly used to treat gastrointestinal diseases such as spleen and stomach qi stagnation, diarrhea, and indigestion. The decoction and volatile oil of costus root have a positive effect on promoting gastric emptying and intestinal peristalsis.

[0019] Dried ginger: spicy, hot in nature, has the effects of warming the middle and dispelling cold, restoring yang and unblocking meridians, warming the lungs and transforming phlegm. Studies have shown that dried ginger is rich in volatile components such as α-gingerene, β-sesquiphellandrene, α-curcumene, and pinene, and has pharmacological activities such as antioxidant, bactericidal, anti-inflammatory, and anti-tumor. Ginger powder and ginger essential oil can increase the total antioxidant capacity in serum and reduce the level of malondialdehyde. Dried ginger has the effect of opening muscle pores. After ginger is processed into dried ginger, its transdermal absorption promoting effect changes. The transdermal absorption promoting effect of dried ginger volatile oil is significantly greater than that of ginger volatile oil.

[0020] Vaseline: A white, odorless solid ointment, it is a commonly used drug in drug therapy. It does not cause adverse effects or chemical reactions, and can provide a local protective and moisturizing effect on the skin. The use of vaseline can also effectively reduce the local irritation caused by drugs.

[0021] Preferably, the above-mentioned traditional Chinese medicine acupoint patch for treating simple obesity, wherein the weight parts of the traditional Chinese medicine composition 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, in the above-mentioned Chinese medicine acupoint patch for treating simple obesity, the weight parts of the Chinese medicine composition 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 Chinese medicine acupoint patch for treating simple obesity is prepared by powdering the Chinese medicine composition according to the weight ratio, sieving, fully mixing, adding medical grade external white vaseline, mixing and making into round pills, and placing them on a blank desensitizing adhesive tape.

[0024] More preferably, the above-mentioned Chinese medicine acupoint patch for treating simple obesity is prepared by powdering the Chinese medicine composition 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 Chinese medicine composition according to the weight ratio, sieving, mixing thoroughly, adding medical grade external white vaseline, mixing well, and filling into a 1 cm opening. 2 Squeeze out a 1 cm long strip of ointment from the ointment tube and place it on a blank desensitizing tape each time you use it.

[0026] More preferably, the above-mentioned Chinese medicine acupoint patch for treating simple obesity is prepared by powdering the Chinese medicine composition 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 adhesive tape.

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

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

[0029] Zhongwan and Qihai belong to the Ren Meridian and are key points for regulating Chong and Ren. When Chong and Ren are out of balance, the organs are deficient in essence and qi, and water and moisture cannot be transformed, which gathers into phlegm. Qi deficiency and blood stagnation, which remain and become blood stasis. The accumulation of phlegm and blood stasis over time can cause obesity. Tianshu and Zusanli belong to the Stomach Meridian of Foot Yangming. The pathogenesis of obesity has been considered to be related to "phlegm and dampness" and "spleen deficiency" since ancient times, among which "phlegm and dampness" is the symptom and "spleen deficiency" is the root. Tianshu is the Mu point of the Large Intestine Meridian of Foot Yangming, and Zhongyuan is the Mu point of the Stomach Meridian of Foot Yangming. The two points work together to regulate the stomach and intestines and improve the pathological state of spleen and stomach dysfunction. Yangming is a meridian with much qi and blood. Zhongyuan acupoint is not only good at treating the spleen and stomach and replenishing the acquired constitution, but also can replenish the qi and blood of Yangming to benefit Chong and Ren, and is a key point for replenishing Chong and Ren. The Suwen·Liuweizhidalun says: "Above Tianshu, the sky is in charge, below Tianshu, the earth is in charge, the qi is divided, the human qi follows it, and all things come from it." Tianshu acupoint regulates the intestines and viscera, and regulates gastrointestinal function in both directions. It plays a major regulatory role in the pathological state of strong stomach and weak spleen in obese patients. The Difficult Classic·Liushiliu Nan says: "The moving qi between the kidneys below the navel is the life of the human body and the root of the twelve meridians." The moving qi between the kidneys is the original qi. The sea of ​​qi is the place where the primordial qi is generated, and it is good at nourishing the primordial qi and strengthening the foundation, and replenishing the kidney and essence. Zusanli is the He point of the Stomach Meridian of Foot Yangming and the He point under the stomach viscera. "He governs the internal organs" and is a key acupoint for treating digestive system diseases. Modern medical research has also shown that Zusanli has a significant regulatory effect on many aspects of the human digestive system and endocrine system. For example, it has a two-way regulatory effect on gastric peristalsis, which can change 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 medicine acupoint patch of the present invention uses fried white mustard as the main medicine, which can warm and transform cold phlegm, disperse stagnation and reduce swelling, can "enter the skin and membrane", and is best at dissolving phlegm that has left the meridians. Processed gansui, honey bran fried atractylodes, and cooked aconite are the ministerial medicines, which can enter the middle jiao, 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", which means that phlegm, water and dampness are removed from the source. Cinnamon and costus root are adjuvants, which warm the meridians, promote qi and blood circulation; dried ginger is an adjuvant, warms yang and transforms drink, warms and unblocks the meridians with cinnamon, and promotes qi and blood circulation with costus root. It is more suitable for simple obesity of spleen deficiency and dampness obstruction syndrome. The cause of simple obesity is often related to bad diet and living habits, insufficient or excessive activity, decreased body function due to aging, or genetic factors. Traditional Chinese medicine believes that obesity is mostly caused by deficiency of spleen and kidney qi, turbid phlegm and internal retention of water and 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. The Chinese medicine acupoint patch of the present invention mainly selects warming yang and phlegm-resolving drugs, acts on the middle jiao spleen and stomach, can invigorate yang, warm and transform cold phlegm and cold dampness, and promote meridian circulation. Acupoint plaster is made by coordinating medical grade external white vaseline, which can produce protection and moist local nursing effect on skin, and can also effectively reduce the stimulation of local drug production, is 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 medicine acupoint patch of the present invention can significantly reduce the BMI and body fat rate of patients with simple obesity, can effectively reduce fat area, and has a more significant effect on subcutaneous fat. The effective rate of treating simple obesity by continuous application for 12 weeks is as high as 83.9%, and the fasting blood sugar level of patients can be significantly reduced. The Chinese medicine acupoint patch is economical, safe, effective, and suitable for long-term use. The Chinese medicine acupoint patch is treated by long-term action of pre-prepared Chinese medicinal materials on specific acupoints. It has a long-lasting efficacy, mild medicinal effect, and small side effects. It is easy to adhere to long-term use, can correct the disordered distribution of adipose tissue, and 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 of BMI in the treatment group and the control group before and after treatment.

[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] Now, various exemplary embodiments of the present invention are described in detail. In this specification, the present invention has been described with reference to its specific embodiments, but this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples. All technologies implemented based on the above content of the present invention belong to the scope of the present invention. Various improvements and changes can be made to the specific embodiments of the present invention specification without departing from the scope or spirit of the present invention. Therefore, the description and drawings should be considered illustrative rather than restrictive.

[0037] Example 1

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

[0039] Example 2

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

[0041] Example 3

[0042] The Chinese medicine acupoint patch prepared in Example 2 was filled into an ointment box, sealed and stored in a dark place below 20° C. Each time, a quantitative medicine spoon was used to scoop out an appropriate amount of ointment and placed on a blank desensitizing adhesive tape.

[0043] Example 4

[0044] The Chinese medicine acupoint patch prepared in Example 1 was molded and cut into 1 cm×1 cm×1 cm cube blocks, which were wrapped with mulberry paper and stored in a dark place below 20° C. When used, the mulberry paper was discarded and the blocks were placed on a blank desensitizing adhesive tape.

[0045] Example 5

[0046] The patient, female, 32 years old, height 158cm, weight 70.7kg, waist circumference 92cm, hip circumference 106cm, mainly engaged in mental work, denied previous medical history, denied history of infectious diseases such as hepatitis and tuberculosis, denied history of surgery and blood transfusion, gave birth to 1 child, and had regular menstruation. Heart rate 72 beats / min, regular rhythm, blood pressure 120 / 70mmHg. BMI was 28.32, waist-to-hip ratio 0.87, self-reported fatigue, heavy limbs, normal appetite, pale and fat tongue, teeth marks on the edges, thin white greasy fur, and soft pulse. Routine blood tests, liver and kidney function, and urine routine tests were all normal, cholesterol 6.42mmol / L, triglycerides 1.32mmol / L, low-density lipoprotein 4.17mmol / L, and fasting blood sugar 5.57mmol / L. Western medicine diagnosis is simple obesity, and Chinese medicine diagnosis is obesity, spleen deficiency and dampness obstruction syndrome, treatment gives Chinese medicine acupoint patch described in embodiment 2,3, 2 times a week, alternately applied on Zhongwan, Tianshu acupoint, and Qihai, Zusanli acupoint two groups of acupoints.Each patch lasts 2~4 hours, and 12 consecutive weeks are a course for the treatment of.During this period, other therapeutic drugs are not taken, only after continuous treatment of 12 weeks using Chinese medicine acupoint patch of the present invention, then check patient weight 60.2kg, waist circumference 77cm, hip circumference 96cm, BMI is 24.11, waist-hip ratio 0.8, cholesterol 5.62mmol / L, triglyceride 0.76mmol / L, low-density lipoprotein 3.68mmol / L, fasting blood sugar 4.79mmol / L.Private prosecution has no obvious tiredness, and the symptoms such as limb weakness and heavy weight have obvious improvement, and the tongue is light red, the fur is thin and white, and the pulse is thin. Simple obesity was clinically cured, blood lipid and blood sugar indexes were lower than before, and TCM symptoms were significantly improved. No adverse reactions were observed during the treatment, and the feedback from use was good.

[0047] Example 6- Observation on the clinical efficacy of the Chinese medicine acupoint patch of the present invention in treating 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. According to medical history, physical examination, laboratory tests, etc., secondary obesity is excluded, and simple obesity can be diagnosed if one or more of the following items are met: 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, 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, white and greasy, 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 differentiation of spleen deficiency and dampness obstruction; ③ Age 18 to 50 years old; ④ No other weight loss measures other than lifestyle intervention have been adopted 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-induced factors; ② Pregnant or lactating women; ③ Patients with liver, kidney, heart, lung dysfunction, or coagulation dysfunction; ④ Patients with organic diseases; ⑤ Patients with severe allergies, allergies to known intervention measures in the study, or those with contraindications to the use of these measures; ⑥ Patients with mental illness or infectious diseases; ⑦ Patients with cognitive or communication impairment; ⑧ Patients 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] After meeting the inclusion criteria, the patients 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, namely, ① performing at least 30 minutes of moderate-intensity physical activity every day; ② dietary control, with the following total calorie control standards: light physical strength is 125.5-146 kJ / kg standard body weight, medium physical strength is 147-167 kJ / kg standard body weight, and heavy physical strength is ≥168 kJ / kg standard body weight, with no restrictions on vitamin and fiber intake. It is recommended to eat more: whole grains, vegetables, fruits, soy and its products, milk and its products, fish, nuts, and drinking water (tea and coffee). Eat less: ① salty, pickled, and smoked foods. ② high-salt foods. ③ high-sugar and sugar-added foods. ④ high-fat and fried foods. ⑤ livestock meat products. ⑥ alcohol and sugary drinks. 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 Surgery Committee of the Surgical Branch of the Chinese Medical Association, etc. Clinical 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 at the same time for 12 consecutive weeks, and a review was conducted after all treatments were completed.

[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 that of Example 3, which was made by mixing starch + pigment and a small amount of ginger powder with 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, until the skin feels hot or hot, or becomes 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). Four weeks is one course of treatment. A total of three 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 only until you are 50% to 60% full. Do not take a bath on the day of treatment.

[0073] 4. Observation indicators

[0074] 4.1 Main 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 of the midpoint between the lower edge of the rib 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 indexes: 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: The visceral fat area was calculated by 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 tests.

[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 Effect 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% male ≤25%, female ≤30%, BMI <28; markedly effective: weight loss ≥5kg, 4cm≤WC decrease <8cm, F% decrease ≥5% but does not reach the standard of recovery, BMI decreases ≥4; effective: weight loss ≥3kg and <5kg, 2cm≤WC decrease <4cm, 3%≤F% decrease <5%, 2≤BMI decrease <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, and statistical analysis was performed using SPSS 21.0 statistical software. Measurement data that met normal distribution were expressed as mean ± standard deviation. If the variance is homogeneous, the two independent sample t test is used for inter-group comparison, and the paired sample t test is used for intra-group comparison; if the variance is unequal, the rank sum test is used for both inter-group and intra-group comparisons; the median is used to represent the average level of skewed variables, and the interquartile range (number) represents the degree of dispersion, and the rank sum test is performed. The count data are expressed as frequency or percentage, and the chi-square test is used for inter-group comparison. P < 0.05 is considered statistically significant.

[0089] 7. Comparison of clinical efficacy data analysis

[0090] General information: All 68 cases were simple obesity patients admitted to the Department of Traditional Chinese Medicine Prevention and Health Care of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from March to August 2024, and were randomly divided into an experimental group and a control group. There was no statistically significant difference in age, gender, BMI, etc. between the two groups (P>0.05), and they were comparable. There was no significant difference in the degree of obesity and blood lipids and blood sugar before enrollment between the treatment group and the control group (P>0.05).

[0091] 7.1 Chinese herbal acupoint patches have significant efficacy in treating simple obesity

[0092] A total of 68 patients were included. During the study, 6 patients were excluded because they did not use acupoint patches as required and were not included in the analysis. At the end of the treatment, there were 31 cases in the treatment group, 5 of which were clinically cured, 16 of which were markedly effective, and 5 of which were effective, with a total effective rate of 83.9%; there were 31 cases in the control group, 0 of which were clinically cured, 14 of which were markedly effective, and 2 of which were effective, with a total 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.

[0093] Table 1. Comparison of clinical efficacy between the treatment group and the control group (cases)

[0094]

[0095] Note: *P<0.05 compared with the control group.

[0096] 7.2 BMI significantly decreased after treatment with Chinese herbal acupoint patches

[0097] After 12 weeks of Chinese medicine acupoint patch treatment, the BMI of the treatment group was significantly reduced. There was a significant difference between the BMI of the treatment group and the control group after treatment (#P<0.05), see Table 2 and Figure 1As shown. Moreover, the BMI of the treatment group was significantly reduced compared with that before treatment (*P<0.05). The results suggest that Chinese herbal acupoint patches can effectively reduce the BMI of patients with simple obesity.

[0098] 7.3 Chinese herbal acupoint patch treatment significantly reduces body fat percentage

[0099] After 12 weeks of Chinese medicine acupoint patch treatment, the body fat percentage (F%) of the treatment group was significantly reduced. The inter-group 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. Moreover, the comparison within the group before and after treatment showed that the F% in the treatment group was significantly reduced compared with that before treatment (*P<0.05). The results suggest that Chinese herbal acupoint patches can effectively reduce the body fat percentage of patients with simple obesity.

[0100] 7.4 The area of ​​subcutaneous fat in the abdomen was significantly reduced after treatment with Chinese herbal acupoint patches

[0101] After 12 weeks of Chinese medicine acupoint patch treatment, the abdominal subcutaneous fat area of ​​the treatment group was significantly reduced. There was a significant difference between the abdominal subcutaneous fat area of ​​the treatment group and the control group after treatment (#P<0.05), see Table 2 and Figure 3 As shown. Moreover, the abdominal subcutaneous fat area of ​​the treatment group was significantly reduced compared with that before treatment (*P<0.05). The results suggest that Chinese herbal acupoint patches can effectively reduce abdominal subcutaneous fat in patients with simple obesity.

[0102] 7.5 Chinese herbal acupoint patch treatment can reduce waist circumference and visceral fat area

[0103] After 12 weeks of Chinese medicine 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 after treatment were different from those of the control group (△P<0.1), see Table 2 and Figure 3 As shown in the figure, the waist circumference and visceral fat area of ​​the treatment group were significantly reduced compared with those before treatment (*P<0.05). The results suggest that Chinese herbal acupoint patches can reduce the waist circumference and visceral fat of patients with simple obesity.

[0104] Table 2. Comparison of changes in obesity indexes between the treatment group and the control group

[0105]

[0106] Note: There is a statistically significant difference between the group before and after treatment, *P<0.05; there is a statistically significant difference between the treatment group and the control group, #P<0.05, △P<0.1.

[0107] 7.6 Chinese herbal acupoint patch therapy can reduce fasting blood sugar

[0108] After 12 weeks of treatment with Chinese herbal acupoint patches, the fasting blood glucose level of the treatment group was lower than before. There was a statistical difference in the fasting blood glucose between the treatment group and the control group (#P<0.05), and no significant difference was found in the various blood lipid indicators, see Table 3. The results suggest that Chinese herbal acupoint patches can reduce the fasting blood glucose level of patients with simple obesity.

[0109] Table 3. Comparison of changes in blood lipid and blood glucose indexes between the treatment group and the control group (unit: mmol / L)

[0110]

[0111] Note: There was a 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 traditional Chinese medicine composition 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, 2-6 parts of cinnamon bark, 2-6 parts of costusroot, and 1-3 parts of dried ginger; The weight ratio of the traditional Chinese medicine composition 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 traditional Chinese medicine composition 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 bark, 3-4 parts of costusroot, 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 traditional Chinese medicine composition are: 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, 4 parts of cinnamon bark, 4 parts of costusroot, 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) crushing the Chinese medicine composition into 80 mesh fine powder for standby 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 1 cm×1 cm×1 cm cubes, placing the medicine blocks on a blank desensitizing adhesive tape; or filling the medicine blocks into a 1 cm 2 Put it into the ointment tube, squeeze out a 1 cm long strip of ointment and place it on the blank desensitizing adhesive tape each time; or fill it into the ointment box, use a quantitative medicine spoon to scoop out an appropriate amount of ointment and place it on the blank desensitizing adhesive tape each time.

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

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

9. The method according to claim 8, characterized in that Apply the Chinese medicine acupoint patch to the acupoints, which are 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 on the acupoints, 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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