External application ointment for treating obesity in children and preparation method thereof

Abstract

The present application relates to a kind of external application ointment for treating obesity in children and its preparation method.The external application ointment includes spleen-warming and damp-dispelling formula for children with spleen deficiency and dampness accumulation and stomach-heat and dampness blocking formula for children with stomach-heat and dampness blocking.The spleen-warming and damp-dispelling formula is prepared from the following weight parts of traditional Chinese medicines: lotus leaf 6-20 parts, raw astragalus 10-20 parts, radix pseudostellariae 10-15 parts, poria cocos 10-15 parts, salvia miltiorrhiza 6-15 parts, dried tangerine or orange peel 3-10 parts, pinellia 6-10 parts, atractylodes 5-15 parts and cassia twig 3-10 parts;The stomach-heat and dampness blocking formula is prepared from the following weight parts of traditional Chinese medicines: rhubarb 3-15 parts, mirabilite 6-15 parts, coptis 2-10 parts, lotus leaf 6-20 parts, raw seed of Chinese medicine 10-30 parts, peilan 5-12 parts, immature bitter orange fruit 6-12 parts, magnolia officinalis 6-12 parts and salvia miltiorrhiza 10-15 parts.The present application also provides the preparation method of the above-mentioned spleen-warming and damp-dispelling formula and stomach-heat and dampness blocking formula.Compared with western medicine treatment means, the present application has wider indications, lower cost and no obvious side effects.Compared with traditional Chinese medicine treatment means, it does not need to be taken orally, reduces the pain of taking medicine and has higher acceptance degree in children.

Description

Technical Field

[0001] This invention relates to a topical ointment for treating childhood obesity and its preparation method, belonging to the field of traditional Chinese medicine preparation technology. Background Technology

[0002] Obesity not only severely damages the physical and mental health of children and adolescents, but also poses a potential threat to many diseases such as asthma, diabetes, hypertension, acanthosis nigricans, cardiovascular disease, and mental illness. These effects can persist into adulthood, placing a significant economic and psychological burden on parents and society. Currently, dietary intervention, exercise adjustments, and lifestyle changes are recognized as important methods for managing childhood and adolescent obesity; however, the effectiveness of many interventions for childhood and adolescent obesity remains unsatisfactory.

[0003] Western medicine treats childhood obesity primarily by controlling diet and increasing exercise, sometimes supplemented by medication. However, medication has limitations in its indications, is expensive, and may cause side effects. Traditional Chinese medicine believes that simple childhood obesity is often caused by impaired spleen and stomach function, leading to internal accumulation of phlegm and dampness. Children's spleen is often deficient, and if they eat improperly, especially rich and sweet foods, their spleen will fail to function properly, resulting in the accumulation of dampness, which then turns into phlegm and heat, leading to obesity. This condition is considered a syndrome of deficiency in the root and excess in the branch, with spleen deficiency as the root and phlegm and dampness as the branch.

[0004] Traditional Chinese medicine (TCM) treatments often involve oral administration of herbal medicines, which, while effective, suffer from drawbacks such as difficulty in taking the medication and low patient compliance, limiting their clinical application. External and internal treatments are theoretically consistent: "The principles of external treatment are the same as those of internal treatment; the medicines used in external treatment are the same as those used in internal treatment; the only difference lies in the method." Topical application therapy, guided by basic TCM theory, uses herbal preparations applied to the skin, orifices, acupoints, and affected areas. It is a type of external TCM treatment and is not only effective with few side effects but also enjoys good patient compliance. Therefore, there is an urgent need to develop a clinically safe, effective, and patient-compliant topical TCM preparation for treating childhood obesity. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the existing technology and provide a topical ointment for treating childhood obesity and its preparation method.

[0006] The first aspect of the present invention is to provide a topical ointment for treating obesity caused by spleen deficiency and dampness. Furthermore, for obesity caused by spleen deficiency and dampness, the external ointment adopts a spleen-strengthening and dampness-removing formula, which is prepared from lotus leaf, raw astragalus, codonopsis, poria, salvia miltiorrhiza, tangerine peel, pinellia, atractylodes lancea, and cinnamon twig.

[0007] Preferably, the spleen-strengthening and dampness-removing formula is prepared from the following Chinese medicinal herbs in parts by weight: lotus leaf 6-20 parts by weight, raw astragalus 10-20 parts by weight, codonopsis pilosula 10-15 parts by weight, poria cocos 10-15 parts by weight, salvia miltiorrhiza 6-15 parts by weight, tangerine peel 3-10 parts by weight, pinellia ternata 6-10 parts by weight, atractylodes lancea 5-15 parts by weight, and cinnamon twig 3-10 parts by weight.

[0008] More preferably, the spleen-strengthening and dampness-removing formula is prepared from the following Chinese medicinal herbs in parts by weight: lotus leaf 12-15 parts by weight, raw astragalus 10-15 parts by weight, codonopsis pilosula 10-12 parts by weight, poria cocos 10-12 parts by weight, salvia miltiorrhiza 6-8 parts by weight, tangerine peel 6-8 parts by weight, pinellia ternata 8-12 parts by weight, atractylodes lancea 8-12 parts by weight, and cinnamon twig 6-8 parts by weight.

[0009] More preferably, the spleen-strengthening and dampness-removing formula is prepared from the following Chinese herbs in parts by weight: 15 parts lotus leaf, 10 parts raw astragalus, 10 parts codonopsis, 10 parts poria, 6 parts salvia miltiorrhiza, 6 parts tangerine peel, 10 parts pinellia, 10 parts atractylodes, and 6 parts cinnamon twig.

[0010] Preferably, the topical ointment further includes pharmaceutically acceptable excipients.

[0011] Preferably, the pharmaceutically acceptable excipient is petrolatum.

[0012] Preferably, the petroleum jelly is in the form of 70-210 parts by weight, more preferably 90-150 parts by weight, and even more preferably 120 parts by weight.

[0013] The above-mentioned spleen-strengthening and dampness-removing formula is suitable for children with simple obesity due to spleen deficiency and dampness. The TCM syndrome diagnosis criteria refer to the "Chinese Expert Consensus on the Clinical Diagnosis and Treatment of Simple Obesity in Children with Integrated Traditional Chinese and Western Medicine": bloated and obese body, heaviness in the limbs, drowsiness and excessive sweating, fatigue and lack of movement, or bland taste and abdominal fullness, or scanty urine and loose stools, pale and swollen tongue with a white and greasy or thin white coating, and a deep and slippery or deep and slow pulse.

[0014] A second aspect of the present invention is to provide a topical ointment for treating obesity caused by spleen deficiency and dampness. Furthermore, the external ointment for obesity due to stomach heat and dampness uses a stomach-clearing and dampness-resolving formula, which is prepared from rhubarb, Glauber's salt, Coptis chinensis, lotus leaf, raw coix seed, Eupatorium fortunei, Citrus aurantium, Magnolia officinalis, and Salvia miltiorrhiza. Furthermore, for obesity due to stomach heat and dampness, the external ointment uses a stomach-clearing and dampness-resolving formula, which is prepared from rhubarb, Glauber's salt, Coptis chinensis, lotus leaf, raw coix seed, Eupatorium fortunei, Citrus aurantium, Magnolia officinalis, and Salvia miltiorrhiza.

[0015] Preferably, the stomach-clearing and dampness-resolving formula is prepared from the following Chinese medicinal herbs in parts by weight: rhubarb 3-15 parts by weight, Glauber's salt 6-15 parts by weight, coptis 2-10 parts by weight, lotus leaf 6-20 parts by weight, raw coix seed 10-30 parts by weight, agastache rugosa 5-12 parts by weight, immature bitter orange 6-12 parts by weight, magnolia bark 6-12 parts by weight, and salvia miltiorrhiza 10-15 parts by weight.

[0016] More preferably, the stomach-clearing and dampness-resolving formula is prepared from the following Chinese medicinal herbs in parts by weight: 7. Rhubarb 8-12 parts by weight, Glauber's salt 8-12 parts by weight, Coptis chinensis 4-8 parts by weight, lotus leaf 10-15 parts by weight, raw coix seed 15-25 parts by weight, Eupatorium fortunei 8-10 parts by weight, Citrus aurantium 8-10 parts by weight, Magnolia officinalis 8-10 parts by weight, and Salvia miltiorrhiza 12-14 parts by weight.

[0017] More preferably, the stomach-clearing and dampness-resolving formula is prepared from the following Chinese medicinal herbs in parts by weight: 10 parts rhubarb, 10 parts Glauber's salt, 6 parts Coptis chinensis, 10 parts lotus leaf, 10 parts raw coix seed, 10 parts Eupatorium fortunei, 10 parts immature bitter orange, 10 parts magnolia bark, and 6 parts Salvia miltiorrhiza.

[0018] Preferably, the topical ointment further includes pharmaceutically acceptable excipients.

[0019] Preferably, the pharmaceutically acceptable excipient is petrolatum.

[0020] Preferably, the petroleum jelly is in the form of 70-210 parts by weight, more preferably 90-150 parts by weight, and even more preferably 120 parts by weight.

[0021] Preferably, the dosage form of the topical ointment is a paste, patch, or gel, more preferably a paste.

[0022] The above-mentioned stomach-clearing and dampness-resolving formula is suitable for children with simple obesity due to stomach heat and dampness obstruction. The TCM syndrome diagnosis criteria refer to the "Chinese Expert Consensus on the Clinical Diagnosis and Treatment of Simple Obesity in Children with Integrated Traditional Chinese and Western Medicine": obese body, abdominal distension, excessive hunger, or lethargy, thirst, halitosis, flushed face, yellow urine, constipation, red tongue, yellow and greasy or slightly yellow coating, and slippery and rapid or slippery pulse.

[0023] A third aspect of the present invention provides a method for preparing the above-mentioned topical ointment. The preparation method includes the following steps: take the corresponding amount of each Chinese herb in the prescription, grind each Chinese herb into fine powder, mix and stir evenly, then add 90-150 parts of excipients, mix evenly again, and the product is obtained.

[0024] Furthermore, the excipients are petrolatum, honey, liquid paraffin, or glycerin.

[0025] A fourth aspect of the present invention provides the use of the above-mentioned topical ointment in the preparation of a medicament for treating childhood obesity. Preferably, the childhood obesity is simple childhood obesity.

[0026] Preferably, the simple obesity in children includes simple obesity in children with spleen deficiency and dampness syndrome and simple obesity in children with stomach heat and dampness obstruction syndrome.

[0027] The common pharmacological effects of the traditional Chinese medicine raw materials selected in this invention in this field are as follows: Lotus leaf: Bitter in taste, neutral in nature. It enters the liver, spleen, and stomach meridians. It has the effects of clearing summer heat and dampness, promoting the upward movement of clear yang, cooling blood and stopping bleeding. It is used for summer heat and thirst, summer heat and dampness diarrhea, spleen deficiency diarrhea, blood heat causing vomiting and nosebleeds, and hematochezia and metrorrhagia.

[0028] Raw Astragalus: Sweet in taste and slightly warm in nature; it enters the spleen and lung meridians. It has the effects of strengthening the spleen and replenishing the middle jiao, raising yang and lifting prolapse, benefiting wei qi and consolidating the exterior, promoting diuresis, and promoting tissue regeneration and detoxification. It is mainly used to treat spleen qi deficiency, lung qi deficiency, spontaneous sweating due to qi deficiency, qi and blood deficiency, and sores that are difficult to ulcerate or heal.

[0029] Codonopsis pilosula: Sweet and slightly bitter in taste; neutral in nature. It enters the spleen and lung meridians. It has the effects of invigorating qi and strengthening the spleen, promoting body fluid production and moistening the lungs. It is used for spleen deficiency with fatigue, loss of appetite, weakness after illness, qi and yin deficiency, spontaneous sweating and thirst, and dry cough due to lung dryness.

[0030] Poria cocos: Sweet and bland in taste, neutral in nature. It enters the heart, spleen, and stomach meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and calming the mind. It is used for edema, difficulty urinating, various symptoms of spleen deficiency, palpitations, and insomnia.

[0031] Salvia miltiorrhiza: Bitter in taste and slightly cold in nature. It enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling. It is used for chest pain, abdominal pain, abdominal masses, pain due to heat, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0032] Dried tangerine peel: pungent and bitter in taste, warm in nature, and enters the spleen and lung meridians. It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It is used for spleen and stomach qi stagnation syndrome and phlegm-dampness accumulation syndrome.

[0033] Pinellia ternata: pungent in flavor and warm in nature. It enters the spleen, stomach, and lung meridians. It has the effects of drying dampness and resolving phlegm, suppressing nausea and vomiting, dissipating lumps and nodules, and externally reducing swelling and relieving pain. It is used for damp phlegm and cold phlegm syndromes, vomiting due to stomach qi rising upwards, chest pain, chest tightness, epigastric fullness, globus hystericus, scrofula, goiter, carbuncles, boils, and snake bites, etc.

[0034] Atractylodes lancea: pungent and bitter in taste, warm in nature. It enters the spleen and stomach meridians. It has the effects of drying dampness and strengthening the spleen, dispelling wind and dampness, and releasing exterior pathogens. It is used for dampness stagnation in the middle jiao, rheumatic arthralgia, and external pathogenic factors with dampness.

[0035] Cinnamon twig: pungent and sweet in taste, warm in nature. It enters the lung, heart, and bladder meridians. It has the effects of inducing sweating and relieving muscle tension, warming the meridians and promoting blood circulation, and promoting yang and qi transformation. It is used for external wind-cold syndrome, arthralgia due to cold stagnation and blood stasis, abdominal pain due to cold, dysmenorrhea, amenorrhea, chest pain, phlegm retention, edema, palpitations, and irregular pulse.

[0036] Rhubarb: Bitter in taste and cold in nature. It enters the spleen, stomach, large intestine, liver, and heart meridians. It has the effects of purging stagnation, clearing heat and purging fire, stopping bleeding, detoxifying, promoting blood circulation and removing blood stasis, and clearing damp-heat. It is used for gastrointestinal stagnation, constipation, bleeding disorders due to blood heat, sores caused by heat toxins, erysipelas, burns, scalds, various blood stasis syndromes, jaundice, and urinary tract infections.

[0037] Glauber's salt: Salty and bitter in taste, cold in nature. It enters the stomach and large intestine meridians. It has the effects of purging, softening hard masses, and clearing heat. It is used for stagnation of excess heat, constipation, mouth ulcers, sore throat, red eyes, and carbuncles and boils. When applied externally, it can also suppress lactation.

[0038] Coptis chinensis: Bitter in taste, cold in nature, and enters the heart, liver, stomach, and large intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying. It is used for damp-heat obstruction in the middle jiao, epigastric fullness and nausea, diarrhea and abdominal pain, high fever due to febrile diseases, irritability and insomnia, vomiting due to stomach heat, disharmony between the liver and stomach, vomiting and acid regurgitation, carbuncles and boils, skin eczema, red and swollen eyes, and bleeding due to blood heat.

[0039] Raw Job's tears: Sweet and bland in taste, slightly cold in nature. It enters the spleen, stomach, and lung meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stopping diarrhea, clearing heat and draining pus, and relieving numbness. It is used for edema, difficulty urinating, spleen deficiency diarrhea, lung abscess, intestinal abscess, and dampness-induced numbness and muscle spasms.

[0040] Peilan: pungent in flavor, neutral in nature, and enters the spleen, stomach, and lung meridians. It has the effects of resolving dampness and relieving summer heat. It is used for dampness stagnation in the middle jiao, external invasion of summer-dampness, or the initial stage of damp-heat syndrome.

[0041] Fructus Aurantii Immaturus: Bitter and pungent in taste, slightly cold in nature. It enters the spleen, stomach, and large intestine meridians. It has the effects of breaking up qi stagnation, eliminating stagnation, resolving phlegm, and relieving abdominal distension. It is used for food stagnation and qi stagnation, abdominal distension, and phlegm obstruction, chest and epigastric distension.

[0042] Magnolia officinalis: Bitter and pungent in taste, warm in nature. It enters the spleen, stomach, lung, and large intestine meridians. It has the effects of drying dampness, promoting qi circulation, eliminating stagnation, and relieving asthma. It is used for dampness obstructing the middle jiao, intestinal and gastrointestinal stagnation, phlegm retention, and cough with wheezing.

[0043] Vaseline: A semi-solid mixture of various hydrocarbons obtained from petroleum and decolorized. Appearance: A white to slightly yellow, uniform ointment; odorless or almost odorless; has a slippery feel upon contact with skin; has stringy properties and can be used as a pharmaceutical excipient.

[0044] Compared with the prior art, the present invention has the following technical effects: The topical ointment of this invention takes "eliminating fat and dampness" as its core treatment principle. Based on the theory of syndrome differentiation and treatment in traditional Chinese medicine, it is formulated with corresponding drug combinations for two syndromes of simple obesity in children: spleen deficiency and dampness excess syndrome and stomach heat and dampness obstruction syndrome. It is highly targeted. As a topical dosage form, it does not require oral administration, which can reduce the pain of taking medicine and is convenient to use. It is highly accepted by children and has good treatment compliance.

[0045] Synergistic effects of drugs and acupoints: ① Precise drug combination: For spleen deficiency with dampness, lotus leaf and raw astragalus are used to form a spleen-strengthening and dampness-removing formula, which has the effects of drying dampness, resolving phlegm, promoting blood circulation and diuresis; for stomach heat with dampness obstruction, rhubarb and Glauber's salt are used to form a stomach-clearing and dampness-removing formula, which has the power to purge heat, clear the bowels, remove blood stasis and remove dampness; ② Reasonable acupoint selection: The main acupoints are Zhongwan, Shuifen, Daimai, Tianshu, Huaroumen, etc., which are closely related to spleen and stomach function and water and dampness metabolism, which can enhance the efficacy of drugs.

[0046] The weight loss effect is definite: it can effectively improve childhood obesity symptoms, reduce weight and BMI, regulate blood lipid metabolism, and increase the body's metabolism, thus promoting weight loss from the root cause; at the same time, it has high safety, is safe for clinical use, and has no obvious side effects.

[0047] Compared with Western medicine treatments, it has a wider range of indications and lower treatment costs; it is targeted, safe, convenient and economical, and has good prospects for clinical application. Detailed Implementation

[0048] The present invention will be further described below with reference to specific embodiments.

[0049] Example 1 Take 10 parts by weight of lotus leaf, 10 parts by weight of raw astragalus, 10 parts by weight of codonopsis, 10 parts by weight of poria, 6 parts by weight of salvia miltiorrhiza, 6 parts by weight of tangerine peel, 6 parts by weight of pinellia, 10 parts by weight of atractylodes lancea, and 6 parts by weight of cinnamon twig. Grind each herb into a fine powder using the grinding method. Then mix and stir them evenly. Add 100 parts by weight of petroleum jelly and mix evenly again to obtain the external ointment for treating childhood obesity with spleen deficiency and dampness - Spleen-strengthening and Dampness-removing Formula 1.

[0050] Example 2 Take 15 parts by weight of lotus leaf, 10 parts by weight of raw astragalus, 10 parts by weight of codonopsis, 15 parts by weight of poria, 10 parts by weight of salvia miltiorrhiza, 6 parts by weight of tangerine peel, 10 parts by weight of pinellia, 10 parts by weight of atractylodes lancea, and 6 parts by weight of cinnamon twig. Grind each herb into a fine powder using the grinding method. Then mix and stir evenly, add 130 parts by weight of petroleum jelly, and mix evenly again to obtain the external ointment for treating childhood obesity with spleen deficiency and dampness - Spleen-strengthening and Dampness-removing Formula 2 of this invention.

[0051] Example 3 Take 15 parts by weight of lotus leaf, 10 parts by weight of raw astragalus, 10 parts by weight of codonopsis, 10 parts by weight of poria, 6 parts by weight of salvia miltiorrhiza, 6 parts by weight of tangerine peel, 10 parts by weight of pinellia, 10 parts by weight of atractylodes lancea, and 6 parts by weight of cinnamon twig. Grind each herb into a fine powder using the grinding method. Then mix and stir evenly, add 120 parts by weight of petroleum jelly, and mix evenly again to obtain the external ointment for treating childhood obesity with spleen deficiency and dampness - Spleen-strengthening and Dampness-removing Formula 3 of this invention.

[0052] Example 4 Take 10 parts by weight of rhubarb, 10 parts by weight of Glauber's salt, 6 parts by weight of coptis chinensis, 10 parts by weight of lotus leaf, 10 parts by weight of raw coix seed, 10 parts by weight of agastache rugosa, 10 parts by weight of immature bitter orange, 10 parts by weight of magnolia bark, and 6 parts by weight of salvia miltiorrhiza. Grind each herb separately into a fine powder using the grinding method. Then mix and stir evenly, add 120 parts by weight of petroleum jelly, and mix evenly again to obtain the external ointment for treating obese children with stomach heat and dampness obstruction syndrome - Qingwei Huashi Formula 1 of this invention.

[0053] Example 5 Take 10 parts by weight of rhubarb, 12 parts by weight of Glauber's salt, 6 parts by weight of coptis chinensis, 10 parts by weight of lotus leaf, 10 parts by weight of raw coix seed, 10 parts by weight of agastache rugosa, 10 parts by weight of immature bitter orange, 10 parts by weight of magnolia bark, and 6 parts by weight of salvia miltiorrhiza. Grind each herb separately into a fine powder using the grinding method. Then mix and stir evenly, add 120 parts by weight of petroleum jelly, and mix evenly again to obtain the external ointment for treating obese children with stomach heat and dampness obstruction syndrome - Qingwei Huashi Formula 2 of this invention.

[0054] Example 6 Take 10 parts by weight of rhubarb, 10 parts by weight of Glauber's salt, 8 parts by weight of coptis chinensis, 10 parts by weight of lotus leaf, 10 parts by weight of raw coix seed, 10 parts by weight of agastache rugosa, 10 parts by weight of immature bitter orange, 10 parts by weight of magnolia bark, and 6 parts by weight of salvia miltiorrhiza. Grind each herb separately into a fine powder using the grinding method. Then mix and stir evenly, add 120 parts by weight of petroleum jelly, and mix evenly again to obtain the external ointment for treating obese children with stomach heat and dampness obstruction syndrome - Qingwei Huashi Formula 3 of this invention.

[0055] Comparative Example 1 (The lotus leaf in Example 3 was replaced with Job's tears) Take 15 parts by weight of Coix seed, 10 parts by weight of raw Astragalus membranaceus, 10 parts by weight of Codonopsis pilosula, 10 parts by weight of Poria cocos, 6 parts by weight of Salvia miltiorrhiza, 6 parts by weight of dried tangerine peel, 10 parts by weight of Pinellia ternata, 10 parts by weight of Atractylodes lancea, and 6 parts by weight of cinnamon twig. Grind each herb into a fine powder using the grinding method. Then mix and stir them evenly. Add 120 parts by weight of Vaseline and mix evenly again to obtain the external application ointment for treating childhood obesity with spleen deficiency and dampness - Comparative Formula 1 of the Spleen-Strengthening and Dampness-Removing Formula.

[0056] Comparative Example 2 (replacing raw Astragalus membranaceus with raw Atractylodes macrocephala in Example 3) Take 15 parts by weight of lotus leaf, 10 parts by weight of raw Atractylodes macrocephala, 10 parts by weight of Codonopsis pilosula, 10 parts by weight of Poria cocos, 6 parts by weight of Salvia miltiorrhiza, 6 parts by weight of tangerine peel, 10 parts by weight of Pinellia ternata, 10 parts by weight of Atractylodes lancea, and 6 parts by weight of cinnamon twig. Grind each herb into a fine powder using the grinding method. Then mix and stir evenly, add 130 parts by weight of Vaseline, and mix evenly again to obtain the external ointment for treating childhood obesity with spleen deficiency and dampness - Comparative Formula 2 of the Spleen-Strengthening and Dampness-Removing Formula.

[0057] Comparative Example 3 (replacing the rhubarb in Example 4 with cassia seed) Take 10 parts by weight of cassia seed, 10 parts by weight of Glauber's salt, 6 parts by weight of coptis root, 10 parts by weight of lotus leaf, 10 parts by weight of raw coix seed, 10 parts by weight of agastache, 10 parts by weight of immature bitter orange, 10 parts by weight of magnolia bark, and 6 parts by weight of salvia root. Grind each herb separately into a fine powder using the grinding method. Then mix and stir evenly, add 120 parts by weight of petroleum jelly, and mix evenly again to obtain the external ointment for treating obese children with stomach heat and dampness obstruction syndrome of this invention - the stomach-clearing and dampness-resolving formula comparison formula 1.

[0058] Comparative Example 4 (the Glauber's salt in Example 4 was replaced with Trichosanthes kirilowii) Take 10 parts by weight of rhubarb, 10 parts by weight of trichosanthes fruit, 6 parts by weight of coptis root, 10 parts by weight of lotus leaf, 10 parts by weight of raw coix seed, 10 parts by weight of agastache, 10 parts by weight of immature bitter orange, 10 parts by weight of magnolia bark, and 6 parts by weight of salvia root. Grind each herb separately into a fine powder using the grinding method. Then mix and stir evenly, add 120 parts by weight of petroleum jelly, and mix evenly again to obtain the external ointment for treating obese children with stomach heat and dampness obstruction syndrome of this invention - the stomach-clearing and dampness-resolving formula comparison formula 2.

[0059] Experimental Example 1 This experimental case verifies the clinical therapeutic effect of the spleen-strengthening and dampness-removing formula on obese children with spleen deficiency and dampness syndrome. 1. Patient selection One hundred and twenty children meeting the diagnostic criteria for simple obesity who visited Suzhou Traditional Chinese Medicine Hospital between January 2024 and August 2025 were randomly divided into a control group and five treatment groups (groups are shown in Table 1), with 20 children in each group. The control group consisted of 11 males and 9 females, aged 6–14 years, with a mean age of (9.4±2.1) years; the treatment groups consisted of 59 males and 41 females, aged 6–14 years, with a mean age of (9.3±2.4) years. There were no statistically significant differences in baseline characteristics between the two groups. P (>0.05), making them comparable.

[0060] Table 1. Treatment prescriptions for the treatment group and the control group 2. Diagnostic criteria Western medicine diagnostic criteria: Refer to the diagnosis of simple obesity in the "Chinese Childhood Obesity Diagnosis Criteria", that is, the weight exceeds the standard weight of healthy children of the same sex and height by more than 20%; Traditional Chinese Medicine diagnostic criteria: Refer to the diagnostic criteria for spleen deficiency and dampness syndrome in the "Expert Consensus on the Clinical Diagnosis and Treatment of Simple Obesity in Chinese Children with Integrated Traditional Chinese and Western Medicine": bloated and obese body, heaviness in the limbs, drowsiness and excessive sweating, fatigue and lack of movement, or bland taste in the mouth and fullness in the abdomen, or scanty urine and loose stools, pale and swollen tongue with a white and greasy or thin white coating, and a deep and slippery or deep and slow pulse.

[0061] 3. Inclusion and Exclusion Criteria Inclusion criteria: (1) Meets the above diagnostic criteria of traditional Chinese and Western medicine and the diagnostic criteria of traditional Chinese medicine syndrome; (2) Age 6 to 14 years; (3) Liver and kidney function, blood lipids, blood sugar and other biochemical indicators are basically normal; (4) The child can cooperate with the treatment, and his / her family or legal guardian is aware of and agrees to the treatment and signs the informed consent form.

[0062] Exclusion criteria: (1) Exclusion of secondary obesity caused by heredity, endocrine disorders, or drugs; (2) Exclusion of patients with serious primary diseases of the heart, lungs, liver, kidneys, hematopoietic system, or nervous system; (3) Exclusion of patients who are allergic to certain components of the test drug.

[0063] 4. Treatment methods The specific treatment method is as follows: five treatment groups were given the above-mentioned Examples 1-3 (Spleen-strengthening and Dampness-removing Formula 1-3) and Comparative Examples 1-2 (Spleen-strengthening and Dampness-removing Formula Comparison 1-2). The total weight of Chinese medicinal materials excluding Vaseline in each dose was 36g, and 54g of Vaseline was added.

[0064] Apply 4 patches each time, externally to Zhongwan, Shuifen, Daimai, Tianshu, and Huaroumen acupoints, 3 times a week, 4 hours each time, for a 12-week treatment cycle.

[0065] The control group received routine lifestyle interventions, including dietary control (low-fat, low-sugar, high-fiber), daily exercise ≥60 minutes, and behavioral correction (reducing screen time, regular sleep schedule, etc.), for 3 consecutive months. The treatment group received the same treatment as the control group, plus a spleen-strengthening and dampness-removing plaster, applied once daily to acupoints such as Zhongwan, Daimai, Shuifen, Tianshu, and Huaroumen, for 4 hours each time, for 3 consecutive months.

[0066] 5. Observation Indicators Observation indicators: Weight, height, BMI, waist circumference, hip circumference, blood lipids (TC, TG, LDL-C, HDL-C), and liver function (ALT, AST) were measured before and after treatment, and TCM syndrome scores were recorded. The severity of symptoms in the TCM diagnostic criteria was scored, with primary symptoms scored as 0, 2, 4, and 6 points respectively, and secondary symptoms scored as 0, 1, 2, and 3 points respectively. Tongue and pulse were not scored. Primary symptoms included obesity, fatigue, and heaviness in the limbs; secondary symptoms included chest and abdominal fullness, poor appetite, bland taste in the mouth, drowsiness, oliguria, and loose stools.

[0067] 6. Statistical methods Data analysis was performed using SPSS 22.0 software. Quantitative data were expressed as mean ± standard deviation (x ± s). The t-test was used for comparisons between groups, and the χ² test was used for categorical data. P < 0.05 was considered statistically significant.

[0068] 7. Research Results Table 2 Comparison of weight loss data between treatment groups and control group Note: *Compared with the control group, P <0.05 (Control group: 20 people; Treatment group: 5 groups, 20 people in each group, 120 people in total) Table 3 Comparison of TCM syndrome scores (x±s, scores) Note: *Compared with the control group, P <0.05 The treatment group showed significant advantages over the control group in terms of weight loss, BMI improvement, and TCM syndrome scores. P <0.05). No significant adverse reactions occurred during the treatment, and no abnormal changes were observed in liver and kidney function.

[0069] Experimental Example 2 This trial case verifies the clinical therapeutic effect of Qingwei Huashi Formula on obese children with stomach heat and dampness obstruction. 1. Patient selection Ninety children meeting the diagnostic criteria for simple obesity who visited Suzhou Traditional Chinese Medicine Hospital between January 2024 and August 2025 were randomly divided into a control group and five treatment groups (groups are shown in Table 4), with 15 children in each group. The control group consisted of 9 males and 6 females, aged 6–14 years, with a mean age of (9.8±2.5) years. The treatment groups consisted of 40 males and 35 females, aged 6–14 years, with a mean age of (9.1±2.1) years, and were randomly divided into five treatment groups (treatment groups 1-5). There were no statistically significant differences in baseline characteristics between the two groups (P>0.05), indicating comparability.

[0070] Table 4. Treatment prescriptions for the treatment group and the control group 2. Diagnostic criteria Western medicine diagnostic criteria: Refer to the diagnosis of simple obesity in the "Chinese Childhood Obesity Diagnosis Criteria", that is, the weight exceeds the standard weight of healthy children of the same sex and height by more than 20%; Traditional Chinese Medicine diagnostic criteria: Refer to the diagnostic criteria for stomach heat and dampness obstruction syndrome in the "Expert Consensus on Clinical Diagnosis and Treatment of Simple Obesity in Chinese Children with Integrated Traditional Chinese and Western Medicine": Obesity, abdominal distension, excessive hunger, or lethargy, thirst, halitosis, flushed face, yellow urine, constipation, red tongue, yellow and greasy or slightly yellow coating, and slippery and rapid or slippery pulse.

[0071] 3. Inclusion and Exclusion Criteria Inclusion criteria: (1) Meets the above diagnostic criteria of traditional Chinese and Western medicine and the diagnostic criteria of traditional Chinese medicine syndrome; (2) Age 6 to 14 years; (3) Liver and kidney function, blood lipids, blood sugar and other biochemical indicators are basically normal; (4) The child can cooperate with the treatment, and his / her family or legal guardian is aware of and agrees to the treatment and signs the informed consent form.

[0072] Exclusion criteria: (1) Exclusion of secondary obesity caused by heredity, endocrine disorders, or drugs; (2) Exclusion of patients with serious primary diseases of the heart, lungs, liver, kidneys, hematopoietic system, or nervous system; (3) Exclusion of patients who are allergic to certain components of the test drug.

[0073] 4. Treatment methods The specific treatment method is as follows: the above-mentioned Examples 4-6 (Qingwei Huashi Formula 1-3) and Comparative Examples 3-4 (Qingwei Huashi Formula Comparative Formula 1-2) are given. The total weight of Chinese medicinal materials excluding Vaseline in each dose is 36g, and 54g of Vaseline is added.

[0074] Apply 4 patches each time, externally to Zhongwan, Shuifen, Daimai, Tianshu, and Huaroumen acupoints, 3 times a week, 4 hours each time, for a 12-week treatment cycle.

[0075] The control group received routine lifestyle interventions, including dietary control (low-fat, low-sugar, high-fiber), daily exercise ≥60 minutes, and behavioral modification (reducing screen time, regular sleep schedule, etc.), for 3 consecutive months.

[0076] The treatment group received additional spleen-strengthening and dampness-removing plaster in addition to the treatment group's medication. The plaster was applied once daily to acupoints such as Zhongwan, Daimai, Shuifen, Tianshu, and Huaroumen for 4 hours each time, for a total of 3 months.

[0077] 6. Observation Indicators Observation indicators: Weight, height, BMI, waist circumference, hip circumference, blood lipids (TC, TG, LDL-C, HDL-C), and liver function (ALT, AST) were measured before and after treatment, and TCM syndrome scores were recorded. The severity of symptoms in the TCM diagnostic criteria was scored, with primary symptoms scored as 0, 2, 4, and 6 points respectively, and secondary symptoms scored as 0, 1, 2, and 3 points respectively. Tongue and pulse were not scored. Primary symptoms included obesity, abdominal distension, and excessive hunger; secondary symptoms included lethargy, thirst, halitosis, flushed face, yellow urine, and constipation.

[0078] 6. Statistical methods Data analysis was performed using SPSS 22.0 software. Quantitative data were expressed as mean ± standard deviation (x ± s). The t-test was used for comparisons between groups, and the χ² test was used for categorical data. P < 0.05 was considered statistically significant.

[0079] 7. Research Results Table 5 Comparison of weight loss data between the experimental and control groups Note: *Compared with the control group, P<0.05 (control group: 15 people; treatment group: 5 groups, 15 people in each group, 90 people in total). Table 6 Comparison of TCM syndrome scores between the two groups (x±s, scores) Note: *P < 0.05 compared with the control group. The results showed that the treatment group was superior to the control group in terms of weight loss, BMI improvement, and TCM syndrome scores, with statistically significant differences (P < 0.05). No significant adverse reactions occurred during the treatment, and no abnormal changes were observed in liver and kidney function. As can be seen from the table above, the treatment group was superior to the control group in terms of weight loss, BMI improvement, and TCM syndrome scores, with statistically significant differences (P < 0.05). No significant adverse reactions occurred during the treatment, and no abnormal changes were observed in liver and kidney function.

[0080] Experimental Example 3 This experimental case provides individual case data on the clinical treatment of the traditional Chinese medicine ointment of the present invention. Case 1 Ms. Chen, female, 13 years old, weighing 68.95 kg, sought medical attention due to obesity. According to traditional Chinese medicine diagnosis, she had spleen deficiency and dampness. She was given the Chinese herbal ointment prepared in Example 3 of this invention, applied externally to Zhongwan, Shuifen, Daimai, Tianshu, and Huaroumen acupoints, 3 times a week, for 4 hours each time, for a treatment period of 12 weeks. After 3 months, her weight decreased by 4.3 kg.

[0081] Case 2 Mr. Xu, male, 11 years old, weighing 61.5 kg, sought medical treatment for obesity. According to traditional Chinese medicine diagnosis, he was diagnosed with spleen deficiency and dampness. He was given the external ointment of Example 3 of this invention, which was applied to Zhongwan, Shuifen, Daimai, Tianshu and Huaroumen acupoints, 3 times a week for 4 hours each time. The treatment cycle was 12 weeks. After 3 months, his weight decreased by 3.1 kg.

[0082] Case 3 Ms. Xu, female, 14 years old, weighing 83.6 kg, sought medical attention due to obesity. According to traditional Chinese medicine diagnosis, she had spleen deficiency and dampness. She was given the external ointment of Example 3 of this invention, applied to Zhongwan, Shuifen, Daimai, Tianshu, and Huaroumen acupoints, 3 times a week, for 4 hours each time, for a treatment period of 12 weeks. After 3 months, her weight decreased by 5.3 kg.

[0083] Case 4 Ms. Jia, female, 13 years old, weighing 70.45 kg, sought medical attention due to obesity. According to traditional Chinese medicine diagnosis, she had stomach heat and dampness obstruction syndrome. She was given the external application ointment of Example 4 of this invention, applied to Zhongwan, Shuifen, Daimai, Tianshu, and Huaroumen acupoints, 3 times a week, for 4 hours each time, for a treatment period of 12 weeks. After 3 months, her weight decreased by 4.8 kg.

[0084] Although specific embodiments of the invention have been described, those skilled in the art will recognize that various changes and modifications can be made to the invention without departing from its scope or spirit. Therefore, the invention is intended to cover all such changes and modifications falling within the scope of the appended claims and their equivalents.

[0085] The above description is merely a preferred embodiment of the present invention, and the specific embodiments described above are not intended to limit the present invention. Various modifications and variations can be made within the scope of the technical concept of the present invention. All refinements, modifications, or equivalent substitutions made by those skilled in the art based on the above description are within the scope of protection of the present invention.

Claims

1. A topical ointment for treating obesity due to spleen deficiency and dampness, characterized in that, The external ointment is formulated to treat obesity caused by spleen deficiency and dampness, using a spleen-strengthening and dampness-removing formula. This formula is prepared from the following Chinese herbs in parts by weight: lotus leaf 12-15 parts by weight, raw astragalus 10-15 parts by weight, codonopsis pilosula 10-12 parts by weight, poria cocos 10-12 parts by weight, salvia miltiorrhiza 6-8 parts by weight, tangerine peel 6-8 parts by weight, pinellia ternata 8-12 parts by weight, atractylodes lancea 8-12 parts by weight, and cinnamon twig 6-8 parts by weight.

2. The topical ointment according to claim 1, characterized in that, The spleen-strengthening and dampness-removing formula is prepared from the following Chinese herbs in parts by weight: lotus leaf 15 parts by weight, raw astragalus 10 parts by weight, codonopsis pilosula 10 parts by weight, poria cocos 10 parts by weight, salvia miltiorrhiza 6 parts by weight, tangerine peel 6 parts by weight, pinellia ternata 10 parts by weight, atractylodes lancea 10 parts by weight, and cinnamon twig 6 parts by weight.

3. The topical ointment according to any one of claims 1-2, characterized in that, The topical ointment further includes a pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient is petrolatum, and the petrolatum is present in a weight range of 70-210 parts by weight.

4. The topical ointment according to claim 3, characterized in that, The amount of petroleum jelly is 90-150 parts by weight.

5. The topical ointment according to claim 4, characterized in that, The amount of petroleum jelly is 120 parts by weight.

6. A method for preparing the topical ointment according to any one of claims 1-5, characterized in that, The preparation method includes the following steps: take the corresponding amount of each Chinese herb in the prescription, grind each Chinese herb into fine powder, mix and stir evenly, then add the prescription amount of excipients, and mix evenly again to obtain the final product.

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