Traditional Chinese medicine damp-clearing navel patch as well as preparation method and application thereof

Through water vapor distillation and ethanol reflux extraction, efficient Chinese medicine damp-removing umbilical patches were prepared, solving the problems of simple preparation technology, high sensitization risk, and uncertain efficacy in the existing technology, and achieving safe and efficient damp-removing effect.

CN119679905AInactive Publication Date: 2025-03-25THE FIRST AFFILIATED HOSPITAL OF ZHEJIANG CHINESE MEDICAL UNIVERSITY
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Patent Information

Application Number
CN202510200803.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-24
Publication Date
2025-03-25
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The existing traditional Chinese medicine anti-humid patches have simple preparation technology, high risk of skin sensitization, and uncertain efficacy.

Method used

The volatile oil and extract of medicinal materials such as moxa vermilion and abalone are extracted by steam distillation, and combined with fine powders of medicinal materials such as Muxiang and Magnolia officinalis, and extracted and concentrated by ethanol reflux to form an efficient Chinese medicine extract for removing dampness, and then mixed with Vaseline to make pills suitable for the umbilical.

Benefits of technology

It increases the concentration of effective ingredients per unit volume of Chinese medicine umbilical patches, reduces skin allergic reactions, enhances the efficacy, and the preparation method is safe and effective.

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Abstract

The invention discloses a traditional Chinese medicine damp-clearing navel patch as well as a preparation method and application thereof, and belongs to the field of traditional Chinese medicines. A pill in the navel patch is prepared from the following components in parts by weight: 10 to 30 parts of moxa, 20 to 60 parts of radix aucklandiae, 20 to 60 parts of cortex magnoliae officinalis, 20 to 60 parts of radix linderae, 5 to 20 parts of pericarpium zanthoxyli, 5 to 20 parts of cortex cinnamomi, 5 to 20 parts of flos caryophylli, 5 to 20 parts of rhizoma kaempferiae, 5 to 20 parts of herba asari and 10 to 30 parts of borneol. According to the navel patch for clearing damp, the basic treatment principle is to warm the middle warmer, promote the circulation of qi, dispel cold and clear damp. The medicine selection thought is based on the traditional Chinese medicine theory and clinical medication experience. Different from traditional prescriptions, cortex magnoliae officinalis and radix aucklandiae are used in the formula. The two medicines are selected from a cortex magnoliae officinalis middle warmer warming decoction and have the effects of promoting the circulation of qi, removing fullness, warming middle warmer and drying dampness. The moxa and the lindera aggregata are clinical experience effect medicines. In addition, pericarpium zanthoxyli, cinnamon, clove, rhizoma kaempferiae and asarum are pungent and warm medicines, and are commonly used for warming spleen and stomach for dispelling cold in traditional Chinese medicine. A plurality of medicines are combined and complement each other to achieve the effects of warming the middle warmer, promoting the circulation of qi, dispelling cold and eliminating dampness.
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Description

Technical Field

[0001] The invention relates to traditional Chinese medicine, in particular to a traditional Chinese medicine dampness-removing navel patch and a preparation method and application thereof. Background Art

[0002] There are many ways to remove dampness, which can be divided into internal treatment and external treatment. The internal treatment method mainly uses partial food or Chinese medicine to strengthen the spleen and stomach. Traditional Chinese medicine believes that the spleen is responsible for transportation and transformation, and poor transportation and transformation will lead to the internal generation of phlegm and dampness. You should try to eat less cold food. You can strengthen the spleen and remove dampness by eating sweet and slightly warm food or food that can be used as medicine, such as lean meat, Codonopsis, Chinese yam, Astragalus, and jujube soup. If the spleen is deficient and damp, the doctor can use drugs to achieve the effects of invigorating qi, strengthening the spleen and removing dampness under the doctor's syndrome differentiation and treatment. For example, patent CN202410128977.5, published on May 7, 2024, discloses a Chinese medicine composition for strengthening the spleen and removing dampness, including the following components in parts by weight: 10-18 parts by weight of arrowroot, 8-12 parts by weight of Uncaria rhynchophylla, 10-14 parts by weight of Sarcandra chinensis, 8-12 parts by weight of Hesperus rotundus, 8-14 parts by weight of Cinnamomum cassia, 9-11 parts by weight of Betula glabra, 9-13 parts by weight of glutinous rice root, 7-11 parts by weight of Acorus calamus, 8-11 parts by weight of Cinnamomum camphora, 9-13 parts by weight of Radix Angelicae Pubescentis, 11-14 parts by weight of Artemisia argyi, and 9-12 parts by weight of Aralia chinensis. External treatments such as cupping, scraping, massage, massage, fire needle, warm acupuncture, foot bath, acupoint application and other suitable Chinese medicine therapies also have a good effect on strengthening the spleen and removing dampness. Huang Xiaoqian and other scholars used warming scraping combined with acupuncture to treat cold-damp type lumbar disc herniation, effectively alleviating symptoms and greatly improving patients' comfort and clinical efficacy.

[0003] The Chinese medicine dehumidifying navel patch belongs to the category of acupoint application. It does not need to take medicine orally to achieve the effect of curing diseases. It has a wide range of applications and is easy to operate and is generally popular. There are many navel patch products on the market, which achieve various therapeutic and health-care effects through different drug ingredients and formulas. For example, Hu Xinjun et al. found that the application of warm stomach and pain-relieving ointment to the navel in the treatment of stomach pain of spleen and stomach deficiency and cold type is more effective than oral administration alone, with a shorter pain relief time and higher treatment efficiency. Wang Ruirui showed that the Guben Zhuyu patch combined with warm acupuncture and moxibustion has a better effect in the treatment of PID cold and dampness stagnation type. Although various types of dehumidifying navel patches are currently available, this type of external medicine generally has problems such as simple preparation process, skin sensitization after application, and uncertain efficacy. Based on this, the present invention provides a new Chinese medicine dehumidifying navel patch that can increase the effective ingredients of external medicine per unit volume, can more effectively strengthen the spleen and eliminate dampness, and improve various symptoms related to spleen deficiency and dampness. Summary of the invention

[0004] Purpose of the invention: The purpose of the present invention is to provide a safe and effective Chinese medicine dehumidifying navel patch and its preparation method and application.

[0005] Technical solution: A Chinese medicine dampness-removing navel patch, the pills in the navel patch include the following components by weight: 10-30 parts of moxa, 20-60 parts of costus root, 20-60 parts of magnolia bark, 20-60 parts of lindera, 5-20 parts of Sichuan pepper, 5-20 parts of cinnamon bark, 5-20 parts of cloves, 5-20 parts of galangal, 5-20 parts of asarum, and 10-30 parts of borneol.

[0006] Preferably, the pills in the navel patch specifically include the following components by weight: 20 parts of moxa, 40 parts of costus root, 40 parts of magnolia bark, 40 parts of lindera stalk, 10 parts of Sichuan pepper, 10 parts of cinnamon bark, 10 parts of cloves, 10 parts of galangal, 10 parts of asarum, and 20 parts of borneol.

[0007] Preferably, the pills in the navel patch are external preparations. The external preparation is an navel patch.

[0008] A method for preparing a Chinese medicine anti-dampness navel patch comprises the following preparation steps: S1. Weigh moxa floss according to the above weight parts, collect volatile oil by steam distillation, and obtain volatile oil A, medicinal residue A and extract A; S2. Weigh Linderae umbellatae, Sichuan pepper, cinnamon bark, cloves, galangal, and asarum according to the above weight parts, collect volatile oil by steam distillation to obtain volatile oil B and extract B; S3. Weigh costusroot, magnolia bark, and borneol according to the above weight proportions, and grind into fine powder to obtain powder C; S4, after drying the residue A, reflux extract with 60% to 90% ethanol at a concentration of 3 to 12 times the mass of the residue for 2 to 3 times, each time for 1 to 3 hours, filter, combine the ethanol extracts, recover the ethanol and concentrate to a concentrated solution A with a relative density of 1.1 to 1.3 at 65°C; S5, combining extract A and extract B, and concentrating to a concentrate B having a relative density of 1.1 to 1.3 at 65°C; S6, combining volatile oil A, volatile oil B, concentrate A, concentrate B, and powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicine extract; S7, the dehumidifying Chinese herbal extract obtained in step S6 is blended with vaseline to make pills of a size suitable for filling the umbilical depression, and then fixed with an external dressing to obtain a Chinese herbal dehumidifying umbilical patch.

[0009] Preferably, in step S4, after the residue A is dried, 8 times the mass of the residue is used for the first time to reflux extract for 2 hours, and 6 times the mass of the residue is used for the second time to reflux extract for 2 hours, filter, combine the ethanol extracts, recover the ethanol and concentrate to a concentrated solution A with a relative density of 1.2 at 65°C.

[0010] Preferably, in step S5, extract A and extract B are combined and concentrated to a concentrated solution B having a relative density of 1.2 at 65°C.

[0011] This Chinese medicine dampness-removing navel patch has a high effective concentration per unit volume, small skin allergic reaction, and is easy to use clinically. It can be used in health care and treatment products for all kinds of patients with spleen deficiency and dampness.

[0012] A method of using a traditional Chinese medicine dampness-removing navel patch is: A. Expose the patient's navel and make sure that the local skin is not damaged or red and swollen. Use a clean damp cloth to clean the navel and surrounding skin.

[0013] B. Apply the medicine to the navel and press the center of the patch appropriately to fully fill the navel with the ointment. After the patch is applied for 3-4 hours, remove it by yourself and clean the navel with a clean wet cloth or cotton swab.

[0014] C. Once a day, one course of treatment is 7 days.

[0015] The beneficial effects of the Chinese medicine anti-dampness navel patch and the preparation method thereof of the present invention are:

[0016] (1) The navel patch for removing dampness of the present invention has the basic treatment principle of warming the middle and promoting the flow of qi, dispelling cold and removing dampness. The idea of ​​drug selection is based on the theory of traditional Chinese medicine and clinical drug use experience. Different from traditional prescriptions, this prescription reuses Magnolia officinalis and costus root. These two herbs are selected from Magnolia officinalis warming middle soup, which has the effect of promoting the flow of qi and removing fullness, warming the middle and removing dampness. Artemisia argyi and Linderae sibiricum are effective herbs in clinical experience. In addition, Sichuan pepper, cinnamon bark, clove, galangal and asarum are all pungent and warm herbs, which are commonly used in traditional Chinese medicine to warm the middle and dispel cold. The combination of multiple herbs complements each other and works together to warm the middle and promote the flow of qi, dispel cold and remove dampness.

[0017] (2) The navel patch for removing dampness of the present invention comprises 9 medicinal materials including moxa, costus root, magnolia bark, lindera strychnifolia, Sichuan pepper, cinnamon bark, clove, galangal, asarum and 1 transdermal agent (borneol). The Chinese medicine comprises moxa, costus root, magnolia bark, lindera strychnifolia and Sichuan pepper as main ingredients. Costus root is pungent, bitter, warming and unblocking, with a strong aromatic aroma, and can regulate the three energizers, and mainly warms the middle, promotes qi and strengthens the spleen. lindera bark is bitter, dry, pungent and dispersing, promotes qi and relieves dampness, and can remove invisible dampness. Costus root and magnolia bark are the main ingredients, warming the middle and promoting qi, and dampness will not be generated if qi is promoted. Sichuan pepper and moxa are the auxiliary ingredients, warming the middle and dispersing cold, and stimulating the gasification function of the three energizers; lindera strychnifolia is pungent and warm to help yang, and where yang is, yin cold and dampness will retreat. The main ingredient and auxiliary ingredients are matched, warming the middle and promoting qi, dispersing cold and strengthening the spleen, and phlegm and dampness will not be generated. Borneol is pungent and cool to open the orifices, and increases the penetration of the medicine, and promotes the transdermal absorption of the Chinese medicine. The nine herbs work together and complement each other to warm the middle and promote the circulation of qi, which is like "like attracts like", greatly increasing the power to remove dampness.

[0018] (3) The preparation method of the present invention comprises extracting moxa and lindera strychnifolia, Sichuan pepper, cinnamon bark, clove, galangal, and asarum by steam distillation to collect the effective components of the medicinal materials to the greatest extent. After extracting moxa by steam distillation, the residue is refluxed for extraction and concentration, which greatly reduces the volume of the pills and allows the strong medicinal power to be condensed in the small pills. Finally, costusroot and magnolia bark are ground into fine powder and mixed with various extracts, so that they can be solidified into navel filling pills. The above-mentioned treatment methods are combined to give full play to the therapeutic value of the medicine.

[0019] (4) The present invention uses the extraction and purification technology of traditional Chinese medicine to obtain traditional Chinese medicine extracts, removes some irritating components in traditional Chinese medicine, such as alkaloids in Linderae umbellatae, and removes the toxic component aristolochic acid in Asarum, and then mixes the extract with the powder to make the medicinal properties more mild, greatly improving the safety of drug use.

[0020] (5) The pills prepared by the present invention are of a size suitable for the umbilical region and are sealed in the umbilicus by applying an external dressing. The pills with the smallest volume exert the greatest medicinal effect and have the functions of sustained release and high efficiency. The effective ingredients can act on the affected area for a long time. Compared with oral drugs, the umbilical patch has fewer side effects and adverse reactions, is relatively safe and convenient, and increases the patient's medication compliance. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A comparison chart of pills prepared by different methods.

[0022] Figure 2 This is a diagram of the allergic reaction to the navel patch. DETAILED DESCRIPTION

[0023] In order to make the technical solution of the present invention clearer, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0024] Example 1

[0025] A Chinese medicine dampness-removing navel patch, wherein the pills in the navel patch comprise the following components by weight: 10 parts of moxa, 20 parts of costusroot, 20 parts of magnolia bark, 20 parts of lindera, 5 parts of Sichuan pepper, 5 parts of cinnamon bark, 5 parts of cloves, 5 parts of galangal, 5 parts of asarum, and 10 parts of borneol.

[0026] The preparation method of the Chinese medicine dampness-removing navel patch comprises: (i) Weigh moxa according to the above weight proportions, collect volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A; (ii) Weigh Linderae umbellatae, Sichuan pepper, cinnamon bark, cloves, galangal, and asarum according to the above weight proportions, and collect volatile oils by steam distillation to obtain volatile oil B and extract B; (III) Weigh costusroot, magnolia bark, and borneol according to the above weight proportions, and grind into fine powder to obtain drug powder C; (IV) After the residue A is dried, 60% ethanol with a concentration of 3 times the mass of the residue is used for reflux extraction for 1 hour, and 60% ethanol with a concentration of 5 times the mass of the residue is used for reflux extraction for 1 hour. The ethanol extracts are combined, and the ethanol is recovered and concentrated to a concentrated solution A with a relative density of 1.1 at 65°C; (V) Combine extract A and extract B and concentrate to a concentrate B having a relative density of 1.1 at 65°C; (VI) combining volatile oil A, volatile oil B, concentrated solution A, concentrated solution B, and medicinal powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicinal extract; (VII) The dehumidifying Chinese herbal extract obtained in step (VI) is blended with vaseline to form pills of a size suitable for filling the umbilical depression, and then fixed with an external dressing to obtain a Chinese herbal dehumidifying umbilical patch.

[0027] Example 2 A Chinese medicine navel patch for removing dampness, wherein the pills in the navel patch comprise the following components by weight: 20 parts of moxa, 40 parts of costusroot, 40 parts of magnolia bark, 40 parts of lindera, 10 parts of Sichuan pepper, 10 parts of cinnamon bark, 10 parts of cloves, 10 parts of galangal, 10 parts of asarum, and 20 parts of borneol.

[0028] The preparation method of the Chinese medicine dampness-removing navel patch comprises: (i) Weigh moxa according to the above weight proportions, collect volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A; (ii) Weigh Linderae umbellatae, Sichuan pepper, cinnamon bark, cloves, galangal, and asarum according to the above weight proportions, and collect volatile oils by steam distillation to obtain volatile oil B and extract B; (III) Weigh costusroot, magnolia bark, and borneol according to the above weight proportions, and grind into fine powder to obtain drug powder C; (IV) After the residue A is dried, 8 times the mass of the residue is used for extraction under reflux for 2 h, and 6 times the mass of the residue is used for extraction under reflux for 2 h. The ethanol extracts are combined, and the ethanol is recovered and concentrated to a concentrated solution A with a relative density of 1.2 at 65°C. (V) Combine extract A and extract B and concentrate to a concentrate B having a relative density of 1.2 at 65°C; (VI) combining volatile oil A, volatile oil B, concentrated solution A, concentrated solution B, and medicinal powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicinal extract; (VII) The dehumidifying Chinese medicine extract obtained in step (VI) is blended with vaseline to form a pill with a diameter of about 0.8 cm suitable for filling the umbilical depression, with a smooth surface, such as Figure 1 As shown in (b) in the figure, the Chinese medicine dampness-removing navel patch can be obtained by applying and fixing it with an external dressing.

[0029] Among them, steps (i) to (vi) are all used for purification and desensitization. The active ingredients in traditional Chinese medicine are extracted and the possible allergenic ingredients are removed, thereby achieving purification and desensitization of the medicine.

[0030] Example 3

[0031] A Chinese medicine dampness-removing navel patch, wherein the pills in the navel patch comprise the following components by weight: 25 parts of moxa, 50 parts of costusroot, 40 parts of magnolia bark, 50 parts of lindera, 10 parts of Sichuan pepper, 15 parts of cinnamon bark, 10 parts of cloves, 20 parts of galangal, 15 parts of asarum, and 20 parts of borneol.

[0032] The preparation method of the Chinese medicine dampness-removing navel patch comprises: (i) Weigh moxa according to the above weight proportions, collect volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A; (ii) Weigh Linderae umbellatae, Sichuan pepper, cinnamon bark, cloves, galangal, and asarum according to the above weight proportions, and collect volatile oils by steam distillation to obtain volatile oil B and extract B; (III) Weigh costusroot, magnolia bark, and borneol according to the above weight proportions, and grind into fine powder to obtain drug powder C; (IV) After the residue A is dried, 60% ethanol with a concentration of 3 times the mass of the residue is used for reflux extraction for 1 hour, and 60% ethanol with a concentration of 5 times the mass of the residue is used for reflux extraction for 1 hour. The ethanol extracts are combined, and the ethanol is recovered and concentrated to a concentrated solution A with a relative density of 1.1 at 65°C; (V) Combine extract A and extract B and concentrate to a concentrate B having a relative density of 1.1 at 65°C; (VI) combining volatile oil A, volatile oil B, concentrated solution A, concentrated solution B, and medicinal powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicinal extract; (VII) The dehumidifying Chinese herbal extract obtained in step (VI) is blended with vaseline to form pills of a size suitable for filling the umbilical depression, and then fixed with an external dressing to obtain a Chinese herbal dehumidifying umbilical patch.

[0033] Example 4

[0034] A Chinese medicine navel patch for removing dampness, wherein the pills in the navel patch comprise the following components by weight: 30 parts of moxa, 60 parts of costusroot, 60 parts of magnolia bark, 60 parts of lindera, 20 parts of Sichuan pepper, 20 parts of cinnamon bark, 20 parts of cloves, 20 parts of galangal, 20 parts of asarum, and 30 parts of borneol.

[0035] The preparation method of the Chinese medicine dampness-removing navel patch comprises: (i) Weigh moxa according to the above weight proportions, collect volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A; (ii) Weigh Linderae umbellatae, Sichuan pepper, cinnamon bark, cloves, galangal, and asarum according to the above weight proportions, and collect volatile oils by steam distillation to obtain volatile oil B and extract B; (III) Weigh costusroot, magnolia bark, and borneol according to the above weight proportions, and grind into fine powder to obtain drug powder C; (IV) After the residue A is dried, 90% ethanol with a concentration of 12 times the mass of the residue is used for reflux extraction for 3 h for the first time, and 90% ethanol with a concentration of 10 times the mass of the residue is used for reflux extraction for 3 h for the second time, and the ethanol extracts are combined, and the ethanol is recovered and concentrated to a concentrated solution A with a relative density of 1.3 at 65°C; (V) Combine extract A and extract B and concentrate to a concentrate B having a relative density of 1.3 at 65°C; (VI) combining volatile oil A, volatile oil B, concentrated solution A, concentrated solution B, and medicinal powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicinal extract; (VII) The dehumidifying Chinese herbal extract obtained in step (VI) is blended with vaseline to form pills of a size suitable for filling the umbilical depression, and then fixed with an external dressing to obtain a Chinese herbal dehumidifying umbilical patch.

[0036] Comparative Example 1 The difference between Comparative Example 1 and Example 1 is that the raw materials of moxa differ by 10 parts, costus root differ by 20 parts, magnolia bark differ by 20 parts, lindera strychnifolia differ by 20 parts, cinnamon differ by 5 parts, clove differ by 5 parts, and borneol differ by 10 parts; and also differ by 5 parts of galangal, 5 parts of asarum, and 5 parts of Sichuan pepper, as follows: A Chinese medicine navel patch for removing dampness, wherein the pills in the navel patch comprise the following components by weight: 20 parts of moxa, 40 parts of costusroot, 40 parts of magnolia bark, 40 parts of lindera striata, 10 parts of cinnamon bark, 10 parts of cloves and 20 parts of borneol.

[0037] The preparation method of the Chinese medicine dampness-removing navel patch comprises: (i) Weigh moxa according to the above weight proportions, collect volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A; (ii) Weigh Linderae umbellatae, cinnamon bark and cloves according to the above weight proportions, collect volatile oils by steam distillation to obtain volatile oil B and extract B; (III) Weigh costusroot, magnolia bark, and borneol according to the above weight proportions, and grind into fine powder to obtain drug powder C; (IV) After the residue A is dried, 8 times the mass of the residue is used for extraction under reflux for 2 h, and 6 times the mass of the residue is used for extraction under reflux for 2 h. The ethanol extracts are combined, and the ethanol is recovered and concentrated to a concentrated solution A with a relative density of 1.2 at 65°C. (V) Combine extract A and extract B and concentrate to a concentrate B having a relative density of 1.2 at 65°C; (VI) combining volatile oil A, volatile oil B, concentrated solution A, concentrated solution B, and medicinal powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicinal extract; (VII) The dehumidifying Chinese medicine extract obtained in step (VI) is blended with vaseline to form a pill with a diameter of about 0.8 cm suitable for filling the umbilical depression, with a smooth surface, such as Figure 1 As shown in (b) in the figure, the Chinese medicine dampness-removing navel patch can be obtained by applying and fixing it with an external dressing.

[0038] Comparative Example 2

[0039] The difference between Comparative Example 2 and Example 1 is that the raw material moxa differs by 10 parts, magnolia bark differs by 20 parts, lindera strychnifolia differs by 20 parts, Sichuan pepper differs by 5 parts, cinnamon differs by 5 parts, cloves differ by 5 parts, galangal differs by 5 parts, asarum differs by 5 parts, and there is also a difference of borneol 10 parts and costus root 20 parts, as follows: A Chinese medicine navel patch for removing dampness, wherein the pills in the navel patch comprise the following components by weight: 20 parts of moxa, 40 parts of magnolia bark, 40 parts of lindera striata, 10 parts of Sichuan pepper, 10 parts of cinnamon bark, 10 parts of cloves, 10 parts of galangal, and 10 parts of asarum.

[0040] The preparation method of the Chinese medicine dampness-removing navel patch comprises: (i) Weigh moxa according to the above weight proportions, collect volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A; (ii) Weigh Linderae umbellatae, Sichuan pepper, cinnamon bark, cloves, galangal, and asarum according to the above weight proportions, and collect volatile oils by steam distillation to obtain volatile oil B and extract B; (III) Weigh Magnolia officinalis according to the above weight proportions and grind into fine powder to obtain medicinal powder C; (IV) After the residue A is dried, 8 times the mass of the residue is used for extraction under reflux for 2 h, and 6 times the mass of the residue is used for extraction under reflux for 2 h. The ethanol extracts are combined, and the ethanol is recovered and concentrated to a concentrated solution A with a relative density of 1.2 at 65°C. (V) Combine extract A and extract B and concentrate to a concentrate B having a relative density of 1.2 at 65°C; (VI) combining volatile oil A, volatile oil B, concentrated solution A, concentrated solution B, and medicinal powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicinal extract; (VII) The dehumidifying Chinese medicine extract obtained in step (VI) is blended with vaseline to form a pill with a diameter of about 0.8 cm suitable for filling the umbilical depression, with a smooth surface, such as Figure 1 As shown in (b) in the figure, the Chinese medicine dampness-removing navel patch can be obtained by applying and fixing it with an external dressing.

[0041] Comparative Example 3 A Chinese medicine navel patch for removing dampness, wherein the pills in the navel patch comprise the following components by weight: 20 parts of raw liquorice.

[0042] The preparation method of the Chinese medicine damp-removing navel patch comprises: weighing the above raw materials by weight, grinding them into fine powder, mixing them with vaseline, and making them into pills with a diameter of about 1.5 cm suitable for filling the navel depression, and then applying and fixing them with an external dressing to obtain the Chinese medicine damp-removing navel patch.

[0043] Comparative Example 4

[0044] The difference between Comparative Example 4 and Example 1 is that the raw materials of moxa differ by 10 parts, costus root differ by 20 parts, magnolia bark differ by 20 parts, lindera strychnifolia differ by 20 parts, Sichuan pepper differ by 5 parts, cinnamon differ by 5 parts, clove differ by 5 parts, galangal differ by 5 parts, asarum differ by 5 parts, and borneol differ by 10 parts, as follows: A Chinese medicine navel patch for removing dampness, wherein the pills in the navel patch comprise the following components by weight: 20 parts of moxa, 40 parts of costusroot, 40 parts of magnolia bark, 40 parts of lindera, 10 parts of Sichuan pepper, 10 parts of cinnamon bark, 10 parts of cloves, 10 parts of galangal, 10 parts of asarum, and 20 parts of borneol.

[0045] The preparation method of the Chinese medicine dampness-removing navel patch comprises: weighing the above raw materials by weight, grinding them into fine powder, mixing them with vaseline, and making them into pills with a diameter of about 1.5 cm suitable for filling the navel depression, with a rough surface and obvious fiber feeling, such as Figure 1 As shown in (a) in the figure, the Chinese medicine dampness-removing navel patch can be obtained by applying and fixing it with an external dressing.

[0046] Comparative Example 5 The difference between Comparative Example 5 and Example 1 is that the raw materials of moxa differ by 5 parts, costus root differ by 5 parts, magnolia bark differ by 5 parts, lindera striata differ by 10 parts, Sichuan pepper differ by 3 parts, cinnamon differ by 3 parts, clove differ by 3 parts, galangal differ by 2 parts, asarum differ by 2 parts, and borneol differ by 5 parts, as follows: A Chinese medicine navel patch for removing dampness, wherein the pills in the navel patch comprise the following components by weight: 5 parts of moxa, 15 parts of costusroot, 15 parts of magnolia bark, 10 parts of lindera, 2 parts of Sichuan pepper, 2 parts of cinnamon bark, 2 parts of cloves, 3 parts of galangal, 3 parts of asarum, and 5 parts of borneol.

[0047] The preparation method of the Chinese medicine dampness-removing navel patch comprises: (i) Weigh moxa according to the above weight proportions, collect volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A; (ii) Weigh Linderae umbellatae, Sichuan pepper, cinnamon bark, cloves, galangal, and asarum according to the above weight proportions, and collect volatile oils by steam distillation to obtain volatile oil B and extract B; (III) Weigh costusroot, magnolia bark, and borneol according to the above weight proportions, and grind into fine powder to obtain drug powder C; (IV) After the residue A is dried, 8 times the mass of the residue is used for extraction under reflux for 2 h, and 6 times the mass of the residue is used for extraction under reflux for 2 h. The ethanol extracts are combined, and the ethanol is recovered and concentrated to a concentrated solution A with a relative density of 1.2 at 65°C. (V) Combine extract A and extract B and concentrate to a concentrate B having a relative density of 1.2 at 65°C; (VI) combining volatile oil A, volatile oil B, concentrated solution A, concentrated solution B, and medicinal powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicinal extract; (VII) The dehumidifying Chinese medicine extract obtained in step (VI) is blended with vaseline to form a pill with a diameter of about 0.8 cm suitable for filling the umbilical depression, with a smooth surface, such as Figure 1 As shown in (b) in the figure, the Chinese medicine dampness-removing navel patch can be obtained by applying and fixing it with an external dressing.

[0048] Comparative Example 6 The difference between Comparative Example 6 and Example X is that the raw materials of moxa differ by 30 parts, costus root differ by 45 parts, magnolia bark differ by 45 parts, lindera striata differ by 50 parts, Sichuan pepper differ by 25 parts, cinnamon differ by 25 parts, clove differ by 20 parts, galangal differ by 20 parts, asarum differ by 15 parts, and borneol differ by 30 parts, as follows: A Chinese medicine navel patch for removing dampness, wherein the pills in the navel patch comprise the following components by weight: 40 parts of moxa, 65 parts of costusroot, 65 parts of magnolia bark, 70 parts of lindera, 30 parts of Sichuan pepper, 30 parts of cinnamon bark, 25 parts of cloves, 25 parts of galangal, 20 parts of asarum, and 40 parts of borneol.

[0049] The preparation method of the Chinese medicine dampness-removing navel patch comprises: (i) Weigh moxa according to the above weight proportions, collect volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A; (ii) Weigh Linderae umbellatae, Sichuan pepper, cinnamon bark, cloves, galangal, and asarum according to the above weight proportions, and collect volatile oils by steam distillation to obtain volatile oil B and extract B; (III) Weigh costusroot, magnolia bark, and borneol according to the above weight proportions, and grind into fine powder to obtain drug powder C; (IV) After the residue A is dried, 8 times the mass of the residue is used for extraction under reflux for 2 h, and 6 times the mass of the residue is used for extraction under reflux for 2 h. The ethanol extracts are combined, and the ethanol is recovered and concentrated to a concentrated solution A with a relative density of 1.2 at 65°C. (V) Combine extract A and extract B and concentrate to a concentrate B having a relative density of 1.2 at 65°C; (VI) combining volatile oil A, volatile oil B, concentrated solution A, concentrated solution B, and medicinal powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicinal extract; (VII) The dehumidifying Chinese medicine extract obtained in step (VI) is blended with vaseline to form a pill with a diameter of about 0.8 cm suitable for filling the umbilical depression, with a smooth surface, such as Figure 1 As shown in (b) in the figure, the Chinese medicine dampness-removing navel patch can be obtained by applying and fixing it with an external dressing.

[0050] Clinical trials 1. Materials and methods 1.1. Source of cases A total of 90 patients who met the inclusion criteria were selected from hospital outpatient clinics.

[0051] 1.2 Diagnostic criteria 1.2.1. Western medicine diagnostic criteria: BMI exceeds 24 kg / m 2 .

[0052] 1.2.2. Standards for determining TCM syndromes: If all the main symptoms and one or more secondary symptoms are present, it can be determined as spleen deficiency and dampness obstruction syndrome. Main symptoms: ① obesity; ② fatigue and weakness. Secondary symptoms: ① heaviness of limbs; ② abdominal distension and poor appetite; ③ tooth marks on the sides of the tongue, and the coating is either thin or greasy; ④ deep, thin or moist pulse.

[0053] 1.3 Inclusion criteria ① Meet the above diagnostic criteria; ② Regardless of gender, age 18-70 years old; ③ No related drug treatment has been used in the past 6 months.

[0054] 1.4. Discharge Standards ① Patients with severe metabolic disorders; ② Patients with severe primary diseases or mental illnesses; ③ Women who are pregnant, preparing to become pregnant, or breastfeeding; ④ Patients with severe skin allergies.

[0055] 1.5 General Information All patients were admitted to the acupuncture outpatient department of the hospital from July 2024 to October 2024, with a total of 120 cases. They were divided into three groups according to the random number table method, with 40 cases in each group. Treatment group 1: 17 males and 23 females; the average age was (32.03±8.67) years old; the average BMI was (31.32±3.43) kg / m. Treatment group 2: 19 males and 21 females; the average age was (35.04±6.47) years old; the average BMI was (30.21±4.53) kg / m; the control group had 19 males and 21 females; the average age was (31.37±6.25) years old; the average BMI was (30.88±3.14) kg / m. There was no significant difference in the baseline indicators among the three groups ( P >0.05).

[0056] 2. Test methods The experiment was divided into three groups. Treatment Group 1 was divided into two parts, one part used the navel patch made in Comparative Example 4, and the other part used the navel patch made in Comparative Example 6; Treatment Group 2 was divided into four parts, each using the navel patch made in Examples 1 to 4; The control group was divided into four parts, each using the navel patch made in Comparative Examples 1 to 3 and 5. The method of use was the same for the three groups: apply the drug to the navel, and press the center of the patch appropriately to fully fill the ointment into the navel, and fix it with a non-woven breathable patch. After the patch is maintained for 4 hours, it can be removed by itself, and the navel can be cleaned with a clean wet cloth or cotton swab; once a day, 3-4 hours each time, and 7 days is a course of treatment. Two courses of treatment.

[0057] 3. Observation indicators The TCM syndrome score was scored before treatment and after two courses of treatment, including five symptoms: fatigue, poor appetite, abdominal distension, heaviness of limbs, tooth marks on the sides of the tongue, and deep or weak pulse. Each symptom was divided into four levels: none (0 points), mild (3 points), moderate (6 points), and severe (9 points).

[0058] 4. Evaluation of allergy rate The three groups of skin around the navel were observed after application. If redness or itching occurred, it was considered an allergy. Figure 2 The allergy rate of each group is shown in Table 1. Allergy rate = (number of allergic people / total number of people) × 100%.

[0059] The mechanism of desensitization is to extract the active ingredients in traditional Chinese medicine and remove the possible allergenic ingredients, thereby achieving drug purification and desensitization. The data is calculated by combining symptoms with formulas. Through the purification step, a large class of possible allergenic ingredients in the components are removed, thereby achieving desensitization.

[0060] Table 1 Allergy status

[0061] 5. Statistical methods SPSS 29.0 was used for statistical analysis. Measurement data were expressed as (x±s), and count data were expressed as rates. Multiple groups of measurement data met the normal distribution and variance homogeneity. One-way ANOVA was used for inter-group comparison, and paired t-test was used for intra-group comparison. The significance test level was P <0.05. The statistical results are shown in Table 2.

[0062] Table 2 Comparison of TCM syndrome scores among three groups of patients (points, x±s)

[0063] Note: Compared with the group before treatment, * P <0.05; compared with the control group after treatment, #P <0.05; compared with the treatment group 1, △ P <0.05.

[0064] 6. Results Compared with the same group before treatment, the fatigue, heaviness of limbs, poor appetite and abdominal distension scores of the two treatment groups were significantly improved after treatment ( P <0.05); after treatment, all TCM symptom scores of the two treatment groups were significantly lower than those of the control group ( P <0.05); the symptom scores of treatment group 2 and treatment group 1 after treatment were compared, and the scores of fatigue, weakness and limb heaviness were significantly lower than those of the control group ( P <0.05), poor appetite, abdominal distension, tongue tooth marks, and deep and thin pulse or wet pulse mean values ​​in treatment group 2 were lower than those in treatment group 1, with no significant difference. At the same time, compared with the control group, the allergy rate in treatment group 2 was lower than that in treatment group 1 and the control group. Therefore, the Chinese medicine dehumidifying navel patch prepared by the present invention not only has good efficacy, but also has a more mild medicinal property, greatly improving the safety of drug use. And by Figure 1 It can be seen that the purification method of the present invention can make the volume of the pill smaller, make the navel patch more suitable for use, and make the pill less squeezing the navel, making it more comfortable to use. Since the Chinese medicine dampness-removing navel patch has a high effective concentration per unit volume, a small skin allergic reaction, and is convenient for clinical application, it can be used in the health care and treatment of various patients with spleen deficiency and dampness.

[0065] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A Chinese medicine dampness-removing navel patch, characterized in that: The pills in the navel patch include the following components by weight: 10-30 parts of moxa, 20-60 parts of costusroot, 20-60 parts of magnolia bark, 20-60 parts of lindera, 5-20 parts of Sichuan pepper, 5-20 parts of cinnamon bark, 5-20 parts of cloves, 5-20 parts of galangal, 5-20 parts of asarum, and 10-30 parts of borneol.

2. The Chinese medicine anti-dampness navel patch according to claim 1, characterized in that: The pills in the navel patch specifically include the following components by weight: 20 parts of moxa, 40 parts of costus root, 40 parts of magnolia bark, 40 parts of lindera stalk, 10 parts of Sichuan pepper, 10 parts of cinnamon bark, 10 parts of cloves, 10 parts of galangal, 10 parts of asarum, and 20 parts of borneol.

3. A method for preparing the Chinese medicine anti-dampness navel patch according to any one of claims 1 to 2, characterized in that: The method comprises the following preparation steps: S1. Weigh moxa floss according to the above weight proportions, collect volatile oil, and obtain volatile oil A, medicinal residue A and extract A; S2. Weigh Linderae umbellatae, Sichuan pepper, cinnamon bark, cloves, galangal, and asarum according to the above weight proportions, collect volatile oils, and obtain volatile oil B and extract B; S3. Weigh costusroot, magnolia bark, and borneol according to the above weight proportions, and grind into fine powder to obtain powder C; S4, drying the residue A, extracting it with ethanol reflux, filtering, combining the ethanol extracts, recovering the ethanol and concentrating it to obtain a concentrated solution A; S5, combining extract A and extract B, and concentrating them to obtain concentrated solution B; S6, combining volatile oil A, volatile oil B, concentrate A, concentrate B, and powder C, and mixing them thoroughly to obtain a dehumidifying Chinese medicine extract; S7, the dehumidifying Chinese herbal extract obtained in step S6 is blended with vaseline to make pills of a size suitable for filling the umbilical depression, and then fixed with an external dressing to obtain a Chinese herbal dehumidifying umbilical patch.

4. The method for preparing the Chinese medicine anti-dampness navel patch according to claim 3, characterized in that: In step S4, 60% to 90% ethanol with a concentration of 3 to 12 times the mass of the medicinal residue is used for reflux extraction 2 to 3 times, each time for 1 to 3 hours, filtered, the ethanol extracts are combined, the ethanol is recovered and concentrated to obtain a concentrated solution A.

5. The method for preparing the Chinese medicine anti-dampness navel patch according to claim 4, characterized in that: When ethanol is recovered and concentrated, it is concentrated to 65°C to obtain concentrated solution A.

6. The method for preparing the Chinese medicine anti-dampness navel patch according to claim 5, characterized in that: The relative density of concentrated liquid A is 1.1~1.

3.

7. The method for preparing the Chinese medicine anti-dampness navel patch according to claim 6, characterized in that: The first time, 8 times the mass of the medicinal residue was used for reflux extraction with 75% ethanol at a concentration of 2h, and the second time, 6 times the mass of the medicinal residue was used for reflux extraction with 75% ethanol at a concentration of 2h. The extracts were filtered, the ethanol extracts were combined, the ethanol was recovered and concentrated to a concentrated solution A with a relative density of 1.2 at 65°C.

8. The method for preparing the Chinese medicine anti-dampness navel patch according to claim 3, characterized in that: In step S5, after the extract A and the extract B are combined, they are concentrated to 65° C. to obtain a concentrated solution B with a relative density of 1.1 to 1.

3.

9. The method for preparing the Chinese medicine anti-dampness navel patch according to claim 3, characterized in that: Both volatile oil A and volatile oil B are obtained by steam distillation.

10. The Chinese medicine dehumidifying navel patch prepared according to the preparation method of the Chinese medicine dehumidifying navel patch according to any one of claims 4 to 9, characterized in that: The navel patch is used in health care and treatment products for patients with various types of spleen deficiency and dampness.

Citation Information

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