A stomach-warming and analgesic external application composition and a stomach-warming and analgesic plaster and preparation method thereof

Abstract

The present invention relates to the technical field of traditional Chinese medicine. The present invention provides a stomach-warming and analgesic external application composition, a stomach-warming and analgesic plaster, and a preparation method. The stomach-warming and analgesic external application composition comprises the following components in parts by weight: 10-40 parts of mugwort leaf, 10-40 parts of raw Chuanwu (Aconiti Radix), 10-40 parts of raw Kusnezoffii (Aconiti Kusnezoffii), 10-40 parts of cinnamon twig, 10-40 parts of mulberry twig, 10-40 parts of Achyranthes bidentata (Achyranthes bidentata), 10-40 parts of papaya (Fructus Caryophylli), 10-40 parts of roasted frankincense, 10-40 parts of roasted myrrh, 10-40 parts of clematis root, 10-40 parts of Qiannianjian (Aconite Herb), 10-40 parts of Zanthoxylum bungeanum, and 10-40 parts of Chuanxiong (Ligusticum chuanxiong). The stomach-warming and analgesic plaster of the present invention has the effects of strengthening the spleen and warming the middle, removing dampness and cold, nourishing the heart and calming the mind through the synergistic effect of various raw materials, and treats epigastric pain, epigastric fullness, insomnia and the accompanying anxiety, depression, fatigue, neurasthenia and the like caused by chronic gastritis from multiple perspectives.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a stomach-warming and analgesic external application composition and a stomach-warming and analgesic plaster and a preparation method thereof. Background Art

[0002] Chronic gastritis is a common disease of the digestive system. It is caused by various reasons and includes different types of gastric mucosal lesions. It is divided into chronic superficial gastritis and chronic atrophic gastritis. Its onset is often related to Helicobacter pylori infection, viruses, or irritants. Chronic gastritis has a long course and is prone to recurring attacks, affecting the patient's life, work quality, mood, and sleep. The difficulty in treating this disease lies in its chronicity, long treatment time, long medication duration, poor patient compliance, changes in gastric mucosal morphology, repeated Helicobacter pylori infection, difficulty in controlling bile reflux, and depression affecting the course of the disease.

[0003] Acupoint application therapy is documented in medical texts such as "The Book of Zhou: Heavenly Officials," "Fifty-two Prescriptions for Diseases," "The Yellow Emperor's Classic of Internal Medicine," and "Liu Juanzi's Guiyi Prescriptions." The publication of "Lihua Pianwen" significantly promoted the development of external plasters. Acupoint application is based on the theory of meridians and acupoints in Traditional Chinese Medicine. Acupoint application involves mixing Chinese herbs or herbal extracts with a suitable matrix and a transdermal absorption enhancer to create a suitable dosage form, which is then applied to acupoints on the body. Traditional Chinese medicine considers acupoints to be specialized sites on the body's surface, while meridians are effective pathways connecting the body's internal and external environments. Through these connections, the body becomes an organic whole, interconnected by its various parts and functions, nourishing the entire body. Through the combined effects of medication, acupoint stimulation, and meridian conduction, it can significantly improve the circulation of Qi and blood, allowing the active ingredients of medications to reach the relevant internal organs and maintain a sustained release, resulting in a strong pharmacological effect. Modern medicine believes that acupuncture points have a thinner stratum corneum, more hair follicles, and richer nerve and blood vessel endings than non-acupuncture points. They have exogenous sensitivity and amplification effects, and have unique physiological functions, which can produce effects that cannot be achieved by non-acupuncture drug administration. Experiments have shown that acupuncture points are superior to non-acupuncture points in terms of drug penetration, absorption, and storage. Its advantages are that the drug reaches the lesion directly, with little toxic and side effects, a long drug release time, and reduced deficiencies of oral administration. It is safe, economical, easy to operate, and has a definite effect. Therefore, it is particularly important to provide a stomach-warming and analgesic plaster for the treatment of common digestive system diseases such as chronic gastritis. Summary of the Invention

[0004] The purpose of the present invention is to provide a stomach-warming and analgesic external application composition and a stomach-warming and analgesic plaster and a preparation method, which can stimulate meridian qi through acupoint stimulation, adjust the yin and yang balance of the spleen and stomach organs, and achieve the purpose of strengthening the spleen and stomach, harmonizing the stomach and relieving pain.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The invention provides a stomach-warming and analgesic external application composition, which comprises the following components in parts by mass: 10-40 parts of mugwort leaves, 10-40 parts of raw Chuanwu, 10-40 parts of raw Caowu, 10-40 parts of cinnamon twigs, 10-40 parts of mulberry branches, 10-40 parts of Liujienu, 10-40 parts of Chuanxiong, 10-40 parts of papaya, 10-40 parts of roasted frankincense, 10-40 parts of roasted myrrh, 10-40 parts of clematis root, 10-40 parts of Qianqianjian, 10-40 parts of Zanthoxylum bungeanum, and 10-40 parts of Chuanxiong.

[0007] Preferably, the composition includes the following components in parts by mass: 30 parts of mugwort, 10 parts of raw Chuanwu, 10 parts of raw Caowu, 20 parts of cinnamon twig, 20 parts of mulberry twig, 20 parts of Liujienu, 10 parts of Chuanxiong, 10 parts of papaya, 10 parts of roasted frankincense, 10 parts of roasted myrrh, 10 parts of Clematidis, 10 parts of Qiannianjian, 10 parts of Zanthoxylum bungeanum, and 10 parts of Chuanxiong.

[0008] The present invention also provides a preparation method of the stomach-warming and analgesic external application composition, comprising the following steps: grinding mugwort leaves, raw Chuanwu, raw Caowu, cinnamon twigs, mulberry branches, Liujienu, Chuanxiong, papaya, roasted frankincense, roasted myrrh, clematis root, Qiannianjian, Zanthoxylum bungeanum, and Chuanxiong into powder, sieving, and mixing to obtain the stomach-warming and analgesic composition.

[0009] Preferably, the mesh size of the sieve during the sieving is 90 to 110 meshes.

[0010] The present invention also provides the use of the composition in preparing a stomach-warming and analgesic plaster.

[0011] The present invention also provides a stomach-warming and analgesic plaster, which comprises the composition.

[0012] The present invention also provides a method for preparing the stomach-warming and analgesic plaster, comprising the following steps:

[0013] (1) Grind mugwort leaf, raw Chuanwu, raw Caowu, cinnamon twig, mulberry twig, Liujinu, Chuanxiong, papaya, roasted frankincense, roasted myrrh, clematis root, Qiannianjian, Zanthoxylum bungeanum, and Chuanxiong into powder, sieve, and obtain a mixed material;

[0014] (2) The mixed material is mixed with the auxiliary material to obtain an intermediate, which is blended into a lump to obtain the stomach-warming and analgesic plaster.

[0015] Preferably, the mesh size of the sieve during sieving in step (1) is 90 to 110 meshes;

[0016] The mass ratio of the mixed material to the auxiliary material in step (2) is 1-2:1-2;

[0017] The auxiliary materials in step (2) include a transdermal absorption enhancer, an excipient and a preservative.

[0018] Preferably, the percutaneous absorption enhancer is 1.5-2.5% of azone and 0.05-0.15% of menthol, based on the mass of the intermediate;

[0019] When the menthol is used, the menthol needs to be ground into powder and passed through a 90-110 mesh sieve.

[0020] Preferably, the excipients are 20-30% of honey, 3-7% of sodium carboxymethylcellulose, 8-12% of propylene glycol, 1-3% of polyethylene glycol-1000 and 2-4% of polyethylene glycol-4000, accounting for 20-30% of the mass of the intermediate;

[0021] The preservatives are 0.1-0.3% of methylparaben and 0.2-0.4% of ethylparaben based on the mass of the intermediate.

[0022] The present invention provides a stomach-warming and analgesic external application composition and a stomach-warming and analgesic plaster and a preparation method. The stomach-warming and analgesic external application composition comprises the following components in parts by weight: 10-40 parts of mugwort leaf, 10-40 parts of raw Chuanwu, 10-40 parts of raw Caowu, 10-40 parts of cinnamon twig, 10-40 parts of mulberry branch, 10-40 parts of Liujienu, 10-40 parts of Chuanxiong, 10-40 parts of papaya, 10-40 parts of roasted frankincense, 10-40 parts of roasted myrrh, 10-40 parts of clematis root, 10-40 parts of Qianqianjian, 10-40 parts of Zanthoxylum bungeanum, and 10-40 parts of Chuanxiong. The stomach-warming and analgesic plaster of the present invention has the effects of strengthening the spleen and warming the middle, dispelling dampness and cold, nourishing the heart and calming the mind, etc. through the synergistic effect of the raw materials, and treats insomnia caused by chronic gastritis and its associated anxiety, depression, fatigue, neurasthenia, etc. from multiple perspectives. The stomach-warming and analgesic plaster of the present invention can increase the local drug concentration by directly applying it to acupuncture points, which is beneficial to the transdermal absorption of drug components. It can also stimulate the meridian qi through acupuncture point stimulation, adjust the yin and yang balance of the spleen and stomach organs, and achieve the purpose of strengthening the spleen and stomach, harmonizing the stomach and relieving pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 Diagram of the structure of the plaster for warming the stomach and relieving pain. DETAILED DESCRIPTION

[0024] The invention provides a stomach-warming and analgesic external application composition, which comprises the following components in parts by mass: 10-40 parts of mugwort leaves, 10-40 parts of raw Chuanwu, 10-40 parts of raw Caowu, 10-40 parts of cinnamon twigs, 10-40 parts of mulberry branches, 10-40 parts of Liujienu, 10-40 parts of Chuanxiong, 10-40 parts of papaya, 10-40 parts of roasted frankincense, 10-40 parts of roasted myrrh, 10-40 parts of clematis root, 10-40 parts of Qianqianjian, 10-40 parts of Zanthoxylum bungeanum, and 10-40 parts of Chuanxiong.

[0025] In the present invention, the composition includes the following components in parts by mass: 30 parts of mugwort leaves, 10 parts of raw Chuanwu, 10 parts of raw Caowu, 20 parts of cinnamon twigs, 20 parts of mulberry branches, 20 parts of Liujienu, 10 parts of Chuanxiong, 10 parts of papaya, 10 parts of roasted frankincense, 10 parts of roasted myrrh, 10 parts of Clematidis, 10 parts of Qianqianjian, 10 parts of Zanthoxylum bungeanum, and 10 parts of Chuanxiong.

[0026] The present invention also provides a preparation method of the stomach-warming and analgesic external application composition, comprising the following steps: grinding mugwort leaves, raw Chuanwu, raw Caowu, cinnamon twigs, mulberry branches, Liujienu, Chuanxiong, papaya, roasted frankincense, roasted myrrh, clematis root, Qiannianjian, Zanthoxylum bungeanum, and Chuanxiong into powder, sieving, and mixing to obtain the stomach-warming and analgesic composition.

[0027] In the present invention, the mesh number of the sieve during the sieving is preferably 90 to 110 meshes, more preferably 100 meshes.

[0028] The present invention also provides the use of the composition in preparing a stomach-warming and analgesic plaster.

[0029] The present invention also provides a stomach-warming and analgesic plaster, which comprises the composition.

[0030] The present invention also provides a method for preparing the stomach-warming and analgesic plaster, comprising the following steps:

[0031] (1) Grind mugwort leaf, raw Chuanwu, raw Caowu, cinnamon twig, mulberry twig, Liujinu, Chuanxiong, papaya, roasted frankincense, roasted myrrh, clematis root, Qiannianjian, Zanthoxylum bungeanum, and Chuanxiong into powder, sieve, and obtain a mixed material;

[0032] (2) The mixed material is mixed with the auxiliary material to obtain an intermediate, which is blended into a lump to obtain the stomach-warming and analgesic plaster.

[0033] In the present invention, the mesh number of the sieve during the sieving in step (1) is preferably 90 to 110 meshes, more preferably 100 meshes;

[0034] The mass ratio of the mixed material to the auxiliary material in step (2) is preferably 1-2:1-2, more preferably 1:1;

[0035] The auxiliary materials in step (2) include a transdermal absorption enhancer, an excipient and a preservative.

[0036] In the present invention, the percutaneous absorption enhancer is preferably 1.5-2.5% of azone and 0.05-0.15% of menthol by weight of the intermediate, and more preferably 2.0% of azone and 0.1% of menthol by weight of the intermediate;

[0037] When the menthol is used, it needs to be ground into powder, preferably through a 90-110 mesh sieve, more preferably through a 100 mesh sieve.

[0038] In the present invention, the excipient is preferably 20-30% of honey, 3-7% of sodium carboxymethylcellulose, 8-12% of propylene glycol, 1-3% of polyethylene glycol-1000 and 2-4% of polyethylene glycol-4000, accounting for the mass of the intermediate, and more preferably 25% of honey, 5% of sodium carboxymethylcellulose, 10% of propylene glycol, 2% of polyethylene glycol-1000 and 3% of polyethylene glycol-4000, accounting for the mass of the intermediate;

[0039] The preservative is preferably 0.1-0.3% of methylparaben and 0.2-0.4% of ethylparaben based on the weight of the intermediate, more preferably 0.2% of methylparaben and 0.3% of ethylparaben based on the weight of the intermediate.

[0040] The technical solutions provided by the present invention are described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0041] The raw materials used in the prescription of the present invention include wormwood leaf, spleen meridian, and kidney meridian, warming meridians and dispelling cold, and removing dampness; raw Chuanwu, heart, liver, and kidney meridian, dispelling dampness and relieving pain, warming meridians and dispelling cold, and anti-inflammatory and dispersing stagnation; raw Caowu, heart, liver, and kidney meridian, dispelling dampness and relieving pain, warming meridians and dispelling cold, and anti-inflammatory and dispersing stagnation; cinnamon twig, heart, lung, and bladder meridian, warming meridians and dispelling cold, and relieving gastrointestinal spasm; mulberry twig, liver, spleen, and lung meridian, anti-inflammatory and analgesic, promoting blood circulation and removing blood stasis; Liu Ji Nu, liver, spleen, and stomach meridian, promoting blood circulation and removing blood stasis, and anti-inflammatory and analgesic; Chuanxiong, liver, and kidney meridian, promoting blood circulation and removing blood stasis, Anti-inflammatory and analgesic; papaya, enters the spleen, stomach, and liver meridians, helps digestion and eliminates stagnation, anti-inflammatory and analgesic, and promotes mucosal repair; roasted frankincense, enters the heart, liver, and spleen meridians, promotes blood circulation and removes blood stasis, has anti-inflammatory and analgesic effects, and calms the mind and stabilizes the spirit; roasted myrrh, enters the liver, spleen, and stomach meridians, promotes blood circulation and removes blood stasis, warms the stomach and relieves pain; Clematidis, enters the liver and kidney meridians, promotes blood circulation and removes blood stasis; Qiannianjian, enters the liver and kidney meridians, removes dampness; Zanthoxylum bungeanum, enters the spleen, stomach, and kidney meridians, warms the middle and relieves pain, and relieves cold pain in the abdomen; Ligusticum chuanxiong, enters the liver meridian, promotes blood circulation and qi, dispels wind and relieves pain; menthol, enters the lung and liver meridians, relieves chest and flank distension and stuffiness.

[0042] Chronic gastritis presents with epigastric pain, fullness, stuffiness, belching, poor appetite, bad breath, constipation, diarrhea, weight loss, insomnia, and anxiety as its primary clinical symptoms. It falls under the categories of "stomach pain," "stomach distension," "fullness," "deficiency distension," and "noise" in Traditional Chinese Medicine. Causes include dietary and emotional imbalances, external pathogens invading the stomach, and congenital spleen and stomach deficiency. The disease is located in the stomach and is related to the liver and spleen. The pathogenesis involves damage to the gastric mucosa, dysfunction of the spleen and stomach, obstruction of stomach qi, and pain caused by obstruction.

[0043] Therefore, using external treatments of Traditional Chinese Medicine, acupoint application is a type of external treatment in Traditional Chinese Medicine. It is a non-oral method that stimulates the meridians, acupoints, skin, and internal organs to warm the meridians and activate the collaterals, promote qi circulation and relieve bloating, promote blood circulation and relieve pain, lower qi and clear the bowels, and strengthen the spleen and nourish the stomach, achieving both symptomatic and root treatment. Based on the etiology and pathogenesis of chronic gastritis, this prescription uses mugwort leaves, cinnamon twigs, and millennium-strengthening herbs to warm the meridians and dispel cold, eliminate dampness, and relieve gastrointestinal spasms; raw Chuanwu and raw Caowu dispel dampness and relieve pain, warm the meridians and dispel cold, and have anti-inflammatory and analgesic effects; mulberry branches, Liuji Nu, and Chuanxiong promote blood circulation and remove blood stasis, and have anti-inflammatory and analgesic effects; papaya promotes digestion and eliminates stagnation, has anti-inflammatory and analgesic effects, and promotes mucosal repair; roasted frankincense, roasted myrrh, and clematis promote blood circulation and remove blood stasis, have anti-inflammatory and analgesic effects, and calm the mind; Sichuan pepper warms the middle and relieves pain, and treats cold pain in the abdomen; Chuanxiong promotes blood circulation and qi circulation, dispels wind and relieves pain; and menthol relieves chest and flank distension and stuffiness. The raw materials act synergistically and have the effects of strengthening the spleen and warming the middle, removing dampness and dispersing cold, nourishing the heart and calming the mind, etc., and treat insomnia caused by chronic gastritis and its accompanying anxiety, depression, fatigue, neurasthenia, etc. from multiple perspectives. The present invention can also treat functional dyspepsia, colitis, irritable bowel syndrome, etc.

[0044] Example 1 Preparation of stomach-warming and analgesic plaster

[0045] (1) Weigh the raw materials according to 30 parts of Artemisia argyi, 10 parts of raw Chuanwu, 10 parts of raw Caowu, 20 parts of cinnamon twig, 20 parts of mulberry twig, 20 parts of Liujinu, 10 parts of Chuanxiong, 10 parts of papaya, 10 parts of roasted frankincense, 10 parts of roasted myrrh, 10 parts of clematis, 10 parts of Qiannianjian, 10 parts of Zanthoxylum bungeanum, and 10 parts of Chuanxiong;

[0046] (2) Grind mugwort leaf, raw Chuanwu, raw Caowu, cinnamon twig, mulberry twig, Liujinu, Chuanxiong, papaya, roasted frankincense, roasted myrrh, clematis root, Qiannianjian, Zanthoxylum bungeanum, and Chuanxiong into powder, sieve, and obtain a mixed material;

[0047] (3) Adding 2.0% of azone and 0.1% of menthol as percutaneous absorption enhancers based on the total weight of the drug, 25% of honey, 5% of sodium carboxymethylcellulose, 10% of propylene glycol, 2% of polyethylene glycol-1000 and 3% of polyethylene glycol-4000 based on the total weight of the drug, and 0.2% of methylhydroxybenzoate and 0.3% of ethylhydroxybenzoate as preservatives based on the total weight of the drug to the mixed material, the mixture is blended into a ball, cut into pieces, and placed into a patch mold to obtain a stomach-warming and analgesic patch.

[0048] Example 2 Preparation of stomach-warming and analgesic plaster

[0049] (1) Weigh the raw materials according to 10 parts of Artemisia argyi, 40 parts of raw Chuanwu, 10 parts of raw Caowu, 40 parts of cinnamon twig, 10 parts of mulberry branch, 40 parts of Liuji Nu, 10 parts of Chuanxiong, 40 parts of papaya, 10 parts of roasted frankincense, 40 parts of roasted myrrh, 10 parts of clematis root, 40 parts of Qianqianjian, 10 parts of Zanthoxylum bungeanum, and 40 parts of Chuanxiong;

[0050] (2) Grind mugwort leaf, raw Chuanwu, raw Caowu, cinnamon twig, mulberry twig, Liujinu, Chuanxiong, papaya, roasted frankincense, roasted myrrh, clematis root, Qiannianjian, Zanthoxylum bungeanum, and Chuanxiong into powder, sieve, and obtain a mixed material;

[0051] (3) Adding 1.5% of azone and 0.15% of menthol as percutaneous absorption enhancers based on the total weight of the drug, 20% of honey, 7% of sodium carboxymethylcellulose, 8% of propylene glycol, 3% of polyethylene glycol-1000 and 2% of polyethylene glycol-4000 based on the total weight of the drug, and 0.1% of methylhydroxybenzoate and 0.4% of ethylhydroxybenzoate as preservatives based on the total weight of the drug to the mixed material, the mixture is blended into a ball, cut into pieces, and placed into a patch mold to obtain a stomach-warming and analgesic patch.

[0052] Example 3 Preparation of stomach-warming and analgesic plaster

[0053] (1) Weigh the raw materials according to 40 parts of Artemisia argyi, 10 parts of raw Chuanwu, 40 parts of raw Caowu, 10 parts of cinnamon twig, 40 parts of mulberry twig, 10 parts of Liu Ji Nu, 40 parts of Chuanxiong, 10 parts of papaya, 40 parts of roasted frankincense, 10 parts of roasted myrrh, 40 parts of clematis, 10 parts of Qianqianjian, 40 parts of Zanthoxylum bungeanum, and 10 parts of Chuanxiong;

[0054] (2) Grind mugwort leaf, raw Chuanwu, raw Caowu, cinnamon twig, mulberry twig, Liujinu, Chuanxiong, papaya, roasted frankincense, roasted myrrh, clematis root, Qiannianjian, Zanthoxylum bungeanum, and Chuanxiong into powder, sieve, and obtain a mixed material;

[0055] (3) Adding 2.5% of azone and 0.05% of menthol as percutaneous absorption enhancers, accounting for 30% of honey, 3% of sodium carboxymethylcellulose, 12% of propylene glycol, 1% of polyethylene glycol-1000 and 4% of polyethylene glycol-4000, and 0.3% of methylhydroxybenzoate and 0.2% of ethylhydroxybenzoate as preservatives to the mixed material, the mixture is blended into a ball, cut into pieces, and placed into a patch mold to obtain a stomach-warming and analgesic patch.

[0056] Clinical effects of experimental cases

[0057] Usage: Apply once a day to Zhongwan, Shenque, Guanyuan, bilateral Shenshu and other acupoints, and remove after 6 to 8 hours.

[0058] A total of 228 outpatients diagnosed with chronic gastritis of spleen and stomach deficiency-cold type by traditional Chinese and Western medicine from July 12, 2019, to August 19, 2023, were selected, including 102 males and 126 females; the youngest was 7 years old and the oldest was 86 years old, with an average age of 44.18 years old (see Table 1);

[0059] The shortest course of the disease was 3 months, the longest was 20 years, and the average was 8 years.

[0060] Table 1 Registration form for outpatient use

[0061]

[0062]

[0063]

[0064]

[0065]

[0066] 1) Chinese and Western diagnostic criteria for chronic gastritis: The diagnostic criteria are in accordance with the "Chinese Consensus on Chronic Gastritis (2017, Shanghai)" and the Consensus on the Diagnosis and Treatment of Chronic Gastritis in Traditional Chinese Medicine (2017).

[0067] ① Endoscopic diagnosis: According to the characteristics of endoscopic mucosal lesions, it can be divided into two categories: chronic atrophic gastritis and chronic non-atrophic gastritis (i.e., chronic superficial gastritis).

[0068] ②Pathological histological diagnosis: The main infiltration is chronic inflammatory cells (mononuclear cells), mainly lymphocytes and plasma cells.

[0069] 2) Diagnostic criteria for insomnia:

[0070] ① Difficulty falling asleep: prolonged sleep latency, longer than 30 minutes;

[0071] ② Restless sleep: increased awakening time, more than 30 minutes per night; actual sleep time decreased, less than 6.5 hours per night;

[0072] Wakefulness accounts for more than 10% of sleep time;

[0073] ③ Early awakening: waking up from sleep 30 minutes earlier than the normal waking time;

[0074] ④ No feeling of recovery after waking up, daytime sleepiness, poor concentration or memory impairment, affecting study and work.

[0075] 3) Case inclusion criteria

[0076] ①Meet the diagnostic criteria;

[0077] ②Age 18 to 85 years old;

[0078] ③ Those without serious systemic diseases such as heart, liver, and kidney diseases;

[0079] ④The patient and his / her family were informed and signed the informed consent form.

[0080] 4) Case exclusion criteria:

[0081] ①In the acute stage of the disease;

[0082] ② Refuse to accept traditional Chinese medicine and other treatments;

[0083] ③Combined with serious organic diseases of the heart, liver, kidney, etc.;

[0084] ④Combined with mental illness or coagulation dysfunction;

[0085] ⑤ Unable to withstand plaster treatment.

[0086] 5) Treatment evaluation criteria

[0087] Markedly effective: The patient's gastritis symptoms completely disappeared, and sleep quality was significantly improved;

[0088] Effective: The patient's gastritis symptoms were alleviated and sleep quality was improved;

[0089] Ineffective: The patient's gastritis symptoms did not improve or even became more severe, and there was no improvement in sleep quality. Sleep quality was assessed using the Ascension Insomnia Scale (AIS), with higher scores indicating worse sleep quality.

[0090] The above patients were treated with plasters for 3 courses, 1 course of treatment being 4 weeks. The results showed that 110 cases were effective, accounting for 48.24%, 101 cases were effective, accounting for 44.3%, and 17 cases were ineffective, accounting for 7.46%. The overall effective rate was 92.54%.

[0091] As can be seen from the above embodiments, the present invention provides a stomach-warming and analgesic external application composition and a stomach-warming and analgesic plaster and a preparation method. The stomach-warming and analgesic external application composition comprises the following components in parts by mass: 10-40 parts of mugwort leaf, 10-40 parts of raw Chuanwu, 10-40 parts of raw Caowu, 10-40 parts of cinnamon twig, 10-40 parts of mulberry twig, 10-40 parts of Liuji Nu, 10-40 parts of Chuanxiong, 10-40 parts of papaya, 10-40 parts of roasted frankincense, 10-40 parts of roasted myrrh, 10-40 parts of clematis root, 10-40 parts of Qianqianjian, 10-40 parts of Zanthoxylum bungeanum, and 10-40 parts of Chuanxiong. The stomach-warming and analgesic plaster of the present invention has the effects of strengthening the spleen and warming the middle, dispelling dampness and cold, nourishing the heart and calming the mind, etc. through the synergistic effect of the raw materials. It treats epigastric pain, epigastric fullness, insomnia and associated anxiety, depression, fatigue, neurasthenia, etc. caused by chronic gastritis from multiple perspectives. The stomach-warming and analgesic plaster of the present invention can increase local drug concentration by directly applying it to acupuncture points, which is conducive to the transdermal absorption of drug components. It can also stimulate meridian qi through acupuncture point stimulation, adjust the yin and yang balance of the spleen and stomach organs, and achieve the purpose of strengthening the spleen and stomach, harmonizing the stomach and relieving pain.

[0092] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A stomach-warming and analgesic external application composition, characterized in that: The composition comprises the following components: 10-40 parts of wormwood leaves, 10-40 parts of raw Chuanwu, 10-40 parts of raw Caowu, 10-40 parts of cinnamon twigs, 10-40 parts of mulberry branches, 10-40 parts of Liujienu, 10-40 parts of Chuanxiong, 10-40 parts of papaya, 10-40 parts of roasted frankincense, 10-40 parts of roasted myrrh, 10-40 parts of clematis root, 10-40 parts of Qianqianjian, 10-40 parts of Zanthoxylum bungeanum, and 10-40 parts of Chuanxiong.

2. The composition according to claim 1, characterized in that The composition comprises the following components: 30 parts of wormwood leaf, 10 parts of raw Chuanwu, 10 parts of raw Caowu, 20 parts of cinnamon twig, 20 parts of mulberry twig, 20 parts of Liujienu, 10 parts of Chuanxiong, 10 parts of papaya, 10 parts of roasted frankincense, 10 parts of roasted myrrh, 10 parts of clematis, 10 parts of Qianqianjian, 10 parts of Zanthoxylum bungeanum, and 10 parts of Chuanxiong.

3. The method for preparing the stomach-warming and analgesic external application composition according to claim 1 or 2, characterized in that: The following steps are involved: Grind mugwort leaves, raw Chuanwu, raw Caowu, cassia twig, mulberry twig, Liujinu, Chuanxiong, papaya, roasted frankincense, roasted myrrh, clematis root, Qiannianjian, Zanthoxylum bungeanum, and Chuanxiong into powder, sieve, and mix to obtain the stomach-warming and analgesic composition.

4. The preparation method according to claim 3, characterized in that The mesh number of the sieve during the sieving is 90 to 110 meshes.

5. Use of the composition according to claim 1 or 2 in the preparation of a stomach-warming and analgesic plaster.

6. A stomach-warming and analgesic plaster, characterized in that: The stomach-warming and analgesic plaster comprises the composition according to claim 1 or 2.

7. The preparation method of the stomach-warming and analgesic plaster according to claim 6, characterized in that: The following steps are involved: (1) Grind mugwort leaves, raw Chuanwu, raw Caowu, cassia twig, mulberry twig, Liujinu, Chuanxiong, papaya, roasted frankincense, roasted myrrh, clematis root, Qiannianjian, Zanthoxylum bungeanum, and Chuanxiong into powder, sieve, and obtain a mixed material; (2) The mixed material is mixed with the auxiliary material to obtain an intermediate, which is blended into a lump to obtain the stomach-warming and analgesic plaster.

8. The preparation method according to claim 7, characterized in that The mesh size of the sieve during the sieving in step (1) is 90-110 mesh; The mass ratio of the mixed material to the auxiliary material in step (2) is 1-2:1-2; The excipients in step (2) are a transdermal absorption enhancer, an excipient, and a preservative.

9. The preparation method according to claim 8, characterized in that The skin permeation enhancer is 1.5-2.5% of azone and 0.05-0.15% of menthol, based on the mass of the intermediate; When the menthol is used, the menthol needs to be ground into powder and passed through a 90-110 mesh sieve.

10. The preparation method according to claim 9, characterized in that The excipients are 20-30% of honey, 3-7% of sodium carboxymethylcellulose, 8-12% of propylene glycol, 1-3% of polyethylene glycol-1000 and 2-4% of polyethylene glycol-4000, accounting for 20-30% of the mass of the intermediate; The preservatives are 0.1-0.3% methylparaben and 0.2-0.4% ethylparaben, based on the mass of the intermediate.

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