A traditional Chinese medicine composition and external application plaster for treating stomachache and application thereof

Abstract

This invention provides a traditional Chinese medicine composition for treating stomach pain, comprising the following ingredients in parts by weight: rhubarb 8-12 parts, borneol 2-5 parts, galangal 7-12 parts, cyperus rotundus 7-12 parts, chuanxiong rhizome 12-18 parts, and fresh ginger 8-12 parts. This invention also provides a topical patch for treating stomach pain, comprising a carrier and an active ingredient, wherein the active ingredient comprises 40-50% of the total mass, and the active ingredient is the aforementioned traditional Chinese medicine composition for treating stomach pain. This topical patch for treating stomach pain, by applying the medicine to local tissues (acupoints) of the human body, can achieve the purpose of preventing and treating disease, effectively treating stomach pain, and has no side effects.

Description

Technical Field

[0001] This invention relates to the field of external medicine technology, specifically to a traditional Chinese medicine composition and external application for treating stomach pain, and their application. Background Technology

[0002] Chronic gastritis has a high incidence rate in the general population, with an incidence rate as high as 71.4% to 83.3% in patients with upper gastrointestinal symptoms. A cross-sectional survey conducted in 2011 by the Chinese Society of Digestive Endoscopy showed that among various types of chronic gastritis, chronic non-atrophic gastritis, chronic non-atrophic or atrophic gastritis with erosion, and chronic atrophic gastritis are the most common. Clinical symptoms of chronic gastritis include upper abdominal pain, bloating, early satiety, belching, decreased appetite, or burning sensation in the upper abdomen. Symptoms lack specificity, and diagnosis relies on gastroscopy and endoscopic pathological examination. The condition falls under the categories of "stomach pain" and "abdominal distension" in Traditional Chinese Medicine.

[0003] As the population ages, the incidence of stomach pain and epigastric fullness among the elderly will increase accordingly. Currently, the most common oral medication for treating chronic gastritis is the proton pump inhibitor (PPI). However, long-term oral administration of PPIs can lead to intestinal flora imbalance and even pathological fractures in the elderly. Therefore, there is an urgent need for a safe and effective medication for treating stomach pain. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a medicine for treating stomach pain, which can prevent and treat the disease, effectively treat stomach pain, and has no side effects.

[0005] The first aspect of the present invention is to provide a traditional Chinese medicine composition for treating stomach pain, comprising the following components in parts by weight:

[0006] Rhubarb 8-12 parts, Borneol 2-5 parts, Alpinia officinarum 7-12 parts, Cyperus rotundus 7-12 parts, Ligusticum chuanxiong 12-18 parts, Ginger 8-12 parts.

[0007] Furthermore, the traditional Chinese medicine composition for treating stomach pain includes the following ingredients in parts by weight: 10 parts rhubarb, 3 parts borneol, 9 parts galangal, 9 parts cyperus rhizome, 15 parts chuanxiong rhizome, and 10 parts fresh ginger.

[0008] A second aspect of the present invention is to provide a topical dressing for treating stomach pain, comprising a carrier and an active ingredient, wherein the content of the active ingredient accounts for 40-50% of the total mass, and the active ingredient is the traditional Chinese medicine composition for treating stomach pain of the first aspect. The content of the active ingredient may be 40%, 45%, or 50% of the total mass, and correspondingly, the content of the carrier accounts for 60%, 55%, or 50% of the total mass.

[0009] Furthermore, the carrier is petrolatum.

[0010] Furthermore, the dosage of the topical dressing is 5-6g / dose.

[0011] Furthermore, the preparation method of the topical dressing is as follows:

[0012] The active ingredients are pulverized, mixed, and then passed through an 80-100 mesh sieve to obtain a mixture;

[0013] After adding petroleum jelly in a certain proportion and stirring evenly, a topical dressing for treating stomach pain is prepared.

[0014] A third aspect of the present invention is to provide a traditional Chinese medicine composition for treating stomach pain and its application in treating digestive diseases with stomach pain.

[0015] A fourth aspect of the present invention is to provide an external dressing for treating stomach pain in the treatment of digestive diseases.

[0016] Compared with the prior art, the traditional Chinese medicine composition and external application for treating stomach pain provided by the present invention, as well as their applications, have the following beneficial effects:

[0017] I. The traditional Chinese medicine composition for treating stomach pain provided by this invention comprises: Alpinia galanga and Cyperus rotundus as principal herbs, which promote qi circulation, dispel cold, relieve pain, soothe the liver, and harmonize the stomach; Rheum palmatum and Ligusticum chuanxiong as assistant herbs, which promote qi circulation and relieve depression, thus clearing stagnation in the middle jiao; Zingiber officinale as adjuvant herb, which harmonizes the stomach and stops vomiting; and Borneol as guiding herb, which directs the medicine through the skin and into the meridians to reach the affected area. The entire formula achieves the effects of promoting qi circulation, relieving depression, relieving pain, harmonizing the stomach, and stopping vomiting.

[0018] II. The external patch for treating stomach pain provided by this invention is an external medicine. It achieves the purpose of preventing and treating diseases by applying the medicine to local tissues (acupoints) of the human body, and has no toxic side effects. Detailed Implementation

[0019] To enable those skilled in the art to better understand the technical solutions in the embodiments of the present invention, and to make the above-mentioned objectives, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be further described below.

[0020] The endpoints and any values ​​of the ranges disclosed herein are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed herein.

[0021] The traditional Chinese medicine composition for treating stomach pain of the present invention comprises the following components in parts by weight:

[0022] Rhubarb 8-12 parts, Borneol 2-5 parts, Alpinia officinarum 7-12 parts, Cyperus rotundus 7-12 parts, Ligusticum chuanxiong 12-18 parts, Ginger 8-12 parts.

[0023] In the formula:

[0024] Rhubarb: Enters the Stomach, Large Intestine, and Liver meridians. *Tangye Bencao* states, "Enters the Hand and Foot Yangming meridians." *Compendium of Materia Medica* states, "It is a blood-regulating medicine for the Foot Taiyin, Hand and Foot Yangming, and Hand and Foot Jueyin meridians." *Ben Cao Jing Jie* states, "Enters the Hand Taiyang Small Intestine meridian, Hand Shaoyin Heart meridian, Hand Shaoyang Sanjiao meridian, and also the Foot Yangming Stomach and Hand Yangming Large Intestine meridians." It clears heat and toxins, breaks up stagnation, and promotes blood circulation. It treats constipation due to excess heat, delirium, food stagnation and abdominal distension, early-stage dysentery, tenesmus, amenorrhea due to blood stasis, abdominal masses, epidemic febrile diseases, sudden red and painful eyes, hematemesis, epistaxis, jaundice, edema, urinary tract infections, sores, boils, and burns. It clears heat and unblocks the intestines, cools the blood and detoxifies, and removes blood stasis and promotes menstruation. It is used for constipation due to excess heat, abdominal pain due to stagnation, incomplete diarrhea, and damp-heat jaundice. The *Shennong Bencao Jing* states: "It removes stagnant blood, treats amenorrhea, chills and fever, breaks up masses and accumulations, removes retained fluids and undigested food, cleanses the intestines and stomach, promotes metabolism, facilitates the flow of water and grains ('water and grains' is also written as 'water and grain passages'), regulates the middle burner and aids digestion, and harmonizes the five internal organs." The *Bielu* states: "It soothes the stomach, lowers qi, removes phlegm and accumulations, treats intestinal heat, abdominal distension, cold blood stasis and distension in women, lower abdominal pain, and blood stasis in the elderly." The *Yaoxing Lun* states: "It treats chills and fever, aids digestion, cleanses the five internal organs, regulates menstruation in women, promotes edema, breaks up phlegm and accumulations, removes cold and heat accumulations, undigested food, benefits the large and small intestines, treats heat-toxin swellings, treats infantile chills and fever, irritability, erodes pus, and breaks up retained blood."

[0025] Borneol: Pungent, bitter, slightly cold. Enters the Heart, Spleen, and Lung meridians. Opens the orifices, disperses stagnant heat, removes corneal opacity and improves vision, reduces swelling and relieves pain. Treats stroke with lockjaw, delirium due to fever, epilepsy with phlegm, deafness due to qi stagnation, sore throat, canker sores, otitis media, carbuncles, hemorrhoids, corneal opacity, and pinworm infection. *Tang Materia Medica*: "Treats evil qi in the heart and abdomen, wind-dampness accumulation, and deafness. Improves vision and removes redness and corneal opacity." *Compendium of Materia Medica*: "Treats sore throat, headache, nasal congestion, toothache, tongue protrusion due to typhoid fever, and smallpox in children. Opens the orifices and disperses stagnant heat."

[0026] Galangal: Pungent, hot. Enters the spleen and stomach meridians. Warms the stomach, dispels wind, disperses cold, promotes qi circulation, and relieves pain. Treats cold in the spleen and stomach, cold pain in the epigastrium and abdomen, vomiting and diarrhea, dysphagia, food stagnation, malaria, and cold accumulation. *Bielu* states: "Treats sudden cold, cold rebellion in the stomach, and abdominal pain due to cholera." *Yaoxing Lun* states: "Treats long-term cold in the lower back, stomach qi rebellion, and vomiting. Treats wind, breaks up qi stagnation, abdominal cold and qi pain; dispels wind-cold numbness and weakness, treats cold rebellion of qi rushing to the heart, abdominal pain, vomiting, and diarrhea." *Bencao Shiyi* states: "Lowers qi and benefits the voice. Boiled and taken as a drink, it stops dysentery and cholera." *Rihuazi Bencao* states: "Treats muscle spasms, diarrhea, vomiting, and eliminates undigested food."

[0027] Cyperus rotundus: pungent, slightly bitter, slightly sweet, neutral. Enters the liver, spleen, and triple burner meridians. Regulates qi and relieves stagnation, stops pain and regulates menstruation. Treats liver and stomach disharmony, qi stagnation, chest, abdominal, and rib pain, phlegm retention, irregular menstruation, metrorrhagia, and leukorrhea. Regulating qi and relieving stagnation: used for chest, rib, and abdominal pain due to liver qi stagnation. Combined with Bupleurum chinense and Citrus reticulata peel to treat chest and rib pain. Combined with Alpinia officinarum (called Liangfu Wan) to treat stomach cold pain. *Diannan Materia Medica*: "Regulates qi in the blood, relieves stagnation, soothes the stomach, aids digestion, and stops vomiting." *Compendium of Materia Medica*: "Disperses seasonal cold and epidemic diseases, benefits the triple burner, relieves six types of stagnation, eliminates food accumulation, phlegm retention, abdominal swelling, abdominal distension, beriberi, stops pain in the heart, abdomen, limbs, head, eyes, teeth, and ears, carbuncles, sores, hematemesis, hematochezia, hematuria, metrorrhagia, leukorrhea, irregular menstruation, and various prenatal and postpartum diseases."

[0028] Chuanxiong (Ligusticum striatum): Enters the liver, gallbladder, and pericardium meridians; invigorates blood and removes blood stasis; promotes qi circulation and relieves stagnation; dispels wind and relieves pain. *Compendium of Materia Medica* states: Chuanxiong ascends to the head and eyes, descends to regulate menstruation, and opens up stagnation in the middle; it is a qi-regulating herb in the blood. It has been used in conjunction with Danggui (Angelica sinensis), not only for its effectiveness in treating blood stasis but also for its remarkable efficacy in regulating qi. It can dispel cold and dampness, eliminate wind, improve eyesight, relieve headaches, alleviate rib pain, nourish the fetus before pregnancy, and benefit the postpartum period. It can also treat masses, blood stasis, painful and itchy sores, carbuncles, fever and chills, weakness and paralysis of the legs, swelling and pain, and difficulty walking. It is pungent and yang in nature, and its qi flows freely without the stagnation or stickiness of yin. Although it enters the blood, it can also dispel all wind and regulate all qi.

[0029] Ginger: pungent, slightly warm. It enters the lung, spleen, and stomach meridians. It relieves exterior syndromes and dispels cold, warms the middle jiao and stops vomiting, resolves phlegm and stops coughing, and detoxifies fish and crab poisoning. *Ben Cao Cong Xin* states: "Ginger juice opens phlegm, treats esophageal obstruction and vomiting, saves from sudden death, treats body odor, and can be applied to frostbite. Roasted ginger harmonizes the stomach and stops vomiting." *Hui Yue Yi Jing* states: "Roasted ginger treats stomach cold, diarrhea, and acid reflux." *Qian Jin Shi Zhi* states: "It promotes sweating and removes foul odor from the diaphragm."

[0030] The herbal composition of this invention follows the principle of formulation as follows: Alpinia galanga and Cyperus rotundus are the principal herbs, which promote qi circulation, dispel cold, relieve pain, soothe the liver, and harmonize the stomach; Rheum palmatum and Ligusticum chuanxiong are the assistant herbs, which help to promote qi circulation and relieve depression, thus opening up stagnation; Zingiber officinale is the adjuvant herb, which harmonizes the stomach and stops vomiting; and Borneol is the guiding herb, which directs the medicine through the skin and into the meridians to reach the affected area. The entire formula achieves the combined effects of promoting qi circulation, relieving depression, relieving pain, harmonizing the stomach, and stopping vomiting.

[0031] The traditional Chinese medicine composition of the present invention is used as a topical dressing. The topical dressing for treating stomach pain of the present invention comprises a carrier and an active ingredient, wherein the carrier is petrolatum, and the active ingredient comprises 40-50% of the total mass, and the active ingredient comprises the following components in parts by weight:

[0032] Rhubarb 8-12 parts, Borneol 2-5 parts, Alpinia officinarum 7-12 parts, Cyperus rotundus 7-12 parts, Ligusticum chuanxiong 12-18 parts, Ginger 8-12 parts.

[0033] The following specific embodiments illustrate in detail the traditional Chinese medicine composition and external application for treating stomach pain of the present invention.

[0034] Example 1

[0035] A traditional Chinese medicine composition for treating stomach pain, comprising the following ingredients in parts by weight:

[0036] 10 parts rhubarb, 3 parts borneol, 9 parts galangal, 9 parts cyperus rhizome, 15 parts chuanxiong rhizome, and 10 parts fresh ginger.

[0037] Example 2

[0038] A traditional Chinese medicine composition for treating stomach pain, comprising the following ingredients in parts by weight:

[0039] 8 parts rhubarb, 2 parts borneol, 7 parts galangal, 7 parts cyperus rhizome, 12 parts chuanxiong rhizome, and 8 parts fresh ginger.

[0040] Example 3

[0041] A traditional Chinese medicine composition for treating stomach pain, comprising the following ingredients in parts by weight:

[0042] 12 parts rhubarb, 5 parts borneol, 12 parts galangal, 12 parts cyperus rhizome, 18 parts chuanxiong rhizome, and 12 parts fresh ginger.

[0043] Example 4

[0044] A topical dressing for treating stomach pain comprises the following ingredients by weight percentage:

[0045] 50% active ingredient, 50% carrier;

[0046] The carrier is petrolatum, and the formulation of the active ingredient is as shown in Example 1.

[0047] In this embodiment, the preparation method of the topical dressing for treating stomach pain is as follows:

[0048] First, the various components in the active ingredients are crushed, mixed, and then passed through an 80-100 mesh sieve to obtain a mixture;

[0049] Then, petrolatum is added in proportion and stirred evenly to prepare the topical dressing.

[0050] In this embodiment, the external dressing is a dressing pill, and the pill size is 5-6g / pill.

[0051] The topical patch for treating stomach pain described in Example 4 was subjected to a clinical trial. The trial methods and results are as follows:

[0052] (1) Case selection

[0053] Eighty patients with epigastric pain from a traditional Chinese medicine hospital in Hunan Province between 2022 and 2023 were selected.

[0054] (2) Diagnostic criteria: Traditional Chinese medicine syndrome criteria

[0055] (3) Exclusion criteria

[0056] ① Individuals under the age of 18 or over the age of 50; ② Individuals with allergies or allergies to this drug; ③ Patients with acute gastric ulcers; ④ Individuals with malignant tumors or gastrointestinal bleeding; ⑤ Patients with serious other systemic primary diseases or mental disorders.

[0057] (4) Treatment methods

[0058] Using the topical patch from Example 4, the patch was applied to the Liangmen, Zusanli, and Zhongwan acupoints. The patch was left in place for at least 8 hours, once daily for one week, and the treatment progress was recorded for each patient. Patients were followed up within one month of the treatment completion date, and laboratory test results and scoring scales were recorded to evaluate the effectiveness and safety of the treatment.

[0059] (5) Observation indicators

[0060] Therapeutic indicator: Symptom improvement rate = (Total score before treatment - Total score after treatment) / Total score before and after treatment * 100%

[0061] Safety indicators: blood pressure and heart rate measurement; routine blood and urine tests; electrocardiogram, liver function (ALT), and kidney function (BUN, Scr) tests.

[0062] (6) Efficacy evaluation criteria

[0063] Referring to the relevant diagnostic principles and severity criteria for stomach pain in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" issued by the National Medical Products Administration, the improvement of indicators was graded as clinical control, significant effect, effective, and ineffective.

[0064] Clinical control: The main symptoms disappear and the syndrome score decreases by more than 90%.

[0065] Significant effect: Main symptoms disappear, and syndrome score decreases by 60-89%.

[0066] Effective: Major symptoms improved, and syndrome scores decreased by 30-59%.

[0067] Ineffective: The main symptoms and indicators show no significant changes or worsen, and the syndrome score decreases by less than 30%.

[0068] (7) Statistical methods

[0069] After all clinical data were collected, a database was created. Statistical analysis was performed using the professional statistical software package SPSS 25.0. Quantitative data were described using mean and standard deviation (x±s). For normally distributed data, independent samples t-tests were used for comparison. For non-normally distributed quantitative data, the rank-sum test (Mann-Whitney U test) was used. Categorical data were analyzed using the rank-sum test and chi-square test. Hypothesis testing was uniformly performed using two-tailed tests, and the test statistics and corresponding p-values ​​were provided. A p-value < 0.05 was considered statistically significant.

[0070] (8) Results

[0071] Case completion status: 80 patients were observed one month after treatment. 5 cases dropped out. The effective rate was 26.6% (20 cases), the effective rate was 53.3% (40 cases), the ineffective rate was 20%, and the total effective rate was 80%.

[0072] During the treatment period, one patient in the treatment group experienced an adverse reaction due to redness and skin allergy at the application site; the adverse reaction rate was 1.3% (1 / 75). No significant changes were found in the blood pressure, heart rate, blood routine, renal function, and electrocardiogram results before and after treatment.

[0073] In summary, the topical patch for treating stomach pain of the present invention can effectively improve symptoms, enhance the overall quality of life of patients, and its efficacy can be maintained, demonstrating clinical safety and effectiveness.

[0074] The embodiments of the present invention have been described in detail above, but the present invention is not limited to the described embodiments. For those skilled in the art, various changes, modifications, substitutions, and variations made to these embodiments without departing from the principles and spirit of the present invention still fall within the protection scope of the present invention.

Claims

1. A topical dressing for treating stomach pain, characterized in that, The active ingredients of the topical dressing are made from the following raw materials in parts by weight: 8-12 parts rhubarb, 2-5 parts borneol, 7-12 parts galangal, 7-12 parts cyperus rhizome, 12-18 parts chuanxiong rhizome, and 8-12 parts fresh ginger.

2. The external dressing for treating stomach pain according to claim 1, characterized in that, The active ingredients of the topical dressing are made from the following raw materials in parts by weight: 10 parts rhubarb, 3 parts borneol, 9 parts galangal, 9 parts cyperus rhizome, 15 parts chuanxiong rhizome, and 10 parts fresh ginger.

3. The topical dressing for treating stomach pain according to claim 1 or 2, characterized in that, The topical dressing consists of a carrier and an active ingredient, wherein the content of the active ingredient accounts for 40-50% of the total mass.

4. The external dressing for treating stomach pain according to claim 3, characterized in that, The carrier is petroleum jelly.

5. The external dressing for treating stomach pain according to claim 3, characterized in that, The external dressing is a dressing pill, and the dressing pill has a specification of 5-6g / pill.

6. The external dressing for treating stomach pain according to claim 3, characterized in that, The preparation method of the external dressing is as follows: crush and mix the raw materials and pass them through an 80-100 mesh sieve to obtain a mixture; add petrolatum in proportion and stir evenly to prepare the external dressing for treating stomach pain.

7. The use of the topical dressing for treating stomach pain as described in claim 3 in the preparation of a topical medicine for treating stomach pain.