An external-use traditional Chinese medicine composition for treating abdominal pain and application thereof

Abstract

The present application relates to the field of traditional Chinese medicine, in particular to a kind of external use traditional Chinese medicine composition for treating abdominal pain and application thereof.The traditional Chinese medicine composition of the present application is composed of the following raw medicinal materials by weight: 50-70 parts of Wuyao, 20-40 parts of Xiaohuixiang, 10-20 parts of Ru Xiang, 20-40 parts of Jiaohuang, 5-15 parts of Xiesheng, 5-15 parts of Tianlong, 5-15 parts of Jiuxiangchong, 5-15 parts of Bingpian, 50-70 parts of Suleye, 20-40 parts of Bohe.The traditional Chinese medicine composition provided by the present application achieves satisfactory curative effect for relieving abdominal pain.Clinical test results show that, on the basis of conventional treatment, abdominal pain severity and disappearance time of the group with external application of patch containing the above-mentioned traditional Chinese medicine composition every day are shorter than those of the control group with only conventional treatment, and the clinical total effective rate (92.5%) is also significantly higher than that of the control group (75%), which fully demonstrates the unique advantages of traditional Chinese medicine in treating abdominal pain and has broad prospects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions, specifically to a topical traditional Chinese medicine composition and its pharmaceutical preparation for treating abdominal pain. Background Technology

[0002] Abdominal pain is a common ailment that occurs throughout all stages of a disease's progression. Epidemiological surveys have found that approximately 25% of adults have experienced abdominal pain, with an annual incidence rate of about 2.29%, which is showing a rising trend year by year. [1] Functional abdominal pain and cancerous abdominal pain are among the most common types of abdominal pain in the gastroenterology department.

[0003] Functional abdominal pain is a non-organic disease mediated by the central nervous system and closely related to psychological factors. It is usually accompanied by severe abdominal pain, but is unrelated to eating or bowel movements. The recurring symptoms significantly impact the patient's life. [2] This condition falls under the category of central pain, and clinical treatment often involves using low-dose tricyclic antidepressants to relieve pain symptoms. [2-3] However, taking antidepressants often causes side effects such as headaches, nausea, vomiting, anxiety, and insomnia, leading to poor patient acceptance. [4] At the same time, the lack of specific diagnostic methods for functional abdominal pain increases the expenditure of medical resources and also adds to the psychological burden on patients.

[0004] Cancer pain is the most common symptom in cancer patients, occurring in about 25% of cases in early-stage cancer and as high as 70-80% in later-stage cancer. [5] Opioids are a representative drug for treating cancerous abdominal pain, but they have side effects such as respiratory depression, changes in gastrointestinal function, and sphincter spasm. [6] .

[0005] Traditional Chinese medicine has not yet distinguished between functional abdominal pain and cancerous abdominal pain, classifying them all under the category of abdominal pain. The pathogenesis of this disease mainly lies in "cold stagnation," "qi stagnation," and "blood stasis." The *Neijing Zhiyao* states, "Experiencing cold leads to illness... Cold on the surface causes body pain, cold in the interior causes abdominal pain." *Zhangshi Yitong* states, "Due to cold drinks or eating raw and cold foods, blood stagnates and flows downwards, inevitably causing abdominal pain and a pale complexion." Prolonged cold stagnation obstructs the meridians, hindering qi and blood flow, leading to qi stagnation and blood stasis; where there is no flow, there is pain. Clinical treatment primarily focuses on warming the middle jiao, dispelling cold, promoting qi circulation, activating blood, unblocking the meridians, and relieving pain. *Danxi Xinfa* also states, "For all abdominal pain, warming and dispersing methods must be used." *Bianzheng Lu* states, "When a person experiences severe abdominal pain, with distension in both hypochondria, bitter taste in the mouth, nausea, acid reflux, and a desire to defecate but being unable to, this is qi pain... The treatment must soothe the stagnation of liver qi."

[0006] Related research used data mining methods to explore the patterns of drugs and prescriptions in traditional Chinese medicine for treating abdominal pain. It confirmed that the drugs are mainly pungent and warm or pungent and hot to warm the middle jiao, dispel cold and relieve pain, and are supplemented with bitter and warm or pungent and warm drugs to regulate qi and blood circulation and harmonize qi. Summary of the Invention

[0007] The purpose of this invention is to provide a topical traditional Chinese medicine composition for treating abdominal pain with few side effects and low recurrence rate, as well as the topical drug preparation thereof. It also provides the application of the traditional Chinese medicine composition in the preparation of topical drugs for treating or relieving abdominal pain.

[0008] Through long-term clinical practice, the inventors discovered that a traditional Chinese medicine composition consisting of Lindera root, fennel, frankincense, and other herbs possesses the effects of warming the middle jiao (spleen and stomach), dispelling cold, promoting blood circulation, and relieving pain, and can significantly improve clinical symptoms of abdominal pain. When formulated into a poultice, it has shown good efficacy in the clinical treatment of abdominal pain.

[0009] In a first aspect, the present invention provides a topical traditional Chinese medicine composition for treating abdominal pain, the composition comprising the following raw materials in parts by weight: 50-70 parts of Lindera strychnifolia; 20-40 parts of fennel; 10-20 parts of frankincense; 20-40 parts of turmeric; 5-15 parts of Asarum heterotropoides; 5-15 parts of Gynostemma pentaphyllum; 5-15 parts of styrax chinensis; 5-15 parts of borneol; 50-70 parts of Perilla frutescens; and 20-40 parts of peppermint.

[0010] Furthermore, the preferred traditional Chinese medicine composition of the present invention is composed of the following raw materials in parts by weight: 60 parts of Lindera strychnifolia, 30 parts of fennel, 15 parts of frankincense, 30 parts of turmeric, 9 parts of Asarum heterotropoides, 9 parts of Tianlong (a type of herb), 9 parts of Jiuxiangchong (another type of herb), 9 parts of borneol, 60 parts of Perilla frutescens, and 30 parts of peppermint.

[0011] In this traditional Chinese medicine composition, the principal herbs are: Lindera root, fennel, and Asarum, which warm the middle jiao, promote qi circulation, and relieve pain. The assistant herbs are: Frankincense and Curcuma longa, which invigorate blood circulation, promote qi circulation, and relieve pain, assisting the principal herbs in enhancing their effect of promoting qi circulation and relieving pain, while also having the effect of invigorating blood circulation and removing blood stasis. The adjuvant herbs are: Tianlong (a type of herb) and Jiuxiangchong (another type of herb), which unblock the meridians and relieve pain. The guiding herbs are: Borneol and Mentha, which open the orifices and help the medicine directly reach the affected area.

[0012] In a second aspect, the present invention provides a patch for treating or relieving abdominal pain, comprising a patch carrier and the aforementioned traditional Chinese medicine composition powder disposed therein.

[0013] The preparation method of the dressing is as follows: Grind all the medicines into powder, put them into a gauze bag (30cm×15cm), sew the gauze bag into three equal parts (a total of 9 compartments) along the longitudinal and transverse axes to make the medicine distribution more even, put it in a constant temperature incubator and heat it to 45-50℃, first put a towel around the patient's navel, then put the heated dressing on and fix it with adhesive tape, remove it after 2 hours, once a day.

[0014] For ease of use, the gauze packets containing the medicine powder can be individually packaged, and the packets should be opened and removed before each use.

[0015] The dosage of this invention is the therapeutically effective dose, and the general treatment period is 2 months.

[0016] The properties, meridians, functions, and common weights of the various drugs in the formulation of this invention are as follows:

[0017] Lindera root: The dried tuberous root of the plant Lindera root. Remove impurities, separate into large and small strips, soak thoroughly in water, changing the water according to the season to prevent spoilage, and promptly remove and slice. If sliced ​​while fresh, sift to remove dust. Lindera root is pungent and warm in nature, entering the spleen, stomach, liver, kidney, and bladder meridians. Its functions include regulating qi, relieving stagnation, dispelling cold, and relieving pain. It is mainly used to treat abdominal distension, cough, asthma, and diarrhea, and can also be used to treat frequent urination, enuresis, prostatitis, dysmenorrhea in women, and postpartum abdominal pain. It is also used to treat chest and abdominal distension and pain due to qi stagnation, indigestion, vomiting, cold hernia, beriberi, and frequent urination.

[0018] Fennel seeds: Harvested in late summer and early autumn when the fruits are ripe, impurities are removed, and they are dried before use. They are pungent and warm in nature. They enter the kidney, bladder, and stomach meridians. They stimulate appetite, regulate qi, dispel cold, and promote yang. Indications: Cold in the middle jiao, loss of appetite, nausea and vomiting, abdominal pain due to cold; hernia pain, testicular swelling and pain; stagnation of qi in the spleen and stomach, abdominal distension and pain.

[0019] Frankincense: The resin exuded from the bark of *Boswellia carterii* Birdw. and *Boswellia bhaurdajiana* Birdw., both belonging to the Burseraceae family. Properties: Bitter, pungent, and warm; enters the heart, liver, and spleen meridians. Functions: Regulates qi and blood circulation, relieves pain, and eliminates toxins. Treats qi and blood stagnation, abdominal pain, carbuncles and boils, traumatic injuries, dysmenorrhea, and postpartum blood stasis and stabbing pain.

[0020] Turmeric: Remove impurities, soak in water, drain, moisten thoroughly, slice, and air dry. Sliced ​​Turmeric: Remove impurities and residual fibrous roots, brush off mud, and air dry. Properties: Bitter and pungent, warm; enters the spleen and liver meridians. Functions: Promotes qi circulation and removes blood stasis, unblocks meridians and relieves pain. Indications: Chest and abdominal distension and pain, shoulder and arm pain, irregular menstruation, amenorrhea, and traumatic injuries.

[0021] Asarum: The whole herb of Asarum heterotropoides, a plant in the Aristolochiaceae family. It is pungent and warm in nature, entering the lung and kidney meridians. Its functions include dispelling wind, dispersing cold, promoting diuresis, and opening the orifices. It is used to treat wind-cold headache, sinusitis, toothache, phlegm-damp cough, and rheumatic pain.

[0022] Tianlong: The entire gecko. Captured in summer and autumn, often at night using lights. Use fresh or after capture, pierce the head and abdomen with a bamboo strip, secure the tail to the bamboo strip with rope, and then dry over a low flame. During collection and processing, care should be taken to prevent the tail from detaching. Properties: Salty and cold in nature. Meridians: Kidney and Liver. Functions: Dispels wind, invigorates blood circulation, and disperses nodules. Indications: Used for stroke paralysis, rheumatic joint pain, osteomyelitis, lymph node tuberculosis, esophageal cancer, lung cancer, primary liver cancer, and intestinal cancer.

[0023] Nine-fragrant insect: This refers to the dried body of the nine-fragrant insect. It has a salty taste, warm nature, and enters the spleen, liver, and kidney meridians. Nine-fragrant insect has the effects of regulating qi and relieving pain, warming the middle and assisting yang. It can be used to treat symptoms such as liver and stomach qi pain, stomach cold and bloating pain, lower back pain, kidney deficiency and impotence, and frequent urination.

[0024] Borneol: This product is a crystal obtained from the resin and volatile oil of borneol, and is nearly pure dextrorotatory borneol. It has a bitter and pungent taste, is cool in nature, and enters the heart and lung meridians. Its functions include: clearing the orifices, dispersing stagnant heat, removing pterygium and improving vision, reducing swelling and relieving pain. It is used to treat stroke with lockjaw, febrile coma, epilepsy with phlegm obstruction, deafness due to qi stagnation, sore throat, canker sores, otitis media, carbuncles, hemorrhoids, pterygium, and pinworm infection.

[0025] Perilla leaf: Properties: pungent, slightly warm, non-toxic; enters the spleen and lung meridians. Indications: dispels cold and relieves exterior symptoms, promotes lung function and stops cough, regulates qi and harmonizes the middle jiao, calms the fetus, and detoxifies. It is mainly used to treat colds due to wind-cold, aversion to cold and fever, cough, asthma, and abdominal distension.

[0026] Peppermint: A plant of the Lamiaceae family, specifically the dried whole herb of other plants in the same genus. It is pungent, warm, and non-toxic. Its functions include dispelling wind and heat, and it is mainly used to treat influenza, headache, red eyes, fever, sore throat, and swollen and painful gums.

[0027] Beneficial technical effects of the present invention

[0028] The traditional Chinese medicine composition provided by this invention has achieved satisfactory therapeutic effects in relieving abdominal pain. Clinical trial results show that, on the basis of conventional treatment, daily application of a patch containing the above-mentioned traditional Chinese medicine composition resulted in shorter severity and disappearance time of abdominal pain compared to the control group that only received conventional treatment. The total clinical effective rate (92.5%) was also significantly higher than that of the control group (75%). This fully demonstrates the unique advantages of traditional Chinese medicine in the treatment of abdominal pain and has broad prospects. Detailed Implementation

[0029] The present invention will now be described in detail with reference to the embodiments, but the implementation of the present invention is not limited thereto.

[0030] Unless otherwise specified, the experimental methods used in the following examples were performed under standard conditions or as recommended by the manufacturer. Unless otherwise noted, all medicinal materials used in the embodiments of this invention can be obtained from Chinese herbal medicine sales companies.

[0031] Example 1: Preparation of Tianxiang Dingtong Powder

[0032] Weigh out 60 parts of Lindera root, 30 parts of fennel, 15 parts of frankincense, 30 parts of turmeric, 9 parts of Asarum, 9 parts of Tianlong (a type of herb), 9 parts of Nine-Fragrance Insect, 9 parts of Borneol, 60 parts of Perilla leaf, and 30 parts of peppermint.

[0033] Weigh the above-mentioned traditional Chinese medicines according to the formula ratio, grind all the medicines into powder, and divide the powdered medicines into a predetermined number of equal parts according to the specification of the gauze bag (30 cm × 15 cm). Sew the gauze bag into three equal parts (a total of 9 grids) along the vertical and horizontal axes to make the drug distribution more uniform.

[0034] Example 2: Clinical observation effect

[0035] Clinical observation effect

[0036] Source of cases: The cases were collected from patients with abdominal pain hospitalized in the Department of Gastroenterology of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from April 2020 to June 2023. Among them, there were 37 males and 43 females; the age range was 36 - 78 years. The included patients were randomly divided into a control group and an observation group using a random number table method, with 40 cases in each group.

[0037] Inclusion and exclusion criteria:

[0038] (1) Inclusion criteria: Patients clearly diagnosed with functional abdominal pain or cancerous abdominal pain; aged 18 - 80 years, regardless of gender; those who had not taken drugs related to abdominal pain treatment within 1 month before enrollment; those who gave informed consent and signed the informed consent form. (2) Exclusion criteria: Patients with severe allergic constitution; those with severe organic diseases of the heart, lungs, kidneys, etc.; pregnant or lactating women; those with mental disorders.

[0039] Treatment methods:

[0040] Patients in the control group were given conventional medical treatment (nutritional support, symptomatic treatment). Patients in the observation group were given Tianxiang Dingtong Powder in Example 1 for abdominal application on the basis of the treatment in the control group.

[0041] Usage: Put Tianxiang Dingtong Powder into an incubator and heat it to 45 - 50 °C. First, place a towel around the patient's umbilicus, then place the hot compress bag and fix it with adhesive tape. Remove it after 2 hours of external application, once a day, and continuously apply it externally for 2 months.

[0042] Evaluation indicators:

[0043] (1) Degree and time of abdominal pain relief: Abdominal pain was scored using the VAS scale, with a score range of 0 - 10 points. The higher the score, the more obvious the degree of abdominal pain. Record the time when abdominal pain is completely relieved.

[0044] (2) Effective rate of abdominal pain relief: Recovery: The abdominal pain symptoms are relieved by 95%. Marked effect: The abdominal pain symptoms basically disappear, and the symptom score is reduced by ≥70%. Effective: Although the abdominal pain symptoms have not disappeared, they are relieved compared with before, and the symptom score is reduced by ≥30%. Ineffective: The abdominal pain symptoms still exist, and the degree has not been reduced, and the symptom score is reduced by less than 30%.

[0045] Effective rate = (Pre-treatment abdominal pain symptom score - Post-treatment abdominal pain symptom score) / Pre-treatment abdominal pain symptom score × 100%

[0046] (3) Karnofsky Performance Status Rating Scale (KPS Rating): scored from 0 to 100. The higher the score, the better the health condition.

[0047] (4) Safety indicators: Blood routine, urine routine, stool routine, liver and kidney function, electrolytes, electrocardiogram, etc. of all patients were tested before and after treatment to evaluate the safety of the treatment.

[0048] Statistical methods:

[0049] SPSS 25.0 software was used for statistical processing of the data. Quantitative data were analyzed using... The data are expressed as follows: t-test is used for data conforming to a normal distribution, and nonparametric rank-sum test is used for data not conforming to a normal distribution; count data are expressed as cases or percentages; chi-square test is used for non-ordination data, and rank-sum test is used for ordination data. A p-value < 0.05 is considered statistically significant.

[0050] Therapeutic effect observation:

[0051] (1) There were no statistically significant differences in gender composition, age, and disease duration between the two groups of patients (P>0.05), indicating comparability. See Table 1:

[0052] Table 1. Comparison of baseline data between the two groups of patients (n=80)

[0053]

[0054] (2) Comparison of abdominal pain severity and relief time between the two groups

[0055] The severity and duration of abdominal pain in the observation group were shorter than those in the control group, and the differences were statistically significant (P<0.05), as shown in Table 2.

[0056] Table 2 Comparison of abdominal pain severity and disappearance time between the two groups ( n=80)

[0057]

[0058] *P<0.05

[0059] (3) Comparison of clinical efficacy between the two groups

[0060] After treatment, the total effective rate in the observation group was 92.5%, while that in the control group was 75%. The efficacy of the observation group was superior to that of the control group, and the difference was statistically significant (P<0.05), as shown in Table 3.

[0061] Table 3 Comparison of clinical efficacy between the two groups of patients (n=80)

[0062]

[0063] *P<0.05

[0064] (4) Comparison of KPS scores before and after treatment in the two groups

[0065] Before treatment, there was no statistically significant difference in KPS scores between the two groups (P>0.05); after treatment, the KPS scores of both groups increased compared to before treatment (P<0.05), and the observation group was higher than the control group (P<0.05), as shown in Table 4.

[0066] Table 4 Comparison of KPS scores before and after treatment in the two groups ( n=80)

[0067]

[0068] Compared with pre-treatment levels, *P<0.05; compared with the control group, #P<0.05

[0069] Classic examples of the present invention

[0070] The patient, a 36-year-old male, presented with a chief complaint of recurrent abdominal pain for over 10 years. His present illness: 10 years ago, he developed abdominal pain accompanied by diarrhea without any obvious cause. The pain was relieved after defecation. He had 2-3 bowel movements per day, unformed stools, without blood or mucus. Previous colonoscopies showed no significant abnormalities. Seeking further diagnosis and treatment, the patient consulted the gastroenterology department of our hospital. Current condition: He is alert and in good spirits, but prone to anxiety. His appetite is good, and the abdominal pain worsens when he eats cold or raw food or is under stress. He is sensitive to cold, has 2-3 bowel movements per day, unformed stools, and poor sleep. His tongue is dark with a thin white coating, and his pulse is wiry.

[0071] Etiology and Pathogenesis: After consuming cold and raw foods, the patient's cold pathogens directly entered the intestines, causing stagnation of blood. The patient was prone to anxiety, leading to liver qi stagnation and impaired qi circulation. Combined with the prolonged illness and internal blood stasis, the cold stagnation, qi stagnation, and blood stasis interacted, exacerbating the abdominal pain. A dark tongue with a thin white coating and a wiry pulse were also signs of the disease. Considering the patient's aversion to oral Chinese medicine and concerns about potential liver and kidney damage from Western medicine, Tianxiang Dingtong San was prescribed for external application, once daily for two hours each time. After two weeks, the patient's abdominal pain significantly improved, and the patient requested additional medication for continued external application. Two months later, a follow-up phone call revealed that the abdominal pain had subsided, diarrhea had significantly improved, and there were no longer any symptoms of cold intolerance.

[0072] References cited in the background section of this invention:

[0073] [1] Qian Jiaming, Li Jingnan, Wu Dong. Guidelines for the diagnosis and treatment of chronic abdominal pain in primary care (2019) [J]. Chinese Journal of General Practitioners, 2019(7):618-627.

[0074] [2] Guo Yu, Su Xiaolan, Wei Wei. Advances and strategies in the diagnosis and treatment of functional abdominal pain using traditional Chinese and Western medicine [J]. Chinese Journal of Traditional Chinese Medicine, 2016, 34(5):1077-1080.

[0075] [3] Zhao Zhongting, Niu Zuoping. Research progress on the pathogenesis of functional abdominal pain syndrome [J]. Electronic Journal of Modern Medicine and Health Research, 2017(4):197-198.

[0076] [4] Jin Weidong, Qian Mincai, Hu Jiming, et al. Evidence-based medicine study on the side effects of venlafaxine and tricyclic antidepressants in the treatment of depression [J]. Evidence-Based Medicine, 2003, 3(4): 215-218.

[0077] [5] Han Lei, Miao Jinwei, Zhao Libo, et al. A study on the relationship between cancer pain treatment and quality of life of cancer pain patients [J]. Practical Oncology Journal, 2011, 26(4):414-417.

[0078] [6] Li Xuetao, Chen Shaochun, Sun Jun, et al. Application of celiac ganglion block in cancerous abdominal pain [J]. Electronic Journal of Clinical Medicine Literature, 2018, 5(37):26-28.

[0079] [7] Lu Yue, Zhao Junyi. Exploring the patterns of ancient prescriptions for treating abdominal pain based on data mining [J]. Chinese Traditional and Folk Medicine, 2024, 4(33): 103-111.

[0080] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A topical traditional Chinese medicine composition for treating abdominal pain, characterized in that, This traditional Chinese medicine composition consists of the following raw materials in parts by weight: Lindera root 50-70 parts, fennel 20-40 parts, frankincense 10-20 parts, turmeric 20-40 parts, asarum 5-15 parts, angelica root 5-15 parts, wormwood 5-15 parts, borneol 5-15 parts, perilla leaf 50-70 parts, and peppermint 20-40 parts.

2. The topical traditional Chinese medicine composition for treating abdominal pain according to claim 1, characterized in that, This traditional Chinese medicine composition consists of the following raw materials in parts by weight: 60 parts of Lindera root, 30 parts of fennel, 15 parts of frankincense, 30 parts of turmeric, 9 parts of Asarum, 9 parts of Tianlong (a type of herb), 9 parts of Jiuxiangchong (another type of herb), 9 parts of borneol, 60 parts of Perilla leaf, and 30 parts of peppermint.

3. The use of the topical Chinese medicine composition for treating abdominal pain as described in claim 1 or 2 in the preparation of a treatment or relief patch for abdominal pain.

4. A poultice for treating or relieving abdominal pain, characterized in that, The preparation method is as follows: all the active pharmaceutical ingredients described in any one of claims 1 to 3 are ground into powder and then evenly packed into a gauze bag.

5. The patch for treating or relieving abdominal pain according to claim 4, characterized in that: in, The gauze bag measures 30cm x 15cm. To ensure even distribution of the medicine, after the medicine powder is placed inside the gauze bag, the gauze bag is sewn into three equal parts along the longitudinal and transverse axes, for a total of 9 compartments.

6. The patch for treating or relieving abdominal pain according to claim 4, characterized in that: in, The therapeutic temperature of the patch is 45-50℃.

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