Ointment for treating diarrhea-type irritable bowel syndrome and preparation method thereof

Abstract

The invention discloses an ointment for treating diarrhea-type irritable bowel syndrome. The ointment is prepared from the following raw material medicines: 10-15g of agastache rugosus, 12-18g of rhizoma atractylodis, 10-15g of pericarpium citri reticulatae, 12-18g of parched white peony root, 28-32g of poria cocos, 10-15g of mangnolia officinalis, 6-12g of pericarpium arecae, 28-32g of rice sprout, 6-12g of divaricate saposhnikovia root, 12-18g of rhizoma cyperi, 6-12g of angelica sinensis, 10-15g of cynanchum paniculatum and 3-9g of honey-fried licorice root. The invention also provides a preparation method of the composition. The ointment disclosed by the invention is applied to the Shenque acupoint during treatment, and can obviously improve symptoms and signs of a patient after treatment, especially diarrhea, stomachache and abdominal distention and fullness; the treatment efficiency, the total effective rate, the IBS-SSS scale and the IBS-DSQ scale evaluation of the traditional Chinese medicine composition are superior to those of a conventional western medicine group. The ointment is remarkable in curative effect, convenient to use, good in safety, low in price, simple in medicine and high in clinical popularization value.

Description

Technical Field

[0001] The invention relates to an ointment for treating diarrhea-type irritable bowel syndrome and a preparation method thereof, belonging to the technical field of traditional Chinese medicine preparations. Background Art

[0002] Irritable bowel syndrome (IBS) is a functional gastrointestinal disease characterized by recurrent abdominal pain, bloating or discomfort, which is associated with defecation or accompanied by changes in bowel habits. Diarrhea-predominant irritable bowel syndrome (IBS-D) is the most common. Its incidence remains high, the disease is prolonged and recurrent, and the clinical efficacy is poor, which seriously affects the patient's physical and mental health and quality of life. Psychological changes, dietary structure, gender, genetics, etc. are the main pathogenic factors.

[0003] The treatment of irritable bowel syndrome is mainly to improve symptoms, improve the quality of life of patients and eliminate worries. The main treatments include changing lifestyle and diet structure, drug treatment, psychological and behavioral therapy, etc. In terms of Western medicine treatment, antispasmodics, antidiarrheal drugs, intestinal motility regulators, probiotics, antibiotics, antidepressants and dietary adjustments are often used, but there are problems such as repeated attacks and poor patient compliance.

[0004] Acupoint application is one of the classic external treatment methods of traditional Chinese medicine. It has been increasingly used in clinical practice because it avoids the disadvantages of Chinese medicine such as inconvenience in carrying, troublesome decoction and preparation, unpalatable medicine, and difficulty in controlling quality and cost. It is convenient, fast, has few side effects, and has high patient compliance. Therefore, it is necessary to develop an acupoint application preparation that can effectively treat IBS-D to meet clinical needs. Summary of the invention

[0005] In view of the above-mentioned prior art, the present invention provides an ointment for treating diarrhea-type irritable bowel syndrome and a preparation method thereof.

[0006] The present invention is achieved through the following technical solutions:

[0007] A paste for treating diarrhea-type irritable bowel syndrome is prepared from the following raw materials: 10-15g of Patchouli, 12-18g of Atractylodes, 10-15g of Citrus reticulata, 12-18g of stir-fried White Peony Root, 28-32g of Poria, 10-15g of Magnolia officinalis, 6-12g of Citrus grandis, 28-32g of Gastrodia elata, 6-12g of Saposhnikovia divaricata, 12-18g of Cyperus rotundus, 6-12g of Chinese Angelica sinensis, 10-15g of Cynanchum wilfordii and 3-9g of roasted Licorice root.

[0008] Preferably, it is made from the following raw materials: Patchouli 12g, Atractylodes 15g, Tangerine Peel 12g, Stir-fried White Peony Root 15g, Poria 30g, Magnolia Bark 12g, Citrus Grandis Peel 9g, Malus Bud 30g, Saposhnikovia 9g, Cyperus 15g, Angelica 9g, Cynanchum 12g, and Radix Glycyrrhizae Preparata 6g.

[0009] The preparation method of the ointment for treating diarrhea-type irritable bowel syndrome comprises the following steps:

[0010] (1) taking Patchouli, Atractylodes, Citrus reticulata, Saposhnikovia divaricata and Cynanchum chinense, heating ethanol solution to reflux extraction, filtering, and concentrating the filtrate into a thick paste 1 for standby use;

[0011] (2) Take Poria cocos, Magnolia officinalis, Chinese magnolia bark and malt sprout, heat and reflux the ethanol solution for extraction, filter, and concentrate the filtrate into a thick paste 2 for later use;

[0012] (3) Take stir-fried white peony root, cyperus rotundus, angelica sinensis and roasted liquorice, grind them into coarse particles, add water, soak them, and collect volatile oil; filter and concentrate the extract, add ethanol to extract, filter, and concentrate the filtrate into a thick paste 3; mix the thick paste 3 with the volatile oil to form a thick paste 4 for later use;

[0013] (4) Mix the thick paste 1, thick paste 2 and thick paste 4 obtained above to obtain a drug extract, and prepare an ointment by a conventional method. It should be noted that steps (1), (2) and (3) are arranged only for the convenience of description, and their order can be changed arbitrarily.

[0014] Furthermore, in the steps (1) and (2), the volume concentration of the ethanol solution is 50% to 95%; the amount of the ethanol solution added is 6 to 12 times the weight of the raw material drug; the heating reflux times are 1 to 3 times, and the extraction time each time is 1 to 2 hours.

[0015] Furthermore, in step (3), the amount of water added is 6 to 12 times the weight of the raw material.

[0016] Furthermore, in steps (1), (2) and (3), the water content of the thick paste (including thick paste 1, thick paste 2, thick paste 3 and thick paste 4) is 15% to 20% (weight percentage), that is, every 1g is equivalent to 2 to 5g of the original medicinal material.

[0017] Furthermore, the specific operation of step (1) is as follows: take Patchouli, Atractylodes, Tangerine Peel, Saposhnikovia and Cynanchum, add 8 times (weight multiple, the same below) of 50% ethanol solution (volume percentage, the same below), heat and reflux to extract twice, each time for 1 hour; combine the extracts, filter, and reduce the filtrate to 50-60° C. to recover ethanol, and concentrate it into a thick paste 1 with a water content of 15%-20%, which is set aside.

[0018] Furthermore, the specific operation of step (2) is as follows: take Poria cocos, Magnolia officinalis, Chinese magnolia bark and malt sprout, add 8 times the amount of 80% ethanol solution, heat and reflux to extract twice, each time for 1.5 hours; combine the extracts, filter, and reduce the filtrate to 50-60°C to recover ethanol, and concentrate it into a thick paste 2 with a water content of 15%-20%, which is set aside.

[0019] Furthermore, the specific operation of step (3) is as follows: take fried white peony root, cyperus rotundus, angelica and roasted licorice, grind them into coarse particles, add 10 times the amount of water, soak for 0.5 hours, and collect volatile oil; filter the extract, concentrate to a relative density of 1.05, cool to room temperature, add ethanol to make the alcohol content reach 70% (volume percentage), refrigerate at 4°C for 24 hours, filter, reduce the filtrate to 50-60°C to recover ethanol, and concentrate it into a thick paste 3 with a water content of 15%-20%; mix the thick paste 3 with the volatile oil to form a thick paste 4 for standby use.

[0020] Furthermore, the specific operation of step (4) is as follows:

[0021] ① Take 50 parts of deionized water, add 0.001-0.003 parts of disodium ethylenediaminetetraacetate and 0.01-0.03 parts of sorbitan monooleate polyoxyethylene ether (Tween 80), stir evenly, add 2 parts of carbomer-940 resin, stir evenly, add 12 parts of carbomer-941 resin, stir evenly, pour into a kneader, stir at a constant speed at 50°C for 2 hours in a vacuum, and let stand to obtain a blank matrix; each component is measured by weight;

[0022] ② Slowly add NaOH solution to the blank matrix to adjust the pH value to 5-7, then slowly add glycerol in a volume of 15%-22% of the volume of the blank matrix, mix well, and obtain a blank matrix containing glycerol;

[0023] ③ The thick paste 1, thick paste 2 and thick paste 4 obtained above are mixed to obtain a drug extract; the drug extract is dissolved into a suspension with a 95% ethanol solution, and then the blank matrix containing glycerol prepared above is slowly added to make the drug extract account for 1% to 5% (volume percentage) of the total amount, stirred and dispersed evenly, applied on a non-woven fabric while hot, cooled to room temperature, and cut into blocks to obtain.

[0024] The ointment for treating diarrhea-type irritable bowel syndrome (named Huoling Antidiarrhea Ointment) of the present invention is used as follows during treatment: after the Shenque point is disinfected with iodine or alcohol, the ointment of the present invention is applied for more than 8 hours, and the ointment is changed once a day. Generally, the disease can be cured after 4 weeks of treatment.

[0025] The ointment for treating diarrhea-type irritable bowel syndrome of the present invention has the following therapeutic ideas:

[0026] In TCM, diarrhea-type irritable bowel syndrome can be classified as "diarrhea" and "abdominal pain". "Diarrhea" was first recorded in Huangdi Neijing, and later appeared in the names of diseases such as "dongxie" and "shunxie". "Suwen" says: "When dampness prevails, there will be diarrhea" and "all dampness and swelling belong to the spleen". The key to the onset of this disease is "spleen failure to function properly", and mental and psychological factors are the main causes of brain-gut axis disorder in IBS-D. The five spirits and five internal organs of a person belong to different things, among which "the spleen stores intention" coincides with the connotation of modern psychology. With the rapid development of society, people's body and mind are also running at a high speed. IBS-D combined with physical symptoms mediated by the brain-gut axis are becoming more and more complex. The "biological-psychological-natural-social" integrated research model has become a new direction and hotspot. The model of studying psychology and psychoneuroimmunology from the microbiome-gut-brain axis is also a manifestation of the "spleen stores intention" theory. The "spleen stores intention" theory has a long history and far-reaching influence. It is an important part of the theory of zang-fu and is also a bridge for the mutual communication between TCM emotional diseases and Western medicine psychology. Based on this theory, when IBS-D is combined with somatic symptoms, the clinical treatment principle of strengthening the spleen and mind is often adopted. This prescription takes this as the starting point, based on the theory of "spleen storing mind" and its guiding role in the treatment of IBS-D, and modifies the bitter, pungent, warm and moving method of the classic prescription Wujiajian Zhengqi San to prepare Huoling Antidiarrhea Acupoint Plaster for the treatment of IBS-D, which also provides new ideas and methods for treating digestive psychosomatic diseases from the perspective of "spleen".

[0027] Wujiajian Zhengqi San comes from Wu Jutong's Treatise on Warm Diseases: Damp-Heat. It is composed of seven herbs: Patchouli, Atractylodes, and Poria, which can move the spleen and eliminate dampness, and Tangerine Peel, Magnolia Bark, Citrus Grandis, and Malus Sprout, which can regulate qi and promote digestion. The original prescription did not indicate the monarch, minister, assistant, and envoy, but it was used to treat various symptoms of abdominal distension and diarrhea. People with insufficient physical strength should warm up the yang qi and help the spleen's movement and transformation; people with yin essence depletion should take into account the likes and dislikes of the internal organs and nourish the five internal organs with the five flavors. Patchouli in the prescription is pungent and slightly warm, enters the spleen, stomach, and lung meridians, eliminates dampness, relieves heat, and stops vomiting. It is good at regulating qi, awakening the spleen and appetizing, and is an important medicine for vomiting. Tangerine peel is pungent, pungent, and warm, enters the spleen and lung meridians, regulates qi and eliminates phlegm, strengthens the spleen and dries dampness, and is an important medicine for treating phlegm. Poria is sweet, mild, and mild, and belongs to the heart, spleen, and kidney meridians. It can promote diuresis and eliminate dampness, strengthen the spleen and calm the mind; it can promote diuresis without hurting the body, and nourish without hindering the stomach, and is an important medicine for removing dampness. Magnolia officinalis is bitter, pungent and warm, and belongs to the spleen, stomach, lung and large intestine meridians. It dries dampness and promotes qi, eliminates accumulation and relieves asthma, and is an essential medicine for cholera. Radix dasyphyllae is pungent and slightly warm, and belongs to the spleen, stomach, large and small intestine meridians. It promotes qi and removes stagnation, promotes diuresis and reduces swelling, strengthens the spleen, stimulates appetite and regulates the middle, and is good at dispersing invisible stagnant qi. Gourd bud is sweet and flat, and belongs to the spleen and stomach meridians. It invigorates the spleen and stomach, eliminates restlessness and relieves stagnation, and digests food and resolves accumulation. It is an essential medicine for invigorating appetite and harmonizing the middle. Atractylodes lancea is pungent, pungent and warm, and belongs to the spleen and stomach meridians. It dries dampness and invigorates the spleen, eliminates rheumatism, and improves eyesight; it treats blurred vision, regulates dampness stagnation in the spleen and stomach, and stops slippery diarrhea and intestinal wind, and is an essential medicine for epidemic prevention. Looking at the whole prescription, the medicine is simple and precise, all of which enter the spleen meridian, bitter and warm to dry dampness, pungent and warm to disperse. Warm the yang of the spleen and stomach to promote digestion and eliminate abdominal distension, and transform the dampness of the spleen and stomach to invigorate movement and stop diarrhea. Or aromatic to wake up the spleen, or dry dampness to move the spleen, or infiltrate dampness to strengthen the spleen, by strengthening the spleen intention, moving the spleen camp, playing the job of harmonizing the spleen and stomach, restoring the rise and fall of qi mechanism, and eliminating the job of internal and external evil. On the basis of the above-mentioned prescription compatibility, the present invention takes the meaning of Tongxie Yaofang and Danggui Shaoyao San, adds white peony root to nourish blood and purge the liver, Fangfeng San to soothe the liver and spleen, Danggui nourishes blood and promotes blood circulation, Cyperus rotundus to relieve depression and regulate menstruation, Cynanchum chinense to dispel wind and stop pain, and Licorice to detoxify and regulate the middle. All medicines match, move the spleen and earth and purge the liver wood, regulate the qi mechanism to stop pain and purge, and promote qi and blood to eliminate dampness and turbidity.

[0028] The present invention also found through network pharmacology research that after TCMSP screening, the prescription of the present invention obtained a total of 196 effective ingredients, including 11 Patchouli (HX), 2 Dianthus grandiflora (DFP), 2 Magnolia officinalis (HP), 15 Poria (FL), 5 Citrus reticulata (CP), 9 Atractylodes (CZ), 18 Saposhnikovia divaricata (FF), 18 Cyperus rotundus (XF), 6 Cynanchum chinense (XCQ), 2 Angelica sinensis (DG), 13 White Peony Root (BS), and 92 Glycyrrhiza uralensis (GC). The main active ingredients include quercetin, baicalein, sitosterol, naringenin, kaempferol, isorhamnetin, β-sitosterol, stigmasterol, eugenol, etc.; the core targets for treating IBS-D are IL6, TNF, IL1B, CXCL8, IL1A, IFNG, IL10, CCL2, IL4, TP53, STAT3, JUN, etc.; the KEGG pathway involves IL-17 signaling pathway, AGE-RAGE signaling pathway, Th17 cell differentiation, cytokine-cytokine receptor interaction, etc.

[0029] At the same time, modern pharmacology has confirmed that the Chinese medicine formula has different degrees of regulating brain gut peptides, reducing visceral sensitivity, anti-inflammatory and analgesic, regulating immunity, and repairing intestinal mucosal barriers. Among them, Patchouli can be antibacterial, anti-inflammatory, regulate gastrointestinal function, anti-oxidant, anti-tumor, and regulate immunity; Patchouli oil and patchouli perfume extract can downregulate the expression of CRF, CGRP, 5-HT in colon tissue and BDNF in hippocampus, and reduce visceral hypersensitivity. Tangerine peel can regulate intestinal flora, anti-inflammatory, anti-viral, and anti-oxidant. The active ingredients improve inflammation through multiple pathways such as IL, TNF-α, Nrf2, and ERK signaling pathways, enhance immunity, antagonize small intestinal contraction caused by 5-HT, and inhibit small intestinal contraction caused by Adr and DA. Magnolia officinalis has anti-inflammatory, anti-oxidative stress, bidirectional regulation of gastrointestinal motility, promotion of Cajal cell proliferation, protection of intestinal mucosa, and regulation of intestinal flora; magnolol and honokiol can be anti-depressant, and honokiol can be anti-anxiety. Atractylodes has the effects of anti-oxidation, regulating brain-gut peptides, anti-inflammatory, protecting the liver, and lowering blood sugar. Atractylodes alcohol and β-eucalyptol can relieve pain and inhibit the central nervous system. Volatile oil can promote the expression of Beclin-1, P62, LC3Ⅱ / Ⅰ, and reduce the levels of IL-6 and TNF-α. The peel of the big belly can expel insects, kill bacteria, promote gastrointestinal motility, lower blood sugar, and resist depression. The water extract can increase the distribution of cholinergic nerves, reduce the distribution of nitrogen nerves, promote the secretion of MTL and substance P, and reduce the expression of VIP to regulate gastrointestinal motility. Poria can resist inflammation, antioxidant, regulate brain-gut peptides and body immunity, intestinal flora, etc. The water extract can upregulate the expression of GAS, MTL, SP, and downregulate the expression of VIP, CCKAR, 5-HT, and CGRP. Poria polysaccharide can calm and resist oxidation, improve depressive behavior; Poria total triterpenes can calm and resist convulsions. Guya contains essential proteins, carbohydrates, fats, and a variety of vitamins, minerals and other nutrients for the human body, and has the effects of aiding digestion and enhancing immunity. The vitamin B1 contained can regulate intestinal flora, vitamin B2 is involved in the function of the nervous system, and minerals such as calcium, iron, zinc, and magnesium maintain the normal function of the immune system. The chromone compounds in Saposhnikovia divaricata have analgesic, antipyretic, immune regulation and anticoagulant effects; Saposhnikovia divaricata polysaccharides can enhance the cellular immunity, nonspecific immunity and humoral immunity of mice; Saposhnikovia divaricata alcohol extract may play an anti-allergic role by inhibiting PAR-2 ​​expression and blocking mast cell degranulation. Ferulic acid, the main active ingredient of Angelica sinensis, can inhibit the release of 5-HT and TXA2-like substances, increase the PGI2 / TXA2 ratio, and improve microcirculation; Ligustilide can relieve pain symptoms in mice; Angelica sinensis polysaccharides can upregulate the content of neurotransmitters DA and 5-HT in the hippocampus tissue of depressed mice through antioxidant and anti-apoptotic pathways. The decoction of Cynanchum chinense can effectively reduce the number of body twisting in mice and enhance the pain threshold; the main ingredient, paeonol, has anti-inflammatory, antiviral, immunomodulatory, and anti-tumor effects; 2,3-dihydroxy-4-methoxyacetophenone and 4,5-dimethoxycatechol can reduce the content of reactive oxygen and calcium ion concentration in HT22 cells through oxidative stress, thereby protecting nerves.White peony root has the effects of protecting nerves and resisting depression, protecting gastrointestinal mucosa, regulating gastrointestinal function, anti-inflammatory, regulating autoimmunity, etc. White peony root total glycosides can inhibit the activation of JAK2 / STAT3 signaling pathway, regulate TPH-1, 5-HT3R, SERT expression in 5-HT signaling pathway, reduce intestinal sensitivity, inhibit cell apoptosis, reduce inflammatory damage, and improve diarrhea symptoms; paeoniflorin can improve bile acid metabolism disorders mediated by intestinal flora, and then repair intestinal barrier damage. Triterpenoid saponins, flavonoids and polysaccharides in licorice have anti-tumor, anti-depression, anti-inflammatory, antioxidant, and immunomodulatory effects. Licorice chalcone can inhibit the abnormal activation of NLRP3 inflammasomes and play an anti-inflammatory role. Licorice honey roasting has a promoting effect on the cellular immunity, humoral immunity and nonspecific immunity and function of mice. It can be seen that the analysis from the perspective of Western medicine also provides a solid theoretical and experimental research basis for the treatment of IBS-D with the ointment of the present invention for the treatment of diarrhea-type irritable bowel syndrome.

[0030] The ointment for treating diarrhea-type irritable bowel syndrome of the present invention is applied to the Shenque acupoint during use, so that the drug can exert a therapeutic effect through direct subcutaneous absorption and indirect stimulation of the acupoint meridian qi. Clinical studies show that after treatment, the symptom scores of the test group and the scores of diarrhea, abdominal pain, and epigastric fullness are lower than those of the control group, and the difference is statistically significant (P < 0.05), wherein the scores of diarrhea and abdominal pain are significantly different (P < 0.01); the marked effectiveness rate and the total effective rate of the test group are 65.00% and 90.00% respectively, and the marked effectiveness rate and the total effective rate of the control group are 35.00% and 75.00% respectively, and the difference between the two groups is statistically significant (P < 0.05 or 0.01); the improvement degree of the IBS-SSS scale and the IBS-DSQ scale in the test group is better than that in the control group, and the difference is significant (P < 0.05).

[0031] The ointment for treating diarrhea-type irritable bowel syndrome of the present invention not only has direct effects and definite curative effects, but is also simple, easy to use, inexpensive, simple in medicine, non-invasive and painless, fully reflecting the advantages of TCM external treatment. In addition, highly effective Chinese medicines are carefully selected and formulated, and a series of studies are conducted, with reasonable process, controllable quality, stable preparation, definite curative effects, and good safety, which further improves the economic benefits of medicines and provides safe and effective guarantees for its clinical promotion and application. In short, the ointment for treating diarrhea-type irritable bowel syndrome of the present invention has significant curative effects, is easy to use, has good safety, is inexpensive, and has high clinical promotion value.

[0032] Various terms and phrases used herein have the general meanings that are well known to those skilled in the art. DETAILED DESCRIPTION

[0033] The present invention will be further described below in conjunction with the embodiments. However, the scope of the present invention is not limited to the following embodiments. It will be appreciated by those skilled in the art that various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention.

[0034] Example 1 Preparation of an ointment for treating diarrhea-type irritable bowel syndrome

[0035] The raw material formula is: Patchouli 12g, Atractylodes 15g, Tangerine peel 12g, stir-fried White Peony Root 15g, Poria 30g, Magnolia officinalis 12g, Citrus grandiflora peel 9g, Gastrodia elata 30g, Saposhnikovia divaricata 9g, Cyperus rotundus 15g, Angelica sinensis 9g, Cynanchum wilfordii 12g, and Radix Glycyrrhizae uralensis 6g.

[0036] The preparation steps are as follows:

[0037] (1) taking Patchouli, Atractylodes, Citrus reticulata, Saposhnikovia divaricata and Cynanchum chinense, adding 8 times the amount of 50% ethanol solution, heating and refluxing extraction twice, each time for 1 hour, combining the extracts, filtering, and recovering ethanol from the filtrate at 50-60° C. under reduced pressure, and concentrating to a thick paste 1 (water content 18%);

[0038] (2) Take Poria cocos, Magnolia officinalis, Chinese magnolia bark and malt sprout, add 8 times the amount of 80% ethanol solution, heat and reflux extraction twice, each time for 1.5 hours, combine the extracts, filter, and recover ethanol from the filtrate at 50-60° C. under reduced pressure, and concentrate to a thick paste 2 (water content 18%);

[0039] (3) Take stir-fried white peony root, cyperus rotundus, angelica sinensis and roasted liquorice, grind them into coarse particles, add 10 times the amount of water, soak for 0.5 hours, collect volatile oil, filter the extract, concentrate to a relative density of 1.05, cool to room temperature, add ethanol to make the alcohol content reach 70%, refrigerate at 4°C for 24 hours, filter, and recover ethanol from the filtrate at 50-60°C under reduced pressure, concentrate to a thick paste 3 (water content 18%), add the above-collected volatile oil, mix well to form a thick paste 4, and set aside;

[0040] (4) Take 50 parts of deionized water, add 0.002 parts of disodium ethylenediaminetetraacetate and 0.012 parts of Tween 800, stir at low speed (70 rpm) to make it uniform, add 2 parts of Carbomer-940 resin, stir at medium speed (300 rpm) to make it uniform, add 12 parts of Carbomer-941 resin in 3 batches, stir at low speed (70 rpm) for 1.5 hours until the mixture is uniform, pour into a kneader, adjust the temperature to a constant temperature of 50°C, stir at a constant speed in vacuum for 2 hours, and let it stand to obtain a blank matrix;

[0041] The blank matrix was stirred at a low speed, and a 10% NaOH solution (weight percentage) was slowly added to adjust the pH value to 6, and then glycerol in a volume of 22% of the volume of the blank matrix was slowly added and mixed to obtain a blank matrix containing glycerol;

[0042] The thick pastes 1, 2 and 4 obtained above are mixed to obtain a drug extract; the drug extract is dissolved into a suspension with 3 times the volume of 95% ethanol solution, the blank matrix containing glycerol is slowly added thereto, and stirred at a low speed so that the drug extract accounts for 3% of the total amount, the mixture is stirred and dispersed evenly, applied on a non-woven fabric while hot, cooled to room temperature, and cut into blocks.

[0043] Example 2 Preparation of an ointment for treating diarrhea-type irritable bowel syndrome

[0044] The raw material formula is: Patchouli 10g, Atractylodes 12g, Tangerine peel 10g, stir-fried White Peony Root 12g, Poria 28g, Magnolia officinalis 10g, Citrus Grandis peel 6g, Gastrodia elata 28g, Saposhnikovia divaricata 6g, Cyperus rotundus 12g, Angelica sinensis 6g, Cynanchum wilfordii 10g, and Radix Glycyrrhizae uralensis 3g.

[0045] The preparation method steps are as follows:

[0046] (1) Take Patchouli, Atractylodes, Citrus Reticulatae, Saposhnikovia Divaricata and Cynanchum Root, add 8 times the amount of 50% ethanol solution, heat and reflux to extract twice, each time for 1 hour, combine the extracts, filter, and recover ethanol from the filtrate at 50-60° C. under reduced pressure, and concentrate to a thick paste 1;

[0047] (2) Take Poria cocos, Magnolia officinalis, Chinese magnolia bark and malt sprout, add 8 times the amount of 80% ethanol solution, heat and reflux to extract twice, each time for 1.5 hours, combine the extracts, filter, and reduce the filtrate to 50-60°C to recover ethanol, and concentrate to a thick paste 2;

[0048] (3) Take stir-fried white peony root, cyperus rotundus, angelica sinensis and roasted liquorice, grind them into coarse particles, add 10 times the amount of water, soak for 0.5 hours, collect volatile oil, filter the extract, concentrate to a relative density of 1.05, cool to room temperature, add ethanol to make the alcohol content reach 70%, refrigerate at 4°C for 24 hours, filter, and recover ethanol from the filtrate at 50-60°C under reduced pressure, concentrate to a thick paste 3, add the above-collected volatile oil, mix well to form a thick paste 4, and set aside;

[0049] (4) Take 50 parts of deionized water, add 0.001 parts of disodium ethylenediaminetetraacetate and 0.03 parts of Tween 800, stir at low speed (60 rpm) to make it uniform, add 2 parts of carbomer-940 resin, stir at medium speed (200 rpm), add 12 parts of carbomer-941 resin in 5 batches, stir at low speed for 1.5 hours until the mixture is uniform, pour into a kneader, adjust the temperature to a constant temperature of 50°C, stir at a constant speed in vacuum for 2 hours, and let it stand to obtain a blank matrix;

[0050] The blank matrix was stirred at a low speed, and a 10% NaOH solution was slowly added to adjust the pH value to 5, and then a glycerol solution with a volume of 15% of the volume of the blank matrix was slowly added and mixed evenly to obtain a blank matrix containing glycerol;

[0051] The thick paste 1, thick paste 2 and thick paste 4 obtained above are mixed to obtain a drug extract; the drug extract is dissolved into a suspension with 3 times the volume of 95% ethanol solution, and the blank matrix containing glycerol is slowly added thereto, and stirred at a low speed so that the drug extract accounts for 1% of the total amount, and the mixture is stirred and dispersed evenly, and applied on a non-woven fabric while hot, cooled to room temperature, and cut into blocks.

[0052] Example 3 Preparation of an ointment for treating diarrhea-type irritable bowel syndrome

[0053] The raw material formula is: Patchouli 15g, Atractylodes 18g, Tangerine peel 15g, stir-fried White Peony Root 18g, Poria 32g, Magnolia officinalis 15g, Citrus Grandis peel 12g, Gastrodia elata 32g, Saposhnikovia divaricata 12g, Cyperus rotundus 18g, Angelica sinensis 12g, Cynanchum wilfordii 15g, and Radix Glycyrrhizae uralensis 9g.

[0054] The preparation steps are as follows:

[0055] (1) Take Patchouli, Atractylodes, Citrus Reticulatae, Saposhnikovia Divaricata and Cynanchum Root, add 8 times the amount of 50% ethanol solution, heat and reflux to extract twice, each time for 1 hour, combine the extracts, filter, and recover ethanol from the filtrate at 50-60° C. under reduced pressure, and concentrate to a thick paste 1;

[0056] (2) Take Poria cocos, Magnolia officinalis, Chinese magnolia bark and malt sprout, add 8 times the amount of 80% ethanol solution, heat and reflux to extract twice, each time for 1.5 hours, combine the extracts, filter, and reduce the filtrate to 50-60°C to recover ethanol, and concentrate to a thick paste 2;

[0057] (3) Take stir-fried white peony root, cyperus rotundus, angelica sinensis and roasted liquorice, grind them into coarse particles, add 10 times the amount of water, soak for 0.5 hours, collect volatile oil, filter the extract, concentrate to a relative density of 1.05, cool to room temperature, add ethanol to make the alcohol content reach 70%, refrigerate at 4°C for 24 hours, filter, and recover ethanol from the filtrate under reduced pressure at 50-60°C, concentrate to a thick paste 3, add the above-collected volatile oil, mix well to form a thick paste 4, and set aside;

[0058] (4) Take 50 parts of deionized water, add 0.003 parts of disodium ethylenediaminetetraacetate and 800.01 parts of Tween, stir at low speed (60 rpm) to make it uniform, add 2 parts of carbomer-940 resin, stir at medium speed (400 rpm), add 12 parts of carbomer-941 resin in 4 batches, stir at low speed for 1.5 hours until the mixture is uniform, pour into a kneader, adjust the temperature to a constant temperature of 50°C, stir at a constant speed for 2 hours under vacuum, and let it stand to obtain a blank matrix;

[0059] The blank matrix was stirred at a low speed, and a 10% NaOH solution was slowly added to adjust the pH value to 7, and then a glycerol solution with a volume of 15% of the volume of the blank matrix was slowly added and mixed evenly to obtain a blank matrix containing glycerol;

[0060] The thick paste 1, thick paste 2 and thick paste 4 obtained above are mixed to obtain a drug extract; the drug extract is dissolved into a suspension with 3 times the volume of 95% ethanol solution, and the blank matrix containing glycerol is slowly added thereto, and stirred at a low speed so that the drug extract accounts for 5% of the total amount, and the mixture is stirred and dispersed evenly, and applied on a non-woven fabric while hot, cooled to room temperature, and cut into blocks.

[0061] Example 4 Preparation of an ointment for treating diarrhea-type irritable bowel syndrome

[0062] The raw material formula is: Patchouli 10g, Atractylodes 18g, Tangerine peel 10g, stir-fried White Peony Root 18g, Poria 28g, Magnolia officinalis 15g, Citrus Grandis peel 6g, Gastrodia elata 32g, Saposhnikovia divaricata 6g, Cyperus rotundus 18g, Angelica sinensis 6g, Cynanchum wilfordii 15g, and Radix Glycyrrhizae uralensis 3g.

[0063] The preparation method is the same as Example 1.

[0064] Example 5 Preparation of an ointment for treating diarrhea-type irritable bowel syndrome

[0065] The raw material formula is: Patchouli 15g, Atractylodes 12g, Tangerine peel 15g, stir-fried White Peony Root 12g, Poria 32g, Magnolia Bark 10g, Citrus Grandis Peel 12g, Gastrodia elata 28g, Saposhnikovia divaricata 12g, Cyperus rotundus 12g, Angelica sinensis 12g, Cynanchum wilfordii 10g, and Radix Glycyrrhizae uralensis 9g.

[0066] The preparation method is the same as Example 1.

[0067] Clinical research data

[0068] The inventor of the present invention has conducted several completed projects in the previous period. Studies have shown that Wujiajian Zhengqi Powder is a clinically effective prescription for the treatment of acute diarrhea. It can regulate the TLR3 signaling pathway and the expression of downstream factors such as IL-6, IL-1β, TNF-α, IFN-β, etc., intervene in the PI3K / AKT / mTOR signaling pathway and autophagy proteins such as Beclin 1, P62, ATG5, ATG12, and exert significant antiviral and antidiarrheal effects. Based on the theory of treating different diseases with the same treatment, the recipe of the bitter, pungent, warm and transporting method was modified to prepare a Huoling antidiarrheal acupoint plaster for the treatment of IBS-D.

[0069] 1 Clinical Data

[0070] 1.1 Diagnostic criteria

[0071] 1.1.1 Western medicine diagnostic criteria

[0072] Refer to the IBS diagnostic criteria proposed in the "2020 Expert Consensus on Irritable Bowel Syndrome": recurrent abdominal pain, bloating, abdominal discomfort, symptoms related to defecation, changes in defecation frequency, and changes in stool characteristics or appearance. 2 or more. And the symptoms have appeared for at least 6 months, and the frequency of onset is more than 1 day per week in the past 3 months. Among them, according to the stool characteristics of patients when they have abnormal bowel movements (Bristol Stool Characteristics Scale), they are divided into 4 subtypes, among which the stool characteristics of IBS-D are: more than 25% of the bowel movements are Bristol type 6 or type 7, and less than 25% of the bowel movements are Bristol type 1 or type 2.

[0073] 1.1.2 TCM diagnostic criteria

[0074] According to the "Expert Consensus on TCM Diagnosis and Treatment of Irritable Bowel Syndrome (2017)" formulated by the Chinese Association of Traditional Chinese Medicine's Spleen and Stomach Diseases Branch, TCM syndrome differentiation is spleen deficiency and dampness obstruction syndrome. The main symptoms are: 1) loose stools; 2) dull abdominal pain. Secondary symptoms: 1) fatigue; 2) poor appetite; 3) abdominal distension. Tongue and pulse: pale tongue, with teeth marks on the edges, greasy white fur; weak pulse. The above syndromes have two of the main symptoms; or one of the main symptoms and two of the secondary symptoms, and can be diagnosed by combining tongue and pulse.

[0075] 1.2 Inclusion criteria

[0076] (1) Meet the above-mentioned Western medicine and Chinese medicine diagnostic criteria for IBS-D. (2) No obvious abnormalities in the three major routine tests of blood, urine and stool, biochemical indicators, coagulation function, and electrocardiogram results. (3) No other organic intestinal diseases such as intestinal tumors, inflammatory bowel disease, etc. were found in gastrointestinal endoscopy. (4) Gender is not limited, age is between 18 and 70 years old. (5) Have an education level higher than elementary school, can communicate and complete the questionnaire independently. (6) Did not take other medications 2 weeks before medication. (7) Voluntarily accept the corresponding treatment and sign the informed consent form.

[0077] 1.3 Exclusion criteria

[0078] (1) Patients with allergic constitution who are allergic to multiple foods and drugs. (2) Those with systemic diseases, mental disorders, or other diseases in the acute stage. (3) Children, pregnant or breastfeeding women. (4) Those participating in other projects.

[0079] 1.4 Falling off and rejection criteria

[0080] (1) Severe complications occurred during the trial and other measures must be taken. (2) Patients with poor compliance, unable to take medication as required, and unable to follow up on schedule. (3) Patients who are unwilling to continue to cooperate with treatment, lost to follow-up or died.

[0081] 1.5 Treatment

[0082] Control group: On the basis of lifestyle education, patients were given conventional Meichangan (Bacillus subtilis combined with live bacteria enteric-coated capsules), specification: 250mg×20 capsules / box, manufacturer: Beijing Hanmei Pharmaceutical Co., Ltd., approval number: National Medicine Standard S20030087, 500mg (2 capsules) each time, 3 times a day, taken warm half an hour after meals, 4 weeks as a course of treatment.

[0083] Experimental group: Based on lifestyle education, Huoling Antidiarrhea Paste (prepared according to the method of Example 1, all prepared by the Chinese Medicine Pharmacy of Shandong Provincial Hospital of Traditional Chinese Medicine) was applied to the acupoints. After the Shenque acupoint was disinfected with iodine or alcohol, the paste was applied and changed once every night to ensure 8 hours of application time, for a total of 4 weeks.

[0084] 1.6 Safety Evaluation Criteria

[0085] Grade 1: safe, no adverse reactions. Grade 2: relatively safe, no impact on continued administration, and no special treatment required. Grade 3: safety issues exist, moderate adverse reactions, administration can continue after treatment. Grade 4: severe adverse reactions occur and the trial is terminated.

[0086] 1.7 Criteria for judging the severity of adverse events

[0087] Mild: Tolerable, does not affect treatment and recovery, no special treatment is required. Moderate: Unbearable, immediate discontinuation of medication or special treatment is required, and has an impact on recovery. Severe: Life-threatening, immediate discontinuation of medication or emergency treatment is required.

[0088] 1.8 Medical Ethics Control

[0089] When enrolled in a clinical study, the researcher will inform the patient of the following matters in detail, including the patient's Chinese and Western medicine diagnosis, Chinese medicine syndrome differentiation, further treatment plan, expected treatment goals, possible adverse reactions, etc. The address and phone number should be recorded in detail for clinical follow-up treatment. If symptoms worsen or discomfort occurs after treatment, the researcher should be contacted by phone in a timely manner to stop treatment, treat symptoms, and withdraw from the study. The whole process is based on the principle of voluntary participation and voluntary withdrawal.

[0090] 1.9 Statistical methods

[0091] According to the collected data, a database was established, and SPSS26.0 was used for statistical analysis. The corresponding statistical method was selected according to the data type, and correlation analysis was used: the measurement data that conformed to the normal distribution was tested by t test, and the measurement data that were not normally distributed were tested by rank sum test. The non-ranked data in the count data were tested by chi-square test, and the ranked data were tested by rank sum test, and multiple comparisons were performed: the test level α = 0.05, and P < 0.05 was considered statistically significant.

[0092] 2 Observation indicators

[0093] 2.1 TCM syndrome scoring

[0094] According to the "Expert Consensus on TCM Diagnosis and Treatment of Irritable Bowel Syndrome (2017)" and the "Guidelines for Clinical Research of New Chinese Medicines", the TCM syndrome scoring table is divided into major symptoms and minor symptoms. The major symptoms include diarrhea and abdominal pain; the minor symptoms include fatigue, poor appetite, and abdominal distension. The symptoms are divided into 4 levels according to the severity, including none, mild, moderate, and severe, and recorded with different scores. The major symptoms are recorded as 0, 2, 4, and 6 points, and the minor symptoms are recorded as 0, 1, 2, and 3 points. The tongue and pulse are not included in the score table.

[0095] 2.2 IBS severity questionnaire (IBS-SSS scale)

[0096] With reference to the Expert Consensus on Diagnosis and Treatment of Irritable Bowel Syndrome in Traditional Chinese Medicine (2017), the patients' abdominal pain severity, frequency of abdominal pain, degree of abdominal distension, bowel satisfaction, and life problems were investigated. Each aspect was divided into five levels (level 1: 20 points, level 2: 40 points, level 3: 60 points, level 4: 80 points, level 5: 100 points), with a minimum of 100 points and a maximum of 500 points.

[0097] 2.3 IBS Stool Characteristics Questionnaire (IBS-DSQ Scale)

[0098] The investigation was conducted in three aspects: stool characteristics, number of days with urgent bowel movements within 10 days, and number of bowel movements per day. The stool characteristics were based on the Bristol Stool Characteristics Scale in the "Expert Consensus on the Diagnosis and Treatment of Irritable Bowel Syndrome in Traditional Chinese Medicine (2017)". Stool characteristics were divided into normal, scattered lumpy soft stools, mushy stools, and watery stools, which were scored as 0, 1, 2, and 3 points respectively.

[0099] 2.4 Efficacy evaluation criteria

[0100] Evaluation criteria for efficacy of TCM syndromes: According to the Guiding Principles for Clinical Research of New Chinese Medicines, the nimodipine method was used for calculation: efficacy index = [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%.

[0101] Clinically cured: clinical symptoms and signs basically disappear, with an efficacy index of 95%. Significantly effective: clinical symptoms and signs are significantly improved, with an efficacy index of 70% ≤ < 95%. Effective: clinical symptoms and signs are improved, with an efficacy index of 30% ≤ < 70%. Ineffective: clinical symptoms and signs are not significantly improved, or even aggravated, with an efficacy index of < 30%.

[0102] 3 Research results

[0103] 3.1 Comparison of baseline data

[0104] There were 22 males and 18 females in the experimental group, and 20 males and 20 females in the control group. The average age of the patients in the experimental group was 35.8 years old, and the average age of the patients in the control group was 36.0 years old. The average age of the patients in the experimental group was 16.1 months, and the average age of the patients in the control group was 16.8 months. There was no significant difference in age, gender, and disease course between the experimental group and the control group (P>0.05).

[0105] 3.2 Comparison of TCM syndrome scores

[0106] As shown in Table 1, there was no significant difference in the symptom scores and syndrome scores between the two groups before treatment (P>0.05), and they were comparable. After treatment, the syndrome scores and the scores of diarrhea, abdominal pain, and abdominal distension in the experimental group were lower than those in the control group, and the differences were statistically significant (P<0.05), among which the scores of diarrhea and abdominal pain were significantly different (P<0.01); although the scores of fatigue and poor appetite were lower than those in the control group, the differences were not statistically significant (P>0.05).

[0107] Table 1 Comparison of TCM syndrome scores (M(P25,P75))

[0108]

[0109]

[0110] Comparison before and after treatment within the group, 1) P < 0.05; comparison between groups after treatment, 2) P < 0.05, 3) P < 0.01, 4) P > 0.05.

[0111] 3.3 Comparison of TCM syndrome efficacy

[0112] As shown in Table 2, in the experimental group, 5 cases were clinically cured, 21 cases were markedly effective, 10 cases were effective, and 4 cases were ineffective. The marked effective rate and the total effective rate were 65.00% and 90.00%, respectively; in the control group, 2 cases were cured, 12 cases were markedly effective, 16 cases were effective, and 10 cases were ineffective. The marked effective rate and the total effective rate were 35.00% and 75.00%, respectively. The differences between the two groups were statistically significant (P < 0.05 or 0.01).

[0113] Table 2 Comparison of efficacy of TCM syndromes

[0114]

[0115] Comparison between groups after treatment: 1) P < 0.01, 2) P < 0.05.

[0116] 3.4 Comparison of IBS severity questionnaire (IBS-SSS scale) scores

[0117] As shown in Table 3, there was no significant difference in the severity scores and total scores between the two groups before treatment (P>0.05), indicating that they were comparable. After treatment, the total score and symptom scores of the experimental group were lower than those of the control group, and the differences were statistically significant (P<0.05).

[0118] Table 3 Comparison of IBS-SSS scale scores

[0119]

[0120]

[0121] Comparison before and after treatment within the group, 1) P < 0.05; comparison between groups after treatment, 2) P < 0.05.

[0122] 3.5 Comparison of IBS Stool Characteristics Questionnaire (IBS-DSQ) Scores

[0123] There was no significant difference in stool characteristics scores between the two groups before treatment (P>0.05), indicating comparability. After treatment, the stool characteristics scores of all groups were skewed distributions, which were analyzed by rank sum test and expressed as M (P25, P75) (see Table 4). The results showed that the stool characteristics scores of the experimental group were lower than those of the control group, and the difference was statistically significant (P<0.05).

[0124] Table 4 Comparison of IBS-DSQ scale scores

[0125]

[0126] Comparison of the same group before and after treatment, 1) P < 0.05; comparison between the two groups after treatment, 2) P < 0.05.

[0127] 4 Discussion

[0128] The etiology of diarrhea-predominant irritable bowel syndrome is not yet clear. It is currently believed to be related to visceral hypersensitivity, abnormal gut-brain axis and intestinal motility, intestinal microecological imbalance, immune regulation dysfunction, bile acid metabolism disorder and psychological factors. The name of the disease is not recorded in ancient medical books. Most doctors classify it as "diarrhea" based on the symptoms of diarrhea. Later, there are many expressions such as "cave diarrhea" and "sun diarrhea". The causes are external evil six evils, improper diet, emotional disorder, weak viscera, and insufficient endowment. The disease is located in the large intestine and is closely related to the liver, spleen, and kidney. The main pathogenesis is spleen deficiency and dampness, and intestinal dysfunction. "Suwen" says: "When dampness prevails, it will cause diarrhea" and "all dampness and swelling belong to the spleen."

[0129] Wu Jutong, in his Treatise on Warm Diseases, established five types of Zhengqi Powder for various symptoms caused by dampness and depression in the three jiao. Among them, Wujiajian Zhengqi Powder is used to harmonize the spleen and stomach, remove dampness and stop diarrhea, and is used for symptoms of "dirty dampness inside, abdominal distension and diarrhea", that is, the symptoms of damp heat turning from yin to cold when the yang qi in the middle jiao is insufficient or the yang of the spleen is suppressed. Previous studies have confirmed that Wujiajian Zhengqi Powder can treat viral enteritis through multiple pathways and multiple targets. Since viral enteritis and diarrhea-type irritable bowel syndrome share the same fundamental pathogenesis of "spleen deficiency and dampness", following the principle of treating different diseases with the same treatment, based on the classic prescription Wujiajian Zhengqi San (recorded in the literature: Clinical Observation on Wujiajian Zhengqi San in the Treatment of Cold-Damp Type Diarrhea-Type Irritable Bowel Syndrome. Chinese Journal of Traditional Chinese Medicine, Vol. 33, No. 1, January 2018), taking into account the subcutaneous absorption efficacy of topical drugs, the purity difference of non-authentic medicinal materials, and the unique pathological characteristics of diarrhea-type irritable bowel syndrome - "spleen stores intention" and "liver stores soul" and other factors, wind-clearing drugs Fangfeng and Xu Changqing were added to dispel wind and dampness, relieve spasms and relieve pain; blood-nourishing drugs Xiangfu and blood-nourishing drugs Angelica were added to soothe the liver and relieve depression, nourish blood and regulate menstruation; liquorice was combined with licorice to strengthen the spleen and replenish qi, harmonize the middle and detoxify, and combined with peony, acid and sweet to transform yin, liver and spleen to harmonize, relieve urgency and relieve pain. All the drugs are matched to soften the liver and awaken the spleen, regulate qi and blood, and calm the intestines and stop diarrhea.

[0130] Huoling Antidiarrhea Plaster Therapeutic Method: Move the spleen and earth to drain the liver and wood, regulate the qi mechanism to stop pain and diarrhea, and promote qi and blood circulation to eliminate dampness and turbidity. "The principle of external treatment is the principle of internal treatment, and the medicine for external treatment is the medicine for internal treatment." Based on the holistic concept of traditional Chinese medicine, the theory of meridians, and the physiological functions of acupoints, the process, quality, stability, etc. of this plaster were studied, and its physical properties were determined to be a yellow-brown thick semi-solid with a fragrant smell and a slightly bitter taste. The total saponin content in the preparation was determined by ultraviolet spectrophotometry. When used, apply it to the Shenque acupoint, so that the drug can exert its therapeutic effect through direct subcutaneous absorption and indirect stimulation of the acupoint meridian qi.

[0131] Clinical studies have shown that after treatment, the symptom scores and the scores of diarrhea, abdominal pain, and abdominal distension in the experimental group were lower than those in the control group, and the difference was statistically significant (P < 0.05), among which the scores of diarrhea and abdominal pain were significantly different (P < 0.01); the marked effectiveness rate and total effectiveness rate of the experimental group were 65.00% and 90.00%, respectively, and the marked effectiveness rate and total effectiveness rate of the control group were 35.00% and 75.00%, respectively, and the differences between the two groups were statistically significant (P < 0.05 or 0.01); the improvement degree of IBS-SSS scale and IBS-DSQ scale in the experimental group was better than that in the control group, and the difference was significant (P < 0.05).

[0132] 5 Conclusion

[0133] The ointment for treating diarrhea-type irritable bowel syndrome of the present invention has a clinical application effect that is significantly better than that of a conventional western medicine group and has good safety. In addition, the ointment is simple, easy to use, inexpensive, and simple in medicine, which provides a guarantee for its clinical promotion.

[0134] The above examples are provided to those skilled in the art to fully disclose and describe how to make and use the claimed embodiments, and are not intended to limit the scope of the disclosure herein. Modifications that are obvious to those skilled in the art will fall within the scope of the appended claims.

Claims

1. An ointment for treating diarrhea-type irritable bowel syndrome, characterized in that: It is made from the following raw materials: Patchouli 10-15g, Atractylodes 12-18g, Tangerine peel 10-15g, stir-fried White Peony Root 12-18g, Poria 28-32g, Magnolia officinalis 10-15g, Citrus Grandis peel 6-12g, Gastrodia elata 28-32g, Saposhnikovia divaricata 6-12g, Cyperus rotundus 12-18g, Angelica sinensis 6-12g, Cynanchum wilfordii 10-15g, and Radix Glycyrrhizae uralensis 3-9g.

2. The ointment for treating diarrhea-type irritable bowel syndrome according to claim 1, characterized in that: It is made from the following raw materials: Patchouli 12g, Atractylodes 15g, Tangerine Peel 12g, Stir-fried White Peony Root 15g, Poria 30g, Magnolia Bark 12g, Citrus Grandis Peel 9g, Valley Bud 30g, Saposhnikovia Divaricata 9g, Cyperus 15g, Angelica Sinensis 9g, Cynanchum Chimonanthus 12g, and Roasted Licorice 6g.

3. The ointment for treating diarrhea-type irritable bowel syndrome according to claim 1, characterized in that: It is made from the following raw materials: Patchouli 10g, Atractylodes 12g, Tangerine Peel 10g, Fried White Peony Root 12g, Poria 28g, Magnolia Bark 10g, Citrus Grandis Peel 6g, Valley Bud 28g, Saposhnikovia Divaricata 6g, Cyperus 12g, Angelica Sinensis 6g, Cynanchum Chimonanthus 10g, and Radix Glycyrrhizae Radix 3g.

4. The ointment for treating diarrhea-type irritable bowel syndrome according to claim 1, characterized in that: It is made from the following raw materials: Patchouli 15g, Atractylodes 18g, Tangerine Peel 15g, Stir-fried White Peony Root 18g, Poria 32g, Magnolia Bark 15g, Citrus Grandis Peel 12g, Valley Bud 32g, Saposhnikovia Divaricata 12g, Cyperus Root 18g, Angelica Sinensis 12g, Cynanchum Chimonanthus 15g, and Radix Glycyrrhizae Radix 9g.

5. The method for preparing the ointment for treating diarrhea-type irritable bowel syndrome according to any one of claims 1 to 4, characterized in that: The following steps are involved: (1) taking Patchouli, Atractylodes, Citrus reticulata, Saposhnikovia divaricata and Cynanchum chinense, heating ethanol solution to reflux extraction, filtering, and concentrating the filtrate into a thick paste 1 for standby use; (2) Take Poria cocos, Magnolia officinalis, Chinese magnolia bark and malt sprout, heat and reflux the ethanol solution for extraction, filter, and concentrate the filtrate into a thick paste 2 for later use; (3) Take stir-fried white peony root, cyperus rotundus, angelica sinensis and roasted liquorice, grind them into coarse particles, add water, soak them, and collect volatile oil; filter and concentrate the extract, add ethanol to extract, filter, and concentrate the filtrate into a thick paste 3; mix the thick paste 3 with the volatile oil to form a thick paste 4 for later use; (4) The thick paste 1, thick paste 2 and thick paste 4 obtained above are mixed to obtain a drug extract, which is then made into an ointment.

6. The method for preparing the ointment for treating diarrhea-type irritable bowel syndrome according to claim 5, characterized in that: In the steps (1) and (2), the volume concentration of the ethanol solution is 50% to 95%; the amount of the ethanol solution added is 6 to 12 times the weight of the raw material drug; the heating reflux times are 1 to 3 times, and the extraction time each time is 1 to 2 hours; Or: In step (3), the amount of water added is 6 to 12 times the weight of the raw material drug; Or: In steps (1), (2) and (3), the water content of the thick paste is 15% to 20%.

7. The method for preparing the ointment for treating diarrhea-type irritable bowel syndrome according to claim 5 or 6, characterized in that: The specific operation of step (1) is as follows: take Patchouli, Atractylodes, Tangerine Peel, Saposhnikovia and Cynanchum, add 8 times the amount of 50% ethanol solution, heat and reflux to extract twice, each time for 1 hour; combine the extracts, filter, and recover ethanol from the filtrate at 50-60° C. under reduced pressure, and concentrate it into a thick paste 1 with a water content of 15%-20%, which is set aside.

8. The method for preparing the ointment for treating diarrhea-type irritable bowel syndrome according to claim 5 or 6, characterized in that: The specific operation of step (2) is as follows: take Poria cocos, Magnolia officinalis, Chinese magnolia bark and malt sprout, add 8 times the amount of 80% ethanol solution, heat and reflux to extract twice, each time for 1.5 hours; combine the extracts, filter, reduce the filtrate at 50-60°C to recover ethanol, and concentrate it into a thick paste 2 with a water content of 15%-20%, which is set aside.

9. The method for preparing the ointment for treating diarrhea-type irritable bowel syndrome according to claim 5 or 6, characterized in that: The specific operation of step (3) is as follows: take stir-fried white peony root, cyperus rotundus, angelica and roasted liquorice, grind them into coarse particles, add 10 times the amount of water, soak for 0.5 hours, and collect volatile oil; filter the extract, concentrate to a relative density of 1.05, cool to room temperature, add ethanol to make the alcohol content reach 70% (volume percentage), refrigerate at 4°C for 24 hours, filter, reduce the filtrate to 50-60°C to recover ethanol, and concentrate it into a thick paste 3 with a water content of 15%-20%; mix the thick paste 3 with the volatile oil to form a thick paste 4 for standby use.

10. The method for preparing the ointment for treating diarrhea-type irritable bowel syndrome according to claim 5, characterized in that: The specific operation of step (4) is as follows: ① Take 50 parts of deionized water, add 0.001-0.003 parts of disodium ethylenediaminetetraacetate and 0.01-0.03 parts of sorbitan monooleate polyoxyethylene ether, stir evenly, add 2 parts of carbomer-940 resin, stir evenly, add 12 parts of carbomer-941 resin, stir evenly, pour into a kneader, stir at a constant speed at 50°C in a vacuum for 2 hours, and let stand to obtain a blank matrix; each component is measured by weight; ② Slowly add NaOH solution to the blank matrix to adjust the pH value to 5-7, then add glycerol in a volume of 15%-22% of the volume of the blank matrix, mix well, and obtain a blank matrix containing glycerol; ③ Mix the thick paste 1, thick paste 2 and thick paste 4 obtained above to obtain a drug extract; dissolve the drug extract into a suspension with a 95% ethanol solution, and then add the blank matrix containing glycerol prepared above to make the drug extract account for 1% to 5% of the total amount, stir and disperse evenly, apply it on a non-woven fabric while hot, cool to room temperature, and cut into blocks to obtain.

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