Pasting Chinese patent medicine composition as well as preparation method, use method and application thereof

Abstract

The invention discloses an application Chinese patent medicine composition as well as a preparation method, a use method and application thereof, relates to the technical field of traditional Chinese medicines, and achieves the purpose of treating diarrhea by virtue of simple combination of scorpion and charred triplet and acupoint application treatment by stimulating specific body surface acupoints of children, dredging channels, regulating yin and yang and improving vitality. Through the simple pharmaceutical composition and the matched use method, the problem that other drugs for treating infantile diarrhea are difficult and do not cooperate with each other is solved. The application has the beneficial effects that the application is simple, the effect is obvious, the application method is simple, acupoint selection is convenient, pain is avoided, dialectical compatibility is not needed, the application can be popularized and applied clinically, the application can be used for treating infantile diarrhea, the cure rate and the total effective rate can be improved, and the application has a wide application prospect. The traditional Chinese medicine composition has the advantages of being simple in use method, free of pain, easy to accept and the like.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a Chinese patent medicine composition for application and a preparation method, use method and application thereof. Background Art

[0002] In traditional Chinese medicine, pediatric diarrhea is mainly due to the fact that children are weak, easily affected by cold evil, and their spleen and stomach are damaged, so that the essence of water and grain cannot be transformed, and the clear and turbid cannot be separated, resulting in diarrhea. Therefore, pediatric diarrhea is closely related to the regulation of gastrointestinal function. Traditional Chinese medicine has a variety of means to supplement the limitations of Western medicine in treating pediatric diarrhea, and combine treatments to improve the cure rate. Traditional Chinese medicine calls pediatric diarrhea "pediatric diarrhea", and its pathogenesis is mainly caused by: exposure to external evil, internal injury to diet, spleen and stomach weakness, spleen and kidney yang deficiency, which further leads to the dysfunction of spleen and stomach transportation and transformation, and the intestinal separation of clear and turbid and conduction function is disordered, causing disease. Most views of traditional Chinese medicine believe that "there is no diarrhea without dampness", and dampness causes water and body fluid metabolism disorders. Dampness is sticky in nature and damages yang energy, making the disease lingering and difficult to treat. Dampness is trapped in the spleen and stomach, resulting in the inability of water and dampness to flow, and water and dampness directly stagnate in the intestines, leading to diarrhea.

[0003] In traditional Chinese medicine treatment, the idea of ​​holistic syndrome differentiation treatment is often combined with a variety of methods, such as oral Chinese medicine, pediatric massage, acupoint application, moxibustion treatment, enema, acupuncture, etc. In particular, acupoint application and pediatric massage treatment are particularly favored by children and parents, with no pain and obvious effects, pure natural green therapy, and no toxic side effects. Oral Chinese medicine for the treatment of diarrhea is mainly composed of Chinese medicine for clearing heat and dampness, strengthening the stomach and spleen, and aromatic dampness, with the purpose of stopping diarrhea, regulating the spleen and stomach, invigorating qi and warming the kidneys, etc. There are many external treatment methods. Acupoint application acts on special acupoints such as the abdomen, back, and legs through drugs, which can promote the circulation of qi and blood in the meridians, harmonize the yin and yang of the internal organs, and then improve immunity and improve symptoms. It is simple to operate, painless and has no side effects, and children cooperate actively. Moxa stick moxibustion for the treatment of diarrhea in children, on the one hand, plays the role of moxa stick in dispelling wind and cold, warming and unblocking meridians, and on the other hand, stimulates acupoints on the basis of warmth, achieving the effect of killing two birds with one stone, but the operation process of moxa stick moxibustion has certain risks, and children may occasionally be burned due to poor cooperation. Enema treatment is currently more commonly used in clinical practice, and montmorillonite powder and Chinese medicine decoction are often used. However, the children do not cooperate and the process is painful, so the operation is somewhat difficult. Acupuncture treatment for pediatric diarrhea mostly uses acupuncture points on the abdomen and lower limbs. According to the condition and the degree of cooperation of the children, the length of time the needle is retained is controlled. It has a certain therapeutic effect, but the pain during acupuncture and the fear of needles in children make this treatment difficult to promote.

[0004] At present, there are many patch medicines for pediatric diarrhea, but the drug compositions are various and the treatment effects are also general. The existing publication number is CN 109106919 A, which is a Shenque acupoint external patch ointment for treating diarrhea and its preparation method, which specifically discloses an external patch ointment made of the following Chinese herbal medicine raw materials in weight proportion: 1-2 parts of cloves, 1-3 parts of cinnamon, 1-3 parts of Evodia rutaecarpa, 1-4 parts of Atractylodes, 1-4 parts of fried fennel, 1-4 parts of gallnut, 1-3 parts of fried hawthorn, 1-5 parts of fried malt, 1-5 parts of Magnolia officinalis, 1-2 parts of costus root, 1-2 parts of dried ginger, 1-2 parts of Coptis chinensis, 1-5 parts of white cardamom, 1-5 parts of antler frost, and 35-45 parts of honey.

[0005] The existing primary medicine forum, in the 12th issue of Volume 28 in 2024, published the effects of Chinese medicine plastering on the Shenque acupoint combined with abdominal massage on the gastrointestinal function of infants with diarrhea. It specifically disclosed the application of Chinese medicine plastering on the Shenque acupoint. 15g each of cloves, Evodia rutaecarpa, Plantago, Gallnut, Aconite, and Cinnamon were selected, ground into powder, added with appropriate amount of ginger juice, and adjusted into a paste-like medicine cake weighing about 5g, and cleaned the Shenque acupoint of the child.

[0006] Existing patch drugs have many components and slow therapeutic effects, which are the same as or lagging behind Western medicine treatments. Therefore, it is of great significance to develop drugs for pediatric diarrhea that have a simple composition, safe and effective efficacy, high treatment acceptance, obvious effects, and are economical. Summary of the invention

[0007] In view of the deficiencies in the prior art, the present invention provides a Chinese patent medicine composition for patch application and its preparation, use and application. Through the simplified combination of Quanxie and Jiao Sanxian, acupoint patch therapy is adopted to stimulate the specific acupoints on the surface of children, dredge the meridians, harmonize yin and yang, and enhance the vitality, so as to achieve the purpose of treating diarrhea. Through the simplified medicine composition and the method of combined use, the problem of difficulty and incompatibility of other medicine treatments and methods for children's diarrhea is solved.

[0008] The invention protects a Chinese patent medicine composition for patch application, which is composed of the following raw materials in parts by weight: 1-5 parts of whole scorpion, 1-3 parts of charred hawthorn, 1-3 parts of charred Shenqu, 1-3 parts of charred malt and 2-20 parts of honey.

[0009] Furthermore, the present invention protects a Chinese patent medicine composition for patch application, which is composed of the following raw materials in parts by weight: 1-2 parts of whole scorpion, 2-3 parts of charred hawthorn, 2-3 parts of charred Shenqu, 2-3 parts of charred malt, and 4-12 parts of honey.

[0010] Furthermore, the present invention protects a Chinese patent medicine composition for patch application, which is composed of the following raw materials in parts by weight: 2-3 parts of whole scorpion, 1-2 parts of charred hawthorn, 1-2 parts of charred Shenqu, 1-2 parts of charred malt, and 4-10 parts of honey.

[0011] Furthermore, the present invention protects a Chinese patent medicine composition for patch application, which is composed of the following raw materials in parts by weight: 1-2 parts of whole scorpion, 1-2 parts of charred hawthorn, 1-2 parts of charred Shenqu, 1-2 parts of charred malt, and 2-8 parts of honey.

[0012] Furthermore, the present invention protects a Chinese patent medicine composition for patch application, which is composed of the following raw materials in parts by weight: 1 part of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt, and 2 parts of honey.

[0013] Furthermore, the present invention protects a Chinese patent medicine composition for patch application, which is composed of the following raw materials in parts by weight: 1 part of whole scorpion, 2 parts of charred hawthorn, 2 parts of charred Shenqu, 2 parts of charred malt, and 6 parts of honey.

[0014] Furthermore, the present invention protects a Chinese patent medicine composition for patch application, which is composed of the following raw materials in parts by weight: 2 parts of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt, and 5 parts of honey.

[0015] Furthermore, the present invention protects a Chinese patent medicine composition for patch application, which is composed of the following raw materials in parts by weight: 3 parts of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt, and 7 parts of honey.

[0016] The present invention also protects the use of a patch-applied Chinese patent medicine composition, wherein the patch-applied Chinese patent medicine composition is used for treating diarrhea in children.

[0017] The present invention also protects a method for preparing a patch Chinese patent medicine composition, which specifically comprises the following steps:

[0018] Step 1, mix the whole scorpion, charred hawthorn, charred Shenqu, and charred malt in the above proportion, grind into powder, and pass through a 100-mesh sieve;

[0019] Step 2: Mix the above powder with honey in a corresponding proportion to make medicine beads with a diameter of 1-2 cm.

[0020] The present invention also protects a method for using the Chinese patent medicine composition for patch application, which is specifically used as follows: placing the prepared medicine beads in the middle of the patch application, and placing the patch application on the Shenque acupoint of the patient, maintaining it for 3-4 hours, once a day, and 3-5 days as a course of treatment;

[0021] According to the patient's symptoms, the above-mentioned Chinese patent medicine composition is applied in combination with stimulation of body surface acupoints, wherein the body surface acupoints are Zusanli and / or Zhongwan acupoints.

[0022] Patients who are allergic to adhesive tape can use gauze or binding dressings instead of acupoint plastering.

[0023] During treatment, the drug is not suitable for infants whose umbilical cord has not fallen off, children with ulcers around the navel, and children who are allergic to scorpion drugs.

[0024] The beneficial effects of the present invention are as follows: the Chinese patent medicine composition for patch application has simple medication, obvious effect, simple method of use, convenient acupoint selection, no pain, no need for syndrome differentiation and combination, can be promoted and applied in clinical practice, and the application of patch therapy to treat diarrhea in children can improve its cure rate and total effective rate, improve the satisfaction of patients' families, and has the advantages of simple method, no pain, easy acceptance, etc. DETAILED DESCRIPTION

[0025] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0026] Example 1

[0027] A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: 1 part of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt and 2 parts of honey.

[0028] Example 2

[0029] A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: 1 part of whole scorpion, 2 parts of charred hawthorn, 2 parts of charred Shenqu, 2 parts of charred malt, and 6 parts of honey.

[0030] Example 3

[0031] A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: 2 parts of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt, and 5 parts of honey.

[0032] Example 4

[0033] A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: 3 parts of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt, and 7 parts of honey.

[0034] Example 5

[0035] A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: 5 parts of whole scorpion, 3 parts of charred hawthorn, 3 parts of charred Shenqu, 3 parts of charred malt, and 20 parts of honey.

[0036] Example 6

[0037] A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: A Chinese patent medicine composition for patch application is composed of the following raw materials in parts by weight: 5 parts of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt, and 16 parts of honey.

[0038] Example 7

[0039] Pharmacology and synergistic effects of combined drugs

[0040] Scorpion (also known as whole insect, scorpion), the drug tastes pungent and flat, belongs to the liver meridian, because it has the effects of calming wind and relieving spasm, unblocking meridians and relieving pain, attacking poison and dispersing knots. It is mainly used to treat liver wind movement, spasm and convulsions, infantile convulsions, stroke and oral Hemiplegia, tetanus, rheumatism, migraine, sore, scrofula, etc. Studies have shown that the polysaccharide components in scorpions have certain anti-inflammatory effects. In addition, they also have multiple activities such as analgesia, growth promotion, and immunity enhancement. Therefore, the use of scorpions is simple, no syndrome differentiation is required, and it is easier to promote.

[0041] Jiao Sanxian is a three-flavor medicine, namely, scorched malt, scorched hawthorn, and scorched Shenqu. All three medicines have good functions of eliminating stagnation, but they have their own characteristics. Scorched malt has a good effect on digesting starchy foods; scorched hawthorn is good at treating food stagnation caused by excessive meat or greasy food; and scorched Shenqu is good for digesting rice and flour foods. The combination of these three medicines can significantly enhance the digestive function. Therefore, in clinical practice, doctors often use the three medicines together and call them "Jiao Sanxian".

[0042] Burnt malt is made by germinating barley. The malt is placed in a pot and lightly fried until it turns yellow, then sprayed with water and taken out to dry. Burnt malt has the functions of strengthening the spleen and stomach, soothing the liver and removing stagnation. It is used to treat indigestion, abdominal distension, loss of appetite, vomiting and diarrhea. Modern research shows that malt is rich in starch decomposition enzymes, invertase, lipase, vitamin B, etc., and has a good digestive effect.

[0043] Scorched hawthorn: slice hawthorn and dry it in the sun, put it in a pot and fry it over high heat until the outside is burnt brown and the inside is yellowish brown, spray it with water, take it out and dry it in the sun. Oral consumption of hawthorn can increase the secretion of digestive enzymes, promote the decomposition and digestion of fat, and is particularly effective for those who suffer from abdominal distension, belching, loss of appetite, abdominal pain, and diarrhea caused by eating too much meat or greasy food. In addition, modern drug tests have shown that hawthorn has the effect of slowly and lastingly lowering blood pressure, lowering cholesterol and triglycerides, preventing atherosclerosis, and dilating coronary arteries, increasing myocardial contractility, and fighting arrhythmias. Therefore, it is beneficial to prevent and treat hypertension, hyperlipidemia, arteriosclerosis and coronary heart disease.

[0044] Jiao Shenqu is a processed product made by mixing whole wheat flour and other medicines (sprouts of Artemisia annua, Xanthium sibiricum, Polygonum hydropiper, almond, adzuki bean, etc.) and fermenting them. Put Shenqu in a pot and fry until the surface is burnt black and the inside is burnt yellow, take it out, spray some water on it, and let it cool. Shenqu is fermented, and all fermented products have the effect of strengthening the spleen and stomach and aiding digestion. Therefore, it is quite effective for indigestion, chest distension and abdominal distension caused by dietary injuries.

[0045] Acupoint application mainly achieves the purpose of stimulating acupoints to treat diseases and improve physical fitness by penetrating drugs into the skin. It is one of the traditional Chinese medical treatment methods. Its advantages are painless, easy to operate, safe and effective. Acupoint application can affect the microbial community on the skin, regulate the distribution of inflammatory neuropeptides in the diseased tissue and acupoints, and reduce the release of inflammatory substances in the diseased tissue. It can also activate the skin immune system as an exogenous stimulus to improve the circulation between blood and tissue fluid and lymph fluid, and the interaction between the skin immune system and the skin microbial community, providing protective defense for the body, thereby maintaining the stability of the human body's internal environment and achieving the purpose of preventing and curing diseases.

[0046] Shenque, also known as the umbilicus, qishe, and qihe. It belongs to the Ren meridian, and is located in the middle of the navel. It has the functions of warming yang and consolidating deficiency, strengthening the spleen and stomach, and nourishing the essence and consolidating the foundation. Shenque acupoint has two meanings: one is that because Shenque is the hub connecting to the mother, it has the meaning of connecting the innate and acquired qi. One is that because Shenque is the hub for the rise and fall of the human body's qi, it is located between the upper, middle and lower three burners and is the source of life force. At the same time, the surrounding organs, large intestine and small intestine, have the functions of separating the clear and turbid and transmitting and storing substances. Therefore, regardless of the anatomy and embryo theory of Western medicine or the meridian theory of traditional Chinese medicine, Shenque has the functions of opening up all meridians, regulating qi and blood, harmonizing yin and yang, and opening up the internal organs. The absorption of drugs is different from the effects of other acupuncture points, and it has a significant effect on the regulation of qi and blood throughout the body. Therefore, regardless of the anatomy and embryo theory of Western medicine or the meridian theory of traditional Chinese medicine, Shenque has the functions of opening up all meridians, regulating qi and blood, harmonizing yin and yang, and opening up the internal organs. [8] . The absorption of drugs is different from other acupuncture points, and it has a significant effect on regulating the qi and blood of the whole body. Therefore, Shenque acupoint is selected to regulate the gastrointestinal tract. Because the skin under the navel has less fat content, rich lymphatic vessels and blood vessels, and high sensitivity, the permeability of drugs applied here is better, and the drugs are more easily absorbed, so this acupoint is selected for treatment.

[0047] Zusanli is located on the outside of the calf, 3 inches below Dubi, on the line connecting Dubi and Jiexi. The simple method of acupuncture is: stand and bend over, with the base of the hand on the same side surrounding the upper outer edge of the patella, and the other four fingers pointing downward, the tip of the middle finger is Zusanli. It can regulate the spleen and stomach: Zusanli is one of the main acupuncture points of the Stomach Meridian of Foot Yangming, and has a good regulating effect on the digestive system. It can treat spleen and stomach diseases such as stomachache, vomiting, abdominal distension, diarrhea, and indigestion. It can strengthen the body's immunity and improve its disease resistance. It has a good health care effect on people with weak constitution, easy fatigue, and low resistance. It can dredge the meridians and activate the collaterals: It can be used to treat lower limb paralysis, knee pain and other diseases, and has a certain effect on relieving symptoms such as leg muscle soreness, numbness, and weakness.

[0048] Zhongwan is an important acupuncture point in the human body. Zhongwan is located in the upper abdomen, on the anterior midline, 4 inches above the navel. It can strengthen the spleen and stomach: Zhongwan acupoint is the gathering point of the stomach and the visceral meeting point of the eight meeting points, and has a good regulating effect on the spleen and stomach functions. It can treat spleen and stomach diseases such as stomachache, abdominal distension, vomiting, diarrhea, and loss of appetite. It can reduce nausea and vomiting: It has a good effect on relieving symptoms such as nausea, vomiting, and hiccups caused by stomach qi rising. It can calm the mind and stabilize the spirit: Zhongwan acupoint also has a certain calming effect, and can assist in the treatment of mental problems such as insomnia and anxiety.

[0049] Example 8

[0050] Efficacy verification test of the pharmaceutical composition of the present invention

[0051] 1. Clinical observation on the treatment of diarrhea in children with whole scorpion combined with Jiao Sanxian powder applied to the "Shenque" acupoint and oral montmorillonite powder.

[0052] 1. Clinical data

[0053] 1.1 General Information

[0054] Data of 120 children with diarrhea admitted to the Department of Pediatrics of Xining Second People's Hospital from January 2021 to April 2023 were selected for prospective study analysis. They were divided into 2 groups according to the random number table method. There were 60 cases in the application group, including 35 boys and 25 girls; the age was 0.6-6 years old, the average was (3.48±0.35) years old, the course of disease was 3-20 days, and the course of disease was concentrated on 4 (2.5, 7) days. There were 60 cases in the observation group, including 30 boys and 30 girls, the age was 0.8-6.5 years old, the average was (4.25±0.21) years old, the course of disease was 2-21 days, and the course of disease was concentrated on 3 (3, 6) days.

[0055] 1.2 Diagnostic criteria

[0056] The Western medicine diagnosis is in line with the relevant diagnostic standards in the "Diagnosis and Treatment of Diarrhea in Children", with watery or mucous stools and no visible pus or blood in the stools; the Chinese medicine diagnosis is in line with the diagnostic standards for diarrhea in the "Standards for Diagnosis and Efficacy of Chinese Medicine Diseases and Syndromes", with diarrhea as the main symptom, and loose or loose stools. If the diet is not careful or the patient is exposed to cold, the frequency of bowel movements will increase, undigested food will be trapped in the stool, the abdomen will be bloated, and there will be occasional abdominal rumbling and dull pain.

[0057] 1.3 Inclusion criteria

[0058] Meet the above diagnostic criteria, age 0.6 to 7 years old, disease course <2 months, no other medications, no other treatments after participating in the treatment. The study obtained informed consent from the family members, and was able to cooperate with the family members and children to complete the course of treatment.

[0059] 1.4 Exclusion criteria

[0060] 1. Patients with other digestive system diseases; patients with malnutrition; patients with severe liver and kidney dysfunction; 2. Patients with skin damage, rashes or other skin lesions; 3. Patients with congenital immunodeficiency and acute abdomen; 4. Patients with coma and severe dehydration symptoms; 5. Patients with signs and symptoms of primary infection foci; patients with heart disease, pneumonia, etc. that affect the body's water and electrolyte metabolism.

[0061] 1.5 Case exclusion criteria

[0062] (1) Those with insufficient information; (2) Parents and children are unable to follow the implementation requirements and have poor medical compliance; (3) Those who experience adverse events or other unpredictable events during treatment and cannot continue treatment.

[0063] (II) Treatment methods

[0064] Clinical observation on the treatment of two groups of children with diarrhea: applying whole scorpion combined with Jiao Sanxian powder on the "Shenque" acupoint and taking montmorillonite powder orally 15-30 minutes before meals.

[0065] 2.1 Patching group:

[0066] Methods: Whole scorpion and Jiao Sanxian powder were applied to the "Shenque" acupoint to treat diarrhea in children. Whole scorpion and Jiao Sanxian were ground into powder and passed through a 150-mesh sieve. Whole scorpion and Jiao Sanxian powder were sieved and mixed with rice wine. The dry and wet conditions were required to be appropriate, without liquid or powder. The powder was filled into the inner circle of 2×2cm empty acupoints for later use. 75% alcohol was used to wipe the navel and surrounding skin of the child and the acupoints filled with medicine were applied to the Shenque acupoint. The application time was controlled according to the age of the child. The application time for children aged 0.6 to 1 year was 2 hours, for children aged 2 to 4 years old, for 4 hours, and for children aged 4 to 6 years old, for 6 hours. Once a day, 3 times as a course of treatment.

[0067] 2.2: Observation Group

[0068] Treatment method: Oral administration of montmorillonite powder 15-30 minutes before meals for the treatment of diarrhea in children, specification: 3g / bag, specific dosage according to the instructions, under 1 year old: 1 / 3 bag once, 3 times / day; 1-2 years old: 1 / 3-2 / 3 bag once, 3 times / day; over 3 years old: 1 bag each time, 3 times / day, diet should be small and frequent, eat light and easily digestible food. 3 days is a course of treatment.

[0069] (III) Observation of therapeutic efficacy

[0070] 3.1 Observation indicators or efficacy evaluation criteria

[0071] (1) After 3 days of treatment, the clinical efficacy of the two groups was compared. The stool characteristics were classified according to the Bristol classification: Type 1 (sheep dung ball-like): hard balls (difficult to pass). Type 2 (twisted dough): twisted dough-like, but with an uneven surface. Type 3 (sausage-like): sausage-like, but with cracks on the surface. Type 4 (banana-like): like a sausage or snake, with a smooth surface. Type 5 (marshmallow-like): soft blocks with smooth broken edges (easy to pass). Type 6 (soft and thick): fluffy blocks with rough edges, mushy stool. Type 7 (liquid): watery, without solid blocks (completely liquid).

[0072] Cured: fever, vomiting, abdominal pain and other symptoms disappeared, bowel movement frequency ≤ 2 times / day, stool characteristics are Bristol type 3-4; Improved: fever, vomiting, abdominal pain and other symptoms improved, bowel movement frequency 3-4 times / day, stool Bristol type 5; Ineffective: diarrhea, fever, vomiting, abdominal pain and other clinical symptoms and stool characteristics have not improved. Total effective rate = (cured + improved) cases / total cases × 100%.

[0073] (2) TCM syndrome score: This was formulated with reference to the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes". The frequency and characteristics of bowel movements, as well as TCM syndromes such as abdominal pain, vomiting, mental state, fever, thirst, diet, urine, complexion, and anal redness were scored before and after treatment. The syndrome score was divided into four levels: none, mild, moderate, and severe, with scores of 0, 2, 4, and 6, respectively. The more severe the clinical symptoms and signs, the higher the score.

[0074] 3.2 Statistical methods

[0075] SPSS 19.0 was used for statistical analysis, and the standard deviation of the quantitative data was used. The data that did not conform to the normal distribution were tested by t-test, and P < 0.01 indicated that the difference was statistically significant. The data that did not conform to the normal distribution were tested by rank sum test, and the median (M) and interquartile range (QR) were used to describe the rank data, and P < 0.05 indicated that the difference was statistically significant.

[0076] 3.3 Results

[0077] (1) Comparison of treatment efficacy between the patch group and the control group

[0078] The total effective rate was 81.6% in the patch group and 76.6% in the control group. The difference between the two groups was statistically significant (P < 0.01). (See Table 1)

[0079] Table 1 Comparison of treatment effects between the application group and the observation group [cases (%)]

[0080]

[0081] (2) Comparison of TCM syndrome scores between the application group and the observation group before and after treatment

[0082] There was no significant difference in TCM syndrome scores between the two groups before treatment (P>0.01), but there was a significant difference before and after treatment (P<0.01) (see Table 2).

[0083] Table 2 Comparison of TCM syndrome scores between the application group and the observation group before and after treatment [M(P25,P75)]

[0084]

[0085] Through long-term observation of the treatment of diarrhea in children with whole scorpion combined with Jiao Sanxian powder applied to the "Shenque" acupoint and oral montmorillonite powder, the effect of whole scorpion combined with Jiao Sanxian powder applied to the "Shenque" acupoint was significantly better than oral montmorillonite powder, and it was highly safe, without toxic side effects, and was highly accepted by parents and children.

[0086] 2. Clinical experimental observation on the treatment of pediatric diarrhea by applying whole scorpion combined with Jiao Sanxian powder to the "Shenque" acupoint and applying to multiple acupoints.

[0087] 1. Clinical data

[0088] 1.1 General Information

[0089] Data of 120 children with diarrhea admitted to the Department of Pediatrics of Xining Second People's Hospital from January 2022 to April 2023 were selected for prospective study analysis. They were divided into two groups according to the random number table method. There were 60 cases in the Shenque group, including 33 boys and 27 girls; the age was 0.7-6 years old, the average was (3.28±0.23) years old, the course of disease was 3-20 days, and the course of disease was concentrated on 4 (2.4, 6.1) days. There were 60 cases in the control group, including 32 boys and 28 girls, the age was 0.6-6.2 years old, the average was (4.2±0.32) years old, the course of disease was 3-21 days, and the course of disease was concentrated on 3 (3.2, 6.1) days.

[0090] 1.2 Diagnostic criteria

[0091] The Western medicine diagnosis is in line with the relevant diagnostic standards in the "Diagnosis and Treatment of Diarrhea in Children", with watery or mucous stools and no visible pus or blood in the stools; the Chinese medicine diagnosis is in line with the diagnostic standards for diarrhea in the "Standards for Diagnosis and Efficacy of Chinese Medicine Diseases and Syndromes", with diarrhea as the main symptom, and loose or loose stools. If the diet is not careful or the patient is exposed to cold, the frequency of bowel movements will increase, undigested food will be trapped in the stool, the abdomen will be bloated, and there will be occasional abdominal rumbling and dull pain.

[0092] 1.3 Inclusion criteria

[0093] Meet the above diagnostic criteria, age 0.6 to 7 years old, disease course <2 months, no other medications, no other treatments after participating in the treatment. The study obtained informed consent from the family members, and was able to cooperate with the family members and children to complete the course of treatment.

[0094] 1.4 Exclusion criteria

[0095] 1. Patients with other digestive system diseases; patients with malnutrition; patients with severe liver and kidney dysfunction; 2. Patients with skin damage, rashes or other skin lesions; 3. Patients with congenital immunodeficiency and acute abdomen; 4. Patients with coma and severe dehydration symptoms; 5. Patients with signs and symptoms of primary infection foci; patients with heart disease, pneumonia, etc. that affect the body's water and electrolyte metabolism.

[0096] 1.5 Case exclusion criteria

[0097] (1) Those with insufficient information; (2) Parents and children are unable to follow the implementation requirements and have poor medical compliance; (3) Those who experience adverse events or other unpredictable events during treatment and cannot continue treatment.

[0098] (II) Treatment methods

[0099] 2.1 Shenque Group:

[0100] Methods: The whole scorpion and Jiao Sanxian powder were applied to the "Shenque" acupoint for treatment. The whole scorpion and Jiao Sanxian were ground into powder and passed through a 150-mesh sieve. The whole scorpion and Jiao Sanxian powder were sieved and mixed with rice wine. The dry and wet conditions were required to be appropriate, without liquid or powder flow. The powder was filled into the inner circle of 2×2cm empty acupoints for standby use. 75% alcohol was used to gently wipe and disinfect the skin inside and around the navel of the child, and the acupoints filled with medicine were applied to the Shenque acupoint. The application time was controlled according to the age of the child. The application time for children aged 0.6 to 1 year was 2 hours, for children aged 2 to 4 years old, for 4 hours, and for children aged 4 to 6 years old, for 6 hours. Once a day, 3 times as a course of treatment.

[0101] 2.2: Observation Group

[0102] Methods: The whole scorpion and Jiao Sanxian powder were applied to acupoints for treatment. The whole scorpion and Jiao Sanxian were ground into powder and passed through a 150-mesh sieve. The whole scorpion and Jiao Sanxian powder were sieved and mixed with rice wine. The dry and wet conditions were required to be appropriate, without liquid or powder. The powder was filled into the inner circle of 2×2cm empty acupoints for later use. 75% alcohol was used to wipe the skin inside and around the navel of the child and disinfected. The acupoints filled with the medicine were applied to Zusanli (double), Zhongwan, Tianshu, Pishu and other acupoints for flexible matching. The application time was controlled according to the age of the child. The application time for children aged 0.6 to 1 year was 2 hours, for children aged 2 to 4 years old, for 4 hours, and for children aged 4 to 6 years old, for 6 hours. Once a day, 3 times as a course of treatment.

[0103] (III) Observation of therapeutic efficacy

[0104] 3.1 Observation indicators or efficacy evaluation criteria

[0105] (1) After 3 days of treatment, the clinical efficacy of the two groups was compared. The stool characteristics were classified according to the Bristol classification: Type 1 (sheep dung ball-like): hard balls (difficult to pass). Type 2 (twisted dough): twisted dough-like, but with an uneven surface. Type 3 (sausage-like): sausage-like, but with cracks on the surface. Type 4 (banana-like): like a sausage or snake, with a smooth surface. Type 5 (marshmallow-like): soft blocks with smooth broken edges (easy to pass). Type 6 (soft and thick): fluffy blocks with rough edges, mushy stool. Type 7 (liquid): watery, without solid blocks (completely liquid).

[0106] Cured: fever, vomiting, abdominal pain and other symptoms disappeared, bowel movement frequency ≤ 2 times / day, stool characteristics are Bristol type 3-4; Improved: fever, vomiting, abdominal pain and other symptoms improved, bowel movement frequency 3-4 times / day, stool Bristol type 5; Ineffective: diarrhea, fever, vomiting, abdominal pain and other clinical symptoms and stool characteristics have not improved. Total effective rate = (cured + improved) cases / total cases × 100%.

[0107] (2) TCM syndrome score: This was formulated with reference to the Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes [3]. The frequency and nature of bowel movements, as well as TCM syndromes such as abdominal pain, vomiting, mental state, fever, thirst, diet, urine, complexion, and anal redness were scored before and after treatment. The syndrome score was divided into four levels: none, mild, moderate, and severe, with scores of 0, 2, 4, and 6, respectively. The more severe the clinical symptoms and signs, the higher the score.

[0108] 3.2 Statistical methods

[0109] SPSS 19.0 was used for statistical analysis, and the standard deviation of the quantitative data was used. The data that did not conform to the normal distribution were compared with the t test, and P < 0.01 indicated that the difference was statistically significant. The data that did not conform to the normal distribution were compared with the rank sum test, and the data with skewed distribution were compared with non-parametric tests, described by the median (M) and interquartile range (QR); for the graded data, the rank sum test was used for comparison. P < 0.05 was considered to be statistically significant.

[0110] 3.3 Results

[0111] (1) Comparison of treatment efficacy between the Shenque group and the observation group

[0112] The total effective rate was 80.0% in the Shenque group and 76.6% in the observation group. The difference between the two groups was statistically significant (P < 0.01). (See Table 3)

[0113] Table 3 Comparison of treatment effects between Shenque group and observation group [cases (%)]

[0114]

[0115] (2) Comparison of TCM syndrome scores between the Shenque group and the observation group before and after treatment

[0116] The intra-group and inter-group comparisons of TCM syndrome scores before and after treatment showed statistically significant differences (P < 0.01). (See Table 4)

[0117] Table 4 Comparison of TCM syndrome scores between Shenque group and observation group before and after treatment [M(P25,P75)]

[0118]

[0119] Through long-term observation, the effect of applying the whole scorpion combined with Jiao Sanxian powder to the "Shenque" acupoint in the treatment of diarrhea in children is significantly better than that of applying the whole scorpion combined with Jiao Sanxian powder to multiple acupoints in the treatment of diarrhea in children. The effect of applying the whole scorpion combined with Jiao Sanxian powder to the "Shenque" acupoint is obvious and it is easy to use without medical experience.

[0120] 3. Clinical observation of Sijunzi powder applied to acupoints, Shenling Baizhu powder applied to acupoints, and Quanxie combined with Jiao Sanxian powder applied to "Shenque" acupoint

[0121] 1. Clinical data

[0122] 1.1 General Information

[0123] Data of 180 children with diarrhea admitted to the Department of Pediatrics of Xining Second People's Hospital from June 2021 to April 2023 were selected for prospective study analysis. They were divided into 3 groups according to the random number table method. There were 60 cases in the Quanxie Jiao Sanxian group, including 33 boys and 27 girls; the age was 0.7-6 years old, with an average age of (3.28±0.23) years old, and the course of disease was 3-20 days, with the course of disease concentrated at 4 (2.4, 6.1) days. There were 60 cases in the Shenling Baizhu group, including 32 boys and 28 girls, with an age of 0.6-6.2 years old, with an average age of (4.2±0.32) years old, and the course of disease was 3-21 days, with the course of disease concentrated at 3 (3.2, 6.1) days. There were 60 cases in the Four Gentlemen group, including 32 boys and 28 girls, aged 0.6-6.2 years (mean, (4.2±0.32) years). The course of disease ranged from 3 to 21 days, with the most common course being 3 (3.2, 6.1) days.

[0124] 1.2 Diagnostic criteria

[0125] The Western medicine diagnosis is in line with the relevant diagnostic standards in the "Diagnosis and Treatment of Diarrhea in Children", with watery or mucous stools and no visible pus or blood in the stools; the Chinese medicine diagnosis is in line with the diagnostic standards for diarrhea in the "Standards for Diagnosis and Efficacy of Chinese Medicine Diseases and Syndromes", with diarrhea as the main symptom, and loose or loose stools. If the diet is not careful or the patient is exposed to cold, the frequency of bowel movements will increase, undigested food will be trapped in the stool, the abdomen will be bloated, and there will be occasional abdominal rumbling and dull pain.

[0126] 1.3 Inclusion criteria

[0127] Meet the above diagnostic criteria, age 0.6 to 7 years old, disease course <2 months, no other medications, no other treatments after participating in the treatment. The study obtained informed consent from the family members, and was able to cooperate with the family members and children to complete the course of treatment.

[0128] 1.4 Exclusion criteria

[0129] 1. Patients with other digestive system diseases; patients with malnutrition; patients with severe liver and kidney dysfunction; 2. Patients with skin damage, rashes or other skin lesions; 3. Patients with congenital immunodeficiency and acute abdomen; 4. Patients with coma and severe dehydration symptoms; 5. Patients with signs and symptoms of primary infection foci; patients with heart disease, pneumonia, etc. that affect the body's water and electrolyte metabolism.

[0130] 1.5 Case exclusion criteria

[0131] (1) Those with insufficient information; (2) Parents and children are unable to follow the implementation requirements and have poor medical compliance; (3) Those who experience adverse events or other unpredictable events during treatment and cannot continue treatment.

[0132] (II) Treatment methods

[0133] 2.1 Scorpio Group:

[0134] Methods: Whole scorpion and Jiao Sanxian powder were applied to the "Shenque" acupoint to treat children with diarrhea. The whole scorpion and Jiao Sanxian were ground into powder and passed through a 150-mesh sieve. The whole scorpion and Jiao Sanxian powder were sieved and mixed with rice wine. The dry and wet conditions were required to be appropriate, without liquid or powder. The powder was filled into the inner circle of 2×2cm empty acupoints for later use. 75% alcohol was used to gently wipe and disinfect the skin inside and around the navel of the child, and the acupoints filled with medicine were applied to the Shenque acupoint. The application time was controlled according to the age of the child. The application time for children aged 0.6 to 1 year was 2 hours, for children aged 2 to 4 years old, for 4 hours, and for children aged 4 to 6 years old, for 6 hours. Once a day, 3 times as a course of treatment.

[0135] 2.2 Ginseng, Poria and Atractylodes macrocephala group

[0136] Methods: Shenling Baizhu powder was applied to Shenque acupoint to treat children with diarrhea. 9 parts of Codonopsis pilosula, 9 parts of Poria cocos, 9 parts of Atractylodes macrocephala, 3 parts of Roasted Licorice root, 12 parts of Stir-fried Lentils, 12 parts of Chinese Yam, 12 parts of Coix seeds, 9 parts of Lotus seeds, 6 parts of Tangerine peel, 3 parts of Amomum villosum, 3 parts of Platycodon grandiflorum, and 5 parts of Jujube were ground into powder and passed through a 150-mesh sieve. The above powders were sieved and mixed with yellow wine. The dry and wet conditions were required to be appropriate, without liquid or powder flow. The powder was filled into the inner circle of 2×2cm empty acupoints for later use. 75% alcohol was used to gently wipe the navel and the surrounding skin of the child for disinfection, and the acupoints filled with the medicine were applied to Shenque, Zusanli (double), Zhongwan, Tianshu, Pishu and other acupoints were flexibly matched. The application time is controlled according to the age of the child: 2 hours for children aged 0.6 to 1, 4 hours for children aged 2 to 4, and 6 hours for children aged 4 to 6. Apply once a day, 3 times as a course of treatment.

[0137] 2.3 Four Gentlemen Group

[0138] Methods: The "Shenque" acupoint was treated with Sijunzi powder. Grind 3 parts of ginseng, 3 parts of white atractylodes, 3 parts of peeled Poria cocos, and 2 parts of roasted licorice into powder, and pass through a 150-mesh sieve. After sieving the above powder, mix it with yellow wine. The dry and wet conditions should be appropriate, and there should be no liquid or powder. The powder should be filled into the inner circle of 2×2cm empty acupoints for later use. Use 75% alcohol to gently wipe and disinfect the skin inside and around the navel of the child, and apply the acupoints filled with medicine to Shenque, Zusanli (double), Zhongwan, Tianshu, Pishu and other acupoints flexibly. The application time is controlled according to the age of the child. The application time for children aged 0.6 to 1 year is 2 hours, for children aged 2 to 4 years old, the application time is 4 hours, and for children aged 4 to 6 years old, the application time is 6 hours. Once a day, 3 times as a course of treatment.

[0139] (III) Observation of therapeutic efficacy

[0140] 3.1 Observation indicators or efficacy evaluation criteria

[0141] (1) After 3 days of treatment, the clinical efficacy of the two groups was compared. The stool characteristics were classified according to the Bristol classification: Type 1 (sheep dung ball-like): hard balls (difficult to pass). Type 2 (twisted dough): twisted dough-like, but with an uneven surface. Type 3 (sausage-like): sausage-like, but with cracks on the surface. Type 4 (banana-like): like a sausage or snake, with a smooth surface. Type 5 (marshmallow-like): soft blocks with smooth broken edges (easy to pass). Type 6 (soft and thick): fluffy blocks with rough edges, mushy stool. Type 7 (liquid): watery, without solid blocks (completely liquid).

[0142] Cured: fever, vomiting, abdominal pain and other symptoms disappeared, bowel movement frequency ≤ 2 times / day, stool characteristics are Bristol type 3-4; Improved: fever, vomiting, abdominal pain and other symptoms improved, bowel movement frequency 3-4 times / day, stool Bristol type 5; Ineffective: diarrhea, fever, vomiting, abdominal pain and other clinical symptoms and stool characteristics have not improved. Total effective rate = (cured + improved) cases / total cases × 100%.

[0143] (2) TCM syndrome score: This was formulated with reference to the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes". The frequency and characteristics of bowel movements, as well as TCM syndromes such as abdominal pain, vomiting, mental state, fever, thirst, diet, urine, complexion, and anal redness were scored before and after treatment. The syndrome score was divided into four levels: none, mild, moderate, and severe, with scores of 0, 2, 4, and 6, respectively. The more severe the clinical symptoms and signs, the higher the score.

[0144] 3.2 Statistical methods

[0145] SPSS 19.0 was used for statistical analysis. The measurement data were expressed as standard deviation (). The data that met the normal distribution were tested by t test. P < 0.01 indicated that the difference was statistically significant. The quantitative data that met the normal distribution and homogeneity of variance were expressed as mean ± standard deviation. The differences between the groups were expressed by analysis of variance, and the differences in the efficacy scores at different time points were compared by repeated measures analysis of variance. When there were differences, the LSD method was used for pairwise comparisons. If normality was not met, the quartiles were expressed and the rank sum test was used. P < 0.05 was considered statistically significant.

[0146] 3.3 Results

[0147] (1) Comparison of the efficacy of the whole scorpion group, the ginseng, Poria cocos, and white atractylodes group, and the four gentlemen group

[0148] The total effective rate was 78.3% in the whole scorpion group, 71.7% in the ginseng, Poria and Atractylodes macrocephala group, and 68.4% in the four gentlemen group. The differences among the three groups were statistically significant (P < 0.05). (See Table 5)

[0149] Table 5 Comparison of the treatment effect of the whole scorpion group, the ginseng, Poria cocos and Atractylodes macrocephala group and the four gentlemen group [cases (%)]

[0150]

[0151] (2) Comparison of TCM syndrome scores before and after treatment in the whole scorpion group, ginseng, Poria cocos, and four gentlemen fruit groups. The TCM syndrome scores of the three groups were compared within and between groups before treatment, so the rank sum test was used, and there was no statistical significance (P>0.05). Therefore, the data of the three groups were comparable before treatment (see Table 6).

[0152] Table 6 Comparison of TCM syndrome scores before and after treatment in the scorpion group, ginseng, Poria cocos, and four gentlemen groups [M (P25, P75)]

[0153]

[0154] Through long-term observation, the effect of applying whole scorpion combined with Jiao Sanxian powder to the "Shenque" acupoint in the treatment of diarrhea in children was significantly better than that of the ginseng, Poria, Atractylodes and Four Gentlemen groups.

Claims

1. A Chinese patent medicine composition for patch application, characterized in that: The invention is composed of the following raw materials in parts by weight: 1-5 parts of whole scorpion, 1-3 parts of charred hawthorn, 1-3 parts of charred Shenqu, 1-3 parts of charred malt and 2-20 parts of honey.

2. A Chinese patent medicine composition for patch application according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 1-2 parts of whole scorpion, 2-3 parts of charred hawthorn, 2-3 parts of charred Shenqu, 2-3 parts of charred malt and 4-12 parts of honey.

3. The Chinese patent medicine composition for patch application according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 2-3 parts of whole scorpion, 1-2 parts of charred hawthorn, 1-2 parts of charred Shenqu, 1-2 parts of charred malt and 4-10 parts of honey.

4. The Chinese patent medicine composition for patch application according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 1-2 parts of whole scorpion, 1-2 parts of charred hawthorn, 1-2 parts of charred Shenqu, 1-2 parts of charred malt and 2-8 parts of honey.

5. The Chinese patent medicine composition for patch application according to claim 1, characterized in that: The invention is composed of the following raw materials in the following parts by weight: 1 part of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt, and 2 parts of honey.

6. The Chinese patent medicine composition for patch application according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 1 part of whole scorpion, 2 parts of charred hawthorn, 2 parts of charred Shenqu, 2 parts of charred malt and 6 parts of honey.

7. The Chinese patent medicine composition for patch application according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 2 parts of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt and 5 parts of honey.

8. The Chinese patent medicine composition for patch application according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 3 parts of whole scorpion, 1 part of charred hawthorn, 1 part of charred Shenqu, 1 part of charred malt and 7 parts of honey.

9. The use of a Chinese patent medicine composition for patch application according to any one of claims 1 to 8, characterized in that: The patch Chinese patent medicine composition is used for treating diarrhea in children.

10. A method for preparing and using a patch Chinese patent medicine composition according to any one of claims 1 to 8, characterized in that: The preparation method specifically comprises the following steps: Step 1, mix the whole scorpion, charred hawthorn, charred Shenqu, and charred malt in the above proportion, grind into powder, and pass through a 100-mesh sieve; Step 2, mix the above powder with honey in a corresponding proportion to make medicine beads with a diameter of 1-2 cm; The method of use is: place the prepared medicinal beads in the middle of the patch, and place the patch on the patient's Shenque acupoint, keep it for 3-4 hours, once a day, and 3-5 days as a course of treatment; According to the patient's symptoms, the above-mentioned Chinese patent medicine composition is applied in combination with stimulation of body surface acupoints, and the body surface acupoints are Zusanli and / or Zhongwan acupoints.

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