A traditional Chinese medicine composition for treating functional dyspepsia in combination with massage, its preparation method and application.

Abstract

This invention discloses a traditional Chinese medicine composition for treating functional dyspepsia in combination with massage, its preparation method, and its application. The composition mainly comprises the following raw materials in parts by weight: 5-15 parts black sesame seeds, 2-8 parts almonds, 2-8 parts wild papaya, 2-8 parts *Drynaria fortunei*, and 2-8 parts peony bark. Compared to existing technologies, this invention provides a novel and simple traditional Chinese medicine composition for treating functional dyspepsia, and its preparation method is simple and low-cost. This composition is specifically designed for use in combination with massage to treat functional dyspepsia, and is especially suitable for children who dislike taking medicine. Applying it around the navel and massaging appropriately can effectively treat functional dyspepsia. Animal experiments have confirmed that the traditional Chinese medicine composition of this invention, used in combination with massage, has a significant effect on treating functional dyspepsia.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and specifically relates to a traditional Chinese medicine composition for treating functional dyspepsia in combination with massage, its preparation method and application. Background Technology

[0002] Functional dyspepsia (abdominal distension syndrome) is a common and frequently occurring disease of the digestive system in internal medicine. In traditional Chinese medicine, it often manifests as symptoms of liver-stomach stagnation, liver-stomach qi stagnation, and stomach disharmony, frequently caused by poor gastrointestinal motility. The disease affects a large population, and its incidence does not show significant regional or temporal differences. Furthermore, most people experience similar symptoms such as abdominal distension and pain at some point in their lives. In recent years, due to factors such as the fast pace of life, emotional and mental factors, and changes in dietary habits, the incidence of this disease has been gradually increasing, seriously affecting the physical and mental health of many patients. It can cause inflammatory changes such as esophageal mucosal congestion, edema, and even erosion, as well as esophageal dysfunction. In severe cases, esophageal mucosal erosion and bleeding can occur, leading to reflux esophagitis, esophageal adenocarcinoma, gastritis, gastric ulcers, and gastric cancer.

[0003] Functional dyspepsia (FD) is a common pediatric condition. It belongs to the category of functional gastrointestinal disorders and is a prevalent gastrointestinal functional disorder in childhood. Clinical symptoms include: persistent or recurrent loss of appetite, upper abdominal fullness or discomfort, heartburn, vomiting, belching, reduced food intake, general weakness, decreased immunity, and susceptibility to illness. Symptoms may recur or be asymptomatic for a considerable period. When these symptoms recur, they can affect a child's eating habits, leading to long-term malnutrition, developmental delays, and significant negative impacts on the child's physical and mental health.

[0004] Chinese Patent 201110285808.5 discloses a traditional Chinese medicine composition for treating functional dyspepsia, comprising the following components by weight: Scutellaria baicalensis 15-19g, Coptis chinensis 15-19g, Phellodendron chinense 15-19g, Gardenia jasminoides 15-19g, Paeonia lactiflora 15-19g, Angelica sinensis 4-6g, Ligusticum chuanxiong 4-6g, and Rehmannia glutinosa 4-6g. Using conventional pharmaceutical techniques, this traditional Chinese medicine composition is formulated into granules. These granules relieve or eliminate symptoms of functional dyspepsia, have few side effects, are convenient to use and carry, and have a rapid onset of action. However, this composition contains many herbs, is costly, requires oral formulation, has a slow onset of action, and is particularly unsuitable for children. Chinese Patent Application 201810021037.0 discloses a self-heating traditional Chinese medicine umbilical patch for treating functional dyspepsia in children. This self-heating herbal umbilical patch for treating functional dyspepsia in children is made by scientifically combining various natural Chinese herbal medicines such as dried tangerine peel, hawthorn, ginger, burnt rice, lemon, peach blossom, Artemisia annua, Thalictrum lucidum, Sophora flavescens, Codonopsis pilosula, Zingiber officinale, and rosemary, along with excipients such as heating and moisturizing materials. It achieves significant effects in strengthening the stomach and aiding digestion, clearing heat and dampness, invigorating the spleen and stomach, and regulating liver qi, thereby regulating the internal organs and enhancing children's immunity. While suitable for children, this herbal umbilical patch still has drawbacks, including a large number of ingredients, a complex preparation process, and high cost. Summary of the Invention

[0005] Purpose of the invention: In order to overcome the deficiencies of the prior art, the present invention provides a traditional Chinese medicine composition for treating functional dyspepsia in combination with massage, as well as its preparation method and application.

[0006] Technical solution: To achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0007] A traditional Chinese medicine composition for treating functional dyspepsia in combination with massage, mainly comprising the following raw materials in parts by weight:

[0008] Black sesame seeds 5-15 parts, almonds 2-8 parts, wild papaya 2-8 parts, drynaria rhizome 2-8 parts, peony bark 2-8 parts.

[0009] Preferably, the traditional Chinese medicine composition for treating functional dyspepsia in combination with massage mainly comprises the following raw materials in parts by weight:

[0010] 5 parts black sesame seeds, 2 parts almonds, 2 parts wild papaya, 2 parts drynaria rhizome, and 2 parts peony bark.

[0011] Preferably, the traditional Chinese medicine composition for treating functional dyspepsia in combination with massage is characterized by comprising the following raw materials in parts by weight:

[0012] 15 parts black sesame seeds, 8 parts almonds, 8 parts wild papaya, 8 parts drynaria rhizome, and 8 parts peony bark.

[0013] Preferably, the traditional Chinese medicine composition for treating functional dyspepsia in combination with massage is characterized by comprising the following raw materials in parts by weight:

[0014] 10 parts black sesame seeds, 5 parts almonds, 5 parts wild papaya, 5 parts drynaria rhizome, and 5 parts peony bark.

[0015] The present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0016] Take the prescribed amounts of black sesame seeds, almonds, wild papaya, drynaria rhizome, and peony bark, add them to an oily solvent, soak them at a certain temperature for a period of time, filter them, and obtain an oily solution.

[0017] Preferably, the oily solvent is selected from one or more of olive oil, sunflower oil, peanut oil, and corn oil.

[0018] Preferably, the amount of oily solvent used is: 80-120 ml of oily solvent for every 30 g of raw material.

[0019] Preferably, the soaking temperature is 90-110℃ and the soaking time is 1-3 hours.

[0020] Finally, this invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for the treatment of functional dyspepsia in combination with massage. Preferably, the functional dyspepsia is childhood functional dyspepsia.

[0021] Beneficial Effects: Compared with existing technologies, this invention provides a novel and simple traditional Chinese medicine composition for treating functional dyspepsia, and its preparation method is simple and low-cost. This traditional Chinese medicine composition is specifically designed for use in conjunction with massage to treat functional dyspepsia, and is especially suitable for children who dislike taking medicine. Applying it around the navel and massaging appropriately can effectively treat functional dyspepsia. Animal experiments have confirmed that the traditional Chinese medicine composition of this invention, used in conjunction with massage, has a significant effect on the treatment of functional dyspepsia. Detailed Implementation

[0022] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0023] Example 1

[0024] Formula: 10g black sesame seeds, 5g almonds, 5g wild papaya, 5g drynaria rhizome, 5g peony bark.

[0025] Preparation process: Take the required amount of black sesame seeds, almonds, wild papaya, drynaria rhizome and peony bark, add them to 100ml of olive oil, soak at 100℃ for 2 hours, filter to obtain an oily solution, which is the product.

[0026] Example 2

[0027] Formula: 5g black sesame seeds, 2g almonds, 2g wild papaya, 2g drynaria rhizome, 2g peony bark

[0028] Preparation process: Take the required amount of black sesame seeds, almonds, wild papaya, drynaria rhizome and peony bark, add them to 100ml of olive oil, soak at 100℃ for 2 hours, filter to obtain an oily solution, which is the product.

[0029] Example 3

[0030] Formula: 10g black sesame seeds, 5g almonds, 5g wild papaya, 5g drynaria rhizome, 5g peony bark.

[0031] Preparation process: Take the required amount of black sesame seeds, almonds, wild papaya, drynaria rhizome and peony bark, add them to 100ml of olive oil, soak at 100℃ for 2 hours, filter to obtain an oily solution, which is the product.

[0032] Example 4

[0033] Formula: 5g black sesame seeds, 2g almonds, 2g wild papaya, 2g drynaria rhizome, 2g peony bark

[0034] Preparation process: Take the required amount of black sesame seeds, almonds, wild papaya, drynaria rhizome and peony bark, add them to 80ml of sunflower oil, soak at 90℃ for 3 hours, filter to obtain an oily solution, which is the product.

[0035] Example 5

[0036] Formula: 15g black sesame seeds, 8g almonds, 8g wild papaya, 8g drynaria rhizome, 8g peony bark.

[0037] Preparation process: Take the required amount of black sesame seeds, almonds, wild papaya, drynaria rhizome and peony bark, add them to 120ml of corn oil, soak at 110℃ for 1 hour, filter to obtain an oily solution, which is the final product.

[0038] Experimental Example

[0039] 1. Experimental drugs

[0040] The concentration of the medicinal olive oil solution obtained in Example 1 of this invention is 0.3 g / ml based on the content of the raw medicinal material.

[0041] Jianwei Xiaoshi Tablets, manufactured by Yuekang Pharmaceutical Group, are available in 0.8g tablets. Dissolve in distilled water to prepare a 0.002g / ml concentration solution and store for later use.

[0042] 2. Laboratory animals

[0043] Eighty male 10-day-old SPF-grade SD rats were purchased from Qinglongshan Animal Breeding Base in Nanjing, Jiangsu Province. Animal housing environment: room temperature (20±2)°C, humidity (50±10)%, with sterile animal feed and drinking water provided 24 hours a day. All animals underwent acclimatization feeding for 3 days before the experiment.

[0044] 3. Experimental Methods

[0045] 3.1 Establishment of a rat model of functional dyspepsia

[0046] Twenty rats were randomly selected from 80 young mice to form a normal control group, which was administered 0.2 ml / rat of 2% sucrose solution by gavage once daily. The remaining 60 young mice were used as the model group, which was administered 0.2 ml / rat of a mixture of 0.1% IA and 2% sucrose by gavage once daily for 6 consecutive days. At 7 weeks of age, a functional dyspepsia model was established using the tail-clamping stimulation method. The model group rats were divided into cages of 5. Each day, the tail of each rat was clamped at the distal 1 / 3 with long sponge clamps, ensuring the skin was not broken, causing the rats to scream and struggle, thus provoking the other rats in the cage. Each stimulation lasted 30 minutes, repeated every 3 hours, 4 times a day for 7 consecutive days. If a rat was scratched, the scratched area was disinfected with 0.5% iodine solution to prevent infection.

[0047] If, after 7 days, the animal shows signs of reduced food intake, decreased gastric emptying rate, and is exhibiting signs of stress, irritability, weight loss, loose stools, and dull, rough, and yellowish fur, then the modeling process is successful.

[0048] 3.2 Grouping and Administration Methods

[0049] At 8 weeks of age, the 60 rats in the model group were randomly divided into a model group (20 rats), a drug group (10 rats), a control group 1 (10 rats), a control group 2 (10 rats), and a positive drug group (10 rats).

[0050] The drug group was given a drug-containing olive oil solution with a crude drug content of 0.3 g / ml, at a dosage of 10 ml / 100 g body weight. The method of administration was to apply the solution around the navel of the rats and massage for 5 minutes, once a day for 7 consecutive days.

[0051] In control group 1, the drug solution was replaced with drug-free olive oil at a dosage of 10 ml / 100 g body weight. The method of administration was as follows: the solution was applied around the navel of the rats and massaged for 5 minutes using the same technique as the drug group, once a day for 7 consecutive days.

[0052] The control group 2 did not use any drugs, but only massaged the area around the rat's navel using the same technique as the drug group for 5 minutes, once a day for 7 consecutive days.

[0053] The positive control group was given 1 ml / 100g body weight of 0.002 g / ml digestive tablet solution by gavage, while the model group and normal group were given 1 ml / 100g body weight of 0.9% sodium chloride solution by gavage. All were administered once daily for 7 consecutive days.

[0054] 3.3 Observation Indicators and Detection Methods

[0055] (1) Observation of rat body weight: Record the rate of change in rat body weight.

[0056] (2) Rat gastric emptying assay:

[0057] After drug administration, gastric emptying was measured in rats. Rats in each group were housed individually. They were fasted for 12 hours before the gastric emptying test, but water was allowed. The next day, each rat was given 15g of food for 3 hours. The remaining food was recorded after 3 hours, and the 3-hour food intake was calculated as: 3-hour food intake = 15g - remaining food. Then, the rats were fasted for 3 hours before gastric emptying was measured. Anesthesia was achieved by intraperitoneal injection of 0.33ml / 100g body weight of 10% chloral hydrate. After anesthesia, the abdominal cavity was opened layer by layer along the midline. The stomach was dried with filter paper, and the total stomach weight was measured. The stomach was then cut along the lesser curvature, and the contents were rinsed with 0.9% sodium chloride solution. The net stomach weight was measured after drying. The 3-hour food residue was calculated as: 3-hour food residue = total stomach weight - net stomach weight. The gastric emptying rate after 6 hours was calculated as: Gastric emptying rate (%) = 100% - (3-hour food residue / 3-hour food intake) × 100%.

[0058] 3.4 Statistical Methods

[0059] Statistical analysis was performed using SPSS 17.0 software. Data for each group are expressed as mean ± standard deviation. One-way ANOVA was used to compare the continuous data among multiple groups. A p-value < 0.05 was considered statistically significant.

[0060] 4. Experimental Results

[0061] 4.1 Changes in rat body weight

[0062] Rats' body weight was recorded, and the rate of change in body weight (compared to body weight on day 1) was calculated. The results are shown in Table 1 below. As can be seen from Table 1, during the drug administration period, the body weight of rats in each group increased to some extent. Compared with other groups, the body weight gain in the model group was slower, and the rate of increase in body weight in the model group was significantly lower than that in the normal group (P<0.01). Compared with control group 1, control group 2, and the positive control group, especially on days 6 and 7, the rate of increase in body weight in the drug group was significantly higher (P<0.01, P<0.05).

[0063] Table 1. Body weight change rate (%, D = number of days) of rats in each group

[0064]

[0065]

[0066] Compared with the normal group, *P<0.01; compared with the drug group, *P<0.01, #P<0.05.

[0067] 4.2 Changes in gastric emptying function in rats

[0068] The results are shown in Table 2 below. The food intake and gastric emptying rate of the model group rats after 3 hours were significantly lower than those of the normal group (P<0.05), while the amount of food residue in the stomach after 3 hours was significantly higher than that of the normal group (P<0.05). Compared with control group 1, control group 2, and the positive control group, the food intake and gastric emptying rate of the drug group rats after 3 hours were significantly increased (P<0.01, P<0.05), while the amount of food residue in the stomach after 3 hours was significantly decreased.

[0069] Table 2. Gastric emptying function indicators of rats in each group

[0070]

[0071] Compared with the normal group, *P<0.01; compared with the drug group, *P<0.01, #P<0.05.

[0072] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition for treating functional dyspepsia in combination with massage, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Black sesame seeds 5-15 parts, almonds 2-8 parts, wild papaya 2-8 parts, drynaria rhizome 2-8 parts, peony bark 2-8 parts.

2. The traditional Chinese medicine composition for treating functional dyspepsia in combination with massage according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 5 parts black sesame seeds, 2 parts almonds, 2 parts wild papaya, 2 parts drynaria rhizome, and 2 parts peony bark.

3. The traditional Chinese medicine composition for treating functional dyspepsia in combination with massage according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts black sesame seeds, 8 parts almonds, 8 parts wild papaya, 8 parts drynaria rhizome, and 8 parts peony bark.

4. The traditional Chinese medicine composition for treating functional dyspepsia in combination with massage according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts black sesame seeds, 5 parts almonds, 5 parts wild papaya, 5 parts drynaria rhizome, and 5 parts peony bark.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, Includes the following steps: Take the prescribed amounts of black sesame seeds, almonds, wild papaya, Drynaria fortunei, and peony bark, add them to an oily solvent, soak them at a certain temperature for a period of time, filter them, and obtain an oily solution. The soaking temperature is 90-110℃ and the time is 1-3 hours.

6. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, The oily solvent is selected from one or more of olive oil, sunflower oil, peanut oil, and corn oil.

7. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, The amount of oily solvent used is: 80-120 ml of oily solvent for every 30 g of raw material.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicament for the treatment of functional dyspepsia in combination with massage.

9. The application according to claim 8, characterized in that, The functional dyspepsia mentioned refers to functional dyspepsia in children.

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