A traditional Chinese medicine composition for improving gastrointestinal function and a preparation method thereof

Abstract

The present application relates to the field of traditional Chinese medicine, and more particularly to a traditional Chinese medicine composition for improving gastrointestinal function and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: basil 20-30 parts, piper longum 17-23 parts, limonium gmelinii 6-12 parts, pterocypsela tomentosa 4-10 parts, divaricate kudou 3-7 parts, lotus seed 2-5 parts, and licorice 1-3 parts. In the prescription, the basil dispels wind and releases the exterior, and dissipates dampness and harmonizes the center, and the piper longum warms the center, dispels cold and stops diarrhea, and they are the monarch drugs; the limonium gmelinii and the pterocypsela tomentosa tonify blood and qi, and the pterocypsela tomentosa also removes blood stasis and stops pain, and they are the ministerial drugs; the divaricate kudou and the lotus seed invigorate the spleen and stomach, and the lotus seed also nourishes the heart and tranquilizes the mind, and they are the auxiliary drugs; and the licorice is the ministerial drug for harmonizing all the drugs. The combination of the drugs has the effects of promoting qi and dissipating distension, warming the center and stopping diarrhea, tonifying blood and stopping pain, and benefiting qi and invigorating the spleen. The traditional Chinese medicine composition of the present application has reasonable compatibility, conforms to the basic theory of traditional Chinese medicine and the method of dialectical analysis, has high safety, and can effectively improve the gastrointestinal function and relieve the discomfort caused by functional gastrointestinal diseases.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for improving gastrointestinal function and its preparation method. Background Technology

[0002] Digestive system diseases can be broadly classified into organic and functional categories. In clinical practice, the incidence of functional diseases far exceeds that of organic diseases. Functional Gastrointestinal Diseases (FGIDs), also known as gastrointestinal syndromes or gastrointestinal dysfunctions, are a group of digestive system disorders resulting from the interaction of physiological, psychological, and social factors. Their clinical manifestations are mainly abnormalities in gastrointestinal eating and excretion, often accompanied by other functional symptoms such as insomnia, anxiety, inattention, forgetfulness, nervousness, and headaches. Based on their location and clinical symptoms, they are further classified into functional esophageal disorders, functional gastroduodenal disorders, functional bowel disorders, functional biliary and sphincter dysfunction, and functional anorectal disorders. Functional gastrointestinal diseases are characterized by long courses and recurrent episodes. Reports indicate that the incidence of functional gastrointestinal diseases in the population is 34.6%, with a consultation rate as high as 62.1%. These diseases not only cause physical suffering but also severely impact quality of life.

[0003] Traditional Chinese medicine (TCM) is a purely natural medicine with a low incidence of adverse reactions and no risk of drug dependence, thus attracting significant attention in the medical field. However, studies have found that TCM compositions for treating diarrhea have poor therapeutic effects. Therefore, there is an urgent need to find TCM compositions that are both highly safe and effectively relieve gastrointestinal discomfort. Summary of the Invention

[0004] In order to overcome the shortcomings of the prior art, one of the objectives of the present invention is to provide a traditional Chinese medicine composition that improves gastrointestinal function and relieves the discomfort caused by functional gastrointestinal disorders.

[0005] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine composition that improves gastrointestinal function, which is simple and easy to operate.

[0006] A third objective of this invention is to provide an application of a composition for improving gastrointestinal function in the preparation of pharmaceutical formulations for improving gastrointestinal function.

[0007] One of the objectives of this invention is achieved through the following technical solution:

[0008] A traditional Chinese medicine composition for improving gastrointestinal function, the composition being made from the following raw materials in parts by weight: basil 20-30 parts, long pepper 17-23 parts, yellow-flowered blood-nourishing herb 6-12 parts, red husk 4-10 parts, medicated leaven 3-7 parts, lotus seed 2-5 parts, and licorice 1-3 parts.

[0009] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 26 parts basil, 19 parts long pepper, 11 parts safflower, 5 parts red husk, 6 parts medicated leaven, 4 parts lotus seeds, and 2 parts licorice.

[0010] The second objective of this invention is achieved by the following technical solution:

[0011] The preparation method of the above-mentioned traditional Chinese medicine composition for improving gastrointestinal function includes the following steps:

[0012] (1) Take the raw materials according to the above formula, soak them in water, decoct them, filter them, and take the decoction, which is recorded as the first decoction.

[0013] (2) Add water to the residue from step (1), boil, filter, and take the decoction, which is recorded as the second decoction; mix the first decoction and the second decoction evenly and concentrate to an extract with a relative density of 1.1-1.2 to obtain the extract.

[0014] Preferably, the volume ratio of water to the first decoction in step (1) is (7-9):1, the soaking time is 25-35 min, and the decocting time is 15-25 min.

[0015] Preferably, the volume ratio of water to the second decoction in step (2) is (1-3):1, and the decoction time is 10-20 min.

[0016] The third objective of this invention is achieved by the following technical solution:

[0017] The above-mentioned traditional Chinese medicine composition for improving gastrointestinal function is used in the preparation of pharmaceutical preparations for improving gastrointestinal function.

[0018] Preferably, the pharmaceutical preparation is a topical preparation.

[0019] Preferably, the topical preparation is an ointment or patch.

[0020] The pharmacological and pharmacodynamic analyses of the active pharmaceutical ingredient used in this invention are as follows:

[0021] Basil: Pungent and sweet in taste, warm in nature. It enters the lung, spleen, stomach, and large intestine meridians. It possesses anti-inflammatory, antibacterial, anti-tumor metastasis, and anti-digestive ulcer effects. Indications: Indigestion, loss of appetite, abdominal distension and pain, vomiting, and diarrhea.

[0022] Piper longum: pungent in flavor and hot in nature. It enters the stomach and large intestine meridians. It has the effects of warming the middle jiao (spleen and stomach), dispelling cold, regulating qi, and relieving pain. Indications: abdominal pain, vomiting of sour fluid, diarrhea caused by stomach cold, angina pectoris due to coronary heart disease, nervous headache, and toothache, etc.

[0023] Yellow-flowered blood-nourishing herb: Mild in taste and cool in nature. Relieves pain, reduces inflammation, and nourishes blood. Indications: Neuralgia, scanty menstruation, tinnitus, insufficient lactation, colds, toothache, and boils and carbuncles.

[0024] Thick red shell: Slightly bitter and astringent in taste, neutral in nature. It enters the liver and lung meridians. It has the effects of removing blood stasis and relieving pain. Indications: Rheumatic pain, traumatic injuries, dysmenorrhea, and external bleeding.

[0025] Shenqu (Medicated Leaven): It has a pungent and sweet taste, and is warm in nature. It enters the spleen and stomach meridians. It has the effects of strengthening the spleen and stomach, promoting digestion and eliminating food stagnation. Its main functions and indications are: food stagnation, indigestion, abdominal distension, loss of appetite, vomiting and diarrhea.

[0026] Lotus seeds: pungent and astringent in taste, neutral in nature. They enter the spleen, kidney, and heart meridians. They have the effects of tonifying the spleen and stopping diarrhea, stopping leukorrhea, benefiting the kidneys and astringing essence, and nourishing the heart and calming the mind. Indications: Spleen deficiency diarrhea, leukorrhea, seminal emission, palpitations, and insomnia.

[0027] Licorice: Sweet in taste and neutral in nature. It enters the heart, lung, spleen, and stomach meridians. It has the functions of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing other herbs. Indications: Weakness of the spleen and stomach, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and alleviating the toxicity and harshness of other drugs.

[0028] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0029] This invention provides a traditional Chinese medicine composition for improving gastrointestinal function. In this composition, basil dispels wind and releases the exterior, resolves dampness and harmonizes the middle jiao; long pepper warms the middle jiao, dispels cold and stops diarrhea, serving as the principal herbs; safflower nourishes blood and invigorates qi; red husk removes blood stasis and relieves pain, serving as the assistant herbs; medicated leaven strengthens the spleen and harmonizes the stomach; lotus seed nourishes the heart and calms the mind, serving as the adjuvant herbs; and licorice root acts as the guiding herb to harmonize the other herbs. The combined effects of these herbs are to promote qi circulation and relieve bloating, warm the middle jiao and stop diarrhea, nourish blood and relieve pain, and invigorate qi and strengthen the spleen. This traditional Chinese medicine composition is rationally formulated, conforms to the theoretical basis of traditional Chinese medicine and dialectical analysis methods, has high safety, and can effectively improve gastrointestinal function and alleviate discomfort caused by functional gastrointestinal disorders. Attached Figure Description

[0030] Figure 1 These are graphs showing the changes in intestinal flora in mice with diarrhea after applying the herbal compositions of Examples 1-3 and Comparative Examples 1-6. Detailed Implementation

[0031] The present invention will be further described below with reference to the accompanying drawings and specific embodiments. It should be noted that, without conflict, the various embodiments or technical features described below can be arbitrarily combined to form new embodiments. Specific conditions not specified in the embodiments shall be performed according to conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, all reagents or instruments used are conventional products obtained through commercial channels.

[0032] Example 1

[0033] This embodiment provides a traditional Chinese medicine composition for improving gastrointestinal function, which is made from the following raw materials in parts by weight: 26 parts basil, 19 parts long pepper, 11 parts yellow clover, 5 parts red husk, 6 parts medicated leaven, 4 parts lotus seeds, and 2 parts licorice.

[0034] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine composition for improving gastrointestinal function, as follows:

[0035] (1) Add the above-mentioned raw materials to a clay pot, soak in water for 30 minutes, decoct for 20 minutes, filter, take the decoction and record it as the first decoction. The volume ratio of water to the volume of the first decoction is 8:1.

[0036] (2) Add water to the clay pot and simmer for 15 minutes. Filter the decoction and record it as the second decoction. The volume ratio of water to the volume of the second decoction is 2:1. Mix the first and second decoctions and concentrate them to an extract with a relative density of 1.1-1.2 to obtain the Chinese herbal composition.

[0037] Example 2

[0038] This embodiment provides a traditional Chinese medicine composition for improving gastrointestinal function, which is made from the following raw materials in parts by weight: 20 parts basil, 22 parts long pepper, 6 parts yellow clover, 10 parts red husk, 3 parts medicated leaven, 2 parts lotus seeds, and 1 part licorice.

[0039] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine composition for improving gastrointestinal function, as follows:

[0040] (1) Add the above-mentioned raw materials to a clay pot, soak in water for 25 minutes, decoct for 15 minutes, filter, take the decoction and record it as the first decoction. The volume ratio of water to the volume of the first decoction is 7:1.

[0041] (2) Add water to the clay pot and simmer for 10 minutes. Filter and take the decoction, which is called the second decoction. The volume ratio of water to the volume of the second decoction is 1:1. Mix the first decoction and the second decoction and concentrate them to an extract with a relative density of 1.1-1.2 to obtain the Chinese herbal composition.

[0042] Example 3

[0043] This embodiment provides a traditional Chinese medicine composition for improving gastrointestinal function, which is made from the following raw materials in parts by weight: 30 parts basil, 23 parts long pepper, 12 parts yellow clover, 10 parts red husk, 7 parts medicated leaven, 5 parts lotus seeds, and 3 parts licorice.

[0044] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine composition for improving gastrointestinal function, as follows:

[0045] (1) Add the above-mentioned raw materials to a clay pot, soak in water for 35 minutes, decoct for 25 minutes, filter, take the decoction and record it as the first decoction. The volume ratio of water to the volume of the first decoction is 9:1.

[0046] (2) Add water to the clay pot and simmer for 20 minutes. Filter the decoction and record it as the second decoction. The volume ratio of water to the volume of the second decoction is 3:1. Mix the first and second decoctions and concentrate them to an extract with a relative density of 1.1-1.2 to obtain the Chinese herbal composition.

[0047] Comparative Example 1

[0048] This comparative example provides a traditional Chinese medicine composition, which differs from Example 1 in that it is made from the following raw materials in parts by weight: 26 parts basil, 19 parts long pepper, 5 parts red husk, 6 parts medicated leaven, 4 parts lotus seeds, and 2 parts licorice.

[0049] The preparation method of the traditional Chinese medicine composition described in this comparative example is the same as that in Example 1.

[0050] Comparative Example 2

[0051] This comparative example provides a traditional Chinese medicine composition, which differs from Example 1 in that it is made from the following raw materials in parts by weight: 26 parts basil, 19 parts long pepper, 11 parts safflower blood-nourishing herb, 6 parts medicated leaven, 4 parts lotus seeds, and 2 parts licorice.

[0052] The preparation method of the traditional Chinese medicine composition described in this comparative example is the same as that in Example 1.

[0053] Comparative Example 3

[0054] This comparative example provides a traditional Chinese medicine composition, which differs from Example 1 in that it is made from the following raw materials in parts by weight: 26 parts basil, 19 parts long pepper, 16 parts safflower, 6 parts medicated leaven, 4 parts lotus seeds, and 2 parts licorice.

[0055] The preparation method of the traditional Chinese medicine composition described in this comparative example is the same as that in Example 1.

[0056] Comparative Example 4

[0057] This comparative example provides a traditional Chinese medicine composition, which differs from Example 1 in that it is made from the following raw materials in parts by weight: 26 parts basil, 19 parts long pepper, 16 parts red husk, 6 parts medicated leaven, 4 parts lotus seeds, and 2 parts licorice.

[0058] The preparation method of the traditional Chinese medicine composition described in this comparative example is the same as that in Example 1.

[0059] Comparative Example 5

[0060] This comparative example provides a traditional Chinese medicine composition, which differs from Example 1 in that it is made from the following raw materials in parts by weight: 45 parts basil, 11 parts safflower blood-nourishing herb, 5 parts red husk, 6 parts medicated leaven, 4 parts lotus seeds, and 2 parts licorice.

[0061] The preparation method of the traditional Chinese medicine composition described in this comparative example is the same as that in Example 1.

[0062] Comparative Example 6

[0063] This comparative example provides a traditional Chinese medicine composition, which differs from Example 1 in that the composition is made from the following raw materials in parts by weight: 45 parts of Piper longum, 11 parts of Hedyotis diffusa, 5 parts of red mulberry bark, 6 parts of Shenqu (medicated leaven), 4 parts of lotus seed, and 2 parts of licorice.

[0064] The preparation method of the traditional Chinese medicine composition described in this comparative example is the same as that in Example 1.

[0065] Effect test:

[0066] The main purpose of this study was to test the therapeutic effect of the traditional Chinese medicine composition prepared in the embodiments of the present invention on mice with diarrhea.

[0067] Experimental Example 1

[0068] Detection of fecal water content in mice with roxithromycin-induced diarrhea

[0069] 1.1 Preparation of a mouse model of diarrhea

[0070] 110 mice were selected and acclimatized for 7 days. Roxithromycin was administered by gavage at a dose of 10 g / kg twice a day for 5 consecutive days. After gavage, the model mice were examined. If the mice had dull fur, reduced food intake, curled up, less activity, sluggish response, and obvious stains on their buttocks, it indicated that the diarrhea model was successfully established.

[0071] 1.2 Experimental grouping and administration method

[0072] 1.2.1 Experimental Grouping

[0073] One hundred and ten diarrheal mice were randomly divided into 11 groups of ten each: Examples 1-3, Comparative Examples 1-6, Model Group, and Piverambromide Tablet Group. Ten healthy mice were used as a blank control group.

[0074] 1.2.2 Administration method

[0075] Experimental group: Take 1g of the traditional Chinese medicine composition prepared in Examples 1-3 and Comparative Examples 1-6, flatten the traditional Chinese medicine composition and place it in the center of the acupoint patch to obtain each group of patches. Apply each group of patches to the Shenque acupoint of mice once a day for 2 hours each time, for 10 consecutive days.

[0076] Pinaverium bromide tablets group: Mice were administered 26 mg / kg by gavage once a day for 10 consecutive days.

[0077] 1.3 Experimental Results and Analysis

[0078] Mouse feces were collected within 10 hours after the application of the dressing. The water content of the collected feces was measured. Fecal water content = (fecal mass before drying - fecal mass after drying) / fecal mass before drying × 100%. The results are shown in Table 1.

[0079] Table 1

[0080] Group Fecal moisture content (%) Blank control group 37.61 Model group 75.17 Example 1 50.28 Example 2 52.31 Example 3 52.54 Comparative Example 1 64.15 Comparative Example 2 62.46 Comparative Example 3 58.30 Comparative Example 4 60.97 Comparative Example 5 67.10 Comparative Example 6 69.83 Piverammonium bromide tablets 50.16

[0081] Table 1 shows that the fecal water content of mice in the model group was significantly higher than that of the blank control group. Compared with the model group, the fecal water content of diarrhea model mice after applying the herbal compositions of Examples 1-6 decreased, while the fecal water content of diarrhea model mice after applying the herbal compositions of Examples 1-3 of this invention decreased significantly. There was no significant difference in fecal water content between mice treated with pinaverium bromide tablets by gavage and mice treated with the herbal compositions of Examples 1-3 of this invention.

[0082] Comparative analysis of the herbal compositions of Examples 1-3 and Comparative Examples 1-6 revealed the following: Compared to the herbal compositions of Examples 1-3, Comparative Example 1 omitted *Hedyotis diffusa*, Comparative Example 2 omitted *Hedyotis diffusa*, Comparative Example 3 omitted *Hedyotis diffusa* and increased the amount of *Hedyotis diffusa*, Comparative Example 4 omitted *Hedyotis diffusa* and increased the amount of *Hedyotis diffusa*, Comparative Example 5 omitted *Piper longum* and increased the amount of *Basil*, and Comparative Example 6 omitted *Basil* and increased the amount of *Piper longum*. Therefore, the herbal compositions of the present invention, through the synergistic effect between the principal herbs *Basil* and *Piper longum*, and the auxiliary effects of the assistant herbs *Hedyotis diffusa* and *Hedyotis diffusa*, can effectively improve diarrhea symptoms.

[0083] Experimental Example 2

[0084] Detection of intestinal flora changes in mice with roxithromycin-induced diarrhea

[0085] 2.1 Preparation of a mouse model of diarrhea

[0086] Same as Experiment 1

[0087] 2.2 Experimental grouping and administration method

[0088] Same as Experiment 1

[0089] 2.3 Experimental Results and Analysis

[0090] Fecal samples from mice within 10 hours after the application of the patch were collected from each group. The collected fecal samples were then serially diluted 10-fold. -1 10 -2 10 -3 10 -4 10 -5 10 -6 10 -7 0.2 mL of fecal sample from each dilution was spread onto LBS and TPY agar plates and incubated at 37°C for 48 h. Lactobacillus and Bifidobacterium were then counted on plates. The results are as follows: Figure 1 As shown.

[0091] Figure 1 These are graphs showing the changes in intestinal flora in mice with diarrhea after applying the herbal compositions of Examples 1-3 and Comparative Examples 1-6. Figure 1 It was found that, compared with the model group and comparative examples 1-6, the levels of Lactobacillus and Bifidobacterium in mice significantly increased after applying the herbal composition of the present invention. There was no significant difference in the levels of Lactobacillus and Bifidobacterium in diarrhea model mice after oral administration of pinaverium bromide tablets and after application of the herbal composition of examples 1-3 of the present invention. This indicates that the herbal composition of the present invention can regulate intestinal flora imbalance.

[0092] Experimental Example 3

[0093] The changes in inflammatory factor levels in mice with roxithromycin-induced diarrhea were detected.

[0094] 3.1 Preparation of a mouse model of diarrhea

[0095] Same as Experiment 1

[0096] 3.2 Experimental grouping and administration method

[0097] Same as Experiment 1

[0098] 3.3 Experimental Results and Analysis

[0099] After collecting mouse feces, the mice were fasted and deprived of water for 12 hours. Blood was then collected from the abdominal aorta of each group of mice. After separating the serum, the levels of 5-HT, SP, and NGF in the serum were detected. The results are shown in Table 2.

[0100] Table 2

[0101] Group 5-HT (pg / mL) SP(ng / L) NGF (pg / mL) Blank control group 69.74 26.19 414.50 Model group 301.25 127.08 1098.63 Example 1 170.61 67.34 590.85 Example 2 185.40 68.55 596.71 Example 3 193.32 70.26 618.46 Comparative Example 1 244.67 93.75 820.62 Comparative Example 2 234.18 87.34 781.51 Comparative Example 3 212.60 80.07 691.28 Comparative Example 4 226.53 85.18 732.61 Comparative Example 5 276.49 109.84 920.33 Comparative Example 6 288.67 114.59 950.57 Piverammonium bromide tablets 167.18 62.65 573.80

[0102] Table 2 shows that compared with the blank control group, the serum levels of 5-HT, SP, and NGF in the model group mice were significantly increased. Compared with the model group, the serum levels of 5-HT, SP, and NGF in each experimental group mice were significantly decreased. Compared with the pinaverium bromide tablet group, there was no significant difference in the serum levels of 5-HT, SP, and NGF in each experimental group mice. These results indicate that the traditional Chinese medicine composition of the present invention can improve gastrointestinal function. The above embodiments are merely preferred embodiments of the present invention and should not be construed as limiting the scope of protection of the present invention. Any non-substantial changes and substitutions made by those skilled in the art based on the present invention are within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for improving diarrhea, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: basil 20-30 parts, long pepper 17-23 parts, yellow-flowered blood-nourishing herb 6-12 parts, red-shelled husk 4-10 parts, medicated leaven 3-7 parts, lotus seed 2-5 parts, and licorice 1-3 parts.

2. The traditional Chinese medicine composition for improving diarrhea according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 26 parts basil, 19 parts long pepper, 11 parts yellow clover, 5 parts red husk, 6 parts medicated leaven, 4 parts lotus seeds, and 2 parts licorice.

3. The method for preparing the traditional Chinese medicine composition for improving diarrhea according to claim 1 or 2, characterized in that, Includes the following steps: (1) Take the raw materials according to the formula of claim 1 or 2, soak them in water, decoct them, filter them, and take the decoction, which is recorded as the first decoction. (2) Add water to the residue from step (1), boil, filter, and take the decoction, which is recorded as the second decoction; mix the first and second decoctions and concentrate them to an extract with a relative density of 1.1-1.2 to obtain the extract.

4. The use of the traditional Chinese medicine composition for improving diarrhea as described in claim 1 or 2 in the preparation of a pharmaceutical formulation for improving diarrhea.

5. The application according to claim 4, characterized in that, The pharmaceutical preparation is for external use.

6. The application according to claim 5, characterized in that, The topical preparation is an ointment or patch.

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