A traditional Chinese medicine composition for improving constipation and its preparation method

Abstract

This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition for improving constipation and its preparation method. The traditional Chinese medicine composition for improving constipation comprises the following raw materials in parts by weight: Astragalus membranaceus 22-27 parts, Cistanche deserticola 20-25 parts, Evodia rutaecarpa 10-13 parts, Pseudostellaria heterophylla 10-15 parts, Morus alba 11-13 parts, Cannabis sativa 13-15 parts, Citrus aurantium 7-12 parts, Citrus aurantium 5-8 parts, and Glycyrrhiza uralensis 3-5 parts. The traditional Chinese medicine composition provided by this invention has a rigorous formulation, integrating the functions of invigorating qi, tonifying the kidneys, nourishing yin, moistening dryness, and promoting qi circulation. It is mild in nature, addresses both the root cause and symptoms, and achieves the effects of tonifying without stagnation, moistening without greasiness, and promoting circulation without harm. It has high safety, few side effects, and good clinical application prospects. Experiments show that this traditional Chinese medicine composition can significantly improve the defecation function of constipation model mice, shorten the time to first black stool, increase fecal water content, enhance small intestinal propulsion rate, and correct gastrointestinal hormone imbalance.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for improving constipation and its preparation method. Background Technology

[0002] Constipation is a common digestive system disease in clinical practice, characterized by reduced bowel movement frequency, hard stools, difficulty in defecation, or a feeling of incomplete defecation. Its prevalence is on the rise globally, especially under the influence of modern lifestyles such as sedentary lifestyles, refined diets, and increased mental stress. Constipation has become a prevalent disease that seriously affects patients' quality of life.

[0003] Currently, commonly used clinical medications include senna leaves, bisacodyl, mosapride, and prucalopride. However, long-term use of these drugs has many limitations: stimulant laxatives can easily cause melanosis coli and drug dependence; osmotic laxatives may lead to electrolyte imbalances; and prokinetic drugs may cause gastrointestinal adverse reactions such as abdominal pain and diarrhea. More importantly, these drugs are mostly symptomatic treatments and cannot fundamentally regulate intestinal function, resulting in a high relapse rate after discontinuation.

[0004] In recent years, with the rapid development of traditional Chinese medicine extraction technology and changes in people's health concepts, public awareness of medication safety has been continuously enhanced. Compared with chemical laxatives with obvious side effects, natural Chinese medicines are increasingly favored by the market due to their mild medicinal properties, ability to address both the symptoms and root cause, and fewer adverse reactions. This has also opened up new research and development avenues for the safe treatment and clinical improvement of functional constipation. Traditional Chinese medicine believes that although constipation is located in the large intestine, it is closely related to the functions of the spleen, kidneys, liver, and lungs. Qi deficiency leads to insufficient propulsion, kidney deficiency leads to intestinal dryness, Qi stagnation leads to abnormal transmission, and internal heat depletes body fluids, all of which can lead to constipation. Therefore, existing drugs often only treat the symptoms and not the root cause, and may even damage the body's vital energy. Therefore, developing a well-formulated, comprehensive, and safe traditional Chinese medicine composition for improving constipation has significant clinical significance and practical value. Summary of the Invention

[0005] The first objective of this invention is to provide a traditional Chinese medicine composition for improving constipation.

[0006] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine composition for improving constipation.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0008] A traditional Chinese medicine composition for improving constipation, comprising the following raw materials in parts by weight: Astragalus membranaceus 22-27 parts, Cistanche deserticola 20-25 parts, Evodia rutaecarpa 10-13 parts, Pseudostellaria heterophylla 10-15 parts, Morus alba 11-13 parts, Cannabis sativa 13-15 parts, Citrus aurantium 7-12 parts, Citrus aurantium 5-8 parts, Glycyrrhiza uralensis 3-5 parts.

[0009] Furthermore, a traditional Chinese medicine composition for improving constipation is composed of the following raw materials in parts by weight: Astragalus membranaceus 25 parts, Cistanche deserticola 22 parts, Evodia rutaecarpa 11 parts, Codonopsis pilosula 13 parts, Morus alba 12 parts, Cannabis sativa 14 parts, Citrus aurantium 8 parts, Citrus aurantium 6 parts, Glycyrrhiza uralensis 4 parts.

[0010] A method for preparing a traditional Chinese medicine composition for improving constipation specifically includes the following steps:

[0011] (1) Take each raw material according to the weight, remove impurities, wash and soak in water, decoct after soaking, filter and collect the filtrate and residue;

[0012] (2) Add water to the filter residue and repeat the above soaking and decoction operations. Filter and collect the filtrate. Combine the filtrates from steps (1) and (2) and concentrate them into an extract. Add pharmaceutically acceptable excipients to prepare the corresponding oral dosage form.

[0013] Furthermore, the amount of water added in steps (1) and (2) is 8-12 times that of the raw material.

[0014] Furthermore, the decoction includes the following steps: first, decoct at 90-100℃ for 15-20 minutes, and then decoct at 70-80℃ for 90-120 minutes.

[0015] Furthermore, the soaking time is 20-30 minutes.

[0016] Furthermore, the relative density of the extract is 1.05-1.18.

[0017] Furthermore, the oral dosage form is a tablet, granule, capsule, or oral liquid.

[0018] The medicinal properties and effects of each raw material in the traditional Chinese medicine composition of the present invention are described below:

[0019] Astragalus: The dried root of *Astragalus membranaceus* or *Astragalus mongholicus*, both belonging to the genus *Astragalus* of the legume family. Properties: Sweet, slightly warm; enters the spleen and lung meridians. It has the effects of tonifying qi and raising yang, tonifying the kidneys and replenishing essence, strengthening the spleen and replenishing the middle jiao. It is mainly used to treat qi deficiency and fatigue, poor appetite and loose stools, sinking of middle qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to superficial deficiency, edema due to qi deficiency, internal heat and thirst, anemia and chlorosis, hemiplegia, numbness and pain, carbuncles and boils that are difficult to ulcerate, and chronic ulcers that do not heal. *Compendium of Materia Medica* records: It is a medicine that tonifies the lungs and strengthens the spleen, strengthens the defensive qi and astringes sweat, and dispels wind and removes toxins.

[0020] Cistanche deserticola: A tall herbaceous plant belonging to the genus Cistanche in the family Orobanchaceae. Taste and nature: Sweet, salty, warm; Meridian tropism: It enters the kidney and large intestine meridians; Functions and indications: Tonify the kidney yang, benefit essence and blood, moisten the intestines and promote defecation. It is used for insufficiency of kidney yang, deficiency of essence and blood, impotence and infertility, soreness and weakness of the waist and knees, weakness of muscles and bones, and constipation due to intestinal dryness. Recorded in "Compendium of Materia Medica": This herb has a tonifying effect without being too drastic, so it has the name "Congrong". Before use, it must be soaked in clear wine overnight. By dawn, use a palm brush to remove the sand and floating shells, split it in the center, and remove a layer of white membrane like bamboo grass. Having this can prevent the qi in front of the heart from dispersing, causing shortness of breath.

[0021] Coluria longifolia: A plant of the genus Coluria in the family Rosaceae, and its whole herb is used as medicine. Taste and nature: Bitter, cool; Meridian tropism: It enters the liver, spleen, and stomach meridians; Functions and indications: Clear heat and detoxify, calm the liver and extinguish wind, promote qi movement and relieve pain, promote digestion and strengthen the stomach. It is used for hypertension, hepatitis, qi stagnation in the spleen and stomach, fullness and distension in the epigastrium and abdomen, abdominal distension due to food accumulation, and rheumatic arthralgia. Coluria longifolia is a commonly used folk medicinal material in the northwest and southwest regions. Recorded in "Handbook of Commonly Used Chinese Herbal Medicines in Qinghai": Calm the liver and extinguish wind, clear heat and detoxify. It is mainly used for hypertension and hepatitis.

[0022] Radix Pseudostellariae: The tuberous root of Pseudostellaria heterophylla, a plant of the genus Pseudostellaria in the Caryophyllaceae family. Taste and nature: Sweet, slightly bitter, flat; Meridian tropism: It enters the spleen and lung meridians; Functions and indications: Tonify qi and strengthen the spleen, promote the production of body fluid and moisten the lungs. It is used for weakness of the spleen and fatigue of the body, loss of appetite, weakness after illness, deficiency of qi and yin, spontaneous sweating and thirst, and dry cough due to lung dryness. Recorded in "Jiangsu Materia Medica": Tonify the lung yin and strengthen the spleen and stomach.

[0023] Fructus Mori: The fruit of plants of the genus Morus in the Moraceae family. Taste and nature: Sweet, sour, cold; Meridian tropism: It enters the heart, liver, and kidney meridians; Functions and indications: Nourish yin and enrich blood, promote the production of body fluid and moisten dryness. It is used for yin deficiency of the liver and kidney, dizziness and tinnitus, palpitation and insomnia, premature whitening of hair, thirst due to fluid impairment, internal heat and polydipsia, and constipation due to intestinal dryness. Recorded in "Compendium of Materia Medica": Drink the juice to relieve alcohol poisoning. Brew and take it to promote diuresis and reduce swelling.

[0024] Fructus Cannabis: The dried ripe fruit of Cannabis sativa, a plant of the genus Cannabis in the Moraceae family. Taste and nature: Sweet, flat; Meridian tropism: It enters the spleen, stomach, and large intestine meridians; Functions and indications: Moisten the intestines and promote defecation. It is used for blood deficiency and fluid depletion, constipation due to intestinal dryness. Recorded in "Shennong Ben Cao Jing": Tonify the middle qi. Taking it for a long time can make one plump and healthy. Recorded in "Yaopin Huayi": Hemp seeds can moisten the intestines. Their moist nature can remove dryness, and they are specifically used for constipation caused by qi stagnation in the large intestine. They can be used to treat cases where the elderly have dry blood, qi and blood are not smooth after childbirth, the vital qi has not recovered after illness, or those with weak constitutions who cannot promote qi movement.

[0025] Fructus Aurantii Immaturus: The dried young fruit of Citrus aurantium and its cultivated varieties or Citrus sinensis in the Rutaceae family. Taste and nature: Bitter, pungent, sour, slightly cold; Meridian tropism: It enters the spleen and stomach meridians; Functions and indications: Break qi and eliminate accumulation, resolve phlegm and disperse stagnation. It is used for internal retention of accumulation, fullness and distension with pain, tenesmus after diarrhea and dysentery, constipation, phlegm stagnation and qi obstruction, chest obstruction, knotted chest, and visceral ptosis. Recorded in "Shennong Ben Cao Jing": It is mainly used for wind in the skin like sesame seeds causing itching, removing cold and heat accumulation, stopping diarrhea, promoting muscle growth, benefiting the five zang-organs, and strengthening the body and lightening the body.

[0026] Gentianae Radix et Rhizoma: A plant of the Gentianaceae family, it is an annual herb. Properties: pungent, bitter, cool; Channels entered: Heart and Liver; Functions and indications: Clears heat and detoxifies, cools blood and reduces swelling, promotes diuresis and relieves pain. Used for carbuncles, sores, snake bites, traumatic injuries, indigestion, etc. The *Compilation of Commonly Used Folk Herbs* records: It breaks up blood stasis and promotes tissue regeneration. Treats leukorrhea, hematuria, and hematemesis.

[0027] Licorice: A perennial herb belonging to the genus Glycyrrhiza in the legume family, also known as Ural licorice or sweet root. It is sweet and neutral in nature, and enters the spleen, stomach, heart, and lung meridians. It has the effects of harmonizing the middle jiao and relieving spasms, invigorating qi, detoxifying, and harmonizing other herbs. It can treat shortness of breath, abdominal pain, food poisoning, and other symptoms. The *Shennong Bencao Jing* records that it treats cold and heat pathogens in the five internal organs and six bowels, strengthens tendons and bones, promotes muscle growth, increases strength, treats wounds and swellings, and detoxifies.

[0028] Compared with the prior art, the main advantages of the present invention are:

[0029] This invention provides a traditional Chinese medicine composition for improving constipation and its preparation method. Astragalus membranaceus, Cistanche deserticola, and Evodia rutaecarpa are the principal herbs, simultaneously tonifying Qi and Yang, nourishing the kidneys and replenishing essence, and promoting blood circulation and Qi flow, directly addressing the core pathogenesis of constipation caused by Qi deficiency, kidney deficiency, and Qi stagnation. Codonopsis pilosula and Morus alba are added as assistant herbs, strengthening the spleen and generating fluids, nourishing Yin and moistening dryness, and assisting in enhancing the effects of strengthening the body and moistening the intestines. Cannabis sativa seed, Citrus aurantium, and Scutellaria baicalensis are then added to moisten the intestines, promote bowel movements, break up stagnation, clear heat and detoxify, and clear away stagnant heat, thus unblocking intestinal obstruction. Glycyrrhiza uralensis is used as the guiding herb to harmonize the other herbs and moderate their properties. The traditional Chinese medicine composition provided by this invention has a rigorous formulation, integrating Qi-tonifying, kidney-nourishing, Yin-nourishing, dryness-moistening, and Qi-regulating effects. It is mild in nature, addresses both the root cause and symptoms, and achieves the effects of tonifying without stagnation, moistening without greasiness, and unblocking without harm. It has high safety, few side effects, and good clinical application prospects. Detailed Implementation

[0030] The technical solution of the present invention will be further described below with reference to specific embodiments. However, those skilled in the art should understand that the following embodiments are only for illustrating the present invention and should not be regarded as limiting the present invention. Specific conditions not specified in the embodiments are performed according to conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, the reagents or instruments used are all conventional products obtained through commercial channels.

[0031] Example 1

[0032] A traditional Chinese medicine composition for improving constipation includes the following raw materials in parts by weight: Astragalus membranaceus 25 parts, Cistanche deserticola 22 parts, Evodia rutaecarpa 11 parts, Codonopsis pilosula 13 parts, Morus alba 12 parts, Cannabis sativa 14 parts, Citrus aurantium 8 parts, Citrus aurantium 6 parts, Glycyrrhiza uralensis 4 parts.

[0033] A method for preparing a traditional Chinese medicine composition for improving constipation specifically includes the following steps:

[0034] (1) Take each raw material according to the weight, remove impurities, wash and mix evenly, add water to soak for 25 minutes, the amount of water added is 10 times that of the raw material, after soaking, decoct at 95℃ for 20 minutes, and then decoct at 75℃ for 100 minutes; filter and collect the filtrate and residue.

[0035] (2) Add water to the filter residue (the amount of water added is 10 times that of the raw drug) and repeat the above soaking and decoction operations. Filter and collect the filtrate. Combine the filtrates from steps (1) and (2) and concentrate under reduced pressure to form an extract with a relative density of 1.1. Add 0.28% starch by weight of the extract, dry at 60°C, pulverize, and obtain a semi-finished product. Then add 0.4wt% microcrystalline cellulose, 0.5wt% sodium carboxymethyl starch, and 0.45wt% magnesium stearate to the semi-finished product and mix well. According to conventional processes, obtain tablets.

[0036] Example 2

[0037] A traditional Chinese medicine composition for improving constipation includes the following raw materials in parts by weight: Astragalus membranaceus 22 parts, Cistanche deserticola 20 parts, Evodia rutaecarpa 10 parts, Codonopsis pilosula 10 parts, Morus alba 11 parts, Cannabis sativa 13 parts, Citrus aurantium 7 parts, Citrus aurantium 5 parts, Glycyrrhiza uralensis 3 parts.

[0038] A method for preparing a traditional Chinese medicine composition for improving constipation specifically includes the following steps:

[0039] (1) Take each raw material according to the weight, remove impurities, wash and mix evenly, add water to soak for 20 minutes, the amount of water added is 8 times that of the raw material, after soaking, decoct at 90℃ for 20 minutes, and then decoct at 70℃ for 120 minutes; filter and collect the filtrate and residue.

[0040] (2) Add water to the filter residue (the amount of water added is 8 times that of the raw drug) and repeat the above soaking and decoction operations. Filter and collect the filtrate. Combine the filtrates from steps (1) and (2) and concentrate under reduced pressure to form an extract with a relative density of 1.05. Add 0.28% starch by weight of the extract, dry at 60°C, pulverize, and obtain a semi-finished product. Then add 0.4wt% microcrystalline cellulose, 0.5wt% sodium carboxymethyl starch, and 0.45wt% magnesium stearate to the semi-finished product and mix well. According to conventional processes, obtain tablets.

[0041] Example 3

[0042] A traditional Chinese medicine composition for improving constipation includes the following raw materials in parts by weight: Astragalus membranaceus 27 parts, Cistanche deserticola 25 parts, Evodia rutaecarpa 13 parts, Codonopsis pilosula 15 parts, Morus alba 13 parts, Cannabis sativa 15 parts, Citrus aurantium 12 parts, Citrus aurantium 8 parts, Glycyrrhiza uralensis 5 parts.

[0043] A method for preparing a traditional Chinese medicine composition for improving constipation specifically includes the following steps:

[0044] (1) Take each raw material according to the weight, remove impurities, wash and mix evenly, add water to soak for 30 minutes, the amount of water added is 12 times that of the raw material, after soaking, decoct at 100℃ for 15 minutes, and then decoct at 80℃ for 90 minutes; filter and collect the filtrate and residue.

[0045] (2) Add water to the filter residue (the amount of water added is 12 times that of the raw drug) and repeat the above soaking and decoction operations. Filter and collect the filtrate. Combine the filtrates from steps (1) and (2) and concentrate under reduced pressure to form an extract with a relative density of 1.18. Add 0.28% starch by weight of the extract, dry at 60°C, pulverize, and obtain a semi-finished product. Then add 0.4wt% microcrystalline cellulose, 0.5wt% sodium carboxymethyl starch, and 0.45wt% magnesium stearate to the semi-finished product and mix well. According to conventional processes, obtain tablets.

[0046] Comparative Example 1

[0047] A traditional Chinese medicine composition for improving constipation includes the following raw materials in parts by weight: Astragalus membranaceus 25 parts, Cistanche deserticola 22 parts, Codonopsis pilosula 13 parts, Morus alba 12 parts, Cannabis sativa 14 parts, Citrus aurantium 8 parts, Citrus aurantium 6 parts, Glycyrrhiza uralensis 4 parts.

[0048] The preparation method of the comparative example Chinese herbal medicine composition is the same as that in Example 1.

[0049] Comparative Example 2

[0050] A traditional Chinese medicine composition for improving constipation includes the following raw materials in parts by weight: Astragalus membranaceus 25 parts, Cistanche deserticola 22 parts, Evodia rutaecarpa 11 parts, Codonopsis pilosula 13 parts, Morus alba 12 parts, Cannabis sativa 14 parts, Citrus aurantium 8 parts, and Glycyrrhiza uralensis 4 parts.

[0051] The preparation method of the comparative example Chinese herbal medicine composition is the same as that in Example 1.

[0052] Experiment Example 1 Safety Test

[0053] SPF-grade healthy BALB / c mice, weighing 18-22g, were selected. The experimental environment was set at a temperature of (22±2)℃ and a relative humidity of 50%±10%, with a 12h / 12h alternating light and dark cycle. Mice had free access to feed and drinking water throughout the experiment and underwent routine acclimatization for one week. The traditional Chinese medicine composition of Example 1 was administered to mice by gavage at a dose of 10g / kg / day (based on raw drug). A negative control group was also set up, which received an equal volume of physiological saline by gavage. Ten mice were in each group, and the treatment continued for 30 days. The mice's activity, coat color, tongue, nose, lips, tail color, paw color, mental state, and fecal condition were observed daily.

[0054] Safety test results showed that no abnormalities were observed in any group of mice after oral administration of the traditional Chinese medicine composition of the present invention, indicating that the traditional Chinese medicine composition of the present invention did not produce obvious toxic side effects on animals, nor did it cause any abnormal reactions such as allergies, and has good biological safety.

[0055] Experiment Example 2: Animal Pharmacodynamics Experiment

[0056] 1. Experimental animals

[0057] SPF-grade healthy BALB / c mice with a body weight of 18-22g were selected. The experimental environment was set at an ambient temperature of (22±2)℃ and a relative humidity of 50%±10%, with a 12h / 12h light-dark cycle. The mice had free access to food and drinking water throughout the experiment and were fed a routine acclimatization diet for one week.

[0058] 2. Animal grouping

[0059] BALB / c mice were randomly divided into blank group, low-dose group of Example 1, medium-dose group of Example 1, high-dose group of Example 1, low-dose group of Example 2, low-dose group of Example 3, low-dose group of Comparative Example 1, low-dose group of Comparative Example 2, model group, and positive control group, with 10 mice in each group.

[0060] 3. Constructing animal models and administering medication

[0061] Except for the control group, all other groups of mice were administered loperamide hydrochloride at a dose of 10 mg / kg / d via gavage to establish the constipation model, once daily for 7 consecutive days. Starting from the 8th day of the experiment, the control group was administered an equal volume of physiological saline via gavage, while the other groups of mice continued to be administered loperamide hydrochloride at a dose of 10 mg / kg / d to maintain the constipation model. At the same time, each administration group (Example 1 low-dose group, Example 1 medium-dose group, Example 1 high-dose group, Example 2 low-dose group, Example 3 low-dose group, Comparative Example 1 low-dose group, and Comparative Example 2 low-dose group) was administered the corresponding test formulation via gavage (the dosage was converted from the original drug): the dosage for the low, medium, and high-dose groups was 1.5 g / kg, 3 g / kg, and 6 g / kg, respectively; the positive control group was administered mosapride at a dose of 2.5 mg / kg via gavage. All groups were administered once daily for 14 consecutive days.

[0062] 4. Observation Indicators and Detection Methods

[0063] 4.1 Time of first black stool excretion and determination of fecal moisture content

[0064] Before the last administration, mice in each group were fasted and allowed free access to water for 12 hours. 30 minutes after the last administration, each mouse was gavaged with 0.2 mL of a charcoal suspension prepared from 5% gum arabic and 10% activated charcoal. Subsequently, normal feeding and individual cage housing were resumed. The time of excretion of the first black feces in each group was recorded, and the results are shown in Table 1. All feces of mice within 6 hours were collected and the wet weight of the feces was measured. The feces were then vacuum freeze-dried, sealed, and weighed, and the dry weight of the feces was recorded. The moisture content of the feces was calculated, and the results are shown in Table 2.

[0065] 4.2 Detection of Small Intestinal Charcoal Powder Propulsion Rate

[0066] After the last administration, mice in each group were fasted but allowed to drink water for 12 hours. Each mouse was given 0.2 mL of a carbon powder suspension prepared from 5% gum arabic and 10% activated charcoal by gavage. 30 min after gavage, the mice were anesthetized and euthanized by overdose inhalation. The small intestine tissue was quickly dissected and the small intestine propulsion rate was measured and calculated. The results are shown in Table 3.

[0067] 4.3 Detection of serum motilin (MTL) levels

[0068] Peripheral blood was collected from the orbital venous plexus of mice after the last administration, serum was separated, and the level of motilin (MTL) in the serum was detected by enzyme-linked immunosorbent assay (ELISA) kit. The results are shown in Table 4.

[0069] Table 1 Blank group 82.1 Model group 172.5 Positive control group 86.4 Example 1 Low-dose group 88.6 In Example 1, the dosage group 84.9 Example 1 High-dose group 83.4 Example 2 Low-dose group 90.3 Example 3 Low-dose group 91.2 Comparative Example 1 Low-dose group 102.7 Comparative Example 2 Low-dose group 98.5

[0070] As shown in Table 1, the time for the first black stool to be expelled in the model group was significantly longer than that in the control group, indicating that the loperamide hydrochloride model was successfully established, slowing down intestinal peristalsis and delaying fecal expulsion in mice, thus effectively establishing the constipation model. In Example 1, the time for the first black stool to be expelled in each dosage group was significantly shorter than that in the model group and close to that in the control group, indicating that the traditional Chinese medicine composition of the present invention improves constipation. Although Comparative Examples 1 and 2 were superior to the model group and had a certain defecation-promoting effect, the improvement was significantly less than that in the example groups. These results indicate that the traditional Chinese medicine composition in each example of the present invention can shorten the time for the first black stool to be expelled and accelerate fecal expulsion.

[0071] Table 2 Blank group 67.8 Model group 46.2 Positive control group 63.5 Example 1 Low-dose group 62.1 In Example 1, the dosage group 64.3 Example 1 High-dose group 65.4 Example 2 Low-dose group 61.2 Example 3 Low-dose group 60.6 Comparative Example 1 Low-dose group 52.7 Comparative Example 2 Low-dose group 56.6

[0072] As shown in Table 2, the fecal moisture content in the model group was significantly lower than that in the control group, indicating that the constipated stool was dry and hard with reduced moisture content, and the model was successfully established. In Example 1, the moisture content of each dose increased significantly, approaching that of the control group; the moisture content increases in Comparative Examples 1 and 2 were limited, and their effect on improving constipation was weaker than that of the Example 1. These results indicate that the herbal composition of the present invention can increase fecal moisture content, alleviate fecal dryness, and improve constipation.

[0073] Table 3 Blank group 88.5 Model group 60.9 Positive control group 83.7 Example 1 Low-dose group 83.2 In Example 1, the dosage group 85.3 Example 1 High-dose group 86.4 Example 2 Low-dose group 82.8 Example 3 Low-dose group 81.2 Comparative Example 1 Low-dose group 69.6 Comparative Example 2 Low-dose group 75.1

[0074] As shown in Table 3, the small intestinal propulsion rate in the model group was significantly lower than that in the control group, indicating inhibited intestinal peristalsis. In each dosage group of Example 1, the small intestinal propulsion rate significantly increased, approaching that of the control group; the improvement in Comparative Examples 1 and 2 was lower than that in the other groups of Example 1. Conclusion: The herbal composition of this invention can significantly improve the small intestinal propulsion rate, accelerate the transport of small intestinal contents, and promote gastrointestinal motility.

[0075] Table 4 Blank group 285.3 Model group 141.4 Positive control group 267.9 Example 1 Low-dose group 263.2 In Example 1, the dosage group 268.5 Example 1 High-dose group 272.7 Example 2 Low-dose group 261.3 Example 3 Low-dose group 259.6 Comparative Example 1 Low-dose group 234.1 Comparative Example 2 Low-dose group 242.8

[0076] As shown in Table 4, the MTL levels in each dosage group of Example 1 were higher than those in the model group, approaching the hormone levels in the blank group; Comparative Examples 1 and 2 only slightly improved gastrointestinal hormones, and their efficacy was significantly inferior to that of Example 1. This indicates that the traditional Chinese medicine composition of the present invention can promote gastrointestinal motility and exert its therapeutic effect on constipation.

[0077] In summary, the traditional Chinese medicine composition provided by this invention has a rigorous formulation, integrating the functions of invigorating qi, tonifying the kidneys, nourishing yin, moistening dryness, and promoting qi circulation. It has a mild medicinal property, addresses both the symptoms and the root cause, and achieves the effects of tonifying without stagnation, moistening without greasiness, and unblocking without harm. It has high safety, few side effects, and good clinical application prospects.

[0078] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. The basic principles and main features of the present invention have been described above with specific implementation schemes. Based on the present invention, some modifications or substitutions can be made, but these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for improving constipation, characterized in that, It is composed of the following ingredients in parts by weight: Astragalus membranaceus 22-27 parts, Cistanche deserticola 20-25 parts, Evodia rutaecarpa 10-13 parts, Codonopsis pilosula 10-15 parts, Morus alba 11-13 parts, Cannabis sativa 13-15 parts, Citrus aurantium 7-12 parts, Citrus aurantium 5-8 parts, Glycyrrhiza uralensis 3-5 parts.

2. The traditional Chinese medicine composition for improving constipation according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: Astragalus membranaceus 25 parts, Cistanche deserticola 22 parts, Evodia rutaecarpa 11 parts, Codonopsis pilosula 13 parts, Morus alba 12 parts, Cannabis sativa 14 parts, Citrus aurantium 8 parts, Citrus aurantium 6 parts, Glycyrrhiza uralensis 4 parts.

3. The preparation method of the traditional Chinese medicine composition for improving constipation according to claim 1 or 2, characterized in that, Specifically, the following steps are included: (1) Take each raw material according to the weight, remove impurities, wash and soak in water, decoct after soaking, filter and collect the filtrate and residue; (2) Add water to the filter residue and repeat the above soaking and decoction operations. Filter and collect the filtrate. Combine the filtrates from steps (1) and (2) and concentrate them into an extract. Add pharmaceutically acceptable excipients to prepare the corresponding oral dosage form.

4. The method for preparing a traditional Chinese medicine composition for improving constipation according to claim 3, characterized in that, The amount of water added in steps (1) and (2) is 8-12 times that of the raw material.

5. The method for preparing a traditional Chinese medicine composition for improving constipation according to claim 3, characterized in that, The decoction process includes the following steps: first, decoct at 90-100℃ for 15-20 minutes, and then decoct at 70-80℃ for 90-120 minutes.

6. The method for preparing a traditional Chinese medicine composition for improving constipation according to claim 3, characterized in that, The soaking time is 20-30 minutes.

7. The method for preparing a traditional Chinese medicine composition for improving constipation according to claim 3, characterized in that, The relative density of the extract is 1.05-1.

18.

8. The method for preparing a traditional Chinese medicine composition for improving constipation according to claim 3, characterized in that, The oral dosage form is a tablet, granule, capsule, or oral liquid.