A composition with intestinal lubricating and defecation function and a preparation method thereof

Abstract

The application discloses a composition with the functions of moistening intestines and defecating, which is prepared from traditional Chinese medicine raw materials in the following proportions by weight: 20-30 parts of ginseng, 18-22 parts of ophiopogon, 15-25 parts of cassia twig, 20-30 parts of cinnamon, 20-30 parts of astragalus, 15-25 parts of prince salvia, 16-20 parts of white atractylodes, 15-25 parts of poria, 20-30 parts of dioscorea, 20-30 parts of prepared rhizome of rehmannia, 15-25 parts of eucommia, 15-25 parts of mint, 15-25 parts of honeysuckle and the like, which are used for treating constipation caused by deficiency of heart yang, lung qi, spleen qi, kidney, lung, blood and yin, moistening intestines and defecating, benefiting qi and ascending, and descending of qi, and the preparation method is disclosed.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine formulation technology, and in particular to a composition with laxative function and its preparation method. Background Technology

[0002] Chronic constipation is characterized by reduced bowel movement frequency, hard stools, and / or difficulty in defecation. Patients typically have fewer than three bowel movements per week, experience straining, difficulty passing stool, or a feeling of incomplete evacuation, and the condition has lasted for at least six months. Traditional Chinese medicine (TCM) classifies constipation into two types: excess constipation and deficiency constipation. Excess constipation can be further divided into qi stagnation and dampness obstruction; while deficiency constipation is further divided into qi deficiency, yin deficiency, yang deficiency, and blood deficiency. In the TCM approach to treating constipation, treatment plans are selected based on the specific syndrome. For example, qi stagnation constipation should be treated primarily by promoting qi circulation and relieving stagnation; qi deficiency constipation should be treated primarily by strengthening the spleen and replenishing qi; blood deficiency constipation should be treated primarily by nourishing the liver and moistening the intestines; and yin deficiency constipation should be treated primarily by nourishing the liver and kidneys. The application number is 201510307522.0, and the invention title is a traditional Chinese medicine for treating constipation due to qi deficiency. It is made from the following raw materials and their weight ratios: Astragalus membranaceus 40-60g, Codonopsis pilosula 20-30g, stir-fried Atractylodes macrocephala 12-15g, Angelica sinensis 12-15g, Prunus persica 10-12g, Citrus reticulata 12-15g, Cannabis sativa 15-30g, and Glycyrrhiza uralensis 10-12g. The constipation treated by this formula is due to spleen and lung qi deficiency, resulting in weak transport function. Therefore, in the above formula, a large dose of Astragalus membranaceus is chosen to greatly tonify the spleen and lung qi, serving as the principal herb. Codonopsis pilosula and stir-fried Atractylodes macrocephala assist Astragalus membranaceus in tonifying the spleen and lungs; they also generate fluids and nourish blood, serving as assistant herbs. Qi deficiency leads to blood deficiency, and blood deficiency leads to fluid depletion; therefore, Angelica sinensis, Prunus persica, and Cannabis sativa are added to tonify and invigorate blood, moisten the intestines, and promote bowel movements. Large doses of qi-tonifying herbs can easily cause qi stagnation; therefore, Citrus reticulata is added to regulate qi and harmonize the middle jiao, serving as adjuvant herbs. Prepared licorice root not only tonifies the middle energizer and replenishes qi, but also harmonizes the properties of other herbs, serving as an adjuvant. When used together, the herbs replenish qi and promote bowel movements, thus eliminating all symptoms. However, this method only addresses the spleen and lungs, and nourishes and invigorates blood, without considering the functions of other organs.

[0003] Currently, there are countless medications on the market for treating constipation due to Qi deficiency, but their effectiveness is generally poor. Some well-regarded medications for this condition are also expensive, and during treatment, they can easily cause adverse reactions such as affecting appetite, hindering the digestive system, failing to regulate or improve bodily functions, and having unpleasant tastes, making long-term use inconvenient. Therefore, we propose a composition for treating constipation due to Qi deficiency to address these problems, possessing the function of lubricating the intestines and promoting bowel movements. Summary of the Invention

[0004] The first objective of this invention is to provide a composition having a laxative function, which is a traditional Chinese medicine composition; a further objective is to provide a formulation of the traditional Chinese medicine composition and its uses.

[0005] The first objective of this invention is achieved as follows: a composition having a laxative function, said composition being prepared from the following Chinese medicinal materials by weight: ginseng 20-30 parts, ophiopogon japonicus 18-22 parts, cinnamon twig 15-25 parts, cinnamon bark 20-30 parts, astragalus membranaceus 20-30 parts, codonopsis pilosula 15-25 parts, atractylodes macrocephala 16-20 parts, poria cocos 15-25 parts, yam 20-30 parts, prepared rehmannia root 20-30 parts, eucommia ulmoides 15-25 parts, peppermint 15-25 parts, honeysuckle 15-25 parts, forsythia suspensa 10-20 parts, angelica sinensis 15-25 parts, raw rehmannia root 20-30 parts, peach kernel 15-25 parts, scrophularia ningpoensis 16-20 parts, cimicifuga foetida 12-20 parts, bupleurum chinense 15-25 parts, immature bitter orange peel 14-18 parts, and tangerine peel 10-20 parts.

[0006] The composition having the function of moistening the intestines and relieving constipation is prepared by extracting the following Chinese herbal raw materials by weight: ginseng 25 parts, ophiopogon japonicus 20 parts, cinnamon twig 20 parts, cinnamon bark 25 parts, astragalus membranaceus 25 parts, codonopsis pilosula 20 parts, atractylodes macrocephala 18 parts, poria cocos 20 parts, yam 25 parts, rehmannia glutinosa 25 parts, eucommia ulmoides 20 parts, peppermint 20 parts, honeysuckle 20 parts, forsythia suspensa 15 parts, angelica sinensis 20 parts, rehmannia glutinosa 25 parts, peach kernel 20 parts, scrophularia ningpoensis 18 parts, cimicifuga foetida 15 parts, bupleurum chinense 20 parts, immature bitter orange peel 16 parts, and tangerine peel 15 parts.

[0007] The composition having the function of moistening the intestines and relieving constipation is prepared by extracting the following Chinese herbal raw materials by weight: ginseng 20 parts, ophiopogon japonicus 22 parts, cinnamon twig 15 parts, cinnamon bark 30 parts, astragalus membranaceus 20 parts, codonopsis pilosula 25 parts, atractylodes macrocephala 16 parts, poria cocos 25 parts, yam 20 parts, rehmannia glutinosa 30 parts, eucommia ulmoides 15 parts, peppermint 25 parts, honeysuckle 15 parts, forsythia suspensa 20 parts, angelica sinensis 15 parts, rehmannia glutinosa 30 parts, peach kernel 15 parts, scrophularia ningpoensis 20 parts, cimicifuga foetida 12 parts, bupleurum chinense 25 parts, immature bitter orange peel 14 parts, and tangerine peel 20 parts.

[0008] The composition having the function of moistening the intestines and relieving constipation is prepared by extracting the following Chinese herbal raw materials by weight: ginseng 30 parts, ophiopogon japonicus 18 parts, cinnamon twig 25 parts, cinnamon bark 20 parts, astragalus membranaceus 30 parts, codonopsis pilosula 15 parts, atractylodes macrocephala 20 parts, poria cocos 15 parts, yam 30 parts, rehmannia glutinosa 20 parts, eucommia ulmoides 25 parts, peppermint 15 parts, honeysuckle 25 parts, forsythia suspensa 10 parts, angelica sinensis 25 parts, rehmannia glutinosa 20 parts, peach kernel 25 parts, scrophularia ningpoensis 16 parts, cimicifuga foetida 20 parts, bupleurum chinense 15 parts, immature bitter orange peel 18 parts, and tangerine peel 10 parts.

[0009] The composition having a laxative function is prepared by adding medically acceptable excipients to the composition into any one of the following formulations: decoction, granules, pills, tablets, capsules, ointment, syrup, and powder.

[0010] Another object of the present invention is to provide a method for preparing a composition having a laxative function.

[0011] The composition having the function of lubricating the intestines and relieving constipation is prepared by the following method: all the medicines are placed in a pot, water is added to cover the medicines by 2-3 cm, soaked for 30 minutes, boiled, kept boiling for 30 minutes, and the juice is taken; an appropriate amount of water is added again, boiled, kept boiling for 10 minutes, the juice is taken, and the juices are combined to obtain the decoction.

[0012] The composition having a laxative function, wherein the granules are prepared by the following process:

[0013] (1) Decoction: Add water to each herb in the formula at a weight ratio of 1:6-10 and decoct 1-3 times, each time for 30-60 minutes, and combine the decoction liquids.

[0014] (2) Concentration: The obtained decoction is concentrated into a thick paste at 50-75℃ and a vacuum of -0.02--0.06MPa. The relative density of the thick paste at 50-60℃ is 1.20-1.35g / ml.

[0015] (3) Drying: Dry the thick paste at 60-70℃ and under a vacuum of -0.02--0.06MPa to form a dry paste for later use;

[0016] (4) Granulation: The dry paste is crushed and passed through a 100-mesh sieve to obtain mixed dry paste powder. Granulation excipients are added and mixed evenly. An appropriate amount of 70-90% ethanol is added, and wet granulation is performed. After drying, granules are obtained.

[0017] The composition having the function of lubricating the intestines and relieving constipation is used in the preparation of a medicine for treating constipation due to qi deficiency.

[0018] The above-mentioned Chinese medicinal herbs, including ginseng, ophiopogon japonicus, cinnamon twig, cinnamon bark, astragalus, codonopsis pilosula, atractylodes macrocephala, poria cocos, yam, rehmannia glutinosa, eucommia ulmoides, mint, honeysuckle, forsythia suspensa, angelica sinensis, rehmannia glutinosa, peach kernel, scrophularia ningpoensis, cimicifuga foetida, bupleurum chinense, immature bitter orange peel, and tangerine peel, all meet the standards of the Chinese Pharmacopoeia.

[0019] Constipation due to Qi deficiency stems from spleen and lung Qi deficiency, leading to impaired digestive function and weak intestinal peristalsis. Therefore, despite the urge to defecate, straining is weak and difficult to pass stool. Lung Qi deficiency causes sweating and shortness of breath; spleen Qi deficiency results in insufficient production of nutrients, hence pale complexion, fatigue, and lethargy. A pale, tender tongue and weak pulse are also signs of Qi deficiency. Symptoms include: stools are not necessarily hard; although there is an urge to defecate, straining is weak and difficult to pass stool; straining leads to sweating, shortness of breath, fatigue after defecation, pale complexion, fatigue, and lethargy. A pale, tender tongue with a white coating and a weak pulse are also present.

[0020] Qi deficiency generally refers to physical weakness, pale complexion, shortness of breath, weakness in the limbs, dizziness, sweating upon exertion, and a weak voice. It includes depletion of primordial qi, ancestral qi, and defensive qi, as well as a decline in the functions of qi in promoting, warming, defending, consolidating, and transforming qi, leading to a decrease or decline in certain bodily functions and a weakened immune system. Fundamentally, human life activities are the movement of primordial qi rising, falling, entering, and exiting; insufficient primordial qi can cause fatigue, weakness, lower back and knee pain, a weak and listless voice, chest tightness, shortness of breath, lethargy, dizziness, insomnia, forgetfulness, loss of appetite, and many other discomforts.

[0021] Constipation in the elderly is often due to Qi deficiency, caused by insufficient Qi and blood, depletion of the lower Jiao (lower burner), and internal accumulation of Yin cold due to Yang deficiency. Qi deficiency manifests as insufficient lung and spleen function. The lung and large intestine are internally and externally related; lung Qi deficiency weakens the large intestine's ability to transport and transform Qi, while spleen Qi deficiency impairs its digestive function. Blood deficiency leads to insufficient body fluids, failing to moisten the large intestine, resulting in difficult and obstructed bowel movements. Kidney Yang deficiency generates internal cold, causing Yin to congeal and stagnate. Impaired Yang Qi hinders the flow of body fluids, or kidney Yang deficiency prevents the transformation and warming of body fluids, making bowel movements difficult and constipation persistent. However, the heart generates the spleen, just as fire generates earth. Therefore, this invention first uses methods to tonify heart Yang, followed by Chinese herbs to tonify lung Qi deficiency and spleen Qi deficiency. The spleen and stomach are internally and externally related, working together to transform and transport the essence of food and water. The kidneys are the foundation of acquired constitution, the source of primordial yin and yang, and the root of yin, yang, qi, and blood in the internal organs. The lungs are the master of qi, and the kidneys are the root of qi. Therefore, strengthening the spleen and stomach requires tonifying the kidneys. The Qing Dynasty text *Shi Shi Mi Lu* (Secret Records of the Stone Chamber) states regarding constipation: "People think constipation is due to dryness of the large intestine, but who knows it's actually due to dryness of the lung qi? When the lungs are dry, the clear and purifying qi cannot descend to the large intestine." Therefore, while tonifying lung qi, appropriate lung-clearing Chinese medicine should be used. Furthermore, since qi deficiency is often accompanied by blood deficiency, and blood deficiency cannot nourish the large intestine, leading to dryness, *Danxi Xinfa* (Danxi's Heart Method) considers constipation to be due to blood deficiency, stating: "Dryness and constipation due to blood deficiency cannot be moistened; yin should be nourished." It also points out that "when the intestines and stomach are affected by wind, dryness and constipation occur; this condition is caused by the accumulation of wind qi." Treatment emphasizes against the indiscriminate use of purgatives: "If strong purgatives are used, fluids will be lost, qi and blood will be depleted, and although temporary relief may occur, constipation will return." Therefore, methods of tonifying blood and nourishing yin are employed. The common pathogenesis of constipation is the obstruction of intestinal qi and the failure of its transformation and transportation functions. Therefore, in the treatment of constipation, the methods of raising and lowering qi are used to achieve the effect of raising before lowering.

[0022] This invention uses ginseng, ophiopogon japonicus, cinnamon twig, and cinnamon bark to tonify heart yang, serving as the principal herbs; astragalus and codonopsis to tonify lung qi deficiency; atractylodes macrocephala, poria cocos, and yam to tonify spleen qi deficiency; rehmannia glutinosa and eucommia ulmoides to tonify the kidneys; and peppermint, honeysuckle, and forsythia suspensa to clear the lungs, serving as the assistant herbs; angelica sinensis and rehmannia glutinosa to tonify blood and nourish yin; and peach kernel and scrophularia ningpoensis to moisten the intestines and promote bowel movement, serving as the adjuvant herbs; and cimicifuga foetida and bupleurum to tonify qi and lift sunken qi; immature bitter orange to break up qi stagnation and descend; and tangerine peel to regulate qi, serving as the guiding herbs. The entire formula contains ginseng, ophiopogon japonicus, cinnamon twig, cinnamon bark, astragalus, codonopsis macrocephala, atractylodes macrocephala, poria cocos, yam, rehmannia glutinosa, eucommia ulmoides, peppermint, honeysuckle, forsythia suspensa, angelica sinensis, rehmannia glutinosa, peach kernel, scrophularia ningpoensis, cimicifuga foetida, bupleurum chinense, immature bitter orange, and tangerine peel. Through tonifying heart yang, tonifying lung qi deficiency, tonifying spleen qi deficiency, clearing the lungs, tonifying blood and nourishing yin, moistening the intestines and promoting bowel movement, tonifying qi and lifting sunken qi, and breaking up qi stagnation and descending, it jointly treats qi deficiency constip

[0023] Pharmacodynamic experiments showed that compared with the control group, the fecal wet weight, fecal pellet number, and fecal water content of constipated rats were significantly reduced in the model group, indicating that the constipation model of Qi deficiency rats was successfully established. Compared with the model group, the present invention can significantly increase the fecal wet weight, fecal pellet number, and fecal water content of constipated rats, indicating that the present invention has a significant laxative effect on constipation caused by Qi deficiency.

[0024] Clinical trials showed that the total effective rate of treatment in the observation group was 92%, which was higher than that in the control group (76%). The difference was statistically significant, indicating that the present invention has a good therapeutic effect on constipation due to qi deficiency. Detailed Implementation

[0025] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, but these equivalent forms also fall within the scope defined by the appended claims.

[0026] Example 1: Take 25g of ginseng, 20g of ophiopogon japonicus, 20g of cinnamon twig, 25g of cinnamon bark, 25g of astragalus membranaceus, 20g of codonopsis pilosula, 18g of atractylodes macrocephala, 20g of poria cocos, 25g of yam, 25g of rehmannia glutinosa, 20g of eucommia ulmoides, 20g of peppermint, 20g of honeysuckle, 15g of forsythia suspensa, 20g of angelica sinensis, 25g of rehmannia glutinosa (raw), 20g of peach kernel, 18g of scrophularia ningpoensis, 15g of cimicifuga foetida, 20g of bupleurum chinense, 16g of immature bitter orange peel, and 15g of dried tangerine peel. Place all the herbs in a pot, add water to cover the herbs by 2cm, soak for 30min, bring to a boil, and keep boiling for 30min. Collect the liquid. Add an appropriate amount of water again, bring to a boil, and keep boiling for 10min. Collect the liquid and combine the liquids to obtain a decoction.

[0027] Example 2: Take 25g of ginseng, 20g of Ophiopogon japonicus, 20g of cinnamon twig, 25g of cinnamon bark, 25g of Astragalus membranaceus, 20g of Codonopsis pilosula, 18g of Atractylodes macrocephala, 20g of Poria cocos, 25g of Dioscorea opposita, 25g of Rehmannia glutinosa (processed), 20g of Eucommia ulmoides, 20g of Mentha haplocalyx, 20g of Lonicera japonica, 15g of Forsythia suspensa, 20g of Angelica sinensis, 25g of Rehmannia glutinosa (raw), 20g of Prunus persica, 18g of Scrophularia ningpoensis, 15g of Cimicifuga foetida, 20g of Bupleurum chinense, 16g of Citrus aurantium, and 15g of Citrus reticulata peel. The preparation process is as follows:

[0028] (1) Decoction: Add water to each ingredient of the formula at a weight ratio of 1:8 and decoct twice, each time for 45 minutes, and combine the decoction liquids.

[0029] (2) Concentration: The obtained decoction was concentrated into a thick paste at 65°C and -0.04MPa vacuum. The relative density of the thick paste at 55°C was 1.30g / ml.

[0030] (3) Drying: Dry the thick paste at 65℃ and -0.04MPa vacuum to form a dry paste for later use;

[0031] (4) Granulation: The dry paste is pulverized and passed through a 100-mesh sieve to obtain mixed dry paste powder. Granulation excipients are added and mixed evenly. An appropriate amount of 70% ethanol is added, and wet granulation is performed. After drying, granules are obtained.

[0032] Example 3: Take 20g of ginseng, 22g of ophiopogon japonicus, 15g of cinnamon twig, 30g of cinnamon bark, 20g of astragalus membranaceus, 25g of codonopsis pilosula, 16g of atractylodes macrocephala, 25g of poria cocos, 20g of yam, 30g of rehmannia glutinosa, 15g of eucommia ulmoides, 25g of peppermint, 15g of honeysuckle, 20g of forsythia suspensa, 15g of angelica sinensis, 30g of rehmannia glutinosa, 15g of peach kernel, 20g of scrophularia ningpoensis, 12g of cimicifuga foetida, 25g of bupleurum chinense, 14g of immature bitter orange peel, and 20g of dried tangerine peel. Place all the herbs in a pot, add water to cover the herbs by 3cm, soak for 30min, bring to a boil, and keep boiling for 30min. Take the liquid; add an appropriate amount of water again, bring to a boil, and keep boiling for 10min. Take the liquid and combine the liquids to obtain a decoction.

[0033] Example 4: Take 20g of ginseng, 22g of Ophiopogon japonicus, 15g of cinnamon twig, 30g of cinnamon bark, 20g of Astragalus membranaceus, 25g of Codonopsis pilosula, 16g of Atractylodes macrocephala, 25g of Poria cocos, 20g of Dioscorea opposita, 30g of Rehmannia glutinosa, 15g of Eucommia ulmoides, 25g of Mentha haplocalyx, 15g of Lonicera japonica, 20g of Forsythia suspensa, 15g of Angelica sinensis, 30g of Rehmannia glutinosa (raw), 15g of Prunus persica, 20g of Scrophularia ningpoensis, 12g of Cimicifuga foetida, 25g of Bupleurum chinense, 14g of Citrus aurantium, and 20g of Citrus reticulata peel. The preparation process is as follows:

[0034] (1) Decoction: Add water to each ingredient of the formula at a ratio of 1:10 by weight and decoct once for 60 minutes each time. Combine the decoction liquids.

[0035] (2) Concentration: The obtained decoction was concentrated into a thick paste at 50℃ and -0.06MPa vacuum. The relative density of the thick paste at 50-60℃ was 1.20g / ml.

[0036] (3) Drying: Dry the thick paste at 70℃ and -0.02MPa vacuum to form a dry paste for later use;

[0037] (4) Granulation: The dry paste is pulverized and passed through a 100-mesh sieve to obtain mixed dry paste powder. Granulation excipients are added and mixed evenly. An appropriate amount of 80% ethanol is added, and wet granulation is performed. After drying, granules are obtained.

[0038] Example 5: Take 30g of ginseng, 18g of Ophiopogon japonicus, 25g of cinnamon twig, 20g of cinnamon bark, 30g of Astragalus membranaceus, 15g of Codonopsis pilosula, 20g of Atractylodes macrocephala, 15g of Poria cocos, 30g of Dioscorea opposita, 20g of Rehmannia glutinosa, 25g of Eucommia ulmoides, 15g of Mentha haplocalyx, 25g of Lonicera japonica, 10g of Forsythia suspensa, 25g of Angelica sinensis, 20g of Rehmannia glutinosa (raw), 25g of Prunus persica, 16g of Scrophularia ningpoensis, 20g of Cimicifuga foetida, 15g of Bupleurum chinense, 18g of Citrus aurantium, and 10g of Citrus reticulata. Place all the herbs in a pot, add water to cover the herbs by 3cm, soak for 30min, bring to a boil, and keep boiling for 30min. Collect the liquid. Add an appropriate amount of water again, bring to a boil, and keep boiling for 10min. Collect the liquid and combine the liquids to obtain a decoction.

[0039] Example 6: Take 30g of ginseng, 18g of Ophiopogon japonicus, 25g of cinnamon twig, 20g of cinnamon bark, 30g of Astragalus membranaceus, 15g of Codonopsis pilosula, 20g of Atractylodes macrocephala, 15g of Poria cocos, 30g of Dioscorea opposita, 20g of Rehmannia glutinosa (processed), 25g of Eucommia ulmoides, 15g of Mentha haplocalyx, 25g of Lonicera japonica, 10g of Forsythia suspensa, 25g of Angelica sinensis, 20g of Rehmannia glutinosa (raw), 25g of Prunus persica, 16g of Scrophularia ningpoensis, 20g of Cimicifuga foetida, 15g of Bupleurum chinense, 18g of Citrus aurantium, and 10g of Citrus reticulata peel. The preparation process is as follows:

[0040] (1) Decoction: Add water to each ingredient in the formula at a weight ratio of 1:6 and decoct 3 times, each time for 30 minutes, and combine the decoction liquids.

[0041] (2) Concentration: The obtained decoction was concentrated into a thick paste at 75℃ and -0.02MPa vacuum. The relative density of the thick paste at 50-60℃ was 1.35g / ml.

[0042] (3) Drying: Dry the thick paste at 60℃ and -0.06MPa vacuum to form a dry paste for later use;

[0043] (4) Granulation: The dry paste is crushed and passed through a 100-mesh sieve to obtain mixed dry paste powder. Granulation excipients are added and mixed evenly. An appropriate amount of 70-90% ethanol is added, and wet granulation is performed. After drying, granules are obtained.

[0044] Example 7: Pharmacodynamic Study

[0045] 1. Establishment of a rat model of constipation due to Qi deficiency: Rats were randomly divided into a control group (n=8) and a model group (n=40). The control group was administered saline via gavage daily, while the model group was administered loperamide suspension (3 mg / (kg·d)) via gavage daily, along with a combination of fasting and excessive fatigue. Rats were fasted every other day and forced to run on a running wheel for 10 minutes daily. The dosage was adjusted by weighing the rats every 5 days for two consecutive weeks to establish the rat model of constipation due to Qi deficiency. The rats exhibited generally poor mental state, decreased coat luster, lethargy, uneven fecal particle size, reduced food and water intake, and weight loss, with a significant decrease in the number and weight of fecal particles (P<0.05), indicating successful establishment of the rat model of constipation due to Qi deficiency.

[0046] 2. Animal grouping and administration: 8 rats in the blank group were continued to be administered physiological saline by gavage daily. 24 rats that successfully developed the model were randomly divided into 3 groups of 8 rats each. The model group was administered physiological saline by gavage daily, the lactulose group was administered lactulose 1.67 g / (kg·day) by gavage daily, and the group in Example 1 of this invention was administered 10 g crude drug / (kg·day) by gavage daily, once a day for 2 weeks.

[0047] 3. Observation indicators: After 2 weeks of gavage, rats were placed in metabolic cages for 24 hours, fasted but allowed water. Rat feces were collected, and the wet weight of each feces was weighed and labeled. The number of fecal pellets per rat was recorded. After natural drying, the dry weight of each rat's feces was weighed, and the fecal moisture content was calculated. The calculation formula is as follows: Fecal moisture content = [(fecal wet weight - fecal dry weight) / fecal wet weight] * 100%.

[0048] The results are shown in Table 1.

[0049] Table 1. Effects of the present invention on body weight and fecal condition in rats with qi deficiency and constipation.

[0050] Group Stool wet weight (g) Number of fecal pellets (particles) Average fecal moisture content (%) Blank group 12.58±4.23 35.73±17.95 67.43±13.87 Model group <![CDATA[5.19±2.67 ** ]]> <![CDATA[14.38±4.93 ** ]]> <![CDATA[48.56±15.76 ** ]]> lactulose group <![CDATA[9.08±4.29 # ]]> <![CDATA[19.11±6.65 # ]]> 52.19±41.88 Example 1 Group <![CDATA[17.39±5.08 ## ]]> <![CDATA[38.29±15.92 ## ]]> <![CDATA[63.72±14.43 ## ]]>

[0051] Note: Compared with the blank group, * P < 0.05 ** P < 0.01; compared with the model group, # P < 0.05 ## P < 0.01

[0052] The results showed that compared with the blank group, the fecal wet weight, fecal particle number, and fecal water content of constipated rats were significantly reduced in the model group, indicating that the constipation model of Qi deficiency rats was successfully established. Compared with the model group, the present invention can significantly increase the fecal wet weight, fecal particle number, and fecal water content of constipated rats, indicating that the present invention has a significant laxative effect on constipation caused by Qi deficiency.

[0053] Example 8: Clinical Study

[0054] One hundred middle-aged and elderly patients with qi deficiency and constipation admitted to Xiaochang County Traditional Chinese Medicine Hospital from January 2021 to January 2023 were randomly divided into an observation group (Example 2) and a control group, with 50 patients in each group. The observation group consisted of 24 males and 26 females, aged 51-74 years, with a disease duration of 5-24 months. The control group consisted of 25 males and 25 females, aged 52-73 years, with a disease duration of 6-26 months. There were no statistically significant differences in general characteristics between the two groups (P>0.05), making them comparable.

[0055] Case selection criteria: Inclusion criteria: Patients meeting the diagnostic criteria for constipation due to Qi deficiency in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases". Exclusion criteria: (1) Patients with intestinal tumors; (2) Patients with intractable constipation caused by organic lesions; (3) Patients with dysfunction of important organs and systems; (4) Patients with mental illnesses.

[0056] Treatment methods: In Example 2, the observation group received the granules prepared in Example 2 of this invention (daily dosage: ginseng 25g, ophiopogon japonicus 20g, cinnamon twig 20g, cinnamon bark 25g, astragalus membranaceus 25g, codonopsis pilosula 20g, atractylodes macrocephala 18g, poria cocos 20g, yam 25g, rehmannia glutinosa 25g, eucommia ulmoides 20g, peppermint 20g, honeysuckle 20g, forsythia suspensa 15g, angelica sinensis 20g, rehmannia glutinosa 25g, peach kernel 20g, scrophularia ningpoensis 18g, cimicifuga foetida 15g, bupleurum chinense 20g, immature bitter orange peel 16g, tangerine peel 15g), taken twice daily, morning and evening. The control group received conventional Western medicine treatment: lactulose oral solution (National Drug Approval Number H20093299, manufacturer: Dalian Meiluo Pharmaceutical Factory Co., Ltd.), 10 ml each time, three times a day. Both groups were treated for one month.

[0057] Observation indicators and methods: Defecation time and frequency: The average duration of each defecation and the weekly defecation frequency of the two groups of patients before and after treatment were statistically analyzed. The results are shown in Table 2.

[0058] Table 2 Clinical Observations

[0059]

[0060] Compared with pre-treatment levels, *<0.05; compared with the control group, #<0.05

[0061] The results showed that before treatment, there was no statistically significant difference in defecation time and frequency between the two groups (P>0.05); after one month of treatment, the defecation time of both groups was shortened and the frequency was increased compared with before treatment, and the degree of shortening or increase in the observation group in Example 2 was greater than that in the control group, and the differences were statistically significant (P<0.05).

[0062] Efficacy evaluation criteria: Efficacy was assessed according to the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine." A cure was defined as the return of bowel movements to normal or back to the patient's pre-illness state; a marked improvement in constipation symptoms with stool consistency approaching normal and an interval of less than 48 hours was considered significantly effective; a shortened interval between bowel movements and improvement in constipation symptoms were considered effective; no change in constipation symptoms was considered ineffective. The total effective rate was calculated as (cured + markedly effective + effective) / total number of cases * 100%. Treatment results are shown in Table 3.

[0063] Table 3 Comparison of treatment effects between the control group and the observation group

[0064] Group get well Effective efficient invalid Overall effectiveness (%) control group 12 16 10 12 76 Example 2 group 18 15 13 4 92

[0065] The results showed that the total effective rate of treatment in the observation group was 92%, which was higher than that in the control group (76%). The difference was statistically significant, indicating that the present invention has a good therapeutic effect on constipation due to qi deficiency.

[0066] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. The application of a composition with laxative function in the preparation of a medicine for treating constipation due to qi deficiency, characterized in that, The composition is prepared by extracting the following Chinese medicinal materials by weight: ginseng 20-30 parts, ophiopogon japonicus 18-22 parts, cinnamon twig 15-25 parts, cinnamon bark 20-30 parts, astragalus membranaceus 20-30 parts, codonopsis pilosula 15-25 parts, atractylodes macrocephala 16-20 parts, poria cocos 15-25 parts, yam 20-30 parts, prepared rehmannia root 20-30 parts, eucommia ulmoides 15-25 parts, peppermint 15-25 parts, honeysuckle 15-25 parts, forsythia suspensa 10-20 parts, angelica sinensis 15-25 parts, raw rehmannia root 20-30 parts, peach kernel 15-25 parts, scrophularia ningpoensis 16-20 parts, cimicifuga foetida 12-20 parts, bupleurum chinense 15-25 parts, immature bitter orange peel 14-18 parts, and tangerine peel 10-20 parts.

2. The application of the composition with laxative function according to claim 1 in the preparation of a medicine for treating constipation due to qi deficiency, characterized in that, The composition is prepared by extracting the following Chinese medicinal materials by weight: ginseng 25 parts, ophiopogon japonicus 20 parts, cinnamon twig 20 parts, cinnamon bark 25 parts, astragalus membranaceus 25 parts, codonopsis pilosula 20 parts, atractylodes macrocephala 18 parts, poria cocos 20 parts, yam 25 parts, rehmannia glutinosa 25 parts, eucommia ulmoides 20 parts, peppermint 20 parts, honeysuckle 20 parts, forsythia suspensa 15 parts, angelica sinensis 20 parts, rehmannia glutinosa 25 parts, peach kernel 20 parts, scrophularia ningpoensis 18 parts, cimicifuga foetida 15 parts, bupleurum chinense 20 parts, immature bitter orange peel 16 parts, and tangerine peel 15 parts.

3. The application of the composition with laxative function according to claim 1 in the preparation of a medicine for treating constipation due to qi deficiency, characterized in that, The composition is prepared by extracting the following Chinese medicinal materials by weight: ginseng 20 parts, ophiopogon japonicus 22 parts, cinnamon twig 15 parts, cinnamon bark 30 parts, astragalus membranaceus 20 parts, codonopsis pilosula 25 parts, atractylodes macrocephala 16 parts, poria cocos 25 parts, yam 20 parts, rehmannia glutinosa 30 parts, eucommia ulmoides 15 parts, peppermint 25 parts, honeysuckle 15 parts, forsythia suspensa 20 parts, angelica sinensis 15 parts, rehmannia glutinosa 30 parts, peach kernel 15 parts, scrophularia ningpoensis 20 parts, cimicifuga foetida 12 parts, bupleurum chinense 25 parts, immature bitter orange peel 14 parts, and tangerine peel 20 parts.

4. The application of the composition with laxative function according to claim 1 in the preparation of a medicine for treating constipation due to qi deficiency, characterized in that, The composition is prepared by extracting the following Chinese medicinal materials by weight: ginseng 30 parts, ophiopogon japonicus 18 parts, cinnamon twig 25 parts, cinnamon bark 20 parts, astragalus membranaceus 30 parts, codonopsis pilosula 15 parts, atractylodes macrocephala 20 parts, poria cocos 15 parts, yam 30 parts, rehmannia glutinosa 20 parts, eucommia ulmoides 25 parts, peppermint 15 parts, honeysuckle 25 parts, forsythia suspensa 10 parts, angelica sinensis 25 parts, rehmannia glutinosa 20 parts, peach kernel 25 parts, scrophularia ningpoensis 16 parts, cimicifuga foetida 20 parts, bupleurum chinense 15 parts, immature bitter orange peel 18 parts, and tangerine peel 10 parts.

5. The use of a composition with laxative function according to any one of claims 1-4 in the preparation of a medicine for treating constipation due to qi deficiency, characterized in that... The composition is formulated with medically acceptable excipients and prepared into any one of the following: decoction, granules, pills, tablets, capsules, ointments, syrups, and powders.

6. The application of the composition with laxative function according to claim 5 in the preparation of a medicine for treating constipation due to qi deficiency, characterized in that, The decoction is prepared as follows: Place all the herbs in a pot, add water to cover the herbs by 2-3 cm, soak for 30 minutes, bring to a boil, keep boiling for 30 minutes, and take the juice; add an appropriate amount of water again, bring to a boil, keep boiling for 10 minutes, take the juice, and combine the juices to obtain the decoction.

7. The application of the composition with laxative function according to claim 5 in the preparation of a medicine for treating constipation due to qi deficiency, characterized in that, The granules are prepared by the following process: (1) Decoction: Add water to each herb in the formula at a weight ratio of 1:6-10 and decoct 1-3 times, each time for 30-60 minutes, and combine the decoction liquids; (2) Concentration: The obtained decoction is concentrated into a thick paste at 50-75℃ and a vacuum of -0.02--0.06MPa. The relative density of the thick paste at 50-60℃ is 1.20-1.35g / ml. (3) Drying: Dry the thick paste at 60-70℃ and under a vacuum of -0.02--0.06MPa to form a dry paste for later use; (4) Granulation: The dry paste is crushed and passed through a 100-mesh sieve to obtain mixed dry paste powder. Granulation excipients are added and mixed evenly. An appropriate amount of 70-90% ethanol is added, and wet granulation is performed. After drying, granules are obtained.

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