A composition for lubricating the intestines and promoting defecation and use thereof

Abstract

The present application relates to a kind of compositions for lubricating intestine and defecation and its application, according to mass fraction, the composition includes: 20-50 parts of Huangqi, 20-50 parts of hemp seed, 8-30 parts of round-boschenchmau shell and 2-20 parts of xylo-oligosaccharide.The present application is reasonably compounded by Huangqi, hemp seed, round-boschenchmau shell and xylo-oligosaccharide under specific ratio, each component is indispensable, synergistic, with excellent technical effect for lubricating intestine and defecation, and compared with the formula component in prior art, it is simple, curative effect is better, with good application prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of food technology, in particular to a composition for lubricating intestines and defecating and application thereof. BACKGROUND

[0002] Constipation is a common problem worldwide, with an incidence ranging from 0.7% to 79% in the general population globally, with a median of 16%, causing a huge economic burden on health care. Constipation is a clinical syndrome, which is caused by weakened colon propulsive force or increased colon content resistance, insufficient pelvic floor muscle relaxation or inability to generate sufficient propulsive force during defecation, resulting in defecation disorder. The main features of constipation are less frequent bowel movements, hard or clumpy stools, straining during bowel movements, and incomplete rectal emptying. With the change of dietary structure and the increase of social pressure, the incidence of constipation is showing a trend of increasing year by year.

[0003] The commonly used drugs for treating constipation at present include osmotic laxatives and stimulant laxatives. The adverse reactions of osmotic laxatives include dose-dependent abdominal cramps and abdominal distension, and excessive use can cause electrolyte disorders, while long-term use of stimulant laxatives can cause intestinal nerve damage, colon melanosis and other problems. The above drugs all have safety problems.

[0004] CN107875255A discloses a composition for lubricating intestines and defecating and losing weight, wherein the mass fraction of the effective raw materials is as follows: 30-70 parts of round buckwheat shells, 10-40 parts of hemp seeds and / or konjac powder, 10-30 parts of sesame seeds and / or cassia seeds, and 10-30 parts of sweet almonds; or 30-60 parts of round buckwheat shells, 10-40 parts of hemp seeds and / or konjac powder, 10-30 parts of sesame seeds and / or cassia seeds, 10-30 parts of sweet almonds, and 10-40 parts of radix astragali. The composition has complex components, and the effects of the components are not clear.

[0005] CN109619487A discloses a composition with the function of lubricating intestines and defecating, which comprises 4 parts of solid microcapsule powder containing hemp seed oil, 5-20 parts of xylo-oligosaccharides, 2-10 parts of round buckwheat shell powder, 1-5 parts of konjac powder, and 10-30 parts of lactitol. The preparation process of the solid microcapsule powder containing hemp seed oil is complex and the cost is high.

[0006] Therefore, it is of good application prospect to develop a composition with the function of lubricating intestines and defecating, which has simple components, good curative effect and high safety. SUMMARY

[0007] To solve the above technical problems, the application provides a composition for lubricating intestines and defecating and application thereof. The application has excellent technical effects of lubricating intestines and defecating by reasonably compounding Astragalus membranaceus, Cannabis sativa L., Isatis tinctoria L. and xylo-oligosaccharide in a specific ratio, and each component is indispensable and synergistic. Compared with the prior art, the composition is simple, has better curative effect and has good application prospect.

[0008] To achieve the purpose, the application adopts the following technical solutions:

[0009] In the first aspect, the application provides a composition for lubricating intestines and defecating, which comprises, in terms of mass fraction:

[0010]

[0011] The fraction of Astragalus membranaceus can be 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, etc., the fraction of Cannabis sativa L. can be 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, etc., the fraction of Isatis tinctoria L. can be 10 parts, 12 parts, 15 parts, 18 parts, 20 parts, 22 parts, 25 parts, 28 parts, etc., and the fraction of xylo-oligosaccharide can be 4 parts, 7 parts, 10 parts, 13 parts, 16 parts, 19 parts, etc. Other specific point values in the above numerical ranges can be selected, and they will not be described one by one here.

[0012] Astragalus membranaceus is a medicinal and edible traditional Chinese medicine, which is the dried root of Astragalus membranaceus or Astragalus membranaceus. Astragalus membranaceus is a qi tonic, and its functions and indications are tonifying qi and ascending yang, consolidating the exterior and stopping sweating, promoting water and reducing swelling, producing saliva and nourishing blood, removing stagnation and relieving arthralgia, removing pus and promoting healing, and promoting healing of ulcers.

[0013] Cannabis sativa L. is the dried mature fruit of Cannabis sativa L., which is a traditional medicinal and edible traditional Chinese medicinal material, and has the effects of lubricating intestines and defecating and tonifying middle and benefiting qi.

[0014] Isatis tinctoria L. is the shell of Isatis tinctoria L. seed, which is a gelatinous soluble fiber with high water retention capacity and can produce anti-dehydration effect.

[0015] Xylo-oligosaccharide is a prebiotic that can increase the beneficial flora in the intestinal tract and improve digestion and intestinal function.

[0016] The application takes core medicine Huangqi and hemp seeds as the basis, wherein Huangqi benefits qi and treats the root, hemp seeds moisten intestines and treat the branch, complement each other, treat the root and branch, cut the pathogenesis, and do not hurt the normal qi, so as to achieve the purposes of nourishing yin and benefiting qi, moistening intestines and defecating.

[0017] Preferably, the composition comprises, by mass fraction:

[0018]

[0019] Preferably, the composition comprises, by mass fraction:

[0020]

[0021]

[0022] The application can obtain more excellent technical effects of moistening intestines and defecating by further limiting the ratio of Huangqi, hemp seeds, round bract psyllium shells and xylo-oligosaccharide.

[0023] Preferably, the water binding ratio of the round bract psyllium shells is (60-85):1, for example, can be 62:1, 64:1, 66:1, 68:1, 70:1, 72:1, 74:1, 76:1, 78:1, 80:1, 82:1, 84:1, etc., preferably (75-85):1.

[0024] The application selects round bract psyllium shells with higher water binding ratio, and the obtained preparation has better swelling effect and more excellent technical effects of moistening intestines and defecating.

[0025] In the second aspect, the application provides a use of the composition for moistening intestines and defecating according to the first aspect in the preparation of a medicine for moistening intestines and defecating.

[0026] Preferably, the dosage form of the medicine comprises any one of powder, granules, tablets, capsules, pills or solution.

[0027] Preferably, the medicine further comprises a pharmaceutically acceptable excipient.

[0028] Preferably, the pharmaceutically acceptable excipient comprises any one or a combination of at least two of diluent, excipient, filler, binder, wetting agent, disintegrant, emulsifier, co-solvent, solubilizer, osmotic pressure regulator, surfactant, coating material, colorant, pH regulator, antioxidant, bacteriostatic agent or buffer.

[0029] In a third aspect, the present application provides a preparation for lubricating intestines and defecating, wherein the preparation is prepared from the composition for lubricating intestines and defecating according to the first aspect.

[0030] Preferably, the preparation further comprises 10-200 parts of excipient, such as 30 parts, 50 parts, 75 parts, 100 parts, 125 parts, 150 parts, 175 parts, etc.

[0031] Preferably, the excipient comprises any one or a combination of at least two of anhydrous lactose, galacto-oligosaccharide, fructo-oligosaccharide, isomalto-oligosaccharide, sorbitol, maltodextrin, starch, microcrystalline cellulose or hydroxypropyl cellulose.

[0032] In a fourth aspect, the present application provides a preparation method of the preparation for lubricating intestines and defecating according to the third aspect, wherein the preparation method comprises the following steps:

[0033] (1) mixing Astragalus membranaceus, Cannabis sativa L. and solvent, decocting and extracting, and then filtering, combining the filtrates, and reducing pressure to concentrate the filtrates to obtain thick paste;

[0034] (2) drying, crushing and sieving the thick paste obtained in step (1) to obtain dry paste powder;

[0035] (3) mixing the dry paste powder obtained in step (2) with Plantago ovata husk, xylo-oligosaccharide, optional anhydrous lactose and optional maltodextrin to obtain the preparation.

[0036] Preferably, in step (1), the solvent comprises water or ethanol.

[0037] Preferably, the volume concentration of the ethanol is 30-80% (such as 40%, 50%, 60%, 70%, etc.).

[0038] Preferably, the mass ratio of the mixture of Astragalus membranaceus and Cannabis sativa L. to the solvent is 1:(6-12), such as 1:7, 1:8, 1:9, 1:10, 1:11, etc.

[0039] Preferably, the number of extraction is 1-3 times, such as 1 time, 2 times, 3 times.

[0040] Preferably, the time of each of said extractions is independently 60-150 min, for example it can be 70 min, 80 min, 90 min, 100 min, 110 min, 120 min, 130 min, 140 min, etc.

[0041] Preferably, in step (1), the temperature of said concentrating is 50-90℃, for example it can be 55℃, 60℃, 65℃, 70℃, 75℃, 80℃, 85℃, etc.

[0042] Preferably, the density of said thick paste is 1.06-1.30 g / cm 3 , for example it can be 1.08 g / cm 3 , 1.10 g / cm 3 , 1.12 g / cm 3 , 1.14 g / cm 3 , 1.16 g / cm 3 , 1.18 g / cm 3 , 1.20 g / cm 3 , 1.22 g / cm 3 , 1.24 g / cm 3 , 1.26 g / cm 3 , 1.28 g / cm 3 , etc.

[0043] Preferably, in step (2), the temperature of said drying is 60-100℃, for example it can be 65℃, 70℃, 75℃, 80℃, 85℃, 90℃, 95℃, etc.

[0044] Preferably, the mesh size of said sieving is 20-100 mesh, for example it can be 30 mesh, 40 mesh, 50 mesh, 60 mesh, 70 mesh, 80 mesh, 90 mesh.

[0045] Compared with the prior art, the present application has at least the following beneficial effects:

[0046] The present application takes core medicine Huangqi and Hunamaren as the basis, wherein Huangqi benefits qi and treats the root, Hunamaren moistens the intestines and treats the branch, complement each other, treat both the root and branch, cut through the pathogenesis, and do not harm the normal qi, so as to achieve the purposes of nourishing yin and benefiting qi, moistening the intestines and defecating. At the same time, the addition of dietary fiber chaff of Isopyrum and prebiotic xylo-oligosaccharide can play a role in moistening the intestines and defecating from promoting small intestine propulsion and gastrointestinal peristalsis, increasing fecal water content, regulating intestinal flora, etc. The present application reasonably compounding Huangqi, Hunamaren, chaff of Isopyrum and xylo-oligosaccharide under a specific ratio, each component is indispensable, and synergistic effect is achieved, which has excellent technical effect of moistening the intestines and defecating. DETAILED DESCRIPTION

[0047] The technical solution of the present invention will be further illustrated below through specific embodiments. However, the following examples are merely simplified examples of the present invention and do not represent or limit the scope of protection of the present invention. The scope of protection of the present invention is determined by the claims.

[0048] The source information of the raw materials and materials used in the following examples, comparative examples, application examples, and test examples is as follows:

[0049] Loperamide Hydrochloride Capsules (Batch No. 20210721, Shanghai Zhaohui Pharmaceutical Co., Ltd.); Febifu (Batch No. 300811, Recipharm Hoganas AB); Fufeng Round Plantago Seed Shell Powder (Batch No. 20230516, Fufeng Ciyuan Biotechnology Co., Ltd.); Meinian Round Plantago Seed Shell Powder (Batch No. AI / 4032 / 2023, Beijing Meinian Meiyue Biotechnology Co., Ltd.); Huaze Round Plantago Seed Shell Powder (Batch No. 20230831, Shaanxi Huaze Biotechnology Co., Ltd.); Astragalus (Batch No. HQi-2023040108-07); Cannabis Seed (Batch No. 230501, Henan Minkang Traditional Chinese Medicine Pieces Co., Ltd.); Xylooligosaccharides (Batch No. 95P20220518, Shandong Longli Biotechnology Co., Ltd.).

[0050] 0.01% balance (ML204T A05-03); electronic balance (YP10002B, E01-01); activated carbon powder (A304261-100g); gum arabic (A108975-500g, purchased from Aladdin Biochemical Technology Co., Ltd.).

[0051] Examples 1-8, Comparative Examples 1-7

[0052] Examples 1-8 and Comparative Examples 1-7 each provide a composition for relieving constipation. The component contents of the compositions, based on parts by mass, are shown in the table below:

[0053]

[0054] In Examples 1-8 and Comparative Examples 1-7, the psyllium husk used was Meinian psyllium husk powder, with a water binding ratio of 79:1.

[0055] Example 9

[0056] This embodiment provides a laxative composition, which differs from Example 3 only in that the Meinian psyllium husk powder is replaced with Fufeng psyllium husk powder, and the water binding ratio is 66:1.

[0057] Example 10

[0058] This embodiment provides a laxative composition, which differs from Example 3 only in that the Meinian psyllium husk powder is replaced with Huaze psyllium husk powder, and the water binding ratio is 72:1.

[0059] Application Example 1

[0060] This application example provides a laxative preparation, the raw materials for which the preparation comprises the composition of Example 1, and the preparation method includes the following steps:

[0061] (1) Mix 38 parts Astragalus membranaceus, 38 parts Cannabis sativa seeds, and water at a material-to-liquid ratio of 1:9 (i.e., the mass ratio of the mixture of Astragalus membranaceus and Cannabis sativa seeds to water), decoct and extract twice, 90 minutes each time, then filter, combine the filtrates, and concentrate the filtrate under reduced pressure at 75℃ to obtain a density of 1.18 g / cm³. 3 A thick paste;

[0062] (2) The thick paste obtained in step (1) is dried at 80°C, then pulverized and passed through a 50-mesh sieve to obtain dry paste powder;

[0063] (3) The dry powder obtained in step (2) is mixed with 14 parts of psyllium husk, 10 parts of xylooligosaccharide, 50 parts of anhydrous lactose and 50 parts of maltodextrin to obtain the preparation.

[0064] Application Example 2

[0065] This application example provides a laxative preparation, the raw materials for which the preparation comprises the composition of Example 2, and the preparation method includes the following steps:

[0066] (1) Mix 37 parts Astragalus membranaceus, 37 parts Cannabis sativa seeds, and 75% ethanol at a material-to-liquid ratio of 1:6 (i.e., the mass ratio of the mixture of Astragalus membranaceus and Cannabis sativa seeds to water), decoct and extract once for 60 minutes, then filter, combine the filtrates, and concentrate the filtrate under reduced pressure at 50℃ to obtain a density of 1.30 g / cm³. 3 A thick paste;

[0067] (2) The thick paste obtained in step (1) is dried at 60°C, then pulverized and passed through a 100-mesh sieve to obtain dry paste powder;

[0068] (3) The dry powder obtained in step (2) is mixed with 17 parts of psyllium husk, 9 parts of xylooligosaccharide, 5 parts of anhydrous lactose and 5 parts of maltodextrin to obtain the preparation.

[0069] Application Example 3

[0070] This application example provides a laxative preparation, the raw materials for which the preparation includes the composition of Example 3, and the preparation method includes the following steps:

[0071] (1) Mix 40 parts of Astragalus membranaceus, 40 parts of Cannabis seed and water according to a material-liquid ratio of 1:12 (i.e., the mass ratio of the mixture of Astragalus membranaceus and Cannabis seed to water), decoct and extract 3 times, each time for 150 min, then filter, combine the filtrates, and concentrate the filtrates under reduced pressure at 90 °C to obtain a thick paste with a density of 1.06 g / cm 3 ;

[0072] (2) Dry the thick paste obtained in step (1) at 100 °C, then pulverize it and pass through a 20-mesh sieve to obtain dry paste powder;

[0073] (3) Mix the dry paste powder obtained in step (2) with 13 parts of psyllium husk, 7 parts of xylooligosaccharide, 100 parts of anhydrous lactose and 100 parts of maltodextrin to obtain the preparation.

[0074] Application Examples 4 - 10, Comparative Application Examples 1 - 7

[0075] Application Examples 4 - 10 and Comparative Application Examples 1 - 7 respectively provide a laxative preparation, which is only different from that of Application Example 3 in that the preparation raw materials respectively adopt the compositions provided by Examples 4 - 10 and Comparative Examples 1 - 7, and the preparation method refers to Application Example 3.

[0076] Test Example 1

[0077] Laxative effect test

[0078] Test samples: The preparations provided by Application Examples 1 - 10 and Comparative Application Examples 1 - 7

[0079] Test animals: ICR male mice with a body weight of 18 - 22 g, 10 mice in each group, purchased from Jiangsu Huachuang Xinnuo Medical Technology Co., Ltd. The experimental animal production license number: SCXK (Su) 2020 - 0009. The mice are raised under standard experimental conditions at a temperature of 25 °C, ensuring sufficient food and water. After 7 days of administering the test samples, the mice in each group are fasted but allowed to drink water for 16 hours.

[0080] Experimental groups: There are 20 groups in total, namely: blank group, model group, Fib (a positive drug of Fibrecolon) 0.5 g / kg (clinical equivalent dose), and 17 sample groups (the preparations provided by Application Examples 1 - 10 and Comparative Application Examples 1 - 7 at 2.28 g / kg (calculated based on the crude drug amount). The blank group and the model group are intragastrically administered the same volume of distilled water once a day for 7 consecutive days.

[0081] Test methods:

[0082] (1) Small intestine propulsion experiment

[0083] Accurately weigh 100g of gum arabic, add 800mL of water, and boil until the solution is clear. Weigh 50g of activated carbon (powder) and add it to the above solution, boiling three times. After the solution cools, add water to bring the volume to 1000mL and store at 4℃. Shake well before use. The dosage of loperamide is 4mg / kg BW. Use according to the practical dosage of loperamide, prepare the solution according to the required concentration for the experiment, and heat until the solute is completely dissolved and shake well before use. Seven days after administering the test samples, mice in each group were fasted but allowed free access to water for 16 hours. The model control group and the drug treatment group were administered loperamide solution (4mg / kg BW) by gavage, while the blank control group was given distilled water.

[0084] 0.5 hours after administration of loperamide, the dosage groups were given ink containing the corresponding test sample (containing 5% activated charcoal powder and 10% gum arabic), while the blank control and model control groups were given ink by gavage. Animals were immediately euthanized by cervical dislocation 25 minutes later. The abdominal cavity was opened, the mesentery was separated, and a section of the intestine from the pylorus to the ileocecal junction was cut and placed on a tray. The small intestine was gently stretched into a straight line, and the length of the intestinal section was measured as the "total length of the small intestine." The distance from the pylorus to the leading edge of the ink was measured as the "ink propulsion length." The ink propulsion rate was calculated using the following formula:

[0085] Ink propulsion rate (%) = Ink propulsion length (cm) / Total small intestine length (cm) × 100%

[0086] (2) Experiment on defecation time, number of fecal particles and fecal weight

[0087] The preparation of the ink was the same as in the small intestinal motility test. The dosage of loperamide was 7 mg / kg BW. The amount of loperamide was taken according to the practical dosage, and the solution was prepared to the required concentration for the experiment. It could be heated until the solute was completely dissolved and thoroughly shaken before use. Seven days after administering the test samples, mice in each group were fasted but allowed free access to water for 16 hours. The negative control group received distilled water, while the model control group and the model-induced drug administration group were administered loperamide (7 mg / kg BW) by gavage.

[0088] 0.5 hours after administration of loperamide, mice in the blank control group and model group were administered ink by gavage, while the treatment group was given ink containing the test sample. All animals were housed individually and had normal access to water and food. From the start of ink administration, the time of the first black feces excreted by each animal, the number of black feces excreted within 6 hours, and their weight were recorded.

[0089] (3) Statistics and Analysis

[0090] Convert the ink propulsion rate data. In the formula, P represents the ink propagation rate, expressed as a decimal. When performing an analysis of variance (ANOVA), the homogeneity of variance test must be performed first, following the ANOVA procedure. If the variances are homogeneous, the F-value is calculated. <F 0.05 Conclusion: There was no significant difference between the means of each group; F-value ≥ F 0.05If P ≤ 0.05, perform statistical analysis by pairwise comparison of the means among multiple experimental groups and one control group; perform appropriate variable transformation on non-normal or unequal variance data until the data meets the requirements of normality or homogeneity of variance, and then use the transformed data for statistical analysis; if the transformation still does not achieve the goal of normality or homogeneity of variance, use the rank-sum test for statistical analysis.

[0091] The laxative effects of the preparations provided in Application Examples 1-10 and Comparative Application Examples 1-7 are shown in Table 1 (n=10,

[0092] ).

[0093] Table 1

[0094]

[0095]

[0096] Note: Compared with the blank group, ## P<0.01, #### P < 0.0001; compared with the model group, * P<0.05, ** P<0.01.

[0097] The test results show that:

[0098] (1) As can be seen from Application Examples 1 to 10, the present invention combines Astragalus membranaceus, Cannabis sativa seed, Plantago asiatica husk and xylooligosaccharide in a specific ratio to obtain a preparation that can significantly promote the motility of the small intestine in mice, shorten the defecation time of constipated mice, and increase the number and weight of fecal pellets in constipated mice, thus having excellent laxative effects.

[0099] (2) By comparing application examples 3 and 4-8, it can be seen that by further limiting the ratio of Astragalus membranaceus, Cannabis sativa seed, Plantago asiatica husk and xylooligosaccharide, the present invention can achieve better bowel-regulating and laxative effects.

[0100] The comparison between Application Example 3 and Application Examples 9-10 shows that the present invention, by using psyllium husk with a higher water binding ratio, can promote small intestinal motility in constipated mice, shorten the defecation time of constipated mice, and has a better technical effect of lubricating the intestines and relieving constipation.

[0101] (3) By comparing Application Example 3 with Comparative Application Examples 1-7, it can be seen that when the ratio of Astragalus membranaceus, Cannabis sativa seed, Plantago asiatica husk and xylooligosaccharide is not within the range specified in this application or when any of the components is missing, the small intestinal propulsion rate of constipated mice is reduced, the defecation time of constipated mice is increased, the number and weight of fecal particles of constipated mice are reduced, and the overall effect of bowel lubrication and defecation is reduced.

[0102] Test Example 2

[0103] Test of the laxative effect of low, medium and high doses

[0104] Test sample: The formulation provided in Example 3

[0105] Experimental groups: a total of 5 groups, namely: blank group, model group, low-dose group (1.14 g / kg, based on crude drug weight), medium-dose group (2.28 g / kg, based on crude drug weight), and high-dose group (4.56 g / kg, based on crude drug weight).

[0106] The test method is the same as in Test Example 1, and the test results are shown in Table 2 (n=10, ).

[0107] Table 2

[0108]

[0109]

[0110] Note: Compared with the blank group, ## P<0.01, #### P < 0.0001; compared with the model group, * P<0.05, ** P<0.01.

[0111] As can be seen from Table 2, the formulation provided by the present invention can significantly promote small intestinal motility, shorten defecation time, and increase the number of fecal particles and fecal weight in constipated mice when used at low, medium and high doses. That is, the formulation at different doses has the effect of lubricating the intestines and relieving constipation.

[0112] Test Example 3

[0113] Determination of water binding capacity and swelling effect

[0114] Test samples: Preparations provided in Examples 3 and 9-10, and psyllium husks from different manufacturers (Fufeng psyllium husk powder, Meinian psyllium husk powder, and Huaze psyllium husk powder).

[0115] Test method:

[0116] (1) Method for determining water-binding capacity: Accurately weigh 1g of each of the 6 samples and place them in a beaker. Add 100mL of boiling water and stir rapidly with a glass rod to ensure the samples are fully combined with water. Let stand for 1 hour to allow the samples to absorb water and swell. After 1 hour, pour the samples into a funnel and filter for 2 hours. After filtration, place the filter paper along with the samples into a 50mL beaker, weigh it on a balance, and record the data.

[0117] Water binding ratio = (Weight of water bound - Initial weight) : Initial weight

[0118] (2) Expansion effect determination method: 1g of each of the 6 samples was accurately weighed and placed in a graduated cylinder. 100mL of boiling water was added and the samples were stirred quickly with a glass rod to allow them to fully absorb water and expand. The scale on the graduated cylinder was observed at 0.5h, 1h, 2h, 4h, 6h, 12h and 24h. The temperature was 80℃ and the expansion effect was recorded.

[0119] Table 3 shows the water-binding capacity data of the formulations provided in Application Examples 3 and 9-10 and psyllium husks from different manufacturers.

[0120] Table 3

[0121]

[0122] As shown in Table 3, the psyllium husk raw materials from Fufeng, Huaze, and Meinian all exhibited good water-binding capacity, with Meinian psyllium husk raw material showing the best water-binding capacity. The formulations prepared using psyllium husks from different manufacturers showed comparable water-binding capacity, with a water-binding ratio reaching (37–38):1.

[0123] Table 4 shows the test data of the swelling effect of the formulations provided in Application Examples 3 and 9-10 and psyllium husks from different manufacturers.

[0124] Table 4

[0125]

[0126]

[0127] As shown in Table 3, the raw material of Meinian psyllium husk has a more prominent swelling effect. The preparation made from Meinian psyllium husk has the best swelling effect, which can expand to 50 mL in 1 hour.

[0128] The results of water-binding capacity and swelling effect tests showed that the preparation containing Psyllium husk of Meinianyuan had better water-binding capacity and swelling effect, which were positively correlated with the results of the efficacy test.

[0129] The applicant declares that the above description is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention fall within the protection and disclosure scope of the present invention.

Claims

1. A composition for promoting bowel movement and relieving constipation, characterized in that, The composition comprises, by weight parts, the following raw materials: Astragalus membranaceus 36-40 parts; 36-40 portions of hemp seeds; 12-17 parts of psyllium husk; 5-10 parts xylooligosaccharides; The water binding ratio of the psyllium husk is (75~85):

1.

2. The use of the laxative composition according to claim 1 in the preparation of a laxative medicine.

3. The application according to claim 2, characterized in that, The dosage form of the drug includes any one of the following: powder, granules, tablets, capsules, pills, or solution.

4. The application according to claim 2, characterized in that, The drug also includes pharmaceutically acceptable excipients.

5. The application according to claim 4, characterized in that, The pharmaceutically acceptable excipients include any one or a combination of two or more of the following: diluents, excipients, fillers, binders, wetting agents, disintegrants, emulsifiers, solubilizers, osmotic pressure regulators, surfactants, coating materials, colorants, pH adjusters, antioxidants, antibacterial agents, or buffers.

6. A laxative preparation, characterized in that, The preparation is made from the laxative composition of claim 1 and excipients.

7. The laxative preparation according to claim 6, characterized in that, The excipients for the formulation are 10 to 200 parts.

8. The laxative preparation according to claim 6, characterized in that, The excipients include any one or a combination of two or more of the following: anhydrous lactose, galactooligosaccharides, fructooligosaccharides, isomaltooligosaccharides, sorbitol, maltodextrin, starch, microcrystalline cellulose, or hydroxypropyl cellulose.

9. A method for preparing a laxative preparation according to claim 6, characterized in that, The preparation method includes the following steps: (1) Mix Astragalus membranaceus and hemp seeds, add water or ethanol with a volume concentration of 30-80%, decoct and extract, then filter, combine the filtrates, concentrate the filtrates under reduced pressure to obtain a thick paste; (2) The thick paste obtained in step (1) is dried, pulverized, and sieved to obtain dry paste powder; (3) The dry powder obtained in step (2) is mixed with psyllium husk, xylooligosaccharide, anhydrous lactose and maltodextrin to obtain the preparation.

10. The preparation method according to claim 9, characterized in that, The mass ratio of the mixture of Astragalus membranaceus and Cannabis sativa seeds to water or ethanol with a volume concentration of 30-80% is 1:(6-12).

11. The preparation method according to claim 9, characterized in that, The extraction is performed 1 to 3 times.

12. The preparation method according to claim 11, characterized in that, The extraction time for each extraction is 60-150 minutes.

13. The preparation method according to claim 9, characterized in that, In step (1), the concentration temperature is 50~90℃.

14. The preparation method according to claim 9, characterized in that, The density of the paste is 1.06~1.30 g / cm³. 3 .

15. The preparation method according to claim 9, characterized in that, In step (2), the drying temperature is 60~100℃.

16. The preparation method according to claim 9, characterized in that, The sieve mesh size is 20-100 mesh.

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