A medicine-food homologous composition for moistening intestines and relieving constipation, and preparation method and use thereof

Abstract

The present invention provides a medicine-food composition for moistening the intestine and relieving constipation, and a preparation method and use thereof. Wherein, by weight, the medicine-food composition comprises or consists of the following components: 5-15 parts of desert cistanche, 0.2-0.8 parts of radish seeds, 0.1-0.5 parts of yellow mustard seeds, 5-15 parts of perilla seeds, 0.5-1.5 parts of cassia seeds, 10-20 parts of hemp seeds and 5-15 parts of lactose. The medicine-food composition of the present invention has significant laxative effect and has significant therapeutic effect on patients with constipation.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine and food, and specifically relates to a medicine-food homologous composition for moistening intestines and relieving constipation, and a preparation method and use thereof. Background Art

[0002] Constipation refers to a series of symptoms of intestinal dysfunction, such as decreased frequency of bowel movements, difficulty in defecation, difficulty in passing stool through the intestines, excessive force during defecation accompanied by a sense of anorectal obstruction, and a sense of incomplete defecation. Functional constipation is a persistent difficulty in defecation caused by non-organic diseases or non-drug factors. With the rapid development of society, the incidence of constipation has continued to increase due to bad living habits, complex dietary structure and huge psychological pressure. Long-term constipation not only affects people's quality of life, but also increases the incidence of cardiovascular and cerebrovascular diseases, seriously affecting physical and mental health.

[0003] Although the drugs commonly used in clinical practice to treat constipation can relieve constipation to a certain extent, most of them have side effects. For example, they are highly irritating to the patient's body, can easily cause drug dependence if taken for a long time, and can seriously damage intestinal nerves, thereby further aggravating constipation and causing drug dependence.

[0004] Compared with Western medicine, Chinese medicine has the characteristics of multiple targets, multiple links and high safety. Chinese medicine focuses on the overall treatment of the disease and emphasizes syndrome differentiation and treatment. The long-term effect is satisfactory and worthy of promotion and use in life practice. Substances with the same origin as medicine and food can be used to prevent and treat diseases, and can also be used as part of daily diet to provide the human body with necessary nutrition. They are derived from nature, without chemical substances added, and have no toxic side effects on the human body, which is more in line with modern people's pursuit of healthy food.

[0005] Therefore, providing a medicine-food composition that can effectively play a laxative effect is an urgent problem to be solved. Summary of the invention

[0006] In view of the above problems, the purpose of the present invention is to provide a medicine-food composition for moistening the intestine and relieving constipation, and a preparation method and use thereof. The inventors have found through research that the medicine-food composition of the present invention has a significant effect of moistening the intestine and relieving constipation, and has a significant therapeutic effect on patients with constipation. Therefore, the present invention provides a medicine-food composition for moistening the intestine and relieving constipation, and a preparation method and use thereof.

[0007] The above object of the present invention is achieved by providing the following technical solutions:

[0008] On the one hand, the present invention provides a medicinal and edible composition for moistening the intestine and promoting bowel movements, which comprises or consists of the following components in parts by weight: 5-15 parts of desert Cistanche, 0.2-0.8 parts of radish seeds, 0.1-0.5 parts of yellow mustard seeds, 5-15 parts of perilla seeds, 0.5-1.5 parts of cassia seeds, 10-20 parts of hemp seeds and 5-15 parts of lactose.

[0009] Preferably, the edible and medicinal composition comprises or consists of the following components in parts by weight: 8-12 parts of Cistanche deserticola, 0.4-0.6 parts of Radish Seed, 0.2-0.4 parts of Yellow Mustard Seed, 8-12 parts of Perilla Seed, 0.8-1.2 parts of Cassia Seed, 12-18 parts of Cannabis Sativa Seed and 8-12 parts of lactose.

[0010] Further preferably, the edible and medicinal composition comprises or consists of the following components in parts by weight: 10 parts of Cistanche deserticola, 0.5 parts of Radish Seed, 0.3 parts of Yellow Mustard Seed, 10 parts of Perilla Seed, 1 part of Cassia Seed, 15 parts of Cannabis Seed and 10 parts of lactose.

[0011] In a second aspect, the present invention provides a food-and-drug product for moistening the intestine and facilitating bowel movements, which is prepared from the food-and-drug composition according to the first aspect of the present invention and optional pharmaceutically and / or food-acceptable excipients.

[0012] According to some embodiments of the present invention, the pharmaceutically and / or food acceptable excipient is selected from one or more of preservatives, antioxidants, flavoring agents, thickeners and absorption enhancers; preferably, the flavoring agent is a sweetener; further preferably, the sweetener is selected from one or more of honey, sucrose, sorbitol, xylitol, erythritol, mogroside and steviol glycoside, more preferably honey.

[0013] According to some embodiments of the present invention, the dosage form of the medicine-food product is selected from one or more of ointments, gels, granules, tablets, solutions, emulsions and suspensions, preferably ointments.

[0014] In a third aspect, the present invention provides a method for preparing the medicine-food homologous product according to the second aspect of the present invention, comprising the following steps:

[0015] (1) mixing desert cistanche deserticola, radish seeds, yellow mustard seeds, perilla seeds, cassia seeds and hemp seeds, adding an extraction solvent for extraction, and then filtering and preliminarily concentrating the obtained extract in sequence to obtain a preliminary concentrated solution;

[0016] (2) adding lactose and optional pharmaceutically and / or food acceptable auxiliary materials to the preliminary concentrated solution and concentrating the solution again.

[0017] According to some embodiments of the present invention, in step (1), the extraction is selected from one or more of decoction, leaching and ultrasonic extraction, preferably decoction.

[0018] Preferably, the decoction is carried out under the following conditions: the decoction temperature is 90-100°C, preferably 95°C; the decoction times are 2-4 times, preferably 3 times; the decoction time each time is 45-75min, preferably 60min; the weight ratio of the extract to the extraction solvent is 1:8-12, preferably 1:10.

[0019] Preferably, in step (1), the extraction solvent is water and / or an ethanol aqueous solution with a volume fraction of 50-70%, preferably water.

[0020] Preferably, in step (1), the radish seeds, yellow mustard seeds, perilla seeds, cassia seeds and hemp seeds are crushed and sieved before extraction; further preferably, the mesh number of the sieving sieve is 10-30 meshes, preferably 20 meshes.

[0021] According to some embodiments of the present invention, in step (1), the relative density of the preliminary concentrated solution is 1.05-1.20, preferably 1.10-1.15.

[0022] In the present invention, "relative density" refers to the ratio of the density of a liquid to the density of water at 4°C under standard atmospheric pressure.

[0023] According to some embodiments of the present invention, in step (2), the solid-liquid ratio of the re-concentrated liquid obtained after re-concentration is 1:0.5-2, preferably 1:1.

[0024] In the present invention, the solid-liquid ratio of the re-concentrated liquid refers to the ratio of the total weight of the initially added Cistanche deserticola, radish seeds, yellow mustard seeds, perilla seeds, cassia seeds, hemp seeds, lactose and optional pharmaceutically and / or food acceptable excipients to the weight of the re-concentrated liquid.

[0025] In a fourth aspect, the present invention provides use of the medicine-food composition according to the first aspect of the present invention or the medicine-food product according to the second aspect of the present invention in the preparation of a medicament for preventing and / or treating intestinal dysfunction and related diseases.

[0026] Preferably, the intestinal dysfunction and its related diseases are defecation disorders; further preferably, the defecation disorder is constipation.

[0027] In a fifth aspect, the present invention provides use of the medicine-food composition according to the first aspect of the present invention or the medicine-food product according to the second aspect of the present invention in preparing food for improving intestinal dysfunction.

[0028] Preferably, the intestinal dysfunction is defecation disorder; further preferably, the defecation disorder is constipation.

[0029] The present invention has at least the following beneficial effects:

[0030] 1. The inventors have found through research that the medicine-food combination of the present invention can effectively play the role of moistening the intestines and relieving constipation, and the efficacy is definite. The inventors evaluated the effect of moistening the intestines and relieving constipation on the prepared medicine-food combination of the present invention and found that it has a good therapeutic effect on patients with constipation.

[0031] 2. The Chinese medicinal components in the edible and medicinal composition of the present invention are all edible and medicinal varieties announced by the National Health Commission, and have the advantages of good effect, low toxicity and easy promotion, and are safer than Western medicine.

[0032] 3. The present invention extracts radish seeds, yellow mustard seeds, perilla seeds, cassia seeds and hemp seeds after crushing and sieving, and examines factors such as extraction conditions and material-liquid ratio to extract the effective ingredients as much as possible, thereby being able to exert their efficacy to a greater extent. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The embodiments of the present invention are described in detail below with reference to the accompanying drawings, wherein:

[0034] Figure 1 This is a statistical chart of the total number of defecations of each group of mice within 6 hours after administration of mouse modeling drugs.

[0035] Figure 2 This is a statistical chart of the total number of defecations of mice in each group within 6 hours after administration of mouse modeling drugs and therapeutic drugs.

[0036] Figure 3 This is a statistical chart of the time of the first black stool in mice; compared with the model group, #### P<0.0001; compared with the model group, the positive drug group and the experimental group were *P<0.05, **P<0.01, ***P<0.001; ****P<0.0001.

[0037] Figure 4 This is a statistical chart of the small intestinal propulsion rate of mice; compared with the model group, #### <0.0001; compared with the model group, the positive drug group and the experimental group were *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001. DETAILED DESCRIPTION

[0038] The present invention is further described in detail below in conjunction with specific embodiments. The given examples are only for illustrating the present invention, but not for limiting the scope of the present invention.

[0039] Experimental Materials

[0040] Cistanche deserticola YCMa was purchased from Anhui Yuankang Chinese Medicine Pieces Co., Ltd. with batch number 20240701; Semen Raphani was purchased from Bozhou Yonggang Pieces Co., Ltd. with batch number 20240914; Brassica napusL was purchased from Anhui Yuankang Chinese Medicine Pieces Co., Ltd. with batch number 20240307; Fructus Perillae was purchased from Anhui Yuankang Chinese Medicine Pieces Co., Ltd. with batch number 20240201; Semen Cassiae was purchased from Anhui Yuankang Chinese Medicine Pieces Co., Ltd. with batch number 20240102; Cannabis sativa was purchased from Anguo Yaoyuan Trading Co., Ltd. with batch number 20240914.

[0041] Senna leaf (non-medicinal and edible variety) was purchased from Anhui Yuankang Chinese Medicine Pieces Co., Ltd., batch number 20240701. Weigh 5 g of senna leaf, add water and reflux extract twice, combine the filtrate, and concentrate it so that the final material-liquid ratio is 1:8 (that is, the ratio of the weight of senna leaf to the weight of the concentrated solution is 1:8), and the concentrated solution is obtained as a positive drug.

[0042] Loperamide hydrochloride capsules were purchased from Shanghai Xinya Pharmaceutical Minhang Co., Ltd. with batch number 220101.

[0043] Activated carbon was purchased from Henan Changyuan Environmental Protection Technology Co., Ltd. with batch number 202406.

[0044] Example 1

[0045] (1) Grind radish seeds, yellow mustard seeds, perilla seeds, cassia seeds, and hemp seeds separately and pass through a 20-mesh sieve;

[0046] (2) taking 10 parts of desert cistanche, 0.5 parts of sifted radish seeds, 0.3 parts of yellow mustard seeds, 10 parts of perilla seeds, 1 part of cassia seeds, and 15 parts of hemp seeds by weight, mixing them, adding water at a weight ratio of 1:10 to the water, then heating to 95° C., decocting for 60 minutes, filtering to obtain an extract, decocting three times, combining the three extracts, and then preliminarily concentrating to a relative density of 1.10-1.15 to obtain a preliminary concentrated solution;

[0047] (3) Add 10 parts of lactose and 3 parts of honey to the preliminary concentrated solution by weight, and concentrate again until the material-liquid ratio is 1:1 (i.e., the total weight of the added Cistanche deserticola, radish seeds, yellow mustard seeds, perilla seeds, cassia seeds, hemp seeds, lactose and honey is in a ratio of 1:1 to the weight of the concentrated solution after the second concentration), to obtain a paste.

[0048] Example 2

[0049] The paste was prepared according to the method of Example 1, the difference from Example 1 being that the material-liquid ratio in step (3) was 1:2.

[0050] Example 3

[0051] The paste was prepared according to the method of Example 1, which differed from Example 1 in that, based on weight fractions, 5 parts of desert cistanche, 0.2 parts of radish seeds, 0.1 parts of yellow mustard seeds, 5 parts of perilla seeds, 0.5 parts of cassia seeds, 10 parts of hemp seeds, 5 parts of lactose, and 3 parts of honey.

[0052] Example 4

[0053] The paste was prepared according to the method of Example 1, which differed from Example 1 in that, based on weight fractions, there were 15 parts of desert cistanche, 0.8 parts of radish seeds, 0.5 parts of yellow mustard seeds, 15 parts of perilla seeds, 1.5 parts of cassia seeds, 20 parts of hemp seeds, 15 parts of lactose, and 3 parts of honey.

[0054] Comparative Example 1

[0055] (1) Grind radish seeds, yellow mustard seeds, perilla seeds, cassia seeds, and hemp seeds separately and pass through a 20-mesh sieve;

[0056] (2) taking 10 parts of desert cistanche, 0.5 parts of sifted radish seeds, 0.3 parts of yellow mustard seeds, 10 parts of perilla seeds, 1 part of cassia seeds, and 15 parts of hemp seeds by weight, mixing them, adding water at a weight ratio of 1:10 to the water, then heating to 95° C., decocting for 60 minutes, filtering to obtain an extract, decocting three times, combining the three extracts, and then preliminarily concentrating to a relative density of 1.10-1.15 to obtain a preliminary concentrated solution;

[0057] (3) Add 3 parts of honey by weight to the preliminary concentrated liquid, and concentrate again until the material-liquid ratio is 1:1 to obtain a paste.

[0058] Comparative Example 2

[0059] The paste was prepared according to the method of Example 1, which differed from Example 1 in that, by weight, 1 part of desert cistanche, 0.5 part of radish seeds, 0.3 part of yellow mustard seeds, 10 parts of perilla seeds, 1 part of cassia seeds, 2 parts of hemp seeds, 10 parts of lactose, and 3 parts of honey.

[0060] Comparative Example 3

[0061] The paste was prepared according to the method of Example 1, which differed from Example 1 in that, by weight, 10 parts of desert cistanche, 5 parts of radish seeds, 3 parts of yellow mustard seeds, 10 parts of perilla seeds, 1 part of cassia seeds, 15 parts of hemp seeds, 10 parts of lactose, and 3 parts of honey were used.

[0062] Test Example 1 Pharmacodynamic Evaluation

[0063] The inventors evaluated the intestinal moistening and laxative effects of the pastes prepared in the above examples and comparative examples, and found that the medicine-food composition of the present invention has a good therapeutic effect on constipation. The following is a specific scheme and test results of the pharmacodynamic evaluation.

[0064] 1. Experimental Animals

[0065] Male KM mice, 18-22 g, SPF grade, were provided by Beijing Sibeifu Biotechnology Co., Ltd.

[0066] 2. Test methods

[0067] 2.1 Model establishment and drug administration regimen

[0068] After one week of adaptive feeding of mice, mice were randomly divided into a control group and a model group. The control group was gavaged with distilled water, and the model group was gavaged with loperamide hydrochloride to establish a constipation model. During the modeling period, mouse feces were collected. After successful modeling, all constipated mice were randomly divided into a model group, a positive drug group and an experimental group, wherein the experimental group was divided into embodiment 1-4 groups and comparative example 1-3 groups. A total of 10 groups, 7 in each group. The control group was gavaged with distilled water, and the other groups were gavaged with loperamide hydrochloride. After 2h, the experimental group was given the paste or positive drug obtained by the corresponding embodiment or comparative example, and the administration volume was 0.3ml / only, and the control group and the model group were gavaged with the same amount of distilled water for four consecutive days.

[0069] 2.3 First black stool experiment

[0070] After the fourth administration, mice in each group were fasted but not watered for 24 h. The control group was gavaged with distilled water, and the other groups were gavaged with loperamide hydrochloride. Two hours later, the positive drug group and the experimental group were gavaged with corresponding drugs. At intervals of 30 min, mice in each group were gavaged with 0.3 ml of activated carbon suspension, and ate and drank normally. The time of the first black stool was recorded.

[0071] 2.4 Small Intestinal Propulsion Experiment

[0072] After the first black stool experiment, each group of mice was given the drug normally for one day to ensure that the activated carbon suspension in the mice was discharged. The next day, the mice were fasted but not watered for 24 hours after the drug was given normally. Each group of mice was gavaged with 0.3 ml of activated carbon suspension. After an interval of 30 minutes, the mice were killed, and the small intestine between the pylorus and the cecum of the mice was taken. The total length of the small intestine and the length from the pylorus to the front of the activated carbon were measured with a soft ruler, that is, the length of suspension advancement. The small intestine advancement rate was calculated.

[0073] Small intestine propulsion rate = suspension propulsion length / total small intestine length × 100%.

[0074] 2.5 Statistics

[0075] The data obtained in this experiment were statistically analyzed using GraphPad Prism9.5, and the analysis method was one-way analysis of variance. The statistical results were all shown as mean ± standard deviation (SD). P < 0.05 was considered statistically significant.

[0076] 3. Test results

[0077] 3.1 Establishment of constipation mouse model

[0078] Figure 1 The defecation status of mice during the modeling period. Figure 1 As shown in the figure, 2 hours after mice were gavaged with loperamide hydrochloride, the number of feces in the model group was significantly reduced compared with that in the control group. After 6 hours, the difference between the number of feces in the model group and the control group further increased, indicating that the constipation model of mice was successfully established.

[0079] 3.2 Results of the defecation experiment on constipated mice

[0080] Figure 2 The number of defecations of constipated mice 6 hours after administration. The results showed that compared with the control group, the number of defecations of the model group mice was significantly reduced, further indicating that the constipation model of mice was successfully established. Compared with the model group mice, the number of defecations of the mice in each embodiment and the comparative example group increased, among which the number of defecations of the mice in each embodiment group increased more significantly than that in each comparative example group, and the number of defecations of the mice in Example 1 increased most significantly.

[0081] Figure 3 It is the statistical result of the time of first black stool discharge of mice. Compared with the control group, the time of first black stool discharge of mice in the model group was significantly prolonged (P<0.0001), indicating that the constipation model of mice was successfully constructed. Compared with the model group, the time of first black stool discharge of mice in each embodiment group was significantly advanced, and there were significant differences compared with each comparative example group, among which the time of first black stool discharge of mice in embodiment 1 group was earlier than that in the positive drug group (P<0.001). It can be seen that the medicine and food homologous composition of the present invention has a significant effect of moisturizing the intestine and relieving constipation.

[0082] 3.3 Results of the small intestinal propulsion experiment in constipated mice

[0083] Figure 4The statistical results of the small intestinal propulsion rate of constipated mice. The results showed that compared with the control group, the small intestinal propulsion rate of the model group mice was significantly reduced (P < 0.01), indicating that the model was successfully constructed. Compared with the model group, each embodiment group significantly improved the small intestinal propulsion rate of mice, and there were significant differences compared with each comparison group. It can be seen that the medicine and food composition of the present invention has a significant effect of promoting intestinal peristalsis in mice.

[0084] The above are only several exemplary embodiments of the present invention, and are not intended to limit the present invention in any form. Although the present invention is disclosed as above with preferred embodiments, they are not intended to limit the present invention. Any technician familiar with the profession, without departing from the scope of the technical solution of the present invention, can make some changes or modifications to the technical content disclosed above to obtain equivalent or equivalent implementation schemes, which belong to the scope of the present invention.

Claims

1. A medicine-food composition for moistening the intestine and relieving constipation, comprising or consisting of the following components by weight: 5-15 parts of desert cistanche, 0.2-0.8 parts of radish seeds, 0.1-0.5 parts of yellow mustard seeds, 5-15 parts of perilla seeds, 0.5-1.5 parts of cassia seeds, 10-20 parts of hemp seeds and 5-15 parts of lactose.

2. The edible-medicinal composition according to claim 1, wherein: The edible and medicinal composition comprises or consists of the following components by weight: 8-12 parts of desert cistanche, 0.4-0.6 parts of radish seeds, 0.2-0.4 parts of yellow mustard seeds, 8-12 parts of perilla seeds, 0.8-1.2 parts of cassia seeds, 12-18 parts of hemp seeds and 8-12 parts of lactose; Preferably, the edible and medicinal composition comprises or consists of the following components in parts by weight: 10 parts of Cistanche deserticola, 0.5 parts of Radish Seed, 0.3 parts of Yellow Mustard Seed, 10 parts of Perilla Seed, 1 part of Cassia Seed, 15 parts of Cannabis Seed and 10 parts of lactose.

3. A medicine-food product for moistening the intestine and relieving constipation, which is made from the medicine-food composition according to claim 1 or 2 and optional pharmaceutically and / or food acceptable excipients.

4. The medicine-food homologous product according to claim 3, wherein: The pharmaceutically and / or food acceptable excipients are selected from one or more of preservatives, antioxidants, flavoring agents, thickeners and absorption enhancers; further preferably, the flavoring agent is a sweetener; more preferably, the sweetener is selected from one or more of honey, sucrose, sorbitol, xylitol, erythritol, mogroside and steviol glycoside, preferably honey.

5. The food-medicine product according to claim 3 or 4, wherein: The dosage form of the medicine-food homologous product is selected from one or more of ointments, gels, granules, tablets, solutions, emulsions and suspensions, preferably ointments.

6. A method for preparing the medicine-food homologous product according to any one of claims 3 to 5, comprising the following steps: (1) mixing desert cistanche deserticola, radish seeds, yellow mustard seeds, perilla seeds, cassia seeds and hemp seeds, adding an extraction solvent for extraction, and then filtering and preliminarily concentrating the obtained extract in sequence to obtain a preliminary concentrated solution; (2) adding lactose and optional pharmaceutically and / or food acceptable auxiliary materials to the preliminary concentrated solution and concentrating the solution again.

7. The method according to claim 6, wherein: In step (1), the extraction is selected from one or more of decoction, leaching and ultrasonic extraction, preferably decoction; Preferably, the decoction is carried out under the following conditions: the decoction temperature is 90-100°C, preferably 95°C; the decoction times are 2-4 times, preferably 3 times; the decoction time each time is 45-75min, preferably 60min; the weight ratio of the extract to the extraction solvent is 1:8-12, preferably 1:10; Preferably, in step (1), the extraction solvent is water and / or an ethanol aqueous solution with a volume fraction of 50-70%, preferably water; Preferably, in step (1), the radish seeds, yellow mustard seeds, perilla seeds, cassia seeds and hemp seeds are crushed and sieved before extraction; further preferably, the mesh number of the sieving sieve is 10-30 meshes, preferably 20 meshes.

8. The method according to claim 6 or 7, wherein: In step (1), the relative density of the preliminary concentrated solution is 1.05-1.20, preferably 1.10-1.15; Preferably, in step (2), the solid-liquid ratio of the re-concentrated liquid obtained after re-concentration is 1:0.5-2, preferably 1:

1.

9. Use of the medicine-food composition according to claim 1 or 2 or the medicine-food product according to any one of claims 3 to 5 in the preparation of a medicament for preventing and / or treating intestinal dysfunction and related diseases; Preferably, the intestinal dysfunction and its related diseases are defecation disorders; further preferably, the defecation disorder is constipation.

10. Use of the medicine-food composition according to claim 1 or 2 or the medicine-food product according to any one of claims 3 to 5 in preparing food for improving intestinal dysfunction; Preferably, the intestinal dysfunction is defecation disorder; further preferably, the defecation disorder is constipation.

Images