A Chinese medicine composition with bowel-moistening and laxative effects and preparation method thereof

Abstract

This invention relates to the field of traditional Chinese medicine composition technology, and proposes a traditional Chinese medicine composition with laxative effect and its preparation method. The raw materials of this traditional Chinese medicine composition, calculated by weight percentage, include: 10-25% Cistanche deserticola, 10-30% Angelica sinensis, 10-30% Prunus persica kernel, 10-35% Platycladus orientalis seed, 10-35% Cannabis sativa seed, 10-20% Almond, and 10-30% Citrus aurantium. The traditional Chinese medicine composition of this invention has few side effects, high safety, and a significant laxative effect.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition with bowel-moistening and laxative effects and a preparation method thereof. Background Art

[0002] Constipation is a common chronic digestive tract disease in clinical practice, usually with prolonged bowel movement intervals, dry and hard stools, and difficult and unsmooth stools as the main symptoms, which may be accompanied by abdominal pain and bloating. Constipation often brings great pain to patients. Carcinogens in the intestines of constipated patients are not easily excreted, and long-term accumulation in the body will increase the risk of colon cancer. People with severe constipation have a 10% chance of developing colon cancer. When constipated patients defecate, abdominal pressure continues to increase, the amount of blood returning to the heart decreases, and the intracranial pressure increases, which can easily cause abnormal heart rate and increase cerebrovascular disease, which can be life-threatening in severe cases. Feces retention leads to an increase in the number of harmful bacteria and the production of some harmful metabolic wastes. The reabsorption of these harmful wastes can cause gastrointestinal nerve dysfunction, a decrease in appetite, and symptoms such as bitter taste in the mouth, belching, and abdominal distension. In severe cases, poisoning may even occur. Some constipated patients are prone to psychological disorders such as insomnia and anxiety, which seriously affect their quality of life. The inner cavity of the digestive tract is compressed by hard feces for a long time, which can induce fecal ulcers and even intestinal perforation in severe cases. Toxins stay in the blood and, as the blood circulates, can induce pigmentation, acne and other skin diseases.

[0003] Due to the growing development of current society, people are facing increasing pressure. At the same time, people lack a good diet, irregular life, and aggravated aging, etc., and the above factors all cause the prevalence of constipation to increase year by year. Due to the high incidence of constipation and complex etiology, patients often have many troubles, and constipation can affect the quality of life when it is serious. Preventing and treating constipation is an important aspect to ensure human health and improve the quality of life. At present, there are many kinds of therapeutic drugs for constipation, most of which are mainly based on symptomatic laxatives for oral administration, and long-term use of laxatives is harmful and can produce side effects such as abdominal distension and vitamin absorption disorders. Therefore, it is urgent to find a Chinese medicine composition with high efficiency, small side effects and high safety to treat constipation. Summary of the invention

[0004] In view of this, the present invention proposes a Chinese medicine composition with laxative effect and a preparation method thereof, aiming to find a treatment method with small side effects and high safety.

[0005] The technical scheme of the present invention is achieved as follows: the present invention provides a Chinese medicine composition with the effect of moistening the intestine and promoting bowel movements, wherein the raw materials of the Chinese medicine composition, calculated by weight percentage, include: 10-25% of Cistanche deserticola, 10-30% of Chinese angelica, 10-30% of peach kernel, 10-35% of cypress seed, 10-35% of hemp seed, 10-20% of sweet almond, and 10-30% of fructus aurantii.

[0006] In some embodiments, the raw materials of the Chinese medicine composition, calculated by weight percentage, include: 10% Cistanche deserticola, 10% Angelica sinensis, 10% peach kernel, 15% Platycladus orientalis, 15% Cannabis seed, 15% Apricot kernel, and 25% Citrus aurantium.

[0007] In some embodiments, the raw materials of the Chinese medicine composition, calculated by weight percentage, include: 12% Cistanche deserticola, 20% Angelica sinensis, 20% peach kernel, 15% Platycladus orientalis seed, 10% Cannabis sativa seed, 10% Apricot kernel, and 13% Citrus aurantium.

[0008] In some embodiments, the raw materials of the Chinese medicine composition, calculated by weight percentage, include: 15% Cistanche deserticola, 15% Chinese angelica, 15% peach kernel, 15% cypress seed, 15% hemp seed, 15% sweet almond, and 10% Citrus aurantium.

[0009] In some embodiments, the raw materials of the Chinese medicine composition, calculated by weight percentage, include: 20% Cistanche deserticola, 10% Angelica sinensis, 10% peach kernel, 10% cypress seed, 20% hemp seed, 10% sweet almond, and 20% Citrus aurantium.

[0010] Cistanche deserticola is the dried fleshy stem with scaly leaves of Cistanche deserticola YCMa or Cistanche tubulosa (Schenk) Wight, a plant of the Orobanchaceae family. It has the effects of tonifying kidney yang, benefiting essence and blood, and moistening the intestines and relieving constipation.

[0011] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant of the Umbelliferae family. It was first recorded in Shennong's Herbal Classic. As a traditional Chinese medicinal material that is both a medicine and food, it is known as "Nine out of Ten Prescriptions are Angelica sinensis". It has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, protecting the liver, regulating intestinal function, and improving constipation.

[0012] Peach kernel is the dried mature seed of Prunus persica (L.) Batsch. or Prunus davidiana (Carr.) Franch. of the Rosaceae family. It tastes bitter, sweet and flat. Peach kernel is a medicinal material that can be used as both medicine and food. It contains nutrients such as fatty acids, proteins, amino acids, iron, manganese, magnesium, and other ingredients such as cyanogenic glycosides, amygdalin, prusin, sterols and their glycosides, flavonoids (catechins, naringenin, prunes, etc.), and phenolic acids. It has the effects of promoting blood circulation and removing blood stasis, moistening the intestines and relieving constipation, and relieving cough and asthma.

[0013] Platycladus orientalis (L.) Franco, a plant of the Cupressaceae family, is a dried mature seed kernel. It has the effects of nourishing the heart and calming the mind, moistening the intestines and relieving constipation, and stopping sweating.

[0014] Hemp seed is the mature seed of Cannabis sativa L., a plant of the Cannabaceae family. It is one of the earliest recorded medicinal and edible plants in my country. Hemp seed contains a large amount of nutrients such as unsaturated fatty acids, proteins, amino acids, vitamin B1, vitamin B2, etc., trace elements such as iron, sodium, manganese, zinc, magnesium, calcium, potassium, etc. It has the effects of moistening the lungs, replenishing qi and blood, and moistening the intestines and relieving constipation.

[0015] Sweet almonds are the dried mature seeds of the Rosaceae plant Prunus armeniaca L. "Compendium of Materia Medica" records that it is "sweet in taste and neutral in nature." It has the effects of moistening the lungs and relieving coughs, moistening the intestines and relieving constipation.

[0016] Citrus aurantium is the dried immature fruit of Citrus aurantium L. and its cultivars. It is harvested in July when the peel is still green, cut in half from the middle, and dried in the sun or at low temperature. It has the effects of regulating qi, relieving fullness, and relieving stagnation and swelling. It is often used for qi stagnation in the chest and flanks, fullness and pain, indigestion, phlegm and fluid retention, and sagging organs.

[0017] The second aspect of the present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0018] Step 1, weighing 10-25% Cistanche deserticola, 10-30% Angelica sinensis, 10-30% Peach Kernel, 10-35% Platycladus Semen, 10-35% Cannabis Sativa Seed, 10-20% Apricot Kernel, and 10-30% Citrus Aurantium by mass percentage, crushing them, adding 10-20 times of 20% ethanol solution, ultrasonically extracting 2-3 times, cooling to room temperature after the extraction, filtering, and combining the filtrate;

[0019] Step 2: vacuum concentrate and dry the filtrate obtained in step 1 to obtain a Chinese medicine composition.

[0020] In the above embodiments, the multiple of the ethanol solution is the ratio of the volume of the ethanol solution to the mass of the medicinal material (ml:g).

[0021] In some embodiments, in step 1, the ultrasonic extraction power is 400-500 W, and each extraction time is 40-60 min.

[0022] In some embodiments, in step 2, the drying temperature is 50-60°C.

[0023] In a third aspect, the present invention further provides a traditional Chinese medicine preparation, which comprises the above-mentioned traditional Chinese medicine composition.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] Compared with the prior art, the present invention has less side effects, high safety and significant activity. The zebrafish is used as an animal model for verification, proving that the traditional Chinese medicine composition has significant effects of moistening the intestines and relieving constipation, thus providing a new idea and method for the treatment of constipation. DETAILED DESCRIPTION

[0026] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the embodiments of the present invention belong. If the definitions set forth in this section are contrary to or otherwise inconsistent with the definitions set forth in the patents, patent applications, published patent applications, and other publications incorporated herein by reference, the definitions listed in this section take precedence over the definitions incorporated herein by reference.

[0028] Unless otherwise specified, the methods used in the following examples are all conventional methods. Unless otherwise specified, the materials, reagents and instruments used are all conventional materials, reagents and instruments in the art, and can be obtained by those skilled in the art through commercial channels.

[0029] When an amount, concentration or other value or parameter is expressed as a range, a preferred range or a range defined by a series of upper preferred values ​​and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pairing of any range upper limit or preferred value with any range lower limit or preferred value, regardless of whether the range is disclosed separately. For example, when a range of "1 to 5" is disclosed, the described range should be interpreted as including the range "1 to 4", "1 to 3", "1 to 2", "1 to 2 and 4 to 5", "1 to 3 and 5", etc. When a numerical range is described herein, unless otherwise stated, the range is intended to include its end values ​​and all integers and fractions within the range. In the present specification and claims, range definitions can be combined and / or interchanged, and if not otherwise stated, these ranges include all subranges contained therein.

[0030] The purpose of this application is to find a method for treating constipation with small side effects and high safety. The zebrafish laxative function detection method is used as a verification method to screen and obtain a Chinese medicine composition of Cistanche deserticola, Angelica sinensis, peach kernel, cypress seed, hemp seed, sweet almond, and Citrus aurantium. This application takes the needs of the population for treating constipation as a starting point and proposes a Chinese medicine composition with laxative effect and its preparation method.

[0031] Constipation is a common chronic digestive tract disease in clinical practice, usually with prolonged bowel movement intervals, dry and hard stools, and difficult and unsmooth stools as the main symptoms. Constipation can cause the following hazards:

[0032] Constipated patients have difficulty in excreting carcinogens in their intestines, which accumulate in the body over a long period of time, increasing the risk of colon cancer. For those with severe constipation, the risk of colon cancer can reach 10%.

[0033] When constipated patients defecate, abdominal pressure continues to increase, the amount of blood returning to the heart decreases, and the intracranial pressure increases, which can easily cause abnormal heart rate and increase cerebrovascular disease, which can be life-threatening in severe cases.

[0034] The retention of feces causes the number of harmful bacteria to increase, and some harmful metabolic wastes will be produced. The reabsorption of these metabolic wastes will lead to gastrointestinal nerve dysfunction, a decrease in appetite, and symptoms such as bitter taste in the mouth, belching, abdominal distension, etc., and even poisoning may occur in severe cases.

[0035] Some constipation patients are prone to psychological disorders such as insomnia and anxiety, which seriously affect their quality of life. The digestive tract cavity is compressed by hard feces for a long time, which can induce fecal ulcers; in severe cases, it can even lead to intestinal perforation.

[0036] Toxins stay in the blood and as the blood circulates, they can induce various skin diseases such as pigmentation and acne.

[0037] Currently, there are many types of drugs for treating constipation, most of which are based on symptomatic laxative treatments taken orally. However, long-term use of laxatives is harmful and will produce a series of side effects.

[0038] The present application designs a Chinese medicine composition with laxative effect and its preparation method. Zebrafish is a model organism with high genetic homology with humans. Compared with mammals, it has advantages such as low cost and short experimental cycle. Therefore, zebrafish is selected as the experimental animal model. Through the zebrafish laxative model, it is proved that this Chinese medicine composition has significant laxative effect, providing a new method for the treatment of constipation.

[0039] The technical solution of the present application is described in detail below through specific embodiments.

[0040] Example 1

[0041] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0042] Medicinal materials weight percentage: 10% Cistanche deserticola, 10% Chinese angelica, 10% peach kernel, 15% cypress seed, 15% hemp seed, 15% sweet almond, 25% Citrus aurantium.

[0043] Medicinal material extraction: grind the formulated amount of Cistanche deserticola, Angelica sinensis, peach kernel, cypress seed, hemp seed, sweet almond, and Citrus aurantium, add 15 times of 20% ethanol solution, extract 3 times at 400W ultrasonic, each time for 60 minutes, cool to room temperature after extraction, filter, and combine the filtrate;

[0044] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 60° C. to obtain a Chinese medicine composition.

[0045] Example 2

[0046] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0047] Medicinal materials weight percentage: 15% Cistanche deserticola, 15% Chinese angelica, 15% peach kernel, 15% cypress seed, 15% hemp seed, 15% sweet almond, 10% Citrus aurantium.

[0048] Medicinal material extraction: grind the formulated amount of Cistanche deserticola, Angelica sinensis, peach kernel, cypress seed, hemp seed, sweet almond, and Citrus aurantium, add 20 times of 20% ethanol solution, extract 3 times at 500W ultrasonic, each time for 60 minutes, cool to room temperature after extraction, filter, and combine the filtrate;

[0049] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 60° C. to obtain a Chinese medicine composition.

[0050] Example 3

[0051] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0052] Medicinal materials weight percentage: 12% Cistanche deserticola, 20% Chinese angelica, 20% peach kernel, 15% cypress seed, 10% hemp seed, 10% sweet almond, 13% Citrus aurantium.

[0053] Medicinal material extraction: grind the formulated amount of Cistanche deserticola, Angelica sinensis, peach kernel, cypress seed, hemp seed, sweet almond, and Citrus aurantium, add 20 times of 20% ethanol solution, extract 3 times at 500W ultrasonic, each time for 50 minutes, cool to room temperature after extraction, filter, and combine the filtrate;

[0054] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 60° C. to obtain a Chinese medicine composition.

[0055] Example 4

[0056] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0057] Medicinal materials weight percentage: 20% Cistanche deserticola, 10% Chinese angelica, 10% peach kernel, 10% cypress seed, 20% hemp seed, 10% sweet almond, 20% Citrus aurantium.

[0058] Medicinal material extraction: grind the formulated amount of Cistanche deserticola, Angelica sinensis, peach kernel, cypress seed, hemp seed, sweet almond, and Citrus aurantium, add 10 times of 20% ethanol solution, extract 3 times at 500W ultrasonic, each time for 60 minutes, cool to room temperature after extraction, filter, and combine the filtrate;

[0059] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 60° C. to obtain a Chinese medicine composition.

[0060] Example 5

[0061] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0062] Medicinal materials weight percentage: 25% Cistanche deserticola, 25% Chinese angelica, 10% peach kernel, 10% cypress seed, 10% hemp seed, 10% sweet almond, 10% Citrus aurantium.

[0063] Medicinal material extraction: grind the formulated amount of Cistanche deserticola, Angelica sinensis, peach kernel, cypress seed, hemp seed, sweet almond, and Citrus aurantium, add 10 times of 20% ethanol solution, extract 3 times at 500W ultrasonic, each time for 60 minutes, cool to room temperature after extraction, filter, and combine the filtrate;

[0064] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 60° C. to obtain a Chinese medicine composition.

[0065] Comparative Example 1

[0066] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0067] Medicinal materials weight percentage: 20% Cistanche deserticola, 20% Chinese angelica, 20% peach kernel, 10% cypress seed, 20% hemp seed, 10% sweet almond.

[0068] Medicinal material extraction: grind the formulated amount of Cistanche deserticola, Angelica sinensis, peach kernel, cypress seed, hemp seed, and sweet almond, add 15 times of 20% ethanol solution, extract 3 times at 400W ultrasonic, each time for 60 minutes, cool to room temperature after extraction, filter, and combine the filtrate;

[0069] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 55° C. to obtain a Chinese medicine composition.

[0070] Comparative Example 2

[0071] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0072] Medicinal materials weight percentage: 25% Cistanche deserticola, 15% Chinese angelica, 10% peach kernel, 10% cypress seed, 20% hemp seed, 20% fructus aurantii.

[0073] Medicinal material extraction: grind the formulated amount of Cistanche deserticola, Angelica sinensis, peach kernel, cypress seed, hemp seed, and fructus aurantii, add 10 times of 20% ethanol solution, extract 3 times at 500W ultrasonic, each time for 50 minutes, cool to room temperature after extraction, filter, and combine the filtrate;

[0074] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 60° C. to obtain a Chinese medicine composition.

[0075] Comparative Example 3

[0076] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0077] Medicinal materials weight percentage: 25% Cistanche deserticola, 30% Chinese angelica, 20% sweet almond, 25% Citrus aurantium.

[0078] Medicinal material extraction: grind the formulated amount of Cistanche deserticola, Angelica sinensis, sweet almond, and Citrus aurantium, add 20 times of 20% ethanol solution, and extract 3 times at 500W ultrasonic, each time for 60 minutes. After the extraction, cool to room temperature, filter, and combine the filtrate;

[0079] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 60° C. to obtain a Chinese medicine composition.

[0080] Comparative Example 4

[0081] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0082] Medicinal materials weight percentage: 20% angelica, 10% peach kernel, 20% cypress seed, 20% hemp seed, 10% sweet almond, 20% aurantium.

[0083] Medicinal material extraction: Crush the formulated amount of angelica, peach kernel, cypress seed, hemp seed, sweet almond, and fructus aurantii, add 15 times of 20% ethanol solution, and extract 3 times at 500W ultrasonic, each time for 60 minutes. After the extraction, cool to room temperature, filter, and combine the filtrate;

[0084] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 60° C. to obtain a Chinese medicine composition.

[0085] Comparative Example 5

[0086] This embodiment provides a Chinese medicine composition and a preparation method thereof, comprising the following steps:

[0087] Medicinal materials weight percentage: 20% Cistanche deserticola, 10% peach kernel, 10% cypress seed, 20% hemp seed, 20% sweet almond, 20% Citrus aurantium.

[0088] Medicinal material extraction: grind the formulated amount of Cistanche deserticola, peach kernel, cypress seed, hemp seed, sweet almond, and Citrus aurantium, add 10 times of 20% ethanol solution, and extract 3 times at 400W ultrasonic, each time for 60 minutes. After the extraction, cool to room temperature, filter, and combine the filtrate;

[0089] Concentration and drying: The filtrate is concentrated and dried under reduced pressure and vacuum at a drying temperature of 60° C. to obtain a Chinese medicine composition.

[0090] The raw material proportions of the above embodiments and comparative examples are shown in the following table:

[0091] Grouping Cistanche deserticola / % Angelica / % Peach kernel / % Bai Ziren / % Hemp seed / % Sweet almond / % Citrus aurantium / % Example 1 10 10 10 15 15 15 25 Example 2 15 15 15 15 15 15 10 Example 3 12 20 20 15 10 10 13 Example 4 20 10 10 10 20 10 20 Example 5 25 25 10 10 10 10 10 Comparative Example 1 20 20 20 10 20 10 - Comparative Example 2 25 15 10 10 20 - 20 Comparative Example 3 25 30 - - - 20 25 Comparative Example 4 - 20 10 20 20 10 20 Comparative Example 5 20 - 10 10 20 20 20

[0092] In order to better demonstrate the effect of the Chinese medicine composition of the present application in moistening the intestines and promoting bowel movements, an animal experiment method for the Chinese medicine composition is provided below.

[0093] Experimental animals

[0094] Zebrafish were raised in 28°C fish farming water (water quality: 200 mg instant sea salt per 1L reverse osmosis water, conductivity 450-550μS / cm; pH 6.5-8.5; hardness 50-100mg / L CaCO3), bred by our company's fish farming center. Wild-type AB strain zebrafish were bred in natural pair mating.

[0095] Experimental reagents and instruments

[0096] Nile red (Cat. No. 19123, Sigma); sodium chloride, sodium bicarbonate, magnesium sulfate heptahydrate, calcium chloride dihydrate (Sinopharm Group); domperidone (Xi'an Janssen Pharmaceutical Co., Ltd.).

[0097] Experimental Principle

[0098] The anatomical structure and cellular structure of the zebrafish digestive tract are similar to those of the human digestive tract, with endothelium, connective tissue, circular muscle and outer longitudinal muscle layer. Starting from 5 dpf (5 days after fertilization), the digestive tract structure of zebrafish shows spontaneous and rhythmic muscle contractions, which are very similar to the peristalsis of the human intestine. Zebrafish have been widely used in the research of peristalsis, enteritis and other related diseases and drugs.

[0099] Nile red is a fluorescent dye that can be used to stain lipids and proteins. After feeding zebrafish with Nile red for a certain period of time, the gastrointestinal tract of the zebrafish will be filled with Nile red, but the Nile red in the intestine itself will not be absorbed by the zebrafish into the body. Therefore, before the Nile red fluorescence is quenched, the weakening of the Nile red fluorescence signal in the zebrafish intestine is basically caused by the excretion of Nile red from the body. The fluorescence in the zebrafish intestine is photographed with a fluorescent stereo microscope and the fluorescence intensity is calculated with image processing software. The fluorescence intensity is negatively linearly related to the excretion rate of Nile red in the zebrafish intestine. The faster the Nile red is excreted, the weaker the fluorescence signal. According to the fluorescence signal value of the zebrafish intestine, the sample's promotion effect on the excretion of food in the zebrafish intestine is calculated, thereby evaluating the sample's laxative function.

[0100] Experimental methods

[0101] Zebrafish Maximum Tolerable Concentration (MTC) Determination:

[0102] Sample preparation: All samples to be tested were prepared into 5.00 mg / mL stock solution with E3 culture medium and used immediately after preparation.

[0103] Experimental method: 6dpf wild-type AB strains were randomly selected in 6-well plates, and 30 zebrafish were treated in each well (experimental group). Samples were dissolved in water (concentrations are shown in Table 1), and a normal control group was set up at the same time, with a volume of 3mL per well. After treatment at 28℃ for 24h, the MTC of the samples on the model zebrafish was measured. The test results are shown in Table 1.

[0104] Evaluation of the effect of Chinese herbal medicine combination on moistening intestine and relieving constipation

[0105] Select zebrafish of 5 dpf after fertilization with normal body shape, fully inflated swim bladder, normal suspension and similar body length. Add Nile red (final concentration of 10 ng / mL) to the container containing zebrafish 5 days after fertilization, and expose overnight for 16 hours to make the zebrafish intestine completely filled with Nile red. After the exposure to Nile red, the zebrafish were eluted with E3 culture medium and transferred to a 6-well plate. Samples were added to E3 culture medium for 30 zebrafish per well. A positive control group and a model control group were set up at the same time, and a solvent control group was set up when necessary. The total volume of the solution for all groups was 3 mL. After thorough mixing, the 6-well plate was wrapped with tin foil and incubated in a biochemical incubator in the dark for 24 hours (28°C) until the end of the experiment. Subsequently, 10 zebrafish were randomly selected from each experimental group and photographed under a fluorescence microscope. The images were analyzed using ZEN software, and the analysis parameters of the software were set to the sum of brightness to calculate the residual Nile red fluorescence signal value in the zebrafish intestine.

[0106] Quantitative calculation of laxative function:

[0107] According to the average value S of the Nile red fluorescence signal value in the intestine of each group of zebrafish, the laxative effect of the sample (expressed as the food excretion promotion rate) was calculated as follows:

[0108]

[0109] The statistical results were expressed as mean ± SE. SPSS 26.0 software was used for statistical analysis. The independent T test was used for normal distribution and the nonparametric Mann-Whitney test was used for non-normal distribution. p < 0.05 indicated a significant difference.

[0110] Experimental Results

[0111] Maximum tolerated concentration (MTC) of the composition for laxative effect

[0112] The experimental results of the maximum tolerated concentration (MTC) of the composition for laxative effect (n=30) are shown in Table 1:

[0113] Table 1 Composition laxative effect maximum tolerated concentration MTC test

[0114]

[0115]

[0116] According to the results in Table 1, under the experimental conditions, the maximum tolerated concentration (MTC) of each Chinese medicine composition for the laxative effect was 1000 μg / mL, so the efficacy test dose was set at 1000 μg / mL.

[0117] The test results of the composition's laxative effect:

[0118] Table 2 Results of zebrafish intestinal motility analysis after treatment with the composition

[0119] Group Total fluorescence intensity of intestinal contents (Nile red) Intestinal motility promoting effect (%) Model Group 219918689.7±5840938.27 - Positive group 123424589.1±13921777.95*** 43.88 Example 1 35477170.0±991487.23*** 83.87 Example 2 20125960.4±566498.19*** 90.85 Example 3 25972796.2±879299.86*** 88.19 Example 4 64859060.9±3485687.98*** 70.51 Example 5 31356221.2±812569.69*** 85.74 Comparative Example 1 189304713.1±3809524.11 13.92 Comparative Example 2 161797865.1±6510178.03*** 26.43 Comparative Example 3 206944687.7±4848469.38 5.90 Comparative Example 4 194196080.4±3298251.38 11.70 Comparative Example 5 176558360.4±6670285.17*** 19.72

[0120] Note: Results of the sample laxative efficacy evaluation experiment (n=10); compared with the model group, ***p<0.001.

[0121] As can be seen from Table 2, the intestinal fluorescence signal value of zebrafish in the model group is higher, indicating that the intestinal staining is successful. The zebrafish intestine treated with positive domperidone showed a weaker fluorescence signal value, and there was a significant difference from the model group (P<0.001), proving that the model was successfully constructed. The total fluorescence intensity of zebrafish intestinal contents (Nile red) in the positive control drug domperidone 1000μg / mL concentration group was lower than that in the model group, and the difference was statistically significant (P<0.001). Its effect on promoting intestinal peristalsis of zebrafish was 43.88%, indicating that domperidone has a significant promoting effect on intestinal peristalsis of zebrafish.

[0122] The total fluorescence intensity of zebrafish intestinal contents (Nile red) in the 1000 μg / mL concentration group of the formula samples in Examples 1, 2, 3, 4, and 5 was lower than that in the model group, and the differences were statistically significant (P < 0.001), indicating that the formula samples had a significant promoting effect on zebrafish intestinal peristalsis under sub-concentration conditions. From the promoting effect of intestinal peristalsis, it can be seen that the Chinese medicine composition composed of Cistanche deserticola, Angelica sinensis, peach kernel, cypress seed, hemp seed, sweet almond, and Citrus aurantium has a better effect of moistening the intestine and relieving constipation at the same concentration than the positive sample domperidone. As shown in Table 2, Comparative Example 1 lacks the medicinal material Citrus aurantium, and the evaluation of zebrafish intestinal moistening and laxative efficacy shows that its promoting effect on zebrafish intestinal peristalsis is 13.92%, which is significantly lower than the effects of the formulas in Examples 1, 2, 3, and 4. In comparative example 2, the sweet almond is missing as a medicinal material. The zebrafish laxative effect evaluation shows that the effect of promoting intestinal peristalsis in zebrafish is 26.43. In comparative example 3, peach kernel, cypress seed and hemp seed are missing as three medicinal materials. The effect of promoting intestinal peristalsis in zebrafish is 5.90%, which is significantly lower than the effect of the prescriptions in Examples 1, 2, 3, 4 and 5. In comparative example 4, the herb Cistanche deserticola is missing as a medicinal material. The effect of promoting intestinal peristalsis in zebrafish is 11.70%, which is significantly lower than the effect of the prescriptions in Examples 1, 2, 3 and 4. In comparative example 5, the herb Angelica sinensis is missing as a medicinal material. The effect of promoting intestinal peristalsis in zebrafish is 19.72%, which is significantly lower than the effect of the prescriptions in Examples 1, 2, 3, 4 and 5. The experimental results show that the compatibility between the components in the composition of the present invention is reasonable, and a good synergistic effect is produced, which is indispensable.

[0123] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition having the effect of moistening the intestine and relieving constipation, characterized in that: The raw materials of the Chinese medicine composition are calculated by weight percentage and include: 10-25% Cistanche deserticola, 10-30% Chinese angelica, 10-30% peach kernel, 10-35% cypress seed, 10-35% hemp seed, 10-20% sweet almond, and 10-30% fructus aurantii.

2. The Chinese medicine composition with laxative effect as claimed in claim 1, characterized in that: The raw materials of the Chinese medicine composition are calculated by weight percentage and include: 10% Cistanche deserticola, 10% Chinese angelica, 10% peach kernel, 15% cypress seed, 15% hemp seed, 15% sweet almond and 25% aurantium.

3. The Chinese medicine composition with laxative effect as claimed in claim 1, characterized in that: The raw materials of the Chinese medicine composition are calculated by weight percentage and include: 12% Cistanche deserticola, 20% Chinese angelica, 20% peach kernel, 15% cypress seed, 10% hemp seed, 10% sweet almond and 13% aurantium.

4. The Chinese medicine composition with laxative effect as claimed in claim 1, characterized in that: The raw materials of the Chinese medicine composition are calculated by weight percentage and include: 15% Cistanche deserticola, 15% Chinese angelica, 15% peach kernel, 15% cypress seed, 15% hemp seed, 15% sweet almond and 10% aurantium.

5. The Chinese medicine composition with laxative effect as claimed in claim 1, characterized in that: The raw materials of the Chinese medicine composition are calculated by weight percentage and include: 20% Cistanche deserticola, 10% Chinese angelica, 10% peach kernel, 10% cypress seed, 20% hemp seed, 10% sweet almond and 20% aurantium.

6. A method for preparing a Chinese medicinal composition having laxative effect as claimed in any one of claims 1 to 5, characterized in that: The steps include: Step 1, weighing 10-25% Cistanche deserticola, 10-30% Angelica sinensis, 10-30% Peach Kernel, 10-35% Platycladus Semen, 10-35% Cannabis Sativa Seed, 10-20% Apricot Kernel, and 10-30% Citrus Aurantium by mass percentage, crushing them, adding 10-20 times of 20% ethanol solution, ultrasonically extracting 2-3 times, cooling to room temperature after the extraction, filtering, and combining the filtrate; Step 2: vacuum concentrate and dry the filtrate obtained in step 1 to obtain a Chinese medicine composition.

7. The preparation method according to claim 6, characterized in that: In step 1, the ultrasonic extraction power is 400-500W, and each extraction time is 40-60min.

8. The preparation method according to claim 6, characterized in that: In step 2, the drying temperature is 50-60°C.

9. A Chinese medicine preparation, characterized in that: The invention relates to a Chinese medicine composition comprising any one of claims 1 to 5.

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