Traditional Chinese medicine composition for treating intestinal obstruction and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating intestinal obstruction and a preparation method thereof, and belongs to the technical field of intestinal obstruction treatment. The traditional Chinese medicine composition for treating intestinal obstruction comprises 5-15 parts of rheum officinale, 20-40 parts of radix paeoniae alba, 5-15 parts of radix rehmanniae recen, 20-40 parts of pericarpium arecae, 5-15 parts of fructus cannabis, 20-40 parts of sargentgloryvine stem, 20-40 parts of moutan bark, 20-40 parts of dandelion, 5-15 parts of coptis chinensis, 2-10 parts of semen pharbitidis and 20-40 parts of mirabilite. The traditional Chinese medicine composition for treating intestinal obstruction has the effects of clearing heat, purging pathogenic fire, nourishing blood, regulating menstruation and the like, can improve the functions of intestines and stomach and digestive systems, can effectively treat intestinal obstruction diseases, and promotes defecation of intestinal obstruction patients.

Description

Technical Field

[0001] The present invention relates to the technical field of intestinal obstruction treatment, and in particular to a traditional Chinese medicine composition for treating intestinal obstruction and a preparation method thereof. Background Art

[0002] Intestinal obstruction is a common symptom in clinical surgery and abdominal tumors. It can not only cause anatomical and functional changes in the intestine itself, but also lead to systemic physiological disorders, which can be life-threatening in severe cases. Due to age, physical condition and other reasons, some patients cannot tolerate surgery or radiotherapy or chemotherapy to relieve obstruction symptoms. Conservative treatments such as fasting, gastrointestinal decompression, and reducing gastrointestinal fluid secretion are usually used, but it is often difficult to achieve therapeutic effects. Over time, water and electrolyte disorders occur, which seriously affect the quality of life.

[0003] At present, the treatments for intestinal obstruction include surgical treatment and conservative treatment. For patients who are suitable for surgery, radical resection can be performed through surgery to restore the original shape of the intestine. However, the surgery itself also has a certain risk of intestinal adhesion and intestinal obstruction. For patients who are not suitable for surgical treatment, palliative surgery is used to restore intestinal patency and relieve symptoms of intestinal obstruction. Since these patients are often accompanied by vomiting, abdominal distension, and difficulty in treatment with oral laxatives, rectal administration is a direct penetration and absorption of drugs through the rectal mucosa, providing an effective treatment for patients with intestinal obstruction.

[0004] In rectal administration, foaming agents can expand under the action of body temperature to form foam, which can reach the descending colon and sigmoid colon after rectal administration, and better disperse and adhere to the mucosal surface. There is no dripping after administration, and there is no discomfort or foreign body sensation after administration of suppositories or enema solutions, which is easy for patients to accept. This method of administration is particularly suitable for patients who are comatose, vomiting, and have difficulty taking oral medications. It can exert the direct contact, penetration and absorption of drugs in the treatment of colon and other diseases, thereby producing irreplaceable therapeutic effects that cannot be replaced by other therapies.

[0005] However, the drugs available in the prior art for treating intestinal obstruction in patients have little efficacy, and the problem of difficulty in defecation in patients with intestinal obstruction is still significant. Based on this, it is of great practical significance to provide a traditional Chinese medicine composition that can effectively treat intestinal obstruction and solve the problem of difficulty in defecation in patients with intestinal obstruction. Summary of the invention

[0006] The object of the present invention is to provide a traditional Chinese medicine composition for treating intestinal obstruction and a preparation method thereof. The traditional Chinese medicine composition for treating intestinal obstruction comprises traditional Chinese medicine ingredients such as rhubarb, white peony root and coptis root, has the effects of clearing away heat and purging fire, nourishing blood and regulating menstruation, can improve the functions of the stomach and digestive system, can effectively treat intestinal obstruction symptoms, and promote defecation in patients with intestinal obstruction.

[0007] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0008] The invention provides a traditional Chinese medicine composition for treating intestinal obstruction, comprising 5-15 parts of rhubarb, 20-40 parts of white peony root, 5-15 parts of raw rehmannia root, 20-40 parts of dried tangerine peel, 5-15 parts of canna seed, 20-40 parts of spatholobi, 20-40 parts of moutan bark, 20-40 parts of dandelion, 5-15 parts of coptis root, 2-10 parts of pharmacopeia seed and 20-40 parts of mirabilite.

[0009] The present invention also provides a method for preparing the Chinese medicine composition for treating intestinal obstruction described in the above technical solution, comprising the following steps:

[0010] Mixing rhubarb, white peony root, raw rehmannia root, dried tangerine peel, hemp seed, spatholobi, peony bark, dandelion, coptis root, pharmacopeia seed and mirabilite to obtain a mixture;

[0011] adding water to the mixture for soaking to obtain a soaked Chinese medicine composition;

[0012] decoct the soaked Chinese medicine composition, and then filter it to obtain the Chinese medicine composition;

[0013] in:

[0014] The soaking time is 0.5 to 1.5 hours;

[0015] The mass ratio of the amount of added water to the mixture is 8 to 12:1.

[0016] Furthermore, the decoction time is 0.5 to 1.5 hours per time; the decoction frequency is 1 to 3 times;

[0017] The present invention also provides the use of the Chinese medicine composition for treating intestinal obstruction described in the above technical solution in a Chinese medicine composition foam for treating intestinal obstruction.

[0018] The invention also provides a traditional Chinese medicine composition foam for treating intestinal obstruction, comprising the following components: 2-9% of extract powder, 0.5-5% of foaming agent, 0.1-2% of stabilizer, 0-15% of thickener and 100 parts, the balance being water.

[0019] Furthermore, the foaming agent is tea saponin.

[0020] Furthermore, the stabilizer is sodium carboxymethyl cellulose.

[0021] Furthermore, the thickener is glycerol.

[0022] The present invention also provides a method for preparing the traditional Chinese medicine composition foam for treating intestinal obstruction described in the above technical solution, comprising the following steps:

[0023] Concentrating the Chinese medicine composition to a clear paste with a relative density of 1.08 to 1.25 g / mL;

[0024] The clear paste is mixed with mirabilite, stirred and then dried to obtain extract powder;

[0025] The extract powder is mixed with a foaming agent, a stabilizer, glycerin and water and stirred to obtain a traditional Chinese medicine composition foaming agent solution;

[0026] The traditional Chinese medicine composition foam solution is poured into a hand-pressed foam pump bottle and screwed tightly to obtain the traditional Chinese medicine composition foam for treating intestinal obstruction.

[0027] Compared with the prior art, the technical solution of the present invention has the following beneficial effects:

[0028] (1) The present invention adds rhubarb to the traditional Chinese medicine composition. The rhubarb is rich in rhubarb and chrysophanol, and has the effects of purging and attacking accumulation, clearing away heat and purging fire, cooling blood and detoxifying, removing blood stasis and promoting menstruation, and promoting dampness and relieving jaundice. It has a strong purgative effect, and its combination with peony bark has a better effect of clearing heat and relieving constipation.

[0029] (2) The present invention adds white peony root to the traditional Chinese medicine composition, which is rich in paeoniflorin and has the effects of nourishing blood and regulating menstruation, astringing yin and stopping sweating, helping to regulate the yin deficiency constitution, having a certain therapeutic effect on constipation caused by yin deficiency, promoting the discharge of stool, and improving the functions of the gastrointestinal and digestive systems.

[0030] (3) The present invention adds coptis chinensis to the traditional Chinese medicine composition, which is rich in berberine hydrochloride and has the effects of clearing away heat and dampness, purging fire and detoxifying; it has an inhibitory effect on Shigella dysenteriae, Escherichia coli, Pneumococcus, Staphylococcus aureus, Streptococcus, Salmonella typhi and amoeba; in addition, berberine hydrochloride promotes the percutaneous penetration of paeoniflorin by regulating the tight junctions of the stratum corneum, facilitating skin transport resistance, affecting skin permeability and competitively binding with the polar head of stratum corneum lipids.

[0031] (4) The present invention further adds raw rehmannia root, dried tangerine peel, cannabinoids seed, spatholobi chinensis, dandelion, coptis root, morning glory seed and mirabilite, which work synergistically with coptis root, white peony root, moutan bark and rhubarb to treat intestinal obstruction and promote defecation in patients with intestinal obstruction. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is a schematic diagram showing the effect of the Chinese medicine composition on the intestinal propulsion of normal mice;

[0033] Figure 2 This is a schematic diagram of the results of the intestinal propulsion effect of the Chinese medicine composition on atropine-induced intestinal dysfunction mice;

[0034] Figure 3 This is a schematic diagram of the intestinal propulsion effect of the Chinese herbal composition on intestinal ileus model mice. DETAILED DESCRIPTION

[0035] The invention provides a traditional Chinese medicine composition for treating intestinal obstruction, comprising 5-15 parts of rhubarb, 20-40 parts of white peony root, 5-15 parts of raw rehmannia root, 20-40 parts of dried tangerine peel, 5-15 parts of canna seed, 20-40 parts of spatholobi, 20-40 parts of moutan bark, 20-40 parts of dandelion, 5-15 parts of coptis root, 2-10 parts of pharmacopeia seed and 20-40 parts of mirabilite.

[0036] In the present invention, the traditional Chinese medicine composition for treating intestinal obstruction further preferably includes: 8-12 parts of rhubarb, 25-35 parts of white peony root, 8-12 parts of raw rehmannia root, 25-35 parts of dried tangerine peel, 8-12 parts of canna seed, 30-40 parts of saffron vine, 25-35 parts of peony bark, 25-35 parts of dandelion, 8-12 parts of coptis root, 4-8 parts of pharmacopeia seed and 25-35 parts of mirabilite.

[0037] In the present invention, the Chinese medicine composition for treating intestinal obstruction more preferably includes: 10 parts of rhubarb, 30 parts of white peony root, 10 parts of raw rehmannia root, 30 parts of dried tangerine peel, 10 parts of canna seed, 35 parts of saffron vine, 30 parts of peony bark, 30 parts of dandelion, 10 parts of coptis root, 6 parts of pharmacopeia seed and 30 parts of mirabilite.

[0038] The present invention adds rhubarb to the traditional Chinese medicine composition. The rhubarb is rich in rhubarb and chrysophanol, and has the effects of purging and attacking accumulation, clearing away heat and purging fire, cooling blood and detoxifying, removing blood stasis and promoting menstruation, and removing dampness and jaundice. It has a strong purgative effect, and cooperates with peony bark to have a better effect of clearing heat and relieving constipation; the white peony root is rich in paeoniflorin, has the effects of nourishing blood and regulating menstruation, restraining yin and stopping sweating, is helpful to regulate the constitution of yin deficiency, has a certain therapeutic effect on constipation caused by yin deficiency, promotes the discharge of stool, and improves the functions of the gastrointestinal and digestive systems; the coptis root is rich in berberine hydrochloride, has the effects of clearing heat and drying dampness, purging fire and detoxifying; and has an inhibitory effect on Shigella dysenteriae, Escherichia coli, Pneumococcus, Staphylococcus aureus, Streptococcus, Salmonella typhi and amoeba; in addition, berberine hydrochloride facilitates skin transport resistance by regulating the tight connection of the stratum corneum, affects skin permeability, and competitively combines with the polar head of the stratum corneum lipid to promote the percutaneous penetration of paeoniflorin. The present invention also adds raw rehmannia root, dried tangerine peel, canna seed, spatholobus pubescens, dandelion, coptis root, morning glory seed and mirabilite, which work synergistically with coptis root, white peony root, moutan bark and rhubarb to jointly treat intestinal obstruction and promote defecation in patients with intestinal obstruction.

[0039] The present invention also provides a method for preparing the Chinese medicine composition for treating intestinal obstruction described in the above technical solution, comprising the following steps:

[0040] Mixing rhubarb, white peony root, raw rehmannia root, dried tangerine peel, hemp seed, spatholobi, peony bark, dandelion, coptis root, pharmacopeia seed and mirabilite to obtain a mixture;

[0041] adding water to the mixture for soaking to obtain a soaked Chinese medicine composition;

[0042] decoct the soaked Chinese medicine composition, and then filter it to obtain the Chinese medicine composition;

[0043] in:

[0044] The soaking time is 0.5 to 1.5 hours;

[0045] The mass ratio of the amount of water added to the mixture is 8 to 12:1.

[0046] In the present invention, the soaking time is preferably 1.0 to 1.5 hours; the mass ratio of the amount of added water to the mixture is preferably 10 to 12:1.

[0047] In the present invention, the decoction time is preferably 0.5 to 1.5 h / time, more preferably 1.0 to 1.5 h / time; the decoction times are preferably 1 to 3 times, more preferably 1 to 2 times.

[0048] The present invention also provides the use of the Chinese medicine composition for treating intestinal obstruction described in the above technical solution in a Chinese medicine composition foam for treating intestinal obstruction.

[0049] The invention also provides a traditional Chinese medicine composition foam for treating intestinal obstruction, comprising the following components: 2-9% of extract powder, 0.5-5% of foaming agent, 0.1-2% of stabilizer and 0-15% of thickener, and the balance is water.

[0050] Furthermore, the foaming agent is tea saponin.

[0051] Furthermore, the stabilizer is sodium carboxymethyl cellulose.

[0052] Furthermore, the thickener is glycerol.

[0053] The present invention also provides a method for preparing the traditional Chinese medicine composition foam for treating intestinal obstruction described in the above technical solution, comprising the following steps:

[0054] Concentrating the Chinese medicine composition to a clear paste with a relative density of 1.08 to 1.25 g / mL;

[0055] The clear paste is mixed with mirabilite, stirred and then dried to obtain extract powder;

[0056] The extract powder is mixed with a foaming agent, a stabilizer, glycerin and water and then stirred for the first time to obtain a traditional Chinese medicine composition foaming agent solution;

[0057] The traditional Chinese medicine composition foam solution is poured into a hand-pressed foam pump bottle and screwed tightly to obtain the traditional Chinese medicine composition foam for treating intestinal obstruction.

[0058] The present invention adopts a specially limited Chinese medicine composition to prepare a foaming agent, which expands to form foam under the effect of body temperature, and the Chinese medicine components therein are better dispersed and adhered to the mucosal surface, and the therapeutic effect is more excellent.

[0059] In the present invention, the temperature of the first stirring is preferably 80 to 100°C, and more preferably 90 to 100°C.

[0060] In the present invention, the relative density is preferably 1.08 to 1.25 g / mL, and more preferably 1.1 to 1.2 g / mL; the relative density of the present invention is preferably the density of the clear paste relative to water at 80°C.

[0061] In the present invention, unless otherwise specified, the required raw materials for preparation are all commercially available products well known to those skilled in the art.

[0062] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0063] Example 1

[0064] (1) 5 parts of rhubarb, 20 parts of white peony root, 5 parts of raw rehmannia root, 20 parts of dried tangerine peel, 5 parts of canna seed, 20 parts of spatholobi, 20 parts of moutan bark, 20 parts of dandelion, 5 parts of coptis root, 2 parts of pharmacopeia seed and 20 parts of sodium sulfate are mixed to obtain a mixture;

[0065] (2) Add 8 times the mass of water to the mixture and soak for 0.5 h;

[0066] (3) The soaked mixture was boiled once for 0.5 h.

[0067] (4) Finally, filtering is performed to separate the medicinal residues to obtain a filtrate, i.e., the Chinese medicine composition.

[0068] Example 2

[0069] (1) mixing 15 parts of rhubarb, 40 parts of white peony root, 15 parts of raw rehmannia root, 40 parts of dried tangerine peel, 15 parts of canna seed, 40 parts of spatholobi, 40 parts of moutan bark, 40 parts of dandelion, 15 parts of coptis root, 10 parts of pharmacopeia seed and 40 parts of sodium sulfate to obtain a mixture;

[0070] (2) Add 12 times the mass of water to the mixture and soak for 1.5 hours;

[0071] (3) The soaked mixture was boiled three times, with each boiling time being 1.5 hours.

[0072] (4) Finally, filtering is performed to separate the medicinal residues to obtain a filtrate, i.e., the Chinese medicine composition.

[0073] Example 3

[0074] (1) mixing 10 parts of rhubarb, 30 parts of white peony root, 10 parts of raw rehmannia root, 30 parts of dried tangerine peel, 10 parts of canna seed, 35 parts of spatholobi, 30 parts of moutan bark, 30 parts of dandelion, 10 parts of coptis root, 6 parts of pharmacopeia seed and 30 parts of sodium sulfate to obtain a mixture;

[0075] (2) Add 10 times the mass of water to the mixture and soak for 0.5 h;

[0076] (3) The soaked mixture was boiled twice, with each boiling time being 0.5 h.

[0077] (4) Finally, filtering is performed to separate the medicinal residues to obtain a filtrate, i.e., the Chinese medicine composition.

[0078] Example 4

[0079] (1) Concentrating the Chinese medicine composition obtained in Example 1 to a clear paste with a relative density of 1.08 to 1.25 g / mL;

[0080] (2) drying the clear paste to obtain extract powder;

[0081] (3) 330 g of extract powder was mixed with 200 g of tea saponin and 50 g of sodium carboxymethyl cellulose, and water was added to 10000 mL, and the mixture was stirred evenly, and then stirred again at a temperature of 80° C. to obtain a traditional Chinese medicine composition foam solution;

[0082] (4) Pour the traditional Chinese medicine composition foam solution into a hand-pressed foam pump bottle and tighten it to obtain the traditional Chinese medicine composition foam for treating intestinal obstruction.

[0083] Example 5

[0084] (1) Concentrating the Chinese medicine composition obtained in Example 1 to a clear paste with a relative density of 1.08 to 1.25 g / mL;

[0085] (2) drying the clear paste to obtain extract powder;

[0086] (3) 330 g of extract powder was mixed with 400 g of tea saponin and 50 g of sodium carboxymethyl cellulose, and water was added to 10000 mL, and the mixture was stirred evenly, and then stirred again at a temperature of 90° C. to obtain a traditional Chinese medicine composition foam solution;

[0087] (4) Pour the traditional Chinese medicine composition foam solution into a hand-pressed foam pump bottle and tighten it to obtain the traditional Chinese medicine composition foam for treating intestinal obstruction.

[0088] Example 6

[0089] (1) Concentrating the Chinese medicine composition obtained in Example 1 to a clear paste with a relative density of 1.1 to 1.2 g / mL;

[0090] (2) drying the clear paste to obtain extract powder;

[0091] (3) 330 g of extract powder was mixed with 400 g of tea saponin, 50 g of sodium carboxymethyl cellulose and 50 g of glycerol, and water was added to 10000 mL, and the mixture was stirred evenly, and then stirred again at a temperature of 100° C. to obtain a traditional Chinese medicine composition foam solution;

[0092] (4) Pour the traditional Chinese medicine composition foam solution into a hand-pressed foam pump bottle and tighten it to obtain the traditional Chinese medicine composition foam for treating intestinal obstruction.

[0093] Test Case

[0094] 1 Experimental Materials

[0095] 1.1 Instruments and reagents

[0096] The Chinese medicine composition obtained in Example 1, Mosapride Citrate Dispersible Tablets (Chengdu Kanghong Pharmaceutical Group Co., Ltd.) and Atropine Sulfate for Injection (Zhejiang Zhebei Pharmaceutical Co., Ltd.)

[0097] 1.2 Experimental Animals Kunming mice, half male and half female, were purchased from Beijing Huafukang Biotechnology Co., Ltd. [License No.: SCXK(Beijing)2019-0008].

[0098] 2. Test Method

[0099] 2.1 Preparation of drug solution

[0100] Take the Chinese medicine composition obtained in Example 1 and make it into a 0.66g / ml solution. According to the body shape coefficient, the dosage of the Chinese medicine composition is 13.13g / kg; take 5mg / tablet of mosapride citrate tablets, take 1.25mg of the drug and dissolve it in 10ml of purified water to prepare a 0.125mg / ml suspension for use.

[0101] 2.2 Effects of Chinese herbal medicine combination on intestinal propulsion in mice

[0102] Fifty mice, 18-22 g, were randomly divided into five groups: a blank group (administered with normal saline by enema), a positive control group of mosapride citrate (0.25 mg / kg), a low-dose group of the Chinese medicine composition (6.56 g / kg), a medium-dose group of the Chinese medicine composition (13.13 g / kg), and a high-dose group of the Chinese medicine composition (26.3 g / kg). Each group had 10 mice, half male and half female. After fasting for 12 hours but not drinking water, the mice were given 1% carmine normal saline (0.2 ml / 10g), immediately give the corresponding drug, hold the mouse back with the left hand, fix it with the head facing down to expose the anus, gently rub the abdomen with the right hand, push from the head to the tail to discharge the feces in the rectum, insert a soft tube, and push 0.5ml of the corresponding drug solution with a syringe. After 30 minutes, the mouse was killed, and the abdomen was immediately opened to take out the stomach and intestines, and the distance from the pylorus to the front of the carpel was measured as the carpel intestinal advancement distance and the distance from the pylorus to the anus was measured as the total intestinal length. The carpel advancement percentage was calculated using the formula:

[0103]

[0104] The card red advancement rate of each group was statistically analyzed using inter-group t-test.

[0105] The results are shown in Table 1 and Figure 1 As shown in Table 1, it can be seen that the low, medium and high doses of the Chinese medicine composition and the positive control drug can increase the carminative propulsion rate of normal mice, and there are significant differences compared with the blank group (P < 0.05), among which the medium and high doses of the Qi-moving and relieving stagnation and the positive control group are P < 0.01 compared with the blank group, indicating that the Qi-moving and relieving stagnation groups have the effect of accelerating intestinal propulsion.

[0106] Table 1 Comparison of the effect of Chinese medicine composition on intestinal propulsion in normal mice (±s, n=10)

[0107]

[0108]

[0109] Compared with the blank group: *P<0.05, **P<0.01

[0110] 2.3 Effect of Chinese herbal medicine combination on intestinal propulsion in mice with atropine-induced intestinal dysfunction

[0111] 60 mice, 18-22g, were randomly divided into 5 groups: blank group (enema given saline), model blank group, mosapride citrate positive control group (75mg / kg), low-dose group of Chinese medicine composition (6.56g / kg), medium-dose group of Chinese medicine composition (13.13g / kg), high-dose group of Chinese medicine composition (26.3g / kg), 10 mice in each group, half male and half female. After fasting for 12h, the blank group and model blank group were given saline by enema, and the other groups were fixed by holding the back of the mouse with the left hand, with the head facing down to expose the anus, and the right hand gently rubbed the abdomen, pushing from the head to the tail to discharge the feces in the rectum, inserting a hose, and pushing 0.5ml of the corresponding liquid with a syringe. 30 minutes after each mouse was given, except for the blank group, the other groups of mice were given 2.5mg / kg of atropine subcutaneously for modeling. After 20 minutes, 60 mice were gavaged with 1% carbapenem saline (0.2 ml / 10 g). After 20 minutes, the mice were killed and the stomach and intestines were immediately taken out and spread out. The distance from the pylorus to the front of the carbapenem, i.e. the carbapenem intestinal advancement distance, and the distance from the pylorus to the anus, i.e. the total intestinal length, were measured. The carbapenem advancement percentage and the carbapenem advancement rate of each group were calculated, and statistical analysis was performed using the inter-group t-test.

[0112] The results are shown in Table 2 and Figure 2 As shown in Table 2, the carmosan propulsion rate of the model group was significantly lower than that of the blank group (P < 0.01), indicating that the model was successful. The low, medium and high doses of the Chinese medicine composition and the positive control drug can increase the carmosan propulsion rate of mice with atropine-induced intestinal dysfunction, and there are significant differences compared with the model group (P < 0.05), among which the medium and high doses of the Chinese medicine composition and the positive control group are compared with the blank group P < 0.01, indicating that each administration group of the Chinese medicine composition has the effect of reversing the decline in intestinal function caused by atropine.

[0113] Table 2 Comparison of the effect of Chinese medicine composition on intestinal propulsion in mice with atropine-induced intestinal dysfunction (±s, n=10)

[0114]

[0115]

[0116] Compared with the control group: ##P<0.01; compared with the model group: *P<0.05, **P<0.01Test Example 2

[0117] 1. Materials

[0118] Animals: 24 Kunming mice, weighing 18 - 22 g, were purchased from Beijing Huafukang Biotechnology Co., Ltd. [License number: SCXK(Beijing) 2019 - 0008]. The mice were caged separately and maintained at a temperature of (25 ± 3)°C and a relative humidity of (55 ± 5)%RH. After 1 week of adaptive feeding, the experiment was conducted.

[0119] 2. Methods

[0120] 2.1 Modeling, grouping and drug administration of experimental animals

[0121] 2.1.1 Establishment of a mouse model of intestinal obstruction

[0122] After fasting the mice for 24 h without water deprivation, a mouse model of intestinal obstruction was replicated by intestinal interference. The mice were anesthetized by intraperitoneal injection of pentobarbital and then placed supine on the operating table. The hair was removed and the area was disinfected. The abdominal cavity was opened along the white line of the abdomen, and a sterile gauze drape was placed over the mouse's abdomen. Two sterile cotton swabs moistened with normal saline were gently used to move the small intestine out of the abdominal cavity and placed on the gauze, and the small intestine was gently rolled back and forth and squeezed 3 times from the proximal jejunum to the distal ileum, taking a total of 15 minutes. After the stimulation, the small intestine was returned to the abdominal cavity, and the abdominal cavity was closed with double - layer continuous suture. In the sham - operation group, the intestinal tract was not intervened after opening the abdomen, and the other operations were the same as above.

[0123] 2.1.2 Preparation of drug solutions

[0124] The traditional Chinese medicine composition obtained in Example 1 was made into a solution of 0.66 g / ml. According to the body surface area coefficient conversion, the dosage of the traditional Chinese medicine composition was 13.13 g / kg. Take mosapride citrate tablets at 5 mg / tablet. Take 1.25 mg of the drug and dissolve it in 10 ml of purified water to prepare a suspension of 0.125 mg / ml for standby.

[0125] 2.1.3 Animal grouping and drug administration

[0126] Twenty - four mice were randomly divided into a blank group, a sham - operation blank group, a model blank group, a mosapride citrate positive control group (75 mg / kg), and a traditional Chinese medicine composition group (13.13 g / kg, equivalent to 52.5 g of crude drug / kg), with 6 mice in each group. The drugs were administered 6 h after the operation in accordance with 2.1.1. The sham - operation blank group and the model blank group were given normal saline by enema. For the other groups, the mice were fixed by grasping the back with the left hand, with the head down to expose the anus. The right hand gently massaged the abdomen from the head to the tail to expel the feces in the rectum, then a soft tube was inserted, and 0.5 ml of the corresponding drug solution was injected with a syringe.

[0127] 2.2 Detection of small intestine propulsion rate

[0128] 24 hours after surgery, each group was given the drug again according to the method in 2.1.3, and the mice were gavaged with charcoal powder compound (10% gum arabic + 10% edible activated charcoal powder, 10 ml / kg). After 30 minutes, the mice were killed by cervical dislocation. The whole small intestine was taken out, the total length of the small intestine and the distance of the charcoal powder advancing were measured, and the small intestine advancement rate was calculated, small intestine advancement rate (%) - charcoal powder advancing distance in the small intestine / total length of the small intestine × 100%. The inter-group t test was used for statistical analysis.

[0129] The results are shown in Table 3 and Figure 3 As shown in Table 3, compared with the sham operation group, the small intestinal propulsion rate of the model group mice 24 hours after surgery was significantly reduced (P<0.01); compared with the model group, after the administration of mosapride citrate and the Chinese medicine composition, the intestinal propulsion rate of the mice was significantly increased (P<0.01), indicating that the Chinese medicine composition has the effect of promoting intestinal propulsion in mice with intestinal obstruction model.

[0130] Table 3 Comparison of the intestinal propulsion effect of the Chinese medicine composition on intestinal ileus model mice by group (±s, n=6)

[0131]

[0132] Compared with the control group: ##P<0.01; compared with the model group: *P<0.05, **P<0.01

[0133] Test Example 3

[0134] 1 Experimental Materials

[0135] 1.1 Instruments and reagents

[0136] Medlab-U / 4C501H biological signal acquisition and processing system (Nanjing Meiyi Technology Co., Ltd.), TOBS2000 in vitro tissue bath system (Beijing Jingong Hongtai Technology Co., Ltd.), 1M100 isometric tension transducer (10 g) (Beijing Jingong Hongtai Technology Co., Ltd.), TP21 constant temperature perfusion apparatus (Beijing Jingong Hongtai Technology Co., Ltd.).

[0137] Kunming mice, SPF grade, 24 mice, body weight 18-22g, were kept in the animal room of the Experimental Center of Shanxi Institute of Traditional Chinese Medicine. The mice were purchased from Beijing Huafukang Biotechnology Co., Ltd. [License No.: SCXK(Beijing)2019-0008]. The experimental protocol complies with the animal ethics requirements of Shanxi Institute of Traditional Chinese Medicine. The indoor temperature of the animal room is 22-25℃, the humidity is 45%-55%, the ventilation is good, the light and dark cycle is maintained for 12h, and the environment is quiet.

[0138] 2. Test Method

[0139] 2.1 Preparation of drug solution

[0140] Take the Chinese medicine composition obtained in Example 1, concentrate it to a suitable concentration, and prepare a 0.66g / ml solution. According to the human dosage, the dosage for promoting qi and removing stagnation is 13.13g / kg (equivalent to 52.5g crude drug / kg) according to the body size coefficient. Take 5mg / tablet of Mosapride Citrate Tablets, take 1.25mg of the drug and dissolve it in 10ml of purified water to prepare a 0.125mg / ml suspension for standby use.

[0141] 2.2 Preparation of Tyrode's solution: 8 g NaCl, 0.2 g 10% KCl, 0.26 g 10% MgS04·7H2O, 5% NaH2PO 4· 2H2O 0.065g, NaHCO3 1g, CaCl2 0.2g, glucose 1g are prepared into 1000ml of table liquid with distilled water. (CaCl2 needs to be mixed with other solutions and distilled water is added to two-thirds of the solution, then added dropwise while stirring to prevent precipitation. Glucose is added just before use).

[0142] 2.3 Effects on the spontaneous activity of isolated intestinal smooth muscle of mice

[0143] After the mice were fasted for 12 hours but not water, they were killed by dislocating the cervical vertebrae, and the abdominal cavity was quickly opened. A section of the colon was cut and placed in 0-4℃ Tyrode's solution. The mesentery was gently peeled off, and the contents of the intestinal tube were washed clean with Tyrode's solution. The intestinal tube was cut into several small sections with a length of 1-2 cm and a width of 0.3-0.5 cm as specimens for later use. The intestinal tube suspension method was adopted, and the specimen was suspended in a constant temperature smooth muscle tank containing 10ml (37.5±0.5)℃ Tyrode's solution. One end of the specimen was fixed on the L-shaped ventilation hook, and the other end was connected to the tension converter. A mixed gas containing 95% O2 and 5% CO2 was introduced. The size of the air valve was adjusted so that it could fully supply oxygen without affecting the work of the tension transducer and the normal movement of the intestinal tube. It was connected to the Medlab-U / 4C501H biological signal acquisition and processing system, and its basic tension was set to 10g. After stabilization for 20 minutes, the experiment was started to observe the changes in the specimen movement curve before and after administration.

[0144] 2.5 Statistical methods

[0145] The measurement data were expressed as (±s) and SPSS26.0 statistical software was used for statistical analysis. P < 0.05 was considered statistically significant.

[0146] After observing the normal colon contraction curve of mice for 10 minutes, 100 μl of the drug solution for promoting qi and removing stagnation was dripped into the Tyrode's solution to observe the colon movement curve. After the experiment, the changes in colon contraction tension and absolute area before and after drug administration were compared.

[0147] The results are shown in Table 4. Based on Table 4, it can be seen that the intestinal movement frequency, absolute area, average tension and amplitude of each dosage group before and after administration all showed an increasing trend. The results show that the Chinese medicine composition can improve the intestinal propulsion rate by increasing the intestinal muscle contraction frequency, average tension and amplitude.

[0148] Table 4 Comparison of intestinal motility of mice in each group (±s, n=6)

[0149]

[0150] Note: Comparison of each group ten minutes before and after administration. * P<0.05.

[0151] Component testing

[0152] (1) The Chinese medicine composition obtained in Example 1 was injected into a liquid chromatograph to detect the extraction amounts of paeoniflorin, emodin, chrysophanol and berberine hydrochloride per 100 g of the Chinese medicine composition. The results showed that the extraction amounts of paeoniflorin, emodin, chrysophanol and berberine hydrochloride were 14544.6 mg, 89.79 mg, 37.98 mg and 2737.0 mg, respectively. It can be seen that a high content of effective ingredients for treating intestinal obstruction symptoms was extracted from the Chinese medicine composition;

[0153] The chromatographic conditions are as follows: octadecylsilane bonded silica gel as filler; acetonitrile as mobile phase A, 0.1% phosphoric acid aqueous solution as mobile phase B for gradient elution, 0-10min, 20%→30% A; 10-15min, 30%→45% A; 15-40min, 45%→100% A. The detection wavelength is 0-13min, 345nm; 13-16min, 230nm; 16-25min, 254nm, the flow rate is 1.0mL / min, the column temperature is 30°C, and the injection volume is 10μL.

[0154] (2) The foaming property and foam stability of the traditional Chinese medicine composition foam for treating intestinal obstruction obtained in Examples 4 to 6 were tested. The initial total height of the foam generated by the Roche method (h1) and the foam height after 10 minutes (h2) were measured on a foam meter. The results were repeated 3 times and the average values ​​were calculated. Wherein h represents the foaming ability of the foam, and the foam stability is represented by the defoaming rate after 10 minutes of foam [RD = (h1-h2) / h1*100%]. The results showed that:

[0155] In Example 4: the initial foaming height is 130 mm, the defoaming rate is 6.25%, the properties are brown foam, there are many cavities in appearance, the foaming volume is small, and the duration is short;

[0156] In Example 5: the initial foaming height is 183 mm, the defoaming rate is 1.46%, the properties are brown foam, the appearance is fine and there are few cavities, the foaming volume is large, and the duration is appropriate;

[0157] In Example 6, the foaming height is 137 mm, the defoaming rate is 11.67%, the property is brown foam, the appearance is fine and there are few cavitations, but the foaming volume is small and the duration is short.

[0158] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating intestinal obstruction, characterized in that: include: 5-15 parts of rhubarb, 20-40 parts of white peony root, 5-15 parts of raw rehmannia root, 20-40 parts of dried tangerine peel, 5-15 parts of canna seed, 20-40 parts of spatholobi, 20-40 parts of peony bark, 20-40 parts of dandelion, 5-15 parts of coptis root, 2-10 parts of pharmacopeia seed and 20-40 parts of sodium sulfate.

2. The method for preparing the Chinese medicine composition for treating intestinal obstruction according to claim 1, characterized in that: The following steps are involved: Mixing rhubarb, white peony root, raw rehmannia root, dried tangerine peel, hemp seed, spatholobi, peony bark, dandelion, coptis root, pharmacopeia seed and mirabilite to obtain a mixture; adding water to the mixture for soaking to obtain a soaked Chinese medicine composition; decoct the soaked Chinese medicine composition, and then filter it to obtain the Chinese medicine composition; in: The soaking time is 0.5 to 1.5 hours; The mass ratio of the amount of water added to the mixture is 8 to 12:

1.

3. The method for preparing the Chinese medicine composition for treating intestinal obstruction according to claim 2, characterized in that: The decoction time is 0.5 to 1.5 hours per time; the decoction frequency is 1 to 3 times.

4. Use of the Chinese medicine composition for treating intestinal obstruction according to any one of claims 1 or 2 to 3 in a Chinese medicine composition foam for treating intestinal obstruction.

5. A Chinese medicine composition foam for treating intestinal obstruction, characterized in that: include: Extract powder 2-9%, foaming agent 0.5-5%, stabilizer 0.1-2% and thickener 0-15%, and the balance is water.

6. The Chinese medicine composition foam for treating intestinal obstruction according to claim 5, characterized in that: The foaming agent is tea saponin.

7. The Chinese medicine composition foam for treating intestinal obstruction according to claim 5, characterized in that: The stabilizer is sodium carboxymethyl cellulose.

8. The Chinese medicine composition foam for treating intestinal obstruction according to claim 5, characterized in that: The thickener is glycerin.

9. The method for preparing the traditional Chinese medicine composition foam for treating intestinal obstruction according to any one of claims 5 to 8, characterized in that: The following steps are involved: Concentrating the Chinese medicine composition to a clear paste with a relative density of 1.08 to 1.25 g / mL; Drying the clear paste to obtain extract powder; The extract powder is mixed with a foaming agent, a stabilizer, glycerin and water and then stirred for the first time to obtain a traditional Chinese medicine composition foaming agent solution; The traditional Chinese medicine composition foam solution is poured into a hand-pressed foam pump bottle and screwed tightly to obtain the traditional Chinese medicine composition foam for treating intestinal obstruction.

10. The method for preparing the traditional Chinese medicine composition foam for treating intestinal obstruction according to claim 9, characterized in that: The temperature of the first stirring is 80-100°C.

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