Application of lespedeza cuneata extract in preparation of medicine for preventing and treating postoperative intestinal paralysis

Abstract

The invention discloses application of lespedeza cuneata, a lespedeza cuneata extract or a composition containing the lespedeza cuneata extract in preparation of a medicine for preventing and treating postoperative intestinal paralysis, and relates to the technical field of traditional Chinese medicines. The application of the lespedeza cuneata, the lespedeza cuneata extract or the composition containing the lespedeza cuneata extract in the treatment of the postoperative enteroparalysis is found, and a new direction is provided for the treatment of the postoperative enteroparalysis.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to the use of Scoparia scoparia, Scoparia scoparia extract or a composition containing Scoparia scoparia extract in the preparation of a drug for preventing and treating postoperative intestinal paralysis. Background Art

[0002] Lespedeza cuneata is an annual herbaceous plant of the genus Lespedeza in the Leguminosae family. It tastes sweet, slightly bitter, and flat. It can clear away heat and dampness, eliminate food accumulation, and relieve phlegm and cough. The ethanol extract of Lespedeza cuneata has a selective excitatory effect on various pregnant animals and isolated uteri sensitized by diethylstilbestrol, but has no obvious effect on the isolated uteri of various non-pregnant animals. Lespedeza cuneata contains a variety of flavonoid compounds as well as phenolic and acidic substances. Zhang Fang et al. studied the relationship between the chemical composition and activity of Lespedeza cuneata. 10 kg of dried Lespedeza cuneata was crushed and extracted with 95% ethanol reflux for 3 times, each time for 2 hours. The ethanol was recovered under reduced pressure to obtain an extract. After adding an appropriate amount of water to suspend, it was extracted with petroleum ether, chloroform, ethyl acetate, and water-saturated n-butanol respectively. The petroleum ether fraction was separated by repeated silica gel column chromatography, petroleum ether-ethyl acetate gradient elution, thin layer chromatography monitoring, and the same components were combined. The ethyl acetate fraction was separated by repeated silica gel column chromatography, chloroform-methanol gradient elution, thin layer chromatography monitoring, and the same components were combined and separated. Eight compounds were separated and identified from the petroleum ether and ethyl acetate parts of the ethanol extract, namely B-sitosterol, n-octacosanol, salicylic acid, vanillic acid, kaempferol, quercetin, kaempferol-3-OBD-glucoside, and carotene.

[0003] Postoperative ileus (POI), also known as postoperative gastrointestinal dysfunction (POGD), is a clinical phenomenon in which the gastrointestinal motility is temporarily suppressed due to non-mechanical reasons after surgery, resulting in the inability to take food orally. It is defined as the prolonged recovery time of gastrointestinal function due to non-mechanical factors after surgery, which makes the patient unable to take food orally. It is characterized by impaired gastrointestinal motility, and can be clinically manifested as postoperative nausea, vomiting, abdominal pain, and cessation of flatulence and defecation. Its pathogenesis involves multiple factors such as surgical trauma, anesthetic drugs, hyperactivity of the sympathetic nervous system, and intestinal inflammatory response.

[0004] At present, Chinese medicine generally combines clinical experience to treat symptoms. Cheng Xiaobin et al. believe that POI is caused by the blockage of qi and blood in the intestines and the obstruction of qi in the intestines. The treatment method should be to regulate qi and relieve constipation, and regulate the intestines. Therefore, Dahuang Jinan Granules were selected to significantly improve the recovery time of anal flatus and bowel sounds. Dong Wenting believes that "qi stagnation" is the main pathogenesis of this disease. Magnolia officinalis decoction is used for treatment to promote qi and eliminate bloating, dry dampness and eliminate fullness. The recovery time of gastrointestinal function is significantly better than that of the control group. Zeng Haiping et al. used the Xiangxiang prescription to treat POI with the treatment principles of strengthening the spleen and awakening the stomach, promoting qi and unblocking the intestines, and found that it can effectively improve gastrointestinal symptoms.

[0005] At present, postoperative intestinal paralysis is affected by many factors, and the pathogenesis is complicated. Conventional drugs that increase gastrointestinal motility are difficult to achieve effective treatment. The clinical use of drugs that simply promote gastrointestinal motility increases the risk of intestinal obstruction. Therefore, there is currently a lack of clear and effective Chinese medicine ingredients that specifically promote postoperative gastrointestinal recovery. At the same time, there is no relevant research on the application of iron broom extract in the treatment of postoperative intestinal paralysis. Summary of the invention

[0006] In view of this, the object of the present invention is to provide a use of a Scotch broom, a Scotch broom extract or a composition comprising a Scotch broom extract in the preparation of a drug for postoperative intestinal paralysis.

[0007] To achieve the above-mentioned purpose of the invention, the technical solution of the present invention is as follows:

[0008] In one aspect, the present invention provides a use of a Scolopax tricolor, an Scolopax tricolor extract or a composition comprising the Scolopax tricolor extract in the preparation of a drug for preventing and / or treating postoperative intestinal paralysis.

[0009] Preferably, the postoperative intestinal paralysis is intestinal paralysis caused by surgery.

[0010] Preferably, the symptoms of postoperative intestinal paralysis include at least one of impaired gastrointestinal motility, nausea, vomiting, abdominal pain, cessation of flatulence, and cessation of defecation.

[0011] Preferably, in the application, the method for preparing the extract of Scoparia scoparia comprises the following steps:

[0012] (1) extracting the medicinal material of Scoparia scoparia 2-4 times and combining them to obtain an extract solution;

[0013] (2) concentrating the extracted medicinal solution obtained in step (1) to obtain a concentrated solution;

[0014] (3) subjecting the concentrated solution obtained in step (2) to alcohol precipitation and drying to obtain the Scotch broom extract.

[0015] Further preferably, in step (1), the extraction is water extraction or alcohol extraction;

[0016] More preferably, the water extraction is as follows: adding 5-10 times the mass of water for the first time, the extraction time is 1-3 hours, and the temperature is 95-100°C; adding 4-8 times the mass of water for the second time, the extraction time is 1-2 hours, and the temperature is 95-100°C;

[0017] More preferably, the first time, 8 times the weight of the medicinal material is used for decoction and extraction for 2 hours; the second time, 6 times the weight of the medicinal material is used for decoction and extraction for 1.5 hours.

[0018] Further preferably, in step (2), the concentration method is double-effect concentration.

[0019] More preferably, the conditions for the double-effect concentration are:

[0020] Steam pressure: 0.05~0.15MPa; vacuum degree of the first effect: -0.06~-0.09MPa, concentration temperature of the first effect: 60~85℃, concentration time: 100-150min, relative density of concentrated liquid: 1.0-1.1; vacuum degree of the second effect:

[0021] -0.06~-0.09MPa, second-effect concentration temperature: 60~85℃; concentration time: 40-80min, relative density of concentrated liquid: 1.1-1.4.

[0022] More preferably, the conditions for the double-effect concentration are:

[0023] Steam pressure: 0.1MPa; vacuum degree of the first effect: -0.08MPa, concentration temperature of the first effect: 75℃, concentration time: 120min, relative density of the concentrated liquid: 1.05; vacuum degree of the second effect: -0.08MPa, concentration temperature of the second effect: 70℃; concentration time: 60min, relative density of the concentrated liquid: 1.20.

[0024] Further preferably, in step (3), the alcohol precipitation specifically comprises: adding ethanol to the concentrated solution to make the ethanol content reach 50-70%, mixing evenly, and letting it stand.

[0025] More preferably, the alcohol precipitation specifically comprises: adding ethanol to the concentrated solution to make the ethanol content reach 60%, mixing evenly, and letting it stand.

[0026] More preferably, the alcohol precipitation is specifically performed by adding ethanol to the concentrated solution to make the ethanol content reach 60%, stirring for 30 minutes until the mixture is uniformly mixed, and standing for 24 hours.

[0027] On the other hand, the present invention provides the use of Kexiemin pills or Kexiemin granules in the preparation of a drug for preventing and / or treating postoperative intestinal paralysis.

[0028] Preferably, the active ingredient of the Kexiemin pills or Kexiemin granules is the aforementioned Cordyceps sinensis extract.

[0029] Preferably, the postoperative intestinal paralysis is intestinal paralysis caused by surgery.

[0030] Preferably, the symptoms of postoperative intestinal paralysis include at least one of impaired gastrointestinal motility, nausea, vomiting, abdominal pain, cessation of flatulence, and cessation of defecation.

[0031] Further preferably, the Kexiemin pills or Kexiemin granules include the aforementioned Scoparia repens extract, and at least one of microcrystalline cellulose, dextrin, starch slurry, and sucrose.

[0032] Preferably, the concentration of the starch slurry is 10-20%, more preferably 10%.

[0033] Preferably, in the Kexiemin pills, the mass ratio of the Scoparia repens extract, microcrystalline cellulose, dextrin and starch slurry is 10-20:3-5:10-20:7.5-18.

[0034] As a specific example of the present invention, the Kexiemin Pills are composed of Scoparia scoparia extract, microcrystalline cellulose, dextrin and starch slurry.

[0035] As a specific example of the present invention, the preparation method of the Kexiemin Pills is: weigh a prescribed amount of Scoparia scoparia extract, add dextrin and microcrystalline cellulose, mix evenly, add starch slurry, make pills, and dry.

[0036] As a specific example of the present invention, the preparation method of the Kexiemin granules is: adding sucrose, mixing, granulating, and drying.

[0037] The beneficial effects of the present invention are:

[0038] The present invention discovers the use of the prepared Scoparia scoparia, Scoparia scoparia extract or a composition containing Scoparia scoparia extract in the treatment of postoperative intestinal paralysis, which solves the problem that intestinal paralysis caused by surgical operations is more difficult to treat and conventional prokinetic drugs are not ideal for postoperative intestinal paralysis, and provides a new direction for the treatment of postoperative intestinal paralysis. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 This is a diagram of the small intestine propulsion experiment in the normal control group.

[0040] Figure 2 This is a diagram of the small intestine propulsion experiment in the model group.

[0041] Figure 3 This is a diagram of the small intestine propulsion experiment in Example 1.

[0042] Figure 4 Figure 3 is the morphological observation of jejunum tissue sections of rats in each group (×100).

[0043] Figure 5 Figure 3 is the morphological observation of ileum tissue sections of rats in each group (×100). DETAILED DESCRIPTION

[0044] The following non-limiting examples can enable those skilled in the art to more fully understand the present invention, but do not limit the present invention in any way. The following content is only an exemplary description of the scope of the present invention, and those skilled in the art can make various changes and modifications to the invention of the present invention based on the disclosed content, and they should also fall within the scope of the present application.

[0045] The present invention is further described below by way of specific examples. The various chemical reagents used in the examples of the present invention are obtained through conventional commercial channels unless otherwise specified. Unless otherwise specified, the contents described below are all weight contents. Unless otherwise specified, it is understood that the process is carried out at room temperature.

[0046] Metoclopramide tablets (Metoclopramide tablets) were purchased from Tianjin Lisheng Pharmaceutical Co., Ltd., with approval number: National Medicine Standard H12020161; Houpo Expelling Mixture was purchased from Ruiyang Pharmaceutical Co., Ltd., with approval number: National Medicine Standard Z20050563; sodium pentobarbital and dextran blue-2000 were purchased from McLean Company; iodine tincture (batch number: 20230702) was purchased from Shandong Anjie High-tech Disinfection Technology Co., Ltd.; EnSpire multi-function microplate reader (Perkin Elmer, USA); D3024R high-speed refrigerated centrifuge (Dalong Medical Equipment Co., Ltd.).

[0047] Example 1

[0048] (1) Extract the Chinese prickly ash with water twice. The first time, use 8 times the weight of the Chinese prickly ash to decoct and extract for 2 h at 50° C.; the second time, use 6 times the weight of the Chinese prickly ash to decoct and extract for 1.5 h. Combine the two to obtain the extract solution.

[0049] (2) The extracted medicinal solution obtained in step (1) is subjected to double-effect concentration, and the conditions of double-effect concentration are: steam pressure: 0.1 MPa; first-effect vacuum degree: -0.08 MPa, first-effect concentration temperature: 75°C, concentration time: 120 min, and relative density of the concentrated solution: 1.05; second-effect vacuum degree: -0.08 MPa, second-effect concentration temperature: 70°C; concentration time: 60 min, and relative density of the concentrated solution: 1.20, to obtain a concentrated solution;

[0050] (3) Add ethanol to the concentrated solution obtained in step (2) to make the ethanol content reach 60%, stir for 30 minutes until the mixture is uniform, let it stand for 24 hours, filter, vacuum concentrate, dry for 3 days, directly collect the paste, crush the dry paste and weigh it, seal it in a bag, and obtain the iron broom extract.

[0051] Example 2

[0052] (1) Extract the Chinese broom with water twice. The first time, use 5 times the weight of the Chinese broom to decoct and extract for 3 hours at 60°C; the second time, use 8 times the weight of the Chinese broom to decoct and extract for 1 hour at 40°C, and combine them to obtain the extract solution;

[0053] (2) The extracted medicinal solution obtained in step (1) is subjected to double-effect concentration, and the conditions of double-effect concentration are: steam pressure: 0.15 MPa; first-effect vacuum degree: -0.09 MPa, first-effect concentration temperature: 85°C, concentration time: 150 min, and relative density of the concentrated solution: 1.10; second-effect vacuum degree: -0.06 MPa, second-effect concentration temperature: 60°C, concentration time: 40 min, and relative density of the concentrated solution: 1.30, to obtain a concentrated solution;

[0054] (3) Add ethanol to the concentrated solution obtained in step (2) to make the ethanol content reach 70%, stir for 30 minutes until the mixture is uniform, let it stand for 24 hours, filter, vacuum concentrate, dry for 3 days, directly collect the paste, crush the dry paste and weigh it, seal it in a bag, and obtain the iron broom extract.

[0055] Example 3

[0056] (1) Extract the Chinese herb Scoparia with water 4 times. For the first and second times, add 10 times the weight of water to the Chinese herb, decoct and extract for 1 hour at 40°C. For the third and fourth times, add 4 times the weight of water to the Chinese herb, decoct and extract for 2 hours at 60°C, and combine to obtain the extract solution.

[0057] (2) double-effect concentrating the extracted medicinal solution obtained in step (1), wherein the conditions for double-effect concentrating are: steam pressure: 0.05 MPa; first-effect vacuum degree: -0.06 MPa, first-effect concentrating temperature: 60° C., concentrating time: 100 min, and relative density of the concentrated solution: 1.0; second-effect vacuum degree: -0.09 MPa, second-effect concentrating temperature: 85° C., concentrating time: 80 min, and relative density of the concentrated solution: 1.40, to obtain a concentrated solution;

[0058] (3) Add ethanol to the concentrated solution obtained in step (2) to make the ethanol content reach 50%, stir for 30 minutes until the mixture is uniform, let it stand for 24 hours, filter, vacuum concentrate, dry for 3 days, directly collect the paste, crush the dry paste and weigh it, seal it in a bag, and obtain the iron broom extract.

[0059] Preparation Example 1

[0060] The difference from Example 1 is that in step (1), 50% ethanol is used for extraction in Preparation Example 1, and the extraction is performed twice, and 5 times the weight of the medicinal material is added with 50% ethanol each time, and the mixture is immersed and extracted for 2 hours at 40°C, and the extracted medicinal solution is combined. The remaining steps are the same.

[0061] Preparation Example 2

[0062] The difference from Example 1 is that step (1) is: extracting the medicinal material of Scoparia scoparia with 50% ethanol for 4 times, adding 70% ethanol 10 times the weight of the medicinal material each time, immersing and extracting at 50°C for 4 hours, and combining to obtain the extracted medicinal solution.

[0063] Preparation Example 3

[0064] The difference from Example 1 is that step (1) is: extracting the medicinal material of Scoparia scoparia with 70% ethanol twice, adding 70% ethanol 5 times the weight of the medicinal material each time, immersing and extracting at 40°C for 2h, and combining to obtain the extracted medicinal solution.

[0065] Preparation Example 4

[0066] The difference from Example 1 is that step (1) is: extracting the medicinal material of Scoparia scoparia with 70% ethanol for 4 times, adding 70% ethanol 10 times the weight of the medicinal material each time, immersing and extracting at 50°C for 4 hours, and combining to obtain the extracted medicinal solution.

[0067] Preparation Example 5

[0068] The difference from Example 1 is that in step (2), evaporation concentration is used in Preparation Example 2 to concentrate to a relative density of 1.20 to obtain a concentrated solution. The remaining steps are the same.

[0069] Preparation Example 6

[0070] The difference from Example 1 is that in step (2), evaporation concentration is used in Preparation Example 2 to concentrate to a relative density of 1.40 to obtain a concentrated solution. The remaining steps are the same.

[0071] Results Test

[0072] The friction method was used to simulate the surgically induced postoperative intestinal paralysis animal model in rats, and the pharmacological activity of the extract in treating postoperative intestinal paralysis was evaluated by gastrointestinal motility test, histopathological examination, inflammatory factor analysis and other indicators. At the same time, the New Zealand rabbit gastrointestinal paralysis animal model induced by colectomy was used to evaluate the pharmacological activity of the extract in treating postoperative intestinal paralysis by indicators such as postoperative bowel sound recovery time and first defecation time. All experimental results are presented in The experimental data were analyzed with Graph-pad Prism 8.0 software, and the statistical differences between each group and the control group were compared using one-way analysis of variance (ANOVA) and Dunnett's t-test.

[0073] Test Example 1: Experiment on the animal model of postoperative intestinal paralysis in rats

[0074] 1. Methods

[0075] 1.1 Animals and groups

[0076] SPF male SD rats, weighing 160-200 g, were purchased from Shanghai Slake Experimental Animal Co., Ltd. (License No.: SCXK (Shanghai) 2022-0004; Certificate No.: 20220004032973), routinely raised in the Experimental Animal Center of Nanjing University of Chinese Medicine, and randomly divided into groups after 7 days of adaptive feeding, with 12 rats in each group: a normal control group (control), a model group (model), a sham operation group (J), a Magnolia bark exhaust mixture group (P), a metoclopramide group (W) and three embodiment groups.

[0077] 1.2 Model establishment and drug administration

[0078] Rats in each group were fasted for 12 hours before surgery. Except for the animals in the normal control group, rats in the other groups were anesthetized by intraperitoneal injection of 1% sodium pentobarbital according to their body weight, and the skin was prepared. After routine disinfection, sterile gauze was laid on the abdominal incision. A vertical incision of about 2 cm was made in the midline of the abdomen. After the small intestine of the rats in the model group and each drug-treated group was placed on the gauze containing normal saline, a slightly wet normal saline cotton swab was used to rub the small intestine from the proximal jejunum to the terminal ileum, and then from the terminal ileum to the proximal jejunum back and forth 3 times, which was completed within 5 minutes. Moderate congestion and edema of the small intestine was appropriate. After the intestinal manipulation of the rats, the small intestine was gently placed back into the intestinal cavity, and the abdominal muscle layer and cortical wounds were sutured with 5-0 silk thread respectively. After the suture was completed, the wound was disinfected again to prevent infection. The model was successful when the small intestine had a certain degree of intestinal adhesion, increased peripheral exudation, and significantly inhibited gastrointestinal motility. The rats in the sham operation group were left to stand for 6 minutes after a 2 cm abdominal incision, and the small intestine was not taken out for wiping during this period.

[0079] Each drug-treated group was intragastrically administered with the dose specified in the following table 3 hours after surgery, and the normal control group, sham operation group and model group were given an equal volume of normal saline.

[0080] Table 1.

[0081] Test substance Dosage Normal saline — Normal saline — Normal saline — Magnolia Bark Exhaust Mixture 8.94mL / kg TSZ Iron Broom Extract 1.3g / kg Metoclopramide group 8mg / kg

[0082] 2. Experimental methods

[0083] Each group of rats was intragastrically administered with Dextran Blue-2000 (20 g / L), 1.5 mL / rat, 30 minutes before being killed. Rats were killed 24 hours after surgery, and gastric emptying rate, gastric volume, and small intestinal propulsion (small intestinal propulsion rate, relative percentage of Dextran Blue-2000 in each segment of the small intestine) were measured.

[0084] 2.1 Gastric volume measurement

[0085] Tie the front and back ends of the stomach with string and place it in a 50mL centrifuge tube containing a fixed volume of water. Observe the height of the water level rise and record the volume change, which is the stomach volume.

[0086] 2.2 Gastric emptying rate measurement

[0087] The stomach was cut into pieces, distilled water was added to 20 mL, mixed, centrifuged at 13000 rpm for 5 min, and the supernatant was collected. The absorbance of the residual pigment in the stomach and the pigment in the standard tube was detected by EnSpire multifunctional microplate reader at a wavelength of 620 nm (A 胃内残留 ) value. Gastric emptying percentage (%) = (1-A 胃内残留 / A 标准管 )×100%, A 标准管 Add water to 1.5 mL of Dextran Blue-2000 (20 g / L) to make up to 20 mL, and measure the A value at 620 nm.

[0088] 2.3 Small intestinal propulsion rate measurement

[0089] The small intestine was laid flat on a cardboard and naturally straightened. The distance from the pyloric sphincter to the ileocecal region (M), the distance from the pyloric sphincter to the front end of the pigment (m), and the small intestine propulsion rate (%) = m / M × 100%.

[0090] Examples of small intestinal propulsion in the normal control group, model group and Example 1 group are as follows Figure 1-Figure 3 shown.

[0091] 2.4 Evaluation of the intestinal segment with the highest relative percentage of dextran blue-2000 in the small intestine

[0092] The small intestine was divided into 10 equal parts and placed in labeled centrifuge tubes. After mincing, distilled water was added to a volume of 2 mL, mixed, and centrifuged at 13,000 rpm for 5 min. The supernatant was taken and the absorbance (A) was measured at 620 nm using an EnSpire multifunctional microplate reader. i , i=1,2......10) value, relative percentage of dextran blue-2000 in each segment of small intestine (%)=A i / (A1+A2+……+A 10 )×100%, and the intestinal segment with the highest relative percentage of dextran blue-2000 in the small intestine was counted. The larger the value of the intestinal segment, the better the small intestinal motility.

[0093] 2.5 Histopathological observation

[0094] The rat small intestinal tissue was sampled in cross section, and the jejunum and ileum were taken. After the intestinal contents were removed, they were fixed with 4% paraformaldehyde tissue fixative, embedded in paraffin, sliced, and stained with HE. At least three views of each group of specimens and each specimen were selected to observe the pathological changes of the jejunum and ileum tissues, and a comprehensive score was given for mucosal damage and the range of lesions.

[0095] 3. Test results

[0096] 3.1 Results of gastric volume, gastric emptying, intestinal propulsion, and number of intestinal breaks in rats

[0097] As shown in Table 2, compared with the normal group, the model group had a significantly increased gastric volume, and the intestinal propulsion rate and intestinal segment values ​​were significantly reduced, indicating that the model mice had severe gastric distension, insufficient gastrointestinal motility, and the rat modeling was successful. Compared with the model group, the Scoparia extract group (embodiment 1-3 group) can significantly reduce gastric distension, improve gastric emptying rate, small intestinal propulsion rate and the number of intestinal segments, and its effect is comparable to the Magnolia bark gas-venting mixture group. The metoclopramide group has a poor effect on gastric distension, gastric emptying rate, intestinal propulsion rate and the number of intestinal segments in rats with postoperative intestinal paralysis, or even ineffective, which is much lower than the Scoparia extract group and the Magnolia bark gas-venting mixture group. It shows that the effect of simple gastric motility-promoting drugs on postoperative intestinal paralysis is not ideal. The Scoparia extract obtained by the preparation method of the present invention has a good effect of treating postoperative intestinal paralysis, and this difference is related to the more complicated pathogenesis of postoperative intestinal paralysis.

[0098] Table 2. Experimental results of the rat postoperative intestinal paralysis animal model

[0099] Stomach volume (mL) Gastric emptying rate (%) Small intestinal propulsion rate (%) Intestinal segment value Normal control group 3.97±1.74 79.01±6.37 75.18±11.1 5.44±1.74 Model Group <![CDATA[11.30±3.34 ## ]]> 80.80±7.73 <![CDATA[21.70±13.33 ## ]]> <![CDATA[2.40±1.07 ## ]]> Sham operation group <![CDATA[5.18±2.70 ** ]]> 84.83±7.91 <![CDATA[72.22±13.44 ** ]]> <![CDATA[4.80±1.69 ** ]]> Houpo Qifa Mixture Group <![CDATA[7.59±3.94 * ]]> 83.77±4.13 <![CDATA[75.43±25.24 ** ]]> <![CDATA[5.40±2.76 ** ]]> Example 1 Group <![CDATA[6.78±3.55 * ]]> <![CDATA[89.48±4.28 ** ]]> <![CDATA[67.09±16.91 ** ]]> <![CDATA[5.20±2.25 ** ]]> Example 2 Group <![CDATA[6.47±2.82 ** ]]> <![CDATA[90.87±2.25 ** ]]> <![CDATA[71.03±16.09 ** ]]> <![CDATA[5.70±2.00 ** <!-- 6 -->]]> Example 3 Group <![CDATA[6.25±2.81 ** ]]> <![CDATA[89.30±2.65 ** ]]> <![CDATA[70.33±11.47 * ]]> <![CDATA[5.30±1.95 ** ]]> Metoclopramide group 8.90±2.84 81.33±2.81 <![CDATA[41.53±16.0 ** ]]> 2.80±1.14

[0100] Note: # P<0.05, ## P < 0.01, model group vs normal group; * P<0.05, ** P<0.01 treatment group vs model group; mean±SD, n=9~12.

[0101] 3.2 Histopathological observation

[0102] HE staining was used to observe the jejunal tissue morphology of rats in each group. The results showed that the jejunal mucosal structure of the normal control group was intact, the intestinal villi were complete, the outlines were clearly visible, and they were arranged tightly and neatly. The villus epithelial cells were continuous and complete. Compared with the control group, a large number of intestinal villus epithelial cells in the jejunal tissue of the rats in the model group fell off, the lamina propria was exposed, the intestinal villus epithelial cells were separated from the lamina propria, the intestinal villi became shorter, the structure was destroyed, the arrangement was obviously loose and messy, the basal layer of the crypts was damaged, and there were bleeding and inflammatory cell infiltration. Compared with the model group, the degree of mucosal damage in the drug-administered groups of Example 1 and Example 2 was significantly reduced, the length of the intestinal villi was significantly increased, the villus tips were slightly ruptured, and the arrangement tended to be regular and orderly.

[0103] Test Example 2: Experimental Pharmacodynamic Model of Postoperative Gastrointestinal Paralysis in Rabbits

[0104] 1. Model Establishment

[0105] New Zealand rabbits were fasted but allowed to drink water for 24 hours, anesthetized by intravenous injection of sodium pentobarbital, and the abdomen was routinely disinfected. A midline incision was made in the lower abdomen, the colon 5 cm away from the ileocecal junction was removed, and the intestinal anastomosis was performed, followed by closing the abdomen. The blank group underwent sham surgery, that is, suturing after laparotomy. There were 24 animals in each group, and the bowel sounds and the time of first defecation were observed in 12 of them.

[0106] 2. Experimental Grouping and Drug Administration

[0107] New Zealand rabbits were purchased from Shanghai Slack Experimental Animal Co., Ltd. (License No.: SCXK (Shanghai) 2022-0004) and were routinely housed in the Experimental Animal Center of Nanjing University of Chinese Medicine.

[0108] New Zealand rabbits were randomly divided into a control group (control), a model group (model), a Houpu Paqi Mixture group (P), a Metoclopramide group (W), and three example groups according to sex and body weight. Gastric gavage was performed 3, 6, and 12 hours after surgery, and the gastric gavage dose was equal each time.

[0109] Table 3.

[0110] Test substance Dosage Normal saline - Normal saline - Magnolia Bark Exhaust Mixture 4.64mg / kg Metoclopramide group 4.15mg / kg TSZ Iron Broom Extract 0.67g / kg

[0111] 3. Detection

[0112] Recovery of bowel sounds and time of first defecation after surgery: Starting from 6 hours after the surgery, the bowel sounds of the animals were recorded once every 1 hour, and the time of first defecation was determined according to the video recording.

[0113] 4. Results

[0114] As shown in Table 4, in rabbit surgery, compared with the model group, there were extremely significant differences in the total bowel sound appearance time and the time of first defecation of New Zealand rabbits in the Lespedeza cuneata extract groups (Example 1-3 groups) and the Houpu Paqi Mixture group (P<0.01), and there were no significant differences among the groups, indicating that: Lespedeza cuneata extract can shorten the total bowel sound appearance time and the time of first defecation after surgery and improve postoperative intestinal paralysis.

[0115] At the same time, the Metoclopramide group did not significantly improve the total bowel sound appearance time of New Zealand rabbits, and the time of first defecation was not much different from that of the model group, indicating that simple prokinetic drugs are not ideal for postoperative intestinal paralysis.

[0116] The above results indicate that the Scoparia officinalis extract obtained by the preparation method of the present invention has a good effect in treating postoperative intestinal paralysis, and this difference is related to the more complicated pathogenesis of postoperative intestinal paralysis.

[0117] Table 4. Rabbit postoperative gastrointestinal paralysis animal efficacy model

[0118]

[0119] Note: # P<0.05, ## P < 0.01, model group vs normal group; * P<0.05, ** P<0.01 treatment group vs model group; mean±SD, n=9~12.

[0120] In summary, the extract of the present invention has an obvious therapeutic effect on postoperative ileus (POI).

[0121] Based on the above experiments, the extract of the Scoparia scoparia was further prepared into common dosage forms in the field, such as pills and granules. The preparation example is as follows:

[0122] (1) Preparation of Kexiemin Pills 1

[0123] Weigh the prescribed amount of iron broom extract, crush it, sieve it, make it into pills with water, coat it, polish it, and dry it to obtain the product.

[0124] (2) Preparation of Kexiemin Pills 2

[0125] Weigh the prescribed amount of Scoparia scoparia extract, add dextrin, mix evenly, add starch slurry, sieve, make pills with water, coat, polish, and dry to obtain the product.

[0126] (3) Preparation of Kexiemin Pills 3

[0127] Weigh the prescribed amount of Scoparia scoparia extract, add dextrin and microcrystalline cellulose, mix evenly, add starch slurry, sieve, make pills with water, coat, polish and dry to obtain the product.

[0128] (4) Preparation of Kexiemin Granules 1

[0129] The preparation method of Kexiemin granules is as follows: taking a prescribed amount of iron broom extract, crushing, sieving, mixing, granulating and drying.

[0130] (5) Preparation of Kexiemin Granules 2

[0131] The preparation method of Kexiemin granules is as follows: take a prescribed amount of iron broom extract, crush it, sieve it, add sucrose, mix it evenly, granulate it, and dry it.

[0132] 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 principle of the present invention should be included in the protection scope of the present invention.

Claims

1. Use of Scoparia scoparia, Scoparia scoparia extract or a composition comprising Scoparia scoparia extract in the preparation of a drug for preventing and / or treating postoperative intestinal paralysis.

2. The use according to claim 1, characterized in that: The postoperative intestinal paralysis is intestinal paralysis caused by surgical operation.

3. The use according to claim 1, characterized in that: The symptoms of postoperative intestinal paralysis include at least one of impaired gastrointestinal motility, nausea, vomiting, abdominal pain, cessation of flatulence, and cessation of defecation.

4. The use according to claim 1, characterized in that: In the application, the preparation method of the Scoparia scoparia extract comprises the following steps: (1) extracting the medicinal material of Scoparia scoparia 2-4 times and combining them to obtain an extract solution; (2) concentrating the extracted medicinal solution obtained in step (1) to obtain a concentrated solution; (3) subjecting the concentrated solution obtained in step (2) to alcohol precipitation and drying to obtain the Scotch broom extract.

5. The use according to claim 4, characterized in that: In step (1), the extraction is water extraction or alcohol extraction.

6. The use according to claim 4, characterized in that: In step (1), the water extraction is as follows: adding 5-10 times the mass of water for the first time, the extraction time is 1-3h, and the temperature is 95-100°C; adding 4-8 times the mass of water for the second time, the extraction time is 1-2h, and the temperature is 95-100°C.

7. The use according to claim 4, characterized in that: The concentration is evaporation concentration or double-effect concentration.

8. The use according to claim 7, characterized in that: The conditions of the double-effect concentration are: Steam pressure: 0.05~0.15MPa; vacuum degree of the first effect: -0.06~-0.09MPa, concentration temperature of the first effect: 60~85℃, concentration time: 100-150min, relative density of the concentrated liquid: 1.0-1.1; vacuum degree of the second effect: -0.06~-0.09MPa, concentration temperature of the second effect: 60~85℃; concentration time: 40-80min, relative density of the concentrated liquid: 1.2-1.

4.

9. The use according to claim 4, characterized in that: In step (3), the alcohol precipitation specifically comprises: adding ethanol to the concentrated solution to make the ethanol content reach 50-70%, mixing evenly, and letting it stand.

10. The use of Kexiemin pills or Kexiemin granules in the preparation of a drug for preventing and / or treating postoperative intestinal paralysis is characterized in that: The active ingredient of the Kexiemin pills or Kexiemin granules is the Scoparia scoparia extract used in the application of claim 1.

11. The use according to claim 10, characterized in that: The postoperative intestinal paralysis is intestinal paralysis caused by surgical operation.

12. The use according to claim 10, characterized in that: The symptoms of postoperative intestinal paralysis include at least one of impaired gastrointestinal motility, nausea, vomiting, abdominal pain, cessation of flatulence, and cessation of defecation.

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