CN111346158A

CN111346158A - Application of traditional Chinese medicine composition in treating gastrointestinal dysfunction

Info

Publication number: CN111346158A
Application number: CN202010335842.8A
Authority: CN
Inventors: 孙成磊; 姜艳玲; 程国良
Original assignee: Lunan Pharmaceutical Group Corp
Current assignee: Lunan Pharmaceutical Group Corp
Priority date: 2020-04-25
Filing date: 2020-04-25
Publication date: 2020-06-30

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and application thereof. The invention relates to a new application of a traditional Chinese medicine composition developed on the basis of a patent CN100453105C, wherein the traditional Chinese medicine composition is mainly prepared from immature bitter orange, largehead atractylodes rhizome, ginseng, barbary wolfberry fruit, donkey-hide gelatin, tuber fleeceflower root, cassia seed and aloe. The pharmacological experiment of the invention shows that: the Chinese medicinal composition can obviously improve the physiological activity of rats and accelerate the gastric emptying and small intestine propulsion rate of the rats; obviously improve the MTL and GAS content in the plasma of the rat, reduce the SS, CCK and VIP content and promote the gastrointestinal motility.

Description

Application of traditional Chinese medicine composition in treating gastrointestinal dysfunction

Technical Field

The invention relates to a new application of a traditional Chinese medicine composition, in particular to an application of the traditional Chinese medicine composition in preparing a medicine for treating or improving gastrointestinal dysfunction, and belongs to the technical field of traditional Chinese medicines.

Background

Gastrointestinal dysfunction, also known as gastrointestinal neurosis, is a general term for a group of gastrointestinal syndromes, and refers to a group of digestive system syndromes which have digestive system symptoms such as abdominal distension, abdominal pain, diarrhea, constipation and the like, are mainly characterized by gastrointestinal motility dysfunction and visceral hypersensitivity, and have no organic lesions found by biochemical, imaging, endoscopic examination or the like, or cannot explain the symptoms by organic diseases. There are many causes of gastrointestinal dysfunction, such as irregular diet, pathological causes, or psychological factors.

The autonomous movement of the gastrointestinal tract is one of the most important functions of the digestive tract, gastrointestinal dysfunction is a common complication after general surgery, and the main causes comprise surgical factors such as surgical anesthesia, trauma, bed rest in the convalescent period, postoperative fasting, electrolyte balance disorder, abdominal inflammation, mechanical stimulation and the like, and also comprise neuroendocrine disorder, gastrointestinal electrophysiological disorder, change of anatomical structure, inflammatory reaction, gastrointestinal microcirculation disorder and the like. The main pathophysiology manifestations of the drug are delayed gastric emptying, slowed intestinal propulsion, and disordered gastrointestinal coordinated movement rhythm, and the clinical manifestations are nausea, vomiting, abdominal distension, abdominal pain, difficult defecation or diarrhea, and the like, and no effective treatment means and drugs exist at present (refer to Zhouyitong, Xiaoyi, and the like, discussion of diagnosis and treatment problem of functional gastric emptying disorder after Whipple operation [ J ]. China general surgical journal, 2002,11 (17): 671-.

A large number of researches prove that mental states play a certain role in the pathogenesis of gastrointestinal functional diseases, the movement and secretion of the stomach even can stop under the terror and disappointed mood, and the intestinal peristalsis is in a suppression state under the depression and the gray heart. Conversely, gastrointestinal dysfunction can lead to further development and progression of depression.

The gastrointestinal dysfunction has high morbidity, long medical history, repeated attack and complex etiology, and the medical science does not determine long-term effective treatment medicines and methods, thereby seriously affecting the life quality of patients.

Chinese patent CN100453105C discloses a composition with functions of relaxing bowels, expelling toxin, losing weight and reducing fat and a preparation method thereof. The composition is prepared from eight traditional Chinese medicines of polygonum multiflorum, aloe, cassia seed, medlar, donkey-hide gelatin, ginseng, bighead atractylodes rhizome and immature bitter orange, and has a good treatment effect on constipation caused by toxin accumulation and yin fluid deficiency. Related products are already on the market and have the product name 'hou hui cathartic capsule'.

Disclosure of Invention

The invention relates to a new application of a traditional Chinese medicine composition developed on the basis of the Chinese patent of invention CN100453105C in treating or improving gastrointestinal dysfunction.

The invention aims to provide application of a traditional Chinese medicine composition mainly prepared from polygonum multiflorum, cassia seed, aloe, medlar, donkey-hide gelatin, ginseng, immature bitter orange and bighead atractylodes rhizome in preparing a medicine for treating or improving gastrointestinal dysfunction and application of the traditional Chinese medicine composition in preparing a medicine for improving gastrointestinal function or promoting gastrointestinal function recovery.

The traditional Chinese medicine composition is prepared from the following components:

80-120 parts of polygonum multiflorum, 100 parts of cassia seed, 120 parts of aloe and 160 parts of aloe

50-80 parts of medlar, 40-80 parts of donkey-hide gelatin, 20-50 parts of ginseng

80-120 parts of immature bitter orange and 30-50 parts of bighead atractylodes rhizome;

preferably, the traditional Chinese medicine composition is prepared from the following components:

120 parts of polygonum multiflorum, 140 parts of cassia seed and 160 parts of aloe

75 parts by weight of medlar, 75 parts by weight of donkey-hide gelatin, 50 parts by weight of ginseng

120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome.

The gastrointestinal dysfunction of the present invention refers to gastrointestinal dysfunction caused by abdominal surgery.

Preferably, the abdominal operation includes, but is not limited to, one of gastrointestinal disease operation, hepatobiliary disease operation, infectious disease operation, and gynecological disease operation.

The gastrointestinal dysfunction of the present invention may be gastrointestinal dysfunction caused by digestive system diseases and diabetes.

Preferably, the digestive system disease includes but is not limited to one of dyspepsia, gastritis, peptic ulcer, colitis, gastroesophageal reflux, cholecystitis, pancreatitis, and gastric cancer;

further preferably, the peptic ulcer includes but is not limited to one of gastric ulcer and duodenal ulcer.

The gastrointestinal dysfunction of the present invention may also be gastrointestinal dysfunction caused by radiotherapy, chemotherapy and/or surgery for malignant tumors.

Preferably, the gastrointestinal dysfunction is gastrointestinal dysfunction caused by pancreatic cancer or cardiac cancer surgery.

The gastrointestinal dysfunction of the invention also comprises gastrointestinal dysfunction caused by dietary factors, mental factors and pharmaceutical factors.

The second purpose of the invention is to provide a traditional Chinese medicine preparation containing the traditional Chinese medicine composition, and the traditional Chinese medicine composition can be prepared into clinically acceptable dosage forms directly through conventional procedures or after medically acceptable auxiliary materials are added;

preferably, the clinically acceptable dosage form comprises one or more of capsules, tablets, granules, pills and powder.

Further preferably, the capsule is a aloe cathartic capsule.

The invention also provides a preparation method of the aloe cathartic capsule, which comprises the following steps:

(1) pulverizing colla Corii Asini into fine powder, and sieving with 80 mesh sieve;

(2) reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol for 2 times, 10 times for the first time and 8 times for the second time, each time for 2 hr, filtering, and mixing filtrates to obtain filtrate I;

(3) decocting the wolfberry fruit, the bighead atractylodes rhizome and the immature bitter orange twice by adding water, adding 8 times of water for the first time, soaking for 1 hour, decocting for 1.5 hours, filtering, adding 6 times of water for the second time, decocting for 1.5 hours, filtering, combining the filtrates, concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃), placing at room temperature, stirring, adding ethanol to ensure that the purity reaches 60 percent (20 ℃), refrigerating, standing for more than 24 hours, and filtering to obtain filtrate II for later use;

(4) and (3) mixing the filtrate I obtained in the step (2) and the filtrate II obtained in the step (3), concentrating to obtain thick paste with the relative density of 1.30-1.35(70 ℃), drying, crushing, adding the donkey-hide gelatin fine powder prepared in the step (1) and a proper amount of dextrin, uniformly mixing, performing dry granulation, and filling into capsules to obtain the donkey-hide gelatin capsule.

Compared with the prior art, the invention has the following remarkable technical effects:

animal pharmacological tests and clinical tests show that the traditional Chinese medicine composition is an effective prescription for treating gastrointestinal dysfunction, improving gastrointestinal function and promoting gastrointestinal function recovery. Animal experiments show that the Chinese medicinal composition can remarkably accelerate the gastric emptying and small intestine propelling speeds of rats, promote the release and secretion of MTL and GAS of the rats, and reduce the content of inhibitory hormones such as VIP, SS, CCK and the like, so that the gastrointestinal motility function is improved.

Clinical effect observation shows that the aloe-laxative capsule has positive promotion effect on improving the intestinal gastrointestinal hormone level of a patient after pancreatic cancer operation, and further promotes the recovery of the gastrointestinal function of the patient; the aloe laxative capsule can increase the times of air exhaust and defecation of patients after the total gastrectomy of cardia cancer and promote the evacuation of intestinal tracts, thereby reducing the reflux of upper digestive tract liquid, relieving the reflux related complications after the total gastrectomy and improving the quality of life.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

First, the detailed description of the invention

The following examples are provided to further disclose the present invention, and it should be noted that these examples are only preferred embodiments of the present invention, and do not limit the scope of the present invention as claimed.

EXAMPLE 1 preparation of Hui Tongbiang Capsule

The prescription is as follows:

120g of polygonum multiflorum, 140g of cassia seed, 160g of aloe

75g of medlar, 75g of donkey-hide gelatin, 50g of ginseng

Immature bitter orange 120g white atractylodes rhizome 50g

The preparation method comprises the following steps:

taking the donkey-hide gelatin in the prescription amount, crushing into fine powder, and sieving with a 80-mesh sieve for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol for 2 times, 10 times for the first time and 8 times for the second time, each time for 2 hr, filtering, and mixing filtrates to obtain filtrate I; decocting wolfberry fruit, bighead atractylodes rhizome and immature bitter orange according to the prescription amount twice by adding water, adding 8 times of water for the first time, soaking for 1 hour, decocting for 1.5 hours, filtering, adding 6 times of water for the second time, decocting for 1.5 hours, filtering, combining filtrates, concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃), standing at room temperature, stirring, adding ethanol until the purity reaches 60% (20 ℃), refrigerating and standing for more than 24 hours, and filtering to obtain a filtrate II; mixing the filtrate I and the filtrate II, concentrating to obtain soft extract with relative density of 1.30-1.35(70 deg.C), drying, pulverizing, adding colla Corii Asini fine powder and appropriate amount of dextrin, mixing, dry granulating, and making into capsule with 1000 granules.

EXAMPLE 2 Capsule preparation

The prescription is as follows:

120g of polygonum multiflorum, 100g of cassia seed, 120g of aloe

50g of medlar, 80g of donkey-hide gelatin, 20g of ginseng

80g of immature bitter orange and 30g of bighead atractylodes rhizome;

the preparation method comprises the following steps: the preparation method is the same as that of example 1.

EXAMPLE 3 Capsule preparation

The prescription is as follows:

polygonum multiflorum 80g cassia seed 150g aloe 160g

80g of medlar, 40g of donkey-hide gelatin, 50g of ginseng

120g of immature bitter orange and 50g of bighead atractylodes rhizome;

the preparation method of the traditional Chinese medicine composition comprises the following steps: the preparation method is the same as that of example 1.

Comparative example 1 preparation of capsules

The prescription is as follows:

120g of fleece-flower root, 140g of fructus cannabis and 160g of rhubarb

75g of medlar, 75g of donkey-hide gelatin, 50g of ginseng

120g of immature bitter orange and 50g of bighead atractylodes rhizome;

the preparation method comprises the following steps:

taking the donkey-hide gelatin in the prescription amount, crushing into fine powder, and sieving with a 80-mesh sieve for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, fructus Cannabis and radix et rhizoma Rhei with 60% ethanol for 2 times, 10 times for the first time and 8 times for the second time for 2 hr each time, filtering respectively, and mixing filtrates to obtain filtrate I; decocting wolfberry fruit, bighead atractylodes rhizome and immature bitter orange according to the prescription amount twice by adding water, adding 8 times of water for the first time, soaking for 1 hour, decocting for 1.5 hours, filtering, adding 6 times of water for the second time, decocting for 1.5 hours, filtering, combining filtrates, concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃), standing at room temperature, stirring, adding ethanol until the purity reaches 60% (20 ℃), refrigerating and standing for more than 24 hours, and filtering to obtain a filtrate II; mixing the filtrate I and the filtrate II, concentrating to obtain soft extract with relative density of 1.30-1.35(70 deg.C), drying, pulverizing, adding colla Corii Asini fine powder and appropriate amount of dextrin, mixing, dry granulating, and making into capsule with 1000 granules.

Comparative example 2

The prescription is as follows:

120g of polygonum multiflorum, 140g of cassia seed, 160g of aloe

75g of medlar, 75g of donkey-hide gelatin, 50g of ginseng

Costustoot 120g and bighead atractylodes rhizome 50 g;

the preparation method comprises the following steps:

taking the donkey-hide gelatin in the prescription amount, crushing into fine powder, and sieving with a 80-mesh sieve for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol for 2 times, 10 times for the first time and 8 times for the second time, each time for 2 hr, filtering, and mixing filtrates to obtain filtrate I; decocting wolfberry fruit, bighead atractylodes rhizome and costustoot according to the prescription amount in water twice, adding 8 times of water for the first time, soaking for 1 hour, decocting for 1.5 hours, filtering, adding 6 times of water for the second time, decocting for 1.5 hours, filtering, combining filtrates, concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃), standing at room temperature, stirring, adding ethanol until the purity reaches 60% (20 ℃), refrigerating and standing for more than 24 hours, and filtering to obtain a filtrate II; mixing the filtrate I and the filtrate II, concentrating to obtain soft extract with relative density of 1.30-1.35(70 deg.C), drying, pulverizing, adding colla Corii Asini fine powder and appropriate amount of dextrin, mixing, dry granulating, and making into capsule with 1000 granules.

Second, zoology experiment

In order to verify the efficacy of the traditional Chinese medicine composition in treating gastrointestinal dysfunction or improving gastrointestinal function, the inventor carries out the following experimental study, only a part of experimental models are taken as an example for illustration, and pharmacological experimental study is also carried out on gastrointestinal dysfunction caused by other reasons described in the specification.

The inventor explains that the following experimental studies are carried out on the basis of the safety of the drug proved by acute toxicity tests and long-term toxicity tests, and the administration dose in the experimental studies is within a safe dose range.

(I) the influence of the traditional Chinese medicine composition on the gastrointestinal dysfunction of rats after abdominal operations.

1 Material

1.1 animals:

SD rat, weight 180 ~ 220g, experimental animal license number: SYXK (lu) 20180008, provided by lumnan pharmaceutical group ltd, was acclimatized for one week prior to the experiment.

1.2 drugs, reagents

1.2.1 medicaments

Capsules obtained in examples 1 and 2 of the present invention

Comparative examples capsules obtained in comparative examples 1 and 2

Positive drug mosapride citrate tablet

1.2.3 dosage for rats

Example 1 capsule: 0.378g/kg (high dose), 0.189g/kg (medium dose), 0.0945g/kg (low dose);

example 2 capsules: 0.189 g/kg;

comparative example 1 capsule: 0.189 g/kg;

mosapride citrate tablets: 1.35 mg/kg.

2. Animal surgery, grouping and administration

Taking 70 rats, after fasting and no water supply for 24 hours, carrying out injection anesthesia by 10% chloral hydrate, opening the abdomen, carrying out transverse incision on the colon 2cm below the cecum without cutting, carrying out in-situ suturing and closing the abdomen, wherein the two parts are 2cm away from each other and have the caliber of about 2 mm; after surgery for 24h, the patients were randomly divided into a surgery model group, a positive drug group, three dose groups of example 1 (high, medium and low), an example 2 group and a comparative example 1 group.

Another 10 rats were selected as a sham-operated group, and the abdominal cavity was opened and closed immediately.

Feeding the rats in a single cage after operation, and injecting penicillin G sodium and streptomycin sulfate subcutaneously for 3 days continuously; after operation, the patient is fasted and not forbidden to drink within 48h, and the patient is gavaged with 20% glucose 2 times daily at intervals of 8h, and the patient is gavaged with 20ml/kg feed paste on day 3 and is free to eat on day 4.

After 24h, the sham operation group and the operation model group are perfused with normal saline according to the volume of 10ml/kg, and the other groups are perfused with corresponding medicines.

Dosing was started 24h after surgery for 10 days.

3. Detecting the index

3.1 postoperative defecation and movement

After the administration for 2 hours on the 3 rd day after operation, each rat is filled with 20ml/kg of gastric lavage feed paste, the first defecation time is observed and recorded, the first defecation time is checked for 1 time every 1 hour, and the time is counted for 10 hours when more than 10 hours of continuous defecation time are not found. Feces in 6h of each group of rats are collected, the wet weight is weighed, and the mental state, the activity condition and the like of the rats are observed.

3.2 postoperative food intake and intestinal transit Rate

3.2.1 adding 50g of feed in the morning on the 3 rd, 6 th and 9 th days before and after the operation respectively, weighing the rest feed at the same time the next day, weighing body mass and calculating the food intake of 24 h.

3.2.2 after the last administration 30min on the 10 th day after operation, each group of rats was gavaged with a mixed solution of 10% acacia gum and 5% activated carbon at 20ml/kg, after 45min, blood was taken from femoral artery, the rats were sacrificed, a median incision was made along the abdomen, the whole stomach and intestine was taken out, the mesentery was separated, the total length of the small intestine (from pylorus to ileocecal part) and the distance of carbon powder propulsion were measured, and the small intestine propulsion index was calculated.

3.3 MTL, GAS content in plasma

After 75min from the last administration, blood was taken from the femoral artery of each rat to prepare plasma, and the MTL and GAS levels in the plasma were measured using an ELISA kit according to the instructions.

4. Results and conclusions

4.1 postoperative defecation and mobility of rats

The skin and hair of the rats in the sham operation group are better in luster, active in posture, regular in excrement and hard in quality and are not adhered to each other; the rest rats showed different degrees of listlessness, slow movement, and scanty stool after operation.

Compared with a sham operation group, the first defecation time of the rats in the rest groups on the third day after operation is obviously prolonged, the defecation amount in 6h is obviously reduced, and the difference is very obvious (P is less than 0.01); compared with the operation model group, the first defecation time of the positive medicine group and the group of the embodiment 1 (high and medium dosage) is obviously shortened, the defecation amount is obviously increased within 6h, and the obvious difference is achieved (P is less than 0.05, and P is less than 0.01); compared with the positive drug, the first defecation time of the rats in the high-dose group is obviously shortened, the defecation amount is obviously increased within 6h, and the rats have obvious difference (P is less than 0.01) in the example 1 (middle and low dose) group and the rats in the example 2 (P is more than 0.05)

TABLE 1 defecation amount at defecation time level for each group of rats

Note: in contrast to the sham-operated group,^@P＜0.05，^*P＜0.01；

in contrast to the set of surgical models,^△P＜0.05，^#P＜0.01；

compared with the positive medicine group,^&P＜0.05，^￥P＜0.01。

4.2 variation in body Mass of rats

The constitution of rats in each group before operation has no difference (P is more than 0.05);

on the 3 rd day after the operation, compared with a sham operation group, the body mass of rats in other groups is obviously reduced, and the body mass of the rats has extremely obvious difference (P is less than 0.01) and is slowly increased; after treatment, compared with a model group, except the group of the comparative example 1, the body mass of rats in the other administration groups is obviously increased, and the obvious difference P is less than 0.05; compared with the positive drug, the body mass of the rats in the high-dose group in the example 1 is obviously increased and has obvious difference (P is less than 0.01), and the rats in the medium-dose and low-dose groups in the example 1 and the example 2 have no difference (P is more than 0.05)

TABLE 2 Mass changes of rats in each group: (

n＝10)

Note: in contrast to the sham-operated group,^@P＜0.05，^*P＜0.01；

in contrast to the set of surgical models,^△P＜0.05，^#P＜0.01；

compared with the positive medicine group,^&P＜0.05，^￥P＜0.01。

4.3 rat food intake of 24h

Before operation, the food intake of rats in each group for 24 hours is not different (P is more than 0.05);

on the 3 rd day after the operation, compared with a sham operation group, the food intake of rats in other groups for 24h is obviously reduced, and the difference is very obvious (P is less than 0.01); after treatment, compared with the model group, the food intake of rats in the other administration groups except the comparative example 1 group is obviously increased, and the difference is obvious (P is less than 0.05); compared with the positive drug, the food intake of the rats in the high-dose group is obviously increased and has obvious difference (P is less than 0.01) in the example 1, and the rats in the medium-dose and low-dose groups have no difference (P is more than 0.05) in the example 2

TABLE 3 rat groups with 24h food intake: (

n＝10)

Note: in contrast to the sham-operated group,^@P＜0.05，^*P＜0.01；

and surgeryThe comparison of the model groups is carried out,^△P＜0.05，^#P＜0.01；

compared with the positive medicine group,^&P＜0.05，^￥P＜0.01。

4.4 Small intestine Propulsion index in rats

Compared with the sham operation group, the treated rats have no difference in small intestine propulsion index (P is more than 0.05) except for the model group, the example 2 group and the comparative example 1 group;

TABLE 4 Small intestine Propulsion index of rats in each group

Note: in contrast to the sham-operated group,^@P＜0.05，^*P＜0.01；

in contrast to the set of surgical models,^△P＜0.05，^#P＜0.01；

compared with the positive medicine group,^&P＜0.05，^￥P＜0.01。

4.5 MTL and GAS content in rat plasma

Compared with a sham operation group, the contents of MTL and GAS in the plasma of the model group are obviously reduced, and the model group has extremely significant difference (P is less than 0.01); after the treatment is finished, compared with the model group, the rats in each treatment group have the significantly increased MTL and GAS contents in the plasma of the other rats except the comparative example 1, and have significant difference (P is less than 0.05); compared with the positive medicine group, the high-dose group in the example 1 has obvious difference (P is less than 0.05)

TABLE 5 plasma MTL and GAS of various groups of rats: (A)

n＝10)

Note: in contrast to the sham-operated group,^@P＜0.05，^*P＜0.01；

in contrast to the set of surgical models,^△P＜0.05，^#P＜0.01；

compared with the positive medicine group,^&P＜0.05，^￥P＜0.01。

(II) the traditional Chinese medicine composition has the influence on the gastrointestinal movement of rats with liver depression type gastrointestinal dysfunction.

1 Material

1.1 animals:

SD level rat, weight 180 ~ 220g, experimental animal license number: SYXK (lu) 20180008, provided by lumnan pharmaceutical group ltd, was acclimatized for one week prior to the experiment.

1.2 drugs, reagents

1.2.1 medicaments

Capsules obtained in examples 1 and 3 of the present invention

Comparative example 2 the obtained capsule

The positive medicine of mosapride citrate tablet.

1.2.3 dosage for rats

example 3 capsules: 0.189 g/kg;

comparative example 2 capsule: 0.189 g/kg;

mosapride citrate tablets: 1.35 mg/kg.

2. Grouping, modeling and administration

80 rats were randomly divided into a blank group, a model group, a positive drug group, three dose groups of example 1 (high, medium, and low), an example 3 group, and a comparative example 2 group, each group consisting of 10 rats.

Except the blank group, the other groups are molded by adopting various methods of external stimulation and drug stimulation, and the molded rats are molded by alternately stimulating (different stimulation methods are carried out on the rats every day) for 15 days continuously.

The stimulation method comprises tail-clamping stimulation (2 tail-clamping stimulation modes are adopted randomly, one mode is that a clamp with cotton cloth clamps each rat for 5min to enable the rats to mutually support due to pain, the other mode is that 10 rats are randomly drawn for tail-clamping stimulation, and the other rats are stimulated by the stimulation of the 10 rats), tail suspension (the heads of the rats are hung downwards 30cm away from the ground to struggle and keep the view of escaping and the state of failing to escape for 5min, the rat is kept in a suspended state all the time), day and night inversion (the rat is kept in a day and night inversion state for 24h), sc adrenaline hydrochloride (0.8mg/kg), rat cage inclination stimulation (the rat cage is obliquely placed to keep an inclination angle of 30 degrees with the ground, the rats in the cage are in an obliquely-clamped state for 24h), water deprivation is carried out for 12h, ice water swimming (the prepared crushed ice is placed into a water bucket, adding water to 50cm, putting the rat into water, struggling and swimming for 4min until it does not float on the water surface, and ultrasonic stimulating (placing the rat beside an ultrasonic cleaning instrument, adjusting frequency to 60Hz, making the rat in dysphoria state, and stopping stimulating after 15 min).

From day 16, the blank and model groups were gavaged with saline and the remaining groups were gavaged with the corresponding drugs. The administration was continued for 7 days.

3. Detection of

3.1 gastric residual rate and intestinal transit rate test: the rats in each group are fasted for no water supply one night before the gastric lavage administration is finished, 2ml (containing 5% carbon powder) of gastric lavage solid nutrition paste is added after 30min of the last gastric lavage administration, after 30min, the rats are dissected, the whole stomach is taken out, after the conventional treatment, the total weight of the stomach is weighed, the residue in the stomach is cleaned, after the surface moisture is sucked up after the cleaning, the net weight of the stomach is weighed, and the residual quantity of the solid nutrition paste in the stomach is calculated.

And taking out the complete small intestine section, soaking the small intestine section into 4% formaldehyde solution, measuring the whole length of the intestine section and the moving length of the solid nutrient paste in the intestine section after the intestine section is solidified and hardened, and calculating the small intestine propulsion rate.

3.2 rat gastro-plasma gut hormone changes: after each group of animals is administered for 30min for the last time, the femoral artery is bled, and the MTL and GAS contents are determined after plasma separation.

4. Results and conclusions

4.1 gastric residual Rate and intestinal Pushing Rate

After treatment, compared with a blank control group, the gastric residual rate of a model group rat is obviously increased, the small intestine propulsion rate is obviously reduced, and the model group rat has obvious difference (P is less than 0.05), and the positive medicine group and the example 1 (high, medium and low dose) group have no difference (P is more than 0.05); compared with the model group, the residual rate of the stomach of the rats in other treatment groups is obviously reduced, the small intestine propulsion rate is obviously improved, and the significant difference is realized (P is less than 0.05).

TABLE 6 gastric residual rate and intestinal propulsion rate of each group of rats

Note: in contrast to the blank group,^@P＜0.05，^*P＜0.01；

in contrast to the model set,^△P＜0.05，^#P＜0.01；

compared with the positive medicine group,^&P＜0.05，^￥P＜0.01。

4.2 gastrointestinal hormone content in rat plasma

After treatment, compared with a blank control group, the contents of MTL and GAS in the plasma of the model group are obviously reduced, and the contents are very different (P is less than 0.01); compared with the model group, the rats in each treatment group have significantly increased MTL and GAS contents in the plasma of the other rats except the comparative example 2 group, and have significant difference (P < 0.05); compared with the positive drug group, the group of example 1 (high and medium dose) was indistinguishable (P > 0.05).

TABLE 7 MTL, GAS in the plasma of various groups of rats: (

n＝10)

Note: in contrast to the blank group,^@P＜0.05，^*P＜0.01；

in contrast to the model set,^△P＜0.05，^#P＜0.01；

compared with the positive medicine group,^&P＜0.05，^￥P＜0.01。

(III) the influence of the traditional Chinese medicine composition on the gastrointestinal function of depressed rats.

1 Material

1.1 animals:

1.2 drugs, reagents

1.2.1 medicaments

Capsules obtained in examples 1 and 2 of the present invention

Comparative example 1 Capsule

The positive medicine of mosapride citrate tablet.

1.2.3 dosage for rats

example 2 capsules: 0.189 g/kg;

comparative example 1 capsule: 0.189 g/kg;

mosapride citrate tablets: 1.35 mg/kg.

2. Modeling, grouping and administration

80 rats were randomly divided into a blank group, a model group, a positive drug group, three dose groups of example 1 (high, medium and low), and an example 2 group, and 10 rats in each group were selected as a comparative example 1 group.

Except for the blank group, the rest groups prepared depression models by combining chronic unpredictable mild stimulation and lone nutrition.

1 rat per cage was fed with the following 8 stress factors randomly given within 21 days: fasting for 24 hours without water supply; the food is not fasted for 24 hours under the condition of water deprivation; clamping tail for 1 min; swimming for 5min with ice water; noise for 5 min; performing restraint stimulation for 6 h; the wet padding and the squirrel cage are inclined for 24 hours; suspending for 5 min.

One stimulus was given daily, and each stimulus was used 2-3 times cumulatively, in a random order, making the rats unpredictable in the occurrence of the stimulus.

From 15d, the blank group and the model group are subjected to intragastric administration of physiological saline, and the other groups are subjected to intragastric administration of corresponding medicaments. The administration was continued for 7 days.

3. Detection of

Blood is taken from the canthus vein in the eye of the rat, plasma is separated, and the content of GAS, MTL, CCK, SS and VIP is determined.

4. Results and conclusions

After treatment, compared with a blank group of rats, the contents of SS, CCK and VIP in the plasma of the model group of rats are obviously increased, the contents of GAS and MTL are obviously reduced, and the significant difference is realized (P is less than 0.01); compared with the model group, the contents of SS, CCK and VIP in the plasma of rats in each treatment group are obviously reduced, the contents of GAS and MTL are obviously increased, and the significant difference is realized (P is less than 0.05 and P is less than 0.01).

TABLE 8 GAS, MTL, CCK, SS, VIP (VIP) in the plasma of various groups of rats

n＝10)

Note: in contrast to the blank group,^@P＜0.05，^*P＜0.01；

in contrast to the model set,^△P＜0.05，^#P＜0.01；

compared with the positive medicine group,^&P＜0.05，^￥P＜0.01。

in conclusion, the traditional Chinese medicine composition can obviously improve the contents of MTL and GAS in the blood plasma of depressed rats, reduce the contents of SS, CCK and VIP and promote gastrointestinal motility.

Third, clinical cases

(one time) the effect of the laxative capsules on gastrointestinal function of patients after pancreatic cancer surgery

1. Introduction of cases

Male, 73 years old, with persistent constipation one month before admission, manifested by anorexia, epigastric pain, emaciation, and upper abdominal pressure pain with lumps; there is no family history of pancreatic cancer, no pancreatitis, there is a history of smoking; the stomach-invigorating and digestion-promoting tablet and the anti-inflammatory treatment are taken before admission, and are not obviously improved. After admission, B-ultrasonic examination and MRI examination are carried out, pancreas puncture tissue disease examination shows that the maximum diameter of the lesion part of the pancreatic head is 5.2cm, the boundary is fuzzy, and the pancreatic cancer is diagnosed. The blood pressure is higher at present, and the blood pressure is moderate and high (the systolic pressure is 171mmHg, and the diastolic pressure is 103 mmHg).

2. Treatment of

After clinical pathological examination, the treatment of pancreaticoduodenectomy is performed according to the condition of a patient. The specific method comprises the following steps: adopting a Beger improvement method, dissociating duodenum and head of pancreas by a Kocher method, exposing pancreas through an approach of a gastrointestinal ligament, cutting off a neck of pancreas in front of a superior mesenteric vein and a portal vein, cutting a pancreas capsule along the inner side of an superior anterior artery of pancreas duodenum, dissecting an upper anterior artery and an upper posterior artery of pancreas duodenum, keeping the integrity of an artery arch of pancreas duodenum, completely excising pancreas head, keeping pancreas tissues 0.5-1.0 cm away from the inner side edge of the duodenum, completely stripping the pancreas tissues at the inner side of the pancreas after exposing a bile duct in pancreas in operation, keeping a thin layer of pancreas tissues between a common bile duct and duodenum and at the outer side of the common bile duct, ligating and cutting off a main pancreas duct at a joint of the bile duct, and intermittently suturing the pancreas tissues at the head end, and performing end-nested double-layer anastomosis of the far-end pancreas and the jejunum. Patient postoperative administration of early enteral immune tube-feeding support therapy: after 2 days of operation, 300ml of normal saline is fed through a nasal duodenum nutrient canal, a rey nutrient preparation (each 100ml contains 2.3g of arginine, 0.3g of omega-3 polyunsaturated fatty acid, proper amount of nucleotide, glutamine and the like, a plurality of vitamins and trace elements) is fed after the patient is confirmed to have no uncomfortable symptoms, then the dose on the 1 st day is 1/3-1/2 of the total dose, the dose on the 2 nd day is 2/3 of the total dose, and the dose on the 3 rd day is the total dose; the infusion speed is gradually increased from 30ml/h to 80-100 ml/h on day 1, and the treatment is continuously carried out for 1 week. The composition is administered orally to patients 1 week after operation, and is administered 3 times per day, 1 granule each time for 1 week

Collecting 5ml of early morning fasting venous blood of the patient at 1 week and 2 weeks before and after operation, respectively, and detecting the levels of serum gastrointestinal hormone Gastrin (GAS), Motilin (MTL) and vasoactive peptide (VIP) by radioimmunoassay, the results are shown in Table 9; the results of comparing the recovery time of gastrointestinal function before and after surgery including anal ventilation time, defecation time, and bowel sound recovery time are shown in table 10.

TABLE 9 comparison of gastrointestinal hormone levels before and after treatment

	GAS(μmol/l)	MTL(ng/l)	VIP(ng/l)
				Before operation	58.72±7.23	153.52±25.82	68.47±17.33
1 week after operation	74.68±6.77	240.18±24.27	53.75±16.57
				2 weeks after surgery	81.33±7.69	267.36±26.24	42.37±15.19

TABLE 10 comparison of gastrointestinal function recovery before and after treatment (Tian)

	Time of anus exhaust	Defecation time	Time to recovery from bowel sound
				Before operation	2.58±0.73	2.63±0.81	2.49±0.82
1 week after operation	2.25±1.03	2.13±1.07	1.86±1.05
				2 weeks after surgery	1.65±0.58	1.42±0.63	1.17±0.58

Early enteral nutrition can reduce the possibility of constipation after pancreatic cancer operation, but after the enteral nutrition is matched with the aloe cathartic capsule, the enteral nutrition has better effect, has positive promotion effect on improving the gastrointestinal hormone level in intestines, and further promotes the recovery of the gastrointestinal function of patients.

(II) the influence of the Hui Tongbi capsule on the complications of the patients with cardia cancer after total gastrectomy.

1. Introduction of cases

Female aged 81 years, before admission, manifested as food intake obstruction, vomiting after food intake, weight loss, epigastric pain, anorexia, asthenia, and dark stool. After the patient is admitted, ultrasonic endoscopy and CT examination are carried out, the maximum diameter of the lesion part is 6.5cm, the proportion of the cardia cancer leaching serosa reaches 90 percent, and the patient is diagnosed with the cardia cancer. The patients have a history of smoking, and the current blood pressure value is higher, the moderate hypertension (the systolic pressure is 173mmHg, the diastolic pressure is 102mmHg) is higher, and the patients have a history of severe esophageal reflux.

2. Treatment of

According to the condition of the patient, after radical total gastrectomy, esophagus jejunum anastomosis and Braun anastomosis treatment are adopted. The specific method comprises the following steps: the patient lies down, after disinfection and anesthesia, the abdomen is opened and the patient enters the abdominal cavity, the jejunum is cut off at a position 15cm below the ligamentum flexor, and the jejunum at the far end is dissociated and left for anastomosis. Then the ligamentum trigonum on the left side is cut off, the peritoneum below and in front of the diaphragmatic fissure is cut off, the left outer lobe of the liver is pulled to the right side by a large-size draw hook, the cardia part of the diaphragm and the esophageal fissure are exposed, the two sides and the front wall of the lower esophagus are separated, after vagus nerves on the two sides are cut off, the lower esophagus is stretched for about 5cm in the abdominal cavity, the front wall is transversely cut at a position, about 2cm above the tumor of the cardia part at the bottom of the stomach, the free distal jejunum upwards passes through the transverse colon and the stomach, the esophagus is anastomosed at the esophageal cut position with the esophagus, and the Braun which is close to 10cm is anastomosed at a position, 40-45 cm below the jejunum anastomotic stoma, of the jejunum output loop and the. After two groups of operations, gastrointestinal decompression is continued for 3 days, diet is forbidden, fluid diet can be taken only after anal canal is exhausted, semifluid is taken after about 8 days, and normal diet is taken after about 2 weeks. The conventional antibiotics are taken after operation to supplement essential nutrients such as protein and the like.

After 5 days after operation, the patient starts to take orally the mosapride 1 capsule with the combination of the initial aloe and the laxative after taking orally the mosapride for 3 days, and the bile reflux and the defecation times of the patient are respectively recorded. The statistical results are shown in table 1.

TABLE 11 comparison of postoperative complications before and after treatment of patients

This case shows that the combination increases the number of exsufflation and defecation times by comparing the single oral administration of mosapride with the combination of hui defaecation capsules for the treatment of cardia cancer postoperative reflux and defecation; meanwhile, the reflux times are reduced, and the reflux amount is reduced obviously. Therefore, the aloe bowel-relaxing capsule combined with the intestinal motility drug can increase the times of air exhaust and defecation and promote the emptying of the intestinal tract, thereby reducing the reflux of upper digestive tract liquid, relieving the reflux related complications after the total gastrectomy and improving the quality of life.

Claims

1. A Chinese medicinal composition for treating or improving gastrointestinal dysfunction is prepared from Polygoni Multiflori radix, semen Cassiae, Aloe, fructus Lycii, colla Corii Asini, Ginseng radix, fructus Aurantii Immaturus, and Atractylodis rhizoma.

2. Use of the composition of claim 1 in the preparation of a medicament for improving or promoting recovery of gastrointestinal function.

3. The use of claim 1, wherein the gastrointestinal dysfunction is gastrointestinal dysfunction caused by abdominal surgery; preferably, the abdominal operation includes, but is not limited to, one of gastrointestinal disease operation, hepatobiliary disease operation, infectious disease operation, and gynecological disease operation.

4. The use according to claim 1, wherein the gastrointestinal dysfunction is gastrointestinal dysfunction caused by digestive diseases, diabetes.

5. The use of claim 4, wherein the digestive system disease includes, but is not limited to, one of dyspepsia, gastritis, peptic ulcer, colitis, gastroesophageal reflux, cholecystitis, pancreatitis, gastric cancer; preferably, the peptic ulcer includes but is not limited to one of gastric ulcer and duodenal ulcer.

6. The use of claim 1, wherein the gastrointestinal dysfunction is gastrointestinal dysfunction caused by radiation therapy, chemotherapy and/or surgery for a malignant tumor.

7. The use of claim 7, wherein the gastrointestinal dysfunction is gastrointestinal dysfunction induced by surgery for pancreatic cancer or cardiac cancer.

8. The use of claim 1, wherein the gastrointestinal dysfunction is gastrointestinal dysfunction caused by dietary factors, psychiatric factors, pharmaceutical factors.

9. The use of any one of claims 1-8, wherein the traditional Chinese medicine composition is prepared from the following components:

10. The use of claim 9, wherein the Chinese medicinal composition can be prepared into clinically acceptable dosage forms by conventional processes directly or after adding pharmaceutically acceptable adjuvants; preferably, the clinically acceptable dosage form is one or more of capsules, tablets, granules and pills; further preferably, the capsule is a aloe cathartic capsule.