CN113304135B - Composition for treating diabetic gastroparesis and application thereof - Google Patents

Abstract

The invention belongs to the field of application of traditional Chinese medicines, and particularly discloses a composition for treating diabetic gastroparesis and application thereof. The composition comprises Ginseng radix, atractylodis rhizoma, colla Corii Asini, polygoni Multiflori radix, fructus Lycii, semen Cassiae, aloe and fructus Aurantii Immaturus. The invention adopts pure traditional Chinese medicine raw materials, has complete medicine preparation and hits the middle case. Clinical medication feedback finds that the traditional Chinese medicine composition can effectively treat gastroparesis syndrome, particularly diabetic gastroparesis, and has short treatment course and good effect; animal experiments show that the effective rate of the medicine for treating the chronic rhinitis is more than 95%. The Chinese medicinal composition can be added into health products and foods according to a certain proportion to prepare products with the same curative effect.

Description

Composition for treating diabetic gastroparesis and application thereof

Technical Field

The invention relates to a traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof, belonging to the field of traditional Chinese medicines.

Background

In recent years, with the change of life style of people, diabetes Mellitus (DM) becomes the third most non-infectious disease in the world, and the incidence rate is increased year by year. From a pathogenesis standpoint, diabetes is a group of metabolic diseases characterized by hyperglycemia due to defective insulin secretion or impaired biological action, or both. Due to the long-standing hyperglycemia during the diabetic complications, chronic damage and dysfunction of various tissues, particularly the eye, kidney, heart, blood vessels, nerves, can result.

From a genetic point of view, diabetes mellitus type 1 or type 2 diabetes mellitus has obvious genetic heterogeneity and has a familial aggregation phenomenon. Diabetes has a family morbidity tendency, and 1/4 to 1/2 patients have a family history of diabetes. Clinically, at least 60 genetic syndromes may be accompanied by diabetes. Type 1 diabetes has multiple DNA sites involved in onset, with the DQ site polymorphism in HLA antigen genes being the most closely related. In type 2 diabetes, a variety of well-defined genetic mutations have been found, such as the insulin gene, insulin receptor gene, glucokinase gene, mitochondrial gene, and the like.

Gastroparesis syndrome refers to a group of clinical symptoms characterized by delayed gastric emptying, which are manifested as early satiety, postprandial epigastric distention, nausea, paroxysmal retching, vomiting, weight loss, and the like, also known as gastroparesis, gastric weakness, and the like. Gastroparesis syndrome occurs not only after gastric surgery but also after other abdominal surgeries. The disease causes can be divided into two types of primary and secondary, the primary is also called idiopathic gastroparesis and is often found in young women. Gastroparesis can be classified into acute and chronic according to the onset and urgency and the duration of the disease. Clinically, the symptoms are chronic and frequently occur continuously or repeatedly for months or even more than 10 years. Diabetic Gastroparesis (DGP) is one of the numerous complications of DM.

Diabetic gastroparesis is a common symptom of diabetic gastrointestinal vegetative neuropathy. Typical symptoms are abdominal distension, early satiety, anorexia, eructation, nausea, vomiting, weight loss, and often severe after a meal. The stomach was full of the stomach and the water-vibrating sound was heard. Most patients have no obvious clinical symptoms, less patients have early satiety, nausea, vomiting, abdominal distension and the like, the severity of symptoms varies from person to person, and the severity of symptoms of the same patient is also influenced by various factors and may be related to the reduction of afferent nerve pathway sensitivity caused by diabetic autonomic neuropathy. Gastric retention may be due to delayed gastric emptying, with repeated gastrolith formation. Gastro-esophageal reflux symptoms (such as acid regurgitation, heartburn, etc.) can occur when the lower esophageal sphincter pressure is reduced, and reflux esophagitis occurs in severe cases. In addition to the above symptoms, abnormalities in MMC may also cause abnormal emptying of the small intestine and colon, resulting in abdominal pain, constipation or diarrhea.

At present, the treatment means for the disease is various, and the treatment means of western medicine is simple, such as metoclopramide, domperidone, mo Sha pride, itopride and cisapride, and has quick response, but the repeated disease condition appears and the drug dosage is gradually increased; the traditional Chinese medicine treatment means mainly warm-keeping and tonifying, and acupuncture therapy has related reports, such as therapeutic concept idea of applying acupuncture in rat experimental models in acupuncture basic research on diabetic gastroparesis animal models, such as Zhi mu and the like. Besides the treatment of medicines and related means, related control is carried out on diet, a small amount of meals are good for eating, and the symptoms of gastroparesis of a patient can be relieved by low-fat diet. Indigestible vegetables should be avoided to prevent the formation of gastroliths in the plant.

Chinese patent CN100453105C discloses a composition with functions of relaxing bowels, expelling toxin, losing weight and reducing fat and a preparation method thereof, and the product is a 'Shohui laxative capsule' which is approved by production at present. The product 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, has definite curative effect and quick response, and has good treatment effect on constipation caused by toxin accumulation and yin fluid deficiency.

Disclosure of Invention

The invention discloses a new application patent which is further developed on the basis of Chinese patent CN100453105C and discloses a composition with functions of relaxing bowels, expelling toxin, losing weight and reducing fat and a preparation method thereof.A Hui Tongbu capsule is one of products prepared by relying on the patent technology, and the application of the medicine in relieving or treating diabetic gastroparesis is discovered occasionally in clinical experiments. Meanwhile, the application of the invention is proved by rat animal model experiments on the medicine and the technical product related in the patent (CN 100453105C). The specific invention process is as follows:

the invention aims to provide a traditional Chinese medicine composition which is prepared from 8 traditional Chinese medicines such as ginseng, bighead atractylodes rhizome, donkey-hide gelatin, cassia seed, aloe, immature bitter orange and the like, and has the effects of tonifying qi, nourishing yin and relaxing bowel.

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

20-100 parts of ginseng, 20-100 parts of bighead atractylodes rhizome, 30-150 parts of donkey-hide gelatin

20-400 parts of tuber fleeceflower root, 40-100 parts of medlar and 30-180 parts of cassia seed

30-600 parts of aloe and 50-200 parts of immature bitter orange.

The preferred weight ratio of the traditional Chinese medicine composition is as follows:

50 parts by weight of ginseng, 50 parts by weight of bighead atractylodes rhizome, and 75 parts by weight of donkey-hide gelatin

120 parts of polygonum multiflorum, 75 parts of barbary wolfberry fruit and 140 parts of cassia seed

160 parts of aloe and 120 parts of immature bitter orange.

The invention also aims to provide a medicine containing the traditional Chinese medicine composition.

The medicine is prepared by combining the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

The medicine can be a pharmaceutically acceptable oral solid preparation;

preferably, the medicine is a capsule, a granule or a tablet.

Further, the preparation method of the solid preparation comprises the following steps:

1) 8 raw material medicaments of ginseng, largehead atractylodes rhizome, rehmannia root, donkey-hide gelatin, chinese angelica, figwort root, dwarf lilyturf tuber, snakegourd seed, cassia seed, aloe and immature bitter orange are taken, wherein the ginseng, the largehead atractylodes rhizome, the rehmannia root, the Chinese angelica, the figwort root and the immature bitter orange are sliced, the donkey-hide gelatin is crushed into fine powder or melted by heat, the snakegourd seed is smashed, the aloe is crushed, and the dwarf lilyturf tuber and the cassia seed are cleaned for standby;

2) Uniformly mixing ginseng, cassia seed and aloe, performing reflux extraction for 1-3 times by using 40-80% ethanol in an amount which is 5-8 times that of the ginseng, cassia seed and aloe, performing filtration, combining filtrates, recovering ethanol under reduced pressure, and concentrating into an extract I for later use, wherein the medicine residue is for later use;

3) Extracting radix Angelicae sinensis with 6-8 times of water to obtain volatile oil, and collecting the volatile oil, medicinal liquid and residue;

4) Rehmannia root, figwort root, dwarf lilyturf tuber, snakegourd seed, immature bitter orange and largehead atractylodes rhizome are uniformly mixed, 8-10 times of water is added for soaking for 1.5 hours, the medicine residue in the step 2) and the medicine residue in the step 3) are added for decoction for 2 hours, the decoction liquid is discharged after the water is further decocted for 2 hours by 8-10 times, the decoction liquid is combined and is combined with the medicine liquid in the step 3), the filtration is carried out, the pressure reduction concentration is carried out until the relative density reaches 1.1-1.2, 95 percent ethanol is added to ensure that the ethanol content reaches 50 percent to 85 percent, the cold precipitation is carried out for 48 hours, the filtration is carried out, the ethanol is recovered under reduced pressure, and the concentrated extract II is reserved;

5) Mixing the extract I and the extract II, uniformly mixing, drying to obtain dry paste, crushing the dry paste, adding donkey-hide gelatin fine powder or a molten donkey-hide gelatin solution, adding conventional auxiliary materials and 75-85% ethanol solution according to the formula amount, uniformly mixing, granulating, drying, grading, adding the obtained granules into the angelica volatile oil in the step 3), and uniformly mixing to obtain granules;

or mixing the extract I and the extract II, uniformly mixing, drying to obtain dry extract, crushing the dry extract, adding donkey-hide gelatin fine powder or a melted donkey-hide gelatin solution, adding conventional auxiliary materials and 75-85% ethanol solution according to the formula amount, uniformly mixing, granulating, drying, grading, adding the obtained granules into the angelica volatile oil in the step 3), uniformly mixing to obtain granules, adding superfine silica gel powder, filling, polishing in a polishing machine, removing damaged capsules, and obtaining capsules;

or mixing the extract I and the extract II, uniformly mixing, drying to obtain dry paste, crushing the dry paste, adding donkey-hide gelatin fine powder or a melted donkey-hide gelatin solution, adding conventional auxiliary materials and 75-85% ethanol solution according to the formula amount, uniformly mixing, granulating, finishing granules, adding the obtained granules into the angelica volatile oil obtained in the step 3), uniformly mixing to obtain granules, adding the conventional auxiliary materials, uniformly mixing, granulating, finishing, adding magnesium stearate, mixing, tabletting, and thus obtaining tablets.

Preferably, the 6 times of 60% ethanol is added in the step 2) and the reflux extraction is carried out for 1 time.

Preferably, step 4) adds 95% ethanol to achieve 60% ethanol content.

The gastroparesis syndrome can be any one of primary gastroparesis and secondary gastroparesis.

The gastroparesis syndrome can be any one of diabetic gastroparesis, connective tissue gastroparesis, gastroparesis caused by stomach operation or vagus nerve amputation, infectious or metabolic abnormality gastroparesis, and gastroparesis caused by central nervous system diseases.

In traditional Chinese medicine, the relation about gastroparesis is less, the gastric paresis is clinically classified into the categories of 'vomiting', 'stomach stuffiness', 'belching' and the like according to symptoms, the qi movement of middle jiao is disordered, and the dysfunction of spleen and stomach is the basic pathogenesis of the diabetic gastroparesis; the disease location is in the spleen and stomach, and the pathogenesis is mostly deficient in origin and excessive in nature, the deficiency of the spleen and stomach and the weakness of transportation and transformation are the primary causes, and the blockage of pathological products such as turbid phlegm, blood stasis and qi stagnation is the secondary cause.

The invention comprises the following medicinal components of ginseng and bighead atractylodes rhizome which are used as monarch medicaments. Ginseng has the actions of tonifying primordial qi, tonifying spleen, benefiting lung, promoting the production of body fluid, tranquilizing, and is reported in Ben Cao gang mu Yun: ginseng can tonify qi in lung, while lung qi is vigorous, so qi of four zang organs is vigorous; bighead atractylodes rhizome has the effects of strengthening spleen and replenishing qi, eliminating dampness and inducing diuresis, preventing miscarriage and arresting sweating, as in Yun from Ben Cao Tong Xuan: baizhu, a spleen and stomach-tonifying herb … …. It is also indicated for food failure, food stagnation and distension and fullness because it can be healthy and transported with vigorous soil. Ginseng is mainly used for tonifying primordial qi, and bighead atractylodes rhizome is mainly used for tonifying spleen and stomach, the two medicines are combined mutually and mutually reinforced, so that the effects of tonifying qi and strengthening spleen are stronger, and the effects of strengthening primordial qi and middle qi mutually, strengthening spleen and invigorating spleen in four seasons and preventing hijack are achieved.

Semen Cassiae, fructus Lycii, colla Corii Asini are ministerial drugs. Cassia seed has the actions of clearing heat, improving vision, moistening intestines and relaxing bowels. Wolfberry fruit has the functions of moistening lung, promoting the production of body fluid, tonifying kidney and nourishing liver. Donkey-hide gelatin has the actions of tonifying blood, nourishing yin, moistening dryness and stopping bleeding, and is a good herb for blood and flesh, especially good at nourishing yin and moistening dryness. The medlar and donkey-hide gelatin in the prescription have the functions of nourishing essence and blood, increasing water, moving boat, moistening intestines and relaxing bowels, so the medlar and donkey-hide gelatin are ministerial drugs. The three components supplement each other with monarch drug, and can strengthen spleen and replenish qi, nourish yin and enrich blood, and clear heat and benefit stomach.

Fleece-flower root and aloe as adjuvant medicines. Polygonum multiflorum has the effects of replenishing vital essence and nourishing blood, and loosening the bowel to relieve constipation, so it is suitable for constipation due to intestinal dryness caused by blood deficiency and fluid deficiency. Aloe has the effects of clearing liver heat and relieving constipation. The two medicines are used together to play the roles of clearing heat and removing toxicity, and lubricating intestines and purging turbid. Meanwhile, the Chinese herbal medicine can assist monarch and minister medicines, and can increase the effects of tonifying kidney, opening yin and clearing liver heat.

Immature bitter orange is used as a guiding drug. Zhi Shi has the actions of breaking qi and relieving food retention, resolving phlegm and dispersing stuffiness. In the formula, the immature bitter orange enters spleen, stomach and large intestine channels to guide all the medicines to directly reach the focus, and meanwhile, the immature bitter orange assists monarch and ministerial medicines to disperse and dredge fu-organ qi, so the immature bitter orange is used as a messenger medicine. In addition, zhi Shi and Bai Zhu are combined and come from Zhi Zhu Tang from jin Kui Yao L ü e. Zhi Shi can reduce diarrhea, descend turbid pathogen and dissolve phlegm to dissipate nodulation; bai Zhu ascends and tonifies, ascends and clears the spleen and dries dampness. The two herbs can tonify and purge simultaneously, and are used for general purpose, ascending in descending middle energizer, tonifying in purging, keeping one in the middle, urgent and slow, and mutually restricted, so that they can be used in combination without retention of tonifying and without impairment of healthy qi by purging. The whole formula acts on the spleen and the stomach to recover the normal functions of ascending the clear and descending the turbid of the spleen and the stomach. Therefore, it plays an important role in the whole prescription.

By supplementing qi and nourishing yin, the gastrointestinal motility is increased, the gastrointestinal peristalsis is accelerated, the glandular secretion is increased, and the paralyzed gastrointestinal function is recovered. The traditional Chinese medicine composition is prepared according to the compatibility theory of monarch, minister, assistant and guide and the compatibility theory of medicine pair of the traditional Chinese medicine and following the concept of 'deficiency leading to tonifying' and 'dryness leading to moistening' of the traditional Chinese medicine, eight medicines are combined, the tonifying is not stagnated, the qi and yin are passed through without damaging qi and yin, the effects of tonifying qi, nourishing yin and relaxing bowel are achieved, and the traditional Chinese medicine composition is mainly used for treating spleen and stomach qi deficiency, blood deficiency and intestine dryness, inappetence, dry mouth and throat, constipation, unsmooth defecation and the like, so that the traditional Chinese medicine composition has the function of gastroparesis syndrome, and particularly has remarkable application in the treatment of diabetic gastroparesis.

In a word, the formula integrates clinical experience according to the traditional Chinese medicine theory, has precise and appropriate medicine selection and strict compatibility, gives consideration to both symptoms and root causes, and hits the pathogenesis. The monarch, minister, assistant and guide medicines are complete, and the seven emotions are combined, so that the effects of strengthening spleen and replenishing qi, nourishing yin and blood, and lubricating intestines and purging turbid are achieved.

Compared with the prior art, the invention has the unexpected beneficial effects that:

the pure traditional Chinese medicine raw materials used by the invention are monarch, minister, assistant and guide, the dosage is complete, the gastroparesis syndrome can be effectively treated, particularly, the diabetic gastroparesis has no toxic or side effect, the treatment course is short, the effect is good, and animal and clinical tests show that the effective rate of the medicine treatment is more than 95%.

In order to verify the effect of relaxing bowel of the traditional Chinese medicine composition, the inventor develops pharmacodynamic test research and medicine clinical research. It should be noted that the drug selected in the pharmacodynamic test and clinical study of the drug of the present invention is a drug obtained by the representative formulation and the preparation method thereof, and the tests and results related to the other formulations and the drugs obtained by the preparation method of the present invention are not exhaustive due to space limitations.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

The following examples are presented 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:

immature bitter orange 200 parts by weight, bighead atractylodes rhizome 20 parts by weight, ginseng 100 parts by weight

30 parts of medlar, 150 parts of donkey-hide gelatin, 20 parts of fleece-flower root

500 parts by weight of cassia seed and 30 parts by weight of aloe.

Grinding colla Corii Asini into fine powder (80 mesh); reflux-extracting Ginseng radix, polygoni Multiflori radix, semen Cassiae, and Aloe with 40% ethanol for 3 times, each for 1 hr, filtering the extractive solution, recovering ethanol, and concentrating to obtain extract; adding 5 times of water into the medlar, the bighead atractylodes rhizome and the immature bitter orange, soaking for 3 hours, decocting for 3 hours, adding 5 times of water, decocting for 2 hours, combining the decoction, filtering, and concentrating under reduced pressure to obtain the following medicinal materials: water =1:1, adjusting alcohol to 85%, cold precipitating for 12 hours, filtering, concentrating to obtain extract for later use; mixing the ethanol extract and water extract, and adding colla Corii Asini fine powder to obtain the Chinese medicinal composition. Making into tablet according to conventional tablet preparation process.

Example 2:

50 parts of immature bitter orange, 100 parts of white atractylodes rhizome and 20 parts of ginseng

150 parts of medlar, 30 parts of donkey-hide gelatin, 400 parts of fleece-flower root

30 parts of cassia seed, 600 parts of aloe.

Melting colla Corii Asini to obtain colla Corii Asini solution; reflux-extracting Ginseng radix, polygoni Multiflori radix, semen Cassiae and Aloe with 80% ethanol for 3 hr for 1 time, filtering the extractive solution, recovering ethanol, and concentrating to obtain extract; adding 10 times of water into the medlar, the bighead atractylodes rhizome and the immature bitter orange, soaking for 0.5 hour, decocting for 1 hour, adding 10 times of water, decocting for 1 hour, combining decoction, filtering, and concentrating under reduced pressure to obtain the following medicinal materials: water =3:1, adjusting alcohol to 65%, performing cold precipitation for 48 hours, filtering, and concentrating into an extract for later use; mixing the ethanol extract and water extract, and adding melted colla Corii Asini solution to obtain the final product. Making into syrup according to conventional syrup preparation method.

Example 3:

immature bitter orange 150 parts by weight of bighead atractylodes rhizome 20 parts by weight of ginseng 20 parts by weight

100 parts of medlar, 30 parts of donkey-hide gelatin, 150 parts of fleece-flower root

80 parts of cassia seed, 200 parts of aloe.

Grinding colla Corii Asini into fine powder (80 mesh); reflux-extracting Ginseng radix, polygoni Multiflori radix, semen Cassiae, and Aloe with 65% ethanol for 2 times, each for 2 hr, filtering the extractive solution, recovering ethanol, and concentrating to obtain extract; adding 8 times of water into the medlar, the bighead atractylodes rhizome and the immature bitter orange, soaking for 1 hour, decocting for 2 hours, adding 5 times of water, decocting for 1 hour, combining the decoction, filtering, and concentrating under reduced pressure to obtain the following medicinal materials: water =3:1, adjusting alcohol to 40%, performing cold precipitation for 48 hours, filtering, and concentrating into an extract for later use; mixing the ethanol extract and water extract, and adding colla Corii Asini fine powder to obtain the Chinese medicinal composition. Making into granule according to conventional granule preparation process.

Example 4:

80 parts of immature bitter orange, 80 parts of white atractylodes rhizome and 80 parts of ginseng

30 parts of medlar, 100 parts of donkey-hide gelatin, 60 parts of tuber fleeceflower root

180 parts of cassia seed and 100 parts of aloe.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); reflux-extracting Ginseng radix, polygoni Multiflori radix, semen Cassiae, and Aloe with 50% ethanol for 2 times, each for 1 hr, filtering the extractive solution, recovering ethanol, and concentrating to obtain extract; adding 6 times of water into the barbary wolfberry fruit, the largehead atractylodes rhizome and the immature bitter orange, soaking for 2 hours, decocting for 2 hours, adding 5 times of water, decocting for 1 hour, combining decoction liquids, filtering, and concentrating under reduced pressure until the medicinal materials: water =2:1, adjusting alcohol to 70%, performing cold precipitation for 48 hours, filtering, and concentrating into an extract for later use; mixing the ethanol extract and water extract, and adding colla Corii Asini fine powder to obtain the Chinese medicinal composition. Making into pill according to conventional pill preparation process.

Example 5:

immature bitter orange 90 parts by weight, largehead atractylodes rhizome 50 parts by weight, ginseng 40 parts by weight

60 parts of medlar, 50 parts of donkey-hide gelatin, 80 parts of fleece-flower root

100 parts by weight of cassia seed and 120 parts by weight of aloe.

Grinding colla Corii Asini into fine powder (80 mesh); reflux-extracting Ginseng radix, polygoni Multiflori radix, semen Cassiae, and Aloe with 65% ethanol for 2 times, each for 2 hr, filtering the extractive solution, recovering ethanol, and concentrating to obtain extract; adding 8 times of water into the medlar, the bighead atractylodes rhizome and the immature bitter orange, soaking for 2 hours, decocting for 2 hours, adding 6 times of water, decocting for 2 hours, combining decoction liquids, filtering, and concentrating under reduced pressure to obtain medicinal materials: water =2:1, adjusting alcohol to 65%, performing cold precipitation for 24 hours, filtering, and concentrating into an extract for later use; mixing the ethanol extract and water extract, and adding colla Corii Asini fine powder to obtain the Chinese medicinal composition. Adding appropriate amount of dextrin, magnesium stearate, and stevioside, mixing, granulating with dry granulating machine, encapsulating, and packaging to obtain capsule.

Example 6:

80 parts of immature bitter orange, 50 parts of largehead atractylodes rhizome and 20 parts of ginseng

80 parts of medlar, 40 parts of donkey-hide gelatin, 120 parts of fleece-flower root

100 parts of cassia seed, 160 parts of aloe.

Grinding colla Corii Asini into fine powder (sieving with 80 mesh sieve); extracting Ginseng radix, polygoni Multiflori radix, semen Cassiae, and Aloe with 70% ethanol under reflux for 3 times, each for 1 hr, filtering the extractive solution, recovering ethanol, and concentrating to obtain extract; adding 9 times of water into fructus lycii and bighead atractylodes rhizome and crushed immature bitter orange, soaking for 1 hour, decocting for 3 hours, adding 5 times of water, decocting for 3 hours, combining decoction, filtering, and concentrating under reduced pressure to obtain medicinal materials: water =3:1, adjusting alcohol to 50%, performing cold precipitation for 12 hours, filtering, and concentrating into an extract for later use; mixing the ethanol extract and water extract, and adding colla Corii Asini fine powder to obtain the Chinese medicinal composition. Adding appropriate amount of dextrin, magnesium stearate, and stevioside, mixing, granulating with dry granulating machine, encapsulating, and packaging to obtain capsule.

Example 7:

120 parts of immature bitter orange, 30 parts of white atractylodes rhizome and 50 parts of ginseng

50 parts of medlar, 80 parts of donkey-hide gelatin, 80 parts of tuber fleeceflower root

150 parts of cassia seed, 120 parts of aloe.

Grinding colla Corii Asini into fine powder (80 mesh); drying and crushing immature bitter orange for later use; extracting Ginseng radix, polygoni Multiflori radix, semen Cassiae, and Aloe with 75% ethanol under reflux for 3 times, each for 1 hr, filtering the extractive solution, recovering ethanol, and concentrating to obtain extract; adding 5 times of water into the crushed fructus lycii, the crushed rhizoma atractylodis macrocephalae and the crushed immature bitter orange, soaking for 2 hours, decocting for 2 hours, adding 5 times of water, decocting for 1 hour, combining the decoction, filtering, and concentrating under reduced pressure to obtain the medicinal materials: water =1:1, adjusting alcohol to 50%, cold precipitating for 12 hours, filtering, concentrating to obtain extract for later use; mixing the ethanol extract and water extract, and adding colla Corii Asini fine powder to obtain the Chinese medicinal composition. Preparing the chewable tablet according to the conventional chewable tablet preparation process.

Example 8:

120 parts of immature bitter orange, 50 parts of white atractylodes rhizome and 50 parts of ginseng

75 parts of medlar, 75 parts of donkey-hide gelatin, 120 parts of fleece-flower root

140 parts of cassia seed, 160 parts of aloe.

Grinding colla Corii Asini into fine powder (80 mesh); drying and crushing immature bitter orange for later use; extracting Ginseng radix, polygoni Multiflori radix, semen Cassiae, and Aloe with 75% ethanol under reflux for 3 times, each for 1 hr, filtering the extractive solution, recovering ethanol, and concentrating to obtain extract; adding 5 times of water into the crushed fructus lycii, the crushed rhizoma atractylodis macrocephalae and the crushed immature bitter orange, soaking for 2 hours, decocting for 2 hours, adding 5 times of water, decocting for 1 hour, combining the decoction, filtering, and concentrating under reduced pressure to obtain the medicinal materials: water =1:1, adjusting alcohol to 50%, cold precipitating for 12 hours, filtering, concentrating to obtain extract for later use; mixing the ethanol extract and water extract, and adding colla Corii Asini fine powder to obtain the Chinese medicinal composition. Granulating with a dry granulating machine, encapsulating, and packaging to obtain capsule.

Verification of the examples:

1. animal test investigation of the composition of the present invention on diabetic gastroparesis rats

1.1 animal Material

SPF grade SD rats, 68 healthy males, body weight (200 + -20) g, lunan pharmaceutical group, inc., laboratory animal license number SYXK (lu) 20180008.

The formula of the common feed comprises: 50% of carbohydrate, 10% of fat and 20% of protein;

the high-energy feed formula comprises: 61% of carbohydrate, 14% of fat, 14% of protein, 10% of sucrose and 1% of cholesterol;

streptozotocin injection (STZ) was produced by Sigma, USA, rat motilin, rat gastrin enzyme linked immunoassay kit was offered by Jiang Lai organism.

The test capsules (hui qian tong capsules) were produced by the lunnan pacho pharmaceutical limited, and the specifications were: 0.35 g/granule, batch number: 019032017.

the products of example 1 and example 2.

1.2 animal modeling and methods of administration

Animal molding: after the rats are adaptively fed for 1 week, dividing the rats into a normal group and a modeling group, and feeding the rats with a common feed in the normal group; feeding the model group rats with high-energy feed, continuously feeding for 4 weeks, injecting 0.1mol/L citric acid buffer solution into the abdominal cavity of the model group rats after 4 weeks to prepare STZ solution with the dosage of 20mg/kg, and measuring the fasting blood glucose of more than 16.7mmol/L by tail vein blood sampling after 72 hours. After the first molding, 50 rats have fasting blood glucose which does not reach the diabetes standard and do not die; the second 25mg/kg dose of the STZ solution is injected into the abdominal cavity, and after 72 hours, the fasting blood sugar is not up to the standard (obviously higher than the first fasting blood sugar) and does not die; 35mg/kg of intraperitoneal STZ solution is injected for the 3 rd time, after 72 hours, 48 rats with fasting blood glucose reach the standard, and 2 rats in the model group die; normal group was injected with an equal amount of sodium citrate buffer. All rats had water ad libitum during the experiment.

1.3 detection index

1.3.1 fasting blood sugar, residual quantity in stomach

After 4 weeks, the molding is finished, and the blood sugar in the stomach and the residue in the stomach of the rat are detected, which is shown in table 1.

TABLE 1 fasting blood sugar and gastric residual amount of each group

Note: ^# indicates P in comparison with the normal group<0.01。

As can be seen from Table 1, the model-making group of the present invention has significant difference (P < 0.01) compared with the normal group, which indicates that the model-making of diabetic gastroparesis of the present invention is successful and further experiments can be performed.

1.3.2 fasting blood glucose and gastric emptying Rate determination

Taking 40 successfully molded rats, dividing the rats into 4 groups of 10 rats, wherein the group A is subjected to intragastric administration to give the content of the test product capsule twice a day; group C gavage the contents of example 1 twice a day; group D was gavaged with the contents of example 2 twice a day; b, performing intragastric administration and adding distilled water with the same volume twice a day; the group A, B, C and D take high energy feed, and take 10 controls, and take normal feed, all with free water for 7 days, and observe the result. Fasting blood glucose and gastric emptying rate are measured in sequence.

Fasting blood glucose: and taking blood from tail vein to measure fasting blood glucose.

Measuring the gastric emptying rate: the experiment is carried out after 7 days, fasting is carried out for 24 hours before the experiment, water is forbidden for 2 hours, cervical vertebra is immediately removed after 2ml of phenol red solution with the concentration of 50mg/dl is perfused into the stomach for 20min before operation, the stomach is killed, the whole stomach is taken out and cut along the greater curvature of the stomach, the content of the stomach is washed, the volume is fixed to 20ml, 20ml of NaOH with the concentration of 0.5ml/L is added, the mixture is stirred uniformly and then stands for 1 hour, 5ml of supernatant is taken, 0.5ml of trichloroacetic acid is added, the mixture is centrifuged after protein removal, the supernatant is taken, the absorbance value (OD) under the wavelength of 560nm is measured by using a spectrophotometer, 2ml of phenol red solution is additionally prepared, 18ml of distilled water, 20ml of 0.5mol/L NaOH and 4ml of trichloroacetic acid are stirred uniformly, and the absorbance value is measured. The gastric emptying rate of the rat = (1-measured phenol red absorbance/standard phenol red absorbance) × 100%, as shown in table 3.

TABLE 2 comparison of fasting plasma glucose and gastric emptying Rate determination

Note: ^★ indicates that P <0.05 compared to the normal group; ^★★ it is indicated that compared to the normal group, ^★★ P＜0.01；

^# indicates P is compared with group B<0.05， ^## Denotes P compared with group B<0.01。

As shown in Table 2, the group A, group C and group D were not significantly different from the normal group (P > 0.05), but the overall index did not reach the range of the normal group. However, compared with the group A, the group C and the group D, the concentration of fasting blood sugar and the gastric emptying rate have extremely significant difference (P is less than 0.01), the group A, the group C and the group D have the best treatment effect, and the group A simultaneously shows that the medicine prepared by the technology of the invention has the effects of reducing blood sugar and relieving gastroparesis syndrome, which also laterally reflects that the medicine of the invention has significant treatment effect on patients with diabetic gastroparesis.

1.3.3 measurement of the content of Substance P (SP) and Motilin (MOT) in the antral tissue of the stomach

In the test of the gastric emptying rate, the cardia and the pylorus of the stomach are ligated by dissecting the whole stomach, dissecting along the greater curvature of the stomach, cleaning with physiological saline, quickly taking out 1.0cm X1.0cm tissues, and measuring the content of MOT and SP by adopting an enzyme-linked immunosorbent assay, wherein the test is strictly operated according to the instruction, and the test result is specifically 3.

TABLE 3 determination of the MOT and SP contents in each group

Group of	Number of	MOT	SP
				Normal group	10	0.55±0.05	0.63±0.06
Group A	10	0.51±0.06 ##	0.61±0.07 ##
				Group B	10	0.38±0.04 ★★	0.45±0.05 ★★
Group C	10	0.45±1.5 #	0.53±2.58 #
				Group D	10	0.48±2.0 #	0.54±3.41 #

Note: ^★ indicates that P <0.05 compared to the normal group; ^★★ it is indicated that compared to the normal group, ^★★ P＜0.01；

^# indicates P is compared with group B<0.05， ^## Denotes P compared with group B<0.01。

It can be seen from table 3 that the group a is not significantly different from the normal group (P > 0.05), but the overall index does not reach the range of the positive group. However, the fasting blood glucose and the gastric emptying rate of the groups A, C and D are significantly different (P < 0.05) compared with the group B, and particularly, the fasting blood glucose and the gastric emptying rate of the groups A and B are significantly different (P < 0.01). This also shows that the medicine of the present invention has the functions of lowering blood sugar and relieving gastroparesis syndrome.

1.3.4 determination of Small intestine Propulsion Rate

The determination of the small intestine propulsion rate is usually carried out simultaneously with the determination of the gastric emptying, the small intestine is taken out simultaneously with the determination of the gastric emptying and is flatly laid on white paper, the full length from the pylorus to the ileocecal part and the distance from the pylorus to phenol red are determined, and the small intestine propulsion rate = the migration distance of the phenol red in the small intestine/the full length X100 percent of the small intestine.

TABLE 4 Effect of compositions on intestinal propulsion in Constipation model rats

Group of	Small intestine full length (cm)	Carbon juice advancing Rate (%)
			Normal control group	49.31±3.17	65.11±2.55
Group A	48.07±5.15	63.39±3.10 ￥￥
			Group B	47.64±3.05	42.00±2.37 ★★
Group C	46.97±4.77	58.17±2.37 ￥￥
			Group D	49.02±4.09	57.69±4.34 ￥￥

Note: ^★ indicates that P <0.05 compared to the normal group; ^★★ indicates that P <0.01 compared to the normal group;

^￥ indicates that p <0.05, ^￥￥ represents p <0.01 compared to group B;

as can be seen from the results of table 4 above: the propulsion rate of carbon juice in the small intestine was significantly increased in group B compared to the normal group (P < 0.01). The difference has statistical significance (P < 0.05), and simultaneously shows that the rat model of the invention is successfully made. It can also be seen from the table that the carbon juice advancement rate of group a is higher than that of group C, D, which may occur because the different processes for preparing the A, C, D product result in different degrees of degradation or change of the effective and different substances in the product, but overall, there are significant differences compared to group B.

Claims (2)

1. The application of a composition consisting of ginseng, bighead atractylodes rhizome, donkey-hide gelatin, polygonum multiflorum, medlar, cassia seed, aloe and immature bitter orange in preparing a product for treating or improving diabetic gastroparesis syndrome is characterized in that the composition is prepared from the following traditional Chinese medicine components:

20-100 parts of ginseng, 20-100 parts of bighead atractylodes rhizome, 30-150 parts of donkey-hide gelatin

20-400 parts of tuber fleeceflower root, 40-100 parts of medlar and 30-180 parts of cassia seed

30-600 parts of aloe, 50-200 parts of immature bitter orange.

2. The use as claimed in claim 1, wherein the composition comprises the following Chinese medicinal components in parts by weight:

50 parts by weight of ginseng, 50 parts by weight of bighead atractylodes rhizome, and 75 parts by weight of donkey-hide gelatin

120 parts of polygonum multiflorum, 75 parts of barbary wolfberry fruit and 140 parts of cassia seed

Aloe 160 parts by weight and immature bitter orange 120 parts by weight.