CN111388587A - Traditional Chinese medicine composition for preparing medicine for treating functional dyspepsia - Google Patents
Traditional Chinese medicine composition for preparing medicine for treating functional dyspepsia Download PDFInfo
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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 traditional Chinese medicine composition can effectively treat functional dyspepsia and improve clinical symptoms of the functional dyspepsia, and clinical tests show that the effective rate of the traditional Chinese medicine composition for treating the functional dyspepsia is over 90 percent.
Description
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 functional dyspepsia, and belongs to the technical field of traditional Chinese medicines.
Background
Functional Dyspepsia (FD) is a group of clinical signs that cannot be explained by organic diseases and shows persistent or recurrent epigastric pain and epigastric discomfort symptoms such as postprandial fullness, abdominal distension, belching, early satiety, nausea, etc. FD is a functional gastrointestinal disease which is common clinically, and is often accompanied by other functional symptoms such as insomnia, anxiety, depression and dizziness, and is mostly accompanied by the background of mental factors. FD is classified into the following two according to the new diagnostic criteria of roman iii: epigastric Pain Syndrome (EPS) and Postprandial Discomfort Syndrome (PDS), which are mostly manifested by delayed onset, long duration, frequent or continuous onset, but mostly without obvious signs.
In recent years, research and treatment of Functional Dyspepsia (FD) have been attracting much attention in the digestive community because FD is highly susceptible and is likely to recur. According to incomplete statistics, the prevalence rate of functional dyspepsia is 5.3% -20.4%, and accounts for about 20% -40% of digestive tract diseases. There is also some variability in the prevalence of FD from region to region, with FD 21.9% in japan, 46% in korea, 24.4% in australia, and about 8% -23% throughout asia. In China, the incidence of FD also varies regionally, 18.2% in Guangdong and 23.29% in Tianjin. With the accelerated pace of life and the increased stress, the psychological stress of patients increases, the number of patients with functional dyspepsia is on the trend of rising year by year, FD has become one of the important diseases of contemporary people, which affects the quality of life and health of patients and causes psychological burden to patients, so that the effective treatment of Functional Dyspepsia (FD) has important clinical significance.
The cause and pathogenesis of functional dyspepsia in western medicine are not completely clear at present, and the general research suggests that the pathogenesis of functional dyspepsia is related to gastrointestinal motility dysfunction (including gastric tolerance damage, abnormal gastric emptying and the like), increased visceral sensitivity, gastrointestinal hormone disorder, gastrin change, motilin reduction, gastrin secretion reduction, substance P change, cholecystokinin change and other factors. In addition, it has been found that the symptoms of discomfort in patients with functional dyspepsia may be related to the mental state of the patient. The western medicine for treating functional dyspepsia mainly comprises gastrointestinal motility promoting drugs (such as metoclopramide, mosapride, domperidone and the like), acid-inhibiting drugs (such as omeprazole, famotidine and the like), gastric mucosa protective drugs (magnesium aluminum carbonate, sucralfate and the like) and the like. Although various medicines are used in western medicine for treating functional dyspepsia, the western medicine is usually only used for treating a certain symptom, and cannot comprehensively treat the functional dyspepsia, and the western medicine has relatively more side effects and contraindications, so that adverse reactions may be caused when patients take the western medicine for a long time.
In traditional Chinese medicine, the functional dyspepsia can be traced back to Huangdi's internal classic, which is called stuffiness and fullness. The functional dyspepsia is classified into fullness, epigastric upset, epigastric pain and the like in traditional Chinese medicine, and symptoms such as hiccup, vomiting, dysphagia, acid regurgitation and the like are also mentioned in the traditional Chinese medicine. For functional dyspepsia, the traditional Chinese medicine theory generally considers that the functional dysfunction of viscera caused by congenital deficiency of the organism and factors such as improper diet, emotional disorder, overstrain and the like is the main reason for the functional dyspepsia. The functional dyspepsia mainly occurs in the four viscera of stomach, spleen, liver and kidney, and mainly refers to the disorders of spleen and stomach elevation, impaired transportation and transformation function, stuffiness and obstruction of the middle energizer, weakness of the spleen and stomach, liver and spleen disorder and liver failure. The pathological basis of functional dyspepsia is liver qi stagnation, transverse invasion of stomach, further development of disease course, and impairment of qi activity of organism, which leads to various symptoms, and finally, functional dyspepsia is caused by stomach qi obstruction or stomach qi loss and descending. In the clinical treatment of functional dyspepsia in traditional Chinese medicine, the treatment is mainly based on the experience of doctors after syndrome differentiation, and decoction is mostly adopted, so that inconvenience is brought to patients in the medicine taking process; the Chinese patent medicine products on the market have fewer medicines for treating functional dyspepsia in a targeted way, and have less patient selectivity and inconvenient medication.
The Chinese invention patent CN100453105C discloses a Chinese medicinal composition with the functions of relaxing bowels, expelling toxin, losing weight and reducing fat, and the product 'Hui Tong jiao nang' prepared by the Chinese patent is approved to be on the market and can effectively treat functional constipation clinically.
Disclosure of Invention
The invention relates to a new application of a traditional Chinese medicine composition developed on the basis of the patent of CN100453105C Chinese invention in treating functional dyspepsia, the traditional Chinese medicine composition can effectively treat the functional dyspepsia, and the recurrence rate after treatment is low.
The traditional Chinese medicine composition is mainly prepared from immature bitter orange, bighead atractylodes rhizome, ginseng, wolfberry fruit, donkey-hide gelatin, polygonum multiflorum, cassia seed and aloe.
The traditional Chinese medicine composition comprises the following components in parts by weight:
50-200 parts of immature bitter orange, 20-100 parts of largehead atractylodes rhizome, 30-600 parts of aloe
30-150 donkey-hide gelatin of medlar, 30-150 fleece-flower root, 25-400
30-500 parts of cassia seed and 20-100 parts of ginseng;
preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:
80-150 parts of immature bitter orange, 20-80 parts of largehead atractylodes rhizome, 100 parts of aloe and 200 parts of aloe
30-100 donkey-hide gelatin of medlar, 30-100 fleece-flower root, 60-150
80-180 parts of cassia seed and 20-80 parts of ginseng;
further preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:
80-120 parts of immature bitter orange, 30-50 parts of largehead atractylodes rhizome, 120 parts of aloe and 160 parts of common aloe
50-80 donkey-hide gelatin of medlar, 40-80 fleece-flower root, 80-120
100 portions of cassia seed and 20 to 50 portions of 150 portions of ginseng;
more preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:
immature bitter orange 110 white atractylodes rhizome 60 aloe 130
Wolfberry fruit 70 donkey-hide gelatin 60 fleece-flower root 80
Cassia seed 100 ginseng 30.
The traditional Chinese medicine composition comprises the following components:
the immature bitter orange is a monarch drug in the formula, has the effects of entering spleen and stomach channels, relieving flatulence, dispersing glomus and removing food retention, is used for treating symptoms such as chest and abdomen fullness, chest impediment, glomus pain, food retention and the like, and is used for treating the main symptoms of upper abdominal pain and fullness.
The largehead atractylodes rhizome, rhizoma atractylodis macrocephalae, which is the essential drug for strengthening the spleen, has the effects of invigorating the spleen and tonifying qi, eliminating dampness and promoting diuresis; aloe enters liver, stomach and large intestine channels, can clear liver and purge fire, and both are ministerial drugs in the formula, and are used together with monarch drug, namely immature bitter orange to assist the spleen and qi to invigorate, promote digestion and break food stagnation, so that the aloe can be used for treating abdominal distension and fullness;
according to the traditional Chinese medicine, the stagnation of liver qi and the unsmooth qi of middle-jiao can cause food stagnation due to qi stagnation, and the qi stagnation leads to the ascending and descending of spleen and stomach disharmony, so that food stagnation is caused.
The medlar and the donkey-hide gelatin enter liver and kidney channels, nourish liver and kidney, enrich blood, nourish yin, moisten dryness, tonify liver and tonify spleen; polygoni Multiflori radix enters liver, heart and kidney meridians; cassia seed, semen Cassiae enters liver and large intestine meridians, and has the effect of clearing heat and purging fire, soothing liver and purging fire. The combination of the four herbs is an adjuvant drug in the recipe.
Ginseng radix enters spleen, lung, heart and kidney meridians. It is a guiding drug in the recipe to tonify primordial qi, tonify spleen and lung, promote fluid production and nourish blood, and to harmonize the effects of the drugs.
According to the theory of traditional Chinese medicine, the key factors of functional dyspepsia are the dysfunction of viscera, especially the dysfunction of spleen and stomach, the weakening of transportation and transformation functions, the stuffiness and stuffiness of the middle-jiao, the weakness of spleen and stomach, the liver and spleen disharmony, the liver failure and the like, so the treatment mainly aims at soothing the liver, regulating the flow of qi, strengthening the spleen and harmonizing the stomach.
In the traditional Chinese medicine formula, the compatibility of the medicinal materials is scientific, the spleen and the stomach are tonified, the liver and the spleen are soothed, and the traditional Chinese medicine has a remarkable curative effect on functional dyspepsia clinically.
In particular, the western medical demonstration of functional dyspepsia of the invention is mainly caused by gastrointestinal motility dysfunction, increased visceral sensitivity, gastrointestinal hormone disorder, gastrin change, motilin reduction, stomach somatotropin secretion reduction, substance P change, cholecystokinin change, helicobacter pylori infection and the like.
Furthermore, the gastrointestinal motility dysfunction is mainly the gastric tolerance damage and the abnormal gastric emptying.
Secondly, the traditional Chinese medicine demonstration of functional dyspepsia is mainly caused by abnormal spleen and stomach, weakness of spleen and stomach, abnormal liver and spleen and liver failure.
The second purpose of the invention is to provide a pharmaceutical preparation of the traditional Chinese medicine composition.
The traditional Chinese medicine composition is prepared into clinically acceptable formulations, such as oral pharmaceutical preparations, directly by the conventional process or by adding pharmaceutically acceptable excipients.
Preferably, the oral pharmaceutical preparation is a clinically conventional oral dosage form such as pills, granules, capsules, tablets, oral liquid or syrup.
Further preferably, the oral pharmaceutical preparation is a capsule.
Meanwhile, the invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following preparation steps:
(1) grinding colla Corii Asini into fine powder, sieving with 80 mesh sieve or melting into colla Corii Asini solution;
(2) mixing Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe, extracting with ethanol under reflux for 1-3 times (1-3 hr for each time) with 40-80% (volume fraction) ethanol, filtering the extractive solution, mixing filtrates, recovering ethanol, and concentrating to obtain extract;
(3) mixing fructus Lycii, Atractylodis rhizoma and fructus Aurantii Immaturus according to prescription amount, adding 5-10 times (by mass) of water, soaking for 0.5-3 hr, decocting for 1-3 hr, and separating decoction; adding 5-10 times (by mass) of water into the residue, decocting for 1-3 hr, and separating the decoction; mixing decoctions, and filtering to obtain filtrate;
(4) and (4) concentrating the filtrate obtained in the step (3) under reduced pressure to obtain medicinal materials: 1-3 of water: 1, adjusting the alcohol to 40-85% (volume fraction), performing cold precipitation for 12-48 hours, filtering, and concentrating the filtrate into an extract for later use;
(5) and (3) mixing or drying the extract obtained in the step (2) and the extract obtained in the step (4), adding the donkey-hide gelatin fine powder or the melted donkey-hide gelatin solution prepared in the step (1), and uniformly mixing to obtain the traditional Chinese medicine composition.
Compared with the prior art, the invention has the following remarkable technical effects:
animal experiments show that the traditional Chinese medicine composition can remarkably accelerate the gastric emptying and small intestine propulsion speed of rats, promote the release and secretion of MT L and GAS of the rats, reduce the content of inhibitory hormones such as VIP, SS, CCK and the like, and further improve the gastrointestinal motility function.
Clinical tests show that the traditional Chinese medicine composition can effectively treat or improve clinical symptoms of patients with functional dyspepsia, and the treatment effective rate is more than 95%. The traditional Chinese medicine composition has high treatment effective rate and low recurrence rate, and has wide market prospect.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
In order to verify the efficacy of the Chinese medicinal composition in treating functional dyspepsia, the inventors conducted the following experimental studies.
The traditional Chinese medicine composition has a treatment effect on rats with functional dyspepsia (gastrointestinal motility dysfunction).
1 Material
1.1 animals:
male SD-grade rats, weight 180-220 g, laboratory animal license number: SCXK (Shandong) 20140007, provided by Jinanpunyue laboratory animal Breeding Co., Ltd, was acclimatized prior to the experiment for one week.
1.2 drugs, reagents
1.2.1 medicaments
The Chinese medicinal composition obtained in embodiment 5 of the invention
Comparative example 1 the obtained Chinese medicinal composition
Positive drug domperidone tablet (10 mg/tablet)
1.2.3 dosage for rats
According to the requirements of animal experiments, the dosage of the rat drug is calculated by conversion factor calculation method according to the conversion of the dosage of the human drug and the rat drug.
The invention comprises the following steps: 5.38g crude drug/kg (large dose), 1.79g crude drug/kg (medium dose), 0.60g crude drug/kg (small dose);
comparative example: 5.38g crude drug/kg;
positive drugs: 2.68 mg/kg.
1.2.3 pharmaceutical formulation
Administered by drenching at a dose of 10 ml/kg.
The invention comprises the following steps: taking the traditional Chinese medicine composition of the embodiment 5 of the invention, and adding physiological saline to prepare a suspension of 0.538g/ml (large dose), 0.179g/ml (medium dose) and 0.060g/ml (small dose);
comparative example: taking the traditional Chinese medicine composition in the comparative example 1, and adding physiological saline to prepare 0.538g/ml suspension;
positive drugs: domperidone tablets were ground and adjusted to a concentration of 0.268mg/ml with physiological saline.
1.2.4 reagents rat motilin (MT L), Gastrin (GAS), Vasoactive Intestinal Peptide (VIP) kit.
2. Test method
2.2.1 model making, namely making a blank group of rats to eat and drink water normally, making a model group of rats to eat irregularly (fasting on a single day and normal diet on two days), and filling acid water (the acid water with the concentration of 0.01 mol/L) for 2 weeks.
2.2.2 taking 60 rats successfully molded in groups, randomly dividing the rats into 6 groups, and 10 rats in each group, wherein the rats are respectively a model group, a positive drug control group (namely a domperidone group), a comparative example group and three dosage groups of the invention; another blank group of 10 rats was used as a blank control group.
2.2.3 after the drug administration and modeling, each group of rats received normal diet and drinking water.
The medicine is administrated by pouring according to 10ml/kg, corresponding medicine liquid is respectively poured into a positive medicine control group, a comparative example group and the three dosage groups of the invention, and equal amount of distilled water is administrated into a blank control group and a model group.
The administration is performed 1 time daily for a fixed period of 2 weeks.
After the last drug filling, fasting is not forbidden on the day, after 24 hours, 3ml of blood is taken from the eye sockets of the rats, 5% of Chinese ink is filled into each group of rats after the blood taking is finished, 3ml of Chinese ink is used for each group of rats, and the rats are killed by removing necks after 30 minutes.
3. Observation of drug efficacy
3.1 changes in rat signs
3.1.1 the rats after successful model building have listlessness, lusterless hair, less luster and other appearance signs, and have slow feeding speed; after treatment, compared with the model group, the rats in each treatment group have greatly improved mental status, more active actions and obviously accelerated eating speed.
3.1.2 rat body weight changes
The body weights were weighed before, after, for one week and two weeks of treatment, respectively, and the body weight changes were observed, as shown in table 1.
TABLE 1 rat body weight changes
Note: in comparison with the blank control group,△p is less than 0.05; and the model group is connected with the model group,*P＜0.05。
as shown in Table 1, there was no significant difference in rat body weight (P > 0.05) before the start of the test, which was in accordance with the test requirements. After the model is made, the weight of the rats in the model group and each treatment group is slowly increased compared with the blank control group, and the weight of the rats is obviously different from that in the blank control group (1)△P is less than 0.05). After one week of treatment and two weeks of treatment, the rats in each treatment group had significant weight gain and significant difference from the rats in the model group (1)*P is less than 0.05). The traditional Chinese medicine composition can obviously improve the physiological activity of rats with functional dyspepsia.
3.2 rat gastric emptying to Small intestine Propulsion ratio
After the death, the abdomen of the rat is cut, the cardia and the pylorus of the stomach are ligated, the stomach is taken out, the full weight of the stomach is weighed, the stomach is cut along the greater curvature of the stomach, the content is washed away, the net weight of the stomach is obtained by weighing, and the content residual rate of the stomach is calculated.
When the stomach of a rat is taken, the small intestine is quickly taken and laid on a glass plate, the total length of the small intestine (the pylorus of the stomach is taken as a starting point and the ileocecal part is taken as an end point) is respectively measured, the distance from the pylorus of the stomach to the front edge of the ink is taken as the ink advancing distance, and the small intestine advancing rate is calculated.
TABLE 2 rat gastric emptying and Small intestine Propulsion ratio
Note: in comparison with the blank control group,△p is less than 0.05; and the model group is connected with the model group,*P＜0.05。
as shown in Table 2, compared with the blank control group, the gastric residual rate of the rats in the model group is obviously increased, the small intestine propulsion rate is obviously reduced, and the differences (A) and (B) are significant△P is less than 0.05); compared with the model group, the gastric residual rate of rats in other treatment groups is obviously reduced, the small intestine propulsion rate is obviously increased, and the significant difference is shown in (A)*P is less than 0.05). The traditional Chinese medicine composition can obviously improve the gastric emptying rate and the small intestine propulsion rate of rats with functional dyspepsia.
3.3 rat serum MT L and NO
3.3.1 serum samples
3ml of blood is collected from the orbit of a rat, blood clots are picked out after water bath, centrifugation is carried out, and the centrifuged supernatant is taken for detection.
3.3.2 antral tissue samples
Weighing the stomach net weight in the 3.2, cutting the tissue of the antrum of the stomach about 1cm, washing with normal saline, weighing, boiling in normal saline, adding 0.1 mol/L hydrochloric acid to prepare homogenate, standing, neutralizing with 0.1 mol/L NaOH, centrifuging, and detecting the supernatant after centrifuging.
TABLE 3 comparison of MT L, GAS and VIP levels in rat serum
Note: in comparison with the blank control group,△p is less than 0.05; and the model group is connected with the model group,*P＜0.05。
as can be seen from Table 3, compared with the blank control group, the serum contents of MT L and GAS in the model group are obviously reduced, the VIP content is obviously increased, and the significant difference is shown (A)△P is less than 0.05), after the treatment, the content of MT L and GAS in the serum of rats in each treatment group is obviously increased and the VIP level is obviously reduced compared with that in the model group, (the difference is significant: (the content of the MT L and the content of the GAS in the serum of rats in each treatment group are obviously reduced and the VIP level is obviously different) ((the content*P is less than 0.05), which shows that the traditional Chinese medicine composition can obviously improve the content of MT L and GAS in the serum of rats with functional dyspepsia and reduce the content of VIP in the serum.
TABLE 4 comparison of MT L, GAS and VIP levels in rat stomach tissue
Note: in comparison with the blank control group,△p is less than 0.05; and the model group is connected with the model group,*P＜0.05。
as can be seen from Table 4, compared with the blank control group, the contents of MT L and GAS in the antrum tissue of the model group are obviously reduced, the VIP content is increased, and the significant differences are (△P is less than 0.05), after the treatment, the content of MT L and GAS in the gastric antrum tissue of rats in each treatment group is obviously increased and the VIP level is reduced compared with that in the model group, and the rats have obvious difference (the content of MT L and GAS in the gastric antrum tissue is obviously increased and the VIP level is reduced*P is less than 0.05), which shows that the traditional Chinese medicine composition can obviously improve the content of MT L and GAS in the gastric antrum tissue of a functional dyspepsia rat and reduce the content of VIP in serum.
To sum up, for rats with functional dyspepsia caused by gastrointestinal motility dysfunction, the traditional Chinese medicine composition can obviously improve the physiological activities of the rats and accelerate the gastric emptying and small intestine propulsion rate of the rats, the traditional Chinese medicine composition can obviously improve the content of MT L and GAS in the serum and the antrum tissue of a model rat, the content of MT L and GAS in the serum and the antrum tissue of the model rat can improve the contraction capability of gastrointestinal muscles, promote gastrointestinal motility and improve gastrointestinal motility, VIP is a gastrointestinal peptide hormone inhibiting the gastrointestinal motility, and the traditional Chinese medicine composition can obviously reduce the content of VIP in the serum and the antrum tissue of the model rat and promote the gastrointestinal motility.
Secondly, the traditional Chinese medicine composition has the treatment effect on rats with functional dyspepsia (liver depression and spleen deficiency type)
1 Material
1.1 animals:
male SD-grade rats, weight 180-220 g, laboratory animal license number: SYXK (Shandong) 20170006, provided by food and drug inspection and testing center of Jining, was acclimatized for one week prior to the experiment.
1.2 drugs, reagents
1.2.1 medicaments
The Chinese medicinal composition obtained in embodiment 5 of the invention
Comparative example 1 the obtained Chinese medicinal composition
Positive drug domperidone tablet (10 mg/tablet)
1.2.3 dosage for rats
According to the requirements of animal experiments, the dosage of the rat drug is calculated by conversion factor calculation method according to the conversion of the dosage of the human drug and the rat drug.
The invention comprises the following steps: 5.38g crude drug/kg (large dose), 1.79g crude drug/kg (medium dose), 0.60g crude drug/kg (small dose);
comparative example: 5.38g crude drug/kg;
positive drugs: 2.68 mg/kg.
1.2.3 pharmaceutical formulation
Administered by drenching at a dose of 10 ml/kg.
The invention comprises the following steps: taking the traditional Chinese medicine composition of the embodiment 5 of the invention, and adding physiological saline to prepare a suspension of 0.538g/ml (large dose), 0.179g/ml (medium dose) and 0.060g/ml (small dose);
comparative example: taking the traditional Chinese medicine composition in the comparative example 1, and adding physiological saline to prepare 0.538 g/ml;
positive drugs: domperidone tablets were ground and adjusted to a concentration of 0.268mg/ml with physiological saline.
1.2.4 reagents: rat Serum Somatostatin (SS), cholecystokinin CCK, Vasoactive Intestinal Peptide (VIP) and Gastrin (GAS) kits.
2. Test method
2.2.1 molding: normally feeding a blank group of rats; the model group rats adopt an irregular feeding (namely, single-day feeding and double-fasting) and a tail clamping fighting method to construct a liver depression and spleen deficiency type functional dyspepsia rat model. The rats in each group had normal drinking water for 2 weeks.
The tail clamping fighting method is specifically operated as follows: the rat tail distal end 1/3 was clamped with long forceps covered with a sponge, which was of moderate strength, and the clamped skin was not damaged, making the rat angry, actively assaulting other rats, and the rats were able to break each other. The composition is administered twice a day, 30min each time, and continuously stimulated to make animals feel irritated and irritated, and fight easily (such as rat with scratch, and iodophor wiping treatment to prevent infection). When the model building is finished, randomly dissecting 2 rats, and observing whether the stomach and the duodenum have organic lesions, thereby verifying the success of the model building.
2.2.2 taking 60 rats successfully molded in groups, randomly dividing the rats into 6 groups, and 10 rats in each group, wherein the groups are respectively a model group, a positive drug control group (namely a domperidone group), a comparative example group and three dosage groups of the invention; another blank group of 10 rats was used as a blank control group.
2.2.3 after the drug administration and modeling, each group of rats received normal diet and drinking water.
The medicine is administrated by pouring according to 10ml/kg, the positive medicine control group and the three dosage groups are respectively filled with corresponding medicine liquid, and the blank control group and the model group are respectively administrated with equal amount of distilled water.
The administration is carried out 1 time daily for 7 days.
3. Observation of drug efficacy
3.1 changes in physiological Activity in rats
Compared with the blank group, the model group rats are obviously lazy to move, have lusterless complexion and are easy to irritate and irritate; after treatment, the condition of rats in each treatment group is obviously improved, and the rats are more active than the rats in the model group and have higher feeding speed.
3.2 rat gastric emptying Rate
After the last drenching, the rats are fasted without water prohibition, after 24 hours, all the rats are fed in a single cage, a certain amount of feed is weighed for feeding, after 3 hours, the feed is weighed again, and the difference of the two weights is the feed intake of the rats; the latter rats are anesthetized, the stomach tissue is picked up, the stomach is weighed after being wiped dry, the stomach body is cut along the greater curvature of the stomach, the content is washed off, the stomach is weighed after being wiped dry, and the food residue in the stomach is obtained by subtracting the stomach net weight from the stomach full weight.
TABLE 5 comparison of food intake and gastric emptying rates in rats
Note: in comparison with the blank control group,△p is less than 0.05; and the model group is connected with the model group,*P＜0.05。
as can be seen from Table 5, the Chinese medicinal composition has a good effect of accelerating gastric emptying in rats with functional dyspepsia caused by liver depression and spleen deficiency, and the gastric emptying rate of the treated rats is obviously higher than that of a model group, and has significant difference (A)*P＜0.05)。
3.3 rat gastrointestinal hormone changes
Before the stomach tissue of the rat is picked up, 4-5ml of blood is collected from the abdominal aorta, the blood is centrifuged, and the supernatant is taken for detection.
TABLE 6 comparison of serum SS, CCK, VIP and GAS content in rats
Note: in comparison with the blank control group,△p is less than 0.05; and the model group is connected with the model group,*P＜0.05。
as can be seen from Table 6, compared with the rats in the blank control group, the serum contents of SS, CCK and VIP of the rats in the model group are obviously increased, the GAS content is obviously reduced, and the significant difference is shown (the content of the SS, the CCK and the VIP in the serum of the rats in the model group is obviously increased and the GAS content is obviously reduced) (△P is less than 0.05); after treatment, the contents of SS, CCK and VIP in the serum of rats in each treatment group are obviously reduced, the content of GAS is obviously increased when the content of SS, CCK and VIP is lower than that in the model group, the content of GAS is obviously increased when the content of GAS is higher than that in the model group, and the significant difference is shown (the content of SS, CCK and VIP in the*P＜0.05)。
SS and VIP are inhibitory hormones, and can inhibit gastrointestinal motility, delay gastric emptying and slow down small intestine motility in a digestive system; CCK stimulates gallbladder contraction, inhibits food intake, and causes early satiety, discomfort and the like. The traditional Chinese medicine composition can obviously reduce the contents of SS, CCK and VIP and reduce the factors inhibiting gastrointestinal motility, thereby promoting the gastrointestinal motility and achieving the purpose of treatment.
The experimental results show that the traditional Chinese medicine composition can effectively treat functional dyspepsia of rats, and the effect is superior to that of a comparative traditional Chinese medicine composition, which shows that the beneficial effect of the traditional Chinese medicine composition is the result of the overall action of each medicinal material, and the traditional Chinese medicine composition can not be obtained by simply combining, replacing, adding or subtracting medicinal materials with the same or similar effects.
Clinically, functional dyspepsia is related to gastrointestinal motility dysfunction (including gastric tolerance damage, abnormal gastric emptying and the like), increased visceral sensitivity, gastrointestinal hormone disorder, gastrin change, motilin reduction, stomach somatotropin secretion reduction, P substance change, cholecystokinin change, helicobacter pylori infection and other factors; the pathogenesis of functional dyspepsia based on traditional Chinese medicine dialectical theory is mainly that the spleen and stomach are in disorder of ascending and descending, the transportation and transformation function is weakened, the middle-jiao glomus and obstruction is obstructed, the spleen and stomach are weak, the liver and spleen are not regulated, and the liver is disordered.
The experimental examples only list the treatment effect of the traditional Chinese medicine composition on a rat model with partial functional dyspepsia, and the inventor also has research on functional dyspepsia caused by other types, and the experimental results show that the effective rate of the traditional Chinese medicine composition on functional dyspepsia caused by other reasons is more than 90%, the effect is related to the medicine dosage and is better than that of a positive medicine control group (namely a domperidone group), and the traditional Chinese medicine composition can effectively treat the functional dyspepsia.
Secondly, the preparation of the invention treats typical cases of functional dyspepsia
1. Basic data
Through diagnosis, 10 patients with functional dyspepsia are diagnosed.
2. Diagnostic criteria
(1) Has one or more symptoms of gastrointestinal tract such as gastral cavity fullness, gastral cavity pain, gastric upset, belch, nausea, emesis and anorexia, and has a chronic history of persistent or recurrent attack;
(2) the above symptoms are still not relieved by defecation;
(3) organic diseases such as liver, gallbladder, spleen, kidney, esophagus, stomach and duodenum are discharged through examination of gastroscope, X-ray, B-ultrasonic and the like;
(4) can be used for treating diabetes, nephropathy, and connective tissue.
3. Method of treatment
The capsule obtained in example 5 of the present invention.
4. Clinical and therapeutic criteria
4.1 clinical Standard
Comprises 10 symptoms of abdominal fullness, epigastric pain, epigastric upset, belching, nausea, vomiting, inappetence, anorexia, loose stool or constipation, and sleep disturbance with grade change. The severity is scored as 0-3: score 0-no symptoms; 1 point-mild, slightly noticed with symptoms; 2 points to moderate, there is symptom voluntarily, do not influence the work; 3 points-severe, which obviously affects life and work. The accumulation of the symptom scores is the symptom score of the patient.
4.2 therapeutic criteria
The effect is shown: the symptoms are obviously improved, and the sum of the traditional Chinese medicine symptom integrals is reduced by more than or equal to 60 percent compared with that before the medicine is taken;
the method has the following advantages: the symptoms are improved, and the sum of the Chinese medicine symptom integrals is reduced by 30 to 60 percent compared with that before the medicine is taken;
and (4) invalidation: the symptoms are not obviously improved compared with the symptoms before treatment, and the sum of the traditional Chinese medicine symptom integrals is reduced by less than 30 percent compared with the sum before administration;
5. test results
5.1 Scoring of clinical symptoms before and after treatment and efficacy
After the patients with functional dyspepsia begin to be treated, the clinical symptoms are improved, and compared with the patients before treatment, the difference is obvious,*p is less than 0.05, and the effect is obvious after 7 days of treatment and is obvious compared with the effect before treatment,#p is less than 0.01, which shows that the traditional Chinese medicine composition product can obviously improve the clinical symptoms of patients with functional dyspepsia, and the clinical symptoms are shown in Table 7.
Table 7 comparison of clinical symptom scores before and after treatment (score,
)
| time of day | Clinical symptom scoring |
| Before treatment | 25.98±1.76 |
| The treatment lasts for 3 days | 20.35±2.56* |
| The treatment lasts for 7 days | 13.35±1.02# |
Note: compared with the treatment before the treatment,*P＜0.05.，#P＜0.01
5.2 clinical treatment effective rate and recurrence rate
TABLE 8 comparison of the therapeutic efficacy of the clinical treatments (example/%)
TABLE 9 drug withdrawal 2 months relapse Rate (%)
As can be seen from tables 8 and 9, the clinical effective rate of the preparation product of the traditional Chinese medicine composition for treating functional dyspepsia is up to 90%, and the patients do not relapse within 2 months after healing. The traditional Chinese medicine composition preparation product can effectively treat functional dyspepsia and has no relapse after healing.
Third, 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
The prescription is as follows:
immature bitter orange 200 parts by weight, bighead atractylodes rhizome 20 parts by weight, aloe 30 parts by weight
30 parts of medlar, 150 parts of donkey-hide gelatin, 25 parts of fleece-flower root
500 parts by weight of cassia seed and 100 parts by weight of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
(1) grinding colla Corii Asini into fine powder, and sieving with 80 mesh sieve;
(2) mixing Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe, extracting with ethanol under reflux for 1-3 times (1-3 hr for each time) with 40-80% (volume fraction) ethanol, filtering the extractive solution, mixing filtrates, recovering ethanol, and concentrating to obtain extract;
(3) mixing fructus Lycii, Atractylodis rhizoma and fructus Aurantii Immaturus, adding 5-10 times (by mass) of water, soaking for 0.5-3 hr, decocting for 1-3 hr, and separating the decoction; adding 5-10 times (by mass) of water into the residue, decocting for 1-3 hr, and separating the decoction; mixing decoctions, and filtering to obtain filtrate;
(4) and (4) concentrating the filtrate obtained in the step (3) under reduced pressure to obtain medicinal materials: 1-3 of water: 1, adjusting the alcohol to 40-85% (volume fraction), performing cold precipitation for 12-48 hours, filtering, and concentrating the filtrate into an extract for later use;
(5) and (3) drying the extract obtained in the step (2) and the extract obtained in the step (4), adding the donkey-hide gelatin fine powder prepared in the step (1), and uniformly mixing to obtain the traditional Chinese medicine composition.
The traditional Chinese medicine composition is prepared into pills by a conventional pill preparation process.
Example 2
The prescription is as follows:
50 parts of immature bitter orange, 100 parts of white atractylodes rhizome and 600 parts of aloe
150 parts of medlar, 30 parts of donkey-hide gelatin, 400 parts of fleece-flower root
30 parts of cassia seed and 20 parts of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
(1) melting the donkey-hide gelatin into a donkey-hide gelatin solution for later use;
(2) mixing Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe, extracting with ethanol under reflux for 1-3 times (1-3 hr for each time) with 40-80% (volume fraction) ethanol, filtering the extractive solution, mixing filtrates, recovering ethanol, and concentrating to obtain extract;
(3) mixing fructus Lycii, Atractylodis rhizoma and fructus Aurantii Immaturus, adding 5-10 times (by mass) of water, soaking for 0.5-3 hr, decocting for 1-3 hr, and separating the decoction; adding 5-10 times (by mass) of water into the residue, decocting for 1-3 hr, and separating the decoction; mixing decoctions, and filtering to obtain filtrate;
(4) and (4) concentrating the filtrate obtained in the step (3) under reduced pressure to obtain medicinal materials: 1-3 of water: 1, adjusting the alcohol to 40-85% (volume fraction), performing cold precipitation for 12-48 hours, filtering, and concentrating the filtrate into an extract for later use;
(5) and (3) mixing the extract obtained in the step (2) and the extract obtained in the step (4), adding the melted donkey-hide gelatin solution obtained in the step (1), and uniformly mixing to obtain the traditional Chinese medicine composition.
The traditional Chinese medicine composition is prepared into syrup according to the conventional syrup preparation process.
Example 3
The prescription is as follows:
immature bitter orange 150 parts by weight of bighead atractylodes rhizome 20 parts by weight of aloe 200 parts by weight of
100 parts of medlar, 30 parts of donkey-hide gelatin, 150 parts of fleece-flower root
80 parts of cassia seed and 20 parts of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps: the same as in example 1.
The obtained Chinese medicinal composition is prepared into granules according to the conventional granule preparation process.
Example 4
The prescription is as follows:
80 parts by weight of immature bitter orange, 80 parts by weight of largehead atractylodes rhizome and 100 parts by weight of aloe
30 parts of medlar, 100 parts of donkey-hide gelatin, 60 parts of tuber fleeceflower root
180 parts of cassia seed and 80 parts of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps: the same as in example 2.
The obtained Chinese medicinal composition is prepared into oral liquid according to conventional oral liquid preparation process.
Example 5
The prescription is as follows:
immature bitter orange 110 parts by weight of bighead atractylodes rhizome 50 parts by weight of aloe 130 parts by weight
70 parts of medlar, 60 parts of donkey-hide gelatin, 80 parts of fleece-flower root
100 parts by weight of cassia seed, 30 parts by weight of ginseng
The preparation method of the traditional Chinese medicine composition comprises the following steps: same as example 2
The obtained Chinese medicinal composition is prepared into capsules according to the conventional capsule preparation process.
Example 6
The prescription is as follows:
80 parts of immature bitter orange, 50 parts of largehead atractylodes rhizome and 160 parts of aloe
80 parts of medlar, 40 parts of donkey-hide gelatin, 120 parts of fleece-flower root
100 parts of cassia seed and 20 parts of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps: the same as in example 1.
The obtained Chinese medicinal composition is prepared into capsules according to the conventional capsule preparation process.
Example 7
The prescription is as follows:
120 parts of immature bitter orange, 30 parts of white atractylodes rhizome and 120 parts of aloe
50 parts of medlar, 80 parts of donkey-hide gelatin, 80 parts of tuber fleeceflower root
150 parts by weight of cassia seed, 50 parts by weight of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps: same as example 1
The obtained Chinese medicinal composition is prepared into tablets according to the conventional tablet preparation process.
Comparative example 1
The prescription is as follows:
120 parts of immature bitter orange, 30 parts of white atractylodes rhizome and 120 parts of rhubarb
50 parts of medlar, 80 parts of donkey-hide gelatin, 80 parts of tuber fleeceflower root
150 parts of bunge cherry seed, 50 parts of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
(1) melting the donkey-hide gelatin into a donkey-hide gelatin solution for later use;
(2) mixing Ginseng radix, Polygoni Multiflori radix and radix et rhizoma Rhei, extracting with ethanol under reflux for 1-3 times (1-3 hr each time) with 40-80% (volume fraction) ethanol, filtering extractive solution, mixing filtrates, recovering ethanol, and concentrating to obtain extract;
(3) mixing semen Pruni, fructus Lycii, Atractylodis rhizoma, and fructus Aurantii Immaturus, adding 5-10 times (by weight) of water, soaking for 0.5-3 hr, decocting for 1-3 hr, and separating the decoction; adding 5-10 times (by mass) of water into the residue, decocting for 1-3 hr, and separating the decoction; mixing decoctions, and filtering to obtain filtrate;
(4) and (4) concentrating the filtrate obtained in the step (3) under reduced pressure to obtain medicinal materials: 1-3 of water: 1, adjusting the alcohol to 40-85% (volume fraction), performing cold precipitation for 12-48 hours, filtering, and concentrating the filtrate into an extract for later use;
(5) and (3) mixing the extract obtained in the step (2) and the extract obtained in the step (4), adding the melted donkey-hide gelatin solution obtained in the step (1), and uniformly mixing to obtain the traditional Chinese medicine composition.
The traditional Chinese medicine composition is prepared into capsules according to a conventional capsule preparation process.
Comparative example 2
The prescription is as follows:
120 parts of immature bitter orange, 30 parts of white atractylodes rhizome and 120 parts of rhubarb
50 parts of poria cocos, 80 parts of donkey-hide gelatin, 80 parts of polygonum multiflorum, and the like
150 parts of bunge cherry seed, 50 parts of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
melting the prescription amount of the donkey-hide gelatin into a donkey-hide gelatin solution for later use;
(2) mixing Ginseng radix, Polygoni Multiflori radix and radix et rhizoma Rhei, extracting with ethanol under reflux for 1-3 times (1-3 hr for each time) with 40-80% (volume fraction) ethanol, filtering the extractive solution, mixing filtrates, recovering ethanol, and concentrating to obtain extract;
(3) mixing semen Pruni, Poria, Atractylodis rhizoma and fructus Aurantii Immaturus, adding 5-10 times (by weight) of water, soaking for 0.5-3 hr, decocting for 1-3 hr, and separating the decoction; adding 5-10 times (by mass) of water into the residue, decocting for 1-3 hr, and separating the decoction; mixing decoctions, and filtering to obtain filtrate;
(4) and (4) concentrating the filtrate obtained in the step (3) under reduced pressure to obtain medicinal materials: 1-3 of water: 1, adjusting the alcohol to 40-85% (volume fraction), performing cold precipitation for 12-48 hours, filtering, and concentrating the filtrate into an extract for later use;
(5) and (3) mixing the extract obtained in the step (2) and the extract obtained in the step (4), adding the melted donkey-hide gelatin solution obtained in the step (1), and uniformly mixing to obtain the traditional Chinese medicine composition.
The traditional Chinese medicine composition is prepared into capsules according to a conventional capsule preparation process.
Claims (10)
1. A Chinese medicinal composition for treating functional dyspepsia is prepared from fructus Aurantii Immaturus, Atractylodis rhizoma, Aloe, fructus Lycii, colla Corii Asini, Polygoni Multiflori radix, semen Cassiae, and Ginseng radix.
2. The use of claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:
50-200 parts of immature bitter orange, 20-100 parts of largehead atractylodes rhizome, 30-600 parts of aloe
30-150 donkey-hide gelatin of medlar, 30-150 fleece-flower root, 25-400
30-500 parts of cassia seed and 20-100 parts of ginseng.
3. The use of claim 2, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:
80-150 parts of immature bitter orange, 20-80 parts of largehead atractylodes rhizome, 100 parts of aloe and 200 parts of aloe
30-100 donkey-hide gelatin of medlar, 30-100 fleece-flower root, 60-150
80-180 parts of cassia seed and 20-80 parts of ginseng.
4. The use of claim 3, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:
80-120 parts of immature bitter orange, 30-50 parts of largehead atractylodes rhizome, 120 parts of aloe and 160 parts of common aloe
50-80 donkey-hide gelatin of medlar, 40-80 fleece-flower root, 80-120
100 portions of cassia seed and 20 to 50 portions of 150 portions of ginseng.
5. The use of claim 4, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:
immature bitter orange 110 bighead atractylodes rhizome 50 aloe 130
Wolfberry fruit 70 donkey-hide gelatin 60 fleece-flower root 80
Cassia seed 100 ginseng 30.
6. The use of any one of claims 1 to 5, wherein the Chinese medicinal composition is prepared into a clinically acceptable dosage form by conventional procedures directly or with pharmaceutically acceptable excipients.
7. Use according to any of claims 6, wherein the clinically acceptable dosage form is an oral pharmaceutical formulation, preferably the oral formulation is a pill, granule, capsule, tablet, oral liquid or syrup; further preferably, the oral formulation is a capsule.
8. The use of claim 1, wherein the functional dyspepsia is caused by dysfunction of gastrointestinal motility, increased visceral sensitivity, gastrointestinal hormone disorders, gastrin modification, decreased motilin, decreased secretion of gastric somatotropin, modification of substance P, modification of cholecystokinin.
9. The use according to claim 8, wherein the dysfunction in gastrointestinal motility is impaired gastric containment and abnormal gastric emptying.
10. The use of claim 1, wherein the functional dyspepsia is caused by abnormal spleen and stomach, weakness of spleen and stomach, abnormal liver and spleen, and loss of liver function.
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