CN112843143A - Traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome and medicament and application thereof - Google Patents
Traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome and medicament and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome, which comprises the following raw materials: cortex Magnolia officinalis, flos Magnoliae officinalis, fructus Aurantii Immaturus, fructus Hippophae, thallus laminariae, fructus Cannabis, Atractylodis rhizoma, radix Angelicae sinensis, fructus Aurantii, Cistanchis herba, and Mori fructus. Adding pharmaceutically conventional adjuvants into the composition according to pharmaceutically conventional process, and making into pharmaceutically common dosage forms. The traditional Chinese medicine composition disclosed by the invention shows a definite curative effect on constipation-type irritable bowel syndrome in both animal experiments and clinical symptoms.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome, and a medicament and application thereof.
Background
Irritable bowel syndrome refers to persistent or recurrent chronic functional gastrointestinal diseases including abdominal discomfort such as abdominal pain and abdominal distension, and abnormal defecation habit and stool character but lack of gastrointestinal tract structural or biochemical abnormalities, and is one of the common diseases in gastroenterology, and clinical manifestations include abdominal pain, abdominal distension, diarrhea, change of defecation habit and abnormal stool character. Irritable bowel syndrome can be classified into diarrhea type, constipation type, mixed type and indeterminate type. With the continuous progress of social life, the continuous acceleration of the life rhythm of people, the increasing competitive pressure, the rapid change of life style and the like in recent years, the incidence rate of constipation-type irritable bowel syndrome tends to rise continuously, the course of the irritable bowel syndrome is long, the recurrence rate is high, patients show constipation, abdominal pain, abdominal distension and the like, are mostly accompanied by anxiety, depression and other general mental symptoms, and the physical and mental health of the patients is seriously affected. If the disease is not actively and timely treated, the disease can affect the progress of other diseases and can cause the generation of new diseases, for example, stool is continuously not released, the increase of the pressure in the abdominal cavity can cause acute myocardial infarction, acute cardiac arrest, cerebral hemorrhage and the like, and can cause or aggravate hemorrhoids, prostatic hypertrophy and the like, the long-term intestinal stagnation and the friction of intestinal mucosa can cause malignant change, and the life can be affected in severe cases. Because the irritable bowel syndrome has complex etiology and unknown pathogenesis, the current western medicine lacks effective medicines and definite treatment targets, and most of the western medicine uses cisapride, otilonium bromide, sertraline and the like for symptomatic treatment, although the symptoms can be relieved, the irritable bowel syndrome has the defects of high treatment cost, high medicine dependence and high recurrence rate.
There are a lot of reports on irritable bowel syndrome in traditional Chinese medicine, but the research on diarrhea-type irritable bowel syndrome is more, and the research on constipation-type irritable bowel syndrome is less. Therefore, there is a need to find an effective and inexpensive traditional Chinese medicine for treating constipation-predominant irritable bowel syndrome.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome, a medicament and an application thereof, wherein the traditional Chinese medicine composition comprises the following raw materials: cortex Magnolia officinalis, flos Magnoliae officinalis, fructus Aurantii Immaturus, fructus Hippophae, thallus laminariae, fructus Cannabis, Atractylodis rhizoma, radix Angelicae sinensis, fructus Aurantii, Cistanchis herba, and Mori fructus. Adding pharmaceutically conventional adjuvants into the composition according to pharmaceutically conventional process, and making into pharmaceutically common dosage forms.
The invention provides a traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome, which comprises the following raw materials in parts by weight: 9-15 parts of mangnolia officinalis, 9-15 parts of mangnolia officinalis flower, 6-12 parts of immature bitter orange, 15-21 parts of sea buckthorn, 25-35 parts of kelp, 9-15 parts of fructus cannabis, 30-50 parts of bighead atractylodes rhizome, 12-25 parts of Chinese angelica, 15-21 parts of fructus aurantii, 25-35 parts of cistanche and 25-35 parts of mulberry.
The invention also provides a traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome, which comprises the following raw materials in parts by weight: 11-13 parts of mangnolia officinalis, 11-13 parts of mangnolia officinalis flower, 8-10 parts of immature bitter orange, 17-19 parts of sea-buckthorn, 28-32 parts of kelp, 11-13 parts of fructus cannabis, 35-45 parts of bighead atractylodes rhizome, 16-20 parts of angelica sinensis, 16-20 parts of fructus aurantii, 28-32 parts of cistanche and 28-32 parts of mulberry.
The invention also provides a traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome, which comprises the following raw materials in parts by weight: 12 parts of mangnolia officinalis, 12 parts of mangnolia officinalis flower, 9 parts of immature bitter orange, 18 parts of sea-buckthorn, 30 parts of kelp, 12 parts of fructus cannabis, 40 parts of bighead atractylodes rhizome, 20 parts of angelica sinensis, 18 parts of fructus aurantii, 30 parts of cistanche and 30 parts of mulberry.
The magnolia officinalis in the traditional Chinese medicine composition has the effects of drying dampness and dissolving phlegm, descending qi and eliminating fullness, the magnolia officinalis flower has the effects of aromatizing and dissolving dampness, regulating qi and relieving epigastric distention, the immature bitter orange has the effects of breaking qi and removing food retention, and the phlegm and the abdominal mass are monarch drugs together. Sea-buckthorn, fructus hippophae, as a ministerial drug, has the effects of strengthening spleen and promoting digestion, relieving cough and eliminating phlegm, kelp, eliminating phlegm and resolving masses, inducing diuresis and reducing edema, and fructus cannabis, as a cathartic, can moisten intestines and relieve constipation. Bighead atractylodes rhizome, rhizoma Atractylodis Macrocephalae, invigorating qi and spleen, drying dampness and inducing diuresis, Chinese angelica, radix Angelicae sinensis, activating blood and relieving pain, moistening intestines and relaxing bowels, fructus Aurantii, regulating qi and relieving epigastric distention, activating stagnancy and relieving flatulence, are used as adjuvant drugs together. Cistanchis herba has effects of invigorating kidney, tonifying yang, loosening bowel to relieve constipation, and Mori fructus has effects of nourishing yin, replenishing blood, promoting fluid production, and loosening bowel.
The invention also provides a granule for treating constipation-predominant irritable bowel syndrome, which comprises the traditional Chinese medicine composition and preparation auxiliary materials; the preparation auxiliary materials are one or more of filling agent, adhesive, wetting agent, disintegrating agent, lubricant and film coating material. The granule can be directly swallowed or drunk by infusing with warm water, and has convenient application and carrying, and rapid dissolution and absorption.
The invention also provides an oral liquid for treating constipation-predominant irritable bowel syndrome, which comprises the traditional Chinese medicine composition and preparation auxiliary materials; the preparation adjuvants are one or more of solvent, aromatic, correctant, clarifier and antiseptic. The oral liquid has the advantages of small dosage, quick absorption, stable quality, convenient carrying and administration, and easy storage, and can improve taste, clarity, stability and product quality by adding adjuvants.
The invention also provides a tablet for treating constipation-predominant irritable bowel syndrome, which comprises the traditional Chinese medicine composition and preparation auxiliary materials; the preparation auxiliary materials are one or more of diluent, adhesive, lubricant and disintegrant. The tablet has the advantages of accurate dosage, stable quality, convenient administration, carrying and transportation, etc.
The invention also provides a capsule for treating constipation-predominant irritable bowel syndrome, which comprises the traditional Chinese medicine composition and preparation auxiliary materials; the preparation auxiliary material is a hard capsule shell or a soft capsule shell. The capsule mainly improves the stability and bioavailability of the medicine.
The invention also provides powder for treating constipation-predominant irritable bowel syndrome, which comprises the traditional Chinese medicine composition. The powder is convenient for administration.
The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating constipation-predominant irritable bowel syndrome.
In summary, compared with the prior art, the invention achieves the following technical effects:
1. the traditional Chinese medicine composition disclosed by the invention has a definite curative effect on constipation-type irritable bowel syndrome in both animal experiments and clinical symptoms, can effectively improve the visceral hypersensitivity of a rat with the irritable bowel syndrome model, and has no toxic or side effect.
2. The traditional Chinese medicine composition can be prepared into various dosage forms, and is more convenient to take, carry and store compared with the traditional Chinese medicine decoction.
3. The traditional Chinese medicine composition disclosed by the invention has no very rare and expensive medicinal materials, is low in preparation cost and is convenient for large-scale popularization.
Detailed Description
In order to make the technical solutions of the present invention better understood by those skilled in the art, the technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, shall fall within the scope of protection of the present invention.
The traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome comprises the following raw materials in parts by weight: 9-15 parts of mangnolia officinalis, 9-15 parts of mangnolia officinalis flower, 6-12 parts of immature bitter orange, 15-21 parts of sea buckthorn, 25-35 parts of kelp, 9-15 parts of fructus cannabis, 30-50 parts of bighead atractylodes rhizome, 12-25 parts of Chinese angelica, 15-21 parts of fructus aurantii, 25-35 parts of cistanche and 25-35 parts of mulberry.
The traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome comprises the following raw materials in parts by weight: 11-13 parts of mangnolia officinalis, 11-13 parts of mangnolia officinalis flower, 8-10 parts of immature bitter orange, 17-19 parts of sea-buckthorn, 28-32 parts of kelp, 11-13 parts of fructus cannabis, 35-45 parts of bighead atractylodes rhizome, 16-20 parts of angelica sinensis, 16-20 parts of fructus aurantii, 28-32 parts of cistanche and 28-32 parts of mulberry.
The traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome comprises the following components: 12 parts of mangnolia officinalis, 12 parts of mangnolia officinalis flower, 9 parts of immature bitter orange, 18 parts of sea-buckthorn, 30 parts of kelp, 12 parts of fructus cannabis, 40 parts of bighead atractylodes rhizome, 20 parts of angelica sinensis, 18 parts of fructus aurantii, 30 parts of cistanche and 30 parts of mulberry.
The magnolia officinalis in the traditional Chinese medicine composition has the effects of drying dampness and dissolving phlegm, descending qi and eliminating fullness, the magnolia officinalis flower has the effects of aromatizing and dissolving dampness, regulating qi and relieving epigastric distention, the immature bitter orange has the effects of breaking qi and removing food retention, and the phlegm and the abdominal mass are monarch drugs together. Monarch drugs are indispensable for the main treatment of the principal symptoms in the prescription, and have less medicinal taste and larger dosage according to the potency; sea-buckthorn, fructus hippophae, as a ministerial drug, has the effects of strengthening spleen and promoting digestion, relieving cough and eliminating phlegm, kelp, eliminating phlegm and resolving masses, inducing diuresis and reducing edema, and fructus cannabis, as a cathartic, can moisten intestines and relieve constipation. Ministerial drugs assist monarch drugs to enhance the therapeutic effect; bighead atractylodes rhizome, rhizoma Atractylodis Macrocephalae, invigorating qi and spleen, drying dampness and inducing diuresis, Chinese angelica, radix Angelicae sinensis, activating blood and relieving pain, moistening intestines and relaxing bowels, fructus Aurantii, regulating qi and relieving epigastric distention, activating stagnancy and relieving flatulence, are used as adjuvant drugs together. Adjuvant drugs assist the monarch drugs in treating concurrent symptoms or secondary symptoms, or inhibit the toxicity and the severity of the monarch and ministerial drugs, or act as an anti-adjuvant. Cistanchis herba has effects of invigorating kidney, tonifying yang, loosening bowel to relieve constipation, and Mori fructus has effects of nourishing yin, replenishing blood, promoting fluid production, and loosening bowel. The guiding drug is a channel guiding drug and can guide the drugs in the prescription to reach the disease focus; or harmonizing drugs, i.e. drugs with the effect of harmonizing the drugs. The positions of the medicines in the prescription and the primary and secondary medicines in treatment in the monarch, minister, assistant and guide prescription are in a synergistic antagonistic relationship, and the basic principle of medicine compatibility is provided. The main disease herbs can reach the disease sites, so there is no need to add guiding herbs. However, the Chinese medicinal composition can not reach the disease focus, so that the cistanche and the mulberry are added as guiding medicaments.
The specific characteristics and effects of each traditional Chinese medicine in the traditional Chinese medicine composition are as follows:
magnolia officinalis: bitter and pungent taste, warm in nature; it enters spleen, stomach, lung and large intestine meridians. Has the effects of eliminating dampness and phlegm, descending qi and eliminating fullness. It can be used for treating damp obstruction of middle energizer, abdominal distention, dyspepsia, abdominal distention, and constipation. Is a monarch drug.
Magnolia flower: bitter taste and warm nature; it enters spleen and stomach meridians. Has the effects of eliminating dampness with aromatics and regulating qi-flowing for relieving epigastric distention. It can be used for treating chest and gastric distention, fullness and distention, and anorexia. Is a monarch drug.
Immature bitter orange: bitter, pungent and sour in flavor, warm in nature, entering spleen, stomach and large intestine meridians. Has the effects of breaking qi, removing food retention, eliminating phlegm and relieving distension and fullness. Can be used for treating gastrointestinal stagnation, damp-heat dysentery, thoracic obstruction, qi stagnation, chest and hypochondriac pain, and puerperal abdominal pain. Is a monarch drug.
Sea-buckthorn: sour, astringent and warm in nature; it enters spleen, stomach, lung and heart meridians. Has the effects of invigorating spleen, promoting digestion, relieving cough, eliminating phlegm, promoting blood circulation, and removing blood stasis. It can be used for treating spleen deficiency, anorexia, abdominal pain due to dyspepsia, cough, excessive phlegm, thoracic obstruction, heart pain, and amenorrhea due to blood stasis. Is used as a ministerial drug.
Kelp: salty taste and cold nature; it enters liver, stomach and kidney meridians. Has effects of eliminating phlegm, softening and resolving hard mass, inducing diuresis and relieving swelling. It is mainly used for treating goiter, scrofula, phlegm-fluid retention and edema, etc. Is used as a ministerial drug.
Fructus cannabis: sweet in flavor and neutral in nature, and entering spleen, stomach and large intestine meridians. Has effects of loosening bowel to relieve constipation. It can be used for treating constipation due to intestinal dryness, rheumatism, and tinea pedis. Is used as a ministerial drug.
White atractylodes rhizome: bitter and sweet in taste, warm in nature, entering spleen and stomach meridians. Has effects of invigorating qi, invigorating spleen, eliminating dampness, promoting diuresis, arresting sweating, and preventing miscarriage. It can be used for treating deficiency of spleen-qi, spleen deficiency, stagnation of spleen-qi, spleen deficiency, fluid retention, excessive sweat due to muscle surface weakness, and threatened abortion. Is used as adjuvant drug.
Chinese angelica: sweet and pungent in flavor, warm in nature, entering liver and heart meridians. Has effects of replenishing blood, regulating menstruation, promoting blood circulation, relieving pain, and loosening bowel to relieve constipation. It can be used for treating blood deficiency, sallow complexion, menoxenia, amenorrhea, dysmenorrhea, blood deficiency, blood stagnation, pain due to blood cold, traumatic injury, rheumatalgia, superficial infection, pyocutaneous disease, intestinal dryness, and constipation. Is used as adjuvant drug.
Fructus aurantii: bitter, pungent and sour in flavor, slightly cold in nature, entering spleen and stomach meridians. Has the effects of regulating qi, relieving epigastric distention, activating stagnancy and relieving flatulence. Can be used for treating qi stagnation in chest and hypochondrium, fullness and pain, dyspepsia, phlegm retention, viscera prolapse, etc. Is used as adjuvant drug.
Cistanche deserticola: sweet, salty and warm in nature, it enters kidney and large intestine meridians. Has the effects of tonifying kidney, supporting yang, moistening intestine and relaxing bowels. Can be used for treating kidney yang deficiency, essence and blood deficiency, sexual impotence, premature ejaculation, infertility due to cold womb, soreness of waist and knees, asthenia, intestinal dryness, and constipation. It is used as a guiding drug.
Mulberry fruit: sweet and sour in flavor, cold in nature, entering heart, liver and kidney meridians. Has the effects of nourishing yin, enriching blood, promoting the production of body fluid and moistening intestines. Can be used for treating vertigo, tinnitus, premature gray hair, amenorrhea due to blood deficiency, thirst due to body fluid consumption, internal heat, diabetes, constipation due to intestinal dryness, etc. It is used as a guiding drug.
Example 1A Chinese medicinal composition for treating constipation-predominant irritable bowel syndrome
The raw materials of the material comprise the following components in parts by weight: 9 parts of mangnolia officinalis, 9 parts of mangnolia officinalis flower, 6 parts of immature bitter orange, 15 parts of sea-buckthorn, 25 parts of kelp, 9 parts of fructus cannabis, 30 parts of bighead atractylodes rhizome, 12 parts of angelica, 15 parts of fructus aurantii, 25 parts of cistanche and 25 parts of mulberry.
Example 2A Chinese medicinal composition for treating constipation-predominant irritable bowel syndrome
The raw materials of the material comprise the following components in parts by weight: 15 parts of mangnolia officinalis, 15 parts of mangnolia officinalis flower, 12 parts of immature bitter orange, 21 parts of sea-buckthorn, 35 parts of kelp, 15 parts of fructus cannabis, 50 parts of bighead atractylodes rhizome, 25 parts of angelica, 21 parts of fructus aurantii, 35 parts of cistanche and 35 parts of mulberry.
Example 3A Chinese medicinal composition for treating constipation-predominant irritable bowel syndrome
The raw materials of the material comprise the following components in parts by weight: 12 parts of mangnolia officinalis, 12 parts of mangnolia officinalis flower, 9 parts of immature bitter orange, 18 parts of sea-buckthorn, 30 parts of kelp, 12 parts of fructus cannabis, 40 parts of bighead atractylodes rhizome, 20 parts of angelica sinensis, 18 parts of fructus aurantii, 30 parts of cistanche and 30 parts of mulberry.
Example 4 animal experiments verify the efficacy of the Chinese medicinal composition of the present invention
In this example, the AL-Chaer method was used to model irritable bowel syndrome-sensitive rats. According to the calculation method of animal experiment research 'equivalent dose', the animal experiment research is randomly divided into an experiment group, a positive drug control group, a model group and a blank control group, the curative effect on a model rat is evaluated by adopting an abdominal wall withdrawal reflex scoring method (AWR method), and the action mechanism of the traditional Chinese medicine composition for treating the irritable bowel syndrome is discussed.
1 materials of the experiment
1.1 test drugs
The tested medicine is the traditional Chinese medicine composition of embodiment 6 of the invention, and consists of mangnolia officinalis, magnolia officinalis flowers, immature bitter oranges, sea buckthorn, kelp, fructus cannabis, bighead atractylodes rhizome, angelica sinensis, fructus aurantii, cistanche and mulberries. The preparation is decocted in a preparation room to prepare liquid medicine. And (5) performing intragastric administration. The positive drug control group used trimebutine maleate capsules, which were prepared into 0.003g/ml solution with distilled water before use. The dosage is calculated according to the calculation method of the equivalent dosage of animal experimental study, namely the equivalent dosage is calculated according to the human-mouse conversion coefficient W which is 6.25.
1.2 Experimental animals
SD rats, female, body mass 180- & ltwbr/& gt 220 g. Purchased from laboratory animal technology, Inc. of Wintolite, Beijing (Charles River Laboratories). The relevant operation of each experiment meets the requirements of 'the management and use guide of experimental animals'.
1.3 statistical methods
The experimental data were analyzed using SPSS 10.0 statistical software, the data results are expressed as mean. + -. standard deviation (x. + -.s), and are analyzed using One-way ANOVA (One-way ANOVA), and the differences between groups are compared using the t-test. P <0.05 is statistically significant for the differences.
2 method of experiment
2.1 animal modeling grouping and administration
The molding adopts an AL-Chaer method. After purchasing SD pregnant mice, the SD pregnant mice are independently raised for production, and the production date is recorded. Subjecting young male rat to percutaneous transluminal coronary angioplasty balloon colon stimulation at 8, 10, 12 days after birth, with pressure of 60mmHg for 1min, 1 time per day, and 3 times in total; control group: the balloon catheter is inserted into the anus, but not expanded.
40 newborn rats were randomly divided into 4 groups: experimental group, positive drug control group, model group and blank control group, each group has 10 pieces. The rats begin to be administrated by gastric perfusion at 60 days after birth, the experimental group is respectively administrated with 1m1 decocted traditional Chinese medicine composition according to 100g body weight, and the positive medicine (trimebutine maleate capsule) is 2m1/100 g; both the model group and the blank control group were given 2m1/100g of physiological saline 2 times a day, and the gavage was continued for 10 days.
2.2 Observation indicators and methods
An abdominal wall withdrawal reflex experiment, namely semi-quantitative scoring of abdominal muscle retraction reflex, colorectal balloon expansion under different pressures is carried out for evaluating visceral sensitivity change, visceral movement reaction caused by colorectal balloon expansion can be quantified and repeated, and the method is a reliable index for evaluating visceral pain. After the completion of the gavage (70 days), the rats were fasted for 12 hours and placed in a home-made transparent glass cage where the rats could move only forward and backward and could not turn. After the rats were acclimated (about 5 minutes), the balloon was inserted through the anus and inserted about 6-8cm, the catheter was fixed to the tail of the rat with an adhesive tape to fix the balloon, and air was injected into the balloon to give different pressure stimuli. The rats were observed under pressure of 10, 20, 40, 60, 80mmHg for abdominal muscle retraction irradiation for rectal balloon dilatation for 20s each time, and for responses to rectal dilatation caused by different pressures, and semi-quantitative behavioral scoring was performed according to their response records. And simultaneously recording the contraction times of the abdominal muscle of the rat within 3min of each expansion of the intrarectal balloon under different pressures, wherein the interval of each time is 30 min. Each pressure value is detected 3 times, an average value is taken for scoring, and the higher the score of the abdominal wall withdrawal reflex test is, the higher the visceral sensitivity is.
2.3 criteria of determination
Rats showed no behavioral response to colon expansion: 0 minute;
the body is still and the head movement is reduced during colon expansion, which is the initial sensory threshold: 1 minute;
the abdominal muscles contract when the colon expands, but the abdominal muscles do not lift off the table at the discomfort threshold: 2 min;
abdominal muscle contraction and lifting off the table when the colon expands is the pain threshold: 3 min;
when the colon is dilated, the pelvis is lifted, the body is arched, and the maximum tolerance threshold is as follows: and 4, dividing.
3 results
3.1 comparison of Abdominal wall withdrawal reflex test threshold scores of rats in each group under different pressure stimuli
After the model group rats are treated in the juvenile period, the visceral expansion tolerance is reduced after the rats grow up, and the statistical difference (P <0.05) between the abdominal wall withdrawal reflex test threshold score and the physiological group (blank control group) in the model group can be seen. After the molded rat is treated by a positive medicament (trimebutine maleate capsules), the state of high viscus sensitivity is improved, and the statistical significance is achieved (P is less than 0.05); the experimental threshold score of the abdominal wall withdrawal reflex of the experimental group (using the traditional Chinese medicine composition of the invention) under different pressures is also significantly lower than that of the model group (P <0.05), and the results are shown in table 1:
table 1 comparison of AWR threshold scores at different pressure stimuli after treatment of rats (min, x ± s, n ═ 10)
| Group of | 10mmHg | 20mmHg | 40mmHg | 60mmHg | 80mmHg |
| Model set | 0.73±0.45 | 1.81±0.64 | 2.56±0.59 | 3.68±0.46 | 3.99±0.25 |
| Blank control group | 0*** | 0.22±0.58*** | 0.56±0.47*** | 2.58±0.87* | 3.24±0.41*** |
| Positive drug group | 0.07±0.27* | 0.57±0.72*** | 1.64±0.62* | 2.58±0.87* | 3.41±0.47* |
| Experimental group | 0.07±0.26* | 0.33±0.63*** | 1.81±0.52*** | 2.67±0.76* | 3.64±0.39* |
Note: in comparison to the model set,*P<0.05，***P<0.001。
3.2 comparison of the number of abdominal muscle contractions in the various groups of rats stimulated by different pressures
Compared with the model group, the abdominal wall contraction frequency of the experimental group (using the traditional Chinese medicine composition of the invention) is obviously reduced under different pressure stimulation within 3min of each rectal dilatation (P is less than 0.05), which indicates that the viscus sensitivity is reduced. The results are shown in Table 2:
table 2 comparison of the number of abdominal muscle contractions under different pressure stimuli after treatment in rats (x ± s, n ═ 10)
| Group of | 10mmHg | 20mmHg | 40mmHg | 60mmHg | 80mmHg |
| Model set | 7.14±1.47 | 15.27±1.28 | 15.81±0.14 | 16.05±0.88 | 16.04±0.85 |
| Blank control group | 0.072±0.24*** | 0.072±0.70*** | 7.17±1.38*** | 10.64±1.54*** | 13.97±1.42*** |
| Positive drug group | 1.00±0.59*** | 3.57±0.84*** | 6.84±0.56*** | 12.81±1.57*** | 14.97±0.88* |
| Experimental group | 0.81±0.68*** | 3.44±1.01*** | 7.22±0.99*** | 12.94±1.47*** | 14.56±1.12* |
Note: in comparison to the model set,*P<0.05，***P<0.001。
the results show that the irritable bowel syndrome high-visceral-sensitivity rat model prepared by the colon chronic acetic acid stimulation method (AL Chaer) is good in stability and high in repeatability, and can better simulate the high-visceral-sensitivity state of patients with clinical irritable bowel syndrome. The abdominal wall withdrawal reflex test score of the visceral hypersensitive rat after the test group (the traditional Chinese medicine composition) treats the irritable bowel syndrome can be obviously reduced, the sensory threshold of the visceral hypersensitive rat on the enlargement of the straight colon is improved, and the traditional Chinese medicine composition can effectively improve the visceral hypersensitive of the irritable bowel syndrome model rat and has obvious curative effect on the irritable bowel syndrome. Rats in the experimental group do not have symptoms such as toxic death and the like in the experimental process, which shows that the traditional Chinese medicine composition is safe and has no toxic or side effect.
Example 5 clinical results confirmed the therapeutic effects of the Chinese medicinal composition of the present invention on constipation-predominant irritable bowel syndrome
In early clinical experiments, the traditional Chinese medicine composition has a good effect of treating constipation caused by various reasons, and is praised by patients. To date, the efficacy of 420 constipation patients was observed and evaluated, 216 men, 204 women, 86 years old for the oldest, and 15 years old for the youngest; the shortest disease duration is 2 months, and the longest disease duration is 42 years. The treatment method is to use the traditional Chinese medicine composition of the embodiment 3 of the invention, 1 dose is taken twice in the morning and at night every day, 2 months are 1 course of treatment, and the symptoms of a patient are obviously relieved after 1-2 courses of treatment.
(1) Typical case 1
Patient late, female, 25 years old, not married. Initial diagnosis: year 2015, 8, 10 months. Before 4 months, patients have no obvious cause of constipation, and do not pay attention to the constipation, and the later illness state is repeated. Before two weeks, the symptoms are aggravated by overeating spicy and greasy food, and the doctor visits an outpatient clinic for systematic treatment. The current major symptoms are: constipation, one row in 4-5 days, hard texture, lumpy granules like sheep manure, no mucus and blood adhesion, no fatigue feeling after defecation, abdominal fullness and discomfort, no nausea, vomiting, anorexia, dry mouth, insomnia, scanty and dark urine, normal menstruation, and 7-month and 25-day last menstruation. A red tongue tip, a white coating, yellow and greasy coating on the middle and back, and a wiry, slippery and rapid pulse. Physical examination: normal development, nutritional, moderate, automatic posture. The skin of the whole body has no yellow stain and bleeding spots, superficial lymph nodes have no swelling, and sclera has no yellow stain. There was no congestion in the pharynx, small tonsils on both sides, central trachea, small thyroid gland, and no abnormality in the heart and lung. Slight tension of abdominal muscles, percussion drum sound, no tenderness, untouched mass, untouched liver and spleen, and no tenderness under xiphoid process. The spine, limbs and nervous system were not abnormal. Traditional Chinese medicine diagnosis: constipation (damp-heat obstructing the middle energizer and liver-stomach disharmony). And (3) Western diagnosis: functional constipation.
The treatment by the traditional Chinese medicine composition in the embodiment 3 of the invention mainly comprises the functions of dissolving turbidity and detoxifying, soothing liver and harmonizing stomach. After 14 doses of the traditional Chinese medicine are taken, the excrement is dry and strip-shaped after going for 1-2 days, and abdominal distension is relieved, and the symptoms are the same as those of the traditional Chinese medicine. A red tongue with white coating and a wiry, slippery and rapid pulse. The medicine is added and reduced according to the symptoms, 14 doses are taken successively, the medicine is decocted with water, 1 dose is taken every day, the medicine is taken half an hour before meals in the morning and evening, and meanwhile, the shalian stomach harmonizing capsule is taken 3 times a day, 3 grains are taken once. At present, patients self-complain of 1-2 rows of excrement in one day, proper stool quality, occasional sticky excrement, occasional vexation and impatience and no other discomfort. The tongue is pale red, the coating is thin and yellow, and the pulse is wiry and smooth. After the medicine is taken for 1 month according to the prescription, the constipation is complained and does not relapse.
(2) Typical case 2
Patient Wangzhi, male, age 68. Initial diagnosis: 6 and 23 months in 2017. The patient is addicted to spicy greasy food, is not drunk for a while, is overeating spicy and is reluctant to have emotion before one year, so that constipation is not smooth and hard to get down, and is in a row in 5-7 days, abdominal fullness and distention, chest and hypochondrium, even gastric cavity dull pain, poor appetite, head and face swelling, and after the patients are treated by taking aloe capsules, fruit-guiding tablets, hemp seeds capsules and the like discontinuously, symptoms are not improved, and the patient does not go for 7 days, so the patient is diagnosed in the hospital. The symptoms are as follows: constipation, no movement for 7 days, abdominal fullness and distention, fullness in chest and hypochondrium, belching, dry mouth and bitter taste, reduced appetite, vague pain in stomach and epigastrium, head covering and head swelling, borborborygmus and flatulence, scanty and brownish urine, red tongue, yellow, thick and greasy coating, and wiry and slippery pulse. Physical examination: normal development, nutritional, moderate, automatic posture. The skin of the whole body has no yellow stain and bleeding spots, superficial lymph nodes have no swelling, sclera has no yellow stain, and pharynx has no congestion. The tonsils on both sides are not large, the trachea is centered, the thyroid is not large, and there is no abnormality in the heart and lung. A soft and flat abdomen, light tenderness in the epigastrium, no rebound pain and muscular tension, palpable mass in the right abdomen, untouched by the liver and spleen, and light tenderness under the xiphoid process. The body of the spine, the four limbs and the nervous system is not abnormal. Traditional Chinese medicine diagnosis: constipation (stagnation of turbid toxin in the interior and stagnation of qi). And (3) Western diagnosis: habitual constipation.
The treatment with the traditional Chinese medicine composition of the embodiment 3 of the invention mainly aims at eliminating turbid pathogen and detoxifying, and guiding qi downward and removing food stagnation. After 7 doses of the traditional Chinese medicine are taken, the patient feels abdominal fullness and distention, chest and hypochondrium fullness are better, eructation is reduced, the mouth is dry and bitter, the patient can take the traditional Chinese medicine, the gastric cavity is dull and painful, the head is covered with head, borborygmus is discharged, dark urine is obtained, the tongue is red, the tongue coating is yellow and greasy, and the pulse is wiry and smooth. Syndrome of tongue vessel, the symptoms of turbid toxin are reduced, while liver and stomach are still not harmonized, so the use of the original recipe with the addition of the above-mentioned herbs can still be used for resolving turbidity, removing toxicity, soothing liver and harmonizing stomach. After 21 doses of the traditional Chinese medicine are taken, 1-2 days of defecation occur, the stool is proper, the abdominal and chest and hypochondrium swelling symptoms are obviously improved, the stomach and abdominal dull pain, the head covering and head swelling disappear, the bowel sound is generated, the people are convenient to adjust, the tongue is red, the coating is slightly greasy, and the pulse is wiry and smooth. The pathogenic factors of turbid toxin are removed by eighty-nine, and the incoordination between liver and stomach can be basically relieved. However, the turbid toxin is difficult to remove quickly, so that the effect is not improved because the turbid toxin is not adhered. When the medicine is added or subtracted in the front, 21 doses are taken subsequently, the stool moves in one row after 1-2 days, the abdominal, chest and hypochondrium distending symptoms basically disappear, the gastric cavity dull pain disappears, the bowel sound disappears, the qi flowing over the body disappears, the urine is adjusted, the tongue is red, the coating is thin and yellow, and the pulse is wiry and smooth. The pathogenic factors of turbid toxin are already eliminated, and the incoordination between liver and stomach can be relieved. Patients are advised to avoid eating pungent, pungent and greasy food to harmonize emotion.
(3) Typical case 3
Patient Lie, female, age 35, married. Initial diagnosis: 3/12/2012. Patients have difficulty in defecating for nearly 4 years, go for a few days, are hard to dry and hard to get down, are reluctant to sit for a long time, need to squat the toilet for more than 1 hour at ordinary times, and need to be assisted by methods such as clysis or digging and the like, which is very painful. It is usually indicated for some time, so it is usually done by taking rhubarb soda tablet and fruit guide tablet. The patients with constipation have the same symptoms as the above, dry mouth, abdominal distension, dysphoria, irritability, red tongue, thin tongue coating and wiry pulse. Physical examination: normal development and emaciation. The mucous membrane of the whole body has no yellow stain, and the heart and lung have no abnormality. The abdomen is flat and soft, no intestinal type or stomach type peristaltic wave is seen, and no abdominal wall varicose veins exist. No tenderness, rebound pain and muscular tension in the whole abdomen. The liver and spleen were not in contact with the mass, and the bowel sounds normal. And (3) Western diagnosis: habitual constipation. Traditional Chinese medicine diagnosis: constipation (liver depression, qi stagnation, lung heat moving down the large intestine).
The treatment according to the traditional Chinese medicine composition of the embodiment 3 of the invention mainly aims at soothing the liver, strengthening the spleen, clearing away the lung-heat and moistening the intestines. 14 doses of the decoction is decocted in water for oral administration, 1 dose is taken twice a day in the morning and at night, and meanwhile, patients are ordered to take soft food, avoid pungent and pungent products and give up anger. After taking the medicine, the patient takes the second dose of the medicine 2 to relieve the bowels immediately, the mood is improved, and then takes the medicine 14, and after taking the medicine, the patient defecates one row a day, the medicine is easy to relieve, and no discomfort exists. The recipe then mainly takes nourishing the liver, strengthening the spleen, tonifying the kidney and moistening the intestines. The traditional Chinese medicine composition is used as a basis for syndrome differentiation, addition and subtraction, and the treatment for 2 months has obvious effect.
The present invention can be produced in various embodiments according to the kind of components, content of components, dosage forms, and the like. For example:
embodiment 1: granules taking the traditional Chinese medicine composition as a medicinal component;
the granule can be directly swallowed or drunk by infusing with warm water, and has convenient application and carrying, and rapid dissolution and absorption. The formulation adjuvants used in the granule are similar to those used in tablet, and include one or more of filler, binder, wetting agent, disintegrant, lubricant and film coating material.
For granules, preferably, the filler is one or more of cellulose and inorganic salts. Such as microcrystalline cellulose, calcium sulfate, calcium hydrogen phosphate, medicinal calcium carbonate, mannitol, etc., to increase the volume of the raw material and assist the shaping.
For granules, preferably, the binder is one or more of water, ethanol, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, gelatin, polyvinylpyrrolidone, and the like.
For granules, preferably, the wetting agent is water or ethanol or a mixture of both. Such as one or more of magnesium stearate, aerosil, talc, hydrogenated vegetable oil, polyethylene glycol and magnesium lauryl sulfate.
For granules, preferably, the disintegrant is one or more of low-substituted hydroxypropyl, crospovidone, croscarmellose sodium, and the like.
For granules, preferably, the film coating material is one or more of hydroxypropyl methylcellulose, polyethylene glycol, cellulose acetate phthalate and polyvinyl acetal diethylamine acetate.
Embodiment 2: the oral liquid takes the traditional Chinese medicine composition as a drug effect component;
taking oral liquid as an example, the oral liquid is a new formulation developed on the basis of decoction and injection, has the advantages of small dosage, quick absorption, stable quality, convenient carrying and taking and easy storage, contains various effective components, and has great influence on quality and taste. On the premise of not changing the structure and the function of the main active ingredients, how to retain the active ingredients to the maximum extent and improve the taste is a difficulty of selecting auxiliary materials. The oral liquid can be added with auxiliary materials to improve the taste, improve the clarity, enhance the stability and improve the product quality.
The common auxiliary materials of the oral liquid comprise: solvent, aromatic, correctant, clarifier, antiseptic, etc., and these adjuvants can be added simultaneously or optionally, wherein the solvent is necessary and water can be used. The different adjuvants are combined with sweetener, aromatic, clarifying agent or antiseptic, or the combination of sweetener and antiseptic, preferably the combination of sweetener and antiseptic. Part of the auxiliary materials have the functions of sweetening and enhancing the fragrance, and only one auxiliary material needs to be added at the moment.
For oral liquids, preferably, the sweetener is selected from one or more of aspartame, xylitol, aspartame and sucralose.
For oral liquids, preferably, the preservative is selected from one or more of parabens, butylated hydroxyanisole, butylated hydroxytoluene, and sorbic acid.
The antiseptic can be selected from p-hydroxybenzoate, butylhydroxytoluene or sorbic acid, preferably butylhydroxytoluene. Combinations may also be used, for example, of hydroxybenzoate esters with butylhydroxytoluene, or butylhydroxytoluene with sorbic acid, or parabens, butylhydroxytoluene and sorbic acid.
For oral liquid, preferably, the aromatic is fruit essence.
For oral liquid, preferably, the clarifying agent is one or a mixture of chitosan and gelatin.
Embodiment 3: tablets taking the traditional Chinese medicine composition as a medicinal component;
the tablet has the advantages of accurate dosage, stable quality, convenient administration, carrying and transportation, etc.
For tablets, the formulation auxiliary materials comprise one or more of diluent, binder, lubricant and disintegrant, and the combination of diluent, binder, lubricant and disintegrant is preferred.
For tablets, preferably, the diluent is one or more of cellulose and inorganic salts. Such as microcrystalline cellulose, calcium sulfate, calcium hydrogen phosphate, medicinal calcium carbonate, mannitol, etc., to increase the volume of the raw material and assist the shaping.
For tablets, preferably, the binder is one or more of water, ethanol, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, gelatin, polyvinylpyrrolidone, and the like.
For tablets, preferably, the lubricant is one or more of magnesium stearate, aerosil, talc, hydrogenated vegetable oil, polyethylene glycol and magnesium lauryl sulfate.
For tablets, preferably, the disintegrant is one or more of low-substituted hydroxypropyl, crospovidone, croscarmellose sodium, and the like.
Embodiment 4: the capsule takes the traditional Chinese medicine composition as a medicinal component;
in the present invention, the capsule mainly improves the stability and bioavailability of the drug. The preparation auxiliary material is a capsule shell, and the capsule shell is a hard capsule shell or a soft capsule shell.
Embodiment 5: the Chinese medicinal composition is powder with the medicinal components.
The invention can also be prepared into powder, and the powder is convenient to be divided into dose and taken.
The above embodiments can adjust the dosage of the medicament in the unit product to adapt to different purposes.
From the results, the traditional Chinese medicine composition disclosed by the invention shows that the traditional Chinese medicine composition has a definite curative effect on constipation-type irritable bowel syndrome in both animal experiments and clinical symptoms, can effectively improve the visceral hypersensitivity of a rat with the irritable bowel syndrome model, and has no toxic or side effect. The traditional Chinese medicine composition is added with pharmaceutically conventional auxiliary materials according to a pharmaceutically conventional process to prepare pharmaceutically acceptable dosage forms, such as granules, oral liquid, tablets, capsules, powder and the like, is convenient to take, carry and store, does not use very rare and expensive medicinal materials in the composition, is low in preparation cost and is convenient for large-scale popularization.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (9)
1. A traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome is characterized by comprising the following raw materials in parts by weight: 9-15 parts of mangnolia officinalis, 9-15 parts of mangnolia officinalis flower, 6-12 parts of immature bitter orange, 15-21 parts of sea buckthorn, 25-35 parts of kelp, 9-15 parts of fructus cannabis, 30-50 parts of bighead atractylodes rhizome, 12-25 parts of Chinese angelica, 15-21 parts of fructus aurantii, 25-35 parts of cistanche and 25-35 parts of mulberry.
2. A traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome is characterized by comprising the following raw materials in parts by weight: 11-13 parts of mangnolia officinalis, 11-13 parts of mangnolia officinalis flower, 8-10 parts of immature bitter orange, 17-19 parts of sea-buckthorn, 28-32 parts of kelp, 11-13 parts of fructus cannabis, 35-45 parts of bighead atractylodes rhizome, 16-20 parts of angelica sinensis, 16-20 parts of fructus aurantii, 28-32 parts of cistanche and 28-32 parts of mulberry.
3. A traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome is characterized by comprising the following raw materials in parts by weight: 12 parts of mangnolia officinalis, 12 parts of mangnolia officinalis flower, 9 parts of immature bitter orange, 18 parts of sea-buckthorn, 30 parts of kelp, 12 parts of fructus cannabis, 40 parts of bighead atractylodes rhizome, 20 parts of angelica sinensis, 18 parts of fructus aurantii, 30 parts of cistanche and 30 parts of mulberry.
4. A granule for treating constipation-predominant irritable bowel syndrome, comprising the Chinese medicinal composition of any one of claims 1 to 3 and formulation auxiliaries;
the preparation auxiliary materials are one or more of filling agent, adhesive, wetting agent, disintegrating agent, lubricant and film coating material.
5. An oral liquid for treating constipation-predominant irritable bowel syndrome, comprising the Chinese medicinal composition of any one of claims 1 to 3 and formulation auxiliaries;
the preparation adjuvants are one or more of solvent, aromatic, correctant, clarifier and antiseptic.
6. A tablet for treating constipation-predominant irritable bowel syndrome, comprising the Chinese medicinal composition of any one of claims 1 to 3 and formulation auxiliaries;
the preparation auxiliary materials are one or more of diluent, adhesive, lubricant and disintegrant.
7. A capsule for treating constipation-predominant irritable bowel syndrome, comprising the Chinese medicinal composition of any one of claims 1 to 3 and formulation auxiliaries;
the preparation auxiliary material is a hard capsule shell or a soft capsule shell.
8. A powder for treating constipation-predominant irritable bowel syndrome, comprising the Chinese medicinal composition according to any one of claims 1 to 3.
9. Use of the Chinese medicinal composition of any one of claims 1 to 3 for the preparation of a medicament for treating constipation-predominant irritable bowel syndrome.
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| CN102379970A (en) * | 2011-10-31 | 2012-03-21 | 江苏省中医药研究院 | TCM composition used for treating IBS |
| CN106822541A (en) * | 2017-02-23 | 2017-06-13 | 谢松甫 | Treat Chinese medicine of habitual constipation and preparation method thereof |
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| CN102008662A (en) * | 2010-04-27 | 2011-04-13 | 泰一和浦（北京）中医药研究院有限公司 | Traditional Chinese medicine composition for treating constipation and preparation method thereof |
| CN102379970A (en) * | 2011-10-31 | 2012-03-21 | 江苏省中医药研究院 | TCM composition used for treating IBS |
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| CN115531361A (en) * | 2022-10-14 | 2022-12-30 | 江苏省中医药研究院(江苏省中西医结合医院) | Application of beta-elemene in preparing medicine for treating irritable bowel syndrome |
| CN115531361B (en) * | 2022-10-14 | 2024-02-09 | 江苏省中医药研究院(江苏省中西医结合医院) | Application of beta-elemene in preparing medicament for treating irritable bowel syndrome |
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