CN107582717B - Traditional Chinese medicine composition and preparation for senile constipation and preparation method thereof - Google Patents

Traditional Chinese medicine composition and preparation for senile constipation and preparation method thereof Download PDF

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CN107582717B
CN107582717B CN201710866882.3A CN201710866882A CN107582717B CN 107582717 B CN107582717 B CN 107582717B CN 201710866882 A CN201710866882 A CN 201710866882A CN 107582717 B CN107582717 B CN 107582717B
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付满玲
郭辉梦
张华安
刘珉甬
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Southwest Medical University
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Abstract

The invention discloses a traditional Chinese medicine composition for senile constipation, a preparation and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following components in parts by weight: 30-180 parts of raw bighead atractylodes rhizome, 20-90 parts of plantain seed, 10-25 parts of mulberry, 8-30 parts of radix rehmanniae recen and 5-25 parts of cistanche. The health-care food has the effects of tonifying spleen and kidney, replenishing vital essence and relaxing bowels, promoting intestinal peristalsis, improving defecation smoothness, avoiding constipation complications, improving intestinal functions, achieving the effect of relaxing bowels after being eaten for a long time, preventing senile constipation from recurring, and treating both principal and secondary aspects of diseases.

Description

Traditional Chinese medicine composition and preparation for senile constipation and preparation method thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicine compositions and preparations, in particular to a traditional Chinese medicine composition and preparation for treating senile constipation and a preparation method thereof.
Background
Senile constipation is a disease with extremely complex starting causes, relates to dietary structure, living habits, social stress and the like, and is represented by a series of changes of physiological, psychological and mental states, wherein functional constipation is common. Constipation is one of common digestive system diseases of old people and increases along with age, the number of old people in China exceeds 2 hundred million in 2015, the incidence rate of senile constipation reaches 15-30%, and the number of long-term hospitalized patients is more than 80%, so that various complications can be caused, and even life can be endangered (the old people with hypertension and cardiovascular and cerebrovascular diseases hold breath for defecation forcibly due to constipation, and sudden cerebral vascular rupture hemorrhage or myocardial infarction leads to sudden death), so that the constipation preventive and therapeutic method has very important significance.
The existing senile constipation mainly comprises the following treatment methods: 1. and (3) drug treatment: many drugs for treating constipation clinically include bulk, osmotic and irritant laxatives such as Du' er Ke, magnesium sulfate, mannitol, lubricants such as glycerin and liquid paraffin, and softeners and prokinetic drugs such as cisapride. However, long-term abuse of stimulant laxatives not only causes the intractable and complicated constipation, but also causes the strong dependence, massive dehydration in vivo, black lesions of colon and intestinal tract, and even canceration. 2. Biofeedback treatment: the essence of the biofeedback treatment of functional constipation is that sound and image feedback is utilized to stimulate and train a patient to correctly control the relaxation and contraction of the external anal sphincter so as to achieve normal defecation. But the traditional Chinese medicine is easy to repeat, has high price, brings certain economic burden to patients, and most of patients with senile constipation cannot insist for a long time. 3. And (3) surgical treatment: the surgical treatment should be considered when the treatment for the intractable constipation is ineffective, the method is a more advocated and approved treatment method for anorectal surgery at home and abroad in nearly 10 years, and particularly, the surgical treatment effect is better for patients with colonic constipation. However, the operation is invasive, has great harm to the elderly patients, and is mostly not advocated. 4. The traditional Chinese medicine treatment comprises the following steps: although functional constipation in the elderly is mostly caused by dysfunction of large intestine in conduction, it is closely related to lung, spleen, liver and kidney, and its pathogenesis is complex, and it can be accompanied by pathogenic heat, fluid deficiency, blood deficiency, yin deficiency, yang deficiency, qi stagnation and blood stasis, and the various factors affect each other, resulting in repeated and difficult healing of constipation. The traditional Chinese medicine has long treatment time, and is difficult for senile constipation patients to insist on, so that the constipation is easy to repeat.
Disclosure of Invention
In view of the above, the application provides a traditional Chinese medicine composition for senile constipation, a preparation and a preparation method thereof, aiming at the characteristics of repeated difficult healing of senile constipation and easy complication generation and the characteristic of decline of physiological functions of the elderly, and the traditional Chinese medicine composition can invigorate spleen and tonify kidney, replenish vital essence and relax bowels, promote intestinal tract peristalsis, improve defecation smoothness, avoid occurrence of constipation complications, improve intestinal tract function, achieve a healing effect after long-term consumption, prevent senile constipation from recurring, and treat both principal and secondary aspects of diseases.
In order to solve the technical problems, the invention provides a traditional Chinese medicine composition for treating senile constipation, which comprises the following components in parts by weight: 30-180 parts of raw bighead atractylodes rhizome, 20-90 parts of plantain seed, 10-25 parts of mulberry, 8-30 parts of radix rehmanniae recen and 5-25 parts of cistanche.
In the technical scheme of the application, the raw white atractylodes rhizome is dried rhizome of white atractylodes rhizome of Compositae. Sweet and bitter in flavor and warm in nature. Enter spleen and stomach meridians. Has the functions of strengthening spleen, benefiting vital energy, eliminating dampness, inducing diuresis, stopping sweating and preventing miscarriage. Can be used for treating anorexia, loose stool, phlegm and fluid retention, edema, leukorrhagia, spontaneous perspiration due to qi deficiency, and threatened abortion due to spleen deficiency.
The plantago seed is dry mature seed of plantago asiatica or plantago asiatica of plantago. Sweet and bland in flavor and cold in nature. Enter kidney, bladder, liver and lung meridians. Has the functions of inducing diuresis for treating stranguria, excreting dampness and stopping diarrhea, clearing liver and improving vision, clearing lung and eliminating phlegm. Can be used for treating damp-heat stranguria, dysuria, liver heat, conjunctival congestion, swelling and pain, heat phlegm cough, etc.
The Mori fructus is the fruit cluster of Morus alba L. Sweet and sour taste and cold in nature. It has effects of nourishing liver and kidney, promoting fluid production and moisturizing intestine, blackening hair and improving eyesight, quenching thirst and removing toxic substance, and caring skin, and can be used for treating yin and blood deficiency, dizziness, night sweat, thirst due to body fluid consumption, diabetes, and constipation due to intestinal dryness.
The radix rehmanniae is root tuber of rehmannia glutinosa Libosch of Scrophulariaceae. Bitter and sweet in taste and cold in nature. Enter heart, liver, stomach and kidney meridians. Clear heat and cool blood, nourish yin, promote the production of body fluid. Can be used for treating fever polydipsia, macula, eruption, yin deficiency, internal heat, hematemesis, epistaxis, diabetes, and infectious liver disease.
The Cistanchis herba is succulent stem of Cistanchis herba of Orobanchaceae. Sweet, salty and warm in flavor. Enter kidney and large intestine meridians. Tonify kidney yang, replenish essence and blood, moisten intestines to relieve constipation. Can be used for treating kidney yang deficiency, sexual impotence due to essence and blood deficiency, spermatorrhea, whitish and turbid urine, frequent micturition, dribbling urination, lumbago, asthenia, tinnitus, blurred vision, menstrual cycle, infertility due to cold womb, and constipation due to intestinal dryness.
The compatibility principle of the technical scheme is as follows: raw white atractylodes rhizome, which is used as a monarch drug, is used for lowering turbid pathogen, and is used for ascending spleen yang to promote qi circulation and promoting fluid production and lubricating intestines due to the fact that white atractylodes rhizome is greasy; although che Qian ren is a diuretic, but it can reinforce the action of relieving diarrhea and can help Bai Zhu to remove damp arthralgia in large intestine and to promote movement, but less dosage and powerless, full of the action of relaxing bowels, it is a ministerial drug; raw rehmannia root, radix rehmanniae is sweet and cold and has more liquid, thereby nourishing yin and increasing liquid, and clearing heat and purging fire; mulberry has the effects of nourishing yin and blood, promoting the production of body fluid and lubricating intestines; cistanchis herba has the effects of moistening and descending, tonifying kidney, replenishing essence, and moistening intestine, and can be used as adjuvant drug together with Mori fructus for warming, invigorating kidney, and relieving constipation. The medicines are combined to play the effects of strengthening spleen and tonifying kidney, and replenishing vital essence and relaxing bowels.
The technical scheme is developed according to the characteristics of senile constipation, the components which are homologous in medicine and food are prepared and formed, the problem of side effect of senile intestinal dysfunction and flora imbalance caused by long-term eating is avoided, the intestinal peristalsis effect can be promoted, the defecation smoothness is improved, the occurrence of constipation complications is avoided, aiming at the characteristics of senile constipation and the intestinal state of the elderly, spleen and kidney tonifying is realized through a composition, essence boosting and bowel relaxing are realized, the intestinal function can be improved, the effect of relaxing the bowels without hurting the body is achieved after long-term eating, the senile constipation relapse is prevented simultaneously, and both principal and secondary aspects of the disease are treated.
Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 50-150 parts of raw bighead atractylodes rhizome, 30-80 parts of plantain seed, 15-20 parts of mulberry, 12-25 parts of radix rehmanniae recen and 10-20 parts of cistanche.
More preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 80-130 parts of raw bighead atractylodes rhizome, 40-60 parts of plantain seed, 16-18 parts of mulberry, 15-20 parts of radix rehmanniae recen and 12-18 parts of cistanche.
Preferably, the traditional Chinese medicine composition further comprises 50-150 parts by weight of xylo-oligosaccharide. Xylo-oligosaccharide is added in the formula, has a plurality of hydrophilic groups, can be aggregated with water molecules into huge molecules, has high viscosity and good stability, can absorb water and form viscous jelly with water in gastrointestinal tracts, softens food residues and directly has the function of relaxing bowels, and can be used in combination with the traditional Chinese medicine components of raw bighead atractylodes rhizome, plantain seed, mulberry, radix rehmanniae and cistanche to improve the water retention performance of excrement, maintain the water content of the excrement in a normal range, reduce the pH value of an intestinal tract and promote the intestinal tract to creep; in addition, as the xylo-oligosaccharide is low-degree polymeric sugar formed by connecting glycosidic bonds, the specific proliferation of beneficial intestinal flora represented by bifidobacteria in organisms is effectively promoted, and meanwhile, the traditional Chinese medicine components can provide active ingredients for the growth of the beneficial intestinal flora, have a bactericidal effect on harmful intestinal flora, improve the intestinal flora structure and avoid flora imbalance; the traditional Chinese medicine composition has the effects of tonifying spleen, tonifying kidney and replenishing vital essence, and the combination of the traditional Chinese medicine composition and the traditional Chinese medicine composition can obviously improve the intestinal function, has a curative effect on senile constipation and prevents relapse.
More preferably, the traditional Chinese medicine composition further comprises 60-100 parts by weight of xylo-oligosaccharide.
The technical scheme of the application also provides a preparation prepared from the traditional Chinese medicine composition for treating senile constipation.
Preferably, the preparation also comprises pharmaceutically acceptable auxiliary materials, wherein the auxiliary materials are one or more of dextrin, starch, cellulose and derivatives thereof.
Preferably, the preparation is in the form of any one of tablets, granules, powder and pills.
The technical scheme of the application also provides a preparation method of the preparation, which is characterized in that: pulverizing Atractylodis rhizoma, semen plantaginis, Mori fructus, radix rehmanniae, and Cistanchis herba, adding xylooligosaccharide and pharmaceutically acceptable adjuvants, and making into preparation by conventional method; or crushing raw bighead atractylodes rhizome, plantain seed, mulberry, radix rehmanniae and cistanche, adding water, soaking for 3-8 h, performing steam distillation, adding xylooligosaccharide and pharmaceutically acceptable auxiliary materials, and preparing the preparation according to a conventional method.
Through the explanation above, compare with prior art, this application technical scheme's beneficial effect lies in:
(1) aiming at the characteristic of senile constipation, the traditional Chinese medicine components of raw bighead atractylodes rhizome, plantain seed, mulberry, raw rehmannia root and desertliving cistanche are compatible, so that the effects of strengthening spleen and tonifying kidney, and replenishing vital essence and relaxing bowels can be achieved;
(2) the food is prepared from medicinal and edible components, so that the problem of side effects of intestinal dysfunction and flora imbalance of the elderly caused by long-term eating is avoided;
(3) the water retention performance of the excrement can be improved, the water content of the excrement is maintained in a normal range, the pH value of an intestinal tract is reduced, the intestinal tract movement is promoted, the defecation smoothness is improved, and the constipation complication is avoided;
(4) can improve the intestinal flora structure and avoid flora imbalance;
(5) can improve intestinal function, achieve cure effect after long-term eating, prevent senile constipation from recurring, and treat both principal and secondary aspect of disease.
Detailed Description
In order to make those skilled in the art better understand the technical solution of the present invention, the following detailed description of the present invention is provided with reference to specific embodiments.
Example 1
The traditional Chinese medicine composition for senile constipation comprises the following components in parts by weight: 30 parts of raw bighead atractylodes rhizome, 20 parts of plantain seed, 10 parts of mulberry, 8 parts of raw rehmannia root and 5 parts of cistanche, and the raw materials are crushed and mixed to obtain the traditional Chinese medicine.
Example 2
The traditional Chinese medicine composition for senile constipation comprises the following components in parts by weight: 180 parts of raw bighead atractylodes rhizome, 90 parts of plantain seed, 25 parts of mulberry, 30 parts of raw rehmannia root and 5 parts of cistanche, and the raw materials are crushed and mixed to obtain the traditional Chinese medicine.
Example 3
The traditional Chinese medicine composition for senile constipation comprises the following components in parts by weight: 50 parts of raw bighead atractylodes rhizome, 30 parts of plantain seed, 15 parts of mulberry, 12 parts of raw rehmannia root and 10 parts of cistanche, and the raw materials are crushed and mixed to obtain the traditional Chinese medicine.
Example 4
The traditional Chinese medicine composition for senile constipation comprises the following components in parts by weight: 150 parts of raw bighead atractylodes rhizome, 80 parts of plantain seed, 20 parts of mulberry, 5 parts of raw rehmannia root and 20 parts of cistanche, and the components are crushed and mixed to obtain the traditional Chinese medicine.
Example 5
The traditional Chinese medicine composition for senile constipation comprises the following components in parts by weight: 80 parts of raw bighead atractylodes rhizome, 40 parts of plantain seed, 16 parts of mulberry, 15 parts of raw rehmannia root and 12 parts of cistanche, and the raw materials are crushed and mixed to obtain the traditional Chinese medicine.
Example 6
The traditional Chinese medicine composition for senile constipation comprises the following components in parts by weight: 130 parts of raw bighead atractylodes rhizome, 60 parts of plantain seed, 18 parts of mulberry, 20 parts of raw rehmannia root and 18 parts of cistanche, and the components are crushed and mixed to obtain the traditional Chinese medicine.
Example 7
The traditional Chinese medicine preparation for senile constipation comprises the following components in parts by weight: 150 parts of raw bighead atractylodes rhizome, 80 parts of plantain seed, 20 parts of mulberry, 5 parts of raw rehmannia root, 20 parts of cistanche and 150 parts of xylo-oligosaccharide. Pulverizing Atractylodis rhizoma, semen plantaginis, Mori fructus, radix rehmanniae, and Cistanchis herba, adding xylooligosaccharide and pharmaceutically acceptable adjuvants, and making into preparation by conventional method.
Example 8
The traditional Chinese medicine preparation for senile constipation comprises the following components in parts by weight: 50 parts of raw bighead atractylodes rhizome, 30 parts of plantain seed, 15 parts of mulberry, 12 parts of raw rehmannia root, 10 parts of cistanche and 50 parts of xylo-oligosaccharide. Pulverizing Atractylodis rhizoma, semen plantaginis, Mori fructus, radix rehmanniae, and Cistanchis herba, adding xylooligosaccharide and pharmaceutically acceptable adjuvants, and making into preparation by conventional method.
Example 9
The traditional Chinese medicine preparation for senile constipation comprises the following components in parts by weight: 130 parts of raw bighead atractylodes rhizome, 60 parts of plantain seed, 18 parts of mulberry, 20 parts of raw rehmannia root, 18 parts of cistanche and 100 parts of xylo-oligosaccharide. Pulverizing raw bighead atractylodes rhizome, plantain seed, mulberry, radix rehmanniae and cistanche, adding water, soaking for 3-8 h, performing steam distillation, adding xylooligosaccharide and pharmaceutically acceptable auxiliary materials, and preparing the preparation according to a conventional method.
Example 10
The traditional Chinese medicine preparation for senile constipation comprises the following components in parts by weight: 80 parts of raw bighead atractylodes rhizome, 40 parts of plantain seed, 16 parts of mulberry, 15 parts of raw rehmannia root, 12 parts of cistanche and 60 parts of xylo-oligosaccharide. Pulverizing raw bighead atractylodes rhizome, plantain seed, mulberry, radix rehmanniae and cistanche, adding water, soaking for 3-8 h, performing steam distillation, adding xylooligosaccharide and pharmaceutically acceptable auxiliary materials, and preparing the preparation according to a conventional method.
Example 11
Determination and establishment of senile constipation model
By comparing the four mouse constipation models, a model with the same or similar clinical performance of senile functional constipation is selected.
1. The experimental method comprises the following steps: dividing 50 mice of 18-20 g into 5 groups at random, wherein each group comprises 10 males and females;
A. compound diphenoxylate group: gavage for 1 time (10 mg/kg);
B. loperamide group: loperamide (9.38mg/kg) was gavaged for 2 times/day for 10 consecutive days;
C. sucralfate group: intragastric administration of sucralfate (25mg/kg) for 1 time/day for 3 consecutive days;
D. ice water set: perfusing with ice water (0.8 ml/tube) for 1 time/day for 7 days;
E. blank control group: the normal saline is infused into the stomach for 1 time/day for 10 consecutive days.
Visual observation indexes are as follows: general condition of mice, first particle black stool discharging time (carbon powder indicator measurement before and after molding), 4h stool quantity, stool water content and death; histological observation indexes are as follows: thickness of distal colonic mucosa, cell morphology.
2. The experimental results are as follows:
(1) general conditions are as follows: the differences in food consumption, water intake and body weight at each time period in the 5 experimental groups were not statistically significant (P > 0.05).
(2) Comparing the time of first particle black stool discharging before and after molding: the iced water group, the sucralfate group and the compound diphenoxylate group have statistical significance (P <0.05), and the blank group and the loperamide group have no statistical significance (P > 0.05); the 4 model groups were compared to the blank group: the compound diphenoxylate group has statistical significance (P <0.001), and other 3 groups have no statistical significance.
(3) Comparing the defecation amount of 4h before and after molding: all 4 model groups had statistical significance (P < 0.05); compared with the blank group, the loperamide group and the compound diphenoxylate group have statistical significance (P <0.001), and the ice water group and the sucralfate group have no statistical significance (P > 0.05).
(4) Comparing the water content of the excrement before and after molding: the compound diphenoxylate group has statistical significance (P <0.05), and the other 3 groups have no statistical significance (P > 0.05); the 4 model groups were compared to the blank group, and each group was statistically insignificant.
3. And (4) experimental conclusion: through comparison of four mouse constipation model preparations, experimental results show that the effect of establishing the senile functional constipation model by the compound diphenoxylate is optimal.
Example 12
Acute toxicity test in mice
1. The experimental method comprises the following steps:
36 SPF-class Kunming mice were randomly divided into 3 groups, each half male and female, 12 control groups, 12 experimental groups A, and 12 experimental groups B. Control group: the stomach is irrigated once by 0.8ml of normal saline; experimental group a: in the application, the traditional Chinese medicine composition for treating senile constipation in the embodiment 6 is used for intragastric administration once, wherein the traditional Chinese medicine composition is 0.4g plus the normal saline solution of 0.8 ml; experimental group B: in example 9 of the present application, 0.4g of the Chinese medicinal preparation for treating senile constipation plus 0.8ml of physiological saline is intragastrically administered once. (the maximum dosage of the Chinese medicinal composition or preparation for senile constipation in examples 6 and 9 of the present application is calculated to be 0.4g, which is equivalent to 400 times of the clinical dose). The observation was continued for 14 days. Observation indexes are as follows: general conditions: body weight, food intake, mental state, activity, stool (character, amount, color); ② whether death occurs or not; ③ gross anatomy and visual observation: organ shape, volume, color; fourthly, observation under a pathological tissue mirror: liver tissue structures, hepatocytes; renal tissue architecture, tubular architecture, cortical to medullary demarcation; morphological changes of cells in the distal colon. And (5) carrying out statistical analysis on the observation indexes.
2. Results of the experiment
General conditions: in the experimental process, the stool character, the activity, the mental state, the weight, the food intake and the water intake of the control group and the experimental group are normal. ② whether death occurs or not: the control group and the experimental group did not die during the experiment. ③ gross anatomy and visual observation: the control group and the experimental group have no abnormal phenomena such as degeneration, congestion, edema, necrosis, etc. Fourthly, observation under a pathological tissue mirror: the control mice had no pathological changes in liver, kidney and distal colon. The liver tissue structure of the experimental group mice is normal; the structure of kidney tissue, the structure of renal tubule is normal, the boundary between cortex and medulla is clear, and no lymphocyte infiltrates; the distal colon cells are normal in morphology and are partially lymphocytosis.
3. And (4) experimental conclusion: the traditional Chinese medicine composition or preparation for treating senile constipation in the embodiments 6 and 9 of the application has no influence on the general condition of a mouse in 400-fold dosage, no adverse reaction on liver and kidney, normal shape of distal colon cells, increase of individual lymphocytes, no toxicity on the mouse and no influence on the health of the mouse.
Example 13
Experiment of drug effect
1.1 Experimental materials
1.1.1 subjects: 180 KM mice with the body mass of 18-22 g and half male and female are selected and provided by the material center of medical colleges of southwest medical university.
1.1.2 drugs: compound diphenoxylate tablet, active carbon powder, Arabic gum and Dumidk, all of which are commercially available; the application examples 6 and 9 are a traditional Chinese medicine composition or preparation for treating senile constipation; physiological saline.
1.1.3 Experimental conditions
The mouse is bred in a nontoxic, high-pressure-resistant, high-temperature-resistant and corrosion-resistant plastic box at the room temperature of 20-25 ℃ and the humidity of 40-70%, drinking water and feed are replaced every day, and padding and a breeding box are replaced 2 times every week.
1.2 appliances
1ml empty needle, ES461 festoon (HC) electronic scale, ES-06B festoon (HC) electronic scale, gastric perfusion needle (12#), filter paper, experimental pathological tissue slicing instrument, sterile surgical instrument scissors, tissue forceps, toothless forceps, sterile surgical instrument handle and 10# blade.
1.3 preparation of reagents
1.3.1 preparation of solution:
(1) preparation of carbon powder liquid (ink, first particle black stool indicator): accurately weighing 100g of Arabic gum, adding 400ml of water to prepare 0.25% transparent solution, adding 50g of activated carbon powder into the solution, boiling for 3 times, cooling the solution, adding water to a constant volume of 500ml, storing in a refrigerator at 4 ℃, shaking uniformly before use, and adding an equivalent amount of physiological saline to prepare carbon powder liquid (Chinese ink) for later use.
(2) Preparing compound diphenoxylate suspension: each tablet contains 2.5mg of compound diphenoxylate, 20 tablets (0.05g/100mL) and 10 tablets (0.025g/100mL) are respectively ground into powder by a mortar, and then water is added to 50mL for preparation before use.
(3) The embodiments 6 and 9 of the present application relate to a traditional Chinese medicine composition or a preparation for treating senile constipation: the different concentrations of the suspension are respectively prepared by using physiological saline and taking 0.0025mg/d of a normal adult as a standard.
1.3.2 Experimental animals grouping and handling
(1) Molding: the compound diphenoxylate described in example 11 was used to establish a model of functional constipation in the elderly.
(2) Experimental group A, B (traditional Chinese medicine composition or preparation for senile constipation in examples 6 and 9 of the present application): after 30 minutes, 3 dose groups (high, medium and low) are respectively set, and after 10 mice in each group, the stomach of the compound diphenoxylate (10mg/kg) is respectively gazed, 2.5 mg/mouse, 5 mg/mouse and 10 mg/mouse (corresponding to 5, 10 and 20 times of the recommended amount of a human body) are respectively gazed, and the suspension is 0.1 mL/(d).
(4) Blank group: the normal saline for gastric perfusion is 0.1mL per tube, and after 30 minutes, the ink is 0.1mL per tube.
(5) Model group: the compound diphenoxylate for intragastric administration (10mg/kg) is 0.1 mL/body, and after 30 minutes, the ink is 0.1 mL/body.
(6) Positive control group (gutter): gavage compound diphenoxylate (10mg/kg)0.1 ml/mouse, after 30 minutes, the mouse gavage 67 mg/mouse; the Du secret positive control group mice are gavaged by 0.1 mL/(d only).
1.3.3 mouse defecation test
Before experiment, 180 KM mice are adaptively fed for 15 days and are divided into 160 model groups and 20 blank groups; after the mice are fasted and are not forbidden to be watered for 16 hours before model building, the model group uses compound diphenoxylate (10 mg/kg); the blank group is administrated with 0.1ml per physiological saline for intragastric administration; after the molding is successful, the test group A, B (each test group is divided into three dose groups), a positive control group, a model group and a blank group are randomly divided. An experimental group A, B (each experimental group is divided into three dose groups), wherein the traditional Chinese medicine composition or preparation for senile constipation in the embodiments 6 and 9 and ink are mixed in equal volume and then are perfused into the stomach, 10 mg/patient is used in a high dose group, 5 mg/patient is used in a medium dose group, and 2.5 mg/patient is used in a low dose group; in the positive control group, the Dumichx and the Chinese ink are mixed in equal volume and are infused into the stomach, and 67mg of the drug is added per patient; the gastric lavage ink of the model group and the blank group is 0.1 mL/mouse. In the experiment, animals are all raised in a single cage, and are fed with water normally.
1.3.4 Small intestine Propulsion experiment
Before experiment, 180 KM mice are adaptively fed for 15 days and are divided into 160 model groups and 20 blank groups; before modeling, after the mice are fasted and are not forbidden to be watered for 16 hours, the model group is subjected to gastric lavage by compound diphenoxylate (10 mg/kg); the blank group is administrated with 0.1ml per physiological saline for intragastric administration; after the molding is successful, the test group A, B (each test group is divided into three dose groups), a positive control group, a model group and a blank group are randomly divided. An experimental group A, B (each experimental group is divided into three dose groups), wherein the traditional Chinese medicine composition or preparation for senile constipation in the embodiments 6 and 9 and ink are mixed in equal volume and then are perfused into the stomach, 10 mg/patient is used in a high dose group, 5 mg/patient is used in a medium dose group, and 2.5 mg/patient is used in a low dose group; in the positive control group, the Dumichx and the Chinese ink are mixed in equal volume and are infused into the stomach, and 67mg of the drug is added per patient; the gastric lavage ink of the model group and the blank group is 0.1 mL/mouse. In the experiment, animals are all raised in a single cage, and are fed with water normally. (sample dose as for mouse defecation experiment). After 25min, the cervical vertebrae is taken off immediately to kill the mouse, the abdominal cavity is opened to separate mesentery, the intestinal canal with the upper end from the pylorus, the lower end to the ileocecal part is cut and taken, the intestinal canal is placed on a tray, the small intestine is slightly pulled into a straight line, the length of the intestinal canal is measured as the total length of the small intestine, the length from the pylorus to the front edge of the ink is measured as the propulsion length of the ink, and a small intestine sample is taken to carry out histopathological examination. The ink propulsion rate was calculated according to the following formula.
The ink propulsion rate (%) is ink propulsion length (cm)/total small intestine length (cm) × 100%
1.3.5 Observation indicators and methods
Visually observing: the first time for defecation.
② the number, the properties, the weight and the water content of the black excrement in 6h (the collected excrement is dried after being weighed, and the dry weight is weighed, and the water content is equal to (wet weight-dry weight)/wet weight multiplied by 100 percent).
And thirdly, whether death occurs or not.
(iv) ink propulsion rate: the ink propulsion rate (%) — the ink propulsion length (cm)/total small intestine length (cm) × 100%.
Histological observation and pathological detection: after the traditional Chinese medicine composition or preparation for senile constipation and the ink with the same dosage are infused in the stomach, the cervical vertebra is taken off immediately after 25min to kill the mouse, the abdominal cavity is opened to separate mesentery, the intestinal canal with the upper end from the pylorus and the lower end to the ileocecal part is cut, the intestinal canal is placed on a tray, the small intestine is pulled to be in a straight line gently, the length of the intestinal canal is measured to be the total length of the small intestine, and the length from the pylorus to the front edge of the ink is measured to be the ink propelling length. Taking small intestine tissues of mice: the cervical vertebrae were removed to kill the mice, the abdominal cavity was opened to separate the mesentery, the jejunum 15cm below the pylorus of the stomach was cut to 2mm × 3mm intestinal wall, washed rapidly with 4 ℃ physiological saline, and placed in a pre-cooled paraformaldehyde-glutaraldehyde stationary liquid (for pathological examination).
1.4 data processing
The statistical software used was a sps 22.0, one-way analysis of variance was used for data consistent with analysis of variance,
the non-normal data was obtained using the Kruskal-Wallis H multi-rank sum test.
1.5 results of the experiment
The results of the above experiments are shown in tables 1-4.
TABLE 1 Effect of the compositions or formulations of the present application on the first granule time to defecation in constipated mice
Figure BDA0001416310060000121
Figure BDA0001416310060000122
The first black defecation time of the mice in each dose group is higher than that in the model group (P is less than 0.01), which indicates that the constipation model is established.
TABLE 2 Effect of the compositions or formulations of the present application on the number of 6h faecal particles in constipated mice
Figure BDA0001416310060000123
Figure BDA0001416310060000124
Figure BDA0001416310060000131
Compared with a model group, the number of the defecation grains in the high-dose, medium-dose and low-dose group mice in 6h of the composition or preparation is remarkably increased (P is less than 0.01), and the difference has statistical significance.
Table 3 effect of the composition or formulation of the present application on water content in constipated mice
Figure BDA0001416310060000132
Figure BDA0001416310060000133
The water content of the mouse feces of the high, medium and low dose groups of the composition or the preparation is obviously different from that of the model group (P < 0.05). Compared with a positive control group, the water content of the feces of the high-dose group, the feces of the medium-dose group, the feces of the low-dose group and the feces of the blank group of the composition or the preparation is less, the difference has statistical significance, P is less than 0.01, the water content of the low-dose group of the composition or the preparation is higher than that of the high-dose group of the composition or the preparation, the difference has statistical significance, and P is less than 0.01.
TABLE 4 Effect of the compositions or formulations of the present application on the ink propulsion rate of constipated mice
Figure BDA0001416310060000134
Figure BDA0001416310060000135
Figure BDA0001416310060000141
Note: indicates that the Kruskal-Wallis H multi-rank-sum test was used.
Compared with the constipation model group, the p of each group is less than 0.05, and the difference has statistical significance, which indicates that the constipation model is established. The Chinese ink propulsion rate of mice in the group administered with the composition or the preparation is higher than that of the mice in the model group, and the statistical analysis of data shows that,
the ink propulsion rates of the mice in the high, medium and low dose administration groups are obviously different from those in the constipation model group (p)
<0.05 and p < 0.01), indicating that the composition or formulation of the present application has the effect of promoting intestinal motility in mice. And
compared with the blank group, the ink propulsion rate of each group is still obviously reduced, and the difference has statistical significance. Compared with the positive control group, the composition has the advantages that,
the ink propulsion rates of the high, medium and low groups of the compositions or formulations of the present application are increased.
Based on the above examples, it can be seen that the composition and the preparation described in the application can improve the defecation ability of mice in a model of senile constipation, can obviously resist the intestinal inhibition effect caused by the compound diphenoxylate, recover the intestinal propulsion ability of the mice, enhance the small intestine peristalsis effect, increase the number of defecation granules, and have the defecation effect.
Example 14
Clinical trial
Test 1
For a queen woman, age 54, constipation occurs for a long time, and before taking the preparation of the application, the stool characteristics are as follows: hard (serious) 3 minutes of excrement and 2 minutes (moderate) less excrement; rectal symptoms: 3 points (serious) of defecation frequency, 4 points (very serious) of defecation labor, 1 point (slight) of incomplete defecation, 3 points (serious) of defecation difficulty and rectal bleeding or 3 points (serious) of tearing; abdominal fullness 4 points (very severe); the stool is normal on day 2, and the stool is normal after the administration for 1 week and is still normal after 3 months.
Test 2
Mr. Zhao 87 years old, constipation for a long time, stool characteristics before taking the preparation of the present application: the hard feces is 2 points (moderate degree), and the less feces is 1 point (slight); rectal symptoms: the defecation is labored for 2 points (moderate), the defecation is not as strong as 1 point (slight), the defecation is happily difficult to discharge for 2 points (moderate), the defecation is normal on day 15, and the defecation is still normal after 3 months of observation. Test 3
For a woman in the family of huds, age 55, with long-term constipation, before taking the preparation of the present application, stool characteristics: hard (moderate) 2 points of feces and small (slight) 1 point of feces; rectal symptoms: the defecation is labored for 2 minutes (moderate), the defecation is difficult to be sensed for 3 minutes (serious), the abdominal distension is 4 minutes (serious), the defecation is normal after 7 days of taking, and the defecation is still normal after 3 months of observation.
Test 4
For a woman, age 88, long-term constipation, stool characteristics before taking the formulation of the present application: hard feces 3 points (severity), less feces 2 points (moderate); rectal symptoms: the defecation is labored for 2 minutes (moderate), the defecation is difficult to be sensed for 3 minutes (serious), the abdominal distension is 4 minutes (serious), the defecation is normal after taking for 15 days, and the defecation is still normal after observing for 3 months.
Test 5
Liu women, 65 years old, constipation for a long time, before taking the preparation of the application, the stool character: the hard feces is 1 point (slight degree), and the less feces is 3 points (serious degree); rectal symptoms: the defecation is labored for 2 minutes (moderate), the defecation is difficult to be sensed for 3 minutes (serious), the abdominal distension is 4 minutes (serious), the defecation is normal after taking for 10 days, and the defecation is still normal after observing for 3 months.
From the above clinical tests, the composition and the preparation have good treatment effect on senile constipation, and can avoid relapse of the senile constipation.
The above is only a preferred embodiment of the present invention, and it should be noted that the above preferred embodiment should not be considered as limiting the present invention, and the protection scope of the present invention should be subject to the scope defined by the claims. It will be apparent to those skilled in the art that various modifications and adaptations can be made without departing from the spirit and scope of the invention, and these modifications and adaptations should be considered within the scope of the invention.

Claims (7)

1. A traditional Chinese medicine composition for senile constipation is characterized in that: the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30-180 parts of raw bighead atractylodes rhizome, 20-90 parts of plantain seed, 10-25 parts of mulberry, 8-30 parts of radix rehmanniae recen, 5-25 parts of cistanche and 50-150 parts of xylo-oligosaccharide.
2. The traditional Chinese medicine composition for senile constipation according to claim 1, which is characterized in that: the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 50-150 parts of raw bighead atractylodes rhizome, 30-80 parts of plantain seed, 15-20 parts of mulberry, 12-25 parts of radix rehmanniae recen, 10-20 parts of cistanche and 60-100 parts of xylo-oligosaccharide.
3. The traditional Chinese medicine composition for senile constipation according to claim 2, which is characterized in that: the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 80-130 parts of raw bighead atractylodes rhizome, 40-60 parts of plantain seed, 16-18 parts of mulberry, 15-20 parts of radix rehmanniae recen, 12-18 parts of cistanche and 60-100 parts of xylo-oligosaccharide.
4. A preparation of the Chinese medicinal composition for senile constipation according to any one of claims 1 to 3.
5. The formulation of claim 4, wherein: the preparation also comprises pharmaceutically acceptable auxiliary materials, wherein the auxiliary materials are one or more of dextrin, starch, cellulose and derivatives thereof.
6. The formulation of claim 4, wherein: the preparation can be any one of tablets, granules, powder and pills.
7. A method of preparing a formulation according to any one of claims 4 to 6, wherein: pulverizing Atractylodis rhizoma, semen plantaginis, Mori fructus, radix rehmanniae, and Cistanchis herba, adding xylooligosaccharide and pharmaceutically acceptable adjuvants, and making into preparation by conventional method; or crushing raw bighead atractylodes rhizome, plantain seed, mulberry, radix rehmanniae and cistanche, adding water, soaking for 3-8 h, performing steam distillation, adding xylooligosaccharide and pharmaceutically acceptable auxiliary materials, and preparing the preparation according to a conventional method.
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