CN115998820B - Medicinal composition for treating constipation and preparation method and application thereof - Google Patents
Medicinal composition for treating constipation and preparation method and application thereof Download PDFInfo
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Classifications
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention provides a pharmaceutical composition for treating constipation, and a preparation method and application thereof, and belongs to the field of traditional Chinese medicines. The medicine composition is prepared from the following raw materials in parts by weight: 1 to 5 parts of burdock, 1 to 5 parts of stir-fried bighead atractylodes rhizome, 1 to 5 parts of rhizoma polygonati, 1 to 5 parts of radish seed, 1 to 5 parts of stir-fried rhizoma atractylodis and 1 to 5 parts of lotus leaf. The medicinal composition has proper compatibility of medicines, can effectively improve constipation symptoms, and has good treatment effect on constipation, especially chronic constipation. Meanwhile, the medicine composition has low occurrence rate of adverse events, low long-term recurrence rate and high safety when being used for treatment. The pharmaceutical composition has good application prospect.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and in particular relates to a pharmaceutical composition for treating constipation, and a preparation method and application thereof.
Background
Constipation is a common gastrointestinal dyskinesia disease, and according to the report of the related literature, the prevalence of constipation in the crowd is between 2-28%, especially the prevalence of constipation in the crowd over 60 years old exceeds 15%, and the symptoms aggravate with the age, seriously affecting the life quality of the patient. Constipation can induce or aggravate certain diseases such as anal canal straight colon diseases (intestinal obstruction, intestinal cancer, hemorrhoid, etc.), prostate diseases, cardiovascular diseases (coronary heart disease, myocardial infarction, cerebral hemorrhage, etc.), and Alzheimer's disease. In the treatment of constipation, western medicine and western medicine mainly use various symptomatic laxatives, such as lactulose, polyethylene glycol, mosapride, pullulan and the like, but most of the medicines treat the symptoms without treating the root cause, relieve the medication, stop the medication and relapse, have larger side effects, easily cause electrolyte disorder, or cause headache, nausea, vomit, abdominal pain and abdominal distention, even cause colon cancer, and have the risk of inducing cardiovascular and cerebrovascular accidents by individual medicines.
The traditional Chinese medicine for treating constipation mainly has the effects of clearing heat and purgation due to bitter and cold, and the traditional Chinese medicines commonly used for treating constipation at present comprise folium sennae, rheum officinale, aloe and the like. Most laxatives are taken immediately after taking, and the effects of stopping and curing are also good for treating the deficiency of qi and yin, and warming yang, but have no meaning of dredging and descending and have larger difference of curative effect. Especially, the effect of treating chronic constipation is poor.
For the problems of poor treatment effect and easy drug dependence of the existing drugs for treating constipation, in particular chronic constipation, a new pharmaceutical composition for treating constipation needs to be studied.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for treating constipation, and a preparation method and application thereof.
The invention provides a pharmaceutical composition for treating constipation, which is prepared from the following raw materials in parts by weight: 1 to 5 parts of burdock, 1 to 5 parts of stir-fried bighead atractylodes rhizome, 1 to 5 parts of rhizoma polygonati, 1 to 5 parts of radish seed, 1 to 5 parts of stir-fried rhizoma atractylodis and 1 to 5 parts of lotus leaf.
Further, the pharmaceutical composition is prepared from the following raw materials in parts by weight: 3 parts of burdock, 2 parts of stir-fried bighead atractylodes rhizome, 2 parts of rhizoma polygonati, 1.5 parts of radish seed, 1.5 parts of stir-fried rhizoma atractylodis and 1 part of lotus leaf.
Further, the pharmaceutical composition is a pharmaceutical preparation prepared from crude drug powder, water or organic solvent extract of the crude drug in each weight ratio, and pharmaceutically, health-care products or food acceptable auxiliary materials or auxiliary components.
Further, the pharmaceutical formulation is an oral formulation.
Further, the oral preparation is decoction, tablets, powder, granules, pills, capsules and oral liquid.
The invention also provides a method for preparing the pharmaceutical composition, which comprises the following steps:
taking the raw materials with the weight ratio, directly powdering, or adding water or an organic solvent for extraction, and then adding pharmaceutically acceptable auxiliary materials or auxiliary components.
Further, the method comprises the following steps:
(1) Taking the raw materials in each weight proportion;
(2) Soaking fructus Arctii, parched Atractylodis rhizoma, rhizoma Polygonati, raphani semen and parched rhizoma Atractylodis in water, boiling, decocting with slow fire for 10-30 min, adding folium Nelumbinis, decocting with slow fire for 10-30 min, and filtering to obtain medicinal liquid;
(3) Adding water into the dregs again, decocting with slow fire for 30-60 min, and filtering the liquid medicine;
(4) Mixing the two medicinal liquids, and concentrating to obtain the final product;
preferably, in the step (4), the concentration is carried out until the crude drug amount is 0.3-0.4 g/ml.
The invention also provides application of the medicinal composition in preparing a medicament for treating constipation.
Further, the constipation is chronic constipation.
The invention also provides a medicine which is prepared by taking the medicine composition as an active ingredient and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.
Analysis of efficacy of pharmaceutical ingredients in the pharmaceutical composition of the invention:
fructus Arctii: enter lung and stomach meridians. Pungent, bitter and cold in nature. Dispelling wind-heat, dispersing lung qi, promoting eruption, removing toxic substance, and relieving sore throat. Can be used for treating wind-heat type common cold, cough with excessive phlegm, measles, rubella, sore throat, mumps, erysipelas, carbuncle, swelling and sore. Fructus Arctii is rich in grease, cold in nature and smooth in property, has the effect of relaxing bowel, simultaneously, the lung qi is downwards and upwards, the lung qi is downwards and downwards communicated with the large intestine, the large intestine is normally conducted, in addition, the fructus arctii downwards communicated with the stomach qi, the large intestine and the small intestine are all in the stomach, the stomach qi downwards communicated with the stomach promotes food to enter the large intestine and promote gastrointestinal peristalsis, so the fructus arctii can effectively relax bowel, and the medical science in the Yizhong Shenxi list records that the fructus arctii can downwards discharge stool. The burdock is used as a monarch drug because of its mild purgative effect, which is not harmful to the body resistance due to attack such as Da Huang and Mirabilitum.
Stir-frying white atractylodes rhizome: raw white atractylodes rhizome: bitter and sweet in taste, warm in nature, and enters spleen and stomach meridians; invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, relieving sweating, and preventing miscarriage. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and fetal movement. Bai Zhu is mainly taken for relaxing bowels and invigorating spleen and qi.
Rhizoma polygonati: enter spleen, lung and kidney meridians. Sex taste: sweet and flat. The functions are mainly to tonify qi and nourish yin, invigorate spleen, moisten lung and tonify kidney. Can be used for treating weakness of spleen and stomach, tiredness, debilitation, dry mouth, anorexia, lung deficiency, cough, essence and blood deficiency, internal heat and diabetes. The miscellaneous records: mainly tonify middle-jiao and qi, remove rheumatism and calm five zang organs. "Japanese Sunji Ben Cao": "tonify five consumptions and seven injuries, promote tendons and bones, stop hunger, resist cold and summer heat, benefit spleen and stomach, moisten heart and lung. Rhizoma Polygonati has the effects of invigorating spleen and replenishing qi.
The two medicines are used as ministerial medicines for strengthening the spleen and tonifying qi, and expelling evil without damaging healthy qi.
Radish seed: pungent, sweet and flat. Enter lung, spleen and stomach meridians. Promote digestion and remove distention, reduce qi and resolve phlegm. Is used for treating food stagnation, abdominal distention and pain, constipation, diarrhea due to accumulation of food stagnation, phlegm accumulation, asthma and cough. The seeds contain fatty oil and volatile oil. The volatile oil contains methyl mercaptan, etc. The fatty oil contains a large amount of erucic acid, linoleic acid, linolenic acid, erucic acid glyceride and the like, and the following is compendium: "lower qi to relieve asthma, treat phlegm, promote digestion, relieve distension, relieve constipation, stop pain, and severe after diarrhea, develop sore and rash. "treating secret of wind and secret of qi": radish seeds (stir-fried) are mixed together, mixed with water and ground to be taken together with gleditsia sinensis powder. (SHOU DONG SHEN FANG). Radish seeds are also seed medicines, are rich in grease, and assist monarch medicine burdock in moistening intestines and reducing blood, and are adjuvant medicines.
Stir-fried rhizoma atractylodis: it enters spleen, stomach and liver meridians. Sex taste: pungent and bitter, warm. The main functions are as follows: dry dampness, invigorate spleen, expel wind, dispel cold, improve eyesight. Can be used for treating abdominal distention, diarrhea, edema, tinea pedis , rheumatalgia, common cold due to wind-cold, and night blindness. Zhu Xuan heng is called "Zhu is a foot yang and Ming Jing medicine, has a strong smell, strengthens stomach and spleen, and generates qi of cereal, can be used as various medicines, dredges dampness of Yangming, passes through and astringes" can live the monarch medicine radish seed and move qi, and helps ministerial medicine largehead atractylodes rhizome to invigorate spleen and dehumidify. But also restrict the burdock from excessively slipping. Modern research has found that: atractylol has effects of promoting gastrointestinal motility, and slightly contracting stomach smooth muscle. The two medicines are used as adjuvant medicines together.
Bitter lotus leaf and flat. It enters liver, spleen and stomach meridians. Clear summer heat, raise clear yang, cool blood and stop bleeding. Can be used for treating summer heat, polydipsia, summer heat, diarrhea, spleen deficiency diarrhea, hematemesis, hematochezia, metrorrhagia, and metrostaxis. In this recipe, the actions of ascending and developing yang are mainly taken to cause qi to circulate. Is a guiding drug in the prescription.
The whole formula is as follows: the product for moistening intestines and removing obstruction is taken as a monarch drug, qi, blood and yin and yang are regulated together as ministerial drugs, and the product for pungent, warm, dry and wet and smooth is taken as auxiliary drugs, so that the product can promote the growth of clear yang, clear the accumulation and the retention of stool in intestines, promote qi circulation and remove stagnation without damaging vital qi, and has remarkable clinical curative effect. Especially has better curative effect on refractory chronic constipation with complicated illness.
In the present invention, chronic constipation refers to constipation with a disease course exceeding 6 months.
The medicinal composition has proper compatibility of medicines, can effectively improve constipation symptoms, and has good treatment effect on constipation, especially chronic constipation. Meanwhile, the medicine composition has low occurrence rate of adverse events, low long-term recurrence rate and high safety when being used for treatment. The pharmaceutical composition has good application prospect.
It should be apparent that, in light of the foregoing, various modifications, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
The above-described aspects of the present invention will be described in further detail below with reference to specific embodiments in the form of examples. It should not be understood that the scope of the above subject matter of the present invention is limited to the following examples only. All techniques implemented based on the above description of the invention are within the scope of the invention.
Detailed Description
The materials and equipment used in the embodiments of the present invention are all known products and are obtained by purchasing commercially available products.
EXAMPLE 1 preparation of the pharmaceutical composition of the invention
The formula comprises the following components: 30g of burdock, 20g of stir-fried bighead atractylodes rhizome, 20g of rhizoma polygonati, 15g of radish seed, 15g of stir-fried rhizoma atractylodis and 10g of lotus leaf.
The preparation method comprises the following steps: 30g of burdock, 20g of stir-fried bighead atractylodes rhizome, 20g of rhizoma polygonati, 15g of radish seed and 15g of stir-fried rhizoma atractylodis are put into a porcelain pot, 800ml of water is added for soaking for 30 minutes, after boiling, the mixture is decocted with slow fire for 10 minutes, then 10g of lotus leaf is put into the pot, the mixture is continuously decocted with slow fire for 20 minutes, the liquid medicine is filtered, 500ml of water is added again, the mixture is decocted with slow fire for 30 minutes, after filtration, the mixture of the two liquid medicines is uniformly mixed and concentrated into 300ml of decoction, and the crude drug content is 0.37g/ml.
The administration method comprises the following steps: the decoction is 1 dose, and is taken three times a day, 100ml each time, and half an hour before three meals.
EXAMPLE 2 preparation of the pharmaceutical composition of the invention
The formula comprises the following components: 10g of burdock, 50g of fried bighead atractylodes rhizome, 10g of rhizoma polygonati, 10g of radish seed, 10g of fried rhizoma atractylodis and 10g of lotus leaf.
The preparation method comprises the following steps: putting fructus Arctii, parched Atractylodis rhizoma, rhizoma Polygonati, raphani semen and parched rhizoma Atractylodis into a porcelain pot, adding 800ml of water, soaking for 30min, boiling, decocting with slow fire for 10 min, adding folium Nelumbinis, decocting with slow fire for 20 min, filtering, adding 500ml of water again, decocting with slow fire for 30min, filtering, mixing the two decoctions, and concentrating into 300ml decoction.
The administration method comprises the following steps: the decoction is 1 dose, and is taken three times a day, 100ml each time, and half an hour before three meals.
EXAMPLE 3 preparation of the pharmaceutical composition of the invention
The formula comprises the following components: 50g of burdock, 10g of stir-fried bighead atractylodes rhizome, 50g of rhizoma polygonati, 50g of radish seed, 50g of stir-fried rhizoma atractylodis and 50g of lotus leaf.
The preparation method comprises the following steps: putting fructus Arctii, parched Atractylodis rhizoma, rhizoma Polygonati, raphani semen and parched rhizoma Atractylodis into a porcelain pot, adding 800ml of water, soaking for 30min, boiling, decocting with slow fire for 10 min, adding folium Nelumbinis, decocting with slow fire for 20 min, filtering, adding 500ml of water again, decocting with slow fire for 30min, filtering, mixing the two decoctions, and concentrating into 300ml decoction.
The administration method comprises the following steps: the decoction is 1 dose, and is taken three times a day, 100ml each time, and half an hour before three meals.
The beneficial effects of the present invention are demonstrated by specific test examples below.
Test example 1 clinical efficacy of the pharmaceutical composition of the present invention on patients with chronic Constipation
1. Experimental method
1.1 Western diagnostic criteria:
according to 2016 Roman IV: diagnostic criteria for functional constipation in functional gastroenteropathy:
(1) The following 2 items or more than 2 items must be included:
1/4 (25%) of the defecation feel laborious
b.1/4 (25%) or more of the feces are dry ball feces or hard feces (Bristol feces property Meter 1-2)
More than 1/4 (25%) of the defecation has an endless feeling
d.1/4 (25%) of the bowel movements have anorectal obstruction/blockage sensation
e.1/4 (25%) of the defecation needs assistance of the manipulation (such as assisting defecation with fingers and supporting the bottom of the basin)
f. Spontaneous Stool (SBM) less than 3 times per week
(2) Little dilute manure is produced when no laxative is used
(3) Does not meet the diagnostic criteria for Irritable Bowel Syndrome (IBS)
(4) The pre-diagnosis symptoms appear for at least 6 months, and the last 3 months meet the diagnosis standards.
1.2 inclusion criteria
(1) Meets the diagnostic criteria, ages 18-70;
(2) The male and female are not limited;
(3) The cognitive ability is normal, the experimental scheme is accepted and complied with voluntarily, and the review and follow-up visit are accepted on time;
(4) And signing an informed consent form.
1.3 test subjects
180 patients are chronic constipation patients meeting the Western diagnosis standard. These patients have the following characteristics in TCM: traditional Chinese medicine mainly shows dryness-syndrome dampness-clamping due to yin deficiency, and has the symptoms of emotional irritability, heavy body, debilitation, dry mouth, yellow urine, distention and fullness in the abdomen, red and dry tongue, thick coating and thready and astringent pulse. Main symptoms are as follows: 1) Dry stool like sheep vector; 2) Abdominal distension; 3) Heavy weight and weakness. Secondary symptoms: 1) Drying the mouth; 2) Difference in sodium; 3) Restlessness and insomnia. Tongue pulse: a red tongue with cracks, thick coating and a thready and astringent pulse.
All patients were outpatients. Test group 60 cases: male 22, female 38; polyethylene glycol group 60 cases: male 27, female 33; fructus Cannabis pill group 60 cases: male 29, female 31.
1.4 methods of administration
Test group orally administered the pharmaceutical composition prepared in example 1 of the present invention one dose per day, 3 times per day; polyethylene glycol 4000 powder 10g qd, optionally added to bid; fructus Cannabis pill group oral fructus Cannabis pill 6g tid. Normal diet during the period of taking the medicine, and any other laxative drugs are stopped.
Day 1, 3 and 7 of administration are observation and record days, and other times are observed at any time. The administration of the medicine is carried out for 7 days as a treatment course, and each group is administered for 4 treatment courses.
1.5 efficacy evaluation criteria
(1) Clinical efficacy evaluation criteria: spontaneous defecation times up to 3 times per week and more, or more than one time before treatment, are defined as effective, otherwise ineffective.
(2) Traditional Chinese medicine syndrome curative effect evaluation standard: reference is made to "Constipation Chinese medical science and treatment expert consensus opinion 2017" (Zhang Shengsheng et al, J.traditional Chinese medicine, 2017,58 (15): 1345-1350.). Calculated by nimodipine method: efficacy index = (pre-treatment integral-post-treatment integral)/pre-treatment integral x 100%. The traditional Chinese medicine is divided into clinical recovery, obvious effect, effectiveness and ineffectiveness, and 4 grades are formed: 1) Clinical recovery: the main symptoms and the physical signs disappear or disappear basically, and the curative effect index is more than or equal to 95%; 2) The effect is shown: the main symptoms and the physical signs are obviously improved, and the curative effect index is more than or equal to 70% and less than 95%; 3) The method is effective: the main symptoms and the physical signs are obviously improved, and the curative effect index is less than 70% and is more than or equal to 30%; 4) Invalidation: the main symptoms and the physical signs are not obviously improved or even aggravated, and the curative effect index is less than 30 percent.
The traditional Chinese medicine syndrome curative effect scale is formulated by referring to the relevant digestive system syndrome part of the guidelines of clinical research of new traditional Chinese medicine in 2002.
The symptoms assessed by this scale include: abdominal distention, diet reduction, weight loss, debilitation, dry mouth, vexation, insomnia, sticky and greasy stool, difficult stool in a stool pond, dry and hard stool, tongue appearance and pulse appearance in total of 11. The severity scale of symptoms was: normal, mild, moderate, severe. Normal refers to the absence of this syndrome, mild refers to a slight impact on life, moderate refers to a significant impact on life, and severe refers to a severe impact on life. Wherein the symptoms except for tongue pulse are respectively assigned 0, 1, 2 and 3 points according to normal, mild, moderate and severe symptoms; the tongue and pulse are normally and abnormally assigned 0 and 1 points. The final score of the traditional Chinese medicine syndromes is the sum of the scores of the syndromes.
2. Results
TABLE 1 clinical efficacy of the pharmaceutical composition of the invention for patients with chronic constipation
| Group of | Effective and effective | Invalidation of | Effective rate of |
| Test group | 55 | 5 | 91.67％ |
| Polyethylene glycol group | 36 | 24 | 60.0％▲ |
| Hemp seed pill group | 31 | 29 | 51.67％★ |
Note that: the graph shows that the difference between the polyethylene glycol group and the test group has statistical significance, and P is less than 0.05; the difference of the fructus cannabis pill group compared with the test group has statistical significance, and P is less than 0.05.
The results in Table 1 show that the effective rate of the pharmaceutical composition for treating chronic constipation is obviously better than that of polyethylene glycol and hemp seed pills, and the difference has statistical significance.
TABLE 2 comparison of the results of the curative effects of the three groups of Chinese medical science syndromes
| Group of | Healing of the wound | Has obvious effect | Effective and effective | Invalidation of | Total effective rate |
| Test group | 26 | 18 | 12 | 4 | 93.33％ |
| Polyethylene glycol group | 12 | 5 | 22 | 21 | 65.0％▲ |
| Hemp seed pill group | 15 | 7 | 25 | 13 | 78.33％★ |
Note that: the graph shows that the difference between the polyethylene glycol group and the test group has statistical significance, and P is less than 0.05; the difference of the fructus cannabis pill group compared with the test group has statistical significance, and P is less than 0.05.
The results in Table 2 show that the traditional Chinese medicine curative effect of the pharmaceutical composition for treating chronic constipation is obviously superior to that of polyethylene glycol and hemp seed pills, and the difference has statistical significance.
Test example 2 clinical efficacy and safety of the pharmaceutical composition of the present invention for patients with chronic Constipation
1. Study object
1.1 test subjects
The study was incorporated into 180 patients, and the department of gastroenterology and anorectal surgery were affiliated to the department of Hospital at Chuan North medical school. According to the following steps of 1:1 ratio, 90 cases were divided into an observation group and a control group by a random numerical method. Test group male 34, female 56; age 25-70 years, average (60.25+ -11.47) years; the course of the disease is 1-9 years, and the average (3.78+/-2.69) years; mild 15 cases, moderate 51 cases and severe 24 cases. Polyethylene glycol group, 35 men and 55 women; age 31-70 years, average (59.18±12.35) years; the course of the disease is 2-11 years, and the average (3.93+/-2.75) years; mild 15 cases, moderate 47 cases and severe 28 cases. The baseline data of gender, age, course of disease and severity of the two groups of patients are compared, and the differences have no statistical significance and are comparable.
Patient severity was judged according to the guidelines for diagnosis and treatment of chronic constipation in China (2013, wuhan) (gastroenterology, volume 18, 10, 605-612, 2013): constipation and related symptoms are classified into mild, moderate and severe according to their extent of influence on life. Mild means that the symptoms are lighter, the daily life is not affected, and normal defecation can be recovered through integral adjustment and short-time medication. Severe constipation means severe and persistent symptoms, severely affecting work and life, requiring medication, failing to stop medication or ineffective medication. The moderate level is between mild and severe.
1.2 diagnostic criteria
According to 2016 Roman IV: diagnostic criteria for functional constipation in functional gastroenteropathy:
(1) The following 2 items or more than 2 items must be included:
1/4 (25%) of the defecation feel laborious
b.1/4 (25%) or more of the feces are dry ball feces or hard feces (Bristol feces property Meter 1-2)
More than 1/4 (25%) of the defecation has an endless feeling
d.1/4 (25%) of the bowel movements have anorectal obstruction/blockage sensation
e.1/4 (25%) of the defecation needs assistance of the manipulation (such as assisting defecation with fingers and supporting the bottom of the basin)
f. Spontaneous Stool (SBM) less than 3 times per week
(2) Little dilute manure is produced when no laxative is used
(3) Does not meet the diagnostic criteria for Irritable Bowel Syndrome (IBS)
(4) The pre-diagnosis symptoms appear for at least 6 months, and the last 3 months meet the diagnosis standards.
1.3 inclusion criteria
(1) Meets the diagnostic criteria, ages 18-70;
(2) The male and female are not limited;
(3) The cognitive ability is normal, the experimental scheme is accepted and complied with voluntarily, and the review and follow-up visit are accepted on time;
(4) And signing an informed consent form.
2. Intervention measures
Test group orally administered the pharmaceutical composition prepared in example 1 of the present invention one dose per day, 3 times per day; polyethylene glycol 4000 powder 10g qd was given to the polyethylene glycol group, which can be added to bid as appropriate. Normal diet during the period of taking and disabling any other laxative medication (including anal topical administration).
Day 1, 3 and 7 of administration are observation and record days, and other times are observed at any time. The administration of the medicine is carried out for 7 days as a treatment course, and each group is administered for 4 treatment courses.
3. Observation index
(1) Constipation main symptom score
TABLE 3 Constipation Primary symptom score
| Score value | Fecal trait | The defecation is laborious | Defecation time/min | Drop, endless, distention feeling | Defecation frequency/time/d | Abdominal distension |
| 0 | IV-VII type | Without any means for | ＜10 | Without any means for | 1～2 | Without any means for |
| 1 | III type | Occasionally | 10～15 | Occasionally | 3 | Occasionally |
| 2 | Type II | Sometimes have | 16～25 | Sometimes have | 4～5 | Sometimes have |
| 3 | Type I | Often times | ＞25 | Often times | ＞5 | Often times |
Fecal trait reference Bristol fecal typing standard: type I nut-shaped hard balls; type II, induration sausage; III, sausage-like, with cracks on the surface; type IV, smooth surface, soft sausage-like; v-shaped, soft dough; VI, pasty feces; type VII, water sample is easy. IV-VII type, counting 0 minutes; type III, count 1 minute; type II, count 2; type I, count 3 minutes.
(2) Constipation patients' symptoms self-rating scale (PAC-SYM) comprising 3 dimensions of abdominal symptoms (3 entries), rectal symptoms (7 entries) and bowel symptoms (2 entries), 12 entries in total, each entry being assigned 0, 1, 2, respectively, according to "no such symptoms", "slight", "moderate", "severe", "very severe" respectively,
3. A score of 4 indicates that the higher the score, the more severe the constipation symptom. Each evaluation was performed 1 time before and after the treatment.
(3) On average, the number of spontaneous complete bowel movements per week (SCBM) was more than or equal to 3, which could be considered normal bowel movements.
4. Efficacy evaluation criteria: is formulated with reference to the consensus opinion of constipation medical science and medical professionals (2017) (Zhang Shengsheng, etc., J.Chinese.J. 2017,58 (15): 1345-1350.). The improvement percentage of symptoms is more than or equal to 80 percent, the defecation is carried out for 1 time/1-2 days, the defecation is smooth without difficulty, and the residual feeling is avoided after defecation; the obvious effect is that the symptom improvement percentage is more than or equal to 50 percent and less than 80 percent, and the excrement is 1 time/3 to 4 days; the constipation symptoms are effectively improved, and the symptom improvement percentage is less than or equal to 30 percent and less than 50 percent; the constipation symptoms are not improved, and the symptom improvement percentage is less than 30%.
Percent symptom improvement = (pre-treatment integral-post-treatment integral)/pre-treatment integral x 100%, pre-treatment and post-treatment integral were calculated as per table 3.
Follow-up for 3 months to observe long-term curative effect and record adverse events
5. Results
5.1 comparison of therapeutic effects
TABLE 4 comparison of efficacy
| Group of | Healing | Has obvious effect | Effective and effective | Invalidation of | Effective rate of |
| Test group | 26 | 45 | 12 | 7 | 92.22％ |
| Polyethylene glycol group | 7 | 16 | 24 | 43 | 52.22％▲ |
Note that: the scale of the table indicates that the differences between the polyethylene glycol group and the test group are statistically significant, and P < 0.05.
From the results in table 4, it can be seen that: the effective rate of the pharmaceutical composition is obviously better than that of polyethylene glycol, and the difference has statistical significance, which proves that the Chinese medicinal composition can effectively relieve chronic constipation.
5.2 comparison of Constipation Primary symptom score after treatment of two groups of patients
TABLE 5 comparison of constipation Primary symptom scores after treatment for two groups of patients
| Score value | Fecal trait | The defecation is laborious | Defecation time/min | Drop, endless, distention feeling | Defecation frequency/time/d | Abdominal distension |
| Test group | 0.50±0.19 | 0.49±0.18 | 0.49±0.16 | 0.49±0.16 | 0.42±0.15 | 0.46±0.14 |
| Polyethylene glycol group | 0.90±0.25 ▲ | 0.92±0.24 ▲ | 0.93±0.29 ▲ | 0.803±0.20 ▲ | 0.82±0.23 ▲ | 0.91±0.23 ▲ |
Note that: the scale of the table indicates that the differences between the polyethylene glycol group and the test group are statistically significant, and P < 0.05.
From the results in Table 5, it can be seen that: the effective rate of the pharmaceutical composition is obviously better than that of polyethylene glycol, and the difference has statistical significance, which proves that the Chinese medicinal composition can effectively relieve chronic constipation.
5.3 comparison of the scores of the two groups of post-treatment PAC-SYM Scale
TABLE 6 comparison of the PAC-SYM scale scores after two groups of treatments
| Score value | Abdominal symptoms | Rectal symptoms | Symptoms of stool | PAC-SYM total score |
| Test group | 2.24±0.58 | 8.11±0.54 | 0.78±0.31 | 11.02±1.77 |
| Polyethylene glycol group | 3.54±0.45 ▲ | 10.57±2.52 ▲ | 1.20±0.55 ▲ | 14.51±4.87 ▲ |
Note that: the scale of the table indicates that the differences between the polyethylene glycol group and the test group are statistically significant, and P < 0.05.
5.4 SCBM comparison after treatment of two groups of patients
TABLE 7 comparison of SCBM after treatment of two groups of patients
| Group of | Number of examples | First week of | Second week | Third week | Fourth periphery |
| Test group | 90 | 1.34±0.35 | 2.13±0.4 | 2.87±0.69 | 4.12±1.02 |
| Polyethylene glycol group | 90 | 1.17±0.38 ▲ | 1.57±0.72 ▲ | 2.01±0.59 ▲ | 2.86±0.69 ▲ |
Note that: the scale of the table indicates that the differences between the polyethylene glycol group and the test group are statistically significant, and P < 0.05.
5.5 comparison of safety and recurrence Rate of two groups of patients
TABLE 8 comparison of safety and recurrence rates for two groups of patients
| Group of | Adverse events | Recurrence of | Recurrence rate |
| Test group | 2 | 11 | 12.22％ |
| Polyethylene glycol group | 12 | 32 | 35.56％▲ |
Note that: the scale of the table indicates that the differences between the polyethylene glycol group and the test group are statistically significant, and P < 0.05.
The experimental results show that: the pharmaceutical composition can effectively reduce the occurrence of adverse events, reduce the recurrence rate and has good safety while effectively treating chronic constipation.
In conclusion, the medicinal composition has proper compatibility of medicines, can effectively improve constipation symptoms, and has good treatment effect on constipation, especially chronic constipation. Meanwhile, the medicine composition has low occurrence rate of adverse events, low long-term recurrence rate and high safety when being used for treatment. The pharmaceutical composition has good application prospect.
Claims (10)
1. A pharmaceutical composition for treating constipation, characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:
3 parts of burdock, 2 parts of stir-fried bighead atractylodes rhizome, 2 parts of rhizoma polygonati, 1.5 parts of radish seed, 1.5 parts of stir-fried rhizoma atractylodis and 1 part of lotus leaf.
2. The pharmaceutical composition according to claim 1, wherein: the medicine is a pharmaceutical preparation prepared from crude drug powder of the raw materials in weight ratio, water or organic solvent extract, and pharmaceutically, health-care products or food acceptable auxiliary materials or auxiliary components.
3. The pharmaceutical composition according to claim 2, wherein: the pharmaceutical preparation is an oral preparation.
4. A pharmaceutical composition according to claim 3, characterized in that: the oral preparation is decoction, tablet, powder, granule, pill, capsule and oral liquid.
5. A process for preparing a pharmaceutical composition according to any one of claims 1 to 4, characterized in that: it comprises the following steps:
taking the raw materials with the weight ratio, directly powdering, or adding water or an organic solvent for extraction, and then adding pharmaceutically acceptable auxiliary materials or auxiliary components.
6. The method according to claim 5, wherein: it comprises the following steps:
(1) Taking the raw materials in each weight proportion;
(2) Soaking fructus Arctii, parched Atractylodis rhizoma, rhizoma Polygonati, raphani semen and parched rhizoma Atractylodis in water, boiling, decocting with slow fire for 10-30 min, adding folium Nelumbinis, decocting with slow fire for 10-30 min, and filtering to obtain medicinal liquid;
(3) Adding water into the dregs again, decocting with slow fire for 30-60 min, and filtering the liquid medicine;
(4) Mixing the two medicinal liquids, and concentrating.
7. The method according to claim 6, wherein: in the step (4), the concentration is carried out until the crude drug amount is 0.3-0.4 g/ml.
8. Use of a pharmaceutical composition according to any one of claims 1 to 4 for the preparation of a medicament for the treatment of constipation.
9. Use according to claim 8, characterized in that: the constipation is chronic constipation.
10. A medicament, characterized in that: the pharmaceutical composition is prepared by taking the pharmaceutical composition as an active ingredient and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.
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Non-Patent Citations (3)
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| "术莱煎剂"治疗泻药性便秘30例临床观察;刘仍海;北京中医药大学学报(中医临床版);-(03);25页右栏第4段 * |
| 中风后便秘的中医证型分布规律及相关因素研究;展文哲;中国优秀硕士学位论文全文数据库 (医药卫生科技辑)(第1期);E056-1012, 16-18页 * |
| 单味牛蒡子治疗习惯性便秘;李贯彻;中医杂志;第38卷(第12期);709页 * |
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