CN116870119B

CN116870119B - Traditional Chinese medicine composition and preparation for treating functional constipation with anxiety depression state and application of traditional Chinese medicine composition and preparation

Info

Publication number: CN116870119B
Application number: CN202310954718.3A
Authority: CN
Inventors: 陈明显; 刘赛月; 陶凌辉
Original assignee: Zhejiang Provincial Tongde Hospital Zhejiang Institute Of Mental Health
Current assignee: Zhejiang Provincial Tongde Hospital Zhejiang Institute Of Mental Health
Priority date: 2023-07-31
Filing date: 2023-07-31
Publication date: 2024-01-30
Anticipated expiration: 2043-07-31
Also published as: CN116870119A

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating functional constipation with anxiety depression, a preparation and application thereof. A traditional Chinese medicine composition for treating functional constipation with anxiety depression state comprises the following active ingredient raw materials in parts by weight: monarch drug: 10-20 parts of kudzuvine root and 10-20 parts of curcuma longa; ministerial drugs: 15-25 parts of fructus cannabis and 5-15 parts of prepared rheum officinale; adjuvant drug: 10-20 parts of poria cocos and 2-10 parts of honey-fried licorice root; the preparation method comprises the following steps: 25-35 parts of calabash shell, 15-25 parts of radix skeleton, 2-10 parts of roasted cimicifugae foetidae and 5-15 parts of fried immature bitter orange. The beneficial effects of the invention are as follows: the traditional Chinese medicine composition for treating the functional constipation with anxiety depression provided by the invention can effectively improve the traditional Chinese medicine symptoms of the patient with the functional constipation with anxiety depression, has low recurrence rate, has a better long-term curative effect, and has good safety.

Description

Traditional Chinese medicine composition and preparation for treating functional constipation with anxiety depression state and application of traditional Chinese medicine composition and preparation

Technical Field

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating functional constipation with anxiety depression, a preparation and application thereof.

Background

Functional constipation (functional constipation, FC) is a functional bowel disorder manifested as difficulty in defecation, reduced number of times of defecation, or dislike of defecation, and does not meet the diagnostic criteria for constipation-predominant irritable bowel syndrome (irritable bowel syndrome with predominant constipation, IBS-C). Related medical researches show that long-term constipation can cause anorectal lesions such as hemorrhoids, anal fissure and the like, and cause a certain psychological burden to patients, so that the problems such as anxiety, depression, insomnia and the like of the patients are caused, even suicide tendency is caused, and cardiovascular and cerebrovascular diseases are often induced to occur accidentally in the old people. For a long time, constipation not only brings more health problems to the social group, but also causes additional medical expenses and increases the social burden. The clinical symptoms of functional constipation are closely related to mental and psychological factors, and are a common heart and body disease. Along with the continuous development of social economy, the life rhythm of people is continuously accelerated, and the mental state is changed, so that bad moods such as anxiety, depression, impatience, low fall and the like are very easy to generate, and the gastrointestinal function is influenced. In recent years, with the advent of bio-psycho-social medical modalities, the understanding of the correlation of functional constipation with anxiety-depressive states has been increasingly appreciated by more medical practitioners.

The reasons why functional constipation is often accompanied by anxiety-depressive states are currently unknown, and may be related to various factors such as nervous system regulation, ghrelin, neurotransmitters, immune system, intestinal microorganisms, and the like. The brain-gut axis, the bi-directional neuro-endocrine network system, has been demonstrated to be the link and pathway of the interaction between the gastrointestinal nervous system and the central nervous system. It has been found that the nerve center can inhibit gastric acid secretion and gastrointestinal motility through certain transmitters. At present, no treatment scheme for clearly treating functional anxiety-depression state clinically exists, and anti-anxiety antidepressant drugs can be added for patients with severe anxiety-depression, but certain side effects and strong dependence exist.

Functional constipation belongs to the category of constipation in traditional Chinese medicine, and ancient doctors recognized that constipation is caused by failure of large intestine conduction, but has close relationship with liver and spleen. "Su Wen-Yu machine Zhen Zong Lun (true dirty discussion of Su Wen-Yu machine): spleen deficiency, nine orifices obstruction. "Suling Weizhiyanjie" is: "diet decompensation, which is the right to spleen; stool is excreted and dredged, and its role is to liver. The anxiety and depression state belongs to the Chinese medicine 'depression syndrome', and the etiology of the anxiety and depression state is mainly viscera weakness or qi dysfunction. The disease location is mainly in the liver and spleen, and is mainly manifested by incoordination between the liver and spleen or impairment of qi and yin. The clinical manifestations are various, especially sad and most irritating. Functional constipation and anxiety depression are both particularly closely related to the liver and spleen. "Zhongxihuitong medical meridian essence-viscera treating Chaozhen" is: liver and large intestine are communicated, liver diseases should dredge large intestine and large intestine diseases should pacify liver mainly. Liver and spleen and stomach are the relationship of wood and earth and qi, and if anxiety and anger occur, the emotion is uncomfortable, qi stagnation damages the liver, liver failing to drain, and the spleen is transversely reversed to affect the stomach, so that the spleen and stomach are incoordinated, qi movement is smooth, and transportation and transformation are abnormal, so constipation is aggravated.

Applicant finds that functional constipation is associated with anxiety-depressive states in more and more patients or is related to overstrain of modern people during clinical diagnosis and treatment. With the development of economy and society, the complexity of work is gradually increased, the technical pressure is gradually enlarged, the study and life cost of people is gradually increased, and the mental pressure is increased day by day, so that liver depression and qi stagnation are caused, and the qi movement is influenced; many bad life habits, such as hunger, alcohol consumption and night, bed trouble, etc., damage healthy qi, cause weakness of spleen and stomach, abnormal ascending and descending, failure of food essence to nourish the viscera and six fu organs, constipation caused by the weak transportation and transformation of the intestinal tract due to deficiency of body fluid, and abnormal liver evacuation caused by qi and blood deficiency, further affecting qi movement. Constipation is caused by stagnation of liver and spleen, malnutrition of muscles, abnormal ascending and descending of qi, weak transportation and transformation of large intestine, and qi obstruction of viscera. On the other hand, liver governs emotion and spleen governs thinking, so that normal functions of the viscera are impaired, and anxiety and depression emotion is generated. The applicant finds that the patients with functional constipation and anxiety depression often have symptoms of neck and back muscle tension in years of clinical observation, and realizes that the symptoms are spleen-dominant muscles, liver-spleen unsmooth expression, qi obstruction of the viscera, abnormal ascending and descending, constipation, and anxiety depression often accompany. Therefore, the core of the treatment of functional constipation and anxiety depression is 'unobstructed liver and spleen'.

Disclosure of Invention

Aiming at the defects of the prior art, the invention provides a traditional Chinese medicine composition for treating functional constipation with anxiety depression and application thereof. The traditional Chinese medicine composition disclosed by the invention is capable of effectively improving the traditional Chinese medicine symptoms of a patient with functional constipation and anxiety depression, low in recurrence rate, good in long-term curative effect and good in safety.

In order to achieve the above purpose, the present invention adopts the following technical scheme:

a traditional Chinese medicine composition for treating functional constipation with anxiety depression state comprises the following active ingredient raw materials in parts by weight:

monarch drug: 10-20 parts of kudzuvine root and 10-20 parts of curcuma longa;

ministerial drugs: 15-25 parts of fructus cannabis and 5-15 parts of prepared rheum officinale;

adjuvant drug: 10-20 parts of poria cocos and 2-10 parts of honey-fried licorice root;

the preparation method comprises the following steps: 25-35 parts of calabash shell, 15-25 parts of radix skeleton, 2-10 parts of roasted cimicifugae foetidae and 5-15 parts of fried immature bitter orange.

Preferably, the active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight:

monarch drug: 12-18 parts of kudzuvine root and 12-18 parts of curcuma longa;

ministerial drugs: 18-22 parts of fructus cannabis and 8-12 parts of prepared rheum officinale;

adjuvant drug: 12-18 parts of poria cocos, 4-8 parts of honey-fried licorice root;

the preparation method comprises the following steps: 28-32 parts of calabash shell, 18-22 parts of radix skeleton, 4-8 parts of roasted cimicifugae foetidae and 8-12 parts of fried immature bitter orange.

monarch drug: 15 parts of kudzuvine root and 15 parts of curcuma longa;

ministerial drugs: 20 parts of fructus cannabis and 10 parts of prepared rheum officinale;

adjuvant drug: 15 parts of poria cocos and 6 parts of honey-fried licorice root;

the preparation method comprises the following steps: 30 parts of cucurbit shell, 20 parts of ground skeleton, 6 parts of roasted cimicifuga foetida and 10 parts of fried immature bitter orange.

Preferably, the Chinese medicinal composition further comprises other Chinese medicinal extracts and/or other raw materials.

Preferably, the traditional Chinese medicine composition preparation comprises a traditional Chinese medicine composition and/or a pharmaceutical adjuvant and/or a food additive.

Preferably, the Chinese medicinal composition preparation is a tablet, a chewable tablet, a powder, a granule, a electuary, a capsule, a paste, a pill or a liquid preparation.

Furthermore, the invention also discloses application of the traditional Chinese medicine composition or the traditional Chinese medicine composition preparation in preparing medicines for treating functional constipation with anxiety depression and/or treating functional constipation with anxiety depression.

The principle of the formula design of the invention:

monarch drug: pueraria lobata and curcuma zedoary are monarch drugs, and Pueraria lobata can activate qi and blood, raise stomach yang, and has the effects of clearing and improving qi and reducing viscera; wenyujin is a herb that can break qi and blood stasis, can lower qi to remove damp-heat in viscera, and can relieve stagnation of meridian qi and dredge liver and spleen.

Ministerial drugs: the prepared rhubarb and the fructus cannabis are ministerial drugs, and are used for purgation without difficulty, moistening dryness and lubricating intestines.

Adjuvant drug: poria cocos and honey-fried licorice root are used as adjuvant drugs to strengthen the spleen and stomach and harmonize the middle energizer.

The preparation method comprises the following steps: the cucurbit shell and the ground skeleton are used as guiding drugs to promote qi circulation and relieve distention, and together assist in purgation. The baked cimicifugae rhizoma and the baked fructus Aurantii Immaturus are combined to circulate the intestinal qi and restore the normal ascending and descending.

The traditional Chinese medicine composition raw materials play roles of purging and softening hard masses and smoothening liver and spleen, so that qi movement of spleen and stomach is smoothened, liver and gall stagnation is relieved, mind is calm, constipation is eliminated, and emotion is self-regulated.

The single medicine analysis of the formula of the invention:

pueraria root, radix Puerariae, pungent and sweet, enters spleen, stomach and large intestine meridians. The book of materia medica book of changes: the kudzuvine root is pungent, sweet and dispersed, and has the effects of activating qi and blood and removing all arthralgia. Pungent and sweet in flavor and entering the stomach, activating stomach yang, yang strengthening spleen yin. The kudzuvine root can induce sweat to relieve muscle, remove arthralgia and dredge collaterals, effectively relieve intestinal canal and muscle spasm, and promote stomach yang and smooth spleen and stomach qi. In the recipe, the actions of ascending yang, activating arthralgia and regulating qi movement are taken. Wherein, the pueraria polysaccharide can reduce the concentration of isovaleric acid and isobutyric acid in cecum and enrich the diversity of intestinal flora. Meanwhile, the compound has good anti-inflammatory, antioxidant, antibacterial and antitumor activities, and can promote the growth of immune cells and immune organs. Puerarin can reverse Aβ -induced nerve injury, inhibit apoptosis of neurons in brain, and improve cognitive function by reducing Aβ level and inhibiting deposition of Aβ in brain tissue.

Wenyujin is pungent, bitter and warm, and enters the liver and spleen meridians. Tang Ben Cao (Tang materia Medica) is called "accumulation of the main heart and abdomen, , the lower qi, and blood stasis. Wenyujin is capable of breaking blood and promoting qi circulation and removing wind-damp arthralgia. Zhang Yue is combined with Zhi Hui, gui Xin and gan Cao to treat distention and inappetence, zhu Danxi is also commonly used to treat distention and fullness, mass, distention and other diseases. The recipe takes the actions of promoting qi circulation, resolving hard mass, breaking blood and relieving arthralgia. Curcumin contained in rhizoma Wenyujin Concisa can well regulate intestinal flora, repair intestinal mucosa barrier, improve intestinal function, and promote digestion and absorption of lipid. Meanwhile, the curcumin can inhibit intestinal inflammation, inhibit intestinal spasm, increase secretion of bicarbonate, gastrin, pancreatic gastrin and pancreatin, and has certain antioxidant and antitumor effects. In addition, curcumin can activate mitogen activated protein kinase/extracellular signal to regulate intracellular targets such as kinase pathway, inhibit gene expression of cytokines in prefrontal cortex and hippocampus, and exert antidepressant effect.

Fructus cannabis, sweet in flavor, neutral in nature, enters spleen, stomach and large intestine meridians. "Liwucang, broken accumulation, anti-arthralgia, taken for a long time" as in Ben Cao Jing Ji Jie Ji, it can moisten stomach and intestine and unblock the nodulation of meridians "as in Chang Sha Yao Jie. Summarizing the clinical application, the traditional Chinese medicine has the effects of relaxing bowel, promoting qi circulation, removing accumulation, nourishing yin, supplementing blood and tonifying deficiency. It is often indicated for constipation due to deficiency of blood and qi, constipation due to dryness of the intestines and fluid, no hunger, no appetite, abdominal distention, etc. In the recipe, it is used to moisten dryness and soften hardness, promote qi circulation and relieve constipation. In addition, fructus cannabis contains rich dietary fibers, can stimulate intestinal mucosa, promote secretion, accelerate intestinal peristalsis, reduce intestinal water absorption, improve intestinal microecological environment, and play a role in relaxing bowel. Also has antiinflammatory, antibacterial, analgesic, antiepileptic, antipsychotic, and anticonvulsant effects.

Rhubarb, radix et rhizoma Rhei, bitter in flavor and cold in nature, enter stomach, large intestine and liver meridian. In Shen nong Ben Cao Jing, it is called "break mass, stay food, purge intestines and stomach, promote aging and bring new, promote diuresis, regulate middle energizer and resolve food, and calm five zang organs". Rhubarb, radix et rhizoma Rhei is a representative drug for diarrhea due to bitter and cold, and has the effects of clearing heat and purging fire, and purging the pathogenic fire. It is commonly used for treating constipation due to various excessive heat and excessive heat. In the recipe, rhubarb is prepared with wine, so that the purgation is weaker to avoid damaging yin, and the rhubarb is used for promoting tissue regeneration, soothing and regulating the five viscera. In addition, the acid anthrone in rheum officinale can stimulate intestinal mucosa, increase intestinal cavity volume, raise intestinal osmotic pressure and promote intestinal peristalsis, and the tannins in the rheum officinale can inhibit the absorption of intestinal moisture, so that the large intestine can be used for diarrhea and diarrhea. The rheum officinale also has the effects of protecting liver, promoting urination, resisting tumors, eliminating oxygen free radicals, resisting inflammation, inhibiting bacteria and the like. The rheum officinale contains emodin which can improve the loss of hippocampal neurons and dendritic spines thereof, thereby playing an anti-depression role.

The cucurbit shell has the advantages of being sweet and neutral in nature, being capable of returning to heart and small intestine channels, and being beneficial to the effects of inducing diuresis to alleviate edema, promoting qi circulation to dissipate stagnation and purging heat. The recipe takes the effect of promoting qi circulation and purging heat. In addition, the cucurbitacin has good diuretic effect, and the cucurbitacin can inhibit growth, proliferation and migration of tumor cells. And can enhance the pharmacological action of curcumin in combination.

Skeleton is a root of Laozhen with the effects of promoting digestion, purging heat, and dredging intestine and activating stagnancy. In Ben Cao gang mu Shi (compendium of materia Medica) recorded that it can "Datong Lung Qi" and strengthen the large intestine by its action of lowering the intestinal Qi and helping the large intestine to conduct. The recipe takes the effects of promoting digestion, promoting qi circulation and purging heat. In addition, the ground skeleton is the root system of old radish, and the sulforaphane contained in the ground skeleton has certain anticancer and antioxidant functions. There is currently less specific research on skeleton. Similar wild radish roots are found to have good antibacterial, cough relieving, asthma relieving and other effects.

Cimicifugae rhizoma, pungent and slightly sweet, enters lung, spleen, stomach and large intestine meridians, and has the effects of raising yang, lifting and sinking, and clearing heat and detoxicating. Cimicifugae rhizoma enters meridians of foot yangming and hand taiyin to promote yang qi of spleen and stomach and lung meridians, and can activate lung qi, which activates large intestine qi. The recipe is taken for lifting, so it is effective for moxibustion. In addition, cimicifugae rhizoma has effects of relieving intestinal spasm, relieving pain, resisting inflammation, resisting oxidation, resisting allergy, and protecting nerve. Can also regulate endocrine, improve postmenopausal climacteric syndrome, and has certain antidepressant effect.

Zhi Shi, pungent and bitter, enters spleen, stomach and large intestine meridians, and has the actions of relieving qi and removing food retention, resolving phlegm and relieving distension. For it can "relieve distention and fullness and remove dampness, remove staleness and clear it" as in Changsha Yao Ji, zhi Shi has good actions of promoting digestion and removing food retention, it is often combined with Da Huang to relieve constipation with purgative. In the recipe, it is used to break qi and remove food retention, and combined with Shengma to smooth qi movement. In addition, zhi Shi can shrink smooth muscle of stomach and intestine, enhance gastric emptying and small intestine propulsion functions, excite gastrointestinal functions, and accelerate gastrointestinal peristalsis [78]. And also plays a certain role in resisting anxiety, oxidation, cancer and the like. The higher the application concentration of the immature bitter orange is, the capability of killing helicobacter pylori is also increased.

Poria cocos, poria, sweet, light and flat, and it has the effects of invigorating spleen, promoting diuresis, removing dampness and tranquillizing. The "Ben Cao Jing Ji Zhi" is a good herb for strengthening the spleen and tonifying deficiency, which can open the viscera, regulate the viscera and qi, benefit the qi and protect the mind. The recipe takes the effects of strengthening spleen, tonifying middle-jiao and soothing nerves. In addition, poria can reduce the reabsorption of kidney to water and promote the metabolism of body water. And has good intestinal tract regulating capability, can regulate the immunity of the organism by recovering the steady state of intestinal flora, and promotes the repair of gastrointestinal mucous membrane.

Glycyrrhrizae radix has effects of invigorating spleen, replenishing qi, and relieving drug property. The Shen nong Ben Cao Jing (Shen nong's herbal) is a key herb for regulating middle warmer and tonifying deficiency, and can be combined with various spleen-invigorating and qi-tonifying herbs to strengthen the efficacy of middle warmer and qi-tonifying. In the recipe, the recipe takes the effects of strengthening the middle energizer and tonifying deficiency, so it is used for moxibustion. In addition, licorice has analgesic, anti-inflammatory, immunity enhancing, and antioxidant effects [83]. The effective components in Glycyrrhrizae radix can improve hypothalamic-pituitary-adrenal axis function, and has antidepressant effect.

The beneficial effects of the invention are as follows: the traditional Chinese medicine composition for treating the functional constipation with anxiety depression provided by the invention can effectively improve the traditional Chinese medicine symptoms of the patient with the functional constipation with anxiety depression, has low recurrence rate, has a better long-term curative effect, and has good safety.

Drawings

Figure 1 shows two groups of patient completion.

Figure 2 is a gender comparison of two groups of patients.

Figure 3 is a comparison of the ages of the two groups of patients.

Figure 4 is a comparison of the overall efficacy of FC for two groups of patients.

Figure 5 is a comparison of FC symptom score for two groups of patients before and after treatment.

Figure 6 is a comparison of FC symptom score before and after treatment for two groups of patients.

Figure 7 is a HAMA score comparison for two groups of patients before and after treatment.

Figure 8 is a HAMA score comparison before and after treatment for two groups of patients.

Fig. 9 is a comparison of HAMD scores for two groups of patients before and after treatment.

Fig. 10 is a comparison of HAMD scores before and after treatment for two groups of patients.

FIG. 11 shows the overall efficacy of the traditional Chinese medicine pattern comparison for two groups of patients.

FIG. 12 is a comparison of total integral of traditional Chinese medicine syndromes in two groups of patients before and after treatment.

Fig. 13 is a comparison of total integral of the symptoms of traditional Chinese medicine before and after treatment of two groups of patients.

Fig. 14 shows the integral comparison of each symptom of the traditional Chinese medicine before treatment.

Fig. 15 is a comparison of the integral of each symptom of the two groups of traditional Chinese medicine after treatment.

Fig. 16 shows the integral comparison of each symptom of the traditional Chinese medicine before and after the treatment of the control group.

Fig. 17 is a graph showing the integral comparison of each symptom of the traditional Chinese medicine before and after treatment of the test group.

Fig. 18 is a comparison of recurrence rates for the two groups.

Detailed Description

The technical solutions in the embodiments are clearly and completely described below in connection with the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Example 1

The active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight:

monarch drug: 15 parts of kudzuvine root and 15 parts of curcuma longa;

Adding water, and decocting to obtain liquid preparation.

The beneficial effects of the invention are studied:

1. research data and method

Study data (I)

1. Study object

The test subjects of the study were all from the department of gastroenterology in Hospital, lithode, zhejiang, and the time of group entry was 12 months in 2020 to 1 month in 2023, and the patients were in compliance with the diagnostic criteria for functional constipation and anxiety-depression.

2. Diagnostic criteria and syndrome differentiation criteria

2.1 Western diagnostic criteria

2.1.1FC is diagnosed by Roman IV diagnostic criteria

Excluding constipation caused by intestinal and systemic organic factors, drugs and other causes and meeting the following criteria:

(1) The following 2 or more symptoms must be met: (1) at least 25% of the time is laborious to defecation; (2) bowel movement is either lumpy or hard for at least 25% of the time (see bristol scale type 1-2); (3) at least 25% of the time the bowel movement is endless; (4) at least 25% of the time bowel movement is anorectal obstruction or obstructive; (5) at least 25% of the time the bowel movement requires manual assistance (e.g., finger assistance, pelvic floor support); (6) spontaneous defecation was less than 3 times per week.

(2) The laxative is not used, so that the loose stool is rarely generated.

(3) Does not meet the diagnostic criteria for IBS-C.

Symptoms appear at least 6 months prior to diagnosis, and symptoms of nearly 3 months meet the above diagnostic criteria.

2.1.2 diagnostic criteria for anxiety and depressive states

Subjects were scored by the hamilton depression scale (Hamilton Depression Scale, HAMD) and hamilton anxiety scale (Hamilton Anxiety Scale, HAMA). And the score of HAMA is more than 7 and less than 29, and the score of HAMD is more than 7 and less than 24, thus the score is the group-entering standard of anxiety and depression in the study.

2.2 dialectical criteria of liver and spleen stagnation in traditional Chinese medicine:

based on the general opinion of diagnosis and treatment (2017) of combined Chinese and Western medicine of functional constipation and qi stagnation in the study, and combined with clinic, the diagnosis standard of the functional constipation, liver and spleen stagnation in the study is formulated as follows:

mainly comprises (1) dry or not very dry stool and uncomfortable defecation; (2) abdominal distension or pain.

The secondary symptoms are (1) borborygmus and flatus; (2) aggravating when the emotion is unsmooth; (3) chest and hypochondrium fullness and distention, frequent eructation; (4) the muscles of the dorsum of the necklace are tensed.

A tongue pulse (1) a red tongue with white and greasy coating; (1) the pulse is wiry.

Diagnosis of the syndrome: the main symptoms are necessary symptoms, the secondary symptoms can be diagnosed according to 1-2 items, and tongue pulse can be used as reference.

3. Inclusion criteria

(1) Age interval is 18 to 75 years old;

(2) meets the diagnosis standard of the traditional Chinese and western medicine in the study;

(3) no drug affecting the results of the study or no drug for more than 4 weeks although taken;

(4) has autonomous behavior capability and voluntarily participates in signing the informed consent.

4. Exclusion criteria

(1) Chronic constipation caused by digestive tract organic diseases such as digestive tract tumor, intussusception, intestinal obstruction, hemorrhoid, etc.;

(2) pregnant women or lactating women or pregnant planners in the near 3 months;

(3) allergic or side effects on traditional Chinese medicine, lactulose and other medicines can not be tolerated;

(4) patients with serious diseases of heart, brain, liver, kidney and other serious organs;

(5) 1 month of internal reference to other clinical trials.

5. Reject criteria

(1) Failing to meet the inclusion standard, and being included by the error into the tester;

(2) patients who do not take medicines according to the planned law;

(3) a person who cannot cooperate with relevant test data such as filling the scale;

(4) the patients who take the medicines privately affect the test results.

(5) A major change in dietary structure.

6. Drop criteria

(1) For various reasons, those who are logged out or lost;

(2) serious adverse reactions or worsening of underlying disease occurred after group entry and the subjects could not continue to be accepted;

(3) anxiety-depressive states exacerbate or do not alleviate psychotropic intervention.

7. Ethical requirements

The study has been approved by the relevant sector for ethical review (ethical review No. 2020, 099), and all subjects have been informed of the relevant risk and signed informed consent.

(II) research method

1. Sample size estimation

The study is a clinical study, the scheme design complies with the random control principle, the final treatment effective rate of the test group and the control group is the ending index of the study, and the sample size calculation formula is as follows:

according to the principle of statistical sample size, let α=0.05, and the degree of certainty be 90%, then Z _α ＝1.96，Z _β =1.28. Through the research on the related literature query of the diseases, the effective rate of a test group is estimated to be 90 percent, and the effective rate of a control group is estimated to be 60 percent, namely P ₁ ＝0.9，P ₂ =0.6. N is calculated to be 44. According to the requirements of the clinical research guidelines of new Chinese medicine and according to the patient's condition of treatment, the expected falling rate is 10%, so n is calculated finally ₁ ＝n ₂ Total of 96 subjects were included for=48.

2. Grouping method

96 subjects collected from the study at 12 months 2020 to 1 month 2023 were randomly grouped by generating a random number table by the statistical software SPSS26.0, and 48 subjects were finally generated in each of the control group and the test group.

3. Treatment regimen

3.1 test group (traditional Chinese medicine treatment group)

The Chinese medicinal composition is subjected to addition and subtraction treatment (comprising 15g of kudzuvine root, 15g of curcuma zedoary, 20g of fructus cannabis, 10g of prepared rheum officinale, 30g of calabash shell, 20g of ground skeleton, 6g of cimicifuga foetida, 10g of fried immature bitter orange, 15g of poria cocos and 6g of honey-fried licorice root), and is uniformly decocted by a preparation room of a hospital, each dose is decocted into 200ml x 2 bags, and 1 bag is taken at a temperature of one hour after breakfast and supper respectively, and is continuously taken for 8 weeks.

3.2 control group

Oral lactulose oral solution (produced by Abbott Biologicals b.v. where the netherlands, imported drug approval mark: HJ 20171057) was administered at an initial dose of 30mL/d, 15mL each one hour after breakfast and dinner. The dosage is reduced according to the actual condition of the patient, the maintenance dosage is 10-25 mL/d, and the patients are continuously taken for 8 weeks.

4. Observation index

4.1 general case

And recording the baseline conditions of the name, sex, age and the like of the subjects when the subjects are in the group, and carrying out statistical analysis to judge whether the test results are affected.

4.2FC efficacy index

Functional constipation symptom score: with reference to the "combined medical consensus for functional constipation (2017)", the degree and frequency of symptoms before and after treatment of two groups were observed, and symptom score = Σ (symptom severity x frequency of onset) was calculated.

4.3 anxiety depression index

Anxiety depression state assessment: scoring by hamilton depression scale (HAMD) and hamilton anxiety scale (HAMA). The HAMD has 24 entries and the HAMA has 14 entries, and the score of each entry is added to obtain the total score. The higher the score, the more severe the anxiety or depression state.

4.4 therapeutic effect index of Chinese traditional medicine syndrome

The traditional Chinese medicine syndrome scale is formulated by referring to 2002 edition of Chinese medicine new medicine clinical study guidelines (trial). According to the symptom severity, each symptom is scored by adopting a 4-level grading standard (grade 0: none; grade I: mild symptom without affecting daily life; grade II: obvious symptom and partial effect on daily life; grade III: severe symptom and significant effect on work and life). The main symptoms are scored as 0, 2, 4 and 6, and the secondary symptoms are scored as 0, 1, 2 and 3.

4.5 assessment of recurrence status

Subjects who are therapeutically effective were followed up 2 times for 8 weeks, 4 th and 8 th weeks after the end of the course of treatment, respectively. The score of functional constipation symptoms at the follow-up of the subject was compared to the end of treatment to determine the recurrence rate.

4.6 safety observations

Vital signs were recorded for two groups of subjects: blood pressure, respiration, heart rate, body temperature. Test results were recorded for two groups of subjects: three general principles, liver and kidney functions. Regular electrocardiographic examination results were recorded for both groups of subjects. Adverse reactions and related measures occurring in the research process are recorded, and the relevance between the adverse reactions and the test drugs is analyzed.

5. Evaluation criteria

5.1FC and traditional Chinese medicine syndrome curative effect evaluation criterion

Calculated by nimodipine method:

efficacy index = (pre-treatment integral-post-treatment integral)/pre-treatment integral x 100%.

(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.

Total effective rate= (number of cure cases + number of significant cases + number of effective cases)/total case number x 100%.

5.2 recurrence rate evaluation criteria

(FC total score before treatment-FC total score at follow-up)/FC total score before treatment x 100% less than or equal to 30% is considered recurrence; recurrence is also considered if the total FC score at follow-up is greater than or equal to the total FC score prior to treatment.

Recurrence index = (total FC score visited-total FC score post-treatment)/total FC score visited x 100%,

recurrence rate = number of recurrence/number of follow-up cases x 100%.

5.3 safety evaluation criteria

Formulation is made with reference to 2002 edition of guidelines for clinical study of New Chinese medicine (trial):

(1) stage I: safety, no adverse reaction occurs during treatment;

(2) stage II: the medicine is safer, and if adverse reaction occurs, the medicine can be subjected to subsequent administration treatment without any special treatment;

(3) class III: the safety problem exists, certain adverse reaction occurs in the test process, and the subsequent test can be carried out after corresponding treatment is adopted;

(4) grade IV: serious adverse reactions occur and the clinical trial should be ended.

(III) statistical methods

The SPSS26.0 is used for analyzing and processing the research data, and t-test is adopted for metering data conforming to normal distribution; the counting data is checked by a chi-square; the non-normally distributed metering data and grade data are analyzed by rank sum test. The analysis results are expressed by the mean (X). + -. Standard deviation(s). The statistical significance level was set to α=0.05. P is less than 0.05, and the detected results have statistical difference; p is less than 0.01, and the detected results have obvious difference; p > 0.05, no statistical difference was observed in the results examined.

2. Results of the study

Case completion

The study included 96 patients from 12 months 2020 to 1 month 2023, randomized into 48 each of the test and control groups. Wherein, 1 patient in each of the control group and the test group is removed because of being unable to match with the completion scale filling. The final test group and the control group each completed this study with 47 cases, and the total shedding rate was 2.1%. See table 1, fig. 1 for details:

table 1 two groups of patient completion

(II) general data comparison

1. Sex comparison

The study was incorporated into 24 men and 70 women. Wherein, the male of the test group is 11 cases, the female is 36 cases, and the ratio of male to female is 1:3.27; control men 13, women 34, men and women 1:2.62. The control and test groups were comparable with no statistical difference in sex composition (P > 0.05). See table 2, fig. 2 for details:

table 2 comparison of gender of two groups of patients

Note that: sex comparison of two groups of patients, using chi-square test

2. Age comparison

The patient of the largest age in this study was 74 years old, with the smallest being 19 years old. The age distribution of the test groups was between 19 and 74 years, with an average age of 46.49+ -15.91; the control group had an age distribution between 20 and 72 years with an average age of 46.40.+ -. 14.91. The comparison of the age and age range distribution of the control group and the test group has no statistical difference (P is more than 0.05), and the comparison is comparable. See table 3 for details:

table 3 comparison of age of two groups of patients

Note that: two groups of patients are compared in age group distribution by using chi-square test

(III) efficacy and safety comparison

1. Overall efficacy comparison

1.1FC efficacy comparison

After 8 weeks of treatment, the total FC efficacy was 87.23% in the test group, 74.47% in the control group, and the total efficacy was statistically different (P < 0.05) in the control and test groups. See table 4, fig. 4 for details:

table 4 comparison of FC efficacy in two groups of patients

Note that: the FC overall efficacy of the two groups of patients was compared using the chi-square test

2. Functional constipation symptom score comparison

2.1 comparison of the FC symptomatic score for two groups of patients before and after treatment

There was no statistical difference in FC symptom score (P > 0.05) for the two groups of patients prior to treatment. FC symptom scores were significantly different in the two groups of patients (P < 0.01) after 8 weeks of treatment with different regimens. See table 5, fig. 5 for details:

TABLE 5 comparison of FC symptom score for two groups of patients before and after treatment

Note that: FC symptom integral comparison of the two groups of patients before and after treatment adopts t test

2.2 comparison of the integral of FC symptoms before and after treatment of two groups of patients

The FC symptom scores after treatment of both the test and control groups were significantly different (P < 0.01) compared to those before treatment. See table 6, fig. 6 for details:

table 6 comparison of FC symptom score before and after treatment for two groups of patients

Note that: the FC symptom score before and after treatment was compared for both groups of patients using t-test

3. Anxiety depression state score comparison

3.1. Comparison of HAMA score for two groups of patients before and after treatment

There was no statistical difference in HAMA scores (P > 0.05) between the two groups of patients prior to treatment. There was a statistical difference in HAMA scores for the two groups of patients (P < 0.05) after 8 weeks of treatment with the different regimens. See table 7, fig. 7 for details:

table 7 comparison of HAMA scores for two groups of patients before and after treatment

Note that: HAMA score comparison of both pre-and post-treatment groups of patients was performed using t-test

3.2 comparison of HAMA score before and after treatment of two groups of patients

The HAMA scores of the two groups of patients before and after treatment are analyzed and compared, the difference has statistical significance (P < 0.05) after the treatment of the control group and the difference has significance (P < 0.01) after the treatment of the test group and the comparison before the treatment. See table 8, fig. 8 for details:

table 8 comparison of HAMA scores before and after treatment for two groups of patients

Note that: the HAMA scores of the two groups of patients before and after treatment are compared by adopting t test

3.3 comparison of HAMD scores of two groups of patients before and after treatment

There was no statistical difference (P > 0.05) in HAMD scores for the two groups of patients compared to when they were pre-treatment. After 8 weeks of treatment with different regimens, there was a significant difference in HAMD scores (P < 0.01) for both groups of patients. See Table 9, FIG. 9 for details.

Table 9 comparison of HAMD scores for two groups of patients before and after treatment

Note that: comparison of HAMD scores of both pre-and post-treatment groups of patients, both using t-test

3.4 comparison of HAMD scores before and after treatment for two groups of patients

After 8 weeks of treatment with the different regimen, both groups of patients had significant differences in HAMD scores (P < 0.01) compared to before treatment. See table 10, fig. 10 for details.

Table 10 comparison of HAMD scores before and after treatment for two groups of patients

Note that: comparison of HAMD scores before and after treatment for both groups of patients, both were tested using t-test

4. Traditional Chinese medicine syndrome curative effect comparison

4.1 comparison of the overall therapeutic effects of the Chinese Condition

After 8 weeks of treatment by different schemes, the total effective rate of traditional Chinese medicine symptoms in the test group is 91.49%, the control group is 70.21%, and the two groups have significant difference (P is less than 0.01). See table 11, fig. 11 for details:

table 11 comparison of the overall efficacy of the traditional Chinese medical Condition in two groups of patients

Note that: the total effective rate of the traditional Chinese medicine symptoms of two groups of patients is compared, and the chi-square test is adopted

4.2 Total integral comparison of two groups of patients before and after treatment

The total integral of the two groups of Chinese medical syndromes has no statistical difference (P > 0.05) before treatment. After 8 weeks of treatment with different protocols, the total integral of the two groups of Chinese medical syndromes has a significant difference (P < 0.01). See table 12, fig. 12 for details:

table 12 comparison of total integral of traditional Chinese medicine syndromes of two groups of patients before and after treatment

Note that: the total integral comparison of the traditional Chinese medicine symptoms of the two groups of patients before and after treatment adopts t test

4.3 comparison of total integral before and after treatment of two groups of patients

After 8 weeks of treatment with different regimens, the total integral of the traditional Chinese medical symptoms of both groups of patients had significant differences (P < 0.01) compared to before treatment. See table 13, fig. 13 for details:

table 13 comparison of total integral of traditional Chinese medicine syndromes before and after treatment of two groups of patients

Note that: the total integral comparison of the traditional Chinese medicine symptoms before and after the treatment of two groups of patients adopts t test

4.4 integral comparison of each condition of Chinese traditional medicine

After 8 weeks of treatment by different schemes, each traditional Chinese medicine syndrome integral of the test group has obvious statistical difference (P < 0.01) compared with the traditional Chinese medicine syndrome integral before treatment; the control group has obvious statistical difference (P < 0.01) between the symptoms of unsmooth stool, abdominal distention and pain, borborygmus and flatulence, fullness and eructation and the symptoms of the disease before treatment (P < 0.05) and the symptoms of the disease before treatment, and has no statistical difference (P > 0.05) between the symptoms of the disease under the influence of emotion and the symptoms of the disease before treatment. Before treatment, there was no statistical difference in the scores of each symptom in the two groups (P > 0.05); after treatment, compared with the integral of each condition of the two groups, the symptoms and signs of abdominal distention and pain are obviously statistically different (P is less than 0.01) due to the aggravation of emotion, the tightness of the neck and the back is statistically different (P is less than 0.05), and the symptoms and signs of constipation, borborygmus and flatulence are not statistically different (P is more than 0.05). See table 14, fig. 15, fig. 16, fig. 17 for details:

table 14 comparison of the integral of each symptom of the traditional Chinese medicine before and after the treatment

Note that: the integral comparison of each syndrome of the traditional Chinese medicine adopts rank sum test analysis

5. Comparison of recurrence rates

After 8 weeks of treatment with the different regimens, 2 follow-up visits for a total of 8 weeks were performed on the therapeutically effective patients in both groups. Wherein 41 patients with functional constipation and anxiety depression state are treated effectively by the test group, and 39 patients are visited successfully, wherein 4 patients relapse after 4 weeks and 5 patients relapse after 8 weeks; the control group effectively treats 35 cases of functional constipation and anxiety depression state patients, and 35 cases of successful follow-up, wherein 8 cases of functional constipation and anxiety depression state patients relapse after 4 weeks, and 12 cases of functional constipation and anxiety depression state patients relapse after 8 weeks. At the first follow-up, the recurrence rates of the two groups were compared without statistical differences (P > 0.05); at the second follow-up, the recurrence rates of the two groups were statistically different (P < 0.05). See table 15, fig. 18 for details.

Table 15 comparison of recurrence rates for two groups

Note that: two groups of recurrence rates were compared using chi-square test

6. Safety and adverse reaction comparison

During the 8-week test, all the vital signs of the subjects fluctuated within the normal range, and three conventional, liver and kidney functions and conventional electrocardiographic examination results before and after treatment are not obviously abnormal, and adverse reaction events are not generated.

3. Analysis of study results

1. Case demographic profile analysis

The study was carried into 96 FC with anxiety depression, and the final 94 patients completed the study. Of these, 70 women, 24 men and more women than men may have anxiety and depression, and constipation may occur due to influence of progestational hormone, pelvic floor function, gynecological operation, etc., and this sex difference is consistent with epidemiological studies of functional constipation and anxiety and depression. The traditional Chinese medicine also considers that women have a lot of anxiety, viscera and channels have a lot of obstruction, so constipation and anxiety and depression are easy to occur. The mean age of the subjects in the study trial group was 46.49+ -15.91 years, and the mean age of the patients in the control group was 46.40+ -14.91 years. This may be related to the severe mental and social stress of middle-aged people, the dual stress of carrying the career and the family, the irregular diet, the delicacy of eating greasy and spicy food, the gastrointestinal damage, and the gradual decline of the body function. Most domestic researches consider that the prevalence rate of functional constipation increases with age, but the research result is different from the prevalence rate, and the research result is considered to be possibly related to long-term constipation of old patients, so that symptoms are serious, the treatment scheme of the research cannot be followed, and enema or other means for relaxing the bowels are often added, so that the research is not included. In traditional Chinese medicine, ancient doctors considered that people from middle to middle aged, spleen and stomach were weakened, food was easily accumulated in middle energizer, and fire was generated from depression to form abdominal distention and constipation, which is consistent with the age distribution of the study. In general, the research samples are all from digestive system department of Hospital in Lithode of Zhejiang province, have certain limitation, and have insufficient sample quantity, so the research samples cannot represent the overall demographic characteristics of patients with FC accompanied anxiety depression, but have certain reference and reference values.

2. Overall efficacy comparative analysis

After 8 weeks of treatment with different regimens, the FC symptom score was improved earlier for both groups of patients, and the differences were statistically significant (P < 0.05). The total effective rate of the test group is 87.23%, the control group is 74.47%, and compared with the two groups, the test group has better effective rate (P is less than 0.05), which indicates that lactulose and the traditional Chinese medicine composition can improve constipation symptoms, but the total curative effect of the traditional Chinese medicine composition is better than western medicines.

Lactulose is a permeable laxative, and swells after absorbing water in the intestinal canal, so that the water content of the stool is increased, and the defecation is promoted. From the perspective of traditional Chinese medicine, lactulose has the effect of relaxing bowel, and is similar to the medicaments such as hemp seeds, and the traditional Chinese medicine composition has better effect of relaxing bowel by adding medicaments such as soothing liver, promoting qi circulation, purging purgation, removing stasis, tonifying qi, strengthening spleen and the like on the basis of relaxing bowel. From the perspective of modern pharmacology, medicines such as kudzu root and curcuma longa have the effect of regulating intestinal flora, medicines such as fructus cannabis and fructus aurantii immaturus have the function of promoting intestinal peristalsis, and the whole formula can play the role of regulating neuro-endocrine and promote the recovery of intestinal functions through the brain intestinal axis, so that the curative effect is better than that of lactulose.

3. Anxiety depression state score comparison analysis

After 8 weeks of treatment with different protocols, the HAMA integration was improved earlier for both groups (P < 0.05), and the differences between the test and control groups were statistically significant (P < 0.05). The HAMD integral was significantly reduced for both groups (P < 0.01) and there was a significant difference between the test and control groups (P < 0.01). It is described that both treatment methods can improve anxiety and depression states of patients, and the effect of the test group is superior to that of the control group in improving anxiety and depression states.

The clinical curative effects of the traditional Chinese medicine composition for improving anxiety states and depression states are better than that of lactulose. The accuracy of the treatment method for regulating the liver and spleen is reflected, the whole body qi movement is dredged while the discharge of dregs and the promotion of aging are helped, so that the stagnation of the liver and spleen is self-removed, and the emotion is improved. The invention also relates to the antidepressant effect and the mental activity regulating effect of the medicines such as kudzuvine root, turmeric, rhubarb, cimicifuga rhizome, liquorice and the like contained in the traditional Chinese medicine composition. Meanwhile, the anxiety and depression state accompanied by functional constipation is possibly related to the severity of constipation symptoms, and the effect of the traditional Chinese medicine composition for improving constipation symptoms is better than that of lactulose, so that the anti-anxiety and depression effect of the traditional Chinese medicine composition is also stronger than that of lactulose.

4. Traditional Chinese medicine syndrome curative effect comparison analysis

4.1 analysis of total integral comparison of the symptoms of Chinese traditional medicine

After 8 weeks of treatment with different protocols, the total integral of the traditional Chinese medicine symptoms of the two groups of patients is improved earlier (P < 0.05), and the two groups of patients have significant differences in comparison (P < 0.01). The total effective rate of the traditional Chinese medicine symptoms in the test group is 91.49%, the contrast group is 70.21%, and the two groups have significant difference (P is less than 0.01) compared with each other, so that the two groups of treatment methods have an improvement effect on the traditional Chinese medicine symptoms, but the total curative effect of the traditional Chinese medicine composition is superior to that of western medicines. By comparing the integral curative effect of the traditional Chinese medicine symptoms with the integral curative effect of the functional constipation symptoms, the overall effective rate of the traditional Chinese medicine symptoms of the control group can be found to be lower than that of the functional constipation symptoms, and the overall effective rate of the traditional Chinese medicine symptoms of the test group is higher than that of the functional constipation symptoms. While confirming the clinical curative effect of the traditional Chinese medicine composition, the traditional Chinese medicine composition also needs to consider the indexes related to anxiety and depression, such as severe symptoms when the traditional Chinese medicine symptoms are included, and neck and back muscle tension. The traditional Chinese medicine composition plays a role in liver-dominant emotion and spleen-dominant muscle theory, and is a representation of the therapeutic effect of the traditional Chinese medicine composition, which is produced by paying attention to smooth liver and spleen. Further illustrates that the traditional Chinese medicine composition has good treatment effect on functional constipation and has a certain effect on improving emotion. Meanwhile, the patient suffering from functional constipation is not simply caused by constipation symptoms, and the patient suffering from the anxiety and depression is likely to suffer from the functional constipation, so that the constipation symptoms can be relieved by improving the anxiety and depression.

4.2 analysis of integral comparison of each symptom in Chinese medicine

The integral of each traditional Chinese medicine syndrome of the test group has obvious statistical difference (P is less than 0.01) compared with the former phase, which proves that the traditional Chinese medicine composition has better curative effect in improving the symptoms of constipation, abdominal distention and pain, borygmus and flatulence, eructation, aggravation of illness caused by emotion influence, tightness of neck and back and the like; compared with the prior group, the symptoms of unsmooth stool, abdominal distention and pain, borborborygmus and flatulence, distention and fullness and belching and the like have obvious statistical difference (P is less than 0.01), the aggravation of the illness state is affected by emotion and has statistical difference (P is less than 0.05), and the tightness of the neck and the back has no statistical difference (P is more than 0.05), so that the lactulose has better curative effect on improving the symptoms of unsmooth stool, the abdominal distention and pain, borborygmus and flatulence, distention and flatulence, fullness and belch and the like, has certain curative effect on improving the symptom of the aggravation of the illness state affected by emotion, is almost ineffective on the tightness of the neck and the improvement of constipation symptoms of people is prompted, and the emotional problem of patients can be relieved. Comparing the integral of each symptom of the two groups after treatment, the traditional Chinese medicine composition has obvious statistical difference (P is less than 0.01) in the aspect that abdominal distention and pain and illness are affected by emotion, and has statistical difference (P is less than 0.05) in the aspect that the tightness of the neck and the back is superior to lactulose in the aspects of promoting qi circulation and relieving pain, soothing liver and relieving depression, relieving muscular tension and the like, and further illustrates that constipation and anxiety and depression have common pathogenesis-liver and spleen depression. From the viewpoint of modern medicine, studies have been conducted to improve the intestinal flora of patients by means of fecal transplantation and the like, and thus improve the mental state of patients suffering from functional constipation. The traditional Chinese medicine composition disclosed by the invention can influence the mental symptoms of a patient by influencing the intestinal flora, and also accords with the theoretical characteristic of a brain intestinal axis, and lactulose does not have the function of enriching the intestinal flora, so that the curative effect is poor. This guess can be confirmed by future experimental comparisons. Meanwhile, the difference of abdominal distension and pain should also consider the side effects of lactulose, such as abdominal distension and pain.

5. Recurrence rate comparative analysis

Patients who were evaluated as effective and above were followed up after 4 weeks and 8 weeks after the end of treatment. At 4 weeks after treatment, the recurrence rate of the test group was 10.53% and the recurrence rate of the control group was 22.86%; at 8 weeks after the end of treatment, the recurrence rate of the test group was 12.82%, and the recurrence rate of the control group was 34.29%. The recurrence rate of the two groups is compared, the difference between 4 weeks has no statistical significance (P is more than 0.05), the difference between 8 weeks has statistical significance (P is less than 0.05), which proves that the traditional Chinese medicine composition has better long-term curative effect for treating functional constipation and anxiety depression, and also proves that the traditional Chinese medicine composition of the invention grasps the key cause of FC and anxiety depression, namely liver and spleen stagnation, so that the problem is fundamentally solved, the organism function is regulated, thereby reducing the recurrence rate of diseases and improving the life quality of patients.

6. Security comparison analysis

During the study period of 8 weeks, no adverse events occurred. All the vital signs of the subjects fluctuate within the normal range, and three general conditions before and after treatment, liver and kidney functions and electrocardiographic examination results are not obviously abnormal. The traditional Chinese medicine composition and the lactulose are both safe and reliable, the number of cases included in the study is not large, the traditional Chinese medicine composition is not represented to be absolutely safe, no side effect is caused, the traditional Chinese medicine composition can be further subjected to pharmacological study or expanded range for clinical test, relevant adverse reactions are clear, and reference is provided for subsequent popularization and application.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art. The generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. The traditional Chinese medicine composition for treating functional constipation with anxiety depression is characterized by comprising the following active ingredient raw materials in parts by weight:

10-20 parts of kudzuvine root and 10-20 parts of curcuma longa;

15-25 parts of fructus cannabis and 5-15 parts of prepared rheum officinale;

10-20 parts of poria cocos and 2-10 parts of honey-fried licorice root;

25-35 parts of calabash shell, 15-25 parts of radix skeleton, 2-10 parts of roasted cimicifugae foetidae and 5-15 parts of fried immature bitter orange.

2. The traditional Chinese medicine composition for treating functional constipation with anxiety depression according to claim 1, wherein the active ingredient raw materials of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight:

12-18 parts of kudzuvine root and 12-18 parts of curcuma longa;

18-22 parts of fructus cannabis and 8-12 parts of prepared rheum officinale;

12-18 parts of poria cocos, 4-8 parts of honey-fried licorice root;

28-32 parts of calabash shell, 18-22 parts of radix skeleton, 4-8 parts of roasted cimicifugae foetidae and 8-12 parts of fried immature bitter orange.

3. The traditional Chinese medicine composition for treating functional constipation with anxiety depression according to claim 1, wherein the active ingredient raw materials of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight:

15 parts of kudzuvine root and 15 parts of curcuma longa;

20 parts of fructus cannabis and 10 parts of prepared rheum officinale;

15 parts of poria cocos and 6 parts of honey-fried licorice root;

30 parts of cucurbit shell, 20 parts of ground skeleton, 6 parts of roasted cimicifuga foetida and 10 parts of fried immature bitter orange.

4. A Chinese medicinal composition preparation for treating functional constipation with anxiety depression, which is characterized by comprising the Chinese medicinal composition according to any one of claims 1-3 and medicinal auxiliary materials.

5. The Chinese medicinal composition preparation for treating functional constipation complicated with anxiety depression as claimed in claim 4, wherein the Chinese medicinal composition preparation is a tablet, granule, capsule, paste, pill or liquid preparation.

6. Use of a Chinese medicinal composition according to any one of claims 1-3 or a Chinese medicinal composition preparation according to any one of claims 4-5 in the manufacture of a medicament for the treatment of functional constipation with anxiety-depression.