Traditional Chinese medicine composition for treating senile functional constipation and preparation method thereof

Abstract

The invention relates to the technical field of biological medicine, in particular to a traditional Chinese medicine composition for treating senile functional constipation, which comprises radix rehmanniae recen, radix ophiopogonis, radix scrophulariae, fructus cannabis, semen pruni, semen boitae, peach kernel, angelica sinensis, poria cocos, raw rhizoma atractylodis macrocephalae, fried endothelium corneum gigeriae galli, fried rice sprout, fried malt, fried fructus aurantii, rhizoma sparganii and curcuma zedoary. The traditional Chinese medicine composition can achieve the technical effects of treating senile functional constipation, improving intestinal functions and promoting natural defecation, has no side effect, and solves the problems that in the prior art, senile constipation treatment mainly depends on laxative, intestinal motility promoting drugs and the like, and the treatment effect is poor. The side effects of intestinal dysfunction, electrolyte imbalance and the like can be caused by long-term use of the medicines.

Description

Technical Field

[0001] The present invention relates to the technical field of biomedicine, and in particular to a traditional Chinese medicine composition for treating functional constipation in the elderly and a preparation method thereof. Background Art

[0002] Functional constipation in the elderly is a common senile condition characterized by difficulty defecating, infrequent bowel movements, and hard, dry stools. With aging, intestinal motility gradually weakens, leading to decreased secretion of digestive juices. Combined with reduced activity levels and an unhealthy diet, constipation is an increasingly common problem. Currently, Western medicine treatments for constipation in the elderly primarily rely on laxatives and prokinetic drugs. However, long-term use of these medications can lead to side effects such as intestinal dysfunction and electrolyte imbalances.

[0003] Traditional Chinese Medicine (TCM) has a long history and rich experience in treating constipation. By regulating the spleen and stomach, moistening the intestines and promoting bowel movements, and promoting intestinal motility, TCM can fundamentally improve constipation. However, existing TCM combinations mostly target general constipation and lack specific formulas for the elderly. Furthermore, some TCM combinations are slow to respond, making them difficult to meet the urgent needs of elderly patients.

[0004] Functional constipation is a common and frequently occurring clinical disease, and its prevalence tends to increase with age. The prevalence in people over 60 years old is as high as 22%. With the aging of the population, the incidence of functional constipation in the elderly has also increased year by year, seriously reducing the quality of life of elderly patients. It may also lead to the occurrence of cardiovascular and cerebrovascular diseases such as colon cancer, rectal cancer, urinary retention, hypertension, angina pectoris, stroke, and dementia. The occurrence of functional constipation is mainly related to factors such as lifestyle, eating habits, gender, age, and autonomic dysfunction. Chronic functional constipation in elderly patients can lead to changes in physiological and psychological behaviors such as general discomfort, fatigue, and negative anxiety. At the same time, changes in physiological and psychological behaviors can aggravate constipation symptoms, forming a vicious cycle.

[0005] Functional constipation falls under the categories of "constipation" and "spleen deficiency" in Traditional Chinese Medicine. Its key pathogenesis is intestinal dysfunction and stagnant intestinal Qi. The large intestine is the primary organ affected, with close connections to the lungs, spleen, stomach, liver, and kidneys. The pathogenesis of functional constipation in the elderly is primarily due to organ dysfunction, slowed intestinal motility, weak intestinal conduction, and blood stasis and fluid deficiency leading to intestinal dryness. Professor Zhang Junping advocates for the treatment of functional constipation in the elderly by increasing fluids to moisten the intestines and dissolving blood stasis and accumulation. Based on years of clinical experience, he developed his own Fluid-Increasing and Accumulation-Removing Decoction, which eliminates pathogenic factors without harming the body.

[0006] Existing treatments often rely on chemical drugs, which, while effective in the short term, can lead to dependence, further deterioration of intestinal function, and side effects with long-term use. Therefore, the present invention aims to provide a safe, effective, and side-effect-free combination of traditional Chinese medicines for the treatment of functional constipation in the elderly, improving intestinal function and promoting natural bowel movements. Summary of the Invention

[0007] The existing technology for treating functional constipation with chemical drugs leads to problems such as dependence, further deterioration of intestinal function and side effects.

[0008] To solve the above problems, the present application provides a safe, effective and side-effect-free Chinese medicine combination for treating functional constipation in the elderly, improving intestinal function and promoting natural defecation.

[0009] The present application provides a traditional Chinese medicine composition for treating functional constipation in the elderly, which comprises raw rehmannia root, ophiopogon japonicus, Scrophularia ningpoensis, cannabinoids, Prunus mume seed, cypress seed, peach kernel, angelica sinensis, Poria cocos, raw atractylodes macrocephala, stir-fried chicken gizzard lining, stir-fried barley sprout, stir-fried malt, stir-fried fructus aurantii, Trillium gracile, and Curcuma zedoaria.

[0010] Specifically, the Chinese medicine composition comprises, by weight, 15 parts of raw Rehmannia root, 15 parts of Ophiopogon japonicus, 15 parts of Scrophularia ningpoensis, 15 parts of Cannabis sativa seed, 15 parts of Prunus mume seed, 15 parts of Platycladus cypress seed, 15 parts of Persica kernel, 15 parts of Angelica sinensis, 15 parts of Poria cocos, 15 parts of raw Atractylodes macrocephala, 15 parts of stir-fried Chicken Gizzard Stone, 15 parts of stir-fried Barley sprout, 15 parts of stir-fried Malt, 10 parts of stir-fried Citrus aurantium, 10 parts of Trillium gracile, and 10 parts of Curcuma zedoaria.

[0011] The dosage form of the Chinese medicine composition is decoction, pill, capsule or granule.

[0012] A method for preparing a decoction for treating functional constipation in the elderly comprises the following steps:

[0013] Step 1: Select raw materials: 15 parts of raw rehmannia root, 15 parts of ophiopogon japonicus, 15 parts of scrophulariae, 15 parts of hemp seed, 15 parts of prunes, 15 parts of cypress seed, 15 parts of peach kernel, 15 parts of angelica sinensis, 15 parts of poria, 15 parts of raw atractylodes macrocephala, 15 parts of stir-fried chicken gizzard lining, 15 parts of stir-fried barley sprout, 15 parts of stir-fried malt, 10 parts of stir-fried fructus aurantii, 10 parts of trillium, and 10 parts of zedoaria;

[0014] Step 2: Soak the selected raw materials in 800mL of drinking water for 60 minutes;

[0015] Step 3: Put the soaked ingredients into a casserole, first boil over high heat until boiling, then simmer over low heat for 20 minutes, then boil over high heat again until boiling, then simmer over low heat for 20 minutes; obtain the decoction.

[0016] The present invention provides a traditional Chinese medicine composition for treating functional constipation in the elderly. The pharmacology of each raw material is as follows:

[0017] Raw Rehmannia root tastes sweet and bitter, is cold in nature, enters the heart, liver, and kidney meridians, clears away heat, promotes fluid production, cools blood, and stops bleeding.

[0018] Ophiopogon japonicus tastes sweet, slightly bitter, and is cold in nature. It enters the heart, lung, and stomach meridians, moistens the lungs and relieves coughs, nourishes yin and promotes fluid production.

[0019] Scrophularia ningpoensis tastes sweet, bitter and salty, is slightly cold in nature, and enters the spleen, stomach and kidney meridians. It can clear away heat and cool blood, nourish yin and reduce fire, and detoxify and disperse stagnation.

[0020] Hemp seed is sweet in taste and neutral in nature. It enters the spleen, stomach and large intestine meridians, nourishes yin, moistens the intestines and promotes bowel movements.

[0021] Prunus mume seeds are pungent, bitter and sweet in taste, and are neutral in nature. They enter the spleen, large intestine and small intestine meridians, moisturize the intestines, and relieve gas and promote diuresis.

[0022] Platycodon chinensis seeds are sweet in taste and neutral in nature. They enter the heart, kidney and large intestine meridians, nourish the heart and calm the mind, and moisten the intestines and promote bowel movements.

[0023] Peach kernel tastes bitter and sweet, is neutral in nature, and enters the heart, liver, and large intestine meridians. It can promote blood circulation, remove blood stasis, and moisten the intestines and promote bowel movements.

[0024] Angelica sinensis is sweet and spicy in taste, warm in nature, and enters the liver, heart, and spleen meridians. It can nourish blood, promote blood circulation, moisten dryness, and lubricate the intestines.

[0025] Poria cocos has a sweet and light taste and is neutral in nature. It enters the heart, lung, spleen and kidney meridians, promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind.

[0026] Raw Atractylodes macrocephala tastes bitter and sweet, is warm in nature, and enters the spleen and stomach meridians. It can strengthen the spleen and replenish qi, dry dampness and promote diuresis.

[0027] Stir-fried chicken gizzard lining tastes sweet and is neutral in nature. It enters the spleen, stomach, small intestine, and bladder meridians, and strengthens the stomach and aids digestion.

[0028] Fried barley sprouts are sweet in taste and warm in nature. They enter the spleen and stomach meridians, strengthen the spleen and appetite, and harmonize the stomach and help digestion.

[0029] Fried malt is sweet in taste and neutral in nature. It enters the spleen and stomach meridians, promotes qi and aids digestion, strengthens the spleen and stimulates appetite.

[0030] Stir-fried Citrus aurantium tastes bitter, pungent and sour, is slightly cold in nature, and enters the spleen and stomach meridians. It can regulate qi, relieve fullness, and relieve stagnation and distension.

[0031] Trillium has a pungent and bitter taste and is neutral in nature. It enters the liver and spleen meridians, can promote blood circulation and qi, eliminate accumulation and relieve pain.

[0032] Curcuma zedoaria, bitter and spicy in taste, warm in nature, enters the liver and spleen meridians, promotes qi and resolves blood, eliminates accumulation and relieves pain.

[0033] Governance rules

[0034] Scrophulariaceae nourishes yin and promotes fluid production, Ophiopogon japonicus increases fluidity and relieves dryness, and Rehmannia glutinosa nourishes yin and strengthens water, embodying the concept of "increasing fluid to sail the boat." Peach kernel invigorates blood circulation and moistens the intestines, while Angelica sinensis nourishes blood and moistens the intestines, promoting blood circulation and sufficient fluid, moistening the intestines and promoting bowel movements. Cypress seed, hemp seed, and Prunus mume seed moisten the intestines and promote defecation. Poria cocos and Atractylodes macrocephala strengthen the spleen and replenish qi. Stir-fried chicken gizzard lining, stir-fried barley sprout, and stir-fried malt aid digestion and invigorate the stomach, supporting the spleen and stomach in digestion. Trillium and Curcuma zedoaria dissolve blood stasis, unclog the meridians, and eliminate stagnation. Citrus aurantium promotes lung function and bowel movements, regulating qi and relaxing the intestines, promoting intestinal motility, and aiding bowel movement. The combined effects of these herbs, combining attack and tonification, moistening and unblocking, and combining movement and stillness, collectively achieve the effects of increasing fluid and moistening the intestines, dissolving blood stasis and relieving accumulation.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] The Chinese medicine composition provided by the present invention can significantly improve the symptoms of dyspnea, reduced defecation frequency, and hard stool in elderly patients with functional constipation, and promote natural defecation. Compared with chemical drugs, the Chinese medicine composition in the present invention is non-addictive. The formula of Zengye Decoction combines angelica and peach kernel, which nourish and promote blood circulation, with cypress seed, hemp seed, and Prunus mume, which are laxatives for moistening the intestines. It also contains Poria cocos, Atractylodes macrocephala, stir-fried chicken gizzard lining, stir-fried barley sprout, and stir-fried malt, which are digestive and stomach-strengthening drugs. It also contains Trigonosciadium japonicum, Curcuma zedoaria, and Citrus aurantium, which are used to relieve stagnation and clear the bowels. Together, they have the effects of nourishing yin and moistening the intestines, removing blood stasis and eliminating accumulation. Long-term use does not cause side effects such as intestinal function degradation or electrolyte imbalance. The Chinese medicine combination in the present invention can not only relieve constipation, but also regulate spleen and stomach function, improve the digestive function of the elderly, and fundamentally prevent the recurrence of constipation.

[0037] The Chinese medicine combination of the present invention can be prepared into various dosage forms, such as pills, capsules, granules, etc., which are convenient for elderly patients to take and improve patient compliance. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The drawings described herein are used to provide a further understanding of the present invention and constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0039] Figure 1 This is a Venn diagram of the drug-disease common target of the present invention;

[0040] Figure 2 A network diagram of the drug-ingredient-target-disease interaction of the present invention;

[0041] Figure 3 This is the core target identification diagram for the intervention of functional constipation in the elderly according to the present invention;

[0042] Figure 4 This is the GO function enrichment analysis diagram of the present invention;

[0043] Figure 5 This is the KEGG pathway analysis diagram of the present invention;

[0044] Figure 6 This is the docking diagram of the active ingredient of the present invention and the core target molecule;

[0045] Figure 7 This is a diagram of the visualized molecular docking results of the present invention. DETAILED DESCRIPTION

[0046] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0047] Example 1

[0048] The invention provides a traditional Chinese medicine composition for treating functional constipation in the elderly. The traditional Chinese medicine composition comprises, by weight, 15 parts of raw rehmannia root, 15 parts of ophiopogon japonicus, 15 parts of scrophulariae ningpoensis, 15 parts of cannabinoids, 15 parts of prunus mume seeds, 15 parts of cypress seeds, 15 parts of peach kernels, 15 parts of angelica sinensis, 15 parts of poria cocos, 15 parts of raw atractylodes macrocephala, 15 parts of stir-fried chicken gizzard lining, 15 parts of stir-fried barley sprouts, 15 parts of stir-fried malt, 10 parts of stir-fried fructus aurantii, 10 parts of trillium, and 10 parts of zedoaria.

[0049] As an example, the Chinese medicine composition includes 15g of raw Rehmannia root, 15g of Ophiopogon japonicus, 15g of Scrophularia ningpoensis, 15g of Cannabis sativa seed, 15g of Prunus mume seed, 15g of Platycladi seed, 15g of Peach kernel, 15g of Angelica sinensis, 15g of Poria cocos, 15g of raw Atractylodes macrocephala, 15g of stir-fried Chicken Gizzard Stone, 15g of stir-fried Barley sprout, 15g of stir-fried Malt, 10g of stir-fried Citrus aurantium, 10g of Trillium gracile, and 10g of Curcuma zedoaria.

[0050] (1) Experimental observation of the efficacy of the Chinese medicine composition in treating functional constipation in the elderly

[0051] 1. Experimental methods

[0052] 1.1. Selection of control group and observation group

[0053] Sixty elderly patients with functional constipation who visited the outpatient clinic between January 2023 and December 2024 were randomly divided into a control group (n=30) and an observation group (n=30). The control group consisted of 18 males and 12 females aged 65 to 78 years (mean, 65.26±5.72 years), with a disease duration of 6 to 10 years (mean, 7.12±2.74 years). The observation group consisted of 20 males and 10 females aged 65 to 80 years (mean, 68.67±8.43 years), with a disease duration of 5 to 11 years (mean, 8.62±3.23 years). General information was comparable between the two groups (P>0.05).

[0054] Diagnostic criteria

[0055] Western medicine diagnosis refers to the Rome III diagnostic criteria for functional constipation: (1) Two or more of the following must be present: ① Straining during defecation in at least 25% of cases; ② Dry or hard stool in at least 25% of cases; ③ Incomplete defecation in at least 25% of cases; ④ Anorectal obstruction and / or blockage in at least 25% of cases; ⑤ Manual defecation in at least 25% of cases; ⑥ Fewer than three bowel movements per week. (2) Loose stools are rare when laxatives are not used. (3) Irritable bowel syndrome is excluded. Symptoms must have occurred for at least six months, and the symptoms in the past three months have met the above criteria.

[0056] Diagnosis of TCM syndromes is based on the "Consensus on the Diagnosis and Treatment of Chronic Constipation in Traditional Chinese Medicine": Fluid and Blood Deficiency Syndrome. Primary symptoms include: ① dry, hard stools resembling sheep droppings; ② red tongue with scant coating, or pale tongue with white coating. Secondary symptoms include: ① dry mouth with scant fluid; ② dizziness and tinnitus; ③ soreness of the waist and knees; ④ palpitations; ⑤ red cheeks; ⑥ weak pulse. The primary symptoms are essential; adding two or more secondary symptoms is sufficient for diagnosis.

[0057] 1.3. Inclusion criteria

[0058] ① Meet the Rome III diagnostic criteria for functional constipation; ② Meet the diagnostic criteria for fluid deficiency and blood deficiency in Traditional Chinese Medicine; ③ Age 65-80 years old, regardless of gender; ④ Patients provide informed consent and voluntarily participate.

[0059] 1.4. Exclusion criteria

[0060] ① Patients with intestinal stenosis caused by organic lesions of the rectum and colon; ② Patients with spinal cord injury, hypothyroidism and other diseases involving the gastrointestinal tract; ③ Patients with mechanical intestinal obstruction; ④ Patients with constipation caused by anticholinergic drugs, calcium ion antagonists, and opioid preparations; ⑤ Patients with positive fecal occult blood; ⑥ Patients with severe cardiovascular and cerebrovascular diseases, severe liver and kidney dysfunction; ⑦ Mental illness; ⑧ Patients with allergic constitution.

[0061] Treatment

[0062] Control group: lactulose oral solution (Beijing Hanmei Pharmaceutical Co., Ltd., approval number: National Medicine Standard H20065730), 30 mL was taken at breakfast, once a day.

[0063] Observation group: Traditional Chinese medicine composition: Rehmannia root 15g, Radix Ophiopogonis 15g, Scrophulariae 15g, Fructus Cannabis Sativa 15g, Prunus mume seed 15g, Fructus Platycladi 15g, Prunus persica 15g, Radix Angelicae Sinensis 15g, Poria 15g, Atractylodes macrocephala 15g, stir-fried Gallus gallus officinalis 15g, stir-fried Barley sprout 15g, stir-fried Fructus Aurantii Immaturus 10g, Trigonosciadium japonicum 10g, and Rhizoma Curcumae 10g. Take one dose daily, decocted in 300ml of water, divided into two doses, morning and evening.

[0064] The treatment course for both groups was 4 weeks.

[0065] 1.6. Observation indicators

[0066] (1) Constipation symptoms and efficacy evaluation: ① Scoring criteria for difficulty in defecation: none, 0 points; occasionally, 1 point; sometimes, 2 points; often, 3 points. ② Scoring criteria for stool characteristics, refer to the Bristol stool classification standard: type I, nut-shaped hard ball; type II, hard sausage-like; type III, sausage-like, with cracks on the surface; type IV, smooth surface, soft sausage-like; type V, soft ball-like; type VI, pasty stool; type VII, watery stool. Types IV to VII, 0 points; type III, 1 point; type II, 2 points; type I, 3 points. ③ Scoring criteria for defecation time (min / time): <10, 0 points; 10 to 15, 1 point; 15 to 25, 2 points; >25, 3 points. ④ Scoring criteria for defecation frequency (1 bowel movement every few days): 1 to 2, 0 points; 3, 1 point; 4 to 5, 2 points; >5, 3 points. ⑤ Scoring criteria for abdominal distension: none, 0 points; occasionally, 1 point; sometimes, 2 points; often, 3 points.

[0067] (2) Quality of life assessment: The Patient-Assessment of Constipation Quality of Life (PAC-QOL) consists of 28 items in four dimensions, namely, physical discomfort, psychosocial discomfort, worry and anxiety, and satisfaction. The degree of discomfort is assigned a score of 0 to 4 from "not at all" to "extremely". A higher score indicates a lower quality of life.

[0068] 1.7. Efficacy evaluation criteria

[0069] Clinical cure: the main symptoms and signs disappear or basically disappear, the efficacy index ≥ 96%; marked effect: the main symptoms and signs are significantly improved, 70% ≤ efficacy index < 95%; ③ Effective: the main symptoms and signs are significantly improved, 30% ≤ efficacy index < 70%; ④ Ineffective: the main symptoms and signs have no significant improvement, or even worsen, the efficacy index < 30%.

[0070] Therapeutic index = [(score before treatment - score after treatment) / score before treatment] × 100%.

[0071] Statistical methods

[0072] SPSS11.5 software was used for data analysis. The measurement data were described using mean ± standard deviation. The t-test was used for comparison between groups. The Ridit test was used for ranked data. P < 0.05 was considered statistically significant.

[0073] 2. Experimental results

[0074] 2.1. Comparison of constipation symptom scores

[0075] The stool characteristics, defecation time, and defecation frequency scores of the control group were lower than those before the intervention (P < 0.05), but the defecation difficulty and abdominal distension scores did not change significantly compared with those before the intervention (P > 0.05). The defecation difficulty, stool characteristics, defecation time, defecation frequency, and abdominal distension scores of the observation group were lower than those before the intervention (P < 0.05), and the improvement degree of the above constipation symptom scores was better than that of the control group (P < 0.05), see Table 1.

[0076] Table 1: Comparison of constipation symptom scores ( point)

[0077]

[0078] Note: Compared with the group before intervention, a P<0.05; compared with the control group after intervention, b P<0.05.

[0079] Comparison of quality of life

[0080] After intervention, the scores of the four dimensions of the PAC-QOL scale, namely, physical discomfort, psychosocial discomfort, worry and anxiety, and satisfaction, were all reduced in both groups compared with those before intervention (P < 0.05). Moreover, the degree of reduction in the scores of the four dimensions of the PAC-QOL scale in the observation group was significantly better than that in the control group (P < 0.05), indicating that Zengye Runchang Huoxue Decoction can improve the quality of life of elderly patients with functional constipation (see Table 2).

[0081] Table 2: Comparison of quality of life ( point)

[0082]

[0083]

[0084] Note: Compared with the group before intervention, a P<0.05; compared with the control group after intervention, b P<0.05.

[0085] Comparison of clinical efficacy

[0086] The total effective rate of the observation group was 86.00%, and the total effective rate of the control group was 74.00%. The difference between the two groups was significant (P<0.05), indicating that the clinical efficacy of the observation group was significantly better than that of the control group.

[0087] Table 3: Comparison of clinical efficacy (cases)

[0088] Group n Clinical recovery Significantly effective efficient invalid Total effective rate (%) control group 30 2 12 8 8 73.33 Observation Group 30 6 16 4 4 <![CDATA[86.67 a ]]>

[0089] Note: Compared with the control group, a P<0.05.

[0090] 3. Experimental Conclusion

[0091] This study shows that the total effective rate of the Chinese medicine composition of the present invention in treating functional constipation in the elderly is 86.67%, which is significantly better than 73.33% of the control group (P<0.05); the Chinese medicine composition can reduce patients' difficulty in defecation, stool characteristics, defecation time, defecation frequency, abdominal distension score and the four dimensions of physical discomfort, psychosocial discomfort, worry and anxiety, and satisfaction in the PAC-QOL scale (P<0.05), indicating that the Chinese medicine composition can improve patients' constipation symptoms and improve their quality of life.

[0092] (II) Study on the mechanism of Zengye Xiaoji Decoction made from a traditional Chinese medicine composition based on network pharmacology in the treatment of functional constipation in the elderly

[0093] 1. Experimental methods

[0094] 1.1. Collection of active ingredients and related targets of Zengye Xiaoji Decoction

[0095] The Traditional Chinese Medicine Systems Pharmacology Analysis Platform (TCMSP) and BATMAN databases were used to search for components of Rehmannia root, Radix Ophiopogonis, Scrophularia ningpoensis, Fructus Cannabis, Fructus Corylifolia, Fructus Platycladi, Fructus Persicae, Radix Angelicae Sinensis, Poria, Atractylodes macrocephala, stir-fried Gallus gallus domestica, stir-fried Barley sprout, stir-fried Fructus Aurantii Immaturus, Fructus Trillium, and Rhizoma Curcumae. Ingredients meeting these criteria were identified, with an oral bioavailability (OB) ≥ 30% and a drug-like property (DL) ≥ 0.18. Based on the component screening results, corresponding targets were searched in the UniProt database (https: / / www.uniprot.org / ), with the species set to "homo sapiens," and gene names were sorted.

[0096] 1.2. Collection of functional constipation targets

[0097] The GeneCards database (https: / / www.genecards.org / ) and the OMIM database (https: / / omim.org / ) were searched for potential targets for functional constipation.

[0098] 1.3. Common targets and the construction of the “TCM-ingredient-target-disease” network

[0099] Venny 2.1.0 was used to map the intersection of drug active ingredient targets and targets for functional constipation in the elderly, identifying the targets of TCM prescriptions for improving functional constipation in the elderly. The Cytoscape 3.8.0 software plug-in, Network Analyzer, was then used to calculate network topology properties. Core genes were selected based on these network topology parameters to construct a "TCM-ingredient-target-disease" network.

[0100] 1.4. Construction of protein-protein interaction (PPI) networks

[0101] The target gene information was imported into the STRING database (https: / / string-db.org / ), the species was selected as “homosapiens”, and the free targets were hidden to construct the PPI network.

[0102] 1.5. Analysis of pathway and functional enrichment

[0103] GO and KEGG analyses were performed using the R language software package to identify common targets of Zengye Xiaoji Decoction for improving functional constipation in the elderly. GO enrichment pathways, including biological process (BP), molecular function (MF), cell component (CC), and KEGG pathways, were screened based on P < 0.05. The results were visualized using bubble plots.

[0104] Molecular docking

[0105] Small molecule mol2 files were obtained from the TCMSP and Pubchem databases, and large molecule target protein pdb files were downloaded from the String data platform and PDB database. Hydrogenation and dehydration of small and large molecules were performed using AutodockTool 4.0 software, and active site docking was performed using PyMOL 2.5 software.

[0106] 2. Experimental results

[0107] 2.1. Results of active ingredient screening and target prediction for Zengye Xiaoji Decoction

[0108] Target prediction of ingredients was performed using the TCMSP and BATMAN databases, and a total of 219 active ingredients were obtained in Zengye Xiaoji Decoction. After removing duplicates, there were 201 active ingredients, corresponding to 1,130 targets.

[0109] 2.2. Screening of functional constipation-related targets and overlapping targets

[0110] Functional constipation-related targets were collected from the GeneCards database and the OMIM database, and a total of 2757 target genes were obtained after integration and deduplication.

[0111] 2.3. Prediction of drug-disease common targets

[0112] 201 drug targets and 2757 disease targets were input into the jvenn online software drawing tool platform to draw a Venn diagram. After the intersection of the two, 455 common drug-disease targets were obtained. Figure 1 .

[0113] 2.4. Construction of Traditional Chinese Medicine-Ingredient-Target-Disease Network

[0114] The drug-active ingredient-disease target network was constructed using Cytoscape 3.8.0 software for 455 common targets, with reference to Figure 2 Using the "Network analyzer" function of Cytoscape 3.8.0 software, the top five active ingredients were screened according to their degree values, namely quercetin, stigmasterol, kaempferol, salidroside, and naringenin.

[0115] 2.5. Identification of core targets for Zengye Xiaoji Decoction in the treatment of functional constipation in the elderly

[0116] The protein interaction between Zengye Xiaoji Decoction and elderly functional constipation was conducted, and the core targets were screened using CC, DC, EC, LAC and NC parameters. A total of core targets were obtained, and the results were compared with those of the control group. Figure 3 .

[0117] GO function enrichment analysis

[0118] GO pathway results showed that in terms of BP, it mainly involves the response to external stimuli, the response to oxidative stress, the response to oxygen levels, the response to hypoxia, the metabolic process of reactive oxygen species, etc. In terms of CC, it mainly affects membrane rafts, etc. In terms of MF, it has a greater impact on G protein-coupled amine receptor activity and nuclear receptor activity, etc., refer to Figure 4 .

[0119] Pathway enrichment analysis

[0120] KEGG analysis yielded 218 pathways, referring to Figure 5 , mainly involving the PI3K-AKT signaling pathway, cAMP signaling pathway, advanced glycation end products (AGE)-advanced glycation end product receptor (RAGE), tumor necrosis factor (TNF), HIF-1 signaling, interleukin-17 (IL-17) pathway, etc., suggesting that the above pathways are related to the intervention of Zengye Xiaoji Decoction in the occurrence and development of functional constipation in the elderly.

[0121] 2.8. Molecular docking of ligand active ingredients with key targets

[0122] The AutoDock Vina software was used to perform molecular docking on the core target proteins (TP53, AKT1, STAT3, TNF, IL6) in the PPI network with quercetin, stigmasterol, kaempferol, and naringenin. The results showed that stigmasterol had the best binding energy with TP53, naringenin had the best binding energy with AKT1, quercetin had the best binding energy with STAT3, and kaempferol had the best binding energy with TNF and IL6. Figure 6 At the same time, molecular docking verification was performed on the active ingredients with good binding ability and key targets, and the docking results were visualized using Pymol software. Figure 7 .

[0123] (3) Two typical cases for Example 1

[0124] Case 1:

[0125] Wang Moumou, male, 72 years old, native place: Tianjin, date of consultation: March 13, 2025, solar term of onset: Jingzhe.

[0126] Chief complaint: Difficulty in defecation for more than one year.

[0127] Current medical history: One year ago, the patient developed constipation and dry stool, with bowel movements occurring approximately every 4-7 days. Gastroscopy and colonoscopy during this period revealed no significant abnormalities. Treatments, including oral lactulose solution, linaclotide capsules, Ma Ren soft capsules, and Liuwei Anxiao capsules, were ineffective, and constipation persisted. He sought treatment with Traditional Chinese Medicine (TCM) and presented to our outpatient clinic. Current symptoms: The patient is alert and well-rested, with constipation and dry stool resembling sheep dung, occurring approximately every 4-7 days. He also has abdominal distension, but no nausea, vomiting, or abdominal pain. He has a poor appetite and a dark red tongue with a thin, dry coating and a deep pulse.

[0128] Past medical history: history of coronary heart disease for more than 20 years, usually treated with oral aspirin enteric-coated tablets 0.1g Qd, atorvastatin calcium tablets 10mg Qn, and isosorbide mononitrate sustained-release tablets 60mg Qd.

[0129] I: Zengye Xiaoji Decoction, the prescription is as follows:

[0130] Raw Rehmannia root 15g, Ophiopogon japonicus 15g, Scrophularia ningpoensis 15g, Cannabis sativa seed 15g;

[0131] Prunus mume seeds 15g, cypress seeds 15g, peach kernel 15g, and Chinese angelica 15g;

[0132] Poria 15g, raw Atractylodes macrocephala 15g, stir-fried chicken gizzard 15g, stir-fried barley sprout 15g;

[0133] Stir-fried malt 15g, stir-fried fructus aurantii 10g, Rhizoma Trigonellae 10g, Rhizoma Curcumae 10g;

[0134] Seven doses, decocted in water, one dose per day, 200ml each time, taken warm in the morning and evening after meals;

[0135] Follow-up visit on March 20, 2025: The patient reported that his constipation was significantly improved compared to before, with soft stool and defecation once a day.

[0136] Case 2:

[0137] Li, female, 68 years old, native place: Tianjin, date of consultation: February 10, 2025, solar term of onset: Beginning of Spring.

[0138] Chief complaint: Dry and hard stool, one stool every 3 to 5 days, lasting for more than 2 years, worsening for 1 month.

[0139] Present medical history: For the past two years, the patient has had dry stools resembling sheep dung, requiring straining to defecate. Occasional use of senna leaves provided temporary relief, but these symptoms recurred after discontinuation. Over the past month, symptoms have worsened, accompanied by abdominal distension and dull pain, which are relieved by defecation. He sought treatment with Traditional Chinese Medicine (TCM) and presented to our outpatient clinic. Current symptoms: The patient is alert and in good spirits, with dry stools resembling sheep dung, accompanied by abdominal distension and dull pain, which are relieved by defecation, dry mouth and thirst, particularly at night, fatigue, soreness in the waist and knees, a dark red tongue with a scanty, dry coating, and a deep, thready pulse.

[0140] Past medical history: 10-year history of hypertension, with the highest blood pressure of 180 / 90 mmHg. Long-term treatment with amlodipine besylate tablets 5 mg Qd, and blood pressure control is acceptable.

[0141] Physical examination: The abdomen is soft, and a cord-like mass (fecal mass) can be felt in the left lower abdomen, with mild tenderness.

[0142] I: Zengye Xiaoji Decoction, the prescription is as follows:

[0143] Raw Rehmannia root 15g, Ophiopogon japonicus 15g, Scrophularia ningpoensis 15g, Cannabis sativa seed 15g;

[0144] Prunus mume seeds 15g, cypress seeds 15g, peach kernel 15g, and Chinese angelica 15g;

[0145] Poria 15g, raw Atractylodes macrocephala 15g, stir-fried chicken gizzard 15g, stir-fried barley sprout 15g;

[0146] Stir-fried malt 15g, stir-fried fructus aurantii 10g, Rhizoma Trigonellae 10g, Rhizoma Curcumae 10g;

[0147] Seven doses, decocted in water, one dose per day, 200ml each time, taken warm in the morning and evening after meals;

[0148] Follow-up visit on February 17, 2025: The patient complained that his stool was dry like sheep dung, which was significantly improved compared with before, the stool was soft, and he had a bowel movement once every two days.

[0149] Example 2

[0150] The present invention provides a method for preparing a decoction for treating functional constipation in the elderly, comprising the following steps:

[0151] Step 1: Select raw materials: 15 parts of raw rehmannia root, 15 parts of ophiopogon japonicus, 15 parts of scrophulariae, 15 parts of hemp seed, 15 parts of prunes, 15 parts of cypress seed, 15 parts of peach kernel, 15 parts of angelica sinensis, 15 parts of poria, 15 parts of raw atractylodes macrocephala, 15 parts of stir-fried chicken gizzard lining, 15 parts of stir-fried barley sprout, 15 parts of stir-fried malt, 10 parts of stir-fried fructus aurantii, 10 parts of trillium, and 10 parts of zedoaria;

[0152] Step 2: Soak the selected raw materials in 800mL of drinking water for 60 minutes;

[0153] Step 3: Put the soaked ingredients into a casserole, first boil over high heat until boiling, then simmer over low heat for 20 minutes, then boil over high heat again until boiling, then simmer over low heat for 20 minutes; obtain the decoction.

[0154] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating functional constipation in the elderly, characterized in that: The traditional Chinese medicine composition comprises raw rehmannia root, ophiopogon japonicus, scrophularia ningpoensis, hemp seed, Prunus mume seed, cypress seed, peach kernel, angelica sinensis, poria cocos, raw atractylodes macrocephala, stir-fried chicken gizzard lining, stir-fried barley sprout, stir-fried malt, stir-fried fructus aurantii, trillium and zedoaria.

2. A Chinese medicine composition for treating functional constipation in the elderly according to claim 1, characterized in that: The Chinese medicine composition comprises, by weight, 15 parts of raw rehmannia root, 15 parts of ophiopogon japonicus, 15 parts of scrophulariae ningpoensis, 15 parts of cannabinoids, 15 parts of prunes, 15 parts of cypress seeds, 15 parts of peach kernels, 15 parts of angelica sinensis, 15 parts of poria, 15 parts of raw atractylodes macrocephala, 15 parts of stir-fried chicken gizzard lining, 15 parts of stir-fried barley sprouts, 15 parts of stir-fried malt, 10 parts of stir-fried fructus aurantii, 10 parts of trillium, and 10 parts of zedoaria.

3. A Chinese medicine composition for treating functional constipation in the elderly according to claim 2, characterized in that: The dosage form of the Chinese medicine composition is pills.

4. A Chinese medicine composition for treating functional constipation in the elderly according to claim 2, characterized in that: The dosage form of the Chinese medicine composition is capsule.

5. A Chinese medicine composition for treating functional constipation in the elderly according to claim 2, characterized in that: The dosage form of the traditional Chinese medicine composition is granules.

6. A Chinese medicine composition for treating functional constipation in the elderly according to claim 2, characterized in that: The dosage form of the Chinese medicine composition is a decoction.

7. The method for preparing a decoction for treating functional constipation in the elderly according to claim 6, wherein: The following steps are involved: Step 1: Select raw materials: 15 parts of raw rehmannia root, 15 parts of ophiopogon japonicus, 15 parts of scrophulariae, 15 parts of hemp seed, 15 parts of prunes, 15 parts of cypress seed, 15 parts of peach kernel, 15 parts of angelica sinensis, 15 parts of poria, 15 parts of raw atractylodes macrocephala, 15 parts of stir-fried chicken gizzard lining, 15 parts of stir-fried barley sprout, 15 parts of stir-fried malt, 10 parts of stir-fried fructus aurantii, 10 parts of trillium, and 10 parts of zedoaria; Step 2: Soak the selected raw materials in 800mL of drinking water for 60 minutes; Step 3: Put the soaked ingredients into a casserole, first boil over high heat until boiling, then simmer over low heat for 20 minutes, then boil over high heat again until boiling, then simmer over low heat for 20 minutes; obtain the decoction.

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