Traditional Chinese medicine composition with kidney tonifying and bowel relaxing functions as well as preparation method, preparation and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition with kidney tonifying and bowel relaxing functions and a preparation method, a preparation and application thereof. The traditional Chinese medicine composition comprises the following components: wine-processed cistanche, angelica sinensis, cooked rhubarb, semen cassiae, achyranthes bidentata, radix paeoniae alba, pericarpium citri reticulatae, rhizoma alismatis, fructus aurantii and rhizoma cimicifugae. The traditional Chinese medicine composition provided by the invention is mainly used for warming the kidney, boosting essence and relaxing bowel. The traditional Chinese medicine is used for treating dry stool, constipation due to intestinal dryness, clear and long urine, soreness and weakness of waist and knees, general weakness, stomachache, abdominal distension, blood deficiency and sallow yellowness, insomnia, headache and dizziness, spontaneous perspiration and inappetence caused by kidney deficiency and body fluid deficiency; the traditional Chinese medicine is used for treating irritable bowel syndrome and menstrual disorder.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition with kidney-tonifying and laxative functions, its preparation method, formulation, and application. Background Technology

[0002] The *Huangdi Neijing* (Yellow Emperor's Inner Classic) states: "What a person possesses is blood and qi," and "When qi is abundant, the whole body is nourished; when blood is abundant, the whole body is sustained; when the body is full, no evil can enter." It also emphasizes "supporting the primordial yang to strengthen its foundation, using yang to guide yin, with yang dominating and yin following." Therefore, whether treating illness or maintaining health, supporting the primordial yang is fundamental. Traditional Chinese medicine's treatment mechanism emphasizes that those who support the primordial yang live, and those who lose it die. All diseases are traced back to damage to the primordial yang, which determines a person's life, health, and lifespan. It bases its treatment and conditioning on the principle that "the spleen governs transformation and transportation, being the foundation of acquired constitution and the source of qi and blood; the kidneys govern the storage of essence, being the foundation of innate constitution; both are the foundation of the five internal organs." It advocates the concept of "supporting the primordial yang, simultaneously replenishing qi and blood, and simultaneously replenishing both acquired and innate constitutions."

[0003] The kidneys are the foundation of the body and are essential for life. They store the essence of both prenatal and postnatal life, preserving it without leakage; essence is the foundation of the body. Kidney Qi, based on kidney essence, manifests its function in two ways: primordial Yin and primordial Yang, the source of Yin and Yang in the body. The kidneys nourish the Yin of the five internal organs and generate their Yang, stimulating and promoting the activities of all organs and tissues, maintaining normal growth and development. If kidney Yang is insufficient, the intestines cannot be warmed, leading to internal coldness, which stagnates and causes constipation. Insufficient kidney Yang weakens Qi transformation, disrupts the bladder's opening and closing, deprives the intestines of moisture, and impairs transmission, resulting in constipation. Kidney Yin deficiency deprives the intestines of nourishment, leading to dry stools. This condition is often categorized as "constipation," "difficulty in defecation," or "obstruction."

[0004] As stated in the "Suwen·Jue Lun": "When Taiyin is in a state of jue, there will be abdominal distension and difficulty in defecation"; "Zhubing Yuanhou Lun·Dabian Nanhou" says: "Difficulty in defecation is due to the imbalance of the five viscera, the deficiency or excess of Yin and Yang, that is, the disharmony of the three jiaos, which causes cold and heat to combine"; it also says: "Evil in the kidneys causes difficulty in defecation"; "Danxi Xinfa·Piyue Wan Lun" says: "When the stomach is strong and the spleen is weak, the body fluids are restricted and cannot be distributed in all directions... hence the name spleen restriction... since it is called spleen restriction, the spleen is weak and cannot pass through"; "Jinkui Yaolue·Bianbi Tonglun" proposes "Qi stagnation and obstruction of bowel movements"; "Wenbing Tiaobian" says: "In Yangming febrile disease, there are no symptoms in the upper jiao, and there is no bowel movement for several days. If the person is weak in Yin and cannot take Chengqi Decoction, Zengye Decoction should be used." It is also said: "In Yangming febrile disease, if purgation fails to relieve the obstruction, there are five symptoms... If the body fluids are insufficient and there is no water to hold the boat, administer Zengye Decoction intermittently. If purgation is repeated, Zengye Chengqi Decoction should be administered." The "Four Essentials of Nourishing Life - Curing Diseases" states: "Kidney deficiency leads to insufficient body fluids, and insufficient body fluids lead to dry and difficult bowel movements." Traditional Chinese medicine believes that all the organs of the human body depend on the nourishment and lubrication of blood, and the motility of the large intestine is no exception. For example, if blood is deficient and cannot nourish the large intestine, it will lead to yin deficiency and blood deficiency, excessive fire and water deficiency, insufficient production of body fluids, and intestinal dryness, resulting in dry and hard stools and difficulty in defecation, thus causing this condition. The "Complete Works of Jingyue" states: "For diseases involving deficiency and constipation, purgatives such as Glauber's salt and rhubarb should not be used. If there is no other way but to relieve constipation, this is the appropriate treatment, as this uses a tonifying agent to promote bowel movement." "Elderly people with qi deficiency and women with postpartum blood deficiency cause the body fluids to stagnate and fail to flow, thus often resulting in constipation." Wang Lun of the Ming Dynasty said in the "Treatise on Solid Pills" in "Miscellaneous Writings of Ming Dynasty Physicians": "This condition belongs to the category of physical and qi deficiency, where both physical and qi are insufficient, the spleen and stomach are weak, and the body fluids and blood are depleted, resulting in difficult bowel movements. This method nourishes and replenishes the source of qi."

[0005] Therefore, there is an urgent need in the field to provide a traditional Chinese medicine composition with the effects of warming the kidneys and replenishing essence, and moistening the intestines and relieving constipation. Summary of the Invention

[0006] This invention addresses the problems existing in the prior art by providing a traditional Chinese medicine composition with kidney-tonifying and laxative functions, as well as its preparation method, formulation, and application.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A traditional Chinese medicine composition with kidney-tonifying and laxative functions includes the following components: Cistanche deserticola (processed with wine), Angelica sinensis, Rheum palmatum (processed), Cassia tora, Achyranthes bidentata, Paeonia lactiflora, Citrus reticulata peel, Alisma plantago-aquatica, Citrus aurantium, and Cimicifuga foetida.

[0008] Preferably, by weight, it comprises the following components: 85-100 parts of Cistanche deserticola (processed with wine), 140-180 parts of Angelica sinensis, 80-100 parts of processed rhubarb, 65-85 parts of Cassia tora, 40-60 parts of Achyranthes bidentata, 50-65 parts of Paeonia lactiflora, 60-80 parts of Citrus reticulata peel, 50-60 parts of Alisma plantago-aquatica, 30-40 parts of Citrus aurantium, and 30-40 parts of Cimicifuga foetida.

[0009] More preferably, by weight, it comprises the following components: 85-90 parts of Cistanche deserticola (processed with wine), 150-170 parts of Angelica sinensis, 80-95 parts of processed rhubarb, 66-80 parts of Cassia tora, 45-55 parts of Achyranthes bidentata, 50-60 parts of Paeonia lactiflora, 65-75 parts of Citrus reticulata peel, 50-55 parts of Alisma plantago-aquatica, 34-36 parts of Citrus aurantium, and 34-36 parts of Cimicifuga foetida.

[0010] More preferably, by weight, it comprises the following components: 89.3 parts of Cistanche deserticola (processed with wine), 160.7 parts of Angelica sinensis, 89.3 parts of processed rhubarb, 71.4 parts of Cassia tora, 53.6 parts of Achyranthes bidentata, 53.6 parts of Paeonia lactiflora, 71.4 parts of Citrus reticulata peel, 53.6 parts of Alisma plantago-aquatica, 35.7 parts of Citrus aurantium, and 35.7 parts of Cimicifuga foetida.

[0011] The medicinal properties and mechanisms of action of each of the above components are as follows: Wine-processed Cistanche: Take cleaned Cistanche slices and stew or steam them in wine until the wine is absorbed. [Properties and Channels Entered] Sweet, salty, warm. Enters the Kidney and Large Intestine channels. [Functions and Indications] Tonifies Kidney Yang, nourishes essence and blood, moistens the intestines and promotes bowel movement. Used for Kidney Yang deficiency, deficiency of essence and blood, impotence and infertility, soreness and weakness of the lower back and knees, weakness of muscles and bones, and constipation due to intestinal dryness.

[0012] Angelica sinensis: [Properties and Channels Entered] Sweet, pungent, warm. Enters the Liver, Heart, and Spleen channels. [Functions and Indications] Nourishes blood and promotes blood circulation, regulates menstruation and relieves pain, moistens the intestines and promotes bowel movement. Used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, traumatic injuries, carbuncles and sores, and constipation due to intestinal dryness. Angelica sinensis infused with wine promotes blood circulation and regulates menstruation. Used for amenorrhea and dysmenorrhea, rheumatic arthralgia, and traumatic injuries.

[0013] Prepared rhubarb: Take clean rhubarb pieces and stew or steam them with wine until they turn black inside and out.

Properties and Channels Entered

Functions and Indications

[0014] Cassia Seed: [Properties and Channels Entered] Sweet, bitter, salty, slightly cold. Enters the Liver and Large Intestine channels. [Functions and Indications] Clears heat and improves vision, moistens the intestines and promotes bowel movement. Used for red, sore, and painful eyes, photophobia with excessive tearing, headache and dizziness, blurred vision, and constipation.

[0015] Achyranthes bidentata: [Properties and Channels Entered] Bitter, sweet, sour, neutral. Enters the Liver and Kidney channels. [Functions and Indications] Removes blood stasis and unblocks menstruation, tonifies the Liver and Kidneys, strengthens tendons and bones, promotes urination and relieves strangury, guides blood downward. Used for amenorrhea, dysmenorrhea, soreness and weakness of the lower back and knees, weakness of tendons and bones, strangury, edema, headache, dizziness, toothache, canker sores, hematemesis, and epistaxis.

[0016] White peony root: [Properties and Channels Entered] Bitter, sour, slightly cold. Enters the Liver and Spleen channels. [Functions and Indications] Nourishes blood and regulates menstruation, astringes Yin and stops sweating, softens the liver and relieves pain, and calms liver Yang. Used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms, headache, and dizziness.

[0017] Dried tangerine peel: [Properties and Channels Entered] Bitter, pungent, warm. Enters the Lung and Spleen channels. [Functions and Indications] Regulates Qi and strengthens the Spleen, dries dampness and resolves phlegm. Used for abdominal distension, poor appetite, vomiting and diarrhea, and cough with excessive phlegm.

[0018] Alisma plantago-aquatica: [Properties and Channels Entered] Sweet, bland, cold. Enters the Kidney and Bladder channels. [Functions and Indications] Promotes diuresis and eliminates dampness, clears heat, resolves turbidity and lowers lipids. Used for dysuria, edema, diarrhea with scanty urine, phlegm retention and dizziness, painful urination due to heat, and hyperlipidemia.

[0019] Fructus Aurantii Immaturus: [Properties and Channels Entered] Bitter, pungent, sour, slightly cold. Enters the Spleen and Stomach channels. [Functions and Indications] Regulates Qi and relieves chest tightness, promotes digestion and eliminates bloating. Used for chest and rib pain due to Qi stagnation, indigestion, phlegm retention, and organ prolapse.

[0020] Cimicifuga rhizome: [Properties and Channels Entered] Pungent, slightly sweet, slightly cold. Enters the Lung, Spleen, Stomach, and Large Intestine channels. [Functions and Indications] Releases exterior pathogens and promotes rash eruption, clears heat and detoxifies, and raises Yang Qi. Used for wind-heat headache, toothache, canker sores, sore throat, incomplete measles eruption, rashes caused by Yang toxins, rectal prolapse, and uterine prolapse.

[0021] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: decocting each medicinal material with water, combining the decoctions, filtering, and collecting the filtrate to obtain the composition.

[0022] Preferably, the decoction process includes: adding 4-6 times the amount of water to the medicinal materials, soaking for 40-60 minutes, and decocting 2-3 times, each time for 1-1.5 hours.

[0023] The present invention also provides a traditional Chinese medicine preparation with the effects of warming the kidney and replenishing essence, moistening the intestine and relieving constipation, comprising the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method and pharmaceutically acceptable excipients.

[0024] Preferably, the excipients include at least one of emulsifiers, fillers, binders, disintegrants, colorants, and cosolvents.

[0025] More preferably, the excipients include one or more of dextrin, starch, microcrystalline cellulose, sucrose, lactose, glucose, silicon dioxide, ethanol, sodium benzoate, and Tween 80.

[0026] Preferably, the dosage form of the preparation is pills, powders, tablets, ointments, capsules, granules, oral liquids, or decoctions.

[0027] More preferably, the dosage form of the preparation is pills, capsules, granules or decoction.

[0028] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition or the above-mentioned traditional Chinese medicine preparation obtained by the above-mentioned preparation method in the preparation of drugs with the effects of warming the kidney and replenishing essence, moistening the intestine and relieving constipation.

[0029] Compared with the prior art, the present invention has the following beneficial effects: (1) The Chinese medicine composition provided by the present invention is mainly used for: warming the kidney and replenishing essence, moistening the intestine and relieving constipation. It is used for constipation, dry stool, frequent urination, soreness of the waist and knees, general weakness, abdominal pain, abdominal distension, blood deficiency and chlorosis, insomnia, headache and dizziness, spontaneous sweating and loss of appetite caused by kidney deficiency and fluid depletion; irritable bowel syndrome, and menstrual disorders with the above symptoms.

[0030] (2) The theory of principal, assistant, adjuvant, and guide herbs in the traditional Chinese medicine composition provided by this invention is as follows: The principal herb, Cistanche deserticola, is sweet and warm, tonifying the kidneys, benefiting essence, and moistening the intestines; Angelica sinensis nourishes blood, regulates menstruation, and moistens dryness in the intestines. The assistant herb, Rheum palmatum, is used to gently purge and relieve constipation; Cassia tora clears the liver and moistens the intestines. The adjuvant herbs are divided into three groups: Achyranthes bidentata tonifies the liver and kidneys and strengthens tendons and bones; Paeonia lactiflora nourishes yin and softens the liver; Citrus reticulata peel and Alisma plantago-aquatica regulate qi, resolve dampness, and prevent stagnation. The guide herb, Citrus aurantium, assists in the transmission of large intestine; Cimicifuga foetida promotes the upward movement of clear qi and descends the downward movement of turbid qi. The whole formula warms the kidneys and nourishes blood as the principal herb, moistens the intestines and relieves stagnation as the assistant herb, and strengthens the foundation and regulates qi as the guide herb, with the ascending and descending herbs complementing each other, which is in line with the pathogenesis of kidney deficiency, intestinal dryness, and qi stagnation. The combination of these herbs works together to warm the kidneys, benefit essence, moisten the intestines, and relieve constipation. Detailed Implementation

[0031] It is worth noting that the raw materials used in this invention are all commercially available products.

[0032] Example 1 A traditional Chinese medicine composition with kidney-tonifying and laxative functions, comprising the following components by weight: 89.3 parts of Cistanche deserticola (processed with wine), 160.7 parts of Angelica sinensis, 89.3 parts of processed rhubarb, 71.4 parts of Cassia tora, 53.6 parts of Achyranthes bidentata, 53.6 parts of Paeonia lactiflora, 71.4 parts of Citrus reticulata peel, 53.6 parts of Alisma plantago-aquatica, 35.7 parts of Citrus aurantium, and 35.7 parts of Cimicifuga foetida.

[0033] The preparation method of this traditional Chinese medicine composition is as follows: The above ten medicinal materials are decocted twice with water. The first time, 6 times the amount of water is added and the mixture is soaked for 40 minutes. The second time, 4 times the amount of water is added and the mixture is decocted for 1 hour each time. The decoctions are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.20 g / mL (60-70℃). An appropriate amount of dextrin is added, mixed well, granulated, dried, and 1000 g is obtained.

[0034] Example 2 A traditional Chinese medicine composition with kidney-tonifying and laxative functions, by weight, consists of the following components: 100 parts of Cistanche deserticola (processed with wine), 140 parts of Angelica sinensis, 80 parts of processed rhubarb, 65 parts of Cassia tora, 60 parts of Achyranthes bidentata, 65 parts of Paeonia lactiflora, 80 parts of Citrus reticulata peel, 60 parts of Alisma plantago-aquatica, 30 parts of Citrus aurantium, and 30 parts of Cimicifuga foetida.

[0035] The preparation method of this traditional Chinese medicine composition is as follows: The above ten medicinal materials are decocted twice with water. The first time, 6 times the amount of water is added and the mixture is soaked for 60 minutes. The second time, 4 times the amount of water is added and the mixture is decocted for 1.5 hours each time. The decoctions are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.25 g / mL (60-70℃). An appropriate amount of dextrin is added, mixed well, granulated, dried, and 1000 g is obtained.

[0036] Example 3 A traditional Chinese medicine composition with kidney-tonifying and laxative functions, by weight, consists of the following components: 85 parts of Cistanche deserticola (processed with wine), 180 parts of Angelica sinensis, 100 parts of processed rhubarb, 85 parts of Cassia tora, 40 parts of Achyranthes bidentata, 50 parts of Paeonia lactiflora, 60 parts of Citrus reticulata peel, 50 parts of Alisma plantago-aquatica, 40 parts of Citrus aurantium, and 40 parts of Cimicifuga foetida.

[0037] The preparation method of this traditional Chinese medicine composition is as follows: The above ten medicinal materials are decocted twice with water. The first time, 5 times the amount of water is added and the mixture is soaked for 60 minutes. The second time, 6 times the amount of water is added and the mixture is decocted for 1.2 hours each time. The decoctions are combined, filtered, and the filtrate is concentrated to an extract with a relative density of 1.20 g / mL (60-70℃). An appropriate amount of dextrin is added, mixed well, granulated, dried, and 1000 g is obtained.

[0038] Comparative Example 1 Compared with Example 1, the only difference is that the bitter orange peel is replaced with hemp seed, resulting in a traditional Chinese medicine composition with kidney-tonifying and laxative functions.

[0039] Comparative Example 2 Compared with Example 1, the only difference is that the dried tangerine peel is replaced with chuanxiong, resulting in a traditional Chinese medicine composition with kidney-tonifying and laxative functions.

[0040] Comparative Example 3 Compared with Example 1, the only difference is that the composition also contains Magnolia officinalis. Specifically, it is a traditional Chinese medicine composition with the function of tonifying the kidney and relieving constipation, which is composed of the following components by weight: 120 parts of Cistanche deserticola, 160 parts of Angelica sinensis, 70 parts of processed rhubarb, 72 parts of Cassia tora, 55 parts of Achyranthes bidentata, 40 parts of Magnolia officinalis, 43 parts of Paeonia lactiflora, 84 parts of Citrus reticulata, 67 parts of Alisma plantago-aquatica, 36 parts of Citrus aurantium and 36 parts of Cimicifuga foetida.

[0041] Comparative Example 4 Compared with Example 1, the only difference is the different component ratios. Specifically, a traditional Chinese medicine composition with kidney-tonifying and laxative functions is composed of the following components by weight: 120 parts of Cistanche deserticola (processed with wine), 160 parts of Angelica sinensis, 70 parts of processed rhubarb, 72 parts of Cassia tora, 55 parts of Achyranthes bidentata, 43 parts of Paeonia lactiflora, 84 parts of Citrus reticulata peel, 67 parts of Alisma plantago-aquatica, 36 parts of Citrus aurantium, and 36 parts of Cimicifuga foetida.

[0042] Comparative Example 5 Compared with Example 1, the only difference is the different component ratios. Specifically, a traditional Chinese medicine composition with kidney-tonifying and laxative functions is composed of the following components by weight: 72 parts of Cistanche deserticola (processed with wine), 120 parts of Angelica sinensis, 100 parts of processed rhubarb, 60 parts of Cassia tora, 55 parts of Achyranthes bidentata, 72 parts of Paeonia lactiflora, 53 parts of Citrus reticulata peel, 50 parts of Alisma plantago-aquatica, 40 parts of Citrus aurantium, and 42 parts of Cimicifuga foetida.

[0043] Test Example 1 Animal experiments were conducted on the traditional Chinese medicine compositions with kidney-tonifying and laxative functions prepared in Examples 1-3 and Comparative Examples 1-5, respectively. The specific experimental methods are as follows: 1. Test samples: Traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-5.

[0044] 2. Experimental animals: SPF-grade male Kunming mice, weighing 18-22 g, half male and half female.

[0045] 3. Prepare the solution: Loperamide hydrochloride suspension: Prepare the following before use: grind loperamide hydrochloride tablets (26 mg) into powder using a mortar and pestle, add pure water to 26 mL, shake well to make a 1 mg / mL suspension, and store at 4℃ for later use.

[0046] Ink: Take 10 g of gum arabic, add 80 mL of distilled water, boil until clear, then add 10 g of activated charcoal (powder), boil 3 times, then add water to make up to 100 mL, refrigerate at 4℃, and shake well before use.

[0047] 4. Grouping and administration: After 7 days of adaptive feeding, the mice were divided into a blank control group, a model group (loperamide hydrochloride), the low-dose group of Example 1, the medium-dose group of Example 1, the high-dose group of Example 1, the groups of Example 2-3 and the comparative examples 1-5, with half males and half females, and 10 mice in each group.

[0048] The mice were administered the herbal composition via gavage. The blank control group and the model group were given 0.5 mL of distilled water per mouse. The low-dose group of Example 1 was given 3.45 g crude drug / kg / d of the herbal composition from Example 1 via gavage; the medium-dose group of Example 1 was given 7.68 g crude drug / kg / d of the herbal composition from Example 1 via gavage; and the high-dose group of Example 1 was given 12.42 g crude drug / kg / d of the herbal composition from Example 1 via gavage. The groups of Examples 2-3 and Comparative Examples 1-5 were given 7.68 g crude drug / kg / d of the corresponding herbal composition continuously for 14 days. Mice in all groups were fasted but allowed free access to water for 24 hours. 30 minutes later, except for the blank control group, all other groups were given 5.2 mg / kg loperamide hydrochloride via gavage. 30 minutes later, each group was given 0.4 mL of ink via gavage. After 20 minutes, the animals were euthanized by cervical dislocation, and the small intestine was removed by opening the abdomen. The intestinal segment from the upper end of the pylorus to the lower end of the ileocecal junction was cut off, gently pulled into a straight line, and the total length of the small intestine and the displacement from the pylorus to the ink movement front were measured to calculate the ink propulsion rate of the small intestine.

[0049] Ink propulsion rate (%) = Ink propulsion length (cm) ÷ Total length of small intestine (cm) × 100%.

[0050] 5. Experimental Results: The intestinal propulsion rate of mice in each group is shown in Table 1. The intestinal propulsion rate of the model group was significantly lower than that of the blank control group (P<0.01), indicating that the small intestinal motility inhibition model was successfully established after administration of loperamide hydrochloride. The intestinal propulsion rates of the medium-dose group in Example 1, the high-dose group in Example 1, and the groups in Example 2 and Example 3 were all significantly higher than those of the model group (P<0.01 or P<0.05), indicating that the traditional Chinese medicine composition of the present invention has the effect of promoting small intestinal motility in mice.

[0051] Table 1 Results of small intestinal ink propulsion rate

[0052] Note: Compared with the model group, # This indicates that P < 0.05. ## This indicates that P < 0.01.

[0053] Test Example 2 The clinical observation of the traditional Chinese medicine composition with kidney-tonifying and laxative functions prepared in Example 1 is as follows: 1. General Information: One hundred cases (54 males and 46 females, aged 40-81 years) were selected and randomly divided into two groups: the experimental group and the control group, with 50 people in each group. Statistical analysis showed no significant differences in general information between the two groups, making them comparable.

[0054] Experimental group: Take the herbal composition of Example 1 for 30 days, twice a day, 28 g each time, dissolved in boiling water.

[0055] Control group: Take polyethylene glycol electrolyte powder (Shutaishen Beijing Biopharmaceutical Co., Ltd.) for 30 days. One packet of each of the two doses, A and B, are dissolved in 125 mL of warm water to form a solution. Take 125 mL each time, twice a day.

[0056] 2. Diagnostic criteria: These mainly include constipation due to intestinal dryness, frequent and clear urination, soreness and weakness of the lower back and knees, general weakness, abdominal pain, abdominal distension, anemia and chlorosis, insomnia, headache and dizziness, spontaneous sweating, and loss of appetite. These symptoms are usually the predominant features. Diagnosis is often based on two or more symptoms combined with the auxiliary examinations shown in the above cases. Symptoms may also change during the course of the disease.

[0057] Traditional Chinese Medicine diagnosis: Kidney deficiency and fluid depletion.

[0058] 3. Exclusion criteria: (1) Constipation caused by organic lesions; (2) Pregnant women; (3) Abnormal liver and kidney function.

[0059] 4. Evaluation of therapeutic effect: The results were formulated according to the Rome II Classification and Diagnostic Criteria for Functional Gastrointestinal Disorders. The results were divided into four categories: cured, significantly effective, effective, and ineffective. Among them, (1) Cured: Symptoms disappeared. (2) Significantly effective: Symptoms and signs decreased, and abnormal indicators improved significantly. (3) Effective: Symptoms and signs were reduced or improved, and abnormal indicators improved. (4) Ineffective: Symptoms, signs, and abnormal indicators did not improve.

[0060] Overall effective rate = (number of cured cases + number of cases with significant effect + number of effective cases) ÷ total number of cases × 100%.

[0061] 5. Efficacy results: The total effective rate of the control group was 76%; the total effective rate of the experimental group was 100%, the follow-up rate was 100%, and the average treatment course was 30 days. The clinical efficacy of the traditional Chinese medicine composition of this invention is superior to that of polyethylene glycol electrolyte powder.

[0062] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition with kidney-tonifying and laxative functions, characterized in that, It includes the following components: Cistanche deserticola (processed with wine), Angelica sinensis, prepared rhubarb, Cassia tora, Achyranthes bidentata, Paeonia lactiflora, Citrus reticulata peel, Alisma plantago-aquatica, Citrus aurantium, and Cimicifuga foetida.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it includes the following components: 85-100 parts of Cistanche deserticola (processed with wine), 140-180 parts of Angelica sinensis, 80-100 parts of processed rhubarb, 65-85 parts of Cassia tora, 40-60 parts of Achyranthes bidentata, 50-65 parts of Paeonia lactiflora, 60-80 parts of Citrus reticulata peel, 50-60 parts of Alisma plantago-aquatica, 30-40 parts of Citrus aurantium, and 30-40 parts of Cimicifuga foetida.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it includes the following components: 85-90 parts of Cistanche deserticola (processed with wine), 150-170 parts of Angelica sinensis, 80-95 parts of processed rhubarb, 66-80 parts of Cassia tora, 45-55 parts of Achyranthes bidentata, 50-60 parts of Paeonia lactiflora, 65-75 parts of Citrus reticulata peel, 50-55 parts of Alisma plantago-aquatica, 34-36 parts of Citrus aurantium, and 34-36 parts of Cimicifuga foetida.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, By weight, it includes the following components: 89.3 parts of Cistanche deserticola (processed with wine), 160.7 parts of Angelica sinensis, 89.3 parts of processed rhubarb, 71.4 parts of Cassia tora, 53.6 parts of Achyranthes bidentata, 53.6 parts of Paeonia lactiflora, 71.4 parts of Citrus reticulata peel, 53.6 parts of Alisma plantago-aquatica, 35.7 parts of Citrus aurantium, and 35.7 parts of Cimicifuga foetida.

5. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The process includes the following steps: decocting each medicinal herb in water, combining the decoctions, filtering, and collecting the filtrate.

6. The preparation method according to claim 5, characterized in that, The decoction process includes: adding 4-6 times the amount of water to the medicinal materials, soaking for 40-60 minutes, and decocting 2-3 times, each time for 1-1.5 hours.

7. A traditional Chinese medicine preparation with the effects of warming the kidneys and replenishing essence, and moistening the intestines and relieving constipation, characterized in that, It includes the traditional Chinese medicine composition according to any one of claims 1-4 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 5-6 and pharmaceutically acceptable excipients.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The excipients include at least one of emulsifiers, fillers, binders, disintegrants, colorants, and solubilizers, and the dosage form of the preparation is pills, powders, tablets, ointments, capsules, granules, oral liquids, or decoctions.

9. The traditional Chinese medicine preparation according to claim 8, characterized in that, The excipients include one or more of dextrin, starch, microcrystalline cellulose, sucrose, lactose, glucose, silicon dioxide, ethanol, sodium benzoate, and Tween 80, and the dosage form of the preparation is pills, capsules, granules, or decoction.

10. The use of a traditional Chinese medicine composition as described in any one of claims 1-4, or a traditional Chinese medicine composition prepared by the preparation method as described in any one of claims 5-6, or a traditional Chinese medicine preparation as described in any one of claims 7-9, in the preparation of a drug with the effects of warming the kidney and replenishing essence, moistening the intestines and relieving constipation.

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