A traditional Chinese medicine composition for treating enuresis due to kidney deficiency.

Abstract

The present invention relates to a Chinese medicine composition for treating kidney qi stagnation type enuresis, wherein the Chinese medicine composition is prepared from 5-40 parts by weight of Rosa laevigatae, 1-30 parts by weight of Alpinia oxyphyllae, 1-30 parts by weight of Rubus idaeus, 1-30 parts by weight of Lotus seeds, 1-30 parts by weight of Codonopsis pilosula, 1-25 parts by weight of Cuscuta australis, 1-25 parts by weight of Linderae scutellariae, 1-25 parts by weight of Silkworm Coodiae, 1-15 parts by weight of Schisandra chinensis and 1-15 parts by weight of Honey Ephedra. The Chinese medicine composition of the present invention has few and fine components, a simple preparation method, is easy to use clinically, and has a significant effect in treating female patients with kidney qi stagnation type enuresis.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating kidney qi insufficiency type enuresis. Background Art

[0002] Kidney Qi insufficiency type enuresis is a common urinary system disease, mainly manifested as stress urinary incontinence (SUI), that is, involuntary urine leakage when abdominal pressure increases due to coughing, laughing, lifting heavy objects, etc., and is most common in postpartum and middle-aged and elderly women (over 40 years old). With the acceleration of the aging process of the population, the incidence of this disease is increasing year by year.

[0003] From the perspective of pathogenesis, stress urinary incontinence is closely related to factors such as pelvic floor support tissue damage, pelvic floor muscle dysfunction, and urethral sphincter insufficiency. Pregnancy, childbirth, postmenopausal estrogen level decline, and long-term heavy physical labor can all lead to pelvic floor muscle damage, which in turn causes urinary control dysfunction. In addition, studies have found that genetic factors, obesity, and chronic cough are also risk factors for the disease.

[0004] At present, Western medicine mainly uses conservative treatment and surgical treatment. Conservative treatment includes lifestyle intervention, pelvic floor muscle exercise (Kegel training) and drug therapy. Although Kegel training is safe and non-invasive, it requires long-term persistence, and the effect varies from person to person. Drug treatment is mainly α-receptor agonists and anticholinergic drugs, but there are adverse reactions such as dry mouth, constipation, blurred vision, and symptoms are prone to recurrence after discontinuation of medication. Although surgical treatment has obvious short-term effects, it is more traumatic, and some patients cannot tolerate surgery due to age, underlying diseases and other factors. There is also a risk of complications such as infection, dysuria, and pain.

[0005] There is no record of the disease name "stress urinary incontinence" in ancient Chinese medical books, but according to its clinical symptoms and signs, it can be classified into the categories of "enuresis", "urinary incontinence", "enuresis", "bladder cough" and so on. The etiology and pathogenesis of this disease are recorded in "Suwen": "If the water spring does not stop, it means that the bladder cannot store it." "Zhubingyuanhoulun" also records: "If you can't urinate, it's because the kidney qi is weak... It can't warm the water, so you can't urinate." Zhang Jingyue recorded in his book "Jingyue Quanshu": "If there are those who can't stop, it's because the qi gate is not firm and the frequency can't be stopped." He believed that the weak kidney qi is the main key pathogenesis of this disease, and advocated the protection of kidney qi in treatment. "Furen Daquan Liangfang" records that the main cause of enuresis is that women damage the bladder during childbirth, and the treatment should focus on warming yang and tonifying the kidney. Therefore, traditional medicine believes that this disease is mostly caused by kidney qi deficiency, failure to seal and store, and inability to restrain the bladder. It is based on kidney deficiency and qi deficiency as the symptom. The disease is located in the lower part of the body, involving the kidney, spleen, bladder and other internal organs. Clinical studies in recent years have shown that the combination of Chinese and Western medicine is more effective in treating stress urinary incontinence than Western medicine alone. Through syndrome differentiation and treatment, the method of warming and tonifying kidney yang and consolidating and stopping nocturnal emission can not only improve symptoms, but also achieve the effect of treating both the symptoms and the root cause by regulating the overall function of the body. Summary of the invention

[0006] To solve the above technical problems, the present invention includes the following aspects:

[0007] The first aspect of the present invention provides a traditional Chinese medicine composition for treating kidney qi instability type enuresis, the traditional Chinese medicine composition is prepared from Rosa laevigata, Alpinia oxyphylla, Rubus idaeus, Lotus seed, Codonopsis pilosula, Cuscuta australis, Linderae scutellariae, Silkworm cocoon, Schisandra chinensis and honey ephedra.

[0008] Preferably, the traditional Chinese medicine composition is made of 5-40 weight parts of Rosa laevigata fruit, 1-30 weight parts of Alpinia oxyphylla, 1-30 weight parts of Rubus idaeus, 1-30 weight parts of Lotus seeds, 1-30 weight parts of Codonopsis pilosula, 1-25 weight parts of Cuscuta australis, 1-25 weight parts of Linderae scutellariae, 1-25 weight parts of Silkworm Cocoon, 1-15 weight parts of Schisandra chinensis and 1-15 weight parts of Ephedra sinica.

[0009] More preferably, the traditional Chinese medicine composition is made of 10-30 weight parts of Rosa laevigata, 5-25 weight parts of Alpinia oxyphylla, 5-25 weight parts of Rubus idaeus, 5-25 weight parts of Lotus seeds, 5-25 weight parts of Codonopsis pilosula, 1-20 weight parts of Cuscuta australis, 1-20 weight parts of Linderae scutellariae, 1-20 weight parts of Silkworm Cocoon, 2-10 weight parts of Schisandra chinensis and 2-10 weight parts of Ephedra sinica.

[0010] Further preferably, the traditional Chinese medicine composition is made of 15-25 weight parts of Rosa laevigata, 10-20 weight parts of Alpinia oxyphylla, 10-20 weight parts of Rubus idaeus, 10-20 weight parts of Lotus seeds, 10-20 weight parts of Codonopsis pilosula, 5-15 weight parts of Cuscuta australis, 5-15 weight parts of Linderae scutellariae, 5-15 weight parts of Silkworm Cocoon, 4-8 weight parts of Schisandra chinensis and 4-8 weight parts of Ephedra sinica.

[0011] Most preferably, the Chinese medicine composition is made of 20 parts by weight of Rosa laevigata, 15 parts by weight of Alpinia oxyphylla, 15 parts by weight of Rubus idaeus, 15 parts by weight of Lotus seeds, 15 parts by weight of Codonopsis pilosula, 10 parts by weight of Cuscuta australis, 10 parts by weight of Linderae scutellariae, 10 parts by weight of Octopus cocoon, 6 parts by weight of Schisandra chinensis and 6 parts by weight of Ephedra sinica.

[0012] Preferably, the traditional Chinese medicine composition further comprises pharmaceutically acceptable excipients.

[0013] Preferably, the Chinese medicine composition is an external preparation or an oral preparation. More preferably, the Chinese medicine composition is an oral preparation.

[0014] Preferably, the Chinese medicine composition is in the form of tablets, capsules, pills, powders, oral liquids or decoctions. More preferably, the Chinese medicine composition is in the form of decoctions.

[0015] Preferably, the preparation method of the traditional Chinese medicine composition comprises the following steps: taking prescribed amounts of Rosa rugosa, Alpinia oxyphylla, Rubus idaeus, Lotus seed, Codonopsis pilosula, Cuscuta australis, Linderae scutellariae, Silkworm cocoon, Schisandra chinensis and Ephedra sinica, mixing and crushing, adding 4-8 times the weight of the traditional Chinese medicine in water and boiling for 1 hour, filtering and concentrating the traditional Chinese medicine filtrate to 1.5 times the total weight of the traditional Chinese medicine initially added, and optionally adding pharmaceutically acceptable excipients to obtain the product.

[0016] Preferably, in the preparation method, water 6 times the weight of the Chinese medicine is added and boiled for 1 hour.

[0017] The second aspect of the present invention provides a method for preparing the above-mentioned Chinese medicine composition, which comprises the following steps: taking prescribed amounts of Rosa rugosa, Alpinia oxyphylla, Rubus idaeus, Lotus seeds, Codonopsis pilosula, Cuscuta australis, Linderae scutellariae, Silkworm cocoon, Schisandra chinensis and Ephedra sinica, mixing and crushing, adding 4-8 times the weight of the Chinese medicine in water and boiling for 1 hour, filtering and concentrating the Chinese medicine filtrate to 1.5 times the total weight of the Chinese medicine initially added, and optionally adding pharmaceutically acceptable excipients to obtain the composition.

[0018] Preferably, in the preparation method, water 6 times the weight of the Chinese medicine is added and boiled for 1 hour.

[0019] The third aspect of the present invention provides use of the above-mentioned Chinese medicine composition in the preparation of a medicament for treating stress urinary incontinence.

[0020] The fourth aspect of the present invention provides the use of the above-mentioned Chinese medicine composition in the preparation of a medicament for treating enuresis of kidney qi insufficiency type.

[0021] The common pharmacological effects of the Chinese medicinal raw materials selected in the present invention in this field are as follows:

[0022] Rosa Laevigata: sour and astringent in nature, neutral, enters the bladder, kidney, and large intestine meridians. Rosa Laevigata consolidates the essence and astringes the intestines, promotes diuresis and stops diarrhea, and is used to treat spermatorrhea, asthma and cough due to lung deficiency, spontaneous sweating and night sweats, metrorrhagia and leukorrhea, frequent urination, and diarrhea due to spleen deficiency.

[0023] Alpinia oxyphylla: pungent, slightly warm, enters the spleen and kidney meridians. Alpinia oxyphylla warms the kidney and assists yang, consolidates semen and reduces urine, warms the spleen and stops diarrhea, stimulates appetite and controls saliva, and is used to treat deficiency-cold in the lower abdomen, spermatorrhea and enuresis, leukorrhea, frequent urination, abdominal pain, vomiting and diarrhea, and spontaneous salivation.

[0024] Raspberry: sweet, sour, warm, and enters the liver, kidney, and bladder meridians. Raspberry nourishes the kidneys, consolidates essence, reduces urine, nourishes the liver, and improves eyesight. It is used to treat impotence and premature ejaculation, spermatorrhea, uterine coldness and infertility, clear and thin vaginal discharge, frequent urination and enuresis, blurred vision, and premature graying of hair.

[0025] Lotus seeds: sweet, astringent, neutral in nature, and enter the spleen, kidney, and heart meridians. Lotus seeds nourish the spleen and stop diarrhea, benefit the kidney and astringe the essence, nourish the heart and calm the mind, and are used to treat spleen deficiency, chronic diarrhea, spermatorrhea, leucorrhea, palpitations and insomnia.

[0026] Codonopsis: It is mild in nature, sweet in taste, and belongs to the spleen and lung meridians. It can replenish qi, strengthen the spleen and benefit the lungs. Codonopsis is used to treat spleen and lung weakness, shortness of breath and palpitations, poor appetite and loose stools, asthma and cough, internal heat and thirst, and has the effects of enhancing the body's stress capacity, immune function, delaying aging, and anti-ulcer.

[0027] Cuscuta: warm in nature, sweet in taste, and enters the liver and kidney meridians. Cuscuta nourishes the liver and kidneys, consolidates the essence and reduces urine, stabilizes the fetus, improves eyesight, and stops diarrhea. It is mainly used for impotence and spermatorrhea, residual urine, enuresis and frequent urination, soreness of the waist and knees, blurred vision and tinnitus, kidney deficiency and fetal leakage, fetal movement disorder, spleen and kidney deficiency diarrhea, external treatment of vitiligo, and has anti-inflammatory, blood pressure lowering, myocardial contractility improvement, and aphrodisiac effects.

[0028] Linderae odoratum: warm in nature, pungent in taste, enters the lung meridian, spleen meridian, kidney meridian, and bladder meridian. Linderae odoratum can relieve depression, dispel cold and relieve pain. It is used to treat chest and abdominal distension and pain due to qi reversal, indigestion, nausea and vomiting, cold hernia, beriberi, frequent urination, etc. It has the effects of analgesia, hemostasis, liver protection, antibacterial, and anti-cancer.

[0029] Mulberry silkworm cocoon: It is mild in nature, sweet in taste, and enters the liver and kidney meridians. Mulberry silkworm cocoon nourishes the kidney and strengthens yang, consolidates essence and reduces urine, and is used to treat impotence, spermatorrhea, spermatorrhea, enuresis, frequent urination, and excessive leucorrhea caused by kidney deficiency and yang deficiency.

[0030] Schisandra chinensis: sour, warm, enters the lung and kidney meridians. Schisandra chinensis has the effects of astringing, strengthening qi and promoting body fluid, tonifying the kidney and calming the mind. It is used to treat chronic cough and asthma, nocturnal emission and spermatorrhea, enuresis and frequent urination, chronic diarrhea, spontaneous sweating, night sweats, thirst due to loss of body fluid, internal heat and thirst, palpitations and insomnia.

[0031] Ephedra: Spicy, slightly bitter, warm in nature, enters the lung and bladder meridians. Ephedra has the effects of expelling cold and relieving exterior symptoms, clearing the lungs and relieving asthma, promoting diuresis and reducing swelling. It is mainly used for symptoms of fever without sweating caused by exogenous wind and cold, rheumatic arthralgia, cold evil invading the lungs or heat evil blocking the lungs to cause cough, asthma, breath reversal, edema, etc. When used in combination with drugs that tonify the kidney and spleen, reduce urine and consolidate semen, it can promote lung qi, clear water channels, lift the pot and open the lid, thereby improving the symptoms of enuresis.

[0032] Method for taking the Chinese medicine composition of the present invention: Take the Chinese medicine decoction of the embodiment of the present invention, take it orally once in the morning and evening every day, 200 mL each time, and take it for 4 weeks as a course of treatment.

[0033] The Chinese medicine composition of the present invention takes "tonifying the kidney, consolidating and treating both the symptoms and the root cause" as the core concept of the prescription, selects the medicinal materials for reasonable compatibility, and emphasizes the importance of consolidating the kidney qi and strengthening the spleen qi. Alpinia oxyphylla and Rubus idaeus are the main drugs, which warm the kidney and spleen, consolidate the essence and reduce urine; Cherry laevigata, Silkworm Cocoon, Codonopsis pilosula, and Cuscuta chinensis are the ministerial drugs, which tonify the kidney, consolidate and astringe, strengthen the spleen and replenish qi, and astringe the lower jiao slippage; Ephedra, Schisandra chinensis, and Lotus Seed are the adjuvant drugs, among which Schisandra chinensis and Lotus Seed are tonifying the kidney, consolidating and astringing, reducing urine and stopping nocturnal emission, and Ephedra promotes the flow of qi and promotes the circulation of qi, regulates the qi mechanism, and prevents excessive astringency from causing evil; Linderae radiata is the guiding drug, which warms the yang and promotes qi, leads the drug directly into the kidney meridian, coordinates the overall medicinal properties, and enhances the efficacy of the whole prescription. The Chinese medicine composition of the present invention "combines tonifying and astringing, consolidates the middle and contains communication", which not only tonifies the kidney qi to treat the root cause, but also prevents the astringent drugs from "blocking evil and leaving trouble" by promoting qi and regulating qi, and has significant scientificity and clinical value.

[0034] The technical effects produced by the present invention are:

[0035] 1. The Chinese medicine composition of the present invention has reasonable compatibility, complementary and synergistic drug functions, and definite therapeutic effect. The inventors have optimized the components and content ratios of the Chinese medicines and selected a Chinese medicine formula with definite therapeutic effect. It has broad promotion value in the treatment of kidney qi instability type enuresis (stress urinary incontinence).

[0036] 2. Clinical studies have shown that the Chinese medicine composition of the present invention can significantly treat the clinical symptoms of patients with kidney qi instability type enuresis, enhance the quality of life of patients, have few adverse reactions, good compliance, and a low recurrence rate. It is particularly suitable for middle-aged and elderly female patients who need to take medication for a long time. DETAILED DESCRIPTION

[0037] The present invention is further described below in conjunction with examples, but the embodiments of the present invention are not limited thereto. The experimental methods used in the following examples are conventional methods unless otherwise specified.

[0038] Example 1

[0039] Take 20g of Rosa rugosa fruit, 15g of Alpinia oxyphylla, 15g of Rubus idaeus, 15g of Lotus seed, 15g of Codonopsis pilosula, 10g of Cuscuta seed, 10g of Linderae scutellariae, 10g of Silkworm Cocoon, 6g of Schisandra chinensis and 6g of Ephedra sinica, mix and grind, add 800mL of water with the weight of traditional Chinese medicine and boil for 1 hour, filter and concentrate the traditional Chinese medicine filtrate to 200mL to obtain the product.

[0040] Example 2

[0041] Take 5g of Rosa Laevigata Fruit, 20g of Alpinia Oxyphylla, 20g of Rubus Idaeus, 20g of Lotus Seed, 15g of Codonopsis Pilosula, 10g of Cuscuta Seed, 10g of Linderae Atractylodes, 10g of Silkworm Cocoon, 6g of Schisandra Chinensis and 6g of Ephedra Sinensis with Honey, mix and grind, add 800mL of water with the weight of traditional Chinese medicine and boil for 1 hour, filter and concentrate the traditional Chinese medicine filtrate to 200mL to obtain the product.

[0042] Example 3

[0043] Take 5g of Rosa rugosa fruit, 15g of Alpinia oxyphylla, 15g of Rubus idaeus, 15g of Lotus seed, 15g of Codonopsis pilosula, 15g of Cuscuta seed, 15g of Linderae scutellariae, 15g of Silkworm Cocoon, 6g of Schisandra chinensis and 6g of Ephedra sinica, mix and grind them, add 800mL of water with the weight of traditional Chinese medicine and boil for 1 hour. After filtering, concentrate the traditional Chinese medicine filtrate to 200mL to obtain the product.

[0044] Example 4

[0045] Mix 20g of Rosa rugosa fruit, 15g of Alpinia oxyphylla, 15g of Rubus idaeus, 15g of Lotus seed, 15g of Codonopsis pilosula, 10g of Cuscuta seed, 10g of Linderae scutellariae, 18g of Silkworm Cocoon, 10g of Schisandra chinensis and 10g of Ephedra sinica. Grind them into powder, add 800mL of water, boil for 1 hour, filter and concentrate the filtrate to 200mL to obtain the product.

[0046] Comparative Example 1 (lotus seeds replaced with gorgon seeds)

[0047] Take 20g of Rosa Laevigata Fruit, 15g of Alpinia Oxyphylla, 15g of Rubus Idaeus, 15g of Euryale ferox, 15g of Codonopsis pilosula, 10g of Cuscuta Seed, 10g of Linderae scutellariae, 10g of Silkworm Cocoon, 6g of Schisandra chinensis and 6g of Ephedra sinica, mix and grind, add 800mL of water with the weight of traditional Chinese medicine and boil for 1 hour, filter and concentrate the traditional Chinese medicine filtrate to 200mL to obtain the product.

[0048] Comparative Example 2 (Ephedra is replaced by Honeysuckle)

[0049] Take 20g of Rosa rugosa fruit, 15g of Alpinia oxyphylla, 15g of Rubus idaeus, 15g of Lotus seed, 15g of Codonopsis pilosula, 10g of Cuscuta seed, 10g of Linderae scutellariae, 10g of Silkworm Cocoon, 6g of Schisandra chinensis and 6g of Honeysuckle, mix and grind, add 800mL of water with the weight of traditional Chinese medicine and boil for 1 hour. After filtering, concentrate the traditional Chinese medicine filtrate to 200mL to obtain the product.

[0050] Test Example 1: Therapeutic effect of the Chinese medicine composition of the present invention on rats with stress urinary incontinence

[0051] 1. Test methods

[0052] 80 rats were randomly selected for sodium pentobarbital anesthesia, and were fixed in supine position. According to simulated birth injury and combined bilateral ovariectomy, stress urinary incontinence model was established. Bladder was emptied via catheter. In the midline incision (1.0-1.5cm) of abdomen, bilateral ovaries were stripped, incision was sutured, 8Fr Frey's catheter was taken and placed in vagina. Sterile saline 3.0mL was injected through air bag, so that its vagina was fully expanded. Catheter was removed after 4h. After 2 weeks of vaginal air bag expansion, rats were anesthetized, tissue was stripped, and rat ovaries were aseptically removed and then sutured. Sneeze experiment was carried out after termination, rat bladder was emptied, and methylene blue solution was injected, sneeze reflex occurred in its nostrils, and blue liquid appeared in rat urethral orifice, i.e., modeling was successful. 70 rats successfully modeled were randomly divided into model group, Chinese medicine composition 1-4 group of the present invention and comparative example 1-2 group, 10 in each group, and 10 rats without any treatment were separately taken as control group.

[0053] 24 hours after the successful modeling, the rats in the Chinese medicine composition groups 1-4 of the present invention and the comparative example 1-2 were gavaged with the Chinese medicine decoctions of Examples 1-4 of the present invention and Comparative Example 1-2 at a dose of 50 mg / kg body weight, respectively, and the rats in the control group and the model group were given an equal amount of normal saline, gavaged once a day for a total of 6 weeks.

[0054] After the last administration, the bladders of the rats in each test group were emptied, and 100 μL / min of sterile saline was injected into the bladders of the rats through the catheter. The bladder capacity when the first drop of urine appeared at the urethral orifice of the rats was the maximum bladder capacity (MBC), and the bladder pressure of the rats at this moment, namely the leakage point pressure (LPP), was recorded. After the end, the bladder was emptied, and saline was continued to be injected at the same flow rate (the injection volume was 50% of the MBC during LPP measurement). The abdomen of the rats was slowly pressed with fingers, causing the abdominal pressure to gradually increase until liquid overflow was observed at the urethral orifice. The bladder pressure at this time was recorded as the abdominal leakage pressure point (ALPP). This was repeated 3 times and the average value was taken.

[0055] 2. Test results

[0056] The effects of the Chinese medicine composition of the present invention on MBC, LPP and ALPP of rats in each test group are shown in Table 1 below.

[0057] Table 1 Comparison of kinetic index levels of rats in each experimental group

[0058] Experimental Group MBC (mL) LPP (mmHg) ALPP (mmHg) Control group 6.84±0.83 45.77±6.35 48.21±6.78 Model Group 1.38±0.62 11.38±4.52 13.39±4.75 A group of Chinese medicine compositions of the present invention 5.29±0.74 38.46±5.17 40.26±5.29 2 groups of Chinese medicine compositions of the present invention 4.31±0.89 30.85±5.36 32.17±6.08 3 groups of Chinese medicine compositions of the present invention 4.25±0.73 31.59±5.57 32.93±6.14 4 groups of Chinese medicine compositions of the present invention 4.14±0.70 28.47±6.19 30.79±5.92 Comparative Example 1 3.24±0.85 20.36±5.19 22.18±5.43 Comparative Example 2 3.47±0.64 22.43±5.23 24.37±5.28

[0059] As can be seen from Table 1 above, compared with the control group, the levels of MBC, LPP, and ALPP in the model group were significantly reduced. Compared with the model group and the comparative example 1-2 group, the MBC, LPP, and ALPP levels of rats in the Chinese medicine composition 1-4 groups of the present invention were significantly increased (the differences were all statistically significant), confirming that the Chinese medicine composition of the present invention can effectively improve the bladder-related urination function of rats. Surprisingly, when the total dosage and the total amount of Chinese medicine extracts were the same, the Chinese medicine composition decoction prepared in Example 1 of the present invention increased the MBC, LPP, and ALPP levels of rats to the greatest extent, producing an excellent therapeutic effect for stress urinary incontinence.

[0060] Test Example 2: Clinical effect of the Chinese medicine composition of the present invention on female enuresis of kidney qi insufficiency type

[0061] A randomized controlled study method was used, and 56 female patients with enuresis of kidney qi insufficiency type who visited the hospital from January 2022 to November 2024 were selected.

[0062] 1. Inclusion criteria

[0063] (1) Female patients aged 40-70 years; (2) Meet the diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Stress Urinary Incontinence in Chinese Women (2017)": uncontrolled urinary incontinence when abdominal pressure increases; positive finger pressure test and 1-hour urine pad test; no accompanying symptoms such as frequent urination and dysuria. Mild: Urine leakage occurs when coughing or sneezing, and no urine pad is needed; moderate: Urine leakage occurs during daily activities such as walking, running and jumping, and a urine pad is needed; severe: Urine leakage occurs when changing body position or doing slight activities. (3) Meet the diagnostic criteria of kidney qi instability type enuresis in traditional Chinese medicine: the main symptoms are frequent urination, enuresis, and soreness of the waist and knees; the secondary symptoms are lower abdominal distension, tinnitus, accompanied by mental fatigue, pale complexion, pale tongue, and deep and thin pulse. The diagnosis can be made if there are 2 or more main symptoms and 1 or more secondary symptoms. (4) The course of the disease is ≥ 3 months, the condition is mild or moderate, and no relevant treatment has been received.

[0064] (5) Sign the informed consent form.

[0065] 2. Exclusion criteria

[0066] (1) Patients with severe heart, liver, or kidney dysfunction. (2) Patients with urinary tract infection or tumor. (3) Patients with severe mental illness or cognitive impairment. (4) Patients who have received relevant treatment within the past 3 months. (5) Women who are pregnant or breastfeeding.

[0067] 3. Research Methods

[0068] The patients were divided into a control group and a treatment group according to the random number table method, with 28 cases in each group. Control group: standard Kegel training was performed. Specific method: the patients were guided to correctly identify and contract the pelvic floor muscles, each contraction was maintained for 5-10 seconds, and relaxation was performed for 3-5 seconds, 15-20 times per group, 3 groups per day, and adhered to for 8 weeks. Treatment group: on the basis of the control group, the Chinese medicine composition of Example 1 of the present invention was taken once in the morning and evening each day, 200 ml each time, and taken for two courses of treatment, i.e. 8 weeks.

[0069] 4. Observation indicators

[0070] (1) 1h urine leakage volume. (2) Urinary incontinence symptom score (ICI-Q-SF). (3) Quality of life score (I-QOL). (4) Clinical efficacy "Guidelines for the Diagnosis and Treatment of Stress Urinary Incontinence in Women (2017)", assessed after 8 weeks of treatment. Cured: no urine leakage when abdominal pressure increases. Markedly effective: urine leakage when abdominal pressure increases, and the urine leakage volume in 1 hour is reduced by ≥50%. Effective: urine leakage when abdominal pressure increases, and the urine leakage volume in 1 hour is reduced by ≥20% and <50%. Ineffective: urine leakage when abdominal pressure increases, and the urine leakage volume in 1 hour is reduced by <20%. Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%

[0071] 5. Test results

[0072] Table 2 Comparison of general information of patients in the two groups

[0073] Group Number of cases (n) Age (years) Disease duration (months) t-value P-value Treatment Group 28 52±6 26.4±8.2 0.27 0.78 Control group 28 53±7 25.8±7.9 0.28 0.77

[0074] The analysis results in Table 2 above showed that there was no statistically significant difference in age and disease course between the two groups of patients (P>0.05), proving that the two groups were comparable.

[0075] Table 3 Comparison of 1h urine leakage between the two groups before and after treatment (g, )

[0076]

[0077]

[0078] Note: Compared with the group before treatment, *P<0.05; compared with the control group during the same period, #P<0.05

[0079] The test results in Table 3 above show that there was no significant difference in the amount of urine leakage in 1 hour between the two groups before treatment (P>0.05), indicating that the two groups were comparable. After 4 and 8 weeks of treatment, the amount of urine leakage in 1 hour in the treatment group was significantly less than that in the control group (P<0.05), indicating that the intervention effect of the treatment group was better than that of the control group.

[0080] Table 4 Comparison of ICI-Q-SF scores between the two groups before and after treatment (points, )

[0081]

[0082] Note: Compared with the group before treatment, *P<0.05; compared with the control group during the same period, #P<0.05

[0083] The test results in Table 4 above show that there was no significant difference in the ICI-Q-SF scores of the two groups of patients before treatment (P = 0.416), indicating that the two groups were comparable at the baseline level. After 4 weeks of treatment, the score of the treatment group was significantly lower than that of the control group (P = 0.006), indicating that the treatment group has shown a more significant therapeutic effect within 4 weeks. After 8 weeks of treatment, the score of the treatment group was significantly lower than that of the control group (P = 0.003), further indicating that the therapeutic effect of the treatment group is better than that of the control group.

[0084] Table 5 Comparison of I-QOL scores between the two groups before and after treatment (points, )

[0085]

[0086] Note: Compared with the group before treatment, *P<0.05; compared with the control group during the same period, #P<0.05

[0087] The test results in Table 5 above show that there was no significant difference in the I-QOL scores of the two groups of patients before treatment, indicating that the two groups were comparable at the baseline level. After 4 weeks of treatment, the scores of the treatment group were significantly higher than those of the control group (P=0.001), indicating that the effect of the treatment group showed good improvement after 4 weeks. After 8 weeks of treatment, the scores of the treatment group were significantly higher than those of the control group (P<0.001), further indicating that the efficacy of the treatment group was better than that of the control group.

[0088] Table 6 Comparison of clinical efficacy between the two groups [n(%)]

[0089] Group Number of cases cure Significant effect efficient invalid Total Effectiveness Treatment Group 28 8(28.57) 12(42.86) 6(21.43) 2(7.14) <![CDATA[26(92.86) * ]]> Control group 28 4(14.29) 8(28.57) 9(32.14) 7(25.00) 21(75.00)

[0090] Note: Compared with the control group, *P<0.05, χ 2 =5.362

[0091] The test results in Table 6 above show that the total effective rate of the treatment group is 92.86%, and the total effective rate of the control group is 75.00%, indicating that the therapeutic effect of the treatment group is better than that of the control group (P<0.05).

[0092] Statistics of adverse reactions: 2 cases (7.14%) of mild stomach discomfort occurred in the treatment group, which did not affect the continuation of treatment. No obvious adverse reactions were observed in the control group.

[0093] 6. Test conclusion

[0094] The above research results show that compared with the control group that only performs Kegel training, the Chinese medicine treatment group of the present invention has significant statistical differences in improving 1h urine leakage, urinary incontinence symptom score (ICI-Q-SF) and quality of life score (I-QOL) (P<0.001), and the total effective rate of the treatment group (92.86%) is significantly higher than that of the control group (75.00%) (P<0.05). In addition, the incidence of adverse reactions in the treatment group is low, and the patient compliance is good. The above test results show that the Chinese medicine composition of the present invention has a definite effect and good safety in treating female kidney qi instability type enuresis (stress urinary incontinence) disease.

[0095] Test Example 3: Clinical case of female kidney qi insufficiency type enuresis treated with the Chinese medicine composition of the present invention

[0096] Case 1

[0097] Patient Zhang, female, 43 years old, first diagnosed with urine leakage after coughing for more than 10 years, aggravated for 3 months. After pregnancy, the patient began to cough or leak urine after activity, gradually aggravated, and had obvious frequent attacks in the past 3 months. Every time she coughed, lifted heavy objects or laughed, she leaked urine. She urinated more frequently during the day (7-8 times a day), but there was no enuresis at night. Accompanied by soreness of waist and knees, shortness of breath and fatigue, mental fatigue, and occasional feeling of lower abdominal distension. She was healthy in the past and had no history of other chronic diseases. Tongue and pulse: pale and fat tongue, thin white fur, and deep and fine pulse. Urinalysis was normal; pelvic floor ultrasound showed that the bladder support structure was slightly moved downward; urodynamic examination found urethral pressure of 40cm H2O (normal value>60cmH2O); diagnosed as stress urinary incontinence, Chinese medicine syndrome type was kidney qi not solid, bladder failure, and the treatment principle was to tonify the kidney and consolidate qi, and stop the semen with astringent. Take 200mL of the decoction of Example 1 of the present invention half an hour after the morning and evening meals for 14 consecutive days.

[0098] After taking 14 doses of medicine, the patient was referred to the hospital for further examination, and the leakage of urine was significantly reduced, with 1-2 times of leakage per day, which only occurred when coughing violently or lifting heavy objects, and the symptoms of soreness of waist and knees and shortness of breath and fatigue were improved. Tongue and pulse: pale and fat tongue, thin white fur, and deep and fine pulse. In the basis of the prescription of Example 1, 15g of Eucommia ulmoides and 15g of Dipsacus asper were added (the decoction preparation method is the same as Example 1), and the function of tonifying the kidney and consolidating the foundation was strengthened, and 14 doses were continued. After taking 14 doses of medicine, the patient was referred to the hospital for further examination, and the symptoms of leakage of urine were further improved, with only occasional slight leakage of urine after activity, soreness of waist and knees was significantly relieved, and the feeling of heaviness in the lower abdomen disappeared, and the mental state was good. The tongue was light red, the fur was thin and white, and the pulse was slow and weak. On the basis of the prescription of Example 1, honey ephedra was removed, and 15g of yam was added (the decoction preparation method is the same as Example 1), and the spleen and kidney were tonified, and the curative effect was consolidated, and 14 doses were continued. After taking 14 doses of medicine, the patient was followed up by regular visits, and the symptoms were completely relieved, and the patient had resumed normal life, and there was no recurrence after a regular visit for 3 months.

[0099] Case 2

[0100] Patient Li, female, 59 years old, complained of urine leakage after activity for half a year at the first visit. More than half a year ago, she had sore waist and knees, physical weakness and fatigue after menopause. Gradually, urine leaked out after activity. The symptoms worsened in the past two months. Urine leakage occurred when walking or lifting heavy objects every day, with occasional urgency, small and frequent urine volume, more than 10 urinations per day, and nocturia 2-3 times / night. Accompanied by dizziness, tinnitus, insomnia and dreaminess. There was no history of major diseases in the past. The tongue was pale red, the fur was thin and white, and the pulse was deep and weak. Urinalysis was normal, and pelvic floor ultrasound showed mild relaxation of the pelvic floor muscles and increased urethral activity; urodynamic examination found decreased bladder compliance; diagnosed as stress urinary incontinence. The Chinese medicine syndrome type is kidney qi deficiency, poor gasification, and bladder failure. The treatment principle is to tonify the kidney and replenish qi, consolidate and stop nocturnal emission. Take 200mL of the decoction of Example 1 of the present invention half an hour after breakfast and dinner for 14 consecutive days.

[0101] After taking 14 doses of medicine, the patient was re-examined, and the number of urine leakage was reduced to 1-2 times per day, the urgency of urination was significantly relieved, the sleep quality was improved, and the dizziness symptom was alleviated. Tongue and pulse: the tongue was pale red, the fur was thin and white, and the pulse was deep and weak. In the prescription basis of Example 1, 12g of Radix Rehmanniae and 15g of Fructus Lycii were added (the decoction preparation method was the same as Example 1), nourishing yin and replenishing qi, replenishing kidney essence, and continuing to take 14 doses. After taking 14 doses of medicine, the patient was re-examined, and the urine leakage symptoms basically disappeared, and there was only occasional slight urine leakage after heavy physical activity, the symptom of frequent urination was significantly improved, and the mental state was restored. The tongue was pale red, the fur was thin and white, and the pulse was slow and weak. In the prescription of Example 1, 30g of Chinese yam and 15g of Poria were added (the decoction preparation method was the same as Example 1), the spleen and kidney were strengthened, and 14 doses were continued. Follow-up after taking 14 doses of medicine, the symptoms were completely relieved, and the patient resumed normal life, and there was no recurrence after follow-up for half a year.

[0102] Case 3

[0103] Patient Wang, female, 67 years old, first diagnosed with urine leakage after activities for more than 2 years, aggravated for 1 week. Self-reported that urine leakage began to occur when coughing or lifting heavy objects 2 years ago, gradually aggravated, and had frequent attacks in the past week. There was urine leakage after a little activity, accompanied by soreness of waist and knees, fatigue and chills, weakness in the lower limbs, dizziness and tinnitus, cold limbs, and loose stools. The patient's physique is weak, and the above symptoms are aggravated due to long-term heavy physical labor. Western medicine treatments such as tamsulosin sustained-release capsules and mirabegron have not been significantly relieved, and the effect is not good. The tongue is pale and fat, the fur is thin and white, and the pulse is deep and weak. Urinalysis is normal; urodynamic examination shows that the maximum urine flow rate is reduced and the urethral pressure is significantly reduced; it is diagnosed as stress urinary incontinence. The Chinese medicine syndrome is kidney qi deficiency and cold, and the bladder is not solid. The treatment principle is to tonify the kidney and consolidate the foundation, warm yang and benefit qi. Take 200mL of the decoction of Example 1 of the present invention half an hour after breakfast and dinner for 14 consecutive days.

[0104] After taking 14 doses of medicine, the patient was referred to the hospital for further examination, and the number of urine leakage was reduced to 1-2 times per day, and the symptoms of soreness of waist and knees and weakness of lower limbs were significantly improved, and the symptoms of fear of cold were alleviated. The tongue was pale and fat, the fur was thin and white, and the pulse was deep and weak. On the basis of the prescription of Example 1, 6g of Aconite and 10g of Eucommia ulmoides were added (the decoction preparation method was the same as Example 1), and the merit of warming the kidney and consolidating the body was strengthened, and 14 doses were continued. After taking 14 doses of medicine, the patient was referred to the hospital for further examination, and the urine leakage symptoms were further improved, and only slight urine leakage was occasionally seen after vigorous activities, and the mental state was good, and the symptoms of dizziness and tinnitus disappeared. The tongue was light red, the fur was thin and white, and the pulse was slow and weak. On the basis of the prescription of Example 1, honey ephedra was removed, 10g of cassia twig was added (the decoction preparation method was the same as Example 1), warming yang and transforming qi, regulating kidney qi, and continuing to serve 14 doses. Follow-up after taking 14 doses of medicine, the patient's symptoms were completely relieved, and normal life was restored, and there was no recurrence after a follow-up of 3 months.

[0105] Although specific embodiments of the present invention have been described, it will be appreciated by those skilled in the art that various changes and modifications may be made to the present invention without departing from the scope or spirit of the present invention. Therefore, the present invention is intended to cover all such changes and modifications that fall within the scope of the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating kidney qi insufficiency type enuresis, characterized in that: The traditional Chinese medicine composition is prepared from golden cherry fruit, alkyl oxyphylla seed, raspberry, lotus seed, codonopsis pilosula, dodder seed, lindera striata, silkworm cocoon, schisandra chinensis and honey ephedra.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from 5-40 parts by weight of Rosa laevigata fruit, 1-30 parts by weight of Alpinia oxyphylla, 1-30 parts by weight of Rubus idaeus, 1-30 parts by weight of Lotus seed, 1-30 parts by weight of Codonopsis pilosula, 1-25 parts by weight of Cuscuta australis, 1-25 parts by weight of Linderae scutellariae, 1-25 parts by weight of Silkworm Coodiae, 1-15 parts by weight of Schisandra chinensis and 1-15 parts by weight of Ephedra sinica.

3. The Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is prepared from 10-30 parts by weight of Rosa laevigata fruit, 5-25 parts by weight of Alpinia oxyphylla, 5-25 parts by weight of Rubus idaeus, 5-25 parts by weight of Lotus seed, 5-25 parts by weight of Codonopsis pilosula, 1-20 parts by weight of Cuscuta australis, 1-20 parts by weight of Linderae scutellariae, 1-20 parts by weight of Silkworm Coodiae, 2-10 parts by weight of Schisandra chinensis and 2-10 parts by weight of Ephedra sinica.

4. The Chinese medicine composition according to claim 3, characterized in that: The traditional Chinese medicine composition is prepared from 15-25 parts by weight of Rosa laevigata fruit, 10-20 parts by weight of Alpinia oxyphylla, 10-20 parts by weight of Rubus idaeus, 10-20 parts by weight of Lotus seed, 10-20 parts by weight of Codonopsis pilosula, 5-15 parts by weight of Cuscuta australis, 5-15 parts by weight of Linderae scutellariae, 5-15 parts by weight of Occulterella mulberrye, 4-8 parts by weight of Schisandra chinensis and 4-8 parts by weight of Ephedra sinica.

5. The Chinese medicine composition according to claim 4, characterized in that: The traditional Chinese medicine composition is prepared from 20 parts by weight of Rosa laevigata fruit, 15 parts by weight of Alpinia oxyphylla, 15 parts by weight of Rubus idaeus, 15 parts by weight of Lotus seed, 15 parts by weight of Codonopsis pilosula, 10 parts by weight of Cuscuta australis, 10 parts by weight of Linderae scutellariae, 10 parts by weight of Occulterella mulberrye, 6 parts by weight of Schisandra chinensis and 6 parts by weight of Ephedra sinica.

6. The Chinese medicine composition according to any one of claims 1 to 5, characterized in that: The traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

7. The Chinese medicine composition according to any one of claims 1 to 5, characterized in that: The Chinese medicine composition is an external preparation or an oral preparation.

8. The Chinese medicine composition according to claim 7, characterized in that: The Chinese medicine composition is in the form of tablets, capsules, pills, powders, oral liquids or decoctions.

9. The method for preparing the Chinese medicine composition according to any one of claims 1 to 8, characterized in that: The preparation method comprises the following steps: taking prescribed amounts of golden cherry fruit, alpinia oxyphylla, raspberry, lotus seed, codonopsis pilosula, dodder seed, lindera striata, silkworm cocoon, schisandra chinensis and honey ephedra, mixing and crushing, adding water 4-8 times the weight of the traditional Chinese medicine and boiling for 1 hour, filtering and concentrating the traditional Chinese medicine filtrate to 1.5 times the total weight of the traditional Chinese medicine initially added, and optionally adding pharmaceutically acceptable excipients to obtain the product.

10. Use of the Chinese medicine composition according to any one of claims 1 to 8 in the preparation of a drug for treating enuresis of kidney qi insufficiency type.

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