Traditional chinese medicine composition for treating urinary incontinence, preparation method therefor, and use thereof

By using transdermal cream or patches of traditional Chinese medicine compositions such as agarwood and yizhiren, and applying them to specific acupoints, the problems of limited efficacy of urinary incontinence treatment and major side effects in the prior art have been solved, and the effect of significantly reducing the number of nocturnal urine and improving urinary incontinence symptoms has been achieved.

WO2025097959A1PCT designated stage expired Publication Date: 2025-05-15XUANWU HOSPITAL OF CAPITAL UNIV OF MEDICAL SCI
View PDF 6 Cites 0 Cited by

Patent Information

Application Number
PCT/CN2024/114701
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-08
Filing Date
2024-08-27
Publication Date
2025-05-15

AI Technical Summary

Technical Problem

The prior art has limited efficacy in treating urinary incontinence, has great side effects of drugs, lacks safety and operability in the treatment of traditional Chinese medicine acupoints, and the Chinese medicine composition has complex medicinal flavor, inconvenient use, toxic medicinal materials, long course of treatment, and poor patient compliance.

Method used

A Chinese medicine composition is adopted, including agarwood, yam, Magnolia officinalis, lilac, raw rhubarb, Glauber's salt and lacetonia. It is applied to Shenque, Guanyuan and bilateral Shenshu acupoints by transdermal administration. The meridian acupoint patch therapy is used to achieve dual treatment of transdermal absorption of the drug and meridian effect.

Benefits of technology

It significantly reduces the number of nocturnal urine, improves urinary incontinence symptoms, has significant treatment effect, and can see obvious results after 5 days of intervention, with long-lasting efficacy, no rebound, good prognosis, and reduces drug toxicity and side effects.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure PCTCN2024114701-FTAPPB-I100001
    Figure PCTCN2024114701-FTAPPB-I100001
  • Figure PCTCN2024114701-FTAPPB-I100002
    Figure PCTCN2024114701-FTAPPB-I100002
  • Figure PCTCN2024114701-FTAPPB-I100003
    Figure PCTCN2024114701-FTAPPB-I100003
Patent Text Reader

Abstract

A traditional Chinese medicine composition for treating urinary incontinence, a preparation method therefor, and use thereof. Raw materials of the composition comprise the following components: agilawood, Fructus Alpiniae oxyphyllae, Magnoliae Officinalis Cortex, Flos Caryophylli, raw rhubarb, mirabilite, and Semen raphani. The preparation method comprises: separately crushing and sieving the raw materials, and mixing the raw materials to obtain a powder; and then adding the powder into a solvent for mixing to obtain the composition. The formula works collectively to warm the kidney, regulate the middle jiao, consolidate essence, and reduce urination, thereby alleviating or curing urinary incontinence in patients with different diseases, as well as symptoms such as frequent urination, urinary urgency, urinary leakage, and urinary retention at night.
Need to check novelty before this filing date? Find Prior Art

Description

A Chinese medicine composition for treating urinary incontinence, preparation method and application Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine treatment, and in particular relates to a traditional Chinese medicine composition for treating urinary incontinence, a preparation method and application thereof. Background Art

[0002] Urinary incontinence is a common clinical symptom of various diseases. Frequent urination, urgency, incontinence, weak urination, and urinary retention not only severely affect patients' sleep, but also aggravate motor symptoms, reduce their ability to function, increase anxiety and pessimism, and even increase the risk of cardiovascular and cerebrovascular emergencies and trauma, severely impacting their quality of life and recovery. With the exception of a few cases where sleep indirectly affects nocturnal urination, urinary incontinence caused by organic diseases is difficult to alleviate and therefore challenging to treat.

[0003] Due to the unique and complex innervation of the bladder, bladder dysfunction can lead to symptoms such as urinary incontinence. Currently, medications for prostate-related urinary dysfunction are available, but these medications are poorly targeted, have limited improvement, and can cause side effects. Traditional Chinese medicine (TCM) offers acupoint treatments, mostly using heat-sensitive moxibustion and thunder-fire moxibustion, but these methods lack safety and operability, making them difficult for patients to self-treat at home and maintain consistent use.

[0004] Chinese invention patent application CN110478455A discloses a drug for treating urinary incontinence and its preparation method. Specifically, it is a Chinese patent medicine for treating urinary incontinence prepared from Chinese herbal medicines and its preparation method. The drug for treating urinary incontinence comprises the following components by mass: 0.5-1% Hyoscyamus chinensis, 20-22% Raw Astragalus membranaceus, 14-15% Silkworm Corydalis, 14-15% Cuscuta australis, 14-15% Psoralea corylifolia, 16-17% Rosa laevigatae, 14-15% Alpinia oxyphyllae, and 4-5% Cinnamomum cassiae, with the total mass percentage of these components being 100%. This drug for treating urinary incontinence reduces the frequency of urinary incontinence and improves patients' quality of life to a certain extent, but the medication requires a long duration and its efficacy needs to be further improved.

[0005] Chinese invention patent application CN106039183A discloses a traditional Chinese medicine composition for treating frequent urination and urinary incontinence. The composition is composed of the following raw materials in the following weight ratios: Codonopsis pilosula, Atractylodes macrocephala, Rehmannia glutinosa, Chinese yam, Cornus officinalis, Psoralea corylifolia, Alpinia oxyphylla, Citrus reticulata, Cimicifuga heracleifolia, Oyster, Astragalus membranaceus, Eucommia bark, Rubus idaeus, Rosa laevigata fruit, Cinnamomum cassia bark, Euryale ferox, Poria cocos, Plantago seed, Aquilaria sinensis, Angelica sinensis, Astragalus complanatus fruit, Cuscuta australis seed, Licorice root, Ossobucus dactylis, Polygonum multiflorum, Imperata cylindrica root, Juncus effusus, and Stephania tetrandra. This traditional Chinese medicine composition has been shown to have a certain therapeutic effect on frequent urination and urinary incontinence. However, as can be seen from specific cases, the treatment cycle is long, the prescription has a complex flavor, includes some toxic herbs, and requires multiple oral doses daily. Compared to topical preparations, the traditional Chinese medicine has a poor taste and overall patient compliance is poor.

[0006] Therefore, existing research on traditional Chinese medicine for the treatment of urinary incontinence and frequent urination and urgency has been conducted to some extent, and has achieved certain results. However, the therapeutic effect needs to be improved. In addition, the above-mentioned formulas are either oral medications, which are not very friendly to patients with frequent urination, urgency, urinary incontinence, etc., or have a complex medicinal composition, which is inconvenient for patients to use and unsafe for long-term use due to the complex medicinal composition. Moreover, some formulas contain toxic medicinal materials. Therefore, the development of a traditional Chinese medicine composition that has good effects on patients with different diseases, relatively simple medicinal composition, simple processing, and convenient use is a relentless pursuit in the field.

[0007] Summary of the Invention

[0008] In view of the deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for treating urinary incontinence, a preparation method and application thereof.

[0009] In order to achieve the purpose of the present invention, the technical solutions adopted are as follows:

[0010] A traditional Chinese medicine composition for treating urinary incontinence comprises the following raw materials: agarwood, alpinia oxyphylla seeds, magnolia bark, cloves, raw rhubarb, sodium sulfate and radish seeds.

[0011] In some embodiments, the raw materials of the present invention include the following components in parts by weight: 5-15 parts of agarwood, 10-20 parts of Alpinia oxyphylla, 5-15 parts of Magnolia officinalis, 1-10 parts of cloves, 5-15 parts of raw rhubarb, 1-10 parts of Glauber's salt and 1-10 parts of radish seeds.

[0012] In some embodiments, the raw materials of the present invention include the following components in parts by weight: 6-12 parts of agarwood, 12-18 parts of Alpinia oxyphylla, 6-12 parts of Magnolia officinalis, 3-8 parts of cloves, 6-12 parts of raw rhubarb, 3-8 parts of Glauber's salt and 6-12 parts of radish seeds.

[0013] In other embodiments, the raw materials of the composition include the following components in parts by weight: 9 parts of agarwood, 15 parts of Alpinia oxyphylla, 9 parts of Magnolia officinalis, 6 parts of cloves, 9 parts of raw rhubarb, 6 parts of Sodium sulfate and 9 parts of Radish seeds.

[0014] In a second aspect, the present invention also provides a method for preparing the above-mentioned composition, comprising the following steps:

[0015] (1) crushing the raw materials separately, sieving, and mixing to obtain powder;

[0016] (2) Add the powder to the solvent and mix.

[0017] In some embodiments, the sieve is a sieve No. 6 to 10.

[0018] In some embodiments, the solvent is an oily solvent;

[0019] Preferably, the oily solvent is selected from paraffin oil.

[0020] Furthermore, the mass volume ratio of the powder and the solvent is 1g:0.2-1mL.

[0021] In a third aspect, the present invention further provides a pharmaceutical preparation, the raw materials of which include the above-mentioned composition and pharmaceutically acceptable excipients.

[0022] Furthermore, the dosage form of the pharmaceutical preparation is selected from one of ointment and patch.

[0023] Both ointments and patches are transdermal delivery methods, offering unique advantages over conventional drug delivery methods. They bypass the liver's "first-pass effect" and gastrointestinal damage, reducing drug toxicity and side effects, maintaining stable and sustained blood drug concentrations, improving efficacy, reducing the frequency of dosing, and providing convenient administration. Traditional Chinese medicine is ground into a 300-grain powder and mixed thoroughly for transdermal absorption, penetrating the stratum corneum and active epidermis to enter the dermis, where it is absorbed by the capillaries of the dermis and enters the systemic circulation. Another pathway involves absorption into the dermis through skin appendages such as hair follicles, sebaceous glands, and sweat glands. Meridian acupoint patch therapy, based on Traditional Chinese Medicine meridian theory, possesses the dual therapeutic properties of transdermal drug absorption and meridian acupoint effects. Drug stimulation of local meridian acupoints can stimulate systemic qi, resulting in a relative advantage in local drug concentration. The drug is then absorbed and transported through microvascular channels to maximize its systemic pharmacological effects. The transdermal drug delivery system, based on the theory of meridians in Traditional Chinese Medicine, absorbs drugs through acupuncture points on the body's surface. Through the circulation of the meridians, the relevant organs receive a higher concentration of the drug than is typically delivered through injection or oral administration. Through the dual action of drug and meridian effects, it regulates organ function and treats disease. Utilizing the principle of directing essence to the body, the drug's effects are delivered through the skin, absorbed, and dredge the meridians, warming the yang and strengthening the kidneys, achieving the combined effects of regulating the qi of the internal organs, strengthening the kidneys, and reducing urination.

[0024] The patch of the present invention is a prescription developed clinically by the team of Professor Gao Li, a nationally renowned traditional Chinese medicine practitioner. It is applied to the Shenque, Guanyuan and bilateral Shenshu points. The patch is sealed and stored, and has a shelf life of 7 hours after application.

[0025] Modern research indicates that the Shenque acupoint possesses anatomical advantages such as thin skin walls, strong permeability, high sensitivity, a large number of tiny capillaries, and rapid absorption. From the perspective of bioholography, Shenque acupoint treatment can be achieved through the inductive conduction of meridians, neurohumoral regulation, and the extensive effects of the holographic umbilicus. Shenque acupoint is closely connected to the Ren, Du, Chong, and Dai meridians. Shenque acupoint is the most structurally unique and well-defined acupoint, and its uniqueness and extensive connections to the entire body are unmatched by any other acupoint. Shenque acupoint serves as a gateway for the flow of spiritual energy, and has the effects of restoring yang, tonifying the spleen and kidneys, regulating the Chong and Ren meridians, and promoting health and longevity. It has been widely used in acupoint application. Guanyuan acupoint is primarily used to warm and tonify kidney yang, replenish qi and tonify deficiency, and is clinically used for nocturia caused by kidney yang deficiency. Shenshu acupoint warms and tonifies kidney yang, relieves or alleviates ureteral spasms, and stabilizes urine.

[0026] In a fourth aspect, another object of the present invention is to provide a use of the above-mentioned Chinese medicine composition in the preparation of medicines for treating urinary system diseases.

[0027] Furthermore, the urinary system disease is one or more of urinary incontinence, frequent urination, urgency, weak urination and urinary retention.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] (1) In the present invention, agarwood and Alpinia oxyphylla are used as the main ingredients. Agarwood is pungent, bitter and slightly warm in nature. It enters the spleen, stomach and kidney meridians and has the functions of warming the kidney, regulating the middle and promoting the flow of qi. "Yi Lin Zuan Yao" records that "Agarwood strengthens the kidney, replenishes the gate of life, and can regulate all kinds of unregulated qi". Alpinia oxyphylla is pungent and warm in nature. It enters the spleen and kidney meridians and has the functions of warming the kidney, consolidating essence and reducing urine, warming the spleen and stopping diarrhea. "Bencao Shiyi" records that "it is used to treat spermatorrhea, residual urine, replenish qi and calm the mind, replenish deficiency, calm the three burners, regulate various qi, and treat frequent urination at night".

[0030] Cloves, raw rhubarb, and Glauber's salt are used as assistant ingredients. Cloves are pungent and warm in nature and enter the spleen, stomach, and kidney meridians. This pungent herb warms the spleen and stomach and dissipates stagnant qi, assisting the main herb in warming the middle and promoting qi circulation, tonifying the kidney and supporting yang. "Bencao Gangmu" states: "It warms the middle, heals kidney qi, strengthens yang, and warms the waist and knees." Alpinia oxyphylla is pungent, bitter, and warm in nature and enters the kidney and spleen meridians, warming the kidney and supporting yang, warming the spleen and stopping diarrhea. "Compendium of Materia Medica" states: "It opens the life gate, warms the dantian, and calms the spirit." Rhubarb is bitter and cold in nature and enters the spleen, stomach, large intestine, liver, and pericardium meridians, purging heat and promoting bowel movements, cooling blood and detoxifying, and removing blood stasis and promoting menstruation. Glauber's salt is salty and cold in nature and primarily enters the spleen, lung, and large intestine meridians, dispersing stagnation and reducing swelling, clearing heat and clearing edema. These three assistant herbs assist the main herb in enhancing its kidney-warming, essence-strengthening, and urination-inducing properties. Radish seeds and Magnolia officinalis are added as adjuvants. Radish seeds are pungent, sweet and neutral in nature, and enter the lung, spleen and stomach meridians. They have the function of promoting qi and relieving bloating and fullness. "Compendium of Materia Medica" says that "it can help digestion, relieve bloating, and promote urination and defecation"; Magnolia officinalis is bitter, pungent and warm in nature, and enters the spleen, stomach and large intestine meridians. It can relieve qi and fullness and promote stagnation. "Compendium of Materia Medica" says that "Magnolia officinalis, bitter can relieve qi, so it can relieve fullness; warm can invigorate qi, so it can disperse dampness"; the two medicines are adjuvants, which can nourish without stagnation; the whole formula works together to warm the kidney and regulate the middle, consolidate essence and reduce urine, and relieve patients' symptoms such as frequent urination at night.

[0031] (2) The prescription of the present invention is simple, and after 5 days of intervention, the frequency of nocturia can be significantly reduced, which is statistically significant compared with the level before treatment.

[0032] (3) The prescription of the present invention has been carefully formulated by the inventors and is a prescription developed by the team clinically. It is applied to the Shenque, Guanyuan, and bilateral Shenshu points. The Chinese medicine patch is sealed and stored, and the effect is 7 hours after application. For example, the combination of Aquilaria sinensis and Magnolia officinalis can synergistically reduce the frequency of urinary incontinence. After 5 days of intervention, the symptoms are significantly relieved or cured. After 10 days and one month of follow-up treatment, the disease has not rebounded, and the prognosis is good. DETAILED DESCRIPTION

[0033] The present invention will be further described below with reference to specific embodiments.

[0034] Example 1

[0035] The raw materials of the present embodiment are composed of the following components in parts by weight: 9 parts of agarwood, 15 parts of Alpinia oxyphylla, 9 parts of Magnolia officinalis, 6 parts of cloves, 9 parts of raw rhubarb, 6 parts of Sodium sulfate and 9 parts of Radish seeds.

[0036] The preparation method is as follows:

[0037] (1) Grind the above herbs into fine powder respectively, pass through No. 7 sieve, and mix well;

[0038] (2) Add paraffin oil to the mixed powder at a mass volume ratio of 1 g of powder to 0.5 mL of solvent and mix well;

[0039] (3) Place the medicine paste on the bottom lining of the patch; place the cover lining on top to obtain the Chinese medicine patch.

[0040] Example 2

[0041] The therapeutic prescription of this embodiment is composed of the following components in parts by weight: 6 parts of agarwood, 12 parts of Alpinia oxyphylla, 6 parts of Magnolia officinalis, 3 parts of cloves, 6 parts of raw rhubarb, 3 parts of Sodium sulfate and 6 parts of Radish seeds.

[0042] The preparation method is as follows:

[0043] (1) Grind the above herbs into fine powder respectively, pass through No. 7 sieve, and mix well;

[0044] (2) Add paraffin oil to the mixed powder at a mass volume ratio of 1 g of powder to 0.2 mL of solvent and mix well;

[0045] (3) Place the medicine paste on the bottom lining of the patch; place the cover lining on top to obtain the Chinese medicine patch.

[0046] Example 3

[0047] The raw materials of the present embodiment are composed of the following components in parts by weight: 12 parts of agarwood, 18 parts of Alpinia oxyphylla, 12 parts of Magnolia officinalis, 8 parts of cloves, 12 parts of raw rhubarb, 8 parts of Glauber's salt and 12 parts of radish seeds.

[0048] The preparation method is as follows:

[0049] (1) Grind the above herbs into fine powder respectively, pass through No. 7 sieve, and mix well;

[0050] (2) Add paraffin oil to the mixed powder at a mass volume ratio of 1 g of powder to 1 mL of solvent and mix well;

[0051] (3) Place the mixed paste into a sealed container (a Lock & Lock box is sufficient), and then place it in a refrigerator at 2°C for future use. When using, take out the paste and place it on the bottom lining of the patch; then place the cover on top of the lining to obtain the Chinese medicine patch.

[0052] The following comparative examples 1-3 are individual prescriptions screened in the early stages of the experiment.

[0053] Comparative Example 1

[0054] This group of prescriptions is compared with Example 1, which is a prescription lacking flavor medicine, and its total dosage remains unchanged. The specific prescription is composed of the following components in parts by weight: 9 parts of agarwood, 15 parts of Alpinia oxyphylla, 9 parts of Magnolia officinalis, 6 parts of cloves, 9 parts of raw rhubarb, and 15 parts of Glauber's salt.

[0055] Its preparation method is:

[0056] (1) Grind the above herbs into fine powder respectively, pass through No. 7 sieve, and mix well;

[0057] (2) Add paraffin oil to the mixed powder at a mass volume ratio of 1 g of powder to 0.5 mL of solvent and mix well;

[0058] (3) Place the medicine paste on the bottom lining of the patch; place the cover lining on top to obtain the Chinese medicine patch.

[0059] Comparative Example 2

[0060] This group of prescriptions is compared with Example 1, which is a prescription lacking flavor medicine, and its total dosage remains unchanged. The specific prescription is composed of the following components in parts by weight: 9 parts of agarwood, 15 parts of Alpinia oxyphylla, 9 parts of Magnolia officinalis, 6 parts of cloves, 9 parts of raw rhubarb, and 15 parts of radish seeds.

[0061] Its preparation method is:

[0062] (1) Grind the above herbs into fine powder respectively, pass through No. 7 sieve, and mix well;

[0063] (2) Add paraffin oil to the mixed powder at a mass volume ratio of 1 g of powder to 0.5 mL of solvent and mix thoroughly;

[0064] (3) Place the medicine paste on the bottom lining of the patch; place the cover lining on top to obtain the Chinese medicine patch.

[0065] Comparative Example 3

[0066] The difference from Example 1 is that the prescription is different, specifically 9 parts of agarwood, 15 parts of Alpinia oxyphylla, 9 parts of Poria, 6 parts of cloves, 9 parts of Psoralea corylifolia, 6 parts of Schisandra chinensis and 9 parts of Radish Seed.

[0067] Its preparation method is:

[0068] (1) Grind the above herbs into fine powder respectively, pass through No. 7 sieve, and mix well;

[0069] (2) Add paraffin oil to the mixed powder at a mass volume ratio of 1 g of powder to 0.5 mL of solvent and mix thoroughly;

[0070] (3) Place the medicine paste on the bottom lining of the patch; place the cover lining on top to obtain the Chinese medicine patch.

[0071] Clinical Trial 1

[0072] The experimental group included 48 patients with Parkinson's disease who presented with autonomic nervous system dysfunction symptoms such as urinary incontinence. They were divided into 8 groups. There was no statistical difference in the frequency of urinary incontinence among the groups.

[0073] Treatment Method: Each group received a Chinese herbal patch applied to the Shenque, Guanyuan, and bilateral Shenshu points. The patch was applied daily at 3:00 PM and removed at 10:00 PM for 7 hours. The patch was applied once daily for 5 days, for a total of 2 courses. Urinary incontinence scores were calculated on the 5th and 10th days of application, using the International Consultative Committee on Incontinence Questionnaire (ICI-Q-SF).

[0074] The results are shown in Table 1.

[0075] Table 1 Urinary incontinence scores

[0076] Clinical Trial 2

[0077] At present, the Beijing Municipal Health Commission is carrying out a special project to cultivate it. The experimental group further systematically recruited 23 cases of Parkinson's disease patients with autonomic nervous system symptoms such as urinary incontinence and other problems.

[0078] The treatment method is to apply the Chinese medicine patch prepared in Example 1 of the present invention to the Shenque, Guanyuan and bilateral Shenshu points of the above patients for intervention. The patch is applied at 3:00 PM daily and removed at 10:00 PM for a duration of 7 hours. Once a day, a course of 5 days, for a total of 2 courses of treatment. The urinary incontinence score, number of nocturnal urinations, single nocturnal urine volume, overactive bladder score and PD sleep scale were calculated for 5 days, 10 days after the patch intervention, and 1 month later to evaluate the therapeutic effect and long-term prognosis of the Chinese medicine patch.

[0079] The overactive bladder score was calculated using the Overactive Bladder Symptom Score (OABSS) table, and the urinary incontinence score was assessed using the International Consultative Committee on Urinary Incontinence Questionnaire (ICI-Q-SF). Higher scores indicate more severe conditions. The Parkinson's Disease Sleep Scale (PDSS) was used for the Parkinson's Disease Sleep Scale. Bladder ultrasound was also used to measure the residual urine volume (urinary retention) before and 5 days after the intervention.

[0080] The results are shown in Tables 2-4.

[0081] Table 2 Comparison of various indicators after 5 days of intervention

[0082] Table 3 Comparison of various indicators after 10 days of treatment

[0083] Table 4 Various indicators after one month of treatment

[0084] Clinical Trial 3

[0085] From March to December 2020, our team randomly enrolled 100 patients with frequent urination and urinary incontinence. The inclusion criteria were: the average number of nocturnal urinations was 5 or more. Considering that there was no statistical difference in the number of nocturnal urinations between the groups, the patients were randomly divided into 7 groups, labeled as Example Groups 1 to 3, Comparative Example Groups 1 to 3, and Placebo Control Group. Except for the 10 cases in the Placebo Control Group, the remaining groups had 15 cases each.

[0086] The treatment method was to apply the corresponding Chinese medicine patch to Shenque, Guanyuan and bilateral Shenshu points of each group of patients, with the patch applied at 3:00 PM every day and removed at 10:00 PM for 7 hours, once a day for a total of 10 days.

[0087] Patients in the placebo control group received a placebo (prepared by mixing buckwheat flour with 0.5 times the amount of paraffin oil, placing the paste on the bottom lining of the patch, and then placing the top lining on top; the placebo was similar in color to the TCM patch of the present invention). The patch was applied at 3:00 PM daily and removed at 10:00 PM, once daily for 10 days.

[0088] A urination diary was used to record water intake, urine output (ml), urination frequency, urinary urgency (0-4), urinary pain (0-10), and residual urine volume (ml). The efficacy criterion of reducing the number of nocturia was used as the main evaluation indicator.

[0089] Cured: Nocturia frequency 0-1 times after treatment;

[0090] Markedly effective: After treatment, the number of nocturia is reduced by 4 times or by 50%;

[0091] Effective: After treatment, the number of nocturnal urinations is reduced by 2-3 times or by 25%;

[0092] Ineffective: Nocturnal urination frequency remains unchanged or increases after treatment.

[0093] Efficacy criteria: total effective rate = (number of cured, markedly effective and effective cases) / total number of cases × 100%; cure rate = number of cured cases / total number of cases × 100%. The results are shown in Table 5.

[0094] Table 5 Treatment results of Chinese medicine patch for frequent urination and urinary incontinence

[0095] The number of cured patients in the Example 1-3 groups was 13, the number of cured patients in the Example 2-3 groups was 12, the number of cured patients in the comparative example 1-3 groups was 9, 11, and 6, respectively, and there was 1 patient in the placebo control group. There were statistically significant differences between each group and the placebo control group (P less than 0.001), and there were also statistically significant differences between the comparative example group and the Example 1 group (P less than 0.001).

[0096] Clinical trial 4: The efficacy of the Chinese medicine patch of the present invention on other diseases such as frequent urination and urinary retention

[0097] The experimental group included 40 patients with cerebrovascular disease and prostate disease combined with frequent urination and urinary retention, including 19 patients with cerebrovascular disease and 21 patients with prostate disease.

[0098] The treatment method involved applying the Chinese medicine patch of Example 1 to the Shenque, Guanyuan, and bilateral Shenshu points for 7 hours, once daily for a total of 5 days. The efficacy of the patch was then evaluated for frequent urination and urinary retention 5 days after the intervention, and the prognosis for frequent urination was further observed 10 and 30 days after the treatment. The results are shown in Tables 6-10.

[0099] Table 6 The efficacy of Chinese medicine patch on nocturnal urination in different diseases (5 days)

[0100] Table 7 The prognostic efficacy of Chinese medicine patch on nocturnal urination in different diseases (10 days)

[0101] Table 8 The prognostic efficacy of Chinese medicine patch on nocturnal urination in different diseases (30 days)

[0102] Table 9 Efficacy of cerebrovascular disease (urinary retention)

[0103] Table 10 Efficacy of prostate disease (urinary retention)

[0104] In addition, the treatment is also provided to patients with spinal cord injury and female patients with urinary incontinence. The cure rate for frequent urination is 100%, and the average number of nocturnal urination times is reduced from 4-6 times per night to 1-2 times per night. For patients with urinary retention, the residual urine fluctuates between 100-300mL, which is significantly reduced by about 20-80mL after treatment and has returned to normal.

[0105] The above detailed description is a specific description of one feasible embodiment of the present invention. This embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification that does not depart from the present invention should be included in the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating urinary incontinence, characterized in that: The raw materials of the composition include the following components: agarwood, oxyphylla, magnolia bark, clove, raw rhubarb, sodium sulfate and radish seed.

2. The Chinese medicine composition according to claim 1, characterized in that: The raw materials of the composition include the following components in parts by weight: 5-15 parts of agarwood, 10-20 parts of alpinia oxyphylla, 5-15 parts of magnolia bark, 1-10 parts of cloves, 5-15 parts of raw rhubarb, 1-10 parts of sodium sulfate and 1-10 parts of radish seeds.

3. The Chinese medicine composition according to claim 1, characterized in that The raw materials of the composition include the following components in parts by weight: 6-12 parts of agarwood, 12-18 parts of Alpinia oxyphylla, 6-12 parts of Magnolia officinalis, 3-8 parts of cloves, 6-12 parts of raw rhubarb, 3-8 parts of sodium sulfate and 6-12 parts of radish seeds.

4. The Chinese medicine composition according to claim 1, characterized in that: The raw materials of the composition include the following components in parts by weight: 9 parts of agarwood, 15 parts of Alpinia oxyphylla, 9 parts of Magnolia officinalis, 6 parts of cloves, 9 parts of raw rhubarb, 6 parts of Sodium sulfate and 9 parts of Radish seeds.

5. A method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The steps include: (1) crushing the raw material components separately, sieving, and mixing to obtain powder; (2) Add the powder into the solvent and mix them.

6. The preparation method according to claim 5, characterized in that: The sieving is through a No. 6 to No. 10 sieve, and the solvent is selected from an oily solvent.

7. The preparation method according to claim 6, characterized in that: The oily solvent is paraffin oil; the mass volume ratio of the powder to the solvent is 1g:0.2-1mL.

8. A pharmaceutical preparation, characterized in that The raw materials of the pharmaceutical preparation include the Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients, and the dosage form of the pharmaceutical preparation is selected from any one of an ointment and a patch.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of medicines for treating urinary system diseases.

10. The use according to claim 9, characterized in that: The urinary system diseases include one or more of urinary incontinence, frequent urination, urgency, weak urination and urine retention.

Citation Information

Patent Citations

  • Medicine for treating prostate disease

    CN101112578A

  • Solid spring navel sticker

    CN105267817A

  • Traditional Chinese medicine formula for treating constipation of Parkinson sufferers and acupoint plaster thereof

    CN106038826A

  • Traditional Chinese medicinal composition used for treating frequent urination and uroclepsia

    CN106039183A

  • Traditional Chinese medicine composition for treating urinary incontinence, preparation method and application

    CN117180382A