A traditional Chinese medicine hot compress preparation for treating urinary disorders, its preparation method and application.

Abstract

This invention discloses a traditional Chinese medicine (TCM) hot compress preparation for treating urinary disorders, its preparation method, and its application, belonging to the field of TCM technology. This invention uses TCM herbs that invigorate blood circulation, regulate Qi, soothe the liver, and promote urination, combined with aromatic transdermal herbs to create the "Honghu Fang" hot compress preparation. The raw materials consist of Pyrrosia lingua, Sargentodoxa cuneata, Polygonum cuspidatum, Ligusticum chuanxiong, Liquidambar formosana, Foeniculum vulgare, and dried ginger. Clinically, TCM hot compress treatment of urinary disorders has shown that the TCM hot compress provided by this invention has few side effects and is clinically safe and effective. When used to treat urinary disorders caused by benign prostatic hyperplasia, it can reduce IPSS scores, improve urinary symptoms, and alleviate TCM symptoms. When combined with modern drug treatment for urinary disorders caused by chronic nonbacterial prostatitis, it can more significantly relieve patients' pain, urinary frequency, urgency, and other urinary symptoms compared to using modern drugs alone, thus improving their quality of life.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine hot compress preparation for treating urinary disorders, its preparation method, and its application. Background Technology

[0002] Urinary retention, or urinary dysfunction, refers to the obstruction of urine expulsion, resulting in urine remaining in the bladder. It is a clinical syndrome caused by many diseases, injuries, surgeries, or anesthesia. Based on the speed of onset, it is classified into acute and chronic urinary retention. Its main symptoms include difficulty urinating, dribbling, severe bloating and pain, or complete urinary obstruction, significantly impacting the patient's quality of life. Urination is a positive feedback reflex physiological activity controlled by higher nerve centers. When the urge to urinate arises, the higher nerve centers control the micturition reflex center in the spinal cord to undergo a catalytic effect, promoting detrusor muscle contraction and internal urethral sphincter relaxation, thus facilitating urination. Problems in any of these processes can lead to urinary retention.

[0003] Based on their etiology, obstructions can be broadly classified into two categories: mechanical obstruction and dynamic obstruction. Mechanical obstruction includes: 1. External mechanical compression of the urethra: prostate diseases such as benign prostatic hyperplasia, acute prostatitis or prostatic abscess, prostate tumors, etc.; pelvic fractures compressing the urethra; rectal tumors, fecal impaction in the rectum; retroverted uterus during pregnancy, hematoma due to imperforate hymen, cervical cancer, uterine fibroids, etc.; phimosis, paraphimosis, priapism. 2. Internal mechanical obstruction of the urethra: urethral injury, urethral stricture. Urethral stricture causing acute urinary retention often occurs after urethral dilation due to local edema and pain; urethritis, urethral tumors; congenital seminal vesicle hyperplasia, urethral valves, bladder neck contracture; urethral stones, urethral foreign bodies. 3. Intrabladder lesions: tumors in the bladder trigone, bladder neck, bladder stones, intrabladder foreign bodies, large blood clots in the bladder, etc., obstructing the bladder neck and urethra. Dynamic urinary obstruction includes: 1. Neurogenic urinary retention: Upper motor neuron lesions (spinal cord injury, tumors, and multiple sclerosis, etc.); lower motor neuron lesions (various spinal cord compressions such as tumors, epidural abscesses, hematomas, central disc herniation, etc.); lesions affecting the motor and sensory nerves of the bladder (common in diabetes, herpes simplex, extensive pelvic surgery, etc.); excessive bladder distension after surgery and anesthesia (spontine spasm caused by perineal surgery, pain, inflammation, etc. can all cause urinary retention). 2. Drug-induced urinary retention: Central nervous system depressants; anticholinergic drugs such as atropine; certain antihypertensive drugs, antiarrhythmic drugs, calcium channel blockers; antihistamines; certain antidepressants, etc. 3. Others: Hypokalemia caused by various reasons such as aldosteronism, diarrhea, long-term use of diuretics; high fever, coma; those who are not used to urinating while lying down; hysteria, etc. Generally speaking, the most common causes of urinary retention in clinical practice are postoperative urinary retention, neurogenic bladder, and benign prostatic hyperplasia in middle-aged and elderly men.

[0004] Urinary retention / dysuria falls under the category of "urinary obstruction" in Traditional Chinese Medicine (TCM). The *Yizong Bidu* (Essential Readings for Physicians) distinguishes between "urinary obstruction" and "urinary retention." "Urinary obstruction" manifests as scanty, dribbling urination with a slow progression, while "urinary retention" is characterized by complete urination with an urgent progression. Both represent different degrees of difficulty urinating, hence they are often collectively referred to as "urinary obstruction." The *Neijing* (Inner Canon of Medicine) provides the earliest detailed explanation of the etiology, pathogenesis, and location of "urinary obstruction." For example, the *Lingshu* (Spiritual Pivot) states, "Lower abdominal swelling and pain, inability to urinate, indicates that the pathogenic factor is in the triple burner"; and the *Suwen* (Plain Questions) states, "Bladder disease, urinary retention." Therefore, the primary location of urinary obstruction is in the bladder and triple burner.

[0005] The causes of urinary retention / dysuria are complex, and there are many methods for its prevention and treatment. Modern medicine mainly uses two approaches: etiological treatment and symptomatic treatment. If the cause is clear and the obstruction can be relieved promptly, the cause should be addressed immediately to restore urination. Endoscopic treatment is the first choice for urinary retention caused by urethral stricture, lower urinary tract stones, bladder tumors, and benign prostatic hyperplasia. Symptomatic treatment primarily involves urine drainage (indwelling catheterization, suprapubic bladder aspiration, cystostomy). Psychological counseling, fluid intake control, medication, and methods to induce urination are also frequently used when drainage is unsuccessful. Neostigmine, an acetylcholinesterase inhibitor, primarily acts on M-cholinergic receptors on the detrusor muscle of the bladder, increasing detrusor muscle tone to restore urination. However, neostigmine cannot be used long-term or in excessive amounts, otherwise it will cause adverse reactions such as abdominal pain, nausea, and coma due to M-receptor excitation. In Western medicine, indwelling catheterization is currently an important method for treating postoperative urinary difficulties. However, catheterization is an invasive procedure that can easily damage the urethral mucosa and may introduce external pathogens, leading to urinary tract infections and bacteriuria. The incidence of bacteriuria is positively correlated with the duration of indwelling catheterization. By the 10th day of indwelling catheterization, the bacteriuria positivity rate can reach 100%. Traditional Chinese medicine is widely promoted and applied in the treatment of urinary retention. It is not only effective, simple, and safe, but also has no toxic side effects, giving it certain advantages. It often uses methods such as oral Chinese medicine, hot compresses with Chinese medicine, acupuncture, acupressure, and ear acupressure. The pathogenesis of urinary retention is mainly due to the dysfunction of bladder qi transformation. According to the principle of "treating the viscera by promoting unobstructed flow," urinary retention should be treated primarily by promoting unobstructed flow. Zhang Zhongjing made significant contributions to the treatment of urinary retention in his works *Treatise on Febrile Diseases* and *Essential Prescriptions of the Golden Chamber*, recording numerous effective prescriptions such as Wu Ling San, Zhu Ling Tang, Zhen Wu Tang, and Gua Lou Qu Mai Wan. Acupuncture treatment for urinary retention was first proposed in the *Huangdi Neijing*, as seen in the *Ling Shu* chapter on "Pathogenic Factors and Diseases of the Zang-Fu Organs," which states that for bladder disorders with lower abdominal swelling and pain, and inability to urinate, the Weizhong acupoint (a He-Sea point on the Bladder Meridian) can be used. Studies show that acupuncture can unblock meridians, alleviate pain, improve pelvic nerve function, induce bladder detrusor muscle contraction, relieve bladder neck and urethral sphincter spasms, and promote urination; the effect is even better when combined with moxibustion. Therefore, there is an urgent need to provide an effective external prescription for treating urinary disorders based on traditional Chinese medicine theory. Summary of the Invention

[0006] The object of the present invention is to provide a traditional Chinese medicine ironing and hot compress package preparation for treating dysuria, its preparation method and application, so as to solve the problems existing in the above-mentioned prior art. The present invention uses traditional Chinese medicines for promoting blood circulation to remove qi stagnation, soothing the liver and promoting diuresis combined with aromatic transdermal to make the "Red Tiger Formula" hot compress package preparation. Compared with only using modern drugs, it can more significantly relieve the dysuria symptoms such as pain, frequent urination, and urgency in patients with dysuria, and improve their quality of life.

[0007] To achieve the above object, the present invention provides the following solutions:

[0008] The present invention provides a pharmaceutical composition for treating dysuria, comprising the following components: Pyrrosia lingua, Sargentodoxa cuneata, Polygonum cuspidatum, Ligusticum chuanxiong, Clerodendron trichotomum, Foeniculum vulgare and Zingiber officinale.

[0009] Preferably, by weight, it comprises the following components:

[0010] 15 parts of Pyrrosia lingua, 30 parts of Sargentodoxa cuneata, 15 parts of Polygonum cuspidatum, 15 parts of Ligusticum chuanxiong, 15 parts of Clerodendron trichotomum, 12 parts of Foeniculum vulgare and 12 parts of Zingiber officinale.

[0011] Among them, Sargentodoxa cuneata for detoxifying and promoting blood circulation, and Polygonum cuspidatum for promoting diuresis and dissipating stasis are the monarch drugs; Ligusticum chuanxiong for regulating qi and promoting blood circulation, Pyrrosia lingua for promoting diuresis and relieving stranguria, and dispelling wind and dredging collaterals are the ministerial drugs together; additionally, Foeniculum vulgare is used as an adjuvant for dispelling cold and relieving pain, and aromatic drugs penetrate into the collaterals through the skin, and Zingiber officinale warms yang qi, restores yang and promotes blood circulation, helps the meridians to function smoothly, and guides the medicine into the acupoints. All the medicines work together to achieve the effects of promoting blood circulation to remove qi stagnation, soothing the liver and promoting diuresis, and dredging the urinary tract.

[0012] The functions and main indications of each raw material medicine in the traditional Chinese medicine ironing and hot compress package preparation provided by the present invention:

[0013] Sargentodoxa cuneata is bitter and flat in nature, mainly enters the liver meridian and large intestine meridian, and has the effects of clearing heat and detoxifying, promoting blood circulation, and dispelling wind and relieving pain. Cnidium monnieri was first recorded in "Illustrated Classic of Materia Medica", which mentioned "attacking blood and removing blood clots". "Chinese Materia Medica": dispelling wind and dredging collaterals, promoting diuresis and killing insects. Treating appendicitis, rheumatic arthralgia, leprosy, gonorrhea: abdominal pain due to roundworms. Treating acute and chronic appendicitis, rheumatic arthralgia, dysentery, bloody stranguria, irregular menstruation, malnutrition, abdominal pain due to insects, and traumatic injury. Attacking blood and treating blood clots. Its modern pharmacological research shows that the water extract can inhibit the swelling of the auricles of mice caused by dimethylbenzene, reduce the swelling degree and swelling rate, and thus has an anti-inflammatory effect; it can prolong the pain threshold latency of mice in the acetic acid-induced pain model and reduce the number of writhing times, and inhibit the proliferation of granulation tissue in mice, and thus has an analgesic effect; the alcohol extract of Sargentodoxa cuneata has anti-inflammatory and analgesic effects equivalent to those of Yunnan Baiyao tincture, which provides a theoretical basis for the folk use of AESC by the method of soaking in wine for dispelling wind and relieving pain, dysmenorrhea, and traumatic swelling and pain. The alcohol extract of Sargentodoxa cuneata can significantly reduce the ear swelling degree of mice caused by dimethylbenzene; compared with the blank group and before administration, it can significantly increase the pain threshold of mice.

[0014] Polygonum cuspidatum is slightly cold in nature and enters the liver, gallbladder, and lung meridians. It has the functions of promoting diuresis and relieving jaundice, clearing heat and detoxifying, dispersing blood stasis and relieving pain, and stopping cough and resolving phlegm. It is used to treat damp-heat jaundice, urinary tract infections, leukorrhea, rheumatic pain, carbuncles and boils, burns, amenorrhea, abdominal masses, traumatic injuries, and cough due to lung heat. Modern pharmacological studies have shown that Polygonum cuspidatum has anti-inflammatory, antioxidant, antiviral, antibacterial, anticancer, hepatoprotective, cardiovascular protective, and immunomodulatory effects, and can be applied to the treatment of diabetes, gout, cancer, and respiratory and cardiovascular diseases. An acute gouty arthritis model was induced in mice by injecting sodium urate crystals (MSU) into the ankle joint. The ethanol extract of Polygonum cuspidatum significantly reduced ankle swelling, decreased the levels of synovial inflammatory factors IL-1β, IL-6, and TNF-α, and reduced the expression of NLR family Pyrin domain protein 3 (NLRP3), apoptosis-associated speckle-like protein (ASC), and caspase-1 axis protein and mRNA. Stilbene derivatives and anthraquinones are likely the main anti-gouty arthritis components in the Polygonum cuspidatum extract.

[0015] Ligusticum chuanxiong is warm in nature, pungent and slightly sweet in taste, and enters the liver, gallbladder, and pericardium meridians. According to the *Chinese Materia Medica*, it has the effects of regulating qi and relieving stagnation, dispelling wind and drying dampness, and promoting blood circulation and relieving pain. As the main active ingredient of Ligusticum chuanxiong, in various oxidative damage, nerve damage, and inflammation models, Ligusticum chuanxiong volatile oil can exert antioxidant, anti-inflammatory, neuroprotective, and vascular homeostatic effects by regulating multiple related pathways and targets inside and outside cells. Ligusticum chuanxiong volatile oil has a repair effect on oxidatively damaged SY5Y cells within a certain range, and its mechanism of action may be related to scavenging ROS, reducing DNA oxidative damage, and inhibiting cell apoptosis. Studies have found that the volatile oil of Ligusticum chuanxiong can promote transdermal drug absorption and has analgesic effects. The volatile oil of Ligusticum chuanxiong can promote transdermal drug absorption by interfering with the lipid arrangement of the stratum corneum and increasing lipid fluidity. In a clinical study on acute knee synovitis, the combination of volatile oil of Ligusticum chuanxiong and volatile oil of frankincense can relieve joint swelling, increase the range of motion of the knee joint, and greatly reduce the pain of patients during treatment.

[0016] Pyrrosia lingua has a sweet and bitter taste, and is slightly cold in nature. It possesses the effects of clearing the lungs and relieving cough, promoting urination and relieving strangury, cooling the blood and stopping bleeding. Extracts have antioxidant, antibacterial, anti-inflammatory, diuretic, wound-healing, anti-kidney-stone, and anti-diabetic effects, with flavonoids and phenols being the main active ingredients. Studies have shown that flavonoids in Pyrrosia lingua have inhibitory effects on various pathogens, including Staphylococcus aureus, Micrococcus luteus, Escherichia coli, and Shigella freundii. Researchers prepared an experimental Pyrrosia lingua ointment, and studies found that it could shorten wound healing time and increase wound healing rate in a rat trauma model. Furthermore, the scar area after treatment with the ointment was significantly smaller than that in the natural recovery group and the positive control group treated with Jingwanhong ointment. During the treatment of infected wounds, HE pathological section results and changes in serum cytokines such as TNF-α, IL-6, and FGF-2 showed that the ointment could antagonize Staphylococcus aureus infection, reduce the infiltration of inflammatory cells such as neutrophils, promote the growth of granulation tissue and epidermal tissue, dermal layer formation and hair follicle regeneration, and restore skin elasticity.

[0017] Lulutong (Ligusticum striatum) is neutral in nature and bitter in taste, and enters the liver and kidney meridians. It dispels wind and unblocks the meridians, promotes diuresis and eliminates dampness. It is mainly used to treat numbness and pain in the limbs, contractures of the hands and feet, stomach pain, edema, abdominal distension, amenorrhea, insufficient lactation, carbuncles, hemorrhoids, scabies, and eczema. Lulutong has anti-inflammatory, swelling-reducing, and analgesic effects. Its main active components are betulinic acid (also known as Lulutong acid) and gallic acid, which exert their anti-inflammatory effects primarily by reducing capillary permeability, inhibiting the secretion of inflammatory mediators, and participating in the NF-κB signaling pathway.

[0018] Fennel seeds are warm in nature and pungent in taste, entering the liver, kidney, spleen, and stomach meridians; they dispel cold and relieve pain, regulate qi and harmonize the stomach. They are used for cold hernia abdominal pain, testicular prolapse, dysmenorrhea, lower abdominal cold pain, epigastric and abdominal distension, poor appetite, vomiting and diarrhea, and hydrocele. Salted fennel seeds warm the kidneys, dispel cold, and relieve pain. They are used for cold hernia abdominal pain, testicular prolapse, and menstrual cramps due to cold. Experiments on healthy men with SD showed that fennel seeds had significant diuretic and sleep-inducing effects, and could also lower ALD and NOS levels in men with cirrhosis. Fennel oil penetrates the skin, flowing inwards along the meridians to reach the internal organs, acting on the bladder. It can relieve spasms caused by excitation of the bladder smooth muscle (detrusor muscle) and internal urethral sphincter, restoring the balance between excitation and inhibition of the urination center.

[0019] Dried ginger is hot in nature and pungent in taste, and it enters the spleen, kidney, stomach, heart, and lung meridians. It warms the middle jiao (spleen and stomach), dispels cold, restores yang, and unblocks the meridians. It treats cold pain in the heart and abdomen, vomiting and diarrhea, cold limbs and weak pulse, cold-induced cough and wheezing, wind-cold-dampness bi syndrome, and vomiting, nosebleeds, and hematochezia due to yang deficiency. The ether extract, water extract, and alcohol extract of dried ginger all have significant anti-inflammatory effects. The analgesic and anti-inflammatory components of dried ginger are mainly lipid-soluble gingerol compounds and sesquiterpene components, particularly gingerol, which can inhibit the expression of phosphodiesterase 4 (PDE4) in inflammatory cells, thus exerting an anti-inflammatory effect. The volatile oils and other pungent components in dried ginger can accelerate local microcirculation, thereby protecting the wound and promoting healing. The volatile oils in dried ginger accelerate local blood circulation, which can speed up blood flow and metabolism in the abdomen and bladder, making it easier to promote urination.

[0020] The present invention also provides the use of the pharmaceutical composition described herein in the preparation of a medicament for treating urinary disorders.

[0021] Preferably, the urinary obstruction is caused by prostate disease.

[0022] Preferably, the prostate disease is benign prostatic hyperplasia or chronic nonbacterial prostatitis.

[0023] Preferably, the urinary disorder is caused by surgical treatment.

[0024] The present invention also provides a medicament for treating urinary disorders, wherein the sole active ingredient of the medicament is the aforementioned pharmaceutical composition.

[0025] Preferably, it also includes pharmaceutically acceptable excipients.

[0026] Preferably, the dosage form of the drug is a traditional Chinese medicine hot compress preparation.

[0027] This invention also provides a method for preparing a traditional Chinese medicine hot compress preparation for treating urinary disorders, comprising:

[0028] Weigh out the above-mentioned drug composition according to the weight parts, pulverize them into the coarsest powder, mix them evenly, and obtain a mixed powder;

[0029] Pack the medicine into bags to obtain the traditional Chinese medicine hot compress preparation.

[0030] Preferably, the bagging process involves packing the mixed powder into non-woven bags at a rate of 60g / bag.

[0031] The present invention discloses the following technical effects:

[0032] This invention utilizes traditional Chinese medicine (TCM) that invigorates blood circulation, regulates Qi, soothes the liver, and promotes urination, combined with aromatic transdermal herbs to create the "Red Tiger Formula" hot compress preparation. The raw materials consist of *Pyrrosia lingua*, *Sargentodoxa cuneata*, *Polygonum cuspidatum*, *Ligusticum chuanxiong*, *Liquidambar formosana*, fennel, and dried ginger. Clinically, this TCM hot compress treatment for urinary disorders has shown to have few side effects and is clinically safe and effective. When used to treat urinary disorders caused by benign prostatic hyperplasia, it can reduce IPSS scores, improve urinary symptoms, and alleviate TCM symptoms. When combined with modern drug treatment for urinary disorders caused by chronic nonbacterial prostatitis, it can more significantly relieve patients' pain, urinary frequency, urgency, and other urinary symptoms compared to using modern drugs alone, thus improving their quality of life. Detailed Implementation

[0033] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0034] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0035] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0036] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be readily apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0037] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0038] The causes of urinary retention / dysuria are complex, and there are many methods for prevention and treatment. Modern medicine mainly uses two approaches: etiological treatment and symptomatic treatment. If the cause is clear and the obstruction can be relieved promptly, the cause should be addressed immediately to restore urination. For urinary retention caused by urethral stricture, lower urinary tract stones, bladder tumors, or benign prostatic hyperplasia, urinary drainage is the first-line treatment. Symptomatic treatment primarily involves urinary drainage (indwelling catheterization, suprapubic bladder aspiration, cystostomy). Psychological counseling, fluid intake control, medication, and methods to induce urination are also frequently used when urinary drainage is unsuccessful. Neostigmine, an acetylcholinesterase inhibitor, primarily acts on M-cholinergic receptors on the detrusor muscle of the bladder, increasing detrusor muscle tone to restore urination. However, neostigmine cannot be used long-term or in excessive amounts, otherwise it will cause adverse reactions such as abdominal pain, nausea, and coma due to M-receptor excitation. In Western medicine, indwelling catheterization is currently an important method for treating postoperative urinary difficulties. However, catheterization is an invasive procedure that can easily damage the urethral mucosa and may introduce external pathogens, leading to urinary tract infections and bacteriuria. The incidence of bacteriuria is positively correlated with the duration of indwelling catheterization. By the 10th day of indwelling catheterization, the bacteriuria positivity rate can reach 100%. Traditional Chinese medicine is widely promoted and applied in the treatment of urinary disorders / urinary retention. It is not only effective, simple, and safe, but also has no toxic side effects, giving it certain advantages. It often uses methods such as oral Chinese medicine, hot compresses with Chinese medicine, acupuncture, acupressure, and ear acupressure. The pathogenesis of urinary retention is mainly due to the dysfunction of bladder qi transformation. According to the principle of "treating the viscera by promoting unobstructed flow," urinary retention should be treated primarily by promoting unobstructed flow. Zhang Zhongjing made significant contributions to the treatment of urinary retention in his works *Treatise on Febrile Diseases* and *Essential Prescriptions of the Golden Chamber*, recording numerous effective prescriptions such as Wu Ling San, Zhu Ling Tang, Zhen Wu Tang, and Gua Lou Qu Mai Wan. Acupuncture treatment for urinary retention was first proposed in the *Huangdi Neijing*, as seen in the *Ling Shu* chapter on "Pathogenic Factors and Diseases of the Zang-Fu Organs," which states that for bladder disorders with lower abdominal swelling and pain, and inability to urinate, the Weizhong acupoint (a He-Sea point on the Bladder Meridian) can be used. Studies show that acupuncture can unblock meridians, alleviate pain, improve pelvic nerve function, induce bladder detrusor muscle contraction, relieve bladder neck and urethral sphincter spasms, and promote urination; the combined effect is even better with moxibustion. Traditional Chinese medicine (TCM) hot compresses are a unique external treatment method in TCM, also known as TCM hot ironing. Its origins can be traced back to the pre-Qin period, boasting a long history. The "ironing" method recorded in the *Neijing* (Inner Canon of Medicine) refers to hot compresses. The efficacy of TCM hot compresses depends on the heat and the herbs inside. There are two common methods: dry and wet compresses. Dry compresses involve placing the herbs in a bag, heating it in a microwave, and then wrapping it in a towel before applying it externally, such as with mugwort and salt packs. Wet compresses often involve steaming or boiling the herbs before wrapping them in a sheet and applying them externally, such as with herbal compresses. This invention uses a dry hot compress method, combining the advantages of TCM hot compresses and acupoint stimulation. After heating, the hot compress opens up the skin texture, allowing the heat vapor to be absorbed through the skin. Through the conduction of acupoints and meridians, it directly reaches the affected area, relieving bladder sphincter spasms, promoting blood circulation, and thus achieving normal urination.

[0039] Traditional Chinese medicine (TCM) external treatments have a long history and unique advantages. As early as the *Neijing* (Inner Canon of Medicine), the importance of external treatments was evident, proposing the concept of "treating internal ailments internally and external ailments externally." Herbal hot compresses, as a form of thermotherapy, utilize the heat to allow the medicinal properties to evaporate and be applied to the affected area, or directly to the disease site through related meridians and acupoints. When the affected area and acupoints are heated, capillaries dilate, blood circulation accelerates, promoting efficient penetration of the herbal medicine, improving drug absorption and utilization. Furthermore, the skin-penetrating technique avoids the gastrointestinal irritation and "first-pass effect" of oral medications, thus achieving the effects of relaxing muscles and tendons, promoting qi and blood circulation, and clearing wind and unblocking the meridians, achieving the effect of treating internal diseases externally. In recent years, hot compresses, along with other therapies, have been widely used in various clinical treatments, such as postoperative recovery, meridian clearing and pain relief, and qi and dampness removal, covering many applications in internal medicine, gynecology, and pediatrics. Compared to traditional oral Chinese medicine, especially for patients who are weak or unable to take oral medication, it has the advantages of being simple, inexpensive, low-toxicity, and highly effective. Traditional Chinese medicine (TCM) hot compresses have a wide range of therapeutic effects. Combining them with acupuncture, acupressure, and oral TCM can further enhance their effectiveness. Numerous clinical studies have demonstrated the definite efficacy of hot compresses in treating postoperative urinary retention. Su Yanqin prepared a hot compress using a combination of Evodia rutaecarpa and coarse salt, which was then repeatedly applied to acupoints such as Shenque (CV8), Qihai (CV6), and Zhongji (CV3) to promote urination in patients with postoperative urinary retention after hemorrhoid surgery. The overall effective rate after treatment was as high as 97.5%, with some pain relief and a low incidence of adverse reactions. This invention utilizes TCM hot compresses to treat various urinary disorders. It is relatively simple to operate, requires only external application, has virtually no side effects, and represents a characteristic external treatment method of traditional Chinese medicine.

[0040] The coarsest powder described in this invention is consistent with the definition of coarsest powder in the "Explanatory Notes of the Chinese Pharmacopoeia, Part II", which refers to powder that can pass through the No. 1 sieve completely, but contains no more than 20% powder that can pass through the No. 3 sieve.

[0041] The inner diameter of the sieve openings of sieve No. 1 is 2000μm±70μm, and the inner diameter of the sieve openings of sieve No. 3 is 355μm±13μm.

[0042] Example 1

[0043] Weigh out 15 parts of Pyrrosia lingua, 30 parts of Sargentodoxa cuneata, 15 parts of Polygonum cuspidatum, 15 parts of Ligusticum chuanxiong, 15 parts of Liquidambar formosana, 12 parts of Foeniculum vulgare and 12 parts of Zingiber officinale according to the weight proportions. Grind them into the coarsest powder, mix them evenly, and pack them into non-woven bags at 60g per bag to prepare a traditional Chinese medicine hot compress preparation for later use.

[0044] Comparative Example 1

[0045] The only difference from Example 1 is that the weight parts of each drug are: 15 parts of Pyrrosia lingua, 15 parts of Sargentodoxa cuneata, 15 parts of Polygonum cuspidatum, 15 parts of Ligusticum chuanxiong, 15 parts of Liquidambar formosana, 15 parts of Foeniculum vulgare and 15 parts of Zingiber officinale.

[0046] Example 2

[0047] For patients with urinary obstruction caused by benign prostatic hyperplasia, the traditional Chinese medicine hot compress preparation provided in this invention was applied, and changes in symptom scores and urinary indicators were assessed.

[0048] 1. Case selection

[0049] 1.1 Diagnostic criteria

[0050] Western medicine diagnostic criteria: formulated with reference to the standards recommended by the International Scientific Committee of the International Advisory Committee on Benign Prostatic Hyperplasia and the "Guidelines for the Diagnosis and Treatment of Urological Diseases in China (2014 Edition)".

[0051] ① Symptoms: Difficulty urinating, urinary hesitancy, weak and thin urine stream, prolonged and labored urination, interrupted urine flow, urinary frequency, nocturia, and even urinary retention or incontinence; ② Digital rectal examination: Enlargement of both lobes of the prostate, shallowing or disappearance of the median sulcus, smooth surface without nodules, firm texture, no tenderness, moderate anal sphincter tension, and no blood staining during examination; ③ Ultrasound examination: Transrectal prostate ultrasound measurement, volume > 20 mL (calculated by the formula 0.52 × anteroposterior diameter × lateral diameter × superior-inferior diameter); ④ Uroflowmetry: Maximum urinary flow rate Qmax < 15 mL / s, urine volume > 150 mL; ⑤ Residual urine volume: Ultrasound examination to determine the presence of residual urine in the bladder, residual urine volume > 50 mL. If any of the following criteria are met, a diagnosis of benign prostatic hyperplasia (BPH) can be made.

[0052] Traditional Chinese Medicine (TCM) syndrome differentiation criteria: The cases selected in this study were based on the "TCM diagnostic and differentiation criteria for benign prostatic hyperplasia" in the "Guiding Principles for Clinical Research of New Chinese Medicine Drugs" of my country. (1) Primary symptoms: dribbling urination, increased frequency of nocturia; (2) Secondary symptoms: ① soreness and weakness of the waist and knees, aversion to cold and cold limbs, fatigue and weakness; ② thin urine stream, intermittent or dribbling; ③ lower abdominal fullness, distension or distending pain; ④ pale tongue, thin and weak pulse. If any of the above primary and secondary symptoms are present, benign prostatic hyperplasia (urinary retention and kidney yang deficiency syndrome) can be diagnosed.

[0053] 1.2 Inclusion Criteria

[0054] ① Male aged 50-80 years; ② Disease duration of more than three months, and no prior formal treatment for benign prostatic hyperplasia (BPH); ③ Meets the Western medicine diagnostic criteria and traditional Chinese medicine syndrome criteria for BPH; ④ International Prognostic Scoring System (IPSS) score ≥ 8 points; ⑤ Maximum urinary flow rate (Qmax) < 15 mL / s; ⑥ Prostate volume > 20 mL; ⑦ Able to adhere to treatment as required and agree to relevant follow-up; ⑧ Symptoms such as urinary frequency, urgency, and incomplete urination caused by BPH are significantly aggravated in winter compared to other seasons.

[0055] 1.3 Exclusion Criteria

[0056] ① Age <50 years or >80 years; ② Allergic to the study drug or with an allergic constitution; ③ Comorbid serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems, refractory diabetes and glycosuria; ④ Mental illness; ⑤ Difficulty urinating caused by neurogenic bladder, bladder neoplasms, bladder neck fibrosis, ureteral crest hypertrophy, seminal colliculus hypertrophy, urethral stricture; ⑥ Oliguria or anuria caused by urethral stones, prostate cancer, acute or chronic renal failure; ⑦ Patients who have had pelvic surgery or damage; ⑧ Patients currently taking medications that may affect bladder outlet function; ⑨ Serum prostaglandin-specific antigen (PSA) >10 ng / mL; ⑩ Failure to follow up with treatment as required.

[0057] 1.4 Basic Information

[0058] Fifty patients with benign prostatic hyperplasia who were treated in the outpatient and inpatient wards of the Department of Urology at Longhua Hospital between 2021 and 2023 were selected.

[0059] 2. Treatment methods

[0060] (1) Verify the doctor's orders, assess the patient, and provide explanations. Instruct the patient to take precautions against drafts and adjust the room temperature.

[0061] (2) Heating the Chinese medicine hot compress prepared in Example 1: Sprinkle 2mL of sterile water on the surface of the hot compress before operation. After the surface of the hot compress is slightly damp, put it in the microwave oven and heat it on low for about 2 minutes. The temperature of the hot compress should be 50℃-60℃.

[0062] (3) Prepare all necessary items (treatment tray, spray bottle, Chinese medicine pack, treatment towel or non-woven fabric, towel (bring your own), thermometer, fastening buckle, and if necessary, prepare blanket, gauze, screen, etc.) and bring them to the bedside.

[0063] (4) Take a supine position, expose the treatment area, and check the local skin condition again. If necessary, use a screen to shield the patient.

[0064] (5) Apply the heated herbal poultice to the designated acupoints (for urinary disorders: Guanyuan, Zhongji, Shuidao) and secure it with buckles as instructed by the doctor. Keep the poultice warm, observe the patient's skin reaction, and inquire about the patient's feelings. The temperature should be tolerable for the patient. If the temperature of the poultice is too low, replace it or reheat it. Each treatment session lasts approximately 20-30 minutes. After the treatment, the poultice can be moved along the abdominal pathways of the Du meridian, Kidney meridian, and Stomach meridian from top to bottom to the bladder and perineum, and repeatedly ironed 20-30 times. This can be done once a day. If the patient feels the urge to urinate during the treatment, they can be instructed to urinate in a squatting or sitting position while the poultice is secured with buckles.

[0065] (6) During the process of applying hot compresses with traditional Chinese medicine, pay attention to the color of the local skin and ask the patient about their temperature sensation.

[0066] (7) After the procedure, clean the local skin, help the patient put on clothes, and arrange a comfortable position. Instruct the patient to avoid wind and keep warm, and drink plenty of warm water.

[0067] Once a day for one month constitutes one course of treatment.

[0068] 3. Observation Items and Methods

[0069] 3.1 Observation Indicators

[0070] Therapeutic indicators: International Prostate Symptom Score (IPSS), Quality of Life (QOL), and Traditional Chinese Medicine syndrome score;

[0071] Safety indicators: General physical examination items: blood pressure and heart rate measurement; laboratory tests: routine blood and urine tests; electrocardiogram, liver function (ALT), and kidney function (BUN, Scr) tests.

[0072] 3.2 Efficacy Evaluation Criteria

[0073] Referring to the relevant diagnostic principles and severity criteria for benign prostatic hyperplasia in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" issued by the National Medical Products Administration, the condition was graded according to the improvement of indicators as clinically controlled, significantly effective, effective, and ineffective.

[0074] Clinical control: The main symptoms disappear and the syndrome score decreases by 90% or more.

[0075] Significant effect: Main symptoms disappear, and syndrome score decreases by 60-89%.

[0076] Effective: Major symptoms improved, and syndrome scores decreased by 30-59%.

[0077] Ineffective: The main symptoms and indicators show no significant changes or worsen, and the syndrome score decreases by less than 30%.

[0078] 3.3 Statistical Methods

[0079] After all clinical data were collected, a database was created. Statistical analysis was performed using the professional statistical software package SPSS 25.0. Quantitative data were expressed using the mean and standard deviation. For normally distributed data, an independent samples t-test is used for difference comparison. For non-normally distributed continuous data, the rank-sum test (Mann-Whitney U test) is used. For categorical data, the rank-sum test and chi-square test are used. Hypothesis testing is uniformly performed using two-tailed tests. The test statistic and its corresponding p-value are given, with p < 0.05 considered statistically significant.

[0080] 4. Results

[0081] 4.1 Case Completion Status

[0082] Fifty patients were observed one month after treatment, with two dropping out (lost to follow-up). Forty-eight patients underwent efficacy evaluation and completed follow-up one month after treatment. The main observation indicators were: a significant efficacy rate of 4.17%, an effective rate of 27.08%, and an ineffective rate of 68.75% in the 48 patients, with a total effective rate of 31.25%. Detailed results are shown in Table 1.

[0083] Table 1. Results of Clinical Efficacy Assessment

[0084]

[0085] One month after treatment, the International Prostate Symptom Score (IPSS), the impact of urinary symptoms on quality of life (QOL), and the TCM syndrome score all showed significant improvement compared to before treatment (P<0.05), as shown in Table 2.

[0086] Table 2 Summary of Symptom Scores

[0087]

[0088] Note: ▲ This indicates a P<0.05 comparison with pre-treatment values.

[0089] 4.2 Adverse event incidence

[0090] During the treatment, one patient in the treatment group experienced an adverse reaction due to itching, redness, and skin allergy at the application site; the adverse reaction rate was 2.08% (1 / 48). No significant changes were found in the blood pressure, heart rate, blood routine, kidney function, liver function, and electrocardiogram results before and after the treatment.

[0091] Experimental Conclusion: The traditional Chinese medicine hot compress treatment for benign prostatic hyperplasia provided by this invention can reduce IPSS scores, improve urinary symptoms, alleviate TCM symptoms, and has few side effects, demonstrating clinical safety and effectiveness. The traditional Chinese medicine hot compress preparation provided by this invention, combined with modern drug treatment for urinary disorders caused by chronic nonbacterial prostatitis, can more significantly relieve patients' pain, urinary frequency, urgency, and other urinary symptoms compared to using modern drugs alone, improving their quality of life, and is safe and effective.

[0092] Example 3

[0093] 1. Case selection

[0094] 1.1 Diagnostic criteria

[0095] The diagnostic criteria for chronic nonbacterial prostatitis refer to the relevant criteria of the National Institutes of Health (NIH) in the United States: ① Urinary abnormalities: urinary frequency, urgency, incomplete urination, or even dribbling; ② Aching and discomfort in the pelvic area, pain; ③ Prostate examination: the surface of the prostate is not smooth and asymmetrical, irregular nodules can be felt, and there is tenderness; ④ Laboratory tests: routine urine test is normal, bacterial culture of prostatic fluid is negative, and the white blood cell count in routine prostate examination is within the normal range (WBC ≤ 5 / HP).

[0096] The diagnosis of damp-heat stagnation syndrome in Traditional Chinese Medicine (TCM) is based on the standards in the "Expert Consensus on the Diagnosis and Treatment of Chronic Prostatitis with Integrated Traditional Chinese and Western Medicine" and the "Guidelines for the Diagnosis and Treatment of Chronic Prostatitis / Chronic Pelvic Pain Syndrome": post-void dribbling, burning and difficult urination, or perineal distension and discomfort, accompanied by distending or stabbing pain in the perineum, scrotum, testicles, etc., lower abdominal distension, and a thin, sometimes obstructed, dribbling urine stream. The tongue is red with dark petechiae, and sublingual veins are visible; the pulse is thready and rapid or choppy.

[0097] 1.2 Inclusion Criteria

[0098] ① Meets the above-mentioned Western medicine diagnostic criteria and traditional Chinese medicine syndrome diagnosis criteria; ② Male, aged 20-50 years; ③ This study has been reviewed and approved by the hospital's ethics committee, and the patients have signed informed consent forms.

[0099] 1.3 Exclusion Criteria

[0100] ① Patients with prostate tumors or benign prostatic hyperplasia; ② Patients with liver or kidney dysfunction or severe cardiovascular or cerebrovascular diseases; ③ Patients with poor compliance; ④ Patients with allergies or mental illnesses.

[0101] 1.4 General Information

[0102] The 90 cases in this embodiment were all from the Urology Department of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2023 to September 2024, and were clearly diagnosed with chronic nonbacterial prostatitis due to damp-heat stagnation syndrome. They were randomly divided into a treatment group and a control group, with 45 cases in each group. There were no statistically significant differences in the mean age and mean course of disease between the treatment group and the control group (P>0.05).

[0103] 2. Treatment methods

[0104] 2.1 Control Group

[0105] Tamsulosin Hydrochloride Extended-Release Capsules (Zhejiang Hailisheng Pharmaceutical Co., Ltd.; Batch No.: National Drug Approval Number H20020623) were administered orally, once daily, one capsule each time. The course of treatment was one month.

[0106] 2.2 Treatment Group

[0107] In addition to the treatment given to the control group, the traditional Chinese medicine hot compress preparation prepared in Example 1 was added for treatment. The detailed steps were the same as in "5. Treatment Method" of Example 2. The treatment was given once daily, with each treatment lasting approximately 20-30 minutes. The course of treatment was one month.

[0108] 3. Observation Items and Methods

[0109] 3.1 Clinical efficacy

[0110] After the treatment course, clinical efficacy was assessed according to the relevant standards in the "Expert Consensus on the Diagnosis and Treatment of Chronic Prostatitis with Integrated Traditional Chinese and Western Medicine" and the "Guidelines for the Diagnosis and Treatment of Chronic Prostatitis with Integrated Traditional Chinese and Western Medicine (Trial Version)". Traditional Chinese Medicine (TCM) symptom scoring criteria and efficacy evaluation criteria: A quantitative scoring table for TCM symptoms was developed based on Zheng Xiaoyu's "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" and the 2020 "Guidelines for the Diagnosis and Treatment of Chronic Prostatitis with Integrated Traditional Chinese and Western Medicine (Trial Version)". The TCM symptoms of both groups of patients were scored before and after treatment.

[0111] The primary symptoms (frequent and urgent urination, urethral burning, dribbling after urination, lower abdominal pain or discomfort, perineal pain or discomfort, lumbosacral pain or discomfort) and secondary symptoms (scrotal dampness, post-micturition dribbling, testicular pain) are both divided into four levels based on their frequency of occurrence. The primary symptoms are scored as 0, 2, 4, and 6 points respectively, and the secondary symptoms are scored as 0, 1, 2, and 3 points respectively. Detailed descriptions of the tongue and pulse are not included in the scoring.

[0112] Traditional Chinese Medicine (TCM) Symptom-Based Therapy Evaluation Criteria:

[0113] 1) Cured: The TCM symptoms have basically disappeared or completely disappeared, and the TCM symptom score has decreased by ≥95% compared with before treatment.

[0114] 2) Significant effect: TCM symptoms are significantly relieved, and the TCM syndrome score is reduced by ≥60% and <95% compared with before treatment;

[0115] 3) Effective: TCM symptoms are relieved, and the TCM syndrome score is reduced by ≥30% and <60% compared with before treatment;

[0116] 4) Ineffective: TCM symptoms do not improve or worsen, and the TCM syndrome score decreases by <30% compared to before treatment;

[0117] Formula for calculating therapeutic effect:

[0118] Therapeutic effect = [(Total TCM syndrome score before treatment - Total TCM syndrome score after treatment) / Total TCM syndrome score before treatment] × 100%.

[0119] 3.2 Chronic prostatitis symptom score (NIH-CPSI score)

[0120] Before and after treatment, the subjects' pain, urination, and quality of life were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Score Index (NIH-CPSI), and a total score was calculated.

[0121] 3.3 Routine Indicators of Prostatic Fluid

[0122] Prostatic fluid was collected from subjects before and after treatment for routine prostate examination and bacterial culture. Changes in white blood cell (WBC) and lecithin body (SPL) levels were recorded.

[0123] 3.4 Statistical Methods

[0124] The experimental data were statistically analyzed using SPSS 25.0 software. Quantitative data were presented as follows: For normally distributed data with homogeneous variances, a t-test is used; for non-normally distributed data, a t'-test is used. Ordinal data are analyzed using the rank-sum test. A p-value < 0.05 is considered statistically significant.

[0125] 4. Test Results

[0126] 4.1 Case Completion Status

[0127] Ninety patients were observed one month after treatment. Three patients in each of the treatment and control groups dropped out (lost to follow-up), and 84 patients completed follow-up after one month of treatment and underwent efficacy evaluation.

[0128] 4.2 Comparison of clinical efficacy

[0129] The total effective rates in the treatment group and the control group were 54.76% and 28.57%, respectively; the clinical efficacy in the treatment group was significantly better than that in the control group (P<0.05). See Table 3.

[0130] Table 3 Comparison of clinical efficacy between the two groups (cases)

[0131]

[0132] Note: * indicates that compared with the control group, P<0.05.

[0133] 4.3 Changes in NIP-CPSI scores

[0134] Within-group comparisons before and after treatment showed statistically significant differences in pain, urination, symptom-related quality of life scores, and total CPSI scores between the two groups (P < 0.05); between-group comparisons also showed statistically significant differences in pain, urination, quality of life scores, and total CPSI scores (P < 0.05). See Table 4.

[0135] Table 4 Comparison of NIH-CPSI scores between the treatment group and the control group ( )

[0136]

[0137] Note: * indicates P < 0.05 compared with the same group before treatment; # indicates P < 0.05 compared with the control group after treatment.

[0138] 4.4 Changes in routine indicators of prostatic fluid

[0139] Within-group comparisons before and after treatment showed statistically significant differences in WBC and SPL levels between the two groups (P < 0.05); between-group comparisons after treatment, the treatment group showed significantly better improvement in WBC and SPL levels than the control group (P < 0.05). See Table 3.

[0140] Table 5 Comparison of changes in routine indicators of prostatic fluid between the treatment group and the control group ( )

[0141]

[0142] Note: * indicates P < 0.05 compared with the same group before treatment; # indicates P < 0.05 compared with the control group after treatment.

[0143] During the treatment period, 3 patients in each of the treatment and control groups experienced orthostatic hypotension. The side effects were relieved after the patient was instructed to take the medication. One patient in the treatment group experienced itching, redness, and skin allergy at the application site. The adverse reaction rate was 2.38% (1 / 42).

[0144] The experimental results in this embodiment show that the traditional Chinese medicine hot compress preparation provided by the present invention, combined with modern drug treatment for urinary disorders caused by chronic nonbacterial prostatitis, can more significantly relieve patients' urinary symptoms such as pain, urinary frequency, and urinary urgency, and improve their quality of life compared with the use of modern drugs alone. It is safe and effective.

[0145] Example 4

[0146] The efficacy of the traditional Chinese medicine hot compress preparation prepared in Example 1 was compared with that of the traditional Chinese medicine hot compress preparation prepared in Comparative Example 1. The experiment is as follows:

[0147] 1. Materials and Methods

[0148] 1.1 General Information

[0149] Ninety middle-aged and elderly male patients who underwent surgical treatment for mixed hemorrhoids between 2019 and 2020 were randomly divided into two groups of 45 each. The control group consisted of 45 males aged 45 to 60 years, with a mean age of (51.9 ± 6.4) years; the experimental group consisted of 45 males aged 45 to 64 years, with a mean age of (53.1 ± 6.2) years. All patients agreed to undergo surgical treatment. Data such as age were entered into the software, and there were no significant differences (P > 0.05).

[0150] 1.2 Treatment methods

[0151] The control group received the initial version of the herbal hot compress preparation from Comparative Example 1, while the experimental group received the herbal hot compress preparation from Example 1. The relevant procedures for hot compress were the same as in "2. Treatment Method" of Example 2. The procedures were consistent in preventing urinary retention. Postoperatively, close observation of rectal bleeding was necessary. If symptoms such as palpitations, pale complexion, or rapid and weak pulse were observed, the doctor should be informed immediately. At the same time, the patient should be assisted to assume a lateral decubitus position after the operation to prevent pressure on the wound and aggravation of pain. The head of the bed should be appropriately elevated to reduce abdominal muscle tension, increase bladder pressure, and promote spontaneous urination.

[0152] In addition, apply warm compresses, instruct the patient to keep the anus clean, and advise them to eat easily digestible foods, quit smoking and drinking, and avoid eating spicy foods.

[0153] 1.3 Observation indicators: The time to first urination, postoperative urinary retention indicators and satisfaction were compared between the groups. The satisfaction assessment was conducted using a satisfaction survey scale developed by our hospital. The scale had a full score of 100 points. Very satisfied: score >70 points, satisfied: score 40-70 points, dissatisfied: score <40 points. The sum of the very satisfied rate and the satisfied rate was used to represent the satisfaction result after the survey.

[0154] 1.4 Statistical methods: SPSS 19.0 statistical software was used. Quantitative data were expressed as mean expressed according to standard deviation. Data expressed as percentages (%) were compared between groups using a t-test. A p-value < 0.05 indicated a statistically significant difference.

[0155] 2. Results

[0156] 2.1 Comparison of first urination time between the two groups: The first urination time in the experimental group was (173.3±78.4) min, which was shorter than that in the control group (202.7±85.9) min, and the difference was significant (P<0.05).

[0157] 2.2 Comparison of the incidence of urinary retention: The incidence of urinary retention in the control group was 15.56% (7 / 45), which was higher than that in the experimental group (8.89% (4 / 45), but the difference was not statistically significant (P>0.05).

[0158] 2.3 Comparison of satisfaction survey results: The satisfaction rate of the experimental group was 68.9%, which was significantly higher than that of the control group (46.7%) (P<0.05), as shown in Table 6.

[0159] Table 6. Results of the Satisfaction Survey

[0160] Group Number of examples Very satisfied satisfy Dissatisfied Satisfaction rate (%) Experimental group (Example 1) 45 17 14 14 68.9* Control group (Comparative Example 1) 45 16 5 24 46.7 <![CDATA[X 2 ]]> 6.925 P 0.031

[0161] Conclusion: Compared with the original equal drug ratio, the drug ratio of the present invention can shorten the postoperative urination time and increase patient satisfaction, indicating that the ratio is more optimized.

[0162] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A pharmaceutical composition for treating urinary disorders, characterized in that, By weight, it consists of the following components: 15 parts of Pyrrosia lingua, 30 parts of Sargentodoxa cuneata, 15 parts of Polygonum cuspidatum, 15 parts of Ligusticum chuanxiong, 15 parts of Liquidambar formosana, 12 parts of Foeniculum vulgare and 12 parts of Zingiber officinale.

2. Use of the pharmaceutical composition as described in claim 1 in the preparation of a medicament for treating urinary disorders.

3. The application as described in claim 2, characterized in that, The urinary obstruction is caused by prostate disease or surgical treatment.

4. The application as described in claim 3, characterized in that, The prostate disease mentioned is benign prostatic hyperplasia or chronic nonbacterial prostatitis.

5. A drug for treating urinary disorders, characterized in that, The sole active ingredient of the drug is the pharmaceutical composition as described in claim 1.

6. The drug as described in claim 5, characterized in that, It also includes pharmaceutically acceptable excipients.

7. The drug as described in claim 5 or 6, characterized in that, The dosage form of the drug is a traditional Chinese medicine hot compress preparation.

8. A method for preparing a traditional Chinese medicine hot compress preparation for treating urinary disorders, characterized in that, include: Weigh out the pharmaceutical composition according to the parts by weight, pulverize them into the coarsest powder, mix them evenly, and obtain a mixed powder. Pack the medicine into bags to obtain the traditional Chinese medicine hot compress preparation.

9. The preparation method according to claim 8, characterized in that, The bagging process involves packing the mixed powder into non-woven bags at a specification of 60 g / bag.

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