Composition for treating prostatitis, frequent micturition, urgent urination and anuresis as well as preparation method and application of composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating prostatitis, frequent urination, urgent urination and anuresis, and belongs to the technical field of traditional Chinese medicines. The composition is prepared from the following raw materials in parts by weight: 3-10 parts of Chinese prickly ash, 4-20 parts of radix clematidis, 2-18 parts of mineral salt, 3-8 parts of calcined escargots and 3-22 parts of sedum sarmentosum. The invention also discloses a preparation method and application of the compound. The traditional Chinese medicine composition is simple in formula, has the effects of warming and activating meridians, softening hardness to dissipate stagnation, clearing heat and promoting diuresis and relieving swelling and pain by being applied to the navel (Shenque acupoint), and is used for treating prostatitis and related urinary system symptoms. The traditional Chinese medicine is quick in effect, short in treatment course, definite in curative effect, green, safe, free of side effects, convenient to use and low in cost, and provides an excellent external treatment choice for patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating prostatitis, urinary frequency, urgency, and urinary retention. Background Technology

[0002] Prostatitis is a common and frequently occurring disease in adult men, especially chronic prostatitis, which has a prolonged course and is prone to relapse. Clinical manifestations mainly include urinary frequency, urgency, dysuria, urinary hesitancy, urinary stream splitting, and perineal distending pain, severely impacting patients' quality of life. Currently, Western medicine treatment primarily relies on antibiotics, alpha-blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs), but these methods suffer from problems such as drug resistance, significant side effects, and a high relapse rate. Traditional Chinese medicine (TCM) treatment for prostatitis often uses oral decoctions, which, while having some efficacy, has drawbacks such as long treatment courses, poor patient adherence, and potential damage to the spleen and stomach from some medications. Summary of the Invention

[0003] In view of the above-mentioned technical deficiencies, the purpose of this invention is to provide a traditional Chinese medicine composition for treating prostatitis, urinary frequency, urgency and urinary retention, so as to treat prostatitis and related urinary system symptoms.

[0004] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: The present invention provides a traditional Chinese medicine composition for treating prostatitis, urinary frequency, urgency, and urinary retention, comprising the following raw materials in parts by weight: 3-10 parts Sichuan peppercorns; Clematis chinensis 4-20 parts; 2-18 parts of mineral salt; 3-8 parts of calcined snails; Sedum sarmentosum 3-22 parts.

[0005] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-8 parts of Sichuan pepper, 8-15 parts of Clematis chinensis, 5-12 parts of mineral salt, 4-6 parts of calcined river snail, and 8-18 parts of Sedum sarmentosum.

[0006] More preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6 parts Sichuan pepper, 12 parts Clematis chinensis, 8 parts mineral salt, 5 parts calcined river snail, and 15 parts Sedum sarmentosum.

[0007] The above-mentioned method for calcining snails is as follows: Take a clean snail shell, place it in a smokeless furnace or crucible, calcine it over a high flame until it turns red-hot, remove it, let it cool, and grind it into fine powder.

[0008] Another object of the present invention is to provide a method for preparing the traditional Chinese medicine composition, comprising the following steps: (1) Weigh each raw material according to the above weight proportions; (2) After drying Sichuan pepper, Clematis chinensis and Sedum sarmentosum, pulverize them and pass them through an 80-120 mesh sieve to obtain medicinal powder A; (3) Grind the mineral salt into a fine powder to obtain powder B; (4) After the snails are calcined according to the above method, they are crushed and passed through an 80-120 mesh sieve to obtain medicinal powder C; (5) Mix powder A, powder B and powder C evenly to obtain the Chinese medicine composition.

[0009] Another objective of this invention is to provide a method of using the aforementioned traditional Chinese medicine composition: Before use, take an appropriate amount of the above-mentioned mixed powder, mix it with warm water, tea, or a small amount of medical petroleum jelly / honey to form a paste of suitable consistency, apply it to the patient's navel (Shenque acupoint), and secure it with medical tape or a breathable dressing. Change the dressing once a day, preferably at night and remove it the next morning. A course of treatment is 7 days, and generally 1-3 courses of treatment are used.

[0010] The beneficial effects of this invention are as follows: Firstly, this composition has a simple formula and scientific compatibility. It can be quickly absorbed through umbilical application. Targeting the pathogenesis of "damp-heat stagnation" in prostatitis, it exerts the effects of warming the meridians and promoting blood circulation, softening and dispersing nodules, and clearing heat and dampness. As a result, it takes effect quickly, significantly improves symptoms such as frequent urination and urgency, and can effectively eliminate inflammation, promote tissue repair, and has a stable curative effect with low recurrence rate.

[0011] Secondly, this invention uses pure natural medicinal materials, applied topically through the skin without passing through the gastrointestinal tract, thus completely avoiding the gastrointestinal irritation and potential liver and kidney damage commonly associated with oral medications, resulting in high safety. At the same time, the method is simple to operate and inexpensive, greatly reducing the economic and psychological burden on patients. Detailed Implementation

[0012] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0013] Example 1: Weigh out 6g of Sichuan pepper, 12g of Clematis chinensis, 8g of mineral salt, 5g of calcined river snail, and 15g of Sedum sarmentosum. Dry the Sichuan pepper, Clematis chinensis, and Sedum sarmentosum, then pulverize them through a 100-mesh sieve; grind the mineral salt into powder; mix all the above powders evenly with the calcined river snail powder, and seal for storage. When using, take 5g of the powder, mix it with warm tea to form a paste, apply it to the navel, and secure it with adhesive tape, once every night.

[0014] Example 2: Weigh out 3g of Sichuan pepper, 20g of Clematis chinensis, 2g of mineral salt, 8g of calcined snails, and 3g of Sedum sarmentosum. The preparation and usage methods are the same as in Example 1.

[0015] Example 3: Weigh out 10g of Sichuan pepper, 4g of Clematis chinensis, 18g of mineral salt, 3g of calcined snails, and 22g of Sedum sarmentosum. The preparation and usage methods are the same as in Example 1.

[0016] Compare with Example 1: Weigh out 6g of Sichuan pepper, 12g of Clematis chinensis, 8g of mineral salt, and 15g of Sedum sarmentosum. (Calcinated snails are missing.) The preparation and usage methods are the same as in Example 1.

[0017] Compare with Example 2: Weigh out 6g of Sichuan pepper, 12g of Clematis chinensis, 5g of calcined snails, and 15g of Sedum sarmentosum. (Mineral salts are missing). The preparation and usage methods are the same as in Example 1.

[0018] Compare with Example 3: Weigh out 8g of mineral salt, 5g of calcined snails, and 15g of Sedum sarmentosum. (Sichuan pepper and Clematis chinensis are missing). The preparation and usage methods are the same as in Example 1.

[0019] Experimental Example 1: Study on the anti-inflammatory effect on experimentally induced prostatitis in rats Experimental materials: Animals: 60 healthy male SD rats, weighing 200±20g.

[0020] Drugs: The powder prepared in Example 1 of this invention; indomethacin enteric-coated tablets (positive control); carrageenan (inflammatory agent).

[0021] Reagents and instruments: physiological saline, electronic balance, vernier caliper, rat gavage device, etc.

[0022] Experimental steps: Grouping and Model Establishment: Rats were randomly divided into 6 groups of 10 rats each: blank control group, model control group, positive control group (indomethacin, 10 mg / kg / d), low-dose group of Example 1 (powder 1 g / kg / d, mixed into a paste and administered by gavage), medium-dose group of Example 1 (powder 2 g / kg / d), and high-dose group of Example 1 (powder 4 g / kg / d). Except for the blank control group, after anesthesia, 25 μl of 1% carrageenan saline solution was injected into the dorsal lobe of the prostate gland in all other groups to establish a prostatitis model.

[0023] Administration: Administration began 24 hours after model establishment. The positive control group was administered the drug paste by gavage. In Example 1, each dosage group was administered the drug paste by gavage according to the dosage (simulating the absorption of the active pharmaceutical ingredient). The blank group and the model group were administered an equal volume of physiological saline by gavage. Once daily for 7 consecutive days.

[0024] Indicator detection: One hour after the last administration, the rats were sacrificed and the prostate tissue was harvested.

[0025] Prostate wet weight and index: Weigh the prostate wet weight and calculate the prostate index (mg / 100g body weight).

[0026] Histopathological scoring: After hematoxylin and eosin (HE) staining, prostate tissue is observed under a light microscope to detect inflammatory cell infiltration, interstitial edema, etc., and a double-blind pathological scoring is performed (0-3 points, with higher scores indicating more severe inflammation).

[0027] Experimental results (table): Table 1. Effects of the composition of the present invention on experimental prostatitis in rats (x±s, n=10) Note: Compared with the control group, **P<0.01; compared with the model group, #P<0.05, ##P<0.01.

[0028] Conclusion: The composition of Example 1 of the present invention can significantly reduce the wet weight, index and pathological score of the prostate in rats with prostatitis in a dose-dependent manner, indicating that it has a good anti-prostate inflammation effect.

[0029] Experimental Example 2: Study on the inhibitory effect on a mouse model of urinary frequency and urgency Experimental materials: Animals: 50 male ICR mice, weighing 18-22g.

[0030] Drugs: Powder from Example 1 of this invention; Flavoviryl hydrochloride tablets (positive control); physiological saline; diuretic experimental apparatus.

[0031] Experimental steps: Grouping and Administration: Mice were randomly divided into 5 groups of 10 mice each: normal control group, model control group, positive control group (flavonoids, 20 mg / kg / d), Example 1 group (powder 2 g / kg / d, mixed into a paste and administered by gavage), and Control 1 group (powder 2 g / kg / d). Except for the normal control group, the other groups were administered 0.5% ammonium chloride solution (20 ml / kg) by gavage to establish a urinary frequency model. Each treatment group received the corresponding drug at the prescribed dosage, while the normal control group and model group received an equal volume of physiological saline, once daily for 5 consecutive days.

[0032] Observation of urination behavior: 30 minutes after administration, mice in each group were placed in metabolic cages. After 1 hour of acclimatization, the number of urinations and total urine volume of each mouse were collected and recorded over the next 6 hours.

[0033] Calculate the average single urine volume: Total urine volume / Number of urinations.

[0034] Experimental results (table): Table 2. Effects of the composition of the present invention on urination behavior in mice with urinary frequency model (x±s, n=10) Note: Compared with the normal group, **P<0.01; compared with the model group, #P<0.05, ##P<0.01.

[0035] Conclusion: The composition of Example 1 of this invention can significantly reduce the frequency of urination in model mice and increase the average amount of urine per urination, indicating that it can effectively improve the symptoms of urinary frequency and urgency. The control example 1 (lacking calcined snails) was significantly less effective than Example 1, indicating that calcined snails are indispensable in this formula.

[0036] Experiment Example 3: Clinical Efficacy Observation Experiment General Information: 120 outpatients meeting the diagnostic criteria for chronic prostatitis (NIH-CP type II) were randomly divided into a treatment group (Example 1 of this invention) and a control group (oral tamsulosin hydrochloride capsules), with 60 patients in each group. There were no statistically significant differences between the two groups in terms of age, disease duration, and disease severity (P>0.05).

[0037] Treatment methods: Treatment group: The powder prepared according to Example 1 of this invention was used. 5g of the powder was taken before bedtime each night, mixed with honey to form a paste, and applied to the navel. It was removed in the morning. This was done once daily for 4 weeks as one course of treatment.

[0038] Control group: Oral administration of tamsulosin hydrochloride capsules (0.2 mg / time), once nightly, for 4 weeks.

[0039] Observation indicators and efficacy criteria: NIH-CPSI score: The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score was performed before and after treatment, including three parts: pain symptoms, urinary symptoms, and impact on quality of life.

[0040] Clinical efficacy evaluation criteria: Cure: NIH-CPSI total score reduced by ≥90%, symptoms and signs disappear.

[0041] Significant effect: NIH-CPSI total score decreased by 60%-89%, and symptoms and signs were significantly improved.

[0042] Effective: NIH-CPSI total score decreased by 30%-59%, and symptoms and signs improved.

[0043] Ineffective: NIH-CPSI total score decreases by <30%, and symptoms and signs do not improve or worsen.

[0044] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0045] Experimental results (table): Table 3 Comparison of NIH-CPSI scores before and after treatment in the two groups (x±s, points) Note: For comparisons within the same group before and after treatment, **P<0.01; for comparisons between groups after treatment, ##P<0.01.

[0046] Table 4 Comparison of clinical efficacy between the two groups of patients Note: According to the chi-square test, the total effective rate in the treatment group was significantly higher than that in the control group (P<0.05).

[0047] Conclusion: Clinical observation shows that applying the herbal composition from Example 1 of this invention to the umbilicus to treat chronic prostatitis can significantly reduce the NIH-CPSI score of patients. It is superior to the oral tamsulosin control group in relieving pain and urinary symptoms, and the overall clinical effective rate is higher, which confirms that this invention has good clinical efficacy and safety.

[0048] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition for treating prostatitis, urinary frequency, urgency, and urinary retention, characterized in that, The ingredients include the following parts by weight: 3-10 parts Sichuan pepper, 4-20 parts Clematis chinensis, 2-18 parts mineral salt, 3-8 parts calcined snail, and 3-22 parts Sedum sarmentosum.

2. The traditional Chinese medicine composition for treating prostatitis, urinary frequency, urgency, and urinary retention as described in claim 1, characterized in that, The ingredients include the following parts by weight: 5-8 parts Sichuan pepper, 8-15 parts Clematis chinensis, 5-12 parts mineral salt, 4-6 parts calcined snail, and 8-18 parts Sedum sarmentosum.

3. A traditional Chinese medicine composition for treating prostatitis, urinary frequency, urgency, and urinary retention as described in claim 1 or 2, characterized in that, The ingredients include the following parts by weight: 6 parts Sichuan pepper, 12 parts Clematis chinensis, 8 parts mineral salt, 5 parts calcined snails, and 15 parts Sedum sarmentosum.

4. The method for preparing a traditional Chinese medicine composition for treating prostatitis, urinary frequency, urgency, and urinary retention as described in claim 1, characterized in that, Includes the following steps: Sichuan pepper, Clematis chinensis, and Sedum sarmentosum are dried and pulverized to obtain medicinal powder A; mineral salt is ground to obtain medicinal powder B. The snails were calcined and then pulverized to obtain medicinal powder C; medicinal powder A, medicinal powder B and medicinal powder C were mixed evenly.

5. A traditional Chinese medicine composition for treating prostatitis and urinary frequency, urgency, and urinary retention as described in any one of claims 1-3, characterized in that, This medication is used to treat prostatitis and / or improve symptoms such as frequent urination, urgency, hesitancy, urinary retention, and nocturia.

6. The traditional Chinese medicine composition for treating prostatitis, urinary frequency, urgency, and urinary retention as described in claim 5, characterized in that, The drug is in the form of an external umbilical application.

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