Traditional Chinese medicine composition for treating chronic prostatitis and preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic prostatitis and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following components in parts by weight: 15-35 parts of polygonum capitatum, 15-30 parts of polygonum cuspidatum, 15-35 parts of rhizoma smilacis glabrae, 10-30 parts of plantain herb, 5-20 parts of fructus kochiae, 5-20 parts of winged euonymus twig, 5-20 parts of turtle shell, 1-5 parts of leech, 5-20 parts of lithospermum, 5-20 parts of artemisia anomala, 5-20 parts of loofah sponge, 5-20 parts of fructus aurantii, 5-20 parts of Chinese waxgourd seed, 5-20 parts of geranium wilfordii, 5-20 parts of chinaroot greenbrier and 5-20 parts of herba epimedii. , 5-20 parts of cowherb seed and 1-10 parts of amber. The traditional Chinese medicine composition has a good treatment effect on chronic prostatitis caused by damp-heat stasis and can effectively solve the problems of existing western medicines.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating chronic prostatitis, a preparation method thereof and an application thereof. Background Art

[0002] Chronic prostatitis is a common and frequently-occurring male reproductive system disease with clinical manifestations of chronic recurrent abnormal urination (such as frequent urination, urgency of urination, dysuria, etc.) and dull pain and discomfort in the pelvic region, often accompanied by sexual function and even fertility disorders. With the increasing social pressure and accelerating pace of life in today's society, the incidence of this disease is continuously tending to increase. Most cases of chronic prostatitis clinically show a chronic course, characterized by slow onset, repeated attacks, complex conditions, numerous symptoms, and protracted and difficult to cure. Although it does not threaten life, it seriously affects the physical and mental health and quality of life of patients.

[0003] At present, the pathological mechanism of chronic prostatitis has not been clearly defined. Western medicine treatment mostly uses drugs such as antibiotics, non-steroidal anti-inflammatory analgesics, and α-receptor blockers. However, such drug treatments have disadvantages such as high adverse reaction rates, easy drug resistance, and easy recurrence. Traditional Chinese medicine treatment of this disease pays attention to the overall concept and individual differences, and adopts the method of combining syndrome differentiation and disease differentiation, with the characteristics of significant curative effect, not easy to relapse, and low adverse reaction rate. Combining with western medicine treatment can shorten the course of treatment and other advantages, and can significantly improve the quality of life of patients. Summary of the Invention

[0004] In view of the above deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for treating chronic prostatitis, a preparation method thereof and an application thereof. This traditional Chinese medicine composition has a good therapeutic effect on chronic prostatitis caused by damp-heat stasis obstruction, and can effectively solve the problems existing in existing western medicines.

[0005] To achieve the above object, the technical solution adopted by the present invention to solve its technical problems is:

[0006] A traditional Chinese medicine composition for treating chronic prostatitis, comprising the following components in parts by weight: 15 - 35 parts of Polygonum capitatum Buch.-Ham., 15 - 30 parts of Polygonum cuspidatum Sieb. et Zucc., 15 - 35 parts of Smilax glabra Roxb., 10 - 30 parts of Plantago asiatica L., 5 - 20 parts of Kochia scoparia (L.) Schrad., 5 - 20 parts of Euonymus alatus (Thunb.) Sieb., 5 - 20 parts of Carapax Trionycis, 1 - 5 parts of Hirudo, 5 - 20 parts of Lithospermum erythrorhizon Sieb. et Zucc., 5 - 20 parts of Artemisia anomala S. Moore, 5 - 20 parts of Fructus Hordei Germinatus, 5 - 20 parts of Fructus Aurantii Immaturus, 5 - 20 parts of Semen Benincasae, 5 - 20 parts of Geranium wilfordii Maxim., 5 - 20 parts of Smilax china L., 5 - 20 parts of Epimedium brevicornu Maxim., 5 - 20 parts of Semen Vaccariae, and 1 - 10 parts of Succinum.

[0007] Furthermore, it includes the following components in parts by weight: 20-25 parts of Polygonum capitatum, 20-25 parts of Polygonum cuspidatum, 20-25 parts of Smilax glabra, 18-25 parts of Plantago asiatica, 10-15 parts of Kochia scoparia, 10-15 parts of Euonymus alatus, 10-15 parts of Carapax Trionycis, 2-4 parts of Hirudo, 10-15 parts of Lithospermum erythrorhizon, 10-15 parts of Herba Artemisiae Anomalae, 10-15 parts of Retinervus Luffae Fructus, 10-15 parts of Fructus Aurantii, 10-15 parts of Semen Benincasae, 10-15 parts of Geranium wilfordii, 10-15 parts of Smilax china, 10-15 parts of Epimedium brevicornu, 10-15 parts of Semen Vaccariae and 4-8 parts of Succinum.

[0008] Furthermore, it includes the following components in parts by weight: 20 parts of Polygonum capitatum, 25 parts of Polygonum cuspidatum, 25 parts of Smilax glabra, 18 parts of Plantago asiatica, 15 parts of Kochia scoparia, 15 parts of Euonymus alatus, 10 parts of Carapax Trionycis, 2 parts of Hirudo, 15 parts of Lithospermum erythrorhizon, 10 parts of Herba Artemisiae Anomalae, 10 parts of Retinervus Luffae Fructus, 15 parts of Fructus Aurantii, 10 parts of Semen Benincasae, 15 parts of Geranium wilfordii, 10 parts of Smilax china, 15 parts of Epimedium brevicornu, 15 parts of Semen Vaccariae and 4 parts of Succinum.

[0009] Furthermore, it includes the following components in parts by weight: 25 parts of Polygonum capitatum, 20 parts of Polygonum cuspidatum, 20 parts of Smilax glabra, 25 parts of Plantago asiatica, 10 parts of Kochia scoparia, 10 parts of Euonymus alatus, 15 parts of Carapax Trionycis, 4 parts of Hirudo, 10 parts of Lithospermum erythrorhizon, 15 parts of Herba Artemisiae Anomalae, 15 parts of Retinervus Luffae Fructus, 10 parts of Fructus Aurantii, 15 parts of Semen Benincasae, 10 parts of Geranium wilfordii, 15 parts of Smilax china, 10 parts of Epimedium brevicornu, 10 parts of Semen Vaccariae and 8 parts of Succinum.

[0010] Furthermore, it includes the following components in parts by weight: 24 parts of Polygonum capitatum, 22 parts of Polygonum cuspidatum, 23 parts of Smilax glabra, 22 parts of Plantago asiatica, 13 parts of Kochia scoparia, 13 parts of Euonymus alatus, 13 parts of Carapax Trionycis, 3 parts of Hirudo, 13 parts of Lithospermum erythrorhizon, 13 parts of Herba Artemisiae Anomalae, 13 parts of Retinervus Luffae Fructus, 13 parts of Fructus Aurantii, 13 parts of Semen Benincasae, 13 parts of Geranium wilfordii, 13 parts of Smilax china, 14 parts of Epimedium brevicornu, 14 parts of Semen Vaccariae and 6 parts of Succinum.

[0011] Furthermore, the Carapax Trionycis is prepared as Carapax Trionycis Rubrus, the Fructus Aurantii is prepared as Fructus Aurantii Praeparatus, the Semen Benincasae is prepared as Semen Benincasae Praeparatum, the Epimedium brevicornu is prepared as Epimedium brevicornu Praeparatum, and the Semen Vaccariae is prepared as Semen Vaccariae Praeparatum.

[0012] The preparation method of the above-mentioned traditional Chinese medicine composition for treating chronic prostatitis includes the following steps: crushing and mixing the raw materials; or preparing from the extracts obtained by mixing or separately extracting the raw materials; or preparing from the active ingredients obtained by further refining and purifying the extracts; or preparing by adding pharmaceutically acceptable excipients to the extracts / active ingredients.

[0013] Furthermore, the dosage form prepared is one of pills, granules, capsules, powders, mixtures, tablets, infusions or oral liquids.

[0014] Further, the specific preparation method is as follows: Among the above eighteen herbs, nine herbs including polygonum cuspidatum, smilax glabra, turtle shell, leech, fructus aurantii, lithospermum erythrorhizon, smilax china, epimedium, and succinum are pulverized into fine powder, screened, and mixed evenly for standby; the remaining nine herbs including polygonum capitatum, plantain herb, Kochia scoparia, winged euonymus, artemisia anomala, luffa cylindrica, semen benincasae, geranium wilfordii, and stir-fried semen vaccaria are added with water, decocted, and the filtrates are combined, filtered, and the filtrate is concentrated into an extract, which is mixed evenly with the above-mentioned fine powder, dried, pulverized into fine powder, made into pills, and dried to obtain the product.

[0015] Use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating chronic prostatitis.

[0016] The beneficial effects produced by the present invention are as follows:

[0017] In the present invention, polygonum capitatum has the effects of clearing heat and promoting diuresis, detoxifying and relieving stranguria, directly attacking the damp-heat in the lower jiao; polygonum cuspidatum has the effects of clearing heat and detoxifying, promoting diuresis and relieving stranguria, and also has the effect of promoting blood circulation; smilax glabra has the effect of promoting diuresis and detoxifying. The above are the monarch herbs in total, and play the main therapeutic role by clearing heat and detoxifying, and promoting diuresis;

[0018] Plantain herb and Kochia scoparia have the effects of promoting diuresis and relieving stranguria, and can guide damp-heat to be excreted through urine; winged euonymus, leech, and artemisia anomala have the effects of promoting blood circulation to remove blood stasis, breaking blood stasis and removing stasis. When used in combination, they can improve local blood stasis in the prostate and promote blood circulation; turtle shell has the effects of softening hardness and dissipating nodules, nourishing yin and suppressing yang, and can effectively prevent the yin from being damaged by diuretic herbs. The above are the ministerial herbs in total, and assist in improving the therapeutic effect through the effect of promoting blood circulation to remove blood stasis;

[0019] Lithospermum erythrorhizon has the effect of cooling blood and detoxifying, and can prevent damp-heat from turning into fire and injuring collaterals; luffa cylindrica and fructus aurantii have the effects of dredging meridians, promoting qi movement, and assisting the medicinal power to reach the affected area; semen benincasae, geranium wilfordii, and smilax china have the effects of promoting diuresis and discharging pus, expelling wind and removing dampness, and assisting in clearing damp-heat stasis and toxin; epimedium has the effect of warming and tonifying the kidney yang, balancing the cold nature of the medicine, and strengthening the body to prevent damage to healthy qi. The above herbs are the adjuvant herbs in total; semen vaccaria has the effects of dredging meridians and collaterals, promoting diuresis and relieving stranguria, and guiding various herbs to act downward, promoting the active ingredients of the medicine to reach the prostate to play a role; succinum has the effects of calming the mind and promoting diuresis, and also has the effect of relieving pain and anxiety. The above herbs are the messenger herbs in total;

[0020] In the present invention, the medicinal flavors in the formula cooperate with each other synergistically, complement each other, and jointly play a therapeutic role against complex etiologies such as damp-heat, blood stasis, kidney deficiency, and qi stagnation, and have a good therapeutic effect on chronic prostatitis caused by damp-heat stasis obstruction. Specific Embodiments

[0021] In order to make the purpose, technical solutions and advantages of the present invention clearer, the following further elaborates on the present invention in combination with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention, and are not used to limit the present invention, that is, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments.

[0022] Accordingly, the following detailed description of the provided embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0023] It should be noted that relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprising", "including" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "comprising one..." does not exclude the existence of additional identical elements in the process, method, article or device including the element.

[0024] The features and properties of the present invention will be further described in detail below in conjunction with embodiments.

[0025] Example 1

[0026] A traditional Chinese medicine composition for treating chronic prostatitis is composed of the following components in parts by weight: 24 parts of Polygonum capitatum, 22 parts of Polygonum cuspidatum, 23 parts of Smilax glabra, 22 parts of Plantago asiatica, 13 parts of Kochia scoparia, 13 parts of Euonymus alatus, 13 parts of turtle shell stir-fried with vinegar, 3 parts of Hirudo, 13 parts of Lithospermum erythrorhizon, 13 parts of Artemisia anomala, 13 parts of Luffa cylindrica, 13 parts of Fructus Aurantii stir-fried with bran, 13 parts of semen benincasae stir-fried, 13 parts of Geranium wilfordii, 13 parts of Smilax china, 14 parts of Epimedium stir-fried with honey, 14 parts of semen vaccariae stir-fried and 6 parts of succinum.

[0027] The preparation method of the above traditional Chinese medicine composition is as follows: of the above eighteen herbs, nine herbs including Polygonum cuspidatum, Smilax glabra, turtle shell stir-fried with vinegar, Hirudo, Fructus Aurantii stir-fried with bran, Lithospermum erythrorhizon, Smilax china, Epimedium stir-fried with honey and succinum are pulverized into fine powder, sieved, mixed evenly and reserved; the remaining nine herbs including Polygonum capitatum, Plantago asiatica, Kochia scoparia, Euonymus alatus, Artemisia anomala, Luffa cylindrica, semen benincasae stir-fried, Geranium wilfordii and semen vaccariae stir-fried are added with 12 times the amount of water, decocted twice, each time for 1.5 h, the filtrates are combined, filtered, and the filtrate is concentrated into an extract with a relative density of 1.2, mixed evenly with the above fine powder, dried, pulverized into fine powder, made into pills and dried to obtain the product.

[0028] Example 2

[0029] A traditional Chinese medicine composition for treating chronic prostatitis, which is composed of the following components in parts by weight: 25 parts of Polygonum capitatum, 20 parts of Polygonum cuspidatum, 20 parts of Smilax glabra, 25 parts of Plantago asiatica, 10 parts of Kochia scoparia, 10 parts of Euonymus alatus, 15 parts of vinegar-processed turtle shell, 4 parts of Hirudo, 10 parts of Lithospermum erythrorhizon, 15 parts of Artemisia anomala, 15 parts of Luffa cylindrica, 10 parts of stir-fried Fructus Aurantii, 15 parts of stir-fried Benincasa hispida seeds, 10 parts of Geranium wilfordii, 15 parts of Smilax china, 10 parts of stir-fried Epimedium, 10 parts of stir-fried Semen Vaccariae, and 8 parts of Succinum.

[0030] The preparation method of the above traditional Chinese medicine composition is as follows: of the above eighteen flavors, nine flavors including Polygonum cuspidatum, Smilax glabra, vinegar-processed turtle shell, Hirudo, stir-fried Fructus Aurantii, Lithospermum erythrorhizon, Smilax china, stir-fried Epimedium, and Succinum are pulverized into fine powder, screened, and mixed evenly for standby; the remaining nine flavors including Polygonum capitatum, Plantago asiatica, Kochia scoparia, Euonymus alatus, Artemisia anomala, Luffa cylindrica, stir-fried Benincasa hispida seeds, Geranium wilfordii, and stir-fried Semen Vaccariae are added with 12 times the amount of water, decocted twice, each time for 1.5 hours, the filtrates are combined, filtered, the filtrate is concentrated into an extract with a relative density of 1.2, mixed evenly with the above fine powder, dried, pulverized into fine powder, made into pills, and dried to obtain.

[0031] Example 3

[0032] A traditional Chinese medicine composition for treating chronic prostatitis, which is composed of the following components in parts by weight: 20 parts of Polygonum capitatum, 25 parts of Polygonum cuspidatum, 25 parts of Smilax glabra, 18 parts of Plantago asiatica, 15 parts of Kochia scoparia, 15 parts of Euonymus alatus, 10 parts of vinegar-processed turtle shell, 2 parts of Hirudo, 15 parts of Lithospermum erythrorhizon, 10 parts of Artemisia anomala, 10 parts of Luffa cylindrica, 15 parts of stir-fried Fructus Aurantii, 10 parts of stir-fried Benincasa hispida seeds, 15 parts of Geranium wilfordii, 10 parts of Smilax china, 15 parts of stir-fried Epimedium, 15 parts of stir-fried Semen Vaccariae, and 4 parts of Succinum.

[0033] The preparation method of the above traditional Chinese medicine composition is as follows: of the above eighteen flavors, nine flavors including Polygonum cuspidatum, Smilax glabra, vinegar-processed turtle shell, Hirudo, stir-fried Fructus Aurantii, Lithospermum erythrorhizon, Smilax china, stir-fried Epimedium, and Succinum are pulverized into fine powder, screened, and mixed evenly for standby; the remaining nine flavors including Polygonum capitatum, Plantago asiatica, Kochia scoparia, Euonymus alatus, Artemisia anomala, Luffa cylindrica, stir-fried Benincasa hispida seeds, Geranium wilfordii, and stir-fried Semen Vaccariae are added with 12 times the amount of water, decocted twice, each time for 1.5 hours, the filtrates are combined, filtered, the filtrate is concentrated into an extract with a relative density of 1.2, mixed evenly with the above fine powder, dried, pulverized into fine powder, made into pills, and dried to obtain.

[0034] Example 4

[0035] A traditional Chinese medicine composition for treating chronic prostatitis, which is composed of the following components in parts by weight: 15 parts of Polygonum capitatum, 30 parts of Polygonum cuspidatum, 15 parts of Smilax glabra, 10 parts of Plantago asiatica, 20 parts of Kochia scoparia, 20 parts of Euonymus alatus, 5 parts of vinegar-processed turtle shell, 1 part of Hirudo, 20 parts of Lithospermum erythrorhizon, 5 parts of Artemisia anomala, 5 parts of Luffa cylindrica, 20 parts of stir-fried Fructus Aurantii, 5 parts of stir-fried Benincasa hispida seeds, 20 parts of Geranium wilfordii, 5 parts of Smilax china, 20 parts of stir-fried Epimedium, 20 parts of stir-fried Semen Vaccariae, and 1 part of Succinum.

[0036] The preparation method of the above traditional Chinese medicine composition is as follows: of the above eighteen herbs, nine herbs including polygonum cuspidatum, smilax glabra, turtle shell stir-fried with vinegar, leech, stir-fried fructus aurantii, lithospermum erythrorhizon, smilax china, epimedium stir-fried with honey, and succinum are pulverized into fine powder, screened, and mixed evenly for standby; the remaining nine herbs including polygonum capitatum, plantain herb, Kochia scoparia, winged euonymus, artemisia anomala, luffa cylindrica, stir-fried winter melon seeds, geranium wilfordii, and stir-fried semen vaccaria are added with 12 times the amount of water, decocted twice, each time for 1.5 hours, the filtrates are combined, filtered, the filtrate is concentrated into an extract with a relative density of 1.3, mixed evenly with the above fine powder, dried, pulverized into fine powder, made into pills, and dried to obtain the product.

[0037] Example 5

[0038] A traditional Chinese medicine composition for treating chronic prostatitis is composed of the following components in parts by weight: 35 parts of polygonum capitatum, 15 parts of polygonum cuspidatum, 35 parts of smilax glabra, 30 parts of plantain herb, 5 parts of Kochia scoparia, 5 parts of winged euonymus, 20 parts of turtle shell stir-fried with vinegar, 5 parts of leech, 5 parts of lithospermum erythrorhizon, 20 parts of artemisia anomala, 20 parts of luffa cylindrica, 20 parts of stir-fried fructus aurantii, 20 parts of stir-fried winter melon seeds, 5 parts of geranium wilfordii, 20 parts of smilax china, 5 parts of epimedium stir-fried with honey, 5 parts of stir-fried semen vaccaria, and 10 parts of succinum.

[0039] The preparation method of the above traditional Chinese medicine composition is as follows: of the above eighteen herbs, nine herbs including polygonum cuspidatum, smilax glabra, turtle shell stir-fried with vinegar, leech, stir-fried fructus aurantii, lithospermum erythrorhizon, smilax china, epimedium stir-fried with honey, and succinum are pulverized into fine powder, screened, and mixed evenly for standby; the remaining nine herbs including polygonum capitatum, plantain herb, Kochia scoparia, winged euonymus, artemisia anomala, luffa cylindrica, stir-fried winter melon seeds, geranium wilfordii, and stir-fried semen vaccaria are added with 12 times the amount of water, decocted twice, each time for 1.5 hours, the filtrates are combined, filtered, the filtrate is concentrated into an extract with a relative density of 1.2, mixed evenly with the above fine powder, dried, pulverized into fine powder, made into pills, and dried to obtain the product.

[0040] Test examples

[0041] I. Clinical trials

[0042] 1. Application objects: 60 patients with chronic prostatitis who came to the hospital for treatment were collected, aged 20 - 58 years old, with an average age of 35.3 years old;

[0043] 2. Diagnostic criteria

[0044] 2.1. Western medicine diagnostic criteria for chronic prostatitis

[0045] It was formulated with reference to the relevant content of prostatitis in the "Diagnosis and Treatment Guidelines for Urological Diseases in China (2014 Edition)" and the classification method of prostatitis issued by the National Institutes of Health of the United States in 1995.

[0046] (1) Recurrent discomfort or pain in the testicles, pubic area, penis, groin, and lumbosacral area; varying degrees of lower urinary tract symptoms; with or without erectile dysfunction and / or premature ejaculation; with or without tension, anxiety, depression, excessive worry about one's own health, memory loss, etc.

[0047] (2) Negative urine bacterial culture after EPS or prostate massage.

[0048] (3) In the prostate massage fluid, the lecithin bodies are normal or reduced or even disappeared. If WBC>10 / HP, it is diagnosed as type IIIA CP; if WBC≤10 / HP, it is diagnosed as type IIIB CP.

[0049] Chronic prostatitis can be diagnosed if (1), (2), and (3) are present at the same time.

[0050] 2.2. TCM Symptom Diagnostic Criteria for Chronic Prostatitis

[0051] Refer to the "Chinese Medicine Surgery" edited by Chen Hongfeng of China Traditional Chinese Medicine Press and the "Guidelines for Diagnosis and Treatment of Common Diseases in Chinese Medicine Surgery" issued by the Chinese Association of Traditional Chinese Medicine in 2012:

[0052] Main symptoms: ① Abnormal urination such as urgency, pain, and frequency; ② Discomfort or pain in the perineum, lower abdomen, groin area, behind the pubic bone, penis, or scrotum.

[0053] Secondary symptoms: ① Drip after urination, feeling of incomplete urination; ② Burning in the urethra; ③ Wet scrotum; ④ Yellow or red urine.

[0054] Tongue and pulse: red or dark tongue with petechiae, yellow tongue coating, and stringy pulse.

[0055] The diagnosis can be made based on 1 or more main symptoms and 2 or more secondary symptoms combined with tongue and pulse.

[0056] 3. Criteria for inclusion of cases

[0057] ⑴ Those who meet the diagnostic criteria for chronic prostatitis.

[0058] ⑵Those who meet the syndrome of damp-heat and blood stasis.

[0059] ⑶Age: 18 to 70 years old.

[0060] 4. Exclusion criteria

[0061] (1) Patients diagnosed with acute prostatitis, prostate cancer, urethral stenosis, chronic epididymitis, or benign prostatic hyperplasia.

[0062] (2) Women who are pregnant, planning to become pregnant or breastfeeding within six months.

[0063] (3) People with allergic constitution or allergies to multiple drugs.

[0064] (4) Diseases with other complications that may affect the observation of treatment efficacy or are contraindicated to the test drug.

[0065] (5) Patients with severe primary diseases in cardiovascular, liver, kidney, and hematopoietic systems, etc., and psychiatric patients.

[0066] 5. Treatment Methods

[0067] The patients diagnosed with chronic prostatitis were randomly divided into 3 groups, with 20 patients in each group. Each group of patients was given the drugs in Example 1 and Comparative Examples 1-2, 3 times a day, 6 g each time (each gram is equivalent to 2.09 g of crude drug), and taken continuously for 30 days. Observe the disease manifestations of each group of patients.

[0068] 6. Observation Indicators

[0069] 6.1 Safety Observation

[0070] (1) Vital signs: such as blood pressure, respiration, heart rate, etc. (before and after the test).

[0071] (2) Routine blood, urine, and stool tests (before and after the test).

[0072] (3) Electrocardiogram, liver function (ALT, AST), kidney function (BUN, Cr, TBIL, TP, ALP) (before and after the test).

[0073] (4) Adverse events (recorded in detail at any time).

[0074] 6.2 Efficacy Observation

[0075] 6.2.1 Observation of Background Information (Before the Test)

[0076] (1) Demographic information: age, height, weight, etc.;

[0077] (2) General clinical information: co-existing diseases and medications, etc.

[0078] 6.2.2 Diagnostic Indicators (Before the Test)

[0079] (1) Specialized examinations: prostatic fluid, B-ultrasound examination;

[0080] (2) Traditional Chinese medicine syndromes;

[0081] (3) Related symptoms and signs (before and after the test);

[0082] 6.2.3 Efficacy Observation

[0083] (1) Traditional Chinese medicine symptoms (before and after the test);

[0084] (2) Related symptoms and signs (before and after the test).

[0085] 7. Clinical Efficacy Evaluation Criteria

[0086] It was formulated with reference to the Diagnostic and Therapeutic Criteria of Traditional Chinese Medicine Syndromes and the Guiding Principles for Clinical Research of New Chinese Medicines.

[0087] Table 1: Quantification Criteria for Symptoms of Traditional Chinese Medicine Syndromes

[0088]

[0089] Clinical control: Clinical symptoms and signs disappear or basically disappear, and the syndrome score reduction N≥95%. Marked effect: Clinical symptoms and signs are significantly improved, and the syndrome score reduction N≥70%, <95%.

[0090] Effective: Clinical symptoms and signs are improved, and the syndrome score reduction N≥30%, <70%.

[0091] Ineffective: Clinical symptoms and signs are not significantly improved or even worsened, and the syndrome score reduction N<30%. Note: The efficacy index N = (total score before treatment - total score after treatment) ÷ total score before treatment × 100%. The total effective rate % = (number of cases with clinical control + number of cases with marked effect + number of effective cases) ÷ total number of cases * 100%

[0092] 8. Therapeutic Results

[0093] Table 2: Therapeutic Statistics

[0094]

[0095] From the results in the above table, it can be seen that the drug in Example 1 has a good therapeutic effect on chronic prostatitis, with a total effective rate as high as 95%. After adjusting the formula in Comparative Example 1 and Comparative Example 2, the therapeutic effect on chronic prostatitis becomes worse, and the total effective rate is reduced to 50% and 40%. It is speculated that after the formula adjustment, the interaction relationship between drugs weakens, resulting in the disappearance or weakening of the complementary effect between drugs, which affects the therapeutic effect on the disease.

[0096] II. Animal Experiments

[0097] 1. Experimental Materials

[0098] (1) Test drugs: The drugs in Example 1, Comparative Example 1 and Comparative Example 2;

[0099] (2) Positive drugs: Aspirin enteric-coated tablets, Prednisone acetate tablets;

[0100] (3) Animals: KM mice, half male and half female;

[0101] 2. Method for Preparing Medicaments

[0102] Taking the drugs in Example 1 and Comparative Examples 1-2 as examples, the drug was converted to a gavage dose of 2.73 g / Kg for mice (equivalent to 5.71 g / kg of crude drug). Since the administration volume was 20 ml / kg, the converted administration concentration was 14%.

[0103] The preparation method was as follows: Weigh 1.4 g of the drugs in Example 1, Comparative Example 1 and Comparative Example 2, add an appropriate amount of purified water, place it in the refrigerator for refrigeration, soak for 12 h, then make up the volume to 10 ml with purified water, and stir evenly with a glass rod to obtain it.

[0104] For the auricular microcirculation test, enteric-coated aspirin tablets were selected as the positive drug. The converted gavage dose for mice was 72.8 mg / Kg. Since the administration volume was 20 ml / Kg, the converted administration concentration was 3.64 mg / ml.

[0105] The preparation method was as follows: Take 1 enteric-coated aspirin tablet, grind it into powder, weigh 36.4 mg of aspirin powder, make up the volume to 10 ml with purified water, and stir evenly to obtain it.

[0106] For the ear swelling and granuloma test, prednisone acetate tablets were selected as the positive drug. The converted gavage dose for mice was 81.9 mg / kg. Since the administration volume was 20 ml / kg, the administration concentration of prednisone tablets was 4.10 mg / ml.

[0107] The preparation method was as follows: Take 1 prednisone tablet, grind it into powder, weigh 41.0 mg of the drug powder, make up the volume to 10 ml with purified water, and stir evenly with a glass rod to obtain a concentration of 4.10 mg / ml.

[0108] 3. Auricular microcirculation test in mice

[0109] 3.1 Grouping

[0110] Select 50 healthy KM mice, half male and half female, weighing 18 - 22 g, and randomly divide them into 5 groups, with 10 mice in each group, namely the blank group, the positive drug group, the drug group of Example 1, the drug group of Comparative Example 1 and the drug group of Comparative Example 2.

[0111] 3.2 Determination before administration

[0112] The mice were anesthetized by intraperitoneal injection of 10% urethane at a dose of 0.17 ml / 10 g (strict disinfection). The mice were fixed ventral side down on the mouse observation table, with the auricles flattened on the ear holders. A little cedarwood oil was dropped on the ear holders and the surface of the auricles. The observation table was placed on the microscopic stage of the BI-2000 microcirculation observation system, and the brightness of the floodlight was adjusted appropriately. Observation was carried out under a 4-fold microscope. The microcirculation software was started, and the field of view under the microscope was adjusted to make the image transmitted to the computer screen clear. A certain boundary was selected near the marked point, and a sketch of the blood vessel distribution was drawn (for finding the original blood vessel site during the next observation). The capillary opening number, blood flow velocity (μm / s), blood vessel input diameter (μm), and blood vessel output diameter (μm) were measured.

[0113] 3.3 Drug administration

[0114] Each group was administered the drug by gavage at a volume of 20 ml / kg. The blank group was gavaged with normal saline, the positive group was gavaged with enteric-coated aspirin tablets at a dose of 18.2 mg / kg, and the other three groups were gavaged with the drugs in Example 1, Comparative Example 1, and Comparative Example 2, once a day for 7 consecutive days.

[0115] 3.4 Measurements after drug administration

[0116] After the 7th drug administration, the capillary opening number, blood flow velocity, blood vessel input diameter, and blood vessel output diameter at the original site of the mice were measured at 30 and 60 min.

[0117] The changes in capillary opening number, blood flow velocity, blood vessel input diameter, and blood vessel output diameter at the original site of the mice at 30 and 60 min were obtained by subtracting the corresponding values before drug administration. Group comparisons were made using the t-test.

[0118] 3.5 Results

[0119] Table 3: Effects on the capillary opening number (pieces) of mice

[0120]

[0121] Table 4: Effects on the blood flow velocity (artery) (μm / s) of mice

[0122]

[0123] Table 5: Effects on the blood flow velocity (vein) (μm / s) of mice

[0124]

[0125] Table 6: Effects on the blood vessel input diameter (μm) of mice

[0126]

[0127] Table 7: Effects on the output diameter (micrometers) of blood vessels in mice

[0128]

[0129]

[0130] From the results in Table 3 - 7, it can be seen that the drug in Example 1 has an obvious increasing trend on the number of open capillaries in the auricles of mice, the arterial blood flow velocity of capillaries in the auricles of mice, the venous blood flow velocity of capillaries in the auricles of mice, the input diameter of capillaries in the auricles of mice, and the output diameter of capillaries in the auricles of mice. However, the effects of the drugs in Comparative Example 1 and Comparative Example 2 are inferior to those of the drug in Example 1. It is speculated that this may be due to the disappearance or weakening of the complementary effects between the formulated drugs after adjusting the drug formulation.

[0131] 4. Mouse ear swelling test

[0132] 4.1 Grouping and drug administration

[0133] Take 50 healthy KM mice, with a body weight of 18 - 22 g, half male and half female. Randomly divide them into 5 groups, with 10 mice in each group, namely the blank group, the positive group, the Example 1 group, the Comparative Example 1 group, and the Comparative Example 2 group. The administration volume is 20 mL / kg, and the drug is administered continuously for 9 days.

[0134] 4.2 Treatment

[0135] 60 minutes after the last drug administration, apply approximately 50 μL of xylene to both the front and back sides of the right ear of the mice, and use the left ear as a normal control. 30 minutes later, decapitate the mice, cut off both ears along the auricle baseline, punch holes at the same position on the left and right ears with a 9 - mm puncher, and weigh them on an electronic balance.

[0136] 4.3 Observation index:

[0137] The swelling degree is the weight of the right ear minus the weight of the left ear. The swelling percentage of the mouse ear swelling is the swelling degree divided by the weight of the left ear and multiplied by 100. For comparison between groups, a t - test is used.

[0138] 4.4 Results

[0139] Table 8: Effects on mouse ear swelling

[0140] Group Number of animals (pcs) Dose (g / kg) Degree of swelling Swelling rate Blank control group 10 - 18.22±4.18 0.99±0.30 Positive control group 10 81.9 mg <![CDATA[11.03±1.60 ** > <![CDATA[0.46±0.12 ** > Example 1 group 10 2.73 <![CDATA[11.40±1.93 * > <![CDATA[0.54±0.12 * > Comparative example 1 group 10 2.73 <![CDATA[15.09±1.44 * > 0.75±0.23 Comparative example 2 group 10 2.73 16.02±7.10 0.81±0.35

[0141] From the results in the above table, it can be seen that the drug in the Example 1 group can significantly inhibit the ear swelling in mice caused by xylene (P < 0.05) and can significantly reduce the swelling rate (P < 0.01). It indicates that this product has a certain inhibitory effect on acute inflammation.

[0142] 5. Mouse cotton pellet granuloma test

[0143] 5.1 Grouping and Modeling

[0144] Fifty KM mice, weighing 18 - 22 g and being male, were randomly divided into 5 groups with 10 mice in each group, namely the blank group, the positive group, Example 1 group, Comparative Example 1 group, and Comparative Example 2 group. Each group of mice was anesthetized with 10% urethane. The hair on the back of the mice was shaved off. After disinfection with iodine tincture and alcohol, a transverse incision was made. The skin tissue was separated to the myofascia with a hemostat. Then the incision was gently pulled open with forceps, and a 5 - mg disinfected cotton ball was buried into the incision. Finally, two stitches were sutured with No. 0 thread to prevent it from falling off.

[0145] 5.2 Drug Administration

[0146] Gavage administration started on the second day after the surgery. Except for the normal saline in the blank group, the groups of Example 1, Comparative Example 1, and Comparative Example 2 were given the corresponding doses of the medicinal liquid, and the positive control group was given prednisone tablets at 81.9 mg / kg. The administration volume was 20 mL / kg, and the administration was continuous for 7 days.

[0147] 5.3 Treatment

[0148] On the second day after the last administration, each group of mice was anesthetized by intraperitoneal injection of 10% urethane at 10 ml / kg, sacrificed by exsanguination from the carotid artery. The granulation tissue was dissected with surgical scissors and forceps, and the blood scab and myofascia attached to the granulation were carefully separated. It was weighed with an electronic balance. The obtained weight minus the original weight of the cotton ball, 5 mg, was the wet weight of the granuloma. The collected granulomas were placed in an oven at 70 °C for 2 h and then taken out. After cooling in a desiccator, the weight obtained was weighed and the original weight of the cotton ball was subtracted to obtain the dry weight of the granuloma. For comparison between groups, t - test was used.

[0149] 5.4 Results

[0150] Table 9: Effects on Cotton Ball Granuloma in Mice

[0151] Group Number of animals (pcs) Dose (g / kg) Degree of swelling Swelling rate Blank control group 10 - 63.25±20.77 13.99±4.76 Positive control group 10 81.9 mg <![CDATA[33.38±2.77 ** > <![CDATA[6.39±4.74 ** > Example 1 group 10 2.73 <![CDATA[37.95±2.01 ** > <![CDATA[6.94±2.81 ** > Comparative example 1 group 10 2.73 <![CDATA[45.29±4.41 * > <![CDATA[7.30±1.78 ** > Comparative example 2 group 10 2.73 46.53±21.37 10.14±3.36

[0152] It was found from the results in the above table that the drug in Example 1 could significantly reduce the wet weight and dry weight of the cotton ball granuloma in mice, while the effects of the drugs in Comparative Example 1 and Comparative Example 2 were far less than that in Example 1, proving that the drug in Example 1 has a certain inhibitory effect on chronic inflammatory hyperplasia.

Claims

1. A traditional Chinese medicine composition for treating chronic prostatitis, characterized in that, It comprises the following components in parts by weight: 15 - 35 parts of Polygonum capitatum, 15 - 30 parts of Polygonum cuspidatum, 15 - 35 parts of Smilax glabra, 10 - 30 parts of Plantago asiatica, 5 - 20 parts of Kochia scoparia, 5 - 20 parts of Euonymus alatus, 5 - 20 parts of Carapax Trionycis, 1 - 5 parts of Hirudo, 5 - 20 parts of Lithospermum erythrorhizon, 5 - 20 parts of Artemisia anomala, 5 - 20 parts of Retinervus Luffae Fructus, 5 - 20 parts of Fructus Aurantii, 5 - 20 parts of Semen Benincasae, 5 - 20 parts of Geranium wilfordii, 5 - 20 parts of Smilax china, 5 - 20 parts of Epimedium brevicornu, 5 - 20 parts of Vaccaria segetalis and 1 - 10 parts of Succinum.

2. The traditional Chinese medicine composition for treating chronic prostatitis according to claim 1, wherein, It comprises the following components in parts by weight: 20 - 25 parts of Polygonum capitatum, 20 - 25 parts of Polygonum cuspidatum, 20 - 25 parts of Smilax glabra, 18 - 25 parts of Plantago asiatica, 10 - 15 parts of Kochia scoparia, 10 - 15 parts of Euonymus alatus, 10 - 15 parts of Carapax Trionycis, 2 - 4 parts of Hirudo, 10 - 15 parts of Lithospermum erythrorhizon, 10 - 15 parts of Artemisia anomala, 10 - 15 parts of Retinervus Luffae Fructus, 10 - 15 parts of Fructus Aurantii, 10 - 15 parts of Semen Benincasae, 10 - 15 parts of Geranium wilfordii, 10 - 15 parts of Smilax china, 10 - 15 parts of Epimedium brevicornu, 10 - 15 parts of Vaccaria segetalis and 4 - 8 parts of Succinum.

3. The traditional Chinese medicine composition for treating chronic prostatitis according to claim 1, wherein, It comprises the following components in parts by weight: 20 parts of Polygonum capitatum, 25 parts of Polygonum cuspidatum, 25 parts of Smilax glabra, 18 parts of Plantago asiatica, 15 parts of Kochia scoparia, 15 parts of Euonymus alatus, 10 parts of Carapax Trionycis, 2 parts of Hirudo, 15 parts of Lithospermum erythrorhizon, 10 parts of Artemisia anomala, 10 parts of Retinervus Luffae Fructus, 15 parts of Fructus Aurantii, 10 parts of Semen Benincasae, 15 parts of Geranium wilfordii, 10 parts of Smilax china, 15 parts of Epimedium brevicornu, 15 parts of Vaccaria segetalis and 4 parts of Succinum.

4. The traditional Chinese medicine composition for treating chronic prostatitis according to claim 1, wherein, It comprises the following components in parts by weight: 25 parts of Polygonum capitatum, 20 parts of Polygonum cuspidatum, 20 parts of Smilax glabra, 25 parts of Plantago asiatica, 10 parts of Kochia scoparia, 10 parts of Euonymus alatus, 15 parts of Carapax Trionycis, 4 parts of Hirudo, 10 parts of Lithospermum erythrorhizon, 15 parts of Artemisia anomala, 15 parts of Retinervus Luffae Fructus, 10 parts of Fructus Aurantii, 15 parts of Semen Benincasae, 10 parts of Geranium wilfordii, 15 parts of Smilax china, 10 parts of Epimedium brevicornu, 10 parts of Vaccaria segetalis and 8 parts of Succinum.

5. The traditional Chinese medicine composition for treating chronic prostatitis according to claim 1, characterized in that, It comprises the following components in parts by weight: 24 parts of Polygonum capitatum, 22 parts of Polygonum cuspidatum, 23 parts of Smilax glabra, 22 parts of Plantago asiatica, 13 parts of Kochia scoparia, 13 parts of Euonymus alatus, 13 parts of Carapax Trionycis, 3 parts of Hirudo, 13 parts of Lithospermum erythrorhizon, 13 parts of Artemisia anomala, 13 parts of Retinervus Luffae Fructus, 13 parts of Fructus Aurantii, 13 parts of Semen Benincasae, 13 parts of Geranium wilfordii, 13 parts of Smilax china, 14 parts of Epimedium brevicornu, 14 parts of Vaccaria segetalis and 6 parts of Succinum.

6. The traditional Chinese medicine composition for treating chronic prostatitis according to any one of claims 1-5, wherein The Carapax Trionycis is prepared from vinegar - processed Carapax Trionycis, the Fructus Aurantii is prepared from bran - stir - fried Fructus Aurantii, the Semen Benincasae is prepared from stir - fried Semen Benincasae, the Epimedium brevicornu is prepared from roasted Epimedium brevicornu, and the Vaccaria segetalis is prepared from stir - fried Vaccaria segetalis.

7. A method for preparing the traditional Chinese medicine composition for treating chronic prostatitis according to any one of claims 1-6, characterized in that, It comprises the following steps: It is prepared by mixing the crude drugs after pulverization; or is prepared from the extracts obtained by mixing or separately extracting the crude drugs; or is prepared from the active ingredients obtained by further refining and purifying the extracts; or is prepared by adding pharmaceutically acceptable excipients to the extracts / active ingredients.

8. The preparation method of the traditional Chinese medicine composition for treating chronic prostatitis according to claim 7, characterized in that, The dosage form prepared is one of pills, granules, capsules, powders, mixtures, tablets, extracts or oral liquids.

9. The preparation method of the traditional Chinese medicine composition for treating chronic prostatitis as claimed in claim 7 or 8 is as follows: Among the above eighteen herbs, polygonum cuspidatum, smilax glabra, turtle shell, leech, fructus aurantii, lithospermum erythrorhizon, smilax china, epimedium, and succinum are pulverized into fine powder, screened, and mixed evenly for standby; the remaining nine herbs, polygonum capitatum, plantago asiatica, Kochia scoparia, winged euonymus, artemisia anomala, luffa cylindrica, benincasa hispida var. chieh-qua, geranium wilfordii, and semen vaccariae are added with water, decocted, and the filtrates are combined, filtered, and the filtrate is concentrated into an extract, which is mixed evenly with the above-mentioned fine powder, dried, pulverized into fine powder, made into pills, and dried to obtain the product.

10. The application of the traditional Chinese medicine composition in claims 1 - 6 in the preparation of drugs for treating chronic prostatitis.

Images