Traditional Chinese medicine composition for treating benign prostatic hyperplasia as well as preparation method and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating benign prostatic hyperplasia and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 to 10 parts of leech, 5 to 10 parts of centipede, 2 to 5 parts of earthworm, 2 to 5 parts of cicada slough, 2 to 5 parts of silkworm chrysalis, 2 to 5 parts of radix achyranthis bidentatae, 2 to 5 parts of pericarpium citri reticulatae, 2 to 5 parts of gecko and 5 to 10 parts of poria cocos. According to the traditional Chinese medicine composition, the formula is reasonably combined through monarch, minister, assistant and guide in traditional Chinese medicine, the medicine effect is maximized through the modern technology, and the effect of treating prostatic hyperplasia is achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating prostatic hyperplasia and a preparation method and application thereof. BACKGROUND

[0002] Prostatic hyperplasia, commonly known as prostatic hypertrophy, is one of the common diseases in middle-aged and elderly men, and the common symptoms are urinary obstruction, frequent urination, urinary urgency, etc. Severe cases can affect the quality of life of patients, and the incidence is increasing with the aging of the population. The main clinical treatment methods for this disease are western medicine treatment, minimally invasive treatment and surgical treatment, etc. For example, the application of tamsulosin hydrochloride preparation in the treatment of prostatic hyperplasia is disclosed in Chinese patent application No. 202411505755.7. However, the marketed western medicines have certain defects in terms of tolerance, such as tamsulosin leading to reverse ejaculation, finasteride leading to breast hyperplasia, and sildenafil causing visual impairment. Minimally invasive treatment and surgical treatment not only have high recurrence rates, but also cause erectile dysfunction in patients. SUMMARY

[0003] The technical problem to be solved by the present application is to provide a safe and effective traditional Chinese medicine composition for treating prostatic hyperplasia and a preparation method and application thereof.

[0004] To solve the above technical problems, the technical scheme adopted by the present application is as follows: a traditional Chinese medicine composition for treating prostatic hyperplasia, comprising the following raw materials in parts by weight: leech 5-10 parts, centipede 5-10 parts, earthworm 2-5 parts, periostracum cicada 2-5 parts, silkworm chrysalis 2-5 parts, radix cyathulae 2-5 parts, dried tangerine or orange peel 2-5 parts, placenta 2-5 parts, and white bezoar 5-10 parts.

[0005] Another technical scheme adopted by the present application is a preparation method of the traditional Chinese medicine composition for treating prostatic hyperplasia, comprising the following steps: S1: grinding and sieving the raw materials separately; S2: mixing the raw materials obtained in S1 uniformly according to the weight parts to obtain a composition; S3: sterilizing the composition obtained in S2.

[0006] Still another technical scheme adopted by the present application is the application of the traditional Chinese medicine composition for treating prostatic hyperplasia in the preparation of a medicine for treating prostatic hyperplasia.

[0007] The present application has the following advantages: the traditional Chinese medicine composition of the present application is reasonably matched by the principle of lord and minister and assistant in traditional Chinese medicine, and the efficacy is maximized by modern technology, thereby achieving the effect of treating prostatic hyperplasia. BRIEF DESCRIPTION OF DRAWINGS

[0008] Figure 1This is a comparison chart of the wet weight of the prostate in each group in the embodiment of the present invention; Figure 2 A comparison chart of the prostate coefficients of each group in the embodiment of the present invention; Figure 3 This is a comparison chart of DHT (dihydrotestosterone) content in each group in the examples of the present invention; Figure 4 This is a comparison chart of E2 (estradiol) content in each group in the examples of the present invention; Figure 5 This is a comparison chart of T (testosterone) content in each group in the examples of the present invention; Figure 6 This is a comparison chart of E2 / T (estradiol content / testosterone content) of each group in the examples of the present invention; Figure 7 This is a comparison chart of MDA (malondialdehyde) content in each group in the examples of the present invention; Figure 8 This is a comparison chart of SOD (superoxide dismutase) content in each group in the examples of the present invention; Figure 9 This is a comparison chart of IL-6 (interleukin-6) content in each group in the examples of the present invention; Figure 10 This is a comparison chart of IL-8 (interleukin-8) content in each group in the examples of the present invention; Figure 11 This is a comparison chart of BUN (urea nitrogen) content in each group in the embodiment of the present invention; Figure 12 This is a comparison chart of CRE (creatinine) content in each group in the examples of the present invention; Figure 13 This is a comparison chart of EGF (epidermal growth factor) content in each group in the examples of the present invention; Figure 14 This is a comparison chart of IGF-1 (insulin-like growth factor-1) content in each group in the examples of the present invention. DETAILED DESCRIPTION

[0009] To illustrate the technical content, achieved objectives and effects of the present invention in detail, the following description is given in conjunction with the embodiments and accompanying drawings.

[0010] A traditional Chinese medicine composition for treating benign prostatic hyperplasia comprises the following raw materials, measured in parts by weight: 5-10 parts of leeches, 5-10 parts of centipedes, 2-5 parts of earthworms, 2-5 parts of cicada sloughs, 2-5 parts of silkworm pupae, 2-5 parts of Achyranthes bidentata, 2-5 parts of tangerine peel, 2-5 parts of gecko, and 5-10 parts of Poria cocos.

[0011] From the above description, the beneficial effects of the present application are that Chinese medicine believes that benign prostatic hyperplasia belongs to the category of "cancer", which is a senile disease. The old and weak, true yang deficiency, kidney qi deficiency, and poor gasification of the state, bladder closed and difficult to appear progressive dysuria, nocturia, and then urine thin and weak, urine after the rest of the leakage, kidney deficiency and weak is the basis of the disease; enlarged prostate obstruction urethra, directly cause dysuria. The key to the pathology is deficiency of vital qi, phlegm and blood stasis, and the treatment principle is to benefit qi, tonify kidney, remove blood stasis, and treat cancer.

[0012] Therefore, the present application researches and develops a traditional Chinese medicine composition with the functions of warming kidney and benefiting essence, invigorating spleen and lung, promoting blood circulation and removing blood stasis, and clearing heat and diuresis to treat benign prostatic hyperplasia. The product is natural in material, safe and effective, and provides safer and more effective protection for patients.

[0013] In the traditional Chinese medicine preparation formula of the present application, the functions of each traditional Chinese medicine are as follows: Water leech: the product is Limnatis humilis Whitmania pigra Whitman, water leech Hirudo nipponica Whitman or Limnatis humilis Whitmania acranulata Whitman. Its function is to break blood, unblock channels, remove blood stasis and eliminate masses. It is used for blood stasis, amenorrhea, masses and lumps, stroke hemiplegia, and injury.

[0014] Centipede: the product is Scolopendra subspinipes mutilans Scolopendra subspinipes mutilans L. Koch dry body. Its function is to calm wind and convulsion, dredge collaterals and stop pain, and attack toxin and disperse knots. It is used for internal liver wind, convulsion, infantile convulsion, stroke, hemiplegia, tetanus, wind-damp stubborn arthralgia, hemiplegia, and headache.

[0015] Earthworm: the product is Pheretima guilinchungensis Pheretima aspergillum (E. Perrier), Pheretima vulgaris Pheretima vulgaris Chen, Pheretima williamsoni Pheretima guillelmi (Michaelsen) or Pheretima virens Pheretima pectinifera Michaelsen dry body. The former is commonly known as "Guangdilong", and the latter three are commonly known as "Shudilong". Its function is to clear heat, calm convulsion, dredge collaterals, relieve asthma and diuresis. It is used for high fever, convulsion, joint pain, numbness of limbs, hemiplegia, lung heat, asthma and less urine.

[0016] Cantapalpus: the product is black cicada of Cicadidae Cryptotympana pustulata Fabricius. Its function is to disperse wind-heat, benefit the throat, penetrate rash, clear the eyes, and relieve convulsion. It is used for wind-heat cold, sore throat, hoarseness, measles, wind rash, itching, red eyes, cataract, convulsion and tetanus.

[0017] Silkworm pupa: This product is from the silkworm family insect Bombyx mori Bombyx mori Dried pupae of L. Its main functions are: promoting the production of body fluids and quenching thirst, promoting digestion and regulating qi. It is used for polydipsia, emaciation, and infantile malnutrition.

[0018] Achyranthes bidentata: This product is Achyranthes bidentata of the Amaranthaceae family Achyranthes bidentata The dried root of Bl. Its main functions include removing blood stasis and promoting menstruation, nourishing the liver and kidneys, strengthening the tendons and bones, promoting urination and relieving stranguria, and guiding blood downward. It is used for amenorrhea, dysmenorrhea, soreness of the waist and knees, weakness of the tendons and bones, stranguria, edema, headache, dizziness, toothache, mouth ulcers, hematemesis, and epistaxis.

[0019] Tangerine peel: This product is from the Rutaceae plant tangerine peel Citrus reticulata The dried, mature peel of Blanco and its cultivated varieties. Its main functions include regulating Qi and strengthening the spleen, drying dampness and resolving phlegm. It is used to treat abdominal distension, loss of appetite, vomiting, diarrhea, and cough with excessive phlegm.

[0020] Gecko: This product is a gecko of the Gekkonidae family Gekko gecko The dried form of Linnaeus. Its main functions and indications are: tonifying the lungs and kidneys, promoting qi and calming asthma, and boosting yang and improving essence. It is used for lung and kidney deficiency, asthenia due to shortness of breath, cough due to fatigue and hemoptysis, impotence, and spermatorrhea.

[0021] Poria: This product is the fungus Poria of the Polyporaceae family Poria cocos Dried sclerotia of Schw. Wolf. Its main functions include promoting diuresis and dispelling dampness, strengthening the spleen, and calming the mind. It is used for edema, oliguria, phlegm and fluid retention, dizziness and palpitations, spleen deficiency, poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0022] Leeches and centipedes are both insect-based medicines. Leeches are good at dispersing blood stasis, dispelling symptoms, and dispersing nodules, while centipedes excel at unblocking meridians. Their combined use enhances their dispersing power, making them the main herb. Earthworms assist the main herb in activating blood circulation and unblocking meridians, as well as promoting diuresis and relieving stranguria. Achyranthes bidentata removes stasis, promotes menstruation, promotes diuresis, and relieves stranguria, guiding the herb downward to the affected area. It also nourishes the liver and kidneys to protect vital energy and mitigate the aggressive nature of the main herb, making them the assistant herb. Tangerine peel regulates qi and promotes circulation, eliminating qi stagnation and enhancing blood circulation. It also eliminates dampness and resolves phlegm, preventing stasis and dampness. Gecko nourishes the kidneys and boosts yang, addressing the root cause of kidney deficiency, complementing the main herb's "symptomatic" approach to address both the symptoms and the root cause. Cicada molts, with their cooling and light properties, counteract the warming and drying properties of leeches and centipedes, preventing damage to yin and blood. Silkworm pupae and Poria cocos strengthen the spleen and replenish deficiency, counteracting the harmful effects of insect-based medicines that damage vital energy and harmonizing the spleen and stomach. These four herbs are collectively known as adjuvants. The combination of these medicines can promote blood circulation and remove blood stasis, disperse nodules and eliminate symptoms, nourish the kidney and replenish qi, promote dampness and relieve stranguria, and harmonize qi.

[0023] Furthermore, the following raw materials are included in parts by weight: 5-7 parts of leeches, 5-7 parts of centipedes, 3-5 parts of earthworms, 3-5 parts of cicada shells, 3-5 parts of silkworm pupae, 3-5 parts of Achyranthes bidentata, 3-5 parts of tangerine peel, 3-5 parts of gecko, and 5-7 parts of Poria cocos.

[0024] Further, the raw materials include the following: leeches 5 parts, centipedes 5 parts, earthworms 3 parts, periostracum cicadae 3 parts, silkworm chrysalis 3 parts, Cyathula 3 parts, dried tangerine or orange peel 3 parts, placenta 3 parts, and Poria cocos 5 parts.

[0025] Another technical solution adopted by the present application is the preparation method of the traditional Chinese medicine composition for treating prostatic hyperplasia, which comprises the following steps: S1: separately pulverize the raw materials and sieve them; S2: uniformly mix the raw materials obtained in S1 according to the weight parts to obtain a composition; S3: sterilize the composition obtained in S2.

[0026] As can be seen from the above description, the present application provides a preparation method of a powder, which can effectively retain effective components while ensuring the safety and stability of the product.

[0027] Further, the pulverizing method in S1 is shearing pulverization or ultrafine pulverization.

[0028] Further, the mesh number of the sieving in S1 is 80-100 mesh.

[0029] As can be seen from the above description, the composition is too fine and is easy to increase irritability and toxicity, and is too coarse and is easy to cause slow drug efficacy, so the mesh number of the sieving is limited to 80-100 mesh.

[0030] Further, the sterilization method in S3 is high-temperature instant sterilization.

[0031] Further, the sterilization method in S3 is sterilization at 140-180℃ for 5-20s.

[0032] As can be seen from the above description, the high-temperature instant sterilization can effectively kill bacteria, fungi, molds and other microorganisms in the traditional Chinese medicine composition in a short time while retaining effective components, thereby significantly reducing the microbial pollution level of the traditional Chinese medicine composition and improving its safety.

[0033] Still another technical solution adopted by the present application is the application of the traditional Chinese medicine composition for treating prostatic hyperplasia in the preparation of a medicine for treating prostatic hyperplasia.

[0034] As can be seen from the above description, the traditional Chinese medicine composition of the present application has the effects of warming the kidney and benefiting essence, invigorating the spleen and benefiting the lung, promoting blood circulation to remove blood stasis, and clearing heat and promoting diuresis, and can effectively treat prostatic hyperplasia.

[0035] Further, the traditional Chinese medicine composition is any one of a oral liquid, granules, powder, capsule, decoction, tablet and pill.

[0036] Example 1 of the present invention is: a traditional Chinese medicine composition for treating benign prostatic hyperplasia, composed of the following raw materials, by weight: 5g of leech, 5g of centipede, 3g of earthworm, 3g of cicada shell, 3g of silkworm pupa, 3g of Achyranthes bidentata, 3g of tangerine peel, 3g of gecko, and 5g of Poria.

[0037] Example 2 of the present invention is: a method for preparing the Chinese medicine composition of Example 1, the specific steps are as follows: S1: Grind the raw materials separately and pass through an 80-mesh sieve; S2: uniformly mixing the raw materials obtained in S1 according to parts by weight to obtain a composition; S3: The composition obtained in S2 was sterilized at 170°C for 10 seconds.

[0038] Example 3 of the present invention is a pharmacodynamic test of the Chinese medicine composition of Example 1 on benign prostatic hyperplasia, and the specific steps are as follows: 1. Experimental Materials 1.1 Experimental animals: Male SD rats, SPF grade, 8 weeks old, weighing 290 g to 340 g.

[0039] 1.2 Chinese medicine composition: the Chinese medicine composition prepared in Example 1.

[0040] 1.3 Reagents: malondialdehyde (MDA) kit, superoxide dismutase (SOD) kit, dihydrotestosterone (DHT) kit, estradiol (E2) kit, testosterone (T) kit, BUN kit, insulin-like growth factor-1 (IGF-1) kit, cyclin D1 antibody, paraformaldehyde, solid paraffin, DAB color development kit, corn oil, anhydrous ethanol, sodium pentobarbital.

[0041] 2. Experimental Methods 2.1 Grouping and Modeling 2.1.1 Rat castration A total of 48 male rats were randomly selected for castration surgery after one week of adaptive feeding, and the other 8 rats underwent sham surgery. The surgical procedure was the same as that of castrated rats, but the testicles were not removed.

[0042] Specific operation: using 45mg of sodium pentobarbital kg -1Rats were paralyzed by intraperitoneal injection and fixed in the supine position on a rat board maintained at 37°C on a heating blanket. Scrotal hair was trimmed, and the scrotal skin was disinfected with iodine. The scrotal skin, capsular tissue, and cremaster muscle were incised layer by layer (approximately 1 cm in length). The testicles were gently pulled out through the incision to fully expose the testicles and spermatic cord. The spermatic cords were then severed with forceps and ligated with silk thread. The testicles and epididymis were completely removed bilaterally, and the stumps were ligated to stop bleeding. Blood was removed from the scrotum with a cotton ball moistened with saline. The incisions were sutured layer by layer, disinfected again, and the skin was sutured. The scrotal area was closely observed for swelling, bleeding from the wound, and respiratory status. After all parameters were observed, the rats were returned to their home cages.

[0043] Eight sham-operated rats served as a blank control group. The scrotal skin, capsular tissue, and cremaster muscle of the rats were incised layer by layer (incision length was approximately 1 cm). The testicles were retracted and then returned to the capsular tissue. The skin was sutured layer by layer without the need for orchiectomy.

[0044] Each rat received a 40,000-unit injection of penicillin intramuscularly for four consecutive days. The rats were allowed to recover for seven days, during which their food intake, mental state, and health were observed daily.

[0045] 2.1.2 Animal grouping and modeling Five days after surgery, 40 castrated rats were randomly divided into five groups according to body weight, with 8 rats in each group: model control group, finasteride treatment group, and high-, medium-, and low-dose groups of the Chinese herbal composition. Eight sham-operated rats served as the blank control group.

[0046] At 8 o'clock every morning, the blank control group rats were subcutaneously injected with an equal volume of solvent (corn oil), and the other rats were subcutaneously injected with testosterone propionate solution (the solvent was corn oil), and the injection volume was 3ml / kg -1 After the needle was removed, the needle hole was pinched for 15 seconds to prevent leakage. Except for the blank control group, the remaining four groups of rats were gavaged with the drug 1 hour after the injection of testosterone propionate. The injections were continued for 28 days to establish the model.

[0047] Model control group: rats were subcutaneously injected with testosterone propionate solution; Finasteride treatment group: 1 hour after injection of testosterone propionate, the drug was administered orally. The finasteride group was given 31.92 mg of finasteride tablet powder. kg -1 (Contains 1.05mg of finasteride kg -1 ); High, medium and low dose groups of Chinese medicine composition: 1 hour after injection of testosterone propionate, oral administration was performed. The Chinese medicine composition prepared according to Example 1 was divided into high, medium and low dose groups of Chinese medicine composition, and the dosage was 1.1g, 0.55g and 0.28g of powder respectively. kg -1 d; Blank control group: 8 sham-operated rats as blank control group.

[0048] 2.1.3 Administration After 1h of testosterone propionate injection, rats in each group were administered by gavage. The finasteride treatment group was given finasteride 31.92mg tablet powder kg -1 (containing finasteride 1.05mg kg -1 ), and the traditional Chinese medicine composition high, medium and low dose groups were given traditional Chinese medicine composition 1.1g, 0.55g, 0.28g powder kg -1 d, and the blank control group and the model control group were given pure water by gavage, and the gavage volume of each group was 10ml / kg. Continuous gavage administration for 28 days.

[0049] Before administration, the rats were weighed, and the weight was measured twice a week (week 3, Sunday), and the administration dose was adjusted according to the weight of the rats.

[0050] 2.1.4 Sampling 24h after the last administration, the rats were weighed, anesthetized with intraperitoneal injection of sodium pentobarbital 50mg*kg-1, dissected and opened the abdominal cavity, and blood samples were collected from the abdominal aorta. After standing at room temperature for 2h, the whole blood was centrifuged at 3000r*min -1 for 15min, and the serum was taken, divided, and stored at -80℃ ultra-low temperature freezer for standby. The prostate tissue was taken, and the wet weight was weighed and recorded. The abdominal lobe of the prostate was divided into two halves, and the left side was fixed with 4% paraformaldehyde, and the right side was quickly frozen with liquid nitrogen and then transferred to -80℃ ultra-low temperature freezer for standby.

[0051] 2.1.5 Calculation of prostate index: The prostate index (PI) was calculated based on the weight of the rat (g) and the wet weight of the prostate (mg). The calculation formula was: PI = wet weight of prostate (mg) / weight of rat (g) 100%.

[0052] 2.1.6 Detection of related indicators in serum by enzyme-linked immunosorbent assay (ELISA) and other methods.

[0053] Each kit and rat serum were equilibrated at room temperature for 30 minutes. After the serum was dissolved, it was centrifuged at low speed. The procedures were strictly carried out according to the instructions of each kit. The serum neutral hormone indicators: dihydrotestosterone (DHT), estradiol (E2), testosterone (T); inflammatory factors: interleukin-6 (IL-6), interleukin-8 (IL-8); oxidative stress indicators: malondialdehyde (MDA), superoxide dismutase (SOD); renal function indicators: blood urea nitrogen (BUN), creatinine (CRE); growth factors: epidermal growth factor (EGF), insulin-like growth factor-1 (IGF-1), etc. were measured.

[0054] 2.1.7 Statistical analysis: GraphPad Prism 8.0 statistical software was used, and the experimental data were ± SEM, one-way ANOVA was used for statistical analysis, and P < 0.05 was considered statistically significant.

[0055] 3. Experimental results 3.1 General behavioral observations of animals After castration, the rats were in good physical condition, able to eat and drink normally, with shiny fur and normal excretion, with no significant abnormalities observed. However, after injection of testosterone propionate, all rats in the modeling groups developed matted fur, irritability, and hyperactivity, with fighting between cagemates occurring. This was particularly severe in the model control group. The animals in the finasteride and Chinese herbal combination groups fared better than the model control group. No significant abnormalities were observed in the blank group.

[0056] 3.2 Effects of Chinese medicine combination group on prostate wet weight and prostate coefficient in rats There were no statistically significant differences in the initial body weights of the rats in each group. At the end of the experiment, the model control group and all treatment groups showed significant weight reduction compared with the blank control group (P < 0.001, P < 0.01, and P < 0.05, respectively). There was a trend toward increased body weight in each treatment group compared with the model group, but these differences were not statistically significant (P > 0.05).

[0057] Compared with the blank control group, the prostate wet weight of rats in the model control group was significantly increased (P<0.001). Compared with the model group, the prostate wet weight of rats in the finasteride group and the low-, medium-, and high-dose groups of the Chinese medicine composition were significantly decreased (P<0.001, P<0.01, P<0.001, and P<0.01, respectively).

[0058] Compared with the blank control group, the prostate coefficient of the rats in the model control group increased significantly (P<0.001). Compared with the model control group, the prostate coefficients of the finasteride group and the low-, medium-, and high-dose groups of the Chinese medicine composition were significantly decreased (P<0.001, P<0.01, P<0.001, and P<0.01, respectively). The results are shown in Table 1 and Figure 1 、 Figure 2 Table 1. Prostate wet weight and prostate coefficient of each group of rats ± SEM, n = 8).

[0059] Table 1

[0060] Note: Compared with the blank control group, ### P < 0.01, ## P < 0.01, # P < 0.05; compared with the model control group, P < 0.01, P < 0.01, P < 0.05.

[0061] 3.3 Effect of the traditional Chinese medicine composition on the serum androgen levels of BPH rats

[0062] Compared with the blank control group, the serum DHT and T levels of the model control group rats were significantly increased (P < 0.001), and the E2 level and E2 / T ratio were significantly decreased (P < 0.001); compared with the model control group, the serum DHT and T levels of the finasteride group and the traditional Chinese medicine composition low, medium and high dose groups were significantly decreased (P < 0.001), and the E2 level and E2 / T ratio were significantly increased (P < 0.001). As shown in Tables 2 and Figure 3 、 4 , 5, 6. Table 2 shows the effect of the traditional Chinese medicine composition on the serum androgen levels of BPH rats ± SEM, n = 8).

[0063] Table 2

[0064] Note: Compared with the blank control group, ### P < 0.001; compared with the model control group, P < 0.001.

[0065] 3.4 Effect of the traditional Chinese medicine composition on the serum MDA and SOD of BPH rats Compared with the blank control group, the serum MDA level of the model control group was significantly increased (P<0.01); compared with the model control group, the serum MDA level of the finasteride treatment group (P<0.001), the low-dose traditional Chinese medicine composition group (P<0.01), the medium-dose traditional Chinese medicine composition group (P<0.01), and the high-dose traditional Chinese medicine composition group (P<0.01) was significantly decreased. Compared with the blank control group, the serum SOD activity of the model control group was significantly decreased (P<0.001); compared with the model control group, the serum SOD activity of the finasteride treatment group (P<0.01), the low-dose traditional Chinese medicine composition group (P<0.05), the medium-dose traditional Chinese medicine composition group (P<0.01), and the high-dose traditional Chinese medicine composition group (P<0.05) was significantly increased. The results are shown in Tables 3 and Figure 7 、 8 Table 3 shows the effects of the traditional Chinese medicine composition on the MDA and SOD of BPH rats ±SEM, n=8).

[0066] Table 3

[0067] Note: Compared with the blank control group, ### P<0.001, ## P<0.001; compared with the model control group, P<0.001, P<0.01, P<0.05.

[0068] 3.5 Effects of the Traditional Chinese Medicine Composition on IL-6 and IL-8 in the Serum of BPH Rats Compared with the blank control, the IL-6 and IL-8 levels of the model control group were significantly increased (P<0.001). Compared with the model control group, the IL-6 and IL-8 levels of the finasteride treatment group and the low-, medium-, and high-dose traditional Chinese medicine composition groups were significantly decreased (P<0.001, P<0.01, and P<0.05, respectively), indicating that the traditional Chinese medicine composition can inhibit the increase in the IL-6 and IL-8 levels in the serum of the model rats. The results are shown in Tables 4 and Figure 9 、 10 Table 4 shows the effects of the traditional Chinese medicine composition on IL-6 and IL-8 of BPH rats ±SEM, n=8).

[0069] Table 4

[0070] Note: Compared with the blank control group, ###P<0.001; compared with model control group, P<0.001, P<0.01, P<0.05.

[0071] 3.6 Effects of Chinese medicine composition on serum BUN and CRE levels of BPH rats Compared with blank control group, the serum BUN level of model control group was significantly increased (P>0.05); compared with model control group, the BUN level of finasteride treatment group was significantly decreased (P>0.05), and the BUN level of each dose group of Chinese medicine composition had a decreasing trend, but there was no statistical difference (P>0.05). Compared with blank control group, the serum CRE level of model control group had an increasing trend, but there was no statistical difference (P>0.05); the serum CRE level of each treatment group had a certain decreasing trend compared with model group, but there was no statistical difference (P>0.05). The results are shown in Tables 5 and Figure 11 , 12 . Table 5 is the effects of Chinese medicine composition on BUN and CRE of BPH rats ±SEM, n=8).

[0072] Table 5

[0073] Note: compared with blank control group # P<0.05; compared with model control group, P<0.05.

[0074] 3.7 Effects of Chinese medicine composition on serum EGF and IGF-1 levels of BPH rats Compared with blank control group, the serum EGF and IGF-1 levels of model control group were significantly increased (P>0.01); compared with model group, the serum EGF and IGF-1 levels of low and medium dose groups of Chinese medicine composition were significantly decreased (both P>0.05), and the serum EGF and IGF-1 levels of high dose group of Chinese medicine composition had a decreasing trend, but there was no statistical difference (P>0.05). There was no statistical difference between low, medium and high dose groups of Chinese medicine composition and finasteride group (P>0.05). The results are shown in Tables 6 and Figure 13 , 14 . Table 6 is the effects of Chinese medicine composition on EGF and IGF-1 levels of BPH rats ±SEM, n=8).

[0075] Table 6

[0076] Note: compared with the blank control group ### P<0.001; compared with the model control group, P<0.001, P<0.01, P<0.05.

[0077] 4. Result analysis In this experiment, testosterone propionate was used to induce castrated rats to establish a BPH model, the prostate wet weight and prostate coefficient of rats were observed, and the levels of sex hormones, oxidative stress indicators, inflammatory indicators, renal function indicators and two growth factors in the serum of rats were detected by ELISA and other methods. The following conclusions are drawn: 1. The prostate wet weight and prostate coefficient (PI) can directly reflect the degree of prostate hyperplasia, which shows that the BPH model of rats is successfully established, and the traditional Chinese medicine composition has obvious improvement effect on the prostate hyperplasia of rats.

[0078] 2. The levels of DHT and T in the serum of model group rats are significantly higher than those of the blank control group, and after the rats are given the traditional Chinese medicine composition by gavage, the levels of DHT and T in the serum of rats are significantly decreased, which shows that the traditional Chinese medicine composition may have the function similar to 5α-reductase inhibitor, and by improving the increase of T and DHT levels caused by testosterone propionate, it can play a role in inhibiting prostate hyperplasia.

[0079] 3. In this experiment, the level of estradiol (E2) in the serum of rats was detected, and the ratio of E2 and T (E2 / T) was calculated, and the results showed that after modeling, the level of E2 in the serum of rats and the ratio of E2 / T were significantly reduced, which showed that under the condition of castration, by subcutaneous injection of testosterone propionate, the balance of estrogen and androgen in the body of rats was destroyed, so that the prostate tissue of rats was hyperplasia under the action of exogenous hormones. The above results show that the traditional Chinese medicine composition may play a role in treating BPH by regulating the balance of estrogen and androgen in the body.

[0080] 4. After modeling, the levels of inflammatory factors such as IL-6 and IL-8 in the serum of rats were significantly increased, and after treatment with the traditional Chinese medicine composition, the levels of IL-6 and IL-8 in the serum of rats were significantly decreased, which showed that the traditional Chinese medicine composition had a certain inhibitory effect on the inflammatory reaction of prostate.

[0081] 5. After modeling, the levels of EGF and IGF-1 in the serum of rats were significantly increased, and the traditional Chinese medicine composition could significantly decrease the levels of EGF and IGF-1 in the serum of model rats, which showed that the traditional Chinese medicine composition could significantly improve the prostate hyperplasia of rats.

[0082] 6. In this experiment, the rats were injected with testosterone for 28 days, and the renal damage was in the early stage. However, the serum BUN and CRE levels only appear in the middle stage of renal damage. It can be seen that there is no significant difference between the two groups of BUN and CRE data in this experiment.

[0083] 7. The serum SOD activity of rats in the model group was significantly reduced and the MDA content was significantly increased, while the Chinese medicine composition could significantly increase the SOD activity and reduce the MDA content of model rats, indicating that the anti-oxidative stress effect of the Chinese medicine composition is also one of its important mechanisms for improving PBH.

[0084] In summary, the Chinese herbal composition has a significant improvement effect on BPH, and its mechanism of action is related to regulating sex hormone balance, improving oxidative congestion, and inhibiting inflammatory response.

[0085] Example 4 of the present invention is: a traditional Chinese medicine composition for treating benign prostatic hyperplasia, composed of the following raw materials, in parts by weight: 10g of leech, 10g of centipede, 5g of earthworm, 5g of cicada slough, 5g of silkworm pupa, 5g of Achyranthes bidentata, 5g of tangerine peel, 5g of gecko, and 10g of Poria.

[0086] Example 5 of the present invention is: a traditional Chinese medicine composition for treating benign prostatic hyperplasia, composed of the following raw materials, by weight: 6g of leech, 6g of centipede, 2g of earthworm, 2g of cicada slough, 2g of silkworm pupa, 2g of Achyranthes bidentata, 2g of tangerine peel, 2g of gecko, and 6g of Poria.

[0087] Example 6 of the present invention is: a traditional Chinese medicine composition for treating benign prostatic hyperplasia, composed of the following raw materials, by weight: 8g of leech, 8g of centipede, 4g of earthworm, 4g of cicada slough, 4g of silkworm pupa, 4g of Achyranthes bidentata, 4g of tangerine peel, 4g of gecko, and 8g of Poria.

[0088] Comparative Examples 1 to 9 of the present invention are: The only difference between Comparative Examples 1 to 9 and Example 1 is that each of them is a single herb.

[0089] In Examples 1, 4-6, Comparative Examples 1-9, the mice in the positive control group (finasteride group), the model control group (untreated) and the blank group were gavaged with the drug 1 hour after the injection of testosterone propionate. The positive control group was given 31.92 mg of finasteride tablet powder. kg -1 (Contains 1.05mg of finasteride kg -1 ), the embodiment group was given 1.1g powder of the Chinese medicine composition. kg -1 d, the blank group and the model control group are given pure water by gavage, the gavage volume of each group is 10ml / kg, and the continuous gavage is given for 8 weeks.After 8 weeks of treatment, the prostate coefficient, prostate wet weight, maximum urine flow (Qmax) and inflammatory factors are evaluated as evaluation indexes, as shown in Table 7.

[0090] Table 7

[0091] Note: It is significantly different from example 1.

[0092] From table 7, the prostate coefficient and prostate wet weight of the leech group are most significantly different, and the effect of removing blood stasis cannot be replaced; the urine function of the lack of achyranthes bidentata group decreases most obviously, which shows that the “downward drug” is essential to improve the urine function. The prescription works through the multiple target synergistic effect of “breaking stasis (leech / centipede) - tonifying kidney (shelled oyster / silkworm chrysalis) - dredging collaterals (achyranthes bidentata, earthworm) - anti-inflammatory (cicada slough / poria cocos / dried tangerine or orange peel) ”, and the absence of any medicinal flavor will lead to the decrease of curative effect.

[0093] Embodiment 7 of the application is a preparation method of the traditional Chinese medicine composition of embodiment 1, and the specific steps are as follows: S1: separately pulverize the raw materials and pass through a 100-mesh sieve; S2: uniformly mix the raw materials obtained in S1 according to the weight parts to obtain a composition; S3: sterilize the composition obtained in S2 at 180 DEG C for 5s.

[0094] Embodiment 8 of the application is a preparation method of the traditional Chinese medicine composition of embodiment 1, and the specific steps are as follows: S1: separately pulverize the raw materials and pass through a 90-mesh sieve; S2: uniformly mix the raw materials obtained in S1 according to the weight parts to obtain a composition; S3: sterilize the composition obtained in S2 at 140 DEG C for 20s.

[0095] Embodiment 9 of the application is the application of the traditional Chinese medicine composition of embodiment 1 in the preparation of a drug for treating prostatic hyperplasia, and the traditional Chinese medicine composition is a powder.

[0096] In summary, the Chinese medicine composition for treating prostatic hyperplasia and the preparation method and application thereof provided by the present application achieve the effect of treating prostatic hyperplasia by selecting specific compatibility. The leech and centipede are both insect medicines, the leech is good at breaking blood and removing blood stasis and removing stasis and knot, the centipede is good at dredging collaterals, the two are combined to enhance the dispersing power and serve as the monarch drug. The earthworm assists the monarch drug in activating blood and dredging collaterals, and diuresis and removes stranguria; the ox knee removes blood stasis and dredges channels, diuresis and removes stranguria, leads the medicine downward to the disease site, at the same time, supplements the liver and kidney to protect the healthy qi, relieves the attacking nature of the monarch drug, and serves as the minister drug. The tangerine peel regulates qi and removes stagnation, eliminates qi stagnation, enhances the effect of activating blood, dries dampness and reduces phlegm, prevents dampness from being generated by blood stasis, the toad's placenta supplements the kidney and assists yang, targets the root of kidney deficiency, and forms the treatment of both the root and the branch with the monarch drug; the periostracum cicadae is cold and light, restrains the warm and dry nature of the leech and the centipede, and prevents the consumption of yin blood, the silkworm chrysalis and the poria cocos invigorate the spleen and supplement deficiency, restrain the damage of the insect medicine to the healthy qi, regulate the spleen and stomach, and serve as the auxiliary drug. The drugs are combined to play the roles of activating blood and removing stasis, removing knot and removing stasis, supplementing the kidney and tonifying qi, removing dampness and removing stranguria, and regulating qi movement.

[0097] The above description is only the embodiment of the present application, and does not limit the patent scope of the present application, and any equivalent transformation or direct or indirect application in the related technical field by using the content of the specification and the drawings of the present application is also included in the patent protection scope of the present application.

Claims

1. A Chinese medicine composition for treating benign prostatic hyperplasia, characterized in that: The preparation comprises the following raw materials in parts by weight: 5-10 parts of leeches, 5-10 parts of centipedes, 2-5 parts of earthworms, 2-5 parts of cicada shells, 2-5 parts of silkworm pupae, 2-5 parts of Achyranthes bidentata, 2-5 parts of tangerine peel, 2-5 parts of geckos, and 5-10 parts of Poria cocos.

2. The Chinese medicine composition for treating benign prostatic hyperplasia according to claim 1, characterized in that The invention comprises the following raw materials in parts by weight: 5-7 parts of leeches, 5-7 parts of centipedes, 3-5 parts of earthworms, 3-5 parts of cicada shells, 3-5 parts of silkworm pupae, 3-5 parts of Achyranthes bidentata, 3-5 parts of tangerine peel, 3-5 parts of geckos, and 5-7 parts of Poria cocos.

3. The Chinese medicine composition for treating benign prostatic hyperplasia according to claim 1, characterized in that The preparation comprises the following raw materials in parts by weight: 5 parts of leeches, 5 parts of centipedes, 3 parts of earthworms, 3 parts of cicada shells, 3 parts of silkworm pupae, 3 parts of Achyranthes bidentata, 3 parts of tangerine peel, 3 parts of geckos, and 5 parts of Poria cocos.

4. The method for preparing the Chinese medicine composition for treating benign prostatic hyperplasia according to any one of claims 1 to 3, wherein: The following steps are involved: S1: crushing the raw materials separately and sieving; S2: uniformly mixing the raw materials obtained in S1 according to parts by weight to obtain a composition; S3: Sterilize the composition obtained in S2.

5. The method for preparing the Chinese medicine composition for treating benign prostatic hyperplasia according to claim 4, wherein: The pulverization method in S1 is shear pulverization or ultrafine pulverization.

6. The method for preparing the Chinese medicine composition for treating benign prostatic hyperplasia according to claim 4, wherein: The mesh size of the sieve in S1 is 80-100 meshes.

7. The method for preparing the Chinese medicine composition for treating benign prostatic hyperplasia according to claim 4, wherein: The sterilization treatment in S3 is carried out by high-temperature instantaneous sterilization.

8. The method for preparing the Chinese medicine composition for treating benign prostatic hyperplasia according to claim 7, wherein: The sterilization treatment in S3 is carried out at 140-180° C. for 5-20 seconds.

9. Use of the traditional Chinese medicine composition for treating benign prostatic hyperplasia according to any one of claims 1 to 3 in the preparation of a medicament for treating benign prostatic hyperplasia.

10. The use according to claim 9, characterized in that The Chinese medicine composition is any one of oral liquid, granules, powders, capsules, granules, tablets and pills.

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