A traditional Chinese medicine composition for treating prostatic hypertrophy and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for auxiliary treatment of prostatic hypertrophy and a preparation method thereof. The traditional Chinese medicine composition is prepared from Uncaria, ethanol extract of Dehaasia bibracteata, Akebia quinata, Nelumbo nucifera, Crossandra infundibuliformis, Rosmarinus officinalis, Prunus armeniaca, Cinnamomum cassia and Salvia officinalis by processing. The traditional Chinese medicine composition has the effect of treating prostatic hypertrophy. The traditional Chinese medicine composition is mainly used for prostatic hypertrophy, and the symptoms include frequent urination, urgent urination and incomplete urination. The traditional Chinese medicine composition can reduce the prostate index of a patient with prostatic hypertrophy, regulate the sex hormone level, reduce the prostate phosphatase activity, and has a remarkable effect on treating the problems of frequent urination, urgent urination and incomplete urination caused by prostatic hypertrophy. Meanwhile, the composition is prepared from traditional Chinese medicines as raw materials, is safe to use, has high bioavailability, and has no any toxic and side effects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and in particular to a traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia and its preparation method. Background Technology

[0002] Benign prostatic hyperplasia (BPH), also known as enlarged prostate, is a common disease among elderly men. Symptoms mainly manifest in two groups: bladder irritation symptoms and obstructive symptoms caused by the enlarged prostate blocking the urinary tract. Bladder irritation symptoms include urinary frequency, urgency, increased nocturia, and urge incontinence. Urinary frequency is an early sign of BPH, especially increased nocturia, which is clinically significant. The disease has three main characteristics: enlarged prostate; bladder outlet obstruction; and lower urinary tract symptoms such as difficulty urinating, urinary frequency, and urgency.

[0003] In normal men, as they age, all organs and tissues atrophy, except for the prostate, which enlarges. Long-term enlargement can lead to hydronephrosis and kidney damage, as well as complications such as stones, infections, and tumors. The pathogenesis of benign prostatic hyperplasia (BPH) is still unclear, and the causes are unknown, with a trend towards affecting younger people. The prostate is the only gland in the human body without blood vessels; injections, oral medications, and intravenous infusions are ineffective. Currently, there is no cure for patients diagnosed with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC). Current treatments primarily involve oral small-molecule hormones and chemotherapy. Previous treatments using traditional Chinese medicine, Western medicine, and surgery have serious drawbacks. These include: 1. Significant side effects from Western medicine: damage to the liver and kidneys, exacerbation of underlying diseases, and worsening of BPH with treatment; 2. Surgical treatment only addresses the symptoms, not the root cause, with a high recurrence rate, high cost, and significant pain; recurrence makes further surgery difficult; 3. Oral Chinese medicine, patches, physical therapy, and external suppositories often have unscientific formulations and are ineffective. Therefore, there is an urgent need to find a treatment method that has no side effects and is easy to use. Summary of the Invention

[0004] In view of the above-mentioned deficiencies in the prior art, the present invention proposes a traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia and its preparation method, so as to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution:

[0006] A traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia (BPH) comprises the following raw materials in parts by weight: 15-20 parts of Uncaria rhynchophylla (Miq.) Miq. ex Havil., 10-20 parts of ethanol extract of the root and rhizome of Alangium chinense subsp. pauciflorum, 5-15 parts of Stauntonia hexaphylla (Thunb.) Decne. var. urophylla Hand.-Mazz. and S. chinensis DC. (used medicinally as roots or whole plant), 8-18 parts of lotus receptacle (dried receptacle of Nelumbo nucifera, Nymphaeaceae), and 2-9 parts of Physalis alkekengi (Solanaceae). (dried persistent calyx or persistent calyx with fruit of *alkekengi* L. var. *Franchetii* (Mast.) Makino), 3–12 parts rosemary, 3–10 parts sweet almond, 2–6 parts cinnamon, 2–7 parts clary sage.

[0007] Preferably, a traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia includes the following raw materials in parts by weight: 18 parts Uncaria rhynchophylla, 15 parts Acer buergerianum ethanol extract, 10 parts Akebia quinata and Acer palmatum, 12 parts Nelumbo nucifera receptacle, 7 parts Physalis alkekengi, 10 parts Rosemary, 5 parts Sweet Almond, 4 parts Cinnamomum cassia, and 5 parts Clary Sage.

[0008] Preferably, the preparation method of the rare-flowered Acer buergerianum ethanol extract includes the following steps:

[0009] (1) Using dried roots and rhizomes of Illicium verum as raw materials, crush them and put them into an extraction tank; add 85-95% ethanol, and extract by vacuum heating and reflux at a vacuum degree of -0.08 to -0.1 MPa and a temperature of 50-80℃. The volume of ethanol used is 4-6 times that of the raw material. Extract 2-4 times, and the extraction time is 30-50 min each time to obtain the extract.

[0010] (2) Combine the extracts obtained in step (1) and then concentrate them under reduced pressure. Concentration conditions: vacuum range -0.08 to -0.1 MPa, temperature 60 to 75℃, concentration for 1 to 3 hours to obtain concentrated solution.

[0011] (3) Centrifuge the concentrate obtained in step (2) and separate it by sedimentation at a speed of 4000-5000 r / min and a centrifugation time of 100-150 min. Take the supernatant.

[0012] (4) The supernatant after sedimentation is passed through an HPD-100 macroporous adsorption resin column, washed with purified water until the effluent is neutral, and then eluted with 60-75% ethanol solution. The ethanol eluent is collected in 2-4 column volumes. The mass ratio of HPD-100 macroporous adsorption resin to raw material is 1:15-20.

[0013] (5) The ethanol eluent obtained in step (4) is concentrated under reduced pressure at 60-75℃ and -0.06-0.08MPa to a relative density of 1.10-1.50. The concentrate is then left to stand for 5-10 hours, filtered with 0.45μm filter paper, and finally dried under vacuum for 2-3 hours to obtain the ethanol extract of Acer buergerianum.

[0014] Preferably, the main component of the ethanol extract of Illicium verum is β-carotene.

[0015] Preferably, a method for preparing a traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia involves pulverizing the raw materials in the specified weight proportions to 80 mesh, extracting with water 2-4 times, adding 15-20 times the weight of water to the raw materials each time, decocting for 1-3 hours, filtering through a 200-mesh sieve and combining the filtrates, concentrating the filtrate to an extract with a relative density of 1.00-1.25, drying for 1.5 hours, and then pulverizing to obtain the traditional Chinese medicine composition.

[0016] Preferably, the traditional Chinese medicine composition is used in the preparation of a drug for treating benign prostatic hyperplasia.

[0017] Existing technology: The traditional Chinese medicine (TCM) is prepared using the patent application CN109793866A, entitled "A TCM for Treating Male Prostate Diseases and its Preparation Method." The formula consists of: honeysuckle 18-22g, houttuynia cordata 13-17g, poria cocos 9-11g, peach kernel 9-11g, polygonatum sibiricum 4-6g, alpinia oxyphylla 4-6g, monk fruit 4-6g, clove 4-6g, cinnamon 4-6g, white hyacinth bean 2-4g, cassia seed 2-4g, nutmeg 2-4g, sea buckthorn 2-4g, oyster shell 0.5-1.5g, chicken gizzard lining 0.5-1.5g, and kelp 0.5-1.5g. The applicant has conducted research and experiments on the above existing technology and found that the efficacy of this TCM in treating prostate diseases is not ideal. Therefore, the applicant is developing a TCM composition for adjuvant treatment of benign prostatic hyperplasia (BPH), which could provide a new treatment method for this problem.

[0018] Compared with the prior art, the beneficial effects of the present invention are:

[0019] (1) The traditional Chinese medicine composition of the present invention can reduce the prostate index of patients with benign prostatic hyperplasia, regulate the level of sex hormones, reduce the activity of prostatic phosphatase, and has a significant effect on treating urinary frequency, urgency and incomplete urination caused by benign prostatic hyperplasia. At the same time, the composition is made of traditional Chinese medicine as raw material, is safe to use, has high bioavailability and no toxic side effects.

[0020] (2) Uncaria rhynchophylla and Illicium verum are classic medicines in Miao traditional medicine. Illicium verum contains chenopogonin, which is toxic to the human body, thus limiting the scope of use of Illicium verum. This application provides a new use for Uncaria rhynchophylla and Illicium verum by making reasonable combination of formulas and giving full play to the active ingredients contained in traditional Chinese medicine, mainly including polyphenols, flavonoids and polysaccharides. Detailed Implementation

[0021] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0022] Example 1

[0023] A traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia includes the following raw materials in parts by weight: 15 parts Uncaria rhynchophylla, 10 parts Acer buergerianum ethanol extract, 5 parts Akebia quinata and Acer palmatum, 8 parts Nelumbo nucifera receptacle, 2 parts Physalis alkekengi, 3 parts Rosemary, 3 parts Almond, 2 parts Cinnamomum cassia, and 2 parts Clary sage.

[0024] The preparation steps of the ethanol extract of Illicium verum (a type of variegated maple) are as follows:

[0025] (1) Using dried Acer buergerianum root and rhizome as raw material, crush and put into an extraction tank; add 85% ethanol, and extract by vacuum heating and reflux at a vacuum degree of -0.08MPa and a temperature of 50℃. The volume of ethanol used is 4 to 6 times that of the raw material. Extract twice, each time for 30 min, to obtain the extract.

[0026] (2) Combine the extracts obtained in step (1) and concentrate them under reduced pressure. Concentration conditions: vacuum range -0.08MPa, temperature 60℃, concentration for 1h to obtain concentrated solution.

[0027] (3) Centrifuge the concentrate obtained in step (2) and separate it by sedimentation at a speed of 4000 r / min and a centrifugation time of 100 min. Take the supernatant.

[0028] (4) The supernatant after sedimentation is passed through an HPD-100 macroporous adsorption resin column, washed with purified water until the effluent is neutral, and then eluted with 60% ethanol solution. The ethanol eluent is collected at a volume of 2 times the column volume. The mass ratio of HPD-100 macroporous adsorption resin to raw material is 1:15.

[0029] (5) The ethanol eluent obtained in step (4) is concentrated under reduced pressure at 60°C and -0.06MPa to a relative density of 1.10. The concentrate is then left to stand for 5 hours, filtered with 0.45μm filter paper, and finally dried under vacuum for 2 hours to obtain the ethanol extract of Acer buergerianum.

[0030] A method for preparing a traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia involves pulverizing the raw materials in the specified weight parts to 80 mesh, extracting them twice with water, adding 15 times the weight of water to the raw materials each time, decocting for 1 hour, filtering through a 200-mesh sieve and combining the filtrates, concentrating the filtrate to an extract with a relative density of 1.00, drying for 1.5 hours, and then pulverizing to obtain the traditional Chinese medicine composition.

[0031] Example 2

[0032] A traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia includes the following raw materials in parts by weight: 20 parts Uncaria rhynchophylla, 20 parts Illicium verum ethanol extract, 15 parts Akebia quinata and Acer palmatum, 18 parts Nelumbo nucifera receptacle, 9 parts Physalis alkekengi, 12 parts Rosemary, 10 parts Sweet Almond, 6 parts Cinnamomum cassia, and 7 parts Clary Sage.

[0033] The preparation steps of the ethanol extract of Illicium verum (a type of variegated maple) are as follows:

[0034] (1) The dried roots and rhizomes of the rare-flowered maple were crushed and put into an extraction tank. 95% ethanol was added, and the extraction was carried out under reduced pressure and reflux. The extraction was carried out at a vacuum of -0.1 MPa and a temperature of 80°C. The volume of ethanol used was 6 times that of the raw material. The extraction was carried out 4 times, and the extraction time was 50 min each time to obtain the extract.

[0035] (2) Combine the extracts obtained in step (1) and then concentrate them under reduced pressure. Concentration conditions: vacuum range -0.1MPa, temperature 75℃, concentration for 3h to obtain concentrated solution.

[0036] (3) Centrifuge the concentrate obtained in step (2) and separate it by sedimentation at a speed of 5000 r / min and a centrifugation time of 150 min. Take the supernatant.

[0037] (4) The supernatant after sedimentation is passed through an HPD-100 macroporous adsorption resin column, washed with purified water until the effluent is neutral, and then eluted with 75% ethanol solution. The ethanol eluent is collected in a gradient of 4 column volumes. The mass ratio of HPD-100 macroporous adsorption resin to raw material is 1:20.

[0038] (5) The ethanol eluent obtained in step (4) is concentrated under reduced pressure at 75°C and -0.08 MPa to a relative density of 1.50. The concentrate is then left to stand for 10 hours, filtered with 0.45 μm filter paper, and finally dried under vacuum for 3 hours to obtain the ethanol extract of Acer buergerianum.

[0039] A method for preparing a traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia involves pulverizing the raw materials in the specified weight proportions to 80 mesh, extracting them with water four times, adding 20 times the weight of water to the raw materials each time, decocting for 3 hours, filtering through a 200-mesh sieve and combining the filtrates, concentrating the filtrate to an extract with a relative density of 1.25, drying for 1.5 hours, and then pulverizing to obtain the traditional Chinese medicine composition.

[0040] Example 3

[0041] A traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia includes the following raw materials in parts by weight: 18 parts Uncaria rhynchophylla, 15 parts Acer buergerianum ethanol extract, 10 parts Akebia quinata and Acer palmatum, 12 parts Nelumbo nucifera receptacle, 7 parts Physalis alkekengi, 10 parts Rosemary, 5 parts Sweet Almond, 4 parts Cinnamomum cassia, and 5 parts Clary Sage.

[0042] The preparation steps of the ethanol extract of Illicium verum (a type of variegated maple) are as follows:

[0043] (1) The dried roots and rhizomes of the rare-flowered maple were crushed and put into an extraction tank. 90% ethanol was added, and the extraction was carried out under reduced pressure and reflux. The extraction was carried out at a vacuum of -0.09 MPa and a temperature of 60°C. The volume of ethanol used was 5 times that of the raw material. The extraction was carried out 3 times, and the extraction time was 40 min each time to obtain the extract.

[0044] (2) Combine the extracts obtained in step (1) and then concentrate them under reduced pressure. Concentration conditions: vacuum range -0.09MPa, temperature 70℃, concentration for 2h to obtain concentrated solution.

[0045] (3) Centrifuge the concentrate obtained in step (2) and separate it by sedimentation at a speed of 4500 r / min and a centrifugation time of 120 min. Take the supernatant.

[0046] (4) The supernatant after sedimentation is passed through an HPD-100 macroporous adsorption resin column, washed with purified water until the effluent is neutral, and then eluted with 70% ethanol solution. The ethanol eluent is collected in a gradient of 3 column volumes. The mass ratio of HPD-100 macroporous adsorption resin to raw material is 1:18.

[0047] (5) The ethanol eluent obtained in step (4) is concentrated under reduced pressure at 70°C and -0.07 MPa to a relative density of 1.25. The concentrate is then left to stand for 8 hours, filtered with 0.45 μm filter paper, and finally dried under vacuum for 2-2.5 hours to obtain the ethanol extract of Acer buergerianum.

[0048] A method for preparing a traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia involves pulverizing the raw materials in the specified weight proportions to 80 mesh, extracting them with water three times, adding 18 times the weight of water to the raw materials each time, decocting for 2 hours, filtering through a 200-mesh sieve and combining the filtrates, concentrating the filtrate to an extract with a relative density of 1.15, drying for 1.5 hours, and then pulverizing to obtain the traditional Chinese medicine composition.

[0049] Comparative Example 1

[0050] The difference between this comparative example and Example 3 is that Uncaria rhynchophylla is not added to the herbal composition, while the other ingredients and steps remain unchanged.

[0051] A traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia includes the following raw materials in parts by weight: 15 parts of ethanol extract of Illicium verum, 10 parts of Akebia quinata and Achyranthes bidentata, 12 parts of lotus seedpod, 7 parts of Physalis alkekengi, 10 parts of rosemary, 5 parts of sweet almond, 4 parts of cinnamon, and 5 parts of clary sage.

[0052] Comparative Example 2

[0053] The difference between this comparative example and Example 3 is that Akebia quinata and Akebia trifoliata are not added to the Chinese herbal composition, while the other ingredients and steps remain unchanged.

[0054] A traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia includes the following raw materials in parts by weight: 18 parts Uncaria rhynchophylla, 15 parts Acer odorata ethanol extract, 12 parts Nelumbo nucifera receptacle, 7 parts Physalis alkekengi, 10 parts Rosemary, 5 parts Sweet Almond, 4 parts Cinnamomum cassia, and 5 parts Clary Sage.

[0055] Comparative Example 3

[0056] The difference between this comparative example and Example 3 is that lotus seedpods are not added to the traditional Chinese medicine composition, while the other ingredients and steps remain unchanged.

[0057] A traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia includes the following raw materials in parts by weight: 18 parts Uncaria rhynchophylla, 15 parts Illicium verum ethanol extract, 10 parts Akebia quinata and Acer palmatum, 7 parts Physalis alkekengi, 10 parts Rosemary, 5 parts Sweet Almond, 4 parts Cinnamomum cassia, and 5 parts Clary Sage.

[0058] Comparative Example 4

[0059] The traditional Chinese medicine was prepared using the patent application CN109793866A, which discloses the name "A Traditional Chinese Medicine for Treating Male Prostate Diseases and its Preparation Method". The formula of the traditional Chinese medicine is as follows: honeysuckle 18-22, houttuynia cordata 13-17, poria cocos 9-11, peach kernel 9-11, polygonatum 4-6, alpinia oxyphylla 4-6, monk fruit 4-6, clove 4-6, cinnamon 4-6, white hyacinth bean 2-4, cassia seed 2-4, nutmeg 2-4, sea buckthorn 2-4, oyster shell 0.5-1.5, chicken gizzard lining 0.5-1.5, and kelp 0.5-1.5.

[0060] Effect of Experiment 1 on the Benign Prostatic Hyperplasia Model

[0061] 1. Materials

[0062] Animals: 105 male SPF-grade SD rats, weighing 180–200g, were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. During the rearing process, the room temperature was maintained at 24℃, with a 12-hour light cycle, good air circulation, and free access to food and water. Adaptation feeding was carried out for 7 days.

[0063] Drugs: The traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-4 of this invention; chloral hydrate, Tianjin Tianli Chemical Reagent Co., Ltd.; testosterone propionate injection, 1ml:25mg, approval number: Veterinary Drug Approval No. 110251054, purchased from Ningbo Second Hormone Factory; estradiol benzoate (E2) injection, purchased from Ningbo Second Hormone Factory; finasteride tablets, 5mg / tablet, approval number: National Drug Approval No. J20150143, purchased from Hangzhou Merck & Co., Ltd.; gentamicin sulfate injection, purchased from Tianjin Jinyao Pharmaceutical Co., Ltd.; 4% paraformaldehyde, purchased from Beijing Solarbio Biotechnology Co., Ltd. Estrogen / androgen (E2 / T) 1:100 mixture: The E2 concentration in the mixture is 100 μg / mL, that is, each 100 mL of the mixture contains 10 mL of estradiol benzoate injection (E2, 1 mg / mL) and 40 mL of testosterone propionate injection (T, 25 mg / mL), as well as 50 mL of olive oil. After mixing, store at room temperature and prepare once a week.

[0064] 2. Test Methods

[0065] 2.1 Modeling and Grouping

[0066] After one week of acclimatization, rats were anesthetized with 0.3 mL / 100 g of 10% chloral hydrate via intraperitoneal injection. Ninety-five rats were randomly selected. After disinfection of the scrotal skin, both testes were removed and sutured. The remaining 10 rats underwent sham surgery (following the surgical procedure, exposing the testes; except for not removing the testes, the rest of the procedure was the same as for rat castration), and sutured. Then, penicillin 200,000 U / kg / day was injected for 7 consecutive days.

[0067] On day 8 after modeling, 90 rats with good recovery were selected from the rats that had undergone bilateral testectomy and randomly divided into 9 groups: the model control group, the finasteride positive control group, the Example 1-3 groups, and the Comparative Example 1-4 groups, with 10 rats in each group; the sham-operated group served as the blank control group. Except for the blank control group, the other groups were subcutaneously injected with a 1:100 estrogen / androgen (E2 / T) mixture at a dose of 0.5 ml / kg, once a day for 30 consecutive days. The blank control group was injected with an equal volume of solvent olive oil.

[0068] 2.2 Administration Method

[0069] Starting from day 8, groups 1-3 and Comparative Example 1 were administered the drug prepared in Examples 1-3 and Comparative Example 1 at a dose of 1.35 g / kg / day (equivalent to 0.5 times the human clinical dose); the finasteride positive control group received 0.83 mg / kg / day (equivalent to 10 times the clinical dose), and the model control group received sterile water. All administrations were performed by gavage for 30 consecutive days (with body weight measured weekly during the administration period to adjust the dosage).

[0070] 2.3 Specimen Collection

[0071] After the last administration, the rats were fasted for 12 hours, and their body weight was weighed. Blood was collected from the orbital sinus, centrifuged, and the serum was collected and stored at -20°C. The rats were euthanized by cervical dislocation, the abdominal cavity was immediately opened, the tissue surrounding the prostate was dissected, the prostate was removed, and its weight was quickly measured. The tissue was stored at -80°C.

[0072] 2.4 Index Measurement

[0073] 2.4.1 Measurement of the prostate index

[0074] The calculation formula is: Prostate Index = Prostate Wet Mass / Body Mass (mg / g)

[0075] 2.4.2 Measurement of sex hormone levels

[0076] Rat serum was collected, and the concentrations of testosterone (T), dihydrotestosterone (DHT), and estradiol injection (E2) in the serum were determined by enzyme-linked immunosorbent assay (ELISA) at a wavelength of 450 nm according to the instructions.

[0077] 2.4.3 Detection of prostatic phosphatase (PACP) in rats

[0078] PACP activity in serum was detected according to the PACP kit procedure.

[0079] 3. Test Results

[0080] The results are shown in Tables 1, 2, and 3:

[0081] Table 1. Measurement of Prostate Index

[0082]

[0083] Table 1 shows that, compared with the blank control group, the wet weight of the prostate and the prostate index of the rats in the model control group were increased, indicating that the benign prostatic hyperplasia (BPH) model was successfully established. Compared with the model control group, the finasteride positive control group, Examples 1-3, and Comparative Examples 1-4 all reduced the prostate index, with Example 3 showing the best effect. The experimental results indicate that the drug of the present invention can treat BPH, and the formulation of Example 3 has the optimal ratio.

[0084] Table 2. Measurement of sex hormone levels

[0085]

[0086]

[0087] Table 2 shows that, compared with the blank control group, the prostate T level in the model control group was significantly decreased, while the prostate DHT and E2 levels were increased, indicating that the rat model of benign prostatic hyperplasia (BPH) was successfully established. Compared with the model control group, the prostate T level was increased and the prostate DHT and E2 levels were decreased in the finasteride positive control group and comparative groups 1-4. The traditional Chinese medicine compositions prepared in Examples 1-3 of this invention can increase the prostate T level in rats and decrease the prostate DHT and E2 levels, indicating that the traditional Chinese medicine compositions have an inhibitory effect on benign prostatic hyperplasia.

[0088] Table 3 Effects on PACP activity in rat serum

[0089]

[0090] Table 3 shows that, compared with the blank control group, the PACP activity in the serum of rats in the model control group was increased. Compared with the model control group, the PACP activity in the serum of rats in Examples 1-3, the finasteride positive control group, and the comparative examples 1-4 were all reduced, indicating that the drug of the present invention has a certain inhibitory effect on prostate tissue growth.

[0091] Effect of Experiment 2 on Urine Output in Rats

[0092] 2.1 Test Materials

[0093] Animals: Forty SPF-grade male SD rats, weighing 180–200g. Drugs: The traditional Chinese medicine compositions prepared in Examples 1–3.

[0094] 2.2 Test Methods

[0095] Male SD rats were randomly divided into 4 groups, with 10 rats in each group. Before the experiment, the rats were fasted for 16 hours but allowed free access to water. Each group received an intraperitoneal injection of physiological saline at a dose of 20 ml / kg body weight, and the bladder was emptied by gentle pressure on the lower abdomen. The rats were then administered the drug via gavage. In Examples 1-3, the gavage dose was 1.0 ml / kg; the control group received the same volume of physiological saline via gavage. Immediately after administration, the rats were placed in metabolic cages, and the total urine volume within 6 hours was collected according to the rat metabolic cage experiment method.

[0096] 2.3 Test Results

[0097] The results are shown in Table 4:

[0098] Table 4 Effects on urine output in rats

[0099]

[0100] As shown in Table 4, compared with the control group, the urine output of rats in Examples 1-3 increased within 6 hours after administration, indicating a diuretic effect in rats.

[0101] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia, characterized in that, It is made from the following ingredients in parts by weight: 15-20 parts Uncaria rhynchophylla, 10-20 parts Acer buergerianum ethanol extract, 5-15 parts Akebia quinata and Acer palmatum, 8-18 parts Nelumbo nucifera receptacle, 2-9 parts Physalis alkekengi, 3-12 parts Rosemary, 3-10 parts Sweet Almond, 2-6 parts Cinnamomum cassia, and 2-7 parts Clary Sage. The preparation steps of the rare-flowered Acer buergerianum ethanol extract are as follows: (1) Using dried roots and rhizomes of Illicium verum as raw materials, crush them and put them into an extraction tank; add 85-95% ethanol, and extract by vacuum heating and reflux at a vacuum degree of -0.08--0.1MPa and a temperature of 50-80℃. The volume of ethanol used is 4-6 times that of the raw material. Extract 2-4 times, and each extraction time is 30-50 min to obtain the extract. (2) Combine the extracts obtained in step (1) and then concentrate them under reduced pressure. Concentration conditions: vacuum range -0.08~-0.1MPa, temperature 60~75℃, concentration for 1~3h to obtain concentrated solution; (3) Centrifuge the concentrate obtained in step (2) at a speed of 4000~5000 r / min and a centrifugation time of 100~150 min, and collect the supernatant. (4) The supernatant after sedimentation and separation is passed through an HPD-100 macroporous adsorption resin column, washed with purified water until the effluent is neutral, and then eluted with 60-75% ethanol solution. The ethanol eluent is collected in 2-4 column volumes. The mass ratio of HPD-100 macroporous adsorption resin to raw material is 1:15-20. (5) The ethanol eluent obtained in step (4) is concentrated under reduced pressure at 60~75℃ and -0.06~-0.08MPa to a relative density of 1.10~1.

50. The concentrate is then left to stand for 5~10h, filtered, and finally dried under vacuum to obtain the ethanol extract of Acer buergerianum.

2. The traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia according to claim 1, characterized in that, It is made from the following ingredients in parts by weight: 18 parts Uncaria rhynchophylla, 15 parts Illicium verum ethanol extract, 10 parts Akebia quinata, 12 parts Nelumbo nucifera receptacle, 7 parts Physalis alkekengi, 10 parts Rosemary, 5 parts Sweet Almond, 4 parts Cinnamon, and 5 parts Clary Sage.

3. The use of the traditional Chinese medicine composition for adjuvant treatment of benign prostatic hyperplasia as described in claim 1 in the preparation of a drug for treating benign prostatic hyperplasia.

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