CN115317550A - Traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome and preparation method and application thereof - Google Patents

Traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome and preparation method and application thereof Download PDF

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CN115317550A
CN115317550A CN202211037574.7A CN202211037574A CN115317550A CN 115317550 A CN115317550 A CN 115317550A CN 202211037574 A CN202211037574 A CN 202211037574A CN 115317550 A CN115317550 A CN 115317550A
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traditional chinese
chinese medicine
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王�琦
郑燕飞
陈国松
黄立明
董丽丹
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Shenzhen Shuangbai Kang Pharmaceutical Technology Co ltd
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Shenzhen Shuangbai Kang Pharmaceutical Technology Co ltd
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Abstract

The invention relates to a traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome and a preparation method and application thereof, and the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2 to 100 portions of bupleurum, 2 to 100 portions of trichosanthes root, 1 to 80 portions of angelica, 1 to 80 portions of peach kernel, 2 to 120 portions of safflower, 3 to 80 portions of sargentgloryvine stem, 2 to 80 portions of dahurian patrinia herb, 2 to 80 portions of combined spicebush root, 2 to 70 portions of rhizoma corydalis and 4 to 80 portions of giant knotweed. The 10 traditional Chinese medicines are scientifically combined according to the theory of traditional Chinese medicines and the results of dialectical treatment and modern pharmaceutical research, and have the effects of clearing heat and cooling blood, activating blood and dissolving stasis, and promoting qi circulation and relieving pain on chronic prostatitis/chronic pelvic pain syndrome.

Description

Traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome and preparation method and application thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome as well as a preparation method and application thereof.
Background
Prostatitis has been a common and confusing disease. This disease is most common in adults, and less frequent in adolescence, and about 25% of the disease incidence was reported by Lipsky (1989) between 1977 and 1978. The incidence of chronic prostatitis is higher. Prostatitis is a common disease for adult men. It can occur in adult men of all ages, and almost 50% of men have been affected by prostatitis at some time during their lives. The prostatitis patient accounts for 8-25% of the urinary surgery outpatient. Most patients are dissatisfied with the treatment effect of the disease, and many doctors feel unsmooth in the process of treating prostatitis. At present, it is recognized that prostatitis is not a disease, but has individual and distinct forms of syndrome, each of which has a distinct cause, clinical features and outcome. It is only possible to obtain good results if they are diagnosed accurately and given appropriate therapeutic measures.
Drach tests 10ml of initial urine before prostate massage (voided bladder one, VB 1), 10ml of mid-stream urine (voided t bladdm two, VB 2), 10ml of prostate massage solution (EPS), and 10ml of urine after prostate massage (voided bladder three, VB 3) according to the "four-cup method" proposed by Mearea-Stamey for localized diagnosis of lower urinary tract bacterial infection. According to the number of leucocytes and the bacterial culture results in four specimens, prostatitis was classified as: acute Bacterial Prostatitis (ABP), chronic Bacterial Prostatitis (CBP), chronic nonbacterial prostatitis (CNBP), prostadynia (PD). The Drach classification reflects the recognition that infection is the main cause of prostatitis, and is the first normative classification of prostatitis, called the traditional classification. However, prostadynia is a vague concept, and there are still associated diseases that are not known or detected, and the classification method is not accurate enough.
The National Institutes of Health (NIH) developed a new classification in 1995 based on the basic and clinical studies of prostatitis: type I corresponds to ABP in the traditional classification, type II corresponds to CBP in the traditional classification, type III chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) corresponds to CNBP in the traditional classification, type III is divided into two subtypes of inflammatory IIIA and non-inflammatory IIIB. Type IV, asymptomatic prostatitis (AIP). The NIH classification was officially approved by the International Prostatitis Collaborative Network (IPCN) in 1998 after 3 years of clinical research and application. This is the currently clinically accepted method of classification of prostatitis. Among them, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS, type iii) is the most common type of prostatitis, accounting for about 90% or more of chronic prostatitis. It is mainly manifested as long-term, recurrent pain or discomfort in the pelvic region, lasting for more than 3 months, which can be accompanied by varying degrees of micturition symptoms and sexual dysfunction, seriously affecting the quality of life of the patient. This type can be further divided into two subtypes, IIIA (inflammatory CPPS) and IIIB (non-inflammatory CPPS).
CP/CPPS has complex etiology, and the pathogenesis is not completely clarified so far, so that no clear treatment scheme is provided, and most of CP/CPPS are empirical treatment. The therapeutic goals are mainly pain relief, improvement of urination symptoms and improvement of quality of life. The three most commonly used drugs in clinic are antibiotics, alpha receptor blockers and non-steroidal anti-inflammatory analgesics, and other treatments are M receptor blockers, botanicals, chinese traditional medicine, antidepressants, anxiolytics, prostate massage, biofeedback and hyperthermia. The single treatment method has unsatisfactory effect, and one treatment method is mainly adopted and is supplemented with the comprehensive treatment of other treatment methods. The IIIA type recommends that the antibiotic is firstly applied for 2-4 weeks, and simultaneously the alpha receptor blocker, the non-steroidal anti-inflammatory analgesic, the M receptor blocker and the plant preparation are applied. The traditional Chinese medicine, the prostate massage and other means are selected as auxiliary treatment. IIIB recommends the use of alpha-blockers (12 weeks), non-steroidal anti-inflammatory analgesics, galenicals, M-blockers and prostate massage as an aid, if necessary psychotherapy and antidepressants and anxiolytics.
Classic traditional Chinese medicine is not described in the book of traditional Chinese medicine, but its manifestations are characterized by pain and abnormal urination in lower abdomen, perineum, lumbosacral and other parts, so it can be roughly classified into categories of lumbago, abdominal pain, stranguria and dysuria. In combination with the knowledge of doctors of all generations, it is generally considered that the pathogenesis of this disease is mostly due to damp, heat, cold, stasis, depression, deficiency and other six aspects, and the disease is complicated by cold, heat, deficiency and excess.
In view of the shortcomings of the traditional Chinese and western medicine in the treatment of CP/CPPS, the Chinese patent medicines for treating CP/CPPS on the market are basically listed before the name of the disease is determined, and the description of the indications in the specification is not specific to the disease. However, many clinically effective decoction prescriptions in real world treatment cannot be developed into new traditional Chinese medicines due to the problem of pharmacy. Therefore, a drug for treating CP/CPPS with remarkable curative effect and low adverse reaction is needed at present.
Disclosure of Invention
In order to overcome the defects of poor treatment effect and drug resistance in the prior art and make up for the deficiency of compatibility of treatment rules in the prior art, the inventor specially provides a prescription suitable for developing new traditional Chinese medicines according to the result of research on the optimization of the pharmacy of new medicines so as to solve the problem that new traditional Chinese medicines which are not used for CP/CPPS for a long time are on the market, therefore, the invention provides a traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome and a preparation method and application thereof.
One purpose of the invention is to provide a traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome, which is dialectical compatibility of a formula aiming at pathogenesis of male reproductive health and has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis, and promoting qi circulation and relieving pain. The invention also aims to provide a preparation method of the traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome. Still another object of the present invention is to provide a pharmaceutical use of the above-mentioned Chinese medicinal composition for preventing and/or treating chronic prostatitis/chronic pelvic pain syndrome.
In order to achieve the purpose, the invention adopts the following technical scheme.
On one hand, the invention provides a traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome, which is prepared from the following raw materials: radix bupleuri, radix trichosanthis, angelica sinensis, peach kernel, safflower, sargentgloryvine stem, dahurian patrinia herb, combined spicebush root, rhizoma corydalis and giant knotweed rhizome.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2 to 100 portions of bupleurum, 2 to 100 portions of trichosanthes root, 1 to 80 portions of angelica, 1 to 80 portions of peach kernel, 2 to 120 portions of safflower, 3 to 80 portions of sargentgloryvine stem, 2 to 80 portions of dahurian patrinia herb, 2 to 80 portions of combined spicebush root, 2 to 70 portions of rhizoma corydalis and 4 to 80 portions of giant knotweed.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3 to 80 parts of bupleurum, 3 to 80 parts of trichosanthes root, 2 to 50 parts of angelica, 2 to 50 parts of peach kernel, 2 to 60 parts of safflower, 3 to 60 parts of sargentgloryvine stem, 4 to 60 parts of dahurian patrinia herb, 2 to 50 parts of combined spicebush root, 2 to 60 parts of rhizoma corydalis and 4 to 60 parts of giant knotweed.
More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 parts of radix bupleuri, 5 parts of radix trichosanthis, 2 parts of angelica sinensis, 2 parts of peach kernel, 2 parts of safflower, 4 parts of sargentgloryvine stem, 5 parts of herba patriniae, 2 parts of radix linderae, 4 parts of rhizoma corydalis and 4 parts of giant knotweed rhizome.
The invention aims at the pathogenesis characteristics of chronic prostatitis pelvic pain syndrome liver collateral blood stasis, and establishes a method for clearing heat and cooling blood, activating blood and dissolving stasis, and promoting qi circulation and relieving pain. In the formula, the radix bupleuri is used as a guide to soothe liver and regulate qi, and qi circulation is performed to promote blood circulation; radix Trichosanthis has effects of clearing heat-fire, nourishing yin and moistening dryness; the two herbs are combined to promote one ascending and descend to eliminate stasis and stagnation, and are used as monarch drugs. The angelica, the peach kernel and the safflower are used as ministerial drugs for promoting blood circulation, removing blood stasis, relieving swelling and pain. Caulis Sargentodoxae has effects of clearing heat and detoxicating, dispelling pathogenic wind, promoting blood circulation, relieving pain, removing blood stasis and resolving hard mass. Herba Patriniae has effects of clearing away heat and toxic materials, resolving carbuncle, expelling pus, removing blood stasis, and relieving pain. Wu Yao warms kidney, dispels cold, promotes qi circulation, relieves pain and detumescence, and can dredge the upper and lower qi. Rhizoma corydalis is a wonderful product for activating blood circulation to dissipate blood stasis, promoting qi circulation to relieve pain, and is especially known for relieving pain. Li Shizhen induces that rhizoma corydalis has four main effects of promoting blood circulation, regulating qi, relieving pain and removing urine in Ben Cao gang mu, and Chong rhizoma corydalis has the functions of promoting qi stagnation in blood and qi stagnation in blood, so it is specially used for treating pain in upper and lower parts of the body. Rhizoma Polygoni Cuspidati has effects of clearing away heat and toxic materials, promoting blood circulation, dispelling blood stasis, resisting bacteria, relieving inflammation, and promoting urination. Caulis Sargentodoxae has the effects of dispelling wind, promoting blood circulation and relieving pain, herba Patriniae has the effects of dispelling blood stasis and relieving pain, radix Linderae has the effects of regulating qi and relieving pain, rhizoma corydalis has the effects of promoting qi circulation and relieving pain, and rhizoma Polygoni Cuspidati, semen Persicae and radix Angelicae sinensis have the effects of moistening blood and dryness and preventing the change of qi and blood stasis, fire and heat transformation, which are used as adjuvant drugs. Qi and blood are classified into all types, and pain comes from . The medicines are combined, so that the traditional Chinese medicine composition can promote blood circulation to remove blood stasis, and can dredge collaterals to relieve pain; has the effects of dispersing stagnated liver qi, promoting qi circulation, clearing heat and removing turbid pathogen. Prescription medicinal materials are processed and required: all meet the requirements of 2020 edition of Chinese pharmacopoeia.
On the other hand, the invention provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) Taking bupleurum, radices trichosanthis, peach kernel, safflower, herba patriniae, combined spicebush root, rhizoma corydalis and giant knotweed rhizome, carrying out continuous reflux extraction for 2-3 times by using 60 v/v-80 v/v% ethanol with the weight 10-20 times of the weight of the medicinal materials, carrying out 30-90min each time, merging the extracting solutions and filtering;
(2) Taking the dregs of the step (1), extracting with water 8-15 times of the mass of the medicinal materials for 1-2 times, each time for 30-60 min, combining the extracting solutions, filtering, and discarding the dregs of the medicine;
(3) Taking sargentgloryvine stem and angelica, extracting for 2-3 times with water 10-20 times of the mass of the medicinal materials, each time for 30-60 min, combining the extracting solutions, filtering under reduced pressure, discarding dregs of a decoction, combining the extracting solutions with the extracting solution obtained in the step (2), and concentrating by 10-20 times;
(4) Mixing the ethanol extract obtained in the step (1) and the concentrated solution obtained in the step (3), adjusting the ethanol concentration to be not less than 60v/v%, standing for more than 8-10h, and respectively collecting supernatant and precipitate;
(5) Concentrating the supernatant obtained in the step (4) to recover ethanol until no ethanol smell exists, passing through a weak-polarity macroporous adsorption resin, washing with water, eluting with 60-80 v/v% ethanol, collecting the eluate, concentrating and recovering the ethanol;
(6) Mixing the precipitate obtained in the step (4) with the concentrated solution obtained in the step (5), sieving with a 200-mesh sieve, and concentrating the filtrate to relative density of 1.0-1.3; adding adjuvants, mixing, and spray drying or vacuum drying to obtain the final product.
According to the preparation method, in the step (6), when the traditional Chinese medicine composition is a powder, the auxiliary material is maltodextrin, and the powder is obtained after conventional spray drying.
According to the preparation method, in the step (6), when the traditional Chinese medicine composition is a wine, the auxiliary material is base wine (the ethanol content of the white spirit is about 50-60 v/v%), and the wine is obtained after blending and filtering.
In another aspect, the invention provides the use of the above-mentioned Chinese medicinal composition in the preparation of a medicament for preventing and/or treating chronic prostatitis/chronic pelvic pain syndrome; preferably, the chronic prostatitis/pelvic pain syndrome is type iii chronic prostatitis/pelvic pain syndrome.
The invention has the beneficial effects that:
the traditional Chinese medicinal materials of the traditional Chinese medicine composition of the invention exert the drug effect together according to the principle of monarch, minister, assistant and guide. The composition can be taken by adopting a conventional dose, can also be taken together with other products for treating the III type chronic prostatitis/pelvic pain syndrome, has reduced side effect and high safety, achieves the drug synergistic effect in the aspects of tonifying kidney and replenishing vital essence, clearing heat and promoting diuresis, promoting blood circulation to remove blood stasis, dredging collaterals and relieving pain, soothing liver and promoting qi circulation, and brings good news to the majority of male CNP patients.
Compared with the prior art, the traditional Chinese medicine composition provided by the invention has the pathogenesis characteristics of stasis and damp-heat blocking of the orifices in the III type chronic prostatitis/pelvic pain syndrome, and has the functions of clearing heat and cooling blood, activating blood and dissolving stasis, and promoting qi circulation and relieving pain. The male rat efficacy research data show that the traditional Chinese medicine composition can obviously improve the prostate tissue IL-6, IL-8, the white blood cell count, the lecithin corpuscle density level and the rat prostate index, and the medicine composition can recover the rat prostate function.
The prescription of the invention is formed by optimizing the new drug development and pharmacy evaluation and then fixing the new drug development and pharmacy evaluation, can ensure that various active ingredients such as saikosaponin, polydatin, emodin, berberine, chlorogenic acid, rutin (rutin), linderanol, cinnamonolactone and the like in the raw medicinal materials are completely extracted, simultaneously, the daily dosage of the extract is reduced, the hygroscopicity of the drug is reduced, the technical requirements of different preparations can be met, the quality of the preparation product is ensured to be stable and controllable, the use of target people is convenient, and the compliance of long-term taking is improved. Is more suitable for the development of new drugs than the decoction prescription used in the past. Clinical verification shows that the medicine has obvious curative effect and no untoward effect. The invention is expected to solve the problem that new traditional Chinese medicine for CNP/CPPS is not available in the market for a long time in China.
Drawings
FIG. 1 shows the pathological results of HE staining of prostate tissue (X200) in Experimental example 5, wherein A, sham-operated group; B. a model group; C. a group of positive drugs; D. example 5, the arrows in the figure indicate the changes in the infiltration of interstitial inflammatory cells in the glandular cavities in different groups of prostate tissues.
Detailed Description
In order to further illustrate the present invention, the following examples are provided to describe a Chinese medicinal composition, a preparation method thereof and its application in treating chronic prostatitis/chronic pelvic pain syndrome of type iii in detail, and the scope of the present invention is not limited by the following examples. The following description will be given with reference to specific embodiments.
Unless otherwise specifically stated, various raw materials, reagents, instruments, equipment and the like used in the present invention are commercially available or can be prepared by existing methods.
Example 1A traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome of type III is prepared by the following steps:
(1) Taking 6g of radix bupleuri, 6g of radix trichosanthis, 3g of peach kernel, 6g of safflower, 6g of herba patriniae, 6g of radix linderae, 6g of rhizoma corydalis and 12g of giant knotweed, adding 510ml of 70v/v% ethanol, soaking for 30min, carrying out continuous reflux extraction for 2 times, 60min each time, filtering, extracting filter residues for 2 times by the same method with 510ml of 70v/v% ethanol solution, combining 3 times of filtrates, and carrying out reduced pressure filtration to obtain 1000ml of filtrate;
(2) Adding purified water into the residue obtained in step (1) for 2 times, adding 600ml of water each time, decocting for 30min, mixing extractive solutions, removing residue, and filtering under reduced pressure to obtain 870ml filtrate;
(3) Taking 9g of sargentgloryvine stem and 3g of Chinese angelica, adding 120ml of purified water, soaking for 30min, decocting for 30min, filtering, extracting filter residues for 2 times by using 120ml of purified water, combining the filtrate for 3 times, removing the residues, and filtering under reduced pressure to obtain 200ml of filtrate;
(4) Merging the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure of-0.06Mpa and 60 ℃ to 500ml, then adding the filtrate obtained in the step (1) into the concentrated solution, supplementing 300ml of 95v/v% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and respectively collecting supernatant and precipitate;
(5) Recovering ethanol from the supernatant obtained in step (4) under reduced pressure of-0.06 Mpa at 60 deg.C, concentrating to 300ml, passing through D101 type macroporous adsorbent resin, washing with purified water to colorless, eluting with 500ml 80v/v% ethanol, collecting eluate, recovering ethanol under reduced pressure of-0.08 Mpa at 60 deg.C, and concentrating to obtain soft extract;
(6) Mixing the precipitate obtained in step (4) with the soft extract obtained in step (5), drying under reduced pressure of-0.085 Mpa at 60 deg.C, pulverizing, and sieving with 60 mesh sieve.
Example 2A traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome of type III is prepared by the following steps:
(1) Taking 300g of radix bupleuri, 300g of radix trichosanthis, 240g of peach kernel, 360g of safflower, 240g of herba patriniae, 240g of radix linderae, 210g of rhizoma corydalis and 240g of giant knotweed, adding 22L of 70v/v% ethanol, soaking for 30min, carrying out continuous reflux extraction for 60min each time, filtering, extracting filter residues for 2 times by using 22L of 70v/v% ethanol solution, combining 3 times of filtrates, and carrying out reduced pressure filtration to obtain 38L of filtrate;
(2) Extracting the residue in step (1) with purified water for 2 times, adding water 20L each time, decocting for 60min, mixing extractive solutions, removing residue, and filtering under reduced pressure to obtain filtrate 36L;
(3) Taking 240g of sargentgloryvine stem and 240g of Chinese angelica, adding 5L of purified water, soaking for 30min, decocting for 60min, filtering, extracting filter residues for 2 times by using 5L of purified water respectively, combining the filtrate for 3 times, removing the residue, and filtering under reduced pressure to obtain 8.6L of filtrate;
(4) Combining the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure of-0.06Mpa and 60 ℃ to 20L, adding the filtrate obtained in the step (1) into the concentrated solution, supplementing 5L of 95v/v% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and respectively collecting the supernatant and the precipitate;
(5) Recovering ethanol from the supernatant obtained in step 4) under reduced pressure of-0.06 Mpa at 60 deg.C, concentrating to 4L, passing through D101 type macroporous adsorbent resin, washing with purified water to colorless, eluting with 80v/v% ethanol 2L, collecting eluate, recovering ethanol under reduced pressure of-0.08 Mpa at 60 deg.C, and concentrating to obtain soft extract;
(6) Mixing the precipitate obtained in step (4) with the soft extract obtained in step (5), drying under reduced pressure of-0.085 Mpa at 60 deg.C, pulverizing, and sieving with 60 mesh sieve.
Example 3A traditional Chinese medicine composition for treating III type chronic prostatitis/chronic pelvic pain syndrome is prepared by the following steps:
(1) Taking 9g of radix bupleuri, 9g of radix trichosanthis, 6g of peach kernel, 6g of safflower, 12g of herba patriniae, 6g of radix linderae, 12g of rhizoma corydalis and 12g of giant knotweed, adding 720mL of 70% ethanol, soaking for 30min, carrying out continuous reflux extraction for 60min each time, filtering, extracting filter residues for 2 times by the same method with 720mL of 70% ethanol solution, combining 3 times of filtrates, and carrying out reduced pressure filtration to obtain 1300mL of filtrate;
(2) Adding purified water into the dregs obtained in the step (1) for extracting for 2 times, adding 720mL of water each time, decocting for 60min, combining extracting solutions, removing the dregs, and filtering under reduced pressure to obtain 1200mL of filtrate;
(3) Taking 9g of sargentgloryvine stem and 6g of Chinese angelica, adding 150mL of purified water, soaking for 30min, decocting for 60min, filtering, extracting filter residues for 2 times by the same method with 150mL of purified water respectively, combining the filtrate for 3 times, removing the residues, and filtering under reduced pressure to obtain 260mL of filtrate;
(4) Combining the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure of-0.06Mpa and 60 ℃ to 400mL, adding the filtrate obtained in the step (1) into the concentrated solution, supplementing 600mL of 95% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and respectively collecting the supernatant and the precipitate;
(5) Recovering ethanol from the supernatant obtained in step 4) under-0.06 Mpa at 60 deg.C under reduced pressure, concentrating to 300mL, passing through D101 type macroporous adsorbent resin, washing with purified water to colorless, eluting with 80% ethanol 2000mL, collecting eluate, recovering ethanol under-0.08 Mpa at 60 deg.C under reduced pressure, and concentrating to obtain soft extract;
(6) Mixing the precipitate obtained in step (4) with the soft extract obtained in step (5), drying under reduced pressure of-0.085 Mpa at 60 deg.C, pulverizing, and sieving with 60 mesh sieve.
Example 4A traditional Chinese medicine composition for treating III type chronic prostatitis/chronic pelvic pain syndrome is prepared by the following steps:
(1) Taking 240g of radix bupleuri, 240g of radices trichosanthis, 150g of peach kernel, 180g of safflower, 180g of herba patriniae, 150g of radix linderae, 180g of rhizoma corydalis and 180g of polygonum cuspidatum, adding 15L of 70v/v% ethanol, soaking for 30min, carrying out continuous reflux extraction for 60min each time, filtering, extracting filter residues for 2 times by using 15L of 70v/v% ethanol solution in the same method, combining 3 times of filtrates, and carrying out reduced pressure filtration to obtain 28L of filtrate;
(2) Extracting the residue in step (1) with purified water for 2 times, adding 13L of water each time, decocting for 60min, mixing extractive solutions, removing residue, and filtering under reduced pressure to obtain 22L filtrate;
(3) Taking 180g of sargentgloryvine stem and 150g of Chinese angelica, adding 3.3L of purified water, soaking for 30min, decocting for 60min, filtering, extracting filter residues respectively with 3.3L of purified water for 2 times, combining the filtrate obtained after 3 times, removing the residues, and filtering under reduced pressure to obtain 3.6L of filtrate;
(4) Combining the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure of-0.06Mpa and 60 ℃ to 3.6L, then adding the filtrate obtained in the step (1) into the concentrated solution, supplementing 1.8L of 95v/v% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and respectively collecting the supernatant and the precipitate;
(5) Recovering ethanol from the supernatant obtained in step (4) under-0.06 Mpa at 60 deg.C, concentrating to 0.9L, passing through D101 type macroporous adsorbent resin, washing with purified water to colorless, eluting with 80v/v% ethanol 2L, collecting eluate, recovering ethanol under-0.08 Mpa at 60 deg.C, and concentrating to obtain soft extract;
(6) Mixing the precipitate obtained in step (4) with the soft extract obtained in step (5), drying under reduced pressure of-0.085 Mpa at 60 deg.C, pulverizing, and sieving with 60 mesh sieve.
Example 5A traditional Chinese medicine composition for treating III type chronic prostatitis/chronic pelvic pain syndrome is prepared by the following steps:
(1) Taking 30g of radix bupleuri, 30g of radix trichosanthis, 12g of peach kernel, 12g of safflower, 30g of herba patriniae, 12g of radix linderae, 24g of rhizoma corydalis and 24g of giant knotweed, adding 1.74L of 70v/v% ethanol, soaking for 30min, carrying out continuous reflux extraction for 60min each time, filtering, extracting filter residues for 2 times by the same method with 1.74L of 70v/v% ethanol solution, combining 3 times of filtrates, and carrying out reduced pressure filtration to obtain 3L of filtrate;
(2) Extracting the residue in step (1) with purified water for 2 times, adding water 1.74L each time, decocting for 60min, mixing extractive solutions, removing residue, and filtering under reduced pressure to obtain filtrate 3L;
(3) Taking 24g of sargentgloryvine stem and 12g of Chinese angelica, adding 0.4L of purified water, soaking for 30min, decocting for 60min, filtering, extracting filter residues with 0.4L of purified water for 2 times respectively, combining the filtrate obtained after 3 times, removing the residues, and filtering under reduced pressure to obtain 0.8L of filtrate;
(4) Combining the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure of-0.06Mpa and 60 ℃ to 1L, adding the filtrate obtained in the step (1) into the concentrated solution, supplementing 1L of 95v/v% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and respectively collecting the supernatant and the precipitate;
(5) Recovering ethanol under reduced pressure of-0.06 Mpa at 60 deg.C from the supernatant obtained in step (4), concentrating to 2L, passing through D101 type macroporous adsorbent resin, washing with purified water to colorless, eluting with 80v/v% ethanol, collecting eluate, recovering ethanol under reduced pressure of-0.08 Mpa at 60 deg.C, and concentrating to obtain soft extract;
(6) Mixing the precipitate obtained in step (4) with the soft extract obtained in step (5), drying under reduced pressure of-0.085 Mpa at 60 deg.C, pulverizing, and sieving with 60 mesh sieve.
Analysis of experiments
Experimental example 1
(I) test materials
1. Experimental animals: rats were randomly grouped by weight into 4 groups of sham operation, model, positive drug, and administration, each group containing 10 animals. Male SD rats (SPF grade, 40) at 7 weeks of age, 220-250g.
2. Administration dose: the administration group of the present invention: example 5, the dose to rats was 11.87g crude drug/kg body weight, positive drug group: the dosage of QIANLIEKANG tablet (0.57 g/tablet, national Standard Z33020303, zhejiang Kang Enbei pharmaceutical Co., ltd.) is 0.5g/kg body weight, and the dosage volume is 0.1ml/10g body weight. The model group and the sham operation group are subjected to intragastric administration for 30 consecutive days by administering physiological saline with the same volume for intragastric administration 1 time each day.
(II) Experimental method
1. The molding method comprises the following steps: 100 g.L is injected into abdominal cavity on the day of molding operation -1 3 mL/kg of chloral hydrate -1 After anesthetizing the rat, an incision of about 1cm was made longitudinally in the lower abdomen to expose the dorsal prostate of the bladder and the seminal fluid sac. The sham-operated rats were immediately sutured with muscle skin; carrageenan group rats were given 10 g.L -1 Carrageenan physiological saline was injected into seminal fluid sacs at both sides at a volume of 0.05mL per side, and the muscle and skin were sutured.
2. Mechanical stimulation paw threshold (PWT): rats were placed in a translucent plexiglass cage and the mid-plantar hind limb was stimulated with a series of standardized fine fibers (Von Frey fibers) and the fiber was bent into an S-shape (representing mechanical stimulation 1-50 g) for 6-8S with the cilia slightly bent as the standard for full force application, and the paw withdrawal response was observed. Von Frey filaments were applied sequentially in gram-order (2, 4, 6, 8, 10, 15, 26 g), with each stimulation lasting 2s, 15s intervals, 5 consecutive times. The lowest Von Frey silky number that can cause 3/5 leg lifts is defined as PWT. In preliminary experiments we found that cox 2-mediated sensitization of spinal cord posterior horn pain in rats begins to increase 6 weeks after molding, so PWT was measured 6 weeks after molding.
3. And (3) prostate index detection: after 30 days of continuous administration, rats were fasted for 12 hours without water prohibition, weighed for body mass, dissected to take prostate tissue, washed with normal saline, filter paper to absorb excessive water, weighed for wet mass on an electronic balance, and calculated for prostate index, wherein the formula is prostate index = [ wet mass of prostate/body mass of rat ] x 100%, swelling rate = [ (inflammatory rat prostate index-sham operation rat prostate index)/sham operation rat prostate index ] × 100%, and swelling inhibition rate = [ (model group swelling rate-drug group swelling rate)/model group swelling rate ] × 100%.
4. Detection of IL-6 and IL-8 levels in prostate tissues: weighing rat left prostate tissue, adding 2 times of physiological saline to homogenate, standing, centrifuging at 3 000r/min for 15min, and detecting IL-6 and IL-8 levels in the prostate tissue homogenate by ELISA method.
5. White blood cell count, small body density level of lecithin: whole blood samples were collected and white blood cell counts (WBCs) were measured in whole blood from each group of rats using a three-differential blood cell analyzer.
Total number of leukocytes/L = total number of leukocytes in 4 large squares × 50 × 10 6 。
Another prostate fluid was selected and placed on a glass slide, covered with a glass slide, and examined under the mirror for small body density of lecithin. The average score standard of the density of the lecithin bodies is that the lecithin bodies have full visual field and are divided into 4 points; lecithin bodies 3/4 of visual field, 3 points; lecithin bodies 1/2 visual field, 2 points; lecithin bodies 1/4 of field, 1 point.
(III) results of the experiment
1. Influence on rat body quality, prostate wet quality and prostate index
Compared with the body quality of rats in each group, the difference has no statistical significance (P is more than 0.05), and the model building and the drug administration have no obvious influence on the body quality increase of the rats. Compared with a sham operation group, the wet quality of the prostate and the prostate index of a rat in the model group are improved, and the pain valve is obviously reduced (P is less than 0.05), so that the molding is successful; compared with the model group, the wet quality of the prostate, the prostate index and the pain valve of the rat in the positive medicine group and the rat in the embodiment 5 of the invention are all obviously changed (P is less than 0.05); by comparison with the positive drugs, the wet quality of prostate, prostate index and pain threshold of rats in the group of example 5 of the present invention are all significantly superior to those of the positive drug group (P < 0.05), as detailed in Table 1.
Table 1: effect of the invention on prostate index in rats
Figure BDA0003816826600000111
Note: in contrast to the sham-operated group, * p<0.05; in contrast to the model set, # p<0.05; compared with the positive medicine group, § p<0.05。
2. the group of the present invention influences the rat prostate tissue IL-6, IL-8, white blood cell count and the density level of lecithin bodies: compared with a sham operation group, the levels of IL-6 and IL-8 in the prostate tissues and the white blood cell count of the rats in the model group are increased (P is less than 0.05), and the density of lecithin corpuscles is reduced (P is less than 0.05), thereby indicating that the modeling is successful; compared with the model group, the levels of IL-6 and IL-8 in prostate tissues and the white blood cell count of rats in the positive drug group and the rats in the group 5 are reduced, and the density of lecithin corpuscles is obviously increased (P is less than 0.05); compared with the positive drug group, the rats in the group 5 of the present example have significantly reduced IL-6 and IL-8 levels and white blood cell counts (P < 0.05), and significantly increased density of lecithin bodies (P < 0.05), as shown in Table 2.
Table 2: the invention group influences the rat prostate tissue IL-6, IL-8, white blood cell count, and lecithin corpuscle density level
Figure BDA0003816826600000121
Note: p in contrast to sham group<0.05; in contrast to the model set, # p<0.05; compared with the positive medicine group, § p<0.05。
(IV) conclusion of the experiment
The test result shows that: in a rat chronic prostatitis experiment, compared with a sham operation group of a control group, the IL-6, IL-8 and leukocyte counts are obviously increased, and the density of lecithin corpuscles is obviously reduced, which indicates that the modeling is successful. Compared with the model group, the prostatitis indexes of the positive medicine group and the prostatitis indexes of the embodiment 5 of the invention are obviously improved, and the effect of the embodiment 5 of the invention is most obvious. Compared with the positive medicine group, the data of the rat prostatitis 30 days after the administration shows that the group of the invention 5 can recover the prostate function of the rat while the prostate data is obviously changed and can obtain a certain degree of protection effect.
Experimental example 2
(I) test materials
1. Experimental animals: rats were randomly assigned to weight groups and divided into sham, model, example 1, example 2, example 3, example 4 and example 5 groups of 10 animals each. Male SD rats (SPF grade, 70) at 7 weeks of age, 220-250g.
2. Administration dose: the rats in each of example 1, example 2, example 3, example 4 and example 5 were administered 11.87g crude drug/kg body weight, and before administration, the drugs were prepared to the corresponding concentrations and administered by gavage in an administration volume of 0.1ml/10g body weight. The model group and the sham operation group are subjected to intragastric administration for 30 consecutive days by administering physiological saline with the same volume for intragastric administration 1 time each day.
(II) Experimental method
1, a molding method: the same as in experimental example 1.
2. Mechanical stimulation Paw Withdrawal Threshold (PWT), prostate index measurement, prostate tissue IL-6, IL-8 level measurement, white blood cell count, lecithin corpuscle density level: the same as in experimental example 1.
(III) results of the experiment
1. Influence on rat body quality, prostate wet quality and prostate index
Compared with the body quality of rats in each group, the difference has no statistical significance (P is more than 0.05), and the model building and the drug administration have no obvious influence on the body quality increase of the rats. Compared with a sham operation group, the wet quality of the prostate and the prostate index of a rat in the model group are improved, and the pain valve is obviously reduced (P is less than 0.05), so that the molding is successful; the wet mass of the prostate, prostate index, pain threshold of rats of example 1, example 2, example 3, example 4 and example 5 were significantly changed compared to the model group (P < 0.05); the wet quality of the prostate, prostate index, pain threshold of rats in group 5 of the invention were superior to those of the other 4 groups of examples, as detailed in table 3.
Table 3: effect of the invention on rat prostate index
Figure BDA0003816826600000131
Note: in contrast to the sham-operated group, * p<0.05; in contrast to the model set, # p<0.05。
2. the group of the present invention influences the rat prostate tissue IL-6, IL-8, white blood cell count and the density level of lecithin bodies: compared with a sham operation group, the levels of IL-6 and IL-8 in the prostate tissues and the white blood cell count of the rats in the model group are increased (P is less than 0.05), and the density of lecithin corpuscles is reduced (P is less than 0.05), thereby indicating that the modeling is successful; compared with the model group, the IL-6 and IL-8 levels and the white blood cell count of the rat prostate tissues of the example 1, the example 2, the example 3, the example 4 and the example 5 are reduced, and the density of the lecithin corpuscle is obviously increased (P < 0.05); the rat prostate tissue IL-6, IL-8 levels and white blood cell counts were decreased to different extents (P < 0.05) and the density of lecithin bodies was significantly increased (P < 0.05) for examples 1, 2, 3, 4 and 5 compared to the model group, as detailed in Table 4.
Table 4: the invention group influences the rat prostate tissue IL-6, IL-8, white blood cell count, and lecithin corpuscle density level
Figure BDA0003816826600000141
Note: in contrast to sham surgery group, p<0.05; in contrast to the model set, # p<0.05。
(IV) conclusion of the experiment
The test result shows that: in a rat chronic prostatitis experiment, compared with a sham operation group of a control group, the IL-6, IL-8 and leukocyte counts are obviously increased, and the density of lecithin corpuscles is obviously reduced, which indicates that the modeling is successful. Compared with the model group, the prostatitis indexes of the example 1, the example 2, the example 3, the example 4 and the example 5 are obviously improved, and the effect is most obvious by the example 5 of the invention. The comparative analysis with the model group shows that the data of the rat prostatitis 30 days after the administration shows that the group of the embodiment 5 of the invention can recover the prostate function of the rat while the prostate data is obviously changed and has a certain protection effect.
Experimental example 3
(I) test materials
1. Experimental animals: rats were randomly grouped by weight into sham-operated, model, a, B, C and D groups for 6 groups of 10 animals each. Male SD rats (SPF grade, 60) at 7 weeks of age, 220-250g.
2. Grouping tests: the specific components of each group are as follows:
group A: taking 30g of rhizoma cimicifugae, 30g of radix trichosanthis, 12g of peach kernel, 12g of safflower, 30g of herba patriniae, 12g of radix linderae, 24g of rhizoma corydalis, 24g of polygonum cuspidatum, 24g of sargentgloryvine stem and 12g of angelica;
group B, taking 30g of radix bupleuri, 30g of radix puerariae, 12g of peach kernel, 12g of safflower, 30g of herba patriniae, 12g of radix linderae, 24g of rhizoma corydalis, 24g of rhizoma polygoni cuspidati, 24g of sargentgloryvine stem and 12g of angelica;
group C, taking radix bupleuri 30g, radix Trichosanthis 30g, semen Persicae 12g, flos Carthami 12g, herba Houttuyniae 30g, radix Linderae 12g, rhizoma corydalis 24g, rhizoma Polygoni Cuspidati 24g, caulis Sargentodoxae 24g, and radix Angelicae sinensis 12g;
group D (example 5) is prepared from bupleuri radix 30g, trichosanthis radix 30g, semen Persicae 12g, carthami flos 12g, herba Patriniae 30g, radix Linderae 12g, rhizoma corydalis 24g, rhizoma Polygoni Cuspidati 24g, caulis Sargentodoxae 24g, and radix Angelicae sinensis 12g;
3. administration dose: the administration amount of rats of group A, group B, group C and group D is 11.87g crude drug/kg body weight; before administration, the medicine is prepared into corresponding concentration and then is administered by gastric lavage, and the administration volume is 0.1ml/10g body weight. The model group and the sham operation group are subjected to intragastric administration for 30 consecutive days by administering equal volume of normal saline for 1 time per day.
(II) Experimental method
1. The molding method comprises the following steps: same as Experimental example 1
2. Mechanical stimulation Paw Withdrawal Threshold (PWT), prostate index measurement, prostate tissue IL-6, IL-8 level measurement, white blood cell count, lecithin corpuscle density level: the same as in experimental example 1.
(III) results of the experiment
1. Influence on rat body quality, prostate wet quality and prostate index
Compared with the body quality of rats in each group, the difference has no statistical significance (P is more than 0.05), and the modeling and the administration have no obvious influence on the body quality increase of the rats. Compared with a sham operation group, the wet quality of the prostate and the prostate index of a rat in the model group are improved, and the pain valve is obviously reduced (P is less than 0.05), so that the molding is successful; the wet quality of prostate, prostate index, pain valve were significantly changed (P < 0.05) in rats in groups a, B, C and D (example 5) compared to the model group; the wet quality of the prostate, prostate index, pain threshold of rats in group 5 of the present invention were superior to those in groups a, B and C, as detailed in table 5.
Table 5: effect of the invention on prostate index in rats
Figure BDA0003816826600000161
Note: in contrast to the sham-operated group, * p<0.05; in contrast to the model set, # p<0.05。
2. the group of the present invention influences the rat prostate tissue IL-6, IL-8, white blood cell count and the density level of lecithin bodies: compared with a sham operation group, the levels of IL-6 and IL-8 in the prostate tissues and the white blood cell count of the rats in the model group are increased (P is less than 0.05), and the density of lecithin corpuscles is reduced (P is less than 0.05), thereby indicating that the modeling is successful; compared with the model group, the level of IL-6 and IL-8 in the prostate tissues and the white blood cell count of rats in the A group, the B group, the C group and the D group are reduced, and the density of lecithin corpuscles is obviously increased (P is less than 0.05); the rats in groups A, B, C and D had different degrees of decrease in IL-6, IL-8 levels and white blood cell counts in prostate tissue (P < 0.05) and significant increases in density of lecithin bodies (P < 0.05) compared to the model group, as detailed in Table 6.
Table 6: the invention group influences the rat prostate tissue IL-6, IL-8, white blood cell count, and lecithin corpuscle density level
Figure BDA0003816826600000162
Note: p in contrast to sham group<0.05; in contrast to the model set, # p<0.05。
(IV) conclusion of the experiment
The test result shows that: in a rat chronic prostatitis experiment, compared with a sham operation group of a control group, the IL-6, IL-8 and leukocyte counts are obviously increased, and the density of lecithin corpuscles is obviously reduced, which indicates that the modeling is successful. Compared with the model group, the prostatitis indexes of the A group, the B group, the C group and the D group are all obviously improved, and the effect of the example 5 (the D group) is most obvious. The comparative analysis with the model group shows that the data of the rat prostatitis 30 days after the administration shows that the group 5 (group D) of the invention has a certain degree of protection effect while the data of the prostate gland is obviously changed, which indicates that the group can recover the prostate function of the rat.
Experimental example 4
(I) test materials
1. Experimental animals: rats were randomly grouped by weight into sham, model, a, B and C groups for 5 groups of 10 animals each. Male SD rats (SPF grade, 50) at 7 weeks of age, 220-250g.
2. Grouping tests: the specific components of each group are as follows:
group a (patent CN1814074 a): collecting 396.3g of radix Salviae Miltiorrhizae, 139g of radix Paeoniae Rubra, 69.8g of herba Lycopi, 46.5g of flos Carthami, 46.5g of semen Persicae, 46.5g of rhizoma corydalis, 115.7g of semen Vaccariae, 23.3g of flos Lonicerae, 46.5g of herba Patriniae, 23.3g of Poria, 23.3g of rhizoma Alismatis, and 23.3g of fructus Jujubae;
group B (CN 106474410A) comprises flos Lonicerae 10g, rhizoma Phragmitis 9g, rubi fructus 6g, bulbus Allii Macrostemi 5g, radix Puerariae 5g, semen euryales 7g, rhizoma Dioscoreae 11g, semen Persicae 5g, thallus laminariae 6g, herba Taraxaci 5g, coicis semen 9g, herba Houttuyniae 5g, fructus Alpinae Oxyphyllae 5g, fructus Foeniculi 6g, and flos Chrysanthemi 6g;
group C (example 5) is prepared by collecting bupleuri radix 30g, trichosanthis radix 30g, semen Persicae 12g, carthami flos 12g, herba Patriniae 30g, radix Linderae 12g, rhizoma corydalis 24g, rhizoma Polygoni Cuspidati 24g, caulis Sargentodoxae 24g, and radix Angelicae sinensis 12g;
3. administration dose: the administration amount of rats of group A, group B and group C is 11.87g crude drug/kg body weight; before administration, the medicine is prepared into corresponding concentration and then is administered by gastric lavage, and the administration volume is 0.1ml/10g body weight. The model group and the sham operation group are subjected to intragastric administration for 30 consecutive days by administering physiological saline with the same volume for intragastric administration 1 time each day.
(II) Experimental method
1. The molding method comprises the following steps: same as Experimental example 1
2. Mechanical stimulation paw threshold (PWT), prostate index measurement, prostate tissue IL-6, IL-8 level measurement, white blood cell count, lecithin corpuscle density level: the same as in experimental example 1.
(III) results of the experiment
1. Influence on rat body quality, prostate wet quality and prostate index
Compared with the body quality of rats in each group, the difference has no statistical significance (P is more than 0.05), and the model building and the drug administration have no obvious influence on the body quality increase of the rats. Compared with a sham operation group, the wet quality of the prostate and the prostate index of a rat in the model group are improved, and the pain valve is obviously reduced (P is less than 0.05), so that the molding is successful; compared with the model group, the wet quality of prostate, prostate index and pain valve of rats in the A group, the B group and the C group are all significantly changed (P is less than 0.05); the wet quality of the prostate, prostate index, pain threshold were better in rats in group C (inventive example 5) than in groups a and B, as detailed in table 7.
Table 7: effect of the invention on prostate index in rats
Figure BDA0003816826600000181
Note: in contrast to the sham-operated group, * p<0.05; in contrast to the model set, # p<0.05。
2. the group of the present invention influences the rat prostate tissue IL-6, IL-8, white blood cell count and the density level of lecithin bodies: compared with a sham operation group, the levels of IL-6 and IL-8 in the prostate tissues and the white blood cell count of the rats in the model group are increased (P is less than 0.05), and the density of lecithin corpuscles is reduced (P is less than 0.05), thereby indicating that the modeling is successful; the rat prostate tissue IL-6, IL-8 levels and white blood cell counts of groups A, B and C were decreased, and the density of lecithin bodies was significantly increased (P < 0.05) compared to the model group; compared with the model group, the rats in the A group, the B group and the C group have different degrees of reduction of IL-6 and IL-8 levels and white blood cell count in prostate tissues (P < 0.05), and the density of lecithin bodies is obviously increased (P < 0.05), which is detailed in Table 8.
Table 8: the invention group influences the rat prostate tissue IL-6, IL-8, white blood cell count, and lecithin corpuscle density level
Figure BDA0003816826600000182
Figure BDA0003816826600000191
Note: in contrast to sham surgery group, p<0.05; in contrast to the model set, # p<0.05。
(IV) conclusion of the experiment
The test result shows that: in a rat chronic prostatitis experiment, compared with a sham operation group of a control group, the IL-6, IL-8 and leukocyte counts are obviously increased, and the density of lecithin corpuscles is obviously reduced, which indicates that the modeling is successful. Compared with the model group, the prostatitis indexes of the A group, the B group and the C group are obviously improved, and the effect of the example 5 (the C group) is most obvious. Compared with the model group, the data of the rat prostatitis 30 days after the administration shows that the group 5 (group C) of the invention has a certain degree of protection effect while the prostate data is obviously changed, which shows that the group of the invention can recover the prostate function of the rat.
Experimental example 5
(I) test materials
1. Experimental animals: rats were randomly grouped by weight into 4 groups of 10 animals each, including sham operated, model, positive drug, example 5. Male SD rats (SPF grade, 40) at 7 weeks of age, 220-250g.
2. Administration dose: the administration group of the present invention: example 5, the dose to rats was 11.87g crude drug/kg body weight, positive drug group: the dosage of QIANLIEKANG tablet (0.57 g/tablet, national Standard Z33020303, zhejiang Kang Enbei pharmaceutical Co., ltd.) is 0.5g/kg body weight, and the dosage volume is 0.1ml/10g body weight. The model group and the sham operation group are subjected to intragastric administration for 30 consecutive days by administering physiological saline with the same volume for intragastric administration 1 time each day.
(II) Experimental method
1. The molding method comprises the following steps: the same as in experimental example 1.
2. Pathological indexes are as follows: and carrying out conventional embedding section on the prostate tissue, carrying out HE staining, taking the prostate tissue fixed by 4% formaldehyde solution, carrying out gradient dehydration after 24h, and carrying out paraffin embedding. The resulting product was sliced (5 μm). After conventional deparaffinization, hematoxylin-eosin staining was performed and observed under an optical microscope.
(III) results of the experiment
1. Pathological result of HE staining of prostate tissue
Pathological results of HE staining of prostate tissue are shown in fig. 1. From the pathological section, it can be seen that: the prostate tissue structure of the sham operation group is complete, the boundary is clear, the gland cavities are regular, the gland epithelial cells are regularly arranged, and a small amount of inflammatory cells infiltrate into the gland cavities. The pathological result of the model group is that the HE staining result of the rat prostate tissue has obvious change compared with that of a blank group, the blood vessel expansion congestion in the prostate tissue can be observed, the secretion in the cavity is reduced, the vacuolar cavity is obviously narrow, the acinar epithelium has papillary hyperplasia, the interstitium is loose, the edema and the fibrosis are caused, and a large amount of lymphocyte infiltration is seen around the acinar interstitium, which indicates that the prostatitis rat model is successfully copied. The pathological result of the positive medicine group is that the glandular cavity of the prostate tissue of a rat is enlarged and irregular, the arrangement of glandular cavity epithelial cells is disordered, and lymphocyte infiltration is rarely seen around glandular cavity interstitium. The pathological results of the group of example 5 were that most of the glandular cavities were structurally intact, but the glandular epithelial cells were not well-aligned, the basement membrane was depressed into the glandular cavities, and the interstitium was infiltrated with a small amount of inflammatory cells.
(IV) conclusion of the experiment
The results in pathological experiments of chronic prostatitis in rats show that: the pathological changes of the model group are obvious by comparing the model group with the false operation group; compared with the model group, the positive drug and the example 5 respectively have better improvement on the pathological result of the prostate of the rat, and only a small amount of inflammatory cell infiltration is seen in the interstitium. Pathological results after 30 days of administration show that the pathological image of the prostate in the group 5 of the invention has obvious change, and the drug has a certain protection effect on prostate tissues, which indicates that the group of the invention can better improve the pathological tissues of the prostate of a rat.

Claims (8)

1. A traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome is prepared from the following raw materials: 2 to 100 portions of bupleurum, 2 to 100 portions of trichosanthes root, 1 to 80 portions of angelica, 1 to 80 portions of peach kernel, 2 to 120 portions of safflower, 3 to 80 portions of sargentgloryvine stem, 2 to 80 portions of dahurian patrinia herb, 2 to 80 portions of combined spicebush root, 2 to 70 portions of rhizoma corydalis and 4 to 80 portions of giant knotweed.
2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3 to 80 parts of bupleurum, 3 to 80 parts of trichosanthes root, 2 to 50 parts of angelica, 2 to 50 parts of peach kernel, 2 to 60 parts of safflower, 3 to 60 parts of sargentgloryvine stem, 4 to 60 parts of dahurian patrinia herb, 2 to 50 parts of combined spicebush root, 2 to 60 parts of rhizoma corydalis and 4 to 60 parts of giant knotweed.
3. The traditional Chinese medicine composition according to claim 1 or 2, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
5 parts of radix bupleuri, 5 parts of radix trichosanthis, 2 parts of angelica sinensis, 2 parts of peach kernel, 2 parts of safflower, 4 parts of sargentgloryvine stem, 5 parts of herba patriniae, 2 parts of radix linderae, 4 parts of rhizoma corydalis and 4 parts of giant knotweed rhizome.
4. A method for preparing the traditional Chinese medicine composition of any one of claims 1 to 3, wherein the method for preparing comprises the following steps:
(1) Taking bupleurum, radices trichosanthis, peach kernel, safflower, herba patriniae, combined spicebush root, rhizoma corydalis and giant knotweed rhizome, carrying out continuous reflux extraction for 2-3 times by using 60 v/v-80 v/v% ethanol with the weight 10-20 times of the weight of the medicinal materials, carrying out 30-90min each time, combining the extracting solutions and filtering;
(2) Taking the medicine residues in the step (1), extracting with water 8-15 times of the mass of the medicinal materials for 1-2 times, each time for 30-60 min, combining the extracting solutions, filtering, and discarding the medicine residues;
(3) Taking sargentgloryvine stem and angelica, extracting for 2-3 times with water 10-20 times of the mass of the medicinal materials, each time for 30-60 min, combining the extracting solutions, filtering under reduced pressure, removing dregs of a decoction, combining the extracting solutions with the extracting solution obtained in the step (2), and concentrating by 10-20 times;
(4) Mixing the ethanol extract obtained in the step (1) and the concentrated solution obtained in the step (3), adjusting the ethanol concentration to be not less than 60v/v%, standing for more than 8-10h, and respectively collecting supernatant and precipitate;
(5) Concentrating the supernatant obtained in the step (4) to recover ethanol until no ethanol smell exists, passing through a weak-polarity macroporous adsorption resin, washing with water, eluting with 60-80 v/v% ethanol, collecting the eluate, concentrating and recovering the ethanol;
(6) Mixing the precipitate obtained in the step (4) with the concentrated solution obtained in the step (5), sieving by a 200-mesh sieve, and concentrating the filtrate to a relative density of 1.0-1.3; adding adjuvants, mixing, and spray drying or vacuum drying to obtain the final product.
5. The preparation method according to claim 4, wherein in the step (6), when the Chinese medicinal composition is a powder, the auxiliary material is maltodextrin, and the powder is obtained by conventional spray drying.
6. The preparation method according to claim 4, wherein, in the step (6), when the Chinese medicinal composition is a wine, the auxiliary material is base wine, and the wine is obtained after blending and filtering, wherein the base wine is white wine containing 50-60 v/v% of ethanol.
7. Use of a Chinese medicinal composition according to any one of claims 1 to 3 in the manufacture of a medicament for the treatment of chronic prostatitis/pelvic pain syndrome.
8. The use according to claim 7, wherein the chronic prostatitis/pelvic pain syndrome is chronic prostatitis/pelvic pain syndrome type III.
CN202211037574.7A 2022-08-26 2022-08-26 Traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome and preparation method and application thereof Pending CN115317550A (en)

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Application publication date: 20221111