Application of pimpinella thellungiana in preparation of medicine for treating chronic prostatitis

By using Yanghong Tan as the only active ingredient of the drug, Yanghong Tan concentrate for oral administration has been prepared, which has solved the shortcomings of the treatment of chronic non-bacterial prostatitis in the prior art, and has significantly improved the symptoms and pathological changes of prostatitis. Have good therapeutic effects.

CN119097650APending Publication Date: 2024-12-10SHANXI UNIV OF CHINESE MEDICINE
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Patent Information

Application Number
CN202411029183.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-07-30
Publication Date
2024-12-10

AI Technical Summary

Technical Problem

There is a lack of effective treatment measures for chronic nonbacterial prostatitis (CNP) in the prior art, especially the use of mutton odor is relatively scarce.

Method used

Using Yanghong Jin as the only active ingredient for medicine, the active ingredient is extracted from Yanghong Jinsheng raw medicinal materials through decoction or other extraction methods, and the Yanghong Jinsheng concentrate is prepared, and combined with appropriate auxiliary materials to form a drug preparation for oral administration. Drugs for the treatment of chronic nonbacterial prostatitis.

Benefits of technology

It significantly reduces pathological damage to prostate tissue, improves inflammation levels, reduces the TNF-α and PGE2 content in serum, reduces the IL-1β and T-PSA content in prostate tissue, and has good therapeutic effects on chronic prostatitis.

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Abstract

The invention discloses an application of pimpinella thellungiana in preparation of a medicine for preventing and / or treating prostatitis, which can effectively treat chronic prostatitis, especially chronic abacterial prostatitis diseases in a targeted manner, can obviously relieve pathological damage of prostate tissues and improve the inflammation level in a model rat body, and particularly, can be used for preparing a medicine for preventing and / or treating prostatitis. The pimpinella thellungiana can remarkably improve the density of lecithin small bodies, relieve pathological changes such as interstitial cell hyperplasia, interstitial edema, inflammatory reaction degree and glandular epithelial cell hyperplasia, remarkably reduce the content of TNF-alpha and PGE2 in serum and the content of IL-1beta and T-PSA in prostate tissue, and has a good treatment effect on chronic prostatitis.
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Description

Technical Field

[0001] The invention relates to the field of Chinese medicine technology, and in particular to an application of sheep red tannins in preparing a medicine for treating chronic prostatitis. Background Art

[0002] Chronic prostatitis is a common chronic disease in middle-aged and elderly men, with an incidence rate of about 2.2%-9.7%. Chronic nonbacterial prostatitis (CNP) is the most common type of prostatitis. Its clinical symptoms are diverse, and it is easy to relapse, difficult to cure, with many associated symptoms, and lack of effective treatment measures. It brings great physical pain and mental burden to patients, and is easy to cause diseases such as prostate hyperplasia and prostate cancer. The pathogenesis of CNP is not fully understood. At present, Western medicine generally believes that its occurrence is the result of multiple factors such as immune abnormalities, pathogen infection, urine reflux, endocrine abnormalities, and psychological pressure. Traditional Chinese medicine does not have the name of "prostatitis". According to clinical symptoms, it is classified into the categories of "sperm turbidity", "stranguria", "leucorrhea", etc., and is mainly divided into four syndromes: qi stagnation and blood stasis, damp heat, kidney yang deficiency, and liver qi stagnation.

[0003] Traditional Chinese medicine has the characteristics of multiple components, multiple targets and multiple pathways, and has unique advantages in treating chronic prostatitis. Pimpinella thellungiana Wolff is the dried whole herb of Pimpinella thellungiana Wolff, which has the effects of warming the kidney and promoting yang, promoting blood circulation and removing blood stasis, nourishing the heart and calming the mind, warming the lung and dispersing cold. At the same time, modern research shows that it has the effects of lowering blood pressure, lowering blood lipids, reducing myocardial oxygen consumption, improving hypoxia tolerance and improving immunity.

[0004] Patent document CN109700891A discloses a pharmaceutical composition for preventing prostatic hyperplasia, which is a preparation prepared from the following raw materials: goat red tan, kudzu root, hawthorn, wolfberry, and American ginseng. Goat red tan is pungent, sweet and warm in nature, and belongs to the kidney meridian. It can warm the kidney and assist yang, and also promote blood circulation and remove blood stasis, which is just right for the pathogenesis of insufficient kidney qi and blood stasis blocking the collaterals; wolfberry nourishes the liver, nourishes the kidney and replenishes essence, balances yin and yang, and is effective in replenishing kidney qi when combined with goat red tan. The two are both the main drugs. The pharmaceutical composition has a clear efficacy in treating prostatic hyperplasia. Experimental observations on a rat prostatic hyperplasia model show that it can improve the hormonal endocrine disorder of the animal model, enhance the antioxidant capacity of the animal model, and has a good therapeutic effect on prostatic hyperplasia caused by testosterone propionate. It should be noted that the pathogenesis and population of prostate hyperplasia and prostatitis are different. Prostate hyperplasia is caused by the increase in the size of the prostate, which compresses the urethra, causing the urethra to become thinner or deformed, resulting in labored urination, bifurcated urination or dysuria. The prevalence of prostate hyperplasia in people over 70 years old is as high as 80%. Chronic prostatitis is a disease characterized by urinary system irritation symptoms such as frequent urination, urgency, and pain when urinating, as well as pelvic pain and discomfort caused by pathogens or certain non-infectious factors in the prostate. It is more common in men under 50 years old.

[0005] Patent document CN104547624A discloses a Chinese medicine composition for treating prostatitis, which is a medicine made from the following raw materials in the following mass proportions: 8-12 parts of Dendrobium, 6-12 parts of Ligustrum lucidum, 9-15 parts of Rhizoma Citrus Grandis, 9-15 parts of Citrus aurantium, 3-9 parts of Citron, 3-9 parts of Campsis Creeper, 6-12 parts of Albizzia julibrissin, 8-12 parts of Radix Trichosanthis, 6-10 parts of Polygala tenuifolia, 3-5 parts of Beehive, and 0.1-0.3 parts of Horsefly. The Chinese medicine composition is developed after re-examining the TCM pathogenesis of prostatitis as an independent disease by freeing traditional Chinese medicine from the misunderstanding that prostatitis is confused with prostatitis. It is a special medicine for treating prostatitis.

[0006] In summary, the existing technology mostly uses sheep red tan in combination with other traditional Chinese medicine ingredients to treat prostatitis or prostatic hyperplasia, rather than clearly and specifically treating chronic prostatitis. Currently, there are few research reports on the effect of sheep red tan on CNP. Summary of the invention

[0007] The invention overcomes the shortcomings of the prior art and provides an application of sheep red tannins in preparing a medicine for preventing and / or treating prostatitis.

[0008] Furthermore, in the medicine, sheep red tannins are the only active pharmaceutical ingredient.

[0009] Furthermore, the prostatitis is chronic nonbacterial prostatitis (CNP).

[0010] In one embodiment of the present invention, the prostatitis is chemical chronic non-bacterial prostatitis.

[0011] In one embodiment of the present invention, the prostatitis is chemical chronic non-bacterial prostatitis caused by carrageenan.

[0012] Furthermore, the sheep red tan is a sheep red tan medicinal material or a sheep red tan extract.

[0013] Furthermore, the preparation method of the sheep red tannin extract comprises the following steps:

[0014] (1) mixing the raw medicinal material of Herba Ophiopogonis with an extractant, and extracting;

[0015] (2) performing solid-liquid separation on the mixture after extraction in step (1), and concentrating the obtained liquid to obtain sheep red tannin concentrate.

[0016] Furthermore, in the preparation method, before step (1), the steps of weighing, chopping and soaking the raw medicinal materials of sheep red tannins are also included.

[0017] Furthermore, the soaking time is 1 to 3 hours (such as 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours), preferably 2 hours.

[0018] Furthermore, the extraction in step (1) adopts one or more combinations of decoction, immersion, steam distillation, reflux, impregnation, supercritical fluid extraction, ultrasonic extraction, etc.

[0019] In one embodiment of the present invention, the extraction of sheep red tannins is carried out by decoction.

[0020] Furthermore, in the step (1), the leaching agent is selected from: one of water, alcohols, ethers and esters; the alcohol is selected from: one of ethanol, isopropanol and tert-butyl alcohol; the ketone is acetone; the ether is ethyl ether or petroleum ether; the ester is ethyl acetate or ethyl formate; preferably, the leaching agent is water.

[0021] Furthermore, in the step (1), the extraction is performed once or more times, for example, twice.

[0022] Furthermore, in the step (1), for a single extraction, the solid-liquid ratio of sheep red tannin to the extractant is 1:5-20 (g / mL), for example, 1:5 (g / mL), 1:10 (g / mL), 1:15 (g / mL), 1:20 (g / mL).

[0023] In one embodiment of the present invention, the extraction times are 2 times, in the first extraction, the solid-liquid ratio of sheep red tannin to the extractant is 1:10 (g / mL), and in the second extraction, the solid-liquid ratio of sheep red tannin to the extractant is 1:10 (g / mL).

[0024] Furthermore, in the step (1), the extraction time is 1-10 hours (specifically 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10 hours).

[0025] In one embodiment of the present invention, the leaching time is 1 hour.

[0026] Furthermore, in step (2), the liquid-solid separation method can be a combination of one or more of filtration, centrifugation, sedimentation, etc.

[0027] In one embodiment of the present invention, the liquid-solid separation in step (2) is carried out by filtration.

[0028] Furthermore, in the preparation method, after step (2), it also includes the steps of concentration and drying.

[0029] Furthermore, the concentration includes one or a combination of two or more of low-temperature concentration or reduced-pressure concentration.

[0030] In one embodiment of the present invention, the low-temperature concentration is a water bath low-temperature concentration.

[0031] In one embodiment of the present invention, the reduced pressure concentration is reduced pressure concentration by rotary evaporation.

[0032] Furthermore, the drying includes one or more combinations of freeze drying, normal pressure drying, reduced pressure drying, boiling drying, spray drying, infrared drying or microwave drying.

[0033] In one embodiment of the present invention, the drying is freeze-drying.

[0034] Furthermore, the drug also includes pharmaceutically acceptable excipients, which include flavoring agents (such as sucrose, xylitol, oligofructose, sodium cyclamate, stevioside, aspartame, monosaccharide syrup, etc.), aromatics (such as spices, flavors, etc.), mucilage agents (such as sodium alginate, gum arabic, gelatin, methylcellulose, sodium carboxymethylcellulose, etc.), clarifiers (such as chitosan, gelatin, etc.), preservatives (such as benzoic acid and its salts (such as sodium benzoate), sorbic acid and its salts (such as potassium sorbate), hydroxyphenyl esters (such as methyl parahydroxybenzoate, ethyl parahydroxybenzoate, butyl parahydroxybenzoate), etc.), disintegrants (such as low-substituted hydroxypropyl cellulose, crospovidone, sodium starch glycolate, etc.), , cross-linked sodium carboxymethyl cellulose, starch, etc.), binders (specifically, hydroxypropyl cellulose, hydroxypropyl methylcellulose, povidone, copovidone, pregelatinized starch, etc.), lubricants (specifically, stearic acid, magnesium stearate, sodium fumayl stearate, etc.), wetting agents (specifically, polyoxyethylene sorbitan fatty acid esters, poloxamer, polyoxyethylene castor oil derivatives, etc.), suspending agents (specifically, hydroxypropyl methylcellulose, hydroxypropyl cellulose, povidone, copovidone, sodium carboxymethyl cellulose, methyl cellulose, etc.), stabilizers (specifically, citric acid, fumaric acid, succinic acid, etc.), fillers (specifically, starch, sucrose, lactose, microcrystalline cellulose, etc.) or adhesives (specifically, cellulose derivatives, alginate, gelatin and polyvinyl pyrrolidone, etc.).

[0035] Furthermore, the dosage form of the drug can be any dosage form, especially an oral dosage form, which can be selected by those skilled in the art according to the circumstances, including, but not limited to, tablets (including sugar-coated tablets, film-coated tablets, sublingual tablets, orally disintegrating tablets, buccal tablets, etc.), pills, powders, granules, capsules (including soft capsules, microcapsules), lozenges, liquid preparations (such as syrups, solutions, emulsions, suspensions), controlled release preparations (for example, instantaneous release preparations, sustained release preparations, sustained release microcapsules), aerosols, films (for example, orally disintegrating films, oral mucosa-adhesive films).

[0036] Furthermore, the drug can be administered in any manner, especially oral administration, which can be selected by those skilled in the art according to the circumstances, including, but not limited to, oral administration, respiratory administration (such as nasal administration) and mucosal administration.

[0037] In one embodiment of the present invention, the drug administration method is oral administration.

[0038] In one embodiment of the present invention, the drug is a liquid preparation.

[0039] Furthermore, the concentration of sheep red tannin in the liquid preparation is 0.1-5 g / mL (such as 0.1 g / mL, 0.15 g / mL, 0.2 g / mL, 0.25 g / mL, 0.3 g / mL, 0.5 g / mL, 1 g / mL, 1.1 g / mL, 1.2 g / mL, 1.3 g / mL, 1.35 g / mL, 1.4 g / mL, 1.5 g / mL, 2 g / mL, 2.5 g / mL, 3 g / mL, 4 g / mL, 5 g / mL), preferably 0.1-2 g / mL.

[0040] In one embodiment of the present invention, the concentration of sheep red tannins in the liquid preparation is 0.15 g / mL.

[0041] In one embodiment of the present invention, the concentration of sheep red tannins in the liquid preparation is 1.35 g / mL.

[0042] Furthermore, the chronic non-bacterial prostatitis includes the following symptoms: decreased lecithin body density; increased prostate index; increased levels of tumor necrosis factor-α (TNF-α), prostaglandin E2 (PGE2), interleukin-1β (IL-1β), and total prostate specific antigen (T-PSA).

[0043] Furthermore, the increased levels of TNF-α and PGE2 refer to increased levels of TNF-α and PGE2 in serum.

[0044] Furthermore, the increased IL-1β and T-PSA levels refer to increased IL-1β and T-PSA levels in prostate tissue.

[0045] The present invention discovers for the first time that goat red tan can effectively treat chronic prostatitis, especially chronic non-bacterial prostatitis, and goat red tan can significantly reduce pathological damage of prostate tissue and improve the inflammation level in model rats. Specifically, goat red tan can significantly increase the density of lecithin bodies, reduce pathological changes such as interstitial cell hyperplasia, interstitial edema and inflammatory reaction degree, and glandular epithelial cell hyperplasia, and the degree of prostate lesions in the high-dose group is significantly inhibited and improved, and the TNF-α and PGE2 contents in serum and the IL-1β and T-PSA contents in prostate tissue are significantly reduced, and the present invention has a good therapeutic effect on chronic prostatitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 Figure 3 shows the changes in body weight of rats in each group.

[0047] Figure 2 The figure is a comparison of the water drinking amount of rats in each group.

[0048] Figure 3The visual field scores of lecithin bodies in each group of rats were given (***P<0.001 compared with the sham operation group; ##P<0.01, ###P<0.001 compared with the model group).

[0049] Figure 4 Is the prostate index of rats in each group (***P<0.001 compared with the sham operation group; ##P<0.01, ###P<0.001 compared with the model group).

[0050] Figure 5 HE staining results of rats in each group (Among them, Figure A is the sham operation group (×200, scale: 50μm), Figure B is the model group (×200, scale: 50μm), Figure C is the prostate group (×200, scale: 50μm), Figure D is the low-dose group (×200, scale: 50μm), and Figure E is the high-dose group (×200, scale: 50μm)).

[0051] Figure 6 is the expression level of tumor necrosis factor-α (TNF-α) in the serum of rats in each group (Note: compared with the sham operation group, ***P < 0.001; compared with the model group, #P < 0.05, ##P < 0.01, ###P < 0.001).

[0052] Figure 7 is the expression level of prostaglandin E2 (PGE2) in the serum of rats in each group (Note: compared with the sham operation group, ***P < 0.001; compared with the model group, #P < 0.05, ##P < 0.01, ###P < 0.001).

[0053] Figure 8 is the expression level of interleukin-1β (IL-1β) in the prostate tissue of rats in each group (Note: compared with the sham operation group, ***P<0.001; compared with the model group, #P<0.05, ##P<0.01, ###P<0.001).

[0054] Fig. 9 is the expression level of total prostate specific antigen (T-PSA) in the prostate tissue of rats in each group (Note: compared with the sham operation group, ***P < 0.001; compared with the model group, #P < 0.05, ##P < 0.01, ###P < 0.001). DETAILED DESCRIPTION

[0055] Unless otherwise defined, all scientific and technical terms used in the present invention have the same meanings as commonly understood by those skilled in the art to which the present invention relates:

[0056] In the technical scheme of the present invention, "Yang Hong Tan" refers to the Chinese medicinal material Pimpinella thellungiana Wolff, which is the root or whole herb of the Umbelliferae plant Pimpinella thellungiana Wolff; it is also called "Yang Hong Tan" and "Liu Yue Han"; it tastes sweet and spicy and is warm in nature; its effects: warming the middle and dispersing cold, nourishing qi and blood, warming the kidney and assisting yang, strengthening the spleen and replenishing qi, nourishing the heart and calming the mind, relieving cough and removing phlegm; collection and processing: harvesting in summer and autumn, removing soil, washing and drying.

[0057] The information of some reagents, drugs, instruments and animals used in the experiments of the examples are as follows:

[0058] 1. Samples and main reagents

[0059] Sheep red tan samples were purchased from Huanglong County, Yan'an City, Shaanxi Province; λ-carrageenan (Sigma-Aldrich Company, USA, CAS9064-57-7); Prostate Conproan tablets (Zhejiang Kangenbei Pharmaceutical Co., Ltd., batch number: 210923); rat tumor necrosis factor-α (TNF-α) ELISA kit, rat prostaglandin E2 (PGE2) ELISA kit, rat total prostate specific antigen (T-PSA) ELISA kit, rat interleukin 1β (IL-1β) ELISA kit (Wuhan Beiyinlai Biotechnology Co., Ltd., catalog numbers are RA20035, RA20013, RA27661, and RA20020, respectively).

[0060] 2. Instruments

[0061] Rotary evaporator (Shanghai Shensheng Technology Co., Ltd.); electronic balance (Ohaus Precision Electronic Balance, China); microscope (Motic Group); low-speed centrifuge (Merick Instrument Shanghai Co., Ltd.); refrigerated centrifuge (Hunan Keda Scientific Instrument Co., Ltd.); KQ5200V ultrasonic cleaner (Kunshan Ultrasonic Instrument Co., Ltd.).

[0062] 3. Experimental animals

[0063] Fifty SPF adult male SD rats, weighing 180-220 g, were purchased from Sibeifu (Beijing) Biotechnology Co., Ltd., with the experimental animal production license number SCXK (Beijing) 2019-0010. The animals were adaptively fed for 1 week, and they were allowed to drink water and eat freely.

[0064] Example 1 Experimental method

[0065] 1.1 Preparation of experimental drug solution

[0066] Sheep red tan test solution: weigh an appropriate amount of sheep red tan medicinal material, chop it into pieces, soak it for 2 hours, add 10 times the amount of distilled water and boil it twice, each time for 1 hour, combine the extracts, concentrate the liquid medicine, and freeze-dry it to obtain lyophilized powder. Before use, prepare the liquid medicine equivalent to 0.15g / mL and 1.35g / mL of the medicinal material for standby use.

[0067] Prostacyclin tablets: Prostacyclin is administered orally at 6.3 times the adult clinical dosage. The daily dosage for rats is 0.72 g / kg, and the suspension is prepared with pure water to a concentration of 0.72 g / mL before use;

[0068] 1.2 Establishment, grouping and drug administration of CNP rat model

[0069] After 1 week of adaptive feeding, the rats were divided into 5 groups according to the random number table method: sham operation group J, model group M, positive drug group P (Qianliekang), low-dose sheep red tan group YD and high-dose sheep red tan group YG (n=10). Modeling: The hair of the lower abdomen of the anesthetized rats was removed with a shaver, and the shaved area was disinfected with iodine. A longitudinal incision of about 2 cm was made in the middle of the lower abdomen. The bladder was found with instruments and cotton swabs to expose the two lateral lobes of the prostate located below the bladder. 100 μL of 3% carrageenan saline solution was injected into the ventral lobes on both sides of the prostate with a 1mL sterile syringe. The sham operation group was injected with an equal amount of saline. After the injection, the organs were returned to their original positions when no liquid flowed out of the wound. The muscles and skin were sutured layer by layer, the wound was disinfected with iodine and the blood around the wound was wiped clean. The rats were then put back into the cage and kept warm. After surgery, the rats in each group were injected with penicillin sodium at a dose of 250,000 U / kg intramuscularly, once a day for 3 consecutive days, and the surgical wounds and overall conditions of the rats were closely observed.

[0070] Gavage administration began 3 days after modeling. The sham operation group and the model group were gavaged with the corresponding volume of distilled water at 10 mL / kg, the positive drug group was gavaged with 0.72 g / kg of Prolean tablet suspension, and the low-dose sheep red tan group YD and the high-dose sheep red tan group YG were gavaged with 1.5 g / kg and 13.5 g / kg of sheep red tan water extract, respectively. The drugs were administered continuously for 14 days.

[0071] 1.3 Body weight and food intake measurement

[0072] Since the model was established, the rats were weighed every 3 days. The food intake was measured regularly every day, and the food intake per 100g of body weight of each group of rats = (100g × total food intake of the group) / total weight of the group.

[0073] 1.4 Determination of lecithin body density and prostate index

[0074] One hour after the last administration, the rats were anesthetized and blood was collected from the abdominal aorta. The prostate tissue was quickly removed and rinsed with physiological saline. The wet weight of the prostate was accurately weighed, and the prostate tissue was massaged to obtain the prostate fluid, which was then smeared on a glass slide and observed under an optical microscope at a magnification of 400 times. The density of the lecithin bodies in the visual field was scored: 4 points for the full visual field, 3 / 4 of the visual field was 3 points, 2 / 4 of the visual field was 2 points, and 1 / 4 of the visual field was 1 point.

[0075] The prostate index (PI) was calculated according to the formula: PI = prostate tissue wet weight (mg) / rat body weight (g).

[0076] 1.5 Histopathological changes

[0077] After the experiment, the prostate tissue of the rats was taken out and a part of the prostate tissue was fixed in 10% formalin solution, embedded in paraffin, dehydrated in the usual way, sectioned, and stained with hematoxylin-eosin (HE). The pathological changes of the prostate tissue of the rats were observed under a microscope combined with a computer graphics image analysis system at ×200 and ×400 magnifications.

[0078] 1.6ELISA method to measure the content of various indicators in rat serum and prostate tissue

[0079] Rat serum and prostate tissue were obtained, and the contents of various biochemical indices were detected according to the specific operating instructions of the enzyme-linked immunosorbent assay (ELISA) kit. Specific operation: dilute the standard to obtain standard solutions of different concentrations; set blank wells, test sample wells and standard wells on the enzyme-labeled plate; add 50 μL of standard solutions of different concentrations to the standard wells in turn, add 40 μL of the test sample and 10 μL of the corresponding biotin-labeled antibody to the test sample wells, and do not add samples to the blank wells; add 50 μL of enzyme-labeled reagent to each well except the blank wells; seal the plate with a sealing film and incubate at 37°C for 0.5 h; remove the sealing film, discard the liquid, spin dry, fill each well with diluted washing solution, let it stand for 30 seconds and then discard it, repeat this 5 times, and pat dry; first add 50 μL of color developer A to each well, then add 50 μL of color developer B, gently shake and mix, and then place at 37°C in the dark for 10 minutes; add 50 μL of stop solution to each well; adjust the blank well to zero within 15 minutes, and measure the absorbance (OD value) of each well at a wavelength of 450 nm.

[0080] 1.7 Statistical processing

[0081] SPSS19.0 statistical software was used to analyze the experimental data. One-way ANOVA was used to compare the differences between the groups. If the variances were equal, the least significant difference (LSD) test was used; if the variances were unequal, the Welch's ANOVA test was used. Dunnett's T3 test was used for post hoc multiple comparisons, and p < 0.05 was considered statistically significant.

[0082] Example 2 Experimental results

[0083] 2.1 Effects of sheep red tannins on body weight and food intake changes in CNP model rats

[0084] There was no significant difference in the changes of body weight and food intake among the rats in each group; and the decrease in food intake and slow weight gain after modeling could return to normal in about 3 days. Figure 1 , 2 .

[0085] 2.2 Effect of Sheep Red Flavour on Phosphatidylcholine Body Density and Prostate Index in CNP Model Rats

[0086] Compared with the sham operation group, the visual field score of lecithin bodies in the model group was significantly reduced (P < 0.001); compared with the model group, the visual field score of lecithin bodies in the positive drug group was significantly increased (P < 0.01), and the visual field score of lecithin bodies in the high-dose sheep red tan group was significantly increased (P < 0.001). Figure 3 .

[0087] Compared with other experimental groups, the prostate index of the model group (M) was the highest; compared with the sham operation group (J), the prostate index of the model group (M) increased; compared with the model group (M), the prostate index of the low-dose and high-dose groups (YD, YG) and the positive drug group (P) decreased. Figure 4 .

[0088] 2.3 Pathological changes of prostate tissue in rats

[0089] HE staining results showed (see Figure 5 ), compared with the sham operation group, the prostate of the rats in the model group showed pathological changes such as interstitial edema, inflammatory cell infiltration mainly composed of lymphocytes, interstitial cell hyperplasia, capsule thickening, acinar expansion and glandular epithelial cell hyperplasia. Compared with the model group, the interstitial cell hyperplasia, interstitial edema and inflammatory reaction degree and glandular epithelial cell hyperplasia of the prostate of the rats in the high-dose and low-dose groups of Sheep Red Tan were alleviated, only the acinar expansion degree did not change significantly, and the degree of prostate lesions in the high-dose group was significantly inhibited and improved.

[0090] 2.4 Effect of sheep red tan on the expression levels of tumor necrosis factor-α (TNF-α), prostaglandin E2 (PGE2) in serum and interleukin-1β (IL-1β) and total prostate specific antigen (T-PSA) in prostate tissue of CNP rats

[0091] Compared with the sham operation group, the levels of TNF-α, PGE2 in serum and IL-1β and T-PSA in prostate tissue of rats in the model group were significantly increased (P<0.001). Compared with the model group, the levels of TNF-α and PGE2 in serum and IL-1β and T-PSA in prostate tissue of rats in the high-dose and low-dose groups of Yang Hong Tan were significantly decreased (P<0.01 or P<0.001); the levels of TNF-α, PGE2 in serum and IL-1β and T-PSA in prostate tissue of rats in the positive drug group were significantly decreased (P<0.001 or P<0.05), indicating that both the Yang Hong Tan group and the positive drug group (Qianliekang group) had a certain improvement effect on CNP model rats; the decrease of TNF-α, PGE2, T-PSA and IL-1β in the high-dose group of Yang Hong Tan was equivalent to that in the positive drug group, and the high-dose Yang Hong Tan had an intervention effect close to that of the positive drug. Results are shown in Figure 6-9 .

[0092] In summary, after the administration of sheep red tan and positive drugs, compared with the rats in the model group, the prostate gland destruction of the rats in the drug group was alleviated, and the pathological changes such as interstitial cell hyperplasia, interstitial edema and inflammatory response as well as glandular epithelial cell hyperplasia were alleviated. The measured biochemical indices were all adjusted back, and the adjustment effect of high concentration of sheep red tan was more obvious. The effect of sheep red tan intervening in CNP was close to that of positive drugs (Qianlikang). Sheep red tan has a good therapeutic effect on chronic prostatitis, especially on CNP.

Claims

1. The use of sheep red tan in the preparation of a drug for preventing and / or treating prostatitis, characterized in that: The prostatitis described is chronic non-bacterial prostatitis.

2. The use according to claim 1, characterized in that In the medicine, sheep red tannins are the only active ingredient.

3. The use according to claim 1, characterized in that The sheep red tan is a sheep red tan crude drug or a sheep red tan extract.

4. The use according to claim 3, characterized in that The preparation method of the sheep red tannin extract comprises the following steps: (1) mixing the raw medicinal material of Herba Ophiopogonis with an extractant, and extracting; (2) performing solid-liquid separation on the mixture after extraction in step (1), and concentrating the obtained liquid to obtain a sheep red tannin concentrate.

5. The use according to claim 4, characterized in that The extraction in step (1) is carried out by one or more of the following methods: decoction, immersion, steam distillation, reflux, immersion, supercritical fluid extraction and ultrasonic extraction, preferably decoction.

6. The use according to claim 4, characterized in that In the step (1), the extracting agent is selected from: one of water, alcohols, ethers and esters. Preferably, the alcohol is selected from: one of ethanol, isopropanol and tert-butanol, the ketone is acetone, the ether is ether or petroleum ether, and the ester is ethyl acetate or ethyl formate.

7. The use according to claim 4, characterized in that In the step (1), the extracting agent is water.

8. The use according to claim 4, characterized in that In the step (1), the extraction times are 1 or 2 times; When the extraction times is 1, the solid-liquid ratio of sheep red tannin to the extractant is 1:5-20 (g / mL); When the extraction times are 2 times, in the first extraction, the solid-liquid ratio of sheep red tannins to the extractant is 1:10 (g / mL), and in the second extraction, the solid-liquid ratio of sheep red tannins to the extractant is 1:10 (g / mL).

9. The use according to claim 1, characterized in that The medicine also includes pharmaceutically acceptable excipients, which include flavoring agents, aromatics, mucilage agents, clarifiers, preservatives, sorbic acid and its salts, hydroxyphenyl esters, disintegrants, binders, lubricants, wetting agents, suspending agents, stabilizers, fillers or adhesives.

10. The use according to claim 1, characterized in that The dosage form of the drug is selected from: tablets, pills, powders, granules, capsules, lozenges, liquid preparations, controlled release preparations, aerosols and films; the liquid preparations include one or a combination of two or more of syrups, solutions, emulsions or suspensions; Preferably, the concentration of sheep red tannin in the liquid preparation is 0.1-5 g / mL.

Citation Information

Patent Citations

  • Traditional Chinese medicine composition for treating prostatodynia

    CN104547624A

  • Pharmaceutical composition against benign prostatic hyperplasia

    CN109700891A