Uighur medicine composition, preparation method thereof and application of Uighur medicine composition in preparation of medicine for treating prostatitis

Abstract

The invention belongs to the technical field of Uighur medicine composition preparation, and particularly relates to a Uighur medicine composition, a preparation method thereof and application of the Uighur medicine composition in preparation of a medicine for treating prostatitis. Based on the Uighur medicine theory, the Uighur medicine composition is prepared from fennel root bark, capparis spinosa root bark, semen cuscutae, chicory seeds, cucumber seeds, muskmelon seeds, anchusa, dracocephalum moldavica, aniseed, fennel and pogonatherum crinitum in parts by weight, has an obvious improvement effect on prostatitis, and particularly can improve pathological damage of chronic abacterial prostatitis; and the levels of various inflammatory factors including PEG2, TL-1beta, TL-6 and TNF-alpha in serum are reduced. Meanwhile, the Uighur medicine composition can be processed into particles, tablets, powder, capsules and other dosage forms, and compared with other existing Uighur medicines for reducing blood fat and treating cardiovascular and cerebrovascular diseases and atherosclerosis, the Uighur medicine composition has the advantages of being stable in dosage form, convenient to carry and take and the like.

Description

Technical Field

[0001] The invention belongs to the technical field of preparation of Uyghur medicine compositions, and in particular relates to a Uyghur medicine composition and a preparation method thereof, and application of the composition in preparing medicines for treating prostatitis. Background Art

[0002] Chronic prostatitis (CP), including chronic bacterial prostatitis and chronic non-bacterial prostatitis, is a common and frequently occurring disease of the male urogenital system, accounting for about 40% of patients visiting urology and men's departments. The clinical symptoms of chronic prostatitis are complex and diverse, and are related to many diseases. It is now recognized that chronic prostatitis is not a disease, but a syndrome with complex etiology, diverse clinical manifestations, and easy recurrence.

[0003] Due to long-term inflammatory stimulation, prostate secretion dysfunction, pathogen infection and toxin release, CP patients suffer from immune dysfunction and psychological disorders caused by physical illness, which are often manifested as anxiety, insomnia, fear, depression and other mental symptoms. At the same time, prostate secretion dysfunction, pathogen infection and toxin release, and immune dysfunction are the main factors leading to repeated symptoms and chronic prostatitis. Long-term inflammatory stimulation leads to proliferation and fibrosis of tissue around the acinus, and spasm or functional urethral obstruction and urodynamic changes in the posterior urethra and bladder neck due to scar tissue proliferation.

[0004] In recent years, modern medicine has made great progress in the treatment of chronic bacterial prostatitis and has accumulated a lot of experience in the application of antibiotics. However, most antibiotics have poor permeability in prostate tissue and it is difficult to reach an effective antibacterial concentration. Although the new generation of quinolone antibiotics has a distribution concentration in prostate tissue and prostatic fluid that exceeds the serum concentration, its efficacy has not been significantly improved (the total effective rate is 76.6%), and it has almost no effect on chronic non-bacterial prostatitis, and it is expensive and has greater side effects. Moreover, in clinical practice, the incidence of chronic non-bacterial prostatitis (CNP) is 8 times that of bacterial prostatitis. Therefore, most prostatitis is not suitable for antibiotic treatment.

[0005] In the treatment of CNP, antibiotic treatment is mostly empirical treatment. The theoretical basis for its use is to speculate that some pathogens with negative routine culture cause the occurrence of this type of inflammation. Therefore, it is recommended to first use antibiotics such as fluoroquinolones for 2 to 4 weeks, and then decide whether to continue antibiotic treatment based on the feedback of its efficacy. Only when the patient's clinical symptoms are indeed alleviated, it is recommended to continue to use antibiotics. The recommended total course of treatment is 4 to 6 weeks. Some patients with this type may have intracellular pathogens such as Chlamydia trachomatis, Ureaplasma urealyticum or Mycoplasma hominis, which can be treated with oral macrolide antibiotics. In addition, the purpose of nonsteroidal anti-inflammatory analgesics is mainly to relieve pain and discomfort. To date, only a few randomized, placebo-controlled studies have evaluated the efficacy of such drugs. Clinical controlled studies have confirmed that celecoxib is effective in improving symptoms such as pain in patients with CNP. Herbal preparations, α-receptor blockers, antidepressants and antianxiety drugs can also be used to relieve related symptoms. Nevertheless, due to the uncertainty in the etiology of chronic non-bacterial prostatitis and the unclear pathological mechanism, the treatment is mostly empirical, and the treatment effect is not satisfactory for most patients. Many doctors still find it difficult to treat prostatitis.

[0006] Chronic nonbacterial prostatitis (CNP) belongs to the category of "sperm turbidity", "stranguria", "leucorrhea" and so on in traditional Chinese medicine. Its pathogenesis is centered on damp-heat stasis. In the early stage, it is mostly damp-heat stasis, in the middle stage, it is mostly accompanied by kidney essence deficiency, and dampness, heat, stasis, stagnation and deficiency run through its different stages. This disease is related to factors such as unsatisfied desire or excessive sexual intercourse, rash movement of the phase fire, or fatigue from alcohol, sex, damage to the spleen and stomach, damp-heat stasis, and sperm stasis. It is closely related to the heart, spleen, liver, kidney and other internal organs. Long-term illness damages the kidney, water and fire are out of balance, yin deficiency and fire are strong, and the sperm chamber is disturbed, causing this disease. Secondly, damp-heat stasis is also one of the important factors. Damp-heat evil can be invaded from the outside or generated from the inside. External invasion can be caused by exogenous damp-heat fire poison, damp-heat turbid evil stasis, or unclean lower genitals, or unclean sexual intercourse, damp-heat evil infiltrates from the lower orifices and stays in the sperm chamber, causing this disease. Endogenous ones may be caused by eating fatty, sweet, alcoholic, cheesy, spicy, and roasted foods, causing dysfunction of the spleen and stomach, causing dampness and heat to flow down to the bladder, or spleen and lung deficiency, cold in the nutrient system, leading to damp heat in the lower part of the body, or long-term illness causing damage to the spleen and kidneys, resulting in dysfunction of the functions of ascending the clear and descending the turbid, and the disease is caused by the inability to separate the clear and turbid. Damp heat cannot be cleared for a long time, the phase fire is suppressed for a long time, and the blood and qi in the essence are stagnant, or the liver fails to release due to emotional discomfort, causing poor circulation of qi and blood, and obstruction of the bladder causing stagnation of qi and blood, or being affected by cold and dampness, causing damage to the collaterals of the yin meridians, and poor circulation of qi and blood, resulting in distension and discomfort in the perineum, lower abdomen, testicles, and lumbar sacrum. Worry, depression and anger, long-term treatment and failure to heal, heart and kidney disharmony, and emotional changes, such as forgetfulness, worry, insomnia, dreaminess, and fever in the five hearts, etc. In short, kidney essence deficiency, spleen dysfunction, dampness and heat, and stagnation of essence are important links in the occurrence and development of this disease. Spleen and kidney deficiency is the root, and dampness and heat are the symptoms, making the disease complicated. For the TCM treatment of CNP, it is necessary to distinguish the symptoms and the root, and to clear and tonify at the same time. In the acute stage, it is necessary to focus on removing dampness, removing blood stasis and removing turbidity. In the chronic stage, it is necessary to take into account both removing evil and strengthening the body, and to pay equal attention to tonifying the deficiency and strengthening the kidney and clearing dampness and heat, and to promote blood circulation and remove blood stasis. Different treatments should be given according to different situations.

[0007] Modern Chinese medicine pharmacology and clinical studies have shown that Chinese medicine can improve the high viscosity of blood in CNP patients, improve microcirculation disorders, promote the absorption of local inflammation and glandular secretion, increase the content of lecithin and zinc in prostatic fluid, regulate the metabolism of local zinc in the prostate, reduce the number of white blood cells in prostatic fluid and its pH value, facilitate the penetration of drugs, and enhance the concentration of local drugs to increase the therapeutic effect. Experimental studies have shown that Chinese medicine blood circulation and stasis-removing drugs can reduce the infiltration of prostatitis cells and fibrous tissue hyperplasia in rats, restore the secretory function of prostate cells in pathological models, increase the content of Zn, enhance the anti-inflammatory and damaged tissue repair ability of the prostate, and reduce the number of white blood cells and increase the lecithin bodies in the prostatic fluid of prostatitis rats. Chinese medicine can improve the continuous low fever state of experimental animals, eliminate local inflammatory reactions, inhibit the hyperplasia of fibrous tissue, improve the pathological vasodilation state, and promote the secretory and metabolic functions of glands. Therefore, the development and research of new Chinese medicines for the treatment of CP has broad market prospects and important clinical value. Summary of the invention

[0008] The purpose of the present invention is to provide a Uygur medicine composition and a preparation method thereof and application of the composition in preparing a medicine for treating prostatitis. The Uygur medicine composition has the function of improving prostatitis and the effect is significant.

[0009] The invention provides a Uyghur medicine composition, which comprises the following raw materials in parts by weight: 9-34 parts of fennel root bark, 9-34 parts of caper root bark, 9-34 parts of dodder seeds, 5-20 parts of chicory seeds, 5-20 parts of cucumber seeds, 5-20 parts of melon seeds, 5-20 parts of bugloss, 7-25 parts of fennel, 5-20 parts of fennel, 5-20 parts of cumin and 5-20 parts of dodder.

[0010] Preferably, the active ingredients of the Uyghur medicine composition include hyperoside and cynarin, and the weight percentages of hyperoside and cynarin in the Uyghur medicine composition are 0.013% to 0.042% and 0.015% to 0.043%, respectively.

[0011] The present invention also provides a method for preparing the Uygur medicine composition described in the above technical solution, comprising the following steps:

[0012] The raw materials and water are mixed and boiled, and the obtained boiled mixture is subjected to solid-liquid separation to obtain a water extract;

[0013] Concentrating the water extract under reduced pressure to obtain an extract;

[0014] The extract is dried to obtain the Uyghur medicine composition.

[0015] Preferably, the weight ratio of the preparation raw materials to water is 1:(8-14).

[0016] Preferably, the decoction is performed 2 to 4 times; the decoction time for each time is 1 to 3 hours; and the water extract is obtained by combining the water extracts of 2 to 4 decoctions.

[0017] Preferably, the pressure of the reduced pressure concentration is 0.08 MPa, the temperature is 60-75° C., and the density at a temperature of 60° C. is 1.22-1.25.

[0018] Preferably, the drying method is vacuum drying; the vacuum drying pressure is 0.08Mpa, the temperature is 55-65°C, and the vacuum drying is performed until the water content of the extract is ≤6%.

[0019] The present invention also provides the use of the Uygur medicine composition described in the above technical solution or the Uygur medicine composition prepared by the preparation method described in the above technical solution in preparing a medicine for treating prostatitis.

[0020] Preferably, the dosage form of the drug includes tablets, powders, granules or capsules.

[0021] The present invention also provides a Uyghur medicine granule for treating prostatitis, wherein the raw materials for preparing the Uyghur medicine granule include a Uyghur medicine composition extract and granules, and the weight ratio of the Uyghur medicine composition extract to the granules is 1:1.5;

[0022] The Uyghur medicine composition extract is the extract of the Uyghur medicine composition described in the above technical solution or the extract of the Uyghur medicine composition obtained by the preparation method described in the above technical solution.

[0023] Beneficial effects:

[0024] The invention provides a Uyghur medicine composition, comprising the following raw materials in parts by weight: 9-34 parts of fennel root bark, 9-34 parts of caper root bark, 9-34 parts of dodder seed, 5-20 parts of chicory seed, 5-20 parts of cucumber seed, 5-20 parts of melon seed, 5-20 parts of oxalis, 7-25 parts of fennel, 5-20 parts of fennel, 5-20 parts of fennel and 5-20 parts of dodder. Based on the theory of Uyghur medicine, the invention prepares fennel root bark, caper root bark, dodder seed, chicory seed, cucumber seed, melon seed, oxalis, fennel, fennel and dodder in the above-mentioned weight-part array to form a Uyghur medicine composition, which has a significant improvement effect on prostatitis, especially can improve the pathological damage of chronic non-bacterial prostatitis, and reduce the levels of multiple inflammatory factors including PEG2, TL-1β, TL-6 and TNF-α in serum.

[0025] At the same time, the Uyghur medicine composition of the present invention can be processed into various dosage forms such as granules, tablets, powders and capsules. Compared with other existing Uyghur medicines for lowering blood lipids, treating cardiovascular and cerebrovascular diseases and atherosclerosis, it has many advantages such as stable dosage form, easy to carry and convenient to take. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required to be used in the embodiments are briefly introduced below.

[0027] Figure 1 The chromatogram (360 nm) of the mixed reference substance of hyperoside and cynaroside in Example 7;

[0028] Figure 2 The chromatogram (330 nm) of the mixed reference substance of hyperoside and cynaroside in Example 7;

[0029] Figure 3 The chromatogram (360 nm) of the Uyghur medicine composition sample measured in Example 2 in Example 7;

[0030] Figure 4The chromatogram (330 nm) of the Uyghur medicine composition sample measured in Example 2 in Example 7;

[0031] Figure 5 These are the results of prostate pathological histology (HE staining) of rats in each group in Example 8. DETAILED DESCRIPTION

[0032] The invention provides a Uyghur medicine composition, which comprises the following raw materials in parts by weight: 9-34 parts of fennel root bark, 9-34 parts of caper root bark, 9-34 parts of dodder seeds, 5-20 parts of chicory seeds, 5-20 parts of cucumber seeds, 5-20 parts of melon seeds, 5-20 parts of bugloss, 7-25 parts of fennel, 5-20 parts of fennel, 5-20 parts of cumin and 5-20 parts of dodder.

[0033] As one embodiment, the weight proportion of fennel root bark in the Uyghur medicine composition of the present invention is 12 to 25 parts; as another embodiment, the weight proportion of fennel root bark is 17 to 22 parts.

[0034] As one embodiment, the weight proportion of the Capparis spinosa root bark in the Uyghur medicine composition of the present invention is 12 to 25 parts; as another embodiment, the weight proportion of the Capparis spinosa root bark is 17 to 20 parts.

[0035] As an embodiment, the weight proportion of the dodder is 12 to 25 parts; as another embodiment, the weight proportion of the dodder is 17 to 21 parts.

[0036] As one embodiment, the weight proportion of chicory seeds in the Uyghur medicine composition of the present invention is 8 to 15 parts; as another embodiment, the weight proportion of chicory seeds is 10 to 12 parts.

[0037] As one embodiment, the weight proportion of cucumber seeds in the Uyghur medicine composition of the present invention is 8 to 15 parts; as another embodiment, the weight proportion of cucumber seeds is 10 to 12 parts.

[0038] As an embodiment, the weight proportion of the melon seeds of the present invention is 8 to 15 parts; as another embodiment, the weight proportion of the melon seeds is 10 to 13 parts.

[0039] As one embodiment, the weight proportion of Herba Cynoglossi in the Uyghur medicine composition of the present invention is 8 to 15 parts; as another embodiment, the weight proportion of Herba Cynoglossi is 10 to 12 parts.

[0040] As one embodiment, the weight proportion of the fragrant blue orchid in the Uyghur medicine composition of the present invention is 10 to 19 parts; as another embodiment, the weight proportion of the fragrant blue orchid is 13 to 16 parts.

[0041] As an embodiment, the weight proportion of the aniseed in the present invention is 8 to 15 parts; as another embodiment, the weight proportion of the aniseed is 10 to 12 parts.

[0042] As one embodiment, the weight proportion of fennel in the Uyghur medicine composition of the present invention is 8 to 15 parts; as another embodiment, the weight proportion of fennel is 10 to 13 parts.

[0043] As one embodiment, the weight proportion of the dodder in the Uyghur medicine composition of the present invention is 8 to 15 parts; as another embodiment, the weight proportion of the dodder is 10 to 12 parts.

[0044] Unless otherwise specified, the present invention has no particular limitation on the sources of the above raw materials, and conventional commercial sources in the art may be used.

[0045] As an embodiment, the active ingredients of the Uyghur medicine composition of the present invention include hyperoside and cynarin, and the weight percentages of hyperoside and cynarin in the Uyghur medicine composition are 0.013% to 0.042% and 0.015% to 0.043%, respectively.

[0046] The present invention also provides a method for preparing the Uygur medicine composition described in the above technical solution, comprising the following steps:

[0047] The raw materials and water are mixed and boiled, and the obtained boiled mixture is subjected to solid-liquid separation to obtain a water extract;

[0048] Concentrating the water extract under reduced pressure to obtain an extract;

[0049] The extract is dried to obtain the Uyghur medicine composition.

[0050] The present invention mixes the raw materials and water and then decocts them, and then separates the obtained decoction mixture into solid and liquid to obtain a water extract. As an embodiment, the weight ratio of the raw materials and water in the present invention is 1: (8-14); as another embodiment, the weight ratio of the raw materials and water is 1: (10-12). As an embodiment, the number of decoctions is 2-4 times; as another embodiment, the number of decoctions is 3 times. As an embodiment, the time for each decoction is 1-3 hours; as another embodiment, the time for each decoction is 1-2 hours. As an embodiment, the water extract is obtained by combining the water extracts of 2-4 decoctions. As an embodiment, the solid-liquid separation method is filtration, and the filtration method is not particularly limited, and the conventional filtration method in the art can be used.

[0051] After obtaining the water extract, the present invention conducts reduced pressure concentration on the water extract to obtain an extract. As an embodiment, the pressure of the reduced pressure concentration is 0.08Mpa. As an embodiment, the temperature of the reduced pressure concentration is 60 to 75°C; as another embodiment, the temperature is 60 to 65°C. As an embodiment, the density of the reduced pressure concentration at a temperature of 60°C is 1.22 to 1.25; as another embodiment, the density of the reduced pressure concentration at a temperature of 60°C is 1.23 to 1.24.

[0052] After obtaining the extract, the present invention dries the extract to obtain the Uyghur medicine composition. As an embodiment, the drying method is vacuum drying. As an embodiment, the pressure of the vacuum drying is 0.08Mpa. As an embodiment, the temperature of the vacuum drying is 55-65°C; as another embodiment, the temperature of the vacuum drying is 60°C. As an embodiment, the vacuum drying is performed until the water content of the extract is ≤6%.

[0053] The invention prepares a Uyghur medicine composition based on the Uyghur medical theory by preparing fennel root bark, caper root bark, dodder seed, chicory seed, cucumber seed, melon seed, bugloss, fennel, anise, cumin and dodder according to the above weight proportion array, which has a significant improvement effect on prostatitis.

[0054] Based on the above advantages, the present invention also provides the use of the Uygur medicine composition described in the above technical solution or the Uygur medicine composition prepared by the preparation method described in the above technical solution in the preparation of a drug for treating prostatitis. As an embodiment, the prostatitis described in the present invention may be but is not limited to chronic non-bacterial prostatitis. As an embodiment, the dosage form of the drug described in the present invention may be tablets, powders, granules or capsules. As an embodiment, the drug described in the present invention also includes pharmaceutically acceptable excipients; the type and source of the excipients are not particularly limited, and can be selected according to the conventional dosage form.

[0055] The present invention also provides a Uyghur medicine granule for treating prostatitis. The raw materials for preparing the Uyghur medicine granule include a Uyghur medicine composition extract and a granule excipient, and the weight ratio of the Uyghur medicine composition extract to the granule excipient is 1:1.5; the Uyghur medicine composition extract is the extract of the Uyghur medicine composition described in the above technical scheme or the extract of the Uyghur medicine composition obtained by the preparation method described in the above technical scheme.

[0056] As an embodiment, the granule excipient is lactose; as an embodiment, the preparation method of the Uyghur medicine granules comprises the following steps: mixing the Uyghur medicine composition extract and lactose, adding ethanol solution to prepare a soft material; granulating, drying and granulating the soft material to obtain the Uyghur medicine composition granules. As an embodiment, before mixing with the lactose, it also includes passing the Uyghur medicine composition extract through a 100-mesh sieve. As an embodiment, the volume percentage of the ethanol solution is 50%. As an embodiment, the aperture of the sieve during granulation is 14 mesh. As an embodiment, the drying temperature is 60°C and the time is 30 minutes. As an embodiment, the aperture of the sieve during granulation is 14 mesh.

[0057] In order to further illustrate the present invention, the technical solution provided by the present invention is described in detail below in conjunction with the accompanying drawings and embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0058] Example 1

[0059] A Uyghur medicine composition, the raw materials are arranged in weight: 17 parts of fennel root bark, 17 parts of caper root bark, 17 parts of dodder seeds, 10 parts of chicory seeds, 10 parts of cucumber seeds, 10 parts of melon seeds, 10 parts of bugloss, 13 parts of fragrant blue orchid, 10 parts of fennel, 10 parts of cumin and 10 parts of dodder grass;

[0060] The preparation method is as follows: 11 medicinal materials including fennel root bark, caper root bark, dodder seed, chicory seed, cucumber seed, melon seed, bugloss, fennel, aniseed, cumin and dodder in the above-mentioned weight proportions are mixed, decocted twice with water of 10 times the weight of the medicinal materials, each time for 1.0 h, the water extracts obtained each time are combined to obtain a water extraction mixture, the water extraction mixture is concentrated under reduced pressure at 0.08 MPa and 60° C. to obtain an extract having a density of 1.22 to 1.25 at a temperature of 60° C., and then the extract is vacuum dried at 0.08 MPa and 60° C. to obtain a Uyghur medicine composition, wherein the mass percentage water content of the Uyghur medicine composition is ≤6%.

[0061] Example 2

[0062] A Uyghur medicine composition, the raw materials are arranged in weight: 17 parts of fennel root bark, 17 parts of caper root bark, 17 parts of dodder seeds, 10 parts of chicory seeds, 10 parts of cucumber seeds, 10 parts of melon seeds, 10 parts of bugloss, 13 parts of fragrant blue orchid, 10 parts of fennel, 10 parts of cumin and 10 parts of dodder grass;

[0063] The preparation method is as follows: add 11 medicinal materials including the required amount of fennel root bark, caper root bark, dodder seed, chicory seed, cucumber seed, melon seed, bugloss, fennel, aniseed, cumin and dodder, add water 12 times the weight of the medicinal materials and boil twice, each time for 1.5 hours, combine the water extracts obtained each time to obtain a water extraction mixture, concentrate the water extraction mixture under reduced pressure at 0.08Mpa and 65°C to obtain an extract with a density of 1.22-1.25 at a temperature of 60°C, then vacuum dry the extract under 0.08Mpa and 65°C to obtain a Uyghur medicine composition, and the mass percentage water content of the Uyghur medicine composition is ≤6%.

[0064] Example 3

[0065] A Uyghur medicine composition, the raw materials are arranged in weight: 17 parts of fennel root bark, 17 parts of caper root bark, 17 parts of dodder seeds, 10 parts of chicory seeds, 10 parts of cucumber seeds, 10 parts of melon seeds, 10 parts of bugloss, 13 parts of fragrant blue orchid, 10 parts of fennel, 10 parts of cumin and 10 parts of dodder grass;

[0066] The preparation method is as follows: add the required amount of 11 medicinal materials including fennel root bark, caper root bark, dodder seed, chicory seed, cucumber seed, melon seed, bugloss, fennel, aniseed, cumin and dodder, add 14 times the weight of water of the seven medicinal materials and boil for 3 times, each time for 2.0 hours, combine the water extracts obtained each time to obtain a water extraction mixture, concentrate the water extraction mixture under reduced pressure at 0.08Mpa and 75°C to obtain an extract with a density of 1.22 to 1.25 at a temperature of 60°C, then vacuum dry the extract at 0.08Mpa and 55°C to obtain a Uyghur medicine composition, and the mass percentage water content of the Uyghur medicine composition is ≤6%.

[0067] Example 4

[0068] A Uyghur medicine composition, wherein the raw materials are arranged in parts by weight: 25 parts of fennel root bark, 25 parts of caper root bark, 25 parts of dodder seeds, 15 parts of chicory seeds, 15 parts of cucumber seeds, 15 parts of melon seeds, 15 parts of bugloss, 19 parts of fennel, 15 parts of fennel, 15 parts of cumin and 15 parts of dodder; the preparation method is the same as that of Example 2.

[0069] Example 5

[0070] A Uyghur medicine composition, wherein the raw materials are arranged in parts by weight: 34 parts of fennel root bark, 34 parts of caper root bark, 34 parts of dodder seed, 20 parts of chicory seed, 20 parts of cucumber seed, 20 parts of melon seed, 20 parts of bugloss, 25 parts of fennel, 20 parts of fennel, 20 parts of cumin and 20 parts of dodder; the preparation method is the same as that of Example 2.

[0071] Example 6

[0072] A Uyghur medicine composition, wherein the raw materials are arranged in parts by weight: 12 parts of fennel root bark, 12 parts of caper root bark, 12 parts of dodder seed, 8 parts of chicory seed, 8 parts of cucumber seed, 8 parts of melon seed, 8 parts of bugloss, 10 parts of fennel, 8 parts of fennel, 8 parts of cumin and 8 parts of dodder; the preparation method is the same as that of Example 2.

[0073] Example 7

[0074] The Uyghur medicine composition prepared in Example 2 was used to determine the contents of hyperoside and cynaroside: a high performance liquid chromatography (HPLC) method was used for the detection and analysis.

[0075] Experimental instrument: LC-2030Plus high performance liquid chromatograph (Shimadzu Corporation, Japan).

[0076] Experimental drugs: Hyperoside reference substance (batch number: 111521-202310) and cynaroside reference substance (batch number: GSB11-3790-2020) were purchased from China Food and Drug Inspection Institutes; Uyghur medicine composition of Example 2.

[0077] Experimental methods:

[0078] Chromatographic conditions: COSMOSILpacked Column 5C18-MS-Ⅱ (4.6 ID × 250 mm), flow rate 1.0 mL min -1 , column temperature 35°C, detection wavelength for hyperoside 360nm, detection wavelength for cynaroside 330nm, acetonitrile as mobile phase A, 0.1% phosphoric acid solution as mobile phase B, gradient elution (see Table 1), injection volume 10 μL.

[0079] Table 1 HPLC content determination gradient elution

[0080]

[0081]

[0082] Preparation of reference solution: Take an appropriate amount of hyperoside reference substance and add methanol to prepare a stock solution containing 448μg per 1mL; take an appropriate amount of cynarin reference substance and add 70% methanol solution to prepare a stock solution containing 101.4μg per 1mL; take 1mL of hyperoside stock solution into a 10mL volumetric flask, add methanol to make up to the volume to obtain a solution with a concentration of 44.8μg / mL, then take 1mL of this solution and 1mL of cynarin stock solution into a 10mL volumetric flask respectively, add methanol to prepare 1mL of a mixed reference solution containing 4.48μg of hyperoside and 10.14μg of cynarin.

[0083] Preparation of the test solution: Take an appropriate amount of the Uyghur medicine composition of Example 2, grind it into powder, take about 5 g, accurately weigh it, put it in a ground-mouth conical flask, accurately add 50 mL of methanol, weigh it, treat it with ultrasound (power 200 W, frequency 40 kHz) for 60 min, cool it, weigh it, make up the lost weight with methanol, shake it well, filter it, and obtain it.

[0084] Content determination: Pipette the reference solution and the test solution separately, and calculate according to the measured peak area using the external standard method. Figures 1 to 4 As shown, Figure 1 is the mixed control chromatogram (360 nm), 1 is the hyperoside control peak; Figure 2 is the mixed control chromatogram (330 nm), 2 is the cynaroside control peak; Figure 3 The chromatogram (360 nm) of the sample solution of the Uyghur medicine composition in Example 2, 1 is the hyperoside reference peak; Figure 4 2 is the chromatogram (330 nm) of the sample solution of the Uyghur medicine composition in Example 2, and 2 is the cynarin control peak.

[0085] in accordance with Figures 1 to 4 The results show that the content of hyperoside in the Uyghur medicine composition sample of Example 2 is 0.1866 mg / g, and the content of cynarin is 0.2164 mg / g. The Uyghur medicine compositions obtained in Examples 1 to 6 were further tested, and the mass content of hyperoside in the samples was in the range of 0.013% to 0.042%, and the mass content of cynarin was in the range of 0.015% to 0.043%.

[0086] It can be concluded that the Uyghur medicine compositions prepared in Examples 1 to 6 all contain active ingredients hyperoside and cynaroside. Some existing studies have shown that cynaroside and hyperoside belong to flavonoid compounds and have a significant effect on improving inflammation. It can be inferred that the Uyghur medicine compositions in Examples 1 to 6 may have the potential to improve prostatitis, and further subsequent pharmacodynamic experiments are conducted.

[0087] Example 8

[0088] The Uygur medicine composition prepared in Example 2 was used for pharmacodynamics experiments, and the results and process are as follows:

[0089] 1. Establishment of rat prostatitis model

[0090] The rat chronic prostatitis model was established by injecting 3% carrageenan into the prostate of rats.

[0091] After one week of adaptive feeding of rats in cages, rats in the model group, positive group, high-dose group, medium-dose group and low-dose group of Uygur medicine composition were anesthetized by intraperitoneal injection of 10% chloral hydrate (dose: 0.3 mL / 100 g). After the rats were clamped with vascular clamps and the abdominal skin of the rats did not react, the rats were moved to a sterile table, the abdominal hair was removed, the abdominal skin of the rats was disinfected with povidone iodine, the surgical area was protected with gauze, a 3 cm long longitudinal incision was cut along the midline of the abdomen, the abdominal cavity was opened layer by layer to fully expose the left and right ventral lobes of the prostate, the injection site was gently fixed, and 1 injection of 3% carrageenan (50 μL per injection, a total of 100 μL / rat) was injected into the left and right ventral lobes of the prostate. After each injection, sterile gauze was pressed on the injection point to prevent the carrageenan solution from extravasating and causing severe abdominal adhesion in the later stage. After the injection, the organs were returned to their positions, and the abdominal cavity was closed layer by layer after observing that there was no obvious bleeding. Povidone iodine was disinfected again to clean blood stains to prevent rats from biting each other. Ceftazidime (20,000 U / kg) was injected intraperitoneally once a day for 1 day. The rats' condition and food intake were observed every day. The rats were weighed after 21 days and the prostate was removed by anesthesia and dissection in the same way.

[0092] 2. Animal grouping and drug administration

[0093] The experimental animals were raised freely in a clean and dry environment with humidity of 30-50%, temperature control of 20-26℃, 12h:12h light and dark alternating lighting. 60 male SD rats weighing 180-220g were randomly divided into a blank control group, a CNP model group, a positive drug Sanjin tablet group, and a low-, medium-, and high-dose group of the Uygur medicine combination after one week of adaptive feeding, with 10 rats in each group. Except for the blank control group, the remaining groups were treated with 10% chloral hydrate (volume: 0.3ml·100g -1 ) Intraperitoneal injection anesthesia, open the abdominal cavity to fully expose the left and right ventral lobes of the prostate, inject 3% carrageenan into the left and right ventral lobes of the prostate, and return the organs to their original positions after the injection. The specific steps are the same as those in the above "Step 1 Establishment of rat prostatitis model".

[0094] After modeling, the model group and the blank control group were gavaged with distilled water, and the positive drug group was gavaged with 0.27 g·kg Sanjin tablets -1 The low, medium and high dose groups of the Uygur medicine composition were given 0.5 g·kg of the test drug by gavage. -1 , 1g·kg -1 and 2 g kg -1 , once a day for 21 consecutive days. The rats' condition and food intake were observed every day. 4 hours after the last administration, the rats were weighed, and blood was collected from the abdominal aorta of the anesthetized rats. The whole blood was equilibrated at room temperature for 2 hours at 12000 r·min -1 The cells were centrifuged at low temperature for 15 min, and the serum ELISA kit was used to determine the PEG2 content in the rat serum. Part of the prostate tissue was taken for HE staining to observe pathological changes, and the rest was made into 10% tissue homogenate at 12000 r·min -1After centrifugation at low temperature for 15 min, the supernatant was collected and the contents of IL-1β, IL-6 and TNF-α were determined using ELISA kits.

[0095] 3. Index determination

[0096] (1) On the 21st day, all rats were weighed after administration, and 10 mL of blood was collected from the abdominal aorta after anesthesia with 10% chloral hydrate for later use. The prostate tissue of the rats was surgically removed, the capsule and surrounding fat tissue were peeled off, washed with physiological saline, dried with filter paper, and weighed with an electronic balance.

[0097] (2) Calculation of prostate index: prostate index = prostate wet weight / body weight × 100%.

[0098] (3) The right 2 / 3 tissue was fixed with 4% neutral paraformaldehyde solution, embedded in paraffin, sectioned, and stained with HE. The pathological changes of prostate tissue were observed under a light microscope.

[0099] (4) After the prostate was weighed, the tissue homogenate was prepared and the supernatant was collected by centrifugation. The levels of IL-6, IL-β, TNF-α, PGE2, SOD and GSH in the prostate tissue homogenate of rats were determined by ELISA.

[0100] 4. Results and Analysis

[0101] 4.1 The results of the changes in rat body weight before and after administration are shown in Table 2.

[0102] Table 2 Comparison of body weight of rats in each group (n=10, )

[0103] Group Before modeling After modeling After administration Blank group 176.24±4.19 267.16±8.52 319.72±20.24 CNP model group 176.59±5.81 <![CDATA[197.31±7.11 ** ]]> <![CDATA[235.87±16.21 ** ]]> Three gold pieces 174.3±4.66 <![CDATA[196.7±6.16 ** ]]> <![CDATA[298.96±19.05 ** ]]> Uyghur medicine composition low dose group 175.96±4.35 <![CDATA[196.8±6.13 ** ]]> <![CDATA[283±18.88 ** ]]> Uyghur medicine composition medium dosage group 177.48±3.72 <![CDATA[200.4±4.67 ** ]]> <![CDATA[286.82±19.75 ** ]]> Uyghur medicine composition high dose group 175.45±4.9 <![CDATA[198.73±2.85 ** ]]> <![CDATA[292.91±19.09 ** ]]>

[0104] Note: Compared with the blank control group, *P<0.05, **P<0.005; compared with the CNP model group, #P<0.05, ##P<0.005.

[0105] The results in Table 2 show that after modeling, compared with the blank control group, the body weights of the rats in the other five groups were reduced; compared with the CNP model group, the body weights of the rats in each drug administration group gradually increased.

[0106] 4.2 HE staining

[0107] Compared with the blank control group, scattered inflammatory cell infiltration was observed in the prostate glandular stroma of CNP model rats, and hyperplasia of glandular duct epithelial cells was observed; after the intervention of Sanjin Tablets, this phenomenon was significantly reduced compared with the model group. After the intervention of different doses of the Uygur medicine composition, the prostate tissue structure gradually returned to normal, and eosinophilic secretions were observed in the glandular cavity. Figure 5 ,exist Figure 5The low-dose group of Zhongreziyana Anti-inflammatory Granules, the medium-dose group of Reziyana Anti-inflammatory Granules and the high-dose group of Reziyana Anti-inflammatory Granules respectively represent the low-dose group of Uyghur medicine composition, the medium-dose group of Uyghur medicine composition and the high-dose group of Uyghur medicine composition.

[0108] 4.3 The results of serum PGE2 and prostate TNF-ɑ, IL-1β, and IL-6 levels in rats in each group are shown in Table 3.

[0109] Table 3 Serum PGE2 and prostate TNF-ɑ, IL-1β, IL-6 levels in rats of each group (n=10, )

[0110] Group PGE2 (pg / mL) TNF-α(pg / mL) IL-1β (pg / mL) IL-6 (pg / mL) Blank group 98.09±8.14 70.38±7.01 64.4±8.5 248.14±23.02 CNP model group <![CDATA[114.61±9.23 ** ]]> <![CDATA[89.03±11.32 *** ]]> <![CDATA[78.54±10.7 ** ]]> <![CDATA[275.5±21.01 * ]]> Three gold pieces <![CDATA[99.98±11.75 ## ]]> <![CDATA[71.49±7.15 ### ]]> <![CDATA[63.72±6.85 ## ]]> <![CDATA[251.55±15.43 # ]]> Uyghur medicine composition low dose group 107.15±9.18 84.06±7.94 74.41±8.48 268.65±13.81 Uyghur medicine composition medium dosage group 104.59±5.47 <![CDATA[76.57±8.77 # ]]> 69.48±11.27 <![CDATA[251.13±16 # ]]> Uyghur medicine composition high dose group <![CDATA[101.17±7.5 # ]]> <![CDATA[73.81±9.66 ## ]]> <![CDATA[65.62±5.85 # ]]> <![CDATA[245.74±17.08 ## ]]>

[0111] Note: Compared with the blank group, *P<0.05, **P<0.005, ***P<0.001; compared with the CNP model group, #P<0.05, ##P<0.005, ###P<0.001.

[0112] It can be concluded from Table 3 that compared with the blank control group, the levels of TNF-ɑ, IL-1β, and IL-6 in the prostate tissue of the rats in the model group were significantly increased (*P<0.05, **P<0.005, ***P<0.001). Compared with the model group, the levels of TNF-ɑ, IL-1β, and IL-6 in the prostate tissue of the rats in the positive drug group were significantly decreased (#P<0.05, ##P<0.005, ###P<0.001). Compared with the model group, the levels of TNF-ɑ, IL-1β and IL-6 in the prostate of rats in the low, medium and high dose groups of the Uyghur medicine composition administration group decreased to varying degrees, among which the medium dose group and the high dose group were more significant (#P<0.05, ##P<0.005); compared with the blank control group, the PGE2 content in the serum of rats in the model group was significantly increased (**P<0.005), and compared with the model group, the PGE2 content in the serum of rats in the positive drug group was significantly decreased (##P<0.005). Compared with the model group, the PGE2 content in the serum of each dose group of the Uyghur medicine composition decreased to varying degrees, among which the high dose was particularly significant (#P<0.05).

[0113] It can be seen from the above examples that the Uyghur medicine composition has a significant improvement effect on prostatitis, especially can improve the pathological damage of chronic non-bacterial prostatitis, and reduce the levels of various inflammatory factors including PEG2, TL-1β, TL-6 and TNF-α in serum.

[0114] Although the above embodiment describes the present invention in detail, it is only a part of the embodiments of the present invention, not all of the embodiments. People can also obtain other embodiments based on this embodiment without creativity, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A Uyghur medicine composition, characterized in that: The invention comprises the following raw materials in parts by weight: 9-34 parts of fennel root bark, 9-34 parts of caper root bark, 9-34 parts of dodder seeds, 5-20 parts of chicory seeds, 5-20 parts of cucumber seeds, 5-20 parts of melon seeds, 5-20 parts of bugloss, 7-25 parts of scutellaria baicalensis, 5-20 parts of fennel, 5-20 parts of cumin and 5-20 parts of dodder.

2. The Uyghur medicine composition according to claim 1, characterized in that: The effective ingredients of the Uyghur medicine composition include hyperoside and cynarin, and the weight percentages of the hyperoside and cynarin in the Uyghur medicine composition are 0.013% to 0.042% and 0.015% to 0.043% respectively.

3. The method for preparing the Uyghur medicine composition according to claim 1 or 2, characterized in that: The steps include: The raw materials and water are mixed and boiled, and the obtained boiled mixture is subjected to solid-liquid separation to obtain a water extract; Concentrating the water extract under reduced pressure to obtain an extract; The extract is dried to obtain the Uyghur medicine composition.

4. The preparation method according to claim 3, characterized in that: The weight ratio of the preparation raw materials to water is 1:(8-14).

5. The preparation method according to claim 3, characterized in that: The decoction is performed 2 to 4 times; the decoction time for each time is 1 to 3 hours; and the water extract is obtained by combining the water extracts of 2 to 4 decoctions.

6. The preparation method according to claim 3, characterized in that: The pressure of the reduced pressure concentration is 0.08 MPa, the temperature is 60-75° C., and the density at 60° C. is 1.22-1.

25.

7. The preparation method according to claim 3, characterized in that: The drying method is vacuum drying; the vacuum drying pressure is 0.08Mpa, the temperature is 55-65°C, and the vacuum drying is performed until the water content of the extract is ≤6%.

8. Use of the Uyghur medicine composition according to claim 1 or the Uyghur medicine composition prepared by the preparation method according to any one of claims 2 to 7 in the preparation of drugs for treating prostatitis.

9. The use according to claim 8, characterized in that: The dosage form of the drug includes tablets, powders, granules or capsules.

10. A Uyghur medicine granule for treating prostatitis, characterized in that: The raw materials for preparing the Uyghur medicine granules include a Uyghur medicine composition extract and granule excipients, and the weight ratio of the Uyghur medicine composition extract to the granule excipients is 1:1.5; The Uyghur medicine composition extract is the extract of the Uyghur medicine composition according to claim 1 or the extract of the Uyghur medicine composition prepared by the preparation method according to any one of claims 2 to 7.

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