Medicine for treating chronic prostatitis as well as preparation method and application thereof

Abstract

The invention discloses a preparation method of a medicine for treating chronic prostatitis, and belongs to the technical field of chronic prostatitis agents.The preparation method comprises the following steps that nitraria davidii leaves are smashed; adding an ethanol-diethyl ether mixed solution into a reflux device, heating for dissolving, and concentrating under reduced pressure; crystallizing and separating out a nitraria davidii leaf extract; loading the mangnolia officinalis root bark powder into an extraction kettle, and extracting the mangnolia officinalis root bark to obtain a mangnolia officinalis root bark extract; and dissolving tamsulosin powder in ethanol, uniformly stirring, heating, and adding the nitraria davidii leaf extract and the cortex magnoliae officinalis root bark extract to obtain the medicine for treating chronic prostatitis. Through comparison, both the nitraria davidii leaf extract and the mangnolia officinalis root bark extract have an auxiliary effect on tamsulosin, and the nitraria davidii leaf extract and the mangnolia officinalis root bark extract generate a synergistic effect; the tamsulosin and the tamsulosin are matched for use, so that the effects of reducing the maximum closing pressure of the urethra and improving the maximum urine flow rate are remarkably improved, and the side effect of the tamsulosin on the renal function can be effectively reduced.

Description

Technical Field

[0001] The invention relates to the technical field of chronic prostatitis medicaments, and in particular to a medicament for treating chronic prostatitis and a preparation method and application thereof. Background Art

[0002] Chronic prostatitis is a common disease of the male reproductive system. Among male patients in urology, those under 50 years old rank first, and those over 51 years old rank second. Its incidence rate is as high as 6%. Among the population, 8% have prostatitis. Chronic prostatitis is a clinical syndrome with urination irritation symptoms and bladder reproductive pain as the main manifestations.

[0003] Western medicine and Chinese medicine each have their own advantages and disadvantages. For example, tamsulosin is an effective drug for chronic prostatitis. Although tamsulosin can selectively block the α1A adrenergic receptors in the prostate and relax the prostate smooth muscle, it has many side effects. In addition, middle-aged and elderly patients with low renal function are prone to renal decline after taking the medicine. Chinese medicine often has problems such as complex formulas and slow effects. After years of clinical practice, it has been found that the combination of Chinese and Western medicine has a good therapeutic effect on chronic prostatitis.

[0004] For example, Chinese patent CN111973678B proposes an umbilical therapy drug for treating chronic prostatitis of damp-heat network obstruction type, which can effectively solve the problem of medication for external treatment of damp-heat network obstruction type prostatitis. The drug is made of the following weight ratios: 0.2-0.3g of artificial musk, 8-12g of frankincense, 8-12g of myrrh, 10-14g of scutellaria baicalensis, 10-14g of wine rhubarb, 10-14g of phellodendron, 10-14g of sophora flavescens, 2.5-3.5g of scalded leech, 2.5-3.5g of mole cricket, 13-17g of tangerine peel, 18-22g of vinegar Corydalis and 11-17g of Cyathula capitata.

[0005] However, the above patents require more than ten types of drugs, which are very diverse; and the absorption rate of umbilical therapy drugs is limited, so there is drug waste, which causes environmental pollution; in addition, umbilical therapy can cause certain damage to the skin; the efficacy still needs to be further improved.

[0006] Based on this, the present invention designs a drug for treating chronic prostatitis and a preparation method and application thereof to solve the above problems. Summary of the invention

[0007] In view of the above-mentioned shortcomings of the prior art, the present invention provides a medicine for treating chronic prostatitis and a preparation method and application thereof.

[0008] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0009] A method for preparing a medicine for treating chronic prostatitis comprises the following steps:

[0010] Step 1: irradiate the leaves of the white thorn flower under ultraviolet light for 2-3 hours, wash, dry, and then grind and grind to obtain white thorn flower leaf powder;

[0011] Step 2: Add ethanol and ether mixture into a reflux device and heat to dissolve;

[0012] Step 3: Filter out the solid matter in the reflux device and concentrate the liquid under reduced pressure;

[0013] Step 4: When the liquid in the reflux device becomes viscous, filter it while it is hot;

[0014] Step 5: naturally cooling, crystallizing and drying to obtain the Nitraria tangutorum leaf extract;

[0015] Step 6: Wash the root bark of Magnolia officinalis with an ethanol solution, dry it, and grind it into powder;

[0016] Step 7: The Magnolia officinalis root bark powder is loaded into an extraction kettle, anhydrous ethanol is used as an entrainer, and supercritical CO2 is used to extract the Magnolia officinalis root bark to obtain the Magnolia officinalis root bark extract;

[0017] Step 8: Dissolve 40-50 parts of tamsulosin powder in ethanol, stir evenly and heat, add 10-15 parts of Nitraria tangutorum leaf extract, continue to stir evenly and heat, add 8-10 parts of Magnolia officinalis root bark extract, mix evenly and continue to heat until ethanol evaporates, thereby obtaining a drug for treating chronic prostatitis.

[0018] Furthermore, in step 1, the drying temperature is 40-50°C.

[0019] Furthermore, in step 2, the volume ratio of ethanol to ether in the ethanol ether mixture is 0.8-1.4:1.

[0020] Furthermore, in step 2, the temperature is heated to 65-70°C.

[0021] Furthermore, in step seven, the extraction pressure is 45 MPa, the extraction temperature is 34-48° C., and the extraction time is 70-80 min.

[0022] Furthermore, the concentration of the entrainer in step seven is 0.2-0.4 g / mL.

[0023] Furthermore, in step eight, the extract of the leaves of the white thorn tree is added when the temperature is heated to 45-50°C.

[0024] Furthermore, in step eight, the extract of Magnolia officinalis root bark is added when the temperature is heated to 55-60°C.

[0025] A medicine for treating chronic prostatitis prepared by a method for preparing a medicine for treating chronic prostatitis.

[0026] The invention discloses an application of a medicine for treating chronic prostatitis in preparing a medicine for treating chronic prostatitis.

[0027] Beneficial Effects

[0028] The drug C of the present invention can reduce the maximum urethral closure pressure and effectively improve the maximum urine flow rate, thereby effectively alleviating the patient's symptoms such as frequent urination and urgency, and further providing an effective therapeutic effect on chronic prostatitis; the present invention requires fewer types of drugs and has low cost; the oral drug absorption rate is high, so there is no drug waste, thereby causing problems such as environmental pollution; and the drug will not cause certain damage to the skin; the efficacy is high and the effect is quick; in addition, through the comparison of drug C, drug D, drug E and drug F groups, it can be seen that the white thorn flower leaf extract and the Magnolia officinalis root bark extract both have auxiliary effects on tamsulosin, and the white thorn flower leaf extract and the Magnolia officinalis root bark extract produce a synergistic effect, and the combined use of the two has a significant improvement effect on reducing the maximum urethral closure pressure and improving the maximum urine flow rate.

[0029] The BUN index and Cr index of the rats infected with chronic prostatitis in the present invention are both within normal values ​​when they are not treated. The BUN and Cr of the rats treated with drug F are slightly higher than the normal values, which shows that the use of tamsulosin to treat chronic prostatitis has an effect on renal function; the Cr content of the rats treated with drug C returns to normal values, and the BUN content is effectively reduced; by comparing the data of drug C, drug D, drug E and drug F groups, it can be seen that the white thorn flower leaf extract has a significant effect on controlling the BUN content, the Magnolia officinalis root bark extract has a significant effect on controlling the Cr content, and the combination of the white thorn flower leaf extract and the Magnolia officinalis root bark extract can effectively reduce the side effects of tamsulosin on renal function. DETAILED DESCRIPTION

[0030] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0031] The present invention will be further described below in conjunction with the embodiments.

[0032] Example 1

[0033] This embodiment provides a method for preparing a drug for treating chronic prostatitis, comprising the following steps:

[0034] Step 1: weigh the raw materials: leaves of Nitraria scabra, root bark of Magnolia officinalis and Tamsulosin;

[0035] Step 2: irradiate the leaves of the white thorn flower under ultraviolet light for 3 hours, wash, dry, and then grind and grind to obtain white thorn flower leaf powder; the drying temperature is 50°C;

[0036] Step 3: Add ethanol and ether mixed solution into a reflux device and heat to 70° C. to dissolve; the volume ratio of ethanol to ether in the ethanol and ether mixed solution is 1.4:1;

[0037] Step 4: Filter out the solid matter in the reflux device and concentrate the liquid under reduced pressure;

[0038] Step 5: When the liquid in the reflux device becomes viscous, filter it while it is hot;

[0039] Step 6: Natural cooling, crystallization and drying to obtain the Nitraria tangutorum leaf extract;

[0040] Step 7: Wash the root bark of Magnolia officinalis with an ethanol solution, dry it, and grind it into powder;

[0041] Step 8: Magnolia officinalis root bark powder is loaded into an extraction kettle, anhydrous ethanol is used as an entrainer, and supercritical CO2 is used to extract the Magnolia officinalis root bark to obtain Magnolia officinalis root bark extract; the extraction pressure is 45Mpa, the extraction temperature is 48°C, the extraction time is 80min, and the concentration of the entrainer is 0.4g / mL;

[0042] Step nine: dissolve 50 g of tamsulosin powder in ethanol, stir evenly and heat, add 15 g of Nectaria japonica leaf extract at 50°C, continue to stir evenly and heat, add 10 g of Magnolia officinalis root bark extract at 60°C, mix evenly and continue to heat until ethanol evaporates, thereby obtaining drug A for treating chronic prostatitis.

[0043] Example 2

[0044] This embodiment provides a method for preparing a drug for treating chronic prostatitis, comprising the following steps:

[0045] Step 1: weigh the raw materials: leaves of Nitraria scabra, root bark of Magnolia officinalis and Tamsulosin;

[0046] Step 2: irradiate the leaves of the white thorn flower under ultraviolet light for 2 hours, wash, dry, and then grind and grind to obtain white thorn flower leaf powder; the drying temperature is 40°C;

[0047] Step 3: Add ethanol and ether mixed solution into a reflux device and heat to 65° C. to dissolve; the volume ratio of ethanol to ether in the ethanol and ether mixed solution is 0.8:1;

[0048] Step 4: Filter out the solid matter in the reflux device and concentrate the liquid under reduced pressure;

[0049] Step 5: When the liquid in the reflux device becomes viscous, filter it while it is hot;

[0050] Step 6: Natural cooling, crystallization and drying to obtain the Nitraria tangutorum leaf extract;

[0051] Step 7: Wash the root bark of Magnolia officinalis with an ethanol solution, dry it, and grind it into powder;

[0052] Step 8: Magnolia officinalis root bark powder is loaded into an extraction kettle, anhydrous ethanol is used as an entrainer, and supercritical CO2 is used to extract the Magnolia officinalis root bark to obtain Magnolia officinalis root bark extract; the extraction pressure is 45Mpa, the extraction temperature is 34°C, the extraction time is 70min, and the concentration of the entrainer is 0.2g / mL;

[0053] Step nine: dissolve 40 g of tamsulosin powder in ethanol, stir evenly and heat, add 10 g of Nilaria japonica leaf extract at 45°C, continue to stir evenly and heat, add 8 g of Magnolia officinalis root bark extract at 55°C, mix evenly and continue to heat until ethanol evaporates, thereby obtaining drug B for treating chronic prostatitis.

[0054] Example 3

[0055] This embodiment provides a method for preparing a drug for treating chronic prostatitis, comprising the following steps:

[0056] Step 1: weigh the raw materials: leaves of Nitraria scabra, root bark of Magnolia officinalis and Tamsulosin;

[0057] Step 2: irradiate the leaves of the white thorn flower under ultraviolet light for 2.5 hours, wash, dry, and then grind and grind to obtain white thorn flower leaf powder; the drying temperature is 48°C;

[0058] Step 3: Add ethanol and ether mixed solution into a reflux device and heat to 66° C. to dissolve; the volume ratio of ethanol to ether in the ethanol and ether mixed solution is 1:1;

[0059] Step 4: Filter out the solid matter in the reflux device and concentrate the liquid under reduced pressure;

[0060] Step 5: When the liquid in the reflux device becomes viscous, filter it while it is hot;

[0061] Step 6: Natural cooling, crystallization and drying to obtain the Nitraria tangutorum leaf extract;

[0062] Step 7: Wash the root bark of Magnolia officinalis with an ethanol solution, dry it, and grind it into powder;

[0063] Step 8: Magnolia officinalis root bark powder is loaded into an extraction kettle, anhydrous ethanol is used as an entrainer, and supercritical CO2 is used to extract the Magnolia officinalis root bark to obtain Magnolia officinalis root bark extract; the extraction pressure is 45Mpa, the extraction temperature is 40°C, the extraction time is 73min, and the concentration of the entrainer is 0.3g / mL;

[0064] Step nine: dissolve 46 g of tamsulosin powder in ethanol, stir evenly and heat, add 14 g of Nectaria japonica leaf extract at 48°C, continue to stir evenly and heat, add 9 g of Magnolia officinalis root bark extract at 57°C, mix evenly and continue to heat until ethanol evaporates, thereby obtaining drug C for treating chronic prostatitis.

[0065] Comparative Example 1

[0066] This embodiment provides a method for preparing a drug for treating chronic prostatitis, comprising the following steps:

[0067] Step 1: weigh the raw materials: leaves of Nitraria sutchuenensis and tamsulosin;

[0068] Step 2: irradiate the leaves of the white thorn flower under ultraviolet light for 2.5 hours, wash, dry, and then grind and grind to obtain white thorn flower leaf powder; the drying temperature is 48°C;

[0069] Step 3: Add ethanol and ether mixed solution into a reflux device and heat to 66° C. to dissolve; the volume ratio of ethanol to ether in the ethanol and ether mixed solution is 1:1;

[0070] Step 4: Filter out the solid matter in the reflux device and concentrate the liquid under reduced pressure;

[0071] Step 5: When the liquid in the reflux device becomes viscous, filter it while it is hot;

[0072] Step 6: Natural cooling, crystallization and drying to obtain the Nitraria tangutorum leaf extract;

[0073] Step nine: dissolving 46 g of tamsulosin powder in ethanol, stirring evenly and heating, adding 14 g of N. tangutica leaf extract at 48° C., continuing to stir evenly and continue to heat until the ethanol evaporates, thereby obtaining drug D for treating chronic prostatitis.

[0074] Comparative Example 2

[0075] This embodiment provides a method for preparing a drug for treating chronic prostatitis, comprising the following steps:

[0076] Step 1: weigh the raw materials: Magnolia officinalis root bark and tamsulosin;

[0077] Step 2: Wash the root bark of Magnolia officinalis with an ethanol solution, dry it, and grind it into powder;

[0078] Step 3: Magnolia officinalis root bark powder is loaded into an extraction kettle, anhydrous ethanol is used as an entrainer, and supercritical CO2 is used to extract the Magnolia officinalis root bark to obtain Magnolia officinalis root bark extract; the extraction pressure is 45Mpa, the extraction temperature is 40°C, the extraction time is 73min, and the concentration of the entrainer is 0.3g / mL;

[0079] Step 4: Dissolve 46 g of tamsulosin powder in ethanol, stir evenly and heat, add 9 g of Magnolia officinalis root bark extract at 57° C., mix evenly and continue heating until the ethanol evaporates, thereby obtaining drug E for treating chronic prostatitis.

[0080] Comparative Example 3

[0081] This embodiment provides a method for preparing a drug for treating chronic prostatitis, comprising the following steps:

[0082] 46 g of tamsulosin powder was dissolved in ethanol, stirred evenly and heated until the ethanol evaporated, thereby obtaining drug F for treating chronic prostatitis.

[0083] Experimental Example 1

[0084] Toxicity test data study of Examples 1-3

[0085] 1. Research Objectives

[0086] In this study, ICR mice were orally administered drugs A, B, and C twice within 24 hours and observed for 14 consecutive days. The results of the single-dose toxicity test in mice were used to understand the extent of toxic reactions and the organs involved, providing a basis for the dose design and selection of toxicity indicators for repeated-dose toxicity tests.

[0087] 2. Experimental Methods

[0088] 40 SPF-grade ICR mice that passed the quarantine were selected, half male and half female, weighing 18.2-23.5g, and were raised in 310mm×205mm×180mm cages, with 5 mice per cage. They were raised in accordance with the international (GB14925-2010) SPF-grade experimental animal environmental conditions, and the animals were quarantined and adapted to the environment for 3 days. They were randomly divided into 4 groups according to gender and weight, namely, blank control group (pure water), drug A (1.0g drug / kg), drug B (1.0g drug / kg) and drug C (1.0g drug / kg), with 10 mice in each group. Before the experiment, they fasted but not watered for more than 12 hours, and then orally administered pure water, drug A, drug B and drug C at a dosage volume of 50mL / kg. The drugs were administered twice on the day of administration. The poisoning manifestations and characteristics of the animals in each group, the occurrence and recovery time of toxic reactions, and the death of the animals were closely observed and recorded within 0-4 hours after each administration. Then, they were observed twice a day, once in the morning and once in the afternoon, for 14 consecutive days. The animals were weighed before administration and on the 4th, 7th, 10th and 14th days after administration, and the weight changes and deaths of the animals were recorded.

[0089] 3. Experimental Results

[0090] Under the experimental conditions, mice were orally administered drugs A, B and C at a volume of 40 mL / kg. The drugs were administered twice on the day of administration, with a cumulative dose of 1.0 g of drug / kg, equivalent to 100 times the intended clinical dosage per kilogram of body weight for adults. No related toxic reactions or deaths were observed in the animals.

[0091] (1) Effects on general activity, animal poisoning symptoms and death: Within 0-4 hours after the end of oral administration, there were no obvious abnormalities in the spontaneous activity, mental state and diet of mice in the blank control group (pure water) and drug groups A, B and C, and no related toxic reactions or animal deaths were observed. After continuous observation for 14 days after administration, there were no obvious abnormalities in the spontaneous activity, mental state and diet of mice in each group, and no related toxic reactions or animal deaths were observed.

[0092] (2) Effect on body weight: The animals were weighed before administration and on the 4th, 7th, 10th and 14th days after administration. No significant difference was found in the body weight of mice in each group. This indicates that oral administration of drug A, drug B and drug C to ICR mice had no significant effect on the weight gain of mice. See Table 1 for details.

[0093] Table 1: Effects of drug A, drug B and drug C on mouse body weight

[0094]

[0095]

[0096] (3) At the end of the experiment, gross anatomical observation of ICR mice showed that no obvious abnormalities were found on the surface and cross-section of the organs.

[0097] Experimental Example 2

[0098] Study on toxicity experimental data of drug C at different doses

[0099] 1. Research Objectives

[0100] In this study, SD rats were given different doses of drug C by oral gavage for 3 consecutive months (13 weeks). The possible clinical adverse reactions caused by the test substance were predicted from the toxicity test results in rats, and the starting dose for the first clinical trial and the safe dose range for repeated medication were estimated; the indicators that need to be monitored in clinical trials are suggested; and a reference is provided for the monitoring of toxic reactions in clinical trials and rescue measures, clinical trials and clinical drug use.

[0101] 2. Experimental Methods

[0102] 120 qualified SD rats were selected, half male and half female, weighing 260.1-273.5g, and were raised in 475×350×200mm cages, with 5 rats per cage. They were raised in accordance with the national standard (GB14925-2010) SPF-level experimental animal environmental conditions, and the animals were quarantined and adapted to the environment for 6 days. 120 SD rats that passed the quarantine were selected, half male and half female, and randomly divided into 4 groups according to gender and weight, namely blank control group (pure water), low-, medium-, and high-dose groups of drug C (10, 50, and 100 mg drug / kg), 30 rats in each group, and each group was gavaged at a volume of 15mL / kg for 3 consecutive months. At the end of the drug administration (the 13th week), 120 rats were dissected as planned, half male and half female. The examination items include: blood routine, coagulation, and histopathological examination.

[0103] 3. Experimental Results

[0104] (1) Routine blood examination: Compared with the blank control group (pure water) of the same period, no abnormalities of toxicological significance were found in the blood parameters of each dose group of drug C (as shown in Table 2).

[0105] Table 2: Effects of each dose group of drug C on blood indicators

[0106]

[0107]

[0108] Note: Red blood cell count (RBC), white blood cell differential count and platelet (PLT), hemoglobin concentration (Hb): hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), red blood cell distribution width (RDW), white blood cell count (WBC), neutrophil count (Neu), lymphocyte count (Lym), monocyte count (Mon), eosinophil count (Eos), basophil count (Bas).

[0109] (2) Coagulation test: Compared with the blank control group (pure water) of the same period, no abnormalities of toxicological significance were found in the coagulation indexes of each dose group of drug C (as shown in Table 3).

[0110] Table 3: Effects of each dose group of drug C on coagulation indexes

[0111] Detection indicators Blank control group Low dose group Medium dose group High dose group PT(s) 12.21±1.25 12.25±1.34 12.37±1.18 12.42±1.47

[0112] Note: PT: Prothrombin time

[0113] (3) Gross anatomy: No obvious pathological changes were observed by naked eye observation in the animals dissected at the middle, end and recovery stages of drug administration.

[0114] Experimental Example 3

[0115] Conduct efficacy experimental data studies on drug C, drug D, drug E, and drug F

[0116] 1. Research Objectives

[0117] In this study, SD rats were given the same dose of drug C, drug D, drug E and drug F by oral gavage for 14 consecutive days. The maximum urine flow rate (Qmax) and maximum urethral closure pressure of the rats were detected to determine the efficacy of the drugs.

[0118] 2. Experimental Methods

[0119] (1) Establishment of a chronic nonbacterial prostatitis model in SD rats

[0120] Fifty male rats (weight 260.1-273.5 g) were randomly divided into 5 groups. On the 1st and 7th days, 1.0 ml of 80 mg / ml rat prostate protein purified solution combined with complete Freund's adjuvant (1:1 suspension) was intradermally injected at multiple points, and 0.5 ml of diphtheria, pertussis and tetanus vaccine was intraperitoneally injected. On the 21st day, 0.5 ml of rat prostate protein purified solution was intraperitoneally injected. The Ca in rat serum was measured. 2+ Mg 2+ , testosterone (T), and dihydrotestosterone (DHT) content, and successfully established a SD rat autoimmune chronic prostatitis model;

[0121] (2) 50 qualified SD autoimmune chronic prostatitis model rats were selected and raised in metabolic cages, with one rat in each cage. The rats were raised in accordance with the national standard (GB14925-2010) SPF-level experimental animal environmental conditions, and the animals were quarantined and adapted to the environment for 6 days. They were randomly divided into 5 groups according to their body weight, namely blank control group (pure water), drug C, drug D, drug E and drug F group (10 mg drug / kg), with 10 rats in each group. Each group was gavaged at a volume of 15 mL / kg for 14 consecutive days, and the maximum urine flow rate (Qmax) (as shown in Table 4) and the maximum urethral closure pressure (as shown in Table 5) of the rats were tested;

[0122] Table 4: Changes in maximum urine flow rate (Qmax) of rats (unit: μL / s)

[0123] Group Before administration <![CDATA[D4 days]]> <![CDATA[D7 days]]> <![CDATA[D 10 Day]]> <![CDATA[D 14 Day]]> Blank control group 2.84±0.21 2.67±1.55 2.57±2.86 2.52±2.17 2.44±1.11 Drug C 2.83±0.24 2.96±1.84 3.17±2.95 3.62±3.41 4.86±3.25 Drug D 2.81±0.19 2.93±1.24 3.45±2.84 4.06±3.21 4.38±3.64 Drug E 2.82±0.17 2.91±1.08 3.14±1.52 3.86±3.59 4.19±3.88 Drug F 2.83±0.22 2.86±1.21 2.89±1.85 2.97±1.92 3.05±3.25

[0124] Table 5: Changes in maximum urethral closure pressure in rats (unit: cmH2O)

[0125]

[0126]

[0127] As shown in Tables 4 and 5, drug C can reduce the maximum urethral closure pressure and effectively improve the maximum urine flow rate, thereby effectively relieving the patient's symptoms such as frequent urination and urgency, and thus providing an effective treatment effect for chronic prostatitis;

[0128] The invention requires fewer types of drugs and has low cost. The oral drug absorption rate is high, so there is no drug waste, which causes environmental pollution and other problems. The drug will not cause certain damage to the skin. The efficacy is high and the effect is fast.

[0129] In addition, through the comparison of drug C, drug D, drug E and drug F groups, it can be seen that both the Nitraria tangutorum leaf extract and the Magnolia officinalis root bark extract have auxiliary effects on tamsulosin, and the Nitraria tangutorum leaf extract and the Magnolia officinalis root bark extract have a synergistic effect. The combined use of the two has a significant effect on reducing the maximum urethral closure pressure and improving the maximum urine flow rate.

[0130] Experimental Example 3

[0131] Conduct side effect experimental data research on drug C, drug D, drug E and drug F respectively

[0132] 1. Research Objectives

[0133] In this study, SD autoimmune chronic prostatitis model rats were orally administered with the same dose of drug C, drug D, drug E and drug F for 14 consecutive days to detect the clinical adverse reactions of the rats, and to suggest the indicators that need to be monitored in clinical trials; this provides a reference for the monitoring of side effects and rescue measures in clinical trials, clinical trials and clinical drug use.

[0134] 2. Experimental steps

[0135] 50 qualified SD autoimmune chronic prostatitis model rats were selected and raised in metabolic cages, with one rat in each cage. The rats were raised in accordance with the national standard (GB14925-2010) SPF-level experimental animal environmental conditions, and the animals were quarantined and adapted to the environment for 6 days. They were randomly divided into 5 groups according to their body weight, namely blank control group (pure water), drug C, drug D, drug E and drug F group (10 mg drug / kg), with 10 rats in each group. Each group was gavaged at a volume of 15 mL / kg for 30 consecutive days, and the renal function indicators (urea nitrogen BUN content, creatinine Cr content) of the rats were detected (as shown in Table 6);

[0136] Table 6: Renal function indexes of rats

[0137] Group Blank control group Drug C Drug D Drug E Drug F BUN (mmol / L) 6.7±0.5 8.5±0.4 8.8±0.7 8.2±0.2 9.1±0.8 Cr(μmol / L) 97.6±3.5 104.8±5.2 102.1±5.6 113.2±3.2 122.8±2.6

[0138] The normal BUN index of rats is 2.5-8mmol / L, and the Cr index is 53-115μmol / L. As shown in Table 6, the above two indexes of rats infected with chronic prostatitis are within normal values ​​without treatment. The BUN and Cr of rats treated with drug F are slightly higher than normal values, which shows that the use of tamsulosin to treat chronic prostatitis has an effect on renal function; the Cr content of rats treated with drug C returns to normal, and the BUN content is effectively reduced; by comparing the data of drug C, drug D, drug E and drug F groups, it can be seen that the extract of the leaves of Nitraria tangutorum has a significant effect on controlling the BUN content, and the extract of Magnolia officinalis root bark has a significant effect on controlling the Cr content. The combination of the extract of the leaves of Nitraria tangutorum and the extract of Magnolia officinalis root bark can effectively reduce the side effects of tamsulosin on renal function.

[0139] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. Such modifications or replacements will not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for preparing a drug for treating chronic prostatitis, characterized in that: The following steps are involved: Step 1: irradiate the leaves of the white thorn flower under ultraviolet light for 2-3 hours, wash, dry, and then grind and grind to obtain white thorn flower leaf powder; Step 2: Add ethanol and ether mixture into a reflux device and heat to dissolve; Step 3: Filter out the solid matter in the reflux device and concentrate the liquid under reduced pressure; Step 4: When the liquid in the reflux device becomes viscous, filter it while it is hot; Step 5: naturally cooling, crystallizing, and drying to obtain a Nitraria tangutorum leaf extract; Step 6: Wash the root bark of Magnolia officinalis with an ethanol solution, dry it, and grind it into powder; Step 7: The Magnolia officinalis root bark powder is loaded into an extraction kettle, anhydrous ethanol is used as an entrainer, and supercritical CO2 is used to extract the Magnolia officinalis root bark to obtain the Magnolia officinalis root bark extract; Step 8: Dissolve 40-50 parts of tamsulosin powder in ethanol, stir evenly and heat, add 10-15 parts of Nitraria tangutorum leaf extract, continue to stir evenly and heat, add 8-10 parts of Magnolia officinalis root bark extract, mix evenly and continue to heat until ethanol evaporates, thereby obtaining a drug for treating chronic prostatitis.

2. The method for preparing the medicine for treating chronic prostatitis according to claim 1, characterized in that: The drying temperature in step 1 is 40-50°C.

3. The method for preparing the medicine for treating chronic prostatitis according to claim 2, characterized in that: In step 2, the volume ratio of ethanol to ether in the ethanol ether mixture is 0.8-1.4:

1.

4. The method for preparing the medicine for treating chronic prostatitis according to claim 3, characterized in that: In step 2, heat to 65-70°C.

5. The method for preparing the medicine for treating chronic prostatitis according to claim 4, characterized in that: In step seven, the extraction pressure is 45 MPa, the extraction temperature is 34-48° C., and the extraction time is 70-80 min.

6. The method for preparing the medicine for treating chronic prostatitis according to claim 5, characterized in that: The concentration of the entrainer in step seven is 0.2-0.4 g / mL.

7. The method for preparing the medicine for treating chronic prostatitis according to claim 6, characterized in that: In step eight, the extract of the leaves of the white thorn tree is added when the temperature is heated to 45-50°C.

8. The method for preparing the medicine for treating chronic prostatitis according to claim 7, characterized in that: In step eight, when the temperature is heated to 55-60° C., the Magnolia officinalis root bark extract is added.

9. A medicine for treating chronic prostatitis prepared by the preparation method according to claim 8.

10. Use of the drug according to claim 9 in preparing a drug for treating chronic prostatitis.

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