CN112057588A

CN112057588A - Pharmaceutical composition for treating nephrolithiasis

Info

Publication number: CN112057588A
Application number: CN202011119618.1A
Authority: CN
Inventors: 周波; 王刚; 汤晓莉; 陈方明; 魏谭军
Original assignee: Dazhou Integrated Tcm & Western Medicine Hospital
Current assignee: Dazhou Integrated Tcm & Western Medicine Hospital
Priority date: 2020-10-19
Filing date: 2020-10-19
Publication date: 2020-12-11
Anticipated expiration: 2040-10-19
Also published as: CN112057588B

Abstract

The invention provides a pharmaceutical composition for treating nephrolithiasis, which can effectively treat nephrolithiasis, shorten the treatment time of calculus, inhibit inflammatory reaction, reduce the recurrence rate of calculus, obviously improve hydroncus of renal pelvis and ureter, relieve pain of nephrolithiasis, and relieve lumbago.

Description

Pharmaceutical composition for treating nephrolithiasis

Technical Field

The invention belongs to the field of medicines, and particularly relates to a pharmaceutical composition for treating nephrolithiasis.

Background

Nephrolithiasis (also known as urolithiasis) refers to a crystalline substance formed in the collecting system of the kidney or in the tubules of the kidney, which is partly retained in the collecting system of the kidney and partly excreted with urine into the ureter or bladder, and becomes a ureteral or bladder stone.

The nephrolithiasis is one of common and multiple diseases of the urinary system, the incidence rate level of the nephrolithiasis is between 3% and 14% in different regions in the south and the north of China, China is also one of three calculosis countries and regions in the world, the nephrolithiasis has higher incidence rate and recurrence rate, urinary tract obstruction, infection, renal failure and systemic multiple system diseases can be caused, and serious patients can endanger the life safety of patients.

In the clinical treatment of nephrolithiasis, both modern medicine and traditional medicine have effective clinical treatment schemes, but have advantages and disadvantages. In the clinical treatment of modern medicine, mainly surgical operation treatment is taken as the main treatment, and mainly comprises methods and means such as external shock wave lithotripsy, ureteroscopy lithotripsy, percutaneous nephrolithotomy and laparoscopic ureteroscopy, and the like. The traditional medical science has deeply known and effectively treated the kidney stone disease from the period of Huangdi's internal classic, the traditional medical science of China classifies the kidney stone disease into the category of the urolithiasis, and the kidney deficiency and damp-heat are considered as main pathogenesis of the kidney stone disease. The traditional Chinese medicine has a plurality of advantages in the aspect of treating the nephrolithiasis, such as the raw materials are obtained from natural plants, the medicine effect is lasting, the side effect is small, the price is compatible with the people, and the like.

Pain caused by calculus, hydronephrosis of renal pelvis and ureter and lumbago caused by hydronephrosis are the main reasons for the patients with nephrolithiasis. Therefore, the traditional Chinese medicine composition has important clinical significance for subjective feeling, compliance and the like of patients, effectively relieves hydronephrosis and hydroureter, can relieve urinary infection, and has positive effects on promoting urine excretion and calculus excretion while promoting calculus excretion and improving pain of patients suffering from renal calculus.

However, many existing traditional Chinese medicine formulas only aim at the effects of breaking, dissolving and removing stones, and reports of improving the common and most painful clinical manifestations of various nephrolithiasis diseases such as pain, hydronephrosis of the renal pelvis and the ureter are not found, so that the medicine capable of effectively treating the nephrolithiasis diseases and the hydronephrosis of the renal pelvis and the ureter and relieving the pain has important significance.

Disclosure of Invention

Aiming at the problems, the invention aims to provide a pharmaceutical composition capable of effectively treating nephrolithiasis, which is prepared from the following raw materials in parts by weight: 20-40 parts of astragalus membranaceus, 10-30 parts of eucommia ulmoides, 20-40 parts of fringed pink, 5-25 parts of cassia twig, 30-50 parts of desmodium, 20-40 parts of endothelium corneum gigeriae galli, 10-30 parts of lygodium japonicum, 30-50 parts of talc, 10-30 parts of pyrrosia lingua, 10-30 parts of salvia miltiorrhiza, 5-25 parts of rhizoma alismatis, 10-30 parts of rhizoma corydalis, 10-30 parts of plantain seed, 20-40 parts of beautiful sweetgum fruit, 10-30 parts of radix curcumae and 1-20 parts of fried szechwan chinaberry fruit.

Further, the pharmaceutical composition is prepared from the following raw materials in parts by weight: 25-35 parts of astragalus membranaceus, 15-25 parts of eucommia ulmoides, 25-35 parts of fringed pink, 10-20 parts of cassia twig, 35-45 parts of desmodium, 25-35 parts of endothelium corneum gigeriae galli, 15-25 parts of spora lygodii, 35-45 parts of talc, 15-25 parts of pyrrosia lingua, 15-25 parts of salvia miltiorrhiza, 10-20 parts of rhizoma alismatis, 15-25 parts of rhizoma corydalis, 15-25 parts of semen plantaginis, 25-35 parts of fructus liquidambaris, 15-25 parts of radix curcumae and 5-15 parts of fried szechwan chinaberry fruit.

Furthermore, the pharmaceutical composition is prepared from the following raw materials in parts by weight: 30 parts of astragalus membranaceus, 20 parts of eucommia ulmoides, 30 parts of fringed pink, 15 parts of cassia twig, 40 parts of desmodium, 30 parts of endothelium corneum gigeriae galli, 20 parts of spora lygodii, 40 parts of talc, 20 parts of folium pyrrosiae, 20 parts of salvia miltiorrhiza, 15 parts of rhizoma alismatis, 20 parts of rhizoma corydalis, 20 parts of semen plantaginis, 30 parts of fructus liquidambaris, 20 parts of radix curcumae and 10 parts of fried szechwan chinaberry fruit.

Furthermore, the pharmaceutical composition is a preparation prepared by taking crude drug powder of the raw materials and/or water extract and/or organic solvent extract as active ingredients and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.

Further, the above preparation is an oral preparation, preferably powder, granule, capsule, tablet, pill, tea, suspension, decoction or oral liquid.

The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: directly pulverizing the raw materials in weight ratio, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.

The invention also provides application of the pharmaceutical composition in preparing a medicament for treating the nephrolithiasis and reducing the recurrence rate of the nephrolithiasis.

Further, the above medicine has effects of inhibiting inflammatory reaction, relieving nephrolithiasis pain, accelerating calculus discharge, promoting dropsy discharge of renal pelvis and ureter, and relieving lumbago.

The invention also provides a combined medicine for treating nephrolithiasis, hydronephrosis and ureter and relieving pain, which is characterized in that: it contains the pharmaceutical composition according to any one of claims 1 to 6 and tamsulosin hydrochloride sustained-release capsules administered simultaneously or separately in unit preparations of the same or different specifications.

The pharmaceutical composition disclosed by the invention is prepared from astragalus membranaceus, eucommia ulmoides, fringed pink, cassia twig, longhairy antenoron herb, fried szechwan chinaberry fruit, endothelium corneum gigeriae galli, radix curcumae, talc, folium pyrrosiae, lygodium japonicum, salvia miltiorrhiza, rhizoma alismatis, rhizoma corydalis, plantain seed and beautiful sweetgum fruit, and has the effects of tonifying kidney, clearing heat, promoting diuresis, treating stranguria and removing urinary calculus. The astragalus membranaceus in the formula has the effects of tonifying qi, promoting urination and tonifying kidney, the eucommia ulmoides has the effects of tonifying liver and kidney, strengthening bones and muscles and promoting urination, is a monarch drug, the pyrrosia lingua, the dianthus superbus, the rhizoma alismatis, the talc and the semen plantaginis have the effects of clearing heat, promoting diuresis, treating stranguria and removing urinary calculus, the endothelium corneum gigeriae galli has the effects of removing calculus, removing heat, promoting urination, cooling blood and stopping bleeding, is a ministerial drug, and the corydalis tuber, the cassia twig, the szechwan chinaberry fruit, the fructus liquidambaris, the salvia miltiorrhiza and the radix curcumae have the effects of activating yang, promoting qi, activating collaterals, relieving pain, promoting blood circulation and removing blood stasis, is an assistant drug, achieves the effects of tonifying kidney, clearing heat, promoting diuresis, treating stranguria.

The experimental result shows that the pharmaceutical composition can effectively treat the nephrolithiasis, reduce the recurrence rate of the calculus, relieve the pain of the nephrolithiasis, promote the calculus discharge to shorten the treatment time, inhibit the inflammatory reaction, obviously improve the hydrops of the renal pelvis and the ureter and relieve the lumbago. The clinical curative effect is definite, the clinical medication is safe, and the application prospect is excellent.

Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.

The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Detailed Description

EXAMPLE 1 preparation of a pharmaceutical composition of the invention for the treatment of nephrolithiasis

The raw material medicines of 30g of astragalus mongholicus, 20g of eucommia ulmoides, 30g of fringed pink, 15g of cassia twig, 40g of longhairy antenoron herb, 30g of endothelium corneum gigeriae galli, 20g of spora lygodii, 40g of talc, 20g of pyrrosia lingua, 20g of salvia miltiorrhiza, 15g of rhizoma alismatis, 20g of rhizoma corydalis, 20g of semen plantaginis, 30g of fructus liquidambaris, 20g of radix curcumae and 10g of fried szechwan chinaberry fruit are taken, water is added for decoction, residues are.

EXAMPLE 2 preparation of the pharmaceutical composition for the treatment of nephrolithiasis according to the present invention

The raw material medicines of 20g of astragalus membranaceus, 10g of eucommia ulmoides, 20g of fringed pink, 5g of cassia twig, 30g of desmodium, 20g of endothelium corneum gigeriae galli, 10g of spora lygodii, 30g of talc, 10g of folium pyrrosiae, 10g of salvia miltiorrhiza, 5g of rhizoma alismatis, 10g of rhizoma corydalis, 10g of semen plantaginis, 20g of fructus liquidambaris, 10g of radix curcumae and 1g of fried szechwan chinaberry fruit are taken, water is added for decoction, residues are removed, and decoction.

EXAMPLE 3 preparation of the pharmaceutical composition for the treatment of nephrolithiasis according to the present invention

The raw material medicines of 40g of astragalus mongholicus, 30g of eucommia ulmoides, 40g of fringed pink, 25g of cassia twig, 50g of desmodium, 40g of endothelium corneum gigeriae galli, 30g of spora lygodii, 50g of talc, 30g of pyrrosia lingua, 30g of salvia miltiorrhiza, 25g of rhizoma alismatis, 30g of rhizoma corydalis, 30g of semen plantaginis, 40g of fructus liquidambaris, 30g of radix curcumae and 20g of fried szechwan chinaberry fruit are taken, water is added for decoction, residues are removed, and.

The following experimental examples prove the beneficial effects of the pharmaceutical composition for treating nephrolithiasis prepared by the invention.

Experimental example 1 clinical efficacy of the pharmaceutical composition of the present invention

1. Experimental drugs: the pharmaceutical composition prepared in example 1 of the present invention; control group: compound herba Lysimachiae granules.

2. The experimental method comprises the following steps:

2.1 patient data

80 urinary calculus patients meeting the diagnosis standard are randomly divided into a control group and a study group, the control group comprises 30 cases and 50 cases in the study group, wherein 17 cases of males and 13 cases in the control group comprise 17 cases of females, the patients are 23-64 years old, the mean age is 42.83 +/-10.42 years old, the transverse diameter of the calculus is 7.43 +/-1.43 mm, the longitudinal diameter of the calculus is 11.13 +/-2.76 mm, 28 cases of males and 22 cases of females, the patients are 22-63 years old, the mean age is 42.32 +/-9.58 years old, the transverse diameter of the calculus is 7.52 +/-1.61 mm, the longitudinal diameter of the calculus is 11.90 +/-2.15 mm, the data of the two groups of patients are not different statistically, and the two groups of patients are comparable to the subsequent study. The basic conditions for both groups of patients are shown in table 1.

TABLE 1 comparison of basic conditions of two groups of patients (x. + -. s)

2.2 inclusion and exclusion criteria

2.2.1 diagnostic criteria:

(1) western diagnostic criteria: nephrolithiasis includes renal calculus, calculus of ureter, vesical calculus and calculus of urethra. History and symptoms: the kidney stone is found in the past physical examination or disease examination for no more than two years, the symptoms of renal colic can be caused during acute attack, accompanied by dysuria, interruption of urination, hematuria, leucocyturia, purulent urine and the like, and no symptoms can be caused or symptoms are not obvious and definite during non-attack. ② sign: percussion pain or tenderness is present at the calculus part or the calculus part of the body during acute attack, and the mass can be touched under the conditions of serious hydrocele, kidney abscess and the like. Thirdly, ultrasonic inspection: the size, morphology and number of stones are examined ultrasonically. Fourthly, urine examination: urine tests include red blood cells, white blood cells, pus cells, crystals, urine specific gravity, and the like, accompanied by urine proteins.

(2) The traditional Chinese medicine diagnosis standard is as follows: pattern of kidney deficiency with dampness-heat: lumbago, soft knee, urgent and full lower abdomen, frequent and red urination, difficult urination, lassitude, fatigue, heaviness, drowsiness, facial puffiness, aversion to cold, cold limbs, damp scrotum, leukorrhagia, dry stool, yellow and greasy tongue coating, slippery rapid pulse or wiry and slippery pulse. The syndrome of kidney deficiency with damp-heat can be identified according to the above main symptoms.

2.2.2 inclusion criteria: (1) the urinary calculus removing device meets the Western diagnosis standard, (2) meets the Chinese medicine diagnosis standard, and (3) simultaneously meets the following conditions that urinary calculus which is difficult to be automatically removed still cannot be automatically removed after calculus lithotripsy at the positions of kidney, ureter and the like, the shape and structure of the urinary system have no obvious malformation or stenosis, the renal function is good or mild renal dysfunction, hydroncus of kidney and ureter is below moderate, the medical history of renal calculus is below 2 years, the general condition of the whole body is good, and life can be self-managed.

2.2.3 exclusion criteria: (1) patients who were less than 18 years old, or patients who were 65 years old or older, were in gestation, lactation, or the like, or were allergic to the medications used in the treatment in this study; (2) serious cardiovascular and cerebrovascular diseases and serious damage to liver and kidney are combined, and the life cannot be managed by oneself; (3) the study was not prescribed for use, or the relevant examinations were not performed on schedule, or other medications affecting the study were taken; (4) in the treatment process of two groups of patients, diclofenac sodium sustained release tablets or racanisodamine hydrochloride injection and the like can be given for treatment according to pain conditions, and if the treatment cannot be carried out or is selected for operation treatment because of pain, the patients can be taken as rejection cases according to the conditions.

2.3 methods of treatment

Control group: the compound desmodium granules and the tamsulosin hydrochloride sustained-release capsules of the comparative example are given together, the compound desmodium granules (Guangxi Wantong pharmaceutical Co., Ltd., national standard: Z45021680) are mixed with water for 2 bags (6g) each time, 300mL of water is mixed for each time, three times a day, 900mL of water is mixed together, and the tamsulosin hydrochloride sustained-release capsules (Zhejiang Hailisheng pharmaceutical Co., Ltd., national standard: H20020623) are mixed for 1 granule (0.2 g/granule) each day;

study group: the treatment was carried out by administering the pharmaceutical composition of example 1 of the present invention by orally administering 900mL of the decoction prepared in example 1 three times a day, followed by 1 tablet (0.2 g/tablet) per day of tamsulosin hydrochloride sustained-release capsule.

Meanwhile, two groups of patients receive rope skipping exercises of 15min each day in the morning and at night, the administration of the medicine is stopped after the stones are discharged, the diet is light, the patients are prevented from eating greasy food, the total water intake per day is more than 3000mL, the pain of the patients cannot be tolerated, diclofenac sodium sustained-release tablets (Hunan Huana large pharmaceutical factory, GmbH 20067776) are orally taken or racanisodamine hydrochloride injection (Hangzhou national folk pharmaceutical industry, GmbH 33021707) is injected after other diseases and contraindications are eliminated, other medicines influencing the urinary stone treatment are not selected in the treatment period, and the total treatment period is 30 days.

2.4 Observation index

Before and after treatment, all patients in two groups carry out examination and evaluation on liver function (the normal value of glutamic-pyruvic transaminase ALT is 0-40U/L, the normal value of glutamic-oxalacetic transaminase AST is 0-40U/L), kidney function (the normal value of blood urea nitrogen BUN is 2.5-7.1 mmol/L, the normal value of blood creatinine CRE is 40-106 umol/L), hypersensitive C-reactive protein (HCRP is 0-10 mg/L), urine analysis, urinary ultrasound, urine analysis (leucocyte, erythrocyte and urine protein characterization), clinical symptoms and the like, before the calculus is not eliminated, the urinary ultrasound is carried out once per week to evaluate the transverse diameter and longitudinal diameter of the calculus, whether hydronephrosis exists or not and the like, the transverse diameter and longitudinal diameter of the calculus are expressed in millimeter (mm), the severity of the kidney and the hydrosis are expressed in the form of none, light, medium and heavy, and the urinary ultrasound examination is carried out once immediately after the self-perceived calculus is eliminated, the method comprises the steps of carrying out urine analysis and examination once after 3 days of calculus discharge in urinary ultrasonic diagnosis, wherein the urine examination mainly comprises qualitative examinations of white blood cells, red blood cells, urine proteins and the like, which are expressed in terms of-0 part, 1 part, 2 parts, 4 parts and 6 parts, and expressing in terms of integral, and repeatedly examining whether the calculus is recurrent or not in the urinary ultrasonic examination 6 months after the calculus is discharged. Detection indexes such as liver function, kidney function, hypersensitivity C-reactive protein, urine analysis and the like are detected by a clinical laboratory of a Chinese and western medicine combined hospital in Dazhou city, and adverse reactions of patients are observed.

Before and after treatment, all patients in the two groups have renal pelvis separation, hydroureter and the like by urinary ultrasound, the renal pelvis separation and the ureter expansion represent the renal pelvis and hydroureter, otherwise, the patients are determined to have no hydroureter, and the number of cases with or without renal pelvis and hydroureter is counted; the number of cases of waist pain of patients before and after clinical treatment is counted, the waist pain caused by reasons except urinary calculus is eliminated, and the clinical treatment effect is judged according to the judgment standard of the clinical treatment effect.

2.5 criteria for clinical efficacy

(1) The effect is shown: the patient feels that the calculus is discharged or a calculus sample is collected, and when the urinary system ultrasound is rechecked, no calculus image is seen; or the calculus shadow disappears in the weekly urinary ultrasonic examination of the patient, and the urinary obstruction and the hydrops are reduced and disappeared.

(2) The method has the following advantages: the patient moves the kidney stone from the renal pelvis and ureter downwards, or the size of the kidney stone changes by more than 20 percent, or the stone is cracked, the obstruction and the hydrops of the urinary system are reduced and disappeared, and urine protein, urine occult blood, leucocyte, renal function, hypersensitive C-reactive protein are obviously reduced, etc.

(3) The calculus size of the patient is changed by less than 20 percent, or the calculus position is not changed, the urinary obstruction and the hydrops are not reduced, and the urine protein, the urine occult blood, the leucocyte, the renal function and the hypersensitive C-reactive protein are not changed or further aggravated.

2.6 statistical methods

All clinical data were collected using SPSS 26.0 softwarePerforming data statistics and analysis, wherein all test data are expressed by x + -s, statistical comparison of data before and after treatment of two groups of patients is performed by one-way variance analysis and independent sample T test, and measurement data is performed by χ²Inspection with P<A difference of 0.05 is statistically significant.

3. Results of the experiment

3.1 results of comparing the clinical efficacy of the two groups of patients are shown in Table 2.

TABLE 2 comparison of clinical efficacy of control and treatment patients

Note: p < 0.05 compared to control group

After treatment, the total effective rate of clinical curative effect of the control group is 70.00 percent, the total effective rate of clinical curative effect of the research group is 96.00 percent, and the total effective rate of clinical curative effect of the research group is Chi²The value is 10.688, P0.001 < 0.05, which is statistically significant.

The results show that the medicine composition can effectively treat the nephrolithiasis and has the effective rate which is obviously higher than that of a control group.

3.2 clinical treatment time and recurrence rate comparison results of two groups of patients are shown in Table 3.

TABLE 3 comparison of treatment time and recurrence rate between control and treatment patients

Note: p < 0.05 compared to control group

After treatment, the clinical treatment time of the control group is 18.08 +/-8.57 days, the clinical treatment time of the study group is 11.56 +/-5.49 days, and the comparison P of the two groups is 0.000 to 0.05, so that the statistical significance is achieved.

The results show that the clinical treatment time of a research group for treating the nephrolithiasis by adopting the pharmaceutical composition is shorter than that of a control group, the calculi can be promoted to be discharged more quickly, and the recurrence rate is lower.

3.3 comparison of the results associated with the inflammatory indicators in the two groups of patients is shown in Table 4.

TABLE 4 comparison of results relating to inflammation indices for patients in control and treatment groups

Note: t is¹Value, P¹The value is the comparison of the study group before treatment with the control group before treatment, T²Value, P²The value is the comparison of the value after the control group treatment and before the control group treatment, T³Value, P³The value is after study group treatment compared with before study group treatment, T⁴Value, P⁴Values are after study treatment compared to after control treatment.

After treatment, the contents of the blood hypersensitivity C-reactive protein, the urine leukocyte score, the urine erythrocyte score and the urine protein score are compared, and the P of the four indexes is¹0.887, 0.725, 0.389 and 0.837, respectively, all greater than 0.05, were not statistically significant, indicating that there was no difference in blood hypersensitivity C-reactive protein content, urinary leukocyte score, urinary erythrocyte score and urinary protein score between the two groups of patients prior to treatment; p of the above four indexes²The total content of the four indexes is 0.000 and less than 0.05, and the statistical significance is realized, which indicates that the treatment method of the control group can effectively reduce the values of the four indexes of the patient; p of the above four indexes³All are 0.000, less than 0.05, with statistical significance. The treatment method of the research group can effectively reduce the values of the four indexes of the patient; p of the above four indexes⁴0.000, 0.008, 0.024 and 0.001 respectively, the P value is less than 0.05, the values of the four indexes after the control group treatment are 14.42 +/-6.85, 1.80 +/-1.32, 2.10 +/-1.61 and 1.97 +/-1.27 respectively, the values of the four indexes after the research group treatment are 9.95 +/-3.10, 1.04 +/-1.14, 1.36 +/-1.26 and 1.06 +/-1.11 respectively, and the difference has statistical significance.

The results show that the research group adopting the pharmaceutical composition to treat the nephrolithiasis has better effects on the content of the hypersensitive C-reactive protein, the urinary leukocyte score, the urinary erythrocyte score and the urinary protein score of the patients, and is superior to the control group.

3.4 comparison of blood test results of two groups of patients is shown in Table 5.

TABLE 5 comparison of blood examination results of patients in control and treatment groups

The P of ALT and AST of the treated patient¹、P²、P³And P⁴Values greater than 0.05 both indicate that treatment regimens of both groups had no significant effect on ALT and AST in both groups of patients and no significant abnormalities in liver function were seen.

After treatment, BUN and Cr of two groups of patients are compared before treatment, P values are 0.799 and 0.310 respectively, and the results show that the two groups of patients have no difference before treatment and are comparable to treatment research; comparing BUN and Cr before and after treatment of the control group, wherein the P values are 0.383 and 0.012 respectively, and the result shows that the treatment scheme of the control group has no statistical significance on reducing BUN of the patient, but has statistical significance on reducing Cr; comparing BUN and Cr before and after treatment in the study group, the P value is 0.000, and the treatment scheme of the control group can effectively reduce BUN and Cr of patients and has statistical difference; the P values of BUN and Cr were 0.011 and 0.006, respectively, after study treatment compared to control treatment, indicating that the study treatment regimen was better at protecting renal function than the control.

The results show that the research group adopting the pharmaceutical composition to treat the nephrolithiasis has excellent renal function protection effect on patients and is superior to a control group.

3.5 treatment of pyelonephoureteral hydrograph A comparison of the efficacy is shown in Table 6.

TABLE 6 comparison of efficiency of treatment of pyelonephoureteral hydrodynamically for control and treatment groups

Note: p < 0.05 compared to control group

Before treatment, the comparison of the two groups of patients shows that the number of cases with hydronephroureter hydrops in the control group is 19, the number of cases without hydronephroureter hydrops is 11, the number of cases with hydronephroureter hydrops in the research group is 34, the number of cases without hydronephroureter hydrops is 16, and the comparison result shows that the patient has hydronephroureter hydrops in the²The value is 0.034, the P value is 0.855 to 0.05, and the proportion of the patients with the hydrops before treatment is not different and is comparable; after treatment, the effective rate of the control group is 31.58 percent, the effective rate of the research group is 67.65 percent, and the effective rate of the chi percent²The value is 6.009, and P is 0.014 < 0.05, indicating that the study group had a higher efficacy in the treatment of pyelonephoureteral water than the control group.

The results show that the research group adopting the pharmaceutical composition for treating nephrolithiasis can effectively treat hydronephropyureteral fluid and has high treatment efficiency.

3.6 comparison of the effectiveness of treating lumbago is shown in Table 7.

TABLE 7 comparison of the effectiveness of the treatment of lumbago between the control group and the treatment group

Note: p < 0.05 compared to control group

The comparison before treatment of the two groups of patients shows that the number of cases with lumbago in the control group is 25, the number of cases without hydrops is 5, the number of cases with hydrops in the research group is 39, the number of cases without lumbago is 11, and the blood pressure is chi²The value is 0.083, P is 0.773 > 0.05, and the proportion of lumbago before treatment of the two groups of patients is not different and is comparable; after treatment, the effective rate of the control group is 40.00 percent, the effective rate of the research group is 76.92 percent, and the effective rate of the chi percent²The values of 7.356 and P0.007 < 0.05 indicate that the study group had a higher efficacy of lumbago treatment than the control group.

The results show that the research group adopting the pharmaceutical composition of the invention to treat nephrolithiasis can effectively treat lumbago with high treatment efficiency.

In conclusion, the invention provides a pharmaceutical composition for treating nephrolithiasis. The pharmaceutical composition provided by the invention can effectively treat the nephrolithiasis, reduce the recurrence rate of the nephrolithiasis, relieve the pain of the nephrolithiasis, accelerate the discharge of the calculus to shorten the treatment time of the calculus, inhibit inflammatory reaction, obviously improve the hydrops of the renal pelvis and the ureter and relieve lumbago, and has the advantages of definite clinical curative effect, safe clinical medication and excellent application prospect.

Claims

1. A pharmaceutical composition for treating nephrolithiasis, comprising: the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 20-40 parts of astragalus membranaceus, 10-30 parts of eucommia ulmoides, 20-40 parts of fringed pink, 5-25 parts of cassia twig, 30-50 parts of desmodium, 20-40 parts of endothelium corneum gigeriae galli, 10-30 parts of lygodium japonicum, 30-50 parts of talc, 10-30 parts of pyrrosia lingua, 10-30 parts of salvia miltiorrhiza, 5-25 parts of rhizoma alismatis, 10-30 parts of rhizoma corydalis, 10-30 parts of plantain seed, 20-40 parts of beautiful sweetgum fruit, 10-30 parts of radix curcumae and 1-20 parts of fried szechwan chinaberry fruit.

2. The pharmaceutical composition of claim 1, wherein: the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 25-35 parts of astragalus membranaceus, 15-25 parts of eucommia ulmoides, 25-35 parts of fringed pink, 10-20 parts of cassia twig, 35-45 parts of desmodium, 25-35 parts of endothelium corneum gigeriae galli, 15-25 parts of spora lygodii, 35-45 parts of talc, 15-25 parts of pyrrosia lingua, 15-25 parts of salvia miltiorrhiza, 10-20 parts of rhizoma alismatis, 15-25 parts of rhizoma corydalis, 15-25 parts of semen plantaginis, 25-35 parts of fructus liquidambaris, 15-25 parts of radix curcumae and 5-15 parts of fried szechwan chinaberry fruit.

3. The pharmaceutical composition of claim 2, wherein: the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 30 parts of astragalus membranaceus, 20 parts of eucommia ulmoides, 30 parts of fringed pink, 15 parts of cassia twig, 40 parts of desmodium, 30 parts of endothelium corneum gigeriae galli, 20 parts of spora lygodii, 40 parts of talc, 20 parts of folium pyrrosiae, 20 parts of salvia miltiorrhiza, 15 parts of rhizoma alismatis, 20 parts of rhizoma corydalis, 20 parts of semen plantaginis, 30 parts of fructus liquidambaris, 20 parts of radix curcumae and 10 parts of fried szechwan chinaberry fruit.

4. The pharmaceutical composition according to any one of claims 1 to 3, wherein: the preparation is prepared by taking crude medicinal powder and/or water extract and/or organic solvent extract of the raw materials as active ingredients and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.

5. The pharmaceutical composition of claim 4, wherein: the preparation is an oral preparation.

6. The traditional Chinese medicine composition of claim 5, wherein: the preparation is powder, granules, capsules, tablets, pills, tea, suspension, decoction or oral liquid.

7. A method for preparing the traditional Chinese medicine composition of any one of claims 1 to 6, which is characterized by comprising the following steps: the method comprises the following steps: directly pulverizing the raw materials in weight ratio, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.

8. Use of the pharmaceutical composition according to any one of claims 1 to 6 in the preparation of a medicament for treating nephrolithiasis and reducing the recurrence rate of nephrolithiasis.

9. Use according to claim 8, characterized in that: the medicine has effects of inhibiting inflammatory reaction, relieving pain due to nephrolithiasis, promoting calculus discharge, promoting discharge of hydrops of renal pelvis and ureter, and relieving lumbago.

10. A combination medicament for the treatment of nephrolithiasis, characterized in that: it contains the pharmaceutical composition according to any one of claims 1 to 6 and tamsulosin hydrochloride sustained-release capsules administered simultaneously or separately in unit preparations of the same or different specifications.