Traditional Chinese medicine composition and application thereof

Abstract

The traditional Chinese medicine composition is prepared from the following raw material components in parts by weight: 10 to 20 parts of herba lysimachiae, 5 to 15 parts of rhizoma atractylodis, 5 to 15 parts of pericarpium citri reticulatae viride, 5 to 15 parts of rhizoma polygoni cuspidati, 5 to 15 parts of radix cyathulae, 5 to 15 parts of trifoliate orange pears, 5 to 15 parts of rhizoma sparganii, 5 to 15 parts of rhizoma curcumae, 5 to 15 parts of semen vaccariae and 5 to 15 parts of spina gleditsiae. The formula is strict, the monarch, minister, assistant and guide are clear, the medicine flavor is concise, the medicine property is mild, compared with similar medicines on the market, the Lianqing Qingqing formula (an original name of a stone eliminating formula) focuses on regulating qi, activating blood, removing blood stasis and eliminating stone on the basis of clearing heat and promoting diuresis, has the advantages of few toxic and side effects, high safety, small economic burden and the like, and has better transformation and application prospects.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition and its application. Background Art

[0002] Stones are urinary stones, which are common diseases in urology. They include all urinary stones, namely kidney stones, ureteral stones, bladder stones, urethral stones, and prostate stones. Young and middle-aged people are the most susceptible group, with an incidence rate of about 3% to 15%. Globally, the incidence rate of urinary stones remains high and continues to rise. Patients often have symptoms such as hematuria, frequent urination, sudden colic, urinary tract obstruction, and dysuria, which cause great trouble to patients' work and life. The formation mechanism of urinary stones is relatively complex. Various factors such as diet, abnormal calcium metabolism, and urethral malformations can cause it. If the treatment is not timely, it will cause complications and increase the patient's pain. Therefore, timely and effective treatment is extremely important. At present, Western medicine treatment is mainly based on surgery. Generally, the treatment plan is selected according to the size, location, composition, degree of obstruction, etc. of the patient's stones. For patients with large stones and severe obstruction, surgical treatment should be the first choice to relieve the condition and prevent further damage to renal function. However, the difficulty in eliminating residual stones and the high recurrence rate are still the two major problems at present. In addition, the surgery itself is traumatic, and the expensive treatment costs bring a heavy economic burden to the medical insurance system. Therefore, conservative treatment can be preferred for patients with stone diameter ≤1.8cm to reduce damage. At present, there are few types of Western medicines used for oral treatment in clinical practice, and they are mainly focused on the prevention and treatment of non-calcium stones with clear causes, such as oral allopurinol and alkaline drugs for uric acid stones. Urinary stones are mainly calcium stones. Due to the unclear pathogenesis and limited drug treatment methods, the main ones are thiazide diuretics and alkaline citrates to prevent stone formation, and α-receptor blockers such as tamsulosin to promote the discharge of ureteral stones. The former has greater side effects, and the efficacy of the latter has been controversial.

[0003] Traditional medicine classifies urinary stones into the categories of "stone stranguria" and "hemargyria". "The Treatise on the Causes and Symptoms of Various Diseases·Symptoms of Stone Stranguria" states: "Symptoms of stone stranguria are stranguria with stones. The kidney governs water, and water turns into stones when it accumulates. Therefore, the kidney is invaded by sand and stones. Kidney deficiency is invaded by heat, and heat causes stranguria. The symptoms of the disease include pain in the penis during urination, inability to urinate suddenly, pain in the lower abdomen, urgency in the bladder, sand and stones coming out of the urinary tract, and severe pain and suffocation." The treatment should clear the accumulated heat and remove the sand and stones.

[0004] "Stranguria with stones" is mainly caused by accumulation of damp heat, liver depression and qi stagnation, spleen and kidney deficiency, insufficient body qi, imbalance of water metabolism, and retention of impurities in urine, which leads to stone accumulation. Traditional Chinese medicine has a unique understanding of stranguria with stones. After the formation of stranguria with stones, it blocks the urinary tract, leading to hematuria and urinary pain. Therefore, Chinese medicine treatment should focus on promoting blood circulation and replenishing qi, clearing away heat and removing dampness, and removing blood stasis and relieving pain. It has the advantages of few toxic and side effects, high safety, and significant efficacy. It can not only make up for the defects of surgery for residual stones and small stones, but also is cheap and effective. The syndrome differentiation of stranguria with stones includes kidney deficiency, damp heat and blood stasis, and blood stasis accompanies the entire pathogenesis of stones. However, the Chinese patent medicines for the treatment of stranguria with stones on the market are mainly for clearing heat and dampness, diuresis and stranguria, and there are fewer drugs for promoting blood circulation and qi, and analgesia. Summary of the invention

[0005] In order to solve the above technical problems, the present application provides a Chinese medicine composition, which includes the following raw material components by weight: 10-20 parts of Herba Lysimachiae, 5-15 parts of Atractylodes, 5-15 parts of Citrus aurantium, 5-15 parts of Polygonum cuspidatum, 5-15 parts of Cyathula officinalis, 5-15 parts of Citrus aurantium, 5-15 parts of Trillium, 5-15 parts of Curcuma, 5-15 parts of Vaccaria segetalis, and 5-15 parts of Gleditsia sinensis.

[0006] The present application also provides a Chinese medicine preparation, which is prepared using the above-mentioned Chinese medicine composition as raw material.

[0007] The present application also provides the use of the above-mentioned Chinese medicine composition or the above-mentioned Chinese medicine preparation in the preparation of a drug for preventing and / or treating stone diseases.

[0008] The beneficial effects brought about by the present application include but are not limited to: the Chinese medicine composition provided in the present application can treat urinary stones, significantly improve the main clinical symptoms and signs caused by stones, significantly reduce the patient's pain, as well as the red blood cell count in the urine, and has a significant stone-excretion effect without obvious toxic and side effects, which provides a new idea and new method for the treatment of the disease and is worthy of further clinical research and application. DETAILED DESCRIPTION

[0009] As shown in this specification and claims, unless the context clearly indicates an exception, the words "a", "an", "an" and / or "the" do not refer to the singular and may also include the plural. Generally speaking, the terms "comprise" and "include" only indicate the inclusion of the steps and elements that have been clearly identified, and these steps and elements do not constitute an exclusive list. The method or device may also include other steps or elements.

[0010] Embodiments are used in this specification to illustrate the operations performed by the system according to the embodiments of this specification. It should be understood that the preceding or following operations are not necessarily performed precisely in order. Instead, the steps may be processed in reverse order or simultaneously. At the same time, other operations may also be added to these processes, or one or more operations may be removed from these processes.

[0011] The present application provides a traditional Chinese medicine composition, comprising the following raw material components by weight: 10-20 parts of Herba Lysimachiae, 5-15 parts of Atractylodes, 5-15 parts of Citrus aurantium, 5-15 parts of Polygonum cuspidatum, 5-15 parts of Cyathula officinalis, 5-15 parts of Citrus aurantium, 5-15 parts of Trillium, 5-15 parts of Curcuma, 5-15 parts of Vaccaria segetalis, and 5-15 parts of Gleditsia sinensis.

[0012] Glechomae Herba: sweet, salty, slightly cold, enters the liver, gallbladder, kidney, and bladder meridians, promotes dampness and jaundice, promotes diuresis and relieves stranguria, detoxifies and reduces swelling. Used for damp-heat jaundice, gallbladder distension and hypochondrium pain, stranguria with stones, stranguria with heat, painful and astringent urination, carbuncle, furuncle, snake and insect bites.

[0013] Atractylodes Rhizoma: pungent, bitter, warm, enters the spleen, stomach, and liver meridians, dries dampness and strengthens the spleen, dispels wind and cold, and improves eyesight. It is used for dampness blocking the middle jiao, abdominal distension, diarrhea, edema, beriberi, rheumatic arthralgia, colds, night blindness, and blurred vision.

[0014] Citri Reticulatae Pericarpium Viride: Soothes the liver and relieves qi, eliminates stagnation and resolves accumulation. It is used for chest and flank distension and pain, hernia pain, breast lumps, breast abscesses, food accumulation and qi stagnation, and abdominal distension and pain.

[0015] Polygoni Cuspidati Rhizoma ET Radix: It can dissipate dampness and reduce jaundice, clear away heat and detoxify, disperse blood stasis and relieve pain, relieve cough and resolve phlegm. It is used for jaundice due to damp-heat, stranguria, leucorrhea, rheumatic pain, carbuncle, scald, amenorrhea, symptom scar, bruise, and cough due to lung heat.

[0016] Cyathulae Radix: Removes blood stasis and promotes menstruation, dredges joints, promotes diuresis and relieves stranguria. Used for amenorrhea, retained placenta, injuries from falls, rheumatic pain, foot paralysis and muscle spasm, hematuria and stranguria.

[0017] Poncirus trifoliata (L.) Raf.: Pungent, pungent and warm, it can promote qi, strengthen the stomach, relieve constipation, soothe the liver and harmonize the stomach; regulate qi and relieve pain; eliminate stagnation. It is used to treat chest and flank distension; abdominal distension and pain; breast lumps; hernia pain; testicular swelling and pain; traumatic injuries; food stagnation; constipation; uterine prolapse.

[0018] Sparganii Rhizoma: It can invigorate blood circulation and promote qi circulation, eliminate stagnation and relieve pain. It is used for symptomatic lumps, dysmenorrhea, amenorrhea due to blood stasis, chest pain, and bloating and pain due to food stagnation.

[0019] Curcumae Rhizoma: It can promote qi circulation, resolve blood stasis, relieve pain, and is used for symptom scars, lumps in the abdomen, amenorrhea due to blood stasis, chest pain, and bloating and pain due to food accumulation.

[0020] Vaccariae Semen: promotes blood circulation and menstruation, promotes lactation and reduces swelling, promotes diuresis and relieves stranguria. It is used for amenorrhea, dysmenorrhea, lack of milk, swelling and pain caused by mastitis, and painful stranguria.

[0021] Gleditsiae Spina: Reduces swelling, removes toxins, discharges pus, kills insects. Used for carbuncle at the beginning or when pus has formed but has not ulcerated; external treatment for scabies, leprosy.

[0022] In the prescription, the herb Lysimachia is the main drug, which tastes sweet and slightly bitter, is cool in nature, and enters the liver, gallbladder, kidney, and bladder meridians, and has the effects of promoting diuresis and relieving stranguria, clearing away heat and detoxifying, and dissolving stones and eliminating stones; the herb Atractylodes and the peel of Citrus aurantium are the assistant drugs, the herb Atractylodes is pungent and bitter, is warm, and enters the spleen, stomach, and liver meridians, and has the effects of drying dampness and invigorating the spleen, dispelling wind and dispersing cold, the peel of Citrus aurantium is bitter and pungent, is warm in nature, and enters the liver, gallbladder, spleen, and lung meridians, and has the effects of soothing the liver, promoting qi and relieving pain, and soothing the liver and regulating qi; the herb Polygonum cuspidatum is bitter and sour, is slightly cold in nature, and enters the liver and gallbladder meridians, and has the effects of promoting blood circulation, dispersing blood stasis and relieving pain, clearing away heat and promoting dampness and detoxifying; the herb Cyathulae is sweet and slightly bitter, is neutral in nature, and enters the liver and kidney meridians, and has the effects of promoting blood circulation and removing blood stasis, promoting diuresis and relieving stranguria, and tonifying the liver and kidney; the herb Trigonosciadium japonicum, the herb Curcuma zedoaria, the herb Pyrus citrifolia, the herb Vaccaria segetalis, and the herb Gleditsia sinensis promote blood circulation and dissolve blood stasis, and are adjuvant drugs together. The whole prescription is used together to play the role of regulating qi and activating blood circulation, relieving stranguria and eliminating stones. Lianshuqing prescription is derived from the famous prescription of Ye Jinghua, a famous Chinese medicine doctor in our hospital. It has been used for more than 30 years and has a significant effect on urinary tract stones. The prescription is rigorous, with clear distinction between monarch, minister, assistant and envoy, concise taste and mild medicinal properties. Compared with similar drugs on the market, Lianshuqing prescription focuses more on regulating qi and activating blood circulation, removing blood stasis and eliminating stones on the basis of clearing heat and removing dampness. It has the advantages of less toxic and side effects, high safety and low economic burden, and has good prospects for transformation and application.

[0023] In some embodiments, the Chinese medicine composition may include the following raw material components by weight:

[0024] 10-20 parts of Lysimachia sibiricum, for example 12-18 parts, 14-16 parts;

[0025] Atractylodes lancea 5-15 parts, such as 7-13 parts, 9-11 parts;

[0026] 5-15 parts of green peel, for example 7-13 parts, 9-11 parts;

[0027] 5-15 parts of Japanese knotweed, for example 7-13 parts, 9-11 parts;

[0028] 5-15 parts of Cyathula capitata, for example 7-13 parts, 9-11 parts;

[0029] 5-15 parts of citrus pear, for example 7-13 parts, 9-11 parts;

[0030] 5 to 15 parts of Tripterygium wilfordii, for example 7 to 13 parts, 9 to 11 parts;

[0031] 5-15 parts of Curcuma zedoaria, for example 7-13 parts, 9-11 parts;

[0032] 5-15 parts of Vaccaria segetalis, for example, 7-13 parts, 9-11 parts;

[0033] 5 to 15 parts of Gleditsia sinensis thorns, for example 7 to 13 parts, 9 to 11 parts.

[0034] In some embodiments, preferably, the Chinese medicine composition can include the following raw material components by weight: 14-16 parts of Lysimachia scabra, 9-11 parts of Atractylodes lancea, 9-11 parts of Citrus aurantium, 9-11 parts of Polygonum cuspidatum, 9-11 parts of Cyathula officinalis, 9-11 parts of Citrus aurantium, 9-11 parts of Trillium gracile, 9-11 parts of Curcuma zedoaria, 9-11 parts of Vaccaria segetalis, and 9-11 parts of Gleditsia sinensis.

[0035] In some embodiments, more preferably, the Chinese medicine composition may include the following raw material components by weight: 15 parts of Herba Lysimachiae, 10 parts of Atractylodes, 10 parts of Citrus aurantium, 10 parts of Polygonum cuspidatum, 10 parts of Cyathula officinalis, 10 parts of Citrus aurantium, 10 parts of Trillium, 10 parts of Curcuma, 10 parts of Vaccaria segetalis, and 10 parts of Gleditsia sinensis.

[0036] The present application also provides a Chinese medicine preparation, which is prepared using the above-mentioned Chinese medicine composition as raw material.

[0037] In some embodiments, the above-mentioned traditional Chinese medicine composition is decocted with water, filtered, concentrated, and spray-dried to obtain the traditional Chinese medicine preparation.

[0038] In some embodiments, the Chinese medicine preparation can be a powder, paste, granules, tablets or capsules. In some embodiments, preferably, the Chinese medicine preparation can be a granule.

[0039] In some embodiments, the Chinese medicine preparation may further include an excipient. In some embodiments, preferably, the excipient may be dextrin.

[0040] In some embodiments, the Chinese medicine preparation can be administered orally.

[0041] The present application also provides the use of the above-mentioned Chinese medicine composition or the above-mentioned Chinese medicine preparation in the preparation of a drug for preventing and / or treating stone diseases.

[0042] The term "prevention and / or treatment" (and grammatical variations thereof) refers to an attempt to alter the natural course of a disease in a treated individual, and may be a clinical intervention performed for prevention or during the course of clinical pathology. Desired effects of treatment include, but are not limited to, preventing the occurrence or recurrence of the disease, alleviating symptoms, reducing any direct or indirect pathological consequences of the disease, preventing metastasis, slowing the rate of disease progression, ameliorating or alleviating the disease state, and eliminating or improving prognosis.

[0043] In some embodiments, the stone disease may include at least one of urinary system stones or biliary system stones.

[0044] In some embodiments, the urinary system stones may include any one or more of kidney stones, ureteral stones, bladder stones, urethral stones or prostate stones.

[0045] In some embodiments, the biliary system stones may include any one or more of gallbladder stones, common bile duct stones, or intrahepatic bile duct stones.

[0046] In some embodiments, the drug may be used to remove stones or reduce red blood cells in the urine.

[0047] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are purchased from conventional biochemical reagent companies unless otherwise specified. The quantitative tests in the following examples are repeated three times, and the results are averaged.

[0048] Example 1 - Preparation of Chinese medicine preparation

[0049] The Chinese medicine preparation comprises the following raw materials in parts by weight: 15 parts of Herba Lysimachiae, 10 parts of Atractylodes, 10 parts of Citrus aurantium, 10 parts of Polygonum cuspidatum, 10 parts of Cyathula officinalis, 10 parts of Citrus aurantium, 10 parts of Trigonella ternate, 10 parts of Curcuma zedoaria, 10 parts of Vaccaria segetalis, and 10 parts of Gleditsia sinensis.

[0050] The preparation method of the Chinese medicine mixture is as follows: put the slices into the equipment, add 6 times ± 10L of water for the first time, open the steam valve (control the steam pressure ≤ 0.2MPa), boil and decoct for 1 hour ± 5 minutes (control the steam pressure ≤ 0.08MPa, the temperature is 90-100℃, and the pressure and temperature are recorded every hour during the decoction process), and the liquid medicine is passed through an 80-mesh sieve and then poured into a liquid medicine storage tank. Add 5 times ± 10L of water for the second time, open the steam valve (control the steam pressure ≤ 0.2MPa), boil and decoct for 0.5 hour ± 5 minutes (control the steam pressure ≤ 0.08MPa, the temperature is 90-100℃, and the pressure and temperature are recorded every hour during the decoction process), and the liquid medicine is passed through an 80-mesh sieve and then poured into a liquid medicine storage tank, and the secondary filtrates are combined. Turn on the vacuum pump, evacuate to -0.03~-0.07MPa, open the feed valve of the concentrator, and close the feed valve when the liquid level reaches 1 / 4 of the evaporator. Open the cooling water system and adjust the steam pressure at 0.03-0.06MPa to heat the liquid in the concentrator to circulating boiling. During the concentration process, adjust the feed valve to keep the liquid level in the concentrator at about half of the evaporator. Pay attention to the pressure change of the steam and adjust the switch of the steam valve in time to avoid material leakage. The concentration temperature is controlled at 70-90℃. After the temperature reaches 70℃, record the steam pressure and temperature. During the concentration process, record the pressure and temperature every hour; concentrate to an extract with a relative density of 1.05-1.07 (70℃-80℃), stop the vacuum system, close the steam valve, connect the discharge valve to the mobile closed material receiving vehicle or the closed stainless steel barrel, open the drain valve, and then open the discharge valve to release the extract. Move the extract to the clean area and pass it through an 80-mesh sieve and then put it into a stainless steel barrel. Transfer the extract to the mixing tank, open the steam valve, heat to (30-40)℃, start recording the temperature when the temperature reaches 30℃, and then record the temperature every hour. Dilute an appropriate amount of dextrin with 3 times the amount of purified water and pass it through a 100-mesh sieve into the mixing tank. Mix it with the extract for 5 minutes and then spray it. (1) Set the inlet temperature to (135-165)℃, the outlet temperature to (90-110)℃, the pressure in the tower to (-0.1-0.6)KPa, and the wall temperature to <45℃. (2) Turn on the blower and exhaust fan, steam heating valve (steam pressure ≤0.45MPa), and electric heating 2 in sequence. When the temperature is insufficient, turn on electric heating 1 to quickly increase the temperature. When the temperature is reached, turn off electric heating 1 and turn on the tower wall fan. (3) Turn on the cooling water of the atomizer and start the atomizer (frequency ≤350hz). Turn on the peristaltic pump (frequency ≤20hz), turn on the vibration, and spray dry to obtain dry paste powder. Install the equipment correctly and install a 12-mesh screen. Set the equipment operating parameters according to the material density and viscosity, and adjust the equipment operating parameters in time during operation to ensure that the particle size and color of the produced particles meet the requirements.The parameter setting range is: extrusion pressure 10-50 kg (about 1-5 MPa), side sealing pressure <30 kg (about 3 MPa), extrusion speed ≤35 rad / min, feeding speed ≤64 rad / min, granulation speed 50-100 rad / min, and cooling temperature is controlled at ≤16 °C. During the production process, pay attention to the operation of the equipment and the granulation situation, and adjust the parameters in time if problems are found. When sieving out the fine powder during granulation, return it to the tablet granulation in time. When the amount of fine powder is less than the minimum granulation requirement (about 0.3 kg), it will not be returned, and the remaining fine powder will be treated as waste. The granulated particles are placed in an oscillating sieve (upper 10 mesh, lower 60 mesh) for granulation.

[0051] Example 2 - Clinical efficacy observation results of the Chinese medicine granules

[0052] The clinical trials are conducted to observe and evaluate the clinical efficacy of the Chinese medicine composition and Chinese medicine granules of the present invention in treating urinary and biliary stones.

[0053] A total of 80 patients with urinary and biliary stones who were treated in our hospital from July 2024 to August 2024 were selected as the research subjects and randomly divided into a treatment group and a control group according to the treatment time, with 40 cases in each group. There were 20 males and 20 females in the treatment group, aged 33 to 64 years old, with an average age of (42.60±6.54) years old; there were 19 males and 21 females in the control group, aged 27 to 60 years old, with an average age of (41.10±7.68) years old. There was no statistically significant difference in general data such as gender and age between the two groups of patients (P>0.05), and they were comparable. This study was approved by the relevant medical ethics committee, and all the subjects were informed and agreed to participate voluntarily and signed the informed consent form.

[0054] Diagnostic criteria: Urinary tract stones refer to the diagnostic criteria of the "Standards for the Diagnosis and Treatment of Urolithiasis Combined with Traditional Chinese and Western Medicine (Trial)", and the main symptoms are lumbar and abdominal colic, soreness, painful urination, interrupted urination, or blood in the urine, stinging during urination, dry stool, yellow and greasy tongue coating, and stringy or rapid pulse. Biliary tract stones refer to the "Consensus on the Diagnosis and Treatment of Chronic Cholecystitis and Gallstones in Traditional Chinese Medicine" (2018 Edition) ① There may be no obvious symptoms, or repeated attacks of right upper abdominal discomfort or pain, which are often related to high-protein and greasy foods; or manifested as repeated attacks of belching, abdominal distension, fullness after meals, nausea and other gastrointestinal discomfort symptoms; ② Abdominal physical examination may not have any positive signs, or there may be tenderness or percussion pain in the right upper abdomen; ③ Abdominal color Doppler ultrasound, abdominal CT or MR examinations suggest gallstones.

[0055] Inclusion criteria: 1) meet the diagnostic criteria; 2) age 27 to 64 years old; 3) patients informed consent and signed the informed consent form; 4) approved by the hospital ethics committee.

[0056] Exclusion criteria: 1) Patients who do not meet the inclusion criteria; 2) Patients with acute onset of cholelithiasis and those with surgical indications; 3) Patients with acute renal failure caused by stones; Patients with a clear diagnosis of decompensated cirrhosis, liver failure, intrahepatic bile duct stones, gallbladder cancer, obstructive jaundice, etc.; 4) Patients who cannot tolerate the treatment regimen of this study; 5) Patients with cognitive impairment or mental illness; 6) Patients with infectious diseases; 7) Pregnant or lactating women.

[0057] Methods: Control group: patients were given Paishi Granules (Nanjing Tongrentang Pharmaceutical Co., Ltd., National Medicine Standard Z32020071, specification: 20g / bag, batch number 240612) for treatment, 1 bag / time, 3 times / day; treatment group: oral administration of the Chinese medicine granules of the present invention, 3 times a day, 1 bag each time (equivalent to 31.51g of decoction pieces). 14 days is a course of treatment, and the results of both groups were evaluated after 3 courses of treatment.

[0058] Observation indicators:

[0059] 1. Clinical efficacy: formulated with reference to the "Guidelines for Clinical Research of New Chinese Medicines". Cured: clinical symptoms disappear, stones are completely discharged, ultrasound, X-ray angiography, etc. show that stone shadows disappear, and water accumulation is significantly reduced. Significantly effective: clinical symptoms disappear, or symptom scores are reduced by more than 70% compared with before treatment, stones move downward, or more than 2 / 3 of stones are discharged. Effective: clinical symptoms improve, symptom scores are reduced by less than 70% and more than 30% compared with before treatment, and more than 1 / 3 of stones are discharged. Ineffective: clinical symptoms do not improve, and stone shadows and water accumulation do not change.

[0060] 2. Safety indicators: Observe the blood, urine, stool routine, electrocardiogram, liver and kidney function tests of the two groups of patients before treatment and 4 weeks after drug treatment, and record them once respectively.

[0061] 3. Efficacy indicators: ① Observation of the efficacy of TCM syndrome score: observe the changes of main symptoms such as low back pain, lower abdominal colic, hematuria, dysuria or interrupted urination, frequent urination before and after treatment; ② Observation of the efficacy of main signs: observe the changes of tenderness and percussion pain in the renal area, tenderness and percussion pain in the ureter before and after treatment; ③ Observation of main indicators: observe the changes of red blood cells in urine before and after treatment.

[0062] 4. Statistical methods The data were analyzed using the statistical software SPSS 19.0. Normally distributed quantitative data were expressed as mean ± standard deviation. The t test was used for comparison between the two groups; the count data were expressed as rates and the chi-square test was used for comparison between the two groups. 2 P<0.05 was considered statistically significant.

[0063] result:

[0064] 1. Comparison of clinical efficacy between the two groups of patients

[0065] The total effective rate of the treatment group was higher than that of the control group, but the difference was not statistically significant (P>0.05). See Table 1.

[0066] Table 1 Comparison of clinical efficacy between the two groups of patients (cases)

[0067] Group Number of cases cure Significant effect efficient invalid Total effective rate (%) Control group 40 28 6 2 4 90.00 Treatment Group 40 22 8 9 1 97.50

[0068] 2. Comparison of stone expulsion rates between the two groups

[0069] The number of stones in the control group before treatment was 52, and 31 stones were discharged after treatment, with a stone discharge rate of 59.62%. The number of stones in the treatment group before treatment was 53, and 39 stones were discharged after treatment, with a stone discharge rate of 73.58%. There was a very significant difference in the stone discharge rate between the two groups after treatment (P<0.01).

[0070] 3. Comparison of symptom scores between the two groups before and after treatment

[0071] TCM syndrome score: The syndrome score was calculated according to the relevant standards of the "Guidelines for Clinical Research of New Chinese Medicines". According to the severity of the symptoms, it was divided into 4 levels: none, mild, moderate, and severe, with 0, 1, 2, and 3 points respectively. The observed syndromes mainly included low back pain, lower abdominal cramps, hematuria, urinary pain or interrupted urination, frequent urination, and other main symptoms before and after treatment. The total score of TCM syndrome was obtained by adding up the scores of each syndrome. None: means no related symptoms appear; Mild: means occasional occurrence, which does not affect normal life; Moderate: means occasional occurrence, which has a slight impact on normal life, but is tolerable; Severe: means severe low back and abdominal pain or interrupted urination, frequent urination, and other symptoms appear too frequently, which is unbearable, affects normal life, and has a sense of fear. The symptom scores of both groups of patients decreased significantly after treatment, which was significantly different from before treatment (P<0.01); and the decrease in the treatment group was more obvious, which was significantly different from the control group after treatment (P<0.01). See Table 2.

[0072] Table 2 Comparison of symptom scores between the two groups of patients before and after treatment (points, )

[0073] Group Number of cases Before treatment After treatment t-value P-value Control group 40 6.78±0.24 1.53±0.15 18.850 <![CDATA[0.000 * ]]> Treatment Group 40 6.13±0.27 1.30±0.16 15.320 <![CDATA[0.000 △ ]]> t-value 1.800 1.045 P-value 0.076 0.300

[0074] Note: Compared with the group before treatment, *P<0.01; compared between groups after treatment, △P<0.05

[0075] 4. Comparison of changes in urine red blood cells between the two groups of patients before and after treatment. After treatment, there was a significant difference in urine red blood cell counts between the two groups of patients (P<0.05). The results are shown in Table 3.

[0076] Table 3 Comparison of changes in urine red blood cells between the two groups of patients before and after treatment

[0077]

[0078] Note: After treatment, the comparison between the two groups was *P<0.05. + means: red blood cells are present in urine; ++ means: moderate urine occult blood test; +++ means: possibility of hematuria.

[0079] 5. No drug-related adverse reactions were found in either group of patients during the treatment.

[0080] This study shows that Lianshuqing Granules can significantly improve the main clinical symptoms and signs caused by urinary stones, as well as the red blood cell count in urine, and has a significant stone-excreting effect without obvious toxic side effects. It provides new ideas and methods for the treatment of this disease and is worthy of further clinical research and application.

[0081] The basic concepts have been described above. Obviously, for those skilled in the art, the above detailed disclosure is only for example and does not constitute a limitation of this specification. Although not explicitly stated here, those skilled in the art may make various modifications, improvements and corrections to this specification. Such modifications, improvements and corrections are suggested in this specification, so such modifications, improvements and corrections still belong to the spirit and scope of the exemplary embodiments of this specification.

[0082] At the same time, this specification uses specific words to describe the embodiments of this specification. For example, "one embodiment", "an embodiment", and / or "some embodiments" refer to a certain feature, structure or characteristic related to at least one embodiment of this specification. Therefore, it should be emphasized and noted that "one embodiment" or "an embodiment" or "an alternative embodiment" mentioned twice or more in different positions in this specification does not necessarily refer to the same embodiment. In addition, certain features, structures or characteristics in one or more embodiments of this specification can be appropriately combined.

[0083] In some embodiments, numbers describing the number of components and attributes are used. It should be understood that such numbers used in the description of the embodiments are modified by the modifiers "about", "approximately" or "substantially" in some examples. Unless otherwise specified, "about", "approximately" or "substantially" indicate that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximate values, which may change according to the required features of individual embodiments. In some embodiments, the numerical parameters should take into account the specified significant digits and adopt the general method of retaining digits. Although the numerical domains and parameters used to confirm the breadth of their range in some embodiments of this specification are approximate values, in specific embodiments, the setting of such numerical values ​​is as accurate as possible within the feasible range.

[0084] Finally, it should be understood that the embodiments described in this specification are only used to illustrate the principles of the embodiments of this specification. Other variations may also fall within the scope of this specification. Therefore, as an example and not a limitation, alternative configurations of the embodiments of this specification may be considered consistent with the teachings of this specification. Accordingly, the embodiments of this specification are not limited to the embodiments explicitly introduced and described in this specification.

Claims

1. A Chinese medicine composition, comprising the following raw material components by weight: 10-20 parts of Herba Lysimachiae, 5-15 parts of Atractylodes, 5-15 parts of Pericarpium Citri Reticulatae, 5-15 parts of Polygonum Cuspidati, 5-15 parts of Cyathula officinalis, 5-15 parts of Pyrus Gleditsiae, 5-15 parts of Trigonosciadium japonicum, 5-15 parts of Curcuma, 5-15 parts of Vaccaria segetalis, and 5-15 parts of Gleditsia sinensis.

2. The Chinese medicine composition according to claim 1, characterized in that By weight, it includes the following raw material components: 14-16 parts of Herba Lysimachiae, 9-11 parts of Atractylodes, 9-11 parts of Pericarpium Citri Reticulatae, 9-11 parts of Polygonum Cuspidati, 9-11 parts of Cyathula officinalis, 9-11 parts of Pyrus Gleditsiae, 9-11 parts of Trigonosciadium japonicum, 9-11 parts of Curcuma, 9-11 parts of Vaccaria segetalis, and 9-11 parts of Gleditsia sinensis.

3. The Chinese medicine composition according to claim 1, characterized in that: By weight, it includes the following raw material components: 15 parts of Herba Lysimachiae, 10 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of Pericarpium Citri Reticulatae, 10 parts of Rhizoma Polygoni Cuspidati, 10 parts of Rhizoma Cyathulae, 10 parts of Pyrus Gleditsiae, 10 parts of Rhizoma Sparganii, 10 parts of Rhizoma Curcumae, 10 parts of Rhizoma Vaccariae, and 10 parts of Spina Gleditsiae.

4. A Chinese medicine preparation, prepared from the Chinese medicine composition according to any one of claims 1 to 3 as a raw material.

5. The Chinese medicine preparation according to claim 4, characterized in that: The Chinese medicine composition according to any one of claims 1 to 3 is decocted with water, filtered, concentrated and spray-dried to obtain the Chinese medicine preparation.

6. The Chinese medicine preparation according to claim 4, characterized in that: The Chinese medicine preparation is a powder, paste, granule, tablet or capsule. Preferably, the Chinese medicine preparation is a granule; And or, the traditional Chinese medicine preparation further comprises an excipient, preferably, the excipient is dextrin. And or, the Chinese medicine preparation is administered orally.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine preparation according to claim 4 in the preparation of a drug for preventing and / or treating stone diseases.

8. The use according to claim 7, characterized in that The stone disease includes at least one of urinary system stones or biliary system stones.

9. The use according to claim 7, characterized in that The urinary system stones include any one or more of kidney stones, ureteral stones, bladder stones, urethral stones or prostate stones; And / or, the biliary system stones include any one or more of gallbladder stones, common bile duct stones or intrahepatic bile duct stones.

10. The use according to claim 7, characterized in that The drugs are used to remove stones or to reduce the number of red blood cells in the urine.

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