Traditional Chinese medicine composition for treating urinary system diseases and application thereof

Abstract

The invention relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating urinary system diseases and application thereof, and is characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 30-70 parts of lysimachia christinae hance, 20-50 parts of astragalus membranaceus, 20-50 parts of lygodium japonicum, 20-50 parts of endothelium corneum gigeriae galli, 10-30 parts of semen cuscutae, 10-30 parts of pyrrosia lingua and 3-10 parts of liquorice. The traditional Chinese medicine composition comprises lysimachia christinae hance, astragalus membranaceus, lygodium japonicum, endothelium corneum gigeriae galli, semen cuscutae, pyrrosia lingua and liquorice, and compared with an existing traditional Chinese medicine composition, the components of the traditional Chinese medicine composition are simplified; according to the application, the addition proportion of alcohol extraction, the percentage of an alcohol solution and optimized parameters are optimized, polyphenol and flavone can be obtained to the maximum extent, the DPPH free radical elimination rate is relatively high, subsequent animal experiments and clinical experiments prove that the traditional Chinese medicine composition can be used for effectively treating urinary system diseases, and the traditional Chinese medicine composition has significant clinical value and economic value.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a Chinese medicine composition for treating urinary system diseases and application thereof. Background Art

[0002] Urinary stones are a common urological disease in clinical practice, and they are the leading cause of hospitalization in urology. China is one of the regions with a high incidence of stones in the world, with an incidence of about 1.0%-5.0%, with the highest incidence in the southern region, which can reach 5.0%-10%. At the same time, the incidence of urinary stones in my country has also been increasing year by year, and the recurrence rate of patients after treatment exceeds 50%. Although the mortality rate caused by urinary stones is relatively low, stones often cause severe pain to the body and can also cause a variety of adverse reactions, which seriously affect the patient's life, health and quality of life. With the continuous deepening of research on the occurrence and development mechanism of urinary stones, and the continuous improvement and improvement of modern medical technology, a variety of drugs and methods have been used in the treatment of urinary stones in clinical practice, and have achieved good therapeutic effects.

[0003] For example, the prior art CN 111419971 B discloses an application of a Chinese medicine composition in the preparation of a medicine for treating stones. The Chinese medicine composition is made of the following raw materials in parts by weight: 150-350 parts of Cuscuta seeds, 100-200 parts of Lycium barbarum, 30-60 parts of Schisandra chinensis, 20-50 parts of Cnidium monnieri, 20-50 parts of Rosa laevigatae, 20-50 parts of Allium tuberosum, 20-50 parts of Morinda officinalis, 20-50 parts of Cistanche deserticola, 30-60 parts of Rehmannia root, 20-50 parts of Cyathula officinalis, 40-100 parts of Epimedium, 20-50 parts of Rubus idaeus, 15-35 parts of Ginseng, 10-25 parts of Pilose antler, 15-35 parts of Hippocampus, and 15-35 parts of Toosendan. The medicine has a good effect on kidney stones, bladder stones, and urinary tract stones, with an effective rate of 94.5%, and a recurrence rate of only 2.3% within one year.

[0004] For example, the prior art CN 110064012 B discloses a traditional Chinese medicine composition for treating urinary tract stones. The active components of the traditional Chinese medicine composition include the following raw materials in parts by weight: 25-35 parts of Lycopodiella Cistanche, 20-50 parts of Lygodium Japonica, 10-20 parts of Plantago, 8-12 parts of Dianthus Superbus, 7-11 parts of Persica Kernel, 8-13 parts of Polygonum Multiflorum, 10-20 parts of Alisma Orientalis, 10-20 parts of Paeonia Rubra, 7-13 parts of Linderae Agrimoniae, and 8-11 parts of Malva Fructus. The whole formula is combined to achieve the effects of clearing away heat and dampness, relieving stranguria and expelling stones, and removing blood stasis and relieving pain, and has a significant therapeutic effect on the treatment of urinary tract stones.

[0005] For example, the prior art CN 106266109 B discloses a Chinese medicine composition for treating urinary system stones, which is made of the following Chinese medicines in the following weight proportions: 10-30 parts of Herba Lycopodii, 10-30 parts of Gallinae Gallifolia, 10-30 parts of Lycopodiella Caulis, 15-40 parts of Pyrola, 5-20 parts of Lycopodiella, 5-20 parts of Fructus Aurantii, 5-15 parts of Fructus Aurantii Immaturus, 5-15 parts of Citrus Reticulatae, 5-20 parts of Talcum powder and 3-10 parts of Licorice. It has a therapeutic effect on urinary system stones including kidney stones, ureteral stones, bladder stones and urethral stones, and has significant efficacy and little toxic and side effects. The preparation method has easily available raw materials, simple steps and good repeatability.

[0006] For example, the prior art CN 106177773 A discloses a traditional Chinese medicine pill for treating urinary system stones, which is made of the following raw materials in parts by weight: 4-8 parts of Lycopodiella, 2-6 parts of Gallus domestica, 4-8 parts of Alisma orientalis, 4-8 parts of Pheretima, 1-3 parts of Aquilaria, 1-3 parts of Amber, 2-6 parts of Saltpeter, 4-8 parts of Equisetum arvense, 8-12 parts of Malva ovata, 4-8 parts of Plantago, 4-8 parts of Curcuma, 4-8 parts of Poria, 15-19 parts of Talcum powder, 2-7 parts of Licorice, 4-8 parts of Platycodon grandiflorum, 4-8 parts of Cyathula capitata, and 8-12 parts of sucrose.

[0007] However, the above-mentioned traditional Chinese medicine components in the prior art are too many and the effects are uneven. Therefore, it is urgent to explore a traditional Chinese medicine composition with simpler components and better effects. Summary of the invention

[0008] In order to solve the above problems, the present invention first provides a traditional Chinese medicine composition for treating urinary system diseases, which comprises Herba Lysimachiae, Radix Astragali, Herba Lygodii, Herba Gallicae Galli, Herba Cuscutae, Herba Pyrrosiae and Radix Glycyrrhizae.

[0009] In certain embodiments, it is made of the following traditional Chinese medicines in the following weight proportions: 30-70 parts of Lysimachia chinensis, 20-50 parts of Astragalus membranaceus, 20-50 parts of Lygodium japonicum, 20-50 parts of Gallus gallus domesticus, 10-30 parts of Cuscuta chinensis, 10-30 parts of Pyrrosia odoratus and 3-10 parts of Licorice.

[0010] In certain embodiments, it is made of the following traditional Chinese medicines in the following weight proportions: 50 parts of Herba Lysimachiae, 30 parts of Radix Astragali, 30 parts of Radix Lygodium Japonicae, 30 parts of Gallinae Giddens, 15 parts of Semen Cuscutae, 15 parts of Pyrrosiae and 5 parts of Radix Glycyrrhizae.

[0011] In certain embodiments, the Chinese medicine dosage form is one or more of tablets, capsules, and pills.

[0012] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition for treating urinary system diseases, which is characterized by comprising the following steps:

[0013] A. Weigh the above components in sequence;

[0014] B. Grind the chicken's gizzard lining and the sea sand after drying, and then sieve through 100 mesh to obtain fine powder for standby use;

[0015] C. Crush and mix Lysimachia chinensis, Astragalus membranaceus, Cuscuta chinensis, Pyrrosia dahurica and Licorice, add 6 times volume of water and boil twice, the first time for 3 hours and the second time for 1 hour, combine the decoction and retain the filter residue, filter the decoction, and decompress and concentrate the filtrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for standby use;

[0016] D. Add 5-30 times the volume of 10-60% ethanol to the filter residue of step C, reflux and extract twice, each time for 2 hours, filter, combine the filtrate, then distill under reduced pressure to remove ethanol, and concentrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for standby use;

[0017] E. Combine the clear pastes from step C and step D, stir evenly, heat to 75°C, filter through a 200-mesh sieve while hot, and spray-dry the filtrate to obtain spray-dried powder. The spray-drying conditions are: outlet temperature 80°C, inlet temperature 120°C, flow rate 0.5kg / min, and liquid temperature 25°C. Then add the fine powder from step B, filter through a 100-mesh sieve and mix evenly to obtain the product.

[0018] In certain embodiments, the step D is to add 10-20 times the volume of 10-60% ethanol to the filter residue of step C and reflux extract twice for 2 hours each time, filter, combine the filtrate, and then distill under reduced pressure to remove the ethanol, and concentrate to a clear paste with a relative density of 1.1-1.3 (60°C) for use.

[0019] Finally, the present invention provides the use of the above-mentioned Chinese medicine composition for treating urinary system diseases in preparing medicines for treating urinary system diseases.

[0020] In certain embodiments, the urinary system disease is urinary stones.

[0021] Compared with the prior art, the present invention has at least the following beneficial effects:

[0022] The Chinese medicine composition of the present invention comprises Herba Lysimachiae, Radix Astragali, Radix Lygodii, Gallinae Galli, Semen Cuscutae, Pyrrosiae and Radix Glycyrrhizae. Compared with the existing Chinese medicine composition, the components of the composition are simplified, and the application optimizes the addition ratio of alcohol extraction and the percentage of alcohol solution. The optimized parameters can obtain polyphenols and flavonoids to the maximum extent, and have a higher DPPH free radical elimination rate. Subsequent animal experiments and clinical experiments have proved that the composition can effectively treat urinary system diseases and has great clinical value and economic value. DETAILED DESCRIPTION

[0023] In order to make the technical problems to be solved, technical solutions and advantages of the present invention more clear, they are described in detail below in conjunction with specific embodiments.

[0024] Example 1

[0025] Formula and composition by weight: 45 parts of Lysimachia scabra, 30 parts of Astragalus membranaceus, 30 parts of Lygodium japonicum, 30 parts of Gallus gallus domesticus, 15 parts of Cuscuta chinensis, 15 parts of Pyrrosia odoratus and 5 parts of Licorice.

[0026] Preparation method:

[0027] A. Weigh the above components in sequence;

[0028] B. Grind the chicken's gizzard lining and the sea sand after drying, and then sieve through 100 mesh to obtain fine powder for standby use;

[0029] C. Crush and mix Lysimachia chinensis, Astragalus membranaceus, Cuscuta chinensis, Pyrrosia dahurica and Licorice, add 6 times volume of water and boil twice, the first time for 3 hours and the second time for 1 hour, combine the decoction and retain the filter residue, filter the decoction, and decompress and concentrate the filtrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for standby use;

[0030] D. Add 20 times the volume of 30% ethanol to the filter residue of step C, reflux and extract twice, each time for 2 hours, filter, combine the filtrate, then distill under reduced pressure to remove ethanol, and concentrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for standby use;

[0031] E. Combine the clear pastes from step C and step D, stir evenly, heat to 75°C, filter through a 200-mesh sieve while hot, and spray-dry the filtrate to obtain spray-dried powder. The spray-drying conditions are: outlet temperature 80°C, inlet temperature 120°C, flow rate 0.5kg / min, and liquid temperature 25°C. Then add the fine powder from step B, filter through a 100-mesh sieve and mix evenly to obtain the product.

[0032] Embodiment 2:

[0033] Formula and composition by weight: 55 parts of Herba Lysimachiae, 40 parts of Lygodium japonicum, 40 parts of Gallus gallus domesticus, 15 parts of Cuscuta seeds, 15 parts of Pyrrosia ovata and 5 parts of Licorice.

[0034] Preparation method:

[0035] A. Weigh the above components in sequence;

[0036] B. Grind the chicken's gizzard lining and the sea sand after drying, and then sieve through 100 mesh to obtain fine powder for standby use;

[0037] C. Crush and mix the Herba Lysimachiae, Semen Cuscutae, Pyrrosiae and Radix Glycyrrhizae, add 6 times the volume of water and boil twice, the first time for 3 hours and the second time for 1 hour, combine the decoction and retain the filter residue, filter the decoction, and decompress and concentrate the filtrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for standby use;

[0038] D. Add 20 times the volume of 30% ethanol to the filter residue of step C, reflux and extract twice, each time for 2 hours, filter, combine the filtrate, then distill under reduced pressure to remove ethanol, and concentrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for standby use;

[0039] E. Combine the clear pastes from step C and step D, stir evenly, heat to 75°C, filter through a 200-mesh sieve while hot, and spray-dry the filtrate to obtain spray-dried powder. The spray-drying conditions are: outlet temperature 80°C, inlet temperature 120°C, flow rate 0.5kg / min, and liquid temperature 25°C. Then add the fine powder from step B, filter through a 100-mesh sieve and mix evenly to obtain the product.

[0040] Example 3

[0041] Formula and composition by weight: 45 parts of astragalus, 45 parts of sea sand, 45 parts of chicken's gizzard lining, 15 parts of dodder seeds, 15 parts of pyrrosia and 5 parts of liquorice.

[0042] Preparation method:

[0043] A. Weigh the above components in sequence;

[0044] B. Grind the chicken's gizzard lining and the sea sand after drying, and then sieve through 100 mesh to obtain fine powder for standby use;

[0045] C. Grind and mix Astragalus, Cuscuta, Pyrrosia and Licorice, add 6 times volume of water and boil twice, the first time for 3 hours and the second time for 1 hour, combine the decoction and keep the filter residue, filter the decoction, and decompress the filtrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for later use;

[0046] D. Add 20 times the volume of 30% ethanol to the filter residue of step C, reflux and extract twice, each time for 2 hours, filter, combine the filtrate, then distill under reduced pressure to remove ethanol, and concentrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for standby use;

[0047] E. Combine the clear pastes from step C and step D, stir evenly, heat to 75°C, filter through a 200-mesh sieve while hot, and spray-dry the filtrate to obtain spray-dried powder. The spray-drying conditions are: outlet temperature 80°C, inlet temperature 120°C, flow rate 0.5kg / min, and liquid temperature 25°C. Then add the fine powder from step B, filter through a 100-mesh sieve and mix evenly to obtain the product.

[0048] Comparative Example 1

[0049] Except for step D, adding 20 times the volume of 10% ethanol to the filter residue of step C, the other conditions are the same as those of Example 1;

[0050] Comparative Example 2

[0051] Except for step D, adding 20 times the volume of 20% ethanol to the filter residue of step C, the other conditions are the same as those of Example 1;

[0052] Comparative Example 3

[0053] Except for step D, adding 20 times the volume of 40% ethanol to the filter residue of step C, the other conditions are the same as those of Example 1;

[0054] Comparative Example 4

[0055] Except for step D, adding 20 times the volume of 50% ethanol to the filter residue of step C, the other conditions are the same as those of Example 1;

[0056] Comparative Example 5

[0057] Except for step D, adding 20 times the volume of 60% ethanol to the filter residue of step C, the other conditions are the same as those of Example 1;

[0058] Comparative Example 6

[0059] Except for step D, adding 10 times the volume of 30% ethanol to the filter residue of step C, the other conditions are the same as those of Example 1;

[0060] Comparative Example 7

[0061] Except for step D, adding 15 times the volume of 30% ethanol to the filter residue of step C, the other conditions are the same as those of Example 1;

[0062] Comparative Example 8

[0063] Except for step D, adding 25 times the volume of 30% ethanol to the filter residue of step C, the other conditions are the same as those of Example 1;

[0064] Comparative Example 9

[0065] Except for step D, adding 30 times the volume of 30% ethanol to the filter residue of step C, the other conditions are the same as those of Example 1;

[0066] Test Example 1: Component Identification and Antioxidant Analysis

[0067] The total phenol content was determined by the Folin-phenol method: 0.1 mL of the methanol extract of the Chinese medicine composition was sequentially added with 6.0 mL of distilled water, 0.5 mL of Folin-phenol reagent, and 1.5 mL of sodium carbonate solution (200 g / L), and the mixture was fixed to 10 mL with distilled water, shaken, and reacted in the dark for 2 hours, and the absorbance was measured at 765 nm. The gallic acid solution was used as the standard solution, and the solution without the standard solution was used as the control. The standard curve was drawn with the mass concentration of gallic acid as the horizontal axis and the absorbance value as the vertical axis.

[0068] Determination of total flavonoid content: 0.5 mL of methanol extract of the Chinese medicine composition and 1.5 mL of 5% sodium nitrite were mixed, shaken and allowed to stand for 6 minutes, 0.3 mL of 10% aluminum nitrate was added, shaken and allowed to stand for 6 minutes, 1 mL of 4% sodium hydroxide was added, 95% ethanol was added to 5 mL, shaken and allowed to stand for 15 minutes, and the absorbance was measured at 510 nm. The rutin solution was used as the standard solution, and the solution without the standard solution was used as the control to draw a standard curve.

[0069] Determination of DPPH free radical scavenging ability: add 0.1 mL of the methanol extract of the Chinese medicine composition to 3.9 mL of 2.5×10-2 mg / mL DPPH methanol solution (prepared and used immediately), react at room temperature in a dark place for 30 minutes, and measure the absorbance at 517 nm. The percentage scavenging rate of DPPH free radicals is calculated according to formula (1):

[0070] (1): DPPH free radical scavenging rate = (A0-A) / A0×100%

[0071] Where: A0-absorbance after reaction without adding the test solution; A-absorbance measured after reaction with the test solution.

[0072] The results of determining the total phenol content, total flavonoid content and DPPH free radical elimination rate of the traditional Chinese medicine composition are shown in Table 1.

[0073] Table 1. Test results of different Chinese medicine compositions

[0074]

[0075] The results in Table 1 show that the total phenol content, total flavonoid content and DPPH free radical elimination rate (P<0.05) in the Chinese medicine composition of Example 1 have significant differences, indicating that the extraction method of 20 times the volume of 30% ethanol is the best; simply increasing the percentage of ethanol or simply increasing the amount of ethanol added cannot obtain more effective substances. Flavonoids and polyphenols can inhibit calcium oxalate stones and are active ingredients for treating urinary stones, indicating that the Chinese medicine composition of Example 1 can have the best therapeutic effect, and the following will further verify this speculation.

[0076] Test Example 2: Animal Model Test

[0077] 1. Effect on kidney stones in rats

[0078] (1) Experimental method: 150 healthy Wistar rats weighing 180-250 g were randomly selected and divided into 15 groups, with 10 rats in each group.

[0079] Blank control group: 10 rats, gavage with normal saline;

[0080] Model control group: 10 rats, intragastrically administered with normal saline;

[0081] Positive control group: 10 rats, intragastrically administered with an aqueous solution of Fufang Shilintong tablets, at a dose of 25 g / kg;

[0082] Test group: gavage of the aqueous solution of the Chinese medicine composition of Examples 1-3 and Comparative Examples 1-9 of the present application, at a dose of 25g / kg. Each group of rats was gavaged once a day for 30 consecutive days. During the feeding period, 2g of ethylene glycol and 1g of ammonium chloride were added to 100g of feed in the model control group, the positive control group and the test group of the present invention, and vitamin D3 was injected intramuscularly once a week at a dose of 30,000 units / kg to form a kidney stone model. After the test, the test animals were killed, the kidneys were taken out, and they were longitudinally cut open to observe whether there were obvious crystalline precipitates and free stones or calcified plaques on the kidney section. According to the amount of stone formation and the degree of kidney damage, it was divided into the following 5 levels, and the model control group, the positive control group and the present invention group were scored.

[0083] Grade I: There are no visible stones and crystal deposits in the renal cortex, medulla and renal papilla, and no abnormal changes in the kidney appearance, and the score is 0;

[0084] Grade II: A small amount of scattered crystalline precipitates can be seen in the renal cortex or medulla, scored 1 point;

[0085] Grade III: Crystal precipitates or small free crystals can be seen in the renal cortex, medulla and renal pelvis, with a score of 2 points;

[0086] Grade IV: more crystals can be seen in the renal cross-section, free stones are formed, calcification spots can be seen in the renal papilla, and the renal pelvis is dilated and hydronephrosis occurs, which is scored 3 points;

[0087] Grade V: A large number of crystals can be seen in the renal cortex and medulla, free stones are formed, calcification spots can be seen in the renal papilla, and the renal pelvis is obviously dilated and hydronephrosis occurs, which is scored as 4 points.

[0088] (2) Test results: As shown in Table 2, there are significant differences between the test group (Example 1) of the present invention and the model control group (P<0.01), the positive control group and comparative examples 1-9 (P<0.05). The Chinese medicine composition of the present invention can significantly prevent the formation of kidney stones induced by ethylene glycol and ammonium chloride, and reduce the stone formation rate of rats. And after combining the results of Examples 1-3 in Tables 1 and 2, it can be found that although the content of polyphenols and flavonoids only slightly decreases after omitting Astragalus or Lysimachia chinensis in the Chinese medicine composition, its effect is much worse (P<0.01), indicating that Lysimachia chinensis and Astragalus have a great influence on kidney stones, indicating that Lysimachia chinensis and Astragalus may contain other active ingredients not included in Table 1.

[0089] Table 2 Effects of each group on renal calculi in rats

[0090] Group Dosage (g / kg) Kidney stone score (points) Blank control group 0 0 Model control group 0 3.11±1.51 Positive control group 25.0 0.46±0.41 Example 1 25.0 0.25±0.31 Example 2 25.0 0.45±0.34 Example 3 25.0 0.66±0.21 Comparative Example 1 25.0 0.47±0.25 Comparative Example 2 25.0 0.37±0.22 Comparative Example 3 25.0 0.39±0.34 Comparative Example 4 25.0 0.49±0.27 Comparative Example 5 25.0 0.61±0.34 Comparative Example 6 25.0 0.59±0.24 Comparative Example 7 25.0 0.51±0.21 Comparative Example 8 25.0 0.49±0.25 Comparative Example 9 25.0 0.57±0.23

[0091] 2. Effect on urination in rats

[0092] (1) Test method: 140 healthy Wsiatar rats weighing 180-250g were randomly selected and divided into 14 groups, with 10 rats in each of the blank control group, positive control group and test group of the present invention. After fasting for 10 days but not water restriction, each rat was gavaged with 5% glucose saline 3mL / 100g. After 30 minutes, the blank control group was gavaged with physiological saline, the positive control group was gavaged with an aqueous solution of Compound Shilintong Tablets, the dosage was 25g / kg, and the present invention group was gavaged with an aqueous solution of the Chinese medicine composition of Examples 1-3 and Comparative Examples 1-9 of the present application, the dosage was 25g / kg. After administration, the lower abdomen of the rats was pressed to drain the remaining urine, and then the rats were placed in a metabolic cage to collect urine for 5 hours, and the lower abdomen of the rats was pressed to drain the remaining urine, and the urine volume of each group of rats was measured respectively.

[0093] (2) Test results: As shown in Table 3, the test group (Example 1) of the present invention has significant differences with the blank control group (P<0.01), the positive control group and comparative examples 1-9 (P<0.05), and the Chinese medicine composition of the present invention can significantly increase the urine output of rats, indicating that it has a significant diuretic effect. And after combining the results of Examples 1-3 in Table 1 and Table 3, it can be found that although the content of polyphenols and flavonoids only slightly decreases after omitting Astragalus or Lysimachia chinensis from the Chinese medicine composition, the effect is much worse (P<0.01), indicating that Lysimachia chinensis and Astragalus have a great influence on urination, indicating that Lysimachia chinensis and Astragalus may contain other active ingredients not included in Table 1.

[0094] Table 3 Effects of each group on rat urination

[0095] Group Dosage (g / kg) 5-hour urine volume (mL) Blank control group 0 1.83±1.01 Positive control group 25.0 3.47±1.11 Example 1 25.0 6.29±1.24 Example 2 25.0 4.98±1.23 Example 3 25.0 3.89±1.12 Comparative Example 1 25.0 4.88±1.31 Comparative Example 2 25.0 5.79±1.29 Comparative Example 3 25.0 5.71±1.21 Comparative Example 4 25.0 4.67±1.52 Comparative Example 5 25.0 4.31±1.44 Comparative Example 6 25.0 4.49±1.21 Comparative Example 7 25.0 5.24±1.50 Comparative Example 8 25.0 5.29±1.41 Comparative Example 9 25.0 4.79±1.21

[0096] Test Example 3: Clinical Trial

[0097] (1) A total of 100 patients with stones admitted to cooperative hospitals in Nanchang, Jiangxi Province from March 2021 to March 2023 were collected as the research subjects of this experiment and were divided into an experimental group and a control group with 50 cases in each group according to the randomized double-blind method.

[0098] Control group: 29 males and 21 females, aged between 33 and 67 years old, with an average age of (48.3±5.2) years old, including 16 cases of kidney stones, 21 cases of bladder stones, and 13 cases of urethral stones.

[0099] Experimental group: 27 males and 23 females, aged between 29 and 69 years old, with an average age of (46.2±4.6) years old; 18 cases of kidney stones, 19 cases of bladder stones, and 13 cases of urethral stones.

[0100] (2) Methods:

[0101] Control group: Western medicine treatment was chosen, including oral progesterone soft capsules, 100 mg twice a day; oral furosemide tablets, 40 mg once a day. Analgesics and antibiotics were given according to the patient's specific symptoms.

[0102] On the basis of the treatment of the control group, the experimental group orally took the Chinese medicine composition of Example 1 of the present invention, 3 times a day, 40 mg each time, and both groups of patients took the medicine for 2 consecutive weeks.

[0103] (3) Efficacy evaluation criteria

[0104] Clinical efficacy

[0105] Markedly effective: All stones are discharged, clinical symptoms disappear completely, and no stones are found in B-ultrasound or X-ray examinations;

[0106] Improvement: Some stones are expelled, clinical symptoms are significantly alleviated, and ultrasound and X-ray examinations show that the stones are smaller or smaller;

[0107] Ineffective: There is no significant change in clinical symptoms, and ultrasound or X-ray examinations reveal no significant changes or aggravation of the stones.

[0108] SPSS17.0 software was used for statistical analysis, and the count data were analyzed using the χ2 test. The difference was considered statistically significant when P < 0.05.

[0109] (4) Results: The total effective rate of the two groups of patients was 96% in the experimental group and 76% in the control group. The total effective rate of the experimental group was significantly higher than that of the control group, and the difference was statistically significant (P < 0.05). See Table 4, which shows that the drug of the present invention has a significant effect on urinary system stones.

[0110] Table 4 Treatment effect

[0111]

[0112]

[0113] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating urinary system diseases, characterized in that: It contains Lycopodiella Cistanche, Astragalus, Lygodium Japonica, Gallus Gallus Ternifolia, Cuscuta Seed, Pyrrosia Sinensis and Licorice.

2. The Chinese medicine composition for treating urinary system diseases according to claim 1, characterized in that: The invention is prepared from the following traditional Chinese medicines in proportion by weight: 30-70 parts of Lysimachia chinensis, 20-50 parts of Astragalus membranaceus, 20-50 parts of Lygodium japonicum, 20-50 parts of Gallus gallus domesticus, 10-30 parts of Cuscuta chinensis, 10-30 parts of Pyrrosia ovata and 3-10 parts of Licorice.

3. The Chinese medicine composition for treating urinary system diseases according to claim 1, characterized in that: The invention is prepared from the following traditional Chinese medicines in proportion by weight: 45 parts of Lysimachia chinensis, 30 parts of Astragalus membranaceus, 30 parts of Lygodium japonicum, 30 parts of Gallus gallifolia, 15 parts of Cuscuta seeds, 15 parts of Pyrrosia odoratus and 5 parts of Licorice.

4. The Chinese medicine composition for treating urinary system diseases according to claim 1, characterized in that: The Chinese medicine dosage form is one or more of tablets, capsules, and pills.

5. A method for preparing a Chinese medicine composition for treating urinary system diseases as described in any one of claims 1 to 4, characterized in that The steps include: A. Weigh the components described in any one of claims 1 to 4 in sequence; B. Grind the chicken's gizzard lining and the sea sand after drying, and then sieve through 100 mesh to obtain fine powder for standby use; C. Crush and mix Lysimachia chinensis, Astragalus membranaceus, Cuscuta chinensis, Pyrrosia dahurica and Licorice, add 6 times volume of water and boil twice, the first time for 3 hours and the second time for 1 hour, combine the decoction and retain the filter residue, filter the decoction, and decompress and concentrate the filtrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for standby use; D. Add 5-30 times the volume of 10-60% ethanol to the filter residue of step C, reflux and extract twice, each time for 2 hours, filter, combine the filtrate, then distill under reduced pressure to remove ethanol, and concentrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for standby use; E. Combine the clear pastes from step C and step D, stir evenly, heat to 75°C, filter through a 200-mesh sieve while hot, and spray-dry the filtrate to obtain spray-dried powder. The spray-drying conditions are: outlet temperature 80°C, inlet temperature 120°C, flow rate 0.5kg / min, and liquid temperature 25°C. Then add the fine powder from step B, filter through a 100-mesh sieve and mix evenly to obtain the product.

6. The preparation method according to claim 5, characterized in that: The step D is to add 10-20 times the volume of 10-60% ethanol to the filter residue of step C and reflux extract twice, each time for 2 hours, filter, combine the filtrate, and then remove the ethanol by reduced pressure distillation, and concentrate to a clear paste with a relative density of 1.1-1.3 (60° C.) for use.

7. Use of the Chinese medicine composition for treating urinary system diseases as claimed in claims 1 to 4 in the preparation of medicines for treating urinary system diseases.

8. The use according to claim 7, characterized in that The urinary system disease is urinary calculi.

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