A traditional Chinese medicine composition for treating urinary system diseases and its application

Abstract

The present invention relates to the field of traditional Chinese medicine. Specifically, it relates to a traditional Chinese medicine composition for treating urinary system diseases and its application. It is characterized in that it is made from traditional Chinese medicines in the following parts by weight: 30-70 parts of Lysimachia christinae Hance, 20-50 parts of Astragalus membranaceus (Fisch.) Bunge, 20-50 parts of Lygodium japonicum (Thunb.) Sw., 20-50 parts of Endothelium corneum gigeriae galli, 10-30 parts of Cuscuta chinensis Lam., 10-30 parts of Pyrrosia lingua (Thunb.) Farwell, and 3-10 parts of Glycyrrhiza uralensis Fisch. The traditional Chinese medicine composition of the present invention contains Lysimachia christinae Hance, Astragalus membranaceus (Fisch.) Bunge, Lygodium japonicum (Thunb.) Sw., Endothelium corneum gigeriae galli, Cuscuta chinensis Lam., Pyrrosia lingua (Thunb.) Farwell, and Glycyrrhiza uralensis Fisch. Compared with the existing traditional Chinese medicine compositions, its components are simplified; and the present application optimizes the addition ratio of alcohol extraction and the percentage of alcohol solution. With the optimized parameters, it can obtain polyphenols and flavonoids to the maximum extent and has a high DPPH free radical scavenging rate. Subsequently, animal experiments and clinical experiments prove that it can effectively treat urinary system diseases and has great 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 traditional Chinese medicine composition for treating urinary system diseases and its application. Background Art

[0002] Urinary system stones are common urological diseases in clinical practice. Although the mortality rate caused by urinary system stones is relatively low, since stones often cause severe pain to the body and can also trigger various adverse reactions, it seriously affects the life health and quality of life of patients. With the continuous in-depth study of the occurrence and development mechanism of urinary system stones, as well as the continuous improvement and enhancement of modern medical technology levels, currently, a variety of drugs and methods have been applied to the treatment of urinary system stones in clinical practice and have achieved good treatment effects.

[0003] For example, the prior art CN 111419971 B discloses the application of a traditional Chinese medicine composition in the preparation of a drug for treating stones. The traditional Chinese medicine composition is made from the following raw materials in parts by weight: dodder seed 150 - 350, wolfberry fruit 100 - 200, schisandra chinensis 30 - 60, fructus cnidii 20 - 50, fructus rosae laevigatae 20 - 50, semen allii tuberosi 20 - 50, morinda officinalis 20 - 50, cistanche deserticola 20 - 50, rehmannia glutinosa 30 - 60, cyathula officinalis 20 - 50, epimedium brevicornum 40 - 100, raspberry 20 - 50, ginseng 15 - 35, pilose antler 10 - 25, hippocampus 15 - 35, toosendan fruit 15 - 35. The drug has good effects on kidney stones, bladder stones, and urinary tract stones, with an effective rate reaching 94.5%, and the recurrence rate within one year is only 2.3%.

[0004] For example, the prior art CN 110064012 B discloses a traditional Chinese medicine composition for treating urinary system stones. The active components of the traditional Chinese medicine composition include the following raw materials in parts by weight: lysimachia christinae 25 - 35 parts, lygodium japonicum 20 - 50 parts, plantago asiatica 10 - 20 parts, dianthus superbus 8 - 12 parts, peach kernel 7 - 11 parts, polygonum aviculare 8 - 13 parts, alisma orientale 10 - 20 parts, radix paeoniae rubra 10 - 20 parts, lindera aggregata 7 - 13 parts, malva verticillata 8 - 11 parts. The whole formula works together to clear heat and promote diuresis, remove gravel by diuresis, and disperse stasis and relieve pain, and has a significant therapeutic effect on the treatment of urinary system stones.

[0005] For example, the prior art CN 106266109 B discloses a traditional Chinese medicine composition for treating urinary system stones, which is made from the following traditional Chinese medicines in parts by weight: Desmodium styracifolium 10 - 30 parts, Endothelium corneum gigeriae galli 10 - 30 parts, Lygodium japonicum vine 10 - 30 parts, Pyrrosia lingua 15 - 40 parts, Lygodium japonicum 5 - 20 parts, Trogopterus dung 5 - 20 parts, Fructus aurantii 5 - 15 parts, Pericarpium citri reticulatae 5 - 15 parts, Talcum powder 5 - 20 parts, and Glycyrrhiza uralensis Fisch. 3 - 10 parts. It has a therapeutic effect on urinary system stones including kidney stones, ureteral stones, bladder stones, and urethral stones, etc., with remarkable curative effect and small 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 from the following raw materials in parts by weight: Lygodium japonicum 4 - 8, Endothelium corneum gigeriae galli 2 - 6, Alisma orientale 4 - 8, Pheretima aspergillum 4 - 8, Aquilaria sinensis (Lour.) Spreng. 1 - 3, Succinum 1 - 3, Nitrum 2 - 6, Equisetum hiemale L. 4 - 8, Malva verticillata L. 8 - 12, Plantago asiatica L. 4 - 8, Curcuma aromatica Salisb. 4 - 8, Poria cocos (Schw.) Wolf 4 - 8, Talcum powder 15 - 19, Glycyrrhiza uralensis Fisch. 2 - 7, Platycodon grandiflorus (Jacq.) A. DC. 4 - 8, Cyathula officinalis Kuan 4 - 8, and sucrose 8 - 12.

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

[0008] To solve the above problems, the present invention first provides a traditional Chinese medicine composition for treating urinary system diseases, which comprises Lysimachia christinae Hance, Astragalus membranaceus (Fisch.) Bunge, Lygodium japonicum, Endothelium corneum gigeriae galli, Cuscuta chinensis Lam., Pyrrosia lingua, and Glycyrrhiza uralensis Fisch.

[0009] In some embodiments, it is made from the following traditional Chinese medicines in parts by weight: Lysimachia christinae Hance 30 - 70 parts, Astragalus membranaceus (Fisch.) Bunge 20 - 50 parts, Lygodium japonicum 20 - 50 parts, Endothelium corneum gigeriae galli 20 - 50 parts, Cuscuta chinensis Lam. 10 - 30 parts, Pyrrosia lingua 10 - 30 parts, and Glycyrrhiza uralensis Fisch. 3 - 10 parts.

[0010] In some embodiments, it is made from the following traditional Chinese medicines in parts by weight: Lysimachia christinae Hance 50 parts, Astragalus membranaceus (Fisch.) Bunge 30 parts, Lygodium japonicum 30 parts, Endothelium corneum gigeriae galli 30 parts, Cuscuta chinensis Lam. 15 parts, Pyrrosia lingua 15 parts, and Glycyrrhiza uralensis Fisch. 5 parts.

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

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

[0013] A. Weigh the above - mentioned 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 application 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] Formulation and composition by weight parts: 45 parts of Lysimachia christinae, 30 parts of Astragalus membranaceus, 30 parts of Lygodium japonicum, 30 parts of Endothelium corneum gigeriae galli, 15 parts of Cuscuta chinensis, 15 parts of Pyrrosia lingua, and 5 parts of Glycyrrhiza uralensis.

[0026] Preparation method:

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

[0028] B. Dry and then separately pulverize Endothelium corneum gigeriae galli and Lygodium japonicum, and then pass through a 100-mesh sieve to obtain fine powder for standby;

[0029] C. Pulverize and mix Lysimachia christinae, Astragalus membranaceus, Cuscuta chinensis, Pyrrosia lingua, and Glycyrrhiza uralensis, add water for decocting twice with 6 times the volume, 3 hours for the first time and 1 hour for the second time, combine the decoction liquid and retain the filter residue, filter the decoction liquid, and concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.1 - 1.3 (60 °C) for standby;

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

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

[0032] Example 2:

[0033] Formulation and composition by weight parts: 55 parts of Lysimachia christinae, 40 parts of Lygodium japonicum, 40 parts of Endothelium corneum gigeriae galli, 15 parts of Cuscuta chinensis, 15 parts of Pyrrosia lingua, and 5 parts of Glycyrrhiza uralensis.

[0034] Preparation method:

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

[0036] B. Dry and then separately pulverize Endothelium corneum gigeriae galli and Lygodium japonicum, and then pass through a 100-mesh sieve to obtain fine powder for standby;

[0037] C. Pulverize and mix Lysimachia christinae, Cuscuta chinensis, Pyrrosia lingua, and Glycyrrhiza uralensis, add water for decocting twice with 6 times the volume, 3 hours for the first time and 1 hour for the second time, combine the decoction liquid and retain the filter residue, filter the decoction liquid, and concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.1 - 1.3 (60 °C) for standby;

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

[0039] E. Combine the clear extracts from steps C and D, stir evenly, heat to 75 °C and filter through a 200 - mesh sieve while it is hot. Spray - dry the filtrate to obtain spray - dried powder. The spray - drying conditions are: outlet temperature 80 °C, inlet temperature 120 °C, flow rate 0.5 kg / min, and feed liquid temperature 25 °C. Then add the fine powder from step B, pass 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 membranaceus, 45 parts of Lygodium japonicum, 45 parts of Endothelium corneum gigeriae galli, 15 parts of Cuscuta chinensis, 15 parts of Pyrrosia lingua, and 5 parts of Glycyrrhiza uralensis.

[0042] Preparation method:

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

[0044] B. Dry and crush Endothelium corneum gigeriae galli and Lygodium japonicum separately, then pass through a 100 - mesh sieve to obtain fine powder for standby;

[0045] C. Crush and mix Astragalus membranaceus, Cuscuta chinensis, Pyrrosia lingua, and Glycyrrhiza uralensis, add 6 times the volume of water and decoct twice. The first time is 3 hours, the second time is 1 hour. Combine the decoction liquid and retain the filter residue. Filter the decoction liquid, and concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.1 - 1.3 (60 °C) for standby;

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

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

[0048] Comparative Example 1

[0049] Except for step D, where 10% ethanol with 20 times the volume is added to the filter residue from step C, the other conditions are the same as in 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 in 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 in 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 in 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 in 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 in 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 in 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 in 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 in Example 1;

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

[0067] The total phenolic content was determined by the Folin-phenol method: 0.1 mL of the methanol extract of the traditional Chinese medicine composition was successively 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 volume was made up to 10 mL with distilled water, shaken well, reacted in the dark for 2 h, and the absorbance was measured at 765 nm. Using the gallic acid solution as the standard solution and the solution without adding the standard solution as the control, a standard curve was plotted with the mass concentration of gallic acid as the abscissa and the absorbance as the ordinate.

[0068] Determination of total flavonoid content: 0.5 mL of the methanol extract of the traditional Chinese medicine composition was mixed with 1.5 mL of 5% sodium nitrite, shaken well and allowed to stand for 6 min. Then, 0.3 mL of 10% aluminum nitrate was added, shaken well and allowed to stand for 6 min. After that, 1 mL of 4% sodium hydroxide was added, and the volume was made up to 5 mL with 95% ethanol. The mixture was shaken well and allowed to stand for 15 min, and the absorbance was measured at 510 nm. Using the rutin solution as the standard solution and the solution without the standard solution as the control, a standard curve was plotted.

[0069] Determination of DPPH free radical scavenging ability: 0.1 mL of the methanol extract of the traditional Chinese medicine composition was added to 3.9 mL of 2.5×10-2 mg / mL DPPH methanol solution (prepared freshly before use), and the reaction was carried out at room temperature in the dark for 30 min. The absorbance was measured at 517 nm. The percentage scavenging rate of DPPH free radicals was calculated according to formula (1):

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

[0071] In the formula: A0 - absorbance after reaction without adding the test solution; A - absorbance measured after adding the test solution and reacting.

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

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

[0074]

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

[0076] Experimental Example 2: Animal model experiment

[0077] 1. Effect on renal calculi in rats

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

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

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

[0081] Positive control group: 10 rats, gavaged with an aqueous solution of Compound Shilin Tablets at a dose of 25 g / kg;

[0082] Test group: Gavaged with an aqueous solution of the traditional Chinese medicine compositions of Examples 1-3 and Comparative Examples 1-9 of the present application at a dose of 25 g / kg. Each group of rats was gavaged once a day for 30 consecutive days. During the feeding period, 2 g of ethylene glycol and 1 g of ammonium chloride were added to 100 g of feed for the model control group, positive control group and test group of the present invention, and vitamin D3 was intramuscularly injected once a week at a dose of 30,000 units / kg to form a kidney stone model. After the experiment, the test animals were sacrificed, the double kidneys were removed, longitudinally dissected, and the renal cross-section was observed for obvious crystalline precipitates, free stones or calcification plaques. According to the amount of stone formation and the degree of kidney damage, it was divided into the following 5 grades, and the model control group, positive control group and the group of the present invention were scored.

[0083] Grade I: No visible stones and crystalline precipitates were observed in the renal cortex, medulla and renal papilla, and the shape of the kidney was normal, scored 0 points;

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

[0085] Grade III: Crystalline precipitates or small free crystals were visible in the renal cortex, medulla and renal pelvis, scored 2 points;

[0086] Grade IV: More crystals were visible in the renal cross-section, free stones were formed, calcification plaques were visible in the renal papilla, and the renal pelvis was dilated and hydrops, scored 3 points;

[0087] Grade V: A large amount of crystals were visible in the renal cortex and medulla, free stones were formed, calcification plaques were visible in the renal papilla, and the renal pelvis was significantly dilated and hydrops, scored 4 points.

[0088] (2) Test results: As shown in Table 2, there were 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 traditional Chinese medicine composition of the present invention could significantly prevent the formation of kidney stones induced by ethylene glycol and ammonium chloride, and reduce the stone formation rate of rats. And it was found after combining the results of Examples 1-3 in Tables 1 and 2 that although the content of polyphenols and flavonoids decreased slightly after omitting Astragalus membranaceus or Lysimachia christinae in the traditional Chinese medicine composition, its effect was much worse (P<0.01), indicating that Lysimachia christinae and Astragalus membranaceus had a great influence on kidney stones, suggesting that Lysimachia christinae and Astragalus membranaceus might contain other active ingredients not included in Table 1.

[0089] Table 2 Effects of each group on kidney stones in rats

[0090] Group Dose (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 rat urination

[0092] (1) Test method: Randomly select 140 healthy Wistar rats weighing 180 - 250 g, and randomly divide them into 14 groups, with 10 rats in the blank control group, positive control group, and experimental group of the present invention respectively. Fast the rats for 10 days without restricting water intake. Then, each rat is intragastrically administered 3 mL / 100 g of 5% glucose saline. After 30 minutes, the blank control group is intragastrically administered normal saline, the positive control group is intragastrically administered an aqueous solution of compound Shilin Tong tablets at a dose of 25 g / kg, and the experimental group of the present invention is intragastrically administered an aqueous solution of the traditional Chinese medicine composition of Examples 1 - 3 and Comparative Examples 1 - 9 of the present application at a dose of 25 g / kg. After administration, compress the lower abdomen of the rats to drain the remaining urine, and then place them in a metabolic cage to collect urine for 5 hours. Then, compress the lower abdomen of the rats to drain the remaining urine, and measure the urine volume of rats in each group respectively.

[0093] (2) Test results: As shown in Table 3, there are significant differences between the experimental group of the present invention (Example 1) and the blank control group (P < 0.01), the positive control group, and Comparative Examples 1 - 9 (P < 0.05). The traditional Chinese medicine composition of the present invention can significantly increase the urine output of rats, indicating a significant diuretic effect. And by 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 decreases slightly after omitting Astragalus membranaceus or Lysimachia christinae in the traditional Chinese medicine composition, its effect is much worse (P < 0.01), indicating that Lysimachia christinae and Astragalus membranaceus have a great impact on urination, suggesting that Lysimachia christinae and Astragalus membranaceus may contain other active ingredients not included in Table 1.

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

[0095] Group Dose (g / kg) Urine volume in 5 hours (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) Collect 100 patients with stones admitted to the cooperative hospital in Nanchang, Jiangxi from March 2021 to March 2023 as the research objects of this experiment, and divide them into an experimental group and a control group of 50 cases each according to the random double - blind method.

[0098] Control group: 29 males and 21 females, aged between 33 and 67 years old, with an average of (48.3 ± 5.2) years old. Among them, there are 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 of (46.2 ± 4.6) years old; among them, there are 18 cases of kidney stones, 19 cases of bladder stones, and 13 cases of urethral stones.

[0100] (2) Method:

[0101] Control group: Western medicine treatment was selected. Oral administration of progesterone soft capsules, 2 times a day, 100 mg each time; oral administration of furosemide tablets, 1 time a day, 40 mg each time. Analgesics and antibiotics can be given according to the specific symptoms of the patients.

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

[0103] (3) Efficacy evaluation criteria

[0104] Clinical efficacy

[0105] Marked effect: All stones are discharged, clinical symptoms completely disappear, and no stones are found by B-ultrasound or X-ray examination;

[0106] Improvement: Some stones are discharged, clinical symptoms are significantly relieved, and the stones are found to be reduced or decreased by B-ultrasound and X-ray examination;

[0107] No effect: Clinical symptoms have no obvious change, and no obvious change or aggravation of the stones is found by B-ultrasound or X-ray examination.

[0108] SPSS 17.0 software was used for statistical analysis. Chi-square test was used for counting data. P < 0.05 indicated that the difference was statistically significant.

[0109] (4) Results: In the comparison of the clinical efficacy of the two groups of patients, the total effective rate of the experimental group was 96%, and that of the control group was 76%. The experimental group was significantly higher than the control group, and the difference was statistically significant (P < 0.05), as shown in Table 4, indicating 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 the preferred implementation manner of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle described in the present invention, several improvements and refinements can still be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating urinary system diseases, characterized in that: The medicine is prepared from the following Chinese medicines in the following weight proportions: 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; The preparation method of the Chinese medicine composition for treating urinary system diseases comprises the following steps: A. Weigh the above components 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 the 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 concentrate the filtrate under reduced pressure to a relative density of 1.1-1.3, and set aside the clear paste at 60°C; 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, and then distill under reduced pressure to remove ethanol, and concentrate to a relative density of 1.1-1.3, 60°C clear paste 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.

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

3. Use of the Chinese medicine composition for treating urinary system diseases as claimed in claim 1 in the preparation of a medicament for treating urinary system diseases, wherein the urinary system disease is kidney stones.

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