A Chinese medicine composition for treating urinary calculi and preparation method thereof

Abstract

The invention discloses a Chinese medicine composition for treating urinary calculi. The Chinese medicine composition is prepared by extracting the following Chinese medicine pieces by weight: 15-25 parts of chuanxiong, 8-12 parts of yanhusuo, 10-20 parts of turmeric, 20-30 parts of angelica, 15-25 parts of prepared rehmannia, 12-18 parts of cornus officinalis, 20-30 parts of astragalus, 18-22 parts of yam, 15-25 parts of platycodon, 10-20 parts of atractylodes, 20-30 parts of codonopsis pilosula, etc., and discloses a preparation method thereof. The Chinese medicine composition can regulate qi and activate blood circulation, invigorate kidney essence, invigorate kidney qi, invigorate lung qi, invigorate spleen, clear away heat and dampness, invigorate diuresis and relieve stranguria, and promote qi circulation and relieve depression, so as to jointly treat urinary calculi of qi and blood stasis syndrome.

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 calculi and a preparation method thereof. Background Art

[0002] Urinary stones belong to the category of "stone stranguria" in traditional Chinese medicine. They refer to pathological products in the surface or deep tissues of the human body. Without the influence of external factors, they lead to stone lesions in the human body. Urinary stones are common diseases in urology, including kidney stones, ureteral stones, bladder stones and urethral stones. Among them, kidney stones and ureteral stones are the most common. The formation of urinary stones is a complex biochemical process, which is usually related to the interaction of multiple factors. The most common types of urinary stones include oxalate stones, urate stones, phosphate stones and cystate stones. The formation of urinary stones is closely related to the following factors: 1. Genetic factors: Individuals with a family history of urinary stones are more likely to get sick. 2. Dietary habits: A high-salt, high-protein, and high-purine diet may cause excessive minerals in the urine, prompting the formation of urinary stones. 3. Insufficient water intake: Insufficient water intake will cause the urine to be too concentrated, increasing the risk of stones. 4. Metabolic diseases: Such as hyperuricemia, hypercholesterolemia, etc., can increase the incidence of urinary stones. 5. Lifestyle habits: Patients who lack exercise, sit for long periods of time, and are bedridden for long periods of time are more likely to develop urinary stones.

[0003] TCM believes that urinary stones are caused by pathological factors such as dampness, heat, qi stagnation, and blood stasis in the body. Through the TCM method of syndrome differentiation and treatment, these pathological conditions can be effectively improved, thereby achieving the purpose of treating urinary stones. Urinary stones belong to the category of sand stranguria and stone stranguria in stranguria syndrome in TCM. "Zhu Bing Yuan Zhou. Lin Bing Zhu Zheng" states: "Stone stranguria is stranguria with stones. The kidney governs water, and water condenses and turns into stones, so the kidney is invaded by sand and stones. Kidney deficiency is taken advantage of by heat, and heat causes stranguria. The symptoms of the disease are pain in the penis during urination, inability to urinate suddenly, pain in the lower abdomen, urgency in the bladder, sand and stones come out of the urinary tract, and severe pain causes suffocation." It can be seen that the disease mainly affects the bladder and kidneys, and is related to the liver and spleen. The pathogenesis is mainly that dampness and heat accumulate in the lower jiao, and the urine is tormented by it. Over time, impurities in the urine condense into sand and stones, which is stone stranguria and sand stranguria. The common symptoms are: 1. Qi and blood stasis syndrome: Main symptoms: distending pain, dull pain or even colic in the waist or lower abdomen, pain pulling the lower abdomen, vulva or inner thigh, red urine or only microscopic hematuria. Tongue and pulse: normal or dark red with petechiae, stringy or stringy pulse. 2. Damp-heat descending syndrome: Main symptoms: low back pain, lower abdominal pain or sudden interruption of urine stream, frequent urination, urgent urination, painful urination, mixed red urine, or hematuria, dry mouth. Tongue and pulse: red tongue with yellow greasy coating, stringy pulse. 3. Kidney deficiency and excess syndrome: Main symptoms: long-term stone stranguria, retention, distending pain in the waist, intermittent, aggravated by fatigue, loss of appetite, weak legs, less urine or more urine, or mild facial edema. Tongue and pulse: pale tongue with white coating, deep and weak pulse (New Edition of Chinese Medicine Surgery, People's Military Medical Publishing House, 1999).

[0004] The popular stone-removing granules on the market are composed of Lianqiancao, Plantago (fried in salt water), Guanketong, Xuchangqing, Pyrola, Dianthus superbus, Honeysuckle, Talc, Semen Abutilonis, and Liquorice. It has the effects of clearing heat and promoting diuresis, and clearing stranguria and removing stones. It is used for stranguria caused by damp-heat in the lower jiao, with symptoms of waist and abdominal pain, dysuria or hematuria; urinary stones with the above symptoms. Lianqiancao in the prescription is the main medicine for clearing heat and promoting diuresis, and clearing stranguria and removing stones. It is supplemented with Plantago, Akebia, Pyrola, Dianthus superbus, Talc, and Semen Abutilonis to promote diuresis and clear damp-heat and relieve stranguria. It is supplemented with Honeysuckle to clear heat and detoxify, clear meridians and relieve pain; Xuchangqing to eliminate dampness and relieve pain. Liquorice clears heat and promotes diuresis, relieves urgency and relieves pain, and harmonizes various medicines, and is an adjuvant medicine. The combination of various medicines can play the role of clearing heat and promoting diuresis, clearing stranguria and removing stones.

[0005] Our company produces stone-clearing tablets, which are made of Herba Lycopersicum, Stigma Corni, Pyrrosia Sinensis, Herba Corydalis, Poria, Herba Plantaine, Herba Lycopersicum, and Imperatae Root. They have the effects of clearing heat and dampness, relieving stranguria and removing stones, and relieving pain and stopping bleeding. They are mainly used clinically for urinary tract infections, cystitis, edema caused by nephritis, urinary tract stones, hematuria, turbidity of stranguria, and burning pain in the urethra. There are not many types of materials used in this product. The Herba Lycopersicum in the prescription is cold in nature, which can clear heat and dampness, promote diuresis and relieve stranguria, detoxify and remove stones, and is the main medicine. Herba Corydalis clears heat and detoxifies, relieves stranguria and stops pain; Pyrrosia Sinensis promotes diuresis and relieves stranguria, cools blood and stops bleeding; Imperatae Root clears heat and promotes diuresis, cools blood and stops bleeding; Herba Lycopersicum and Herba Plantaine clear heat and promote diuresis, relieve stranguria and stop pain, and are all ministerial medicines. Herba Corni is a diuretic and relieves stranguria; Poria is light infiltration of water and dampness, and promotes bladder function, and are all adjuvants. All the medicines are used together to play the effects of clearing heat and dampness, relieving stranguria and removing stones, and stopping bleeding.

[0006] It can be seen that the above two Chinese patent medicines for treating urinary stones are both used for patients with damp-heat syndrome, while in clinical practice, there are often patients with urinary stones of qi and blood stasis syndrome. If these two Chinese patent medicines are used, good results cannot be achieved. Summary of the invention

[0007] In order to overcome the deficiencies of the prior art, one of the purposes of the present invention is to provide a Chinese medicine composition for treating urinary stones, which can better treat urinary stones of Qi and blood stasis syndrome and has a stable therapeutic effect.

[0008] The second object of the present invention is to provide a method for preparing a Chinese medicine composition for treating urinary stones.

[0009] One of the purposes of the present invention is achieved by the following technical solution:

[0010] A Chinese medicine composition for treating urinary stones, which is prepared by extracting the following Chinese medicine pieces, measured by weight: 15-25 parts of Chuanxiong, 8-12 parts of Yanhusuo, 10-20 parts of Curcuma, 20-30 parts of Angelica, 15-25 parts of Rehmannia, 12-18 parts of Cornus, 20-30 parts of Astragalus, 18-22 parts of Dioscorea, 15-25 parts of Platycodon, 10- 20 parts, Codonopsis pilosula 20-30 parts, Herba Lysimachiae 40-50 parts, Herba Aconiti Lateralis Preparata 20-25 parts, Pyrrosiae 20-25 parts, Rhizoma Imperatae 20-25 parts, Herba Lygodii 12-18 parts, Herba Plantaine 12-18 parts, Stigma Maydis 28-32 parts, Poria 20-25 parts, Radix Aucklandiae 15-25 parts, Bark of Magnolia Bark 20-30 parts, Rhizoma Cyperi 18-22 parts, Semen Raphani 20-30 parts.

[0011] The Chinese medicine composition for treating urinary stones is prepared by extracting the following Chinese medicine pieces, measured by weight: 20 parts of chuanxiong, 10 parts of yanhusuo, 15 parts of turmeric, 25 parts of angelica, 20 parts of rehmannia, 15 parts of cornus, 25 parts of astragalus, 20 parts of yam, 20 parts of platycodon, 15 parts of atractylodes, 25 parts of codonopsis, 45 parts of lycopodiella cuneata, 22 parts of pyrrosia, 22 parts of cogongrass root, 15 parts of sea wormwood, 15 parts of plantain, 30 parts of corn silk, 22 parts of tuckahoe, 20 parts of costusroot, 25 parts of magnolia bark, 20 parts of cyperus rotundus, and 25 parts of radish seeds.

[0012] The Chinese medicine composition for treating urinary stones is prepared by extracting the following Chinese medicine pieces, measured by weight: 15 parts of chuanxiong, 12 parts of yanhusuo, 10 parts of turmeric, 30 parts of angelica, 15 parts of rehmannia, 18 parts of cornus, 20 parts of astragalus, 22 parts of yam, 15 parts of platycodon, 20 parts of atractylodes, 20 parts of codonopsis, 50 parts of lycopodiella, 20 parts of scutellaria, 25 parts of pyrrosia, 20 parts of imperata rhizome, 18 parts of sea lily, 12 parts of plantain, 32 parts of corn silk, 20 parts of tuckahoe, 25 parts of costusroot, 20 parts of magnolia bark, 22 parts of cyperus, and 20 parts of radish seeds.

[0013] The Chinese medicine composition for treating urinary stones is prepared by extracting the following Chinese medicine pieces, measured by weight: 25 parts of chuanxiong, 8 parts of yanhusuo, 20 parts of turmeric, 20 parts of angelica, 25 parts of prepared rehmannia, 12 parts of cornus, 30 parts of astragalus, 18 parts of yam, 25 parts of platycodon, 10 parts of atractylodes, 30 parts of codonopsis, 40 parts of lycopodiella cuneata, 25 parts of jasmine, 20 parts of pyrrosia, 25 parts of imperata rhizome, 12 parts of sea lily, 18 parts of plantain, 28 parts of corn silk, 25 parts of tuckahoe, 15 parts of costusroot, 30 parts of magnolia bark, 18 parts of cyperus rotundus, and 30 parts of radish seeds.

[0014] The Chinese medicine composition for treating urinary calculi, the preparation method comprises the steps:

[0015] (1) weighing Chinese herbal medicine slices according to proportion, adding water and decocting twice, adding 10-15 times the amount of water for the first time and decocting for 1.5 hours, and adding 8-10 times the amount of water for the second time and decocting for 1.5 hours, combining the extracts, filtering, and concentrating the filtrate under reduced pressure to an extract with a relative density of 1.2-1.3 at 60° C.;

[0016] (2) vacuum drying the extract at 60° C., −0.09 MPa, and 15 h to obtain an extract powder having a water content of less than 7%;

[0017] (3) adding auxiliary materials, wetting agents, and flavoring agents to the extract powder, mixing and granulating, and then passing through a 12-mesh sieve to obtain wet granules;

[0018] (4) Drying the wet granules to prepare granules, tablets or capsules.

[0019] The conditions for reduced pressure concentration in step (1) of the preparation method of the traditional Chinese medicine composition for treating urinary stones are: -0.08-0.1Mpa, 65-70°C, 3h.

[0020] The traditional Chinese medicine composition for treating urinary stones has the drying conditions in step (4) of the preparation method as follows: 50-70° C., 4 h.

[0021] The Chinese medicine composition for treating urinary stones is used in preparing medicine for treating urinary stones of qi and blood stasis syndrome.

[0022] Qi stagnation and blood stasis syndrome is caused by the long retention of stones in the urinary system, resulting in poor blood circulation. Clinical manifestations include urinary pain, hematuria, waist and abdominal distension and pain, etc. Main symptoms: distension and pain in the waist or lower abdomen, dull pain or even colic, pain traction in the lower abdomen, vulva or inner thigh, red urine or only microscopic hematuria. Tongue and pulse: normal or dark red with petechiae, stringy or stringy pulse. The Treatise on the Causes and Symptoms of Various Diseases says: "Stranguria with stones is caused by stranguria. The kidney governs water, and water turns into stones when it is condensed. Therefore, the kidney is invaded by sand and stones. Kidney deficiency is invaded by heat, and heat causes stranguria. The symptoms of the disease are pain in the penis during urination, inability to urinate suddenly, pain in the lower abdomen, urgency in the bladder, and sand and stones coming out of the urinary tract. In severe cases, there is blockage and pain, which can cause suffocation." The Medical Encyclopedia of Zhang says: "Stranguria with stones causes dull pain in the navel and abdomen, difficulty in urination, unbearable pain, and urine that is like sand and stones, or yellow and red, or turbid, with uncertain colors, just like a soup bottle that has been boiled for a long time, with white alkali at the bottom. It is advisable to clear the accumulated heat and remove the sand and stones. In the treatment of urinary stones of qi stagnation and blood stasis syndrome, the root cause should be treated before the symptoms. Therefore, Chuanxiong, Corydalis, Curcuma, and Angelica are used to regulate qi and activate blood circulation as the main medicines; at the same time, as the Zhongzang Jing·On Stranguria and Inconvenience in Urinating says: "Stranguria with sand is caused by weak kidney qi... deficiency damages the true qi, and the evil heat gradually deepens and forms sand. Another example is boiling salt with a big fire and little water, so the salt gradually turns into stone. The kidney governs water, so salt goes to the kidney and water stays below. The deficiency heat gets worse day by day and the stone is formed. It is not a one-time thing. "It means that this disease is mainly caused by kidney deficiency and bladder heat accumulation. Rehmannia glutinosa and Cornus officinalis are used to nourish kidney essence and kidney qi, while Astragalus membranaceus and Chinese yam are used to nourish lung qi, Platycodon grandiflorum is used to soothe the lungs, and the lungs give birth to the kidneys, that is, metal gives birth to water, such as the essence of the lungs descends to nourish kidney essence, and the lung qi descends to help the kidneys absorb qi; Atractylodes macrocephala and Codonopsis pilosula are used to nourish the spleen, and the spleen and stomach are the foundation of the acquired constitution and the hub of the ascending and descending of qi. Dysfunction of the spleen and stomach, the inability to ascend the clear and descend the turbid, stagnation in the middle burner, accumulation of damp heat, and "the kidney is the gate of the stomach", and the heavy turbid damp heat must flow to the lower burner; and the dysfunction of the qi transformation function of the middle burner hub will also affect the qi transformation of the lower burner, and the damp heat and turbid evil cannot be discharged, and gather into stones. Rehmannia glutinosa, Cornus officinalis, Astragalus membranaceus, Chinese yam, Platycodon grandiflorum, Atractylodes macrocephala, and Codonopsis pilosula are all ministerial drugs; and then Herba Lysimachiae, Herba Polygoni Multiflori, Pyrrosia Root, Herba Imperatae, Herba Lygodii, and Herba Plantaginis are used to clear away heat It can remove dampness, promote diuresis and relieve stranguria. Corn silk can promote diuresis and relieve stranguria. Poria can infiltrate dampness and clear the bladder. Herba Lysimachiae, Herba Corydalis, Pyrrosiae, Imperatae Root, Herba Lysimachiae, Herba Plantaine, Corn silk and Poria are adjuvants. Herba Aucklandiae, Magnolia Bark, Cyperus Rhizome and Semen Raphani are guiding herbs to promote qi and relieve depression. The qi in the middle jiao is unobstructed, the lung qi is promoted, the liver qi is relieved, the heart fire is lowered and the kidney water is raised. The whole prescription contains Rhizoma Chuanxiong, Rhizoma Corydalis, Curcuma, Angelica, Rehmannia Glutinosa, Fructus Corni, Astragalus, Dioscorea Oppositae, Platycodon, Atractylodes, Codonopsis Pilosulae, Herba Lysimachiae, Herba Corydalis, Pyrrosiae, Imperatae Root, Herba Lysimachiae, Herba Plantaine, Corn silk, Poria, Rhizoma Aucklandiae, Magnolia Bark, Cyperus Rhizome and Semen Raphani. It can regulate qi and activate blood circulation, tonify kidney essence, tonify kidney qi, tonify lung qi, tonify spleen, clear away heat and remove dampness, promote diuresis and relieve stranguria, promote qi and relieve depression, and treat urinary stones of qi and blood stasis syndrome together. DETAILED DESCRIPTION

[0023] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0024] Embodiment 1: take Chuanxiong 20g, Corydalis 10g, Curcuma 15g, Angelica 25g, Rehmannia glutinosa 20g, Cornus officinalis 15g, Astragalus 25g, Dioscorea batatas 20g, Platycodon 20g, Atractylodes macrocephala 15g, Codonopsis pilosula 25g, Desmodium 45g, Herba Aconiti Lateralis 22g, Pyrrosia 22g, Imperatae 22g, Lygodium japonicum 15g, Plantago asiatica 15g, Stigma maydis 30g, Poria 22g, Aucklandia 20g, Magnolia officinalis 25g, Cyperus rotundus 20g, Radish seed 25g, the preparation method comprises the following steps:

[0025] (1) Weigh the Chinese herbal medicine pieces according to the proportion, add water and boil twice, add 12 times the amount of water for the first time, boil for 1.5 hours, add 9 times the amount of water for the second time, boil for 1.5 hours, combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.25 at 60° C. The conditions for reduced pressure concentration are: -0.09 MPa, 68° C., 3 h;

[0026] (2) vacuum drying the extract at 60° C., −0.09 MPa, and 15 h to obtain an extract powder having a water content of less than 7%;

[0027] (3) adding starch, polyethylene glycol, and stevioside to the extract powder, mixing and granulating, and then passing through a 12-mesh sieve to obtain wet granules;

[0028] (4) Drying the wet granules at 60°C for 4 h to prepare tablets.

[0029] Embodiment 2: Take 15g of Chuanxiong, 12g of Corydalis, 10g of Curcuma, 30g of Angelica, 15g of Rehmannia, 18g of Cornus, 20g of Astragalus, 22g of Dioscorea, 15g of Platycodon, 20g of Atractylodes, 20g of Codonopsis, 50g of Herba Lysimachiae, 20g of Herba Codonopsis, 25g of Pyrrosia, 20g of Imperatae, 18g of Herba Lygodii, 12g of Herba Plantaginis, 32g of Stigma Canis, 20g of Poria, 25g of Aucklandia, 20g of Magnolia officinalis, 22g of Cyperus, and 20g of Radish Seed, and the preparation method comprises the following steps:

[0030] (1) Weigh the Chinese herbal medicine pieces according to the proportion, add water and decoct twice, add 10 times the amount of water for the first time, decoct for 1.5 hours, add 10 times the amount of water for the second time, decoct for 1.5 hours, combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.2 at 60° C. The conditions for reduced pressure concentration are: -0.1 MPa, 65° C., 3 h;

[0031] (2) vacuum drying the extract at 60° C., −0.09 MPa, and 15 h to obtain an extract powder having a water content of less than 7%;

[0032] (3) adding dextrin, microcrystalline cellulose and stevioside to the extract powder, mixing and granulating, and then passing through a 12-mesh sieve to obtain wet granules;

[0033] (4) Drying the wet granules at 70° C. for 4 h to prepare granules.

[0034] Embodiment 3: Take 25g of Chuanxiong, 8g of Corydalis, 20g of Curcuma, 20g of Angelica, 25g of Rehmannia, 12g of Cornus, 30g of Astragalus, 18g of Dioscorea, 25g of Platycodon, 10g of Atractylodes, 30g of Codonopsis, 40g of Herba Lysimachiae, 25g of Herba Glehniae, 20g of Pyrrosia, 25g of Imperatae, 12g of Herba Lygodii, 18g of Plantago, 28g of Stigma Canis, 25g of Poria, 15g of Aucklandia, 30g of Magnolia Bark, 18g of Cyperus, and 30g of Radish Seed, and the preparation method comprises the following steps:

[0035] (1) Weigh the Chinese herbal medicine pieces according to the proportion, add water and boil twice, add 15 times the amount of water for the first time, boil for 1.5 hours, add 8 times the amount of water for the second time, boil for 1.5 hours, combine the extracts, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.3 at 60° C. The conditions for reduced pressure concentration are: -0.08 MPa, 70° C., 3 h;

[0036] (2) vacuum drying the extract at 60° C., −0.09 MPa, and 15 h to obtain an extract powder having a water content of less than 7%;

[0037] (3) adding dextrin, microcrystalline cellulose and sodium cyclamate to the extract powder, mixing and granulating, and then passing through a 12-mesh sieve to obtain wet granules;

[0038] (4) Drying the wet granules at 50° C. for 4 h to prepare capsules.

[0039] Example 4: Pharmacodynamics Study

[0040] Modeling: 80 male rats weighing 200-250g were selected and randomly divided into 4 groups, each with 20 rats, namely, blank control group, model control group, Example 1 group of the present invention and Paishi granule group (National Medicine Standard Z32020070, Nanjing Tongrentang Pharmaceutical Co., Ltd., production batch number: 20231210), and the dosage of Example 1 group of the present invention and Paishi granule group was 20g crude drug amount / kg. Oral gavage once a day for 30 consecutive days. During this period, except for the blank control group, the remaining groups were fed with a basic feed with 2% ethylene glycol and 1% ammonium chloride (2g ethylene glycol and 1g ammonium chloride were added to every 100g feed), and vitamin D3 was injected intramuscularly once a week, 30,000 units / kg, to create a kidney stone model, and the blank control group was fed with the same dose of normal saline.

[0041] Experimental results: At the end of the experiment, the animals were killed, and the appearance of both kidneys was observed by laparotomy. Both kidneys were removed and cut open longitudinally. The renal cross-section was observed with a dissecting microscope to see if there were obvious crystal precipitates, free stones or calcification spots as the standard for judging stones. According to the number of stones formed and the degree of kidney damage, it was divided into 5 levels: Grade I: no visible stones and crystal precipitates in the renal cortex, medulla and renal papilla, and no abnormal changes in the kidney appearance, 0 points; Grade II: a small amount of scattered crystal precipitates can be seen in the renal cortex or medulla, 1 point; Grade III: crystal precipitates or small free crystals can be seen in the renal cortex, medulla and renal pelvis, 2 points; Grade IV: more crystals can be seen in the renal cross-section, and free stones are formed, calcification spots can be seen in the renal papilla, and the renal pelvis is dilated and hydronephrosis, 3 points; 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, 4 points; and compared with the model group according to the renal stone formation rate and the degree of renal stones. The results are shown in Table 1.

[0042] Table 1 Effect of the present invention on rat kidney stones

[0043] Grouping quantity Kidney stone degree (points) Stone formation rate (%) Blank group 20 0 0 Model Group 20 <![CDATA[2.45±1.28 ### ]]> <![CDATA[17(85) ### ]]> Control group 20 <![CDATA[0.67±0.36 ** ]]> <![CDATA[6(30) ** ]]> Embodiment 1 of the present invention 20 <![CDATA[0.39±0.24 ** ]]> <![CDATA[4(20) ** ]]>

[0044] Compared with the blank group, ###P<0.001, compared with the model group, *P<0.05, **P<0.01.

[0045] Kidney stones are a type of urinary stones. The experimental results show that Example 1 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 in rats. The effect is better than that of stone-removing granules, indicating that the present invention has the function of treating kidney stones in urinary stones.

[0046] Example 5: Clinical study

[0047] Case selection: This clinical study selected patients with urinary stones with clinical qi and blood stasis syndrome from January 2024 to August 2024, who met the inclusion and exclusion criteria, and the patients agreed to participate in this clinical observation. A total of 100 cases were collected and divided into two groups, 50 cases in each group, namely, group 2 of Example 2 of the present invention and a control group. The granules prepared by Example 2 of the present invention or the reference product were used for treatment, and relevant indicators were observed.

[0048] Diagnostic criteria: ① Imaging examination, B-ultrasound examination, X-ray or CT examination confirms the patient as having urinary stones; ② Confirmed as Qi and blood stasis syndrome: Main symptoms: distending pain, dull pain or even colic in the waist or lower abdomen, pain pulling the lower abdomen, vulva or inner thigh, red urine or only microscopic hematuria. Tongue and pulse: normal or dark red with petechiae, stringy or stringy pulse.

[0049] The dropout and exclusion criteria for cases are as follows: ① The subjects have poor compliance and cannot persist in treatment; ② The subjects have serious adverse reactions, such as abnormal neurological function; ③ The subjects develop other serious diseases during the clinical trial; ④ The treatment is effective, but the efficacy cannot be determined when other treatments are added.

[0050] Efficacy observation index: According to relevant standards, the treatment effect of patients is divided into three levels: if the patient's clinical symptoms basically disappear, the stones in the body are discharged, the stone shadow disappears after B-ultrasound examination, and the urine routine indicators also tend to be normal, it is markedly effective; if the patient's clinical symptoms partially disappear, and the stone shadow shrinks and moves downward after B-ultrasound examination, it is effective; if the patient's symptoms do not improve and the stones do not change after B-ultrasound examination, it is ineffective. The total effective rate of treatment is the sum of the markedly effective rate and the effective rate.

[0051] Method of administration: The second group of the present invention took the Chinese medicine granules prepared in the second embodiment of the present invention, and the daily dosage was: 20g of Chuanxiong, 10g of Corydalis, 15g of Curcuma, 25g of Angelica, 20g of Rehmannia glutinosa, 15g of Cornus officinalis, 25g of Astragalus, 20g of Dioscorea batatas, 20g of Platycodon grandiflorum, 15g of Atractylodes macrocephala, 25g of Codonopsis pilosula, 45g of Herba Lysimachiae, 22g of Herba Codonopsis pilosulae, 22g of Pyrola, 22g of Imperatae cyrtonemae, 15g of Herba Lygodii, 15g of Herba Plantaginis, 30g of Cornus officinalis, 22g of Poria, 20g of Aucklandia lappa, 25g of Magnolia officinalis, 20g of Cyperus rotundus, and 25g of Radish Seed, and took them for 15 days. The control group took Paishi Granules (National Medicine Standard Z32020070, Nanjing Tongrentang Pharmaceutical Co., Ltd., production batch number: 20231210), 2 bags at a time, 3 times a day, and took them for 15 days.

[0052] Results: See Table 2.

[0053] Table 2 Comparison of clinical efficacy of two groups of drugs in treating urinary stones of Qi and blood stasis syndrome

[0054] Grouping Significant effect efficient invalid Effectiveness (%) Control group 18 22 10 80 Embodiment 2 of the present invention 26 21 3 <![CDATA[94 * ]]>

[0055] Compared with the model group * P<0.05

[0056] As shown in Table 2, after the two groups of drug treatment, 18 cases in the control group were effective, 22 cases were effective, 10 cases were ineffective, and the total effective rate was 80%; 26 cases in the second group of the embodiment of the present invention were effective, 21 cases were effective, 3 cases were ineffective, and the total effective rate was 94%. The difference in clinical efficacy between the two groups was statistically significant (P<0.05), indicating that the present invention has a good effect in treating urinary stones of qi and blood stasis syndrome, and is superior to the stone-removing granules.

[0057] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating urinary calculi, characterized in that: The Chinese medicine composition is prepared by extracting the following Chinese medicinal pieces by weight: 15-25 parts of chuanxiong, 8-12 parts of yanhusuo, 10-20 parts of turmeric, 20-30 parts of angelica, 15-25 parts of rehmannia, 12-18 parts of cornus, 20-30 parts of astragalus, 18-22 parts of yam, 15-25 parts of platycodon, 10-20 parts of atractylodes, 20-30 parts of codonopsis, 40-50 parts of leucoderma, 20-25 parts of pyrrosia, 20-25 parts of imperata rhizome, 12-18 parts of sea wormwood, 12-18 parts of plantain, 28-32 parts of corn silk, 20-25 parts of tuckahoe, 15-25 parts of costusroot, 20-30 parts of magnolia bark, 18-22 parts of cyperus rotundus and 20-30 parts of radish seeds.

2. The Chinese medicine composition for treating urinary calculi according to claim 1, characterized in that: The Chinese medicine composition is prepared by extracting the following Chinese medicinal pieces, measured by weight: 20 parts of chuanxiong, 10 parts of yanhusuo, 15 parts of turmeric, 25 parts of angelica, 20 parts of rehmannia, 15 parts of cornus, 25 parts of astragalus, 20 parts of yam, 20 parts of platycodon, 15 parts of atractylodes, 25 parts of codonopsis, 45 parts of lycopodiella cuneata, 22 parts of pyrrosia, 22 parts of imperata rhizome, 15 parts of sea sand grass, 15 parts of plantain, 30 parts of corn silk, 22 parts of tuckahoe, 20 parts of costusroot, 25 parts of magnolia bark, 20 parts of cyperus rotundus, and 25 parts of radish seeds.

3. The Chinese medicine composition for treating urinary calculi according to claim 1, characterized in that: The Chinese medicine composition is prepared by extracting the following Chinese medicinal pieces, measured by weight: 15 parts of Chuanxiong, 12 parts of Corydalis, 10 parts of Curcuma, 30 parts of Angelica, 15 parts of Rehmannia, 18 parts of Cornus, 20 parts of Astragalus, 22 parts of Dioscorea, 15 parts of Platycodon, 20 parts of Atractylodes, 20 parts of Codonopsis, 50 parts of Lysimachia, 20 parts of Herba Centipedalis, 25 parts of Pyrrosia, 20 parts of Imperata Rhizome, 18 parts of Lygodium japonicum, 12 parts of Plantago, 32 parts of Corn Silk, 20 parts of Poria, 25 parts of Costusroot, 20 parts of Magnolia officinalis, 22 parts of Cyperus rotundus, and 20 parts of Radish Seed.

4. The Chinese medicine composition for treating urinary calculi according to claim 1, characterized in that: The Chinese medicine composition is prepared by extracting the following Chinese medicinal pieces, by weight: 25 parts of chuanxiong, 8 parts of yanhusuo, 20 parts of turmeric, 20 parts of angelica, 25 parts of rehmannia, 12 parts of cornus, 30 parts of astragalus, 18 parts of yam, 25 parts of platycodon, 10 parts of atractylodes, 30 parts of codonopsis, 40 parts of lycopodiella cuneata, 25 parts of pyrrosia, 25 parts of imperata rhizome, 12 parts of sea jelly, 18 parts of plantain, 28 parts of corn silk, 25 parts of tuckahoe, 15 parts of costusroot, 30 parts of magnolia bark, 18 parts of cyperus rotundus, and 30 parts of radish seeds.

5. The Chinese medicine composition for treating urinary calculi according to claim 1, characterized in that: The preparation method comprises the steps of: (1) weighing Chinese herbal medicine slices according to proportion, adding water and decocting twice, adding 10-15 times the amount of water for the first time and decocting for 1.5 hours, and adding 8-10 times the amount of water for the second time and decocting for 1.5 hours, combining the extracts, filtering, and concentrating the filtrate under reduced pressure to an extract with a relative density of 1.2-1.3 at 60° C.; (2) vacuum drying the extract at 60° C., −0.09 MPa, and 15 h to obtain an extract powder having a water content of less than 7%; (3) adding auxiliary materials, wetting agents, and flavoring agents to the extract powder, mixing and granulating, and then passing through a 12-mesh sieve to obtain wet granules; (4) Drying the wet granules to prepare granules, tablets or capsules.

6. The Chinese medicine composition for treating urinary calculi according to claim 5, characterized in that: The conditions for reduced pressure concentration in step (1) of the preparation method are: -0.08-0.1Mpa, 65-70°C, 3h.

7. The Chinese medicine composition for treating urinary calculi according to claim 5, characterized in that: The drying conditions in step (4) of the preparation method are: 50-70° C., 4 h.

8. Use of the Chinese medicine composition for treating urinary calculi as claimed in claim 5 in the preparation of a medicine for treating urinary calculi of qi and blood stasis syndrome.