New application of Chinese knotweed rhizome and aloe bowel-relaxing capsule

Abstract

The invention belongs to the field of traditional Chinese medicines, and relates to a novel application of a Chinese knotweed rhizome and aloe bowel-relaxing capsule, in particular to an application of the Chinese knotweed rhizome and aloe bowel-relaxing capsule in a medicine for treating ureteral reflux. Pharmacodynamic tests prove that the traditional Chinese medicine composition provided by the invention can enhance tension and motility of ureteral and ileum smooth muscles, has very important effects on relieving spasm of ureteral smooth muscles and expanding a ureteral lumen, is beneficial to urine delivery, has a remarkable anti-ureteral regurgitation effect, is high in safety, and is free of toxic and side effects. Wide application prospects and positive clinical significance are realized.

Description

Technical Field

[0001] The present invention relates to the use of a traditional Chinese medicine composition, belonging to the field of traditional Chinese medicine. It relates to a new use of Shouhui Laxative Capsule, specifically to the use of Shouhui Laxative Capsule in the medicine for treating ureteral reflux. Background Art

[0002] Bladder cancer (BCa) is the ninth most common cancer in the world and the thirteenth most common cause of death. It ranks seventh in the incidence of male malignancies and eighteenth in the incidence of female malignancies.

[0003] Radical cystectomy (RC) plus urinary diversion (UD) is the standard method for treating high-risk non-muscle-invasive bladder cancer and organ-confined muscle-invasive bladder cancer. The probability of complications after radical cystectomy plus urinary diversion is 25%. Postoperative complications are mainly divided into early complications and late complications. Early complications mainly include postoperative bleeding, incision infection, intraperitoneal infection, urinary tract infection, urine leakage, intestinal leakage, intestinal obstruction, urinary reflux, urinary incontinence, etc. Most of the late complications are due to infectious, obstructive factors and tumor recurrence. The common late complications and their corresponding incidence rates are renal function or morphological changes (27%), stoma complications (24%), ureteroileal anastomosis complications (14%) and urolithiasis (9%) respectively.

[0004] Vesicoureteral reflux (VUR) refers to the reflux of urine from the bladder to the ureter and renal pelvis during urination. Reflux nephropathy (RN) is a syndrome caused by VUR and intrarenal reflux (IRR) accompanied by repeated urinary tract infections, resulting in kidney scarring, atrophy and abnormal renal function. It may lead to problems such as urinary tract infections. If not treated and corrected in time, it can develop into chronic renal failure. Generally speaking, smooth muscle contraction is divided into tonic contraction and phasic contraction. Tonic contraction plays a very important role in maintaining the pressure in the lumen (such as blood pressure), while phasic contraction is crucial for pushing the substances in the lumen to move distally (blood, urine). Ureteral smooth muscle tone mainly refers to the smooth muscle tone during the tonic contraction period of the ureter. Reducing the tone of the ureteral smooth muscle is very important for relieving ureteral smooth muscle spasm and dilating the ureteral lumen. Therapeutic drugs include antibiotics, anticholinergic drugs, α-blockers, etc. Clinically, M cholinergic receptor blockers (atropine), calcium ion antagonists (nimodipine), etc. are commonly used to relax the ureteral smooth muscle, but they are limited by the impact on the cardiovascular system and other side effects.

[0005] Chinese Patent CN100453105C discloses a composition with functions of relieving constipation, expelling toxins, losing weight and reducing lipid, as well as its preparation method. It has now obtained production approval, and the product is Shouhui Laxative Capsule. This product is a compound traditional Chinese medicine preparation made from eight traditional Chinese medicines, namely Polygonum multiflorum, Aloe vera, Cassia obtusifolia, Lycium barbarum, Colla Corii Asini, Panax ginseng, Atractylodes macrocephala and Aurantii Fructus Immaturus, after extraction and processing, and can specifically treat functional constipation. The prescription of Shouhui Laxative Capsule is a clinical experience prescription of a famous old Chinese medicine doctor. Based on traditional Chinese medicine theory and integrating clinical experience, products for moistening the intestines and relieving constipation and purging turbidity and expelling toxins are supplemented with products for enriching blood and moistening dryness, assisted by products for invigorating qi and strengthening the spleen, and made with medicines for descending turbidity and relieving distension, achieving the effects of combining tonification and purgation, using purgation as the main method, having ascending in descending, having supplementation in purgation, one moving and one guarding, one urgent and one slow, restricting each other and functioning with each other, with supplementation not causing retention and purgation not damaging healthy qi. Thus, guiding the whole prescription to act on the spleen and stomach, enabling the middle-jiao spleen and stomach to restore the normal function of ascending clear and descending turbid. Shouhui Laxative Capsule has definite curative effect and quick onset, and has a good therapeutic effect on constipation caused by internal accumulation of toxic pathogens and deficiency of yin fluid.

[0006] At present, there is no research or report on the anti-vesicoureteral reflux of Shouhui Laxative Capsule. In recent years, with the in-depth development of the research on traditional Chinese medicine preparations, more and more new effects of Shouhui Laxative preparations have been discovered. Summary of the Invention

[0007] The formula patent of the Shouhui Laxative Capsule product is CN100453105C, and the invention title "A Composition with Functions of Relieving Constipation, Expelling Toxins, Losing Weight and Reducing Lipid and Its Preparation Method" has been authorized. The technical problem to be solved by the present invention is to develop a new use for the already marketed product "Shouhui Laxative Capsule" on the basis of Chinese Patent CN100453105C. The application of this product in the preparation of drugs for treating vesicoureteral reflux. The use described in the present invention was discovered during the clinical application of the company's drugs and was later confirmed by relevant pharmacodynamic experiments, having great commercial value.

[0008] The object of the present invention is mainly achieved through the following technical solutions:

[0009] The traditional Chinese medicine composition of the present invention is prepared from Polygonum multiflorum, Aloe vera, Cassia obtusifolia, Lycium barbarum, Colla Corii Asini, Panax ginseng, Atractylodes macrocephala and Aurantii Fructus Immaturus as raw materials.

[0010] The use of the traditional Chinese medicine composition of the present invention in the preparation of drugs for treating vesicoureteral reflux.

[0011] In some embodiments, the ureteral reflux is primary vesicoureteral reflux and ureteral reflux in the reconstructed bladder after surgery.

[0012] Among them, each component is in parts by weight: 60 - 150 parts by weight of Polygonum multiflorum Thunb., 100 - 200 parts by weight of Aloe vera L., 80 - 180 parts by weight of Cassia obtusifolia L., 30 - 150 parts by weight of Lycium barbarum L., 30 - 150 parts by weight of Colla Corii Asini, 20 - 100 parts by weight of Panax ginseng C. A. Mey., 20 - 100 parts by weight of Atractylodes macrocephala Koidz., 50 - 200 parts by weight of Fructus Aurantii Immaturus.

[0013] In some embodiments, each component is in parts by weight: 120 parts by weight of Polygonum multiflorum Thunb., 160 parts by weight of Aloe vera L., 140 parts by weight of Cassia obtusifolia L., 75 parts by weight of Lycium barbarum L., 75 parts by weight of Colla Corii Asini, 50 parts by weight of Panax ginseng C. A. Mey., 50 parts by weight of Atractylodes macrocephala Koidz., 120 parts by weight of Fructus Aurantii Immaturus.

[0014] The preparation method of the traditional Chinese medicine composition of the present invention includes: (1) grinding and sieving Colla Corii Asini and Panax ginseng C. A. Mey. to obtain fine powder for standby;

[0015] (2) Weighing Lycium barbarum L., Atractylodes macrocephala Koidz., and Fructus Aurantii Immaturus according to the ratio, soaking them in water, boiling, filtering, and concentrating to obtain a concentrated solution;

[0016] (3) Weighing Polygonum multiflorum Thunb., Cassia obtusifolia L., and Aloe vera L. according to the ratio, removing impurities, washing, drying, grinding, and sieving to obtain fine powder;

[0017] (4) Combining the fine powder obtained in step (1) and the concentrated solution obtained in step (2), mixing evenly, concentrating into a thick paste, adjusting the pH value to 5.5 - 6.5, drying under reduced pressure, pulverizing, sieving, and mixing with the fine powder in step (3) to obtain the traditional Chinese medicine composition.

[0018] The traditional Chinese medicine composition provided by the present invention may further contain pharmaceutically acceptable excipients.

[0019] In some embodiments, the traditional Chinese medicine composition and the pharmaceutically acceptable excipients are made in a weight - part ratio of 1:1.5 - 8.5.

[0020] The traditional Chinese medicine composition provided by the present invention may also be made into clinically acceptable dosage forms.

[0021] In some embodiments, the dosage form is tablets, granules, capsules, mixtures, pills, dripping pills, solid dispersants or microcapsules.

[0022] In a more preferred embodiment, the dosage form is capsules.

[0023] In the present invention, the pharmaceutically acceptable excipients include fillers and binders. The filler is one or more of mannitol, lactose, sorbitol, sucrose, cyclodextrin, and the binder is one or more of a 75% ethanol solution of 3% PVP, a 50% ethanol solution of 3% hydroxypropyl methylcellulose, an aqueous solution of 10% polyvinylpyrrolidone K30, and a 30% starch paste.

[0024] In some embodiments, the filler is a mixture of cyclodextrin and sorbitol. Calculated by weight ratio, the ratio of cyclodextrin to sorbitol is 1:0.5 - 1.5.

[0025] In a more preferred embodiment, the cyclodextrin is hydroxypropyl-β-cyclodextrin.

[0026] The traditional Chinese medicine preparation described in the present invention is Shouhui Laxative Capsule.

[0027] The present invention has achieved the following technical effects:

[0028] Shouhui Laxative Capsule has a contracting effect on the isolated ureteral smooth muscle of normal rabbits, can dilate the ureteral lumen, and is beneficial for urine transportation. In the verification experiment of the contraction of the isolated ileum of guinea pigs, Shouhui Laxative Capsule can cause an increase in the intestinal tube tension of the ileum and an enhancement of smooth muscle contraction, indicating that Shouhui Laxative Capsule has a certain anti-ureteral reflux effect.

[0029] To verify the anti-ureteral reflux efficacy of the traditional Chinese medicine composition of the present invention, the inventors carried out pharmacodynamic experimental research and drug clinical research. It should be noted that the drugs selected for the pharmacodynamic experiments and clinical research of the drugs of the present invention are the drugs obtained from the representative formula of the present invention and its preparation method. Due to space limitations, the experiments and results of the drugs obtained from other formulas and preparation methods included in the present invention are not listed one by one here. Specific Embodiments

[0030] The present invention will be further described in detail below in conjunction with specific embodiments. However, the embodiments of the present invention are not limited by the following embodiments. Any further changes, modifications, substitutions, combinations, and simplifications made on the basis of the essence of the present invention should be regarded as equivalent substitutions and included within the protection scope of the present invention.

[0031] Pharmacodynamic Experimental Examples

[0032] Example 1 Experimental Study on the Effect of Medicated Serum of Shouhui Laxative Capsule on Isolated Ureteral Smooth Muscle of Rabbits

[0033] 1. Experimental Materials

[0034] 1.1 Experimental Animals

[0035] 110 clean-grade big ear white rabbits, 6 - 8 months old, half male and half female, weighing 2 - 2.5 kg. 40 were used for the preparation of medicated serum, and 70 were used for the preparation of experimental specimens, provided by Lunan Pharmaceutical Group Co., Ltd. Certificate number: SYXK(Lu)20230023.

[0036] 1.2 Experimental Drugs and Reagents

[0037] Shouhui Tongbian Capsule (Lunan Houpu Pharmaceutical Co., Ltd., National Medicine Approval Number: Z20150041), phentolamine 2×10 - 6 mol / L, atropine 2×10 -5 mol / L.

[0038] Preparation of Krebs solution: In 1000 mL of Kerbs solution, it contains: 6.9 g of NaCl, 3.0 mL (0.35 g) of 10% KCl, 2.9 mL (0.29 g) of 10% MgSO4·7H2O, 1.6 mL (0.16 g) of 10% KH2PO4, 2.1 g of NaHCO3, 0.28 g of CaCl2, and 2.0 g of glucose. Prepare 1000 mL of Kerbs solution and store it in a refrigerator at 4℃ for later use.

[0039] 2 Experimental methods

[0040] In this experiment, the serum pharmacology method was used to study the effects of sera of different concentrations of Shouhui Tongbian Capsule on the smooth muscle of isolated ureters of normal rabbits, and to observe the effects of intragastric administration of sera of different concentrations of Shouhui Tongbian Capsule on the isolated specimens.

[0041] 2.1 Preparation of drug-containing serum

[0042] Randomly divide into blank serum group, low (L), medium (M), and high (H) concentration groups of Shouhui Tongbian Capsule. After fasting for 12 h, the blank serum group was given an equal amount of normal saline by intragastric administration. The low, medium, and high concentration groups were respectively given Shouhui Tongbian Capsule by oral gavage at concentrations of 0.048 g / kg, 0.096 g / kg, and 0.192 g / kg, administered 2 times a day for a total of 3 days. 1 h after the last intragastric administration (fasting for 12 h before dosing, not restricting water intake), blood was taken from the carotid artery and centrifuged at 3000 r / min for 10 min. The upper-layer serum was labeled differently and stored at -20℃ for later use.

[0043] 2.2 Preparation of experimental specimens

[0044] Use a blunt wooden stick to strike the back of the rabbit's head, quickly open the abdomen, take out the ureter, immediately place it in a glass petri dish containing Krebs solution, introduce a mixed gas of 95% O2 + 5% CO2, and carefully remove the surrounding fat and connective tissue to prepare a ureter segment about 1 cm long.

[0045] 2.3 Group experiments

[0046] Suspend the ureteral segment in a thermostatic smooth muscle bath containing Krebs solution at ([38.5 ± 0.5) °C, pH = 7.4], and introduce a mixed gas containing 95% O2 and 5% CO2. Apply a basal tension of 2 g to the specimen and stabilize it for 60 min (changing the solution once every 15 min). Use a Powerlab biological function signal acquisition and processing system controlled by a microcomputer to record the contraction of the specimen, and observe the contraction frequency (times / 10 min), intensity (g), and motility ([g·times) / 10 min motility = intensity × frequency] of the specimen. After each experiment, rinse the specimen 3 times with Krebs solution to restore the specimen tension to the baseline before conducting the next experiment.

[0047] 2.4 Statistical processing method

[0048] The data results are expressed as mean ± standard deviation (X ± S). The analysis software uses the SPSS 16.0 statistical software package. One-way analysis of variance is used for comparing data between groups. A significant difference is considered when P < 0.05.

[0049] 3 Experimental results

[0050] 3.1 Results of the effects of 1 mL of serum containing Shouhui Tongbian Capsule at different concentrations on the isolated ureteral smooth muscle of rabbits are shown in Table 1.

[0051] It can be seen from the results in Table 1 that both the blank serum group and the serum groups containing Shouhui Tongbian Capsule at different concentrations can enhance the tension and motility of the isolated ureteral smooth muscle of normal rabbits, and there are significant differences compared with the blank control group (P < 0.05).

[0052] Table 1 Effects of serum groups containing Shouhui at different concentrations on the isolated ureteral smooth muscle of rabbits

[0053] Grouping n Tension (g) Frequency (times / 10 min) Activity [g·times) / 10 min] Blank control group 10 2.17±0.47 32.15±5.45 69.77±10.34 Blank serum group 10 2.36±0.33* 35.33±5.16 83.38±11.68* Shouhui Tongbian Capsule (L) 10 2.77±0.28** 38.67±3.64 107.12±12.41** Shouhui Tongbian Capsule (M) 10 2.81±0.23** 39.02±2.72 109.64±9.76** Shouhui Tongbian Capsule (H) 10 2.94±0.31** 39.74±3.44 116.84±8.66**

[0054] Note: Compared with the blank control group, *P < 0.05, **P < 0.01.

[0055] 3.2 Effects of blockers plus medium-concentration serum of Shouhui Tongbian Capsule on the isolated ureteral smooth muscle of rabbits, and the results are shown in Table 2.

[0056] It can be seen from the results that atropine and phentolamine can block the contraction effect of medium-concentration serum of Shouhui Tongbian Capsule on the ureteral smooth muscle (P < 0.05).

[0057] Table 2 Effects of the blocker plus medium-concentration serum group on the isolated ureteral smooth muscle of rabbits

[0058] Grouping n Tension (g) Frequency (times / 10 min) Activity [g·times) / 10 min] Shouhui Tongbian Capsule (M) 10 2.81±0.23 39.02±2.72 109.64±9.76 Atropine + serum group 10 2.54±0.21* 37.41±4.42 95.02±7.26* Phentolamine + serum group 10 2.47±0.36* 35.67±3.35 88.10±8.34*

[0059] According to the results of this experiment, the blank serum group and the serum groups containing different concentrations of Shouhui Tongbian Capsule had a contracting effect on the isolated ureteral smooth muscle of normal rabbits, which was beneficial to the transportation of urine. At the same time, it was found that the atropine group and the phentolamine group could block the contracting effect of the serum of medium-concentration Shouhui Tongbian Capsule on the ureteral smooth muscle, and there were significant differences. Therefore, Shouhui Tongbian Capsule can dilate the ureteral lumen, is beneficial to the transportation of urine, and has a certain anti-ureteral reflux effect. Experimental Example 2 Experimental study on the contracting effect of Shouhui Tongbian Capsule on guinea pig ileum

[0060] 1. Experimental materials

[0061] 1.1 Experimental animals

[0062] 50 clean-grade guinea pigs, male, weighing 300±50 g, were raised in an environment with a temperature of 20-25°C and a relative humidity of 40%-70%, and were provided by Lunan Pharmaceutical Group Co., Ltd. Certificate number: SYXK(Lu)20230023.

[0063] 1.2 Experimental drugs and reagents

[0064] Shouhui Tongbian Capsule (Lunan Houpu Pharmaceutical Co., Ltd., National Drug Approval Number: Z20150041), histamine dihydrochloride (Suzhou Zhonghua Pharmaceutical Industry Co., Ltd., batch number: H20030447, specification: 10 mg / tablet)

[0065] Preparation of Krebs solution: According to the content in 1000 mL of Kerbs solution: 6.9 g of NaCl, 3.0 mL (0.35 g) of 10% KCl, 2.9 mL (0.29 g) of 10% MgSO4·7H2O, 1.6 mL (0.16 g) of 10% KH2PO4, 2.1 g of NaHCO3, 0.28 g of CaCl2, and 2.0 g of glucose, 1000 mL of Kerbs solution was prepared and stored in a refrigerator at 4°C for later use.

[0066] 2. Experimental methods

[0067] In this experiment, taking the Shouhui Tongbian Capsule preparation as an example, an isolated ileum experiment was used to observe the effects of different concentrations of Shouhui Tongbian Capsule on its contractility.

[0068] 2.1 Grouping

[0069] The 50 guinea pigs were randomly divided into 5 groups, with 10 in each group. They were respectively the blank group; the positive control group: the histamine dihydrochloride group; the low (L), medium (M), and high (H) concentration groups of Shouhui Tongbian Capsule.

[0070] 2.2 Preparation of experimental specimens

[0071] Guinea pigs were fasted for 24 h before the experiment and had unrestricted access to water. During the experiment, they were killed by a heavy blow to the head, and then the abdomen was immediately opened to find the ileocecal junction. It was cut at 1 cm away from the ileocecal junction, and about 10 cm of the ileum was removed and placed in a Petri dish containing Tyrode's solution filled with air. The mesentery was removed along the intestinal wall, and the intestinal contents were rinsed clean with a syringe filled with Tyrode's solution. Then the ileum was cut into several small segments (each small segment was 1 - 1.5 cm) and placed in fresh Tyrode's solution for standby. Note that during the operation, do not pull the intestinal segment to avoid affecting the contraction function.

[0072] 2.3 Observation of isolated ileum contraction

[0073] Take a small segment of the intestinal tube and place it in a Petri dish containing Krebs' solution. One end of the intestinal tube was tied to the ventilation hook and then placed in a Magnus bath at 37 °C. Use a screw clip to adjust the rubber tube at the air outlet of the air pump, and the ventilation speed should be such that the bubbles in the Magnus bath escape one by one. The other end of the intestinal tube was attached to a force transducer and led to the computer interface, and the specimen load was adjusted to 1 g. After the isolated ileum was stable for 10 - 30 min, a normal contraction curve was recorded, and then the drugs used were added dropwise to the Magnus bath in turn. The change in ileum tension was recorded using a Powerlab biological signal acquisition and analysis system. After adding a test drug solution, contact for 3 min and observe the contraction amplitude, and then rinse continuously with Tyrode's solution twice. Wait until the baseline returns to the level before drug administration, and then record a baseline, and then add the second test drug solution. The volume of the bath liquid should be the same each time.

[0074] This experiment was divided into 5 groups, namely the blank group (normal saline group), the positive control group using 0.1 mL of 0.01% histamine as the control, and the low (L), medium (M), and high (H) concentration groups of Shouhui Tongbian Capsule with 0.06 g / kg, 0.12 g / kg, and 0.24 g / kg respectively. Each drug solution was injected into the bath to observe the contraction of the ileum and record the contraction tension of the ileum. Each group was repeated 6 times.

[0075] 2.4 Statistical treatment method

[0076] The data results were expressed as mean ± standard deviation (X±S). The analysis software used the SPSS 16.0 statistical software package. One-way ANOVA was used for data comparison between groups, and significant differences were considered when P < 0.05.

[0077] 3 Experimental results

[0078] The results of the effects of different concentrations of Shouhui Tongbian Capsule on the contraction tension of isolated ileum of guinea pigs are shown in Table 3.

[0079] The ileum of guinea pigs in the blank group showed rhythmic contractions. After the positive control group was given histamine, the ileum smooth muscle produced a persistent spastic contraction; the Shouhui Tongbian Capsule group caused a significant difference in the contraction of the isolated ileum compared with the blank group (P < 0.05), and the difference became more significant with the increase in concentration.

[0080] Table 3 Table of changes in the contractile tension of the isolated ileum of guinea pigs

[0081] Group n Contractile tension of guinea pig ileum (g) Blank control group 6 0.507±0.043 Histamine group 6 2.179±0.079** Shouhui Tongbian Capsule (L) 6 1.436±0.057* Shouhui Tongbian Capsule (M) 6 1.652±0.064** Shouhui Tongbian Capsule (M) 6 2.281±0.043**

[0082] Note: Compared with the blank control group, *P < 0.05, **P < 0.01.

[0083] The ileum of guinea pigs is rich in histamine receptors. Histamine can bind to the H1 histamine receptors on the ileum mucosa, causing smooth muscle excitation, ileum contraction and spasm. Under the action of histamine, the contraction of the smooth muscle of the guinea pig ileum is enhanced, and the contraction amplitude increases rapidly. When Shouhui Tongbian Capsule is administered to the isolated ileum of guinea pigs, it will produce an increase in the intestinal tube tension of the ileum and an enhancement of smooth muscle contraction, and there is a significant difference compared with the blank control group, and the effect is equivalent to that of the histamine group.

Claims

1. Use of a Chinese medicine composition prepared from Polygonum multiflorum, aloe, Cassia seed, wolfberry fruit, donkey-hide gelatin, ginseng, Atractylodes macrocephala and Citrus aurantium in preparing a drug for treating vesicoureteral reflux.

2. The use according to claim 1, characterized in that The Polygonum multiflorum, aloe, cassia seed, wolfberry, donkey-hide gelatin, ginseng, Atractylodes macrocephala and Citrus aurantium are calculated in parts by weight: 60-150 parts by weight of Polygonum multiflorum, 100-200 parts by weight of aloe, 80-180 parts by weight of cassia seed, 30-150 parts by weight of wolfberry, 30-150 parts by weight of donkey-hide gelatin, 20-100 parts by weight of ginseng, 20-100 parts by weight of Atractylodes macrocephala and 50-200 parts by weight of Citrus aurantium.

3. The use according to claim 2, characterized in that The Polygonum multiflorum, aloe, cassia seed, wolfberry, donkey-hide gelatin, ginseng, Atractylodes macrocephala and Citrus aurantium are calculated in parts by weight: 120 parts by weight of Polygonum multiflorum, 160 parts by weight of aloe, 140 parts by weight of cassia seed, 75 parts by weight of wolfberry, 75 parts by weight of donkey-hide gelatin, 50 parts by weight of ginseng, 50 parts by weight of Atractylodes macrocephala and 120 parts by weight of Citrus aurantium.

4. The use according to any one of claims 1 to 3, characterized in that: The preparation method of the Chinese medicine composition comprises the following steps: (1) Grind donkey-hide gelatin and ginseng into fine powder and set aside; (2) Weighing wolfberry, Atractylodes macrocephala, and Citrus aurantium according to the ratio, soaking in water, boiling, filtering, and concentrating to obtain a concentrated solution; (3) Weighing Polygonum multiflorum, Cassia seed, and Aloe according to the proportion, removing impurities, washing, drying, grinding, and sieving to obtain fine powder; (4) combining the fine powder obtained in the above step (1) and the concentrated solution obtained in step (2), mixing them evenly, concentrating them into a thick paste, adjusting the pH value to 5.5-6.5, drying under reduced pressure, crushing them, sieving them and mixing them with the fine powder obtained in step (3) to obtain a Chinese medicine composition.

5. A pharmaceutical preparation, characterized in that The pharmaceutical preparation is composed of the Chinese medicine composition according to any one of claims 1 to 3 and a pharmaceutically acceptable excipient. Preferably, the Chinese medicine composition and the pharmaceutically acceptable excipient are prepared in a weight ratio of 1:1.5-8.

5.

6. The pharmaceutical preparation according to claim 5, characterized in that: The pharmaceutical preparation is a clinically acceptable dosage form, preferably, the dosage form is tablets, granules, capsules, mixtures, pills, pellets, solid dispersions or microcapsules, and more preferably capsules.

7. The capsule according to claim 6, characterized in that The pharmaceutically acceptable excipients include fillers and binders, wherein the filler is one or more of mannitol, lactose, sorbitol, sucrose, and cyclodextrin, and the binder is one or more of 3% PVP in 75% ethanol solution, 3% hydroxypropyl methylcellulose in 50% ethanol solution, 10% povidone K30 aqueous solution, and 30% starch slurry.

8. The capsule according to claim 7, characterized in that The filler is a mixture of cyclodextrin and sorbitol. The ratio of cyclodextrin to sorbitol is 1:0.5-1.5 calculated by weight ratio. Preferably, the cyclodextrin is hydroxypropyl-β-cyclodextrin.

9. The pharmaceutical preparation according to claim 5, characterized in that The traditional Chinese medicine preparation is Shouhui laxative capsule.

10. The use according to claim 1, wherein the ureteral reflux is primary vesicoureteral reflux and ureteral reflux in postoperative bladder reconstruction.