A mongolian medicine composition for treating chronic kidney disease and application thereof

Abstract

The application discloses a Mongolian medicine composition for treating chronic kidney disease and application thereof, and belongs to the technical field of biological medicine. The Mongolian medicine composition comprises the following components: 35-45 parts of rhubarb, 30-40 parts of Guangming salt, 15-25 parts of alkali flower, 20-30 parts of Punica granatum, 15-25 parts of Cyclocarya paliurus, 20-30 parts of Kaempferia, 10-20 parts of Inula helenium and 15-25 parts of Terminalia chebula. According to the theory of three roots and seven elements, the theory of viscera, the theory of metabolism of clear and turbid and the whole view, and in combination with the theory of "gut-kidney axis", the Mongolian medicine composition with remarkable curative effect on chronic kidney disease is developed. The enema administration is adopted, the drug directly acts on the intestinal mucosa, the liver first-pass effect is avoided, the drug utilization rate is improved, the administration scheme is optimized, the operation is simple and the safety is high. Moreover, all the components of the composition are natural Mongolian medicine components, the toxic and side effects are small, the patient compliance is good, a new treatment idea is provided for the clinical treatment of chronic kidney disease.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a Mongolian medicine composition for treating chronic kidney disease and its application. Background Technology

[0002] Chronic kidney disease (CKD) is a common clinical term referring to the gradual loss of kidney structure or function caused by various primary, secondary, and congenital or hereditary kidney diseases, with a course of 3 months or more. Its insidious onset and long incubation period increase the difficulty of prevention and treatment.

[0003] Currently, the treatment principle for CKD in modern medicine is to actively treat the primary disease, eliminate reversible risk factors for disease progression, and slow the deterioration of kidney function. Specific measures include correcting electrolyte and acid-base imbalances, reducing azotemia, performing hemodialysis and peritoneal dialysis, preventing infection, and providing symptomatic treatment. However, these measures have drawbacks such as long treatment cycles, high costs, and relatively low efficacy. Therefore, developing safe, effective, inexpensive, and easy-to-use drugs for treating CKD has become a crucial issue that urgently needs to be addressed in the medical field.

[0004] Mongolian medicine has a long history and unique understanding and treatment experience in kidney diseases. Mongolian medicine classifies CKD (Kidney Disease) as a type of chronic kidney disease. It believes that long-term consumption of cold and cooling foods and living in cold and damp environments lead to an excess of *Badaganhei* (a type of kidney ailment). This excess *Badaganhei* then clashes with *Shira* (another type of kidney ailment) in the kidneys, causing an imbalance of fluids and the seven elements (vital energy, blood, and toxins) in the body. This disrupts the metabolism of clear and turbid substances, preventing the transformation of essence into kidney essence, which then transforms into yellow fluid that combines with heat and stagnates in the kidney meridians, causing the disease. Existing research has shown that some Mongolian medicine preparations have potential in treating kidney diseases. However, current Mongolian medicine treatment plans for CKD still need further improvement and optimization, lacking systematic and in-depth research and standardized treatment drugs.

[0005] In conclusion, developing a Mongolian medicine composition based on Mongolian medicine theory that is effective, safe, and easy to use for the treatment of chronic kidney disease (CKD) has significant practical and clinical value. It can not only provide new treatment options for CKD patients but also contribute to the development of Mongolian medicine in the field of kidney disease treatment, enriching and improving the treatment methods for CKD. Summary of the Invention

[0006] The purpose of this invention is to provide a Mongolian medicine composition for treating chronic kidney disease and its application, thereby addressing the problems existing in the prior art. Based on the Mongolian medicine theories of "Three Roots and Seven Elements," "Internal Organs," "Metabolism of Clear and Turbid Elements," and a holistic view, combined with the "Intestinal-Kidney Axis" theory, this invention has developed a Mongolian medicine composition with significant therapeutic effects on chronic kidney disease. This invention innovatively employs enema administration, allowing the drug to act directly on the intestinal mucosa, avoiding the first-pass effect of the liver and improving drug utilization; the optimized administration regimen is simple to operate and highly safe. Furthermore, this composition uses all natural Mongolian medicine ingredients, has few toxic side effects, and good patient compliance, providing a new treatment approach for the clinical treatment of chronic kidney disease.

[0007] To achieve the above objectives, the present invention provides the following solution:

[0008] This invention provides a Mongolian medicine composition for treating chronic kidney disease. The raw materials of the Mongolian medicine composition, by weight, include the following components: 35-45 parts rhubarb, 30-40 parts of bright salt, 15-25 parts of alkali flower, 20-30 parts of pomegranate, 15-25 parts of galangal, 10-20 parts of costus root, and 15-25 parts of chebula.

[0009] Optionally, the raw materials of the Mongolian medicine composition, by weight, include the following components: 45 parts rhubarb, 40 parts bright salt, 25 parts alkali flower, 30 parts pomegranate, 25 parts galangal, 20 parts costus root, and 25 parts chebula.

[0010] Furthermore, the preparation method of the Mongolian medicine composition is as follows: rhubarb, cinnamon salt, alkali flower, pomegranate, cinnamon bark, galangal, costus root, and chebula are mixed and pulverized to obtain a drug mixture; the drug mixture is soaked in water, and the supernatant is taken as the Mongolian medicine composition.

[0011] Optionally, the ratio of the drug mixture to water is 1g:20-30mL; the soaking time is 8-15min.

[0012] Optionally, the temperature of the water is 39℃±1℃.

[0013] The present invention also provides the use of the above-mentioned Mongolian medicine composition in the preparation of a medicament for treating chronic kidney disease.

[0014] Optionally, the drug is in the form of an enema.

[0015] Optionally, the method of using the drug includes the step of injecting the drug into the intestine by enema.

[0016] Optionally, the dosage of the drug is 150-300 mL / time / day.

[0017] Optionally, the drug is administered at a rate of 10-15 minutes per dose.

[0018] The present invention discloses the following technical effects:

[0019] This invention, based on the Mongolian medicine theories of "Three Roots and Seven Elements," "Internal Organs," "Metabolism of Clear and Turbid Elements," and "Holistic View," and combined with the "Intestinal-Kidney Axis" theory, uses rhubarb, cinnamon salt, alkali flower, pomegranate, tung oil, galangal, costus root, and chebula to prepare a medicinal preparation for enema administration via the intestinal route, developing an enema with significant efficacy for chronic kidney disease. This drug composition conforms to the theory of treating kidney disease through the intestines. Clinical trial data shows that after 10 treatments, patients' symptoms and signs improved significantly. It can reduce the intestinal barrier function index D-lac in CKD (stage 3-4) patients, significantly downregulate the levels of enterogenic uremic toxins IS and PCS, and improve renal function Ccr and eGFR levels, thereby improving toxin accumulation, protecting renal function, and delaying disease progression. This invention innovatively uses enema administration, allowing the drug to act directly on the intestinal mucosa, avoiding the first-pass effect of the liver and improving drug utilization. The optimized dosing regimen (150-300 mL / time, 10-15 min infusion) is simple to operate and highly safe. In addition, the composition is made entirely of natural Mongolian medicine ingredients, with few toxic side effects and good patient compliance, providing a new treatment approach for the clinical treatment of chronic kidney disease. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 The IS test results are shown in the control group and the treatment group before and after treatment.

[0022] Figure 2 The results of PCS testing before and after treatment are shown in the control group and the treatment group.

[0023] Figure 3 The results of D-lac detection before and after treatment are shown in the control group and the treatment group. Detailed Implementation

[0024] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0025] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0026] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0027] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0028] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0029] Mongolian medicine classifies CKD as a chronic kidney disease. It believes that long-term consumption of cold and cooling foods and living in cold and damp environments lead to an excess of Badaganheyi. This excess Badaganheyi, along with Xila, clashes with the kidneys, causing an imbalance of body fluids and the disruption of the seven elements, affecting the metabolism of clear and turbid substances. The essence fails to be transformed into kidney essence and instead turns into yellow fluid, which combines with heat evil and obstructs the kidney meridians, thus causing the disease.

[0030] Based on the principles of Mongolian medicine for treating "kidney disease," this invention develops a Mongolian medicine composition for intestinal treatment, comprising the following components by weight: 35-45 parts rhubarb, 30-40 parts malachite, 15-25 parts alkali flower, 20-30 parts pomegranate, 15-25 parts galangal, 10-20 parts costus root, and 15-25 parts chebula. Among them, rhubarb can purge all diseases and can be used to purge toxic heat, intestinal heat, and dapoxetine; sage can eliminate cold diseases, dapoxetine, hei, and indigestion; alkali flower can stop putrefaction and aid digestion; pomegranate can thoroughly clear stomach diseases, raise stomach fire, and suppress dapoxetine and cold; tung oil can remove worms, reduce swelling, raise stomach fire, and also has a strong purgative effect; galangal can suppress dapoxetine and hei, purify blood, and raise stomach fire; chebula is the king of medicines, which can cure various diseases caused by the three evils, regulate the body's three roots, and detoxify; costus root can suppress hei, raise stomach fire, aid digestion, calm the nerves, and relieve pain. According to the analysis of the efficacy of the single herbs in the formula, most of them have the effects of raising stomach fire, aiding digestion, and eliminating dapoxetine, followed by the effects of detoxification and purgation. The use of this composition for enema treatment of chronic kidney disease not only regulates the downward flow of Qi, raises stomach fire, and eliminates phlegm, improving symptoms such as indigestion, abdominal distension, flatulence, constipation, and edema, but also, through its purgative and detoxifying effects, helps eliminate accumulated metabolic toxins from the body. Classic Mongolian medical texts such as *Mijue Fanghai*, *Mongolian Medicine Golden Chamber*, and *Zhedu Ningnuoer* record the use of single-herb formulas administered rectally to treat kidney deficiency, constipation, urinary retention, seminal emission, and indigestion. Based on traditional Mongolian medicine administration methods and the understanding of this formula in both Mongolian and Western medicine, this Mongolian medicine composition was administered via enema to treat CKD. This clinical study not only changed the route of administration but, more importantly, leveraged the kidney-gut axis, regulating intestinal flora to exert its kidney-repairing effect. It improved kidney function while simultaneously alleviating gastrointestinal symptoms such as indigestion, abdominal distension, belching, and constipation.

[0031] The preparation and use of this composition are as follows: Weigh all raw materials, pulverize them, sieve them through a gradient (100-250 mesh), soak them in distilled water, filter them, and take the supernatant for rectal dripping. The Mongolian medical classic *Ganlu Sibu* records various routes of administration, such as oral administration, sublingual administration, application, dripping, smearing, external application, blowing medicine, soaking, enema, fumigation, wrapping, and carrying. Modern research shows that all oral medications can be administered via the rectum. This method of administration involves injecting a medicinal liquid with specific effects into the body through the rectum, thereby drawing the disease out of the body. Mongolian medicine takes a holistic view as its main guiding principle, believing that human life is a comprehensive and complex holistic process. The life activities of the three roots and seven elements, the five viscera and six bowels, the internal organs and organs, and the local and the whole body are coordinated and mutually influential, maintaining the dynamic balance of the internal environment. Therefore, this invention starts with the physiological and pathological characteristics of the large intestine, and under the guidance of the theory of viscera and the holistic view, it uses natural Mongolian medicine with relatively few toxic side effects to treat chronic kidney disease via the intestine. It is unique and has a definite curative effect, and has value for research, development and promotion.

[0032] Example 1: Preparation of Mongolian Medicine Composition

[0033] Weigh out 45g of rhubarb, 40g of bright salt, 25g of alkali flower, 30g of pomegranate, 25g of tamarisk, 30g of galangal, 20g of costus root, and 25g of chebula. Mix all raw materials together and pulverize them, then sieve through a gradient (100-250 mesh). Mix the pulverized raw materials with distilled water (39℃±1℃) at a ratio of 1g:25mL and soak for 10 minutes. After filtration, take the supernatant, which is the Mongolian medicine composition.

[0034] Experimental Example 1: Application of Mongolian Medicine Combination in the Treatment of Chronic Kidney Disease

[0035] 1. General information of clinical patients

[0036] Fifty-nine patients with CKD (stages 3-4) who met the screening criteria were collected from the Nephrology Department of Inner Mongolia International Mongolian Medicine Hospital between June 2023 and December 2024. The patients were randomly divided into a control group and a treatment group using a random number table. The control group consisted of 29 patients and the treatment group consisted of 30 patients.

[0037] Inclusion criteria:

[0038] (1) Patients who meet the modern medical diagnostic criteria and the CKD G3-4 staging criteria;

[0039] (2) Meets the Mongolian medicine diagnostic criteria for the cold-predominant type;

[0040] (3) Patients aged 18-75 years;

[0041] (4) Patients who agree to and are able to accept treatment, observation and examination.

[0042] Exclusion criteria:

[0043] (1) Primary or secondary CKD patients with severe heart, brain, liver and other organ diseases;

[0044] (2) Patients who have already undergone dialysis or renal replacement therapy;

[0045] (3) Pregnant or lactating women;

[0046] (4) Individuals with allergic constitutions or allergies to the medications used in this treatment;

[0047] (5) Patients with mental illness or epilepsy;

[0048] (6) Bleeding near the intestines and anal area, severe hemorrhoids or anal laxity that prevents tolerance to enemas;

[0049] (7) Those who have recently undergone surgery for rectal cancer, colon cancer, or lower gastrointestinal tract.

[0050] 2. Test methods

[0051] The control group received routine Western medicine treatment plus enema with uremic toxin-clearing granules, while the treatment group received routine Western medicine treatment plus the Mongolian medicine composition described in Example 1. Both groups received enemas once daily, followed by a one-day rest period after two enemas, with 10 enemas constituting one course of treatment. After the trial, renal function (Ccr, eGFR, 24h-UTP), enterogenic uremic toxins (IS, PCS), intestinal mechanical barrier function (D-lac), symptom quantitative scores, and clinical efficacy were measured before and after treatment in both groups. The experimental data were statistically analyzed using SPSS 27.0 software.

[0052] All patients were fully informed of the colonic therapy instructions and treatment plan before the trial, and the therapeutic effects and timing of colonic therapy were explained in detail. Informed consent forms were signed by all patients.

[0053] 3. Intestinal administration

[0054] All patients should be placed in a left lateral decubitus position with their hips elevated by 10 cm. Their pants should be pulled down to their knees to fully expose the anus. The disposable bowel irrigation bag catheter should be gently inserted 10-15 cm into the anus, and the medication should be slowly infused at a dose of 200 mL per day over a period of 10-15 minutes. After administration, patients should be instructed to change position to retain as much medication as possible.

[0055] 4. Results

[0056] 4.1 The effects of Mongolian medicine combination therapy on renal function in CKD (stages 3-4) patients are shown in Table 1.

[0057] Table 1. Comparison of Ccr, eGFR, and 24h-UTP before and after treatment in the two groups {M(P25,P75)}

[0058]

[0059]

[0060] Note: a represents the independent samples t-test, and d represents the paired samples t-test.

[0061] As shown in Table 1, after treatment, both the control group and the treatment group showed significant increases in Ccr and eGFR compared to before treatment, and a significant decrease in 24h-UTP. In contrast, the treatment group, after using the Mongolian medicine composition of this invention, showed a more significant increase in Ccr and eGFR and a more significant decrease in 24h-UTP, indicating a more significant therapeutic effect.

[0062] 4.2 The effects of Mongolian medicine combination therapy on enterogenic uremic toxins IS and PCS in CKD (stage 3-4) patients are shown in Table 2. Figure 1 , Figure 2 .

[0063] Table 2 Comparison of IS and PCS before and after treatment in the two groups (M±SD)

[0064]

[0065] As can be seen from Table 2, the values ​​of IS and PCS in both the control group and the treatment group were significantly lower after treatment than before treatment; in contrast, the decrease in IS and PCS values ​​in the treatment group after using the Mongolian medicine composition of the present invention was more obvious, indicating that the treatment effect was more significant.

[0066] 4.3 The effect of Mongolian medicine combination therapy on intestinal barrier function D-lac in CKD (stage 3-4) patients is shown in Table 3. Figure 3 .

[0067] Table 3 Comparison of D-lac before and after treatment in the two groups (M±SD)

[0068]

[0069] Note: a represents the independent samples t-test, b represents the Wilcoson signed-rank test, c represents the Mann-Whitney U nonparametric test, and d represents the paired samples t-test.

[0070] As can be seen from Table 3, the D-lac values ​​in both the control group and the treatment group were significantly lower after treatment than before treatment; in contrast, the decrease in D-lac values ​​was more pronounced in the treatment group after using the Mongolian medicine composition of the present invention, indicating a more significant therapeutic effect.

[0071] 4.4 Clinical efficacy is shown in Table 4.

[0072] Table 4 Comparison of clinical efficacy between the two groups after treatment (n, %)

[0073]

[0074] As shown in Table 3, the treatment group using the Mongolian medicine composition of the present invention had a significantly higher effective rate than the control group. This indicates that the Mongolian medicine composition of the present invention is significantly more effective than existing drugs in the treatment of chronic kidney disease.

[0075] 4.5 Safety Evaluation

[0076] Safety monitoring was conducted on both groups of patients before and after treatment in this study. During treatment, vital signs (pulse, respiration, blood pressure, and body temperature) of both groups remained within a controllable range. Blood routine tests, liver function tests, and electrolyte levels showed no significant changes before and after treatment (P>0.05). No adverse reactions such as rash, abdominal pain, or allergies occurred in either group during the trial, indicating that the medication used in this study was safe and did not exhibit significant toxic side effects.

[0077] 5. Conclusion

[0078] In summary, this invention, based on the principles of Mongolian medicine for treating chronic kidney disease, has developed a Mongolian medicine composition for treating chronic kidney disease. This composition, administered via the intestines, can significantly alleviate clinical symptoms such as loss of appetite, nausea and vomiting, abdominal distension, and constipation. It also improves toxin accumulation, protects kidney function, and slows disease progression. Its mechanism of action may be related to promoting the excretion of metabolic toxins from the intestines and improving intestinal barrier function.

[0079] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. The application of a Mongolian medicine composition in the preparation of a medicament for treating chronic kidney disease, characterized in that, The raw materials of the Mongolian medicine composition, by weight, include the following components: 35-45 parts rhubarb, 30-40 parts bright salt, 15-25 parts alkali flower, 20-30 parts pomegranate, 15-25 parts galangal, 10-20 parts costus root, and 15-25 parts chebula. The drug is in the form of an enema; The chronic kidney disease mentioned is chronic kidney disease stage G3-4.

2. The application according to claim 1, characterized in that, The raw materials of the Mongolian medicine composition, by weight, include the following components: 45 parts rhubarb, 40 parts bright salt, 25 parts alkali flower, 30 parts pomegranate, 25 parts galangal, 20 parts costus root, and 25 parts chebula.

3. The application according to claim 1, characterized in that, The preparation method of the Mongolian medicine composition is as follows: rhubarb, cinnamon salt, alkali flower, pomegranate, cinnamon bark, galangal, costus root, and chebula are mixed and pulverized to obtain a drug mixture; the drug mixture is soaked in water, and the supernatant is taken as the Mongolian medicine composition.

4. The application according to claim 3, characterized in that, The ratio of the drug mixture to water is 1g:20-30mL; the soaking time is 8-15min.

5. The application according to claim 3, characterized in that, The temperature of the water is 39℃±1℃.

6. The application according to claim 1, characterized in that, The method of using the drug includes the step of injecting the drug into the intestine by enema.

7. The application according to claim 6, characterized in that, The dosage of the drug is 150-300 mL / time / day.

8. The application according to claim 6, characterized in that, The drug is administered at a rate of 10-15 minutes per dose.

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