Traditional Chinese medicine formula for preventing and treating diabetic nephropathy

Abstract

The invention discloses a traditional Chinese medicine formula for preventing and treating diabetic nephropathy. The important composition is prepared from the following raw material medicines: 100g of gynura divaricata, 100g of silybum marianum seeds, 100g of clerodendranthus spicatus, 60g of melastoma dodecandrum, 60g of horseradish tree leaves, 60g of sappan wood, 60g of pseudo-ginseng, 60g of ligusticum chuanxiong hort, 60g of leech, 60g of gardenia jasminoides, 60g of sweet potato pulp, 60g of centella asiatica and 60g of cottonrose hibiscus leaves. The traditional Chinese medicine composition is prepared into pills and granules, is a pure traditional Chinese medicine preparation, and has a special effect on treating the diabetic complication kidney. The traditional Chinese medicine composition can effectively inhibit and degrade blood muscle liver, urea nitrogen and blood toxins, can gradually restore the renal function of some mild and moderate diabetic nephropathy patients to normal, and can replace hemodialysis or reduce the number of dialysis times for some severe uremia patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine manufacturing technology, specifically a traditional Chinese medicine formula for the prevention and treatment of diabetic nephropathy. Background Technology

[0002] Diabetic nephropathy, one of the most common microvascular complications of diabetes, has become a major cause of chronic kidney disease and end-stage renal disease worldwide, placing a heavy burden on patients' health and the social healthcare system. According to relevant data, approximately 20%-40% of diabetic patients will develop diabetic nephropathy, and its incidence is increasing year by year as the disease progresses. The disease often manifests as microalbuminuria in its early stages, gradually progressing to persistent proteinuria and decreased renal function, eventually potentially leading to end-stage renal failure. Patients then require dialysis or kidney transplantation to sustain life, resulting in a severely diminished quality of life and exorbitant treatment costs.

[0003] Currently, clinical treatment for diabetic nephropathy primarily focuses on symptomatic relief, such as controlling blood sugar and blood pressure, improving microcirculation, and reducing proteinuria. Commonly used medications include insulin, ACEI / ARB antihypertensive drugs, and statins. However, while these treatments can slow disease progression to some extent, they cannot fundamentally prevent the continued development of kidney damage. Furthermore, long-term medication use may be accompanied by adverse reactions such as hypoglycemia, further deterioration of kidney function, and electrolyte imbalances. In addition, when the disease progresses to the middle or late stages, existing treatments often have limited effectiveness and cannot effectively reverse pathological changes such as renal fibrosis. Therefore, finding safe and effective new methods for treating diabetic nephropathy has become an urgent problem to be solved in the medical field.

[0004] Traditional Chinese medicine (TCM) has a long history and unique advantages in the treatment of chronic diseases. Its holistic regulation and individualized treatment principles align well with the pathological characteristics of diabetic nephropathy, which is characterized by deficiency of the root cause and excess of the symptoms, and a complex interplay of deficiency and excess. In recent years, increasing research has shown that TCM compound formulas, through multiple components, targets, and pathways, demonstrate promising application prospects in improving clinical symptoms, protecting renal function, and slowing disease progression in patients with diabetic nephropathy. Many TCM herbs have been proven to possess hypoglycemic, anti-inflammatory, antioxidant, renal fibrosis-inhibiting, and renal microcirculation-improving effects, providing abundant medicinal resources for the treatment of diabetic nephropathy. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine formula for the prevention and treatment of diabetic nephropathy, thereby resolving the technical problems mentioned in the background section.

[0006] This invention is achieved using the following technical solution:

[0007] A traditional Chinese medicine formula for the prevention and treatment of diabetic nephropathy, wherein the main components of the formula are: 100g of Panax notoginseng, 100g of milk thistle seeds, 100g of cat's whiskers grass, 60g of ground ivy, 60g of Moringa leaves, 60g of Sappanwood, 60g of Panax notoginseng, 60g of Ligusticum chuanxiong, 60g of leech, 60g of Gardenia jasminoides, 60g of Dioscorea opposita, 60g of Centella asiatica, and 60g of Hibiscus mutabilis leaves; the dosage form of the traditional Chinese medicine formula is pills or granules.

[0008] A method for preparing a formula for the prevention and treatment of diabetic nephropathy includes the following steps:

[0009] S1. Weigh out the above-mentioned weight proportions of thirteen medicinal materials, including white-backed Panax notoginseng, milk thistle seeds, cat's whiskers grass, ground ivy, moringa leaves, sappanwood, Panax notoginseng, Ligusticum chuanxiong, leech, gardenia, yam, centella asiatica, and hibiscus leaves, mix them together and grind them into 600-1000 mesh ultrafine powder.

[0010] S2. Take half of the total amount of the above ultrafine powder, i.e., 450g, add 1000ml of purified water and 500ml of white wine with an alcohol content of about 75 degrees, and mix well in a stirrer.

[0011] S3. Then heat to 100 degrees and maintain at around 100 degrees for 30 minutes, then let it cool naturally to room temperature for about an hour.

[0012] S4. Mix the remaining half of the ultrafine powder with the ultrafine powder mixture that has undergone the above high-temperature treatment, dry it, and then make it into pellets or granules to obtain the final product.

[0013] The beneficial effects of this invention are as follows:

[0014] This traditional Chinese medicine formula is a scientific combination of 13 carefully selected medicinal herbs, including Panax notoginseng, milk thistle seeds, and cat's whiskers grass. The herbs complement and synergistically enhance each other's effects. Specifically, Panax notoginseng and milk thistle seeds protect the liver and kidneys and regulate metabolism; cat's whiskers grass and centella asiatica clear heat and dampness, and improve renal microcirculation; Panax notoginseng, chuanxiong rhizome, and leeches invigorate blood circulation, remove blood stasis, and reduce blood viscosity; while gardenia fruit and yam fruit nourish yin and tonify the kidneys, regulating the body's yin-yang balance. The combined effects of these herbs not only specifically lower serum creatinine and blood urea nitrogen levels, reducing the formation of blood toxins (such as advanced glycation end products), but also improve overall kidney function, slowing the progression of diabetic nephropathy and achieving both preventative and therapeutic effects.

[0015] The formula uses only natural Chinese herbs, which are widely available and highly safe. Compared to chemical drugs, long-term use is less likely to cause drug resistance and serious adverse reactions, making it more suitable for long-term use by patients with diabetic nephropathy to control their condition. Furthermore, the dosage form is pills or granules, making it convenient to take and improving patient compliance. It is suitable for patients of different ages and with varying degrees of diabetic nephropathy, and has broad clinical application prospects.

[0016] This formula does not simply treat a single symptom, but works through multiple components and multiple targets. It can improve renal function indicators (such as serum creatinine and blood urea nitrogen) in patients with diabetic nephropathy, regulate the body's metabolism, inhibit inflammatory responses, and resist oxidative stress, thereby fundamentally improving the pathological damage to the kidneys.

[0017] Pharmacodynamic studies:

[0018] Experiment 1: Effects on serum creatinine levels in a diabetic nephropathy model rat

[0019] Experimental groups: normal control group (10 animals, normal diet), model control group (10 animals, diabetic nephropathy model, administered saline by gavage), low-dose traditional Chinese medicine group (10 animals, diabetic nephropathy model, administered 0.5 g / kg of the traditional Chinese medicine formula pills of this invention by gavage), medium-dose traditional Chinese medicine group (10 animals, diabetic nephropathy model, administered 1.0 g / kg of the traditional Chinese medicine formula pills of this invention by gavage), and high-dose traditional Chinese medicine group (10 animals, diabetic nephropathy model, administered 2.0 g / kg of the traditional Chinese medicine formula pills of this invention by gavage).

[0020] Results: After 4 weeks of intervention, the serum creatinine level in the normal control group was (58.2±6.5) μmol / L; the serum creatinine level in the model control group was (165.8±12.6) μmol / L; the serum creatinine level in the low-dose traditional Chinese medicine group was (128.6±10.5) μmol / L; the serum creatinine level in the medium-dose traditional Chinese medicine group was (92.5±8.6) μmol / L; and the serum creatinine level in the high-dose traditional Chinese medicine group was (70.3±7.2) μmol / L. Compared with the model control group, the serum creatinine levels in each traditional Chinese medicine dosage group were significantly reduced (P<0.05), and the reduction was dose-dependent.

[0021]

[0022] Experiment 2: Effects on blood urea nitrogen levels in a diabetic nephropathy model rat

[0023] Experimental grouping: Same as Experiment 1.

[0024] Results: After 4 weeks of intervention, the blood urea nitrogen (BUN) level in the normal control group was (6.2±0.8) mmol / L; in the model control group, it was (25.6±2.3) mmol / L; in the low-dose traditional Chinese medicine (TCM) group, it was (19.8±1.6) mmol / L; in the medium-dose group, it was (14.5±1.2) mmol / L; and in the high-dose group, it was (9.8±0.9) mmol / L. Compared with the model control group, the BUN levels in each TCM dosage group were significantly lower (P<0.05), and the higher the dosage, the more significant the reduction.

[0025]

[0026] Experiment 3: Effects on the levels of blood toxins (using advanced glycation end products as an example) in diabetic nephropathy model rats

[0027] Experimental grouping: Same as Experiment 1.

[0028] Results: After 4 weeks of intervention, the level of advanced glycation end products (AGEs) in the normal control group was (125.6±15.2) ng / mL; the level in the model control group was (486.3±32.5) ng / mL; the level in the low-dose traditional Chinese medicine (TCM) group was (365.2±25.8) ng / mL; the level in the medium-dose TCM group was (258.6±20.3) ng / mL; and the level in the high-dose TCM group was (186.5±16.8) ng / mL. Compared with the model control group, the levels of AGEs in each TCM dosage group were significantly reduced (P<0.05), with the high-dose group showing the most significant reduction.

[0029] Detailed Implementation

[0030] The raw materials are: 100g of Panax notoginseng, 100g of milk thistle seeds, 100g of cat's whiskers grass, 60g of ground ivy, 60g of Moringa leaves, 60g of Sappanwood, 60g of Panax notoginseng, 60g of Ligusticum chuanxiong, 60g of leech, 60g of Gardenia jasminoides, 60g of Dioscorea opposita, 60g of Centella asiatica, and 60g of Hibiscus mutabilis leaves; the dosage form of the Chinese herbal composition is pills and granules.

[0031] A method for preparing a formula for the prevention and treatment of diabetic nephropathy includes the following steps:

[0032] Weigh out the above-mentioned weight proportions of thirteen medicinal materials, including white-backed Panax notoginseng, milk thistle seeds, cat's whiskers, ground ivy, moringa leaves, sappanwood, Panax notoginseng, chuanxiong, leech, gardenia, yam, centella asiatica, and hibiscus leaves, mix them together, and grind them into an ultrafine powder of 600-1000 mesh.

[0033] Take half of the total amount of the above ultrafine powder, i.e., 450g, add 1000ml of purified water and 500ml of white wine with an alcohol content of about 75 degrees, and mix well in a stirrer.

[0034] Then heat to 100 degrees Celsius and maintain the temperature at around 100 degrees Celsius for 30 minutes, then let it cool naturally to room temperature for about an hour;

[0035] Mix the remaining half of the ultrafine powder with the ultrafine powder mixture that has undergone the above high-temperature treatment, dry it, and then make it into pellets or granules to obtain the final product.

Claims

1. A Chinese medicine composition for preventing and treating diabetic nephropathy, characterized in that: The raw medicinal composition of the traditional Chinese medicine composition comprises 100 g of gynura japonica, 100 g of sibirica, 100 g of cat grass, 60 g of geophyte, 60 g of morinda, 60 g of gynura japonica, 60 g of notoginseng, 60 g of radix cyathulae, 60 g of water leech, 60 g of mountain gardenia, 60 g of mountain potato, 60 g of centella asiatica, and 60 g of hibiscus leaf. ​ 2. The preparation method of the traditional Chinese medicine composition according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is pill or granule.

3. The preparation method of the traditional Chinese medicine composition according to claim 2, characterized in that, The preparation method of the pill or granule is as follows: S1, weigh the above-mentioned white back three seven, water fly seed, cat grass, ground, hot leaf, redwood, three seven, chuanqiong, water leech, mountain gardenia, mountain potato, centella asiatica, and hibiscus leaf, and mix them together to be ground into 600-1000 mesh ultrafine powder; S2, take half of the total amount of the above-mentioned ultrafine powder, i.e. 450 g, and add 1000 ml of pure water and 500 ml of 75 degree white wine, and mix them in a stirrer; S3, then heat to 100 degrees, and keep the temperature at about 100 degrees for 30 minutes, and then naturally cool to room temperature for about one hour; S4, mix the remaining half of the ultrafine powder with the ultrafine powder mixture treated by the above-mentioned high temperature, and dry to make pills or granules, and then obtain the pills or granules.

4. The application of the traditional Chinese medicine agent prepared by the preparation method of claim 1 or claim 2 in the preparation of a medicine for treating blood muscle liver, urea nitrogen and blood toxin formation.

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