Traditional Chinese medicine ointment for treating kidney deficiency and damp-heat syndrome type chronic glomerulonephritis as well as preparation method and application of traditional Chinese medicine ointment

Abstract

The invention discloses a traditional Chinese medicine ointment formula for treating kidney deficiency and damp-heat syndrome type chronic glomerulonephritis as well as a preparation method and application thereof. The ointment formula is prepared from astragalus membranaceus, codonopsis pilosula, bighead atractylodes rhizome, donkey-hide gelatin, radix aconiti lateralis preparata, semen cuscutae, eucommia ulmoides, the root of kudzu vine, dried ginger, medicated leaven, rhizoma polygonati, gynostemma pentaphylla, teasel root, lucid ganoderma, divaricate saposhnikovia root, ligusticum wallichii, the root of bidentate achyranthes, parasitic loranthus, deer-horn glue, angelica sinensis, pulp of dogwood fruit, caulis spatholobi, gastrodia elata and pyrrosia lingua. According to the pathogenesis characteristics of the chronic glomerulonephritis, according to clinical practice, treatment based on syndrome differentiation, emphasis on tongue vein change, emphasis on combination of four diagnoses, mastering of yin and yang, and taking flat as a period; five internal organs are harmonized, and spleen and kidney are used as the basis; warm and clear effects are combined, and dynamic and static effects are combined; clinical test results show that after the ointment provided by the invention is used for treatment, the improvement condition of a treatment group is obviously superior to that of a control group, and the total effective rates of the treatment group and the control group in the treatment effect of the traditional Chinese medicine syndromes are 93.3% and 46.7% respectively; therefore, the ointment has a remarkable curative effect in the aspect of relieving the traditional Chinese medicine syndromes of the patients with the kidney-deficiency damp-heat syndrome type chronic nephritis.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine ointment, specifically a traditional Chinese medicine ointment for treating chronic nephritis of the kidney deficiency and damp-heat syndrome type, its preparation method and application, belonging to the field of traditional Chinese medicine technology. Background Technology

[0002] Chronic glomerulonephritis (CGH) is one of the most common chronic kidney diseases, characterized by proteinuria, hematuria, hypertension, and edema, accompanied by kidney function impairment. If it continues to progress, it can lead to end-stage renal disease.

[0003] The guiding principle for the TCM syndrome differentiation of chronic glomerulonephritis is "deficiency as the root and excess as the manifestation." The root syndrome includes lung and kidney qi deficiency syndrome, spleen and kidney qi deficiency syndrome, qi and yin deficiency syndrome, liver and kidney yin deficiency syndrome, and spleen and kidney yang deficiency syndrome; the manifestation syndromes include damp-heat syndrome, blood stasis syndrome, and damp turbidity syndrome.

[0004] Traditional Chinese medicine believes that various medicinal pastes replenish qi and blood, while also correcting imbalances and treating diseases. Therefore, medicinal pastes differ from ordinary tonics in that they combine tonification with treatment, nourishing deficiency and strengthening weakness. Previous research has shown that medicinal pastes are widely used by the elderly and those suffering from general weakness. The principle of "tonifying deficiency and purging excess" applies; when discussing deficiency syndromes, tonification is the primary approach. Master Qin Bowen once said, "Medicinal pastes are made by decocting medicinal juices into a lipid-like liquid, used to nourish the dry and weak internal organs." This clarifies that the primary purpose of medicinal pastes is to nourish a weak body, focusing on strengthening the body. When using medicinal pastes for tonification, methods of purging are often combined with other tonifying and purging methods, supplemented with blood-activating, heat-clearing, and qi-regulating herbs, gradually achieving the desired effect.

[0005] Although the composition of traditional Chinese medicine pastes is complex, it is actually well-organized. Physicians carefully select medicinal materials and meticulously consider multiple factors such as the patient's constitution, symptoms, condition, and season, employing the four diagnostic methods (inspection, auscultation and olfaction, inquiry, and palpation) to comprehensively regulate Qi, blood, Yin, and Yang before cautiously formulating a paste prescription. Compared to decoctions, pastes place greater emphasis on individualized treatment and holistic conditioning. While their components are numerous, they are not chaotic and comprehensively address all aspects of health.

[0006] Traditional Chinese medicine pastes, once prepared, can be taken continuously for several months. Their effects are gentle, stable, long-lasting, and penetrating, unlike decoctions which aim for "effectiveness after a few doses." Traditional Chinese medicine decoctions are complex to prepare, inconvenient to carry, and have an unpleasant taste. Pastes, on the other hand, are made with honey, donkey-hide gelatin, and other ingredients, making them convenient to carry and with a delicate taste, better suited to modern fast-paced lifestyles. Although the preparation of pastes requires precious medicinal materials, their concentrated nature means that the actual dosage is small, and a single batch can last for a longer period, making them a cost-effective option overall.

[0007] Traditional Chinese medicine pastes (gaofang) focus on strengthening the body's resistance, eliminating pathogenic factors, regulating qi and blood, and balancing yin and yang, while also considering prevention and treatment. Their pleasant taste, concentrated dosage, and portability help improve patient adherence. Therefore, gaofang exhibits significant advantages in the treatment of chronic glomerulonephritis, especially in long-term management, where they possess unique value. Summary of the Invention

[0008] Purpose of the Invention: The purpose of this invention is to address the shortcomings of existing technologies. Based on clinical practice, this invention emphasizes syndrome differentiation and treatment, focusing on changes in the tongue and pulse, combining the four diagnostic methods, grasping the balance of Yin and Yang, aiming for equilibrium, harmonizing the five internal organs, with the spleen and kidneys as the foundation, using both warming and cooling methods, combining movement and stillness, combining disease and syndrome, and tailoring medication to the individual. Through in-depth understanding and grasp of the etiology and pathogenesis of chronic nephritis with kidney deficiency and damp-heat syndrome, this invention has screened out an effective herbal paste formula, which has a significant therapeutic effect in the clinical treatment of chronic nephritis with kidney deficiency and damp-heat syndrome.

[0009] Technical solution: To achieve the above objectives, the technical solution adopted by this invention is as follows:

[0010] A traditional Chinese medicine ointment for treating chronic glomerulonephritis of the kidney deficiency and damp-heat syndrome is made from the following ingredients in the indicated weight proportions:

[0011] Astragalus membranaceus 25-100 parts, Codonopsis pilosula 20-80 parts, Atractylodes macrocephala 20-80 parts, Colla corii asini 25-100 parts, processed Aconitum carmichaelii 6-24 parts, Cuscuta chinensis 20-80 parts, Eucommia ulmoides 25-100 parts, Pueraria lobata 20-80 parts, Zingiber officinale 12-48 parts, Massa fermentata 20-80 parts, Polygonatum sibiricum 20-80 parts, Gynostemma pentaphyllum 25-100 parts, Dipsacus asper 20-80 parts, Ganoderma lucidum 25-100 parts, Saposhnikovia divaricata 15-60 parts, Ligusticum chuanxiong 20-80 parts, Achyranthes bidentata 15-60 parts, Taxillus chinensis 20-80 parts, Cervi cornu colla 25-100 parts, Angelica sinensis 20-80 parts, Cornus officinalis 20-80 parts, Spatholobus suberectus 20-80 parts, Gastrodia elata 20-80 parts, Pyrrosia lingua 25-100 parts.

[0012] As a preferred embodiment, the aforementioned traditional Chinese medicine ointment for treating chronic glomerulonephritis of the kidney deficiency and damp-heat syndrome is made from the following raw materials in the indicated weight proportions:

[0013] Astragalus membranaceus 25-75 parts, Codonopsis pilosula 20-60 parts, Atractylodes macrocephala 20-60 parts, Colla corii asini 25-75 parts, processed Aconitum carmichaelii 6-18 parts, Cuscuta chinensis 20-60 parts, Eucommia ulmoides 25-75 parts, Pueraria lobata 20-60 parts, Zingiber officinale 12-36 parts, Massa fermentata 20-60 parts, Polygonatum sibiricum 20-60 parts, Gynostemma pentaphyllum 25-75 parts, Dipsacus asper 20-60 parts, Ganoderma lucidum 25-75 parts, Saposhnikovia divaricata 15-45 parts, Ligusticum chuanxiong 20-60 parts, Achyranthes bidentata 15-45 parts, Taxillus chinensis 20-60 parts, Cervi cornu colla 25-75 parts, Angelica sinensis 20-60 parts, Cornus officinalis 20-60 parts, Spatholobus suberectus 20-60 parts, Gastrodia elata 20-60 parts, Pyrrosia lingua 25-75 parts.

[0014] As a preferred embodiment, the aforementioned traditional Chinese medicine ointment for treating chronic glomerulonephritis of the kidney deficiency and damp-heat syndrome is made from the following raw materials in the indicated weight proportions:

[0015] Astragalus membranaceus 25-50 parts, Codonopsis pilosula 20-40 parts, Atractylodes macrocephala 20-40 parts, Colla corii asini 25-50 parts, processed Aconitum carmichaelii 6-12 parts, Cuscuta chinensis 20-40 parts, Eucommia ulmoides 25-50 parts, Pueraria lobata 20-40 parts, Zingiber officinale 12-24 parts, Massa fermentata 20-40 parts, Polygonatum sibiricum 20-40 parts, Gynostemma pentaphyllum 25-50 parts, Dipsacus asper 20-40 parts, Ganoderma lucidum 25-50 parts, Saposhnikovia divaricata 15-30 parts, Ligusticum chuanxiong 20-40 parts, Achyranthes bidentata 15-30 parts, Taxillus chinensis 20-40 parts, Cervi cornu colla 25-50 parts, Angelica sinensis 20-40 parts, Cornus officinalis 20-40 parts, Spatholobus suberectus 20-40 parts, Gastrodia elata 20-40 parts, Pyrrosia lingua 25-50 parts.

[0016] As a particularly preferred embodiment, the traditional Chinese medicine ointment for treating chronic glomerulonephritis of the kidney deficiency and damp-heat syndrome is made from the following raw materials in the indicated weight proportions:

[0017] Astragalus membranaceus 25 parts, Codonopsis pilosula 20 parts, Atractylodes macrocephala 20 parts, Colla corii asini 25 parts, processed Aconitum carmichaelii 12 parts, Cuscuta chinensis 20 parts, Eucommia ulmoides 25 parts, Pueraria lobata 20 parts, Zingiber officinale 12 parts, Massa fermentata 20 parts, Polygonatum sibiricum 20 parts, Gynostemma pentaphyllum 25 parts, Dipsacus asper 20 parts, Ganoderma lucidum 25 parts, Saposhnikovia divaricata 15 parts, Ligusticum chuanxiong 20 parts, Achyranthes bidentata 15 parts, Taxillus chinensis 20 parts, Cervi cornu colla 25 parts, Angelica sinensis 20 parts, Cornus officinalis 20 parts, Spatholobus suberectus 20 parts, Gastrodia elata 20 parts, Pyrrosia lingua 25 parts.

[0018] The present invention provides a method for preparing a traditional Chinese medicine ointment for treating chronic glomerulonephritis of the kidney deficiency and damp-heat syndrome, which includes the following steps:

[0019] Take the following Chinese medicinal materials by weight: Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, processed Aconitum carmichaelii, Cuscuta chinensis, Eucommia ulmoides, Pueraria lobata, dried ginger, Massa fermentata, Polygonatum sibiricum, Gynostemma pentaphyllum, Dipsacus asper, Ganoderma lucidum, Saposhnikovia divaricata, Ligusticum chuanxiong, Achyranthes bidentata, Taxillus chinensis, Angelica sinensis, Cornus officinalis, Spatholobus suberectus, Gastrodia elata, and Pyrrosia lingua. Place the medicinal materials in a bucket, add water to cover the surface of the herbs, soak, and stir appropriately. Put the soaked herbs and the extract into a tilting jacketed kettle, add an appropriate amount of water, boil, and retain for a period of time to allow the herbs to be fully simmered. Release the liquid, add water to the dregs and boil 1-2 times, filter, combine the liquids, let stand, sieve, pour the filtrate into the jacketed kettle, boil, and begin to concentrate. Then add the melted donkey-hide gelatin and deer antler gelatin, as well as an appropriate amount of rock sugar and honey, stir constantly, concentrate, and obtain the paste.

[0020] Chronic nephritis has a complex etiology, involving both pathogenic invasion and weakened vital energy. However, its progression begins with congenital kidney deficiency, later linked to imbalances in the five internal organs. The spleen and kidneys are the primary sites of the disease. Based on this foundation, external pathogens or internal disturbances gradually spread throughout the body as the disease progresses, contributing to the overall illness. Professor Sun Wei, the inventor of this theory, possesses profound clinical diagnostic skills and believes that the underlying deficiency permeates the entire course of chronic nephritis, with kidney deficiency as the root cause, while dampness is a consistent pathological element. The primary pathogenic factor is dampness and turbidity, often causing symptoms such as nausea and vomiting. Heavy and turbid dampness, over time, easily transforms into heat, frequently resulting in damp-heat syndrome. Damp-heat easily generates blood stasis, which in turn exacerbates damp-heat, creating a vicious cycle that makes the condition difficult to cure over time. Prolonged illness can also lead to pathogenic factors gradually entering the collaterals, causing obstruction and blood stasis, ultimately damaging the kidney collaterals. Overall, kidney deficiency is the root cause of chronic nephritis, while damp-heat and blood stasis are present throughout the entire course of the disease.

[0021] Based on this principle, this invention focuses on tonifying and strengthening the body's vital energy. The prescription emphasizes the mildness of the medicinal properties to achieve balance and harmony, while also possessing the effects of clearing heat and dampness, and promoting blood circulation. The formulation of the herbal paste also follows the principles of monarch, minister, assistant, and guide, aiming to gently tonify the kidney essence, focusing on strengthening the foundation of kidney qi. Simultaneously, it harmonizes qi, blood, yin, and yang, supplemented with qi-regulating and blood-activating herbs to unblock qi and blood. The use of medicine is cautious, emphasizing mild medicinal properties and avoiding excessively cold or hot herbs, striving for gradual efficacy rather than quick results. Its aim is to unblock the meridians, promote the smooth flow of qi and blood, and harmonize the various elements such as the internal organs, essence, qi, blood, and body fluids, ultimately achieving a state of harmony among the five internal organs and balance of yin and yang.

[0022] In this invention's herbal paste formula, Astragalus membranaceus, Atractylodes macrocephala, and Codonopsis pilosula are key herbs for tonifying Qi and strengthening the spleen, harmonizing the Qi and blood throughout the body; Eucommia ulmoides, Achyranthes bidentata, and Cuscuta chinensis focus on tonifying the liver and kidneys, consolidating essence and nourishing blood; Dried ginger and processed Aconitum carmichaelii have the effect of warming Yang and dispelling cold; Donkey-hide gelatin not only nourishes blood but also helps the paste to solidify; Massa fermentata strengthens the spleen, aids digestion, and promotes the circulation of Qi, thus facilitating the absorption of the herbal paste. It can be seen that the herbal paste formula focuses on tonifying deficiency, especially tonifying the liver and kidneys, and tonifying Qi and strengthening the spleen.

[0023] Donkey-hide gelatin: It is sweet and neutral in nature, and enters the lung, liver and kidney meridians. It is good at nourishing blood and yin. As an important gelatinous material in ointments, donkey-hide gelatin not only helps the ointment to take shape, but also has the effect of regulating the spleen and stomach and improving qi and blood deficiency. It is a "quiet medicine" with strong tonifying power, but it is easy to stagnate qi. It is often used in combination with qi-regulating and blood-activating products.

[0024] Aconite: pungent, sweet, and very hot. The "Benjing Fengyuan" records: "Aconite has a strong and pungent flavor, and can circulate through all twelve meridians, warming the spleen and stomach and relieving esophageal obstruction, tonifying the gate of life and rescuing yang deficiency." The inventor believed that chronic illness often leads to yang deficiency, so he often increased the use of warming yang medicines in his prescriptions to warm yang and transform qi, eliminate yin and resist pathogens, and achieve the effect of supporting the body's resistance and eliminating pathogens.

[0025] Cuscuta seed: A food and medicine of the same origin, the *Rihuazi Materia Medica* records that it "nourishes the five weaknesses and seven injuries, treats seminal emission and hematuria, and moistens the heart and lungs." Cuscuta seed is warm without being drying, and nourishing without causing stagnation, making it a well-regarded tonic. For patients with symptoms such as lower back and knee pain, and frequent urination at night, which are mainly due to kidney deficiency and instability, Cuscuta seed is often combined with Cornus officinalis, Taxillus chinensis, and Atractylodes macrocephala to enhance its kidney-tonifying and sperm-strengthening effects.

[0026] Eucommia ulmoides is good at tonifying the liver and kidneys and strengthening muscles and bones, and is especially suitable for patients with stiffness and pain in the lower back and spine; Pueraria lobata is known for relieving muscle tension and promoting the flow of qi, and can also relieve discomfort in the neck and back; Atractylodes macrocephala is regarded as an important medicinal material for strengthening the spleen and replenishing qi.

[0027] Lower back and knee weakness is commonly seen in patients with kidney deficiency. The kidneys govern the lower back and knees; insufficient kidney essence or weak kidney qi leads to poor blood and qi circulation, resulting in malnourishment of the tendons and veins, and consequently, symptoms such as lower back and knee weakness. Herbs like Polygonatum sibiricum, Gynostemma pentaphyllum, and Codonopsis pilosula are primarily used to nourish yin and tonify the kidneys, as well as invigorate qi and strengthen the spleen; while herbs like Achyranthes bidentata and Angelica sinensis further unblock meridians and harmonize qi and blood by replenishing qi and nourishing blood, promoting blood circulation, and removing blood stasis.

[0028] Fatigue is often caused by long-term kidney disease, which damages the spleen and stomach. Deficiency of both the spleen and kidneys leads to loss of essence and qi, and insufficient circulation of qi and blood. Ganoderma lucidum (reishi mushroom) invigorates qi and calms the mind, while Codonopsis pilosula (dangshen) strengthens the spleen and nourishes blood. Based on the patient's diagnosis of deficiency and excess, the inventor focuses on nourishing qi and blood and regulating the spleen and kidneys. Angelica sinensis (danggui) and Ligusticum chuanxiong (chuanxiong vine) promote blood circulation and remove blood stasis, further improving qi and blood circulation and enhancing physical strength.

[0029] Lower back pain is often caused by kidney deficiency and poor blood circulation. The inventor believes that mulberry mistletoe nourishes the liver and kidneys and strengthens tendons and bones, while chicken blood vine invigorates blood circulation, removes blood stasis, and relieves pain. These herbs are selected to harmonize qi and blood, nourish the liver and kidneys, and primarily aim to relax muscles and tendons and relieve pain. At the same time, herbs such as achyranthes bidentata, eucommia ulmoides, and cornus officinalis can also be used as adjunctive therapies to enhance lower back comfort.

[0030] Frequent urination at night is often seen in cases of kidney deficiency or bladder dysfunction. The applicant believes that dried ginger warms the middle jiao, dispels cold, restores yang, and tonifies the kidneys. Combined with drugs such as achyranthes bidentata and deer antler glue, it can tonify the kidneys, strengthen yang, consolidate essence, and stop urination.

[0031] Polygonatum and Taxillus chinensis, among other herbs that nourish the liver and kidneys, work synergistically to consolidate kidney essence and tonify the liver and kidneys. This can alleviate symptoms such as spermatorrhea, frequent urination at night, and lower back and knee weakness caused by kidney deficiency. Gynostemma pentaphyllum, with its heat-clearing and detoxifying properties, can effectively clear heat from the liver and kidneys, balance internal heat, and thus harmonize the liver and spleen qi and blood. Ganoderma lucidum, on the other hand, primarily tonifies qi and calms the mind, relieving symptoms such as anxiety and insomnia caused by kidney deficiency, enhancing the body's immunity, harmonizing qi and blood, and nourishing the internal organs.

[0032] Dried ginger warms the meridians and promotes Yang energy, dispelling cold and dampness and invigorating Yang Qi; Pyrrosia lingua relieves urinary tract infections and pain, improving symptoms such as loss of appetite and abdominal distension caused by dampness affecting the spleen and stomach. The overall treatment focuses on tonifying the kidneys and assisting Yang, while also harmonizing Qi and blood and promoting the function of the spleen and stomach.

[0033] This prescription combines five herbs: Polygonatum sibiricum, Saposhnikovia divaricata, dried ginger, Dipsacus asper, and Ligusticum chuanxiong. It has the effects of tonifying qi and blood, dispelling wind and cold, and strengthening tendons and bones. Polygonatum sibiricum nourishes yin and tonifies qi, benefits the lungs and kidneys; Saposhnikovia divaricata dispels wind and relieves pain, and releases the exterior and dispels cold; dried ginger warms yang and dispels cold, and warms the middle jiao and relieves pain; Dipsacus asper strengthens tendons and tendons, invigorates the kidneys and strengthens bones; Ligusticum chuanxiong invigorates blood and qi, unblocks meridians, and relaxes tendons and tendons. This prescription is suitable for the pathogenesis of rheumatic pain, cold-dampness stagnation, and qi and blood deficiency caused by chronic nephritis. It is especially suitable for rheumatic diseases caused by cold-dampness constitution and kidney yang deficiency, and can improve symptoms such as soreness and weakness of the lower back and knees, joint pain, and weakness of tendons and bones.

[0034] Grasp Yin and Yang, and strive for balance.

[0035] The inventor's clinic primarily treats patients with chronic illnesses, characterized by a complex interplay of deficiency and excess, and an imbalance of Yin and Yang. The inventor emphasizes gentle and pure herbs in their prescriptions. While the herbal pastes contain a large number of carefully selected herbs, they are not overly complex, ensuring comprehensive balance and addressing the imbalances of Qi, Blood, Yin, and Yang. The approach to tonifying with these pastes avoids brute force, instead striking a balance between tonification and purgation—a method that is neither excessive nor chaotic. Commonly used herbs include Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, and Dioscorea opposita to strengthen the spleen and kidneys; Eucommia ulmoides and Dipsacus asper to strengthen the lower back; Angelica sinensis and Ligusticum chuanxiong to invigorate blood and relieve stagnation; Saposhnikovia divaricata to disperse and release exterior pathogens; Gastrodia elata to calm wind and relieve pain; and Pyrrosia lingua to eliminate turbidity and detoxify. Bitter and cold herbs that damage the stomach or break up blood stasis are used sparingly, as they may harm kidney Qi and deplete Yin. The use of herbs is characterized by small doses but strong application, focusing on subtle details, considering the regulation of the internal organs and meridians, the balance of Qi, Blood, and body fluids, and the ascending and descending of Qi. The core principle is to adjust Yin and Yang, striving for a state of "Yin-Yang harmony." This kind of prescription benefits those with weak constitutions and eliminates those with strong pathogenic factors, demonstrating its unique style of "finding wonder in the ordinary".

[0036] Harmony of the five internal organs is fundamental, with the spleen and kidneys as the foundation.

[0037] Based on the therapeutic concept of balancing the five internal organs, the inventor focuses on regulating and tonifying the spleen and kidneys as the core of treatment. Treatment involves a holistic approach, differentiating qi and blood, and flexibly applying methods such as tonifying the kidneys, strengthening the spleen, nourishing the heart, benefiting the lungs, and regulating the liver. Traditional Chinese medicine theory states that "the kidneys are the foundation of innate constitution, while the spleen and stomach are the foundation of acquired constitution," emphasizing the fundamental role of the spleen and kidneys in the body's internal balance. They nourish and complement each other. Following the principle of syndrome differentiation and treatment, the balance of medicinal properties is emphasized. Herbs such as Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, Dipsacus asper, Eucommia ulmoides, Cuscuta chinensis, and Taxillus chinensis are used to warm and tonify the spleen and kidneys. However, many kidney-tonifying herbs tend to be nourishing or warming, which can easily hinder the spleen and stomach's digestive function. Therefore, Atractylodes macrocephala and Pueraria lobata are added to strengthen the spleen, ensuring healthy spleen and stomach function, thereby promoting the replenishment of kidney essence. The treatment is warm and tonifying without being greasy or drying. This method of regulating the spleen and tonifying the kidneys ensures sufficient sources of biochemical processes, allowing essence and blood to be regenerated and each of the five internal organs to receive proper nourishment. In winter, the kidneys are responsible for storing essence; if kidney essence is abundant, the body will surely be robust the following year.

[0038] Use both warm and cool methods, and combine movement and stillness.

[0039] Chronic diseases have complex pathogenesis and diverse clinical manifestations. Although they are often rooted in spleen and kidney deficiency, many other pathological factors such as damp-heat, turbid toxins, and blood stasis are frequently present, with mixed cold and heat patterns and deficiency and excess patterns being particularly common. Therefore, while warming and tonifying, it is essential to clear damp-heat and eliminate turbidity and toxins, flexibly applying methods that combine warming and clearing to achieve harmony between cold and heat and balance between yin and yang. As stated in the "Ling Shu: Official Functions" chapter, "Cold and heat contend, but can be harmonized and regulated." Therefore, by clearing heat from the upper and middle jiao, and supplementing with warming and dispersing herbs such as dried ginger and aconite, the qi mechanism of the upper and lower jiao can be unblocked, and yin and yang can be balanced.

[0040] Beneficial effects: Compared with the prior art, the present invention has the following advantages:

[0041] (1) Based on the pathogenesis of chronic glomerulonephritis with kidney deficiency and damp-heat syndrome, this invention selects formulas according to traditional Chinese medicine theory and clinical experience. Based on clinical practice, it differentiates syndromes and treats accordingly, pays attention to changes in tongue and pulse, emphasizes the four diagnostic methods, grasps the balance of Yin and Yang, and aims for balance; harmonizes the five internal organs, with the spleen and kidney as the foundation; uses both warming and clearing methods, and combines movement and stillness; combines disease and syndrome, and uses medicine according to the patient's condition. It deeply understands and grasps the pathogenesis of chronic nephritis with kidney deficiency and damp-heat syndrome to select the effective ointment formula of this invention.

[0042] (2) Clinical trials of this invention found that the TCM syndrome scores of both groups of patients improved after treatment (P<0.05), but the improvement in the treatment group was significantly better than that in the control group (P<0.05). Furthermore, the total effective rates of TCM syndrome treatment in the treatment group and the control group were 93.3% and 46.7%, respectively, and the difference was statistically significant (P<0.05). This result indicates that the herbal paste has a significant effect in relieving the TCM syndrome manifestations of patients with chronic nephritis of the kidney deficiency and damp-heat type.

[0043] Further comparison of the overall clinical efficacy between the two groups revealed that the total effective rate in the treatment group was 70.0%, significantly higher than the 46.7% in the control group (P < 0.05). This difference further validates that the clinical efficacy of herbal paste in treating chronic nephritis is superior to that in the control group. Therefore, herbal paste, as a treatment option, has a relatively significant therapeutic effect in the clinical treatment of chronic nephritis.

[0044] In this study, after three months of treatment, the treatment group showed significant improvements in 24-hour urinary protein quantification, glomerular filtration rate, and serum creatinine levels (P < 0.05), while the control group showed no significant changes in any of these indicators, remaining stable (P > 0.05). Furthermore, both groups maintained stable levels of blood urea nitrogen and albumin (P > 0.05). These results indicate that herbal paste treatment can effectively reduce proteinuria levels, improve glomerular filtration rate, and lower serum creatinine levels in patients with chronic nephritis, thereby protecting renal function. Detailed Implementation

[0045] The present invention can be better understood from the following embodiments. However, those skilled in the art will readily understand that the specific material ratios, process conditions, and results described in the embodiments are for illustrative purposes only and should not, and will not, limit the invention as described in detail in the claims.

[0046] Example 1

[0047] 1. A traditional Chinese medicine ointment for treating chronic glomerulonephritis of the kidney deficiency and damp-heat syndrome, which is made from the following ingredients in parts by weight:

[0048] Astragalus membranaceus 250g, Codonopsis pilosula 200g, Atractylodes macrocephala 200g, Colla corii asini 250g, Prepared Aconitum carmichaelii 120g, Cuscuta chinensis 200g, Eucommia ulmoides 250g, Pueraria lobata 200g, Zingiber officinale 120g, Massa fermentata 200g, Polygonatum sibiricum 200g, Gynostemma pentaphyllum 250g, Dipsacus asper 200g, Ganoderma lucidum 250g, Saposhnikovia divaricata 150g, Ligusticum chuanxiong 200g, Achyranthes bidentata 150g, Taxillus chinensis 200g, Cervi cornu colla 250g, Angelica sinensis 200g, Cornus officinalis 200g, Spatholobus suberectus 200g, Gastrodia elata 200g, Pyrrosia lingua 250g.

[0049] 2. The preparation process of the herbal paste provided by this invention includes the following steps:

[0050] Take the following Chinese medicinal materials by weight: 250g Astragalus membranaceus, 200g Codonopsis pilosula, 200g Atractylodes macrocephala, 120g Prepared Aconitum carmichaelii, 200g Cuscuta chinensis, 250g Eucommia ulmoides, 200g Pueraria lobata, 120g Zingiber officinale, 200g Massa fermentata, 200g Polygonatum sibiricum, 250g Gynostemma pentaphyllum, 200g Dipsacus asper, 250g Ganoderma lucidum, 150g Saposhnikovia divaricata, 200g Ligusticum chuanxiong, 150g Achyranthes bidentata, 200g Taxillus chinensis, 200g Angelica sinensis, 200g Cornus officinalis, 200g Spatholobus suberectus, 200g Gastrodia elata, and 250g Pyrrosia lingua. Place the medicinal materials in a clean cloth bag, put the bag in a clean stainless steel bucket, add water to cover the herbs by 2-3cm, soak for 4 hours, and stir occasionally. Place the soaked medicinal herbs and their extract into a tilting jacketed kettle, add an appropriate amount of water, and boil. After boiling, maintain the temperature at 100℃ and the pressure at 0.1 MPa for 1.5 hours to ensure the herbs are fully simmered. Release the liquid, add water to the dregs again, boil for another hour, filter, combine the two liquids, pour into a clean stainless steel container, and let it stand on a stainless steel rack. Filter through a 120-mesh sieve. Pour the filtrate into a jacketed kettle, bring to a boil, and begin concentration. Add 250g of melted donkey-hide gelatin and 250g of deer antler gelatin, along with appropriate amounts of rock sugar, honey, and other flavoring agents. Stir constantly and continue concentrating until the specified relative density is reached. Continue heating and refining, stirring constantly and skimming off any foam on the surface. The final density of the paste is generally around 1.4. Refrigerate.

[0051] Example 2

[0052] 1. A traditional Chinese medicine ointment for treating chronic glomerulonephritis of the kidney deficiency and damp-heat syndrome, which is made from the following ingredients in parts by weight:

[0053] Astragalus membranaceus 500g, Codonopsis pilosula 400g, Atractylodes macrocephala 400g, Colla corii asini 500g, Prepared Aconitum carmichaelii 120g, Cuscuta chinensis 400g, Eucommia ulmoides 500g, Pueraria lobata 400g, Zingiber officinale 240g, Massa fermentata 400g, Polygonatum sibiricum 400g, Gynostemma pentaphyllum 500g, Dipsacus asper 400g, Ganoderma lucidum 500g, Saposhnikovia divaricata 300g, Ligusticum chuanxiong 400g, Achyranthes bidentata 300g, Taxillus chinensis 400g, Cervi cornu colla 500g, Angelica sinensis 400g, Cornus officinalis 400g, Spatholobus suberectus 400g, Gastrodia elata 400g, Pyrrosia lingua 500g.

[0054] 2. The preparation method is the same as in Example 1.

[0055] Example 3

[0056] 1. A traditional Chinese medicine ointment for treating chronic glomerulonephritis of the kidney deficiency and damp-heat syndrome, which is made from the following ingredients in parts by weight:

[0057] Astragalus membranaceus 1000g, Codonopsis pilosula 800g, Atractylodes macrocephala 800g, Colla corii asini 1000g, Prepared Aconitum carmichaelii 240g, Cuscuta chinensis 800g, Eucommia ulmoides 1000g, Pueraria lobata 800g, Zingiber officinale 480g, Massa fermentata 800g, Polygonatum sibiricum 800g, Gynostemma pentaphyllum 1000g, Dipsacus asper 800g, Ganoderma lucidum 1000g, Saposhnikovia divaricata 600g, Ligusticum chuanxiong 800g, Achyranthes bidentata 600g, Taxillus chinensis 800g, Cervi cornu colla 1000g, Angelica sinensis 800g, Cornus officinalis 800g, Spatholobus suberectus 800g, Gastrodia elata 800g, Pyrrosia lingua 1000g.

[0058] 2. The preparation process of the herbal paste provided by this invention includes the following steps:

[0059] Take the following Chinese medicinal materials by weight: Astragalus membranaceus 1000g, Codonopsis pilosula 800g, Atractylodes macrocephala 800g, processed Aconitum carmichaelii 240g, Cuscuta chinensis 800g, Eucommia ulmoides 1000g, Pueraria lobata 800g, dried ginger 480g, Massa fermentata 800g, Polygonatum sibiricum 800g, Gynostemma pentaphyllum 1000g, Dipsacus asper 800g, Ganoderma lucidum 1000g, Saposhnikovia divaricata 600g, Ligusticum chuanxiong 800g, Achyranthes bidentata 600g, Taxillus chinensis 800g, Angelica sinensis 800g, Cornus officinalis 800g, Spatholobus suberectus 800g, Gastrodia elata 800g, and Pyrrosia lingua 1000g. Place the Chinese medicinal materials in a clean cloth bag, put it in a clean stainless steel bucket, add water to cover the surface of the herbs by 2-3cm, soak for 4 hours, and stir appropriately. Add the soaked medicinal herbs and extract to a tilting jacketed kettle, add an appropriate amount of water, and boil. After boiling, maintain the temperature at 100℃ and the pressure at 0.1 MPa for 2 hours to ensure the herbs are fully simmered. Release the liquid, add water to the dregs again, boil for 1.5 hours, filter, collect the filtrate, add water to the dregs again, boil for 1 hour, combine the three liquids, pour into a clean stainless steel container, and let it stand on a stainless steel rack. Filter through a 120-mesh sieve. Pour the filtrate into a jacketed kettle, bring to a boil, and begin concentration. Add 1000g of melted donkey-hide gelatin and 1000g of deer antler gelatin, as well as appropriate amounts of rock sugar, honey, and other flavoring agents. Stir constantly and continue to concentrate to the specified relative density. Continue heating and refining, stirring constantly and skimming off any foam on the surface. The density of the concentrated paste is generally around 1.4. Refrigerate.

[0060] Example 4: Clinical efficacy trial

[0061] 1. Clinical Data

[0062] 1.1 Source of cases

[0063] Sixty outpatients and inpatients who met the inclusion and exclusion criteria and visited the Department of Nephrology at Jiangsu Provincial Hospital of Traditional Chinese Medicine between October 2022 and October 2024 were selected.

[0064] 1.2 Case Screening

[0065] 1.2.1 Diagnostic criteria

[0066] 1.2.1.1 Western Medicine Diagnostic Criteria

[0067] The Western medicine diagnostic criteria for this study were determined with reference to the "Guidelines for the Diagnosis and Treatment of Chronic Glomerulonephritis" published by the China Association of Traditional Chinese Medicine in 2011, as detailed in Table 1.

[0068] Table 1 Western Medicine Diagnostic Criteria

[0069]

[0070] 1.2.1.2 Traditional Chinese Medicine Diagnostic Criteria

[0071] Based on the spleen and kidney qi deficiency and damp-heat syndromes in the "Diagnosis, Syndrome Differentiation and Efficacy Evaluation of Chronic Glomerulonephritis (Trial Scheme)" (Liu Baohou, Xu Yun, Diagnosis, Syndrome Differentiation and Efficacy Evaluation of Chronic Glomerulonephritis (Trial Scheme) [J]. Shanghai Journal of Traditional Chinese Medicine, 2006, (06): 8-9), see Table 2 for details.

[0072] Table 2 Traditional Chinese Medicine Diagnostic Criteria

[0073] Spleen and kidney qi deficiency (this syndrome) Damp-heat syndrome (symptom) Main symptoms Lower back pain, fatigue, or edema, poor appetite, and abdominal distension. Abdominal distension, dark yellow urine or burning sensation during urination secondary symptoms Frequent urination or nocturia, loose stools Dry mouth, bitter taste Tongue pulse The tongue is pale red with teeth marks, the coating is thin and white, and the pulse is thready or weak and feeble. Yellow and greasy tongue coating, slippery and rapid pulse

[0074] Note: If a patient meets one or more of the main symptoms and one or more of the secondary symptoms of spleen and kidney qi deficiency syndrome, and meets at least one of the above symptoms of damp-heat syndrome, then the patient can be diagnosed with kidney deficiency and damp-heat syndrome (tongue and pulse are for reference only).

[0075] 1.2.2 Inclusion Criteria

[0076] (1) Those who meet the above Western medicine diagnostic criteria and have a glomerular filtration rate ≥60ml / min / 1.73m2;

[0077] (2) Those who meet the above-mentioned TCM syndrome diagnosis criteria and whose syndrome belongs to kidney deficiency and damp-heat;

[0078] (3) Individuals with 24-hour urine protein quantification <3.5g / 24h;

[0079] (4) Those aged between 18 and 80 years old;

[0080] (5) The clinical data is complete and reliable, and the patient has regular medical visits and a follow-up period of at least 3 months.

[0081] 1.2.3 Exclusion Criteria

[0082] (1) Secondary glomerulonephritis caused by allergic purpura and systemic lupus erythematosus;

[0083] (2) Those who have recently taken glucocorticoids or immunosuppressants;

[0084] (3) Patients with acute renal failure or after kidney transplantation;

[0085] (4) Patients with severe respiratory failure, heart failure, cardiovascular and cerebrovascular accidents or other critical illnesses;

[0086] (5) Women who are pregnant or breastfeeding or have allergies.

[0087] 2. Research Methods

[0088] 2.1 Treatment methods

[0089] 2.1.1 Basic Treatment

[0090] (1) Health education and nutrition: Pay attention to rest, avoid fatigue, regulate emotions, avoid wind and cold, control diet, and follow the principle of low salt, low fat and high quality protein diet.

[0091] (2) Symptomatic treatment: Actively control blood pressure. For patients with 24-hour urine protein quantification within 1g / d, ensure that blood pressure is maintained below 130 / 80 mmHg during the treatment follow-up period. If the 24-hour urine protein quantification is between 1g / d and 3.5g / d, adjust the blood pressure target to below 125 / 75 mmHg. For patients with diabetes, actively control blood glucose to maintain normal levels. For patients with hyperlipidemia, develop individualized treatment plans based on their age and comorbidities (such as coronary heart disease, diabetes, ischemic stroke, etc.). In addition, actively control infection, carefully select drugs, and avoid using drugs that are harmful to kidney function; for patients with significant edema, diuretics should be used as appropriate to reduce swelling, and for patients with hypercoagulable states, anticoagulation and other symptomatic treatments should be given in a timely manner.

[0092] 2.1.2 Treatment with herbal pastes

[0093] The herbal paste prepared according to Example 1 of this invention shall be taken by the patient twice a day, morning and evening, with a warm dose of about 15g each time. It can be dissolved in hot water or chewed. The course of treatment lasts for 3 months.

[0094] 2.2 Grouping Scheme

[0095] Based on the treatment methods recorded in the medical records, 60 patients were divided into a treatment group and a control group. The control group received basic treatment, while the treatment group received basic treatment combined with herbal paste treatment. The efficacy of both groups was determined after a 3-month treatment course.

[0096] 2.3 Observation Indicators

[0097] 2.3.1 Efficacy indicators (recorded once before and once after treatment)

[0098] (1) TCM syndrome score: The patient's symptoms were scored and evaluated according to the TCM Symptom Grading and Quantification Table (Table 3). The primary and secondary symptoms were assigned scores of 0, 2, 4, and 6 points respectively according to their severity. The sum of the scores of all symptoms was the patient's TCM syndrome score. In this assessment, tongue appearance and pulse appearance were only used as reference items for auxiliary diagnosis and were not included in the score calculation.

[0099] (2) Laboratory indicators: ① 24-hour urine protein quantification (24hUTP); ② Renal function indicators: including estimated glomerular filtration rate (eGFR), serum creatinine (Scr), blood urea nitrogen (BUN); ③ Albumin (ALB).

[0100] 2.3.2 Safety Indicators

[0101] This includes basic vital signs (body temperature, blood pressure, respiration, pulse), complete blood count, liver function, electrocardiogram, and electrolytes.

[0102] 2.4 Criteria for Evaluating Therapeutic Effect

[0103] Overall effective rate = (clinical control + significant effect + effective) / total number of cases.

[0104] 2.4.1 The criteria for judging the efficacy of TCM syndromes are detailed in Table 4.

[0105] Table 3. Quantitative Table of Traditional Chinese Medicine Symptom Grading

[0106]

[0107]

[0108] Table 4. Criteria for Judging Syndrome and Therapeutic Effect

[0109] therapeutic effect Judgment criteria Therapeutic efficacy index (n) Clinically cured Traditional Chinese medicine clinical symptoms and signs disappeared or basically disappeared n≥95％ Effective The clinical symptoms and signs of TCM patients have been significantly improved. 70％≤n＜95％ efficient The clinical symptoms and signs have all improved according to traditional Chinese medicine. 30％≤n＜70％ invalid Traditional Chinese medicine clinical symptoms and signs showed no significant improvement, or even worsened. n＜30％

[0110] Note: The efficacy index is calculated using the formula: [(Pre-treatment score - Post-treatment score) ÷ Pre-treatment score] × 100%. (Nimodipine method)

[0111] 2.4.2 The criteria for judging the efficacy of Western medicine are detailed in Table 5.

[0112] Table 5. Criteria for Judging the Efficacy of Disease Treatment

[0113] therapeutic effect Judgment criteria Clinical control 24-hour urine protein quantification is normal; renal function is normal. Effective 24-hour urine protein quantification decreased by ≥40%, and renal function was normal or essentially normal. efficient 24-hour urine protein quantification decreased by <40%; renal function was normal or improved. invalid Clinical manifestations and laboratory tests show no significant improvement or even worsen.

[0114] 2.5 Statistical Methods

[0115] SPSS 27.0 software was used for statistical analysis. For continuous data, if they followed a normal distribution, they were expressed as mean ± standard deviation and analyzed using t-tests. If they did not follow a normal distribution, they were expressed as median and interquartile range and analyzed using nonparametric tests. For categorical data, they were expressed as number of cases and percentages and analyzed using chi-square tests. A p-value < 0.05 was considered statistically significant.

[0116] 3. Research Results

[0117] 3.1 General Information

[0118] This study included 60 patients, with 30 in the treatment group and 30 in the control group. In the treatment group, there were 14 males and 16 females, aged 22-74 years, with a mean age of 48.83±10.99 years, a mean body mass index (BMI) of 23.11±2.97 kg / m², and a mean disease duration of 5.77±3.45 years. In the control group, there were 15 males and 15 females, aged 19-78 years, with a mean age of 50.37±13.82 years, a mean BMI of 23.90±3.19 kg / m², and a mean disease duration of 6.2±5.77 years. Statistical analysis showed no statistically significant differences in age, sex, BMI, or disease duration between the two groups (P>0.05), indicating good baseline comparability (see Table 6).

[0119] Table 6 Comparison of general data between the two groups

[0120] Comparison Projects Treatment group control group t / χ2 P Number of examples (examples) 30 30 - - Age (years) 48.83±10.99 50.37±13.82 -0.476 0.636 Gender (Male / Female) 14 / 16 15 / 15 0.067 0.796 BMI (kg / m2) 23.11±2.97 23.90±3.19 -0.994 0.324 Disease duration (years) 5.77±3.45 6.2±5.77 -0.353 0.725

[0121] 3.2 Primary disease type

[0122] Of the 60 patients included in this study, 14 in the treatment group underwent renal biopsy for definitive pathological diagnosis, including 6 cases of IgA nephropathy, 4 cases of membranous nephropathy, 1 case of focal segmental glomerulonephritis, 1 case of membranoproliferative glomerulonephritis, and 2 cases of mesangial proliferative glomerulonephritis; the remaining 16 patients did not undergo renal biopsy. In the control group, 16 patients underwent renal biopsy for definitive diagnosis, including 7 cases of IgA nephropathy, 4 cases of membranous nephropathy, 2 cases of focal segmental glomerulonephritis, and 3 cases of mesangial proliferative glomerulonephritis; the remaining 14 patients did not undergo renal biopsy. Statistical analysis showed no significant difference in the distribution of primary disease types between the two groups (P>0.05), indicating comparability (see Table 7).

[0123] Table 7 Comparison of the distribution of primary diseases between the two groups of patients

[0124] Primary disease Treatment group (number of cases / percentage) Control group (number of cases / proportion) Chronic nephritis 16(53.3％) 14(46.7％) IgA nephropathy 6(20.0％) 7(23.3％) Membranous nephropathy 4(13.3％) 4(13.3％) Focal segmental sclerosing nephritis 1(3.3％) 2(6.7％) membranoproliferative glomerulonephritis 1(3.3％) 0(0.0％) Mesangial proliferative glomerulonephritis 2(6.7％) 3(10.0％)

[0125] The test showed that P = 0.883 (P > 0.05).

[0126] 3.3 Comparison between the two groups before treatment

[0127] Statistical analysis using software showed no statistically significant differences in 24hUTP, eGFR, Scr, BUN, ALB, and TCM syndrome scores between the treatment group and the control group before treatment (P>0.05), indicating comparability (see Table 8).

[0128] Table 8 Comparison of observation indicators between the two groups before treatment

[0129]

[0130] 3.4 Comparison of therapeutic effects

[0131] 3.4.1 Comparison of TCM syndrome scores between the two groups

[0132] Compared with before treatment, both groups of patients showed significant improvement in TCM syndrome scores after 3 months of treatment, with statistically significant differences (P < 0.05). Intergroup comparison showed that the TCM syndrome scores in the treatment group were significantly better than those in the control group after treatment (P < 0.05), indicating that the treatment group was more effective than the control group in improving TCM syndrome scores (see Table 9).

[0133] Table 9 Comparison of TCM syndrome scores before and after treatment in the two groups (points)

[0134]

[0135] 3.4.2 Comparison of therapeutic effects between the two groups of TCM syndromes

[0136] After 3 months of treatment, the overall effective rate of the treatment group reached 93.3% in terms of total TCM syndrome efficacy, while that of the control group was 46.7%. The intergroup comparison showed that the efficacy of the treatment group was significantly better than that of the control group, with a statistically significant difference (P<0.05), as shown in Table 10.

[0137] Table 10 Comparison of TCM syndrome efficacy between the two groups after treatment (cases)

[0138]

[0139] 3.4.3 Comparison of overall clinical efficacy between the two groups of diseases

[0140] After 3 months of treatment, the overall effective rate in the treatment group was 70.0%, while that in the control group was 46.7%. The treatment group showed significantly better efficacy than the control group (P < 0.05), as shown in Table 11.

[0141] Table 11 Comparison of clinical efficacy between the two groups after treatment (cases)

[0142]

[0143] 3.4.4 Comparison of the two groups of laboratory indicators

[0144] 3.4.4.1 24-hour urine protein quantification

[0145] Compared with pre-treatment levels, the 24-hour UTP in the treatment group decreased significantly after 3 months of treatment, with a statistically significant difference (P < 0.05); compared with pre-treatment levels, the 24-hour UTP in the control group remained stable after 3 months of treatment, with no statistically significant difference (P > 0.05). See Table 12.

[0146] Table 12 Comparison of 24-hour urinary protein quantification before and after treatment in the two groups (g / 24h)

[0147]

[0148] 3.4.4.2 Glomerular Filtration Rate

[0149] Compared with pre-treatment levels, the eGFR of the treatment group improved significantly after 3 months of treatment, with a statistically significant difference (P < 0.05); compared with pre-treatment levels, the eGFR of the control group remained stable after 3 months of treatment, with no statistically significant difference (P > 0.05). Intergroup comparisons showed that the eGFR level in the treatment group was higher than that in the control group after treatment, with a statistically significant difference (P < 0.05), as shown in Table 13.

[0150] Table 13 Comparison of glomerular filtration rate before and after treatment in the two groups (mL / min / 1.73m) 2 )

[0151]

[0152] 3.4.4.3 Serum creatinine

[0153] Compared with pre-treatment levels, the Scr levels in the treatment group decreased significantly after 3 months of treatment, with a statistically significant difference (P < 0.05); compared with pre-treatment levels, the Scr levels in the control group remained stable after 3 months of treatment, with no statistically significant difference (P > 0.05). See Table 14.

[0154] Table 14 Comparison of serum creatinine levels before and after treatment in the two groups (umol / L)

[0155]

[0156]

[0157] 3.4.4.4 Urea Nitrogen

[0158] Compared with before treatment, the BUN levels of both groups remained stable after 3 months of treatment, with no statistical difference (P>0.05); the BUN levels of the two groups after treatment were not statistically different (P>0.05), as shown in Table 15.

[0159] Table 15 Comparison of blood urea nitrogen before and after treatment in the two groups (mmol / L)

[0160]

[0161] 3.4.4.5 Albumin

[0162] Compared with before treatment, ALB levels in both groups remained stable after 3 months of treatment with no statistical difference (P>0.05); however, the ALB level in the treatment group was higher than that in the control group, with a statistical difference (P<0.05), as shown in Table 16.

[0163] Table 16 Comparison of albumin levels before and after treatment in the two groups (g / L)

[0164]

[0165] 3.5 Observation Results of Safety Indicators

[0166] Throughout the treatment process, no abnormalities were observed in any of the safety indicators of the two groups of patients, including vital signs, liver function, and electrolyte levels.

[0167] 4. Clinical efficacy analysis

[0168] 4.1.1 Comparative Analysis of Therapeutic Effects

[0169] In this study, both groups of patients showed improvement in TCM syndrome scores after treatment (P < 0.05), but the improvement in the treatment group was significantly better than that in the control group (P < 0.05). Furthermore, the total effective rates of TCM syndrome treatment in the treatment group and the control group were 93.3% and 46.7%, respectively, with a statistically significant difference (P < 0.05). This result indicates that the herbal paste has a significant therapeutic effect in alleviating the TCM syndrome manifestations of patients with chronic nephritis of the kidney deficiency and damp-heat type.

[0170] Further comparison of the overall clinical efficacy between the two groups revealed that the total effective rate in the treatment group was 70.0%, significantly higher than the 46.7% in the control group (P < 0.05). This difference further validates that the clinical efficacy of herbal paste in treating chronic nephritis is superior to that in the control group. Therefore, herbal paste, as a treatment option, has a relatively significant therapeutic effect in the clinical treatment of chronic nephritis.

[0171] 4.1.2 Comparative Analysis of Laboratory Indicators

[0172] In this study, after three months of treatment, the treatment group showed significant improvements in 24-hour urinary protein quantification, glomerular filtration rate, and serum creatinine levels (P < 0.05), while the control group showed no significant changes in any of these indicators, remaining stable (P > 0.05). Furthermore, both groups maintained stable levels of blood urea nitrogen and albumin (P > 0.05). These results indicate that herbal paste treatment can effectively reduce proteinuria levels, improve glomerular filtration rate, and lower serum creatinine levels in patients with chronic nephritis, thereby protecting renal function.

[0173] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it. They should not be used to limit the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine ointment for treating chronic glomerulonephritis, characterized in that, It is made from the following parts by weight of raw materials: Astragalus membranaceus 25-100 parts, Codonopsis pilosula 20-80 parts, Atractylodes macrocephala 20-80 parts, Colla corii asini 25-100 parts, processed Aconitum carmichaelii 6-24 parts, Cuscuta chinensis 20-80 parts, Eucommia ulmoides 25-100 parts, Pueraria lobata 20-80 parts, Zingiber officinale 12-48 parts, Massa fermentata 20-80 parts, Polygonatum sibiricum 20-80 parts, Gynostemma pentaphyllum 25-100 parts, Dipsacus asper 20-80 parts, Ganoderma lucidum 25-100 parts, Saposhnikovia divaricata 15-60 parts, Ligusticum chuanxiong 20-80 parts, Achyranthes bidentata 15-60 parts, Taxillus chinensis 20-80 parts, Cervi cornu colla 25-100 parts, Angelica sinensis 20-80 parts, Cornus officinalis 20-80 parts, Spatholobus suberectus 20-80 parts, Gastrodia elata 20-80 parts, Pyrrosia lingua 25-100 parts.

2. The traditional Chinese medicine ointment for treating chronic glomerulonephritis according to claim 1, characterized in that, It is made from the following parts by weight of raw materials: Astragalus membranaceus 25-75 parts, Codonopsis pilosula 20-60 parts, Atractylodes macrocephala 20-60 parts, Colla corii asini 25-75 parts, processed Aconitum carmichaelii 6-18 parts, Cuscuta chinensis 20-60 parts, Eucommia ulmoides 25-75 parts, Pueraria lobata 20-60 parts, Zingiber officinale 12-36 parts, Massa fermentata 20-60 parts, Polygonatum sibiricum 20-60 parts, Gynostemma pentaphyllum 25-75 parts, Dipsacus asper 20-60 parts, Ganoderma lucidum 25-75 parts, Saposhnikovia divaricata 15-45 parts, Ligusticum chuanxiong 20-60 parts, Achyranthes bidentata 15-45 parts, Taxillus chinensis 20-60 parts, Cervi cornu colla 25-75 parts, Angelica sinensis 20-60 parts, Cornus officinalis 20-60 parts, Spatholobus suberectus 20-60 parts, Gastrodia elata 20-60 parts, Pyrrosia lingua 25-75 parts.

3. The traditional Chinese medicine ointment for treating chronic glomerulonephritis according to claim 2, characterized in that, It is made from the following parts by weight of raw materials: Astragalus membranaceus 25-50 parts, Codonopsis pilosula 20-40 parts, Atractylodes macrocephala 20-40 parts, Colla corii asini 25-50 parts, processed Aconitum carmichaelii 8-12 parts, Cuscuta chinensis 20-40 parts, Eucommia ulmoides 25-50 parts, Pueraria lobata 20-40 parts, Zingiber officinale 12-24 parts, Massa fermentata 20-40 parts, Polygonatum sibiricum 20-40 parts, Gynostemma pentaphyllum 25-50 parts, Dipsacus asper 20-40 parts, Ganoderma lucidum 25-50 parts, Saposhnikovia divaricata 15-30 parts, Ligusticum chuanxiong 20-40 parts, Achyranthes bidentata 15-30 parts, Taxillus chinensis 20-40 parts, Cervi cornu colla 25-50 parts, Angelica sinensis 20-40 parts, Cornus officinalis 20-40 parts, Spatholobus suberectus 20-40 parts, Gastrodia elata 20-40 parts, Pyrrosia lingua 25-50 parts.

4. A traditional Chinese medicine ointment for treating chronic glomerulonephritis, characterized in that, It is made from the following parts by weight of raw materials: Astragalus membranaceus 25 parts, Codonopsis pilosula 20 parts, Atractylodes macrocephala 20 parts, Colla corii asini 25 parts, processed Aconitum carmichaelii 12 parts, Cuscuta chinensis 20 parts, Eucommia ulmoides 25 parts, Pueraria lobata 20 parts, Zingiber officinale 12 parts, Massa fermentata 20 parts, Polygonatum sibiricum 20 parts, Gynostemma pentaphyllum 25 parts, Dipsacus asper 20 parts, Ganoderma lucidum 25 parts, Saposhnikovia divaricata 15 parts, Ligusticum chuanxiong 20 parts, Achyranthes bidentata 15 parts, Taxillus chinensis 20 parts, Cervi cornu colla 25 parts, Angelica sinensis 20 parts, Cornus officinalis 20 parts, Spatholobus suberectus 20 parts, Gastrodia elata 20 parts, Pyrrosia lingua 25 parts.

5. The method for preparing the traditional Chinese medicine ointment for treating chronic glomerulonephritis according to any one of claims 1 to 4, characterized in that, Includes the following steps: Take the following Chinese medicinal materials by weight: Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, processed Aconitum carmichaelii, Cuscuta chinensis, Eucommia ulmoides, Pueraria lobata, dried ginger, Massa fermentata, Polygonatum sibiricum, Gynostemma pentaphyllum, Dipsacus asper, Ganoderma lucidum, Saposhnikovia divaricata, Ligusticum chuanxiong, Achyranthes bidentata, Taxillus chinensis, Angelica sinensis, Cornus officinalis, Spatholobus suberectus, Gastrodia elata, and Pyrrosia lingua. Place the medicinal materials in a bucket, add water to cover the surface of the herbs, soak, and stir appropriately. Put the soaked herbs and the extract into a tilting jacketed kettle, add an appropriate amount of water, boil, and retain for a period of time to allow the herbs to be fully simmered. Release the liquid, add water to the dregs and boil 1-2 times, filter, combine the liquids, let stand, sieve, pour the filtrate into the jacketed kettle, boil, and begin to concentrate. Then add the melted donkey-hide gelatin and deer antler gelatin, as well as an appropriate amount of rock sugar and honey, stir constantly, concentrate, and obtain the paste.

6. The use of the traditional Chinese medicine ointment according to any one of claims 1 to 4 in the preparation of a medicament for treating chronic glomerulonephritis.

7. The use of the traditional Chinese medicine ointment according to any one of claims 1 to 4 in the preparation of a medicine for treating chronic nephritis of the kidney deficiency and damp-heat syndrome.

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