Deficiency-tonifying and toxin-expelling enema as well as preparation method and application thereof

Abstract

The invention discloses a deficiency-tonifying and toxin-expelling enema as well as a preparation method and application thereof. Relates to the technical field of Zhuang medicine. The traditional Chinese medicine composition comprises the following components in parts by weight: 200 parts of polygala fallax hemsl, 200 parts of herba epimedii, 200 parts of salted morinda officinalis, 200 parts of cooked rhubarb, 200 parts of calcined oyster, 133 parts of centella asiatica, 133 parts of rhizoma smilacis glabrae, 100 parts of rhizoma alismatis, 67 parts of pseudo-ginseng and 200 parts of philippine flemingia root. The invention also provides a preparation method and pharmaceutical application. According to the invention, through the treatment of regulating qi, detoxifying and tonifying deficiency, 'three channels and two channels' are communicated and regulated to moisten and regulate viscera and recover internal and external balance of a body, so that synchronization of natural qi, qi and human qi and smoothness of'valley channels', 'airway 'and'waterway' are realized, the kidney function is improved, and the progress of CKD is effectively delayed.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of Zhuang medicine, in particular to a virtual deficiency and toxin elimination enema and a preparation method and application thereof. BACKGROUND

[0002] Chronic kidney disease (CKD) is a disease caused by one or more reasons leading to abnormal kidney structure and / or function for more than 3 months, thereby causing kidney function decline or irreversible damage of the kidney. At the same time, chronic kidney disease belongs to the category of water disease and deficiency disease in Zhuang medicine, the water disease includes “Bengfu” (edema), “Ruzhou” (stranguria), “Ruka” (urinary retention), and the deficiency disease includes “Lei Nei” (deficiency of QI and blood) and “Xu Nei” (deficiency of healthy QI).

[0003] In the theory of etiology and pathogenesis, Zhuang medicine has a classic theory that “toxins and deficiency cause all diseases”, and it is believed that toxins can be a pathogenic factor and also a pathological product, and the disease is caused by toxins, and the treatment principle of “detoxification” is established. The external toxins such as water, dampness and heat of chronic kidney disease enter the human body through various channels, and the water, dampness, heat and blood stasis toxins stay in the body for a long time, which leads to that the physiological metabolites of the body cannot be discharged through the water channel in time, the pathological products accumulate in the body, and the functions of QI and blood, viscera and three channels and two routes are weakened, and the toxin evil accumulates in the body. It is recorded in “Jing Yue Quan Shu” (Complete Works of Jingyue) that “the arrival of deficiency and evil harms the lesser yin, and the five Zang organs are injured, and the kidney must be involved.” It is recorded in “Suwen Ping Reedisease Theory” (Discussion on Therapeutic Methods of Heat Diseases) that “the evil gathers where the QI is deficient”. Deficiency is the fundamental reason for aggravating and making the disease lingering and difficult to cure, and toxin evil is the necessary condition for the occurrence and persistence of chronic kidney disease.

[0004] Therefore, whether a virtual deficiency and toxin elimination enema based on Zhuang medicine and a preparation method thereof can treat chronic kidney disease is a problem to be solved by those skilled in the art. SUMMARY

[0005] Therefore, the application provides a virtual detox enema and a preparation method and application thereof. The application emphasizes the mechanism of "treatment according to syndrome differentiation" and "use of fu organs to promote the flow and to reduce to keep the order", and develops the Zangyao virtual detox enema, which is suitable for chronic renal failure combined with spleen and kidney deficiency, deficiency of qi and blood, and internal accumulation of turbid blood caused by various reasons. The prescription is formulated according to the principle of "main, auxiliary and supporting", and the virtual detox enema can supplement deficiency and detoxify. In the prescription, Qianjipu, Yinyanghuo and Yebagutian are main drugs. Qianjipu tastes sweet and mild, and is good at supplementing deficiency, strengthening bones, clearing dampness and detoxifying. Yinyanghuo and Yebagutian are tonics, and have the effects of tonifying kidney yang and strengthening bones. Yebagutian also has the effect of removing dampness and detoxifying. Huanghuadoushilian tastes sweet and mild, and is good at supplementing qi and blood, removing dampness and detoxifying, and promoting the flow of dragon road. Huanghuadoushilian, Zexie, and Sanqi are auxiliary drugs, and they are good at removing dampness and detoxifying, promoting the flow of dragon road, supplementing blood deficiency, removing blood stasis, and removing dampness and detoxifying. The Zangyao virtual detox enema can supplement qi and blood, support deficiency, remove blood stasis, detoxify, dredge the flow of three channels and two roads, synchronize three qi, and keep the smooth flow of pulse and the order of zangfu organs, so that the disease is cured.

[0006] In addition, the application does not contain toxic and modern pharmacology proved toxic medicinal materials, and does not contain compatibility taboos such as "eighteen contraindications" and "nineteen fears".

[0007] In order to achieve the above purpose, the application adopts the following technical scheme: The virtual detox enema comprises, by weight, Huanghuadoushilian 200 parts, Yinyanghuo 200 parts, Yebagutian 200 parts, cooked Dahuang 200 parts, calcined Muo 200 parts, Jixuecao 133 parts, Tufuling 133 parts, Zexie 100 parts, Sanqi 67 parts, and Qianjipu 200 parts.

[0008] Preferably, the virtual detox enema further comprises, by weight, sodium benzoate 2.5 parts.

[0009] The application further provides a preparation method of the virtual detox enema, which comprises the following steps: mixing medicinal materials except sodium benzoate, soaking in water, and decocting twice, 10 times the amount of water is added in the first time of decocting, and decocting for 1 hour, 8 times the amount of water is added in the second time of decocting, and decocting for 1 hour, the decocting liquid is combined, filtered, concentrated, and sodium benzoate is added and dissolved in purified water, and then the solution is added into the medicinal liquid, water is added to 1000 ml, and then the mixture is uniformly mixed, filled, and sterilized.

[0010] Preferably, the soaking time is 30 min, the filling is 150 ml per bottle, and the sterilization is 100-105 DEG C for 30 min.

[0011] The application further provides application of the virtual detox enema or the preparation method in preparation of a medicine for treating chronic kidney disease.

[0012] Compared with the prior art, the application provides a virtual deficiency and toxin elimination enema, a preparation method and application thereof, and achieves the technical effects that the application combines with colon dialysis to treat CKD 3-5 stage patients, treats through "qi regulation, toxin elimination and deficiency supplementation", regulates "three channels and two pathways" to nourish and harmonize viscera, restores the internal and external balance of the body, realizes the synchronization of three qi, "grain channel", "qi channel" and "water channel", improves kidney function, and effectively delays the progression of CKD.

[0013] Select 101 patients who visited the outpatient and inpatient department of the nephrology department of the Guangxi International Zhuang Medicine Hospital from September 2019 to September 2024 and whose case diagnoses were consistent with the Zhuang medicine Xinele Nei and the traditional Chinese medicine chronic kidney disease spleen and kidney yang deficiency syndrome as the research objects, and use the Zhuang medicine virtual deficiency and toxin elimination enema combined with colon dialysis treatment, once a day, 5 days as a course of treatment, and continuously for 2 courses of treatment. The clinical signs and symptoms of the patients before and after treatment are observed, and the effect and safety of the enema combined with colon treatment after treatment are evaluated. The research results show that: ① After treatment, the serum creatinine and urea nitrogen of the 101 patients decreased obviously, and the endogenous creatinine clearance rate increased. The overall clinical total efficacy reached 80.20%, among which 0 cases were cured, 31 cases were markedly effective, 50 cases were effective, 20 cases were stable, and 0 cases were invalid. The clinical efficacy effective rate of the patients diagnosed with chronic kidney disease 3-5 stages by western medicine is in the range of 63.64-83.02. ② Zhuang medicine syndrome score comparison: after treatment, chronic kidney disease can significantly improve the Zhuang medicine syndrome, and the difference is statistically significant (p<0.05). ③ Safety detection: there are no abnormal changes in the blood routine, urine routine, stool routine, electrocardiogram and liver function of the patients before and after treatment. After taking the medicine, no serious adverse events, serious complication events or adverse reactions occur. It is shown that the virtual deficiency and toxin elimination enema has exact curative effect on patients with chronic kidney disease 3-5 stages, can obviously improve the clinical symptoms such as fatigue, poor appetite and constipation of the patients, can effectively reduce the serum creatinine and urea nitrogen levels, stabilize the kidney function, and has no adverse reactions, so it has good clinical application prospect. BRIEF DESCRIPTION OF DRAWINGS

[0014] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiment or prior art description. Obviously, the drawings in the following description are only embodiments of the application, and for those skilled in the art, other drawings can also be obtained without creative labor on the basis of the provided drawings.

[0015] Figure 1 The accompanying drawings provide a process flowchart of the application.

[0016] Figure 2 The accompanying drawings provide a part of the patient information chart of the application.

[0017] Figure 3The accompanying drawings are part of the present application to provide part of the patient information chart.

[0018] Figure 4 The accompanying drawings are part of the present application to provide part of the patient information chart.

[0019] Figure 5 The accompanying drawings are part of the present application to provide part of the patient information chart.

[0020] Figure 6 The accompanying drawings are part of the present application to provide part of the patient information chart.

[0021] Figure 7 The accompanying drawings are part of the present application to provide part of the patient information chart. DETAILED DESCRIPTION

[0022] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0023] The embodiments of the present application disclose a virtual deficiency and detoxification enema, a preparation method and application thereof.

[0024] The diagnostic criteria and index involved in the embodiments are as follows: Zhuang medicine diagnosis The Zhuang medicine diagnosis criteria are formulated with reference to the relevant contents of Chinese Zhuang Medicine (Huang Hanru, Guangxi Nationalities Press, 2000), Chinese Zhuang Medicine Internal Medicine (Pang Shenghang, Wang Baican, Mo Gu, Guangxi Science and Technology Press, 2004), Chinese Zhuang Medicine Disease and Syndrome Diagnosis and Treatment Specification (Zhong Ming, Guangxi Science and Technology Press, 2009), Concise Zhuang Medicine (Zhong Ming, Guangxi Nationalities Press, 2009), and Zhuang Medicine Internal Medicine (Pang Yuzhou, Li Weiwie, China Press of Traditional Chinese Medicine, 2018).

[0025] La Nei and Xe Nei are divided into La Nei and Xe Nei. Xe Nei is a disease mainly characterized by shortness of breath, lazy speech, fatigue, dizziness, self-sweating, and exacerbation of symptoms during activity due to deficiency of Qi. La Nei is a disease mainly characterized by pale or yellowish complexion, dizziness, fatigue, heart palpitations, and shortness of breath due to deficiency of Qi and blood caused by various reasons.

[0026] Main symptoms of Xe Nei: shortness of breath, lazy speech, fatigue, body wasting, low voice, exacerbation of symptoms during activity, and easy catching cold.

[0027] Associated symptoms: fever, self-sweating, heart palpitations, insomnia, irritability, loss of appetite, dry stool, blurred vision, dizziness, tinnitus, and soreness of waist and knees.

[0028] Objective signs: "Le Da" white eye a few curved less, small degree of curvature, color is lighter. Nail diagnosis: nail color pale, soft and not hard, press the nail tip after release, nail color does not restore or long time does not restore the original color, can see the green pipe nail, bamboo shoot nail, horizontal ditch nail, white nail or atrophy nail. Finger diagnosis: finger muscle atrophy not use. Check the ear: auricle color is light, ear tip touch ice cold.

[0029] Main symptoms: pale or yellow, dizziness, eye, fatigue, palpitation and shortness of breath.

[0030] Symptoms: easy to forget, insomnia, dream; or tinnitus, numbness; or short breath, low voice; or food intake, loose stool, stomach, women, menstrual quantity, period or amenorrhea, tongue pale, rotate not spirit, pale lips.

[0031] Objective signs: "Le Da" white eye a few curved less, small degree of curvature. Pulse diagnosis: palm heart part is small pulse. Nail diagnosis: nail thin and brittle, color pale or pale, even easy to break; too much exposure to the moon mark, press the nail tip after release, nail color does not restore or long time does not restore the original color, can see the green pipe nail, bamboo shoot nail, horizontal ditch nail, white nail or atrophy nail. Finger diagnosis: finger color white, muscle atrophy not use. Check the ear: auricle color is light, ear tip pale, touch ice cold.

[0032] Synchronous Chinese medicine diagnosis standard The diagnosis standard of TCM syndrome is summarized as follows according to the diagnosis standard of "chronic renal failure" in "Diagnosis, syndrome differentiation and efficacy evaluation of chronic renal failure (trial scheme)" and "Internal Medicine Common Disease Diagnosis and Treatment Guide of Traditional Chinese Medicine" (2008 edition) of China Association of Chinese Medicine: main symptoms of spleen and kidney yang deficiency: fear of cold, cold limbs, cold stomach, hot drink, cold pain in waist and knees, loose stool, nausea and vomiting, poor appetite, skin itching, dark complexion, waist pain, little urine. Secondary symptoms: pale or dark complexion, hair loss, teeth shaking, significant sexual dysfunction, heavy and drowsy, skin and limbs numb, frequent or long night urination. Tongue is thick and tender with tooth marks, or purple tongue, or with blood stasis spots; pulse is slow and weak, or pulse is tight or tight.

[0033] Note: 2 main symptoms or 1 main symptom + 2 secondary symptoms, combined with tongue and pulse.

[0034] Western medicine diagnosis standard Refer to "KDIGO-CKD Guidelines" published by International Society of Nephrology in 2012.

[0035] Chronic kidney disease definition: 1. kidney damage ≧ 3 months, kidney damage refers to abnormality of kidney structure or function, with or without GFR reduction, manifested as one of the following: pathological abnormalities; or there are indicators of kidney damage, including blood or urine components are abnormal, or imaging examination is abnormal; 2. GFR < 60ml / min / 1.73㎡ ≧ 3 months, with or without kidney damage.

[0036] Diagnosis of disease stage: Chronic kidney disease (CKD) is divided into: CKD1: GFR normal or elevated, ≧ 90min·1.73m 2 CKD2: GFR slightly reduced, 60-89min·1.73m 2 CKD3a: GFR slightly to moderately reduced, 45-59min·1.73m 2 CKD3b: GFR moderately to severely reduced, 30-44min·1.73m 2 CKD4: GFR severely reduced, 15-29min·1.73m 2 CKD5: end-stage renal disease, < 15min·1.73m 2 Or dialysis Observation content and method I. Safety indicators: (1) general physical examination items; (2) blood, urine, and stool routine; (3) liver function tests.

[0037] II. Efficacy indicators: (1) symptoms: chills and cold limbs, cold stomach and hot drink, cold pain in waist and knees, loose stool, nausea and vomiting, poor appetite, skin itching, sallow complexion, lumbago, oliguria. Secondary evidence: pale or dark complexion, hair loss and tooth shaking, significant decrease in sexual function, heavy and drowsy, sleepiness, skin and nails, numbness, nocturia or clear and long urine. Tongue is thick and tender with tooth marks, or tongue is purple and dark, or there are ecchymoses; pulse is slow and weak, or pulse is tight or tight. (2) Tongue, tongue fur, pulse, and eye diagnosis.

[0038] III. Efficacy evaluation criteria Reference "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine (Trial)" (China Medical Science and Technology Press, 2002).

[0039] 1. Symptom efficacy evaluation criteria (1) Significant effect ① Clinical symptom score reduction ≧ 60%.

[0040] ② Endogenous creatinine clearance rate increased ≧ 20%.

[0041] ③Serum creatinine decreased by ≥20%.

[0042] The above ① is essential, and ② and ③ have one, which can be determined.

[0043] 2. Effective ①Clinical symptom score decreased by ≥30%.

[0044] ②Endogenous creatinine clearance increased by ≥10%.

[0045] ③Serum creatinine decreased by ≥10%.

[0046] ④The slope has significant meaning by analyzing the logarithm or reciprocal of serum creatinine before and after treatment using linear regression equation.

[0047] The above ① is essential, and the others have one, which can be determined.

[0048] 3. Stable ①Clinical symptoms have improved, and the score decreased by <30%.

[0049] ②Endogenous creatinine clearance has no decrease or increased by <10%.

[0050] ③Serum creatinine has no increase or decreased by <10%.

[0051] The above ① is essential, and ② and ③ have one, which can be determined.

[0052] 4. Ineffective ①Clinical symptoms have no improvement or aggravation.

[0053] ②Endogenous creatinine clearance decreased.

[0054] ③Serum creatinine increased.

[0055] The above ① is essential, and ② and ③ have one, which can be determined.

[0056] 5. Syndrome Efficacy Determination Criteria Clinical recovery Chinese medicine clinical symptoms and signs disappear or basically disappear, and syndrome score decreased by ≥95%.

[0057] Marked effectiveness Chinese medicine clinical symptoms and signs have significantly improved, and syndrome score decreased by ≥70%.

[0058] Effective Chinese medicine clinical symptoms and signs have improved, and syndrome score decreased by ≥30%.

[0059] Ineffective Chinese medicine clinical symptoms and signs have no significant improvement, or even aggravation, and syndrome score decreased by <30%.

[0060] Note: Calculation formula is: [(pre-treatment score - post-treatment score) ÷ pre-treatment score] × 100%.

[0061] 6. Therapeutic effect evaluation of main symptoms The therapeutic effect analysis of fatigue, lumbago, anorexia, nausea and vomiting is mainly carried out.

[0062] 7. Therapeutic effect evaluation of main detection indexes The therapeutic effect analysis of endogenous creatinine clearance rate, blood creatinine, hemoglobin, plasma albumin and urine protein is mainly carried out.

[0063] Example 1 A kind of tonifying and detoxifying enema, including by weight: yellow flower 200 parts, epimedium 200 parts, salt Ba Ji 200 parts, cooked rhubarb 200 parts, calcined oyster 200 parts, gotu kola 133 parts, smilax 133 parts, alisma 100 parts, radix notoginseng 67 parts, flos gelsemium 200 parts.

[0064] To further optimize the technical scheme: by weight also includes sodium benzoate 2.5 parts.

[0065] Preparation method, including the following steps: Mix the medicinal materials, soak in water for 30 min, decoct twice, add 10 times the amount of water for the first time, decoct for 1 hour, add 8 times the amount of water for the second time, decoct for 1 hour, combine the two decoctions, filter (200 mesh), concentrate the filtrate to a suitable amount (to a relative density of 1.02-1.12, 60℃), take sodium benzoate 2.5g, add a suitable amount of purified water to dissolve and add to the medicinal liquid, add water to 1000ml, mix evenly, fill (150ml / bottle), sterilize at 100-105℃ for 30min.

[0066] The process flow is shown in Figure 1 .

[0067] Usage and dosage: external use, retention enema for 1-2 hours, 150ml each time, once a day, 5 times a week, 5 times as a course of treatment. The effect is better with colon dialysis.

[0068] Daily crude drug amount: yellow flower 30g, epimedium 30g, salt Ba Ji 30g, cooked rhubarb 30g, calcined oyster 30g, gotu kola 20g, smilax 20g, alisma 15g, radix notoginseng 10g, flos gelsemium 30g.

[0069] Comparative test Study on extraction process Using orthogonal experiment method, the amount of water, extraction time and extraction times are studied, and the index: extract yield is investigated. Four factors and three levels L9(34) are selected 4An orthogonal array was constructed, and the factor levels are shown in Table 3. A total of 9 experiments were conducted, with parameters such as water addition, extraction time, and number of extractions as specified in Table 1.

[0070] orthogonal experiment Double the amount of medicinal materials: 60g of dried yellow flowers, 60g of epimedium, 60g of salted morinda root, 60g of prepared rhubarb, 60g of calcined oyster shell, 40g of centella asiatica, 40g of smilax glabra, 30g of alisma plantago-aquatica, 20g of notoginseng, and 60g of smilax glabra, totaling 490g.

[0071] The process was evaluated based on the yield of the ointment; the measured results are shown in Table 2. Analysis of variance is shown in Table 3. The specific methods are as follows: Table 1. Extraction of Conditional Factor Levels

[0072] Table 2. Orthogonal Experiment Table for Extraction Conditions

[0073]

[0074] Note: "*" indicates a significant difference ( P <0.05) As shown in Table 2, the order of influence of the three level factors on the yield is C > A > B. The optimal combination is A3B2C3, which means 3 extractions, 10 times the amount of water added, and 1 hour of extraction time.

[0075] As shown in Table 3, factor C is significant ( p (<0.05), factors A and B had no significant effect, meaning that neither the amount of water added nor the extraction time had a significant impact. Considering the water absorption rate of the medicinal materials during the first extraction, the amount of water added must be replenished first during the soaking process. Taking into account actual production costs, energy consumption, and other influencing factors, the optimal process is: Boil twice. The first time, add 10 times the amount of water and boil for 1 hour. The second time, add 8 times the amount of water and boil for 1 hour.

[0076] Verification Experiment Three sets of verifications were conducted based on the selected extraction process, and the optimal conditions in the orthogonal experiment were compared with those in the verification. The amount of feed in each experiment was the amount of one prescription. The evaluation indicators and measurement methods were the same as those in item 4. The results are shown in Table 4.

[0077] Groups 1, 2, and 3 were weighed according to the prescription dosage of 1 dose, and decocted twice. The first time, 8 times the amount of water was added and decocted for 1.0 hour. The second time, 6 times the amount of water was added and decocted for 1 hour. The yield of the ointment was used as the evaluation index.

[0078] Group 4: the optimal condition for the evaluation index of the extraction rate is A3B2C3, i.e. 1 dose of prescription amount of medicinal materials, 10 times the amount of water, extraction 3 times, 1.0 hour each time.

[0079] Table 4 verification result table

[0080] The average yield of dry extract was 32.26% in the verification test with the optimal parameters repeated 3 times. The determined extraction process is similar to the highest value of each index in the orthogonal test, and has good repeatability, indicating that the process is stable and the method is feasible.

[0081] Technical effect verification: Clinical observation site: Guangxi International Zhuang Medicine Hospital Clinical application start and end date: September 2019-September 2024 Drug regimen: Zhuang medicine enema combined with colon dialysis treatment, once a day, 5-7 days for a course, 2 consecutive courses.

[0082] Patient general information: 101 patients were inpatients and outpatients in our hospital, including 71 males and 30 females. The oldest was 87 years old and the youngest was 19 years old, with an average age of 60.76±12.03 years old. The diagnosis of all cases met the diagnostic criteria of chronic kidney disease 3-5 (belonging to the category of "Lei Neixu" disease in Zhuang medicine).

[0083] Observation index: general physical examination items, blood and urine routine examination, liver and kidney function examination, electrolyte, iron four item examination, Zhuang medicine symptoms, tongue, tongue fur, pulse, and eye diagnosis.

[0084] Clinical observation method: 101 patients selected according to the diagnostic criteria were observed for safety and effectiveness after drug use.

[0085] Evaluation standard: Calculate symptom score according to the method of nimodipine, and determine efficacy according to symptom score.

[0086] Statistical analysis method: Ridit analysis for ordinal data, 2 test for count data, and t(u) test for measurement data.

[0087] Before treatment, the total symptom score, main symptom score, secondary symptom score, and tongue, pulse, and eye diagnosis score were 19.39±3.84, 6.40±3.09, 9.76±1.96, and 3.23±0.78, respectively. After treatment, the total symptom score, main symptom score, secondary symptom score, and tongue, pulse, and eye diagnosis score were 8.83±2.74*, 2.80±1.03*, 3.2±1.54*, and 0.82±0.87*, respectively. The symptom scores before and after treatment were analyzed by t test, and the improvement difference was statistically significantp <0.05). It is shown that the Zhuang Medicine Deficiency and Detoxification Enema can significantly improve the symptoms of chronic kidney disease and has good efficacy. The main symptoms: heavy head and body, limbs tired, joint muscle pain, joint swelling, chest tightness, abdominal distension, unformed stool, loose stool, sticky stool, vomiting, were significantly improved, as shown in the following Table 5: Table 5 Improvement of main symptoms of Zhuang Medicine Deficiency and Detoxification Enema No. 1

[0088] Efficacy results: The total clinical effective rate was 79.20%, and the significant efficiency was 30.69% (101 patients using Zhuang Medicine Deficiency and Detoxification Enema before and after treatment showed significant improvement in symptom scores, 0 cases were cured, 31 cases were markedly effective, 49 cases were effective, 21 cases were stable, and 0 cases were ineffective), the efficacy was stable.

[0089] The total clinical efficacy of different stages of chronic kidney disease is shown in the following Table 6 Table 6

[0090] Safety results: No obvious adverse reactions were found in the use of this prescription (ECG, urine routine, liver function and stool routine showed no abnormal changes). After treatment with Zhuang Medicine Deficiency and Detoxification Enema, the levels of serum creatinine and urea nitrogen in patients with chronic kidney failure and spleen and kidney yang deficiency syndrome (chronic kidney disease 3-5 period) were effectively reduced, the kidney function was stable, and the total symptom score, main symptom score and secondary symptom score were improved.

[0091] Some patient information is shown in Figures 2-7 .

[0092] Typical case 1: Patient Zhang, male, 61 years old, with elevated serum creatinine for more than 2 years and lower limb pain for 1 week, was diagnosed with chronic kidney disease 5 period on November 27, 2023 at Guangxi International Zhuang Medicine Hospital.

[0093] For further treatment, the patient was admitted to Guangxi International Zhuang Medicine Hospital on November 27, 2023, with symptoms of: the patient's spirit was clear, the spirit was still good, the lower limbs were sore, the soreness was more obvious when walking for a long time, and it could be relieved after rest, no joint redness and pain, no limb numbness, no fever, dizziness, nausea, vomiting, shortness of breath, palpitation, chest tightness, abdominal distension, etc. No discomfort, sleep and diet were acceptable, night urine 3-4 times, about 150ml, usual urine volume 1500ml, recent urine volume decreased to about 800ml, a little foam urine, stool volume was small, oral iron supplement, stool color was slightly dark, recent body weight showed no significant change.

[0094] Physical Examination: Temperature: 36.6℃, Pulse: 56 bpm, Respiration: 18 breaths / min, Blood Pressure: 140 / 66 mmHg. Height: 165cm, Weight: 62.3kg. No jaundice of mucous membranes, no palmar erythema or spider angiomas, no enlarged or tender lymph nodes. Clear breath sounds bilaterally, no dry or wet rales. No cardiac enlargement, no pathological heart sounds. Flat abdomen, no visible abdominal wall veins; soft abdomen, no tenderness or rebound tenderness, no masses palpable, liver and spleen not palpable below the costal margin, negative hepatojugular reflux; negative shifting dullness. Normal bowel sounds, 4 times / min, no vascular murmurs. Specialist Examination: Alert, fair mental state, anemic appearance, no jugular venous distension or edema, no eyelid or facial edema, lower extremity soreness, no edema, negative percussion tenderness in the renal area.

[0095] Auxiliary examinations: (November 26, 2023, our outpatient department) Complete blood count + five-part differential: Neutrophil percentage 76.30%↑, Lymphocyte count 0.78×10^9 / L↓, Lymphocyte percentage 13.80%↓, Red blood cells 2.92×10^12 / L↓, Hemoglobin 79g / L↓, Hematocrit 25.10%↓, Platelets 100×10^9 / L↓, Plateletcrit 0.110%↓; Renal function tests: Carbon dioxide 17.8mmol / L↓, Urea 31.3mmol / L↑, Creatinine 764umol / L↑, Uric acid 460umol / L↑; Electrolyte tests: Potassium 6.5mmol / L↑, Calcium 2.08mmol / L↓, Magnesium 1.08mmol / L↑, Phosphorus 1.54mmol / L↑; Random blood glucose on admission: 5.6mmol / L. Diagnosis: Shunner-Yin syndrome, chronic renal failure - spleen and kidney yang deficiency syndrome, stage 5 chronic kidney disease. After taking the medication, Mr. Zhang returned for a follow-up visit on January 5, 2024. His condition had significantly improved, with clinical symptoms showing marked improvement compared to before treatment. His TCM syndrome score had decreased significantly, with serum creatinine dropping from 764 umol / L to 450 umol / L, serum uric acid from 460 umol / L to 276 umol / L, and blood urea nitrogen level from 31.3 mmol / L to 11.9 mmol / L. Overall, the treatment was effective.

[0096] Physical examination: Vital signs are stable. Tongue is pale red with a thin white coating; pulse is moderate. Visual examination: Tongue is pale red with a thin white coating; pulse is strong, but the "le-da" pulse is tortuous and faint. The patient is alert and in good spirits; auscultation of the heart and lungs is normal. Abdomen is flat and soft, without significant tenderness or rebound tenderness. Neurological examination is normal.

[0097] Auxiliary examinations: (2024-01-05) Renal function tests: Urea 11.9 mmol / L↑, Creatinine 450 umol / L↑, Uric acid 276 umol / L↑ Diagnosis: Xinele Nei- Yin syndrome, chronic renal failure- spleen and kidney yang deficiency syndrome, chronic kidney disease 5 Zhang Moumou was cured after treatment.

[0098] Typical case 2: Patient Ma Moumou, male, 49 years old. Because of creatinine elevation for more than 9 months, cough and sputum for 5 days, he was diagnosed with chronic kidney disease 5 in Guangxi International Zhuang Medicine Hospital on July 12, 2019.

[0099] The patient found that the creatinine was elevated when he had a physical examination in October 2018. At that time, the blood creatinine was about 600 umol / L, with foam urine, and night urine about 2 times / night. At that time, there was no obvious nausea, vomiting, loss of appetite, no hematuria, no rash, joint pain, no dizziness, fatigue and other discomforts. After the disease, he went to the Affiliated Hospital of Guangxi Medical University for treatment, considering chronic renal insufficiency, and giving kidney protection, detoxification and other treatment. The follow-up examination of renal function showed that the blood creatinine fluctuated between 500-600 umol / L. Five days ago, he had no obvious inducement and appeared cough, sputum, coughing yellow sputum, which was not easy to cough out. It was obvious when lying down, with shortness of breath, loss of appetite, no chills, fever, no night sweats, muscle aches, no nausea, vomiting, no facial and lower extremity edema.

[0100] For further treatment, he came to the hospital on July 12, 2019. Symptoms: cough, night cough, sputum, yellow and sticky sputum, body heat, body temperature up to 37.9℃, accompanied by headache, dizziness, four limbs aching, fatigue, constipation, dry mouth and bitter taste in mouth.

[0101] Physical examination: body temperature: 36.0℃, pulse: 59 times / min, respiration: 20 times / min, blood pressure: 143 / 78 mmHg. Height: 166 cm, weight: 61 kg. Consciousness, general spirit, pharynx red, no tonsil enlargement, chest symmetry without deformity, local no protrusion and depression, sternum no tenderness, chest wall no venous distension. Right lung wet rales, no wheezing sound, no pleural friction sound was heard in both lungs. Voice transmission was symmetrical on both sides. Heart rate 59 times / min, regular, normal heart sound. No murmur was heard in the listening area of each valve, and no pericardial friction sound was heard. Abdomen was flat and soft, no tenderness and rebound tenderness, no edema in both lower extremities.

[0102] Auxiliary examination: (2019-07-12) renal function four items: urea 23.8 mmol / L↑, creatinine 684 umol / L↑, uric acid 609 umol / L↑ Diagnosis: Xinele Nei- Yin syndrome, chronic renal failure- spleen and kidney yang deficiency syndrome, chronic kidney disease 5 After taking the medication, Mr. Ma returned for a follow-up visit on July 21, 2019. His condition had significantly improved, with clinical symptoms showing marked improvement compared to before treatment. His TCM syndrome score had decreased significantly, with serum creatinine dropping from 684 umol / L to 558 umol / L, serum uric acid from 609 umol / L to 409 umol / L, and blood urea nitrogen level from 23.8 mmol / L to 23.5 mmol / L. Overall, the treatment was effective.

[0103] Physical examination: Vital signs are stable. Tongue is pale red with a thin white coating; pulse is strong and forceful, with superficial "le-da" veins and no petechiae. Breath sounds are clear in both lungs, and no dry or wet rales are heard. Cardiac and abdominal examinations are unremarkable. Neurological examination is unremarkable.

[0104] Auxiliary examinations: (2019-07-21) Renal function tests: Urea 23.5 mmol / L↑, Creatinine 558 umol / L↑, Uric acid 409 umol / L↑ Diagnosis: Shunner-Yin syndrome, chronic renal failure - spleen and kidney yang deficiency syndrome, stage 5 chronic kidney disease. After treatment, Ma was assessed as having significant therapeutic effect.

[0105] Typical Case 3: Patient Zhan, female, 60 years old. Due to elevated creatinine levels for more than 3 years and a cough for 1 week, she was diagnosed with stage 5 chronic kidney disease at Guangxi International Zhuang Medicine Hospital on December 30, 2023.

[0106] The patient and his family sued 2020 due to "hyperthyroidism" to 303 hospital when found that the blood creatinine was about 200 umol / L, at that time there was no visible hematuria, foam urine, oliguria, facial and lower extremity edema and other discomfort, not to be taken seriously. 2023-12-13, because of "facial edema" to our hospital endocrinology department, diagnosis "hyperthyroidism", "chronic kidney disease 5", "secondary hyperparathyroidism", "hypertension 3", etc., after symptomatic treatment such as anti-hyperthyroidism, antihypertensive, kidney protection, alkalization of urine, active vitamin D supplementation, etc., the patient was improved and discharged, with creatinine 341 umol / L. 1 week ago, the patient had cough, sputum, white and thin sputum, easy to cough out, occasional chest tightness and palpitation, no chill and fever, no nausea and vomiting, no oliguria and other discomfort, 2023-12-29, outpatient review of blood routine: white blood cells 9.40 10^9 / L, neutrophil percentage 72.80%, hemoglobin 116g / L, platelets 281 10^9 / L; kidney function: carbon dioxide 27.9mmol / L, urea 29.5mmol / L, creatinine 512umol / L, uric acid 773umol / L; electrolyte six: potassium 3.4mmol / L, magnesium 1.20mmol / L, phosphorus 1.59mmol / L; albumin 39.7g / L; CRP was normal. So it is "chronic kidney disease 5" and admitted to hospital.

[0107] For further treatment, on December 30, 2023, the patient came to the hospital. The patient was conscious, with general spirit, occasional cough and sputum, white and thin sputum, easy to cough out, accompanied by nasal congestion, mild facial edema, occasional chest tightness and palpitation, no nausea and vomiting, oliguria, fever and chill, abdominal pain and diarrhea, etc. The patient had normal diet and sleep, and normal urination and defecation. The patient's weight had not changed significantly in the recent period.

[0108] Physical examination: body temperature: 36.6℃, pulse: 84 times / min, respiration: 20 times / min, blood pressure: 134 / 83mmHg. Height: 148cm, weight: 54.8kg. There was no yellow staining of the whole body mucosa, no liver palms, spider nevi, and no general body surface lymph node enlargement and tenderness. The lung breath sound was clear, and no dry and wet rales were heard. The heart border was not enlarged, and no pathological heart sounds were heard. The abdomen was flat, and the abdominal wall veins were not prominent; the abdomen was soft, and there was no abdominal tenderness, rebound tenderness, and no mass was palpated in the whole abdomen. The liver and spleen were not palpated below the ribs, and the liver-cervical vein reflux sign was negative; the shifting dullness was negative. The bowel sounds were normal, 4 times / min, and no blood vessel murmur was heard. Special examination: the patient was conscious, with general spirit, mild facial edema, thyroid Ⅱ degree enlargement, no obvious tremor was palpated, several thyroid nodules were palpated in both sides of the thyroid, the larger one was about 0.5cm*0.5cm, soft, good mobility, no tenderness. The left tonsil was Ⅰ° enlarged, and the pharynx was slightly congested and edematous. The lung breath sound was clear, no dry and wet rales were heard, and no percussion pain was heard in the kidney area. There was no tenderness in the ureter point, and there was no edema in the lower extremities.

[0109] Auxiliary examination: (2023-12-29, our hospital) blood routine: white blood cells 9.40 10^9 / L, neutrophil percentage 72.80%, hemoglobin 116g / L, platelets 281 10^9 / L; renal function: carbon dioxide 27.9mmol / L, urea 29.5mmol / L↑, creatinine 512umol / L↑, uric acid 773umol / L↑; electrolyte six: potassium 3.4mmol / L↓, magnesium 1.20mmol / L↑, phosphorus 1.59mmol / L↑; albumin 39.7g / L↓; CRP showed no abnormality.

[0110] Diagnosis: Xinnelu Nei- negative syndrome, chronic renal failure- spleen and kidney yang deficiency syndrome, chronic kidney disease 5 After taking the medicine, on January 6, 2024, the patient's condition improved significantly, and the clinical symptoms improved significantly compared with before treatment. The TCM syndrome score decreased significantly, serum creatinine decreased from 512umol / L to 359umol / L, serum uric acid decreased from 773umol / L to 440umol / L, urea nitrogen level decreased from 29.5mmol / L to 17.0mmol / L, and the treatment was overall effective.

[0111] Physical examination: Vital signs were stable. The tongue was pale red, the fur was white and slightly thick, the pulse was slow, the "Leda" pulse was red, active, curved and thick. There was no edema on the face and lower extremities. Heart, lung, abdomen and nervous system examination was normal.

[0112] Auxiliary examination: (2019-07-21) renal function four: urea 17.0mmol / L↑, creatinine 359umol / L↑, uric acid 440umol / L↑ Diagnosis: Xinnelu Nei- negative syndrome, chronic renal failure- spleen and kidney yang deficiency syndrome, chronic kidney disease 5 After treatment, the patient's condition improved significantly.

[0113] Quality inspection verification: Production process verification 1. Purpose: To investigate the production feasibility of the preparation process of Example 1, to prepare samples for quality standard research and stability test.

[0114] 2. Production verification content 2.1 Product batch 3 batches (20230924, 20230926, 20230928) 2.2 The yield is about 15000ml / batch 2.3 Drug material feeding, take the prescription of traditional Chinese medicine decoction pieces, and feed according to 25 times the standard prescription amount.

[0115] The products of three batches were tested, and all met the requirements, indicating that the process was feasible. The test results are shown in Table 7.

[0116]

[0117] In summary, the present application moistens and nourishes, and harmonizes viscera and bowels by detoxifying and regulating three channels and two pathways, restores the internal and external balance of the body, realizes the synchronization of three qi of heaven, qi and human, and makes the “grain channel”, “qi channel” and “water channel” unobstructed, has the effects of warming yang, tonifying deficiency, tonifying qi and blood, removing dampness and detoxifying, and discharging bowels and removing turbidity, and achieves the effects of reducing blood creatinine and urea nitrogen, and stabilizing kidney function. No adverse reactions are found during use, and the present formula is safe and effective in clinical application.

[0118] The various embodiments in the specification are described in a progressive manner, and each embodiment focuses on the difference from other embodiments. The same or similar parts between the various embodiments can be mutually referred to.

[0119] Many modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other embodiments without departing from the spirit or scope of the application. Accordingly, the present application is not to be limited to these embodiments shown herein but is to be accorded the broadest scope consistent with the principles and novel features disclosed herein.

Claims

1. A tonic and detoxifying enema, characterized in that, The ingredients, by weight, are: 200 parts of *Euphorbia hirta*, 200 parts of *Epimedium*, 200 parts of *Morinda officinalis* (salted), 200 parts of *Rheum palmatum* (processed), 200 parts of calcined oyster shell, 133 parts of *Centella asiatica*, 133 parts of *Smilax glabra*, 100 parts of *Alisma plantago-aquatica*, 67 parts of *Panax notoginseng*, and 200 parts of *Millettia speciosa*.

2. The tonifying and detoxifying enema as described in claim 1, characterized in that, It also includes 2.5 parts sodium benzoate by weight.

3. The preparation method of the tonifying and detoxifying enema according to claim 2, characterized in that, The process includes the following steps: Mix the medicinal materials except for sodium benzoate, soak them in water, and decoct them twice. For the first decoction, add 10 times the amount of water and decoct for 1 hour. For the second decoction, add 8 times the amount of water and decoct for 1 hour. Combine the two decoctions, filter them, concentrate the filtrate, dissolve sodium benzoate in an appropriate amount of purified water and add it to the decoction. Add water to 1000ml, mix well, fill the container, and sterilize.

4. The preparation method according to claim 3, characterized in that, Soaking time: 30 min; Filling: 150 ml / bottle; Sterilization: 100~105℃ for 30 min.

5. The application of the tonifying and detoxifying enema as described in claim 1 or 2, or the preparation method as described in claim 3 or 4, in the preparation of drugs for treating chronic kidney disease.

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