A kidney- tonifying and blood- regulating traditional Chinese medicine composition, a preparation method and application thereof
By using a combination of traditional Chinese medicines that nourish the kidneys and regulate blood, including Rehmannia glutinosa (raw and prepared), Angelica sinensis, and other herbs, this method addresses the issues of liver and kidney yin deficiency, blood stasis, and turbidity in elderly patients with lower jiao disease. It achieves the effects of tonifying the kidneys and replenishing essence, nourishing blood and promoting blood circulation, and detoxifying and clearing the meridians, thus improving the symptoms of elderly patients.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- ZHEJIANG ZANGQIGE PHARMACEUTICAL CO LTD
- Filing Date
- 2026-04-21
- Publication Date
- 2026-07-14
AI Technical Summary
Current technologies lack appropriate traditional Chinese medicine treatments for lower abdominal diseases in the elderly, such as benign prostatic hyperplasia, pelvic floor disorders, and kidney stones, which can lead to liver and kidney yin deficiency, blood stasis and turbidity, resulting in symptoms such as frequent urination at night and soreness in the lower back and knees.
A traditional Chinese medicine composition for nourishing the kidneys and regulating blood is provided, which is composed of Chinese herbs such as Rehmannia glutinosa (raw and prepared), Angelica sinensis, Eucommia ulmoides, Carapax Trionycis, Ficus pumila, Smilax china, Eupolyphaga sinensis, and Cinnamomum cassia. The decoction is extracted by boiling and is used to nourish the kidneys and replenish essence, nourish blood and promote blood circulation, and detoxify and unblock the meridians.
It has achieved good effects in tonifying the kidneys and replenishing essence, nourishing blood and replenishing blood, and detoxifying and clearing the meridians, thus improving the symptoms of elderly patients with lower jiao diseases, such as frequent urination at night and soreness in the waist and knees.
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Abstract
Description
Technical Field
[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a kidney-tonifying and blood-regulating traditional Chinese medicine composition, its preparation method, and its application. Background Technology
[0002] Lower Jiao disease refers to the condition where lingering pathogenic heat depletes the Yin essence of the lower Jiao, damaging the liver and kidneys, resulting in symptoms of liver and kidney Yin deficiency. Examples include benign prostatic hyperplasia, pelvic floor disorders, kidney stones, urinary tract stones, kidney tumors, bladder tumors, chronic urinary tract infections, gynecological tumors, colonic polyps, rectal mucosal prolapse, lumbar disc herniation, knee osteoarthritis, and heel pain, all diagnosed as kidney essence deficiency, weakened Qi transformation in the lower Jiao, and stagnation of turbid fluids. Common symptoms include frequent urination at night, or frequent and urgent urination, abdominal distension and discomfort, loose stools or difficulty defecating, accompanied by dizziness, tinnitus, fatigue, poor sleep, lower back and knee weakness, cold hands and feet, a dark red tongue or cracked tongue, a thin white coating, and a thready and hesitant pulse.
[0003] For this type of disease, there is a lack of effective traditional Chinese medicines available in current technology. Summary of the Invention
[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for nourishing the kidneys and regulating blood, its preparation method and application, which can effectively tonify the kidneys and replenish essence, nourish blood and promote blood circulation, and detoxify and unblock the meridians.
[0005] To solve the above-mentioned technical problems, the present invention specifically provides the following technical solution: This invention provides a traditional Chinese medicine composition for nourishing the kidneys and regulating blood, wherein, by weight, the formulation of the traditional Chinese medicine composition includes at least the following: 14-16 parts raw Rehmannia glutinosa, 14-16 parts prepared Rehmannia glutinosa, 11-13 parts Angelica sinensis, 5-7 parts licorice, 27-33 parts Eucommia ulmoides, 14-16 parts turtle shell, 14-16 parts creeping fig fruit, 8-10 parts Smilax china, 8-10 parts ground beetle, 2-4 parts cinnamon.
[0006] Preferably, the formula of the traditional Chinese medicine composition is as follows: 15 parts raw Rehmannia glutinosa, 15 parts prepared Rehmannia glutinosa, 12 parts Angelica sinensis, 6 parts licorice, 30 parts Eucommia ulmoides, 15 parts turtle shell, 15 parts fig fruit, 9 parts Smilax china, 9 parts Eupolyphaga sinensis, and 3 parts cinnamon.
[0007] Preferably, the traditional Chinese medicine composition is formulated as follows, by weight: 16 parts raw Rehmannia glutinosa, 16 parts prepared Rehmannia glutinosa, 13 parts Angelica sinensis, 7 parts licorice, 33 parts Eucommia ulmoides, 16 parts turtle shell, 16 parts fig fruit, 10 parts Smilax china, 10 parts Eupolyphaga sinensis, and 4 parts cinnamon.
[0008] Preferably, the formula of the traditional Chinese medicine composition is as follows: 14 parts raw Rehmannia glutinosa, 14 parts prepared Rehmannia glutinosa, 11 parts Angelica sinensis, 5 parts licorice, 27 parts Eucommia ulmoides, 14 parts turtle shell, 14 parts Ficus pumila fruit, 8 parts Smilax china, 8 parts Eupolyphaga sinensis, and 2 parts cinnamon.
[0009] Preferably, the formulation of the traditional Chinese medicine composition further includes one or more of Codonopsis pilosula, Astragalus membranaceus, and Dioscorea opposita, by weight.
[0010] Preferably, the formulation of the traditional Chinese medicine composition further includes one or more of Morinda officinalis, Cynomorium songaricum, and Cistanche deserticola, by weight.
[0011] Preferably, the formulation of the traditional Chinese medicine composition further includes one or more of the following, based on parts by weight: costus root, chicken gizzard lining, and agarwood extract.
[0012] Preferably, the traditional Chinese medicine composition further includes, by weight, one or more of the following: Trichosanthes kirilowii, Citrus reticulata peel, and apricot kernel. In a second aspect of the present invention, a method for preparing a traditional Chinese medicine composition for nourishing the kidneys and regulating blood is provided, wherein all the raw materials of traditional Chinese medicine are mixed according to the formula of the traditional Chinese medicine composition, and 400ml of water is added, brought to a boil over high heat and then decocted for 30 minutes, and the decoction is filtered and extracted. Add 400ml of water to the dregs, bring to a boil over high heat, and continue to simmer for 30 minutes. Filter to extract the liquid. Combine the extracts from the two extractions.
[0013] In a third aspect of the present invention, there is an application of a traditional Chinese medicine composition for nourishing the kidneys and regulating blood, which is used to treat lower jiao disease in the elderly and has the effects of tonifying the kidneys and replenishing essence, nourishing blood and promoting blood circulation, and detoxifying and unblocking collaterals.
[0014] Compared with the prior art, the present invention has the following advantages: This invention has good effects of tonifying the kidneys and replenishing essence, nourishing blood and replenishing blood, and detoxifying and clearing the meridians.
[0015] Raw Rehmannia root, prepared Rehmannia root, and Angelica sinensis are the principal herbs, which tonify the kidneys and replenish essence, as well as nourish and replenish blood.
[0016] Eucommia ulmoides, fig fruit, and turtle shell are used as assistant herbs. Eucommia ulmoides tonifies the liver and kidneys, strengthens tendons and bones, and invigorates the waist and knees; fig fruit tonifies kidney essence, consolidates kidney qi, and resolves blood stasis; turtle shell nourishes kidney yin, subdues floating yang, and softens hard masses. These three herbs play the role of tonifying the liver and kidneys, replenishing essence and consolidating the foundation, and resolving blood stasis and dissipating masses.
[0017] Smilax china promotes diuresis and eliminates turbidity, dispels wind and relieves numbness, detoxifies and disperses blood stasis; Eupolyphaga sinensis breaks up blood stasis, removes turbidity and promotes circulation, and eliminates pathogens and unblocks the meridians. Together they serve as adjuvant herbs.
[0018] Cinnamon warms the meridians and invigorates Yang, guiding fire back to its source; licorice root is sweet and soothing, protecting the stomach and harmonizing the effects of the other herbs. Both serve as guiding herbs. The entire formula works to nourish blood and Yin, replenish essence and benefit the kidneys, dispel turbidity and resolve stagnation, invigorate blood circulation and unblock the meridians, and guide fire back to its source. Detailed Implementation
[0019] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0020] This invention provides a traditional Chinese medicine composition for nourishing the kidneys and regulating blood, wherein, by weight, the composition comprises at least the following: 14-16g of raw Rehmannia glutinosa, 14-16g of prepared Rehmannia glutinosa, 11-13g of Angelica sinensis, 5-7g of licorice root, 27-33g of Eucommia ulmoides, 14-16g of turtle shell, 14-16g of Ficus pumila fruit, 8-10g of Smilax china, 8-10g of Eupolyphaga sinensis, and 2-4g of cinnamon.
[0021] Among them, Rehmannia glutinosa (raw), Rehmannia glutinosa (processed), and Angelica sinensis are the principal herbs, which tonify the kidneys and replenish essence, and nourish and replenish blood.
[0022] Eucommia ulmoides, fig fruit, and turtle shell are used as assistant herbs. Eucommia ulmoides tonifies the liver and kidneys, strengthens tendons and bones, and invigorates the waist and knees; fig fruit tonifies kidney essence, consolidates kidney qi, and resolves blood stasis; turtle shell nourishes kidney yin, subdues floating yang, and softens hard masses. These three herbs work to tonify the liver and kidneys, replenish essence and consolidate the foundation, and resolve blood stasis and dissipate masses.
[0023] Smilax china promotes diuresis and eliminates turbidity, dispels wind and relieves numbness, detoxifies and disperses blood stasis; Eupolyphaga sinensis breaks up blood stasis, removes turbidity and promotes circulation, and eliminates pathogens and unblocks the meridians. Together they serve as adjuvant herbs.
[0024] Cinnamon warms the meridians and invigorates Yang, guiding fire back to its source; licorice root is sweet and soothing, protecting the stomach and harmonizing the effects of the other herbs. Both serve as guiding herbs. The entire formula works to nourish blood and Yin, replenish essence and benefit the kidneys, dispel turbidity and resolve stagnation, invigorate blood circulation and unblock the meridians, and guide fire back to its source.
[0025] This traditional Chinese medicine composition is indicated for lower jiao diseases in the elderly, such as benign prostatic hyperplasia, pelvic floor disorders, kidney stones, urinary tract stones, kidney tumors, bladder tumors, chronic urinary tract infections, gynecological tumors, colonic polyps, rectal mucosal prolapse, lumbar disc herniation, knee osteoarthritis, heel pain, etc., where the syndrome is attributed to kidney essence deficiency, weak qi transformation in the lower jiao, and stagnation of turbidity. Common symptoms include frequent urination at night, or frequent and urgent urination, abdominal distension and discomfort, loose stools or difficulty in defecation, accompanied by dizziness, tinnitus, fatigue, poor sleep, soreness and weakness of the lower back and knees, cold hands and feet, dark red tongue or cracked tongue, thin white coating, and thready and hesitant pulse. Example 1:
[0026] The formula for the traditional Chinese medicine composition is as follows: 15g of raw Rehmannia glutinosa, 15g of prepared Rehmannia glutinosa, 12g of Angelica sinensis, 6g of licorice, 30g of Eucommia ulmoides, 15g of turtle shell, 15g of fig fruit, 9g of Smilax china, 9g of Eupolyphaga sinensis, and 3g of cinnamon. Example 2:
[0027] The formula for the traditional Chinese medicine composition is as follows: 16g of raw Rehmannia glutinosa, 16g of prepared Rehmannia glutinosa, 13g of Angelica sinensis, 7g of licorice, 33g of Eucommia ulmoides, 16g of turtle shell, 16g of fig fruit, 10g of Smilax china, 10g of Eupolyphaga sinensis, and 4g of cinnamon. Example 3:
[0028] The formula of the traditional Chinese medicine composition is as follows: 14g of raw Rehmannia glutinosa, 14g of prepared Rehmannia glutinosa, 11g of Angelica sinensis, 5g of licorice, 27g of Eucommia ulmoides, 14g of turtle shell, 14g of fig fruit, 8g of Smilax china, 8g of Eupolyphaga sinensis, and 2g of cinnamon.
[0029] The preparation method is as follows: according to the formula of the Chinese herbal composition, mix all the Chinese herbal raw materials, add 400ml of water, bring to a boil over high heat, continue to decoct for 30 minutes, and filter to extract the medicinal liquid; Add 400ml of water to the dregs, bring to a boil over high heat, and continue to simmer for 30 minutes. Filter to extract the liquid. Combine the two extracts. Take directly.
[0030] Based on the understanding of the physiological laws of the elderly in traditional Chinese medicine, and combined with clinical experience, the pathological basis of elderly patients with diseases caused by deficiency of the lower jiao is the deficiency of kidney essence and the gradual decline of yin and yang. Due to the "fundamental deficiency", the circulation of qi, blood and body fluids is obstructed, resulting in the accumulation of stagnation and turbidity. As Zhu Danxi pointed out in "On Elderly Care", "After sixty or seventy years of life, essence and blood are depleted".
[0031] These patients have two characteristics. First, they are older, in poor overall health, and have significant deficiency of vital energy. Second, they have been ill for a long time, with a long course of disease, having sought treatment from various sources, combining Chinese and Western medicine, resulting in a complex combination of deficiency and excess patterns, making diagnosis quite complicated.
[0032] Based on the above two aspects, when treating patients, it is necessary to consider that if one only focuses on tonifying the deficiency, the deficiency may not be able to withstand the tonification, or it may help the pathogenic factors to linger; if one only focuses on attacking the pathogenic factors, it is easy to damage the body's vital energy, leading to an unfavorable situation where the body's vital energy becomes even weaker while the pathogenic factors are not eliminated.
[0033] Therefore, while focusing on replenishing essence and blood, and strengthening the kidneys and consolidating the foundation, it is also important to appropriately invigorate blood circulation, clear the meridians, detoxify and remove turbidity, and help the body's vital energy to lead the elimination of pathogens. This process removes stagnation and promotes new tissue growth, creating a positive feedback loop between expelling pathogens and supporting the body's vital energy. This allows elderly patients with complex pathogenesis to enter a virtuous cycle during treatment. In my experience, in addition to the sweet and warm herbs that replenish essence and blood and the cool and bitter herbs that disperse stagnation and turbidity in Gui Shen Li Xue Tang (Kidney-Nourishing and Blood-Regulating Decoction), the use of a small amount of cinnamon is a brilliant move. Cinnamon can warm and tonify kidney yang, warm and unblock the meridians, generate qi with a gentle fire, enhance the qi transformation power of the lower jiao, help distribute fluids, expel turbid pathogens, and help coordinate yin and yang in the kidneys, achieving a balance of water and fire in the lower jiao, guiding the "strong fire" and floating yang back to their origin.
[0034] When treating diseases of the lower abdomen in the elderly, Gui Shen Li Xue Tang (Kidney-Nourishing and Blood-Regulating Decoction) grasps the basic pathogenesis of deficiency of essence and blood and obstruction of collaterals by blood stasis, which is a mixture of deficiency and excess. Based on the principle of nourishing the kidney, regulating blood and unblocking collaterals, the formula is flexibly modified according to the patient's varied clinical manifestations, and it can indeed achieve satisfactory results.
[0035] The following specific clinical data is provided: Mr. Li, male, 80 years old. Chief complaint: Frequent urination at night, up to 10 times a night in the past month, affecting sleep, fatigue, and lower back pain. He has a history of benign prostatic hyperplasia (BPH), and a urologist recommended surgery. The patient is afraid of surgery and is currently taking baicalein tablets. He previously suffered a right hip injury due to trauma, resulting in dull pain and discomfort in the buttock and leg, and a limp. An endoscopy at another hospital showed chronic superficial gastritis; no obvious abnormalities were found in the rectum and colon. Appetite is good, bowel movements are occasionally difficult, and he is prone to abdominal distension. His tongue is large and dark red with a thin, white, greasy coating, and his pulse is wiry.
[0036] Western medicine diagnosis: Benign prostatic hyperplasia; Traditional Chinese medicine diagnosis: Frequent urination.
[0037] The diagnosis is liver and kidney deficiency with stagnation of blood stasis and turbidity. The treatment principle is to tonify the liver and kidneys and remove blood stasis and turbidity.
[0038] Example 1 is preferred, using a modified traditional Chinese medicine composition for nourishing the kidneys and regulating blood.
[0039] Prescription: 15g Rehmannia glutinosa (raw), 15g Rehmannia glutinosa (prepared), 12g Angelica sinensis, 6g Glycyrrhiza uralensis, 30g Eucommia ulmoides, 15g Trionyx sinensis, 15g Ficus pumila fruit, 9g Smilax china, 9g Eupolyphaga sinensis, 3g Cinnamomum cassia.
[0040] After 14 doses of the above formula, the patient returned for a follow-up visit: After taking the medication, the frequency of urination at night decreased, sleep became more stable, and lower back and hip pain was relieved.
[0041] After more than two months of treatment based on the above prescription, the patient experienced about three episodes of nocturia, and all symptoms improved significantly.
[0042] Because the conditions of elderly patients are quite complex, they often have multiple underlying diseases, and their conditions can vary, sometimes exhibiting more deficiency than pathogenic factors, or vice versa. Treatment should comprehensively consider the Yin and Yang of the internal organs to strengthen the body's resistance, while addressing pathogenic factors without neglecting phlegm, turbidity, and blood stasis. In selecting specific medications, mild remedies should be used, avoiding excessive or aggressive tonifying or purging methods.
[0043] For those with weak spleen and stomach, it is advisable to add Codonopsis pilosula, Astragalus membranaceus, and Dioscorea opposita, with each of these ingredients used in a dosage of 5 to 15 parts by weight.
[0044] For those with obvious liver and kidney yang deficiency, it is advisable to add Morinda officinalis, Cynomorium songaricum, and Cistanche deserticola, with each of the following dosages being 5 to 15 parts by weight.
[0045] For those with qi stagnation and food accumulation, it can be combined with costus root, chicken gizzard lining, and agarwood malt, etc. The dosage of costus root, chicken gizzard lining, or agarwood malt is 3 to 10 parts by weight.
[0046] For those with phlegm obstruction, it can be combined with Trichosanthes kirilowii, dried tangerine peel, and apricot kernel, with each of the following dosages being 5 to 12 parts by weight.
[0047] Further examples are provided below: Benign prostatic hyperplasia (BPH) is a common lower urinary tract obstructive disease in middle-aged and elderly men. Clinically, it often presents with urinary frequency, urgency, nocturia, difficulty urinating, and a feeling of incomplete emptying. Prolonged symptoms can affect quality of life and even lead to complications such as urinary retention and urinary tract infections. Current treatment often involves a combination of alpha-blockers and 5α-reductase inhibitors to improve urine flow and reduce prostate volume. However, issues remain regarding individual differences in efficacy, poor long-term medication adherence, and adverse reactions. Traditional Chinese medicine considers this disease to fall under the category of "urinary retention," commonly manifesting as "kidney deficiency and blood stasis syndrome," and treatment should focus on tonifying the kidneys, promoting blood circulation, and resolving stasis and relieving urinary tract obstruction. The Gui Shen Li Xue Tang (Kidney-Nourishing and Blood-Regulating Decoction) mentioned in this invention embodiment is composed of Rehmannia glutinosa (raw and prepared), Angelica sinensis, Eucommia ulmoides, Carapax Trionycis, Smilax china, Eupolyphaga sinensis, and Cinnamomum cassia, combining kidney-tonifying and essence-replenishing with blood-activating and mass-dissolving effects.
[0048] Based on this, this study selected patients who visited the hospital between January 2024 and June 2025 to compare the effects of Gui Shen Li Xue Tang combined with conventional Western medicine versus Western medicine alone on clinical symptoms, quality of life, TCM syndrome scores, and urodynamics, in order to provide clinical evidence for the integrated TCM and Western medicine treatment of BPH.
[0049] For details, please see below: I. Materials and Methods 1. Case data: 82 patients with BPH who received treatment at Yuyao Central Hospital from January 2024 to June 2025 were selected and randomly divided into a study group and a control group, with 41 patients in each group.
[0050] The patients in the study group were aged 51–78 years, with a mean age of (60.23±6.21) years and a disease duration of 1–11 years, with a mean duration of (6.02±2.14) years. The patients in the control group were aged 51–80 years, with a mean age of (60.73±7.03) years and a disease duration of 1–12 years, with a mean duration of (6.13±2.25) years. There were no significant differences in clinical data between the two groups (P>0.05).
[0051] 2. Diagnostic criteria Western Medicine Diagnostic Criteria: Based on the 2022 edition of the "Guidelines for the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Benign Prostatic Hyperplasia," clinical symptoms mainly cover the storage phase, voiding phase, and post-voiding manifestations. Storage phase symptoms include urinary frequency, urgency, incontinence, and nocturia; voiding phase symptoms commonly include delayed initiation of urination, straining during urination, and interrupted urine flow; post-voiding symptoms often manifest as a feeling of incomplete bladder emptying and post-voiding dribbling. Physical Examination: An examination of the external genitalia is performed to rule out lesions that may affect urinary function, such as urethral stricture, phimosis, and penile tumors. Digital rectal examination reveals an enlarged prostate, soft and elastic in texture, with a shallowed or absent median sulcus. Auxiliary examination results include: urinary system ultrasound showing an enlarged prostate volume exceeding 25 ml, or a residual urine volume greater than 10 ml; uroflowmetry indicating a maximum urinary flow rate less than 15 ml / s.
[0052] Traditional Chinese Medicine (TCM) diagnostic criteria: Based on the "Expert Consensus on the Diagnosis and Treatment of Benign Prostatic Hyperplasia with Traditional Chinese Medicine" and the "Guiding Principles for Clinical Research of New Chinese Medicines" regarding the criteria for "Kidney Deficiency and Blood Stasis Syndrome": ① Frequent urination, especially at night; difficulty and time spent urinating, or a trickle of urine, or difficulty in passing urine, or intermittent flow, with a weak urine stream and difficulty urinating; ② Distending pain in the lower abdomen and perineum; ③ Soreness and weakness in the lower back and knees; ④ Pale purple or dark tongue, deep, thready, weak, large, and slow pulse.
[0053] 3. Inclusion and Exclusion Criteria Inclusion criteria: ① Age > 50 years; ② Meeting the above-mentioned diagnostic criteria in both traditional Chinese and Western medicine; ③ Disease duration > 3 months; ④ Informed consent from the patient or their family. Exclusion criteria: ① Patients with severe heart, lung, liver, or kidney diseases; ② History of other major illnesses or surgical trauma within the past 3 months; ③ Patients taking medications that may affect the results of this study; ④ Patients allergic to the investigational drug; ⑤ Patients with mental disorders; ⑥ Patients with malignant tumors.
[0054] 4. Treatment methods The control group received conventional Western medicine treatment, including oral finasteride tablets (Guangdong Yishu Pharmaceutical Co., Ltd., National Drug Approval Number H20051699, specification: 5mg*10 tablets), 1 tablet / day; and tamsulosin hydrochloride capsules (Anstar Pharmaceutical Group Co., Ltd., National Drug Approval Number H20000681, specification: 0.2mg*10 capsules), 1 capsule / day.
[0055] In addition to the treatment given to the control group, the study group also received Gui Shen Li Xue Tang (15g of raw Rehmannia glutinosa, 15g of prepared Rehmannia glutinosa, 12g of Angelica sinensis, 6g of raw Glycyrrhiza uralensis, 30g of Eucommia ulmoides, 15g of turtle shell (decocted first), 15g of Ficus pumila fruit, 9g of Smilax china, 9g of Eupolyphaga sinensis, and 3g of Cinnamomum cassia), which was decocted in water to 300ml. The patients took the decoction once in the morning and once before bedtime, one dose per day. Both groups of patients continued the treatment for 3 months.
[0056] 5. Observation Indicators and Methods (1) International Prostate Symptom Score (IPSS): This scale contains 7 questions, with scores ranging from 0 to 5, for a total of 0 to 35. The higher the patient's score, the more severe their symptoms. The patient was assessed once before and once after treatment.
[0057] (2) Quality of Life (QOL): This scale is often used to assess the impact of lower urinary tract symptoms on a patient's quality of life. The scale is scored from 0 to 6 points, with lower scores indicating better quality of life. The assessment is performed once before and once after treatment.
[0058] (3) TCM syndrome score: Referring to the "Expert Consensus on the Diagnosis and Treatment of Benign Prostatic Hyperplasia with Traditional Chinese Medicine", the patient's main symptoms such as post-void dribbling, urinary frequency and urgency, weak urination, and increased nocturia were scored from none to mild, moderate, and severe, respectively, with scores of 0, 2, 4, and 6. Secondary symptoms such as lower abdominal distension and pain, and lower back pain and fatigue were scored from 0, 1, 2, and 3, respectively. The patient was assessed once before and once after treatment.
[0059] (4) Prostate volume (PV) and serum prostate-specific antigen (PSA): Prostate volume was measured using color Doppler ultrasound. Fasting venous blood was collected from patients, and serum PSA levels were measured using an enzyme-linked immunosorbent assay (ELISA) reader (Bokco BKEL10A). Measurements were taken once before and once after treatment.
[0060] 6. Statistical Analysis Data analysis was performed using SPSS 26.0 statistical software. Normally distributed continuous data were expressed as mean ± standard deviation (s). Independent samples t-tests were used for comparisons between groups, and paired samples t-tests were used for comparisons within groups. Count data were expressed as percentages (%). Comparisons between groups were performed using... Test. A p-value < 0.05 indicates that the difference is statistically significant.
[0061] II. Results Statistics 1. Patient's IPSS and QOL scores After treatment, the IPSS and QOL scores of both the study group and the control group were lower than before treatment, and the IPSS and QOL scores of the study group were even lower than those of the control group (P<0.05), as shown in Table 1 (Comparison of IPSS and QOL scores before and after treatment in the study group and the control group). ±s, minutes).
[0062] Table 1 Note: a, Compared with the pre-treatment values, the study group and the control group showed P < 0.05.
[0063] 2. Patient's TCM syndrome score After treatment, the scores for post-void dribbling, urinary frequency and urgency, weak urination, increased nocturia, lower abdominal distension and pain, and lower back pain and fatigue in both the study group and the control group were lower than before treatment. Furthermore, the scores for post-void dribbling, urinary frequency and urgency, weak urination, increased nocturia, lower abdominal distension and pain, and lower back pain and fatigue in the study group were also lower than those in the control group (P < 0.05). See Tables 2 and 3 (Comparison of TCM symptom scores before and after treatment in the study group and the control group). ±s, minutes).
[0064] Table 2 Table 3 Note: a, Compared with the pre-treatment values, the study group and the control group showed P < 0.05.
[0065] 3. Patient's PV and serum PSA levels After treatment, the PV and PSA levels of patients in both the study group and the control group were lower than before treatment, and the PV and PSA levels in the study group were lower than those in the control group (P<0.05), as shown in Table 4 (comparison of PV and serum PSA levels between the study group and the control group).
[0066] Table 4 Note: a, Compared with the pre-treatment values, the study group and the control group showed P < 0.05.
[0067] III. Results Analysis From the perspective of TCM etiology and pathogenesis, benign prostatic hyperplasia (BPH) is more common in middle-aged and elderly men. The root cause is the gradual decline of kidney qi, leading to dysfunction of bladder qi transformation and thus urinary obstruction. Prolonged illness affects the collaterals, causing qi stagnation and blood stasis, which manifests as blood stasis in the lower jiao (lower burner). This blood stasis can cause a weak urine stream, difficulty urinating, and dribbling after urination. It can also cause lower abdominal and perineal distending pain. Therefore, its pathogenesis can be summarized as "deficiency in the root and excess in the branch," with kidney deficiency as the root and blood stasis as the branch. Treatment should focus on tonifying the kidney to restore qi transformation, promoting blood circulation to unblock the collaterals and eliminate masses, while also addressing blood stasis and promoting urination to improve urinary difficulty and related accompanying symptoms.
[0068] The proposed Gui Shen Li Xue Tang formula, as described in this example, uses raw and prepared Rehmannia glutinosa to nourish yin and blood, tonify the kidneys and replenish essence to strengthen the body's foundation; Eucommia ulmoides tonifies the kidneys and strengthens the lower back to assist kidney qi; Angelica sinensis nourishes and invigorates blood to "regulate blood"; Eupolyphaga sinensis breaks up blood stasis, eliminates masses and dissipates nodules, specifically treating symptoms of blood stasis leading to masses; Trionyx sinensis enters the liver and kidneys, softens hardness and dissipates nodules to eliminate masses; Ficus pumila fruit and Smilax china are primarily used to dispel dampness, unblock the meridians, and benefit the lower burner to assist in "relieving strangury"; Cinnamomum cassia warms and tonifies kidney yang, warms and unblocks the meridians, allowing yin to contain yang and assisting qi transformation; Glycyrrhiza uralensis harmonizes the various herbs and protects the middle burner. Overall, it embodies the principle of "returning to the kidneys to restore qi transformation, regulating blood to unblock the meridians and eliminate masses, warming yang to promote water metabolism, and relieving strangury to eliminate dampness," which aligns with the pathogenesis of "kidney deficiency and blood stasis syndrome."
[0069] This experimental case showed that after treatment, the IPSS and QOL scores of patients in the study group were lower than those in the control group. This is because alpha-receptor blockers can relieve the tension of the smooth muscle of the prostate and bladder neck and reduce dynamic obstruction, while 5α-reductase inhibitors can inhibit glandular proliferation and reduce volume by lowering dihydrotestosterone (DHT) levels. The AUA guidelines suggest that 5α-reductase inhibitors combined with alpha-receptor blockers should be mainly used for LUTS patients with definite prostate enlargement.
[0070] Based on this, Gui Shen Li Xue Tang, through its comprehensive effects of tonifying the kidney and promoting qi transformation, activating blood circulation and unblocking collaterals, softening and eliminating masses, and promoting urination and eliminating dampness, may further improve the qi mechanism of the lower jiao and local microcirculation, thereby generating cumulative benefits for symptoms during both the urine storage and voiding periods, ultimately resulting in a more significant decrease in IPSS and QOL.
[0071] This experimental case shows that after treatment, the scores for post-void dribbling, urinary frequency and urgency, weak urination, increased nocturia, lower abdominal distension and pain, and lower back pain and fatigue in the study group were lower than those in the control group. Analysis of the "syndrome-treatment-effect" relationship indicates that the improvement in lower back pain and fatigue, and increased nocturia suggests tonifying the kidneys and strengthening the body's resistance, gradually restoring qi transformation; the improvement in lower abdominal distension and pain and post-void dribbling suggests that stagnation has been cleared and the meridians are unblocked; the improvement in urinary frequency, urgency, and weak urination suggests that the qi mechanism in the lower jiao (lower burner) is smooth and the water passages are unobstructed. These results suggest that TCM syndrome differentiation and modification can have a certain advantage in improving overall symptoms.
[0072] Furthermore, after treatment, the levels of PV and PSA in the study group were lower than those in the control group. Besides the androgen / 5α-reductase pathway, chronic inflammation, tissue remodeling, and fibrosis are also closely related to symptom burden and progression risk in the development and progression of BPH. Existing research indicates that chronic prostatitis is consistent in the pathophysiology and clinical manifestations of BPH. Therefore, the pharmacological potential of Gui Shen Li Xue Tang (a traditional Chinese medicine formula) in "activating blood circulation, removing blood stasis, softening masses, and eliminating lumps" is related to improving local microcirculation, reducing inflammatory responses, and addressing tissue hardening-related processes, thus showing additional benefits to PV and PSA indicators within a 3-month treatment course.
[0073] This formula may have a positive effect on prostate tissue through mechanisms such as improving local microcirculation, reducing inflammatory response and tissue hardening.
[0074] In conclusion, the combination of Gui Shen Li Xue Tang (Kidney-Nourishing and Blood-Regulating Decoction) and conventional Western medicine has significant efficacy in treating BPH patients. The overall formula embodies the treatment principle of "tonifying the kidney and replenishing essence, nourishing blood and promoting blood circulation, and detoxifying and unblocking the meridians," which aligns with the pathogenesis of "deficiency of the root and excess of the branch" in elderly patients with lower jiao disease. Clinical controlled studies have shown that adding this formula to conventional Western medicine treatment can significantly improve the International Prostate Symptom Score (IPSS), Quality of Life Index (QOL), and TCM syndrome scores (such as post-void dribbling, urinary frequency and urgency, weak urination, increased nocturia, lower abdominal distension and pain, and lower back pain and fatigue) in patients with benign prostatic hyperplasia, with efficacy superior to Western medicine treatment alone.
[0075] The above embodiments are merely exemplary embodiments of this application and are not intended to limit this application. The scope of protection of this application is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to this application within its substance and scope of protection, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of this application.
Claims
1. A traditional Chinese medicine composition for nourishing the kidneys and regulating blood, characterized in that, The formulation of the traditional Chinese medicine composition, by weight, includes at least the following: 14-16 parts raw Rehmannia glutinosa, 14-16 parts prepared Rehmannia glutinosa, 11-13 parts Angelica sinensis, 5-7 parts licorice, 27-33 parts Eucommia ulmoides, 14-16 parts turtle shell, 14-16 parts creeping fig fruit, 8-10 parts Smilax china, 8-10 parts ground beetle, 2-4 parts cinnamon.
2. The traditional Chinese medicine composition for nourishing the kidneys and regulating blood according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, is as follows: 15 parts raw Rehmannia root, 15 parts prepared Rehmannia root, 12 parts Angelica sinensis root, 6 parts licorice root, 30 parts Eucommia ulmoides bark, 15 parts turtle shell, 15 parts creeping fig fruit, 9 parts Smilax china, 9 parts ground beetle, and 3 parts cinnamon.
3. The kidney-tonifying and blood-regulating traditional Chinese medicine composition according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, is as follows: 16 parts raw Rehmannia root, 16 parts prepared Rehmannia root, 13 parts Angelica sinensis root, 7 parts licorice root, 33 parts Eucommia ulmoides bark, 16 parts turtle shell, 16 parts creeping fig fruit, 10 parts Smilax china, 10 parts ground beetle, and 4 parts cinnamon.
4. The kidney-tonifying and blood-regulating traditional Chinese medicine composition according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, is as follows: 14 parts raw Rehmannia root, 14 parts prepared Rehmannia root, 11 parts Angelica sinensis root, 5 parts licorice root, 27 parts Eucommia ulmoides bark, 14 parts turtle shell, 14 parts creeping fig fruit, 8 parts Smilax china, 8 parts ground beetle, and 2 parts cinnamon.
5. The kidney-tonifying and blood-regulating traditional Chinese medicine composition according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, also includes one or more of the following: Codonopsis pilosula, Astragalus membranaceus, and Dioscorea opposita.
6. The traditional Chinese medicine composition for nourishing the kidneys and regulating blood according to claim 1, characterized in that, The traditional Chinese medicine composition, by weight, also includes one or more of Morinda officinalis, Cynomorium songaricum, and Cistanche deserticola.
7. The kidney-tonifying and blood-regulating traditional Chinese medicine composition according to claim 1, characterized in that, The formula of the traditional Chinese medicine composition, by weight, also includes one or more of the following: costus root, chicken gizzard lining, and agarwood extract.
8. The kidney-tonifying and blood-regulating traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition also includes, by weight, one or more of the following: Trichosanthes kirilowii, Citrus reticulata peel, and apricot kernel.
9. A method for preparing a traditional Chinese medicine composition for nourishing the kidneys and regulating blood as described in any one of claims 1-8, characterized in that, According to the formula of the Chinese herbal composition, mix all the Chinese herbal raw materials, add 400ml of water, bring to a boil over high heat, continue to decoct for 30 minutes, and filter to extract the medicinal liquid. Add 400ml of water to the dregs, bring to a boil over high heat, and continue to simmer for 30 minutes. Filter to extract the liquid. Combine the extracts from the two extractions.
10. The application of a traditional Chinese medicine composition for regulating kidney and blood as described in any one of claims 1-8, characterized in that, The aforementioned herbal composition for nourishing the kidneys and regulating blood is used to treat diseases caused by kidney essence deficiency, weak qi transformation in the lower jiao, and blood stasis and turbidity. It has the effects of tonifying the kidneys and replenishing essence, nourishing blood and promoting blood circulation, and detoxifying and unblocking the meridians.