Traditional Chinese medicine composition for treating chronic kidney diseases and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic kidney diseases. The traditional Chinese medicine composition is prepared from the following raw materials: codonopsis pilosula, radix astragali preparata, prepared rehmannia root, moutan bark, peach kernel, safflower and oldenlandia diffusa. The traditional Chinese medicine composition has the effects of improving renal anemia, enhancing the immune function, effectively reducing kidney microthrombus, regulating the filtration state of the kidney and relieving the microinflammation state of a patient, and has no side effect. The traditional Chinese medicine composition has an excellent effect on patients with chronic kidney diseases, and can improve renal fibrosis and delay the progress of diseases. Through reasonable compatibility of the raw materials, the raw materials give full play to the unique performance and efficacy of the raw materials, and also give full play to the complementary effect of the raw materials, and the medicinal effects of the raw materials supplement each other, so that the kidney function is gradually recovered.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating chronic kidney disease and a preparation method thereof. Background Art

[0002] Chronic kidney disease is a highly prevalent disease globally. The prevalence rate of CKD in China has reached 10.8%, with nearly 120 million people. If not intervened in time, it can develop into end-stage renal disease, bringing a heavy economic burden to families and society. At present, there is a lack of effective treatment means for chronic kidney disease in clinical practice. In addition to diet therapy and symptomatic treatment for the conservative treatment of chronic renal failure in modern medicine, there is no better countermeasure. Traditional Chinese medicine has unique advantages in aspects such as anti-inflammatory, antiviral, improving microcirculation, and regulating immunity. Therefore, traditional Chinese medicine has gradually been applied to the clinical treatment of chronic renal failure with remarkable curative effects. At present, for some compound traditional Chinese medicines for treating chronic kidney disease, a small number of patients may experience discomfort symptoms such as palpitation, abdominal distension, and nausea after taking them for a long time, resulting in their inability to complete the whole course of medication and poor curative effects. In addition, the compound traditional Chinese medicines in the prior art are just a simple combination and accumulation of many single herbs, without a certain number of clinical verifications and the support of traditional Chinese medicine theory, and their clinical curative effects remain to be evaluated. Summary of the Invention

[0003] Object of the Invention: The object of the present invention is to provide a traditional Chinese medicine composition, which can be used to treat chronic kidney disease. The technical solution of the present invention is based on the understanding of the pathogenesis and treatment principles of chronic kidney disease in traditional Chinese medicine, referring to the achievements of modern pharmacological research, and is formulated according to the principle of supplementing qi to strengthen the spleen, warming the kidney yang mainly, and concurrently promoting blood circulation to remove stasis, removing dampness and discharging turbidity, and dredging the kidney collaterals.

[0004] The present invention provides a traditional Chinese medicine composition for treating chronic kidney disease, which is composed of the following raw materials: 10 - 20 g of Codonopsis pilosula, 20 - 30 g of Astragalus membranaceus (prepared with honey), 10 - 20 g of Rehmannia glutinosa (prepared), 5 - 10 g of Paeonia suffruticosa, 5 - 10 g of Prunus persica, 5 - 15 g of Carthamus tinctorius, and 10 - 20 g of Hedyotis diffusa.

[0005] Preferably, the traditional Chinese medicine composition for treating chronic kidney disease is composed of the following raw materials: 10 - 15 g of Codonopsis pilosula, 20 - 25 g of Astragalus membranaceus (prepared with honey), 10 - 15 g of Rehmannia glutinosa (prepared), 8 - 10 g of Paeonia suffruticosa, 8 - 10 g of Prunus persica, 10 - 15 g of Carthamus tinctorius, and 10 - 15 g of Hedyotis diffusa.

[0006] Preferably, the traditional Chinese medicine composition for treating chronic kidney disease is composed of the following raw materials: 12 g of Codonopsis pilosula, 24 g of Astragalus membranaceus (prepared with honey), 12 g of Rehmannia glutinosa (prepared), 10 g of Paeonia suffruticosa, 10 g of Prunus persica, 10 g of Carthamus tinctorius, and 15 g of Hedyotis diffusa.

[0007] The present invention also provides a preparation method of a traditional Chinese medicine composition for treating chronic kidney disease, and the preparation method includes: 1) Weigh Codonopsis pilosula, Astragalus membranaceus (Fried), Rehmannia glutinosa Libosch., Cortex Moutan, Persica vulgaris Mill., Carthamus tinctorius L., and Hedyotis diffusa Willd. according to the ratio. 2) Add the raw materials in step 1) to water and decoct three times to obtain three decoction solutions. 3) Combine the three decoction solutions in step 2) to obtain a traditional Chinese medicine solution.

[0008] Step 2) includes: The water addition amount for the first decoction is 9 times the total weight of the raw materials, and decoct for 3 hours; after filtration, add water to the residue. The water addition amount for the second decoction is 6 times the total weight of the raw materials, and decoct for 2 hours; after filtration, add water to the residue. The water addition amount for the third decoction is 3 times the total weight of the raw materials, and decoct for 1 hour.

[0009] The present invention also provides another preparation method of a traditional Chinese medicine composition for treating chronic kidney disease. The preparation method includes: 1) Weigh Codonopsis pilosula, Astragalus membranaceus (Fried), Rehmannia glutinosa Libosch., Cortex Moutan, Persica vulgaris Mill., Carthamus tinctorius L., and Hedyotis diffusa Willd. according to the ratio. 2) Mix the raw materials obtained in step 1), then crush, grind and sieve to obtain fine powder. 3) Add a pharmaceutically acceptable carrier and / or excipient to the fine powder obtained in step 2) to prepare a clinically acceptable dosage form.

[0010] Preferably, the sieving in step 3) is through a 180-mesh sieve.

[0011] Preferably, the clinically acceptable dosage form can be tablets, pills, capsules, granules, or instant granules.

[0012] Preferably, the clinically acceptable dosage form can be pills. The pills also include refined honey. Add refined honey to the fine powder obtained in step 3) and mix evenly to prepare pills.

[0013] Preferably, the refined honey is Jinghua honey.

[0014] Research believes that chronic kidney disease is caused by both pathogenic factors and deficiency of vital qi. The internal accumulation of pathogenic factors runs through the whole process, with deficiency of vital qi as the root cause; deficiency of vital qi makes the body vulnerable to external pathogenic factors, and internal factors can trigger diseases. The obstruction of pathogenic factors can further damage vital qi, and the two are mutually causal. Among them, pathogenic factors can be invasion of external pathogenic factors such as wind, cold, dampness, heat, and toxin, or internal generation of pathogenic factors such as blood stasis, phlegm retention, and toxic turbidity. The root deficiency is mainly manifested by deficiency of the spleen and kidney: the kidney of Shaoyin is the congenital foundation of the body, containing true yin and true yang, governing water metabolism and storing essence, playing a leading role in the onset and progression of chronic kidney disease. If the kidney essence is deficient and qi transformation is abnormal, edema will occur; if the kidney qi is deficient and the sperm gate is not firm, protein and essence will leak into the urine, resulting in proteinuria. Master Zhu believes that the pathological changes of the spleen of Taiyin are also closely related to the occurrence and development of chronic kidney disease. First, spleen deficiency is likely to cause or aggravate edema; second, spleen deficiency is likely to cause and aggravate proteinuria; third, spleen deficiency can cause or aggravate hematuria; fourth, spleen deficiency can lead to or aggravate anemia. It can be seen that the spleen and kidney play a key role in chronic kidney disease. The Yishen Huoxue Prescription applied in this project is aimed at the syndrome type of chronic kidney disease with qi deficiency of the spleen and kidney. Based on the actual clinical efficacy requirements, the prescription has been continuously improved, modified and gradually refined and adjusted, and has been used in the ward and outpatient clinic of our department. Looking at the whole prescription, by invigorating qi and strengthening the spleen, warming the kidney yang mainly, and concurrently promoting blood circulation to remove blood stasis, removing dampness and discharging turbidity, dredging the kidney collaterals, etc., the qi and blood of the body are replenished, yin and yang are harmonized, stasis and turbidity are transformed, tonifying is combined with purging, and finally the renal function is gradually restored. Beneficial effects: In this prescription, Astragalus membranaceus is used in large doses to tonify the qi of the spleen and lung, promote the movement of water and dampness, Codonopsis pilosula invigorates qi and strengthens the spleen, Rehmannia glutinosa nourishes the kidney yin, replenishes essence and marrow, Paeonia suffruticosa clears heat and cools blood, the combination of Prunus persica and Carthamus tinctorius strengthens the effect of promoting blood circulation to remove blood stasis, Hedyotis diffusa clears heat, promotes diuresis and relieves stranguria. The combination of these herbs forms a prescription that mainly invigorates qi and strengthens the spleen, warms the kidney yang, and concurrently promotes blood circulation to remove blood stasis, removes dampness and discharges turbidity, dredges the kidney collaterals. This prescription can improve renal anemia, enhance immune function, effectively reduce renal microthrombi, regulate the filtration state of the kidneys, relieve the microinflammatory state of patients, and has no side effects. It has particularly good effects on patients with chronic kidney disease, can improve renal fibrosis and delay the progression of the disease. The various raw materials in the present invention are rationally combined. While giving full play to the unique properties and effects of each raw material itself, the complementary effects between them are also taken into account. Their medicinal effects complement each other, thus gradually restoring renal function. Detailed implementation methods

[0015] To deepen the understanding of the present invention, the following will further elaborate on the present invention in combination with embodiments. These embodiments are only used to explain the present invention and do not constitute a limitation on the protection scope of the present invention.

[0016] Example 1 Traditional Chinese medicine composition The composition ingredients are: 12 g of Codonopsis pilosula, 24 g of stir-fried Astragalus membranaceus, 12 g of Rehmannia glutinosa, 10 g of Paeonia suffruticosa, 10 g of Prunus persica, 10 g of Carthamus tinctorius, and 15 g of Hedyotis diffusa.

[0017] The preparation method of the pill includes: ① removing impurities, washing, and drying Codonopsis pilosula, Astragalus membranaceus (prepared with honey), Rehmannia glutinosa, Paeonia suffruticosa, Prunus persica, Carthamus tinctorius, and Hedyotis diffusa, and weighing the raw Chinese medicinal materials according to the above dosages; ② pulverizing the above raw Chinese medicinal materials into fine powder, passing through a 180-mesh sieve, and reserving; ③ adding an appropriate amount of 100 g of Jinghua honey to the fine powder in step ②, mixing well, making it suitable in hardness and softness, and making pills to obtain the product.

[0018] The preparation method of the Chinese medicine liquid: ① removing impurities, washing, and drying Codonopsis pilosula, Astragalus membranaceus (prepared with honey), Rehmannia glutinosa, Paeonia suffruticosa, Prunus persica, Carthamus tinctorius, and Hedyotis diffusa, and weighing the raw Chinese medicinal materials according to the above dosages; ② adding the raw Chinese medicinal materials in step ① to water and decocting three times to obtain three decoction liquids. The water addition amount for the first decoction is 9 times the total weight of the raw materials, and decoct for 3 hours; after filtration, add water to the residue. The water addition amount for the second decoction is 6 times the total weight of the raw materials, and decoct for 2 hours; after filtration, add water to the residue. The water addition amount for the third decoction is 3 times the total weight of the raw materials, and decoct for 1 hour; ③ combining the three decoction liquids in step ② to obtain the Chinese medicine liquid.

[0019] Example 2 Chinese medicine composition The composition components are: 15 g of Codonopsis pilosula, 25 g of Astragalus membranaceus (prepared with honey), 15 g of Rehmannia glutinosa, 8 g of Paeonia suffruticosa, 8 g of Prunus persica, 10 g of Carthamus tinctorius, and 10 g of Hedyotis diffusa.

[0020] The preparation method of this example is the same as the preparation method of the pill in Example 1.

[0021] Example 3 Chinese medicine composition The composition components are: 18 g of Codonopsis pilosula, 27 g of Astragalus membranaceus (prepared with honey), 16 g of Rehmannia glutinosa, 10 g of Paeonia suffruticosa, 10 g of Prunus persica, 15 g of Carthamus tinctorius, and 18 g of Hedyotis diffusa.

[0022] The preparation method of this example is the same as the preparation method of the Chinese medicine liquid in Example 1.

[0023] Example 4 Clinical trial (1) Medicine Yishen Huoxue Formula (specifically the Chinese medicine oral liquid prepared in Example 1 of the present invention, provided by Zhenjiang Hospital of Integrated Traditional Chinese and Western Medicine) (2) Experimental methods: 60 patients with stages 2 - 4 of chronic kidney disease admitted to the outpatient and inpatient departments of the Nephrology Department of Zhenjiang Hospital of Integrated Traditional Chinese and Western Medicine were selected in this study and randomly divided into an experimental group and a control group, with 30 patients in each group. Both groups of patients were given basic treatment, including: (1) High-quality low-protein diet, with the daily protein intake controlled at the level of 0.6 g / kg, among which the high biological value protein exceeded 50%, and appropriate amounts of carbohydrates and fats were supplemented to provide sufficient calories for the body. (2) Referring to the recommended standards of JNCC and K / DOQI to control blood pressure, blood sugar, blood lipids, etc. (3) Maintaining water, acid-base, and electrolyte balance, and reasonably using antibacterial drugs for patients with infections. (4) Paying attention to rest, avoiding overwork, and not using drugs toxic to the kidneys. On this basis, the experimental group was combined with Huoxue Yishen Decoction. Administration method: 1 dose per day, decocted in water and taken warm in 2 divided doses, and the treatment course was 3 months.

[0024] (3) Experimental results 3.1 Comparison of the clinical efficacy of the two groups of patients: The clinical effective rates of the experimental group and the control group were 86.67% and 66.67% respectively. The clinical effective rate of the experimental group was significantly better than that of the control group, and the difference was statistically significant (P < 0.05). See Table 1 for details.

[0025] Table 1 Comparison of the clinical efficacy of the two groups of patients

[0026] Note: Compared with the control group, *P < 0.05 As can be seen from Table 1, the efficacy of the experimental group was 86.67%, which was significantly better than that of the control group, and the difference was statistically significant (P < 0.05). It can be seen that combining the treatment with Huoxue Yishen Decoction on the basis of improving the inducing factors of blood stasis syndrome in chronic kidney disease can significantly improve the clinical effect, indicating that the long-term efficacy of the experimental group is better.

[0027] 3.2 Comparison of renal function indexes of the two groups of patients before and after treatment After treatment, the levels of serum urea nitrogen and serum creatinine in the experimental group were significantly lower than those in the control group, and the difference was significant (P < 0.05). See Table 2 for details.

[0028] Table 2 Comparison of renal function indexes of the two groups of patients before and after treatment

[0029] Note: Compared with before treatment in this group, *P < 0.05, compared with the experimental group, #P < 0.05 Before treatment, there was no significant difference in blood SCr and BUN between the two groups of patients (P>0.05), indicating that the renal functions of the two groups of patients were comparable before the clinical observation. After treatment, blood SCr and BUN in the experimental group decreased significantly compared with those before treatment (P<0.05). After treatment, SCr in the experimental group decreased compared with that in the control group (P<0.05), and BUN in the treatment group decreased compared with that in the control group, but there was no significant difference between the two groups after treatment (P>0.05).

[0030] 3.3 Comparison of GFR levels between the two groups of patients before and after treatment The glomerular filtration rate level of the patients in the experimental group was higher than that in the control group, and the difference was statistically significant (P<0.05). See Table 3 for details.

[0031] Table 3 Comparison of GFR levels between the two groups of patients before and after treatment

[0032] Note: Compared with before treatment in this group, *P<0.05; compared with the experimental group, #P<0.05 Before treatment, there was no significant difference in GFR between the two groups of patients (P>0.05), and the two sets of data were comparable. After treatment, GFT in the experimental group increased significantly compared with that before treatment (P<0.05), and GFR in the control group also increased, but the difference was not statistically significant (P>0.05). After treatment, GFR in the experimental group increased compared with that in the control group, but the difference was not significant (P>0.05).

[0033] 3.4 Comparison of 24-hour urine protein levels between the two groups of patients before and after treatment After treatment, the 24-hour urine protein quantitative level in the experimental group was significantly lower than that in the control group, and the difference was significant (P<0.05). See Table 4 for details.

[0034] Table 4 Comparison of 24-hour urine protein levels between the two groups of patients before and after treatment

[0035] Note: Compared with the control group, *P<0.05 Before treatment, there was no significant difference in the 24-hour urine protein quantitative results between the two groups of patients (P>0.05), and the two sets of data were comparable. There was no significant difference in the 24-hour urine protein quantitative results between the two groups of patients before and after treatment (P>0.05), but the 24-hour urine protein quantitative level in the experimental group decreased compared with that before treatment, while that in the control group increased. Therefore, the level of decrease in the 24-hour urine protein quantitative level after treatment in the experimental group was better than that in the control group after treatment.

[0036] (4)Experimental conclusion The Huoxue Yishen Decoction of the present invention can effectively reduce proteinuria, delay the decline of renal function, and play a role in stabilizing GFR to a certain extent, which is worthy of clinical promotion and application.

[0037] The clinical trial methods of other embodiments provided by the present invention are the same as those of Embodiment 1. Through experiments, it is proved that the traditional Chinese medicines prepared in other embodiments can also effectively reduce proteinuria, delay the decline of renal function, and play a role in stabilizing GFR to a certain extent.

[0038] The above embodiments are only used to illustrate the technical concept and characteristics of the present invention. The purpose is to enable those who are familiar with this technology to understand the content of the present invention and implement it accordingly, and it cannot be used to limit the protection scope of the present invention. All equivalent changes or modifications made according to the spirit and essence of the present invention should be covered within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating chronic kidney disease, characterized in that: The Chinese medicine combination for treating chronic kidney disease is composed of the following raw materials: 10-20g of Codonopsis pilosula, 20-30g of roasted Astragalus membranaceus, 10-20g of Rehmannia glutinosa, 5-10g of Paeonia suffruticosa, 5-10g of Peach Kernel, 5-15g of Carthamus tinctorius and 10-20g of Hedyotis diffusa.

2. The Chinese medicine composition for treating chronic kidney disease according to claim 1, characterized in that: The Chinese medicine combination for treating chronic kidney disease is composed of the following raw materials: 10-15g of Codonopsis pilosula, 20-25g of roasted Astragalus membranaceus, 10-15g of Rehmannia glutinosa, 8-10g of Paeonia suffruticosa, 8-10g of Peach Kernel, 10-15g of Carthamus tinctorius and 10-15g of Hedyotis diffusa.

3. The Chinese medicine composition for treating chronic kidney disease according to claim 2, characterized in that: The Chinese medicine combination for treating chronic kidney disease is composed of the following raw materials: 12g of Codonopsis pilosula, 24g of roasted Astragalus membranaceus, 12g of Rehmannia glutinosa, 10g of Paeonia suffruticosa, 10g of Peach Kernel, 10g of Carthamus tinctorius and 15g of Hedyotis diffusa.

4. A method for preparing a Chinese medicine composition for treating chronic kidney disease, characterized in that: The preparation method comprises: Weigh Codonopsis pilosula, roasted Astragalus membranaceus, Rehmannia root, Paeonia suffruticosa root, Prunus persica, Carthamus tinctorius, and Hedyotis diffusa according to the proportions; Add the raw materials in step 1) into water and boil three times to obtain three portions of decoction; The three decoctions from step 2) are combined to obtain a Chinese medicine solution.

5. The preparation method according to claim 4, characterized in that: The step 2) comprises: adding water in an amount of 9 times the total weight of the raw materials for the first decoction, and decoct for 3 hours; after filtering, adding water to the filter residue, adding water in an amount of 6 times the total weight of the raw materials for the second decoction, and decoct for 2 hours; after filtering, adding water to the filter residue, adding water in an amount of 3 times the total weight of the raw materials for the third decoction, and decoct for 1 hour.

6. A method for preparing a Chinese medicine composition for treating chronic kidney disease, characterized in that: The preparation method comprises: 1) Weigh Codonopsis pilosula, roasted Astragalus membranaceus, Rehmannia root, Paeonia suffruticosa root, Prunus persica, Carthamus tinctorius, and Hedyotis diffusa according to the proportion; 2) mixing the raw materials obtained in step 1), crushing, grinding and sieving to obtain fine powder; 3) Adding a pharmaceutically acceptable carrier and / or excipient to the fine powder obtained in step 2) to prepare a clinically acceptable dosage form.

7. The method for preparing the Chinese medicine composition for treating chronic kidney disease according to claim 5, characterized in that: The sieving in step 3) is through a 180-mesh sieve.

8. The method for preparing the Chinese medicine composition for treating chronic kidney disease according to claim 7, characterized in that: The clinically acceptable dosage form may be tablets, pills, capsules, granules, or granules.

9. The method for preparing the Chinese medicine composition for treating chronic kidney disease according to claim 8, characterized in that: The clinically acceptable dosage form may be a pill, which may also include refined honey. Refined honey is added to the fine powder obtained in step 3), and the mixture is mixed evenly to prepare the pill.

10. The method for preparing the Chinese medicine composition for treating chronic kidney disease according to claim 9, characterized in that: The refined honey is vitex honey.

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