Traditional Chinese medicine composition formula for treating renal insufficiency, traditional Chinese medicine preparation and preparation method

Abstract

The invention discloses a traditional Chinese medicine composition formula for treating renal insufficiency. The traditional Chinese medicine composition formula comprises the following raw material medicines: radix astragali, semen lepidii, semen plantaginis and radix cynanchi paniculati. In addition, the invention further discloses a traditional Chinese medicine preparation for treating renal insufficiency, the traditional Chinese medicine preparation is prepared according to the traditional Chinese medicine composition formula, and the traditional Chinese medicine preparation is at least one of water decoction, powder, tablets, granules or capsules. Correspondingly, the invention also discloses a preparation method of the traditional Chinese medicine preparation, which comprises the following steps: boiling and extracting the raw materials in a closed container for at least two times to obtain a decoction; and preparing at least one of water decoction, powder, tablets, granules or capsules from the decoction. The traditional Chinese medicine preparation prepared by adopting the traditional Chinese medicine composition formula designed by the invention can effectively improve the creatinine level of a patient with renal artery stenosis and can reduce blood pressure, so that the traditional Chinese medicine preparation is used for treating renal insufficiency caused by renal artery stenosis.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a formula of a traditional Chinese medicine composition, a traditional Chinese medicine preparation, a preparation method of the traditional Chinese medicine preparation, uses of the traditional Chinese medicine composition, and uses of the traditional Chinese medicine preparation. Background Art

[0002] The prevalence rate of renal artery stenosis (RAS) accounts for 5.4% in the population of young patients with secondary hypertension and can reach 7% in people over 65 years old, which is one of the common causes of secondary hypertension. This disease mainly accumulates in local or multiple segments of the unilateral or bilateral renal arteries. Clinically, it is mainly manifested by elevated levels of renin and aldosterone, abnormal renal function, and refractory hypertension that is difficult to control with drugs. Renal artery stenosis has an insidious onset and is easily overlooked in clinical practice. It is a common cause of insufficient renal blood perfusion, renovascular hypertension, and progressive decline in renal function.

[0003] Atherosclerosis, metabolic syndrome, fibromuscular dysplasia, and autoimmune diseases are the main inducing factors for renal artery stenosis, mostly manifested as renovascular hypertension and ischemic nephropathy. The treatment of RAS is mainly to delay or improve renal function damage, and most patients also need to control blood pressure. Currently, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor antagonists (ARBs), calcium channel blockers (CCBs), and β-blockers (β-blockers) are all class I recommended drugs for hypertension treatment. However, in patients with severe renal artery stenosis, the use of ACEI and ARB drugs may exacerbate kidney disease and even lead to acute renal failure. Therefore, most patients with renal artery stenosis cannot benefit from this. In addition, patients with progressive renal insufficiency due to renal artery stenosis have more relative and absolute contraindications for interventional or surgical operations, higher surgical risks, and less clinical benefit. Therefore, renal artery stenosis causing renal insufficiency remains a difficult point in clinical treatment. Summary of the Invention

[0004] One of the purposes of the present invention is to provide a formula of a traditional Chinese medicine composition for treating renal insufficiency, which can benefit qi and warm yang, promote blood circulation, promote diuresis, and reduce swelling, can effectively improve the creatinine level of patients with renal artery stenosis, and can lower blood pressure, so as to treat renal insufficiency caused by renal artery stenosis.

[0005] To achieve the above purpose, the present invention provides a formula of a traditional Chinese medicine composition for treating renal insufficiency, which includes raw materials: Astragalus membranaceus, Lepidium apetalum, Plantago asiatica, and Pyrola decorata.

[0006] In addition, the present invention also provides a formula of a traditional Chinese medicine composition for treating renal insufficiency, which is composed of raw materials: Astragalus membranaceus, Lepidium apetalum, Plantago asiatica, and Pyrola decorata.

[0007] It should be noted that the raw medicinal materials involved in the present invention are Chinese medicinal herbs included in the Chinese Pharmacopoeia 2000 Edition and meet the quality requirements of the Pharmacopoeia.

[0008] Renal insufficiency caused by renal artery stenosis can be attributed to the categories of "edema", "guan ge" in traditional Chinese medicine. The premise of this disease is the damage of the body and function of the kidney, which leads to the accumulation of dampness and blood stasis. Therefore, the pathogenesis of this disease is mostly deficiency in origin and excess in superficiality. The deficiency in origin is the deficiency of spleen and kidney yang qi, and the excess in superficiality is dampness, phlegm and turbidity. When dampness floods, blood stasis blocks the collaterals, and dampness, phlegm and turbidity, and blood stasis condense in the blood vessels, this disease occurs.

[0009] In the formula of the traditional Chinese medicine composition of the present invention, astragalus membranaceus benefits qi and warms yang, and is the monarch drug; semen lepidii and semen plantaginis promote diuresis and percolate dampness, and are the ministerial drugs; herba pycnostelmatis removes blood stasis and promotes blood circulation, and is the assistant drug. Through the cooperation of the above components, the formula of the traditional Chinese medicine composition takes into account both the root and the branch, so that the spleen and kidney yang qi can be invigorated, blood stasis can be removed, and dampness, phlegm and turbidity can be dispelled.

[0010] Furthermore, in the formula of the traditional Chinese medicine composition described in the present invention, the mass ratio of the raw medicinal materials is as follows:

[0011] Astragalus membranaceus: 10 parts - 60 parts,

[0012] Semen lepidii: 12 parts - 60 parts,

[0013] Semen plantaginis: 12 - 60 parts,

[0014] Herba pycnostelmatis: 5 parts - 20 parts.

[0015] Even further, in the formula of the traditional Chinese medicine composition described in the present invention, the mass ratio of the raw medicinal materials is as follows:

[0016] Astragalus membranaceus: 35 parts - 48 parts,

[0017] Semen lepidii: 35 parts - 60 parts,

[0018] Semen plantaginis: 35 - 60 parts,

[0019] Herba pycnostelmatis: 10 parts - 20 parts.

[0020] Correspondingly, another object of the present invention is to provide a traditional Chinese medicine preparation for treating renal insufficiency, which is prepared from the above formula of the traditional Chinese medicine composition, and the traditional Chinese medicine preparation is at least one of decoction, powder, tablet, granule or capsule.

[0021] In addition, another object of the present invention is to provide a preparation method of a traditional Chinese medicine preparation for treating renal insufficiency, including the steps of: placing each raw medicinal material in a closed container and decocting at least twice to obtain a decoction; using the decoction to prepare at least one of decoction, powder, tablet, granule or capsule.

[0022] Further, in the preparation method of the traditional Chinese medicine preparation for treating renal insufficiency according to the present invention, during the first decoction, water with a weight 3 - 7 times that of the raw medicinal materials is used, and after boiling, it is kept warm within the temperature range of 88 - 95°C for 28 - 35 minutes. After filtration, the decoction obtained from the first decoction is obtained; during the second decoction, water with a weight 1 - 5 times that of the raw medicinal materials is used, and after boiling, it is kept warm within the range of 88 - 95°C for 18 - 25 minutes. After filtration, the decoction obtained from the second decoction is obtained; the decoctions from at least two decoctions are combined.

[0023] Further, in the preparation method of the traditional Chinese medicine preparation for treating renal insufficiency according to the present invention, the decoction is filtered, concentrated under reduced pressure, and dried to obtain a dry extract; excipients are added to the dry extract to make at least one of powder, tablets, granules, or capsules.

[0024] In addition, the present invention also provides the use of the above traditional Chinese medicine composition formula, which is used for treating renal insufficiency caused by renal artery stenosis.

[0025] Further, for the use of the traditional Chinese medicine composition formula according to the present invention, the creatinine level is reduced by more than 30 μmol / L compared with before treatment; and / or the systolic blood pressure is reduced by more than 20 mmHg compared with before treatment; and / or the creatinine level is maintained below 90 μmol / L; and / or the systolic blood pressure is maintained below 140 mmHg; and / or the left - right kidney mass ratio is increased to more than 0.9.

[0026] Correspondingly, the present invention also provides the use of the above traditional Chinese medicine preparation, which is used for treating renal insufficiency caused by renal artery stenosis.

[0027] Further, for the use of the traditional Chinese medicine preparation according to the present invention, the creatinine level is reduced by more than 30 μmol / L compared with before treatment; and / or the systolic blood pressure is reduced by more than 20 mmHg compared with before treatment; and / or the creatinine level is maintained below 90 μmol / L; and / or the systolic blood pressure is maintained below 140 mmHg; and.

[0028] The traditional Chinese medicine composition formula described in the present invention can effectively improve the creatinine level of patients with renal artery stenosis and can reduce blood pressure, thereby being used for treating renal insufficiency caused by renal artery stenosis.

[0029] Correspondingly, the traditional Chinese medicine preparation prepared by using the traditional Chinese medicine composition formula designed by the present invention can also effectively improve the creatinine level of patients with renal artery stenosis and can reduce blood pressure, thereby being used for treating renal insufficiency caused by renal artery stenosis.

[0030] In addition, besides having the above - mentioned advantages, the traditional Chinese medicine preparation described in the present invention also has the advantages of convenient administration, small dosage, and safe and reliable curative effect. Detailed implementation manners

[0031] The following will further explain and illustrate the formula of the traditional Chinese medicine composition, the traditional Chinese medicine preparation and its preparation method, and the use for treating renal insufficiency according to the present invention in combination with specific embodiments. However, this explanation and illustration shall not unduly limit the technical solution of the present invention.

[0032] Table 1 lists the mass parts ratio of the traditional Chinese medicine composition formula of Examples 1-5.

[0033] Table 1.

[0034]

[0035] In the present invention, when designing and preparing the traditional Chinese medicine preparations of Examples 1-5, each part of the components used represents 1 g.

[0036] Each example is made into a traditional Chinese medicine preparation according to the traditional Chinese medicine composition formula of Examples 1-5 listed in Table 1, and specifically includes the steps of: placing each raw material drug in a closed container and decocting at least twice to obtain a decoction; preparing at least one of a decoction, a powder, a tablet, a granule or a capsule from the decoction.

[0037] Table 2 lists the specific process steps of Examples 1-5 in preparing the traditional Chinese medicine preparation.

[0038] Table 2.

[0039]

[0040] Example 1:

[0041] In this embodiment, the following raw material drugs are weighed: 48 parts of Astragalus membranaceus, 12 parts of Lepidium apetalum, 36 parts of Plantago asiatica, and 20 parts of Cynanchum paniculatum.

[0042] The above raw material drugs are placed in a closed container and decocted twice. When decocting for the first time, 3 times the weight of the raw material drugs of water is added, and after boiling, it is kept warm at 88 °C for 35 min to obtain the decoction of the first decoction; when decocting for the second time, 5 times the weight of the raw material drugs of water is added, and after boiling, it is kept warm at 95 °C for 18 min to obtain the decoction of the second decoction; the decoctions of the two decoctions are combined, filtered, and the filtrates are combined. Concentrate under reduced pressure, dry under reduced pressure to obtain a dry extract, and pulverize it into fine powder (for example, passing through 80 meshes).

[0043] In order to verify the therapeutic effect of the traditional Chinese medicine composition formula or the traditional Chinese medicine preparation described in this technical solution, for the traditional Chinese medicine preparation obtained in Example 1, the following tests are further carried out in this technical solution:

[0044] 1. Research test on improving renal ischemia in rats and reducing peripheral blood pressure

[0045] 1.1 Test method

[0046] Twenty-eight SPF-grade male Wistar rats, weighing 200 - 220 g, were purchased from Shanghai Experimental Animal Center, Chinese Academy of Sciences, with the production license number: SCXK(Shanghai): 2012 - 0002.

[0047] Five rats in the model group, the control group, and the traditional Chinese medicine group were made into a model of unilateral renal ischemic hypertension rats (RAS model) by abdominal aortic coarctation method. The experimental rats were fasted for 12 h before surgery without water restriction. After anesthesia by intraperitoneal injection of 2% pentobarbital sodium at 35 mg / kg, the abdomen was opened, with an opening of about 1.5 cm. The abdominal soft tissues were bluntly separated to expose the abdominal aorta. The abdominal aorta between the bilateral renal arteries was separated. A blunt metal needle with a diameter of about 0.6 mm was placed parallel to this section of the abdominal aorta, and then ligated with a surgical suture (5 - 0), and the metal needle was quickly withdrawn to cause abdominal aortic coarctation. This caused high perfusion, high glomerular capsule pressure, and high glomerular filtration pressure in the right kidney of the model animals, while the left renal parenchyma was ischemic, resulting in obvious atrophy of the left kidney and compensatory hypertrophy of the right kidney. Five rats in the sham operation group only had the abdomen opened to expose and separate the abdominal aorta between the bilateral renal arteries without ligation.

[0048] 1.1.2 Grouping and drug administration

[0049] Five rats in the sham operation group: Given an equal amount of double-distilled water.

[0050] Five rats in the model group: Given an equal amount of double-distilled water.

[0051] Five rats in the control group: Given the ACEI drug perindopril at a concentration of 0.036 mg / ml.

[0052] Five rats in the traditional Chinese medicine group: 6.75 g / kg of the powder group described in Example 1 (calculated by raw drug amount). Drug intervention started 2 weeks after surgery in both groups, and the intervention course was 4 weeks.

[0053] 1.1.3 Statistical analysis

[0054] It should be noted that the P value is the probability, which reflects the likelihood of an event occurring and is the probability that the difference between samples is caused by sampling error. The P value can be less than 0.05 or 0.01. The smaller the P value, the more significant the result. P < 0.05 indicates that the difference is statistically significant; P > 0.05 means that the difference is not statistically significant. Among them, Tables 3, 4, 5, 6, 7, 8, 9, 10, and 11 belong to measurement data that meet independence, normality, and homogeneity of variance. The independent sample t-test was used to calculate the probability P for the comparison of rat kidney weights; the grouped t-test was used to calculate the probability P for the comparison between the control group before treatment and the traditional Chinese medicine group before treatment; the paired t-test was used to calculate the probability P for the control group before and after treatment; the paired t-test was used to calculate the probability P for the traditional Chinese medicine group before and after treatment; the grouped t-test was used to calculate the probability P for the comparison between the control group after treatment and the traditional Chinese medicine group after treatment. The above calculation methods are known calculation methods in the prior art, so they will not be elaborated here.

[0055] 1.2 Test results

[0056] 1.2.1. Comparison results of the ratio of left and right kidney weights

[0057] After 4 weeks of intervention treatment, the kidney sizes of the two groups were compared. That is, the ratio of the left and right kidney weights of the rats in the traditional Chinese medicine preparation group (i.e., the traditional Chinese medicine group in Table 3) of Example 1 of this case was compared, and the comparison results are listed in Table 3.

[0058] Table 3.

[0059]

[0060] Note: In Table 3 and subsequent Tables 4 - 11, n represents the sample size of the rats, that is, there are 5 rats in the control group and also 5 rats in the traditional Chinese medicine group.

[0061] In the above Table 3, both the left and right kidney weights and ratios are expressed in the form of the mean plus or minus the standard deviation. In Table 3 and subsequent Tables 5 and 7, "#" and "##" respectively indicate that when comparing the kidney weight of this group with the model group, the P values of this group are P < 0.05 and P < 0.01, and the differences are statistically significant. In Table 3 and subsequent Tables 5 and 7, "*" and "**" indicate that when comparing the traditional Chinese medicine group of this group with the control group, the P values of this group are P < 0.05 and P < 0.01 respectively, and the differences are statistically significant.

[0062] It can be seen from the above Table 3 that after 4 weeks of treatment, when comparing the kidney ratio of the traditional Chinese medicine rats using the traditional Chinese medicine preparation of Example 1 of this case with the simple western medicine treatment group, the statistical analysis shows that P < 0.05, which means that the difference is significantly statistically significant. It can be seen that after the traditional Chinese medicine loading treatment using the traditional Chinese medicine preparation of Example 1 of this case, the effect of improving renal ischemia caused by RAS is better than that of the control group.

[0063] 1.2.2 Comparison results of peripheral blood pressure in rats with abdominal aortic constriction

[0064] The peripheral blood pressures of the rats in the simple western medicine treatment group (i.e., the control group in Table 4) before and 4 weeks after the intervention treatment were compared with those of the rats in the traditional Chinese medicine preparation group (i.e., the traditional Chinese medicine group in Table 4) of Example 1 of this case. The comparison results are listed in Table 4.

[0065] Table 4 lists the comparison results of peripheral blood pressure in the control group and the traditional Chinese medicine group before and after treatment.

[0066] Table 4

[0067]

[0068] In the above Table 4, the peripheral blood pressure before treatment and after treatment is expressed by , that is, in the form of the mean plus or minus the standard deviation. The "#" in Table 4 indicates that when the peripheral blood pressure after treatment is compared with the model group, the P value of this group is P < 0.05, and the difference is statistically significant. The "△" indicates that when the peripheral blood pressure after modeling is compared with the sham operation, the P value of this group is P < 0.05, and the difference is statistically significant.

[0069] It can be seen from Table 4 that after 4 weeks of intervention treatment, the peripheral blood pressures of the rats in the traditional Chinese medicine group and the simple western medicine treatment group (control group) both decreased, and the statistical analysis showed P < 0.05, that is, both groups could reduce the peripheral blood pressure after treatment.

[0070] In summary, it can be seen that the traditional Chinese medicine treatment using the traditional Chinese medicine preparation of Example 1 of this case can not only reduce the peripheral blood pressure of RAS rats, but also the formula of the traditional Chinese medicine composition described in the present invention has a better curative effect on improving the blood supply of the ischemic side kidney of RAS than the western medicine group.

[0071] Example 2

[0072] Weigh the following raw materials: 24 parts of Astragalus membranaceus, 48 parts of Lepidium apetalum Willd., 60 parts of Plantago asiatica L., and 5 parts of Cynanchum paniculatum (Bge.) Kitag.

[0073] Put the above raw materials in a closed container and decoct them twice. When decocting for the first time, add 5 times the weight of the raw materials of water, keep warm at 91 °C for 30 minutes after boiling to obtain the decoction of the first decoction; when decocting for the second time, add 3 times the weight of the raw materials of water, keep warm at 90 °C for 23 minutes after boiling to obtain the decoction of the second decoction; combine the decoctions of the two decoctions, filter, and combine the filtrates. Concentrate under reduced pressure and dry under reduced pressure to obtain a dry extract, and then add an appropriate amount of excipient such as dextrin to prepare a granule.

[0074] To verify the therapeutic effect of the traditional Chinese medicine composition formula or traditional Chinese medicine preparation described in this technical solution, the following tests were further carried out on the traditional Chinese medicine preparation of Example 2 obtained:

[0075] 2. Research test on improving renal ischemia in rats and reducing peripheral blood pressure

[0076] 2.1 Test method

[0077] Same as Example 1

[0078] 2.1.1 Intervention plan

[0079] Same as Example 1

[0080] 2.1.2 Grouping

[0081] Control group: Given the ACEI drug perindopril at a concentration of 0.036 mg / ml.

[0082] Traditional Chinese medicine group: 6.75 g / kg of the capsule group described in Example 2 (calculated by raw drug amount). Drug intervention started 2 weeks after the operation in both groups, and the intervention course was 4 weeks.

[0083] 2.2 Test results

[0084] 2.2.1. Comparison results of the ratio of left and right kidney weights

[0085] After 4 weeks of intervention treatment, the sizes of the kidneys in the two groups were compared. That is, the ratio of the left and right kidney masses of the rats in the traditional Chinese medicine preparation group of Example 1 of this case (i.e., the traditional Chinese medicine group in Table 5) was compared, and the comparison results are listed in Table 5.

[0086] Table 5.

[0087]

[0088] As can be seen from Table 5 above, after 4 weeks of treatment, compared with the simple western medicine treatment group, the statistical analysis P < 0.05 for the ratio of the kidney sizes of the traditional Chinese medicine rats using the traditional Chinese medicine preparation of Example 2 of this case, that is, the difference is statistically significant. It can be seen that after treatment with the traditional Chinese medicine preparation of Example 2 of this case, it can significantly improve renal ischemia caused by RAS.

[0089] 2.2.2. Comparison results of peripheral blood pressure in rats with abdominal aortic constriction

[0090] The peripheral blood pressure of the rats in the simple western medicine treatment group (i.e., the control group in Table 6) before and 4 weeks after the intervention treatment was compared with that of the rats in the traditional Chinese medicine preparation group of Example 2 of this case (i.e., the traditional Chinese medicine group in Table 6), and the comparison results are listed in Table 6.

[0091] Table 6 lists the comparison results of peripheral blood pressure between the control group and the traditional Chinese medicine group before and after treatment.

[0092] Table 6

[0093]

[0094] In the above Table 6, the peripheral blood pressure before treatment and the peripheral blood pressure after treatment are represented by , that is, in the form of mean plus or minus standard deviation. The "#" in Table 6 indicates that when the peripheral blood pressure after treatment is compared with the model group, the P value of this group is P < 0.05, and the difference is statistically significant. "△" indicates that when the peripheral blood pressure after modeling is compared with the sham operation, the P value of this group is P < 0.05, and the difference is statistically significant.

[0095] It can be seen from Table 6 that after 4 weeks of intervention treatment, the peripheral blood pressure of rats in the traditional Chinese medicine group and the simple western medicine treatment group (control group) decreased, and the statistical analysis showed P < 0.05, that is, both groups could reduce the peripheral blood pressure after treatment.

[0096] In summary, it can be seen that the traditional Chinese medicine treatment using the traditional Chinese medicine preparation of Example 2 of the present case can not only reduce the peripheral blood pressure of RAS rats, but also the formula of the traditional Chinese medicine composition of the present invention has a better curative effect on improving the blood supply of the ischemic side kidney of RAS than the western medicine group.

[0097] Example 3

[0098] Weigh the following raw materials: 36 parts of Astragalus membranaceus, 24 parts of Lepidium apetalum, 12 parts of Plantago asiatica, and 16 parts of Pyrola decorata.

[0099] Put the above raw materials in a sealed container and decoct them twice. When decocting for the first time, add 7 times the weight of the raw materials of water, boil and keep warm at 93 °C for 28 minutes to obtain the decoction of the first decoction; when decocting for the second time, add 1 time the weight of the raw materials of water, boil and keep warm at 89 °C for 25 minutes to obtain the decoction of the second decoction; combine the decoctions of the two decoctions, filter, and combine the filtrates. Concentrate under reduced pressure and dry under reduced pressure to obtain a dry extract, and then add appropriate excipients to prepare tablets.

[0100] In order to verify the therapeutic effect of the traditional Chinese medicine composition formula or the traditional Chinese medicine preparation described in this technical solution, for the traditional Chinese medicine preparation of Example 3 obtained, the following tests were further carried out in this technical solution:

[0101] 3. Research test on improving renal ischemia and reducing peripheral blood pressure in rats

[0102] 3.1 Test method

[0103] Same as Example 1

[0104] 3.1.1 Intervention plan

[0105] Same as Example 1

[0106] 3.1.2 Grouping

[0107] Control group: Given the ACEI drug perindopril at a concentration of 0.036 mg / ml.

[0108] Traditional Chinese medicine group: 6.75 g / kg of the tablet group described in Example 3 (calculated by raw drug amount). Drug intervention started 2 weeks after the operation in both groups, and the intervention course was 4 weeks.

[0109] 3.2 Test results

[0110] 3.2.1 Comparison results of the weight ratio of the left and right kidneys

[0111] After 4 weeks of intervention treatment, the sizes of the kidneys in the two groups were compared. That is, the weight ratio of the left and right kidneys of the rats in the traditional Chinese medicine preparation group of Example 3 of this case (i.e., the traditional Chinese medicine group in Table 7) was compared, and the comparison results are listed in Table 7.

[0112] Table 7.

[0113]

[0114] It can be seen from Table 7 above that after 4 weeks of treatment, the kidney size ratio of the traditional Chinese medicine rats using the traditional Chinese medicine preparation of Example 3 of this case was compared with that of the simple western medicine treatment group, and the statistical analysis showed P < 0.05, which means the difference was statistically significant. It can be seen that after treatment with the traditional Chinese medicine preparation of Example 3 of this case, it can significantly improve the renal ischemia caused by RAS.

[0115] 3.2.2 Comparison results of the peripheral blood pressure of rats with abdominal aortic constriction

[0116] The peripheral blood pressure of the rats in the simple western medicine treatment group (i.e., the control group in Table 8) before and 4 weeks after the intervention treatment was compared with that of the rats in the traditional Chinese medicine preparation group of Example 3 of this case (i.e., the traditional Chinese medicine group in Table 8), and the comparison results are listed in Table 8.

[0117] Table 8 lists the comparison results of the peripheral blood pressure of the control group and the traditional Chinese medicine group before and after treatment.

[0118] Table 8

[0119]

[0120] In Table 8 above, the peripheral blood pressure before treatment and the peripheral blood pressure after treatment were used It is expressed in the form of the mean plus or minus the standard deviation. In Table 8, "#" indicates that when comparing the peripheral blood pressure after treatment with that of the model group, the P value of this group is P < 0.05, indicating a statistically significant difference. "△" indicates that when comparing the peripheral blood pressure after modeling with that of the sham operation group, the P value of this group is P < 0.05, indicating a statistically significant difference.

[0121] As can be seen from Table 8, after 4 weeks of intervention treatment, the peripheral blood pressure of rats in the traditional Chinese medicine group and the simple western medicine treatment group (control group) decreased. Statistical analysis showed P < 0.05, indicating that both groups could reduce the peripheral blood pressure after treatment.

[0122] In summary, it can be seen that the traditional Chinese medicine treatment using the traditional Chinese medicine preparation in Example 3 of this case can not only reduce the peripheral blood pressure of RAS rats, but also the formula of the traditional Chinese medicine composition of the present invention is superior to that of the western medicine group in improving the blood supply of the ischemic side kidney of RAS.

[0123] It should be noted that in order to save limited funds and experimental resources, Example 1, Example 2, and Example 3 were carried out simultaneously, and the control group, model group, and western medicine group were the same group. The traditional Chinese medicine group was given the drugs described in Example 1, Example 2, and Example 3.

[0124] Example 4

[0125] Weigh the following raw materials: 60 parts of Astragalus membranaceus, 36 parts of Lepidium apetalum Willd., 24 parts of Plantago asiatica L., and 13 parts of Cynanchum paniculatum (Bge.) Kitag.

[0126] Put the above raw materials in a closed container and decoct twice. When decocting for the first time, add 4 times the weight of the raw materials in water, boil, and keep warm at 89 °C for 31 minutes to obtain the decoction of the first decoction; when decocting for the second time, add 4 times the weight of the raw materials in water, boil, and keep warm at 93 °C for 22 minutes to obtain the decoction of the second decoction; combine the decoctions of the two decoctions, filter, and combine the filtrates. Concentrate under reduced pressure and dry under reduced pressure to obtain a dry extract, and then add appropriate excipients to prepare capsules.

[0127] Example 5

[0128] Weigh the following raw materials: 12 parts of Astragalus membranaceus, 60 parts of Lepidium apetalum Willd., 48 parts of Plantago asiatica L., and 8 parts of Cynanchum paniculatum (Bge.) Kitag.

[0129] Put the above raw materials in a closed container and decoct twice. When decocting for the first time, add 6 times the weight of the raw materials in water, boil, and keep warm at 95 °C for 33 minutes to obtain the decoction of the first decoction; when decocting for the second time, add 2 times the weight of the raw materials in water, boil, and keep warm at 88 °C for 20 minutes to obtain the water decoction of the second decoction (for example, the obtained water decoction is 100 ml in total. Take orally twice a day, 50 ml each time, take the medicine 7 days a week, and 2 weeks is a course of treatment).

[0130] 1. Research and test on improving renal function

[0131] 1.1 Clinical trial method

[0132] According to the order of medical treatment, 30 patients with RAS-induced renal insufficiency were enrolled and randomly assigned to the control group and the treatment group according to the random number table.

[0133] 1.1.1 Intervention plan

[0134] 1.1.2. Basic treatment plan

[0135] Both the pure western medicine treatment group and the traditional Chinese medicine loading treatment group were given western medicine-based and standardized treatment.

[0136] Western medicine standardized treatment plan: Refer to the "Chinese Expert Consensus on the Diagnosis and Treatment of Renal Artery Stenosis in 2017" and the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, and appropriately give standardized treatment with traditional drugs such as statins, angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), β-blockers, calcium channel blockers (CCBs), etc. Patients who require intervention or surgery are excluded from this embodiment.

[0137] 1.1.3 Grouping

[0138] Control group: ACEI, ARB, β-blocker, CCB, statin were used.

[0139] Traditional Chinese medicine group: On the basis of western medicine basic treatment, the traditional Chinese medicine preparation of Example 5 of this case was added, taken twice a day after meals in the morning and evening, and intervened for 4 weeks.

[0140] 2.2 Test results

[0141] 2.2.1 Comparison results of creatinine

[0142] The creatinine of the patients in the pure western medicine treatment group (i.e., the control group in Table 9) before and 4 weeks after the intervention treatment was compared with that of the patients in the traditional Chinese medicine loading treatment group (i.e., the traditional Chinese medicine group in Table 9) using the traditional Chinese medicine preparation of Example 3 of this case, and the comparison results are listed in Table 9.

[0143] Table 9.

[0144]

[0145]

[0146] In Table 9 above, "#" and "##" represent the comparison of creatinine before and after treatment in the control group and the traditional Chinese medicine group, and the P values of this group are P < 0.05 and P < 0.01 respectively; "*" represents the comparison of creatinine after treatment between the traditional Chinese medicine group and the control group, and the P value of this group is P < 0.05.

[0147] As can be seen from Table 9, before the intervention treatment, a statistical analysis was conducted on the creatinine levels of the patients in the pure western medicine treatment group and the traditional Chinese medicine loading treatment group. The result showed that P > 0.05, indicating that there was no statistically significant difference and the two groups were comparable. After 4 weeks of treatment, the creatinine level in the traditional Chinese medicine loading treatment group decreased significantly. According to the statistical analysis of the creatinine data before and after treatment in the traditional Chinese medicine loading treatment group, P < 0.01, indicating that there was a statistically significant difference. After 4 weeks of treatment, the creatinine level in the pure western medicine treatment group also decreased. According to the statistical analysis of the creatinine data before and after treatment in the pure western medicine treatment group, P < 0.05, indicating that there was a statistically significant difference. In addition, when comparing the creatinine levels between the traditional Chinese medicine loading treatment group and the pure western medicine treatment group, the decline in the traditional Chinese medicine loading treatment group was more obvious. According to the statistical analysis of the creatinine data of the pure western medicine treatment group after treatment and the traditional Chinese medicine loading treatment group after treatment, P < 0.05, indicating that there was a statistically significant difference.

[0148] It can be seen from this that both the traditional Chinese medicine loading treatment group using the traditional Chinese medicine preparation in Example 5 of this case and the pure western medicine treatment group can reduce the creatinine level, but the curative effect of the traditional Chinese medicine loading treatment group is better than that of the pure western medicine treatment group.

[0149] 2.2.2. Comparison results of systolic blood pressure

[0150] The systolic blood pressure levels of the patients in the pure western medicine treatment group (i.e., the control group in Table 10) before the intervention treatment and 4 weeks after the intervention treatment, and the traditional Chinese medicine loading treatment group using the traditional Chinese medicine preparation in Example 5 of this case (i.e., the traditional Chinese medicine group in Table 10) were compared. The comparison results are listed in Table 10.

[0151] Table 10.

[0152] Group n Systolic blood pressure before treatment (mmHg) Systolic blood pressure after treatment (mmHg) Control group 15 149±13 <![CDATA[129±12 # > Traditional Chinese medicine group 15 156±15 <![CDATA[132±10 # >

[0153] In the above Table 10, "#" represents the comparison of the systolic blood pressure levels of the control group before and after treatment, and the probability P value < 0.05.

[0154] As can be seen from Table 10, before the intervention treatment, a statistical analysis was conducted on the systolic blood pressure comparison between the pure western medicine treatment group and the traditional Chinese medicine loading treatment group. The result showed that P > 0.05, indicating that there was no statistically significant difference and the two groups were comparable. After 4 weeks of treatment, the systolic blood pressure in the traditional Chinese medicine loading treatment group decreased significantly. According to the statistical analysis of the systolic blood pressure data before and after treatment in the traditional Chinese medicine loading treatment group, P < 0.05, indicating that there was a statistically significant difference. After 4 weeks of treatment, the systolic blood pressure in the pure western medicine treatment group also decreased significantly. According to the statistical analysis of the systolic blood pressure data before and after treatment in the pure western medicine treatment group, P < 0.05, indicating that there was a statistically significant difference. When comparing the decline in systolic blood pressure between the traditional Chinese medicine loading treatment group and the pure western medicine treatment group, the decline in the traditional Chinese medicine loading treatment group reached 24 mmHg (mean before treatment - mean after treatment), and the decline in the pure western medicine treatment group was 20 mmHg.

[0155] It can be seen from this that both the Western medicine treatment group and the Chinese medicine loading treatment group using the Chinese medicine preparation of Example 5 of this case can reduce the systolic blood pressure of the patients.

[0156] In order to verify the safety of the Chinese medicine preparation prepared by the Chinese medicine composition formula of the present invention, the patient's liver function was selected as an evaluation index and a safety test was conducted. In the safety test, the treatment time was controlled to be 4 weeks, and the alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of the simple Western medicine treatment group (i.e., the control group in Table 11) and the Chinese medicine loading treatment group using the Chinese medicine preparation of Example 5 of this case (i.e., the Chinese medicine group in Table 11) were compared to test and obtain the content of the above-mentioned components before and after treatment, and the test results are listed in the following Table 11.

[0157] Table 11.

[0158] Group Time n ALT (IU / L) AST (IU / L) Control group After treatment 15 25.07±11.28 20.91±6.08 Traditional Chinese medicine group After treatment 15 21.13±8.07 21.73±8.15

[0159] In the above Table 11, the values ​​of ALT and AST are It is expressed as the mean plus or minus the standard deviation. As shown in Table 11, after 4 weeks of intervention treatment, there was no significant increase in alanine aminotransferase and aspartate aminotransferase in the Chinese medicine loading treatment group and the Western medicine treatment group, and the ALT normal range was (9-50) and AST normal range was (15-40).

[0160] It can be seen from this that after treatment with the Chinese medicine preparation of Example 3 of this case, there was no significant change in the alanine aminotransferase and aspartate aminotransferase of RAS patients.

[0161] In summary, it can be found through the animal experiments of Examples 1-3 above that the Chinese medicine composition for treating RAS-induced renal insufficiency of the present invention has been experimentally proven to significantly improve renal ischemia in rats with RAS-induced renal insufficiency and reduce peripheral blood pressure.

[0162] Accordingly, through the clinical experiments of Examples 4 and 5 above, it can be found that the Chinese medicine preparation prepared according to the Chinese medicine composition formula designed by the present invention can also reduce the creatinine level of patients with renal insufficiency caused by RAS and reduce the systolic blood pressure of patients.

[0163] It should be noted that the above examples are only specific embodiments of the present invention, and the present invention is obviously not limited to the above examples, and there are many similar variations. All variations directly derived or associated from the contents disclosed by the technicians in this field should fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition formula for treating renal insufficiency, characterized in that, It includes crude drugs: Astragalus membranaceus, Lepidium apetalum, Plantago asiatica, and Cynanchum paniculatum.

2. The traditional Chinese medicine composition formula according to claim 1, characterized in that, It is composed of crude drugs: Astragalus membranaceus, Lepidium apetalum, Plantago asiatica, and Cynanchum paniculatum.

3. The traditional Chinese medicine composition formula according to claim 1 or 2, characterized in that, The mass ratio of its crude drugs is: Astragalus membranaceus: 10 parts - 60 parts, Lepidium apetalum: 12 parts - 60 parts, Plantago asiatica: 12 - 60 parts, Cynanchum paniculatum: 5 parts - 20 parts.

4. The traditional Chinese medicine composition formula according to claim 3, characterized in that, The mass ratio of its crude drugs is: Astragalus membranaceus: 35 parts - 48 parts, Lepidium apetalum: 35 parts - 60 parts, Plantago asiatica: 35 - 60 parts, Cynanchum paniculatum: 10 parts - 20 parts.

5. A traditional Chinese medicine preparation for treating renal insufficiency, characterized in that, It is prepared from the traditional Chinese medicine composition formula described in any one of claims 1 - 4, and the traditional Chinese medicine preparation is at least one of decoction, powder, tablet, granule or capsule.

6. The preparation method of the traditional Chinese medicine preparation according to claim 5, characterized in that, It includes the steps: placing each crude drug in a closed container and decocting at least twice to obtain a decoction; preparing at least one of decoction, powder, tablet, granule or capsule from the decoction.

7. The preparation method of the traditional Chinese medicine preparation according to claim 6, characterized in that: In the first decoction, use 3 - 7 times the weight of the crude drug in water volume, keep it warm at a temperature range of 88 - 95°C for 28 - 35 min after boiling, filter to obtain the decoction of the first decoction; in the second decoction, use 1 - 5 times the weight of the crude drug in water volume, keep it warm at 88 - 95°C for 18 - 25 min after boiling, filter to obtain the decoction of the second decoction; combine the decoctions of at least two decoctions.

8. The preparation method of the traditional Chinese medicine preparation for treating cardio-renal syndrome according to claim 6 or 7, characterized in that, Filter, reduce pressure and concentrate, and dry the decoction to obtain a dry extract; Add excipients to the dry extract to prepare at least one of powder, tablet, granule or capsule.

9. Use of the traditional Chinese medicine composition formula according to any one of claims 1-4, characterized in that, It is used for treating renal insufficiency caused by renal artery stenosis.

10. Use of the traditional Chinese medicine composition formula according to claim 9, characterized in that, It reduces the creatinine level by more than 30 μmol / L compared with before treatment; and / or reduces the systolic blood pressure by more than 20 mmHg compared with before treatment; and / or keeps the creatinine level below 90 μmol / L; and / or keeps the systolic blood pressure below 140 mmHg; and / or raises the left - right kidney mass ratio to more than 0.

9.

11. Use of the traditional Chinese medicine preparation according to claim 5, characterized in that, It is used for treating renal insufficiency caused by renal artery stenosis.

12. Use of the traditional Chinese medicine preparation according to claim 11, characterized in that, It reduces the creatinine level by more than 30 μmol / L compared with before treatment; and / or reduces the systolic blood pressure by more than 20 mmHg compared with before treatment; and / or keeps the creatinine level below 90 μmol / L; and / or keeps the systolic blood pressure below 140 mmHg; and / or raises the left - right kidney mass ratio to more than 0.9.

Images