A Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion and its preparation method

Abstract

The invention discloses a Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion and a preparation method thereof, wherein the composition comprises the following components by weight: 12-18 parts of Pueraria root; 8-12 parts of Coptis chinensis; 8-12 parts of Curcuma zedoariae; 12-18 parts of Millettia reticulatae; 8-12 parts of Pheretima; and 8-12 parts of Cinnamomum cassiae. The composition provided by the invention can effectively treat diabetic lower limb arteriosclerosis and vascular occlusion.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion and a preparation method thereof. Background Art

[0002] Globally, the morbidity and mortality of chronic limb-threatening ischemia (CLTI) continue to rise, and medical costs continue to increase, placing a heavy burden on patients and society. Epidemiology shows that 5% to 10% of asymptomatic peripheral arterial disease (PAD) patients usually develop into CLTI after 5 years. Type 2 diabetes is one of the high-risk factors, and its role cannot be ignored. Diabetes is one of the high-risk factors for cardiovascular and cerebrovascular diseases and peripheral vascular diseases, and hyperglycemia is an important cause of various complications. The increase in advanced glycation end products caused by hyperglycemia can promote the production of reactive oxygen species to reduce intracellular nitric oxide, increase the level of endothelin, promote vascular contraction, and aggravate ischemia.

[0003] Diabetic peripheral vascular disease corresponds to "gangrene" in traditional Chinese medicine. Gangrene was first seen in the "Lingshu·Carbuncle" chapter of "Huangdi Neijing": "It occurs on the toes, called carbuncle, and its appearance is red and black." Gangrene, also known as "bone-losing carbuncle", is a disease characterized by unbearable pain in the toe joints, necrosis and shedding, black rot and ulceration, and long-term wound healing. Traditional Chinese medicine believes that "blood stasis" is the key to the cause of gangrene. Gangrene is often secondary to diabetes, which is often caused by improper diet, excessive eating of fat and sweet foods, extreme emotions, and fever. Its basic pathogenesis is loss of yin and fluid, and excessive dryness and heat.

[0004] However, there are few reports on Chinese herbal medicine compositions for treating diabetic lower limb arteriosclerosis and vascular occlusion.

[0005] In view of this, the present invention is proposed. Summary of the invention

[0006] The purpose of the present invention is to overcome the deficiencies of the above-mentioned prior art and provide a Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion and a preparation method thereof, which can effectively treat diabetic lower limb arteriosclerosis and vascular occlusion.

[0007] In order to achieve the above technical objectives, the present invention adopts the following technical solutions:

[0008] The invention provides a traditional Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion, which comprises the following components by weight: 12-18 parts of kudzu root; 8-12 parts of coptis root; 8-12 parts of zedoaria; 12-18 parts of millettia reticulata; 8-12 parts of earthworm; and 8-12 parts of cassia twig.

[0009] Optionally, the composition comprises, by weight:

[0010] 12 parts of Puerariae Radix; 12 parts of Coptis Rhizome; 8 parts of Curcuma Rhizoma; 18 parts of Millettia Spatholobi; 8 parts of Pheretima; 12 parts of Cinnamomum cassia twig.

[0011] Optionally, the composition comprises, by weight:

[0012] 18 parts of Puerariae Radix; 8 parts of Coptis Rhizome; 12 parts of Curcuma Rhizoma; 12 parts of Millettia Spatholobi; 12 parts of Pheretima; 8 parts of Cinnamomum Cassiae Ramulus.

[0013] Optionally, the composition comprises, by weight:

[0014] 15 parts of Puerariae Radix; 10 parts of Coptis Rhizome; 10 parts of Curcuma Rhizoma; 15 parts of Millettia Spatholobi; 10 parts of Pheretima; 10 parts of Cinnamomum Cassiae Ramulus.

[0015] Another aspect of the present invention provides a method for preparing a Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion, comprising:

[0016] Prepare the medicinal slices according to the components in the above-mentioned Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion;

[0017] Soak the medicinal pieces in cold water for 20-40 minutes, then add water and boil twice, each time for 40-50 minutes. Mix the two medicinal juices and filter them, let them stand to clarify, absorb the supernatant, filter it, and set aside.

[0018] Optionally, the preparation method further comprises:

[0019] Soak the medicinal pieces in cold water for 30 minutes.

[0020] Optionally, the decoction time is 45 minutes each time.

[0021] Modern pharmacology shows that in addition to berberine, the main components of Coptis chinensis also include lignin, flavonoids and other substances, which have the effects of lowering blood sugar, anti-inflammatory, and protecting cardiovascular and cerebrovascular vessels; Pueraria lobata mainly contains isoflavones, triterpenoids, coumarins and other ingredients, which have the effects of promoting fluid production and quenching thirst, and anti-inflammatory; the main components of Millettia reticulata include progesterone, anthraquinones, triterpenes, etc., which have antioxidant effects; the main components of Pheretima include chemical components such as amino acids, polypeptides, nucleosides, etc., which have anti-inflammatory, anti-thrombotic, and anti-fibrotic effects; Curcuma zedoaria mainly contains hemiterpenoids and diphenylheptane compounds, which have antioxidant, anti-inflammatory, and blood sugar-lowering effects; the main components of cinnamon twig include organic acids, flavonoids and other ingredients, which have anti-inflammatory, vasodilator, and microcirculation improvement effects.

[0022] The present invention provides a Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion and a preparation method thereof, which is composed of six herbs, namely, coptis root, zedoaria, millet blood vine, cinnamon twig, kudzu root and earthworm. The prescription is mainly for promoting blood circulation and removing blood stasis, and is combined with warming meridians and dredging channels, clearing away heat and promoting body fluid. Traditional Chinese medicine believes that diabetic peripheral vascular disease is caused by evil toxins turning into heat, consuming qi and yin, thus damaging channels and meridians, and preventing qi and blood from flowing; therefore, the treatment of peripheral vascular disease should be based on clearing heat and promoting body fluid, promoting blood circulation and removing blood stasis, and treating both the symptoms and the root causes. Among them, coptis root and kudzu root clear heat and promote body fluid; earthworm and millet blood vine promote blood circulation and dredge channels; zedoaria breaks blood and eliminates symptoms; cinnamon twig warms the meridians and dredges channels. The combined use of the whole prescription has played a positive role in the prognosis of patients in clinical practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 The present invention provides a Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion and other experimental groups of the vascular tissue HE staining results of rats in the diabetic lower limb balloon injury-induced lower limb ischemia model (A: sham operation group; B: model group; C: simvastatin group; D: low-dose Chinese medicine group; E: high-dose Chinese medicine group);

[0024] Figure 2 The present invention provides a Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion, and compares the Masoon staining results of vascular tissues of rats in a diabetic lower limb balloon injury-induced lower limb ischemia model with other experimental groups (A: sham operation group; B: model group; C: simvastatin group; D: low-dose Chinese medicine group; E: high-dose Chinese medicine group). DETAILED DESCRIPTION

[0025] In order to enable those skilled in the art to better understand the solution of the present application, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present application.

[0026] A Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion provided by an embodiment of the present invention comprises the following components by weight: 12-18 parts of Pueraria root; 8-12 parts of Coptis chinensis; 8-12 parts of Curcuma zedoaria; 12-18 parts of Millettia reticulata; 8-12 parts of Pheretima; 8-12 parts of Cinnamomum cassia. The medicinal slices are soaked in cold water for 20-40 minutes to allow the medicine to be completely infiltrated by water, which is convenient for the dissolution of the effective ingredients, and then water is added for 40-50 minutes, and the water should be added at one time. The decoction temperature is usually heated to boiling with high heat (high heat), adjusted to low heat (low heat) or medium heat, and kept slightly boiling. The temperature is based on the principle of "high heat first and low heat later". Decoction is continued for 2 times (also 45 minutes), the juice is mixed and filtered, and it is allowed to stand for clarification, and the supernatant is absorbed, filtered, and set aside. It is also possible to use ethanol of appropriate concentration as a solvent to extract the effective ingredients in the medicinal materials, and the extract is used after recovering ethanol. The extract is concentrated to a specified relative density to obtain a clear paste.

[0027] Example 1

[0028] A Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion provided in an embodiment of the present invention is composed of: 15g of Pueraria root; 10g of Coptis chinensis; 10g of Curcuma zedoaria; 15g of Millettia spatholobi; 10g of Pheretima; 10g of Cinnamomum cassia. Each medicinal piece is soaked in cold water for 20-40 minutes to allow the medicine to be completely infiltrated by water, which is convenient for the dissolution of the effective ingredients, and then water is added for 40-50 minutes, and the water should be added once. The decoction temperature is usually heated to boiling with strong fire (high fire), adjusted to slow fire (low fire) or medium fire, and kept slightly boiling. The temperature is based on the principle of "first strong and then gentle". Decoction is continued for 2 times (also 45 minutes), the juice is mixed and filtered, and it is allowed to stand for clarification. The supernatant is absorbed, filtered, and reserved. The present invention refers to the composition provided in Example 1 as the heat-clearing and blood-activating prescription.

[0029] Example 2

[0030] Compared with Implementation 1, this embodiment is different in that the distribution ratio of each group is different, specifically: 12g of Pueraria root; 12g of Coptis chinensis; 8g of Curcuma; 18g of Millettia reticulata; 8g of Pheretima; and 12g of Cinnamomum cassia.

[0031] The rest of the preparation method is the same as in Example 1.

[0032] Example 3

[0033] Compared with Implementation 1, this embodiment is different in that the distribution ratio of each group is different, specifically: g Pueraria root; 8g Coptis chinensis; 12g Curcuma; 12g Millettia reticulata; 12g Pheretima; 8g Cinnamomum cassia.

[0034] The rest of the preparation method is the same as in Example 1.

[0035] The following is an introduction to the effect of the Chinese medicine composition for treating diabetic lower extremity arteriosclerosis and vascular occlusion provided by the embodiment of the present invention through relevant experiments. It should be noted that, for the convenience of introduction or description, the "high-dose Chinese medicine group", "low-dose Chinese medicine group" and the like in the following test examples, the "Chinese medicine" and the "re-clearing and blood-activating prescription" all refer to the Chinese medicine composition for treating diabetic lower extremity arteriosclerosis and vascular occlusion provided by Example 1 of the present invention.

[0036] Materials and Methods

[0037] 1. Animals

[0038] Sprague Dawley (SD) rats, 50, male, SPF grade, weight (350-500) g, were selected and provided by Beijing Sibeifu (Beijing) Biotechnology Co., Ltd., Beijing Experimental Animal License: SCXK (Beijing) 2019-0010. The breeding environment was the barrier-level animal room of Xiyuan Hospital, China Academy of Chinese Medical Sciences, with a license number (SYXK (Beijing) 2018-0018), humidity was controlled at 50%-70%, temperature was controlled at (24-26) °C, animals were free to eat and drink, and the experiment began after 1 week of adaptive feeding. High-fat feed (10% lard, 10% sucrose, 2.0% cholesterol, 0.5% bile salt, 77.5% basic feed) was provided by Beijing Keao Xieli Feed Co., Ltd., animal feed license: SCXK (Beijing) 2019-0012. The animal husbandry and experimental procedures involved in the experiment complied with the relevant guidelines for the management and protection of experimental animals, and were reviewed by the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences, approval number: NO.2021XLC053-2.

[0039] 2. Drugs and reagents

[0040] The heat-clearing and blood-activating Chinese medicine is provided by the preparation room of Xiyuan Hospital of China Academy of Chinese Medical Sciences. The Chinese medicine composition in Example 1 is used, which is referred to as the heat-clearing and blood-activating prescription, that is, the raw materials of the composition are 15g of Pueraria root; 10g of Coptis chinensis; 10g of Curcuma zedoaria; 15g of Millettia reticulata; 10g of Pheretima; 10g of Cinnamomum cassia twig. The medicinal pieces are soaked in cold water for 30 minutes to make the medicine completely penetrated by water, which is convenient for the dissolution of the effective ingredients, and then boiled in water for 45 minutes. The water should be added once. The boiling temperature is usually heated to boiling with strong fire (high fire), adjusted to slow fire (low fire) or medium fire, and kept slightly boiling. The heat is based on the principle of "first strong and then gentle". Decoction is continued for 2 times (also 45 minutes), the juice is mixed and filtered, and it is left to stand for clarification. The supernatant is absorbed, filtered, and set aside.

[0041] Simvastatin tablets (10 mg / tablet) were produced by Harbin Pharmaceutical Group Sanjingmingshui Pharmaceutical Co., Ltd., batch number: 1202005. Streptozotocin (STZ) was produced by Sigma Aldrich, USA, batch number:; 2% lidocaine hydrochloride injection (100 mg / ml) was produced by China Otsuka Pharmaceutical Co., Ltd., batch number: 3178D1.

[0042] ⑴Fat metabolism indicators: ①High-density lipoprotein (HDL-C) kit, batch number: 542151; ②Low-density lipoprotein (LDL-C) kit, batch number: 519885; ③Triglyceride (TG) kit, batch number: 547960; ④Cholesterol (TC) kit, batch number: 573741; ⑵Carbohydrate metabolism indicators: ⑤Blood glucose (GLU) kit, batch number: 563746; ⑥Glycated serum protein (GSP) kit, batch number: 5680719; The above kits were provided by Roche Diagnostics (Roche / Germany) Co., Ltd., measured by ROCHE / E601 automatic biochemical analyzer, and produced by Roche (Roche / Switzerland) Co., Ltd.

[0043] 3. Experimental instruments

[0044] Cobas 6000, fully automatic biochemical analyzer, produced by Roche, Switzerland; QL-902, vortex shaker, produced by Haimen Qilin Bell Instrument Manufacturing Co., Ltd.; Centrifuge 5415D, high-speed refrigerated centrifuge, produced by Eppendorf (Germany); NANODROP2000, spectrophotometer, produced by Therno scientific (USA); E1101, electrophoresis instrument, produced by Bio-Rad (USA). Microscope. ACCU-CHEK blood glucose meter, produced by Roche (Roche Germany) Diagnostics Co., Ltd.

[0045] 4. Establishment of diabetic balloon injury lower limb ischemia model

[0046] Referring to the previous method of the research group, a high-fat diet induced by a small dose of streptozotocin (STZ) was used to establish a high-fat diabetic rat model. The STZ dose was 25 mg / kg body weight. Blood sugar can be stably increased 72 hours after intraperitoneal injection, accompanied by three poly symptoms. Rapid blood sugar detection above 11.1 mmol / L can be selected as a successful model. STZ should be freshly prepared during modeling, and animals with elevated blood sugar values ​​that do not meet the requirements should be eliminated.

[0047] After intraperitoneal anesthesia with 4% chloral hydrate (9ml / Kg body weight), the rats were fixed in the supine position. The surgical site was disinfected. This included hair removal, skin disinfection, and isolation of the surgical site. The sequence was: 2% iodine tincture, 75% ethanol deiodination, isolation of the surgical site, and surgery. A longitudinal incision was made at the midpoint of the groin, with a length of about 2cm. The superficial femoral artery was exposed to the external iliac artery, and care was taken to avoid damaging the internal iliac artery. The artery, vein, and nerve were separated, and the movements were gentle when separating the tissues to minimize bleeding. After the proximal end of the external iliac artery was controlled by line 4, 1% lidocaine was locally infiltrated into the femoral artery. A 21G puncture needle was used to puncture the common femoral artery from the bifurcation of the superficial and deep femoral arteries, and a 0.014 guide wire was introduced for about 5cm. A 1.5-2.0×20mm balloon was inserted in exchange, and the end of the balloon was located above the puncture point. The pressure pump inflated the balloon with a pressure of 2-4 atm for 30 seconds, and gently pushed and pulled the balloon along the shape of the blood vessel. After repeating twice, the balloon and guidewire were removed. Compression hemostasis. Incomplete ligation of the middle segment of the common femoral artery and the proximal end of the superficial femoral artery (the guidewire was removed after the blood vessel and guidewire were ligated at the same time with line 1). The incision was closed by suture layer by layer. After surgery, 200,000 U / d / Kg of penicillin sodium was injected intramuscularly for 3 consecutive days to prevent infection and establish a chronic lower limb ischemia model.

[0048] 5. Grouping and intervention methods

[0049] One week after surgery, when the wound was basically healed, the rat gavage dosage was calculated according to the body surface area conversion formula, and 40 rats were randomly divided into ① model control group, gavage with equal volume of pure water; ② positive drug control group (simvastatin group, 3.60mg / kg·d×body weight); ③ the composition of Example 1, i.e., the low-dose group of Qingre Huoxue Fang (6.3g crude drug / kg·d×body weight); ④ the composition of Example 1, i.e., the high-dose group of Qingre Huoxue Fang (12.6g crude drug / kg·d×body weight). The rat gavage dosage was calculated based on the commonly used dose in clinical practice combined with the body surface area conversion formula. ⑤ sham operation control group (sham operation group, separation of superficial femoral artery to external iliac artery, normal suture after passing guide wire without balloon injury, gavage with equal volume of pure water, and ordinary feed feeding) were set up separately. The rats in the drug administration group were gavaged with equal volume of drug suspension, and all rats except the sham operation group continued to be fed with high-fat feed. There were 10 rats in each group, and the drug was administered for four consecutive weeks.

[0050] 6. Specimen preparation and testing

[0051] After 4 weeks of oral administration, all rats were fasted but not watered for 12 hours before tissue samples were collected. When collecting specimens, rats were anesthetized with 4% chloral hydrate (9 ml / kg body weight). After anesthesia, they were placed on a rat stand, the abdominal cavity was opened layer by layer, the abdominal aorta was freed and 5 ml of blood was collected, and then the femoral artery on the affected side was freed to the distal end. Three rats were fixed in 10% formaldehyde solution, and five rats were frozen in liquid nitrogen. For the detection of blood lipids in rats, GLU was detected by the glycokinase method, TC, HDL-C, and LDL-C were detected by enzyme colorimetry; TG was detected by colorimetry. ELISA method was used for glycation end products (AGES), endothelin (ET), reactive oxygen species (ROS), nitric oxide (NO), reduced glutathione (GSH), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6).

[0052] 7. Statistical processing

[0053] SPSS 20.0 software was used for statistical analysis. The experimental data of each group were expressed as mean ± standard deviation (x ± s). If the data of each group conformed to normal distribution and variance was homogeneous, one-way analysis of variance and F test were used, and SNK test was used for comparison between two groups; if it did not conform to normal distribution or variance was unequal, rank sum test was used for comparison between multiple groups, and Steel-Dwass test was used for comparison between two groups. P < 0.05 was considered to be significantly different.

[0054] Experimental Results

[0055] 1. Effect of Qingre Huoxue Decoction on the pathological morphology of diabetic lower limb ischemia model induced by balloon injury

[0056] HE staining results of vascular tissues of rats in each group showed that the sham-operated group had regular blood vessel morphology, smooth intima, uniform wall thickness, and evenly and compactly distributed vascular smooth muscle cells (VSMC); the model group had uneven blood vessel wall thickness, hyperplasia of the intima, thickening of the middle membrane, lipid deposition, and an increased number of VSMCs with uneven arrangement; the thickness of the blood vessel wall in each treatment group decreased, and the decrease in the number of VSMCs in the large and small Chinese medicine treatment groups was more obvious. Masoon staining showed that only a small amount of collagen fiber deposition in the blood vessel wall of the sham-operated group was obvious in the model group. Each treatment group had an improvement in collagen fiber deposition, and the effect of the small-dose Chinese medicine group was the most obvious. Figure 1 and Figure 2 .

[0057] 2. Effect of Qingre Huoxue Decoction on Glucose and Lipid Metabolism in Diabetic Lower Limb Balloon Injury-induced Lower Limb Ischemia Model

[0058] Compared with the sham operation group, the serum GLU in the model group increased to varying degrees (P<0.01). Compared with the model group, the serum GLU level in the simvastatin group was significantly increased (P<0.01). Compared with the sham operation group, the TC and TG levels in the model group were significantly increased (P<0.01), the LDL and GSP levels were increased, and the HDL level was reduced. Each treatment group had a significant control effect on TC and TG (P<0.01 or P<0.05), among which the high-dose group of traditional Chinese medicine in Example 1 of the present invention had the best effect; the low-dose group of traditional Chinese medicine also had a trend of reducing GSP, reducing LDL, and increasing HDL. As shown in Table 1.

[0059] Table 1 Effects of the heat-clearing and blood-activating prescription of Example 1 of the present invention on glucose and lipid metabolism in rats

[0060]

[0061]

[0062] Note: Compared with the sham operation group, there is a difference # P<0.05, ## P<0.01; compared with the model group, there were significant differences *P<0.05, **P<0.01

[0063] 3. Effect of the Qingre Huoxue Recipe of Example 1 of the present invention on vascular endothelial function in a diabetic lower limb ischemia model induced by lower limb balloon injury

[0064] The ET of the model group increased significantly (P<0.01), and each treatment group decreased to varying degrees, with the low-dose Chinese medicine group being the most significant (P<0.01, P<0.05). As for NO, the model group was significantly lower than the sham operation group (P<0.01), and each treatment group increased significantly (P<0.01), with the low-dose Chinese medicine group being the most significant. See Table 2.

[0065] Table 2 Effect of the heat-clearing and blood-activating prescription of Example 1 of the present invention on vascular endothelial function in rats

[0066]

[0067] Note: Compared with the sham operation group, there is a difference # P<0.05, ## P<0.01; compared with the model group, there were significant differences *P<0.05, **P<0.01

[0068] 4. Effect of the Qingre Huoxue Recipe of Example 1 of the present invention on oxidative stress function in a diabetic lower limb ischemia model induced by lower limb balloon injury

[0069] Compared with the sham operation group, AGES in the model group increased significantly (P<0.01). Among the treatment groups, only the low-dose Chinese medicine group showed a difference (P<0.05), and the other treatment groups showed a decreasing trend. ROS in the model group increased significantly (P<0.01), and each treatment group decreased to varying degrees, with the low-dose Chinese medicine group being the most obvious (P<0.01, P<0.05). Compared with the sham operation group, GSH in the model group decreased significantly, and the low-dose Chinese medicine group increased the GSH content (P<0.05). As shown in Table 3.

[0070] Table 3 Effect of the heat-clearing and blood-activating prescription of Example 1 of the present invention on oxidative stress in rats

[0071]

[0072]

[0073] Note: Compared with the sham operation group, there is a difference # P<0.05, ## P<0.01; compared with the model group, there were significant differences *P<0.05, **P<0.01

[0074] 5. Effect of the Qingre Huoxue Recipe of Example 1 of the present invention on inflammatory factors in the lower limb ischemia model caused by diabetic lower limb balloon injury

[0075] Compared with the sham operation group, the model group significantly increased the levels of TNF-a and IL-6, and all treatment groups decreased them (P<0.05, P<0.01), with the low-dose Chinese medicine group being the most significant (P<0.01). See Table 4.

[0076] Table 4. Effects of the Qingre Huoxue Recipe of Example 1 of the present invention on inflammatory factors

[0077]

[0078] Note: Compared with the sham operation group, there is a difference # P<0.05, ## P<0.01; compared with the model group, there were significant differences *P<0.05, **P<0.01

[0079] Diabetes is one of the high-risk factors for cardiovascular and cerebrovascular diseases and peripheral vascular diseases, and hyperglycemia is an important predisposing factor for various complications. The increase in AGEs caused by hyperglycemia can promote the production of ROS to reduce intracellular NO, increase the level of ET, promote vascular contraction, and aggravate ischemia. All treatment groups can reverse this effect, and the low-dose Chinese medicine group is the most significant. GLUT4 is the main protein for glucose transmembrane transport, and the expression of GLUT4 can effectively lower blood sugar. In this study, although the simvastatin group increased the content of GLUT4, others have obtained similar results.

[15] ; However, previous researchers have also observed a significant increase in serum blood glucose levels; the Chinese medicine treatment group can reduce the GLU level of rats and reduce the production of AGEs.

[0080] After macrophages engulf ox-LDL, they form foam cells and deposit in the vascular endothelium, which can also activate ROS and damage the oxidative stress function of the cell endothelium. GSH is an important antioxidant enzyme in the body's antioxidant system, which can remove oxygen free radicals produced by cellular respiration and delay cell apoptosis. The results show that the control of LDL levels in each treatment group is comparable, but the protection of cell oxidative stress function by the traditional Chinese medicine group is better than simvastatin.

[0081] TNF-α is a pro-inflammatory cytokine mainly produced by macrophages and monocytes, and is involved in the body's inflammatory response. IL-6, as an inflammatory factor, promotes tissue damage during the development of atherosclerosis. Simvastatin is believed to have the effect of inhibiting the expression of inflammatory factors, which is consistent with the experimental results. Both the high-dose and low-dose groups of the Chinese medicine in the embodiment of the present invention can reduce the expression of inflammatory factors, and the effect is better than that of the simvastatin group.

[0082] In this test example, it was observed that the levels of IL-6 and TNF-α in each treatment group were significantly reduced, and it was speculated that the heat-clearing and blood-activating prescription in the embodiment of the present invention inhibited the expression of inflammatory factors by inhibiting the signal transduction downstream of the PKC pathway. Traditional Chinese medicine has unique advantages in treating type 2 diabetic peripheral vascular disease. The heat-clearing and blood-activating prescription can improve rat glucose and lipid metabolism, reduce oxidative stress, and promote angiogenesis by activating the PKC pathway. At the same time, it can inhibit inflammatory factors, reduce vascular collagen fiber deposition, and promote angiogenesis to delay the occurrence and development of atherosclerosis, providing a basis for the treatment of type 2 diabetic peripheral vascular disease with traditional Chinese medicine.

[0083] The above is only a preferred implementation of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application. These improvements and modifications should also be regarded as the scope of protection of the present application.

Claims

1. A Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion, characterized in that: The invention is composed of the following components by weight: 12-18 parts of Pueraria root; 8-12 parts of Coptis chinensis; 8-12 parts of Curcuma zedoaria; 12-18 parts of Millettia spatholobi; 8-12 parts of Pheretima; and 8-12 parts of Cinnamomum cassia.

2. The Chinese medicine composition for treating diabetic lower extremity arteriosclerosis and vascular occlusion according to claim 1, characterized in that: The composition consists of the following components by weight: 12 parts of Puerariae Radix; 12 parts of Coptis Rhizome; 8 parts of Curcuma Rhizoma; 18 parts of Millettia Spatholobi; 8 parts of Pheretima; 12 parts of Cinnamomum cassia twig.

3. The Chinese medicine composition for treating diabetic lower extremity arteriosclerosis and vascular occlusion according to claim 1, characterized in that: The composition consists of the following components by weight: 18 parts of Puerariae Radix; 8 parts of Coptis Rhizome; 12 parts of Curcuma Rhizoma; 12 parts of Millettia Spatholobi; 12 parts of Pheretima; 8 parts of Cinnamomum Cassiae Ramulus.

4. The Chinese medicine composition for treating diabetic lower extremity arteriosclerosis and vascular occlusion according to claim 1, characterized in that: The composition consists of the following components by weight: 15 parts of Puerariae Radix; 10 parts of Coptis Rhizome; 10 parts of Curcuma Rhizoma; 15 parts of Millettia Spatholobi; 10 parts of Pheretima; 10 parts of Cinnamomum Cassiae Ramulus.

5. A method for preparing a Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion, characterized in that: include: Prepare the medicinal pieces according to the components of the Chinese medicine composition for treating diabetic lower limb arteriosclerosis and vascular occlusion according to any one of claims 1 to 4; Soak the medicinal pieces in cold water for 20-40 minutes, then add water and boil twice, each time for 40-50 minutes. Mix the two medicinal juices and filter them, let them stand to clarify, absorb the supernatant, filter it, and set aside.

6. The preparation method according to claim 5, characterized in that: The preparation method further comprises: Soak the medicinal pieces in cold water for 30 minutes.

7. The preparation method according to claim 5, characterized in that: The decoction time is 45 minutes each time.

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