CN115969950A - Traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy and preparation method thereof - Google Patents
Traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy and a preparation method thereof, belonging to the technical field of traditional Chinese medicine compositions. The feed comprises the following raw materials in parts by weight: 20 to 60 portions of astragalus root, 20 to 60 portions of white peony root, 20 to 60 portions of cassia twig, 40 to 120 portions of ginger and 20 to 50 portions of Chinese date. Putting the mixture into a proper container, adding 4-8 times of water by volume, decocting for 30-90 minutes, filtering, directly freezing and drying the filtrate or concentrating the filtrate into thick paste with the relative density of 1.05-1.35, and decompressing or freezing and drying to obtain the traditional Chinese medicine composition for preventing and treating the peripheral neuropathy of the diabetes. The traditional Chinese medicine composition has the beneficial effects that the key of pathogenesis of diabetic peripheral neuropathy qi deficiency and blood stasis is grasped, the qi tonifying and blood activating and meridian warming and arthralgia dredging are taken as treatment principles, the traditional Chinese medicine composition is selected, and the traditional Chinese medicine composition is used for warming, tonifying, dredging and regulating, so that the effective traditional Chinese medicine composition special for treating the diabetic peripheral neuropathy is obtained, and the prescription is reasonable in monarch, minister, assistant and guide matching and has an outstanding curative effect on treating the diabetic peripheral neuropathy.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy, and a preparation method and application thereof.
Background
Diabetic peripheral neuropathy refers to symptoms related to peripheral nerve dysfunction of a diabetic patient, which are clinically manifested by abnormal sensation at the distal ends of limbs, weakness of limbs, spontaneous pain, cooling and numbness of the extremities, and is one of the most common chronic complications of diabetes mellitus, under the condition of excluding other causes. Research shows that the incidence rates of the diabetes mellitus reach 30%, 60% and 90% after 5 years, 10 years and 20 years respectively. The disability rate of the disease is high, the patients with severe diabetic peripheral neuropathy can form ulcer or gangrene, amputation is finally selected, the life quality of the patients is seriously reduced, and the heavy burden is brought to the family and social economy of the patients. Therefore, the prevention and treatment of diabetic peripheral neuropathy has become one of the issues of intensive research and conquering all over the world.
Modern medicine considers hyperglycemia to be the leading cause of peripheral neuropathy. The exact pathogenesis of diabetic peripheral neuropathy is not fully understood and is generally thought to be the result of multifactorial interactions. Pathogenic factors of diabetic peripheral neuropathy include metabolic disorder, vascular injury, neurotrophic factor deficiency, cytokine abnormality, oxidative stress, immune factors and the like, li is lucidus, huangda, li Ming Dy, etc. the formula for warming yang and activating blood circulation and dredging arthralgia affects the nerve conduction speed of the diabetic peripheral neuropathy due to yang deficiency, cold coagulation and blood stasis and the plasma Hcy [ J ] J.J.TCM J.2016, 57, (17) 1486-1489. Western medicine mainly treats metabolic disorders, microcirculation, oxidation resistance, nervousness nutrition, symptomatic pain relief, surgical operations and the like, and often uses insulin, mecobalamin, epalrestat, sodium prostaglandins and other medicaments, and has more side effects and unsatisfactory clinical effect.
In recent years, the traditional Chinese medicine for treating diabetic peripheral neuropathy has certain advantages in the aspects of controlling symptoms, improving objective indexes and long-term curative effect. According to clinical manifestations of diabetic peripheral neuropathy, the traditional Chinese medicine belongs to the categories of diabetes-induced vessel bi-syndrome, arthralgia syndrome and the like, and the causes of the diabetes are 'essential deficiency and secondary excess', and blood stasis is caused by deficiency and compatible with deficiency and blood stasis. The treatment of the disease by internal treatment or external treatment after the treatment based on syndrome differentiation in traditional Chinese medicine has better effect and is proved in basic research. The traditional Chinese medicine is mainly used for treating the diabetes mellitus by overall regulation, has the treatment effect of multiple ways, multiple targets, multiple aspects and multiple systems, and has remarkable effects on improving symptoms and physical signs of diabetic peripheral neuropathy, improving the life quality of patients and the like, so that the traditional Chinese medicine is popular with the patients.
Disclosure of Invention
The invention provides a traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy and a preparation method thereof.
The technical scheme adopted by the invention is as follows:
the invention firstly provides a traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy, which comprises the following raw materials in parts by weight:
20 to 60 portions of astragalus root, 20 to 60 portions of white peony root, 20 to 60 portions of cassia twig, 40 to 120 portions of ginger and 20 to 50 portions of Chinese date.
Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:
40 parts of astragalus membranaceus, 40 parts of radix paeoniae alba, 40 parts of cassia twig, 80 parts of ginger and 35 parts of Chinese date.
The invention also provides a preparation method of the traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy, which comprises the following steps:
putting the five medicines into a proper container, adding 4-8 times of water, decocting for 30-90 minutes, filtering, directly freezing and drying the filtrate or concentrating the filtrate into thick paste with the relative density of 1.05-1.35 (80 ℃), and decompressing or freezing and drying to obtain the traditional Chinese medicine composition for preventing and treating the diabetic peripheral neuropathy.
The invention also provides application of the traditional Chinese medicine composition in medicines for preventing and treating diabetic peripheral neuropathy.
The traditional Chinese medicine composition can be added with common pharmaceutical excipients to prepare pharmaceutically acceptable oral preparations such as tablets, capsules or granules and the like, and the tablets, capsules or granules can be prepared by adopting the conventional preparation method of corresponding preparations.
The invention has the beneficial effects that:
the key of pathogenesis of diabetic peripheral neuropathy qi deficiency and blood stasis is grasped, the treatment principles of tonifying qi and activating blood circulation and warming channels and dredging arthralgia are adopted, 5 traditional Chinese medicine compositions are selected and used in a warm, tonifying, dredging and regulating manner, and the effective traditional Chinese medicine composition specially used for treating the diabetic peripheral neuropathy is obtained. The prescription has reasonable monarch, minister, assistant and guide collocation, and has outstanding curative effect on treating diabetic peripheral neuropathy.
Although there is no clear description of the concept of diabetic peripheral neuropathy in traditional Chinese medicine, it is classified into the categories of "diabetes-plus-syndrome", "diabetes", "arthralgia syndrome", "flaccidity syndrome", etc., according to the symptoms of the disease such as numbness, pain, coolness, flaccidity, etc. In the book of secret book of orchid Chamber, there are records of "the upper and lower teeth are numb, the tongue root is strong and hard, the swelling and pain, the limbs are flaccid, and the anterior yin is as cold" for the patient with diabetes. The Wangxxugao medical record (Wang Xugao) is in the name of: diabetes can be caused for a long time, but the hands and feet are numb, and the limbs are cold like ice. The recorded book of Bing Yuan Li (essential formula for syndrome treatment) records that the symptoms of long-term diabetes, essence and blood deficiency can cause night blindness or numbness and pain of limbs. The symptoms of swelling, pain, flaccidity and numbness are the description of the clinical manifestations of this disease. Su Wen Bi Lun (Su Wen & Bi Lun) states that "Bi is heavy in bones, blood is coagulated but does not flow in vessels, tendons are bent and not stretched in muscles, muscles are not benevolent, and skins are cold, so that pain is not caused by these five symptoms. For arthralgia and the like, worms are produced when the wind is cold and longitudinal when the wind is hot. "Nei Jing" (the classic of medical science) cloud "all the five zang organs are weak, fever with fever is lost", the patient pathogenesis of diabetes is deficient and excessive according to the patient's pathogenesis indicated in the patient's complete medical need. Long-term diabetes, deficiency of qi and yin, burning nutrient blood due to yin deficiency and internal heat, and stagnation of blood in vessels; or the disease is caused by deficiency of vital energy for a long time, weakness to promote blood circulation, blood stasis in the vessels, yang qi failing to reach the four ends, malnutrition of the limbs and body which causes numbness, pain, local coolness and other symptoms of limbs, and finally the disease is caused by impotence and disuse of the limbs. Because qi deficiency and blood stasis are the key points of the pathogenesis of the disease, the treatment should be performed by tonifying qi and activating blood, and warming channels and dredging arthralgia as the major treatment method.
The inventor grasps the key of pathogenesis of diabetic peripheral neuropathy qi deficiency and blood stasis, takes qi tonifying and blood circulation promoting as well as meridian warming and arthralgia relieving as treatment principles, and selects 5 traditional Chinese medicine compositions. The whole formula takes the astragalus root as the monarch, has sweet taste and warm property, and is used for tonifying qi and tonifying defensive qi on the surface. Cassia twig, ramulus Cinnamomi, which dispels wind-cold and warms the channels and unblocks arthralgia, is combined with Huang Qi to tonify qi, warm yang, activate blood and dredge meridians. Ramulus Cinnamomi can invigorate qi of radix astragali and stimulate wei yang; astragalus root is used as cassia twig to strengthen the exterior without retention of pathogenic factors. The white peony root has the effects of nourishing blood, regulating ying and wei and dredging blood arthralgia, is combined with the cassia twig, regulates ying and wei and harmonizes exterior and interior, and takes two medicines as ministerial medicines. Ginger, rhizoma Zingiberis recens, being pungent and warm in property, disperses pathogenic wind to help the force of ramulus Cinnamomi; the Chinese dates are sweet and warm, nourish blood and tonify qi, and have the effects of the astragalus and the Chinese herbaceous peony; it is used with Sheng Jiang to coordinate with Ying and Wei and regulate various herbs to assist and guide. The whole formula has only five flavors, but the medicines are used for warming, tonifying, dredging and regulating simultaneously, and have the effects of tonifying qi, activating blood, warming channels and dredging arthralgia, so that the effects of harmonizing ying and wei, promoting qi and blood circulation, dredging tendons and vessels, nourishing skin and removing various symptoms can be achieved.
The Chinese medicine theory and modern pharmacological research result of the Chinese medicines in the prescription are as follows:
astragalus root: sweet and warm, and warm in nature, it enters spleen and lung meridians. It is recorded in Shen nong Ben Cao Jing (Shen nong's herbal Jing), li Shi Zhen in Ben Cao gang mu (compendium of materia Medica), which is named as "Huang is the best tonic drug". It has the actions of tonifying qi of spleen and lung, tonifying qi to strengthen superficies, tonifying blood and activating blood, and also has the actions of ascending yang and descending sinking. In Zhongyun from Ben Jing Shu Zheng (the syndrome of this meridian dredging), huang Qi is used to dredge the root of triple energizer and to promote the qi of ying-wei, so it is difficult to dredge the ying-wei space. Astragalus root has the effects of tonifying qi of the spleen and lung, promoting blood circulation, removing blood stasis, dredging collaterals, harmonizing ying and wei, warming and moistening muscle, skin and striae. Modern pharmacology indicates that astragalus has the effects of regulating body immunity, resisting inflammation, resisting oxidation, inhibiting platelet aggregation and the like and can delay the progress of DPN. The astragalus contains various effective components, wherein the astragalus polysaccharide component has a function regulating effect on vascular endothelial cells, and can improve immunity and regulate and control blood sugar.
Cassia twig: pungent and sweet with warm property enter heart, lung and bladder meridians. The medicine has effects of promoting perspiration, relieving exterior syndrome, warming and dredging channels and collaterals, dispelling cold and relieving pain. In the Changsha medicine Jie, it enters liver and circulates blood and runs channels and collaterals to reach Ying Yu \8230, and \8230, it is indicated for acute spasm of muscles and tendons, obstruction of joints, and obstruction of channels and collaterals to relieve arthralgia and even remove damp-cold. In the effective components of ramulus Cinnamomi, cinnamaldehyde has antiinflammatory, analgesic, and blood sugar lowering effects; cinnamic acid has obvious analgesic effect; cinnamyl alcohol can improve nerve conduction velocity and protect nerves.
Peony: bitter and slightly cold entering liver meridian. The main efficacy is to clear heat and cool blood, and has the functions of promoting blood circulation, removing blood stasis and relieving pain. The compendium of materia Medica says: peony can dispel pathogens stagnation in the blood. Entering liver meridian, clearing liver heat and cooling blood, removing blood stasis and promoting blood circulation, the liver governs tendons and muscles, and the muscles and tendons can be nourished, thus relieving the symptoms of difficult dredging. Paeonia lactiflora pall has the effects of promoting blood circulation to remove blood stasis and relieving pain, and is particularly suitable for the pathogenesis of pain caused by obstruction of the disease. Pharmacological research proves that various glycoside components in the Chinese herbaceous peony have various neuroprotective effects of protecting liver, inhibiting tumor, expanding capillary, eliminating oxygen free radical, resisting oxidation stress reaction and the like.
Ginger: pungent and warm herbs enter lung, spleen and stomach meridians, and have the actions of relieving exterior syndrome, dispelling cold, warming middle energizer to arrest vomiting, warming lung to relieve cough and removing toxicity. Shen nong Ben Cao Jing: pungent and warm in flavor. Relieving chest fullness, cough, ascending qi, warming middle energizer to stop bleeding, inducing sweating, expelling wind, damp arthralgia, and promoting bowel movement. For the healthy and healthy people, the herb can be taken for a long time to remove the odor and activate the mind. "miscellaneous records of famous physicians": to eliminate pathogenic wind, cold and heat, typhoid, headache, nasal obstruction, cough, dyspnea, vomiting and phlegm. The modern pharmacological research shows that the ginger has the pharmacological effects of antiemetic, antibacterial, anti-inflammatory, analgesic, antioxidant, antitumor, antidiabetic, cardiovascular and cerebrovascular system diseases, immune system diseases and the like. Researches show that the zingerone in the ginger has a good blood sugar reducing effect and can obviously reduce the blood sugar of diabetes model mice induced by streptozotocin. The ginger alcohol extract can also improve the utilization rate of glucose in the body of a diabetic mouse, regulate the blood sugar level of the diabetic mouse, and obviously relieve the symptoms of polydipsia, polyphagia, weight loss and the like of the diabetic mouse caused by in-vivo protein and fat metabolic disorder. In addition, researches show that the ginger extract has a certain treatment effect on diabetic complications, namely diabetic cataract.
Chinese date: sweet and warm, and has the effects of invigorating spleen and stomach, invigorating qi and replenishing blood, promoting fluid production, regulating ying and wei, and removing toxic materials. In the book of Jing, yun governs heart and abdominal pathogenic qi, and strengthens the spleen and twelve meridians. Pacify stomach qi, unblock nine orifices, nourish qi and fluids, deficiency of body and middle energizer, severe convulsion, heaviness of limbs, and Bai Yao. "Zi Zao mainly tonifies body fluids, washes heart and abdomen to eliminate pathogenic qi, and poisons by various herbs, unblocks nine orifices, tonifies insufficient qi, boils to tonify intestines and stomach, fattens middle-jiao to replenish qi for the first time, children suffer from autumn dysentery, and eat well with Chongzao". The modern pharmacological research result shows that the components contained in the Chinese date have the anti-fatigue effect by enhancing muscle strength, weight and endurance, can promote the hematopoietic function of bone marrow, enhance immunity, improve the intestinal environment and reduce the toxic and harmful substance contact of the intestinal mucosa. In addition, it also has tranquilizing, hypnotic, antioxidant, antiaging, liver protecting, mutation resisting, antitumor, antiallergic, antiinflammatory and blood lipid reducing effects. The qi-tonifying and blood-enriching functions of the Chinese dates can relieve anemia of the diabetic patients to a certain extent.
The inventor finds that the medicine obtained by the formula and the preparation method can obviously improve the traditional Chinese medicine syndrome score and shorten the symptom relieving time by applying the medicine to clinic. Pharmacological tests also prove that the traditional Chinese medicine composition can play a role in preventing and treating diabetic peripheral neuropathy by reducing the blood sugar and the blood fat of diabetic rats and protecting islet cells.
Drawings
FIG. 1 is a graph of the effect of composition on pathological changes in pancreatic tissue, in which A. Control; B. a model group; C. a group of positive drugs; D. a high dose group; E. a medium dose group; F. low dose group.
Detailed Description
The present invention is further described in detail with reference to the following specific examples, wherein the raw materials and auxiliary materials used in the examples are commercially available.
Example 1 preparation of a Chinese medicinal composition for the prevention and treatment of diabetic peripheral neuropathy
Weighing the following raw materials in parts by weight:
40g of astragalus, 40g of white paeony root, 40g of cassia twig, 80g of ginger and 35g of Chinese date.
Placing the five medicines in a medicine decocting pot, adding 6 times of water, decocting for 60 minutes, filtering, and freeze-drying the filtrate to obtain the traditional Chinese medicine.
Example 2 preparation of a Chinese medicinal composition (granule) for preventing and treating diabetic peripheral neuropathy
Weighing the following raw materials in parts by weight:
60g of astragalus, 60g of white peony root, 60g of cassia twig, 120g of ginger and 50g of Chinese date.
Placing the five medicinal herbs in a decocting pot, adding 8 times of water, decocting for 90 minutes, filtering, concentrating the filtrate to obtain a thick paste with the relative density of 1.35 (80 ℃), drying under reduced pressure, adding a proper amount of dextrin, soluble starch, stevioside and the like, uniformly mixing, and preparing into granules.
Example 3 preparation of a Chinese medicinal composition (tablet) for preventing and treating diabetic peripheral neuropathy
Weighing the following raw materials in parts by weight:
20g of astragalus membranaceus, 20g of radix paeoniae alba, 20g of cassia twig, 40g of ginger and 20g of Chinese date.
Placing the five medicines in a decocting pot, adding 4 times of water, decocting for 30 minutes, filtering, concentrating the filtrate into thick paste with the relative density of 1.30 (80 ℃), drying under reduced pressure, adding a proper amount of starch, magnesium stearate and the like, mixing uniformly, granulating, drying, tabletting and coating to obtain the traditional Chinese medicine.
The prevention and treatment effect of the traditional Chinese medicine composition on diabetic peripheral neuropathy is further illustrated by specific animal experiments.
1. Experimental Material
1.1 test animals
SD rat, 180-220 g, purchased from Liaoning Biotechnology Limited, animal grade: SPF grade, quality certification for experimental animals in liaoning province, NO:211002300005370. license number: SCXK (Liao) 2010-0001.
1.2 Experimental Environment
Clean-grade animal room, license number: SYXK (ji) 2010-0006, animal room temperature: 19-23 ℃ and the relative humidity is 45-65 percent.
1.3 feed
The experimental animal high fat feed comprises the following raw materials: 10% of beef tallow, 2.5% of cholesterol, 0.5% of sodium cholate, 5% of egg yolk powder and 82% of rat basal feed. The manufacturer: changchun city yi si laboratory animal technology Limited liability company. Production license: gavage certificate (2014) 01092.
The compound granulated feed for experimental animals is prepared from corn, fish meal, soybean meal, calcium bicarbonate, flour, stone powder and the like. The manufacturer: changchun city yi si laboratory animal technology Limited liability company. Production license: SCXK- (gib) 2003-0008.
1.4 drugs
The test substance: the composition obtained in example 1 had the following properties: yellow-white powder, 10.87g crude drug/g, provided by New drug center of academy of traditional Chinese medicine and sciences of Jilin province.
Positive drugs: the diabetes hypoglycemic capsule: the main component is guava leaf. The usage and dosage are as follows: orally administered 3-5 granules at a time, 3 times a day. Specification: each capsule is filled with 0.3g (equivalent to 3g of raw medicinal materials). The functional indications are as follows: produce saliva and slake thirst, nourish stomach, astringe and consolidate yin. Can be used for treating polydipsia, diuresis, polyphagia, marasmus, asthenia, and diabetes due to increase of urine sugar and blood sugar; mild and moderate adult-onset diabetes. Product batch number: 131202. the manufacturer: jiren pharmaceutical Co., ltd, heilongjiang province.
1.5 preparation of model drug
Streptozotocin (STZ): a melphalan organism. Production batch number: A1126A.
1.6 kits and reagents
Wonderful hand blood sugar test paper: zhongmei joint venture Jiujin medical electronic stockings limited company, lot number: 1410020723. glycated Serum Protein (GSP) test kit: nanjing institute for bioengineering, lot number: 20150326. free fatty acid (NEFA) test kit: nanjing was established as a bioengineering institute, lot number: 20150310. high density lipoprotein cholesterol (HDL-C) test kit: nanjing institute for bioengineering, lot number: 20150211. low density lipoprotein cholesterol (LDL-C) test kit: nanjing was established as a bioengineering institute, lot number: 20150203. an insulin kit: product of RD biosciences, shanghai-sourced leaf biosciences, inc, split, lot No. 20150301A. Triglyceride (TG) assay kit: ou diagnosis products of Zhejiang east, ltd, lot number: 2014120008. total Cholesterol (TC) assay kit: ou diagnosis products of Zhejiang east, batch number: 2014110033. citric acid: beijing chemical plant, lot number: 20121128. sodium citrate: beijing chemical plant, lot number: 20121116.
1.7 instruments
AG-606 blood glucose tester, tianjin Jiu' an medical electronics GmbH. DNM-9602 enzyme reader, new technology, beijing Pulang, inc. 752 ultraviolet raster spectrophotometer, manufactured by shanghai third analytical instrument factory. LBY-N6K semi-automatic hemorheometer, beijing PrisyIn Instrument Co. HC-3618R high-speed refrigerated centrifuge, anhui Zhongzhongjia scientific instruments, inc. CS-600B full-automatic biochemical analyzer, changchun Dirui industries, ltd.
2. Test methods and results
2.1 test methods
100 male rats were randomly divided into 2 groups, of which 12 rats in the normal control group and 88 rats in the rest were type 2 diabetes model group. The normal control group was fed with normal diet and the model group was fed with high fat diet. Weighing the body once a week, after 4 weeks, fasting the rats for 12 hours without water prohibition, anesthetizing with ether, collecting blood in an eye vein for 0.5ml, standing for 1-2 hours, centrifuging for 5 minutes (5000 rpm/min), taking serum at 20 ℃, measuring the content of triglyceride and total cholesterol in the serum by using a CS-600B full-automatic biochemical analyzer, and removing the cholesterol of the rats with the concentration of less than 2.0mmol/L and more than 5.0mmol/L and the triglyceride of less than 0.9 mmol/L. The remaining model group rats were injected intraperitoneally with Streptozotocin (STZ) (dissolved in 0.1mol/L citric acid buffer solution at pH 4.5) in amounts of 25mg/kg and 35mg/kg, respectively, and normal control group was injected intraperitoneally with 0.1mol/L citric acid buffer solution at pH 4.5. Measuring fasting blood glucose with glucometer after 5 days, selecting rat with fasting blood glucose value higher than 9.4mmol/L as type 2 diabetes model. 65 rats in the model group are successfully modeled, and the successfully modeled rats are divided into a model group (16 rats), a positive drug group (13 rats), a high dose group (12 rats), a medium dose group (12 rats) and a low dose group (12 rats) according to fasting blood glucose values. The normal control group is infused with distilled water at a ratio of 20ml/kg, and is fed with common feed; the model group is filled with distilled water at a ratio of 20ml/kg, and is fed with high fat feed; the positive medicine group is fed with high-fat feed according to the proportion of 0.5 percent of CMC-Na suspension of 9.2g crude medicine per kg content of the capsule for stomach irrigation, diabetes and blood sugar reduction; the high, medium and low dosage components are respectively infused with the stomach composition according to corresponding dosage, and are fed with high-fat feed. Each group of rats was administered once daily by gavage for 4 weeks. Rats were tested for blood glucose using blood glucose strips every 2 weeks. Before measurement, the rats are fasted for 12 hours without water supply, and the fasting blood sugar of the rats is measured by a glucometer. After the last measurement of blood glucose, 10% chloral hydrate was anesthetized, blood was taken from the abdominal aorta, centrifuged for 10min (3000 rpm), the supernatant was taken, the contents of free fatty acids, total cholesterol, triglycerides, high-density lipoproteins, low-density lipoproteins, glycated serum proteins, and insulin in serum were measured, and the insulin resistance value (insulin content: fasting blood glucose value/22.5) was calculated.
2.2 results
2.2.1 Effect on rat body weight during high fat diet modelling
The weight growth rate of the rats fed with the high-fat feed is obviously lower than that of the normal control group, and the two groups have obvious difference (P <0.001 or P < 0.01) in corresponding time. The results are shown in Table 1.
TABLE 1 weight change values of rats during administration of high fat diet
Note: compared with the normal control group, ** represents P<0.01, *** P<0.001
2.2.2 Effect on triglyceride and Total Cholesterol levels in rats fed high fat diet for 4 weeks
After 4 weeks of administration of the high-fat diet, the total cholesterol content of the rats was significantly increased, which was significantly different from that of the control group, and the triglyceride content of the rats was also increased, but was not significantly different from that of the control group. The results are shown in tables 2 and 3.
Table 2 administration of high fat diet four weeks of rats Total Cholesterol and Triglycerides
The results show that rats with total cholesterol less than 2.0mmol/L, greater than 5.0mmol/L, and triglycerides less than 0.9mmol/L should be removed.
2.2.3 Effect on body weight of rats given streptozotocin
After streptozotocin administration, the body weight of the rats in the model group is obviously reduced, and compared with that in the control group, the body weight of the rats in the model group is obviously different (P < 0.001). The results are shown in Table 3.
TABLE 3 weight of rats before and after streptozotocin administration
2.2.4 Effect on rat body weight after drug administration
After the thirst quenching and blood sugar reducing capsule and the composition are used for treatment, the weight of middle and low dose groups of the composition is improved compared with that of a model group, and the weight of the thirst quenching and blood sugar reducing capsule and the composition is not obviously improved in high dose groups. The results are shown in Table 4.
TABLE 4 Effect of compositions on body weight (g) of type 2 diabetic rats
2.2.5 Effect on type 2 diabetes model rat blood sugar related indicators
Compared with the normal control group, the fasting blood glucose value and the insulin resistance value of the model group are obviously increased (P < 0.01), and the model group conforms to the characteristics of the type 2 diabetes model. After 2 weeks and 4 weeks of administration, the high, medium and low dose groups of the positive drug group and the composition can obviously reduce the blood sugar and insulin resistance values (P < 0.05) compared with the model group, wherein the dose group in the composition has the best effect, the high dose group has the effect superior to that of the low dose group, and the positive drug effect is close to that of the high dose group of the composition. In the aspect of saccharifying serum protein, the model group is obviously higher than a normal control group (P < 0.01), and accords with the characteristics of a type 2 diabetes model. Compared with the model group, the dosage group and the low dosage group in the composition can obviously reduce the content of glycated serum protein in serum (P < 0.05), and although the high dosage group and the positive drug group have the reduction trend, the result has no obvious difference (P > 0.05), and the specific result is shown in Table 5.
TABLE 5 Effect of composition extracts on blood glucose related indices in type 2 diabetic rats
Note: # comparison of representation to model set P<0.05， ## Comparison of representation to model set P<0.01, the same applies below
2.2.6 Effect on type 2 diabetes model rat blood lipid-related indices
Compared with a normal control group, the serum content of free fatty acid, total cholesterol and triglyceride in the model group is obviously increased (P < 0.01), the high-density lipoprotein is obviously reduced (P < 0.01), the low-density lipoprotein is obviously increased (P < 0.01), and the model group accords with the characteristics of a type 2 diabetes model. In the aspect of free fatty acid, compared with a model group, the high-dose group, the medium-dose group, the low-dose group and the positive drug group of the composition can obviously reduce the content of the free fatty acid in serum (P < 0.01), wherein the low-dose group of the composition has the best effect. In the aspect of total cholesterol, compared with a model group, the composition can obviously reduce the content of cholesterol in serum (P < 0.05) in a high-dose group, a medium-dose group and a low-dose group, wherein the effect of the dose group in the composition is optimal, the dose group in the composition has obvious difference (P < 0.01) compared with the model group, and the positive medicine group has no obvious difference (P > 0.05) compared with the model group. In the aspect of triglyceride, compared with a model group, the composition in the high, medium and low dose groups and the positive drug can obviously reduce the content of triglyceride in serum (P < 0.05), wherein the effect of the high dose group is optimal, and the high dose group has a significant difference (P < 0.01) compared with the model group. In the aspect of high-density lipoprotein, compared with a model group, the high-density lipoprotein content in serum can be obviously increased in the high-dose, medium-dose and low-dose groups of the composition (P is less than 0.05), and the positive medicine group has no obvious difference (P is more than 0.05) compared with the model group. In the aspect of low-density lipoprotein, compared with a model group, the high-dose, medium-dose and low-dose groups of the composition can obviously reduce the content of the low-density lipoprotein in serum (P < 0.05), and compared with the model group, the positive medicine group has no obvious difference (P > 0.05). The results are shown in Table 6.
TABLE 6 Effect of composition extracts on blood lipid related indices in type 2 diabetic rats
Note: # comparison of representation to model set P<0.05， ## Comparison of representation to model set P<0.01, the same applies below
2.2.7 Effect on pathological tissues of pancreas in type 2 diabetes model rats
Normal control group: the number of the islets is large, the outline is regular and regular, and the cells in the islets are arranged regularly.
Model group: the number of islets is reduced, the islet morphology is irregular, the cell arrangement is disordered, and the cells are usually atrophied and collapsed.
Positive drug group: the volume of the pancreatic islets is reduced, and the phenomenon of atrophy of the pancreatic islet cells is reduced.
Composition high, medium, low dose groups: the islet volume is reduced in different degrees, the number is reduced in different degrees, but the arrangement of islet cells is better than that of a model group, the atrophy phenomenon of islet cells is reduced, and the swelling phenomenon of islet cells is reduced.
And (4) conclusion: the composition has good effect on the morphological protection degree of islet cells by medium and high dose groups. The results are shown in FIG. 1.
3. Conclusion of the experiment
In conclusion, the traditional Chinese medicine composition can play a role in preventing and treating diabetic peripheral neuropathy by reducing the blood sugar and the blood fat of diabetic rats and protecting islet cells.
Claims (6)
1. A traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy is characterized by comprising the following raw materials in parts by weight:
20 to 60 portions of astragalus root, 20 to 60 portions of white peony root, 20 to 60 portions of cassia twig, 40 to 120 portions of ginger and 20 to 50 portions of Chinese date.
2. The traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy according to claim 1, which comprises the following raw materials in parts by weight:
40 parts of astragalus membranaceus, 40 parts of radix paeoniae alba, 40 parts of cassia twig, 80 parts of ginger and 35 parts of Chinese date.
3. The preparation method of the traditional Chinese medicine composition for preventing and treating diabetic peripheral neuropathy as claimed in claim 1 or 2, comprising the steps of:
putting the five medicines into a proper container, adding 4-8 times of water, decocting for 30-90 minutes, filtering, directly freeze-drying the filtrate or concentrating the filtrate into thick paste with the relative density of 1.05-1.35 (80 ℃), and decompressing or freeze-drying to obtain the traditional Chinese medicine composition for preventing and treating the peripheral neuropathy of the diabetes.
4. The use of the Chinese medicinal composition of claim 1 or 2 in the preparation of a medicament for preventing and treating diabetic peripheral neuropathy.
5. The Chinese medicinal composition of claim 1 or 2, which can be added with common pharmaceutical excipients to prepare a pharmaceutically acceptable oral preparation.
6. The oral preparation of claim 5 comprises tablets, capsules or granules, and the tablets, capsules or granules can be prepared by adopting a conventional preparation method of corresponding preparations.
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