Traditional Chinese medicine composition for reducing blood sugar, protecting kidney and resisting aging as well as preparation and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for reducing blood sugar, protecting kidney and resisting aging as well as a preparation and a preparation method thereof, and belongs to the field of traditional Chinese medicine preparation of sugar-reducing and kidney-tonifying prescriptions. The traditional Chinese medicine composition for reducing blood sugar, protecting kidney and resisting aging is prepared from the following components in parts by weight: 3 to 4 parts of radix rehmanniae recen extract, 2 to 3 parts of fructus corni extract, 3 to 4 parts of ampelopsis grossedentata extract, 3 to 4 parts of rhizoma polygonati extract, 3 to 4 parts of phellinus igniarius extract, 3 to 4 parts of poria cocos extract, 3 to 5 parts of rhizoma dioscoreae extract and 1 part of rhizoma coptidis extract. The traditional Chinese medicine composition provided by the invention can be used for remarkably reducing the blood sugar level of diabetes, improving the condition of diabetic nephropathy and delaying disease progression, and is good in safety.

Description

Technical Field

[0001] The invention relates to the technical field of Chinese medicine pharmaceutical preparation of Antang Yishen prescription, and more specifically to a Chinese medicine composition for reducing blood sugar, protecting kidney and resisting aging, and a preparation method thereof. Background Art

[0002] Diabetic Kidney Disease (DKD) is an important and extremely harmful microvascular complication in diabetic patients, and is also the primary cause of end-stage renal disease (ESRD). Clinically, the main manifestations of DKD are persistent albuminuria and / or a progressive decrease in glomerular filtration rate (GFR), which may eventually progress to ESRD. Epidemiological studies have revealed that the prevalence of diabetic nephropathy is increasing year by year. According to the International Diabetes Federation, the number of diabetic patients worldwide will increase to 700 million by 2045, and the prevalence of diabetic nephropathy, as a common complication of diabetes, will also continue to rise. In China, the hospitalization rate of patients with diabetic nephropathy has increased from 3.58% in 2010 to 4.95% in 2017, showing a steady growth trend. At present, the clinical treatment of DKD includes both drug and non-drug treatments. Non-drug treatments include lifestyle intervention, weight loss, smoking cessation, alcohol restriction, blood pressure reduction, and lipid regulation. Classical therapeutic drugs mainly rely on angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists. However, since the therapeutic effects of existing drugs are still uncertain and the side effects are more obvious, the development of new treatment strategies and drugs is of vital importance to improve the prognosis of DKD patients.

[0003] Modern medicine believes that the pathogenesis of DKD is quite complex, involving multiple aspects such as oxidative stress, inflammation and autophagy. Therefore, compared with drugs with a single target, traditional Chinese medicine can play a role in multiple ways, including reducing inflammatory response, reducing oxidative stress and regulating cell autophagy, relying on its overall dynamic fine-tuning and early adjustment of multiple targets, multiple pathways, multiple levels, multiple systems and multiple time limits, thus showing significant advantages in the prevention and treatment of diabetic nephropathy. Traditional Chinese medicine has a long history of understanding and research on diabetic nephropathy. As early as in the Yellow Emperor's Classic of Internal Medicine, the name of the disease "Xiao Ke" was proposed: "This is the origin of fat and delicious food. This person must eat sweet and delicious food frequently and fat. Fat makes people hot inside, and sweet food makes people full, so the qi overflows and turns into Xiao Ke." Later, the clinical manifestations of Xiao Ke were recorded in the Golden Chamber: "When the qi is strong, the urine is frequent, and the frequent urine is hard, and the hardness and frequency are fighting, which is Xiao Ke." According to this paragraph, Xiao Ke is equivalent to diabetes in modern medicine. Later, the name "kidney consumption" was proposed in "Zhengzhi Zhunsheng. Xiaoyan": "Thirst and drinking a lot is upper consumption (called diaphragmatic consumption in the classics), hunger after eating is middle consumption (called xiaozhong in the classics), thirst and frequent stools with oil is lower consumption (called kidney consumption in the classics)." The "kidney consumption" referred to here is equivalent to diabetic nephropathy in modern medicine. Finally, in Volume 53 of "Taiping Shenghui Fang", the description of diabetic nephropathy is more detailed: "If you have stool after drinking water, sweet and white urine, and thin waist and legs, it is kidney consumption." This description clearly points out that patients with diabetic nephropathy will have proteinuria.

[0004] In traditional Chinese medicine, the basic pathogenesis of diabetes is attributed to Yin deficiency and dryness. Among them, Yin deficiency is the root and dryness and heat are the symptoms. The two are mutually causal. The more Yin is deficient, the more dryness and heat are severe, and the more dryness and heat are severe, the more Yin is deficient, forming a vicious cycle. The lesions mainly involve the lungs, stomach and kidneys, especially the kidneys. The three organs influence each other, and at the same time, each has its own emphasis. The lungs are the upper source of water and distribute body fluids. If dryness and heat damage the lungs, the body fluids cannot be distributed and go straight down, resulting in frequent and large urination. If the lungs fail to distribute body fluids, thirst and drinking a lot of water will occur. If dryness and heat damage the spleen and stomach, the stomach fire will be strong and the spleen yin will be insufficient, resulting in thirst and drinking a lot of water, eating a lot and being hungry; if the spleen is deficient and fails to function, the essence of water and grain will flow down into the urine, and the urine will taste sweet. If the essence of water and grain is depleted, the body will become thinner day by day. If the thirst lasts for a long time and the condition is out of control, the yin will be damaged and the yang will be damaged, the heat will burn the body fluid and cause blood stasis, which will damage both the qi and yin, and both the yin and yang will be deficient, the collaterals will be blocked, and the internal organs will be damaged, resulting in furuncles, carbuncles, dizziness, chest pain, deafness, blindness, numbness and pain in the limbs, lower limb gangrene, renal failure edema or stroke coma and other complications. Traditional Chinese medicine has shown unique advantages in improving the clinical symptoms of DKD patients, improving the quality of life of patients and blocking the progression of DKD. Through syndrome differentiation and treatment, traditional Chinese medicine can not only effectively control blood sugar, reduce proteinuria, and eliminate edema, but also delay the progression of chronic kidney disease (CKD) through external treatment, thereby significantly improving the quality of life of patients. Summary of the invention

[0005] In view of the problems existing in the prior art, the first object of the present invention is to provide a Chinese medicine composition for lowering blood sugar, protecting the kidney and anti-aging, the second object of the present invention is to provide a Chinese medicine composition preparation, and the third object of the present invention is to provide a method for preparing the Chinese medicine composition; the Chinese medicine composition provided by the present invention has high safety and shows the efficacy of lowering blood sugar, protecting the kidney and anti-aging in efficacy experiments, and can be used to treat diabetic nephropathy (DKD).

[0006] To solve the above problems, the present invention adopts the following technical solutions.

[0007] A Chinese medicine composition for lowering blood sugar, protecting kidneys and resisting aging, comprising the following formula in proportion by weight: 3-4 parts of raw rehmannia root extract, 2-3 parts of cornus officinalis extract, 3-4 parts of rattan tea extract, 3-4 parts of polygonatum sibiricum extract, 3-4 parts of mulberry linterus extract, 3-4 parts of tuckahoe extract, 3-5 parts of yam extract and 1 part of coptis root extract.

[0008] The present invention also provides a method for preparing a Chinese medicine composition for reducing blood sugar, protecting kidneys and resisting aging, comprising the following steps: firstly, extracts of Radix Rehmanniae, Fructus Corni, Ampelopsis Alpiniae, Polygonatum sibiricum, Phellinus Linn., Poria, Dioscorea opposita and Rhizoma Coptidis in the Chinese medicine composition are obtained by the following method:

[0009] (1) Crush the raw Rehmannia root body, add 6 to 10 times the amount of water and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it and pass it through a No. 6 sieve to obtain a raw Rehmannia root extract powder;

[0010] (2) Crush the cornus officinalis, add 6 to 10 times the amount of water and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it and pass it through a No. 6 sieve to obtain a cornus officinalis extract powder;

[0011] (3) adding 6 to 10 times the amount of water to the rattan tea and boiling it for 2 to 3 times, each time for 1 hour, removing the residue and taking the decoction, combining the filtrate, and concentrating the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-drying the extract in a vacuum, crushing it through a No. 6 sieve, and obtaining a rattan tea extract powder;

[0012] (4) adding 6 to 10 times the amount of water to the polygonatum sibiricum and boiling for 1 to 2 times, each time for 1 hour, removing the residue and taking the decoction, combining the filtrate, and concentrating the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-drying the extract in a vacuum, crushing it through a No. 6 sieve, and obtaining a polygonatum sibiricum extract powder;

[0013] (5) adding 6 to 10 times the amount of water to Phellinus igniarius and boiling for 2 to 3 times, each time for 1 hour, removing the residue and taking the decoction, combining the filtrate, and concentrating the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-drying the extract in a vacuum, crushing it through a No. 6 sieve, and obtaining a Phellinus igniarius extract powder;

[0014] (6) Add 6 to 10 times the amount of water to Poria cocos and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it and pass it through a No. 6 sieve to obtain a Poria cocos extract powder;

[0015] (7) Add 6 to 10 times the amount of water to the Chinese yam and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it through a No. 6 sieve, and obtain a Chinese yam extract powder;

[0016] (8) Add 5 to 10 times the amount of water to the coptis root and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it and pass it through a No. 6 sieve to obtain a coptis root extract powder;

[0017] Finally, the eight extract powders of Rehmannia root, Cornus officinalis, Ampelopsis pilosula, Polygonatum sibiricum, Coriolus linteus, Poria cocos, Dioscorea opposita and Coptis chinensis are mixed in a certain proportion.

[0018] The present invention also provides a Chinese medicine composition preparation for reducing blood sugar, protecting kidneys and resisting aging, and the Chinese medicine composition preparation comprises the above-mentioned Chinese medicine composition and appropriate amounts of other raw materials.

[0019] Furthermore, the Chinese medicine composition preparation is a tablet, chewable tablet, powder, granule, granule, capsule, paste, pill or liquid preparation.

[0020] Furthermore, the Chinese medicine composition preparation also includes food additives.

[0021] Rehmannia glutinosa, scientific name Rehmanniae Radix, is the fresh or dried root of Rehmannia glutinosa Libosch., a plant of the Scrophulariaceae family. Rehmannia glutinosa tastes sweet and bitter, is cold in nature, and enters the heart, liver, and kidney meridians. It has the effects of clearing away heat and promoting fluid, nourishing yin and tonifying the kidney, and cooling blood and stopping bleeding. In addition, Rehmannia glutinosa also has the effect of removing blood stasis: "Yao Xing Lun" mentioned that Rehmannia glutinosa can "relieve all kinds of heat, break up blood, promote menstrual blockage, and also promote water channels. It can remove blood stasis when it is pounded into thin pieces in the heart and abdomen." This shows that Rehmannia glutinosa has the effect of promoting blood circulation and removing blood stasis. Rehmannia glutinosa was first recorded in "Shen Nong's Herbal Classic" in the Han Dynasty in my country. It mentioned that Rehmannia glutinosa can "expel blood stasis and remove stasis", where "stasis" refers to rheumatism. Rehmannia glutinosa can move blood vessels, and has an improvement effect on insufficient blood vessels and poor blood circulation. Pharmacological studies have shown that the active ingredients of Rehmannia glutinosa have many effects, including promoting blood production, lowering blood sugar, lowering blood lipids, lowering blood pressure, anti-inflammatory, and improving insulin resistance. These effects are particularly important for diabetic patients because it not only lowers blood sugar, but also reduces complications caused by diabetes.

[0022] Cornus officinalis, scientific name Corni Fructus, is the dried mature pulp of Cornus offcinalis Sieb.et Zucc., a plant of the Cornaceae family. Cornus officinalis is sour and astringent, slightly warm in nature, and enters the liver and kidney meridians. It has the effects of nourishing the liver and kidney, astringing the essence and consolidating the deficiency, and consolidating the meridians and stopping bleeding. "Shennong's Herbal Classic" records that Cornus officinalis: "It can cure evil spirits under the heart, cold and heat, warm the middle, expel cold and dampness, remove three worms, and lighten the body after long-term use." Modern research shows that Cornus officinalis has the effects of lowering blood sugar, lowering blood lipids, anti-oxidation and anti-aging. Specific research results show that Cornus officinalis polysaccharides can enhance the glucose uptake of insulin-resistant HepG2 cells in vitro in a concentration-dependent manner and significantly improve glucose consumption. In vivo, Cornus officinalis polysaccharides can significantly reduce the fasting blood glucose level, glycosylated hemoglobin level and amylase activity of diabetic rats induced by streptozotocin (STZ). In addition, cornus extract can improve the expression of lipopolysaccharide-induced macrophage interleukin-1β (IL-1β), interleukin-6 (IL-6) and nuclear factor kappa B (NF-κB), and protect the kidneys by downregulating protein kinase B (AKT) phosphorylation, thereby improving diabetic nephropathy (DKD). The above pharmacological effects are the key mechanisms of cornus to fight DKD.

[0023] Ampelopsis grossedentata, scientific name, is the dried stems and leaves of Ampelopsis grossedentata (Handel-Mazzetti) WTW of the grape family. The Book of Songs records that Ampelopsis grossedentata was first called "ancient tea Uncaria rhynchophylla". Lu Yu, a master of tea in the Tang Dynasty, named it Ampelopsis grossedentata in the Classic of Tea, and it is still used today. Ampelopsis tea is green in color and white in frost. It tastes slightly bitter at first, but the aftertaste is long-lasting and refreshing. Ampelopsis grossedentata tastes sweet, light, slightly astringent, and cool in nature. It belongs to the lung, liver, kidney, and stomach meridians. It has the effects of clearing away heat and detoxifying, promoting dampness and reducing swelling, purging fire and calming the liver, promoting blood circulation and removing turbidity, and detoxifying alcohol. It is commonly used in clinical treatment of colds and wind-heat, sore throat, sores in the mouth and tongue, carbuncles, sores, boils, damp-heat jaundice, dysentery, diarrhea, painful urination, red and swollen eyes, headache and dizziness, blood turbidity (hyperlipidemia), and alcohol poisoning. A clinical trial showed that one month of intervention with rattan tea can significantly reduce the levels of fasting plasma glucose (FPG), glycosylated albumin (GA), cystatin C and retinol binding protein 4 (RBP4) in adults with type II diabetes, thereby significantly improving the renal function of patients with type II diabetes. Studies have shown that the main active ingredients of rattan tea are flavonoids such as dihydromyricetin (DHM), which have multiple effects such as lowering blood sugar, anti-oxidation, alcohol detoxification and liver protection, anti-tumor, anti-inflammatory, anti-pathogenic microorganisms and anti-thrombosis. For example, DHM can alleviate the abnormal increase in blood sugar in Zucker diabetic obese rats by inhibiting PPARγ phosphorylation; in db / db mice, DHM can also improve insulin resistance by upregulating the tyrosine phosphorylation level of IRS-1.

[0024] Polygonatum sibiricum, scientific name Polygonatum Rhizoma, is the dried rhizome of Polygonatum kingianum Coll.et Hemsl., Polygonatum sibiricum Red. or Polygonatum cyrtonemaHua, plants of the Liliaceae family. Polygonatum sibiricum is sweet in taste and neutral in nature. It enters the spleen, lung and kidney meridians and has the effects of replenishing qi and nourishing yin, strengthening the spleen and replenishing qi, nourishing yin and moistening the lungs, and replenishing the kidney and filling essence. In terms of pharmacological effects, Polygonatum sibiricum has multiple effects such as lowering blood sugar, lowering blood pressure, lowering blood lipids, improving immunity, resisting fatigue, improving memory and anti-oxidation. These effects not only help to effectively control the overall symptoms of diabetic patients, but also significantly improve chronic kidney damage. Studies have shown that Polygonatum sibiricum water extract can enhance the expression of glucose transporter 4 (GLUT-4) gene in rats with type 2 diabetes (T2DM), thereby playing a role in lowering blood sugar. In addition, Polygonatum sibiricum extract can significantly reduce blood glucose levels in diabetic mice induced by alloxan and reduce hyperglycemia caused by adrenaline or exogenous glucose.

[0025] Phellinus igniarius, scientific name Sanghuangporus, is the dried fruiting body of the fungus Sanghuangporus vaninii (Ljub) LWZhou et YCDai of the family Pucciniaceae. Phellinus igniarius is a very precious large medicinal fungus, sweet, spicy, slightly bitter, cold in nature, non-toxic, and enters the liver and kidney meridians, with the effects of nourishing the liver and kidney and strengthening the tendons and bones. Phellinus igniarius is used in traditional Chinese medicine to treat various symptoms caused by liver and kidney deficiency, and has a certain protective effect on patients with diabetic nephropathy. Modern pharmacological studies have shown that Phellinus igniarius contains a variety of active ingredients such as polysaccharides, flavonoids, triterpenes and polyphenols, and has antioxidant, anti-tumor, immunomodulatory, anti-inflammatory and hypoglycemic effects. Studies have found that Phellinus igniarius polysaccharides can effectively improve the glucose tolerance of diabetic mice and significantly reduce their fasting blood sugar levels. In addition, Phellinus igniarius polysaccharides can also alleviate the pathological changes in diabetic mice and reduce the levels of IL-1 and IL-6. It is worth noting that Phellinus igniarius polysaccharides can also effectively alleviate the symptoms of hyperglycemia in rats with type II diabetes (T2DM) model. Many studies have shown that mulberry ignia polysaccharide has a certain therapeutic effect on diabetes.

[0026] Poria cocos, scientifically known as Poria, is the dried sclerotium of the fungus Poria cocos (Schw.) wolf of the Polyporaceae family. Poria cocos tastes sweet and light, is neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and removing dampness, strengthening the spleen, and calming the mind and nerves. "Shennong's Herbal Classic" records that "it is used to treat chest and rib reversal of qi, worry and anger, shock and evil, fear and palpitations, heart knot pain, cold and heat, fullness and fullness, cough and reverse, dry mouth and tongue, and promotes urination. Long-term use can calm the soul, nourish the spirit, prevent hunger, and prolong life." In terms of pharmacological effects, Poria cocos has multiple effects such as regulating immunity, diuresis, reducing swelling, reducing proteinuria, improving renal function, anti-inflammatory and anti-renal fibrosis, and is especially suitable for kidney protection and diabetic nephropathy patients. Studies have shown that Poria cocos and its surface layer can exert kidney protection through a variety of molecular mechanisms, including TGF-β1 / Smad, Wnt / β-catenin, IκB / NF-κB and Keap1 / Nrf2 pathways, thereby effectively improving diabetic nephropathy.

[0027] Chinese yam, scientifically known as Dioscoreae Rhizoma, is the dried rhizome of Dioscorea opposita Thunb. of the Dioscoreaceae family. Chinese yam is sweet in taste and neutral in nature. It enters the spleen, lung and kidney meridians. It has the effects of nourishing qi and yin, tonifying the spleen, lung and kidney, and stopping leukorrhea. The Shennong's Herbal Classic lists Chinese yam as a top-grade product, recording that it "treats the middle, tonifies deficiency, removes cold and heat evil spirits, tonifies the middle and strengthens qi and strength, grows muscles, and makes the ears and eyes smarter after long-term use." The Compendium of Materia Medica also believes that Chinese yam "tonifies kidney qi and strengthens the spleen and stomach", highlighting its significant role in tonifying the spleen and stomach, tonifying the kidney and astringing essence. Modern pharmacological studies have further shown that Chinese yam has multiple functions such as regulating gastrointestinal function, lowering blood sugar, enhancing immunity, delaying aging, reducing proteinuria and improving renal function. It can effectively control the blood sugar level of diabetic patients and protect renal function. Studies have also shown that Chinese yam polysaccharides can significantly improve blood sugar, creatinine, urea nitrogen and renal pathological damage in mice with alloxan-induced diabetic nephropathy. In addition, prescriptions based on yam can improve various pathological changes of chronic renal failure; for example, Liuwei Dihuang Decoction can inhibit and reduce renal interstitial fibrosis of renal tubular epithelial cells, thereby reducing and delaying the progression of renal fibrosis and protecting kidney function.

[0028] Coptis chinensis, scientific name Coptis Rhizoma, is the dried rhizome of Coptis chinensis Franch., Coptis deltoidea CYCheng et Hsiao or Coptis teeta Wall. of the Ranunculaceae family. Changsha Yaojie records that Coptis chinensis is "bitter in taste, cold in nature, and enters the Shaoyin Heart Meridian. It clears the heart and reduces fever, and clears fire and relieves restlessness." Coptis chinensis is bitter and cold in nature, and enters the heart, spleen, liver, stomach, gallbladder, and large intestine meridians. It has the effects of clearing heat and dampness, clearing fire and detoxifying. Because of its effect of lowering blood sugar, Coptis chinensis can be used to treat diabetes and its complications. Studies on the mechanism of action of Coptis chinensis have found that the active ingredients of Coptis chinensis can significantly increase the serum glutathione level of diabetic rats, enhance the body's antioxidant capacity, and protect vascular endothelial cells. In addition, Coptis chinensis can increase endogenous insulin secretion, improve the body's sensitivity to insulin, and thus reduce insulin resistance. Several studies have shown that berberine extracted from the rhizome of Coptis chinensis can significantly improve various clinical symptoms of diabetic patients and help delay the occurrence of diabetic complications.

[0029] In summary, this prescription aims to achieve the effects of lowering blood sugar, protecting kidneys and delaying aging by combining the pharmacological effects of various medicinal materials through multiple functions such as nourishing the liver and kidneys, clearing away heat and promoting body fluid, and promoting blood circulation and unblocking collaterals. This prescription is based on the theory of traditional Chinese medicine and combined with modern pharmacological research to provide a comprehensive treatment plan for patients with diabetes and DKD.

[0030] Compared with the prior art, the advantages of the present invention are:

[0031] (1) The raw materials in the formula of the Chinese medicine composition for reducing blood sugar, protecting kidneys and resisting aging provided by the present invention are all Chinese medicines that are both medicinal and edible. In the safety experiment, LD 50 >5000mg / kg, indicating that the Chinese medicine composition has good safety.

[0032] (2) The blood sugar lowering, kidney protection and anti-aging Chinese medicine composition provided by the present invention has a significant protective effect on diabetic kidney damage induced by STZ combined with a high-sugar and high-fat diet.

[0033] (3) The present invention can effectively reduce fasting blood sugar, insulin and glycosylated serum protein levels by combining Rehmannia root extract, Cornus officinalis extract, Ampelopsis pilosula extract, Polygonatum sibiricum extract, Phellinus linteus extract, Poria extract, Dioscorea opposita extract and Coptis chinensis extract, thereby achieving a hypoglycemic effect. At the same time, the composition can also reduce renal index, blood creatinine, blood urea nitrogen and 24h urine protein levels, significantly improving diabetic kidney damage. In addition, it can also effectively reduce cholesterol, triglyceride and low-density lipoprotein levels, and increase high-density lipoprotein levels, thereby improving lipid metabolism disorders caused by diabetic nephropathy.

[0034] (4) The present invention achieves the therapeutic effect of preventing diabetic nephropathy by scientifically combining Rehmannia root extract, Cornus officinalis extract, Ampelopsis pilosula extract, Polygonatum sibiricum extract, Phellinus linteus extract, Poria cocos extract, Dioscorea opposita extract and Coptis chinensis extract. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 This is a graph showing the levels of fasting blood glucose, insulin and glycosylated hemoglobin in serum of each group of mice in the pharmacodynamic experiment of the present invention;

[0036] Figure 2 The graphs of kidney index, blood creatinine, blood urea nitrogen, and 24-hour urine protein levels of mice in each group of the pharmacodynamic experiment of the present invention are shown;

[0037] Figure 3 This is a graph showing the levels of serum cholesterol, triglycerides, low-density lipoprotein, and high-density lipoprotein in each group of mice in the pharmacodynamic experiment of the present invention;

[0038] Figure 4 This is a schematic diagram of the results of HE staining, Masson staining, and PAS staining of renal tissue of mice in each group in the pharmacodynamic experiment of the present invention. DETAILED DESCRIPTION

[0039] Example 1: Tablet Formation

[0040] Mix 3 parts of Rehmannia root extract, 2 parts of Cornus officinalis extract, 3 parts of Ampelopsis pilosula extract, 3 parts of Polygonatum sibiricum extract, 3 parts of Phellinus igniarius extract, 3 parts of Poria cocos extract, 5 parts of Dioscorea opposita extract and 1 part of Coptis chinensis extract, add starch and carboxymethyl cellulose, mix well, granulate, compress and coat to make tablets.

[0041] Example 2: Tablet Formation

[0042] Mix 4 parts of Rehmannia root extract, 2 parts of Cornus officinalis extract, 3 parts of Ampelopsis pilosula extract, 3 parts of Polygonatum sibiricum extract, 3 parts of Phellinus igniarius extract, 3 parts of Poria cocos extract, 5 parts of Dioscorea opposita extract and 1 part of Coptis chinensis extract, add starch and carboxymethyl cellulose, mix well, granulate, compress and coat to make tablets.

[0043] Example 3: Tablet Formation

[0044] Mix 4 parts of Rehmannia root extract, 3 parts of Cornus officinalis extract, 3 parts of Ampelopsis pilosula extract, 3 parts of Polygonatum sibiricum extract, 3 parts of Phellinus igniarius extract, 3 parts of Poria cocos extract, 5 parts of Dioscorea opposita extract and 1 part of Coptis chinensis extract, add starch and carboxymethyl cellulose, mix well, granulate, compress and coat to make tablets.

[0045] Example 4: Tablet Formation

[0046] Mix 4 parts of Rehmannia root extract, 3 parts of Cornus officinalis extract, 4 parts of Ampelopsis pilosula extract, 3 parts of Polygonatum sibiricum extract, 3 parts of Phellinus linteus extract, 3 parts of Poria cocos extract, 5 parts of Dioscorea opposita extract and 1 part of Coptis chinensis extract, add starch and carboxymethyl cellulose, mix well, granulate, compress and coat to make tablets.

[0047] Example 5: Tablet Formation

[0048] Mix 4 parts of Rehmannia root extract, 3 parts of Cornus officinalis extract, 4 parts of Ampelopsis pilosula extract, 4 parts of Polygonatum sibiricum extract, 4 parts of Phellinus linteus extract, 4 parts of Poria cocos extract, 5 parts of Dioscorea opposita extract and 1 part of Coptis chinensis extract, add starch and carboxymethyl cellulose, mix well, granulate, compress and coat to make tablets.

[0049] Example 6: Preparation of hard capsules

[0050] 3 parts of Rehmannia glutinosa extract, 2 parts of Cornus officinalis extract, 3 parts of Ampelopsis pilosula extract, 3 parts of Polygonatum cyrtonema extract, 3 parts of Phellinus igniarius extract, 3 parts of Poria cocos extract, 5 parts of Dioscorea opposita extract and 1 part of Coptis chinensis extract were mixed evenly, crushed, passed through a No. 3 sieve, made into granules, and dried at 70-90° C. After drying, the granules were sized to ensure uniformity and consistency of the granules. Finally, the sized granules were filled into gelatin hard capsules to make hard capsules, and the content of each capsule was 0.5 g.

[0051] Example 7: Preparation of hard capsules

[0052] 4 parts of Radix Rehmanniae extract, 2 parts of Fructus Corni extract, 3 parts of Rhizoma Anemarrhenae extract, 3 parts of Polygonatum sibiricum extract, 3 parts of Phellinus igniarius extract, 3 parts of Poria cocos extract, 5 parts of Dioscorea opposita extract and 1 part of Coptis chinensis extract were mixed evenly, crushed, passed through a No. 3 sieve, made into granules, and dried at 70-90° C. After drying, the granules were sized to ensure uniformity and consistency of the granules. Finally, the sized granules were filled into gelatin hard capsules to make hard capsules, and the content of each capsule was 0.5 g.

[0053] Example 8: Preparation of hard capsules

[0054] 4 parts of Rehmannia glutinosa extract, 3 parts of Cornus officinalis extract, 3 parts of Ampelopsis pilosula extract, 3 parts of Polygonatum cyrtonema extract, 3 parts of Phellinus igniarius extract, 3 parts of Poria cocos extract, 5 parts of Dioscorea opposita extract and 1 part of Coptis chinensis extract were mixed evenly, crushed, passed through a No. 3 sieve, made into granules, and dried at 70-90° C. After drying, the granules were sized to ensure uniformity and consistency of the granules. Finally, the sized granules were filled into gelatin hard capsules to make hard capsules, and the content of each capsule was 0.5 g.

[0055] Test example:

[0056] The formula of the present invention is named as Antang Yishen Recipe, and a series of safety and efficacy experiments have been conducted, and the results are as follows:

[0057] 1. Safety experiment

[0058] Objective: To observe the activity and death of mice after administration of the test product and determine the safety of the formula.

[0059] Test sample: An Tang Yi Shen Fang dry extract for lowering blood sugar, protecting kidneys and resisting aging (An Tang Yi Shen Fang)

[0060] Method: The clinical dosage of the Antang Yishen prescription for adults is 72g / 60kg = 1.2g / kg of raw medicine, which is converted to a mouse dosage of 1.2g / kg*12.3 = 14.76g / kg of raw medicine. (12.3 is the conversion factor for human and mouse use, and the actual dosage is determined based on specific experimental data.)

[0061] 216g of the water extract of the medicinal material was refined and freeze-dried at room temperature to obtain 51.2g of extract and powder, with a yield of 51.2g / 216g*100%=23.7%, and each gram of extract powder was equivalent to 216g / 51.2g=4.22g of crude drug.

[0062] Weigh 20g of extract powder, dissolve it in distilled water and make up to 30mL (0.667g / mL). After fasting for 16h, mice were given oral gavage (ig) 4 times at an interval of 4h at a dose of 0.15mL / 10g*bw (bw is body weight), with a total dose of 60mL / kg, that is, the daily extract dose of mice was 0.667g / mL*60mL / kg=40g / kg. The mice were then observed for 14 days, and the activity and death after gavage were recorded in detail to determine the safety of the formula.

[0063] Results: After each administration of the test product, the mice moved normally, and no death or other abnormalities occurred after gavage. At the same time, after 14 consecutive days of observation, no mice died or had other abnormalities, and their weight continued to grow. Therefore, the maximum tolerated dose (MTD) of the test product (extract) taken orally by mice within 24 hours is 40g / kg. This dose is equivalent to 40*4.22=168.8g / kg of the original medicinal material.

[0064] Conclusion: No animals died in the acute oral toxicity test, and the LD 50 Greater than 5000mg / kg (5g / kg), toxicity classification is practically non-toxic. (The actual dosage depends on the specific number of experiments)

[0065] 2. Pharmacodynamics experiment:

[0066] Experimental design: 50 male SD rats aged 4-6 weeks were selected. After 1 week of adaptation to normal diet, 10 rats were randomly selected as the normal diet feeding group (control group), and the remaining rats were fed with high-fat diet for 6 weeks. After 6 weeks, they were fasted for 12 hours and intraperitoneally injected with 3% streptozotocin (STZ) once. After 2 weeks of feeding, 24-hour metabolic testing was performed, and urine was collected to test urine sugar, urine total protein and urine microalbumin content.

[0067] Model screening: Diabetic rats that meet the following conditions were selected as diabetic nephropathy models: blood glucose values ​​≥16.7mmol / L measured three times within two weeks, positive urine glucose, urine volume >50% of the control group, total urine protein and urine microprotein >100% of the control group.

[0068] Grouping and intervention: The rats that met the conditions were then divided into 4 groups, namely: model group (Model, same dose of ddH2O, ig), metformin group (Met, dosage of 180 mg / kg / d, ig), low-dose of An Tang Yi Shen Fang group (ATYS-L, dosage of An Tang Yi Shen Fang was 3.5 g / kg / d, ig) and high-dose of An Tang Yi Shen Fang group (ATYS-H, dosage of An Tang Yi Shen Fang was 7 g / kg / d, ig), and the intervention continued for 5 weeks.

[0069] Sample collection and detection: First, 24 hours before the rats were killed, their 24-hour urine samples were collected using metabolic cages. After the experiment, the rats fasted for 12 hours, then blood was collected through the eye sockets, and the fasting blood glucose levels of the rats were measured using a blood glucose meter; then, the levels of glycosylated serum protein (GSP), blood urea nitrogen (BUN), serum creatinine (Scr), 24-hour urine protein (24hUP), total cholesterol (T-CHO), triglycerides (TC), low-density lipoprotein (LDL-C) and high-density lipoprotein (HDL-C) in the rat serum were determined using an automatic biochemical analyzer. In addition, we also used a kit to detect the level of insulin in serum. Finally, the kidney tissue was isolated to prepare pathological sections and HE staining was performed. All results were statistically analyzed using GraphPad software and one-way analysis of variance, and the data were expressed as mean ± standard deviation (x ± s).

[0070] Results: Figure 1-Figure 3As shown in the results, under the premise of successfully establishing the DKD model, compared with the control group, the renal index, fasting blood glucose, insulin, GSP, Scr, BUN, 24h UP, T-CHO, TC and LDL-C levels in the model group were significantly increased, while the HDL-C level was significantly decreased. It is worth noting that the high-dose and low-dose Antang Yishen Fang groups were superior to the model group in the above indicators, specifically, the renal index, insulin, fasting blood glucose, GSP, Scr, BUN, 24h UP, T-CHO, TC and LDL-C levels were significantly lower than those in the model group, while the HDL-C level was significantly higher than that in the model group, and this improvement effect showed a dose-dependent manner. In addition, the Scr, BUN, 24h UP and LDL-C levels in the high-dose and low-dose Antang Yishen Fang groups and the positive drug Met group were significantly reduced. These results show that high-dose and low-dose Antang Yishen Fang can significantly improve the renal function abnormalities of DKD model rats, thereby effectively delaying the progression of CKD.

[0071] like Figure 4 As shown in the figure, H&E staining showed that compared with the control group, rats in the DKD model group had glomerular hypertrophy, basement membrane thickening, increased mesangial matrix, and tubular cavitation. However, the high-dose and low-dose Antang Yishen Fang groups significantly improved these pathological abnormalities. Masson staining further confirmed that the glomerular and interstitial fibrosis lesions were significant in the DKD model group rats, while the high-dose and low-dose Antang Yishen Fang groups significantly reduced the fibrosis levels of the glomeruli and renal interstitium. PAS staining showed that the glomerular basement membrane of rats in the DKD model group was thickened, while the glomerular basement membrane thickening of rats in the high-dose and low-dose Antang Yishen Fang groups was significantly improved. The above pathological results show that both the high-dose and low-dose Antang Yishen Fang groups can significantly improve the glomerular and tubular damage, basement membrane thickening and fibrosis of DKD rats, and most pathological indicators are better than the positive drug Met group. In summary, the Antang Yishen prescription of the present invention can not only reduce the blood sugar level of DKD, but also significantly improve its abnormal renal function, thickening of glomerular basement membrane, increase of mesangial matrix and degree of fibrosis, thereby delaying the progression of chronic kidney disease (CKD).

Claims

1. A Chinese medicine composition for reducing blood sugar, protecting kidneys and resisting aging, characterized in that: The invention is composed of the following formula in proportion by weight: 3-4 parts of Rehmannia root extract, 2-3 parts of Cornus officinalis extract, 3-4 parts of Ampelopsis pilosula extract, 3-4 parts of Polygonatum sibiricum extract, 3-4 parts of Phellinus igniarius extract, 3-4 parts of Poria cocos extract, 3-5 parts of Dioscorea opposita extract and 1 part of Coptis chinensis extract.

2. The method for preparing a Chinese medicine composition for reducing blood sugar, protecting kidneys and resisting aging according to claim 1, characterized in that: The method comprises the following steps: firstly, extracts of Radix Rehmanniae, Fructus Corni, Ampelopsis Alpiniae, Polygonatum sibiricum, Phellinus linteus, Poria, Dioscorea opposita and Rhizoma Coptidis in the traditional Chinese medicine composition are obtained by the following method: (1) Crush the raw Rehmannia root body, add 6 to 10 times the amount of water and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it and pass it through a No. 6 sieve to obtain a raw Rehmannia root extract powder; (2) Crush the cornus officinalis, add 6 to 10 times the amount of water and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it and pass it through a No. 6 sieve to obtain a cornus officinalis extract powder; (3) adding 6 to 10 times the amount of water to the rattan tea and boiling it for 2 to 3 times, each time for 1 hour, removing the residue and taking the decoction, combining the filtrate, and concentrating the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-drying the extract in a vacuum, crushing it through a No. 6 sieve, and obtaining a rattan tea extract powder; (4) adding 6 to 10 times the amount of water to the polygonatum sibiricum and boiling for 1 to 2 times, each time for 1 hour, removing the residue and taking the decoction, combining the filtrate, and concentrating the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-drying the extract in a vacuum, crushing it through a No. 6 sieve, and obtaining a polygonatum sibiricum extract powder; (5) adding 6 to 10 times the amount of water to Phellinus igniarius and boiling for 2 to 3 times, each time for 1 hour, removing the residue and taking the decoction, combining the filtrate, and concentrating the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-drying the extract in a vacuum, crushing it through a No. 6 sieve, and obtaining a Phellinus igniarius extract powder; (6) Add 6 to 10 times the amount of water to Poria cocos and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it and pass it through a No. 6 sieve to obtain a Poria cocos extract powder; (7) Add 6 to 10 times the amount of water to the Chinese yam and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it through a No. 6 sieve, and obtain a Chinese yam extract powder; (8) Add 5 to 10 times the amount of water to the coptis root and boil for 2 to 3 times, each time for 1 hour, remove the residue, take the decoction and combine the filtrate, and concentrate the filtrate under reduced pressure at 70 to 90° C. to obtain an extract; freeze-dry the extract in a vacuum, crush it and pass it through a No. 6 sieve to obtain a coptis root extract powder; Finally, the eight extract powders of Rehmannia root, Cornus officinalis, Ampelopsis pilosula, Polygonatum sibiricum, Coriolus linteus, Poria cocos, Dioscorea opposita and Coptis chinensis are mixed in a certain proportion.

3. A Chinese medicine composition preparation for reducing blood sugar, protecting kidney and resisting aging according to claim 1, characterized in that: The Chinese medicine composition preparation comprises the above-mentioned Chinese medicine composition.

4. A Chinese medicine composition preparation for reducing blood sugar, protecting kidney and resisting aging according to claim 3, characterized in that: The Chinese medicine composition preparation is in the form of tablets, powders, granules, granules, capsules, pastes, pills or liquid preparations.

5. A Chinese medicine composition preparation for reducing blood sugar, protecting kidney and resisting aging according to claim 3, characterized in that: The Chinese medicine composition preparation also includes food additives.

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