Traditional chinese medicine composition for treating diabetes

Abstract

In the present invention, a specific traditional Chinese medicine composition is formed on the basis that consumptive thirst (diabetes) has the etiology and pathogenesis of qi deficiency, yin deficiency and blood stasis. There is a certain synergistic effect between drugs having the effects of nourishing yin and benefiting qi and drugs having the effects of promoting blood circulation for removing obstructions in collaterals in the prescription, wherein the drugs having the effects of nourishing yin and benefiting qi indirectly participate in hemodynamic regulation mainly by means of regulating blood glucose, and the drugs having the effects of promoting blood circulation for removing obstructions in collaterals act on blood vessels to improve microcirculation. The traditional Chinese medicine composition of the present invention has the following composition: 10-45 parts of Panacis quinquefolii radix, 120-300 parts of Rehmanniae radix, 85-110 parts of Ophiopogonis radix, 90-120 parts of Trichosanthis radix, 200-400 parts of Lycii cortex, 80-110 parts of Carthami flos, 100-300 parts of Polygoni multiflori radix praeparata, 85-120 parts of Bombyx batryticatus, and 85-120 parts of Cervi cornu degelatinatum.

Description

A traditional Chinese medicine composition for treating diabetes Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating diabetes. Background Art

[0002] In Western medicine, diabetes is considered a syndrome of metabolic disorders involving sugar, protein, fat, water, and electrolytes, caused by various pathogenic factors such as genetic factors, immune dysfunction, and free radical toxins acting on the body, leading to insulin deficiency and insulin resistance. According to the latest data from the International Diabetes Federation in 2021, the number of people with diabetes worldwide has reached 537 million, and my country's number is expected to exceed 175 million by 2045. Diabetes is mainly divided into type 1 and type 2 diabetes, of which type 2 diabetes accounts for 90%-95%. Type 2 diabetes is a dual hormone disease caused by the long-term interaction of genetic and environmental factors, resulting in insufficient insulin secretion or defective action, accompanied by inappropriate and increased glucagon. It is a metabolic disorder syndrome with elevated blood glucose levels as the biochemical characteristic and polydipsia, polyphagia, polyuria, weight loss, and fatigue as the clinical features. Clinically, it is characterized by three highs and three lows: high prevalence, high complications, high cost expenditure, low awareness, low treatment rate, and low control rate.

[0003] Diabetes falls under the category of "xiaoke disease" in Traditional Chinese Medicine (TCM). TCM believes that xiaoke disease is caused by innate deficiencies, emotional disorders, and an irregular diet, with yin deficiency and dryness and heat as the basic pathogenesis. Clinically, there are multiple classifications, with qi and yin deficiency being one of the main syndromes. At the same time, xiaoke disease is a disease affecting multiple internal organs, affecting the normal flow of qi and blood. Yin deficiency and internal heat, which consume body fluids, also cause poor blood circulation and lead to blood stasis. Therefore, blood stasis is one of the important pathogenesis of xiaoke disease, and the occurrence of various complications of xiaoke disease is also closely related to blood stasis. Through continuous improvement by doctors of various schools throughout the ages, it is believed that the onset of xiaoke disease is based on a yin deficiency constitution, combined with an irregular diet or partiality, emotional disorders, excessive exertion, and the six exogenous pathogenic factors. Yin deficiency is the root cause, and dryness and heat are the symptoms, with the two being mutually causal.

[0004] Currently, no drug that can completely cure diabetes has been reported. There are many types of Western medicine used to control blood sugar in clinical practice, including insulin and its analogs, sulfonylureas, biguanides, glibenclamides, etc. Although they can quickly control blood sugar, long-term use can easily cause a series of problems such as hypoglycemia, gastrointestinal reactions, and cardiovascular diseases. Western medicine often uses drugs to improve microcirculation and nourish nerves, but the symptoms do not improve significantly. As the disease progresses, the patient's dependence on exogenous drugs gradually increases, and eventually liver and kidney dysfunction, or even complications such as cardiovascular disease, may occur. Traditional Chinese medicine has the characteristics of mild efficacy and multiple targets. Therefore, it is of great significance to develop a traditional Chinese medicine composition for the treatment of diabetes that is effective, reasonably compatible, and safe to use.

[0005] Chinese patent CN 106822663 A discloses a Chinese medicine composition for treating type II diabetes, which contains 3-9g of Astragalus, 3-9g of Rosa Laevigata, 3-9g of Cuscuta, 3-9g of Asparagus, 3-9g of Morus Albizia, 3-9g of Placenta, 3-9g of Polygonatum, 3-9g of Anemarrhena, 3-7g of Gypsum, 3-9g of Radix Trichosanthis, 2-7g of Artemisia Annua, 2-7g of Paeonia Suffruticosa, 2-7g of Rehmannia Glutinosa, 2-7g of Puerariae Root, 2-8g of Ganoderma Lucidum, 2-7g of Bletilla Striata, and 2-7g of Radix Angelicae Dahuricae. A Chinese herbal medicine combination of 2-7g of Grass Frost, 2-8g of Belamcanda Root, 2-6g of Polygala Tenuifolia, 2-9g of Polygonum Cuspidati, 2-9g of Salvia Miltiorrhiza, 2-7g of Cinnabarinia 2-6g of Lycium bark, 2-7g of Pomegranate Peel, 2-6g of Lotus Seed, 2-7g of Imperata Rhizome, 3-9g of Panax Notoginseng, 5-9g of American Ginseng, 2-4g of Bombyx Batryticatus, 2-4g of Agrimoniae, 2-4g of Gecko, 2-4g of Leech, 2-4g of Ant, and 2-4g of Tortoise Shell. However, the Chinese medicine composition has a complex formula and focuses on repairing the metabolic function in the body to control and stabilize blood sugar, but does not focus on the etiology and pathogenesis of diabetes. For example, Chinese patent CN110787258A discloses a Chinese medicine composition for treating diabetes, which is composed of the following Chinese medicines: 10-100 parts of red ginseng, 10-100 parts of Panax notoginseng, 10-100 parts of leech, 10-100 parts of pearl, 10-100 parts of bombyx batryticatus, 10-100 parts of coptis chinensis, 10-100 parts of cinnamon bark, 10-100 parts of polygonum multiflorum, 10-100 parts of trichosanthes root, 10-100 parts of kudzu root, 10-100 parts of salvia miltiorrhiza, 10-100 parts of ophiopogon, 10-100 parts of polygonatum and 10-100 parts of hawthorn. This prescription achieves the purpose of treating diabetes from the perspective of preventing diabetes and treating complications caused by diabetes, but similarly ignores the etiology and pathogenesis of diabetes.

[0006] The present invention is based on the Chinese medicine composition disclosed in “Treatment of 30 Cases of Diabetes with Tangyoukang Capsules, Shaanxi Journal of Traditional Chinese Medicine, Vol. 21, No. 3, 2000, Affiliated Hospital of Shaanxi Institute of Traditional Chinese Medicine (71003), Xu Jianqin, Lu Bo, Shen Lu, Yang Mingli, Zhang Xiaozheng, Wang Dong”, which comprises 0.5g of American ginseng, 2g of safflower, 2.5g of Lycium bark, 2.5g of Morus alba bark, and 1.5g of Bombyx batryticatus, and the Chinese medicine composition disclosed in “Study on Improving the Quality Standard of Tangyoukang Capsules, Hu Jing, Xu Jianqin, Chen Zhiyong, Ren Hui, Zhang Xiaofeng, Shaanxi Institute of Traditional Chinese Medicine, Xi’an, Shaanxi 71003, China”. 0061; 2. Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi'an, Shaanxi 710003. The disclosed Chinese medicine composition comprises American ginseng, rehmannia root, ophiopogon japonicus, radix trichosanthis, cortex rehmanniae, safflower, processed polygonum multiflorum, bombyx batryticatus, and antler frost. Based on this, and in accordance with the etiology and pathogenesis of diabetes mellitus and the principle of treating both the symptoms and the root causes, a specific Chinese medicine composition is formed. There is a certain synergistic effect between the drugs that nourish yin and replenish qi and those that activate blood circulation and dredge collaterals in the formula. The drugs that nourish yin and replenish qi mainly participate in the regulation of hemodynamics indirectly by regulating blood sugar, while the drugs that activate blood circulation and dredge collaterals act on blood vessels to improve microcirculation.

[0007] Summary of the Invention

[0008] The present invention takes nourishing yin and replenishing qi, and promoting blood circulation and unblocking collaterals as the treatment principle, and verifies the blood sugar lowering effect of the Chinese medicine composition of the present invention through the fasting blood sugar of mice before and after meals, thereby confirming the present invention.

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating diabetes, which treats diabetes by nourishing yin and replenishing qi, and promoting blood circulation and unblocking meridians. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10-45 parts of American ginseng, 120-300 parts of Rehmannia glutinosa, 85-110 parts of Ophiopogon japonicus, 90-120 parts of Radix Trichosanthis, 200-400 parts of Cortex Lycii, 80-110 parts of Carthamus tinctorius, 100-300 parts of processed Polygonum multiflorum, 85-120 parts of Bombyx batryticatus, and 85-120 parts of antler frost.

[0010] Preferably, the traditional Chinese medicine composition is made of the following traditional Chinese medicines in parts by weight: 20-40 parts of American ginseng, 120-250 parts of Rehmannia glutinosa, 90-110 parts of Ophiopogon japonicus, 95-110 parts of Radix Trichosanthis, 270-350 parts of Cortex Lycii, 90-105 parts of Carthamus tinctorius, 150-250 parts of processed Polygonum multiflorum, 95-110 parts of Bombyx batryticatus, and 90-110 parts of Deer Antler Cream.

[0011] Preferably, the Chinese medicine composition is made of the following Chinese medicinal materials in parts by weight: 30 parts of American ginseng, 200 parts of Rehmannia glutinosa, 100 parts of Ophiopogon japonicus, 100 parts of Radix Trichosanthis, 300 parts of Cortex Lycii, 100 parts of Carthamus tinctorius, 200 parts of processed Polygonum multiflorum, 100 parts of Bombyx batryticatus, and 100 parts of Deer Antler Cream.

[0012] In a second aspect, the present invention provides a preparation of a traditional Chinese medicine composition for treating diabetes. The traditional Chinese medicine preparation may comprise a traditional Chinese medicine composition for treating diabetes and a pharmaceutically acceptable excipient. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10-45 parts of American ginseng, 120-300 parts of Rehmannia glutinosa, 85-110 parts of Ophiopogon japonicus, 90-120 parts of Radix Trichosanthis, 200-400 parts of Cortex Lycii, 80-110 parts of Carthamus tinctorius, 100-300 parts of processed Polygonum multiflorum, 85-120 parts of Bombyx batryticatus, and 85-120 parts of antler frost.

[0013] Preferably, the traditional Chinese medicine composition is made of the following traditional Chinese medicines in parts by weight: 20-40 parts of American ginseng, 120-250 parts of Rehmannia glutinosa, 90-110 parts of Ophiopogon japonicus, 95-110 parts of Radix Trichosanthis, 270-350 parts of Cortex Lycii, 90-105 parts of Carthamus tinctorius, 150-250 parts of processed Polygonum multiflorum, 95-110 parts of Bombyx batryticatus, and 90-110 parts of Deer Antler Cream.

[0014] Preferably, the Chinese medicine composition is made of the following Chinese medicinal materials in parts by weight: 30 parts of American ginseng, 200 parts of Rehmannia glutinosa, 100 parts of Ophiopogon japonicus, 100 parts of Radix Trichosanthis, 300 parts of Cortex Lycii, 100 parts of Carthamus tinctorius, 200 parts of processed Polygonum multiflorum, 100 parts of Bombyx batryticatus, and 100 parts of Deer Antler Cream.

[0015] Furthermore, the excipient is a pharmaceutical excipient that enhances the efficacy, reduces toxicity and / or alleviates side effects of the main drug.

[0016] Furthermore, the preparation of the Chinese medicine composition can be a paste, pills, pills, decoctions, granules, capsules, powders, tablets, etc.

[0017] In one embodiment, the preparation of the traditional Chinese medicine composition is selected from capsules.

[0018] The diabetes described in the present invention is a metabolic disease characterized by high blood sugar, which mainly refers to diabetes of the Qi and Yin deficiency and blood stasis type.

[0019] In a third aspect, the present invention provides a method for preparing the Chinese medicine composition according to the first aspect, the method comprising the following steps:

[0020] S1. Grind American ginseng, antler frost, and trichosanthes root into fine powder;

[0021] S2. Boil Rehmannia root, Radix Ophiopogonis, Cortex Lycii, Carthamus tinctorius, Polygonum multiflorum and Bombyx batryticatus in water, combine the decoction, filter, and concentrate the filtrate to a clear paste of relative density;

[0022] S3. The fine powder obtained in step S1 is added to the clear paste obtained in step S2, and then mixed, dried, and ground into a fine powder;

[0023] S4. The fine powder obtained in step S3 is granulated with 75% ethanol, dried, and loaded into capsules to obtain a capsule preparation, or added with corresponding excipients to prepare other dosage forms, such as pastes, pills, pills, decoctions, granules, powders, tablets, etc.

[0024] Furthermore, the amount of water added is 5-15 times the amount of water added to the Chinese medicinal materials.

[0025] Furthermore, the relative density is 1.32-1.38 (60°C).

[0026] In a fourth aspect, the present invention provides a use of the traditional Chinese medicine composition as described in the first aspect in preparing a drug for treating diabetes, wherein the diabetes is diabetes of the Qi and Yin deficiency and blood stasis type.

[0027] The medicinal properties and effects of each Chinese medicinal material in the present invention are as follows:

[0028] American ginseng: Sweet, slightly bitter, and cooling in nature, it enters the heart, lung, and kidney meridians. It has the effects of tonifying qi and nourishing yin, and is used to treat symptoms such as qi and yin deficiency, asthenic heat, and fatigue.

[0029] Rehmannia root: sweet and bitter in taste, cold in nature, enters the heart, liver and kidney meridians, can clear away heat and cool blood, nourish yin and produce body fluid; treats heat entering the blood, red tongue and thirst, macules, vomiting and bleeding, yin deficiency and internal heat, bone steaming and tuberculosis, thirst due to loss of body fluid, internal heat and polydipsia, and dry intestines and constipation.

[0030] Ophiopogon japonicus: sweet, slightly bitter and slightly cold in nature, it enters the lung, stomach and heart meridians, can nourish yin and moisten the lungs, benefit the stomach and produce fluid, clear the heart and relieve restlessness, moisten the intestines and promote bowel movements, and treat stomach yin deficiency syndrome, lung yin deficiency syndrome, and heart yin deficiency syndrome.

[0031] Radix Trichosanthis: It tastes sweet and slightly bitter, is slightly cold in nature, and enters the lung and stomach meridians. It has the effects of clearing away heat and purging fire, promoting fluid production and quenching thirst, reducing swelling and discharging pus. It is generally used to treat fever, thirst, lung heat and dry cough, internal heat and thirst, sores and swelling, etc.

[0032] Rehmannia root bark: sweet in taste, cold in nature, enters the lung, liver, and kidney meridians, has the effects of cooling blood and removing steaming, clearing the lungs and reducing fire, and is mainly used to treat yin deficiency fever, night sweats and bone steaming, lung heat cough, blood heat bleeding, etc.

[0033] Safflower: sweet in taste, warm in nature, enters the heart and liver meridians, has the effects of promoting blood circulation, dredge menstruation, dispersing blood stasis and relieving pain.

[0034] Processed Polygonum multiflorum: tastes sweet, bitter, astringent, and is slightly warm in nature. It enters the liver, heart, and kidney meridians and has the effects of detoxification, eliminating carbuncle, stopping malaria, and moistening the intestines and promoting bowel movements. The processed Polygonum multiflorum tastes sweet and thick, and has the effects of nourishing the liver and kidneys, replenishing essence and blood, blackening hair, and strengthening tendons and bones. It can be used to treat diseases caused by liver and kidney yin deficiency.

[0035] Bombyx batryticatus: salty and spicy in taste, neutral in nature, enters the liver meridian, lung meridian, and stomach meridian, has the effects of calming wind and stopping spasms, dispelling wind and relieving pain, and resolving phlegm and dispersing nodules.

[0036] Deer antler frost: salty and astringent in taste, warm in nature, enters the liver meridian and kidney meridian, has the effect of warming the kidney and assisting yang, astringing and stopping bleeding.

[0037] The Chinese medicine composition of the present invention comprises American ginseng, rehmannia root, ophiopogon japonicus, root of trichosanthes, bark of Chinese wolfberry, safflower, processed polygonum multiflorum, bombyx batryticatus, and antler frost, which can nourish yin and qi, activate blood circulation and dredge meridians, and is used for treating symptoms of diabetes characterized by thirst, polydipsia, polyuria, weight loss, fatigue, sweating, numbness and pain in limbs, and the like. Among them, American ginseng tastes sweet and slightly bitter, and is cool in nature; it enters the lung, heart, kidney, and spleen meridians, replenishes qi and produces fluid; Rehmannia root tastes sweet, mainly replenishes blood and nourishes yin, benefits essence and fills marrow, and the two are together the main medicines to replenish qi, nourish yin and produce fluid; Ophiopogon japonicus tastes sweet, nourishes yin and moistens the lungs, benefits the stomach and produces fluid; Rehmannia root bark tastes sweet and is cold in nature; it enters the lung and kidney meridians, clears away heat and drains lung fire; processed Polygonum multiflorum nourishes blood and nourishes yin, moistens the intestines and promotes bowel movements; Safflower is pungent and warm, promotes blood circulation and unblocks menstruation, disperses blood stasis and relieves pain; Bombyx batryticatus is neutral in nature, resolves phlegm and disperses nodules; it can nourish blood and dredge meridians, nourish yin and disperse blood stasis. The above five flavors are together the minister medicines; Radix Trichosanthis tastes sweet, slightly bitter, and slightly cold; it enters the lung and stomach meridians, clears heat and drains fire, produces fluid and quenches thirst, and can prevent the qi-invigorating and yin-nourishing agents from nourishing and producing heat, and is an adjuvant. Deer antler frost is sweet and salty, slightly warm, and enters the liver and kidney meridians, warming the kidneys and assisting yang. It is a guiding drug. When used together with the whole formula, it has the effects of nourishing yin and qi, promoting fluid production and quenching thirst, and resolving phlegm and activating blood circulation. DETAILED DESCRIPTION

[0038] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with specific embodiments, but this should not be construed as limiting the scope of the present invention to the following embodiments.

[0039] Example 1: Preparation of Chinese medicine composition capsule I

[0040] This embodiment is an example of a Chinese medicine composition for treating diabetes, wherein the Chinese medicine composition is formulated as follows: 10g of American ginseng, 100g of Rehmannia root, 100g of Ophiopogon japonicus, 100g of Radix Trichosanthis, 300g of Lycium bark, 100g of Carthamus tinctorius, 200g of Polygonum multiflorum processed, 100g of Bombyx batryticatus, and 100g of Deer Antler Powder. The preparation method for the above-mentioned Chinese medicine composition is as follows:

[0041] The first step is to grind American ginseng, deer antler powder and tricholoma into fine powder.

[0042] In the second step, add 10 times the amount of water to Rehmannia root, Ophiopogon japonicus, Lycium bark, Carthami, Polygonum multiflorum and Bombyx batryticatus, decoct twice, each time for 1.5 hours, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.33 (60°C) (the amount or density of the substance in the embodiment cannot be a range, because this is a demonstration of a specific experiment, and the amount measured in the experiment is what it is).

[0043] The third step is to add the fine powder prepared in the first step to the clear paste prepared in the second step, mix well, dry, and grind into fine powder.

[0044] The fourth step is to granulate the fine powder obtained in the third step with 75% ethanol, dry it, and put it into capsules to make 100 capsules in total (the content of each capsule is equivalent to the following crude drugs: American ginseng 0.1g, Rehmannia glutinosa 1g, Ophiopogon japonicus 1g, Radix Trichosanthis 1g, Cortex Lycii 3g, Carthamus tinctorius 1g, Polygonum multiflorum processed 2g, Bombyx batryticatus 1g, and Deer Antler Powder 1g).

[0045] Example 2: Preparation of Chinese medicine composition capsule II

[0046] This embodiment is another embodiment of a traditional Chinese medicine composition for treating diabetes, wherein the traditional Chinese medicine composition comprises the following proportions: 30g of American ginseng, 100g of Rehmannia root, 100g of Ophiopogon japonicus, 100g of Radix Trichosanthis, 200g of Cortex Lycii, 150g of Carthamus tinctorius, 200g of Preparata polygoni multiflori, 100g of Bombyx batryticatus, and 100g of Deer Antler Powder. The preparation method for the above-mentioned traditional Chinese medicine composition is as follows:

[0047] The first step is to grind American ginseng, deer antler powder and tricholoma into fine powder.

[0048] The second step is to add 10 times the amount of water to Rehmannia root, Ophiopogon japonicus, Lycium bark, Safflower, processed Polygonum multiflorum and Bombyx batryticatus, and boil them twice, each time for 1.5 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.33 (60°C).

[0049] The third step is to add the fine powder prepared in the first step to the clear paste prepared in the second step, mix well, dry, and grind into fine powder.

[0050] The fourth step is to granulate the fine powder obtained in the third step with 75% ethanol, dry it, and put it into capsules to make 100 capsules in total (the content of each capsule is equivalent to the following crude drugs: American ginseng 0.3g, Rehmannia glutinosa 1g, Ophiopogon japonicus 1g, Radix Trichosanthis 1g, Cortex Lycii 2g, Carthamus tinctorius 1.5g, Polygonum multiflorum processed 2g, Bombyx batryticatus 1g, and Deer Antler Powder 1g).

[0051] Example 3: Preparation of Chinese medicine composition capsule III

[0052] This embodiment is another embodiment of a Chinese medicine composition for treating diabetes, wherein the Chinese medicine composition comprises the following proportions: 30g of American ginseng, 200g of Rehmannia root, 60g of Ophiopogon japonicus, 100g of Radix Trichosanthis, 400g of Cortex Lycii, 100g of Carthamus tinctorius, 200g of Polygonum multiflorum processed, 80g of Bombyx batryticatus, and 100g of Deer Antler Powder. The preparation method for the above-mentioned Chinese medicine composition is as follows:

[0053] The first step is to grind American ginseng, deer antler powder and tricholoma into fine powder.

[0054] The second step is to add 10 times the amount of water to Rehmannia root, Ophiopogon japonicus, Lycium bark, Safflower, processed Polygonum multiflorum and Bombyx batryticatus, and boil them twice, each time for 1.5 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.33 (60°C).

[0055] The third step is to add the fine powder prepared in the first step to the clear paste prepared in the second step, mix well, dry, and grind into fine powder.

[0056] The fourth step is to granulate the fine powder obtained in the third step with 75% ethanol, dry it, and put it into capsules to make 100 capsules in total (the content of each capsule is equivalent to the following crude drugs: American ginseng 0.3g, Rehmannia glutinosa 2g, Ophiopogon japonicus 0.6g, Radix Trichosanthis 1g, Cortex Lycii 4g, Carthamus tinctorius 1g, Polygonum multiflorum processed 2g, Bombyx batryticatus 0.8g, and Pyrola antler frost 1g).

[0057] Example 4: Preparation of Chinese medicine composition capsule IV

[0058] This embodiment is another embodiment of a Chinese medicine composition for treating diabetes, wherein the Chinese medicine composition has the following proportions:

[0059] 30g of American ginseng, 200g of Rehmannia root, 100g of Ophiopogon japonicus, 100g of Radix Trichosanthis, 300g of Rehmannia root bark, 100g of Carthamus tinctorius, 200g of processed Polygonum multiflorum, 100g of Bombyx batryticatus, and 100g of Deer Antler Powder.

[0060] The preparation method for preparing the above-mentioned Chinese medicine composition is as follows:

[0061] The first step is to grind American ginseng, deer antler powder and tricholoma into fine powder.

[0062] The second step is to add 10 times the amount of water to Rehmannia root, Ophiopogon japonicus, Lycium bark, Safflower, processed Polygonum multiflorum and Bombyx batryticatus, and boil them twice, each time for 1.5 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.33 (60°C).

[0063] The third step is to add the fine powder prepared in the first step to the clear paste prepared in the second step, mix well, dry, and grind into fine powder.

[0064] The fourth step is to granulate the fine powder obtained in the third step with 75% ethanol, dry it, and put it into capsules to make 100 capsules in total (the content of each capsule is equivalent to the following crude drugs: American ginseng 0.3g, Rehmannia glutinosa 2g, Ophiopogon japonicus 1g, Radix Trichosanthis 1g, Cortex Lycii 3g, Carthamus tinctorius 1g, Polygonum multiflorum processed 2g, Bombyx batryticatus 1g, and Pyrola antler frost 1g).

[0065] Example 5 Preparation of Diabetes Capsules V

[0066] This embodiment is the ratio of the early in-hospital preparation of Tangyoukang Capsules of Shaanxi Provincial Hospital of Traditional Chinese Medicine:

[0067] 50g of American ginseng, 100g of safflower, 300g of Lycium bark, 300g of Morus alba bark, 100g of Bombyx batryticatus. The preparation method for preparing the above-mentioned Chinese medicine composition is as follows:

[0068] The first step is to grind American ginseng, deer antler powder and tricholoma into fine powder.

[0069] The second step is to add 10 times the amount of water to Rehmannia root, Ophiopogon japonicus, Lycium bark, Safflower, processed Polygonum multiflorum and Bombyx batryticatus, and boil them twice, each time for 1.5 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.33 (60°C).

[0070] The third step is to add the fine powder prepared in the first step to the clear paste prepared in the second step, mix well, dry, and grind into fine powder.

[0071] The fourth step is to granulate the fine powder obtained in the third step with 75% ethanol, dry it, and put it into capsules to make a total of 100 capsules to obtain a capsule preparation (the content of each capsule is equivalent to the following crude drugs: American ginseng 0.5g, safflower 1g, Chinese wolfberry bark 3g, mulberry bark 3g, and bombyx batryticatus 1g).

[0072] Example 6 Preparation of Chinese medicine composition granules

[0073] This embodiment is another embodiment of a Chinese medicine composition for treating diabetes, wherein the Chinese medicine composition comprises the following ingredients: 30g American ginseng, 200g Rehmannia root, 100g Ophiopogon japonicus, 100g Radix Trichosanthis, 300g Lycium bark, 100g Carthamus tinctorius, 200g Polygonum multiflorum processed, 100g Bombyx batryticatus, and 100g Deer Antler Powder. The preparation method for the above-mentioned Chinese medicine composition is as follows:

[0074] The first step is to grind American ginseng, deer antler powder and tricholoma into fine powder.

[0075] The second step is to add 10 times the amount of water to Rehmannia root, Ophiopogon japonicus, Lycium bark, Safflower, processed Polygonum multiflorum and Bombyx batryticatus, and boil them twice, each time for 1.5 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.33 (60°C).

[0076] The third step is to add the fine powder prepared in the first step to the clear paste prepared in the second step, mix well, dry, and grind into fine powder.

[0077] The fourth step is to granulate the fine powder obtained in the third step with 75% ethanol, dry, granulate, and package to prepare 100 packages of granules.

[0078] Example 7 Preparation of Chinese medicine composition tablets

[0079] This embodiment is another embodiment of a traditional Chinese medicine composition for treating diabetes, wherein the proportions of the traditional Chinese medicine composition are: 30g of American ginseng, 200g of Rehmannia glutinosa, 100g of Ophiopogon japonicus, 100g of Radix Trichosanthis, 300g of Cortex Lycii, 100g of Carthamus tinctorius, 200g of processed Polygonum multiflorum, 100g of Bombyx batryticatus, and 100g of Deer Antler Powder.

[0080] The preparation method for preparing the above-mentioned Chinese medicine composition is as follows:

[0081] The first step is to grind American ginseng, deer antler powder and tricholoma into fine powder.

[0082] The second step is to add 10 times the amount of water to Rehmannia root, Ophiopogon japonicus, Lycium bark, Safflower, processed Polygonum multiflorum and Bombyx batryticatus, and boil them twice, each time for 1.5 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.33 (60°C).

[0083] The third step is to add the fine powder prepared in the first step to the clear paste prepared in the second step, mix well, dry, and grind into fine powder.

[0084] The fourth step is to make pills from the fine powder obtained in the third step, press the pills, dry them, inspect the quality, and package them into 100 tablets in total (each pill contains the following crude drugs: 0.3g of American ginseng, 2g of Rehmannia root, 1g of Ophiopogon japonicus, 1g of Radix Trichosanthis, 3g of Lycium bark, 1g of Carthamus tinctorius, 2g of processed Polygonum multiflorum, 1g of Bombyx batryticatus, and 1g of Deer Antler Powder).

[0085] Example 8 Effects of Different Amounts of Chinese Medicine Composition on Treating Diabetes in Mice

[0086] 1. Experimental Materials

[0087] Experimental animals: 70 db / db mice (spontaneous type 2 diabetes mice caused by a defect in the leptin receptor gene on chromosome 4), SPF grade, male, weighing 35±3g, and 10 db / m male mice of the same age, weighing 20±3g, were purchased from Jiangsu Cuiyaokang Biotechnology Co., Ltd.

[0088] Test reagents: The above-mentioned Chinese medicine composition capsule preparations I, II, III, and IV, and Diabetes Capsule V. Metformin hydrochloride tablets (positive control drug), batch number H20023370, were purchased from Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd. A glucose assay kit was purchased from Shanghai Rongsheng Biopharmaceutical Co., Ltd.

[0089] Seventy db / db mice with fasting blood glucose levels greater than 11.1 mmoL / L were randomly assigned to seven cages of 10 mice each. These mice were then randomly divided based on blood glucose and body weight into a model group (Control group), a metformin group (Met group), Chinese herbal composition capsule preparations I, II, III, and IV, and Tangyoukang capsule preparation group V, with 10 mice in each group. Ten db / m male mice of the same age served as normal controls (Normal group). Both the Normal and Control groups were given equal volumes of normal saline by gavage daily from 9:00 to 10:00 am, with a supplemental dose of 10 mg / dL for 6 consecutive weeks.

[0090] 2. Experimental methods

[0091] 2.1 Blood glucose monitoring

[0092] All mice were fasted for 8 hours at the same time every week, and blood was collected from the orbital vein to measure fasting blood glucose.

[0093] 2.2 Detection of PI3K, AKT, and FoxO1 protein expression levels in mouse liver tissue by BCA assay

[0094] (1) BCA protein extraction: Take an appropriate amount of liver tissue and place it in a 2 ml EP tube. Add 300 μl of lysis buffer (containing PMSF) to each tube in turn, place it in an automatic homogenizer for homogenization, and then place it on ice for 30 minutes to fully lyse it. Transfer it to a centrifuge tube and add 3 μl of phosphatase inhibitor in turn. After completion, place it in a 4 ° C centrifuge at 12000 rpm for 10 minutes and take the supernatant.

[0095] (2) Determination of protein concentration by BCA method: Use the BCA protein quantification kit to dilute the standard and protein samples, add them to a 96-well plate, avoid bubbles, incubate at 37°C in the dark for 30 minutes, and measure the OD value using a microplate reader.

[0096] 2.3 Biochemical index detection

[0097] At the end of the sixth week after administration, mice were fasted but not watered for 12 h. One h after gavage, blood was collected from the eyeballs and centrifuged at 12,000 r / min and 4°C for 8 min. The supernatant was collected and the plasma was collected after centrifugation and stored at -20°C for later use. GLU, TC, TG, and LDL in the serum were measured using a multifunctional microplate reader.

[0098] 2.4 Statistical analysis

[0099] All experimental data were analyzed using SPSS 25.0 software. Results are expressed as x ± s. Multiple groups were compared using one-way analysis of variance. Nonparametric tests were used when the data did not conform to a normal distribution. P < 0.05 was considered statistically significant. Statistical graphs were created using GraphPad Prism 8 software.

[0100] 3. Results

[0101] The experimental study found that: compared with the Normal group, the blood sugar level of the Control group was stable, and the blood sugar level of the Control group was significantly higher than that of the Normal group (P<0.01). Compared with the Control group, the fasting blood sugar of db / db mice was significantly reduced in the Chinese medicine composition capsule preparation IV after 4 weeks of intervention (P<0.05), and the fasting blood sugar of db / db mice was also significantly reduced in the Chinese medicine composition capsule preparation III after 5 weeks of intervention (P<0.05). After 6 weeks of intervention, the fasting blood sugar of db / db mice in the Chinese medicine composition capsule preparation II, III, IV and V groups was also significantly reduced (P<0.05), among which the Chinese medicine composition capsule preparation IV was extremely significant (P<0.01), see Table 1 for details.

[0102] Table 1 Effects of different contents of Chinese medicine compositions on blood glucose in mice (mmol / L, n=10)

[0103] Note: Compared with the Normal group, the Control group ## P<0.01,

[0104] Compared with the Control group, each treatment group * P<0.05, ** P<0.01

[0105] Compared with the Normal group, the expression of PI3K and AKT proteins in the liver of the Control group mice was significantly decreased, and the expression of FoxO1 protein was significantly increased (P<0.05). Compared with the Control group, the expression of PI3K and AKT proteins in the liver of the Chinese medicine composition capsule preparation groups III, IV and V was also significantly increased (P<0.05), and the expression of FoxO1 protein in groups III and IV was significantly decreased (P<0.05), as shown in Table 2 for details.

[0106] Table 2 Effects of Chinese medicine capsule preparations on the PI3K / AKT / FoxO1 signaling pathway in mice (x±s)

[0107] Note: Compared with the Normal group, the Control group # P<0.05,

[0108] Compared with the Control group, each treatment group * P<0.05

[0109] Experimental results: Compared with the Normal group mice, the TC, TG, and LDL-L levels of the Control group db / db mice were significantly increased (P<0.05, P<0.01), indicating that the Control group db / db mice had obvious dyslipidemia; compared with the Control group mice, the Chinese medicine composition groups III, IV, and V could significantly reduce the TC and TG levels (P<0.05), among which the reduction in group IV was extremely significant (P<0.01), and there was no significant difference in the improvement of TC and TG between groups I and II. The Chinese medicine composition capsule preparation groups II, III, IV, and V could significantly reduce the LDL-L level (P<0.05), see Table 3 for details.

[0110] Table 3 Effects of Chinese medicine capsule preparations on lipid metabolism in mice (mmol / L, n=10)

[0111] Note: Compared with the Normal group, the Control group ## P<0.01,

[0112] Compared with the Control group, each treatment group * P<0.05, ** P<0.01

[0113] The above experiments have shown that the Chinese medicine composition of the present invention can improve the problem of elevated blood sugar, improve vascular microcirculation through the synergistic effect between the drugs that nourish yin and replenish qi and activate blood circulation and dredge collaterals, thereby achieving the effect of treating diabetes.

Claims

1. A capsule preparation of a traditional Chinese medicine composition for treating diabetes, wherein the capsule preparation of the traditional Chinese medicine composition treats the diabetes by nourishing yin and replenishing qi, and promoting blood circulation and unblocking collaterals, and the capsule preparation of the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 30 parts of American ginseng, 200 parts of rehmannia root, 100 parts of ophiopogon japonicus, 300 parts of lycium bark, 200 parts of processed polygonum multiflorum, 100 parts of safflower, 100 parts of bombyx batryticatus, 100 parts of radix trichosanthis, and 100 parts of antler frost; the diabetes refers to diabetes of both qi and yin deficiency and blood stasis type.

2. A method for preparing a Chinese medicine capsule preparation as claimed in claim 1, wherein the Chinese medicine composition is prepared from the following Chinese medicinal materials in parts by weight: 30 parts of American ginseng, 200 parts of Rehmannia root, 100 parts of Ophiopogon japonicus, 300 parts of Lycium bark, 200 parts of Polygonum multiflorum processed, 100 parts of Carthamus tinctorius, 100 parts of Bombyx batryticatus, 100 parts of Radix Trichosanthis, and 100 parts of Prunus cervifolia, wherein the diabetes is Qi and Yin deficiency and blood stasis type diabetes, and the method comprises the following steps: S1. Grind American ginseng, antler frost and Radix Trichosanthis into fine powder; S2. Add water to decoct Rehmannia root, Radix Ophiopogonis, Cortex Lycii, Carthamus tinctorius, Radix Polygoni Multiflori and Bombyx Batryticatus, combine the decoctions, filter, and concentrate the filtrate to a clear sound with a relative density of 1.33 at 60°C; S3. The fine powder obtained in step S1 is added to the clear paste obtained in step S2, and then mixed, dried, and crushed into a fine powder; S4. The fine powder obtained in step S3 is granulated with 75% ethanol, dried, and filled into capsules to obtain a capsule preparation.

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