Traditional Chinese medicine composition for treating middle-jiao type diabetes mellitus as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating middle-jiao type diabetes as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-30 parts of herba eupatorii, 10-20 parts of radix astragali, 8-15 parts of radix codonopsis, 1-3 parts of gypsum, 6-12 parts of radix rehmanniae preparata, 6-12 parts of radix rehmanniae recen, 9-15 parts of Chinese yam, 18-30 parts of radix trichosanthis, 12-20 parts of rhizoma anemarrhenae, 12-20 parts of radix ophiopogonis, 9-15 parts of dendrobe, 9-15 parts of radix polygonati officinalis, 3-6 parts of safflower, 3-6 parts of coptis chinensis, 9-15 parts of radix scrophulariae, 9-15 parts of dogwood, 6-10 parts of liquorice and 9-15 parts of seville orange flower. , 9-15 parts of loquat flower, 6-12 parts of penthorum chinense pursh and 6-12 parts of angelica keiskei. The traditional Chinese medicine composition is suitable for nourishing yin, moistening the lung, clearing the stomach, clearing heat, moistening dryness and promoting the secretion of saliva or body fluid, has a positive regulation effect on blood sugar and blood fat of diabetes patients, and is used for middle-digestion diabetes.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating diabetes of the middle consumption type, a preparation method and application thereof. BACKGROUND

[0002] Diabetes in modern medicine belongs to the category of diabetic syndrome in traditional Chinese medicine, but diabetic syndrome in traditional Chinese medicine is not diabetes in modern medicine; diabetes is defined as “diabetic disease” in traditional Chinese medicine, and it is pointed out in the Canon of Internal Medicine that overeating, indulging in wine and housework, emotional disorders, and weakness of five internal organs are the main causes of the onset of diabetic disease; it refers to a kind of disease with the typical symptoms of polydipsia, polyphagia and polyuria caused by excessive intake of delicious food, or excessive emotional fluctuations, or excessive sexual activity, or damage by warm evil, or abuse of gold, stone and medicine, etc., which leads to excessive heat in the stomach, liquid loss, or dry skin caused by lung heat, heart fire, kidney yin damage, and further leads to dysfunction of gasification, and inability to control liquid and fine substances, and thus causes the phenomenon of downward flow, thereby causing a kind of disease with the typical symptoms of polydipsia, polyphagia and polyuria. The symptoms of diabetic disease are divided into three types: upper consumption, middle consumption and lower consumption (consumption of kidney), among which, polydipsia but still thirsty is upper consumption, voracious appetite is middle consumption, and frequent urination with uncontrollable cream-like substances is lower consumption. The commonly used drug for treating diabetes, metformin, has different effects on the three symptoms of diabetes, as recorded in the prior art “Preliminary Study on the Significance of Three Consumption Classification Method in Clinical Application of Metformin” (Liu Jinxing. Chinese Folk Therapy, 2021-08-14): after 1 month of treatment with metformin, the FBG, 2hPG and HbA1c levels of the patients in the three groups were lower than those before treatment (P<0.05), and the middle consumption group was lower than the other two groups (P<0.05), and there was no statistically significant difference in the above indexes between the upper consumption group and the lower consumption group (P>0.05); the TCM syndrome scores of the patients in the three groups were lower than those before treatment (P<0.05), but there was no statistically significant difference between the groups (P>0.05); the total effective rate of the upper consumption group and the middle consumption group was 89.0%, which was significantly higher than that of the lower consumption group (72.0%), and the difference was statistically significant (P<0.05). Conclusion: metformin can reduce the blood glucose level of patients with newly diagnosed T2DM, improve the TCM syndrome, and the effect is better in patients with middle consumption type.

[0003] The main symptoms of the middle-elimination type (stomach heat flourishing syndrome) of diabetes are strong appetite but easy to be hungry, thirst, frequent urination, gradual body weight loss, dry stool, yellow tongue fur, and forceful pulse; the regulating method is to clear stomach and drain fire, and to nourish yin and increase fluid; the commonly used traditional Chinese medicines include gypsum, anemarrhena, ophiopogon, radix rehmanniae, dendrobium, and so on; the recommended Chinese patent medicines include Yu Nv Jian, Sijunzi Decoction, Dahuang Huanglian Xie Xin Decoction, Banxia Xie Xin Decoction, and Dachaihu Decoction, and so on. As recorded in the prior art “Baiyunshen Decoction in the treatment of 60 cases of postprandial hyperglycemia in patients with middle-elimination type of type 2 diabetes”, Baiyunshen Decoction has the effects of clearing stomach and draining fire, and nourishing yin and increasing fluid, and is used for the middle-elimination type of diabetes, clearing stomach heat can eliminate the consumption of the spleen and stomach, and reduce the consumption of the stomach, thereby improving the postprandial blood glucose of the patient, and the observation results show that P2HBG, FBG, and HbAlc are obviously improved after the treatment of the treatment group of traditional Chinese medicine + western medicine (P<0.05), and the effect is better than that of the control group of western medicine alone (P<0.05), and reasonable western medicine plus Baiyunshen Decoction can effectively reduce the sugar metabolism indexes such as FBG and HbAlc, and the effect on reducing P2HBG is more significant. However, the treatment scheme of traditional Chinese medicine + western medicine in the prior art does not show the treatment effect of traditional Chinese medicine alone on the middle-elimination type of diabetes.

[0004] Therefore, it is urgent to provide a traditional Chinese medicine composition which has good effect and can achieve good treatment effect on the middle-elimination type of diabetes by using traditional Chinese medicine alone, and a preparation method and application thereof. SUMMARY

[0005] In order to solve the problems in the prior art, the present application provides a traditional Chinese medicine composition for treating the middle-elimination type of diabetes, a preparation method and application thereof, which is specially used for the middle-elimination type of diabetes, significantly improves the treatment effect, and can achieve good treatment effect on the middle-elimination type of diabetes by using traditional Chinese medicine alone.

[0006] In order to achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows: The present application provides a traditional Chinese medicine composition for treating the middle-elimination type of diabetes, which comprises the following raw medicinal materials by weight: Pueraria pedunculata 15-30 parts, Astragalus 10-20 parts, Codonopsis 8-15 parts, raw gypsum 1-3 parts, Radix Rehmanniae Preparata 6-12 parts, Radix Rehmanniae 6-12 parts, Dioscorea 9-15 parts, Radix Trichosanthis 18-30 parts, Anemarrhena 12-20 parts, Ophiopogon 12-20 parts, Dendrobium 9-15 parts, Polygonatum 9-15 parts, Carthamus 3-6 parts, Coptis 3-6 parts, Scrophularia 9-15 parts, Cornus 9-15 parts, Glycyrrhiza 6-10 parts, Daidai 9-15 parts, Eriobotrya 9-15 parts, Chaseshuo 6-12 parts, and Mistletoe 6-12 parts.

[0007] Preferably, the traditional Chinese medicine composition comprises the following raw materials by weight: Peilan 18-25 parts, Huangqi 12-18 parts, Dangshen 8-12 parts, Shengshigao 1-3 parts, Shudihuang 6-10 parts, Shengdihuang 6-10 parts, Shanyao 9-15 parts, Tianhuafen 18-25 parts, Zhimu 12-18 parts, Maidong 12-18 parts, Shihuchong 10-15 parts, Yuzhu 10-15 parts, Honghua 3-5 parts, Huanglian 3-5 parts, Xuanshen 9-12 parts, Shanzhu 9-12 parts, Gancao 6-10 parts, Daidehua 9-12 parts, Pipaflower 9-12 parts, Ganhuangcao 6-12 parts, Mingriye 6-12 parts.

[0008] Preferably, the traditional Chinese medicine composition comprises the following raw materials by weight: Peilan 20 parts, Huangqi 15 parts, Dangshen 10 parts, Shengshigao 2 parts, Shudihuang 8 parts, Shengdihuang 6 parts, Shanyao 12 parts, Tianhuafen 22 parts, Zhimu 15 parts, Maidong 15 parts, Shihuchong 12 parts, Yuzhu 12 parts, Honghua 3 parts, Huanglian 3 parts, Xuanshen 12 parts, Shanzhu 9 parts, Gancao 8 parts, Daidehua 10 parts, Pipaflower 12 parts, Ganhuangcao 8 parts, Mingriye 8 parts.

[0009] The second aspect of the present application relates to a preparation method of the above-mentioned traditional Chinese medicine composition, comprising the following steps: (1) steam distill the raw materials Peilan, Honghua, Daidehua and Pipaflower, collect the distillate, separate the volatile oil part, and prepare a volatile oil inclusion compound by cyclodextrin inclusion; (2) mix the residue after extracting the volatile oil in step (1) with the remaining medicines, and extract by adding water to obtain an extract; (3) add a compound enzyme preparation to the extract for enzymolysis to obtain an enzymolysis liquid; (4) mix the volatile oil inclusion compound with the enzymolysis liquid after drying under reduced pressure to obtain the traditional Chinese medicine composition.

[0010] Preferably, the cyclodextrin in step (1) is selected from α-cyclodextrin, β-cyclodextrin or γ-cyclodextrin.

[0011] Preferably, the mass ratio of the volatile oil to cyclodextrin in step (1) is 0.05-0.5:1.

[0012] Further preferably, the preparation method of the volatile oil-cyclodextrin inclusion compound is as follows: cyclodextrin is added to water to prepare a cyclodextrin saturated solution, the volatile oil is added to anhydrous ethanol to prepare a volatile oil-ethanol solution, the volatile oil-ethanol solution is added to the cyclodextrin saturated solution at a constant speed, and stirring, standing, suction filtration and drying are performed to obtain the volatile oil-cyclodextrin inclusion compound.

[0013] More preferably, the stirring is performed at 30-40°C for 1-2h.

[0014] More preferably, the standing is performed at 0-10°C for 20-30h.

[0015] Preferably, in step (2), water extraction is performed 1-2 times, with the amount of water added each time being 6-10 times the mass of the raw drug, and the extraction time being 1-2 hours.

[0016] Preferably, the compound enzyme preparation in step (3) includes 1-2 parts of cellulase, 0.05-0.2 parts of pectinase and 0.1-0.5 parts of β-glucosidase.

[0017] Preferably, the amount of the compound enzyme preparation used in step (3) is 0.3-0.8 wt. of the active pharmaceutical ingredient.

[0018] Preferably, the enzymatic hydrolysis temperature in step (3) is 35-40℃ and the enzymatic hydrolysis time is 60-80min.

[0019] A third aspect of the present invention relates to pharmaceutical preparations containing the above-described traditional Chinese medicine composition.

[0020] Preferably, the pharmaceutical preparation further includes one or more pharmaceutically acceptable excipients and / or excipients; the dosage form of the pharmaceutical preparation includes granules, tablets, and capsules.

[0021] The fourth aspect of the present invention relates to the use of the above-mentioned traditional Chinese medicine composition or a pharmaceutical preparation containing the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for middle-aged and young children with diabetes.

[0022] All raw medicinal materials used in the prescription of this invention meet the requirements of the Pharmacopoeia of the People's Republic of China (2020 Edition) (hereinafter referred to as the Pharmacopoeia).

[0023] In Traditional Chinese Medicine (TCM) theory, the core pathogenesis of moderate-onset diabetes mellitus is often attributed to "excessive stomach heat and deficiency of both Qi and Yin." Common symptoms include polyphagia, excessive thirst, emaciation, fatigue, constipation, a red tongue with a yellow or thin coating, and a slippery, rapid, or thready pulse. The composition of this invention follows the principles of "clearing heat and generating fluids, tonifying Qi and nourishing Yin, and supplementing with blood-activating and dampness-removing agents." Through the combination of principal, assistant, adjuvant, and guiding herbs, it achieves a synergistic effect in treating moderate-onset diabetes mellitus. The specific formula is explained below: (1) Chief herb: Clears heat and nourishes yin, replenishes qi and generates fluids, directly targets the core pathogenesis, and is composed of Eupatorium fortunei, Astragalus membranaceus, raw gypsum, prepared Rehmannia glutinosa, and raw Rehmannia glutinosa.

[0024] Eupatorium fortunei: pungent in flavor and neutral in nature, it enters the spleen, stomach, and lung meridians. Its core functions are to resolve dampness, invigorate the spleen, dispel foulness, and harmonize the middle jiao. Many patients with wasting disease suffer from spleen damage due to prolonged stomach heat, leading to impaired spleen function and the generation of dampness. This dampness, in turn, further impairs the spleen's ability to transport and transform body fluids, creating a vicious cycle of "dampness obstruction and fluid deficiency." Eupatorium fortunei can resolve dampness in the spleen and stomach, restoring the spleen's function of transporting and transforming body fluids, clearing obstacles to the generation and distribution of body fluids. Simultaneously, its fragrant properties can invigorate the spleen and stimulate appetite, improving symptoms of dampness obstruction such as loss of appetite and abdominal distension that may accompany wasting disease, preventing further depletion of qi and yin due to dampness.

[0025] Astragalus: Sweet in taste and slightly warm in nature, it enters the spleen and lung meridians. Prolonged wasting and thirsting syndrome leads to stomach heat depleting qi, resulting in spleen qi deficiency. Qi deficiency weakens the body's ability to propel fluids and retain them, exacerbating symptoms such as thirst and fatigue. Astragalus is a key qi-tonifying herb, especially effective in tonifying the spleen and stomach qi. It enhances the spleen's ability to transform and transport the essence of food and generate body fluids. Furthermore, since "qi generates body fluids" and "qi retains body fluids," astragalus's qi-tonifying effect indirectly promotes body fluid production and reduces unnecessary fluid loss, alleviating symptoms of qi deficiency such as fatigue, shortness of breath, and reluctance to speak, thus laying the foundation for the body to restore qi and yin balance.

[0026] Gypsum: It has a pungent and sweet taste, is extremely cold in nature, and enters the lung and stomach meridians. Due to its cold and heavy nature, it effectively clears stomach fire and purges heat evil, making it a key drug targeting the core pathogenesis of "excessive stomach heat" in the middle jiao (digestive disorders). Excessive stomach heat leads to the rapid digestion of food and water, resulting in excessive eating and hunger; the heat evil damages the fluids in the stomach, causing thirst, excessive drinking, and constipation. Gypsum can directly enter the stomach meridian, clearing and purging excessive stomach fire, quickly relieving the typical symptoms of "excessive eating and hunger" in the middle jiao. At the same time, clearing heat reduces the consumption of body fluids, creating conditions for subsequent yin-nourishing and fluid-generating processes. However, due to its extremely cold nature, the dosage is relatively light to avoid damaging the spleen and stomach yang qi.

[0027] Rehmannia glutinosa (processed): Sweet in taste and slightly warm in nature, it enters the liver and kidney meridians. It nourishes yin and blood, replenishes essence and marrow. Although middle jiao deficiency is mainly due to stomach heat, the five internal organs are interconnected. Prolonged stomach heat will inevitably deplete kidney yin. The kidney is the "foundation of innate essence," responsible for storing essence. Kidney yin deficiency prevents the lungs and stomach from nourishing, further aggravating lung and stomach fluid depletion, forming a chain reaction of "stomach heat → kidney yin deficiency → further depletion of lung and stomach fluids." Rehmannia glutinosa nourishes kidney yin, replenishes essence and marrow, fundamentally replenishing the depleted kidney yin essence. By "nourishing kidney water to moisten stomach dryness," it indirectly alleviates the symptoms of stomach heat damaging fluids, while also improving symptoms that may accompany kidney yin deficiency, such as lower back and knee weakness, dizziness, and tinnitus.

[0028] Rehmannia glutinosa (raw): sweet and bitter in taste, cold in nature, and enters the heart, liver, and kidney meridians. Its functions include clearing heat and cooling the blood, nourishing yin and generating fluids. Its cold nature helps gypsum clear stomach heat, its bitter taste clears heat and dries dampness, and its sweet and moistening properties directly replenish the fluids damaged by heat in the stomach and kidneys. It is especially suitable for those with significant "heat damaging fluids" in the middle jiao (digestive system), relieving symptoms such as thirst, excessive drinking, and a red tongue with little saliva. Compared to raw Rehmannia glutinosa, processed Rehmannia glutinosa is more focused on "nourishing kidney yin without clearing heat," while raw Rehmannia glutinosa is more focused on "clearing heat and nourishing yin simultaneously." The combination of the two can both nourish kidney yin to strengthen the root cause and clear heat and nourish yin to treat the symptoms, addressing both the root and the symptoms and strengthening the yin-nourishing effect.

[0029] (2) Assistant herbs: assist the principal herbs in clearing heat, replenishing qi, and nourishing yin, while also promoting blood circulation and enhancing efficacy. Based on the principal herbs' "clearing heat, nourishing yin, and replenishing qi", the efficacy is further refined. At the same time, in response to the possible accompanying symptoms of "exacerbated fluid depletion and internal obstruction of blood stasis", the herbs are composed of Codonopsis pilosula, Dioscorea opposita, Trichosanthes kirilowii, Anemarrhena asphodeloides, Ophiopogon japonicus, Dendrobium nobile, Polygonatum odoratum, Carthamus tinctorius, Coptis chinensis, and Scrophularia ningpoensis.

[0030] Codonopsis pilosula: Sweet in taste and neutral in nature, it enters the spleen and lung meridians. Its functions are to replenish qi and strengthen the spleen and lungs. Although its qi-replenishing power is not as strong as that of Astragalus membranaceus, it is more focused on strengthening the spleen and stomach. It can assist Astragalus membranaceus in enhancing the qi of the spleen and stomach, promoting the transformation of food essence into body fluids, and improving symptoms such as fatigue, loss of appetite, and abdominal distension caused by spleen and stomach qi deficiency. At the same time, "the spleen is the foundation of acquired constitution," and strengthening the spleen can further consolidate the qi-replenishing effect of Astragalus membranaceus, providing continuous power for the recovery of qi and yin in the body.

[0031] Yam: Sweet in taste and neutral in nature, it enters the spleen, lung, and kidney meridians. It can nourish the spleen and stomach, promote the production of body fluids and benefit the lungs, and tonify the kidneys and astringe essence. Its medicinal properties are mild. It can assist Codonopsis pilosula and Astragalus membranaceus in strengthening the spleen and replenishing qi, enhancing the spleen's function of transporting and transforming body fluids, and can also directly promote the production of body fluids and quench thirst, relieving excessive thirst and drinking. At the same time, it enters the kidney meridian and can assist Rehmannia glutinosa (processed and raw) in nourishing kidney yin. Moreover, its astringent properties can prevent the loss of body fluids caused by kidney yin deficiency. It is a key auxiliary medicine for "tonifying both qi and yin and regulating the spleen and kidneys".

[0032] Trichosanthes kirilowii root: It tastes sweet and slightly bitter, and is slightly cold in nature. It enters the lung and stomach meridians. Its core functions are clearing heat and purging fire, and promoting body fluid and quenching thirst. It has a strong ability to promote body fluid and can directly reach the lung and stomach meridians. It can help gypsum clear stomach heat and directly replenish lung and stomach fluids, relieving the core symptom of "thirst and excessive drinking" in middle-aged and young children. It is especially suitable for those with obvious fluid deficiency and is the core drug for "promoting body fluid and quenching thirst" among the auxiliary drugs.

[0033] Anemarrhena asphodeloides: It has a sweet and bitter taste, is cold in nature, and enters the lung, stomach, and kidney meridians. It can clear heat and purge fire, nourish yin and moisten dryness. Its cold nature can help gypsum clear stomach heat, its bitter taste can dry dampness, and its sweet and moistening nature can nourish yin. Compared with gypsum, Anemarrhena asphodeloides "clears heat without harming yin, and nourishes yin without hindering pathogens". It is especially suitable for those with "stomach heat and yin deficiency" in middle-aged and diabetic patients. It can relieve symptoms of stomach heat such as excessive eating and constipation, and improve symptoms of dry mouth and tongue, red tongue with little coating caused by yin deficiency. At the same time, it enters the kidney meridian and can assist Rehmannia glutinosa in nourishing kidney yin and enhance the synergistic effect of "clearing heat and nourishing yin".

[0034] Ophiopogon japonicus: It tastes sweet and slightly bitter, and is slightly cold in nature. It enters the heart, lung, and stomach meridians. Its functions are to nourish yin and generate fluids, moisten the lungs and clear the heart. Its sweet and moistening properties are relatively strong, which can directly replenish the fluids of the lung, stomach, and heart meridians. It is especially good at relieving "thirst due to fluid depletion" and can assist Trichosanthes kirilowii and Anemarrhena asphodeloides in enhancing the ability to generate fluids and quench thirst. At the same time, its slightly cold nature can clear residual heat in the lungs and stomach, and improve symptoms such as irritability and insomnia caused by heat disturbing the heart. It is an auxiliary medicine that "nourishes yin and clears heat, and also takes care of the mind".

[0035] Dendrobium: Sweet in taste and slightly cold in nature, it enters the stomach and kidney meridians. It can benefit the stomach and promote the production of body fluids, nourish yin and clear heat. Its medicinal properties are mild, and it enters the stomach meridian directly to nourish stomach yin and replenish stomach fluids, improving stomach pain, dry mouth and throat caused by stomach heat damaging yin. At the same time, it enters the kidney meridian and can assist Rehmannia glutinosa in nourishing kidney yin. It is especially suitable for patients with wasting disease who have "mainly stomach yin deficiency and concurrent kidney yin deficiency". When used with Ophiopogon japonicus and Trichosanthes kirilowii, it can further enhance the effect of "producing body fluids and nourishing the stomach".

[0036] Polygonatum odoratum: Sweet in taste and neutral in nature, it enters the lung and stomach meridians. It can nourish yin and moisten dryness, promote body fluid and quench thirst. Its medicinal properties are mild, neither cold nor hot. It can replenish lung and stomach fluids, relieve symptoms such as thirst and excessive drinking, dry cough with little phlegm, and avoid damage to the spleen and stomach caused by cold drugs such as gypsum and anemarrhena. It is especially suitable for patients with "deficiency of body fluids and weak spleen and stomach function" in the middle-stage of diabetes. When used with dendrobium and ophiopogon japonicus, it can enhance the effect of nourishing yin and promoting body fluid, while taking into account the tolerance of the spleen and stomach.

[0037] Safflower: It has a pungent taste and warm properties, and enters the heart and liver meridians. Its functions include promoting blood circulation, clearing the meridians, dispersing blood stasis, and relieving pain. In patients with diabetes mellitus, "heat evil injures body fluids," leading to blood viscosity and "internal obstruction of blood stasis." Safflower can promote blood circulation, remove blood stasis, improve microcirculation, and clear blood stasis from the body, thus clearing obstacles for the flow of body fluids. At the same time, "promoting blood circulation can unblock the meridians," which can relieve early symptoms of diabetic complications such as numbness and pain in the limbs caused by blood stasis. It is a key drug in the herbal formula that "also promotes blood circulation."

[0038] Coptis chinensis: Bitter in taste and cold in nature, it enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. It can clear heat and dry dampness, purge fire and detoxify. Its bitter and cold nature is relatively strong, which can help gypsum and anemarrhena to clear stomach heat. It is especially suitable for those with "excessive stomach heat and damp heat" in the middle jiao, and can relieve symptoms such as abdominal distension, bitter taste in the mouth, and sticky and unsatisfactory stools caused by damp heat trapping the spleen. At the same time, Coptis chinensis enters the heart meridian, which can clear heart fire and improve irritability and insomnia caused by "excessive heart and stomach fire". Its "heat-clearing and dampness-drying" power can also reduce the consumption of body fluids by dampness and turbidity, and assist the chief herb to enhance the heat-clearing effect.

[0039] Scrophularia: It tastes sweet, bitter, and salty, and is slightly cold in nature. It enters the lung, stomach, and kidney meridians. It can clear heat and cool the blood, nourish yin and reduce fire, and detoxify and dissipate nodules. Its salty and cold nature can help Rehmannia glutinosa and Anemarrhena asphodeloides to nourish yin and reduce fire. It is especially good at nourishing kidney yin and clearing deficiency fire. It is suitable for those with "prolonged stomach heat damaging the kidneys, leading to kidney yin deficiency and upward flaring of deficiency fire" in the middle jiao. It can relieve symptoms such as dry mouth and throat, night sweats, etc. caused by deficiency fire. At the same time, Scrophularia can clear heat and detoxify, and can prevent complications such as diabetic skin infections caused by prolonged heat and toxins. When used with Rehmannia glutinosa (processed) and Rehmannia glutinosa (raw), it can further enhance the effect of nourishing kidney yin.

[0040] (3) Adjuvant herbs: to enhance the efficacy of the principal and assistant herbs, to balance the medicinal properties, and to harmonize the internal organs. In this formula, the adjuvant herbs are mainly "assisting" and also "controlling". They assist the principal and assistant herbs in enhancing their efficacy, while restraining the side effects of the cold-natured herbs in the principal herb and harmonizing the functions of the internal organs. They are composed of Cornus officinalis, Citrus aurantium, and Gynostemma pentaphyllum.

[0041] Cornus officinalis: Sour, astringent in taste, slightly warm in nature, attributing to the liver and kidney meridians. Its efficacy is to tonify the liver and kidney, astringe and secure the dissipation. Its property of "sour and astringent" can "astringe and secure". In patients with middle-stage consumptive thirst, due to the deficiency of kidney yin and the weakened function of "the kidney storing essence", body fluids are likely to be lost. Cornus officinalis can astringe kidney yin, secure body fluids, reduce the无故耗散 of body fluids, and assist Rehmannia glutinosa and Rehmannia glutinosa recens in tonifying kidney yin. At the same time, its power of "tonifying the liver and kidney" can enhance the effect of the monarch drug in tonifying kidney yin, improve weakness in the waist and knees, dizziness and tinnitus caused by deficiency of the liver and kidney, and it is the key drug in the assistant drugs that "assist in tonifying the kidney, astringing and securing body fluids".

[0042] Citrus aurantium var. amara: Sweet and slightly bitter in taste, neutral in nature, attributing to the liver, spleen and stomach meridians. Its efficacy is to regulate qi and relieve fullness, soothe the liver and harmonize the stomach. In patients with middle-stage consumptive thirst, due to "stomach heat injuring the spleen", the spleen fails to transport and transform properly, resulting in qi stagnation. Citrus aurantium var. amara can regulate qi and relieve fullness, restore the smooth flow of qi in the spleen and stomach, promote the distribution of body fluids, and relieve symptoms such as abdominal distension and loss of appetite. At the same time, its power of "soothing the liver and harmonizing the stomach" can regulate the liver and spleen, prevent the liver qi stagnation from affecting the function of the spleen and stomach, and assist Eupatorium fortunei and Codonopsis pilosula in enhancing the effect of strengthening the spleen and harmonizing the stomach. It is the drug in the assistant drugs that "assist in regulating qi and harmonizing the liver and spleen".

[0043] Penthorum chinense Pursh: Sweet and warm in taste, attributing to the liver and spleen meridians. Its efficacy is to promote diuresis and remove dampness, activate blood circulation and detoxify. In patients with middle-stage consumptive thirst, due to the spleen failing to transport and transform properly, dampness turbidity is likely to breed. The internal obstruction of dampness turbidity further aggravates the disorder of body fluid transportation and transformation. Penthorum chinense Pursh can promote diuresis and remove dampness, clear the dampness turbidity in the spleen and stomach, and assist Eupatorium fortunei in enhancing the effect of eliminating dampness. At the same time, its power of "activating blood circulation" can assist Carthamus tinctorius in promoting blood circulation to remove blood stasis, improve the internal obstruction of blood stasis, and prevent the mutual binding of dampness turbidity and blood stasis. Its warm nature can restrict the cold nature of the cold drugs such as Gypsum Fibrosum, Rehmannia glutinosa recens, Anemarrhena asphodeloides and Coptis chinensis in the monarch drug and ministerial drugs, preventing damage to the yang qi of the spleen and stomach. It is the key drug in the assistant drugs that "assist in promoting diuresis and activating blood circulation, and restrict cold nature".

[0044] (4) Guiding drug: Composed of Glycyrrhiza uralensis, Eriobotrya japonica flower and Angelica keiskei, it can guide all the drugs in the formula to directly reach the diseased sites such as the lung, stomach and kidney, and at the same time harmonize the cold and heat, ascending and descending properties in the formula, and protect the spleen and stomach.

[0045] Glycyrrhiza uralensis: Sweet and neutral in taste, attributing to the heart, lung, spleen and stomach meridians. Its efficacy is to invigorate the spleen and replenish qi, clear heat and detoxify, resolve phlegm and relieve cough, relieve spasm and pain, and harmonize all drugs. It is the core "harmonizing drug" in this formula.

[0046] Eriobotrya japonica flower: Sweet and slightly pungent in taste, warm in nature, attributing to the lung and stomach meridians. Its efficacy is to disperse wind and relieve cough, harmonize the stomach and suppress adverse qi. Its power of "harmonizing the stomach and suppressing adverse qi" can guide all the drugs in the formula (such as the drugs for clearing stomach heat like Gypsum Fibrosum, Anemarrhena asphodeloides and Trichosanthes kirilowii) to directly reach the stomach meridian, enhance the effect of clearing stomach heat and nourishing stomach yin, and at the same time relieve symptoms such as nausea, vomiting and hiccups caused by the upward adverse flow of stomach heat. Its power of "dispersing wind and relieving cough" can assist Ophiopogon japonicus and Polygonatum odoratum in nourishing lung yin, relieve dry cough with little phlegm caused by deficiency of lung fluid, and take into account the simultaneous regulation of the lung and stomach. Its warm nature can further restrict the cold nature of the cold drugs in the formula, protect the yang qi of the spleen and stomach, and cooperate with Penthorum chinense Pursh to play a "restricting" role.

[0047] Ashitaba: Sweet and bitter in taste, cool in nature, and enters the liver, spleen, and stomach meridians. Its functions include clearing heat and promoting diuresis, strengthening the stomach and aiding digestion. Firstly, its ability to "strengthen the stomach and aid digestion" can assist Codonopsis pilosula and Dioscorea opposita in enhancing the spleen and stomach's digestive function, improving poor appetite and indigestion caused by spleen and stomach weakness, and providing a material basis for the body to generate body fluids. Secondly, its ability to "clear heat and promote diuresis" can guide the heat in the formula to be excreted through urine, assisting Gypsum fibrosum and Coptis chinensis in clearing stomach heat, while preventing the accumulation of heat in the body. Thirdly, its cool but not cold nature can balance the warming and drying properties of the warming herbs in the formula (such as Astragalus membranaceus, Rehmannia glutinosa, and Cornus officinalis), and work synergistically with Glycyrrhiza uralensis to harmonize the properties of the entire formula. Simultaneously, its effect of "guiding heat downwards" can guide the heat-clearing power of the herbs directly to the lower burner, assisting in nourishing kidney yin and achieving "harmonious regulation of the upper and lower parts of the body."

[0048] In summary, this formula, through the meticulous combination of principal, assistant, adjuvant, and guide herbs, focuses on "clearing heat and generating fluids, replenishing qi and nourishing yin," while also taking into account "activating blood and removing dampness, and harmonizing the internal organs." It targets the core pathogenesis of "excessive stomach heat and deficiency of both qi and yin" in the middle-stage diabetes mellitus, while also addressing concurrent symptoms such as "dampness and blood stasis." Furthermore, by using the guide herbs to harmonize the properties of the herbs and protect the spleen and stomach, the entire formula combines attack and tonification, as well as the use of both cold and hot herbs, to achieve the therapeutic effect of treating the middle-stage diabetes mellitus.

[0049] Compared with the prior art, the beneficial effects that this invention can achieve are: (1) The traditional Chinese medicine composition prepared by this invention has the effects of nourishing yin and moistening the lungs and clearing the stomach, clearing heat and moistening dryness and promoting body fluid, and can effectively lower blood sugar and lipids, and is used for diabetes mellitus of the middle type; (2) By selecting the ingredients and dosage of the traditional Chinese medicine in the formula and the composition of the compound enzyme preparation, the effect is better than that of each comparative ratio and positive drug. Detailed Implementation

[0050] The present invention will be illustrated below with examples to make the technical solution of the present invention easier to understand and master, but the present invention is not limited thereto. Unless otherwise specified, the experimental methods described in the following examples are conventional methods; unless otherwise specified, the medicinal materials and reagents can be obtained commercially; and the performance of products from different sources does not have a significant impact.

[0051] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0052] Unless otherwise specified, all chemical reagents and raw materials used in the embodiments of this invention are obtained through conventional commercial channels, and products from different manufacturers do not have a significant impact on the effect.

[0053] Example 1 A traditional Chinese medicine composition for treating diabetes mellitus of the middle stage, wherein the raw materials of the traditional Chinese medicine composition are, by weight: 15 parts of Eupatorium fortunei, 20 parts of Astragalus membranaceus, 8 parts of Codonopsis pilosula, 3 parts of Gypsum fibrosum, 6 parts of Rehmannia glutinosa (processed), 12 parts of Rehmannia glutinosa (raw), 9 parts of Dioscorea opposita, 30 parts of Trichosanthes kirilowii, 12 parts of Anemarrhena asphodeloides, 20 parts of Ophiopogon japonicus, 9 parts of Dendrobium nobile, 15 parts of Polygonatum odoratum, 3 parts of Carthamus tinctorius, 6 parts of Coptis chinensis, 9 parts of Scrophularia ningpoensis, 15 parts of Cornus officinalis, 6 parts of Glycyrrhiza uralensis, 15 parts of Citrus aurantium, 9 parts of Eriobotrya japonica, 12 parts of Gynostemma pentaphyllum, and 6 parts of Akebia quinata.

[0054] The preparation method is as follows: (1) The raw materials, including Eupatorium fortunei, safflower, Citrus aurantium and Eriobotrya japonica, were steam distilled. The distillate was collected, and the volatile oil was separated. Ten times the amount of β-cyclodextrin was added to water to prepare a saturated cyclodextrin solution. The volatile oil was added to an equal amount of anhydrous ethanol to prepare a volatile oil-ethanol solution. The volatile oil-ethanol solution was added dropwise to the saturated cyclodextrin solution at a uniform rate. The mixture was stirred at 30°C for 1 hour and allowed to stand at 0°C for 25 hours. The mixture was then filtered and dried to obtain the volatile oil inclusion complex. (2) Mix the residue after extracting the volatile oil in step (1) with the remaining drugs, add water and decoct twice, each time adding water at a rate of 8 times the mass of the raw drug, decoct for 1 hour, filter, combine the filtrates to obtain the extract; (3) Add 0.5 wt.% of the compound enzyme preparation (cellulase, pectinase and β-glucosidase in a mass ratio of 1:0.1:0.25) to the extract, enzymatically hydrolyze at 35°C for 60 min, and then inactivate the enzyme at 90°C for 5 min to obtain the enzymatic hydrolysate. (4) After the enzymatic hydrolysate is dried under reduced pressure, it is mixed with the volatile oil inclusion complex to obtain the final product.

[0055] Example 2 A traditional Chinese medicine composition for treating diabetes mellitus of the middle stage, wherein the raw materials of the traditional Chinese medicine composition are, by weight: 30 parts of Eupatorium fortunei, 10 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 1 part of Gypsum fibrosum, 12 parts of Rehmannia glutinosa (processed), 6 parts of Rehmannia glutinosa (raw), 15 parts of Dioscorea opposita, 18 parts of Trichosanthes kirilowii, 20 parts of Anemarrhena asphodeloides, 12 parts of Ophiopogon japonicus, 15 parts of Dendrobium nobile, 9 parts of Polygonatum odoratum, 6 parts of Carthamus tinctorius, 3 parts of Coptis chinensis, 15 parts of Scrophularia ningpoensis, 9 parts of Cornus officinalis, 10 parts of Glycyrrhiza uralensis, 9 parts of Citrus aurantium, 15 parts of Eriobotrya japonica, 6 parts of Gynostemma pentaphyllum, and 12 parts of Akebia quinata.

[0056] The preparation method is as follows: (1) The raw materials, including Eupatorium fortunei, safflower, bitter orange, and loquat flower, were steam distilled. The distillate was collected, and the volatile oil was separated. Ten times the amount of β-cyclodextrin was added to water to prepare a saturated cyclodextrin solution. The volatile oil was added to an equal amount of anhydrous ethanol to prepare a volatile oil-ethanol solution. The volatile oil-ethanol solution was added dropwise to the saturated cyclodextrin solution at a uniform rate. The mixture was stirred at 30°C for 2 hours and allowed to stand at 0°C for 20 hours. The mixture was then filtered and dried to obtain the volatile oil inclusion complex. (2) Mix the residue after extracting the volatile oil in step (1) with the remaining drugs, add water and decoct twice, each time adding water at a rate of 6 times the mass of the raw drug, decoct for 1 hour, filter, combine the filtrates to obtain the extract; (3) Add 0.3 wt.% of the compound enzyme preparation (cellulase, pectinase and β-glucosidase in a mass ratio of 2:0.05:0.5) to the extract, enzymatically hydrolyze at 35°C for 80 min, and then inactivate the enzyme at 90°C for 5 min to obtain the enzymatic hydrolysate. (4) After the enzymatic hydrolysate is dried under reduced pressure, it is mixed with the volatile oil inclusion complex to obtain the final product.

[0057] Example 3 A traditional Chinese medicine composition for treating diabetes mellitus of the middle type, wherein the raw materials of the traditional Chinese medicine composition are, by weight: 20 parts of Eupatorium fortunei, 15 parts of Astragalus membranaceus, 10 parts of Codonopsis pilosula, 2 parts of Gypsum fibrosum, 8 parts of Rehmannia glutinosa (processed), 6 parts of Rehmannia glutinosa (raw), 12 parts of Dioscorea opposita, 22 parts of Trichosanthes kirilowii, 15 parts of Anemarrhena asphodeloides, 15 parts of Ophiopogon japonicus, 12 parts of Dendrobium nobile, 12 parts of Polygonatum odoratum, 3 parts of Carthamus tinctorius, 3 parts of Coptis chinensis, 12 parts of Scrophularia ningpoensis, 9 parts of Cornus officinalis, 8 parts of Glycyrrhiza uralensis, 10 parts of Citrus aurantium, 12 parts of Eriobotrya japonica, 8 parts of Gynostemma pentaphyllum, and 8 parts of Akebia quinata.

[0058] Preparation method: (1) The raw materials, including Eupatorium fortunei, safflower, bitter orange, and loquat flower, were steam distilled. The distillate was collected, and the volatile oil was separated. Ten times the amount of β-cyclodextrin was added to water to prepare a saturated cyclodextrin solution. The volatile oil was added to an equal amount of anhydrous ethanol to prepare a volatile oil-ethanol solution. The volatile oil-ethanol solution was added dropwise to the saturated cyclodextrin solution at a uniform rate. The mixture was stirred at 40°C for 1.5 h, allowed to stand at 5°C for 25 h, filtered, and dried to obtain the volatile oil inclusion complex. (2) Mix the residue after extracting the volatile oil in step (1) with the remaining drugs, add water and decoct twice, each time adding water 10 times the mass of the raw drug, decoct for 1.5 hours, filter, combine the filtrates to obtain the extract; (3) Add 0.8 wt.% of the compound enzyme preparation (cellulase, pectinase and β-glucosidase in a mass ratio of 1:0.2:0.1) to the extract, enzymatically hydrolyze at 35°C for 80 min, and then inactivate the enzyme at 90°C for 5 min to obtain the enzymatic hydrolysate. (4) After the enzymatic hydrolysate is dried under reduced pressure, it is mixed with the volatile oil inclusion complex to obtain the final product.

[0059] Comparative Example 1 A traditional Chinese medicine composition for treating diabetes mellitus of the middle stage, wherein the raw materials of the traditional Chinese medicine composition are, by weight: 20 parts of Agastache rugosa, 15 parts of Astragalus membranaceus, 10 parts of Codonopsis pilosula, 2 parts of Gypsum fibrosum, 8 parts of Rehmannia glutinosa (processed), 6 parts of Rehmannia glutinosa (raw), 12 parts of Dioscorea opposita, 22 parts of Trichosanthes kirilowii, 15 parts of Anemarrhena asphodeloides, 15 parts of Ophiopogon japonicus, 12 parts of Dendrobium nobile, 12 parts of Polygonatum odoratum, 3 parts of Carthamus tinctorius, 3 parts of Coptis chinensis, 12 parts of Scrophularia ningpoensis, 9 parts of Cornus officinalis, 8 parts of Glycyrrhiza uralensis, 10 parts of Citrus aurantium, 12 parts of Eriobotrya japonica, 8 parts of Gynostemma pentaphyllum, and 8 parts of Akebia quinata.

[0060] The difference from Example 3 is that the agastache rugosa is replaced with an equal amount of patchouli, and all other aspects are the same.

[0061] The preparation method is the same as in Example 3, except that the agastache is replaced with the patchouli.

[0062] Comparative Example 2 A traditional Chinese medicine composition for treating diabetes mellitus of the middle type, wherein the raw materials of the traditional Chinese medicine composition are, by weight: 20 parts of Eupatorium fortunei, 15 parts of Astragalus membranaceus, 10 parts of Codonopsis pilosula, 2 parts of Gypsum fibrosum, 8 parts of Rehmannia glutinosa (processed), 6 parts of Rehmannia glutinosa (raw), 12 parts of Dioscorea opposita, 22 parts of Pueraria lobata, 15 parts of Anemarrhena asphodeloides, 15 parts of Ophiopogon japonicus, 12 parts of Dendrobium nobile, 12 parts of Polygonatum odoratum, 3 parts of Carthamus tinctorius, 3 parts of Coptis chinensis, 12 parts of Scrophularia ningpoensis, 9 parts of Cornus officinalis, 8 parts of Glycyrrhiza uralensis, 10 parts of Citrus aurantium, 12 parts of Eriobotrya japonica, 8 parts of Gynostemma pentaphyllum, and 8 parts of Akebia quinata.

[0063] The difference from Example 3 is that the pollen was replaced with an equal mass of kudzu root, and all other aspects are the same.

[0064] The preparation method is the same as in Example 3, except that Trichosanthes kirilowii is replaced with Pueraria lobata.

[0065] Comparative Example 3 The raw materials are the same as in Example 3.

[0066] The only difference between this example and Example 3 is the composition of the compound enzyme preparation in the preparation method. In Comparative Example 3, the compound enzyme preparation contained only cellulase and pectinase (mass ratio 1:0.2). The total amount used was the same as in Example 3.

[0067] Comparative Example 4 The raw materials are the same as in Example 3.

[0068] The only difference from Example 3 is the composition of the compound enzyme preparation in the preparation method. In Comparative Example 4, the compound enzyme preparation contains only cellulase and β-glucosidase (mass ratio of 1:0.1). The total amount used is the same as the total amount of compound enzyme preparation used in Example 3.

[0069] Comparative Example 5 The raw materials are the same as in Example 3.

[0070] The only difference from Example 3 is the composition of the compound enzyme preparation in the preparation method. In Comparative Example 5, the compound enzyme preparation contains only pectinase and β-glucosidase (mass ratio of 2:1). The total amount used is the same as the total amount of the compound enzyme preparation used in Example 3.

[0071] Comparative Example 6: The raw materials are the same as in Example 3.

[0072] The only difference from Example 3 is the composition of the compound enzyme preparation in the preparation method. In Comparative Example 6, cellulase was replaced with an equal amount of hemicellulase in the compound enzyme preparation, that is, the composition of the compound enzyme preparation in Comparative Example 6 was hemicellulase, pectinase, and β-glucosidase in a mass ratio of 1:0.2:0.1. The total amount used was the same as the total amount of the compound enzyme preparation used in Example 3.

[0073] Experimental Example 1: The hypoglycemic effects of the traditional Chinese medicine compositions in Examples 1-3 and Comparative Examples 1-6 were tested using the following methods: Preparation process of 1% STZ (streptozotocin) solution: Freshly prepared in an ice bath at 4°C with streptozotocin at a concentration of 0.1 mol / L and citrate-sodium citrate buffer at pH 4.2.

[0074] The traditional Chinese medicine compositions of Examples 1-3 and Comparative Examples 1-6 were suspended in distilled water before administration, and Xiaoke Pills were dissolved in distilled water before administration.

[0075] Male SD rats, weighing 180-200g, were acclimatized for one week and randomly divided into a control group, a model group, a positive drug group (Xiaoke Pill + Xuezhikang Capsule), Examples 1-3, and Comparative Examples 1-6, with 10 rats in each group. The control group was fed a basal diet, while the other groups were fed a high-fat, high-sugar diet (10% lard, 20% sucrose, 2.5% cholesterol, 1% bile salts, 5% egg yolk powder, and 61.5% normal feed) for 4 consecutive weeks. After this period, the rats were fasted but allowed free access to water for 12 hours. Except for the control group, all other groups were intraperitoneally injected with 1% STZ (streptozotocin) solution at a dose of 35mg / kg. The control group was injected with an equal dose of 0.1mol / L citrate-sodium citrate buffer solution (pH 4.2). 72 hours after injection, blood glucose was measured by tail vein sampling. A random blood glucose level above 14.2mmol / L was considered a successful establishment of the diabetic model.

[0076] Administration: The positive control group was administered Xiaoke Pills + Xuezhikang Capsules by gavage at a dose of 1.5 g / kg Xiaoke Pills + 0.5 g / kg Xuezhikang Capsules. Groups 1-3 and Comparative Examples 1-6 were administered the corresponding traditional Chinese medicine composition suspension by gavage at a dose of 1.25 g / kg. The blank control group and model group were administered the same volume of distilled water by gavage. The gavage volume was 10 mL / kg, once daily, for 4 consecutive weeks. After the last administration, blood was collected from the tail vein 12 hours after fasting, and blood glucose levels were measured using a glucometer. Rats were anesthetized with chloral hydrate, and blood was collected from the abdominal aorta, centrifuged, and serum levels of total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL-C), and low-density lipoprotein (LDL-C) were measured using a kit method. One-way ANOVA was performed using SPSS 13.0 software; a p-value < 0.05 was considered statistically significant. The results of blood glucose measurement are shown in Table 1, and the results of TC, TG, HDL-C and LDL-C measurement are shown in Table 2.

[0077] Table 1: Blood glucose measurement results in rats (mean ± standard deviation, n = 10)

[0078] Note: Compared with the blank group, ### P < 0.001; compared with the model group, & P < 0.05 && P < 0.01, &&& P < 0.001; compared with Example 3, there were no significant differences between the drug administration groups. % P < 0.05.

[0079] The results in the table above show that the blood glucose levels in the model group rats were significantly higher than those in the control group. After drug administration, the blood glucose levels in each drug administration group decreased significantly compared to the model group, indicating that the drugs in the positive control group, Examples 1-3, and Comparative Examples 1-6 could all reduce the blood glucose levels in hyperglycemic rats. However, the hypoglycemic effect of the examples was significantly better than that of the comparative examples and the positive control group.

[0080] Table 2: Results of TC, TG, HDL-C and LDL-C measurements in rat serum (mean ± standard deviation, n = 10)

[0081] Note: Compared with the blank group, # P < 0.05 ## P < 0.01, ### P < 0.001; compared with the model group, & P < 0.05 && P < 0.01; compared with Example 3, there were no significant differences between the drug administration groups. % P < 0.05.

[0082] Based on the above results, it can be seen that compared with the blank group, TC, TG, and LDL-C in the model group were significantly increased, while HDL-C was significantly decreased, indicating that the modeling was successful. Compared with the model group, the positive drug group, Examples 1-3, and Comparative Examples 1-6 showed significant positive regulatory effects on TC, TG, HDL-C, and LDL-C in the model group after administration. However, the effect of the drugs in the example groups was significantly better than that of the positive drug group and the drugs in Comparative Examples 1-6.

[0083] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetes mellitus of the middle stage, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15-30 parts of Eupatorium fortunei, 10-20 parts of Astragalus membranaceus, 8-15 parts of Codonopsis pilosula, 1-3 parts of Gypsum fibrosum, 6-12 parts of Rehmannia glutinosa (processed), 6-12 parts of Rehmannia glutinosa (raw), 9-15 parts of Dioscorea opposita, 18-30 parts of Trichosanthes kirilowii, 12-20 parts of Anemarrhena asphodeloides, 12-20 parts of Ophiopogon japonicus, 9-15 parts of Dendrobium nobile, 9-15 parts of Polygonatum odoratum, 3-6 parts of Carthamus tinctorius, 3-6 parts of Coptis chinensis, 9-15 parts of Scrophularia ningpoensis, 9-15 parts of Cornus officinalis, 6-10 parts of Glycyrrhiza uralensis, 9-15 parts of Citrus aurantium, 9-15 parts of Eriobotrya japonica, 6-12 parts of Gynostemma pentaphyllum, and 6-12 parts of Akebia quinata.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 18-25 parts of Eupatorium fortunei, 12-18 parts of Astragalus membranaceus, 8-12 parts of Codonopsis pilosula, 1-3 parts of Gypsum fibrosum, 6-10 parts of Rehmannia glutinosa (processed), 6-10 parts of Rehmannia glutinosa (raw), 9-15 parts of Dioscorea opposita, 18-25 parts of Trichosanthes kirilowii, 12-18 parts of Anemarrhena asphodeloides, 12-18 parts of Ophiopogon japonicus, 10-15 parts of Dendrobium nobile, 10-15 parts of Polygonatum odoratum, 3-5 parts of Carthamus tinctorius, 3-5 parts of Coptis chinensis, 9-12 parts of Scrophularia ningpoensis, 9-12 parts of Cornus officinalis, 6-10 parts of Glycyrrhiza uralensis, 9-12 parts of Citrus aurantium, 9-12 parts of Eriobotrya japonica, 6-12 parts of Gynostemma pentaphyllum, and 6-12 parts of Akebia quinata.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20 parts of Eupatorium fortunei, 15 parts of Astragalus membranaceus, 10 parts of Codonopsis pilosula, 2 parts of Gypsum fibrosum, 8 parts of Rehmannia glutinosa (processed), 6 parts of Rehmannia glutinosa (raw), 12 parts of Dioscorea opposita, 22 parts of Trichosanthes kirilowii, 15 parts of Anemarrhena asphodeloides, 15 parts of Ophiopogon japonicus, 12 parts of Dendrobium nobile, 12 parts of Polygonatum odoratum, 3 parts of Carthamus tinctorius, 3 parts of Coptis chinensis, 12 parts of Scrophularia ningpoensis, 9 parts of Cornus officinalis, 8 parts of Glycyrrhiza uralensis, 10 parts of Citrus aurantium, 12 parts of Eriobotrya japonica, 8 parts of Gynostemma pentaphyllum, and 8 parts of Akebia quinata.

4. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: (1) The raw materials, including Eupatorium fortunei, safflower, bitter orange blossom and loquat flower, were steam distilled, the distillate was collected, the volatile oil fraction was separated, and cyclodextrin was used to encapsulate the volatile oil fraction to obtain the volatile oil inclusion complex; (2) Mix the residue after extracting the volatile oil in step (1) with the remaining drugs, add water to extract, and obtain the extract; (3) Add a compound enzyme preparation to the extract for enzymatic hydrolysis to obtain the hydrolysate; (4) After the enzymatic hydrolysate is dried under reduced pressure, it is mixed with the volatile oil inclusion complex to obtain the final product.

5. The preparation method according to claim 4, characterized in that, In step (2), water extraction is performed 1-2 times, with the amount of water added each time being 6-10 times the mass of the raw drug, and the extraction time being 1-2 hours.

6. The preparation method according to claim 4, characterized in that, The compound enzyme preparation in step (3) includes 1-2 parts of cellulase, 0.05-0.2 parts of pectinase and 0.1-0.5 parts of β-glucosidase; the amount of the compound enzyme preparation is 0.3-0.8 wt.% of the raw material; the enzymatic hydrolysis temperature is 35-40℃ and the enzymatic hydrolysis time is 60-80 min.

7. A pharmaceutical preparation, characterized in that, The pharmaceutical preparation comprises the traditional Chinese medicine composition according to any one of claims 1-3 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 4-6.

8. The pharmaceutical preparation according to claim 7, characterized in that, The pharmaceutical preparation further includes one or more pharmaceutically acceptable excipients and / or excipients; the dosage form of the pharmaceutical preparation includes granules, tablets, and capsules.

9. The use of a traditional Chinese medicine composition according to any one of claims 1-3, or a traditional Chinese medicine composition obtained by the preparation method according to any one of claims 4-6, or a pharmaceutical preparation according to any one of claims 7-8, in the preparation of a drug for treating diabetes mellitus.

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