Traditional Chinese medicine compound composition for improving early-stage symptoms of diabetes and application of traditional Chinese medicine compound composition

Abstract

According to the traditional Chinese medicine compound composition, rhizoma polygonati, radix codonopsis, rhizoma dioscoreae and fried rhizoma atractylodis macrocephalae are used as monarch medicines, and are used for replenishing qi and strengthening the spleen, and earthing up to build the middle energizer, so that transportation and transformation are right; poria cocos, coix seeds and radix fici simplicissimae are used as ministerial drugs, dried orange peel and fructus amomi are used as ministerial drugs, and the effects of dredging and regulating water channels, resolving dampness, enlivening the spleen, and promoting middle-jiao ascending and descending are achieved, so that three- Radix paeoniae alba, radix curcumae, fructus aurantii and radix cyathulae are matched with radix salviae miltiorrhizae as assistant medicines to soften the liver, dispel depression, regulate qi, guide stagnation, promote blood circulation and dredge collaterals, so that wood is prepared without lumbering, and collaterals are dredged without bitter cold; the radix scrophulariae and the radix ophiopogonis are used for nourishing yin, clearing and moistening, and strengthening yin without moistening greasy middle energizer so as to avoid dampness-aiding and spleen-trapping; and honey-fried licorice root and jujube are used as guide medicines to harmonize the medicines, regulate the middle warmer and protect the stomach so as to improve the symptoms of the diabetes mellitus in the early stage.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound composition for improving prediabetes symptoms and application thereof. BACKGROUND

[0002] Prediabetes refers to a metabolic abnormality state with blood glucose level higher than normal but not reaching the diagnostic criteria of diabetes, which is often manifested as impaired fasting glucose, abnormal glucose tolerance or both. A large number of studies have shown that prediabetes is a key transitional stage of the occurrence of type 2 diabetes, and if effective intervention is carried out at this stage, the risk of diabetes can be significantly reduced.

[0003] Modern medicine mainly uses lifestyle intervention or some chemical drugs for intervention of prediabetes, but the long-term compliance is poor, and some people have the risk of adverse reactions. Traditional Chinese medicine has unique advantages in regulating overall metabolism and improving sub-health state.

[0004] In the existing traditional Chinese medicine technology, for the treatment of diabetes or diabetes, the treatment idea of clearing heat and purging fire, nourishing yin and generating fluid or bitter cold reducing blood sugar is often adopted from the pathogenesis of "yin deficiency and dryness-heat", "deficiency of both qi and yin" and "endogenous phlegm-heat". However, it is found in clinical practice that a large number of prediabetes people do not have obvious symptoms such as polydipsia, polyuria and other "diabetes" typical symptoms, but more show symptoms such as fatigue, drowsiness, lethargy, postprandial indigestion, weight gain or metabolic abnormalities. The use of pure heat-clearing and bitter cold drugs has unstable curative effect, and even affects the function of the spleen and stomach.

[0005] In addition, the existing disclosed traditional Chinese medicine preparations are mainly focused on tonifying, anti-fatigue, immune regulation and other directions, and there is still a lack of systematic formula design and application for specific syndromes of prediabetes.

[0006] Therefore, it is urgent to develop a traditional Chinese medicine compound which is based on the real pathogenesis of prediabetes and takes into account the functions of invigorating the spleen, tonifying qi, nourishing yin and improving metabolic microcirculation, so as to effectively intervene in prediabetes. SUMMARY

[0007] The purpose of the present application is to provide a traditional Chinese medicine compound which can improve the state of prediabetes by innovative syndrome positioning and reasonable compatibility, so as to delay or block the occurrence of diabetes.

[0008] Another purpose of the present application is to provide the use of the traditional Chinese medicine compound in the preparation of a medicine or health product for improving prediabetes.

[0009] A traditional Chinese medicine compound composition for improving prediabetes symptoms is prepared from the following weight parts of traditional Chinese medicine decoction pieces:

[0010] The monarch drug is selected from one or more of Huangjing 20-30 parts, Dangshen 15-25 parts, Shanyao 10-20 parts, and / or Fried Baishu 15-25 parts;

[0011] The minister drug is selected from one or more of Fuling 10-20 parts, Wuweixie 8-12 parts, Yiyiren 15-25 parts, Chenpi 10-20 parts, and / or Sharen 8-12 parts;

[0012] The assistant drug is selected from one or more of Baishao 20-30 parts, Yujin 15-25 parts, Zhike 10-20 parts, Chuan Niuxi 15-25 parts, Danshen 10-20 parts, Xuanshen 8-12 parts, and / or Maidong 10-20 parts;

[0013] The messenger drug is selected from one or more of Zhigancao 5-10 parts and / or Dazao 8-12 parts.

[0014] Preferably, the one kind of traditional Chinese medicine compound composition for improving prediabetes symptoms is characterized by being prepared from the following weight parts of traditional Chinese medicine decoction pieces:

[0015] The monarch drug is selected from one or more of Huangjing 25-30 parts, Dangshen 20-25 parts, Shanyao 15-20 parts, and / or Fried Baishu 20-25 parts;

[0016] The minister drug is selected from one or more of Fuling 15-20 parts, Wuweixie 10-12 parts, Yiyiren 20-25 parts, Chenpi 15-20 parts, and / or Sharen 10-12 parts;

[0017] The assistant drug is selected from one or more of Baishao 25-30 parts, Yujin 20-25 parts, Zhike 15-20 parts, Chuan Niuxi 20-25 parts, Danshen 15-20 parts, Xuanshen 10-12 parts, and / or Maidong 15-20 parts;

[0018] The messenger drug is selected from one or more of Zhigancao 8-10 parts and / or Dazao 10-12 parts.

[0019] More preferably, the one kind of traditional Chinese medicine compound composition for improving prediabetes symptoms is characterized by being prepared from the following weight parts of traditional Chinese medicine decoction pieces:

[0020] The monarch drug is selected from one or more of Huangjing 25 parts, Dangshen 20 parts, Shanyao 15 parts, and / or Fried Baishu 20 parts;

[0021] The minister drug is selected from one or more of Fuling 15 parts, Wuweixie 10 parts, Yiyiren 20 parts, Chenpi 15 parts, and / or Sharen 10 parts;

[0022] The assistant drug is selected from one or more of Baishao 25 parts, Yujin 20 parts, Zhike 15 parts, Chuan Niuxi 20 parts, Danshen 15 parts, Xuanshen 10 parts, and / or Maidong 15 parts;

[0023] The herb is selected from one or more of the following: 8 parts of prepared licorice root and / or 10 parts of jujube.

[0024] In one embodiment of the present invention, a traditional Chinese medicine compound composition for improving prediabetic symptoms is prepared by extracting the following traditional Chinese medicine slices in parts by weight: 20-30 parts of Polygonatum sibiricum, 15-25 parts of Codonopsis pilosula, 10-20 parts of Dioscorea opposita, 15-25 parts of stir-fried Atractylodes macrocephala, 10-20 parts of Poria cocos, 8-12 parts of Ficus hirta, 15-25 parts of Coix lacryma-jobi, 10-20 parts of Citrus reticulata peel, 8-12 parts of Amomum villosum, 20-30 parts of Paeonia lactiflora, 15-25 parts of Curcuma longa, 10-20 parts of Citrus aurantium, 15-25 parts of Achyranthes bidentata, 10-20 parts of Salvia miltiorrhiza, 8-12 parts of Scrophularia ningpoensis, 10-20 parts of Ophiopogon japonicus, 5-10 parts of prepared Glycyrrhiza uralensis, and 8-12 parts of Ziziphus jujuba.

[0025] Preferably, the traditional Chinese medicine compound composition for improving prediabetes symptoms is prepared by extracting the following traditional Chinese medicine slices in parts by weight: 25 parts Polygonatum sibiricum, 20 parts Codonopsis pilosula, 15 parts Dioscorea opposita, 20 parts stir-fried Atractylodes macrocephala, 15 parts Poria cocos, 10 parts Ficus hirta, 20 parts Coix lacryma-jobi, 15 parts Citrus reticulata peel, 10 parts Amomum villosum, 25 parts Paeonia lactiflora, 20 parts Curcuma longa, 15 parts Citrus aurantium, 20 parts Achyranthes bidentata, 15 parts Salvia miltiorrhiza, 10 parts Scrophularia ningpoensis, 15 parts Ophiopogon japonicus, 8 parts prepared Glycyrrhiza uralensis, and 10 parts Ziziphus jujuba.

[0026] Secondly, the present invention provides a method for preparing a traditional Chinese medicine preparation made from the traditional Chinese medicine composition described in the first aspect.

[0027] The traditional Chinese medicine compound composition for improving prediabetes symptoms is prepared by the following steps:

[0028] (1) Take the above-mentioned Chinese herbal medicine slices, add water and decoct three times, each time adding 5-10 times the weight of the Chinese herbal medicine slices, and decoct for 1-3 hours each time; filter while hot, combine the filtrates, concentrate the filtrate to 1-2g of Chinese herbal medicine slices per 1ml; add ethanol to make the alcohol content 75%, refrigerate for 12 hours, take the supernatant, filter, recover the ethanol from the filtrate and concentrate until there is no alcohol taste, add dextrin to make the relative density of the extract 1.13-1.25 (40℃), spray dry to obtain the extract;

[0029] (2) Take the extract from step (1) and add excipients to prepare an oral dosage form.

[0030] Preferably, in the preparation method step (1) of the traditional Chinese medicine compound composition for improving prediabetes symptoms, water is added at a rate of 8 times the weight of the traditional Chinese medicine slices each time, and the decoction is carried out for 2 hours each time.

[0031] Alternatively, in step (1) of the preparation method of the traditional Chinese medicine compound composition for improving prediabetes symptoms, the relative density of the extract is 1.20 (40°C).

[0032] The oral dosage form in step (2) of the preparation method of the Chinese medicine compound composition for improving prediabetes symptoms is one of granules, oral liquid, tablets, syrup, and paste.

[0033] In a third aspect, the present application provides the use of the Chinese medicine composition of the first aspect in the preparation of a medicine for improving prediabetes symptoms.

[0034] Preferably, the use of the Chinese medicine compound composition for improving prediabetes symptoms in the preparation of a medicine for improving prediabetes symptoms is for treating prediabetes symptoms caused by spleen deficiency, liver stagnation, and disorder of the triple energizer.

[0035] More preferably, the use of the Chinese medicine compound containing rhizoma polygonati for improving prediabetes in the preparation of a medicine for treating prediabetes symptoms caused by spleen deficiency, liver stagnation, and disorder of the triple energizer, and accompanied by dampness obstruction, collateral obstruction, and yin depletion.

[0036] The prediabetes state referred to herein refers to the following standard: fasting blood glucose 6.1-6.9 mmol / L according to the prediabetes diagnosis standard of Western medicine. The main clinical manifestations of traditional Chinese medicine are fatigue, drowsiness after meals, poor appetite and abdominal distension, sticky mouth without thirst or slight thirst, sticky stool without comfort or loose stool, often accompanied by chest and hypochondriac stuffiness, belching and sighing, emotional discomfort, pale or pale tongue, white or thin and greasy fur, and soft or stringy pulse.

[0037] Prediabetes belongs to the early stage of the "consumption" and "spleen" categories in traditional Chinese medicine. The pathogenesis is due to improper diet, long sitting and lack of exercise, and emotional disorder, leading to spleen deficiency, and poor qi movement. Spleen deficiency leads to abnormal distribution of body fluid, and over time, qi and yin are depleted, and there is no obvious dry heat. At the same time, the liver loses its function of dredging, and the pancreatic islets and peripheral tissue microcirculation are blocked. Therefore, the core pathogenesis is: spleen deficiency, yin depletion, and liver stagnation. Based on the above pathogenesis, the present application establishes the following treatment methods: tonifying qi and invigorating the spleen; nourishing yin without dampness; soothing the liver and promoting blood circulation to improve metabolic microcirculation; regulating qi and blood, yin and yang to prevent disease progression. The performance is: "prediabetes state" syndrome type with spleen deficiency as the root, liver stagnation as the branch, and disorder of the triple energizer as the core pivot, accompanied by dampness obstruction, collateral obstruction, and yin depletion.

[0038] Based on the five-element generation and restraint, triple energizer and qi-blood-fluid theory, the present application believes that prediabetes is not simply a yin deficiency or heat excess syndrome, but a prediabetes state caused by spleen deficiency, liver stagnation, and disorder of the triple energizer. Therefore, the treatment principle of "supporting earth and restraining wood, regulating the triple energizer first, nourishing yin and consolidating the root without dampness, and dredging collaterals without clearing heat" is established to conform to the disease evolution rule and distinguish from the prior art.

[0039] The Canon of Internal Classic proposed the concept of Xiaodan, emphasizing its occurrence and improper diet, and damage to the spleen and stomach. Jingyue's Complete Works of Medicine and Surgery emphasizes that diabetes is closely related to the deficiency of the spleen and kidney and the deficiency of Yin essence, and is not simply due to excessive heat. Especially in the early stage / early stage of diabetes, it is often seen that the Qi movement is not beneficial, and the spleen is not healthy. Therefore, the pre-diabetes is in the early stage of Xiaodan / early stage of diabetes, and the heat image is not necessarily significant, and the pathogenesis is often the first to be healthy and the spleen, and then the Yin part is dark. Therefore, the present invention does not take "simple Yin deficiency and excessive heat" as the only pathogenesis premise. At the same time, the Canon of Internal Classic-Linglan Secret Classic Theory states that the spleen and stomach are the "officials of the warehouse", which is responsible for the reception and digestion of food and drink, and is the source of Qi and blood. The theory of traditional Chinese medicine "spleen governing transportation" points out that if the spleen is not healthy, the water and food essence will not be distributed, and the transportation of body fluid will be abnormal, which can appear "wet and congested in the middle jiao, and the Qi movement is not smooth". This is consistent with the common symptoms of pre-diabetes, such as drowsiness, poor appetite, postprandial fullness, and greasy tongue. According to the theory of "spleen governing transportation, and the basis of afterlife", the common imbalance of water and food essence transportation and wet and congested in the middle jiao in pre-diabetes, so the treatment should be to cultivate the spleen and restore the transportation and gasification. The present invention selects Huangjing, Dangshen, Shanyao and Fried Baishu as the monarch, Dangshen, Shanyao and Fried Baishu to cultivate the spleen and restore the transportation and gasification, Huangjing to supplement Qi and nourish Yin, and to stabilize the Yin part of the bottom plate, so that the Yin part is not dark during the gasification recovery process, thereby meeting the overall balance principle of "Yin Ping Yang Mi", and in line with the stage characteristics of pre-diabetes "deficiency without heat, and wetness obstruction not yet complete".

[0040] The Huangdi Neijing Ying Sheng Ji Hui states that the Sanjiao is the official of the decision and the water channel, which indicates that the metabolism and regulation of water and liquid belong to the regulation of the Sanjiao. The pre-diabetes is often accompanied by the dampness stagnation in the middle jiao, the poor transportation of liquid, and the failure of the clear yang to ascend, which is not necessarily accompanied by the typical dryness-heat. Therefore, the treatment should be to make the water channel smooth and the dampness stagnation disappear, and to make the gasification system resume operation. According to the discussion of the Sanjiao in the Huangdi Neijing, which states that the Sanjiao is the official of the decision, the water and food channel, and the end and beginning of the gas, the metabolic abnormality of the pre-diabetes is understood as the whole transportation disorder caused by the gasification disorder of the Sanjiao. Therefore, the treatment method emphasizes the regulation of the Sanjiao gasification to restore the ascending and descending and the transportation of water and liquid. The invention uses the poria cocos and the coix seed to regulate the water channel and remove the dampness, which provides the path for the recovery of the Sanjiao gasification, and conforms to the stage characteristics of the pre-diabetes, which is accompanied by the dampness stagnation and the heat is not necessarily obvious. The pre-diabetes is often accompanied by the deficiency and stagnation in the middle jiao, and the treatment should be to support the healthy and not to stagnate. The invention uses the five-fingered lotus to supplement the spleen and the lung, which is not too harsh, so that the method of supporting the earth and building the middle jiao does not hinder the qi movement, which is beneficial to the continuous recovery of the Sanjiao gasification. In the theory of traditional Chinese medicine, the transportation and digestion is not only the digestion and absorption of the material layer, but also the system function of the ascending and descending of the qi movement. When the qi movement is not good, even if the spleen is invigorated, it may also appear that the invigoration is not good and the transportation is not good. The Sanjiao gasification depends on the ascending and descending of the qi movement, and the middle jiao is the pivot of ascending the clear and descending the turbid. The invention uses the pericarpium citri reticulatae and the amomum villosum to regulate the qi and wake up the spleen, which makes the invigorating products be transported and digested, and promotes the Sanjiao qi movement, so as to embody the treatment method of regulating the Sanjiao gasification. In short, the invention uses the poria cocos, the coix seed, the five-fingered lotus, the pericarpium citri reticulatae, and the amomum villosum as the ministerial medicinal, the poria cocos and the coix seed regulate the water channel and remove the dampness, the five-fingered lotus supplements the earth and does not stagnate, and the pericarpium citri reticulatae and the amomum villosum regulate the ascending and descending.

[0041] In the theory of five elements, the liver belongs to wood and the spleen belongs to earth. When the spleen is weak, the liver wood is not restricted, and the liver depression and qi stagnation, the transverse invasion of the spleen, and the transportation and digestion are worse. The Suwen Cang Qi Fa Shi Lun has the principle of treating the liver disease by taking it from the spleen. The pre-diabetes is often accompanied by the deficiency of the spleen, the stagnation of the qi movement, the dampness, and the heat is not necessarily obvious. The invention sets the wood restriction, the collateral dredging, and the yin nourishing in the auxiliary medicinal layer, which aims to correct the transverse invasion of the liver wood, the collateral obstruction, and the yin deficiency, so that the main axis of supporting the earth and regulating the Sanjiao can be implemented stably, and the excessive heat clearing or the excessive nourishing can be avoided. The invention uses the radix paeoniae alba, the radix curcumae, the fructus aurantii, and the radix cyathulae to form the wood restriction system of “softening-soothing-regulating-leading”, which aims to restrict the transverse invasion of the wood and not to cut the growth of the wood, which conforms to the principle of the five elements that the wood restricts the earth but does not cut the growth of the earth.

[0042] Meanwhile, the *Suwen* (Plain Questions) chapter on regulating the meridians states that "when blood and qi are not in harmony, all kinds of diseases arise," emphasizing the importance of the harmony and smooth flow of qi and blood. Prediabetes often presents with metabolic fluctuations, fatigue, a dark tongue, or a choppy pulse—characteristics of "impaired flow"—which can be attributed to "obstruction of the collaterals / blood stasis" preceding the condition. If bitter and cold herbs are used to clear heat initially, it can easily damage the middle yang and hinder qi transformation, thus hindering early intervention. This invention believes that heat symptoms in prediabetes may not be significant, while collateral obstruction may occur first. Therefore, it uses *Danshen* (Salvia miltiorrhiza) to invigorate blood and unblock the collaterals, and *Chuanniuxi* (Achyranthes bidentata) to guide the flow downwards, first unblocking the qi and blood meridians to restore their order, rather than first using bitter and cold herbs to clear heat.

[0043] The Yin-Yang theory emphasizes "Yin and Yang in balance" (Suwen·Shengqi Tongtian Lun), indicating that the stability of Yin is a prerequisite for the long-term balance of the system. Prediabetes often presents with "insufficient Yin depletion and lingering dampness." Using rich and cloying Yin-nourishing herbs like Rehmannia glutinosa (processed and raw) can easily hinder the transformation and transportation of Qi in the middle Jiao and exacerbate dampness, which does not conform to the principle of "regulating the Qi transformation of the three Jiaos first." This invention uses Scrophularia ningpoensis and Ophiopogon japonicus as a safety valve for Yin, ensuring that Yin is consolidated without being cloying and hindering the middle Jiao. Combined with the principal and assistant herbs to regulate the middle Jiao and resolve dampness, it achieves Yin nourishment without promoting dampness.

[0044] In summary, the formula uses white peony root, turmeric, immature bitter orange, Sichuan achyranthes root, salvia miltiorrhiza, scrophularia root, and ophiopogon root as adjuvant herbs. White peony root, turmeric, immature bitter orange, and Sichuan achyranthes root restrain wood without damaging it; Sichuan achyranthes root and salvia miltiorrhiza unblock the meridians without clearing heat first; and scrophularia root and ophiopogon root nourish yin without promoting dampness.

[0045] Prepared licorice root and jujube harmonize and protect the middle jiao (digestive system) and coordinate the effects of other herbs.

[0046] The entire formula consists of Polygonatum sibiricum, Codonopsis pilosula, Dioscorea opposita, stir-fried Atractylodes macrocephala, Poria cocos, Ficus hirta, Coix lacryma-jobi, Citrus reticulata peel, Amomum villosum, Paeonia lactiflora, Curcuma longa, Citrus aurantium, Achyranthes bidentata, Salvia miltiorrhiza, Scrophularia ningpoensis, Ophiopogon japonicus, prepared Glycyrrhiza uralensis, and Ziziphus jujuba. The key pathogenesis of prediabetes is "spleen deficiency as the root, liver dysfunction as the manifestation, and disorder of the three jiaos as the pivot, accompanied by dampness obstruction, collateral obstruction, and yin depletion". The treatment principle is "strengthening the spleen and controlling the liver, first regulating the qi transformation of the three jiaos, nourishing yin and consolidating the foundation without promoting dampness, and unblocking the collaterals without clearing heat first". The formula uses Polygonatum sibiricum, Codonopsis pilosula, Dioscorea opposita, and stir-fried Atractylodes macrocephala as the chief herbs to invigorate Qi, strengthen the spleen, and nourish the middle Jiao, thus enabling proper digestion and transformation. Poria cocos, Coix lacryma-jobi, and Ficus hirta, along with Citrus reticulata and Amomum villosum, serve as assistant herbs to regulate water metabolism, resolve dampness, invigorate the spleen, and promote the ascending and descending of Qi in the middle Jiao, thus restoring the Qi transformation of the three Jiaos. Paeonia lactiflora, Curcuma longa, Citrus aurantium, Achyranthes bidentata, and Salvia miltiorrhiza are used as adjuvant herbs to soothe the liver, relieve stagnation, regulate Qi, promote blood circulation, and unblock the meridians, thus controlling the liver without damaging it and unblocking the meridians without being bitter and cold. Scrophularia ningpoensis and Ophiopogon japonicus are used to nourish Yin and clear heat, consolidating Yin without being greasy or cloying, so as not to promote dampness and impair the spleen. Glycyrrhiza uralensis and Ziziphus jujuba are used as guiding herbs to harmonize the other herbs, harmonize the middle Jiao, and protect the stomach. Attached Figure Description

[0047] Figure 1 The effect of this invention on blood glucose in type 2 diabetic rats;

[0048] Figure 2 This is a clinical result of the present invention. Detailed Implementation

[0049] Example 1: Take Huangjing 250g, Dangshen 200g, Shanyao 150g, Fried Baishu 200g, Fuling 150g, Wu Zhi Mao Tang 100g, Yiyiren 200g, Chenpi 150g, Sharen 100g, Baishao 250g, Yujin 200g, Jujie 150g, Chuan Niuxi 200g, Danshen 150g, Xuanshen 100g, Maidong 150g, Zhigancao 80g, Dazao 100g, the preparation method comprises the following steps:

[0050] (1) Take the above-mentioned traditional Chinese medicine decoction pieces, add water and decoct three times, each time adding 8 times the weight of the traditional Chinese medicine decoction pieces, each time decocting for 2 hours; filter while hot, combine the filtrates, concentrate the filtrate to 1.5g of traditional Chinese medicine decoction pieces per 1ml; add ethanol to make the alcohol content 75%, store in cold storage for 12 hours, take the supernatant, filter, recover ethanol from the filtrate and concentrate to no alcohol taste, add dextrin to make the extract relative density 1.20 (40℃), spray dry to obtain the extract;

[0051] (2) Take the extract described in step (1) and add starch to prepare granules.

[0052] Example 2: Take Huangjing 200g, Dangshen 250g, Shanyao 100g, Fried Baishu 250g, Fuling 100g, Wu Zhi Mao Tang 120g, Yiyiren 150g, Chenpi 200g, Sharen 80g, Baishao 300g, Yujin 150g, Jujie 200g, Chuan Niuxi 150g, Danshen 200g, Xuanshen 80g, Maidong 200g, Zhigancao 50g, Dazao 120g, the preparation method comprises the following steps:

[0053] (1) Take the above-mentioned traditional Chinese medicine decoction pieces, add water and decoct three times, each time adding 10 times the weight of the traditional Chinese medicine decoction pieces, each time decocting for 1 hour; filter while hot, combine the filtrates, concentrate the filtrate to 2g of traditional Chinese medicine decoction pieces per 1ml; add ethanol to make the alcohol content 75%, store in cold storage for 12 hours, take the supernatant, filter, recover ethanol from the filtrate and concentrate to no alcohol taste, add dextrin to make the extract relative density 1.13 (40℃), spray dry to obtain the extract;

[0054] (2) Take the extract described in step (1) and add dextrin to prepare tablets.

[0055] Example 3: Take Huangjing 300g, Dangshen 150g, Shanyao 200g, Fried Baishu 150g, Fuling 200g, Wu Zhi Mao Tang 80g, Yiyiren 250g, Chenpi 100g, Sharen 120g, Baishao 200g, Yujin 250g, Jujie 100g, Chuan Niuxi 250g, Danshen 100g, Xuanshen 120g, Maidong 100g, Zhigancao 100g, Dazao 80g, the preparation method comprises the following steps:

[0056] (1) Take the above-mentioned traditional Chinese medicine decoction pieces, decoct three times, each time add 5 times the weight of the traditional Chinese medicine decoction pieces of water, each time decoct for 3 hours; filter while hot, combine the filtrates, concentrate the filtrate to 1 g of traditional Chinese medicine decoction pieces per 1 ml; add ethanol to make the alcohol content 75%, store in a cold place for 12 hours, take the supernatant, filter, recover ethanol from the filtrate and concentrate to no alcohol taste, add dextrin to make the extract relative density 1.25 (40°C), spray dry to obtain the extract;

[0057] (2) Take the extract described in step (1) and add microcrystalline cellulose to prepare a capsule.

[0058] Example 4: Pharmacodynamic study

[0059] 2 Type diabetes mellitus rat model: high sugar high fat feed plus low dose STZ (intraperitoneal injection of 10 mg / kg) to induce experimental type 2 pre-diabetes rat model, male SD rats, body weight (200±20) g, randomly divided into normal group 20, diabetes group 60, the normal group was fed with ordinary feed, continuously fed for 4 weeks, after the model was successful, the diabetes group was divided into model group 20, example 1 group of the present application 20, metformin group 20. The model group and the normal group ig the same amount of distilled water, the metformin group ig metformin 200 mg / kg, the example 1 group of the present application was given granules prepared in example 1 20 g of crude drug / kg, and the drug was given for 8 weeks.

[0060] After the last administration, the rats were fasted for 12 h, anesthetized with chloral hydrate, and then fixed on a rat plate in a supine position. Blood was taken from the abdominal aorta and placed in a blood collection tube. After centrifugation at 4°C, the supernatant was taken in an EP tube and stored at -80°C for later use. The fasting blood glucose value was measured, and the results are shown in Table 1.

[0061] Table 1 Effect of the present application on blood glucose in type 2 diabetic rats

[0062]

[0063] (Compared with the control group, # P<0.05, compared with the model group * P<0.05)

[0064] The experimental results showed that after modeling, the blood glucose of each group except the normal group was significantly increased, and the difference between the model group and the normal group was statistically significant (P<0.05). The difference between the metformin group and the example 1 group of the present application and the model group was statistically significant (P<0.05). The experimental results showed that the present application could effectively reduce the fasting blood glucose value of type 2 diabetic rats.

[0065] Example 5: Clinical study

[0066] Case selection: Patients with prediabetes who visited the outpatient department of Xiaochang County Traditional Chinese Medicine Hospital in Hubei Province between October 2022 and December 2024 were collected. One hundred patients aged 48 to 72 years were selected and randomly divided into a positive drug group and Example 1 group. Complete clinical data were recorded for all enrolled patients, including medical history and physical examination, examination results, and follow-up on treatment response.

[0067] Diagnostic criteria: Western medicine follows the WHO diagnostic criteria for prediabetes: fasting blood glucose 6.1-6.9 mmol / L. In Traditional Chinese Medicine (TCM), the main symptoms include fatigue, postprandial drowsiness, poor appetite, abdominal distension, sticky mouth with little or no thirst, sticky and unsatisfactory stools or loose stools, often accompanied by chest and rib distension, belching, sighing, emotional distress, pale or dark tongue with a white and greasy or thin and greasy coating, and a soft and slow or wiry and slippery pulse. This is considered a pre-metabolic pathological state caused by spleen deficiency, liver dysfunction, and disordered Qi transformation in the Triple Burner. Some patients may also exhibit mild Yin deficiency without obvious heat signs, and may show abnormal blood glucose and insulin resistance.

[0068] Treatment methods: The positive control group took Shenqi Jiangtang Granules (National Drug Approval Number Z10950075, Lunan Houpu Pharmaceutical Co., Ltd.), orally, 5g each time, 3 times a day, for 8 weeks. The Example 1 group took the granules prepared in Example 1 (daily dosage: Polygonatum 25g, Codonopsis pilosula 20g, Dioscorea opposita 15g, stir-fried Atractylodes macrocephala 20g, Poria cocos 15g, Ficus hirta 10g, Coix lacryma-jobi 20g, Citrus reticulata 15g, Amomum villosum 10g, Paeonia lactiflora 25g, Curcuma longa 20g, Citrus aurantium 15g, Achyranthes bidentata 20g, Salvia miltiorrhiza 15g, Scrophularia ningpoensis 10g, Ophiopogon japonicus 15g, prepared Glycyrrhiza uralensis 8g, Ziziphus jujuba 10g), orally, 3 times a day, for 8 weeks.

[0069] Treatment criteria: Primary symptoms: Loose / unformed stools; increased frequency or easy defecation; fatigue and lethargy; abdominal distension / suppression. Secondary symptoms: Poor appetite; sticky mouth / bland taste without thirst; heaviness and fatigue / headache; sticky, difficult-to-flush stools; nausea / belching. Scoring example (0-3 points): 0 points: None; 1 point: Mild (occasional, does not affect daily life); 2 points: Moderate (frequent, affects some activities); 3 points: Severe (persistent or frequent, significantly affects life / work). Total syndrome score = Primary symptom score + Secondary symptom score.

[0070] The rate of decrease in syndrome score (%) = (total score before treatment - total score after treatment) / total score before treatment × 100%; grading: clinical cure: decrease rate ≥ 95%, and the main symptoms have basically disappeared and bowel movements have basically returned to normal; significant effect: decrease rate 70-94%, the main symptoms have significantly improved, and bowel movements are close to normal; effective: decrease rate 30-69%, symptoms have been relieved but there are still residual symptoms; ineffective: decrease rate < 30% or symptoms have worsened.

[0071] Clinical results are shown in Table 2:

[0072] Table 2 Clinical results of the present application (number of people)

[0073]

[0074] From Table 2, after 8 weeks of treatment, the example 1 group had a total of 50 cases, 4 cases were ineffective, 28 cases were effective, 12 cases were markedly effective, and 6 cases were cured, with a total effective rate of 92%, the positive drug group had a total of 50 cases, 14 cases were ineffective, 26 cases were effective, 8 cases were markedly effective, and 2 cases were cured, with a total effective rate of 72%, the example 1 group was significantly better than the positive drug group, and the present application had a good effect on improving the symptoms of prediabetes.

[0075] In summary, the results of the present study show that the use of the preparation of the present application has the beneficial effects of good curative effect, not easy to relapse, and no toxic side effects, and compared with the prior art, the safety and effectiveness are better than the control drug / conventional idea, showing a better improvement effect / dependency / safety trend.

[0076] The above is only a preferred embodiment of the present application, and all technical solutions formed by equivalent substitution or equivalent transformation without departing from the principles of the present application are within the scope of protection of the present application.

Claims

1. A traditional Chinese medicine compound composition for improving prediabetes symptoms, characterized in that, It is prepared from the following parts by weight of traditional Chinese medicine decoction pieces: The principal ingredient is selected from one or more of the following: 20-30 parts of Polygonatum sibiricum, 15-25 parts of Codonopsis pilosula, 10-20 parts of Dioscorea opposita and / or 15-25 parts of stir-fried Atractylodes macrocephala. The auxiliary ingredients are selected from one or more of the following: Poria cocos 10-20 parts, Ficus hirta 8-12 parts, Coix lacryma-jobi 15-25 parts, Citrus reticulata 10-20 parts and / or Amomum villosum 8-12 parts; The adjuvant herbs are selected from one or more of the following: 20-30 parts of white peony root, 15-25 parts of turmeric, 10-20 parts of immature bitter orange peel, 15-25 parts of Sichuan achyranthes root, 10-20 parts of salvia miltiorrhiza root, 8-12 parts of scrophularia root, and / or 10-20 parts of ophiopogon root. The herb is selected from one or more of the following: 5-10 parts of prepared licorice root and / or 8-12 parts of jujube.

2. The traditional Chinese medicine compound composition for improving prediabetic symptoms as described in claim 1, characterized in that, It is prepared from the following parts by weight of traditional Chinese medicine decoction pieces: The principal ingredient is selected from one or more of the following: 25-30 parts of Polygonatum sibiricum, 20-25 parts of Codonopsis pilosula, 15-20 parts of Dioscorea opposita, and / or 20-25 parts of stir-fried Atractylodes macrocephala. The auxiliary ingredients are selected from one or more of the following: Poria cocos 15-20 parts, Ficus hirta 10-12 parts, Coix lacryma-jobi 20-25 parts, Citrus reticulata 15-20 parts and / or Amomum villosum 10-12 parts; The adjuvant herbs are selected from one or more of the following: white peony root 25-30 parts, turmeric 20-25 parts, immature bitter orange 15-20 parts, achyranthes root 20-25 parts, salvia miltiorrhiza 15-20 parts, scrophularia root 10-12 parts and / or ophiopogon root 15-20 parts; The herb is selected from one or more of the following: 8-10 parts of prepared licorice root and / or 10-12 parts of jujube.

3. The traditional Chinese medicine compound composition for improving prediabetic symptoms as described in claim 1, characterized in that, It is prepared from the following parts by weight of traditional Chinese medicine decoction pieces: The principal herb is selected from one or more of the following: 25 parts of Polygonatum sibiricum, 20 parts of Codonopsis pilosula, 15 parts of Dioscorea opposita and / or 20 parts of stir-fried Atractylodes macrocephala. The ingredients are selected from one or more of the following: 15 parts Poria cocos, 10 parts Ficus hirta, 20 parts Coix lacryma-jobi, 15 parts Citrus reticulata peel and / or 10 parts Amomum villosum. The adjuvant herbs are selected from one or more of the following: white peony root 25 parts, turmeric 20 parts, immature bitter orange peel 15 parts, Sichuan achyranthes root 20 parts, salvia miltiorrhiza 15 parts, scrophularia root 10 parts and / or ophiopogon root 15 parts; The herb is selected from one or more of the following: 8 parts of prepared licorice root and / or 10 parts of jujube.

4. The traditional Chinese medicine compound composition for improving prediabetic symptoms as described in claim 1, characterized in that, It is prepared by extracting the following Chinese medicinal herbs in parts by weight: Polygonatum sibiricum 20-30 parts, Codonopsis pilosula 15-25 parts, Dioscorea opposita 10-20 parts, stir-fried Atractylodes macrocephala 15-25 parts, Poria cocos 10-20 parts, Ficus hirta 8-12 parts, Coix lacryma-jobi 15-25 parts, Citrus reticulata 10-20 parts, Amomum villosum 8-12 parts, Paeonia lactiflora 20-30 parts, Curcuma longa 15-25 parts, Citrus aurantium 10-20 parts, Achyranthes bidentata 15-25 parts, Salvia miltiorrhiza 10-20 parts, Scrophularia ningpoensis 8-12 parts, Ophiopogon japonicus 10-20 parts, prepared Glycyrrhiza uralensis 5-10 parts, and Ziziphus jujuba 8-12 parts.

5. The traditional Chinese medicine compound composition for improving prediabetic symptoms as described in claim 1, characterized in that, It is prepared by extracting the following Chinese medicinal herbs in the indicated weight parts: Polygonatum sibiricum 25 parts, Codonopsis pilosula 20 parts, Dioscorea opposita 15 parts, stir-fried Atractylodes macrocephala 20 parts, Poria cocos 15 parts, Ficus hirta 10 parts, Coix lacryma-jobi 20 parts, Citrus reticulata 15 parts, Amomum villosum 10 parts, Paeonia lactiflora 25 parts, Curcuma longa 20 parts, Citrus aurantium 15 parts, Achyranthes bidentata 20 parts, Salvia miltiorrhiza 15 parts, Scrophularia ningpoensis 10 parts, Ophiopogon japonicus 15 parts, prepared Glycyrrhiza uralensis 8 parts, and Ziziphus jujuba 10 parts.

6. The traditional Chinese medicine compound composition for improving prediabetic symptoms as described in claim 1, characterized in that, The preparation method includes the following steps: (1) Take the above-mentioned Chinese herbal medicine slices, add water and decoct three times, each time adding 5-10 times the weight of the Chinese herbal medicine slices, and decoct for 1-3 hours each time; filter while hot, combine the filtrates, concentrate the filtrate to 1-2g of Chinese herbal medicine slices per 1ml; add ethanol to make the alcohol content 75%, refrigerate for 12 hours, take the supernatant, filter, recover the ethanol from the filtrate and concentrate until there is no alcohol taste, add dextrin to make the relative density of the extract 1.13-1.25 (40℃), spray dry to obtain the extract; (2) Take the extract from step (1) and add excipients to prepare an oral dosage form.

7. The traditional Chinese medicine compound composition for improving prediabetic symptoms as described in claim 6, characterized in that, In step (1) of the preparation method, add 8 times the weight of the Chinese herbal medicine slices of water each time and decoct for 2 hours each time. In step (1), make the relative density of the extract 1.20 at 40℃.

8. The traditional Chinese medicine compound composition for improving prediabetic symptoms as described in claim 6, characterized in that, In the preparation method step (2), the oral dosage form is one of granules, oral liquid, tablets, syrup, or paste.

9. The use of the traditional Chinese medicine compound composition for improving prediabetes symptoms as described in claim 1 in the preparation of a drug for improving prediabetes symptoms.

10. The use of the traditional Chinese medicine compound composition for improving prediabetes symptoms as described in claim 1 in the preparation of a drug for improving prediabetes symptoms, characterized in that, Prediabetes symptoms are a pre-metabolic condition caused by spleen deficiency, liver dysfunction, and disordered Qi transformation in the Triple Burner, with fasting blood glucose levels of 6.1-6.9 mmol / L.

Images