A traditional Chinese medicine composition for treating diabetes of qi deficiency and internal heat, a preparation method, application and medicine thereof

Abstract

The application belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating diabetes due to deficiency of vital energy and internal heat, a preparation method, application and medicine of the traditional Chinese medicine composition. The composition comprises the following components in parts by mass: 2-8 parts of Astragalus membranaceus, 1-7 parts of Coptis chinensis, 1-7 parts of Pueraria lobata, 1-6 parts of Anemarrhena asphodeloides, 2-8 parts of Dioscorea opposita, 1-7 parts of Lonicera japonica and 1-6 parts of Cynanchum paniculatum. The application solves the problems of high cost or complex preparation process of the medicine composition for treating diabetes in the prior art, and provides the traditional Chinese medicine composition which can clear heat and benefit vital energy, and can be used for diabetes due to deficiency of vital energy and internal heat and mild, moderate type non-insulin dependent diabetes.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a traditional Chinese medicine composition for treating diabetes mellitus of the Qi deficiency and internal heat type, its preparation method, application and drug. Background Technology

[0002] The main symptoms of diabetes mellitus include excessive thirst, frequent urination, fatigue, weight loss, or sweet-tasting urine. It is caused by congenital deficiency, improper diet, emotional imbalance, and other factors. It is a common disease, but if it is not treated in time, it can lead to yin deficiency affecting yang, deficiency of both yin and yang, and prolonged illness can penetrate the collaterals and cause blood stasis.

[0003] Diabetes mellitus (Xiao Ke) has existed in ancient China, and there are numerous records of it in ancient Chinese medical texts. For example, the *Huangdi Neijing* (Yellow Emperor's Inner Classic) discusses the naming, etiology, pathogenesis, symptoms, treatment principles, and prognosis of Xiao Ke. It states that "this is caused by excessive consumption of rich and fatty foods; such people must frequently eat sweet and fatty foods. Fat causes internal heat, and sweetness causes fullness in the middle, so the qi overflows upwards, turning into diabetes mellitus." Later, the *Jingyue Quanshu* (Complete Works of Jingyue) further explains the behavior of Xiao Ke: "Diabetes mellitus originates from excessive consumption of rich and fatty foods, and from overexertion and excessive drinking and sexual activity. It is mostly seen in the wealthy and noble, and rarely in the poor and lowly." Research shows that traditional Chinese medicine has good effects in improving the symptoms of Xiao Ke, preventing complications, and improving the quality of life of patients.

[0004] The diabetes we commonly refer to in Western medicine has similar main symptoms to diabetes mellitus, including polyuria, polydipsia, polyphagia, and weight loss. However, not all cases of diabetes mellitus are accompanied by polydipsia. Only mild to moderate non-insulin-dependent diabetes mellitus symptoms fall under the category of diabetes mellitus.

[0005] The existing prescriptions for treating diabetes mellitus are mainly used to treat mild to moderate non-insulin-dependent diabetes mellitus. For example, Chinese patent CN 201310454063 discloses a drug for treating diabetes and its preparation method. It is mainly prepared from a specific mass ratio of Rehmannia glutinosa (processed), Rehmannia glutinosa (raw), Cornus officinalis, Paeonia suffruticosa, Poria cocos, Dioscorea opposita, Alisma plantago-aquatica, Eucommia ulmoides, Achyranthes bidentata, Coptis chinensis, Taraxacum mongolicum, Leonurus japonicus, Rosa laevigata, and Euryale ferox, along with 23 other medicinal herbs. The drug prepared using this method has the functions of promoting diuresis, strengthening the spleen and stomach, and tonifying the lungs and kidneys. It has the advantages of rapid effectiveness, short treatment course, and no recurrence after treatment for diabetes. However, this method involves as many as 37 Chinese medicinal herbs, resulting in high costs and a complex preparation process.

[0006] Chinese patent CN 202211277365 discloses a glucose and lipid metabolism regulator, its preparation method, and its application. The method involves weighing 12-18 parts of Astragalus membranaceus, 12-18 parts of Pueraria lobata, 8-12 parts of Coptis chinensis, 12-18 parts of charred Crataegus pinnatifida, 12-18 parts of stir-fried Raphanus sativus, 8-12 parts of Polygonatum sibiricum, 8-12 parts of Lycium chinense root bark, 8-12 parts of Eucommia ulmoides, and 12-18 parts of stir-fried Anemarrhena asphodeloides. These ingredients are decocted 2-3 times with water, filtered, and the filtrates are combined, concentrated, dried, pulverized, and sieved to obtain the glucose and lipid metabolism regulator. This regulator is formulated based on the principles and methods of treating diabetes in traditional Chinese medicine. It can regulate glucose and lipid metabolism at multiple targets, and has the effects of regulating glucose and lipid metabolism, controlling systemic chronic inflammation, and improving intestinal flora imbalance, significantly improving glucose and lipid metabolism disorders. However, the prescription in this technical solution contains as many as nine medicinal materials.

[0007] Chinese patent CN 200410018739 discloses a drug for treating diabetes and its preparation method. It uses Coptis chinensis, Astragalus membranaceus and Lonicera japonica as raw materials. According to the different characteristics of each Chinese herb, they are pretreated by pulverizing into fine powder, soaking in water, and extracting with ethanol, and then mixed in proportion to make tablets and other dosage forms. Although this technical solution reduces the use of medicinal materials, its preparation process is relatively complex (Coptis chinensis is pulverized into fine powder; Astragalus membranaceus is extracted three times by reflux with 50% ethanol (4 hours, 2 hours, 2 hours), the extracts are combined, allowed to stand, the supernatant is collected, and the extract is concentrated under reduced pressure to a thick paste with a relative density of 1.22-1.28 (measured at 50℃); one-sixth of Lonicera japonica is pulverized into fine powder, and the remaining Lonicera japonica is soaked in water at 80℃ twice (1 hour, 1 hour), the soaking liquid is filtered, the extracts are combined and allowed to stand, the supernatant is collected, and the extract is concentrated under reduced pressure to a thick paste with a relative density of 1.22-1.28 (measured at 50℃), the thick pastes are combined, Coptis chinensis and Lonicera japonica fine powder are added, mixed well, vacuum dried, the dried paste is pulverized into fine powder, mixed well, 20-30 parts of starch are added, granulated, compressed into tablets, and coated). Summary of the Invention

[0008] This invention addresses the problems of high cost or complex preparation process in existing pharmaceutical compositions for treating diabetes mellitus. It provides a traditional Chinese medicine composition for treating diabetes mellitus with qi deficiency and internal heat, along with its preparation method, application, and medicine. The traditional Chinese medicine composition clears heat and replenishes qi, and can be used for diabetes mellitus with qi deficiency and internal heat syndrome, as well as mild to moderate non-insulin-dependent diabetes mellitus.

[0009] The first aspect of the present invention provides a pharmaceutical composition for treating diabetes mellitus of the Qi deficiency and internal heat type, comprising the following components by weight: 2-8 parts of Astragalus membranaceus, 1-7 parts of Coptis chinensis, 1-7 parts of Pueraria lobata, 1-6 parts of Anemarrhena asphodeloides, 2-8 parts of Dioscorea opposita, 1-7 parts of Lonicera japonica, and 1-6 parts of Lycium chinense root bark.

[0010] Preferably, the pharmaceutical composition comprises, by weight, the following components: 3-7 parts Astragalus membranaceus, 2-6 parts Coptis chinensis, 2-6 parts Pueraria lobata, 2-5 parts Anemarrhena asphodeloides, 3-7 parts Dioscorea opposita, 2-6 parts Lonicera japonica, and 2-5 parts Lycium chinense root bark.

[0011] Preferably, the mass ratio of Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark is 4-6:3-5:3-5:2-4:4-6:3-5:2-4.

[0012] Preferably, the mass ratio of Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark is 5:4:4:3:5:4:3.

[0013] A second aspect of the present invention provides a method for preparing a pharmaceutical composition for treating diabetes mellitus of the Qi deficiency and internal heat type, comprising the following steps:

[0014] S1. According to the mass fractions, add water to Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica and Lycium chinense root bark to decoct and obtain the total decoction.

[0015] S2. The total decoction is concentrated under reduced pressure to a clear extract with a relative density of 1.04-1.08 (60℃), and then dried to obtain the final product.

[0016] Preferably, S1 specifically involves: mixing Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark with water according to mass parts for a first decoction, filtering to obtain a first decoction and dregs; mixing the dregs with water for a second decoction, filtering to obtain a second decoction; and combining the first and second decoctions to obtain a total decoction.

[0017] Preferably, the solid-liquid ratio of the first decoction is 1:8-15.

[0018] Preferably, the solid-liquid ratio of the first decoction is 1:9-14.

[0019] Preferably, the solid-liquid ratio of the first decoction is 1:10-12, and more preferably 1:11.

[0020] Preferably, the first decoction time is 0.5-2 hours, and more preferably 1.0 hour.

[0021] Preferably, the solid-liquid ratio of the second decoction is 1:6-12.

[0022] Preferably, the solid-liquid ratio of the second decoction is 1:7-11.

[0023] Preferably, the solid-liquid ratio of the second decoction is 1:8-10, and more preferably 1:9.

[0024] Preferably, the second decoction time is 0.5-2 hours, and more preferably 1.0 hour.

[0025] A third aspect of the present invention provides the use of a pharmaceutical composition in the preparation of a medicament for treating diabetes mellitus of the Qi deficiency and internal heat type.

[0026] A fourth aspect of the present invention provides a medicament for treating diabetes mellitus of the Qi deficiency and internal heat type, comprising the above-mentioned pharmaceutical composition and pharmaceutically acceptable excipients.

[0027] Preferably, the excipients are selected from at least one of starch, dextrin, sucrose, microcrystalline cellulose, lactose, crospovidone, crospovidone sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, magnesium stearate, and calcium stearate.

[0028] Preferably, the dosage form of the drug is granules, tablets, capsules, ointments, injections, or oral liquids.

[0029] Preferably, the dosage form of the drug is granules.

[0030] The formulation of this invention is as follows: Astragalus and Coptis are the principal herbs, used to tonify the middle energizer and replenish qi, promote the upward movement of clear yang and transport body fluids, clear heat and purge fire, dry dampness and clear heat, addressing both the root cause and the symptoms. Kudzu root assists Astragalus in promoting the upward movement of clear yang in the spleen and stomach, distributing body fluids and quenching thirst; Anemarrhena assists Coptis in clearing heat and purging fire, nourishing yin and moistening dryness; these two herbs assist the principal herbs as assistant herbs. Dioscorea tonifies the spleen and kidneys, and preserves essence; Lonicera japonica clears heat and detoxifies; Lycium chinense root bark clears deficiency heat, generates body fluids and quenches thirst; these three herbs serve as adjuvant herbs. All the herbs work together to clear heat and replenish qi, used for diabetes mellitus with qi deficiency and internal heat syndrome.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] (1) This invention uses a specific ratio of Coptis chinensis, Astragalus membranaceus, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica and Lycium chinense root bark. The components are reasonably matched. In particular, the use of Pueraria lobata and Anemarrhena asphodeloides is beneficial to the efficacy of Astragalus membranaceus and Coptis chinensis, which can effectively reduce insulin resistance and have good hypoglycemic and hypolipidemic effects. It also reduces the types of medicinal materials and lowers the cost.

[0033] (2) The traditional Chinese medicine composition obtained by the present invention through a specific preparation method can effectively exert its efficacy while avoiding the separate extraction of individual medicinal materials. The preparation method is simpler and more convenient, and improves production efficiency. Detailed Implementation

[0034] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention are obtained through conventional commercial channels. The efficacy of the components and drugs described in the present invention is not significantly affected by products from different manufacturers.

[0035] Example 1

[0036] A pharmaceutical composition for treating diabetes mellitus of the Qi deficiency and internal heat type comprises, by weight, the following components: 4 parts Astragalus membranaceus, 5 parts Coptis chinensis, 5 parts Pueraria lobata, 2 parts Anemarrhena asphodeloides, 6 parts Dioscorea opposita, 3 parts Lonicera japonica, and 2 parts Lycium chinense root bark.

[0037] The method for preparing the pharmaceutical composition includes the following steps:

[0038] S1. According to the mass fractions, mix Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark with water for the first decoction, filter, and obtain the first decoction liquid and dregs; mix the dregs with water for the second decoction, filter, and obtain the second decoction liquid; combine the first decoction liquid and the second decoction liquid to obtain the total decoction liquid.

[0039] S2. Concentrate the total decoction under reduced pressure to a clear extract with a relative density of 1.04 (60℃), dry it, add dextrin, mix well, and prepare granules.

[0040] The solid-liquid ratio of the first decoction was 1:11.

[0041] The first decoction time is 1.0 h.

[0042] The solid-liquid ratio for the second decoction is 1:9.

[0043] The second decoction time is 1.0 h.

[0044] The amount of dextrin added is 10% of the total mass of the granules.

[0045] Example 2

[0046] A pharmaceutical composition for treating diabetes mellitus of the Qi deficiency and internal heat type comprises, by weight, the following components: 5 parts Astragalus membranaceus, 4 parts Coptis chinensis, 4 parts Pueraria lobata, 3 parts Anemarrhena asphodeloides, 5 parts Dioscorea opposita, 4 parts Lonicera japonica, and 3 parts Lycium chinense root bark.

[0047] The method for preparing the pharmaceutical composition includes the following steps:

[0048] S1. According to the mass fractions, mix Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark with water for the first decoction, filter, and obtain the first decoction liquid and dregs; mix the dregs with water for the second decoction, filter, and obtain the second decoction liquid; combine the first decoction liquid and the second decoction liquid to obtain the total decoction liquid.

[0049] S2. Concentrate the total decoction under reduced pressure to a clear extract with a relative density of 1.05 (60℃), dry it, add dextrin, mix well, and prepare granules.

[0050] The solid-liquid ratio of the first decoction was 1:11.

[0051] The first decoction time is 1.0 h.

[0052] The solid-liquid ratio for the second decoction is 1:9.

[0053] The second decoction time is 1.0 h.

[0054] The amount of dextrin added is 8% of the total mass of the granules.

[0055] Example 3

[0056] A pharmaceutical composition for treating diabetes mellitus of the Qi deficiency and internal heat type comprises, by weight, the following components: 6 parts Astragalus membranaceus, 3 parts Coptis chinensis, 3 parts Pueraria lobata, 4 parts Anemarrhena asphodeloides, 4 parts Dioscorea opposita, 5 parts Lonicera japonica, and 4 parts Lycium chinense root bark.

[0057] The method for preparing the pharmaceutical composition includes the following steps:

[0058] S1. According to the mass fractions, mix Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark with water for the first decoction, filter, and obtain the first decoction liquid and dregs; mix the dregs with water for the second decoction, filter, and obtain the second decoction liquid; combine the first decoction liquid and the second decoction liquid to obtain the total decoction liquid.

[0059] S2. Concentrate the total decoction under reduced pressure to a clear extract with a relative density of 1.08 (60℃), dry it, add dextrin, mix well, and prepare granules.

[0060] The solid-liquid ratio of the first decoction was 1:11.

[0061] The first decoction time is 1.0 h.

[0062] The solid-liquid ratio for the second decoction is 1:9.

[0063] The second decoction time is 1.0 h.

[0064] The amount of dextrin added is 5% of the total mass of the granules.

[0065] Comparative Example 1

[0066] Unlike Example 2, the pharmaceutical composition for treating diabetes mellitus of Qi deficiency and internal heat type includes the following components by mass: 4 parts Coptis chinensis, 5 parts ginseng, 4 parts Scutellaria baicalensis, 3 parts Anemarrhena asphodeloides, 5 parts Dioscorea opposita, 4 parts Lonicera japonica and 3 parts Lycium chinense root bark.

[0067] Comparative Example 2

[0068] Unlike Example 2, the pharmaceutical composition for treating diabetes mellitus of Qi deficiency and internal heat type includes the following components by weight: 5 parts Astragalus membranaceus, 4 parts Coptis chinensis, 4 parts Pueraria lobata, 3 parts Gypsum fibrosum, 5 parts Rehmannia glutinosa, 4 parts Lonicera japonica, and 3 parts Lycium chinense root bark.

[0069] Comparative Example 3

[0070] Unlike Example 2, the pharmaceutical composition for treating diabetes mellitus of Qi deficiency and internal heat type includes the following components by weight: 5 parts Astragalus membranaceus, 10 parts Coptis chinensis, 1 part Pueraria lobata, 0.5 parts Anemarrhena asphodeloides, 5 parts Dioscorea opposita, 10 parts Lonicera japonica and 0.5 parts Lycium chinense root bark.

[0071] Comparative Example 4

[0072] Unlike Example 2, the pharmaceutical composition for treating diabetes mellitus of Qi deficiency and internal heat type includes the following components by weight: 5 parts Astragalus membranaceus, 4 parts Coptis chinensis, 4 parts Pueraria lobata, 3 parts Anemarrhena asphodeloides, 5 parts Dioscorea opposita, 4 parts Lonicera japonica, 3 parts Lycium chinense root bark, 3 parts Paeonia suffruticosa root bark, 3 parts Cornus officinalis, 4 parts Ophiopogon japonicus, and 3 parts Alisma plantago-aquatica.

[0073] Comparative Example 5

[0074] Unlike Example 2, the pharmaceutical composition for treating diabetes mellitus of the Qi deficiency and internal heat type replaces Coptis chinensis with Poria cocos.

[0075] Comparative Example 6

[0076] Unlike Example 2, the pharmaceutical composition for treating diabetes mellitus of the Qi deficiency and internal heat type replaces Anemarrhena asphodeloides with Euonymus alatus.

[0077] Example of effectiveness: Pharmacodynamic test and result analysis

[0078] Establishment of the animal model: SPF-grade male SD rats, weighing 160-200g, were fed a high-sugar, high-fat diet for 2 weeks. After fasting for 12 hours, streptozotocin (STZ, prepared with 0.1mol / L, pH 4.4 citrate-sodium citrate buffer and injected within 30 minutes) was injected intraperitoneally at a dose of 35mg / kg. Three days after the injection, a blood glucose level greater than 16.7mmol / L in the tail vein was considered a successful establishment of the hyperglycemia model.

[0079] Experimental Methods: One hundred rats successfully modeled as described above were randomly divided into a model control group, Example 1-3 groups, and Comparative Example 1-6 groups, with 10 rats in each group. Ten normal rats fed a standard diet were also selected as the normal control group. Each treatment group was administered the drug composition of Example 1-3 and Comparative Example 1-6 by gavage at a dose of 8 g crude drug / kg and a volume of 20 mL / kg. The model control group and the blank control group were administered an equal volume of physiological saline by gavage. Administration was once daily for 30 consecutive days. After the last administration, the rats were fasted for 12 hours. After anesthesia, 1 mL of abdominal venous blood was collected, centrifuged at 2000 r / min for 20 min, and total cholesterol (TC) and triglycerides (TG) were measured. Fasting blood glucose was measured from tail vein blood, and fasting insulin was measured from abdominal aortic blood. The insulin resistance index (IR) was calculated. The results are shown in Tables 1 and 2.

[0080] Insulin resistance index (IR) = fasting blood glucose × fasting insulin / 22.5

[0081] Table 1 Effects on blood glucose

[0082]

[0083]

[0084] Note: Compared with the normal control group, * P < 0.05 ** P < 0.01; compared with the model control group, # P < 0.05 ## P < 0.01; compared with Example 2 group, △ P < 0.05.

[0085] As can be seen from Table 1, the pharmaceutical compositions of Examples 1-3 of the present invention can significantly reduce fasting blood glucose and insulin resistance index in rats, indicating that the pharmaceutical compositions of the present invention can alleviate insulin resistance and have a good hypoglycemic effect.

[0086] Table 2 Effects on blood lipids

[0087]

[0088]

[0089] Note: Compared with the normal control group, * P < 0.05; compared with the model control group, # P < 0.05; compared with Example 2 group, △ P < 0.05.

[0090] As can be seen from Table 2, the pharmaceutical compositions of Examples 1-3 of the present invention can significantly reduce total cholesterol and triglycerides in rats, indicating that the pharmaceutical compositions of the present invention have a good lipid-lowering effect.

[0091] 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 pharmaceutical composition for treating diabetes mellitus of the Qi deficiency and internal heat type, characterized in that, It is made from the following raw materials: Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark; the mass ratio of Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark is 4-6:3-5:3-5:2-4:4-6:3-5:2-4.

2. The pharmaceutical composition according to claim 1, characterized in that, The mass ratio of Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark is 5:4:4:3:5:4:

3.

3. A method for preparing a pharmaceutical composition for treating diabetes mellitus of qi deficiency and internal heat type according to any one of claims 1-2, characterized in that, Includes the following steps: S1. According to the mass fractions, add water to Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica and Lycium chinense root bark to decoct and obtain the total decoction. S2. The total decoction is concentrated under reduced pressure to a clear extract with a relative density of 1.04-1.08, and then dried to obtain the final product.

4. The preparation method according to claim 3, characterized in that, S1 is specifically as follows: According to the mass fraction, Astragalus membranaceus, Coptis chinensis, Pueraria lobata, Anemarrhena asphodeloides, Dioscorea opposita, Lonicera japonica, and Lycium chinense root bark are mixed with water and decocted for the first time, filtered, to obtain the first decoction and dregs; the dregs are mixed with water and decocted for the second time, filtered, to obtain the second decoction; the first decoction and the second decoction are combined to obtain the total decoction.

5. The use of a pharmaceutical composition according to any one of claims 1-2 in the preparation of a medicament for treating diabetes mellitus of the Qi deficiency and internal heat type.

6. A medicine for treating diabetes mellitus of the Qi deficiency and internal heat type, characterized in that, It is made from the pharmaceutical composition according to any one of claims 1-2 and pharmaceutically acceptable excipients.

7. The drug according to claim 6, characterized in that, The excipients are selected from at least one of starch, dextrin, sucrose, microcrystalline cellulose, lactose, crospovidone, crospovidone sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, magnesium stearate, and calcium stearate.

8. The drug according to claim 6 or 7, characterized in that, The dosage form of the drug is granules, tablets, capsules, ointments, injections, or oral liquids.

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