A traditional Chinese medicine composition for treating diabetes and its preparation method

Abstract

The present application relates to the technical field of traditional Chinese medicine, and specifically discloses a traditional Chinese medicine composition for treating diabetes and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, Citrus grandis peel, soy lecithin, and unsaturated fatty acids; the present application innovatively adds soy lecithin and unsaturated fatty acids to the traditional Chinese medicine compound, mixes and emulsifies the two with volatile oil extracted from the traditional Chinese medicine formula, and then mixes them with a concentrated paste extracted from the traditional Chinese medicine components to prepare the desired traditional Chinese medicine composition; the active ingredients of the obtained traditional Chinese medicine composition have good stability and high absorption and utilization rate, and can significantly lower blood sugar, reduce insulin resistance, increase insulin sensitivity, promote insulin secretion, improve pancreatic islet function, and regulate the immune system, thereby achieving the purpose of treating diabetes and reducing complications.

Description

Technical Field

[0001] The present application relates to the technical field of traditional Chinese medicine, and more specifically, to a traditional Chinese medicine composition for treating diabetes and a preparation method thereof. Background Art

[0002] Diabetes mellitus is a group of disorders of carbohydrate, protein and fat metabolism caused by absolute or relative insulin deficiency and / or impaired insulin utilization, with hyperglycemia as the main hallmark. Diabetes is mainly divided into type 1 diabetes and type 2 diabetes. Diabetes mellitus (DM) is the third largest chronic disease in the world, second only to cancer and cardiovascular and cerebrovascular diseases. According to the latest statistics from the International Diabetes Federation (IDF), there are as many as 140 million diabetes patients in my country, of which more than 90% suffer from type 2 diabetes. Type 2 diabetes mellitus (T2DM) is a complex disorder of glucose and lipid metabolism. Insulin resistance (IR) and β-cell dysfunction are important pathophysiological mechanisms of T2DM. Long-term poor control of diabetes can lead to a variety of serious complications such as myocardial infarction, heart failure, cerebral infarction, renal failure, blindness, etc., which seriously threaten the life and health of patients.

[0003] In the existing technology, the main therapeutic drugs for patients with type 2 diabetes include hypoglycemic drugs (such as metformin), insulin secretagogues (such as sulfonylureas), insulin sensitizers (such as thiazolidinediones), α-glucosidase inhibitors, insulin, and the newly emerged GLP-1 receptor agonists and SGLT-2 inhibitors in recent years. These hypoglycemic drugs require patients to take them and monitor their blood sugar on a long-term basis, and sometimes require a combination of multiple drugs. The treatment plan is complex and poses a challenge to patient compliance. In addition, even if blood sugar is controlled, diabetic patients still face the risk of chronic complications such as cardiovascular disease, kidney disease, and neuropathy. Some hypoglycemic drugs may even have side effects.

[0004] Traditional Chinese Medicine (TCM) has a long history of use in the treatment of diabetes, with references to diabetes found in ancient texts such as the Yellow Emperor's Classic of Internal Medicine and Treatise on Febrile and Miscellaneous Diseases. The theoretical basis for TCM treatment of diabetes primarily includes concepts such as "Qi stagnation and blood stasis" and "Yin deficiency and Yang hyperactivity." By regulating the balance of yin and yang in the body, TCM can improve the symptoms and signs of diabetic patients. However, existing TCM is not widely used in the treatment of diabetes, primarily due to issues such as a long treatment process and slow onset of efficacy. Based on the foregoing, the present application provides a TCM composition for the treatment of diabetes and a method for its preparation. Summary of the Invention

[0005] In order to solve the problems that existing traditional Chinese medicine is not widely used in the treatment of diabetes, mainly due to the long treatment process and slow effect, the present application provides a traditional Chinese medicine composition for treating diabetes and a preparation method thereof.

[0006] The present application provides a Chinese medicine composition for treating diabetes and a preparation method thereof, which adopts the following technical solutions:

[0007] In the first aspect, the present application provides a traditional Chinese medicine composition for treating diabetes, which comprises the following raw materials in parts by weight: 18-25 parts of Morinda officinalis, 12-18 parts of Cistanche deserticola, 12-18 parts of Cynomorium songaricum, 12-18 parts of Rehmannia root, 12-18 parts of Cornus officinalis, 12-18 parts of Chinese yam, 7-11 parts of dried tangerine peel, 20-26 parts of Poria peel, 4-8 parts of ginger peel, 7-11 parts of Morus alba bark, 7-11 parts of Citrus grandis peel, 3-5 parts of soy lecithin, and 1-2 parts of unsaturated fatty acids.

[0008] Preferably, the traditional Chinese medicine composition for treating diabetes comprises the following raw materials in parts by weight: 20-22 parts of Morinda officinalis, 14-16 parts of Cistanche deserticola, 14-16 parts of Cynomorium songaricum, 14-16 parts of Rehmannia root, 14-16 parts of Cornus officinalis, 14-16 parts of Chinese yam, 8-10 parts of dried tangerine peel, 22-24 parts of Poria peel, 5-7 parts of ginger peel, 8-10 parts of Morus alba bark, 8-10 parts of Citrus grandis peel, 3.5-4.5 parts of soy lecithin, and 1.2-1.8 parts of unsaturated fatty acids.

[0009] Preferably, the traditional Chinese medicine composition for treating diabetes comprises the following raw materials in parts by weight: 20 parts of Morinda officinalis, 15 parts of Cistanche deserticola, 15 parts of Cynomorium songaricum, 15 parts of Rehmannia root, 15 parts of Cornus officinalis, 15 parts of Chinese yam, 9 parts of dried tangerine peel, 24 parts of Poria peel, 6 parts of ginger peel, 9 parts of Morus alba bark, 9 parts of Citrus grandis peel, 4 parts of soy lecithin, and 1.5 parts of unsaturated fatty acids.

[0010] Preferably, the unsaturated fatty acid is at least one of OMEGA-3 fatty acid, OMEGA-6 fatty acid and oleic acid.

[0011] In a second aspect, the present invention provides a method for preparing the Chinese medicine composition for treating diabetes described in the first aspect, the preparation method comprising the following steps:

[0012] S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, Soy lecithin, and unsaturated fatty acids by weight and set aside;

[0013] S2, mixing and grinding Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel, extracting volatile oil and extract, and concentrating the extract under reduced pressure to obtain a thick paste;

[0014] S3, taking volatile oil, adding soybean lecithin and unsaturated fatty acids and mixing them evenly to form emulsified oil;

[0015] S4. Mix the concentrated ointment and emulsified oil evenly, sterilize and package.

[0016] Preferably, the particle size of the mixed medicinal powder in S2 is 60-80 mesh.

[0017] Preferably, the volatile oil in S2 is obtained by steam distillation for 3-5 hours.

[0018] Preferably, the extract in S2 is obtained by adding ethanol solution to the residue extracted with volatile oil and refluxing for 2-3 hours.

[0019] Preferably, the mass fraction of the ethanol solution in S2 is 50-70%, and the material-liquid ratio of the medicinal residue to the ethanol solution is 1:8-10.

[0020] Preferably, the volume of the concentrated paste in S2 is 0.20-0.25 times the volume of the extract.

[0021] Preferably, the amount of volatile oil in S3 is 9-12 parts by weight.

[0022] Preferably, the mass ratio of the concentrated paste to the emulsified oil in S4 is 20-22:1.

[0023] In summary, this application has the following beneficial effects:

[0024] The formula of this application is scientific and the proportion is rigorous. The selection of raw materials focuses on regulating the overall yin and yang balance of diabetic patients, fundamentally improving the patient's physical fitness and immune function, and thus reducing the occurrence of diabetes and complications; among them, Morinda officinalis is slightly warm, pungent and sweet in nature and flavor, and enters the liver and kidney meridians; it has the effects of nourishing kidney yang, benefiting essence and blood, strengthening bones and tendons, and removing rheumatism; Cistanche deserticola is warm, sweet and salty in nature and flavor, and enters the kidney and large intestine meridians; it has the effects of nourishing kidney yang, benefiting essence and blood, and moistening intestines; Lock Yang is warm and sweet in nature and flavor, and enters the liver , kidney, large intestine meridian; has the effects of nourishing kidney yang, benefiting essence and blood, moistening intestines and dryness; Rehmannia glutinosa is sweet and slightly warm in nature and enters the liver and kidney meridians; has the effects of nourishing yin and moistening dryness, nourishing blood, benefiting essence and filling marrow; Cornus officinalis is sour, sweet and slightly warm in nature and enters the liver and kidney meridians; has the effects of warming and nourishing the kidney and liver, and astringing essence and blood; Chinese yam is sweet and flat in nature and enters the spleen, lung and kidney meridians; has the effects of nourishing qi and nourishing yin, nourishing the spleen and lungs, and stopping leukorrhea; the addition of the above components helps to regulate blood sugar, warm and nourish kidney yang, promote diuresis and reduce swelling, and enhance physical fitness. It can enhance the overall quality of the patient's body, harmonize the balance of yin and yang, improve metabolic function and promote physical recovery; it has an auxiliary therapeutic effect on kidney yin deficiency, endocrine disorders, dryness symptoms caused by diabetes, and can reduce the occurrence of complications; among them, tangerine peel is warm, pungent and bitter in nature, enters the spleen and lung meridians, and has the effects of regulating qi, drying dampness, and resolving phlegm; Poria peel is sweet, light and flat in nature, enters the kidney, lung and spleen meridians; it has the effects of dispersing dampness and promoting diuresis, consolidating the surface and stopping sweating; ginger peel is pungent and cool in nature, enters the lungs , lung meridian; it has the effects of diaphoresis, warming the middle and dispersing cold, promoting diuresis and reducing swelling; Morus alba bark is sweet and cold in nature and enters the lung meridian; it has the effects of purging the lung and relieving asthma, promoting diuresis and reducing swelling; Cibotium bark is pungent and slightly warm in nature and enters the spleen, stomach, large intestine and small intestine meridians; it has the effects of promoting qi and relieving fullness, drying dampness and promoting diuresis, resolving phlegm and relieving cough; the addition of the above components is beneficial to improving the patient's digestive function and water metabolism regulation, improving qi stagnation and water dampness caused by diabetes, helping to clear away heat and dampness, regulate gastrointestinal and lung function, and reduce the burden on the kidneys.

[0025] The present application innovatively adds soybean lecithin and unsaturated fatty acids to the traditional Chinese medicine compound, mixes and emulsifies the two with volatile oil extracted from the traditional Chinese medicine formula, and then mixes them with concentrated paste extracted from the traditional Chinese medicine components to prepare the required traditional Chinese medicine compound; the active ingredients of the obtained traditional Chinese medicine compound have good stability and high absorption and utilization rate, and can significantly lower blood sugar, reduce insulin resistance, increase insulin sensitivity, promote insulin secretion, improve pancreatic islet function, and regulate the immune system, thereby achieving the purpose of treating diabetes and reducing complications. DETAILED DESCRIPTION

[0026] The present application is further described in detail below with reference to the embodiments.

[0027] Examples 1-5 provide traditional Chinese medicine compositions for treating diabetes.

[0028] Example 1

[0029] A traditional Chinese medicine composition for treating diabetes, comprising the following raw materials in parts by weight: 18 parts of Morinda officinalis, 12 parts of Cistanche deserticola, 12 parts of Cynomorium songaricum, 12 parts of Rehmannia root, 12 parts of Cornus officinalis, 12 parts of Chinese yam, 7 parts of dried tangerine peel, 20 parts of Poria peel, 4 parts of ginger peel, 7 parts of Morus alba bark, 7 parts of Citrus grandis peel, 3 parts of soybean lecithin, and 1 part of oleic acid;

[0030] The preparation method thereof comprises the following steps:

[0031] S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, Soy lecithin, and oleic acid by weight and set aside;

[0032] S2, Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel were mixed and ground, and then passed through a 60-mesh sieve to obtain a mixed powder;

[0033] The volatile oil in the mixed powder was extracted by steam distillation for 3 h to obtain the volatile oil and the medicinal residue.

[0034] The medicinal residue was added with 50% ethanol solution at a material-liquid ratio of 1:8 and refluxed for 2 h to obtain an extract, which was then concentrated under reduced pressure to 0.20 times the original volume to obtain a concentrated paste.

[0035] S3, taking 9 parts by weight of volatile oil, adding soybean lecithin and oleic acid and mixing evenly to form an emulsified oil;

[0036] S4. Mix the concentrated paste with emulsified oil in a mass ratio of 20:1, sterilize and package.

[0037] Example 2

[0038] A traditional Chinese medicine composition for treating diabetes, comprising the following raw materials in parts by weight: 20 parts of Morinda officinalis, 14 parts of Cistanche deserticola, 14 parts of Cynomorium songaricum, 14 parts of Rehmannia root, 14 parts of Cornus officinalis, 14 parts of Chinese yam, 8 parts of dried tangerine peel, 22 parts of Poria peel, 5 parts of ginger peel, 8 parts of Morus alba bark, 8 parts of Citrus grandis peel, 3.5 parts of soybean lecithin, and 1.2 parts of omega-3 fatty acids;

[0039] The preparation method thereof comprises the following steps:

[0040] S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, Soy lecithin, and Omega-3 fatty acids by weight and set aside;

[0041] S2, Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel were mixed and ground, and then passed through a 60-mesh sieve to obtain a mixed powder;

[0042] The volatile oil in the mixed powder was extracted by steam distillation for 3.5 h to obtain the volatile oil and the medicinal residue.

[0043] The residue was added with 55% ethanol solution at a material-liquid ratio of 1:8.5 and refluxed for 2.2 h to obtain an extract, which was then concentrated under reduced pressure to 0.22 times the original volume to obtain a concentrated paste.

[0044] S3, taking 10 parts by weight of volatile oil, adding soybean lecithin and OMEGA-3 fatty acid and mixing them evenly to form an emulsified oil;

[0045] S4. Mix the concentrated paste with emulsified oil in a mass ratio of 20.5:1, sterilize and package.

[0046] Example 3

[0047] A traditional Chinese medicine composition for treating diabetes, comprising the following raw materials in parts by weight: 20 parts of Morinda officinalis, 15 parts of Cistanche deserticola, 15 parts of Cynomorium songaricum, 15 parts of Rehmannia root, 15 parts of Cornus officinalis, 15 parts of Chinese yam, 9 parts of dried tangerine peel, 24 parts of Poria peel, 6 parts of ginger peel, 9 parts of Morus alba bark, 9 parts of Citrus grandis peel, 4 parts of soybean lecithin, 1 part of oleic acid, and 0.5 parts of omega-3 fatty acids;

[0048] The preparation method thereof comprises the following steps:

[0049] S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, Soy lecithin, Oleic acid, and Omega-3 fatty acids by weight and set aside;

[0050] S2, the Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel were mixed and ground and passed through a 70-mesh sieve to obtain a mixed powder;

[0051] The volatile oil in the mixed powder was extracted by steam distillation for 4 h to obtain the volatile oil and the medicinal residue.

[0052] The residue was added with 50-70% ethanol solution at a material-liquid ratio of 1:9 and refluxed for 2.5 hours to obtain an extract, which was then concentrated under reduced pressure to 0.23 times the original volume to obtain a concentrated paste.

[0053] S3, taking 11 parts by weight of volatile oil, adding soybean lecithin, oleic acid, and omega-3 fatty acids and mixing them evenly to form an emulsified oil;

[0054] S4. Mix the concentrated paste with emulsified oil in a mass ratio of 21:1, sterilize and package.

[0055] Example 4

[0056] A traditional Chinese medicine composition for treating diabetes, comprising the following raw materials in parts by weight: 22 parts of Morinda officinalis, 16 parts of Cistanche deserticola, 16 parts of Cynomorium songaricum, 16 parts of Rehmannia root, 16 parts of Cornus officinalis, 16 parts of Chinese yam, 10 parts of dried tangerine peel, 24 parts of Poria peel, 7 parts of ginger peel, 10 parts of Morus alba bark, 10 parts of Citrus grandis peel, 4.5 parts of soybean lecithin, and 1.8 parts of oleic acid;

[0057] The preparation method thereof comprises the following steps:

[0058] S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, Soy lecithin, and oleic acid by weight and set aside;

[0059] S2, the Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel were mixed and ground and passed through a 70-mesh sieve to obtain a mixed powder;

[0060] The volatile oil in the mixed powder was extracted by steam distillation for 4.5 h to obtain the volatile oil and the medicinal residue.

[0061] The residue was added with 65% ethanol solution at a material-liquid ratio of 1:9.5 and refluxed for 2.8 h to obtain an extract, which was then concentrated under reduced pressure to 0.24 times the original volume to obtain a concentrated paste.

[0062] S3, taking 11 parts by weight of volatile oil, adding soybean lecithin and oleic acid and mixing them evenly to form an emulsified oil;

[0063] S4. Mix the concentrated paste with emulsified oil in a mass ratio of 21.5:1, sterilize and package.

[0064] Example 5

[0065] A traditional Chinese medicine composition for treating diabetes, comprising the following raw materials in parts by weight: 25 parts of Morinda officinalis, 18 parts of Cistanche deserticola, 18 parts of Cynomorium songaricum, 18 parts of Rehmannia root, 18 parts of Cornus officinalis, 18 parts of Chinese yam, 11 parts of dried tangerine peel, 26 parts of Poria peel, 8 parts of ginger peel, 11 parts of Morus alba bark, 11 parts of Citrus grandis peel, 5 parts of soybean lecithin, and 2 parts of oleic acid;

[0066] The preparation method thereof comprises the following steps:

[0067] S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, Soy lecithin, and oleic acid by weight and set aside;

[0068] S2, Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel were mixed and ground, and then passed through an 80-mesh sieve to obtain a mixed powder;

[0069] The volatile oil in the mixed powder was extracted by steam distillation for 5 h to obtain the volatile oil and the medicinal residue.

[0070] The medicinal residue was added with 70% ethanol solution at a material-liquid ratio of 1:10 and refluxed for 3 h to obtain an extract, which was then concentrated under reduced pressure to 0.25 times the original volume to obtain a concentrated paste.

[0071] S3, taking 12 parts by weight of volatile oil, adding soybean lecithin and oleic acid and mixing them evenly to form an emulsified oil;

[0072] S4. Mix the concentrated ointment and emulsified oil in a mass ratio of 22:1, sterilize and package.

[0073] In order to verify the comprehensive efficacy of the Chinese medicine composition for treating diabetes prepared in Examples 1-5 of the present application, the applicant set up comparative examples 1-3, which are as follows:

[0074] Comparative Example 1

[0075] A traditional Chinese medicine composition for treating diabetes, comprising the following raw materials in parts by weight: 18 parts of Morinda officinalis, 12 parts of Cistanche deserticola, 12 parts of Cynomorium songaricum, 12 parts of Rehmannia root, 12 parts of Cornus officinalis, 12 parts of Chinese yam, 7 parts of dried tangerine peel, 20 parts of Poria peel, 4 parts of ginger peel, 7 parts of Morus alba bark, 7 parts of Citrus grandis peel, 3 parts of soybean lecithin, and 1 part of oleic acid;

[0076] The preparation method thereof comprises the following steps:

[0077] S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, Soy lecithin, and oleic acid by weight and set aside;

[0078] S2, Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel were mixed and ground, and then passed through a 60-mesh sieve to obtain a mixed powder;

[0079] The mixed powder was added with 50% ethanol solution at a material-liquid ratio of 1:8 and refluxed for 2 h to obtain an extract, which was then concentrated under reduced pressure to 0.20 times the original volume to obtain a concentrated paste.

[0080] S3, taking soybean lecithin and oleic acid and mixing them evenly to form an emulsified oil;

[0081] S4. Mix the concentrated paste with emulsified oil in a mass ratio of 20:1, sterilize and package.

[0082] Comparative Example 2

[0083] A traditional Chinese medicine composition for treating diabetes, comprising the following raw materials in parts by weight: 18 parts of Morinda officinalis, 12 parts of Cistanche deserticola, 12 parts of Cynomorium songaricum, 12 parts of Rehmannia root, 12 parts of Cornus officinalis, 12 parts of Chinese yam, 7 parts of dried tangerine peel, 20 parts of Poria peel, 4 parts of ginger peel, 7 parts of Morus alba bark, 7 parts of Citrus grandis peel, 3 parts of soybean lecithin, and 1 part of oleic acid;

[0084] The preparation method thereof comprises the following steps:

[0085] S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, Soy lecithin, and oleic acid by weight and set aside;

[0086] S2, Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel were mixed and ground, and then passed through a 60-mesh sieve to obtain a mixed powder;

[0087] The volatile oil in the mixed powder was extracted by steam distillation for 3 h to obtain the volatile oil and the medicinal residue.

[0088] The medicinal residue was added with 50% ethanol solution at a material-liquid ratio of 1:8 and refluxed for 2 h to obtain an extract, which was then concentrated under reduced pressure to 0.20 times the original volume to obtain a concentrated paste.

[0089] S3. Take 9 parts by weight of volatile oil, add soybean lecithin, oleic acid, and concentrated paste, mix evenly, sterilize and package; wherein, the amount of concentrated paste added is 20 times the total mass of volatile oil, soybean lecithin, and oleic acid.

[0090] Comparative Example 3

[0091] A traditional Chinese medicine composition for treating diabetes, comprising the following raw materials in parts by weight: 18 parts of Morinda officinalis, 12 parts of Cistanche deserticola, 12 parts of Cynomorium songaricum, 12 parts of Rehmannia root, 12 parts of Cornus officinalis, 12 parts of Chinese yam, 7 parts of dried tangerine peel, 20 parts of Poria peel, 4 parts of ginger peel, 7 parts of Morus alba bark, 7 parts of Citrus grandis peel, and 4 parts of soy lecithin;

[0092] The preparation method thereof comprises the following steps:

[0093] S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, and soy lecithin by weight and set aside;

[0094] S2, Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel were mixed and ground, and then passed through a 60-mesh sieve to obtain a mixed powder;

[0095] The volatile oil in the mixed powder was extracted by steam distillation for 3 h to obtain the volatile oil and the medicinal residue.

[0096] The medicinal residue was added with 50% ethanol solution at a material-liquid ratio of 1:8 and refluxed for 2 h to obtain an extract, which was then concentrated under reduced pressure to 0.20 times the original volume to obtain a concentrated paste.

[0097] S3, taking 9 parts by weight of volatile oil and adding soybean lecithin and mixing evenly to form an emulsified oil;

[0098] S4. Mix the concentrated paste with emulsified oil in a mass ratio of 20:1, sterilize and package.

[0099] Experimental example

[0100] In this experiment, the above Examples 1-5 and Comparative Examples 1-3 were used as drug samples, and metformin was used as a control sample, and the research was carried out according to the following experimental method.

[0101] 1. Modeling

[0102] 100 SD male rats (purchased from Liaoning Changsheng Biotechnology Co., Ltd.) weighing 180-220 g were randomly selected. After one week of adaptive feeding, 10 rats were randomly selected as the blank group and fed with ordinary feed (ordinary feed for rats and mice maintenance feed (ordinary grade), purchased from Jilin Jintai Medi Biotechnology Co., Ltd.), and the remaining 90 rats were fed with high-fat feed (high-fat feed consisted of 6% egg yolk powder, 10% lard, 8% sucrose, 1% sodium cholate, 1% cholesterol, and 74% ordinary feed).

[0103] After 6 weeks of feeding, all rats were fasted for 12 hours but not water. Rats in the blank group were injected with normal saline. 90 rats fed a high-fat diet were given a single intraperitoneal injection of 100 mg / kg streptozotocin (STZ) to induce type 2 diabetes in rats. STZ was dissolved in sodium citrate saline buffer (pH = 4.5). After 1 week of induction, the rats were fasted for 12 hours but not water. Blood was collected from the tail vein to measure the fasting blood glucose of the rats. A fasting blood glucose concentration (FBG) value greater than 11.1 mmol / L measured at the same time for 3 consecutive days was considered to be a successful T2DM model.

[0104] 2. Grouping

[0105] 90 rats fed a high-fat diet were randomly divided into 9 groups according to blood sugar levels, namely a model group, Example 1-5 groups, Comparative Example 1-3 groups and a control group (metformin), with 10 rats in each group.

[0106] 3. Administer medication

[0107] The dosage of the drug samples in the control examples 1-5 groups and the comparative examples 1-3 groups was 1.5 g / kg / d, and they were all dissolved in an appropriate amount of physiological saline and then gavage treated; the metformin dosage of the control group was 0.25 g / kg / d and dissolved in the same volume of physiological saline and then gavage treated, and the blank group and the model group were gavage treated with the same volume of physiological saline every day, once a day at the same time, for 8 consecutive weeks, and the rats in each corresponding group were fed normally with basal feed and high-fat feed until the end of the experiment.

[0108] 4. Blood sugar and blood lipid testing

[0109] After the experiment, all rats were fasted for 12 h, and the fasting blood glucose and blood lipid indexes (serum total cholesterol TC, triglycerides TG, high-density lipoprotein cholesterol HDL-C and low-density lipoprotein cholesterol LDL-C) of rats in each group were tested. The test results are shown in Table 1.

[0110] 5. Statistical analysis

[0111] The data were expressed as mean ± standard deviation. Multiple groups were compared using one-way analysis of variance (ANOVA). Post hoc comparisons were performed using LSD. P < 0.05 indicated statistical significance.

[0112] Table 1 Results of four tests for fasting blood glucose and blood lipids

[0113]

[0114]

[0115] Note: Different letters represent P < 0.05.

[0116] The data shown in Table 1 above show that the Chinese herbal compound for treating diabetes prepared in Examples 1-5 of the present application can effectively lower blood sugar and regulate blood lipids in T2DM model rats, with significant and stable therapeutic effects.

[0117] The data shown in Example 1, Comparative Examples 1-3 and the control group show that the formulation and preparation method of Example 1 of the present application significantly improve the blood sugar control effect compared with metformin in Comparative Examples 1-3 and the control group, and have excellent blood lipid regulation effects.

[0118] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make non-creative modifications to the present embodiment as needed, but as long as they are within the scope of the claims of the present application, they are protected by the patent law.

Claims

1. A Chinese medicine composition for treating diabetes, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 18-25 parts of Morinda officinalis, 12-18 parts of Cistanche deserticola, 12-18 parts of Cynomorium songaricum, 12-18 parts of Rehmannia root, 12-18 parts of Cornus officinalis, 12-18 parts of Chinese yam, 7-11 parts of dried tangerine peel, 20-26 parts of Poria peel, 4-8 parts of ginger peel, 7-11 parts of Morus alba bark, 7-11 parts of Citrus grandis peel, 3-5 parts of soybean lecithin, and 1-2 parts of oleic acid; The Chinese medicine composition for treating diabetes is prepared by the following method: S1. Weigh the raw materials Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, Tangerine peel, Poria peel, Ginger peel, Morus alba bark, Citrus grandis peel, Soy lecithin, and oleic acid by weight and set aside; S2, mixing and grinding Morinda officinalis, Cistanche deserticola, Cynomorium songaricum, Rehmannia root, Cornus officinalis, Chinese yam, dried tangerine peel, Poria peel, ginger peel, Morus alba bark, and dried tangerine peel, extracting volatile oil and extract, and concentrating the extract under reduced pressure to obtain a thick paste; S3, taking volatile oil, adding soybean lecithin and oleic acid and mixing them evenly to form an emulsified oil; S4. Mix the concentrated ointment with emulsified oil evenly, sterilize and package.

2. The Chinese medicine composition for treating diabetes according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-22 parts of Morinda officinalis, 14-16 parts of Cistanche deserticola, 14-16 parts of Cynomorium songaricum, 14-16 parts of Rehmannia root, 14-16 parts of Cornus officinalis, 14-16 parts of Chinese yam, 8-10 parts of dried tangerine peel, 22-24 parts of Poria peel, 5-7 parts of ginger peel, 8-10 parts of Morus alba bark, 8-10 parts of Citrus grandis peel, 3.5-4.5 parts of soybean lecithin, and 1.2-1.8 parts of oleic acid.

3. The Chinese medicine composition for treating diabetes according to claim 2, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 parts of Morinda officinalis, 15 parts of Cistanche deserticola, 15 parts of Cynomorium songaricum, 15 parts of Rehmannia root, 15 parts of Cornus officinalis, 15 parts of Chinese yam, 9 parts of dried tangerine peel, 24 parts of Poria peel, 6 parts of ginger peel, 9 parts of Morus alba bark, 9 parts of Citrus grandis peel, 4 parts of soybean lecithin, and 1.5 parts of oleic acid.

4. The Chinese medicine composition for treating diabetes according to claim 1, characterized in that The particle size of the mixed medicinal powder obtained after mixing and pulverizing in S2 is 60-80 mesh.

5. The Chinese medicine composition for treating diabetes according to claim 1, characterized in that The volatile oil in S2 is extracted by steam distillation for 3-5 hours; the extract is obtained by adding ethanol solution to the volatile oil extraction residue and refluxing for 2-3 hours; the volume of the concentrated paste is 0.20-0.25 times the volume of the extract.

6. The Chinese medicine composition for treating diabetes according to claim 5, characterized in that The mass fraction of the ethanol solution in S2 is 50-70%, and the material-liquid ratio of the medicinal residue to the ethanol solution is 1:8-10.

7. The Chinese medicine composition for treating diabetes according to claim 1, characterized in that The amount of volatile oil in S3 is 9-12 parts by weight.

8. The Chinese medicine composition for treating diabetes according to claim 1, characterized in that The mass ratio of the concentrated paste to the emulsified oil in S4 is 20-22:1.

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