CN107648330B

CN107648330B - Blood sugar reducing composition based on nigella sativa and mongolian medicine for reducing blood sugar

Info

Publication number: CN107648330B
Application number: CN201711071958.XA
Authority: CN
Inventors: 胡日查; 鲍明明
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-11-03
Filing date: 2017-11-03
Publication date: 2021-03-23
Anticipated expiration: 2037-11-03
Also published as: CN107648330A

Abstract

The invention relates to a nigella sativa-based blood sugar reducing composition, which comprises seeds of nigella plant, elecampane, Chinese olive peel and oregano. The invention also provides a hypoglycemic mongolian medicine taking the composition as an active ingredient. The composition and the Mongolian medicine provided by the invention can be used for preparing medicines for preventing and treating hyperglycemia or diabetes. The product provided by the invention has very obvious hypoglycemic effect, has good treatment effect on hyperglycemia and diabetes, and has no toxic or side effect; the raw materials adopted by the invention are plants cultivated in large area in China, the cost is low, the market development value is high, and the method has great significance for a huge number of hyperglycemia patients in China.

Description

Blood sugar reducing composition based on nigella sativa and mongolian medicine for reducing blood sugar

Technical Field

The invention relates to a pharmaceutical composition, and in particular relates to a blood sugar reducing composition based on nigella sativa.

Background

Diabetes seriously threatens the health of human beings. According to the world health organization's estimate, 1500 million people died of diabetes worldwide in 2012, which is the eighth cause of death. Another 2200 million people have an increased probability of cardiovascular disease and other diseases such as renal failure due to hyperglycemia, and their death factors are not listed in the diabetic category. For example, the international diabetes association estimates that diabetes causes 4900 million deaths, which are caused directly or indirectly by diabetes. In 2016, 42200 million people worldwide suffer from diabetes, of which type II diabetes accounts for 90%. The current approach to treat diabetes is to lower blood glucose concentrations. The drugs are oral, such as metformin, which is the first choice for the treatment of type II diabetes; the injection comprises GLP-1 receptor activator; type I diabetes can only be treated with insulin or its analogs.

Nigella sativa L.is the main component of various traditional Mongolian medicine formulas, and the content of nigella sativa L.in various Mongolian medicine formulas is 2.73 percent (treasure pill) at the lowest and 20 percent at the highest (5-flavor nigella sativa L.powder). Nigella sativa is an annual plant belonging to the genus Nigella (Nigella) of the family Ranunculaceae (Ranunculaceae). The genus has 18 species, and the common Nigella plants, which are rich in bioactive components and thus have medicinal value, are mainly three species of Nigella sativa (Nigella sativa), Nigella glandulifera Freyn & tint) and Nigella sativa (Nigella damascona). Wild and cultivated dark glandular hair seeds exist in Xinjiang, Tibet and the like in China. The black grass is cultivated in large quantities in countries such as India and is widely used in cooking and civil medicine. The chemical component analysis result of the dark glandular hair seed shows that the active molecules contained in the dark glandular hair seed are very similar to the dark glandular hair seed, and also contain polyunsaturated fatty acid, thymoquinone and other bioactive substances. The black grass seeds used by Mongolian medicine are also called Harri-Sara "," Sailana Hubu-Chaoge ", or" elegant and basil ", sweet and bitter in taste, warm, light, sharp and dry in nature; the effects of the toothpaste are antipyretic, digestion-aiding and tooth-protecting; the method is mainly used for: (1) for stomach cold, it can be added with ferula-8 flavor; (2) liver hypofunction, dyspepsia, liver pain, it can be used in 8 Ha La Bao Er san; (3) toothache and tooth nutritional deficiency, 5-ingredient nigella sativa seed powder can be added. The medicinal method of Mongolian medicine black grass seed is similar to folk application in middle east region. For example, 5 kinds of nigella sativa seed powder has the effects of fixing teeth and killing parasites, while pure nigella sativa seed powder for Egyptian people can inhibit toothache, oral ulcer and the like. For example, Egyptian nationality generally believes that nigella sativa can stabilize and enhance the immunity of human bodies, and Mongolian medicine precious pills containing the nigella sativa have good immunity enhancing effects. Modern medical research finds that the black grass seeds and the extracts thereof have the effects of resisting respiratory diseases, allergic diseases, skin diseases, hypertension, rheumatoid arthritis, cancers and the like.

Although several nigella sativa species do not differ greatly in morphology, their microstructures and chemical compositions differ greatly. For example, there is a great difference between Nigella sativa (Nigella sativa) and Nigella damascona (Nigella damascona) in the content of volatile components, unsaturated fatty acid components and other important biologically active substances. The most biologically active Thymoquinone (Thymoquinone) in black grass seed is not present in black grass seed. The glandular hair black grass seeds contain the small molecular active ingredient. The chemical composition and biological activity of black grass (Nigella sativa) is widely studied in western medicine. The omega-3, omega-6, omega-9 series unsaturated acid in the black grass seeds has extremely high content, and also contains a plurality of volatile components and effective components such as thymoquinone. The chemical substances endow the nigella sativa seeds with oxidation resistance, cancer resistance and inflammation resistance, so that the diseases such as allergic rhinitis, asthma, bronchitis, hypertension and the like can be effectively prevented and relieved. Studies have shown that Thymoquinone (Thymoquinone) contained in black grass seeds has a variety of biological activities. The chemical components of the glandular hair black grass seed (Nigella glandulifera Fryn & Sint) are researched and found to contain various unsaturated fatty acids, thymoquinone, nigellidine, nigellanin and nigellamine. Extracting volatile oil by steam distillation, and analyzing to find that the content of thymoquinone in the black grass seed is 3.73%, the content of Nigella sativa seed is 3.80%, and the content of Nigella sativa seed (Nigella damascona) is only 0.08%; the total content of thymoquinone in the dark glandular hair seed is 1.58%, and the content of black medinilla seed is 0.95-2.6%. Of the total 50 target chemical substances to be detected, the chemical compositions of two plant seeds are remarkably different: m-Cymene (m-Cymene), the relative content of the former is 61.4%, and the relative content of the latter is 33.7%; thymol, not detected in the former, was 26.78% in the latter. The remaining ingredients were not significantly different. It can be seen that the bioactive component of the Mongolian ingredient "Harri-Saila", i.e., the glandular hair nigella sativa seed, is similar to that of the black seed of the Jia-nigella sativa, and thus the two plants have the same potency and can be mutually supplemented.

Although the nigella sativa seeds have the biological activity, the drug effect of a single plant component is lack of reasonable matching of properties and tastes such as heat, cold and the like, so that an ideal treatment effect is difficult to achieve, and the drug effect has obvious limitation.

Disclosure of Invention

The invention aims to provide a nigella sativa-based blood sugar reducing composition which has an excellent blood sugar reducing effect, no obvious toxic or side effect, a simple formula and easily available raw materials.

Specifically, the present invention provides a composition comprising: seeds of nigella, elecampane, elaeagnus angustifolia and oregano.

Wherein the nigella plant comprises one or more of nigella sativa, and nigella glandulifera; in practical application, the invention preferably adopts the black grass of family, and the black grass of glandular hair. The origin of the nigella plant related to the invention is far away from Mongolian plateau, but in the traditional Mongolian medicine, at least 10 formulas contain nigella sativa seeds, and most of the formulas take the nigella sativa seeds as main components. The intelligence of ancient and western medicine in Mongolian medicine is fully reflected, and the essences of different countries and national medicine and pharmacology are absorbed and adopted; more importantly, the Mongolian medicine gives full play to the advantages of the prescription, and various important and commonly used Mongolian medicinal materials are matched with the nigella sativa seeds for use according to the cold-heat theory of Mongolian medicine, so that the biological activity and the treatment effect of the nigella sativa seeds are developed to the maximum extent. Mongolian medicine theory considers that the nigella sativa L. expect; according to the 'qi-cila-barda dryness' theory and the 'cold-heat' theory, the Mongolian medicinal material with high performance is matched with the nigella sativa seeds for use, so that the combined effect of the medicaments can be fully exerted, the curative effect is enhanced, and the potential toxic and side effects of the medicaments can be effectively reduced. According to folk usage of the black grass seeds in the origin place and the latest result of modern pharmaceutical research, and by combining the theory of Mongolian medicine, the composition provided by the invention takes the seeds of the black grass as the main raw material and takes the pure natural Mongolian medicinal material as the auxiliary material, and can realize good blood sugar reducing effect.

The elecampane is a herbal medicine recorded in Chinese pharmacopoeia, and the medicinal source of the elecampane is dried roots of elecampane (Inula helenium L.) or Inula racemosa hook. Collected in autumn, removed silt and dried in the sun. Has the effects of strengthening spleen and stomach, regulating qi and relieving depression, relieving pain and preventing miscarriage, and can be used for treating chest and hypochondrium, abdominal pain, emesis, dysentery, chest and hypochondrium contusion, pain in chest and abdomen, and threatened abortion.

The invention relates to a crabapple peel, which is the peel of the fruit of crabapple (Malus asiatica Nakai) belonging to the genus Malus of the family Rosaceae. The fructus amomi is a plant peculiar to China, is distributed in areas such as Heilongjiang, Jilin, Liaoning, Yunnan, Tibet, inner Mongolia and the like, has the advantages of being similar to apple in raw taste, sour, sweet and delicious, and has the effects of promoting the production of body fluid and quenching thirst.

The oregano (with the scientific name: Origanum vulgare L.) is perennial shrub or herb of the Origanum of the Labiatae family. The whole herb can be used as a medicine for preventing influenza, treating symptoms such as heatstroke, cold, headache, body weight, abdominal pain, emesis, chest and diaphragm fullness, qi stagnation, food stagnation, infantile dyspepsia, abdominal distention, diarrhea, menorrhagia, metrorrhagia, leukorrhagia, skin pruritus and edema, and has the effect of dispelling cold and relieving exterior syndrome, especially in comparison with peppermint.

In the invention, the usage amount of the seeds of the nigella plant in the composition is more than 25% of the total mass of the composition.

In order to fully exert the synergistic effect among the components in the composition, realize excellent blood sugar reduction effect and reduce toxic and side effects, the invention optimizes the relative dosage of the components.

Specifically, the composition preferably comprises the following components in parts by weight: 15-25 parts of nigella plant seeds, 20-28 parts of elecampane inula roots, 20-28 parts of sand pericarp and 20-28 parts of oregano.

The invention further preferably selects the composition comprising the following components in parts by weight: 24-25 parts of nigella plant seeds, 24-26 parts of elecampane, 24-26 parts of sand pericarp and 24-26 parts of oregano.

As a best scheme of the invention, the composition comprises the following components in parts by weight: 25 parts of nigella plant seeds, 25 parts of elecampane, 25 parts of sand pericarp and 25 parts of oregano.

When the composition provided by the invention is prepared, the raw materials are respectively ground into powder and uniformly mixed to obtain the composition.

The invention also provides application of the composition in preparing a medicament for preventing and treating hyperglycemia or diabetes.

The invention further protects a Mongolian medicine for preventing and treating hyperglycemia or diabetes, which takes the hypoglycemic composition provided by the invention as an active ingredient. In addition to the active ingredient, pharmaceutically acceptable excipients may be added, and the present invention is not particularly limited.

In a preferred embodiment of the present invention, the Mongolian medicine is an oral preparation, wherein the active ingredient is orally administered into the body to exert its effect.

In order to improve the bioavailability of the oral preparation, the specific formula of the oral preparation is optimized. Specifically, besides the active ingredients, the preparation also comprises sodium carboxymethyl starch accounting for 5-10% of the mass of the active ingredients. According to the invention, a large number of practices show that the active ingredients in the Mongolian medicine can be fully absorbed by gastrointestinal tracts by oral administration by adopting the specific formula, so that the blood sugar reducing effect of the Mongolian medicine can be fully exerted.

In practical application, the safe dose of the effective components in the Mongolian medicine can refer to 1000mg/kg body weight.

Compared with the prior art, the product provided by the invention has a very obvious effect of reducing blood sugar, is superior to the existing medicine metformin, has a good treatment effect on hyperglycemia and diabetes, and has no toxic or side effect; the raw materials adopted by the invention are plants cultivated in large area in China, the cost is low, the market development value is high, and the method has great significance for a huge number of hyperglycemia patients in China.

Drawings

FIG. 1 is a graph showing the effect of nigella sativa formula on blood glucose of STZ diabetic rats in experimental examples;

FIG. 2 is a graph showing the effect of body weight on white STZ diabetic rats in experimental examples;

FIG. 3 is a graph showing the effect of body weight on STZ diabetic rats in the model group in the experimental example;

FIG. 4 is a graph showing the effect of body weight on STZ diabetic rats in the positive group in the experimental examples;

FIG. 5 is a graph showing the effect of weight on STZ diabetic rats in the low dose administration group in the experimental examples;

FIG. 6 is a graph showing the effect of weight on STZ diabetic rats in the high dose group in the experimental examples.

Detailed Description

The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.

In the following examples, the black grass seeds refer to the seeds of black grass.

Example 1

The embodiment provides a blood sugar reducing composition, which is prepared by mixing 25g of nigella sativa seed powder, 25g of elecampane inula root powder, 25g of Chinese pear-leaved crab apple peel powder and 25g of oregano powder.

Example 2

The embodiment provides a blood sugar reducing composition, which is prepared by mixing 15g of nigella sativa seed powder, 20g of elecampane inula root powder, 20g of Chinese olive peel powder and 20g of oregano powder.

Example 3

The embodiment provides a blood sugar reducing composition, which is prepared by mixing 25g of nigella sativa seed powder, 28g of elecampane inula root powder, 28g of Chinese pear-leaved crab apple peel powder and 28g of oregano powder.

Example 4

The embodiment provides a blood sugar reducing composition, which is prepared by mixing 25g of nigella sativa seed powder, 10g of elecampane inula root powder, 10g of Chinese olive peel powder and 10g of oregano powder.

Example 5

The embodiment provides a blood sugar reducing composition, which is prepared by mixing 25g of nigella sativa seed powder, 50g of elecampane inula root powder, 50g of Chinese pear-leaved crab apple peel powder and 50g of oregano powder.

Comparative example 1

Compared with example 1, the difference is only that: licorice was used in place of the elecampane root.

Comparative example 2

Compared with example 1, the difference is only that: the sand pericarp is replaced by humifuse euphorbia herb.

Comparative example 3

Compared with example 1, the difference is only that: replacing the oregano with lettuce offspring.

Comparative example 4

A traditional Chinese medicine for reducing blood sugar, namely blood sugar-reducing tablet (or capsule), has a formula as follows: ginseng, astragalus, radix rehmanniae, polygonatum, acanthopanax and salvia miltiorrhiza; the components are combined according to the dosage disclosed by the blood sugar reducing tablet.

Examples of the experiments

1. Experimental Material

Animals: wistar rat, body weight 200 g. The SPF level is that the animal is raised in an animal room with the temperature of 22 ℃, the constant humidity of 50 percent and the artificial illumination of light and shade of 12 hours respectively, and the model is made after the animal is fed for a week and adapted.

Reagent: 0.5% CMC-Na: adding 200mL of pure water into 1g of CMC-Na, and stirring;

streptozotocin (STZ): sigma corporation, good number; s0130, Lot # S: WXBC2544V

The instrument equipment comprises: analytical balance (Ohaus)

1ml sterile syringe;

vitality type of the Roche glucometer: (ACCU-CHEK Active, Roche); blood glucose test paper: LOT 24672231

2. Experimental methods

1) Acute toxicity test:

KM mice, 20g in weight, 10 males and females, respectively, were subjected to intragastric administration, and the dynamic state 2 days after administration was recorded;

2) and (3) blood sugar reduction experiment:

wistar rats with the weight of 200g are divided into 5 groups, and each group comprises 6 to 9 rats; blank group: 6, only one of the raw materials is used; model group: 40 pieces of the Chinese herbal medicine are added;

performing intraperitoneal injection on the STZ for molding, wherein the dosage is 60 mg/kg; blood is collected for 72 hours, and the success of modeling is judged when the blood glucose concentration is determined to be more than or equal to 11.1 mmoL/L;

animals which are successfully molded are grouped into 4 groups: a model group, a positive control group, a low dose of a hypoglycemic composition (provided in example 1), a high dose of a hypoglycemic composition (provided in example 1); the positive control group is administered with metformin, and the dosage is 260 mg/kg; the low dose group is administered at a dose of 60 mg/kg; the high dose group is administered at a dose of 120 mg/kg; each group was administered 1 time a day for 21 consecutive days;

during the experiment, the activities, feeding, fur, defecation, spirit, piloerection and the like of each group of animals are recorded; weigh and record weight changes.

3. Results of the experiment

The results of the acute toxicity test are shown in table 1.

Table 1: summary of acute toxicity test results for mice

The results of the effect of nigella sativa formulation on blood glucose in STZ diabetic rats are shown in fig. 1 (P <0.05vs model; P <0.01vs model). The results of the effects of nigella sativa formula on the body weight of the STZ diabetic rats are shown in fig. 2-6.

4. Conclusion of the experiment

The composition provided by the invention has little acute toxicity and obvious hypoglycemic effect on STZ-guided hyperglycemic animals; the dosage is dependent, the blood sugar reducing efficiency of low dosage (60mg/kg) is obviously higher than that of metformin (260mg/kg), and the blood sugar reducing effect of high dosage (120mg/kg) is more prominent.

According to the method of the experimental example, the effects of the other examples and the comparative examples are detected, and the results show that the blood sugar reducing effects of the examples 2-5 are lower than that of the example 1, but better than those of the comparative examples 1-4; the blood sugar reducing effects of the comparative examples 1 to 4 are all significantly lower than those of the example 1.

The analysis shows that: the content of the nigella sativa seeds serving as the main component in the

embodiments

2, 3 and 5 is lower than 25 percent, so that the blood sugar reducing effect is lower than that of the embodiment 1; in example 4, the contents of 4 components were not within the optimum balance point, and therefore the hypoglycemic effect was also lower than that of example 1. Comparative examples 1-3 replace the types of the medicaments in the example 1 respectively, so that the loss and proportion imbalance of the effective components in the formula are caused, and the blood sugar reducing effect of the formula is obviously lower than that of the formula listed in the example 1; compared with the hypoglycemic drug provided by the comparative example 4, the hypoglycemic drug has the advantages of simpler formula, low toxicity and obvious hypoglycemic effect.

Although the invention has been described in detail hereinabove by way of general description, specific embodiments and experiments, it will be apparent to those skilled in the art that many modifications and improvements can be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims

1. The nigella sativa-based blood sugar reducing composition is characterized by being prepared from the following raw materials in parts by weight: 15-25 parts of seeds of nigella plants, 20-28 parts of elecampane, 20-28 parts of sha-pericarp and 20-28 parts of oregano; the amount of the black grass seeds accounts for more than 25% of the total mass of the composition, and the black grass seeds are one or more of black grass, black grass and glandular hair black grass.

2. The composition of claim 1, wherein the nigella plant is nigella sativa.

3. The composition according to claim 1, which is prepared from the following raw materials in parts by weight: 24-25 parts of nigella plant seeds, 24-26 parts of elecampane, 24-26 parts of sand pericarp and 24-26 parts of oregano.

4. The composition as claimed in any one of claims 1 to 3, wherein the composition is obtained by grinding each raw material into powder and mixing the powder.

5. A hypoglycemic mongolian medicine characterized by comprising the composition according to any one of claims 1 to 4 as an active ingredient.

6. The Mongolian medicine according to claim 5, wherein the Mongolian medicine is an oral preparation.

7. The Mongolian medicine according to claim 6, further comprising 5-10% by mass of sodium carboxymethyl starch in the active ingredient.

8. Use of a composition according to any one of claims 1 to 4 or a Mongolian agent according to any one of claims 5 to 7 for the manufacture of a medicament for the prevention or treatment of hyperglycemia or diabetes.