CN109394968B - Composition with auxiliary blood sugar reducing function and application thereof - Google Patents
Composition with auxiliary blood sugar reducing function and application thereof Download PDFInfo
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- CN109394968B CN109394968B CN201811487687.0A CN201811487687A CN109394968B CN 109394968 B CN109394968 B CN 109394968B CN 201811487687 A CN201811487687 A CN 201811487687A CN 109394968 B CN109394968 B CN 109394968B
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- reducing
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
- A61K35/644—Beeswax; Propolis; Royal jelly; Honey
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- General Health & Medical Sciences (AREA)
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- Medical Informatics (AREA)
- Nutrition Science (AREA)
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- Animal Husbandry (AREA)
- Organic Chemistry (AREA)
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- Obesity (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Zoology (AREA)
- Medicines Containing Plant Substances (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The invention discloses a composition with an auxiliary blood sugar reducing function and application thereof. The invention firstly discloses a composition with the function of assisting in reducing blood sugar, which is prepared from raw material medicines of astragalus, rhizoma polygonati, propolis powder and chromium picolinate. The invention further adds the raw material medicine of pseudo-ginseng on the basis of the astragalus, the sealwort, the propolis powder and the chromium picolinate, thereby having better effect of assisting in reducing blood sugar. The invention further discloses application of the composition in preparing a medicinal preparation or health-care food for reducing blood sugar. The composition with the auxiliary blood sugar reducing function provided by the invention has the effects of tonifying qi and blood and reducing blood sugar by matching the raw material medicines, has an exact blood sugar reducing effect, is suitable for people with high blood sugar, and can be applied to hyperglycemia caused by various reasons. The composition provided by the invention is prepared from raw materials which are homologous in medicine and food, is safe and effective, and has no toxic or side effect.
Description
Technical Field
The invention relates to a composition with a function of assisting in reducing blood sugar, and also relates to application of the composition in preparing a medicinal preparation or health-care food for reducing blood sugar, belonging to the field of health-care food for assisting in reducing blood sugar.
Background
Diabetes is a group of endocrine metabolic diseases of which the etiology and pathogenesis are not completely clear, the incidence rate of the diabetes is on the trend of increasing year by year, the diabetes is the third major difficult disease after cardiovascular and cerebrovascular diseases and malignant tumors, and no radical treatment therapy exists at present. The focus of traditional Chinese and western medicine is also different in the treatment of diabetes. Western medicine mainly adopts oral hypoglycemic agent or insulin supplementation for treating pancreatic islet insufficiency or absolute or relative insulin insufficiency, and has the advantages of quickly and accurately reducing blood sugar, controlling the blood sugar within an ideal range, and particularly playing a unique role in the acute complications of ketoacidosis, hyperosmolar coma and the like of diabetes. However, the progressive damage and other side effects of the traditional Chinese medicine composition to the vascular nerves do not have effective measures for preventing and delaying the occurrence of the progressive damage and other side effects. The treatment of diabetes in traditional Chinese medicine is based on treatment based on syndrome differentiation, and 2 refracting surfaces of the disease's principal and secondary aspects' are usually grasped from the whole body. Diabetes causes disorder of metabolism of sugar, protein and fat and imbalance of water and electrolyte, so the clinical manifestations are polydipsia, diuresis, emaciation, hypodynamia, etc., the essence of the disease is deficiency syndrome, and the sign is heat syndrome. Therefore, the traditional Chinese medicine usually adopts the therapeutic principles of clearing heat, tonifying qi, nourishing yin, warming yang and the like to achieve the balance of yin and yang of the organism.
Diabetes has become a major stubborn disease in today's society, and due to the large population base in China, the total number of diabetics has become one of the most frequent countries in the world. Therefore, the task of diabetes prevention and treatment is becoming one of the major public health problems in China. The huge group of diabetics makes the market of Chinese health-care food for assisting in reducing blood sugar greatly demanded. Therefore, in order to meet the requirements of the majority of people with high blood sugar, the traditional Chinese medicine theory is combined, a composition with the function of assisting in reducing blood sugar is developed, and the composition can assist the people with high blood sugar or the diabetics in controlling blood sugar so as to improve symptoms caused by blood sugar increase, and has important significance and value.
Disclosure of Invention
The invention aims to solve the first technical problem of providing a composition with the function of assisting in reducing blood sugar, wherein the composition has the health-care effects of tonifying qi and blood and reducing blood sugar by matching raw material medicines, and has a definite function of assisting in reducing blood sugar;
the second technical problem to be solved by the invention is to provide the application of the composition with the auxiliary hypoglycemic function in preparing hypoglycemic pharmaceutical preparations or health-care foods.
In order to solve the technical problems, the technical scheme adopted by the invention is as follows:
the invention firstly discloses a composition with an auxiliary blood sugar reducing function, which is prepared from the following raw materials: astragalus root, Siberian solomonseal rhizome, propolis powder and chromium picolinate.
The weight parts of the raw materials are as follows: 2-15 parts of astragalus root, 2-15 parts of sealwort, 1-8 parts of propolis powder and 0.001-1 part of chromium picolinate. Preferably, the weight parts of the raw materials are as follows: 10 parts of astragalus root, 10 parts of sealwort, 1.34 parts of propolis powder and 0.00534 parts of chromium picolinate.
The invention further discloses a composition with the function of assisting in reducing blood sugar, which is prepared from the following raw materials: astragalus root, Siberian solomonseal rhizome, bee glue powder, notoginseng and chromium picolinate.
The weight parts of the raw materials are as follows: 2-15 parts of astragalus membranaceus, 2-15 parts of rhizoma polygonati, 1-8 parts of propolis powder, 1-10 parts of pseudo-ginseng and 0.001-1 part of chromium picolinate. Preferably, the weight parts of the raw materials are as follows: 10 parts of astragalus membranaceus, 10 parts of rhizoma polygonati, 1.34 parts of propolis powder, 2 parts of pseudo-ginseng and 0.00534 parts of chromium picolinate.
The invention is based on the pathogenesis of diabetes of traditional Chinese medicine, and is matched with the blood sugar-reducing raw material formula according to the compatibility of heat-clearing and lung-moistening, spleen-invigorating and qi-replenishing, yin-nourishing and kidney-tonifying, and blood-activating and blood-enriching. In the formula, rhizoma polygonati has the effects of nourishing yin, invigorating spleen, moistening lung and tonifying kidney; radix astragali, invigorating qi and ascending qi, exciting qi machine, and invigorating kidney yang; pseudo-ginseng, radix astragali, with the effects of enriching blood and promoting blood circulation, has more remarkable tonifying effect; the propolis powder and the chromium picolinate mainly have the effect of reducing blood sugar; the bulk drugs are combined to play the health-care effects of tonifying qi and blood and reducing blood sugar.
Notoginseng is root of Panax notoginseng belonging to family Wusolanaceae. Sweet, slightly bitter and warm in nature. Enter liver, stomach and large intestine meridians. The functional indications are as follows: stop bleeding, dissipate blood stasis, resolve swelling and alleviate pain. It is used to treat hematemesis, hemoptysis, epistaxis, hematochezia, dysentery, metrorrhagia, metrostaxis, puerperal dizziness, lochiorrhea, traumatic hemorrhage, carbuncle, swelling and pain.
The invention adds the raw material pseudo-ginseng on the basis of the astragalus, the rhizoma polygonati, the propolis powder and the chromium picolinate, and has better auxiliary hypoglycemic effect.
The result of a sugar tolerance experiment shows that the addition of the raw material pseudo-ginseng on the basis of the astragalus, the rhizoma polygonati, the propolis powder and the chromium picolinate can obviously reduce the area under a blood sugar curve (P is less than 0.05) of a hyperglycemic model mouse after the administration of glucose for 0-2 hours, and the effect of reducing blood sugar is obviously better than the addition of the raw material medicines such as rhizoma anemarrhenae, radix ophiopogonis, Chinese yam or medlar and the like.
Astragalus membranaceus is root of Astragalus membranaceus bge Astragalus membranaceus (Fisch.) Bunge and Astragalus membranaceus bge A. mongholicus Bunge of Astragalus of Leguminosae. Sweet in nature and taste, slightly warm. The functional indications are as follows: tonify qi and strengthen superficies, support sores and promote tissue regeneration. It can be used for treating spontaneous perspiration due to asthenia, chronic diarrhea, proctoptosis, uterine prolapse, chronic nephritis, edema due to asthenia, chronic ulcer, and unhealed sore.
Rhizoma Polygonati is dried rhizome of Polygonatum kingianum Coll et Hemsl, Polygonatum sibiricum Red or Polygonatum cyrtonema Hua of Liliaceae. Sweet in nature and taste and mild in nature. It enters spleen, lung and kidney meridians. The functional indications are as follows: tonify qi and yin, invigorate spleen, moisten lung and tonify kidney. Can be used for treating weakness of spleen and stomach, asthenia, xerostomia, anorexia, lung deficiency, cough, essence and blood deficiency, and internal heat diabetes.
Propolis is the secretion of worker bees to fill and smooth the bee nest. Pungent and warm in nature and flavor. The functional indications are as follows: softening keratinized tissue and relieving pain.
The chromium picolinate has the function of reducing blood sugar, can enhance the activity of insulin of a human body and improve the glycometabolism of the human body.
The traditional Chinese medicine in the composition contains various blood sugar reducing components such as total saponins, polysaccharides, flavones and alkaloids, has various blood sugar reducing action mechanisms, and is embodied in the following aspects:
radix astragali has effects of invigorating qi, consolidating superficial resistance, promoting urination, expelling pus, healing sore, and promoting granulation; can be used for treating deficiency of qi, asthenia, anorexia, loose stool, collapse of middle-jiao, blood deficiency, sallow complexion, internal heat, and diabetes. Rhizoma Polygonati is sweet in flavor, mild in nature, slow in action, and can be used as tonic for long-term administration; can be used for treating weakness of spleen and stomach, asthenia, xerostomia, dry cough due to lung deficiency, insufficiency of essence and blood, and diabetes. The propolis powder mainly contains flavonoids, terpenes, enzymes, etc., has effects of lowering blood sugar, improving activity of islet cells, and rapidly recovering blood sugar in a short time. The main active component of the panax notoginseng is panax notoginseng saponins, which has the effects of removing blood stasis and stopping bleeding; modern researches show that the panax notoginseng saponins have the effects of inhibiting platelet aggregation, remarkably reducing whole blood viscosity, improving hemodynamics, increasing blood flow, reducing oxygen consumption of organisms, improving oxygen tolerance of the organisms and the like, and have good effects of assisting in reducing blood sugar and blood fat.
Animal experiment results show that different doses of the composition with the auxiliary blood sugar reducing function are orally administered to mice for 30 days, compared with a hyperglycemia model control group (0g/kgBw), the composition can reduce the blood sugar value at 0.5 hour after glucose administration (P <0.01) and reduce the area under the blood sugar curve at 0-2 hour after glucose administration (P <0.05) in a 1.2g/kgBW group; and has no adverse effect on fasting blood glucose and body weight of normal mice.
The composition can be prepared into a proper oral preparation according to a conventional preparation forming method. Such oral formulations include, but are not limited to: tablet, granule, capsule, powder, pill or oral liquid. In terms of dosage form selection, the present invention is preferably a capsule, more preferably a hard capsule. Capsule formulations are more acceptable to consumers than other liquid formulations, wherein hard capsules have the following characteristics: the appearance is smooth and beautiful, the improper bitter taste and odor of the raw materials can be covered, the irritation of the components is reduced, the medicine is convenient to take, is more suitable for the modern life rhythm, and is easy to carry; the hard capsule has the advantages of rapid onset of drug action, good absorption, rapid disintegration, good stability, and high bioavailability.
The invention also discloses application of the composition in preparing a medicinal preparation for reducing blood sugar.
The invention also discloses application of the composition in preparing health-care food for reducing blood sugar.
Animal function tests and human body test food prove that the composition has definite efficacy of assisting in reducing blood sugar, is suitable for people with high blood sugar, and can be applied to hyperglycemia caused by various reasons.
Compared with the prior art, the technical scheme of the invention has the following beneficial effects:
the composition with the auxiliary blood sugar reducing function is prepared from rhizoma polygonati, radix astragali, pseudo-ginseng, propolis powder and chromium picolinate serving as main raw materials, is scientific in formula, combines various raw materials together, has the health care effects of tonifying qi and blood and reducing blood sugar, and has the exact blood sugar reducing effect. The composition provided by the invention is prepared from raw materials which are homologous in medicine and food, is safe and effective, and has no toxic or side effect.
Detailed Description
The invention will be further described with reference to specific embodiments, and the advantages and features of the invention will become apparent as the description proceeds. It is to be understood that the described embodiments are exemplary only and are not limiting upon the scope of the invention. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be within the scope of the invention.
Example 1 composition with an auxiliary hypoglycemic function
The weight parts of the raw materials are as follows: 2 parts of astragalus root, 2 parts of sealwort, 1 part of propolis powder and 0.001 part of chromium picolinate.
Example 2 composition with an auxiliary hypoglycemic function
The weight parts of the raw materials are as follows: 15 parts of astragalus membranaceus, 15 parts of rhizoma polygonati, 8 parts of propolis powder and 1 part of chromium picolinate.
Example 3 composition with auxiliary hypoglycemic function
The weight parts of the raw materials are as follows: 10 parts of astragalus root, 10 parts of sealwort, 1.34 parts of propolis powder and 0.00534 parts of chromium picolinate.
Example 4 composition with auxiliary hypoglycemic function
The weight parts of the raw materials are as follows: 2 parts of astragalus membranaceus, 2 parts of rhizoma polygonati, 1 part of propolis powder, 1 part of pseudo-ginseng and 0.001 part of chromium picolinate.
Example 5 composition with auxiliary hypoglycemic function
The weight parts of the raw materials are as follows: 15 parts of astragalus membranaceus, 15 parts of rhizoma polygonati, 8 parts of propolis powder, 10 parts of pseudo-ginseng and 1 part of chromium picolinate.
Example 6 composition with auxiliary hypoglycemic function
The weight parts of the raw materials are as follows: 10 parts of astragalus membranaceus, 10 parts of rhizoma polygonati, 1.34 parts of propolis powder, 2 parts of pseudo-ginseng and 0.00534 parts of chromium picolinate.
EXAMPLE 7 preparation of capsules
The weight parts of the raw materials are as follows: 10 parts of astragalus membranaceus, 10 parts of rhizoma polygonati, 1.34 parts of propolis powder, 2 parts of pseudo-ginseng, 0.00534 parts of chromium picolinate and 1.74 parts of dextrin.
The capsule preparation method comprises the following steps:
(1) decocting radix astragali and rhizoma Polygonati in water for 2 times (8-15 times of the weight of radix astragali and rhizoma Polygonati for 2-3 hr), filtering, mixing filtrates, and drying under reduced pressure or vacuum continuously to obtain extract A;
(2) pulverizing propolis into coarse powder (20 mesh), soaking in 75-95% ethanol for 60-90 hr, filtering with 100-200 mesh sieve, standing the extractive solution, centrifuging the supernatant, and drying the centrifugate under reduced pressure or vacuum continuously to obtain extract B;
(3) pulverizing Notoginseng radix, sieving with 50-150 mesh sieve, and pulverizing60Performing Co (5KGy) irradiation sterilization, and sterilizing the pseudo-ginseng powder for later use;
(4) mixing Notoginseng radix powder and chromium picolinate fine powder (prepared by sieving chromium picolinate with 50-150 mesh sieve) by equivalent incremental method to obtain mixed powder A; mixing the mixed powder A with the extract B and dextrin (the dextrin is sieved by a 50-150 mesh sieve) to obtain mixed powder B; drying the mixed powder B at 40-70 deg.C under reduced pressure, pulverizing, and sieving with 50-150 mesh sieve; drying and crushing the extract A, and sieving the extract A by a sieve of 50-150 meshes to obtain fine powder of the extract A; uniformly mixing the fine powder of the extract A and the mixed powder B for 10-40 minutes to obtain total mixed powder C;
(5) and (4) mixing the total mixed powder C in the step (4), adding starch or magnesium stearate, preparing granules, and filling into capsules to obtain the capsule.
EXAMPLE 8 preparation of tablets
The weight parts of the raw materials are as follows: 10 parts of astragalus membranaceus, 10 parts of rhizoma polygonati, 1.34 parts of propolis powder, 2 parts of pseudo-ginseng, 0.00534 parts of chromium picolinate and a proper amount of dextrin.
The preparation method of the tablet comprises the following steps:
(1) decocting radix astragali and rhizoma Polygonati in water for 1 time, each time adding water 2-8 times of the weight of radix astragali and rhizoma Polygonati, each time decocting for 0.5-2 hr, filtering, mixing filtrates, and drying under reduced pressure or vacuum continuously to obtain extract A;
(2) pulverizing propolis into coarse powder (20 mesh), soaking in 60-85% ethanol for 12-36 hr, filtering with 100-200 mesh sieve, standing the extractive solution, centrifuging the supernatant, and drying the centrifugate under reduced pressure or vacuum continuously to obtain extract B;
(3) pulverizing Notoginseng radix, sieving with 50-120 mesh sieve, and pulverizing60Co (5KGy) irradiation sterilization for standby;
(4) mixing Notoginseng radix powder and chromium picolinate fine powder (prepared by sieving chromium picolinate with 50-120 mesh sieve) by equivalent incremental method to obtain mixed powder A, mixing mixed powder A with extract B and dextrin (prepared by sieving dextrin with 50-120 mesh sieve) to obtain mixed powder B; drying the mixed powder B at the low temperature of 40-60 ℃ under reduced pressure, crushing, and sieving by a sieve of 50-120 meshes; drying and crushing the extract A, sieving the dried and crushed extract A by a sieve of 50 to 120 meshes, and uniformly mixing the extract A with the mixed powder B for 5 to 20 minutes to obtain total mixed powder C;
(5) and (4) mixing the mixed powder C in the step (4), adding starch or magnesium stearate, preparing granules, and pressing into tablets.
EXAMPLE 9 preparation of granules
The weight parts of the raw materials are as follows: 10 parts of astragalus membranaceus, 10 parts of rhizoma polygonati, 1.34 parts of propolis powder, 2 parts of pseudo-ginseng, 0.00534 parts of chromium picolinate and 2 parts of dextrin.
The preparation method of the granules comprises the following steps:
(1) decocting radix astragali and rhizoma Polygonati in water for 3 times (4-8 times of the weight of radix astragali and rhizoma Polygonati for 1-3 hr), filtering, mixing filtrates, and drying under reduced pressure or vacuum continuously to obtain extract A;
(2) pulverizing propolis into coarse powder (sieving with 10-30 mesh sieve), soaking in 85-98% ethanol for 36-96 hr, filtering with 100-200 mesh sieve, standing the extractive solution, centrifuging the supernatant, and drying the centrifugate under reduced pressure or vacuum continuously to obtain extract B;
(3) pulverizing Notoginseng radix, sieving with 50-120 mesh sieve, and pulverizing60Co (5KGy) irradiation sterilization for standby;
(4) mixing Notoginseng radix powder and chromium picolinate fine powder (prepared by sieving chromium picolinate with 50-120 mesh sieve) by equivalent incremental method to obtain mixed powder A, mixing mixed powder A with extract B and dextrin (prepared by sieving dextrin with 50-120 mesh sieve) to obtain mixed powder B; drying the mixed powder B at the low temperature of 40-65 ℃ under reduced pressure, crushing, and sieving by a sieve of 50-120 meshes; drying and crushing the extract A, sieving the dried and crushed extract A by a sieve of 50 to 120 meshes, and uniformly mixing the extract A with the mixed powder B for 10 to 30 minutes to obtain total mixed powder C;
(5) and (5) mixing the mixed powder C obtained in the step (4), adding starch or magnesium stearate, and preparing into granules.
EXAMPLE 10 preparation of capsules
The weight parts of the raw materials are as follows: 2 parts of astragalus membranaceus, 2 parts of rhizoma polygonati, 1 part of propolis powder, 1 part of pseudo-ginseng, 0.001 part of chromium picolinate and 1 part of dextrin.
The capsule preparation method comprises the following steps:
(1) decocting radix astragali and rhizoma Polygonati in water for 1 time, each time adding water 3-8 times of the weight of radix astragali and rhizoma Polygonati, each time decocting for 0.5-2 hr, filtering, mixing filtrates, and drying under reduced pressure or vacuum continuously to obtain extract A;
(2) pulverizing propolis into coarse powder (sieving with 10-30 mesh sieve), soaking in 70-85% ethanol for 12-36 hr, filtering with 100-200 mesh sieve, standing the extractive solution, centrifuging the supernatant, and drying the centrifugate under reduced pressure or vacuum continuously to obtain extract B;
(3) pulverizing Notoginseng radix, sieving with 40-80 mesh sieve, and pulverizing60Co (5KGy) irradiation sterilization for standby;
(4) mixing Notoginseng radix powder and chromium picolinate fine powder (prepared by sieving chromium picolinate with 40-80 mesh sieve) by equivalent incremental method to obtain mixed powder A, mixing mixed powder A with extract B and dextrin (prepared by sieving dextrin with 40-80 mesh sieve) to obtain mixed powder B; drying the mixed powder B at the low temperature of 40-65 ℃ under reduced pressure, crushing, and sieving by a 40-65-mesh sieve; drying and crushing the extract A, sieving the extract A by a 40-65-mesh sieve, and uniformly mixing the extract A with the mixed powder B for 5-20 minutes to obtain total mixed powder C;
(5) and (4) mixing the mixed powder C in the step (4), adding starch or magnesium stearate, preparing granules, and filling into capsules to obtain the capsule.
EXAMPLE 11 preparation of powders
The weight parts of the raw materials are as follows: 15 parts of astragalus membranaceus, 15 parts of rhizoma polygonati, 8 parts of propolis powder, 10 parts of pseudo-ginseng, 1 part of chromium picolinate and 4 parts of dextrin.
The preparation method of the powder comprises the following steps:
(1) decocting radix astragali and rhizoma Polygonati in water for 3 times (10-15 times of the weight of radix astragali and rhizoma Polygonati for 2-4 hr), filtering, mixing filtrates, and drying under reduced pressure or vacuum continuously to obtain extract A;
(2) pulverizing propolis into coarse powder (sieving with 10-30 mesh sieve), soaking in 85-98% ethanol for 36-96 hr, filtering with 150-200 mesh sieve, standing the extractive solution, centrifuging the supernatant, and drying the centrifugate under reduced pressure or vacuum continuously to obtain extract B;
(3) pulverizing Notoginseng radix, sieving with 50-100 mesh sieve, and mixing60Co (5KGy) irradiation sterilization for standby;
(4) mixing Notoginseng radix powder and chromium picolinate fine powder (prepared by sieving chromium picolinate with 50-100 mesh sieve) by equivalent incremental method to obtain mixed powder A, mixing mixed powder A with extract B and dextrin (prepared by sieving dextrin with 50-100 mesh sieve) to obtain mixed powder B; drying the mixed powder B at a low temperature of between 60 and 85 ℃ under reduced pressure, crushing, and sieving by a sieve of between 50 and 100 meshes; drying and crushing the extract A, sieving the dried and crushed extract A by a sieve of 50 to 100 meshes, and uniformly mixing the extract A with the mixed powder B for 10 to 50 minutes to obtain total mixed powder C;
(5) and (4) mixing the mixed powder C in the step (4), adding starch or magnesium stearate, preparing granules, and crushing.
Test example 1 animal test for auxiliary hypoglycemic function of the composition of the present invention
1. Materials and methods
1.1 sample
The content of the capsule prepared in example 7 of the present invention was brown granular solid, 0.4 g/granule.
1.2 Experimental animals
Selecting Beijing Huafukang biotech GmbH [ license number: the SCXK- (Jing) 2009-0007] bred 25 +/-2 g female mice of Kunming species healthy and clean grade are 120 in total, and the experiment is divided into three batches. Experiments are carried out in batch to carry out an experiment on the influence of normal mice on fasting blood glucose; experiment two batches are carried out to carry out experiments on the influence of the fasting blood sugar of the hyperglycemic model mouse; experiment three batches were subjected to sugar tolerance experiments. The experimental animals are bred in SPF animal room of health food function detection center of applied literature college of university of Beijing union, and the license number SYXK (Jing) 2007-0020 is used for the experimental animals.
1.3 dosage
The recommended dosage of the capsule of the invention is 2.4g per day for an adult (measured on a 60kg body weight basis), corresponding to 0.04 g/day/kg body weight. The experiment is 5 times, 10 times and 30 times of the recommended amount of human body, namely 0.2g/kgBW, 0.4g/kgBW and 1.2g/kgBW are low, medium and high dose groups and a hyperglycemic model control group (0g/kgBW) per day. The test sample is prepared with water (disinfected), orally taken once a day, and continuously perfused for 30 days to measure various indexes. The gavage volume of the mice was 0.1mL/l0g mouse weight. The hyperglycemia model control group uses water (disinfected) to replace the test object, and the daily gavage volume is the same as that of each test object group.
And additionally arranging a test object group and a blank control group to perform an experiment on the influence of the test object on the fasting blood glucose of the normal mice.
1.4 Main instruments and reagents
1.4.1 Instrument
Type 755 spectrophotometer (2002001), thermostatic water bath (2004009), centrifuge (98090)
1.4.2 reagents
Glucose assay kit (glucose oxidase method), zhongsheng bei accuse biotechnology limited, lot number: 102251. tetraoxypyrimidine, manufactured by SIGMA corporation of America.
1.5 Experimental methods
1.5.1 Effect of test substances on fasting plasma glucose in Normal mice
The mice are fasted for 4 hours, blood is taken from the angular venous plexus, and fasting blood glucose values are measured and divided into two groups according to the blood glucose level: blank control group (0g/kgBW) and test subject group, 12 of each group. By means of intragastric administration, the test group was intragastric administered with a high dose of test substance (1.2g/kgBW) and the blank control group was intragastric administered with a corresponding volume of water (sterilized). After continuously feeding for 30 days, measuring fasting blood glucose value, and calculating blood glucose decrease percentage.
Percent of blood sugar reduction ═ (blood sugar value before experiment-blood sugar value after experiment)/blood sugar value before experiment x 100%
1.5.2 preparation of hyperglycemic model mice
Mice are fasted for 16 hours, the mice are injected with physiological saline solution of alloxan (45mg/kgBW) into tail veins, on the 6 th day after injection, the mice are fasted for 4 hours, blood is taken from inner canthus vein plexus, fasting blood sugar value is determined, and the mice with blood sugar value of 10.0mmol/L-25.0mmol/L are selected as the successful animals of the hyperglycemic model.
1.5.3 Effect on fasting plasma glucose in hyperglycemic model mice
The hyperglycemic model mice are taken and divided into a hyperglycemic model control group and three dosage groups according to the blood sugar level, and each group contains 12 mice. Three dose groups were administered with corresponding doses of test substance; the hyperglycemic model control group was gazed with a corresponding volume of water (disinfected). After continuously feeding for 30 days, fasting for 4 hours, blood is taken from angular venous plexus, fasting blood glucose value of each group of animals is measured, and percentage of blood glucose decrease is calculated.
On the premise that the model is established, compared with a high-blood-glucose model control group, the reduction of the fasting blood glucose measured value or the percentage of blood glucose reduction has statistical significance, and the result of the fasting blood glucose reduction test of the test sample can be judged to be positive.
1.5.4 sugar tolerance test
The animals were grouped and fed in the same manner as 1.5.3, and after 30 days of continuous feeding, after fasting for 4 hours, each group was given different concentrations of the test substance, and the hyperglycemia model control group was given the same volume of water (sterilized). After 20 minutes, each group of animals orally administered glucose 2.0g/kgBW, and blood glucose levels were measured at 0 hour, 0.5 hour and 2 hours after the administration of glucose. And observing the change of the area under the blood glucose curve of each time point after the hyperglycemia model control group and the test sample group are given glucose.
Area under blood glucose curve is 0.25 × (blood glucose level at 0 hour + blood glucose level at 4 × 0.5 hour + blood glucose level at 3 × 2 hours)
On the premise that the model is established, compared with a hyperglycemia model control group, the decrease of the area under the blood glucose curve at 0, 0.5 and 2 hours after glucose administration has statistical significance, and the test sample can be judged to have positive glucose tolerance test result.
1.5.5 blood glucose determination method
Blood was collected, centrifuged at 3000r/min for 10 minutes to separate serum, and the procedure was as in Table 1.
TABLE 1
| Blank tube | Standard tube | Sample tube | |
| Working fluid | 3.00mL | 3.00mL | 3.00mL |
| Distilled water | 0.02mL | ─ | ─ |
| Standard of merit | ─ | 0.02mL | ─ |
| Diluted serum | ─ | ─ | 0.02mL |
If the measured value exceeds the upper limit of linearity specified in the kit, serum is diluted with physiological saline and then measured.
Respectively mixing uniformly, keeping the temperature at 37 ℃ for 10-15 minutes, adjusting the temperature to be zero by using a reagent blank tube at the wavelength of 505nm, and respectively reading AStandard of meritAnd ASample (I)。
1.6 data processing
Data processing was performed with SPSS software. Performing anova, calculating F value, and F value<F0.05And the conclusion is that: the difference between the average numbers of all groups is not significant; f value is more than or equal to F0.05P is less than or equal to 0.05, and statistics is carried out by a pairwise comparison method of mean values between a plurality of experimental groups and a control group; carrying out appropriate variable conversion on the data which are not normal or uneven in variance, and counting by using the converted data after the requirements of normal or uniform variance are met; if the variable still does not reach the goal of being normal or uniform in variance after conversion, the statistics is carried out by using the rank sum test. The influence experiment of the normal mice on the fasting blood glucose adopts t test of independent samples for statistics.
1.7 basis for determination of results
One of the two indexes of fasting blood sugar and glucose tolerance is positive, and has no influence on the fasting blood sugar of normal animals, so that the positive test result of the animal with the function of assisting to reduce blood sugar of the test sample can be judged.
2. Results
2.1 Effect on mouse body weight
TABLE 2 initial body weights of the groups of mice
As can be seen from Table 2, the initial body weight of the mice was compared between the three experimental animal dose groups and the 0g/kgBW group, and the difference was not significant (P > 0.05). I.e. the initial body weight of the mice was more balanced between the groups.
TABLE 3 Effect of the capsules of the invention on the body weight of mice in hyperglycemic model
As can be seen from Table 3, the body weight of mice after 30 days of oral administration of the capsules at different doses to the mice was not significantly different (P >0.05) when compared between the three experimental animal dose groups and the 0g/kgBW group. Namely, the capsule of the invention has no influence on the weight of mice.
2.2 Effect on fasting plasma glucose in Normal mice
TABLE 4 Effect of capsules on fasting plasma glucose in Normal mice
As can be seen from Table 4, the blood glucose level and the percentage of blood glucose decrease before the experiment of the normal mice and after the test of the test object for 30 days have no significant difference (P is more than 0.05) when comparing the test object group with the blank control group, i.e. the capsule of the invention has no influence on the fasting blood glucose of the normal mice.
2.3 Effect on fasting plasma glucose of high blood glucose model mouse
TABLE 5 Effect of capsules on fasting plasma glucose in hyperglycemic model mice
As can be seen from Table 5, the percentage of blood glucose reduction in each dose group was not significant (P >0.05) when compared to the 0g/kgBW group by orally administering the capsules to the mice at different doses for 30 days. Namely, the capsule provided by the invention has no influence on fasting plasma glucose of a high-blood-glucose model mouse.
2.4 Effect on glucose tolerance in hyperglycemic model mice
TABLE 6 Effect of capsules on blood glucose levels after administration of glucose to hyperglycemic model mice
*: compared with the 0g/kgBW group, the difference is significant.
As can be seen from Table 6, when the capsules were orally administered to the mice at different doses for 30 days, the 1.2g/kgBw group showed a significant difference in blood glucose level at 0.5 hour after glucose administration (P <0.01) as compared with the 0g/kgBW group. Namely, the capsule of the invention can reduce the blood sugar value 0.5 hour after the glucose is given in the 1.2g/kgBW group.
TABLE 7 Effect of capsules on the area under the 0-2 hour blood glucose curve after glucose administration in hyperglycemic model mice
*: compared with the 0g/kgBW group, the difference is significant.
As can be seen from Table 7, the 1.2g/kgBW group showed a significant difference in area under the blood glucose curve at 0-2 hours after glucose administration (P <0.05) compared to the 0g/kgBW group when the capsules were orally administered to the mice at different doses for 30 days. Namely, the capsule of the invention can reduce the area under the blood glucose curve 0-2 hours after the glucose is given in the 1.2g/kgBW group.
In summary, the composition with auxiliary hypoglycemic function of the present invention, administered orally to mice at different dosages for 30 days, can lower the blood glucose level at 0.5 hour after glucose administration (P <0.01) and lower the area under the blood glucose curve at 0-2 hour after glucose administration (P <0.05) in the 1.2g/kgBW group compared with the high blood glucose model control group (0 g/kgBW). The composition with the auxiliary blood sugar reducing function has no adverse effect on fasting blood sugar and body weight of normal mice.
Test example 2 component screening test for the composition of the present invention
1. Test method
Composition 1: 10 parts of astragalus root, 10 parts of rhizoma polygonati, 1.34 parts of propolis powder and 0.00534 parts of chromium picolinate (parts by weight, the same below);
the compositions 2 to 8 are respectively added with the following raw material medicaments on the basis of the composition 1:
composition 2: 2 parts of pseudo-ginseng;
composition 3: 1 part of rhizoma anemarrhenae and 1 part of radix ophiopogonis;
composition 4: 2 parts of rhizoma anemarrhenae;
composition 5: 2 parts of radix ophiopogonis;
composition 6: 2 parts of Chinese yam;
composition 7: 2 parts of medlar;
composition 8: 2 parts of kudzu root;
composition 9: 2 parts of rhodiola rosea;
composition 10: 2 parts of balsam pear;
composition 11: 2 parts of polygonum multiflorum;
each of the compositions was prepared separately as capsules in the same manner as in example 7 at 0.4 g/capsule.
A glucose tolerance test was performed to measure the change in area under the blood glucose curve at each time point after the administration of glucose to the hyperglycemia model control group and the test sample group, and the specific test method was the same as in test example 1. Wherein the dosage of the capsules prepared by the compositions 1-11 is 0.4g/kgBW per day; hyperglycemic model control group (0g/kgBW) was given the same volume of water (disinfected).
2. Test results
The effect of each composition on the area under the 0-2 hour blood glucose curve after glucose administration to hyperglycemic model mice is shown in table 8.
TABLE 8 Effect of compositions on the area under the 0-2 hour blood glucose curve after glucose administration in hyperglycemic model mice
*: compared with the 0g/kgBW group, the difference is significant.
The experimental results in table 8 show that composition 2 significantly differs in area under the 0-2 hour blood glucose curve after glucose administration (P <0.05) compared to the g/kgBW group for 30 days of different compositions orally administered to mice, i.e., composition 2 significantly reduced the area under the 0-2 hour blood glucose curve after glucose administration. The composition obtained by adding 2 parts of pseudo-ginseng on the basis of 10 parts of astragalus, 10 parts of rhizoma polygonati, 1.34 parts of propolis powder and 0.00534 parts of chromium picolinate is obviously superior to other compositions in the effect of reducing blood sugar.
Claims (6)
1. The composition with the auxiliary blood sugar reducing function is characterized by being prepared from the following raw materials: astragalus root, Siberian solomonseal rhizome, propolis powder, notoginseng and chromium picolinate; the weight parts of the raw materials are as follows: 2-15 parts of astragalus membranaceus, 2-15 parts of rhizoma polygonati, 1-8 parts of propolis powder, 1-10 parts of pseudo-ginseng and 0.001-1 part of chromium picolinate.
2. The composition according to claim 1, wherein the weight parts of the raw materials are as follows: 10 parts of astragalus membranaceus, 10 parts of rhizoma polygonati, 1.34 parts of propolis powder, 2 parts of pseudo-ginseng and 0.00534 parts of chromium picolinate.
3. A composition according to claim 1 or 2, characterized in that: preparing into suitable oral preparation according to conventional preparation molding method.
4. The composition of claim 3, wherein said oral dosage form comprises: tablet, granule, capsule, powder, pill or oral liquid.
5. Use of the composition of claim 1 or 2 for the preparation of a hypoglycemic pharmaceutical formulation.
6. Use of the composition of claim 1 or 2 for the preparation of a health food for the auxiliary reduction of blood glucose.
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