CN101433667A - Pharmaceutical composition with function for reducing blood sugar and preparation method thereof - Google Patents
Pharmaceutical composition with function for reducing blood sugar and preparation method thereof Download PDFInfo
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- CN101433667A CN101433667A CNA2007101774885A CN200710177488A CN101433667A CN 101433667 A CN101433667 A CN 101433667A CN A2007101774885 A CNA2007101774885 A CN A2007101774885A CN 200710177488 A CN200710177488 A CN 200710177488A CN 101433667 A CN101433667 A CN 101433667A
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- propolis
- rhizoma
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- chromium picolinate
- radix ophiopogonis
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Abstract
The invention discloses a pharmaceutical composition with the function of reducing blood sugar and a method for preparing the same. The pharmaceutical composition is prepared from milkvetch root, rhizoma polygonati, rhizome of wind-weed, lilyturf root, picolinic acid chromium and propolis. The pharmaceutical composition can be prepared into a common internal use formulation. The pharmaceutical composition has the efficacy of reducing blood sugar, so that the pharmaceutical composition can be used to treat diabetes.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, belong to medicine and field of health care food with function of blood sugar reduction.
Background technology
Diabetes are the one group of Developmental and Metabolic Disorder syndromes that is caused by the h and E factor interaction.Long-term diabetes can cause the chronic complicating diseases of a plurality of systems organ, cause dysfunction and depletion, become disable, lethal main cause.At present, the prevalence of diabetes had the trend of remarkable rising in recent years in the population of China.Because the cause of disease and the pathogenesis of diabetes are not clear fully as yet, therefore also lack effective etiological treatment method at present.Clinically treatment of diabetes is adopted insulinize and oral hypoglycemic drug therapy more now, yet diabetes spp is in a kind of lifelong participation disease, need long-term prescription, the drug administration by injection method of insulin tends to bring many inconvenience to the patient, and clinical orally-taken blood sugar reducing medicine commonly used belongs to chemical drugs more, takes for a long time also and can cause a series of untoward reaction.In view of there being above problem, so exploitation a kind of hypoglycemic drug and health food safe, effective, that be suitable for taking for a long time are badly in need of on present market very much.
Summary of the invention
The object of the invention just provides a kind of pharmaceutical composition with function of blood sugar reduction.
Another object of the present invention has provided this preparation of drug combination method.
The present invention is achieved by the following technical solutions:
The present invention is made by the following weight proportion raw material:
Radix Astragali 9-30 part, Rhizoma Polygonati 9-15 part, Rhizoma Anemarrhenae 6-12 part, Radix Ophiopogonis 6-12 part, chromium picolinate 0.001-0.009 part, propolis 0.1-0.5 part
Be preferably:
20 parts of the Radixs Astragali, 12 parts of Rhizoma Polygonatis, 9 parts of the Rhizoma Anemarrhenaes, 9 parts of Radix Ophiopogonis, 0.006 part of chromium picolinate, 0.3 part of propolis
Preparation of drug combination method of the present invention is as follows:
The Radix Astragali with described weight proportion, Rhizoma Polygonati, the Rhizoma Anemarrhenae, add water Radix Ophiopogonis or ethanol extracts, extracting solution is concentrated, dry, make dry extract, be ground into powder, add propolis, chromium picolinate, add various conventional adjuvant required when preparing different dosage form, as diluent, disintegrating agent, excipient, binding agent, lubricant, surfactant, filler, antiseptic, stabilizing agent, correctives, thickening agent, fluidizer etc., method of Chinese medicinal with routine is prepared into any peroral dosage form commonly used, as tablet, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, buccal tablet, chewable tablet, capsule, soft capsule, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid etc.
The preferred for preparation method of Chinese medicine composition of the present invention is as follows:
The Radix Astragali with described weight proportion, Rhizoma Polygonati, the Rhizoma Anemarrhenae, twice of the ethanol extraction that adds 10 times of amounts and 8 times amount 70% Radix Ophiopogonis, merge extractive liquid,, filter, reclaim ethanol, be evaporated to relative density and measure 1.25-1.30 down for 60 ℃, drying under reduced pressure, make dry extract, be ground into powder, add propolis, chromium picolinate, add various conventional adjuvant required when preparing different dosage form, as diluent, disintegrating agent, excipient, binding agent, lubricant, surfactant, filler, antiseptic, stabilizing agent, correctives, thickening agent, fluidizer etc., method of Chinese medicinal with routine is prepared into any peroral dosage form commonly used, as tablet, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, buccal tablet, chewable tablet, capsule, soft capsule, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid etc.
The using method of Chinese medicine composition of the present invention:
Oral; Day dose is in crude drug: Radix Astragali 9-30g, Rhizoma Polygonati 9-15g, Rhizoma Anemarrhenae 6-12g, Radix Ophiopogonis 6-12g, chromium picolinate 0.001-0.009g, propolis 0.1-0.5g, preferred: Radix Astragali 20g, Rhizoma Polygonati 12g, Rhizoma Anemarrhenae 9g, Radix Ophiopogonis 9g, chromium picolinate 0.006g, propolis 0.3g; Every day 2-3 time.
Each drug mechanism is as follows among the present invention:
Chromium picolinate: Cr3+ is the trace element of needed by human, and it is the constituent of glucose tolerance factor, has ILA, can promote the utilization of cell, promote the oxidative phosphorylation of glucose, promote glycogen synthetic glucose, improve the stability of insulin, thus blood sugar lowering.Pyridine carboxylic acid is the amino acid metabolites that produces in people and mammalian liver, the kidney, and is present in a large number in the food such as milk, and it combines closely into chromium picolinate with Cr3+, can be absorbed well by human body.Therefore chromium picolinate be a kind of by Ministry of Public Health allowed, can add the functional component in the health food to.Chromium picolinate can directly act on histiocyte by cell membrane smoothly, can strengthen insulin active, improves the human body carbohydrate metabolism.
The Radix Astragali: effect with benefiting QI for strengthening the superficies, diuretic, promoting pus discharge and tissue regeneration strengthening, the astragalus polysaccharides that contains in the Radix Astragali has the effect of two-ways regulation blood glucose, can make that the blood sugar level of mice significantly descends behind the glucose load, and the mouse blood sugar level rising that can obviously cause antiadrenergic drug, and insulin hypoglycemia is not had obvious influence.
Rhizoma Polygonati: sweet in the mouth, property are put down, and are a kind of of tonic.Function such as have spleen invigorating, the kidney invigorating, lung moistening, promote the production of body fluid.Pharmacological research shows that Rhizoma Polygonati has hypoglycemic effect.
The Rhizoma Anemarrhenae: the effect that has clearing away heat-fire, promotes the production of body fluid and moisturize.Be used for osteopyrexia and fever, again can nourishing kidney-yin, the profit kidney is dry and move back hectic fever due to YIN-deficiency, so the merit of nourishing YIN to lower pathogenic fire is arranged.Be used for hyperactivity of fire caused by deficiency of YIN, osteopyrexia and fever, night sweat, disease such as vexed.Pharmacological evaluation shows that Rhizoma Anemarrhenae water extract and polysaccharide have hypoglycemic activity to normal rabbits, and diabetic mice due to alloxan diabetes rabbit and mice and the insulin antiserum is had more obvious hypoglycemic activity, and can make that ketoboidies reduces in the mouse retention.The Rhizoma Anemarrhenae does not have facilitation to the normal rat glucose oxidase, but can promote the picked-up of diaphragm, fatty tissue, make and drill the disease due to obstruction of QI of middle-JIAO glycogen content and increase, but hepatic glycogen content descend glucose, the hypoglycemic effective ingredient of the Rhizoma Anemarrhenae is Rhizoma Anemarrhenae polysaccharide A, B, C, D, and is the strongest with the B activity.
Radix Ophiopogonis: YIN-tonifying drug.Have Yin-nourishing and body fluid promoting, nourishing the lung to arrest cough, the effect of the relieving restlessness that clears away heart-fire.Modern medicine think have heart tonifying Radix Ophiopogonis, diuresis, antimicrobial effect.Cure mainly consumption of body fluid caused by febrile disease, vexed, thirsty, dry pharynx, lung-heat type cough.Pharmacological evaluation shows that Radix Ophiopogonis polysaccharide has the obvious suppression effect to the blood sugar increasing due to the alloxan, can the adrenergic blood glucose increasing effect of antagonism.Oral glucose tolerance test shows that Radix Ophiopogonis polysaccharide might produce hypoglycemic activity in the absorption of mouse intestinal by stoping glucose.Radix Ophiopogonis polysaccharide also has tangible reduction effect to the blood glucose of normal mouse.
Propolis: be that Apis is used the resin of gathering from plant plumule and trunk, the secretions in Hubei Province, Cera Flava, a small amount of pollen process on the Apis a kind ofly has an aromatic odor, and tough natural mixture has special fragrance during burning, and mildly bitter flavor is puckery.The main component of propolis has flavone, the rare class of terpene, organic acid, armaticity aldehydes and several amino acids enzyme, vitamin, mineral etc., and the effective ingredient of complexity is the material base of good natural health-care products and medicine in the propolis.Propolis energy activating cell promotes tissue regeneration, repairs sick islet cells and the tissue that decreases, the help blood sugar lowering; Diminish inflammation, treatment is infected, prevention and treatment infection complication; Blood fat reducing, vessel softening, microcirculation improvement, diabetics are taken propolis can prevent visual deterioration and cardiovascular and cerebrovascular complication; Regain one's strength, eliminate " three-many-one-little " symptom; But the diabetes patient adheres to taking propolis reinforced immunological function, and health invigorating is improved the quality of living.
In the present composition, Radix Astragali QI invigorating diuretic, Rhizoma Polygonati spleen reinforcing kidney, Rhizoma Anemarrhenae clearing away heat-fire, promote the production of body fluid and moisturize, nourishing YIN Radix Ophiopogonis, relieving restlessness clears away heart-fire, four Chinese medicine can reach nourishing and the moist effect comprehensively of diabetes patient's human body, improve ubiquitous agitation among the diabetes patient, weak phenomenon, and four Chinese medicine all has hypoglycemic effect, being aided with propolis diminishes inflammation, treatment is infected, microcirculation improvement, can strengthen insulin active in adding, improve the glycometabolic chromium picolinate of human body, Six-element medicine compatibility is fundamentally regulated diabetes patient's body comprehensively, improve diabetes patient's physical condition, can be with diabetes patient's blood glucose regulation to normal level.
In sum, the present composition has the QI invigorating nourishing YIN, the relieving restlessness that clears away heart-fire, diminishes inflammation, microcirculation improvement, blood sugar lowering, prevents and treats the extremely effect of infection complication of diabetes.Can be used for treating diabetes.Can be used for preparing the Chinese medicine and the health product of prevention and treatment diabetes.
The present invention with respect to prior art have determined curative effect, have no side effect, taking convenience, cheap advantage.
Further set forth the beneficial effect of Chinese medicine composition of the present invention by following experiment.
According to Ministry of Public Health " provisions for new drugs approval " requirement, experiment moulding animal is selected healthy Wistar rat and Kunming kind white mice for use, with the alloxan animal glycosuria pathology moulding that experimentizes, adopt the known Western medicine phenbutamide of treatment diabetes sheet as this research control drug of dividing into groups.
The pharmacological research of this group system is total: medicine of the present invention is to the blood sugar influence of first section moulding animal, influence to serum insulin content, influence to blood glucagon content, to blood superoxide dismutase content (SOD) and active influence thereof, influence to liver tissue lipid peroxide content, to the metabolic influence of serum lipid, to the body fatigue resistance effect, influence to the organism adaptation ability, influence to the peritoneal macrophage phagocytic function, be model promptly, the relevant index of the group effect of this medicine blood sugar reducing function mechanism and medicine has been done mensuration than system with big (little) Mus of model induced by alloxan diabetes.
This experimental system pharmacological research confirms: (1) large and small dosage has very significantly repeatably hypoglycemic activity to different experiments moulding animal (large and small Mus).To studies show that of moulding mice, hypoglycemic effect is better than the Western medicine phenbutamide.And, show stronger after effect.(2) big low dose all can obviously improve insulin content in the moulding animal blood.Improve with drug level, the rising insulin content is more obvious.Simultaneously, reduce glucagon content in the blood.One of its hypoglycemic mechanism may be to reduce glucagon content, improves insulin content, and then, suppress liver glycogen and decompose and blood sugar lowering content.This blood sugar reducing function and effect are better than Western medicine phenbutamide group.(3) obviously improve with the same moulding animal blood superoxide dismutase (SOD) content that can make of phenbutamide, and can make the active raising of SOD in the blood, simultaneously, can obviously reduce Lpo in the hepatic tissue, harmful free radical effect in the tangible elimination body has been described.Be the treatment diabetes, improving the body vitality provides foundation.(4) general diabetics has more existing hyperlipemia, and the plasma concentration of T-CHOL (TC) and triglyceride (TG) is all apparently higher than the normal person.Plasma TC, the TG level is relevant with the control of the diabetes state of an illness.Hypercholesterolemia is the main cause of diabetes complicated macroangiopathic, medicine of the present invention can obviously reduce moulding animal TC and cholesterol acid (TCE) content, it is more obvious to increase dosage, can reduce serum high-density LP cholesterol (HDL-C), above-mentioned effect is better than the phenbutamide sheet, this effect is consistent with its obvious blood sugar reducing function, points out this medicine that the treatment diabetes are caused that the concurrent angiopathy of hyperlipemia is particularly suitable.
(5) general pharmacology studies show that, medicine of the present invention can obviously improve the mice swimming with a load attached to the body time, improve body resisting fatigue ability, can obviously improve mice to low temperature, pyritous adaptive capacity, enhancing body is to the adaptive capacity of environment, can obviously improve the mouse peritoneal emigrated cell and engulf the erythrocytic ability of chicken, thereby increase immunity of organisms.
Toxicological study conclusion general introduction before clinical:
1. in order to guarantee the safety of clinical administration reliability, we have at first carried out acute toxicity testing research: the experiment kunming mice, every day at upper and lower noon twice administration various dose (40g/kg, 67g/kg, 70g/kg) respectively observed continuously, 7 days as a result mice all act normally, abnormal responses such as short of breath, tic all do not occur, none is only dead.When being equivalent to 1167 times of clinical consumptions of people, median lethal dose(LD 50) LD50 fails to measure, and avirulence is described, and is clinical safe and reliable.
2. long term toxicity test research, then carried out this medicine to the rat sub-acute toxicity test, connect gastric infusion 3 months, be divided into matched group and large, medium and small three dosage group (7.2g/kg at random, 4.5g/kg, 1.8g/kg), promptly being equivalent to 120,75,30 times of the clinical consumption of people, matched group is given equal-volume water.Observe the general state respectively organize rat, behavior, fur color and luster, body weight, peripheral blood phase, hepatic and renal function, blood triglyceride, blood glucose, gross anatomy, microscopy etc., the result shows, administration is respectively organized general state, body weight, hepatic and renal function of rat etc. and is not seen notable difference with matched group, all in normal range.
The specific embodiment
Embodiment 1:
The preparation of the capsule of pharmaceutical composition of the present invention
A) take by weighing Radix Astragali 20kg, Rhizoma Polygonati 12kg, Rhizoma Anemarrhenae 9kg, Radix Ophiopogonis 9kg, chromium picolinate 0.006kg, propolis 0.3kg, standby;
B) with the Radix Astragali, Rhizoma Polygonati, the Rhizoma Anemarrhenae and the Radix Ophiopogonis ethanol extraction twice with 10 times of amounts and 8 times of amounts 70%, merge extractive liquid, filters, and reclaims ethanol, is evaporated to relative density and measures 1.25-1.30 down for 60 ℃, and drying under reduced pressure makes dry extract;
C) dry extract is broken into powder, adds propolis, chromium picolinate, drying, the snap fit capsule of packing into.
Embodiment 2:
The preparation of the granule of pharmaceutical composition of the present invention
A) take by weighing Radix Astragali 30kg, Rhizoma Polygonati 15kg, Rhizoma Anemarrhenae 12kg, Radix Ophiopogonis 12kg, chromium picolinate 0.009kg, propolis 0.5kg, standby;
B) with the Radix Astragali, Rhizoma Polygonati, the Rhizoma Anemarrhenae and the Radix Ophiopogonis ethanol extraction twice with 10 times of amounts and 8 times of amounts 70%, merge extractive liquid, filters, and reclaims ethanol, is evaporated to relative density and measures 1.25-1.30 down for 60 ℃, and drying under reduced pressure makes dry extract;
C) dry extract is pulverized, added propolis, chromium picolinate, add appropriate amount of starch and make filler, make granule.
Embodiment 3:
The preparation of the granule of pharmaceutical composition of the present invention
A) take by weighing Radix Astragali 25kg, Rhizoma Polygonati 10kg, Rhizoma Anemarrhenae 8kg, Radix Ophiopogonis 8kg, chromium picolinate 0.004kg, propolis 0.4kg, standby;
B) Radix Astragali, Rhizoma Polygonati, the Rhizoma Anemarrhenae and Radix Ophiopogonis are extracted twice with 10 times of amounts and 8 times of water gagings, merge extractive liquid, filters, and reclaims ethanol, is evaporated to relative density and measures 1.25-1.30 down for 60 ℃, and drying under reduced pressure makes dry extract;
C) dry extract is pulverized, added propolis, chromium picolinate, add ethanol and make adhesive, add appropriate amount of starch and make filler, make granule.
Embodiment 4:
The preparation of the tablet of pharmaceutical composition of the present invention
A) take by weighing Radix Astragali 9kg, Rhizoma Polygonati 9kg, Rhizoma Anemarrhenae 6kg, Radix Ophiopogonis 6kg, chromium picolinate 0.001kg, propolis 0.1kg, standby;
B) with the Radix Astragali, Rhizoma Polygonati, the Rhizoma Anemarrhenae and the Radix Ophiopogonis ethanol extraction twice with 10 times of amounts and 8 times of amounts 80%, merge extractive liquid, filters, and reclaims ethanol, is evaporated to relative density and measures 1.25-1.30 down for 60 ℃, and drying under reduced pressure makes dry extract;
C) dry extract is pulverized, added propolis, chromium picolinate, add adjuvant and make granule, and dry, and compacting is in flakes.
Embodiment 5:
The preparation of the effervescent tablet of pharmaceutical composition of the present invention
A) take by weighing Radix Astragali 25kg, Rhizoma Polygonati 12kg, Rhizoma Anemarrhenae 10kg, Radix Ophiopogonis 10kg, chromium picolinate 0.002kg, propolis 0.2kg, standby;
B) with the Radix Astragali, Rhizoma Polygonati, the Rhizoma Anemarrhenae and the Radix Ophiopogonis ethanol extraction twice with 10 times of amounts and 8 times of amounts 70%, merge extractive liquid, filters, and reclaims ethanol, is evaporated to relative density and measures 1.25-1.30 down for 60 ℃, and drying under reduced pressure makes dry extract;
C) dry extract is pulverized, added propolis, chromium picolinate, add tartaric acid, sodium bicarbonate, sweeting agent, filler mixing, granulate with dehydrated alcohol, drying adds the lubricant mixing, tabletting, promptly.
Embodiment 6:
The preparation of the dispersible tablet of pharmaceutical composition of the present invention
A) take by weighing Radix Astragali 15kg, Rhizoma Polygonati 10kg, Rhizoma Anemarrhenae 9kg, Radix Ophiopogonis 9kg, chromium picolinate 0.003kg, propolis 0.3kg, standby;
B) with the Radix Astragali, Rhizoma Polygonati, the Rhizoma Anemarrhenae and the Radix Ophiopogonis ethanol extraction twice with 10 times of amounts and 8 times of amounts 70%, merge extractive liquid, filters, and reclaims ethanol, is evaporated to relative density and measures 1.25-1.30 down for 60 ℃, and drying under reduced pressure makes dry extract;
C) dry extract is pulverized, added propolis, chromium picolinate, add disintegrating agent, filler or diluent, mix homogeneously adds binding agent and makes soft material, the system granule, and drying adds part disintegrating agent, fluidizer or lubricant mixing, tabletting, promptly.
Claims (5)
1, a kind of pharmaceutical composition with hypoglycemic activity, it is characterized in that said composition is to be made by following bulk drugs: Radix Astragali 9-30 part, Rhizoma Polygonati 9-15 part, Rhizoma Anemarrhenae 6-12 part, Radix Ophiopogonis 6-12 part, chromium picolinate 0.001-0.009 part, propolis 0.1-0.5 part.
2, pharmaceutical composition according to claim 1 is characterized in that, said composition is to be made by following bulk drugs: 20 parts of the Radixs Astragali, 12 parts of Rhizoma Polygonatis, 9 parts of the Rhizoma Anemarrhenaes, 9 parts of Radix Ophiopogonis, 0.006 part of chromium picolinate, 0.3 part of propolis.
3, claim 1 or 2 described preparation of drug combination methods is characterized in that this method is:
The Radix Astragali, Rhizoma Polygonati, the Rhizoma Anemarrhenae, Radix Ophiopogonis of described weight proportion added water or ethanol extracts, extracting solution is concentrated, drying makes dry extract, is ground into powder, adds propolis, chromium picolinate, is prepared into active component; The gained active component is mixed with adjuvant, make any medicament on the pharmaceutics.
4, according to the described preparation of drug combination method of claim 3, it is characterized in that this method is:
Twice of the ethanol extraction of 10 times of amounts and 8 times of amounts 70% will be added the Radix Astragali, Rhizoma Polygonati, the Rhizoma Anemarrhenae, Radix Ophiopogonis of described weight proportion, merge extractive liquid,, filter, reclaim ethanol, be evaporated to relative density and measure 1.25-1.30, drying under reduced pressure down for 60 ℃, make dry extract, be ground into powder, add propolis, chromium picolinate, be prepared into active component; The gained active component is mixed with adjuvant, make any medicament on the pharmaceutics.
5, claim 1 or 2 described pharmaceutical compositions are used to prepare prevention and the medicine of treatment diabetes or the application of health food.
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102380051A (en) * | 2010-09-06 | 2012-03-21 | 柯依坤 | Medicinal steamed bread for treating diabetes |
CN102475712A (en) * | 2010-11-30 | 2012-05-30 | 上海羿康生物科技有限公司 | Pharmaceutical composition for preventing and treating diabetes and complications thereof |
CN109394968A (en) * | 2018-12-06 | 2019-03-01 | 东阿阿胶股份有限公司 | Composition and its application with auxiliary hyperglycemic function |
CN109430721A (en) * | 2018-10-17 | 2019-03-08 | 广州市好孝心医疗器械有限公司 | A kind of wheat embryo composition and preparation method thereof with hypoglycemic effect |
CN109588718A (en) * | 2018-12-06 | 2019-04-09 | 东阿阿胶股份有限公司 | The preparation method of health food with auxiliary hyperglycemic function |
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2007
- 2007-11-16 CN CNA2007101774885A patent/CN101433667A/en active Pending
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102380051A (en) * | 2010-09-06 | 2012-03-21 | 柯依坤 | Medicinal steamed bread for treating diabetes |
CN102380051B (en) * | 2010-09-06 | 2013-10-30 | 柯依坤 | Medicinal steamed bread for treating diabetes |
CN102475712A (en) * | 2010-11-30 | 2012-05-30 | 上海羿康生物科技有限公司 | Pharmaceutical composition for preventing and treating diabetes and complications thereof |
CN102475712B (en) * | 2010-11-30 | 2013-05-01 | 上海羿康生物科技有限公司 | Pharmaceutical composition used for preventing and treating diabetes and complications thereof |
CN109430721A (en) * | 2018-10-17 | 2019-03-08 | 广州市好孝心医疗器械有限公司 | A kind of wheat embryo composition and preparation method thereof with hypoglycemic effect |
CN109394968A (en) * | 2018-12-06 | 2019-03-01 | 东阿阿胶股份有限公司 | Composition and its application with auxiliary hyperglycemic function |
CN109588718A (en) * | 2018-12-06 | 2019-04-09 | 东阿阿胶股份有限公司 | The preparation method of health food with auxiliary hyperglycemic function |
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Open date: 20090520 |