CN103550281B - The pharmaceutical composition of a kind of prevention and therapy diabetes and complication thereof and preparation thereof - Google Patents
The pharmaceutical composition of a kind of prevention and therapy diabetes and complication thereof and preparation thereof Download PDFInfo
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Abstract
The invention provides the pharmaceutical composition of a kind of prevention and therapy diabetes and complication thereof, it is made up of the component of following weight proportion: the Radix Notoginseng extract of 40 ~ 120 parts, the Radix Panacis Quinquefolii extract of 60 ~ 180 parts, the chromium picolinate of 0.2 ~ 0.6 part and the Fructus Momordicae charantiae extract of 10 ~ 70 parts.The non-enzymatic glycation of pharmaceutical composition energy blood sugar lowering of the present invention, effectively Profilin matter, therefore effectively can prevent and treat the diabetic complication such as atherosclerosis, diabetic nephropathy, diabetic cardiovascular disease change, diabetic renal papillary necrosis caused by the nonenzymatic glycosylation of protein.The present invention also provides the preparation of prevention and therapy diabetes and the complication thereof prepared by described pharmaceutical composition.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of prevention and therapy diabetes and complication thereof, and the preparation prepared by this pharmaceutical composition.
Background technology
Diabetes are whole body chronic progressive diseases that metabolism disorder causes, and belong to the traditional Chinese medical science and to quench one's thirst category.In recent years, along with raising and the living-pattern preservation of people's living standard, the sickness rate of diabetes is in the trend significantly risen, and become the third-largest disease after malignant tumor and cardiovascular disease, the health of the mankind in serious threat.Diabetes take persistent high blood sugar as a kind of complex disease of basic biochemical character.The hyperglycemia state continued can cause the non-enzymatic glycation in body to accelerate, thus causes advanced glycosylation end-products accumulation in vivo.Advanced glycosylation end-products can change protein structure and function, affects lipid metabolism, modification of nucleic acids and induced oxidation stress, be the principal element that diabetic complication occurs.Protein non-enzyme glycosylation can't be stopped because blood glucose is controlled, final like this generation and the development that can cause chronic complicating diseases of diabetes, as atherogenesis, cardiopulmonary compliance lowers, lenticular opacity causes cataract, glomerular basement membrane permeability raises and causes diabetic nephropathy etc.The treatment of people to diabetes in the past focuses on the control of blood glucose, but going deep into along with research, protein non-enzyme glycosylation reaction is subject to people's attention day by day with the relation of diabetic complication.The non-enzymatic glycation of body internal protein is relevant with the pathomechanism of a lot of complication, by blocking non-enzymatic glycation thus the generation development preventing and treating above-mentioned disease is the New Policy in pharmacotherapeutics field in recent years.
Research both domestic and external shows, diabetes and complication thereof are the diseases that can control, and selects best Scientific Treatment method to be the key of preventing and treating diabetes and complication thereof.At present, treatment diabetes are on the basis of diet and exercise therapy, the methods such as doctor trained in Western medicine many employings oral antidiabetic drug (sulphanylureas, biguanides) or insulin injection, although this can reduce blood glucose effectively, but most of blood sugar lowering Western medicine still rests on the stage of curing the symptoms, not the disease, and diabetics can be caused to produce drug resistance, cause hypoglycemia, merge the multiple toxic and side effects in various degree such as renal function reduction, accelerate generation and the development of diabetic complication.
Chinese medicine has its clear superiority in treatment diabetes, and Recent study finds, the reduction blood glucose effect side effect of Chinese medicine is little, has manifold effect, multidigit point and the advantage such as multi-functional.In recent years, the raw material that research worker make use of several integration of edible and medicinal herbs such as Radix Ginseng, Fructus Momordicae charantiae proposes some and has the health food and medicine that improve blood glucose function, but blood sugar decreasing effect is still not ideal enough, and especially in prevention and therapy complication, curative effect is not remarkable.
The present invention, just based on above-mentioned background technology, proposes a kind ofly significantly to reduce blood glucose and can the pharmaceutical composition of prevention and therapy diabetic complication, for the control of diabetes is offered help.
Summary of the invention
The object of the invention is to: the pharmaceutical composition that a kind of prevention and therapy diabetes and complication thereof are provided.
The present invention also aims to: the preparation preventing and treating diabetes prepared with described Chinese medicine composition is provided.
Object of the present invention is achieved through the following technical solutions:
There is provided the pharmaceutical composition of a kind of prevention and therapy diabetes and complication thereof, it is made up of the component of following weight proportion:
The Radix Notoginseng extract of 40 ~ 120 parts, the Radix Panacis Quinquefolii extract of 60 ~ 180 parts, the chromium picolinate of 0.2 ~ 0.6 part and the Fructus Momordicae charantiae extract of 10 ~ 70 parts.
Described Chinese medicine composition, is preferably made up of the component of following weight proportion: the Radix Notoginseng extract of 40 ~ 100 parts, the Radix Panacis Quinquefolii extract of 80 ~ 150 parts, the chromium picolinate of 0.3 ~ 0.6 part and the Fructus Momordicae charantiae extract of 25 ~ 60 parts.
Described Chinese medicine composition, the preferred component by following weight proportion forms further: the Radix Notoginseng extract of 60 ~ 80 parts, the Radix Panacis Quinquefolii extract of 80 ~ 100 parts, the chromium picolinate of 0.4 ~ 0.5 part and the Fructus Momordicae charantiae extract of 25 ~ 50 parts.
A kind of most preferred pharmaceutical composition of the present invention, is made up of the component of following weight proportion: the Radix Notoginseng extract of 60 parts, the Radix Panacis Quinquefolii extract of 80 parts, the chromium picolinate of 0.41 part and the Fructus Momordicae charantiae extract of 50 parts.
The another kind of most preferred pharmaceutical composition of the present invention, is made up of the component of following weight proportion: the Radix Notoginseng extract of 75 parts, the Radix Panacis Quinquefolii extract of 80 parts, the chromium picolinate of 0.5 part and the Fructus Momordicae charantiae extract of 35 parts.
Another most preferred pharmaceutical composition of the present invention, is made up of the component of following weight proportion: the Radix Notoginseng extract of 70 parts, the Radix Panacis Quinquefolii extract of 95 parts, the chromium picolinate of 0.45 part and the Fructus Momordicae charantiae extract of 25 parts.
In described Chinese medicine composition, Radix Notoginseng extract derives from panax araliaceae plant Panaxnotoginseng(Burk.) root extract of F.H.Chen is brown color powder; Radix Panacis Quinquefolii extract derives from the root extract of Araliaceae Radix Panacis Quinquefolii PanaxquinquefoliumL., is brown powder product; Fructus Momordicae charantiae extract derives from the fruit extract of cucurbitaceous plant Fructus Momordicae charantiae MomordicaCharantiaL., is brown ceramic powder; Chromium picolinate (Chromiumpicolinate) molecular formula is Cr (C
6h
4nO
2)
3, molecular weight is 418.33, this strain burgundy crystals fine powder.
The all commercially available acquisition of extract in described Chinese medicine composition, the preparation method of described Chinese medicine composition is simply mixed by described several Chinese medicine extract.
The present invention also provides the preparation preventing and treating diabetes and complication thereof prepared with described Chinese medicine composition.
Described preparation contains described Chinese medicine composition and customary adjuvant, and wherein said adjuvant accounts for 15% ~ 65% of total formulation weight amount.
Described adjuvant can be one or more in disintegrating agent, filler, lubricant, correctives or excipient.Wherein said disintegrating agent can be starch; Described filler can be starch or dextrin; Described lubricant can be magnesium stearate; Described correctives can be lactose; Described excipient can be microcrystalline Cellulose.
The dosage form of described preparation can be hard capsule, tablet or granule.
The hard capsule preparation of diabetes and complication thereof such as can be prevented and treated in accordance with the following methods with Chinese medicine composition preparation of the present invention:
Step 1: take the Radix Notoginseng extract, Radix Panacis Quinquefolii extract, Fructus Momordicae charantiae extract, the chromium picolinate that are up to the standards by formula proportion;
Step 2: add appropriate filler, disintegrating agent, mix homogeneously;
Step 3: be filled to capsule with Autocapsulefillingmachine;
Step 4: by above-mentioned capsule granulate, polishing, packaging.
The common medicinal supplementary material that in step 2, indication filler, disintegrating agent specify for meeting 2010 editions " Chinese Pharmacopoeia " pharmaceutic adjuvant standards, as starch etc.
The Radix Notoginseng extract main component that the present invention adopts is Radix Notoginseng total arasaponins; there is obvious blood vessel dilating, improve hemodynamics, effect of inhibition thrombosis, reduction myocardial oxygen consumption; to myocardial cell ischemia injury, there is direct protective effect; clinical being usually used in treats coronary heart disease, arrhythmia, apoplexy and apoplexy sequela, and the cardiovascular pathological changes cause diabetes and diabetic nephropathy have good therapeutical effect.Radix Panacis Quinquefolii extract can stimulate the generation of insulin, the loss of prevention β cell by suppressing the activity of mitochondrion UCP-2, improve ATP level, cloning Bcl-2 is increased, lower short apoptosis factor Caspase-9 simultaneously, reduce apoptotic generation, thus improve the blood sugar level of diabetics.Radix Panacis Quinquefolii also has the formation of Profilin matter nonenzymatic glycosylation end-product (AGEs), changes platelet adhesion reaction and coherent condition, has and improve microcirculation, anticoagulation and prevent thrombosis effect, have good preventive and therapeutic action to diabetic complication.Fructus Momordicae charantiae extract has stimulating activity G cells secrete insulin, para-insulin effect and promotes the effect of liver glycogen synthesis.Chromium picolinate, trivalent chromium is the important component part of glucose tolerance factor (GTF), histiocyte can be directly acted on smoothly by cell membrane, increase insulin active (sensitivity), make it active to strengthen, involved in sugar metabolic process, prevents the blood glucose caused because of insulin generation or underutilization to raise safely and effectively, thus makes it the effective ingredient becoming auxiliary adjustment blood sugar in diabetic patients level.
Pharmaceutical composition of the present invention is on prior art basis, and find with groping through lot of experiments, after reaching particular range by regulating the ratio of above-mentioned several component, the blood sugar decreasing effect of compositions can be promoted significantly.Specifically, the present inventor finds in test, can produce synergism, significantly reduce blood sugar level after Radix Notoginseng extract, Radix Panacis Quinquefolii extract and Fructus Momordicae charantiae extract compatibility.But the present inventor also finds further, and be the compatibility of three equally, the synergism under different proportion compatibilities is significantly different.Particularly when the ratio of Fructus Momordicae charantiae extract is higher than Radix Notoginseng extract and Radix Panacis Quinquefolii extract, not only the hypoglycemic activity of its entirety is starkly lower than the compatibility of Fructus Momordicae charantiae extract ratio lower than Radix Notoginseng extract and Radix Panacis Quinquefolii extract, and, in Profilin matter non-enzymatic glycation, effect is especially remarkable.Therefore, the present inventor obtains the formula of pharmaceutical composition of the present invention through lot of experiments screening, and remarkable blood sugar lowering, Profilin matter non-enzymatic glycation effect that through experimental verification, this pharmaceutical composition has.
The efficacy test results of Chinese medicine composition of the present invention is as follows:
1. experiment material
1.1 test specimen
Given the test agent: product prepared by the embodiment of the present invention 1.
High Fructus Momordicae charantiae content reference substance: the product that Radix Notoginseng extract 40g, Radix Panacis Quinquefolii extract 40g, chromium picolinate 0.45g, Fructus Momordicae charantiae extract 130g, starch 189.55g are prepared through the embodiment of the present invention 1 same procedure.
1.2 laboratory animal
Thered is provided by Hubei Province's Experimental Animal Center, male mice in kunming, body weight (20.0 ± 2.0) g.
1.3 instruments and reagent
1.3.1 instrument RF-5301PC spectrofluorophotometer (Japanese Shimadzu Corporation), UV-2501 ultraviolet-visible spectrophotometer (Japanese Shimadzu Corporation).
1.3.2 reagent aminoguanidine Hemisulphate, alloxan available from Sigma; Bovine serum albumin is purchased from Jiang Lai bio tech ltd, Shanghai.Glucose estimation kit is purchased from Sen Beijia bio tech ltd, Nanjing.All the other experimental drugs are commercially available analytical pure.
1.4 dose design
Be 0.02g/kgBW by test product human body recommended amounts, establish low, high two dose of test sample sets with these 10,20 times, be respectively 0.2,0.4g/kgBW.High Fructus Momordicae charantiae content matched group establishes 0.4g/kgBW dosage group.
2. method
2.1 external protein non-enzyme glycosylation reaction and mensuration
Prepare that whole mass concentration is 5.0g/L bovine serum albumin with pH7.2 phosphate buffer, the liquid of 3mmol/L sodium azide and 1mol/L glucose.Pharmaceutical intervention group add in glycosylation system aminoguanidine, by test product or high Fructus Momordicae charantiae content reference substance, wherein, aminoguanidine group is for containing aminoguanidine 4mmol/L, by test product component be 0.2,0.4g/kgBW two groups, high Fructus Momordicae charantiae content matched group is 0.4g/kgBW, do not add glucose in blank group reaction system, hatch 7 ~ 28d continuously respectively under 37 DEG C of constant temperature lucifuge conditions.Respectively at 7,14,21,28d gets different experiments group sample and preserves to be measured in-70 DEG C of refrigerator freezings.Glycosylated protein can produce fluorescence, and this experimentation understands the suppression situation by test product by the situation of change measuring fluorescence-causing substance.Each sample is through fluorescence spectrophotometry assay.Each parameter is respectively excitation wavelength 370nm, emission wavelength 440nm, sensitivity 2, gain 5, stitches wide 5nm.
2.2 in body zoopery
Disposable tail vein injection alloxan 80mg/kg, makes diabetic mouse model.Fasting 3h after 5 days, gets blood from survival mice vena ophthalmica, and surveying blood glucose value is that 16 ~ 25mmol/L person is selected.Get qualified mice 40, be divided into model group, high Fructus Momordicae charantiae content group at random, by test product low dose group with by test product high dose group, often organize 10, separately get healthy mice 10 and only make Normal group.Normal mouse group, model group and carry out gastric infusion with normal saline and Fructus Momordicae charantiae extract respectively, every day 1 time, continuous 30d by test product group.Last administration fasting 5h, surveys fasting glucose, more each treated animal blood glucose value and blood glucose down ratio.Each group of mice gavage 2.0g/kgBW glucose solution again, measuring blood glucose value respectively at getting tail blood after 0h, 0.5h, 2h, observing tested material to the impact of blood glucose and carbohydrate tolerance after alloxan hyperglycemia model mouse glucose load.Put to death each group of mice after fasting 12h, cut open the belly rapidly and take out the heart, liver, kidney, preserve in-70 DEG C of refrigerator freezings, to be measured.
The mensuration of nonenzymatic glycosylation product in 2.3 hearts, liver, nephridial tissue
Shredded by tissue, add chloroform-methanol (2:1) 5mL degrease in homogenate, centrifugation, 4 DEG C of shakes spend the night, and rinse, spend the night, add collagenase at HEPES buffer through aquation, 37 DEG C of concussion digestion 24h.Centrifuging and taking supernatant, spectrofluorophotometer measures fluorescence intensity at 370nm/440nm place.Be any flat fluorescent AUF with HEPES buffer fluorescent value, fluorescent intensity is converted according to this.
2.4 statistical procedures
Application SPSS11.5 statistical software carries out date processing, and group difference significance compares employing t inspection.P < 0.05 has statistical significance.
3 results
The inhibitory action of 3.1 pairs of external protein non-enzyme glycosylations
Experiment in vitro shows (table 1), along with the prolongation of time, model group nonenzymatic glycosylation product produces and increases gradually, the effect all having Profilin matter nonenzymatic glycosylation by test product group of each concentration, comparing with high Fructus Momordicae charantiae content group by test product group of each concentration, the effect of its Profilin matter nonenzymatic glycosylation is more remarkable, and in concentration-inhibitory action positive correlation, wherein completely inhibit the generation of external protein non-enzyme glycosylation by test product high dose group, by test product and high Fructus Momordicae charantiae content group comparative effectiveness remarkable.
Table 1 is subject to the different incubation time of test product on the impact of protein non-enzyme glycosylation
Note:
*p < 0.01 is compared with blank group;
△ △p < 0.01 is compared with model group;
▲ ▲p < 0.01 is compared with high Fructus Momordicae charantiae content group.3.2 impacts that AGEs in the diabetic mice heart, liver, kidney is generated
By test product AGEs in diabetic mice tissue generated and there is inhibitory action significantly, and present control of the concentration effect positive correlation, by test product and high Fructus Momordicae charantiae content group comparative effectiveness remarkable.In table 2.
The impact (AUF/mg) that table 2 generates AGEs in the diabetic mice heart, liver, kidney by test product
Note:
*p < 0.05 is compared with blank group;
*p < 0.01 is compared with blank group;
△p < 0.05 is compared with model group;
△ △p < 0.01 is compared with model group;
▲p < 0.05 is compared with high Fructus Momordicae charantiae content group;
▲ ▲p < 0.01 is compared with high Fructus Momordicae charantiae content group.
3.3 impacts on hyperglycemia model mice fasting glucose
Getting 10 animals survey fasting glucose before modeling is at random 6.0 ± 1.1mmol/L, from table 3, after modeling type, each group mice fasting glucose obviously raises (18.6 ± 1.71mmol/L), has significance (P < 0.01), illustrate that model is set up with comparing difference before modeling.After test, by test product each dosage group mice fasting glucose all lower than model and high Fructus Momordicae charantiae content group, difference has significance, model and high Fructus Momordicae charantiae content group is all greater than by test product each dosage group blood glucose rate of descent, difference compares with matched group significance, illustrate that tested material has alloxan hyperglycemia model mice and fall hypoglycemic effect, and Be very effective is better than high Fructus Momordicae charantiae content group.
Table 3 is on the impact (mmol/L) of hyperglycemia model mice fasting glucose
Note:
△p < 0.05 is compared with model group;
△ △p < 0.01 is compared with model group;
▲p < 0.05 is compared with high Fructus Momordicae charantiae content group;
▲ ▲p < 0.01 is compared with high Fructus Momordicae charantiae content group.
3.4 impacts on alloxan hyperglycemia model glucose tolerance in mice:
After giving glucose solution by test product each dosage treated animal, 0h, 0.5h, 2h blood glucose value is all lower than model group and high Fructus Momordicae charantiae content group, and difference has significance, in table 4; After giving sugar, under each dosage group glucose curve, area is less than model and high Fructus Momordicae charantiae content group, and difference has significance, in table 5; Prompting tested material has the effect raising carbohydrate tolerance to hyperglycemia model mice, and Be very effective is better than high Fructus Momordicae charantiae content group.
Table 4 gives the impact (mmol/L) of the rear blood glucose of sugar to hyperglycemia model mice
Note:
△p < 0.05 is compared with model group;
△ △p < 0.01 is compared with model group;
▲p < 0.05 is compared with high Fructus Momordicae charantiae content group;
▲ ▲p < 0.01 is compared with high Fructus Momordicae charantiae content group.
Table 5 gives the impact (hmmol/L) of the rear blood glucose of sugar to hyperglycemia model mice
Note:
△ △p < 0.01 is compared with model group;
▲p < 0.05 is compared with high Fructus Momordicae charantiae content group;
▲ ▲p < 0.01 is compared with high Fructus Momordicae charantiae content group.
In sum, the present invention with existing with Fructus Momordicae charantiae be primary raw material Chinese medicine composition compared with, there is hypoglycemic effect more significantly, the more important thing is, compositions of the present invention can effective Profilin matter nonenzymatic glycosylation end-product (advancedglycationendproducts in control diabetic complication, AGEs) formation, evident in efficacy to diabetic complication.
Specific embodiment
Following examples are the examples using Chinese medicine composition of the present invention preparation to prevent and treat the preparation of diabetes.
Embodiment one
1. take Radix Notoginseng extract 70g, Radix Panacis Quinquefolii extract 90g, chromium picolinate 0.45g, Fructus Momordicae charantiae extract 30g, starch 209.55g bacterium inspection respectively, qualified for subsequent use.
2. by material mix homogeneously each described in 1, be then filled to capsule with fully-automatic capsule machine, every capsules content is 400mg, obtained 1000 altogether.
3. by gained capsule granulate, polishing, inspection, packaging in 2.
Embodiment two
1. by Radix Notoginseng extract 60g, Radix Panacis Quinquefolii extract 80g, chromium picolinate 0.41g, Fructus Momordicae charantiae extract 50g, starch 209.59g bacterium inspection respectively, qualified for subsequent use.
2. by material mix homogeneously each described in 1, be then filled to capsule with fully-automatic capsule machine, every capsules content is 400mg, obtained 1000 altogether.
3. by gained capsule granulate, polishing, inspection, packaging in 2.
Embodiment three
1. take Radix Notoginseng extract 70g, Radix Panacis Quinquefolii extract 90g, chromium picolinate 0.35g, Fructus Momordicae charantiae extract 30g, 193.65g starch, 15g microcrystalline Cellulose and 1g magnesium stearate, for subsequent use after bacterium inspection respectively;
2. by material (except magnesium stearate) mix homogeneously each described in step 1, with 60% ~ 80% alcohol granulation, dry, granulate, adds magnesium stearate, and mixing, is pressed into 1000, the tablet prevented diabetes.
Embodiment four
1. take Radix Notoginseng extract 70g, Radix Panacis Quinquefolii extract 90g, chromium picolinate 0.35g, Fructus Momordicae charantiae extract 50g, 174.65g starch, 15g microcrystalline Cellulose, for subsequent use after bacterium inspection respectively;
2., by material mix homogeneously each described in step 1, with 60% ~ 80% alcohol granulation, dry, granulate, is distributed into the granule 1000 bags prevented diabetes.
Claims (8)
1. the pharmaceutical composition of prevention and therapy diabetes and complication thereof, it is characterized in that, it is made up of the component of following weight proportion: the Radix Notoginseng extract of 60 ~ 80 parts, the Radix Panacis Quinquefolii extract of 80 ~ 100 parts, the chromium picolinate of 0.4 ~ 0.5 part and the Fructus Momordicae charantiae extract of 25 ~ 50 parts.
2. pharmaceutical composition according to claim 1, is characterized in that, described Chinese medicine composition is made up of the component of following weight proportion: the Radix Notoginseng extract of 60 parts, the Radix Panacis Quinquefolii extract of 80 parts, the chromium picolinate of 0.41 part and the Fructus Momordicae charantiae extract of 50 parts.
3. pharmaceutical composition according to claim 1, is characterized in that, described Chinese medicine composition is made up of the component of following weight proportion: the Radix Notoginseng extract of 75 parts, the Radix Panacis Quinquefolii extract of 80 parts, the chromium picolinate of 0.5 part and the Fructus Momordicae charantiae extract of 35 parts.
4. pharmaceutical composition according to claim 1, is characterized in that, described Chinese medicine composition is made up of the component of following weight proportion: the Radix Notoginseng extract of 70 parts, the Radix Panacis Quinquefolii extract of 95 parts, the chromium picolinate of 0.45 part and the Fructus Momordicae charantiae extract of 25 parts.
5., for a preparation for prevention and therapy diabetes and complication thereof, it is characterized in that: containing pharmaceutical composition according to claim 1 and customary adjuvant, wherein said adjuvant accounts for 15% ~ 65% of total formulation weight amount.
6. preparation according to claim 5, is characterized in that: described adjuvant is one or more in disintegrating agent, filler, lubricant, correctives or excipient.
7. preparation according to claim 6, is characterized in that: described disintegrating agent is starch; Described filler is starch or dextrin; Described lubricant is magnesium stearate; Described correctives is lactose; Described excipient is microcrystalline Cellulose.
8. preparation according to claim 6, is characterized in that: described preparation formulation is hard capsule, tablet or granule.
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| CN102871116A (en) * | 2011-07-14 | 2013-01-16 | 重庆市生物技术研究所有限责任公司 | Traditional Chinese medicine type blood sugar-lowering health care food |
| CN103082298A (en) * | 2013-01-17 | 2013-05-08 | 吉林省中药制剂工程研究中心有限公司 | Health-care food for reducing blood glucose in assisted mode and preparation method thereof |
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| CN102871116A (en) * | 2011-07-14 | 2013-01-16 | 重庆市生物技术研究所有限责任公司 | Traditional Chinese medicine type blood sugar-lowering health care food |
| CN103082298A (en) * | 2013-01-17 | 2013-05-08 | 吉林省中药制剂工程研究中心有限公司 | Health-care food for reducing blood glucose in assisted mode and preparation method thereof |
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