CN105535070B - The pharmaceutical composition and its preparation method and application for treating diabetes - Google Patents
The pharmaceutical composition and its preparation method and application for treating diabetes Download PDFInfo
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Abstract
The invention discloses a kind of pharmaceutical compositions for treating diabetes.Described pharmaceutical composition is the medicament made of the raw material of following weight: 9 ~ 55 parts of Radix et Rhizoma Gynurae divaricatae, 7 ~ 53 parts of Fructus Corni.The pharmaceutical composition is only used as medicine by Radix et Rhizoma Gynurae divaricatae and two taste Chinese medicine compatibility of Fructus Corni, and adjusting its weight is 9 ~ 55 parts of Radix et Rhizoma Gynurae divaricatae, 7 ~ 53 parts of Fructus Corni, Radix et Rhizoma Gynurae divaricatae and Fructus Corni is set to play synergistic effect, it is significant to treat diabetes curative effect, and the pharmaceutical composition component is simple, quality is easy to control, it is curative for effect.The present invention also provides the preparation method of described pharmaceutical composition, which can effectively extract the active pharmaceutical ingredient in Radix et Rhizoma Gynurae divaricatae and Fructus Corni, and easy to operate.The present invention further provides application of the described pharmaceutical composition in the drug that preparation improves diabetes, hyperlipidemia or metabolic syndrome.
Description
Technical field
The invention belongs to pharmaceutical fields, are related to a kind of pharmaceutical composition, in particular to a kind of to treat diabetes or hyperlipidemia
Pharmaceutical composition and its preparation method and application.
Background technique
Diabetes (diabetes mellitus, DM) are impaired caused with hypoinsulinism or its biological effect
Metabolic disease characterized by hyperglycemia.According to the opposite of insulin secretion with can absolutely not be divided into type-1 diabetes mellitus and II completely
Patients with type Ⅰ DM；Wherein by islet beta cell function failure, diabetes caused by excreting insulin absolute magnitude is insufficient are type-1 diabetes mellitus；
It is sufficient with excreting insulin absolute magnitude, and because caused by insulin resistance diabetes type-2 diabetes mellitus.Cut-off 2014, in
State diabetic more than 100,000,000 people, accounts for the one third of whole world patient populations.More importantly with domestic population
Aging and the change of resident living mode are so that obvious ascendant trend is presented in diabetes prevalence.It is aobvious according to health ministry investigation
Show, China is 3000 about newly-increased daily, every year at least newly-increased 1,200,000 diabetics [Hu Shanlian, Liu Guoen, perhaps camphor tree
Honor waits the China diabetes epidemiology and study of disease financial burden status [J] China Health economy, 2008 (08):
5-8.].It can be seen that diabetes have become the significant problem for threatening broad masses of the people's general level of the health, exploitation treatment diabetes
Superior drug always be the effort target of Chinese and western medical personal.
Currently, the conventional medicament for the treatment of diabetes mainly includes sulfonylurea drugs, biguanides, α glucuroide
Inhibitor, insulin sensitizer, Insulin secretagogues, insulin preparation etc..These drugs can by the intake of glucose,
The modes such as the secretion of insulin, the enhanced sensitivity of insulin or direct supplement insulin level, which play, reduces blood glucose effect, however above-mentioned
There is gastrointestinal reaction, the influence of liver kidney, heart or maincenter adverse reaction to some extent in drug.It is new according to diabetes in recent years
Pathogenesis research and develop and used different types of drug, such as be directed to glucagon-like-peptide-1 (glucagon-like
Peptide 1, GLP-1) receptor play a role GLP-1 class drug, to GLP-1 hydrolase DPP IV
The DPP-IV inhibitor and the sodium-glucose association paid close attention to by industry that (Dipeptidyl Peptidase IV, DPP-IV) works
Same transport protein (Sodium-glucose co-transporters, SGLT) inhibitor etc., these drugs are considered as
The breakthrough for treating diabetes.However there is different degrees of adverse reaction (pharyngitis, headache, the infection of the upper respiratory tract, evil
The heart, vomiting, diarrhea, constipation, kidney function damage, symptomatic hypotension, fungal infection etc.), and the treatment in some patientss is made
With still person of modern times does not anticipate.So clinical still there is an urgent need to develop curative for effect, toxic side effect is small, and the newtype drug of affordable.
In recent years, domestic and international experts and scholars increasingly pay attention to Chinese medicine and natural drug, and are applied to diabetes clinical treatment.
Radix et Rhizoma Gynurae divaricatae is " Chinese draft " precious Chinese herbal medicine for including, be compositae plant Gynura divaricata (Gynura divaricata(L.) DC.) herb, alias rescues greatly, big fat cow, and divaricate gynura root and rhizome, white young dish medicine dissipate blood ginger etc..Mainly at
Divide includes alkaloids, flavonoids, triterpenes and some long-chain fat same clans compound；With hypoglycemic, blood pressure lowering, drop blood
The pharmacological actions such as rouge, resist oxygen lack, anti-mutagenesis.Existing document report Radix et Rhizoma Gynurae divaricatae, which has experimental type 2 diabetes mellitus, significantly to be controlled
Treatment effect, mechanism may with the ability of enhancing body Scavenger of ROS, mitigate oxygen radical to the damage of beta Cell of islet, promote
Into beta Cell of islet reparation the effects of related [Ma Zhengdong, Chen Lei, Song Hongtao wait Radix et Rhizoma Gynurae divaricatae water extract to 2 types sugar
Urinate the hypoglycemic effect and its mechanism [J] Chinese herbal medicine of sick rat, 2010 (04): 623-626.].Separately there is the white back of document report
Radix Notoginseng improves significantly to Insulin Resistance of Rats, and mechanism of action may be with the table of up-regulation InsR mRNA
[Han Haifeng, Zhang Xueying, Shen Hongli wait Radix et Rhizoma Gynurae divaricatae to insulin resistance rat hepatic insulin expression of receptor up to related
Influence [J] Pharmacology and Clinics of Chinese Materia Medica, 2014 (05): 102-105.].In addition, still thering are related patents to report Radix et Rhizoma Gynurae divaricatae
Purposes in diabetes discloses one kind including patent of invention CN100475232C with Radix et Rhizoma Gynurae divaricatae extract as original
The oral drugs and purposes of material treatment diabetes.Patent of invention CN101147749B discloses the preparation of white-backed pseudo-ginseng total flavonoid
Method and its application in hypoglycemic medicine.Patent of invention CN102389454B, CN103191039B, CN103988964A,
CN102389454B discloses a kind of compound preparation being made of multiple flavour of a drug containing Radix et Rhizoma Gynurae divaricatae and its application.But it is above-mentioned about
Mutual reinforcement between mutually makes between suffering for want of medical supplies when the patent of Radix et Rhizoma Gynurae divaricatae is applied alone, and excessive compound is unfavorable for drug development again.Therefore, above special
Radix et Rhizoma Gynurae divaricatae extract or compound disclosed in benefit cannot still play the combination between Radix et Rhizoma Gynurae divaricatae and important antidiabetic medicine completely
Object advantage and clinical value.
Fructus Corni be Cornaceae plant Fructus Corni (Cornus officinalisSieb. et Zucc.) maturation
Dry fruit, containing ingredients such as cornin, saponin(e, tannin, ursolic acid and vitamin As, Traditional Chinese Medicine thinks that Fructus Corni has benefit
Liver kidney, arresting seminal emission gas, solid collapse and hypoglycemic and other effects.Fructus Corni is since Han dynasty always as the key medicine for treating " diabetes ".
Document report shows that Fructus Corni can significantly reduce blood glucose in diabetic mice level, improves serum insulin level, and to glycerol three
Ester also has decreasing trend, and [Yang Yong, Rong Rong, Jiang Chunhong wait Zhu English opposed polarity extract drop blood in the mountain to ward off the research China of effect
Pharmacological Bulletin, 2009,25 (suppl): 181.].Mountain cornel cornel can also increase hepatic glycogen content simultaneously, significantly reduce saccharification blood
Albumin levels, to significantly reduce blood glucose in diabetic mice level, [Korea Spro's Jing is super, and Ji Hui, Xue Chengfeng wait Fructus Corni total
Hypoglycemic effect [J] the China natural drug of terpene, 2006,4 (02) .125-129.].In addition, the Chinese medicine compound prescription containing Fructus Corni
It is more in use patent in diabetes, including patent of invention CN 103479874A, CN 103705723A, CN
104336715A, CN103749819A, CN 101040982, CN101904994A etc. disclose it is a kind of containing Fructus Corni by multiple
The compound preparation of flavour of a drug composition and its application.It is combined the very rare of object research with two taste Chinese medicines, especially with white back three
Seven have not been reported with Fructus Corni independent compatible use, and obtaining the epidemic proportion of its composition by research is even more blank.
By upper sight, it is simple, curative for effect to find component, it is low in cost and to the significant Chinese medicine for the treatment of diabetes curative effect at
Fang Feichang is urgently and important.
Summary of the invention
It is an object of the invention to overcome the above-mentioned deficiency in the presence of the prior art, a kind of medicine for treating diabetes is provided
Compositions.The pharmaceutical composition is 9 ~ 55 parts of Radix et Rhizoma Gynurae divaricatae according to weight by Radix et Rhizoma Gynurae divaricatae and Fructus Corni, Fructus Corni 7
~ 53 parts are raw material, and component is simple, curative for effect, and Radix et Rhizoma Gynurae divaricatae and Fructus Corni from improvement insulin sensitivity and increase insulin
Secretion aspect plays synergistic effect, can effectively treat diabetes, significant in efficacy.
It is a further object of the present invention to provide the preparation methods of described pharmaceutical composition.The preparation method simple process, can
The active constituent of Radix et Rhizoma Gynurae divaricatae and Fructus Corni is effectively extracted, the pharmaceutical composition of preparation is curative for effect, and treatment diabetes effect is aobvious
It writes.
Another object of the present invention is to provide the application of described pharmaceutical composition.
In order to achieve the above-mentioned object of the invention, the present invention provides following technical schemes:
The pharmaceutical composition for the treatment of diabetes of the present invention, is the medicament made of the raw material of following weight:
9 ~ 55 parts of Radix et Rhizoma Gynurae divaricatae, 7 ~ 53 parts of Fructus Corni.
The pharmaceutical composition for the treatment of diabetes of the present invention, using Radix et Rhizoma Gynurae divaricatae and Fructus Corni as medicinal raw material.It is wherein white
It is sweet in flavor to carry on the back Radix Notoginseng, it is light, it is mild-natured；Return lung, the heart two pass through.Function is to dispel to quench one's thirst, clearing heat and cooling blood, promoting blood circulation and hemostasis analgesic；It can be used for sugar
Urinate disease, bronchitis, metrorrhagia and metrostaxis, traumatic injury etc..Fructus Corni is sour, puckery, tepor；It is cool in nature；Return liver and kidney channel；With tonify the liver and kidney,
The effect of arresting seminal emission prevent prolapse.Papillary can dispel quench one's thirst, tonify the liver and kidney, arresting seminal emission prevent prolapse.
Inventor has found through test of many times, only using two kinds of medicinal materials of Radix et Rhizoma Gynurae divaricatae and Fructus Corni as raw material, and adjusts white back three
Seven and Fructus Corni weight be 9 ~ 55 parts of Radix et Rhizoma Gynurae divaricatae, 7 ~ 53 parts of Fructus Corni, can effectively treat diabetes.The present invention
Described pharmaceutical composition is compared with the pharmaceutical composition of existing treatment diabetes, and component is simpler, and only there are two types of bulk pharmaceutical chemicals
Material is allowed to the available better control of quality, curative for effect, has no toxic and side effect to human body.Meanwhile it is aobvious to diabetes curative effect
It writes, and taking dose is small.
Diabetes of the present invention include type-1 diabetes mellitus, type-2 diabetes mellitus or insulin resistance related disease.
Preferably, described pharmaceutical composition is the medicament made of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 15 ~ 50
Part, 7 ~ 42 parts of Fructus Corni.
It is further preferred that described pharmaceutical composition is the medicament made of the raw material of following weight: white back three
7 15 ~ 30 parts, 7 ~ 25 parts of Fructus Corni.
It is further preferred that described pharmaceutical composition is the medicament made of the raw material of following weight: white back three
7 15 ~ 25 parts, 7 ~ 20 parts of Fructus Corni.
It is further preferred that described pharmaceutical composition is the medicament made of the raw material of following weight: white back
20 ~ 25 parts of Radix Notoginseng, 9 ~ 11 parts of Fructus Corni.
By to the preferred of Radix et Rhizoma Gynurae divaricatae in pharmaceutical composition and Fructus Corni weight, can be further improved above
Curative effect of the pharmaceutical composition to treatment diabetes.
Most preferably preferably, described pharmaceutical composition is the medicament made of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae
22 parts, 10 parts of Fructus Corni.Preferably by this, the pharmaceutical composition can be made to reach best to the curative effect for the treatment of diabetes.
The preparation method of the pharmaceutical composition of above-mentioned treatment diabetes, comprising the following steps:
(1) Radix et Rhizoma Gynurae divaricatae medicinal material is taken, is added water to cook extraction 2 ~ 3 times, decocting extraction time every time is 1 ~ 3h, is filtered, and is merged
Filtrate is concentrated under reduced pressure, dry, obtains Radix et Rhizoma Gynurae divaricatae extract；
(2) Fructus Corni is taken, crushes as coarse powder, is extracted 2 ~ 3 times using the alcohol reflux of 40-80%, each return time
For 1 ~ 3h, filtering, merging filtrate is concentrated under reduced pressure, dry, obtains cornel extractive；
(3) above-mentioned Radix et Rhizoma Gynurae divaricatae extract and cornel extractive are mixed, acceptable pharmaceutical preparation is made.
Preparation method of the present invention can effectively extract the active pharmaceutical ingredient in Radix et Rhizoma Gynurae divaricatae and Fructus Corni, obtain
The pharmaceutical composition taking dose arrived is small, significant in efficacy, has no toxic and side effect to human body, and easy to operate.
Preferably, water boiling and extraction 2 ~ 3 times of 6 ~ 10 times of volumes are added in the step (1).By above preferred, Ke Yiyou
Effect extracts the active pharmaceutical ingredient in Radix et Rhizoma Gynurae divaricatae.
Preferably, it is added water to cook extraction 2 ~ 3 times in the step (2) with the water of 6 ~ 10 times of volumes.It, can by above preferred
Effectively to extract the active pharmaceutical ingredient in the Fructus Corni.
In the above preparation method, it is pharmaceutically acceptable to be added that acceptable pharmaceutical preparation is made described in step (3)
Carrier or excipient acceptable various pharmaceutical preparations, such as capsule, tablet, granule, powder, lozenge etc. is made.
The pharmaceutical composition for the treatment of diabetes of the present invention can be used for preparing the medicine for improving cognitive memory functions obstacle
Object.
Compared with prior art, the beneficial effects of the present invention are:
(1) it is of the present invention treatment diabetes pharmaceutical composition using two kinds of medicinal materials of Radix et Rhizoma Gynurae divaricatae and Fructus Corni as raw material,
And the weight for adjusting Radix et Rhizoma Gynurae divaricatae and Fructus Corni is 9 ~ 55 parts of Radix et Rhizoma Gynurae divaricatae, 7 ~ 53 parts of Fructus Corni.Medicine of the present invention
Compositions are compared with the pharmaceutical composition of existing treatment diabetes, and component is simpler, and only there are two types of raw medicinal materials, are allowed to
The available better control of quality, it is curative for effect, it is significant to diabetes curative effect, and taking dose is small.
(2) preparation method of pharmaceutical composition of the present invention can effectively extract the drug in Radix et Rhizoma Gynurae divaricatae and Fructus Corni
Active constituent, and it is easy to operate.
Specific embodiment
Below with reference to test example and specific embodiment, the present invention is described in further detail.But this should not be understood
It is all that this is belonged to based on the technology that the content of present invention is realized for the scope of the above subject matter of the present invention is limited to the following embodiments
The range of invention.
Embodiment 1
Raw medicinal material is weighed by following weight: 22 parts of Radix et Rhizoma Gynurae divaricatae, 10 parts of Fructus Corni.
Above-mentioned medicinal material is prepared as follows into the pharmaceutical composition for the treatment of diabetes:
(1) Radix et Rhizoma Gynurae divaricatae medicinal material is taken, extraction 3 times is added water to cook, for the first time plus the water boiling and extraction 2h of 8 times of volumes is filtered,
The water boiling and extraction 1h filtering of the water boiling and extraction 1h filtering of second plus 8 times volume, third time plus 6 times of volumes, merging filtrate,
It is concentrated under reduced pressure, it is dry, Radix et Rhizoma Gynurae divaricatae extract is obtained, receiving cream rate is 22.61%；
(2) Fructus Corni is taken, crushes as coarse powder, is extracted 3 times using 60% alcohol reflux, each return time is 2h,
Filtering, merging filtrate are concentrated under reduced pressure, dry, obtain cornel extractive；Receiving cream rate is 24.63%；
(3) Radix et Rhizoma Gynurae divaricatae extract and cornel extractive are uniformly mixed, obtain pharmaceutical composition A.
Embodiment 2
Raw medicinal material is weighed by following weight: 18 parts of Radix et Rhizoma Gynurae divaricatae, 18 parts of Fructus Corni.
Preparation method with embodiment 1, obtains pharmaceutical composition B.
Embodiment 3
Raw medicinal material is weighed by following weight: 30 parts of Radix et Rhizoma Gynurae divaricatae, 20 parts of Fructus Corni.
Preparation method with embodiment 1, obtains pharmaceutical composition C.
Embodiment 4
Raw medicinal material is weighed by following weight: 55 parts of Radix et Rhizoma Gynurae divaricatae, 35 parts of Fructus Corni.
Preparation method with embodiment 1, obtains pharmaceutical composition D.
Embodiment 5
Raw medicinal material is weighed by following weight: 40 parts of Radix et Rhizoma Gynurae divaricatae, 53 parts of Fructus Corni.
Preparation method with embodiment 1, obtains pharmaceutical composition E.
Comparative example 1
Raw medicinal material is weighed by following weight: 56 parts of Radix et Rhizoma Gynurae divaricatae, 6 parts of Fructus Corni.
Preparation method with embodiment 1, obtains pharmaceutical composition F.
Comparative example 2
Raw medicinal material is weighed by following weight: 8 parts of Radix et Rhizoma Gynurae divaricatae, 55 parts of Fructus Corni.
Preparation method with embodiment 1, obtains pharmaceutical composition G.
Test example 1
Investigate influence of the Radix et Rhizoma Gynurae divaricatae to insulin resistance 3T3-L1 fat cell glucose uptake
The method of reference literature report establishes insulin resistance 3T3-L1 fat cell model [Yang Guizhi, Gao little Ping, a surname
Chrysanthemum virtue waits the southwest molecule mechanism [J] of dexamethasone and insulin induction 3T3-L1 fat cell insulin resistance pedagogical
College journal (natural science edition), 2003 (03): 460-464.], i.e., 10%FBS, 100UmL (are contained using DMEM in high glucose-1It is green
Mycin, 100 μ gmL-1Streptomysin) 3T3-L1 PECTORAL LIMB SKELETON is incubated at 6 well culture plates, reach 90% to cell fusion degree
When, it uses instead containing 0.25 μm of ol L-1Dexamethasone, 0.5mmol L-1IBMX and 5 μ g mL-1The above-mentioned training of insulin
It supports base noble cells two days, then uses and only contain 0.25 μm of olL-1Dexamethasone and 5 μ gmL-1The culture medium of insulin is trained
It supports two days, 3T3-L1 PECTORAL LIMB SKELETON is divided into 3T3-L1 fat cell at this time, and seeds cells into 24 well culture plates, with just
Normal culture medium continues culture two days.Hereafter, by cell inoculation and it is divided into normal group (non-resistance group), model group (resistance group) and each
Pharmaceutical composition group, every group is set up 6 multiple holes, and guidance model group is resisted in the steps below: being used and is contained 1 μm of ol L-1Dexamethasone
And 10nmolL-1The DMEM in high glucose of insulin (contains 10%FBS, 100UmL-1Penicillin, 100 μ gmL-1Streptomysin) culture
It two days, then uses instead and contains 1 μm of olL without phenol red-1Dexamethasone and 10nmolL-1The DMEM in high glucose of insulin (contains 10%
FBS, 100 U·mL-1Penicillin, 100 μ gmL-1Streptomysin) culture two days, 5 μ l cell culture are taken out from every hole at this time
Base evaluates each pharmaceutical composition to 3T3-L1 fat cell with concentration of glucose in glucose determination reagent box detection culture medium
The influence of glucose uptake.
1 Radix et Rhizoma Gynurae divaricatae of table to concentration of glucose in insulin resistance 3T3-L1 adipocyte culture base influence (,n
=6)
Note: compared with model group,* P<0.05；** P<0.01
By table 1 the results show that Radix et Rhizoma Gynurae divaricatae of the present invention is to insulin resistance 3T3-L1 fat cell glucose uptake
There is facilitation, and is in concentration-dependent relation.The cell supernatant glucose for the Radix et Rhizoma Gynurae divaricatae extract that wherein prepared by embodiment 1
Concentration is 4.263 mmolL-1, optimal effect is in multiple concentration.
Test example 2
Investigate influence of the Fructus Corni to blood sugar reducing function and level of insulin secretion.
Reference literature method uses alloxan to establish mouse type i diabetes model, and [ Yang Yong, Rong Rong, Jiang Chunhong wait
The Liaoning research [J] Journal of Traditional Chinese Medicine of Fructus Corni opposed polarity extract blood sugar reducing function, 2011,38 (1): 170-172. ],
Use 1% Alloxan 50mgkg of tail vein injection-1;Continuous 3 days, the fasting 12h after final injection, next day docking
It takes blood to survey fasting blood-glucose, chooses blood sugar concentration and be higher than 11. 1mmolL-1Mouse be diabetic mice；And press blood glucose water
It is flat to be randomly divided into model group, positive group (gliclazide, 26.6mgkg-1), the high, medium and low dosage group (agent of cornusol extract
Amount is respectively 400 mgkg-1、200 mg·kg-1、100 mg·kg-1), every group 12；Separately take 12 with batch normal mouse
For Normal group.Each group successive administration 7 days, administered volume was 20 mLkg-1, normal group and model group are given isometric
Distilled water.It takes a blood sample before administration and after administration 7 days and measures fasting blood-glucose content, 1h is measured in serum after the last administration
Insulin level.
2 Fructus Corni of table alloxan is caused type-1 diabetes mellitus mouse blood sugar and insulin level influence (, n=12)
Note: compared with model group,* P<0.05；** P<0.01。
By table 2 the results show that cornusol extract of the present invention, which can reduce to dose-dependant alloxan, causes I type sugar
It is horizontal to urinate sick mouse blood sugar, and have extremely significant statistical difference (P< 0.01).It is exhausted to the insulin of type-1 diabetes mellitus mouse simultaneously
To lack have significantly improve effect (P< 0.05), show that Fructus Corni reduces the effect of type-1 diabetes mellitus mouse blood sugar and promotes pancreas islet
Plain secretion level is related.
Test example 3
Investigate influence of each pharmaceutical composition to diabetes B rat blood sugar, blood lipid and insulin resistance.
The method of reference literature report establishes diabetes B rat model, and [Ma Zhengdong, Chen Lei, Song Hongtao wait white
Carry on the back hypoglycemic effect and its mechanism [J] the Chinese herbal medicine of Radix Notoginseng water extract to diabetes B rat, 2010 (04): 623-
626.], i.e., low dosage streptozotocin is merged using high-sugar-fat-diet and establishes 2 patients with type Ⅰ DM rat models.Choose normal SD
Rat, feed high-sugar-fat-diet 1 month (high-sugar-fat-diet formula are as follows: lard 10.0%, sucrose 20.0%, cholesterol 2.5%,
Cholate 1.0%, conventional feed 66.5%)；Again with 30 mgkg-12% streptozotocin solution preparation 2 is injected intraperitoneally in dosage
Patients with type Ⅰ DM (T2DM) model, blood sampling detection blood glucose, chooses blood glucose >=16.7 mmolL after 72h-1It is dynamic that person is included in model
Object.Diabetes B rat will be successfully established and be randomly divided into model group, positive group (glibenclamide 25mgkg by blood glucose value-1·d-1), pharmaceutical composition A, B, C, D, E, F, G group and Radix et Rhizoma Gynurae divaricatae extract group, cornel extractive group, every group 10；Separately take 10
It is only Normal group with batch healthy animal；Pharmaceutical composition dosage group is 400 mgkg-1·d-1, daily stomach-filling one
Secondary, normal group and model group give corresponding solvent, and successive administration 30 days.Respectively at the preceding 1 day measuring blood sugar of blood extracting basis of administration
Value, 30 days measuring blood sugar of blood extracting (GLU), total cholesterol (TC), triglycerides (TG) and serum insulin (INS) water after administration
It is flat.
As shown in Table 3, pharmaceutical composition A ~ E of the present invention can significantly shorten blood glucose, the blood of diabetes B rat model
Rouge and the insulin level of resistance have extremely significant sex differernce compared with model group.Wherein, pharmaceutical composition prepared by embodiment 1
Blood glucose, blood lipid and the insulin level of resistance of A group, hence it is evident that be lower than drug alone group and other composition groups, be in composition
In optimal proportioning effect.
By pharmaceutical composition A of the present invention ~ E group latent time and Radix et Rhizoma Gynurae divaricatae extract group and cornel extractive
Group is compared, and difference is obvious, is shown Radix et Rhizoma Gynurae divaricatae extract and cornel extractive compatible use, and two kinds of medicinal materials can be effectively played
Synergistic function, significantly reduce the insulin level of blood glucose, blood lipid and resistance.
3 pharmaceutical composition of table to diabetes B rat blood sugar, blood lipid and insulin resistance influence (, n=10)
Note: compared with model group,* P<0.05；** P<0.01。
Pharmaceutical composition A of the present invention ~ E group latent time is compared with pharmaceutical composition F, G group, difference is bright
It is aobvious, show when the weight of Radix et Rhizoma Gynurae divaricatae and Fructus Corni not within the scope of the invention as claimed, reduce blood
Sugar, blood lipid and the insulin action of resistance weaken.
In summary experimental result, pharmaceutical composition of the present invention, by Radix et Rhizoma Gynurae divaricatae and Fructus Corni according to parts by weight
Proportion is 9 ~ 55 parts of Radix et Rhizoma Gynurae divaricatae, and 7 ~ 53 parts of compatibilities of Fructus Corni can effectively play the synergistic function of two kinds of raw medicinal materials, right
It is significant to treat diabetes curative effect, and dosage is small.Cancel any one of Radix et Rhizoma Gynurae divaricatae and Fructus Corni medicinal material to be used as medicine, all will
Its drug effect can largely be reduced.
Embodiment 6
Starch 60g, beta cyclodextrin 90g is added in the pharmaceutical composition A for taking 100g embodiment 1 to prepare, and mixes, granulation sieving,
It is packed into capsule after drying, capsule is made.
Embodiment 7
Raw medicinal material is weighed by following weight: 22 parts of Radix et Rhizoma Gynurae divaricatae, 10 parts of Fructus Corni.
Above-mentioned medicinal material is prepared as follows into the pharmaceutical composition for the treatment of diabetes.
(1) Radix et Rhizoma Gynurae divaricatae medicinal material is taken, extraction 2 times is added water to cook, for the first time plus the water boiling and extraction 3h of 10 times of volumes is filtered,
The water boiling and extraction 1h filtering of second plus 6 times volume, merging filtrate is concentrated under reduced pressure, dry, obtains Radix et Rhizoma Gynurae divaricatae extract；
(2) Fructus Corni is taken, coarse powder is ground into, adds water to cook extraction 2 times, for the first time plus the decoction of the water of 10 times of volumes mentions
3h is taken to filter, the water boiling and extraction 1h filtering of second plus 6 times volume, merging filtrate is concentrated under reduced pressure, and it is dry, obtain Fructus Corni
Extract；
(3) Radix et Rhizoma Gynurae divaricatae extract and cornel extractive are uniformly mixed, obtain pharmaceutical composition；
(4) the pharmaceutical composition 100g for taking step (3) to prepare, beta cyclodextrin 200g, sucrose 100g are mixed, and are pelletized, dry,
Whole grain mixing, obtains granule；
Or the pharmaceutical composition 100g for taking step (3) to prepare, starch 60g, beta cyclodextrin 90g are mixed, granulation sieving is done
Tabletting after dry, is made tablet.
Claims (11)
1. a kind of pharmaceutical composition for treating diabetes, which is characterized in that it is made of the raw material of following weight
Medicament: 9~55 parts of Radix et Rhizoma Gynurae divaricatae, 7~53 parts of Fructus Corni.
2. pharmaceutical composition according to claim 1, it is characterised in that: it is made of the raw material of following weight
Medicament: 15~50 parts of Radix et Rhizoma Gynurae divaricatae, 7~42 parts of Fructus Corni.
3. pharmaceutical composition according to claim 2, it is characterised in that: it is made of the raw material of following weight
Medicament: 15~30 parts of Radix et Rhizoma Gynurae divaricatae, 7~25 parts of Fructus Corni.
4. pharmaceutical composition according to claim 3, it is characterised in that: it is made of the raw material of following weight
Medicament: 15~25 parts of Radix et Rhizoma Gynurae divaricatae, 7~20 parts of Fructus Corni.
5. pharmaceutical composition according to claim 4, it is characterised in that: it is made of the raw material of following weight
Medicament: 20~25 parts of Radix et Rhizoma Gynurae divaricatae, 9~11 parts of Fructus Corni.
6. pharmaceutical composition according to claim 5, it is characterised in that: it is made of the raw material of following weight
Medicament: 22 parts of Radix et Rhizoma Gynurae divaricatae, 10 parts of Fructus Corni.
7. a kind of preparation method of any one of such as claim 1~6 described pharmaceutical composition, which is characterized in that including following step
It is rapid:
(1) Radix et Rhizoma Gynurae divaricatae medicinal material is taken, is added water to cook or alcohol extracting 2~3 times, each decoction/extraction time is 1~3h, is filtered, and is closed
And filtrate, it is concentrated under reduced pressure, it is dry, obtain Radix et Rhizoma Gynurae divaricatae extract；
(2) Fructus Corni is taken, crushes as coarse powder, is extracted 2~3 times using the alcohol reflux of 40-80%, each return time is
1~3h, filtering, merging filtrate are concentrated under reduced pressure, dry, obtain cornel extractive；
(3) above-mentioned Radix et Rhizoma Gynurae divaricatae extract and cornel extractive are mixed, acceptable pharmaceutical preparation is made.
8. preparation method according to claim 7, it is characterised in that: add the decocting of 6~10 times of volumes in the step (1)
It boils extraction 2~3 times.
9. a kind of application such as any one of claim 1~6 described pharmaceutical composition in the drug that preparation improves diabetes.
10. a kind of application such as any one of claim 1~6 described pharmaceutical composition in the drug that preparation improves hyperlipidemia.
11. a kind of answering in the drug that preparation improves metabolic syndrome such as any one of claim 1~6 described pharmaceutical composition
With.
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