CN105535070A - Medicine composition for treating diabetes and preparation method and application thereof - Google Patents

Medicine composition for treating diabetes and preparation method and application thereof Download PDF

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CN105535070A
CN105535070A CN201610043265.9A CN201610043265A CN105535070A CN 105535070 A CN105535070 A CN 105535070A CN 201610043265 A CN201610043265 A CN 201610043265A CN 105535070 A CN105535070 A CN 105535070A
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radix
pharmaceutical composition
fructus corni
gynurae divaricatae
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吴建明
高小平
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/40Cornaceae (Dogwood family)
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    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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Abstract

The invention discloses a medicine composition for treating diabetes. The medicine composition is prepared from, by weight, 9-55 parts of Gynura divaricata(L.) DC and 7-53 parts of dogwood. The medicine composition is only composed of the Gynura divaricata(L.) DC and the dogwood, the parts by weight of the Gynura divaricata(L.) DC are adjusted to be 9-55, and the parts by weight of the dogwood are adjusted to be 7-53, so that the synergistic interaction effect of the Gynura divaricata(L.) DC and the dogwood is brought into play, and the remarkable effect on treating diabetes is achieved. The medicine composition is simple in composition, the quality is easy to control, and the curative effect is extract. The invention further provides a preparation method of the medicine composition. According to the preparation method, the medicine active ingredients in the Gynura divaricata(L.) DC and the dogwood can be effectively extracted, and operation is easy. The invention further provides application of the medicine composition for preparing medicine for improving diabetes or hyperlipidemia or metabolic syndrome.

Description

Pharmaceutical composition for the treatment of diabetes and its preparation method and application
Technical field
The invention belongs to pharmaceutical field, relate to a kind of pharmaceutical composition, particularly a kind ofly treat pharmaceutical composition of diabetes or hyperlipidemia and its preparation method and application.
Background technology
Diabetes (diabetesmellitus, DM) are that impaired what cause take hyperglycemia as the metabolic disease of feature with hypoinsulinism or its biological effect.According to insulin secretion relatively with absolutely not can be divided into type i diabetes and type ii diabetes completely; Wherein by islet beta cell function exhaustion, the diabetes that excreting insulin absolute magnitude deficiency causes are type i diabetes; Sufficient with excreting insulin absolute magnitude, and the diabetes caused because of insulin resistant are type ii diabetes.End 2014, diabetes mellitus in China patient, more than 100,000,000 people, accounts for whole world patient populations's 1/3rd.What is more important, along with the change of domestic aged tendency of population and resident living mode makes diabetes prevalence present obvious ascendant trend.According to health ministry investigation display, China is routine for every day about newly-increased 3000, annual at least newly-increased 1,200,000 diabetics [Hu Shanlian, Liu Guoen, Xu Zhangrong, Deng. China's diabetes epidemiology and study of disease financial burden present situation [J]. China Health economy, 2008 (08): 5-8.].As can be seen here, diabetes have become the significant problem threatening broad masses of the people's health level, and the superior drug of exploitation treatment diabetes always is the effort target of Chinese and western medical personal.
At present, the conventional medicament for the treatment of diabetes mainly comprises sulfonylurea drugs, biguanides, α glucosidase inhibitor, euglycemic agent, Insulin secretagogues, insulin preparation etc.These medicines by the picked-up of glucose, the secretion of insulin, the enhanced sensitivity of insulin or directly supplementation with insulin water Peer Mode play and reduce blood glucose effect, but there is gastrointestinal reaction, Liver and kidney impact, heart or maincenter untoward reaction in said medicine to some extent.Pathogenesis new according to diabetes is is in the last few years researched and developed and has been used dissimilar medicine, as for glucagon-like-peptide-1 (glucagon-likepeptide1, GLP-1) receptor exerts effect GLP-1 class medicine, to GLP-1 hydrolytic enzyme DPP IV (DipeptidylPeptidaseIV, DPP-IV) DPP-IV inhibitor of onset and the white (Sodium-glucoseco-transporters of sodium glucose co-transporter 2 that paid close attention to by industry, SGLT) inhibitor etc., these medicines are all considered to the breakthrough for the treatment of diabetes.But the untoward reaction (pharyngitis, headache, upper respiratory tract infection, nausea,vomiting,diarrhea, constipation, renal function injury, symptomatic hypotension, fungal infection etc.) all existed in various degree, and to the therapeutical effect in some patients still not person of modern times meaning.So clinical, still in the urgent need to exploitation determined curative effect, toxic and side effects is little, and the newtype drug of affordable.In recent years, domestic and international experts and scholars more and more pay attention to Chinese medicine and natural drug, and are applied to diabetes clinical treatment.
The precious Chinese herbal medicine that Radix et Rhizoma Gynurae divaricatae is included for " Chinese draft " is the herb of feverfew Gynura divaricata (Gynuradivaricata (L.) DC.), and another name is rescued greatly, large cattle, divaricate gynura root and rhizome, white young dish medicine, loose blood Rhizoma Zingiberis Recens etc.Main component comprises alkaloids, flavonoid, triterpenes and some long-chain fat same clan compounds; There is the pharmacological actions such as blood sugar lowering, blood pressure lowering, blood fat reducing, anoxia enduring, antimutagenic.Existing bibliographical information Radix et Rhizoma Gynurae divaricatae has obvious therapeutical effect to experimental type 2 diabetes mellitus, its mechanism may with the ability of enhancing body Scavenger of ROS, alleviate oxygen-derived free radicals to the damage of beta Cell of islet, promote that the reparation etc. of beta Cell of islet acts on relevant [horse due east, Chen Lei, Song Hongtao, Deng. Radix et Rhizoma Gynurae divaricatae water extract is to the hypoglycemic activity of type 2 diabetes mellitus rat and mechanism [J] thereof. Chinese herbal medicine, 2010 (04): 623-626.].Bibliographical information Radix et Rhizoma Gynurae divaricatae is separately had to improve significantly to Insulin Resistance of Rats, its mechanism of action may with the relevant [Han Haifeng of expression raising InsR mRNA, Zhang Xueying, Shen Red snapper, Deng. Radix et Rhizoma Gynurae divaricatae is on the impact [J] of insulin resistance rat hepatic insulin expression of receptor. Pharmacology and Clinics of Chinese Materia Medica, 2014 (05): 102-105.].In addition, still have Patents to report the purposes of Radix et Rhizoma Gynurae divaricatae in diabetes, disclosing a kind of comprising patent of invention CN100475232C is the raw material treatment oral drugs of diabetes and purposes with Radix et Rhizoma Gynurae divaricatae extract.Patent of invention CN101147749B discloses the preparation method of white-backed pseudo-ginseng total flavonoid and the application in hypoglycemic medicine thereof.Patent of invention CN102389454B, CN103191039B, CN103988964A, CN102389454B disclose a kind of compound preparation be made up of multiple flavour of a drug containing Radix et Rhizoma Gynurae divaricatae and application thereof.But the mutual reinforcement between mutual-assistance between the above-mentioned patent about Radix et Rhizoma Gynurae divaricatae suffers for want of medical supplies time alone, excessive compound recipe is unfavorable for drug development again.Therefore, Radix et Rhizoma Gynurae divaricatae extract or compound recipe disclosed in above patent still can not play compositions advantage between Radix et Rhizoma Gynurae divaricatae and important antidiabetic medicine and clinical value completely.
Fructus Corni is the ripe dry fruit of Cornaceae plant Fructus Corni (CornusofficinalisSieb.etZucc.), containing compositions such as cornin, saponin, tannin, ursolic acid and vitamin A, Traditional Chinese Medicine thinks that Fructus Corni has the effects such as invigorating the liver and kidney, arresting seminal emission gas, solid collapse and blood sugar lowering.Fructus Corni since Han dynasty always as treatment " diabetes " key medicine.Bibliographical information display Fructus Corni can significantly reduce blood glucose in diabetic mice level, improve serum insulin levels, and also have reduction trend [Yang Yong to triglyceride, Rong Rong, Jiang Chunhong, Deng. the research that blood wards off effect falls in mountain Zhu English opposed polarity extract. Chinese Pharmacological Bulletin, 2009,25 (suppl): 181.].Mountain cornel cornel also can increase hepatic glycogen content simultaneously, remarkable reduction glycated serum protein level, thus it is super significantly to reduce blood glucose in diabetic mice horizontal [Han Jing, Ji Hui, Xue Chengfeng, Deng. the hypoglycemic activity [J] of Terpenes from Fructus Corni. Chinese natural drug, 2006,4 (02) .125-129.].In addition, containing more in use patent in diabetes of the Chinese medicine compound of Fructus Corni, disclose a kind of compound preparation be made up of multiple flavour of a drug containing Fructus Corni and application thereof comprising patent of invention CN103479874A, CN103705723A, CN104336715A, CN103749819A, CN101040982, CN101904994A etc.Carry out the very rare of compositions research with two taste Chinese medicines, what especially use with Radix et Rhizoma Gynurae divaricatae and the independent compatibility of Fructus Corni has no report, and is obtained the blank especially of the epidemic proportion of its compositions by research.
By upper sight it, find that component is simple, determined curative effect, with low cost and very urgent and important to the significant prescriptions of Chinese medicine for the treatment of diabetes curative effect.
Summary of the invention
The object of the invention is to overcome above-mentioned deficiency existing in prior art, a kind of pharmaceutical composition for the treatment of diabetes is provided.This pharmaceutical composition is Radix et Rhizoma Gynurae divaricatae 9 ~ 55 parts by Radix et Rhizoma Gynurae divaricatae and Fructus Corni according to weight, Fructus Corni 7 ~ 53 parts is raw material, component is simple, determined curative effect, Radix et Rhizoma Gynurae divaricatae and Fructus Corni are from improving insulin sensitivity and increasing the effect that insulin secretion aspect plays Synergistic, effectively can treat diabetes, evident in efficacy.
Another object of the present invention is to provide the preparation method of described pharmaceutical composition.This preparation method technique is simple, effectively can extract the active component of Radix et Rhizoma Gynurae divaricatae and Fructus Corni, the pharmaceutical composition determined curative effect of preparation, treatment diabetes Be very effective.
Another object of the present invention is to provide the application of described pharmaceutical composition.
In order to realize foregoing invention object, the invention provides following technical scheme:
The pharmaceutical composition for the treatment of diabetes of the present invention is the medicaments be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 9 ~ 55 parts, Fructus Corni 7 ~ 53 parts.
The pharmaceutical composition for the treatment of diabetes of the present invention, with Radix et Rhizoma Gynurae divaricatae and Fructus Corni for medicinal raw material.Wherein Radix et Rhizoma Gynurae divaricatae sweet in the mouth, light, and property is put down; Return lung, the heart two warp.Function is quenched one's thirst for dispelling, clearing away heat and cooling blood, promoting blood circulation and hemostasis pain relieving; Can be used for diabetes, bronchitis, metrorrhagia, traumatic injury etc.Fructus Corni sour in the mouth, puckery, tepor; Cool in nature; Return liver, kidney channel; There is effect of liver and kidney tonifying, essence astringing and desertion stemming.Papillary can dispel quench one's thirst, liver and kidney tonifying, essence astringing and desertion stemming.
Inventor finds through test of many times, only with Radix et Rhizoma Gynurae divaricatae and Fructus Corni two kinds of medical materials for raw material, and regulate the weight of Radix et Rhizoma Gynurae divaricatae and Fructus Corni to be Radix et Rhizoma Gynurae divaricatae 9 ~ 55 parts, Fructus Corni 7 ~ 53 parts, effectively can treat diabetes.Pharmaceutical composition of the present invention is compared with the pharmaceutical composition of existing treatment diabetes, and component is more simple, and only have two kinds of raw medicinal materials, making it quality can be controlled better, determined curative effect, to human non-toxic's side effect.Meanwhile, remarkable to diabetes curative effect, and taking dose is little.
Diabetes of the present invention comprise type i diabetes, type ii diabetes or insulin resistant relevant disease.
Preferably, described pharmaceutical composition is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 15 ~ 50 parts, Fructus Corni 7 ~ 42 parts.
Further preferably, described pharmaceutical composition is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 15 ~ 30 parts, Fructus Corni 7 ~ 25 parts.
Further preferably, described pharmaceutical composition is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 15 ~ 25 parts, Fructus Corni 7 ~ 20 parts.
Still more preferably, described pharmaceutical composition is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 20 ~ 25 parts, Fructus Corni 9 ~ 11 parts.
By above preferred to Radix et Rhizoma Gynurae divaricatae in pharmaceutical composition and Fructus Corni weight, the curative effect of this pharmaceutical composition to treatment diabetes can be improved further.
Preferably, described pharmaceutical composition is the medicament be made up of the raw material of following weight to the best: Radix et Rhizoma Gynurae divaricatae 22 parts, Fructus Corni 10 parts.Preferred by this, the curative effect of this pharmaceutical composition to treatment diabetes can be made to reach best.
The preparation method of the pharmaceutical composition of above-mentioned treatment diabetes, comprises the following steps:
(1) get Radix et Rhizoma Gynurae divaricatae medical material, decoct with water extraction 2 ~ 3 times, each decoction extraction time is 1 ~ 3h, filters, merging filtrate, concentrating under reduced pressure, dry, obtains Radix et Rhizoma Gynurae divaricatae extract;
(2) get Fructus Corni, pulverize as coarse powder, the alcohol reflux of employing 40-80% 2 ~ 3 times, each return time is 1 ~ 3h, filters, merging filtrate, concentrating under reduced pressure, dry, obtains Fructus Corni extract;
(3) by above-mentioned Radix et Rhizoma Gynurae divaricatae extract and Fructus Corni extract mixing, acceptable pharmaceutical preparation is made.
Preparation method of the present invention, effectively can extract the active constituents of medicine in Radix et Rhizoma Gynurae divaricatae and Fructus Corni, and the pharmaceutical composition taking dose obtained is little, evident in efficacy, to human non-toxic's side effect, and simple to operate.
Preferably, the water boiling and extraction 2 ~ 3 times of 6 ~ 10 times of volumes is added in described step (1).By preferably above, the active constituents of medicine in Radix et Rhizoma Gynurae divaricatae effectively can be extracted.
Preferably, extraction is decocted with water 2 ~ 3 times with the water of 6 ~ 10 times of volumes in described step (2).By preferably above, the active constituents of medicine in described Fructus Corni effectively can be extracted.
In above-mentioned preparation method, described in step (3), make acceptable pharmaceutical preparation for adding pharmaceutically acceptable carrier or acceptable various pharmaceutical preparation made by excipient, such as capsule, tablet, granule, powder, buccal tablet etc.
The pharmaceutical composition for the treatment of diabetes of the present invention may be used for preparing the medicine improving cognitive memory functions obstacle.
Compared with prior art, beneficial effect of the present invention is:
(1) pharmaceutical composition for the treatment of diabetes of the present invention is with Radix et Rhizoma Gynurae divaricatae and Fructus Corni two kinds of medical materials for raw material, and regulates the weight of Radix et Rhizoma Gynurae divaricatae and Fructus Corni to be Radix et Rhizoma Gynurae divaricatae 9 ~ 55 parts, Fructus Corni 7 ~ 53 parts.Pharmaceutical composition of the present invention is compared with the pharmaceutical composition of existing treatment diabetes, and component is more simple, and only have two kinds of raw medicinal materials, making it quality can be controlled better, determined curative effect, remarkable to diabetes curative effect, and taking dose is little.
(2) preparation method of pharmaceutical composition of the present invention effectively can extract the active constituents of medicine in Radix et Rhizoma Gynurae divaricatae and Fructus Corni, and simple to operate.
Detailed description of the invention
Below in conjunction with test example and detailed description of the invention, the present invention is described in further detail.But this should be interpreted as that the scope of the above-mentioned theme of the present invention is only limitted to following embodiment, all technology realized based on content of the present invention all belong to scope of the present invention.
Embodiment 1
By following weight weighting raw materials material: Radix et Rhizoma Gynurae divaricatae 22 parts, Fructus Corni 10 parts.
Above-mentioned medical material is prepared into by the following method the pharmaceutical composition for the treatment of diabetes:
(1) Radix et Rhizoma Gynurae divaricatae medical material is got, decoct with water extraction 3 times, the water boiling and extraction 2h that first time adds 8 times of volumes filters, the water boiling and extraction 1h that second time adds 8 times of volumes filters, and the water boiling and extraction 1h that third time adds 6 times of volumes filters, merging filtrate, concentrating under reduced pressure, drying, obtains Radix et Rhizoma Gynurae divaricatae extract, and receiving cream rate is 22.61%;
(2) get Fructus Corni, pulverize as coarse powder, the alcohol reflux of employing 60% 3 times, each return time is 2h, filters, merging filtrate, concentrating under reduced pressure, dry, obtains Fructus Corni extract; Receiving cream rate is 24.63%;
(3) by Radix et Rhizoma Gynurae divaricatae extract and Fructus Corni extract mix homogeneously, pharmaceutical composition A is obtained.
Embodiment 2
By following weight weighting raw materials material: Radix et Rhizoma Gynurae divaricatae 18 parts, Fructus Corni 18 parts.
Preparation method, all with embodiment 1, obtains pharmaceutical composition B.
Embodiment 3
By following weight weighting raw materials material: Radix et Rhizoma Gynurae divaricatae 30 parts, Fructus Corni 20 parts.
Preparation method, all with embodiment 1, obtains pharmaceutical composition C.
Embodiment 4
By following weight weighting raw materials material: Radix et Rhizoma Gynurae divaricatae 55 parts, Fructus Corni 35 parts.
Preparation method, all with embodiment 1, obtains pharmaceutical composition D.
Embodiment 5
By following weight weighting raw materials material: Radix et Rhizoma Gynurae divaricatae 40 parts, Fructus Corni 53 parts.
Preparation method, all with embodiment 1, obtains pharmaceutical composition E.
Comparative example 1
By following weight weighting raw materials material: Radix et Rhizoma Gynurae divaricatae 56 parts, Fructus Corni 6 parts.
Preparation method, all with embodiment 1, obtains pharmaceutical composition F.
Comparative example 2
By following weight weighting raw materials material: Radix et Rhizoma Gynurae divaricatae 8 parts, Fructus Corni 55 parts.
Preparation method, all with embodiment 1, obtains pharmaceutical composition G.
Test example 1
Investigate Radix et Rhizoma Gynurae divaricatae to the impact of insulin resistant 3T3-L1 adipose cell glucose uptake
The method establishment insulin resistant 3T3-L1 adipose cell model [Yang Guizhi of reference literature report, higher primary school puts down, Yan Jufang, Deng. the molecule mechanism [J] of dexamethasone and insulin induction 3T3-L1 adipose cell insulin resistant. Southwestern Normal University's journal (natural science edition), 2003 (03): 460-464.], namely adopt DMEM in high glucose (containing 10%FBS, 100UmL -1penicillin, 100 μ gmL -1streptomycin) 3T3-L1 PECTORAL LIMB SKELETON is incubated at 6 well culture plates, when cell fusion degree reaches 90%, use instead containing 0.25 μm of olL -1dexamethasone, 0.5mmolL -1iBMX and 5 μ gmL -1the above-mentioned culture medium noble cells of insulin two days, then with only containing 0.25 μm of olL -1dexamethasone and 5 μ gmL -1the culture medium culturing of insulin two days, now 3T3-L1 PECTORAL LIMB SKELETON is divided into 3T3-L1 adipose cell, and seeds cells into 24 well culture plates, continues cultivation two days with normal incubation medium.After this, inoculated by cell and be divided into normal group (non-opposing group), model group (opposing group) and each pharmaceutical composition group, often group sets up 6 multiple holes, guidance model group opposing in the steps below: with containing 1 μm of olL -1dexamethasone and 10nmolL -1the DMEM in high glucose of insulin is (containing 10%FBS, 100UmL -1penicillin, 100 μ gmL -1streptomycin) cultivate two days, then use instead and contain 1 μm of olL without phenol red -1dexamethasone and 10nmolL -1the DMEM in high glucose of insulin is (containing 10%FBS, 100UmL -1penicillin, 100 μ gmL -1streptomycin) cultivate two days, from every hole, now take out 5 μ l cell culture mediums, detect concentration of glucose in culture medium with glucose determination reagent box, evaluate the impact of each pharmaceutical composition on 3T3-L1 adipose cell glucose uptake.
Table 1 Radix et Rhizoma Gynurae divaricatae on the impact of concentration of glucose in insulin resistant 3T3-L1 adipocyte culture base ( , n=6)
Note: compare with model group, *p<0.05; *p<0.01
Shown by table 1 result, Radix et Rhizoma Gynurae divaricatae of the present invention has facilitation to insulin resistant 3T3-L1 adipose cell glucose uptake, and in concentration-dependent relation.Wherein the cell conditioned medium liquid concentration of glucose of the Radix et Rhizoma Gynurae divaricatae extract of embodiment 1 preparation is 4.263mmolL -1, in multiple concentration, be in best effect.
Test example 2
Investigate the impact of Fructus Corni on blood sugar reducing function and level of insulin secretion.
Reference literature method adopts alloxan to set up mice type i diabetes model [ Yang Yong, Rong Rong, Jiang Chunhong, Deng. the research [J] of Fructus Corni opposed polarity extract blood sugar reducing function. Liaoning Journal of Traditional Chinese Medicine, 2011,38 (1): 170-172. ], namely tail vein injection 1%Alloxan50mgkg is adopted -1; For three days on end, fasting 12h after final injection, docking next day is got blood and is surveyed fasting glucose, chooses blood sugar concentration higher than 11.1mmolL -1mice be diabetic mice; And be divided into model group, positive group of (gliclazide, 26.6mgkg at random by blood sugar level -1), (dosage is respectively 400mgkg to the high, medium and low dosage group of cornusol extract -1, 200mgkg -1, 100mgkg -1), often organize 12; Separately getting 12 with batch normal mouse is Normal group.Each group of successive administration 7 days, administration volume is 20mLkg -1, normal group and model group give isopyknic distilled water.Take a blood sample after 7 days respectively at before administration with administration and measure fasting glucose content, after last administration, 1h measures insulin level in serum.
Table 2 Fructus Corni on alloxan cause type i diabetes mouse blood sugar and insulin level impact ( , n=12)
Note: compare with model group, *p<0.05; *p<0.01.
Shown by table 2 result, cornusol extract of the present invention can cause type i diabetes mouse blood sugar level by reduction alloxan in dose-dependant ground, and has extremely significantly significant difference (P<0.01).The insulin of type i diabetes mice is definitely lacked simultaneously and there is remarkable improvement result (P<0.05), show that Fructus Corni reduces the effect of type i diabetes mouse blood sugar relevant with promotion level of insulin secretion.
Test example 3
Investigate the impact of each pharmaceutical composition on type 2 diabetes mellitus rat blood sugar, blood fat and insulin resistant.
Method establishment type 2 diabetes mellitus rat model [the horse due east of reference literature report, Chen Lei, Song Hongtao, Deng. Radix et Rhizoma Gynurae divaricatae water extract is to the hypoglycemic activity of type 2 diabetes mellitus rat and mechanism [J] thereof. Chinese herbal medicine, 2010 (04): 623-626.], namely adopt high-sugar-fat-diet to merge low dosage streptozotocin and set up type 2 diabetes mellitus rat model.Choose normal SD rats, feed high-sugar-fat-diet 1 month (high-sugar-fat-diet formula is: Adeps Sus domestica 10.0%, sucrose 20.0%, cholesterol 2.5%, cholate 1.0%, conventional feed 66.5%); Again with 30mgkg -1dosage lumbar injection 2% streptozotocin solution prepares type 2 diabetes mellitus (T2DM) model, and after 72h, blood sampling detects blood glucose, chooses blood glucose>=16.7mmolL -1person includes animal pattern in.Model group, positive group of (glibenclamide 25mgkg is divided at random by blood glucose value by successfully setting up type 2 diabetes mellitus rat -1d -1), pharmaceutical composition A, B, C, D, E, F, G group and Radix et Rhizoma Gynurae divaricatae extract group, Fructus Corni extract group, often organize 10; Separately getting 10 with batch healthy animal is Normal group; Pharmaceutical composition dosage group is 400mgkg -1d -1, every day gavage once, normal group and model group give corresponding solvent, successive administration 30 days.Respectively at administration first 1 day measuring blood sugar of blood extracting basic value, 30 days measuring blood sugar of blood extracting (GLU), T-CHOL (TC), triglyceride (TG) and serum insulin (INS) levels after administration.
As shown in Table 3, pharmaceutical composition A ~ E of the present invention significantly can shorten the insulin level of the blood glucose of type 2 diabetes mellitus rat model, blood fat and opposing, compares, tool pole significant difference with model group.Wherein, the blood glucose of pharmaceutical composition A group prepared by embodiment 1, the insulin level of blood fat and opposing, be starkly lower than drug alone group and other compositions groups, be in proportioning effect best in compositions.
The latent time of pharmaceutical composition A of the present invention ~ E group is compared with Fructus Corni extract group with Radix et Rhizoma Gynurae divaricatae extract group, obvious difference, Radix et Rhizoma Gynurae divaricatae extract and Fructus Corni extract compatibility is shown to use, effectively can play the synergistic function of two kinds of medical materials, significantly reduce the insulin level of blood glucose, blood fat and opposing.
Table 3 pharmaceutical composition on the impact of type 2 diabetes mellitus rat blood sugar, blood fat and insulin resistant ( , n=10)
Note: compare with model group, *p<0.05; *p<0.01.
By the latent time of pharmaceutical composition A of the present invention ~ E group compared with pharmaceutical composition F, G group; obvious difference; show when the weight of Radix et Rhizoma Gynurae divaricatae and Fructus Corni is not in the protection domain of the claims in the present invention, it reduces blood glucose, the insulin action of blood fat and opposing weakens.
Comprehensive above-mentioned experimental result, Radix et Rhizoma Gynurae divaricatae and Fructus Corni are Radix et Rhizoma Gynurae divaricatae 9 ~ 55 parts according to weight by pharmaceutical composition of the present invention, Fructus Corni 7 ~ 53 parts of compatibilities, effectively can play the synergistic function of two kinds of raw medicinal materials, remarkable to treatment diabetes curative effect, and dosage is little.Any one medical material cancelled in Radix et Rhizoma Gynurae divaricatae and Fructus Corni is used as medicine, and all will reduce its drug effect largely.
Embodiment 6
Get pharmaceutical composition A prepared by 100g embodiment 1, add starch 60g, beta cyclodextrin 90g, mixing, granulation is sieved, and incapsulates after drying, makes capsule.
Embodiment 7
By following weight weighting raw materials material: Radix et Rhizoma Gynurae divaricatae 22 parts, Fructus Corni 10 parts.
Above-mentioned medical material is prepared into by the following method the pharmaceutical composition for the treatment of diabetes.
(1) get Radix et Rhizoma Gynurae divaricatae medical material, decoct with water extraction 2 times, the water boiling and extraction 3h that first time adds 10 times of volumes filters, and the water boiling and extraction 1h that second time adds 6 times of volumes filters, merging filtrate, and concentrating under reduced pressure is dry, obtains Radix et Rhizoma Gynurae divaricatae extract;
(2) get Fructus Corni, be ground into coarse powder, decoct with water extraction 2 times, the water boiling and extraction 3h that first time adds 10 times of volumes filters, and the water boiling and extraction 1h that second time adds 6 times of volumes filters, merging filtrate, and concentrating under reduced pressure is dry, obtains Fructus Corni extract;
(3) by Radix et Rhizoma Gynurae divaricatae extract and Fructus Corni extract mix homogeneously, pharmaceutical composition is obtained;
(4) get pharmaceutical composition 100g prepared by step (3), beta cyclodextrin 200g, sucrose 100g mixes, and granulates, dry, and granulate mixes, and obtains granule;
Or get pharmaceutical composition 100g prepared by step (3), starch 60g, beta cyclodextrin 90g mixes, and granulation is sieved, tabletting after dry, makes tablet.

Claims (12)

1. treat a pharmaceutical composition for diabetes, it is characterized in that, it is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 9 ~ 55 parts, Fructus Corni 7 ~ 53 parts.
2. pharmaceutical composition according to claim 1, is characterized in that: it is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 15 ~ 50 parts, Fructus Corni 7 ~ 42 parts.
3. pharmaceutical composition according to claim 2, is characterized in that: it is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 15 ~ 30 parts, Fructus Corni 7 ~ 25 parts.
4. pharmaceutical composition according to claim 3, is characterized in that: it is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 15 ~ 25 parts, Fructus Corni 7 ~ 20 parts.
5. pharmaceutical composition according to claim 4, is characterized in that: it is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 20 ~ 25 parts, Fructus Corni 9 ~ 11 parts.
6. pharmaceutical composition according to claim 5, is characterized in that: it is the medicament be made up of the raw material of following weight: Radix et Rhizoma Gynurae divaricatae 22 parts, Fructus Corni 10 parts.
7. the preparation method of pharmaceutical composition as described in any one of claim 1 ~ 6, is characterized in that, comprise the following steps:
(1) get Radix et Rhizoma Gynurae divaricatae medical material, decoct with water or alcohol extraction 2 ~ 3 times, each decoctions/extraction time is 1 ~ 3h, filters, merging filtrate, concentrating under reduced pressure, and drying, obtains Radix et Rhizoma Gynurae divaricatae extract;
(2) get Fructus Corni, pulverize as coarse powder, the alcohol reflux of employing 40-80% 2 ~ 3 times, each return time is 1 ~ 3h, filters, merging filtrate, concentrating under reduced pressure, dry, obtains Fructus Corni extract;
(3) by above-mentioned Radix et Rhizoma Gynurae divaricatae extract and Fructus Corni extract mixing, acceptable pharmaceutical preparation is made.
8. preparation method according to claim 7, is characterized in that: the water boiling and extraction 2 ~ 3 times adding 6 ~ 10 times of volumes in described step (1).
9. preparation method according to claim 7, is characterized in that: decoct with water extraction 2 ~ 3 times with the water of 6 ~ 10 times of volumes in described step (2).
10. the application that pharmaceutical composition improves in the medicine of diabetes in preparation as described in any one of claim 1 ~ 6.
11. 1 kinds of application that pharmaceutical composition improves in the medicine of hyperlipidemia in preparation as described in any one of claim 1 ~ 6.
12. 1 kinds of application that pharmaceutical composition improves in the medicine of metabolic syndrome in preparation as described in any one of claim 1 ~ 6.
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