Background technology
Diabetes are a kind of complex diseases because of syndrome, be since in the body hormone of insulin deficit or antagonism insulin increase, or insulin can not be brought into normal play physiological action and a kind of syndrome of the glucose, protein and the lipid metabolic disorder that cause in target cell.It is characterized by the unusual rising of concentration of glucose and glucose in urine in the blood circulation, occur typical " three-many-one-little " symptom when blood glucose is too high, promptly eat, polyuria, polyphagia and lose weight more, and with fatigue and weak.Ketoacidosis, hypertonicity diabetic coma can take place in severe patient, and easily merge multiple infection.Along with the prolongation of the course of disease, its metabolism disorder can cause the chronic pathological changes of histoorgans such as eye, kidney, nerve, blood vessel and heart.If can not get timely, appropriate treatment, heart change, cerebrovascular disease, renal failure then take place, lose the sight of both eyes, situation such as lower limbs necrosis, become disable, lethal main cause.And onset diabetes rate height, the national sampling survey of 1995-1996, natural crowd's prevalence is up to 3.21% more than 20 years old, the whole nation 300,000 census of the population results in 1980, prevalence 4.21% more than 60 years old, single Jiangsu elderly population diabetes, impaired glucose tolerance prevalence then are respectively 14.49% and 10.21%, and no matter are developed country or developing country, and the sickness rate of diabetes is all rising year by year.
Mostly the medicine of clinical treatment 2 types is chemicals, widely used sulphanylureas, biguanides, other antidiabetic drugs and the adjuvant drug of being broadly divided into except that insulin at present.The sulfonylureas drugs for diabetes thing is topmost Remedies for diabetes.Can make that hepatic glycogen is synthetic to be increased,, surrounding tissue be strengthened to the sensitivity of insulin, the picked-up of glucose is increased, thereby reach the effect of blood sugar lowering again by the effect behind pair cell receptor or the receptor.But more easily cause untoward reaction such as hypoglycemia, granulocytopenia and cardiovascular disease.Biguanides antidiabetic drug heavy dose can cause digestive tract should, have the patient of pathological changes easily to cause lactic acidosis at lung, liver, kidney.Bring hidden danger for the extensive patients drug safety, for a change this situation for a long time, attempts treating with protocol in the plant clinically always.The traditional Chinese medical science is consistent to the cause of disease view of diabetes, thinks it mainly is that surfeit delicious food, overaction of the five emotions, chamber do not save, the dry and not enough Several Factors of natural endowment of calentura fire.But Chinese medicine also comes with some shortcomings, and is slow as onset, need having the experience old docter of TCM to identify and correct use etc. under instructing.The present invention attempts Chinese medicine and Western medicine are combined, and with the problem of avoiding existing separately, and improves the treatment of diabetes effect, promptly produces synergism.
Summary of the invention
One object of the present invention is to provide the Pharmaceutical composition of being made up of rosiglitazone and a kind of Chinese medicine extract, wherein prepares on the prescription basis of the Chinese medicine extract of said composition according to Chinese patent CN1232291C embodiment 1, and is as follows:
With 10 parts of Cortex Acanthopanciss, 5 parts of Rhizoma Polygoni Cuspidati, 10 parts of Radix campsis, 10 parts of Rhizoma Dioscoreaes, 10 parts of Herba Agrimoniaes, 8 parts on Folium Mori, decoct with water by weight, filter, be concentrated into thick paste, drying.
One object of the present invention is to provide the purposes of above-mentioned Pharmaceutical composition in the medicine of preparation treatment diabetes.
This Chinese medical concrete is called " the described Chinese medicine extract of this paper (or above) " hereinafter.
Above-mentioned composition and mixing acceptable accessories can be made acceptable forms clinically, as tablet, capsule, granule, oral liquid, subcutaneous administration preparation, suppository etc.
Pharmacological research
The main pharmacodynamics of Pharmaceutical composition of the present invention studies confirm that it has strong antidiabetic effect, i.e. hypoglycemic activity.
Edit with reference to Zhang Juntian, " modern pharmacology test method " (first volume), combined publication society of China Concord Medical Science University of Beijing Medical University, the 984-985 page or leaf, disclosed method in " animal model of the similar type ii diabetes of second joint ", set up experimental obesity and diabetes rat model, carry out the hypoglycemic pharmacodynamics test of Pharmaceutical composition of the present invention.
The test grouping:
1 model control group: after the animal model modeling success, normal physiological saline is irritated stomach;
2 pure Chinese drug-treated group: the water extracted immersing paste 1.02g/kg body weight as indicated above
3 rosiglitazone groups: the 10mg/kg body weight is irritated stomach
4 compositions groups: 10mg/kg body weight rosiglitazone+extractum 1.02g/kg body weight mentioned above is irritated stomach.
Group |
Blood glucose mmol/l |
0 day |
7 weeks |
Group 1 |
5.2±1.7 |
5.2±1.3 |
Group 2 |
4.9±1.1 |
4.0±2.5 |
Group 3 |
5.3±1.4 |
4.1±1.8 |
Group 4 |
5.5±1.1 |
3.9±0.9 |
This table shows that all there is significant difference (P<0.05) in each group (pure Chinese drug-treated group, rosiglitazone group, compositions group) of treatment with model control group, and all there are significant difference (P<0.05) in compositions group and pure Chinese drug-treated group, compositions group and rosiglitazone group.Show that there are cooperative effect in rosiglitazone and described Chinese medicinal components in the compositions group.
The pharmaceutics test
Can produce the tablet that contains following component in a conventional manner:
Component
The Mg/ sheet
Pharmaceutical composition 200-1000 of the present invention
Corn starch 125.0
Pulvis Talci 75.0
Magnesium stearate 1.0
Wherein compositions is made up of with weight ratio rosiglitazone and described Chinese medicine extract at 1: 102.Can produce the capsule that contains following component in a conventional manner:
Component
The Mg/ sheet
Pharmaceutical composition 200-1000 of the present invention
Lactose 10.0
Corn starch 20.0
Pulvis Talci 5.0
Wherein compositions is made up of with weight ratio rosiglitazone and described Chinese medicine extract at 1: 102.