Background technology
In recent years, along with China's rapid economy development, the raising of people's living standard, the sickness rate of type ii diabetes is more preceding obviously to be increased.Nineteen ninety-five whole nation Epidemiological study shows that the sickness rate of type ii diabetes has reached about 3%, is higher than type i diabetes far away, accounts for more than 90% of diabetes sum, has now become one of commonly encountered diseases of serious threat China people ' s health.Type ii diabetes does not still have the way of radical cure at present, and complication such as cardiovascular and cerebrovascular disease, renal failure and retinopathy usually occur to the later stage, and wherein hyperlipemia, blood high viscosity syndrome are most common complication.Overwhelming majority type ii diabetes patient need take hypoglycemic medicine throughout one's life, and clinical orally-taken blood sugar reducing drug main commonly used will have sulphanylureas, biguanides, non-sulphanylureas insulin succagoga, euglycemic agent and α glycosidase inhibitor at present.Clinical practice shows that there is certain individual variation in the patient for the blood sugar lowering curative effect of these medicines, and part patient exists constitutional to lose efficacy and secondary failure to sulfonylureas drugs for diabetes.In addition, also there are some side reactions in the part patient to oral antidiabetic drug.
The Chinese medicine diabetes have history of more than one thousand years, the Chinese patent medicine that some treatment diabetes are also arranged simultaneously, and compatibility adopts Chinese medicines such as QI invigorating, spleen invigorating, the kidney invigorating, heat clearing away more, medicine as treatment diabetes in the patent documentation adopts raw materials such as the Radix Astragali, Radix Scutellariae, Fructus Perillae, Radix Codonopsis, Radix Et Rhizoma Rhei, Radix Rehmanniae, Radix Bupleuri, Radix Salviae Miltiorrhizae, Radix Curcumae, Radix Trichosanthis, Gypsum Fibrosum, Semen Plantaginis, Rhizoma Dioscoreae, Fructus Schisandrae Chinensis to make (number of patent application: 02110059.4); With the Rhizoma Anemarrhenae, Radix Trichosanthis, Radix Panacis Quinquefolii, Radix Salviae Miltiorrhizae, Radix Et Rhizoma Rhei, Radix Notoginseng, Fructus Crataegi is that Main Ingredients and Appearance is made (number of patent application: 02104040.0).Both at home and abroad the hypoglycemic activity of effective ingredient, single medicinal material and the Chinese medicine compound of natural drug has also been done big quantity research, as: using Rhizoma Coptidis, Cortex Phellodendri and Radix Berberidis total alkaloids to be expected to develop becomes the medicine (number of patent application: 03111502.0) of diseases such as preparation treatment diabetes, blood fat reducing; Adopting the single medicinal material Cortex Mori by extracting its active component---the medicament of Cortex Mori polysaccharide preparation can be used for reducing post-prandial glycemia; Another kind is the medicament that is extracted the dried cream preparation of gained by Cortex Mori and Radix Salviae Miltiorrhizae, can be used for reducing post-prandial glycemia and while blood circulation promoting and blood stasis dispelling, blood circulation promoting helps generation, the development of delaying complications of diabetes and reduces the infringement (number of patent application: 02126798.7) of complication to the patient.Someone confirms that Folium Mori can reach blood sugar reducing function (" Chinese silkworm industry ", 2003.5) by suppressing the α glycosidase.
But existing medicine or prescription is numerous and jumbled, compatibility is unreasonable, or effect is too single, many target spots advantage of failing to embody Chinese medicine, effect is not very good, and the patient still has to depend on some Western medicine, as insulin.Therefore selection science, rationally and truly have the Chinese prescription of curative effect treatment diabetes extremely important concerning extensive patients.
Summary of the invention
The object of the present invention is to provide a kind of reasonable recipe, have blood sugar lowering, blood fat reducing improves high blood coagulation state, reduces the periphery serum insulin levels, controlling body weight, the Chinese patent medicine of minimizing, the effect of diabetes-alleviating complication.
The understanding that solution of the present invention is changeed diabetes pathology machine based on motherland's medical science, with reference to the modern pharmacological research achievement, draft the heat clearing away of hot profit, ascending the clear and descending the turbid, blood circulation promoting and blood stasis dispelling method of treatment according to theory of Chinese medical science, select the Folium Mori of hot profit heat clearing away, the Radix Salviae Miltiorrhizae of blood circulation promoting and blood stasis dispelling, the Folium Nelumbinis prescription of ascending the clear and descending the turbid, compatibility is reasonable, main pathology link at diabetes and complication thereof, promote endogenous insulin secretion, promote carbohydrate metabolism, controlling body weight makes blood glucose, blood fat reduce blood viscosity lowering, promote microcirculation, thus treatment diabetes and complication thereof.
The present invention is achieved by the following technical programs.
Chinese patent medicine of the present invention is to be made up of following component by weight percentage:
Folium Mori 26~49%, Folium Nelumbinis 16~48%, Radix Salviae Miltiorrhizae 25~42%, more than the consumption sum of each component be 100%.
Chinese patent medicine of the present invention, each components contents is preferably:
Folium Mori 32~40%, Folium Nelumbinis 24~32%, Radix Salviae Miltiorrhizae 28~36%.
Chinese patent medicine of the present invention, the best proportioning of each component is:
Folium Mori 38.5%, Folium Nelumbinis 30.8%, Radix Salviae Miltiorrhizae 30.7%.
The preparation method of Chinese patent medicine preparation of the present invention is:
(1), Folium Mori are soaked, adopt ultrasonic extraction method and its liquid is concentrated, the centrifugal precipitation of removing, supernatant is walked post, is washed till eluent with distilled water and adds till ethanol do not have a precipitation, eluent is concentrated, filtrate adds ethanol after concentrating again, leaves standstill the back sucking filtration, and precipitation is respectively washed for several times with dehydrated alcohol, acetone, drying obtains Folium Mori extract.
(2), Folium Nelumbinis is cut into filament, adding ethanol or sour water soaks, adopt heating reflux method to extract its concentrated solution, ethanol extract is admixed suitable resin, volatilizes ethanol, resin is added on the macroporous adsorptive resins, acid water extracting liquid is direct upper prop after the sodium hydroxide solution modulation, washes decontamination with water, reuse ethanol-water elution, decompression recycling ethanol, volatilize Folium Nelumbinis extract.
(3), Radix Salviae Miltiorrhizae chopping, boiling water boils to be carried, extracting solution washes decontamination through concentrating after-filtration with water by macroporous resin adsorption, water-ethanol-water elution again, the reclaim under reduced pressure eluent, drying, Radix Salviae Miltiorrhizae extract.
(4), get three kinds of extracts of above-mentioned Folium Mori, Folium Nelumbinis, Radix Salviae Miltiorrhizae and mix after routinely drug formulation process make Chinese patent medicine of the present invention.
Chinese patent medicine preparation of the present invention can be a said preparation on any pharmaceutics.
Characteristics of the present invention are to draft the heat clearing away of hot profit, ascending the clear and descending the turbid, blood circulation promoting and blood stasis dispelling method of treatment, treat at the main pathology link of diabetes and complication thereof, have overcome deficiencies such as existing medicament composing prescription is numerous and jumbled, effect is single, curative effect is not very good.
Further illustrate beneficial effect of the present invention by following zoopery.
Experimental example 1. the present invention are to the influence of normal mouse blood sugar
Get 30 of mices, male and female half and half, body weight 18~22g.Be divided into 3 groups at random, i.e. normal group, Chinese patent medicine group of the present invention and glipizide group.The morning every day gastric infusion, continuous 14d, fasting is 3 hours after the last administration, gets blood from the mouse orbit vein, surveys blood glucose.The result shows that Chinese patent medicine of the present invention obviously influences the nothing of normal mouse blood sugar.
Experimental example 2. the present invention are to the influence of the close pyridine diabetic mice of four oxygen
Get 10 of normal mouses, survey its blood glucose value, conventional feed is fed then.Get into the mould mice again and be divided into 3 groups at random, be i.e. model group, Chinese patent medicine group of the present invention and glipizide group, successive administration 14d.After the last administration 1 hour, with above 4 groups of mices, eye socket was got blood, surveys its blood glucose value.The result shows that Chinese patent medicine of the present invention can make the alloxan diabetes mouse blood sugar reduce (P<0.05), sees Table 1.
The influence of the table 1. pair close pyridine blood glucose in diabetic mice of four oxygen
After the group Mus is counted the preceding administration of administration
Blood glucose (mmol/L)
Normal group 10 6.82 ± 2.61 6.36 ± 1.25
Model group 9 16.14 ± 3.32
* *11.88 ± 3.20
* *
Chinese drug-treated group 9 15.01 ± 3.73
* *8.24 ± 1.69
* △
Glipizide group 8 14.37 ± 4.41
* *5.27 ± 2.66
△ △ △
Annotate: compare with normal group,
*P<0.05,
* *P<0.001; Compare with model group,
△P<0.05,
△ △ △<0.001
3. pairs of streptozotocin mycin diabetes rat influences of experimental example
The method that adopts streptozotocin mycin (STZ) intravenous injection (30mg/kg) and give high caloric diet is duplicated type ii diabetes rat model (NIDDM), treated for 4 weeks respectively with Chinese patent medicine of the present invention, glipizide, measure body weight, serum insulin, serum levels of triglyceride, cholesterol, hemorheology and glucose tolerance test.
The result shows, Chinese patent medicine of the present invention has good improving carbohydrate tolerance, blood fat reducing, reduction blood viscosity, stop the generation of obesity and reduce the periphery serum insulin levels, improve the effect of type ii diabetes rat insulin opposing, point out Chinese patent drugs for treatment diabetes of the present invention to have multinomial regulating action.See Table 2,3,4,5,6.
The influence of table 2. pair NIDDM rat body weight
The group Mus is counted body weight (g)
Normal group 8 265.00 ± 15.96
NIDDM organizes 9 308.00 ± 18.49
*
Chinese drug-treated group 9 277.50 ± 18.95
△ △
Glipizide group 8 283.22 ± 19.09
△
Annotate: with the normal group ratio
*P<0.01; With NIDDM group ratio
△P<0.05,
△ △P<0.01
The influence of table 3. pair NIDDM rat glucose tolerance
Group n blood glucose value (mmol/L)
0 30 60 120
Normal group 8 6.26 ± 1.58 10.50 ± 1.36 8.16 ± 2.37 6.85 ± 2.42
NIDDM organizes 9 7.27 ± 1.42 17.24 ± 2.63
* *14.2 ± 3.68
*10.2 ± 2.37
* ▲
Chinese drug-treated group 9 6.83 ± 1.86 14.22 ± 1.58
* * △ △11.0 ± 1.52
* △8.03 ± 1.24
△
Glipizide group 8 6.58 ± 2.45 13.22 ± 2.74
* △ △10.53 ± 3.39
△7.89 ± 1.56
△
Annotate: compare with normal group,
*P<0.05,
*P<0.01,
* *P<0.001; Compare with the NIDDM group,
△P<0.05,
△ △P<0.01;
At once compare with this group
▲P<0.05.
The influence of table 4. pair NIDDM rat blood serum insulin
Group n insulin (μ IU/mL)
Normal group 8 22.73 ± 2.22
NIDDM organizes 9 27.13 ± 2.38
*
Chinese drug-treated group 9 24.88 ± 1.62
* △
Glipizide group 8 24.96 ± 1.23
* △
Annotate: compare * P<0.05, * * P<0.01 with normal group; Compare with the NIDDM group
△P<0.05
The influence of table 5. pair NIDDM rat blood serum triglyceride, cholesterol
Group n triglyceride (mmol/L) cholesterol (mmol/L)
Normal group 8 1.19 ± 0.25 2.74 ± 0.45
NIDDM organizes 9 2.48 ± 0.30
* *5.58 ± 0.33
* *
Chinese drug-treated group 9 1.61 ± 0.27
* △ △ △3.78 ± 0.24
* * △ △ △
Glipizide group 8 2.52 ± 0.33
* *5.70 ± 0.38
* *
Annotate: compare with normal group,
*P<0.01,
* *P<0.001; Compare with the NIDDM group
△ △ △P<0.001
The influence of table 6. pair NIDDM rat serum viscosity
Group n whole blood viscosity plasma viscosity reduced viscosity
192S
-1 3.84S
-1
Normal group 8 3.65 ± 0.18 7.74 ± 1.11 1.56 ± 0.09 0.19 ± 0.03
NIDDM organizes 9 3.71 ± 0.37 7.46 ± 1.64 1.65 ± 0.08*, 0.21 ± 0.02*
Chinese drug-treated group 9 3.87 ± 0.36 5.83 ± 0.46
△1.43 ± 0.06
△0.14 ± 0.02
△ △
Glipizide group 8 4.05 ± 0.42 6.13 ± 0.81 1.54 ± 0.08 0.14 ± 0.01
△ △
Annotate: compare with normal group,
*P<0.05; Compare with the NIDDM group
△P<0.05
△ △P<0.01
The specific embodiment
Below in conjunction with embodiment preparation method of the present invention is described further, following each embodiment only is used to the present invention is described but not limitation of the present invention.
Embodiment 1
Take by weighing total raw material 1000 grams by following proportioning:
Folium Mori 26~49%, Folium Nelumbinis 16~48%, Radix Salviae Miltiorrhizae 25~42%.
Take by weighing Folium Mori and add 10 times of amounts of water, soaked 20 minutes, supersound process is carried out under normal pressure, 40-60 ℃ of control ultrasound wave temperature, and ultrasonic time 30 minutes, double.Extracting solution is concentrated into certain volume, the centrifugal precipitation of removing, supernatant is walked post, and chromatographic column is filled with AB-8 type macroporous adsorbent resin wet method, is washed till eluent with distilled water and adds till 95% ethanol do not have a precipitation in macroporous adsorptive resins, again eluent is concentrated, filtrate concentrates the back and adds 95% ethanol and make and contain the alcohol amount and reach 80% concentration, leaves standstill the back sucking filtration, and precipitation is respectively given a baby a bath on the third day after its birth inferior with dehydrated alcohol, acetone, 60 ℃ of cold drying obtain amorphous powder.Take by weighing Folium Nelumbinis, be cut into filament, solubilization dosage 10-20 doubly soaked 30 minutes, and with ethanol or acid extraction, the time is 2 hours twice.Be concentrated into certain volume, ethanol extract is admixed suitable resin, volatilizes ethanol, the resin that is mixed with sample is added on the macroporous adsorptive resins of filling in advance; Acid water extracting liquid is transferred pH to 9~11 through 0.5% sodium hydroxide solution, directly upper prop.Wash decontamination earlier with water, reuse ethanol-water elution, decompression recycling ethanol, volatilize Folium Nelumbinis extract.Take by weighing Radix Salviae Miltiorrhizae, chopping, boiling water boils to be carried, and extracting solution washes decontamination through concentrating after-filtration with water by macroporous resin adsorption, water-ethanol-water elution again, the reclaim under reduced pressure eluent, drying, Radix Salviae Miltiorrhizae extract.After getting three kinds of extracts of above-mentioned Folium Mori, Folium Nelumbinis, Radix Salviae Miltiorrhizae and mixing routinely drug formulation process make Chinese patent medicine of the present invention.
Embodiment 2
Get Folium Mori 27%, Folium Nelumbinis 38%, Radix Salviae Miltiorrhizae 35%, the preparation technology of shining embodiment 1 makes Chinese patent medicine of the present invention.
Embodiment 3
Get Folium Mori 40%, Folium Nelumbinis 29%, Radix Salviae Miltiorrhizae 31%, the preparation technology of shining embodiment 1 makes Chinese patent medicine of the present invention.
Embodiment 4
Get Folium Mori 32%, Folium Nelumbinis 32%, Radix Salviae Miltiorrhizae 36%, the preparation technology of shining embodiment 1 makes Chinese patent medicine of the present invention.
Embodiment 5
Get Folium Mori 38.5%, Folium Nelumbinis 30.8%, Radix Salviae Miltiorrhizae 30.7%, the preparation technology of shining embodiment 1 makes Chinese patent medicine of the present invention.