3. summary of the invention:
The purpose of this invention is to provide a kind of blood sugar lowering, blood fat reducing, blood pressure lowering, raising microcirculatory blood flow and immunologic function, alleviate and prevent and treat the medicament of diabetic complication effect.
Another object of the present invention provides this medicaments preparation method.
The present invention is to diabetes (diabetes) and pathogenetic understanding of complication and Therapeutic Principle according to Chinese medicine, with reference to modern pharmacological research achievement and advanced technologies, from natural plant, filter out supplementing QI and nourishing YIN, blood sugar lowering, blood fat reducing, blood pressure lowering, blood circulation and channel invigorating, can improve the medical material of blood microcirculation flow and immunity, by the theory of Chinese medical science prescription, skim the cream off milk with modern advanced technologies, make the integrally-regulated and blood circulation and channel invigorating of its performance, the all methods such as blood flow and immunity that improve cooperate, promote endogenous secretion of insulin, reduce exogenous insulin periphery drag, effective blood sugar regulation, in the time of metabolism disorder of blood lipid, microcirculation improvement is prevented and treated diabetes, hyperlipidemia patient merges cardiovascular pathological changes, retinopathy.
Medicine of the present invention is made (consumption is a weight) by following component:
Radix Ginseng 10-30 part Radix Ophiopogonis 10-20 part Fructus Schisandrae Chinensis 10-20 part
Fructus Lycii 10-25 part Fructus Ligustri Lucidi 15-25 part Radix Puerariae 20-30 part
Semen Cassiae 20-35 part Radix Salviae Miltiorrhizae 10-20 part Rhizoma Polygonati 10-30 part
Rhizoma Atractylodis Macrocephalae 10-25 part
The formula optimization weight proportion scope of preparation medicine of the present invention is:
Radix Ginseng 3-10 part Radix Ophiopogonis 5-15 part Fructus Schisandrae Chinensis 6-10 part
Fructus Lycii 6-15 part Fructus Ligustri Lucidi 10-20 part Radix Puerariae 15-25 part
Semen Cassiae 8-15 part Radix Salviae Miltiorrhizae 5-15 part Rhizoma Polygonati 10-25 part
Rhizoma Atractylodis Macrocephalae 8-15 part
The optimum weight proportioning of medicine of the present invention is:
6 parts of 14 parts of Fructus Schisandrae Chinensis of 8 parts of Radix Ophiopogonis of Radix Ginseng
10 parts of 14 parts of Radix Puerariaes of 14 parts of Fructus Ligustri Lucidi of Fructus Lycii
20 parts of 10 parts of Rhizoma Polygonatis of 9 parts of Radix Salviae Miltiorrhizaes of Semen Cassiae
15 parts of the Rhizoma Atractylodis Macrocephalaes
Above-mentioned each component is made medicine production method of the present invention is:
1. Radix Ginseng, Radix Puerariae, Fructus Ligustri Lucidi is broken by above-mentioned prescription medical material mixed powder, make coarse powder, enable pass is crossed No. 1 sieve or No. 2 sieves, use alcohol reflux, filtration, alcohol extract and medicinal residues are preserved respectively;
2. Radix Ophiopogonis, Fructus Lycii, Fructus Schisandrae Chinensis, Semen Cassiae, Radix Salviae Miltiorrhizae, Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae are broken into coarse powder by above-mentioned prescription medical material mixed powder, add above-mentioned medicinal residues (after the alcohol extraction), fry in shallow oil, extract volatile oil and medicinal liquid according to a conventional method with multi-functional pouring water;
3. the decocting medicinal liquid is filtered, clarifies, concentrates;
4. volatile oil is handled with β-CDBao He;
5. add adjuvant (solubilizing agent, antiseptic, antioxidant) after alcohol extract, volatile oil, decocting medicinal liquid being cooperated and obtain dosing;
6. according to a conventional method the Chinese patent medicine dosage form is made in dosing again, as hard capsule, soft capsule, tablet, granule, powder, pill, teabag, medicated wine, oral liquid, distillate medicinal water, injection etc.
An important feature of the present invention is to contain terpenes and flavonoid composition in the medicament, terpenes total content 0.5%-1.0%, flavonoid total content 0.9%-1.8%.Wherein the terpenes composition has good blood sugar lowering, cholesterol reducing effect.Contained flavone compound has very strong oxidation resistance, energy vessel softening, reduction vascular fragility, and microcirculation improvement can reduce too high blood fat, blood pressure, treatment of vascular sclerosis.The terpenes flavone compound has remarkable blood sugar decreasing effect, can increase the islets of langerhans blood perfusion, helps the synthetic and secretion of insulin; Platelet aggregation and thrombosis there are the good restraining effect, can blood circulation promoting and blood stasis dispelling, cleaning blood vessel, blood circulation promoting, raising blood flow; Also has the effect of very strong defying age, enhancing body immunity.
Clinical drug of the present invention uses the result to show that following advantage is arranged:
(1) to select natural edible-plant for use be raw material in the present invention, and each component meets the pharmaceutical control law regulation.Utilize comprehensive function treatment diabetes, hyperlipidemia, hypertension and the complication of prescription medicine, nontoxic, harmless to human body.
(2) select alcohol extracting method and use multi-functional extraction to irritate and extract active ingredient for use, the drug bioavailability height reaches quick-acting, purpose efficiently.
(3) diabetes and hyperlipidemia complications, hypertension and retinopathy there is good therapeutic effect.
For showing the present invention to the treatment of diabetes effect, through the clinical observation of 100 routine systems, and selection medical history, the state of an illness, age, sex and suitable diabetics 50 examples of former Therapeutic Method are matched group.From being in hospital and endocrine special outpatient clinic selection case, press the diabetes diagnosis standard that WHO1980 formulates, the maturity-onset diabetes patient who makes a definite diagnosis, on the basis of Diet Therapy method and medicine (oral antidiabetic drug and insulin) treatment, fasting glucose 7.2mmoI/L person is the object of observation, wherein male 48 examples, women 52 examples, age 27-50 year, course of disease half a year to 20 year.Test group: on former treatment basis, the lipid lowerers of stopping using is obeyed medicine of the present invention.Matched group: blood sugar lowering, blood fat reducing treatment routinely, wherein hypoglycemic medicine, kind instructions about how to take medicine consumption and test group are complementary, and lipid lowerers adopts the import fenofibrate.Adopt same procedure to make regular check on fasting glucose and blood fat, two months observation periods, 20 days is a course of treatment, totally three courses of treatment.
Instructions of taking: oral liquid of the present invention 20ml/ time, day clothes 3 times, ante cibum, boiled water was taken after mixing it with water.Clinical test results such as subordinate list 1-2.
Subordinate list 1 is taken medicine of the present invention front and back insulin, and diamicron is with being and change of blood sugar
Case load | Insulin dosage (U/d) | Diamicron consumption (mg/d) | Fasting glucose decline (mmol/L) |
Before | After | Before | After | Before | After |
Test group 100 matched groups 50 T P | 46.2 45.89 0.28 >0.05 | 20.59 49.18 10.87 <0.01 | 260 240 0.26 >0.05 | 60 280 8.75 <0.01 | 11.7±3.69 11.37±3.18 0.54 >0.05 | 7.55±2.32 9.78±3.01 2.46 <0.01 |
Subordinate list 2 is taken medicine front and back lipid lowerers consumption of the present invention and the average concentration change of blood fat
Case load | Fenofibrate consumption (U/d) | Serum cholesterol meansigma methods (mg/d) | Serum glycerol meansigma methods (mmol/L) |
Before | After | Before | After | Before | After |
Test group 100 | 0 | 0 | 5.77±1.10 | 4.52±0.82 | 2.12±1.07 | 1.34±0.53 |
Matched group 50 T P | 300 | 300 | 5.87±1.06 0.84 >0.05 | 5.13±0.97 4.32 >0.01 | 2.08±0.93 0.76 >0.05 | 2.51±0.32 3.55 >0.05 |
From subordinate list 1 as can be seen, fasting glucose concentration is similar substantially with the hypoglycemic medicine consumption before two groups of tests, P<0.05, and blood glucose descended after test group was taken the present invention, and the antidiabetic drug consumption is but than original minimizing 1/3-1/2.
Subordinate list 2 data show that serum cholesterol and triglyceride mean concentration do not have significant difference before two groups of tests; But test group is not used any other lipid lowerers with behind the medicine of the present invention, can reach the blood fat reducing purpose.
Take the relevant data of immunity of organisms before and after the medicine of the present invention, measurement result 3 (matched group is the normal person, and test group is the diabetes patient) of seeing attached list.
Subordinate list 3T Lymphocyte Subsets Determination result
| The example number | OKT(%) | OKT
4(%)
| OKT
3(%)
| OKT
4 OKT
3 |
Test group | Before the treatment | 50 | 64.47±6.23 | 36.47±4.27 | 31.48±3.68 | 1.27±0.14 |
Before the treatment | 50 | 64.37±7.28 | 38.91±4.12 | 27.57±4.32 | 1.43±0.32 |
Matched group | 40 | 64.36±8.70 | 38.91±4.11 | 25.43±4.18 | 1.46±0.24 |
The detection method of T cell mass is to adopt conventional alkaline phosphorus enzyme alkali resistance phosphoric acid enzyme process.Determination data shows that diabetics is OKT before taking medicine of the present invention
3Be significantly higher than the normal person, OKT
4/ OKT
3Ratio obviously reduces, and takes after the medicine of the present invention, and the two all roughly recovers normal, shows that medicine of the present invention has the enhancing human body immunity function.
Test statistics shows: with medicament of the present invention 100 diabeticss are done therapeutic test, that obtains significant curative effect accounts for 53%, substantially effectively accounts for 42%, and invalid accounts for 5%, and total effective rate reaches 95%.