CN103142844A - Pharmaceutical composition for treating diabetic nephropathy - Google Patents

Abstract

The invention relates to a pharmaceutical composition for treating diabetic nephropathy. Based on traditional Chinese medicine theories, the pharmaceutical composition comprises traditional Chinese medicine raw material medicines such as cooked rehmannia root, astragalus root, polygonati, salvia root, Chinese yam, white atratylodes rhizome, atractylodes rhizome, notoginseng root, alisma rhizome, and poria, has the effects of tonifying qi and yin, and clearing dampness and dredging collaterals; and is used for treating the diabetic nephropathy.

Description

A kind of pharmaceutical composition for the treatment of diabetic nephropathy

Technical field

The present invention relates to a kind of Chinese medicine composition, particularly relate to a kind of pharmaceutical composition for the treatment of diabetic nephropathy; Belong to medical technical field.

Background technology

Diabetic nephropathy (DN) is one of common microvascular complication of diabetes, is also one of main cause of death of diabetics.The data demonstration, DN is about 36.39% in whole renal failure in latter stage (ESRF) patient of the U.S., and European DN accounts for 7.9% in ESRF, and Japan is 16%, and China D N accounts for 5% of ESRF sum.Although the present sickness rate of China is lower than western countries, but the change along with rapid raising, the prolongation of the average life span and the dietary structure of living standards of the people, sickness rate and the prevalence of diabetes raise year by year, add China's large population base, definitely patient's number will become far above western countries DN the one of the main reasons that causes end stagerenaldisease.The DN cause of disease is complicated, and the factor that affects its progress and prognosis relates to many aspects.

Modern medicine thinks, the genesis of DN is the multifactor interactional results such as hyperglycemia, hypertension, Abnormal Blood Rheology, disorders of lipid metabolism, and wherein hyperglycemia, hypertension are that DN occurs, the Fundamentals of development.The key factor of diabetic microvascular complication and blood viscosity increases, erythrocyte deformability weakens, platelet adhesion reaction and aggregation increase.Blood viscosity increases and increases the weight of renal ischemic, anoxia, and in glomerular basement membrane, the thio-alcohol heparin reduces, and causes the glomerular basement membrane permeability to increase and produces albuminuria.The hemorheologys such as Gao Ning, height stick, slow blood flow change can accelerate renal function injury.Wherein, microdose urine protein is an important indicator of glomerule infringement.Therefore, the treatment of DN should when effectively controlling blood glucose, blood pressure, also should be paid attention to microdose urine protein and hemorheological variation, find early and treat, improving microcirculation, suppressing platelet activation and gathering, improve renal function, to delay the process of glomerular sclerosis.

Treat at present diabetes, hypoglycemic drug commonly used mainly contains more than 20 kinds such as acarbose, metformin, gliclazide, gliquidone, glipizide, glibenclamide, glimepiride and McI; Diabetic nephropathy is as diabetic complication, and drug combination is normally adopted in its treatment.But the side effect of chemical medicine strengthens, and long-term taking will strengthen the human tolerance, and dependency is larger, thereby it is necessary to develop the little Chinese medicine preparation of toxic and side effects.

Chinese medicine is thought, DN is many by the deficiency of both QI and YIN onset, turbid damp, blood stasis are the key factor of its genesis, especially in early days in DN, deficiency of both QI and YIN is it, and mark mostly is wet and the stasis of blood actually, and the wet stasis of blood is tied mutually, touchingly do not heal, finally cause negative and positive of qi and blood all empty, produce multiple deteriorated case, therefore the treatment of DN focuses on supplementing QI and nourishing YIN, treatment of arthritis and promoting collateral and channels.

The inventor in conjunction with the modern medicine neodoxy, invents out the pharmaceutical composition for the treatment of diabetic nephropathy based on above-mentioned theory of Chinese medical science.

Summary of the invention

In order to address the above problem, purpose of the present invention just is to provide a kind of pharmaceutical composition for the treatment of diabetic nephropathy, and this pharmaceutical composition focuses on supplementing QI and nourishing YIN, treatment of arthritis and promoting collateral and channels, treats clinically all empty diabetic nephropathyes of QI and blood.

For achieving the above object, the pharmaceutical composition for the treatment of diabetic nephropathy provided by the invention is prepared from by the processing of the crude drug of following weight parts:

Radix Rehmanniae Preparata 20-30 part Radix Astragali 12-18 part Rhizoma Polygonati 12-18 part Radix Salviae Miltiorrhizae 10-15 part

Rhizoma Dioscoreae 5-10 part Rhizoma Atractylodis Macrocephalae 5-10 part Rhizoma Atractylodis 10-15 part Radix Notoginseng 5-10 part

Rhizoma Alismatis 5-10 part Poria 5-10 part.

Preferred plan is prepared from by the processing of the crude drug of following weight parts:

12 parts of 15 parts of Radix Salviae Miltiorrhizaes of 15 parts of Rhizoma Polygonatis of 25 parts of Radixs Astragali of Radix Rehmanniae Preparata

8 parts of 12 portions of Radix Notoginseng of 8 parts of Rhizoma Atractylodis of 8 parts of Rhizoma Atractylodis Macrocephalaes of Rhizoma Dioscoreae

8 parts, 8 parts of Poria of Rhizoma Alismatis.

A kind of pharmaceutical composition for the treatment of diabetic nephropathy of the present invention can be prepared into any existing clinical applicable dosage form in capsule, tablet, granule, oral liquid, pill.

Described weight portion can be the weight metering units such as gram, two, jin, kilogram, ton.

Pharmaceutical composition of the present invention can adopt the ingredients of conventional method in writing out a prescription to carry out in proportion compatibility, makes various clinical applicable dosage forms by existing preparation process, and ingredients used is the Chinese crude drug that commercially available process is up to the standards.

Why the present invention selects above-mentioned medical material as raw material, is because they have following effect:

Radix Rehmanniae Preparata: nourishing YIN and supplementing blood, beneficial essence is filled out marrow.Be used for the hepatic and renal YIN deficiency, soreness of the waist and knees, osteopyrexia and fever, the night sweat seminal emission, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, severe palpitation, menoxenia, metrostaxis, dizzy, tinnitus, early whitening of beard and hair.

The Radix Astragali: modern pharmacological research shows, the expansible peripheral blood vessel of the Radix Astragali, coronary vasodilator, cerebrovascular and microcirculation, has hypotensive effect, can effectively reduce the platelet activation degree, suppress the synthetic and release of 5 one hydroxytryptamines in platelet, reduce Platelet, reduce thrombosis, improve high blood coagulation state, reach anticoagulant, reduce the effect that urine protein is discharged.

Rhizoma Polygonati: have blood pressure lowering, blood sugar lowering, blood fat reducing, atherosclerosis, slow down aging and the effect such as antibiotic, polygonatum polysaccharide has Immunestimulatory effect.

Radix Salviae Miltiorrhizae: improve plasmin activity; Extend, clotting time; Anticoagulant (improving the interior cAMP level inhibition of platelet TXA2 synthetic); Improve hemorheological properties (blood viscosity reduction, erythrocyte electrophoretic time shorten).

Rhizoma Dioscoreae: have the effect that promotes the interferon generation and increase the T cell number.Tonify without causing stagnation, not hot not dry, can enriching spleen-QI and stomach reinforcing is cloudy, and invigorating the lung and the kidney can only be as the product of assisting.

The Rhizoma Atractylodis Macrocephalae: adjust gastrointestinal motility function, antiulcer, protect the liver, the effects such as enhancing human body immunity function, anti-stress, enhancing hemopoietic function; Its dampness diuretic effect is relevant with diuresis; And antiabortive effect is relevant with the effect of inhibition uterine contraction.The Rhizoma Atractylodis Macrocephalae also has the effects such as antioxidation, slow down aging, blood sugar lowering, anticoagulation, antitumor.

Rhizoma Atractylodis: adjust gastrointestinal motility function, antiulcer, protect the liver.Antibacterial etc.The main effective ingredient of Rhizoma Atractylodis is the volatile oil take sagittol and hinesol as representative.The impact of Rhizoma Atractylodis on blood glucose.Anti-hypoxia, maincenter inhibition, antitumor, the calcification of promotion skeleton reach the effects such as impact on cardiovascular system, are the modern study progress of its pharmacological action.

Radix Notoginseng: have the dissipating blood stasis hemostasis, the effect of subduing swelling and relieving pain.Cure mainly spitting of blood, spit blood, epistaxis is had blood in stool, metrorrhagia, and traumatic hemorrhage, breast ventral spine pain, tumbling down swells and ache.Compendium of Material Medica cloud: " Radix Notoginseng hemostasis, loose blood, analgesic therapy." " jade is seized the medicine solution " cloud: " and Radix Notoginseng and battalion hemostasis, the clots absorbing of promoting blood circulation, clots absorbing blood and hold back fresh blood ".

Rhizoma Alismatis: diuresis, clearing away damp-heat.Be used for dysuria, edema distension, the oliguria of having loose bowels, dizziness due to fluid-retention, the puckery pain of pyretic stranguria; Hyperlipidemia.

Poria: promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.Be used for the edema oliguria, the phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in the loose stool, irritability, palpitation with fear insomnia.

Pharmaceutical composition provided by the invention has the effect of supplementing QI and nourishing YIN, treatment of arthritis and promoting collateral and channels; Be used for clinically the diabetic nephropathy due to deficiency of both QI and YIN.

Clinical research:

1. clinical data:

The patient is totally 42 examples, and all cases all meet diabetes diagnosis and the typing of WHO formulation in 1999, diabetic nephropathy typing standard.Therapy of combining Chinese and Western medicine group 21 examples, male's 10 examples, women's 11 examples, age 43～80, average 65 years old.Diabetic duration 2～3O, average 13 years.WM therapy group 21 examples, male 12, women's 9 examples, age 37～83,63 years old mean age.Diabetic duration 3～28 years, average 12 years.Treatment group is compared difference without explicitly with matched group at aspects such as age, sex, type, the course of disease, coincident with severity degree of conditions, has comparability.

2. Therapeutic Method

2.1 matched group gives diabetes education, reasonable diet (controlling heat, less salt, absorption high-quality protein etc.), on the basis of appropriate exercise and mental adjustment etc., give acarbose, gliquidone control blood glucose, with glycemic control at empty stomach＜7.8mmol/L, post-prandial glycemia＜10.0mml/L.As control the undesirable insulinize of using instead.Routine of western medicine is controlled blood pressure, adopts angiotensin converting enzyme inhibitor (ACEI) or angiotensin-ii receptor blocker (ARB).Control not good enough person and coordinate other antihypertensive drugs.Make controlling of blood pressure in 140/90mmHg.Coordinate simultaneously ginkgo bilobate extract 15mml dead point, once a day, be used in conjunction 15～20 days.Patient's rear follow-up of leaving hospital, 2 months courses for the treatment of.

2.2 adding with differential diagnosis in tcm on the matched group basis, treatment group treats, with pharmaceutical composition best prescription of the present invention: Radix Rehmanniae Preparata 25g, Radix Astragali 15g, Rhizoma Polygonati 15g, Radix Salviae Miltiorrhizae 12g, Rhizoma Dioscoreae 8g, Rhizoma Atractylodis Macrocephalae 8g, Rhizoma Atractylodis 12g, Radix Notoginseng 8g, Rhizoma Alismatis 8g, Poria 8g, the decocting extracting juice, day takes potion, minute secondary clothes.

2.3 two groups of observational techniques are all treated 2 months statistics curative effects, check the indexs such as fasting glucose (FPG), serum urea nitrogen (BUN), creatinine (cr), urine protein are qualitative, 24h urine protein quantitation.

3 observation of curative effect

3.1 criterion of therapeutical effect produce effects: clinical symptoms and sign disappear or obviously improve, normal renal function or improvement, and edema disappears, and blood glucose is in the scope that is satisfied in the main, 24h urine protein quantitation＜0.5g.Effectively: renal function takes a turn for the better, and edema obviously alleviates or disappears, 24h urine protein quantitation＜0.5g, and more than the qualitative minimizing of urine protein "+", the scope that blood glucose is being satisfied in the main; Invalid: symptom is without taking a turn for the better or increasing the weight of, and urine protein is qualitative without changing.

3.2 in therapeutic outcome treatment group 21 examples, produce effects 13 examples account for 61.9%, effective 5 examples account for 23.8%, and invalid 3 examples account for 14.3%, total effective rate 85.7%.In matched group 21 examples, produce effects 6 examples account for 28.6%, and effective 8 examples account for 38.1%, and invalid 7 examples account for 33.3%, total effective rate 66.7%.Two groups of total effective rates are learned processing by statistics, and there were significant differences.

Above-mentioned studies show that, medicine of the present invention has good curative effect aspect the treatment diabetic nephropathy.

The specific embodiment

The specific embodiment that the below adopts describes the present invention, and the description of this part is only exemplary and explanatory, should any restriction not arranged to protection scope of the present invention.

Embodiment 1

10 parts of 12 parts of Radix Salviae Miltiorrhizaes of 12 parts of Rhizoma Polygonatis of 20 parts of Radixs Astragali of Radix Rehmanniae Preparata

5 parts of 10 portions of Radix Notoginseng of 5 parts of Rhizoma Atractylodis of 5 parts of Rhizoma Atractylodis Macrocephalaes of Rhizoma Dioscoreae

5 parts, 5 parts of Poria of Rhizoma Alismatis

Embodiment 2

15 parts of 18 parts of Radix Salviae Miltiorrhizaes of 18 parts of Rhizoma Polygonatis of 30 parts of Radixs Astragali of Radix Rehmanniae Preparata

10 parts of 15 portions of Radix Notoginseng of 10 parts of Rhizoma Atractylodis of 10 parts of Rhizoma Atractylodis Macrocephalaes of Rhizoma Dioscoreae

10 parts, 10 parts of Poria of Rhizoma Alismatis

Embodiment 3

12 parts of 15 parts of Radix Salviae Miltiorrhizaes of 15 parts of Rhizoma Polygonatis of 25 parts of Radixs Astragali of Radix Rehmanniae Preparata

8 parts of 12 portions of Radix Notoginseng of 8 parts of Rhizoma Atractylodis of 8 parts of Rhizoma Atractylodis Macrocephalaes of Rhizoma Dioscoreae

8 parts, 8 parts of Poria of Rhizoma Alismatis

The application of above-mentioned composition aspect diabetic nephropathy.

Above-mentioned composition can be made any existing clinical applicable dosage form in capsule, tablet, granule, oral liquid, pill according to prior art.

Claims (3)

1. pharmaceutical composition for the treatment of diabetic nephropathy is characterized in that being prepared from by the crude drug processing of following weight parts:

Radix Rehmanniae Preparata 20-30 part Radix Astragali 12-18 part Rhizoma Polygonati 12-18 part Radix Salviae Miltiorrhizae 10-15 part

Rhizoma Dioscoreae 5-10 part Rhizoma Atractylodis Macrocephalae 5-10 part Rhizoma Atractylodis 10-15 part Radix Notoginseng 5-10 part

Rhizoma Alismatis 5-10 part Poria 5-10 part.

2. a kind of pharmaceutical composition for the treatment of diabetic nephropathy according to claim 1 is characterized in that being prepared from by the crude drug processing of following weight parts:

12 parts of 15 parts of Radix Salviae Miltiorrhizaes of 15 parts of Rhizoma Polygonatis of 25 parts of Radixs Astragali of Radix Rehmanniae Preparata

8 parts of 12 portions of Radix Notoginseng of 8 parts of Rhizoma Atractylodis of 8 parts of Rhizoma Atractylodis Macrocephalaes of Rhizoma Dioscoreae

8 parts, 8 parts of Poria of Rhizoma Alismatis.

3. one of them described a kind of pharmaceutical composition for the treatment of diabetic nephropathy according to claim 1 and 2, is characterized in that, preparation is any existing clinical applicable dosage form in capsule, tablet, granule, oral liquid, pill.