CN103830589B - A kind of pharmaceutical composition treating hypertensive renal damage and preparation method and purposes - Google Patents
A kind of pharmaceutical composition treating hypertensive renal damage and preparation method and purposes Download PDFInfo
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Abstract
The invention discloses a kind of pharmaceutical composition treating hypertensive renal damage, this pharmaceutical composition is made up of the raw material of following ratio of weight and number: Rhizoma Dioscoreae 10～60 parts, Flos Chrysanthemi 10～60 parts, Radix Rehmanniae Preparata 5～50 parts, 5～50 parts of Poria, Cortex Moutan 5～50 parts, 5～50 parts of Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis 5～50 parts, Spica Prunellae 5～50 parts, Concha Haliotidis 5～50 parts.The present invention also disclosed preparation method and the purposes of this pharmaceutical composition.Pharmaceutical composition of the present invention composition is simple, novel formula has that cost is low, good effect, have no side effect, be not likely to produce toleration, take and easy to carry, be generally applicable to the feature such as patient of hypertensive renal damage.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition treating hypertensive renal damage and preparation method thereof.
Background technology
Hypertensive cerebral renal damage is long-term, lasting, a progressive evolution, long-term hypertension can cause nephrosclerosis, then may result in glomerulonephritis tubule ischemic lesions, cause glomerular sclerosis, renal tubules atrophy, kidney region fibrosis, and progress is chronic renal failure (chronicrenalfailure, CRF) gradually.The 1950's Perera report first time confirm human essential hypertension to the hazardness of kidney because hypertension causes kidney damage to enter end stagerenaldisease (endstagerenaldisease, ESRD) patient numbers is in the trend increased year by year, the ESRD that research shows 28% is relevant with hypertension, and current doctor trained in Western medicine is mainly based on Treatment of Hypertensions such as ACEI, ARB.By the difference of goal, efferent glomerular arteriole degrees of expansion, thus reaching to reduce the situations such as glomerule HT, high filtration, alleviating glomerule burden, reaching to delay the effect of renal fibrosis.But current study show that, although by controlling of blood pressure in certain amplitude, but the process of renal fibrosis is not substantially changed.
Motherland's medical science is without hypertensive cerebral renal damage name of disease, but can belong to the categories such as motherland's medical science " asthenia ", " impairment of the kidney caused by overstrain ", " poison of drowning ", " obstruction and rejection " from its clinical manifestation.Motherland's medical science is thought, the kidney being the origin of congenital constitution, the root of vigour, people is after the middle age, the age increases, and inevitable kidney qi is gradually lost, in addition the factor reciprocal action such as diet, spirit, labor desire, kidney qi is made more to lose, deficiency of kidney-QI, disturbance in functioning of QI, astringency inducing is had no right, clinic occur soreness of the waist and knees, weak, nocturia and precise and tiny under let out, and see the diseases such as albuminuria.The primary disease course of disease is tediously long, recurrent exerbation, therefore pathogen usually intruding into collateral in protracted disease, suffer from a deficiency of the kidney and cause the stasis of blood.Simultaneously at pathological changes middle and late stage, due to nephrons virtual loss, opening entire mistake department, cause turbid damp retention, accumulate in middle Jiao, taste abnormal ascending-descending of QI, in conjunction with clinical findings, how double patient is sees that nausea and vomiting, edema, purplish tongue have the blood stasis turbid damp internal resistance such as ecchymosis, greasy fur to see disease more.
Hypertensive renal damage is had good therapeutical effect by Chinese medicine, the research of hypertensive renal damage is also increased by the current traditional Chinese medical science gradually, as Chinese patent 200810055064.6 discloses a kind of medicine treating hypertensive renal damage and preparation method thereof, this pharmaceutical composition is made up of the Radix Astragali, Radix Rehmanniae, Rhizoma Polygonati, Rhizoma Dioscoreae, Rhizoma Atractylodis；Chinese patent 200910055794.0 discloses a kind of compound Chinese medicinal preparation treating early high blood pressure renal damage, and said preparation is formed by Radix Rehmanniae Preparata, the Cortex Eucommiae, Herba Taxilli, Ramulus Uncariae Cum Uncis, Herba Apocyni veneti, Radix Puerariae and Radix Cyathulae compositions；Chinese patent 201210322847.2 discloses a kind of Chinese medicine treating hypertension early-stage kidney damage and preparation method thereof, and this pharmaceutical composition is made up of Radix Rehmanniae Preparata, Fructus Corni, Rhizoma Dioscoreae, the Cortex Eucommiae, Radix Salviae Miltiorrhizae and Carapax Et Plastrum Testudinis.Above-mentioned compound recipe is all treated with kidney tonifying suppressing the hyperactive liver for main.The horizontal liver oral liquid for depressing blood pressure of taste is made up of Rhizoma dioscoreae, Radix Rehmanniae Preparata, Poria, Cortex Moutan, the Cortex Eucommiae, Herba Taxilli, Radix Cyathulae, Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis, Flos Chrysanthemi, Spica Prunellae, Concha Haliotidis, Concha Margaritifera, Radix Et Rhizoma Rhei, show that blood pressure renal damage is had good therapeutical effect through early-stage Study, but the party's dosage is more, the more difficult control of the impurity of this compound recipe when industrialization, therefore need further the party to be furtherd investigate.
Summary of the invention
It is an object of the present invention to overcome the deficiencies in the prior art, there is provided one composition simple, the pharmaceutical composition of the treatment hypertensive renal damage of novel formula, this pharmaceutical composition has that cost is low, good effect, have no side effect, be not likely to produce toleration, take and easy to carry, be generally applicable to the feature such as patient of hypertensive renal damage.
Further object is that the preparation method providing a kind of pharmaceutical composition treating hypertensive renal damage, this preparation method is simple to operate, is applicable to industrialized production.
It is an object of the invention to be achieved through the following technical solutions: a kind of pharmaceutical composition treating hypertensive renal damage, it is made up of the raw material of following ratio of weight and number: Rhizoma Dioscoreae 10～60 parts, Flos Chrysanthemi 10～60 parts, Radix Rehmanniae Preparata 5～50 parts, 5～50 parts of Poria, Cortex Moutan 5～50 parts, 5～50 parts of Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis 5～50 parts, Spica Prunellae 5～50 parts, Concha Haliotidis 5～50 parts.
Preferably, the ratio of weight and number of described each raw material is: Rhizoma Dioscoreae 15～50 parts, Flos Chrysanthemi 15～50 parts, Radix Rehmanniae Preparata 10～40 parts, 10～40 parts of Poria, Cortex Moutan 10～40 parts, 10～40 parts of Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis 10～40 parts, Spica Prunellae 10～40 parts, Concha Haliotidis 10～40 parts.
Preferably, the ratio of weight and number of described each raw material is: Rhizoma Dioscoreae 20～40 parts, Flos Chrysanthemi 20～40 parts, Radix Rehmanniae Preparata 15～30 parts, 15～30 parts of Poria, Cortex Moutan 15～30 parts, 15～30 parts of Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis 15～30 parts, Spica Prunellae 15～30 parts, Concha Haliotidis 15～30 parts.
Preferably, the ratio of weight and number of described each raw material is: Rhizoma Dioscoreae 25 parts, Flos Chrysanthemi 25 parts, Radix Rehmanniae Preparata 20 parts, 20 parts of Poria, Cortex Moutan 20 parts, 20 parts of Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis 20 parts, Spica Prunellae 20 parts, Concha Haliotidis 20 parts.
A kind of method preparing any of the above-described treatment hypertensive renal damage pharmaceutical composition, it is characterised in that: it comprises the following steps:
S1: weigh each raw material by weight, after mixing, the water soaking of addition medical material 6～8 times amount 0.5～1 hour, decocts subsequently 0.5～1 hour, is filtrated to get decocting liquid, and medicinal residues are standby；
S2: the medicinal residues in S1 step adding the soak by water 1～1.5 hour of 6～8 times of medical material amounts, is filtrated to get decocting liquid, medicinal residues discard；
S3: be condensed into extractum after S1 step being merged with the decocting liquid in S2 step, then obtains dry cream by extractum vacuum drying, and dried cream powder is broken, adds pharmaceutically acceptable adjuvant and prepares into pharmaceutically conventional pharmaceutical preparation.
Pharmaceutical preparation of the present invention is tablet, capsule, granule, powder or oral liquid.
Pharmaceutically acceptable adjuvant of the present invention includes starch, magnesium stearate, dextrin and microcrystalline Cellulose.
The arbitrary pharmaceutical composition of the present invention application in preparation treatment hypertensive renal damage medicine.
The pharmaceutical composition of the present invention can prepare into dosage form described on any pharmaceutics according to the conventional method of pharmaceutical field；Pharmaceutical composition can be applied to patient by modes such as oral, suction or intestinal external administrations.The described dosage form on pharmaceutics includes: the tablet of use, capsule, pill, powder, granule, syrup, oral liquid etc. during oral administration；The freeze-dried powder used when intestinal external administration and injection etc..
For making above-mentioned dosage form be capable of, pharmaceutically acceptable adjuvant need to be added when preparing these dosage forms, for instance: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, preservative, substrate etc..Filler includes: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.；Disintegrating agent includes: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.；Lubricant includes: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.；Suspending agent includes: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl methyl cellulose etc.；Binding agent includes, starch slurry, polyvinylpyrrolidone, hydroxypropyl methyl cellulose etc.；Sweeting agent includes: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.；Correctives includes: sweeting agent and various essence；Preservative includes: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, acetic acid chloroethene are fixed, Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods；Substrate includes: PEG6000, PEG4000, insect wax etc..
Rhizoma Dioscoreae in pharmaceutical composition of the present invention, Flos Chrysanthemi, Radix Rehmanniae Preparata, Poria, Cortex Moutan, Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis, Spica Prunellae and Concha Haliotidis are 2010 editions " Chinese Pharmacopoeias " first Chinese medicine recorded or its processed product.Rhizoma Dioscoreae is the rhizome of Dioscoreaceae plant Rhizoma Dioscoreae, sweet, flat, returns lung, spleen, kidney channel, has QI invigorating tonifying YIN, the effect of tonifying the lung spleen kidney；Flos Chrysanthemi is the head inflorescence of feverfew chrysanthemum, pungent, sweet, bitter, is slightly cold, and returns lung, Liver Channel, has dispelling wind and heat pathogens, suppressing liver-YANG, liver heat removing and eyesight improving, the effect of heat-clearing and toxic substances removing；Radix Rehmanniae Preparata is the rhizome of scrophulariaceae rehmannia glutinosa plant, sweet in the mouth, warm in nature, returns liver, kidney channel, has the effect of with functions of blood enriching and yin nourishing, benefit essence；Poria is the sclerotium of On Polyporaceae Poria, sweet, light, flat, and GUIXIN, lung, spleen channel have invigorating the spleen and regulating the stomach, the effect of mind tranquilizing and the heart calming；Cortex Moutan is the dry root bark of ranunculaceae peony, bitter, pungent, be slightly cold, and GUIXIN, liver, kidney have clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling, the effect of clearing away deficiency-heat；Rhizoma Gastrodiae is the orchid family Gastrodia herbaceos perennial, sweet, flat, returns Liver Channel, has endogenous wind stopping relieving convulsion, suppressing the hyperactive liver and subsiding YANG, the effect of dispelling wind and removing obstruction in the collateral；Ramulus Uncariae Cum Uncis is the stem and branch with belt hook of Maguireothamnus speciosus Ramulus Uncariae Cum Uncis, Ramulus Uncariae macrophyllae, Ramulus Uncariae Cum Uncis, Uncaria sinensis (Oliv.) Havil. or stockless fruit Ramulus Uncariae Cum Uncis, sweet, be slightly cold, and returns liver, pericardium channel, has endogenous wind stopping relieving convulsion, the effect of heat clearing away suppressing the hyperactive liver；Spica Prunellae is the fruit ear of labiate Spica Prunellae, and bitter, acrid, cold return Liver Channel, have clearing away liver-fire, the effect of detoxicating and resolving stagnation of pathogens；Concha Haliotidis is the shell of Bao Ke animal Haliotis diversicolor, haliotis discus hannai Ino, ear Bao, sheep Bao etc., salty, cold, returns Liver Channel, has suppressing the hyperactive liver and subsiding YANG, the effect of liver heat removing and eyesight improving.
The invention has the beneficial effects as follows: the present composition is for growing horizontal liver oral liquid for depressing blood pressure (growing horizontal liver oral liquid for depressing blood pressure: Rhizoma dioscoreae, Radix Rehmanniae Preparata, Poria, Cortex Moutan, the Cortex Eucommiae, Herba Taxilli, Radix Cyathulae, Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis, Flos Chrysanthemi, Spica Prunellae, Concha Haliotidis, Concha Margaritifera, Radix Et Rhizoma Rhei) addition or subtraction of changes, it is shown experimentally that, growing horizontal liver oral liquid for depressing blood pressure and remove Concha Margaritifera, Radix Et Rhizoma Rhei, the Cortex Eucommiae, Herba Taxilli and Radix Cyathulae, the clinical efficacy of its treatment hypertensive renal damage is still close with former side.Inventive formulation is novel, and composition is simple, and all inexpensively, holistic cost is cheap, and then reduces drug cost, and preparation method of the present invention is simple to operate, is applicable to industrialized production for each taste principal agent price.
Detailed description of the invention
Below in conjunction with specific embodiment, technical scheme is described in further detail, but protection scope of the present invention is not limited to the following stated.
Embodiment 1:
Weigh raw material Rhizoma Dioscoreae 10g, Flos Chrysanthemi 10g, Radix Rehmanniae Preparata 5g, Poria 5g, Cortex Moutan 5g, Rhizoma Gastrodiae 5g, Ramulus Uncariae Cum Uncis 5g, Spica Prunellae 5g, Concha Haliotidis 5g, add supplementary product starch 60g and granulate, magnesium stearate 5g, dextrin 50g, microcrystalline Cellulose 50g, uniformly prepare granule, tabletting, obtain tablet.
Embodiment 2:
Weigh raw material Rhizoma Dioscoreae 60g, Flos Chrysanthemi 60g, Radix Rehmanniae Preparata 50g, Poria 50g, Cortex Moutan 50g, Rhizoma Gastrodiae 50g, Ramulus Uncariae Cum Uncis 50g, Spica Prunellae 50g, Concha Haliotidis 50g, add supplementary product starch 400g and granulate, magnesium stearate 40g, dextrin 300g, microcrystalline Cellulose 300g, uniformly prepare granule, tabletting, obtain tablet.
Embodiment 3:
Weigh raw material Rhizoma Dioscoreae 15g, Flos Chrysanthemi 15g, Radix Rehmanniae Preparata 10g, Poria 10g, Cortex Moutan 10g, Rhizoma Gastrodiae 10g, Ramulus Uncariae Cum Uncis 10g, Spica Prunellae 10g part, Concha Haliotidis 10g, add supplementary product starch 180g and granulate, magnesium stearate 12g, dextrin 120g, microcrystalline Cellulose 120g, uniformly prepare granule, tabletting, obtain tablet.
Embodiment 4:
Weigh raw material Rhizoma Dioscoreae 50g, Flos Chrysanthemi 50g, Radix Rehmanniae Preparata 40g, Poria 40g, Cortex Moutan 40g, Rhizoma Gastrodiae 40g, Ramulus Uncariae Cum Uncis 40g, Spica Prunellae 40g, Concha Haliotidis 40g, add supplementary product starch 350g and granulate, magnesium stearate 30g, dextrin 300g, microcrystalline Cellulose 300g, uniformly prepare granule, tabletting, obtain tablet.
Embodiment 5:
Weigh raw material Rhizoma Dioscoreae 20g, Flos Chrysanthemi 20g, Radix Rehmanniae Preparata 15g, Poria 15g, Cortex Moutan 15g, Rhizoma Gastrodiae 15g, Ramulus Uncariae Cum Uncis 15g, Spica Prunellae 15g, Concha Haliotidis 15g, add supplementary product starch 150g and granulate, magnesium stearate 20g, dextrin 100g, microcrystalline Cellulose 100g, uniformly prepare granule, tabletting, obtain tablet.
Embodiment 6:
Weigh raw material Rhizoma Dioscoreae 40g, Flos Chrysanthemi 40g, Radix Rehmanniae Preparata 30g, Poria 30g, Cortex Moutan 30g, Rhizoma Gastrodiae 30g, Ramulus Uncariae Cum Uncis 30g, Spica Prunellae 30g, Concha Haliotidis 30g, add supplementary product starch 300g and granulate, magnesium stearate 30g, dextrin 250g, microcrystalline Cellulose 200g, uniformly prepare granule, tabletting, obtain tablet.
Embodiment 7:
Weigh raw material Rhizoma Dioscoreae 25g, Flos Chrysanthemi 25g, Radix Rehmanniae Preparata 20g, Poria 20g, Cortex Moutan 20g, Rhizoma Gastrodiae 20, Ramulus Uncariae Cum Uncis 20g, Spica Prunellae 20g, Concha Haliotidis 20g, add supplementary product starch 200g and granulate, magnesium stearate 20g, dextrin 150g, microcrystalline Cellulose 150g, uniformly prepare granule, load capsule, obtain capsule.
Embodiment 8:
Weighing raw material Rhizoma Dioscoreae 10g, Flos Chrysanthemi 10g, Radix Rehmanniae Preparata 5g, Poria 5g, Cortex Moutan 5g, Rhizoma Gastrodiae 5g, Ramulus Uncariae Cum Uncis 5g, Spica Prunellae 5g, Concha Haliotidis 5g, add supplementary product starch 60g and granulate, magnesium stearate 5g, dextrin 50g, microcrystalline Cellulose 50g, conventionally technique prepares into powder.
Embodiment 9:
Weigh raw material Rhizoma Dioscoreae 60g, Flos Chrysanthemi 60g, Radix Rehmanniae Preparata 50g, Poria 50g, Cortex Moutan 50g, Rhizoma Gastrodiae 50g, Ramulus Uncariae Cum Uncis 50g, Spica Prunellae 50g, Concha Haliotidis 50g, adding supplementary product starch 400g to granulate, magnesium stearate 40g, dextrin 300g, microcrystalline Cellulose 300g, conventionally technique prepares into oral liquid.
Embodiment 10:
Weigh raw material Rhizoma Dioscoreae 15g, Flos Chrysanthemi 15g, Radix Rehmanniae Preparata 10g, Poria 10g, Cortex Moutan 10g, Rhizoma Gastrodiae 10g, Ramulus Uncariae Cum Uncis 10g, Spica Prunellae 10g part, Concha Haliotidis 10g, adding supplementary product starch 180g to granulate, magnesium stearate 12g, dextrin 120g, microcrystalline Cellulose 120g, conventionally technique prepares into powder.
Embodiment 11:
Weigh raw material Rhizoma Dioscoreae 50g, Flos Chrysanthemi 50g, Radix Rehmanniae Preparata 40g, Poria 40g, Cortex Moutan 40g, Rhizoma Gastrodiae 40g, Ramulus Uncariae Cum Uncis 40g, Spica Prunellae 40g, Concha Haliotidis 40g, after being mixed by each raw material, the water soaking of addition medical material 6～8 times amount 0.5～1 hour, decocts subsequently 0.5～1 hour, is filtrated to get decocting liquid, and medicinal residues are standby；Medicinal residues adding the soak by water 1～1.5 hour of 6～8 times of medical material amounts, is filtrated to get decocting liquid, medicinal residues discard；It is condensed into extractum after being merged by twice decocting liquid, then extractum vacuum drying is obtained dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant and prepare into tablet.
Embodiment 12:
Weigh raw material Rhizoma Dioscoreae 20g, Flos Chrysanthemi 20g, Radix Rehmanniae Preparata 15g, Poria 15g, Cortex Moutan 15g, Rhizoma Gastrodiae 15g, Ramulus Uncariae Cum Uncis 15g, Spica Prunellae 15g, Concha Haliotidis 15g, after being mixed by each raw material, the water soaking of addition medical material 6～8 times amount 0.5～1 hour, decocts subsequently 0.5～1 hour, is filtrated to get decocting liquid, and medicinal residues are standby；Medicinal residues adding the soak by water 1～1.5 hour of 6～8 times of medical material amounts, is filtrated to get decocting liquid, medicinal residues discard；It is condensed into extractum after being merged by twice decocting liquid, then extractum vacuum drying is obtained dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant and prepare into capsule.
Embodiment 13:
Weigh raw material Rhizoma Dioscoreae 40g, Flos Chrysanthemi 40g, Radix Rehmanniae Preparata 30g, Poria 30g, Cortex Moutan 30g, Rhizoma Gastrodiae 30g, Ramulus Uncariae Cum Uncis 30g, Spica Prunellae 30g, Concha Haliotidis 30g, after being mixed by each raw material, the water soaking of addition medical material 6～8 times amount 0.5～1 hour, decocts subsequently 0.5～1 hour, is filtrated to get decocting liquid, and medicinal residues are standby；Medicinal residues adding the soak by water 1～1.5 hour of 6～8 times of medical material amounts, is filtrated to get decocting liquid, medicinal residues discard；It is condensed into extractum after being merged by twice decocting liquid, then extractum vacuum drying is obtained dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant and prepare into powder.
Embodiment 14:
Weigh raw material Rhizoma Dioscoreae 25g, Flos Chrysanthemi 25g, Radix Rehmanniae Preparata 20g, Poria 20g, Cortex Moutan 20g, Rhizoma Gastrodiae 20, Ramulus Uncariae Cum Uncis 20g, Spica Prunellae 20g, Concha Haliotidis 20g, after being mixed by each raw material, the water soaking of addition medical material 6～8 times amount 0.5～1 hour, decocts subsequently 0.5～1 hour, is filtrated to get decocting liquid, and medicinal residues are standby；Medicinal residues adding the soak by water 1～1.5 hour of 6～8 times of medical material amounts, is filtrated to get decocting liquid, medicinal residues discard；It is condensed into extractum after being merged by twice decocting liquid, then extractum vacuum drying is obtained dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant and prepare into oral solutions.
Embodiment 15:
Weigh raw material Rhizoma Dioscoreae 25g, Flos Chrysanthemi 25g, Radix Rehmanniae Preparata 20g, Poria 20g, Cortex Moutan 20g, Rhizoma Gastrodiae 20, Ramulus Uncariae Cum Uncis 20g, Spica Prunellae 20g, Concha Haliotidis 20g, after being mixed by each raw material, the water soaking of addition medical material 6～8 times amount 0.5～1 hour, decocts subsequently 0.5～1 hour, is filtrated to get decocting liquid, and medicinal residues are standby；Medicinal residues adding the soak by water 1～1.5 hour of 6～8 times of medical material amounts, is filtrated to get decocting liquid, medicinal residues discard, and prepare into decoction.
Beneficial effects of the present invention is verified below by concrete clinical research:
1 physical data
The inpatient meeting hypertensive cerebral renal damage diagnostic criteria of this group all case selections oneselfs institute treatment.It is divided into two groups, treatment group 46 example, wherein male 26 examples by random parallel control method, female 20 example, 31～78 years old age, 56.52 ± 13.34 years old mean age, the most elder of hypertensive disease 40 years, the shortest person 5 years, average course of disease 16.45 ± 9.53 years, wherein CKD1 phase 10 example, CKD2 phase 16 example, CKD3 phase 10 example, CKD4 phase 5 example, CKD5 phase 5 example；Matched group 45 example, wherein male 24 examples, female 21 example, 28～81 years old age, 57.13 ± 12.56 years old mean age, the most elder of hypertensive disease 44 years, the shortest person 7 years, average course of disease 17.43 ± 9.45 years, wherein CKD1 phase 12 example, CKD2 phase 10 example, CKD3 phase 8 example, CKD4 phase 15 example.The aspects such as the sex of two groups, age, the course of disease, blood pressure, renal function, by statistical procedures, there was no significant difference, have comparability.
2 diagnostic criterias
Hypertensive cerebral renal damage diagnostic criteria: requirement: be 1. essential hypertension；2. occur albuminuria previous as the persistence hypertension (the general > 150/100mmHg of degree) of existing more than 5 years；3. having continuous proteinuria (being generally mild to moderate), microscopy visible component is few；4. retinal arteriosclerosis or arteriosclerotic retina is had to change；5. various constitutionales and Secondary cases kidney disease except.Auxiliary or reference conditions: 1. the age is more than 40～50 years old；2. there are hypertension-related left ventricular hypertrophy, coronary heart disease, heart failure；3. there are cerebral arteriosclerosis or cerebrovas-cularaccident history；4. blood uric acid raises；5. renal tubular function infringement damages prior to glomerular function；6. course advancement is slow.
Chronic kidney disease (chronickidneydisease, CKD) the diagnosis with CKD by stages that diagnoses replaces with reference to GFR endogenous creatinine clearance rate (Ccr) with staging scale, Ccr assay method: Ccr (ml/min)=urine creatine (mg/dl) × urine volume (ml) × 1.73/ serum creatinine (mg/dl) × (60 × 24) (min).
Inclusive criteria: meet hypertensive cerebral renal damage diagnostic criteria requirement and all and possess more than 3 auxiliary or reference conditions；Meet the diagnostic criteria of CKD1～5 phase；Chinese medical discrimination belongs to the hepatic and renal YIN deficiency, excessive rising of liver-YANG.
3 Therapeutic Method
Primary Care group: give less salt, low fat, high-quality low protein diet, patient more than the CKD3 phase gives the low albumen of high-quality+open same diet；Strictly control reach mark blood pressure, first-selected angiotensin converting enzyme inhibitor (ACEI) or Angiotensin Ⅱ receptor antagonist (ARB), Combined with Calcium antagonistic (CCB) etc.；250 μm of ol/L first-selection CCB of Scr >, associating beta-blocker, alpha-blocking agent, diuretic etc.；Control to infect；Anemia and Water-Electrolyte, acid base imbalance；Lipid modulating, complications Treatment.
Treatment group: giving pharmaceutical composition of the present invention on Primary Care group and treat, material rate is: Rhizoma Dioscoreae 20g, Flos Chrysanthemi 20g, Radix Rehmanniae Preparata 15g, Poria 15g, Cortex Moutan 15g, Rhizoma Gastrodiae 15g, Ramulus Uncariae Cum Uncis 15g, Spica Prunellae 15g, Concha Haliotidis 15g.
Matched group: giving the horizontal liver oral liquid for depressing blood pressure of taste on Primary Care group and treat, material rate is: quasi-Rhizoma Dioscoreae 30g, Radix Rehmanniae Preparata 15g, Poria 15g, Cortex Moutan 15g, Cortex Eucommiae 20g, Herba Taxilli 20g, Radix Cyathulae 5g, Rhizoma Gastrodiae 20g, Ramulus Uncariae Cum Uncis 15g, Flos Chrysanthemi 30g, Spica Prunellae 15g, Concha Haliotidis 15g, Concha Margaritifera 15g, Radix Et Rhizoma Rhei 10g.
Instructions of taking: take 1 dose every day, every bu is taken for 3 times, within 1 month, is 1 course for the treatment of, observes 3 months.
4 observation of curative effect
Criterion of therapeutical effect: reference " new Chinese medicine treatment chronic Renal Failure guideline " (Zheng Xiao cornel. new Chinese medicine guideline of clinical investigations ［ M ］. Beijing: China Medical Science Press, 2002:163～168) formulate.Effective: clinical symptoms integration reduces >=30%, serum creatinine reduces < 10%；Stable: clinical symptoms makes moderate progress, integration reduces < 30%, serum creatinine is without increasing or reducing < 10%；Invalid: clinical symptoms without improve or increase the weight of, serum creatinine increase.
Observational technique: the 1. change of symptom integral before and after treatment: formulate with reference to " new Chinese medicine treatment chronic renal failure guideline " SRS, each symptom is divided into gently according to its order of severity, in, weigh 3 degree, slight integration 1～3 point, moderate integration 3～6 points, severe integration 7～9 points.2. clinical observation: blood pressure situation before and after treatment, the symptom such as weak, soreness of waist and knee joint, urine volume, nocturnal urine output and number of times, edema, nausea and vomiting, constipation.3. lab index: the control indexes situations such as treatment front and back serum creatinine (Scr), blood urea nitrogen (BUN), blood uric acid (UA), endogenous creatinine clearance rate (Ccr), hemoglobin (Hgb), 24h urine protein quantitation, osmotic pressure of urine, urine β 2-MG, urine α 1-MG.
5 statistical methods
SPSS11.5 statistical software is adopted to carry out data statistics.Measurement data withRepresent, before and after treatment, use paired t-test analysis, compare between group and check with two sample average t.Grade money grain Ridit analyzes.
6 results
Clinical efficacy relatively in Table 1, before and after treatment, blood pressure compares in Table 2, before and after treatment Scr, BUN, UA, Hgb, Ccr relatively in Table 3,24h urine protein quantitation before and after treatment, urine prohibit water penetration pressure, urine β 2-MG, urine α 1-MG relatively in Table 4.
1 liang of table group patient's total effective rate compares
After treatment, the effective case for the treatment of group is 15 examples, effective case not 22 example, the effective case of matched group is 16 examples, effective case is 19 examples, and the total effective rate for the treatment of group reaches 80.43%, and the total effective rate of matched group is 77.78%, treatment group and matched group clinical efficacy no difference of science of statistics, it was shown that the curative effect that pharmaceutical composition of the present invention grows horizontal liver oral liquid for depressing blood pressure with former side is close.
Before and after 2 liang of table group patient treatment, blood pressure compares
Note: with this group before treatment,*P<0.05。
Before and after 3 liang of table group patient treatment, Scr, BUN, UA, Ccr, Hgb compare
Note: with this group before treatment,*P<0.05。
Table 424h urine protein quantitation, urine prohibit water penetration pressure, urine β 2-MG, urine α 1-MG compare
Above-mentioned test result indicate that, pharmaceutical composition of the present invention is after former side is grown and reduced Concha Margaritifera, Radix Et Rhizoma Rhei, the Cortex Eucommiae, Herba Taxilli and Radix Cyathulae on the basis of horizontal liver oral liquid for depressing blood pressure, the curative effect of its treatment hypertensive renal damage is still closer to the clinical efficacy of former side, is worth promoting on a large scale in clinic.
Claims (5)
1. the pharmaceutical composition treating hypertensive renal damage, it is characterized in that: it is made up of the raw material of following ratio of weight and number: Rhizoma Dioscoreae 10～60 parts, Flos Chrysanthemi 10～60 parts, Radix Rehmanniae Preparata 5～50 parts, 5～50 parts of Poria, Cortex Moutan 5～50 parts, 5～50 parts of Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis 5～50 parts, Spica Prunellae 5～50 parts, Concha Haliotidis 5～50 parts.
2. a kind of pharmaceutical composition treating hypertensive renal damage according to claim 1, it is characterized in that: the ratio of weight and number of described each raw material is: Rhizoma Dioscoreae 15～50 parts, Flos Chrysanthemi 15～50 parts, Radix Rehmanniae Preparata 10～40 parts, 10～40 parts of Poria, Cortex Moutan 10～40 parts, 10～40 parts of Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis 10～40 parts, Spica Prunellae 10～40 parts, Concha Haliotidis 10～40 parts.
3. a kind of pharmaceutical composition treating hypertensive renal damage according to claim 1, it is characterized in that: the ratio of weight and number of described each raw material is: Rhizoma Dioscoreae 20～40 parts, Flos Chrysanthemi 20～40 parts, Radix Rehmanniae Preparata 15～30 parts, 15～30 parts of Poria, Cortex Moutan 15～30 parts, 15～30 parts of Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis 15～30 parts, Spica Prunellae 15～30 parts, Concha Haliotidis 15～30 parts.
4. a kind of pharmaceutical composition treating hypertensive renal damage according to claim 1, it is characterized in that: the ratio of weight and number of described each raw material is: Rhizoma Dioscoreae 25 parts, Flos Chrysanthemi 25 parts, Radix Rehmanniae Preparata 20 parts, 20 parts of Poria, Cortex Moutan 20 parts, 20 parts of Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis 20 parts, Spica Prunellae 20 parts, Concha Haliotidis 20 parts.
5. pharmaceutical composition as described in any one claim application in preparation treatment hypertensive renal damage medicine in Claims 1 to 4.
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