CN103830589A - Pharmaceutical composition for treating hypertensive kidney lesion and preparation method and application - Google Patents
Pharmaceutical composition for treating hypertensive kidney lesion and preparation method and application Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating hypertensive kidney lesion, which consists of the following raw materials in parts by weight: 10-60 parts of rhizoma dioscoreae, 10-60 parts of flos chrysanthemi, 5-50 parts of radix rehmanniae praeparata, 5-50 parts of poria cocos, 5-50 parts of cortex moutan, 5-50 parts of rhizoma gastrodiae, 5-50 parts of uncaria rhynchophylla, 5-50 parts of spica prunellae and 5-50 parts of concha haliotidis. The invention also discloses a preparation method and application of the pharmaceutical composition. The pharmaceutical composition disclosed by the invention is simple in composition and novel in formula and has the characteristics of low cost, good curative effect, no toxic or side effect, rare generation of tolerance, convenience in taking and carrying, universal relevance to patients suffering hypertensive kidney lesion and the like.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of 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 can cause glomerulonephritis tubule ischemic lesions, cause glomerular sclerosis, renal tubules atrophy, kidney region fibrosis, and progress is chronic renal failure (chronicrenal failure, CRF) gradually.The 1950's, the report of Perera confirmed that human essential hypertension enters end stagerenaldisease (end stage renal disease to the hazardness of kidney because hypertension causes kidney damage for the first time, ESRD) patient's number is the trend of increasing year by year, studies show that 28% ESRD is relevant with hypertension, doctor trained in Western medicine is mainly take the Treatment of Hypertension such as ACEI, ARB as main at present.By the difference of goal, efferent glomerular arteriole degrees of expansion, reduce the situation such as glomerule HT, high filtration thereby reach, alleviate glomerule burden, reach the effect that delays renal fibrosis.But at present research shows, although by controlling of blood pressure in certain amplitude, the process of renal fibrosis is not obviously 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 thinks, the kidney being the origin of congenital constitution, the root of vigour, people is after the middle age, age growth, inevitable kidney qi is gradually lost, in addition the factor reciprocal action such as diet, spirit, labor wish, kidney qi is more lost, deficiency of kidney-QI, disturbance in functioning of QI, astringency inducing is had no right, clinical 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, and outbreak repeatedly, therefore pathogen usually intruding into collateral in protracted disease is suffered from a deficiency of the kidney and caused the stasis of blood.Simultaneously at pathological changes middle and late stage, due to kidney unit virtual loss, open 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 internal resistance of the blood stasis such as ecchymosis, greasy fur turbid damp to see disease more.
Chinese medicine has good therapeutical effect to hypertensive renal damage, the traditional Chinese medical science also increases gradually to the research of hypertensive renal damage at present, announced a kind of medicine for the treatment of hypertensive renal damage and preparation method thereof as Chinese patent 200810055064.6, this pharmaceutical composition is made up of the Radix Astragali, Radix Rehmanniae, Rhizoma Polygonati, Rhizoma Dioscoreae, Rhizoma Atractylodis; Chinese patent 200910055794.0 has been announced a kind of compound Chinese medicinal preparation for the treatment of 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 has been announced a kind of Chinese medicine for the treatment of hypertension Renal Injury 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 as main take kidney tonifying suppressing the hyperactive liver.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 through early-stage Study blood pressure renal damage is had to good therapeutical effect, but the party's dosage is more, the more difficult control of the impurity of this compound recipe in the time of industrialization, therefore need further the party to be furtherd investigate.
Summary of the invention
One object of the present invention is to overcome the deficiencies in the prior art, provide a kind of composition simple, the fill a prescription pharmaceutical composition of novel treatment hypertensive renal damage, this pharmaceutical composition has that cost is low, good effect, have no side effect, be difficult for producing toleration, take and the feature such as patient easy to carry, to be generally applicable to hypertensive renal damage.
Another object of the present invention is to provide a kind of preparation method of pharmaceutical composition for the treatment of hypertensive renal damage, and this preparation method is simple to operate, applicable to suitability for industrialized production.
The object of the invention is to be achieved through the following technical solutions: a kind of pharmaceutical composition for the treatment of hypertensive renal damage, it is made up of the raw material of following ratio of weight and number: 10～60 parts of Rhizoma Dioscoreaes, 10～60 parts of Flos Chrysanthemis, 5～50 parts of Radix Rehmanniae Preparata, 5～50 parts, Poria, 5～50 parts of Cortex Moutans, 5～50 parts, Rhizoma Gastrodiae, 5～50 parts of Ramulus Uncariae Cum Uncis, 5～50 parts of Spica Prunellaes, 5～50 parts of Concha Haliotidis.
Preferably, the ratio of weight and number of described each raw material is: 15～50 parts of Rhizoma Dioscoreaes, 15～50 parts of Flos Chrysanthemis, 10～40 parts of Radix Rehmanniae Preparata, 10～40 parts, Poria, 10～40 parts of Cortex Moutans, 10～40 parts, Rhizoma Gastrodiae, 10～40 parts of Ramulus Uncariae Cum Uncis, 10～40 parts of Spica Prunellaes, 10～40 parts of Concha Haliotidis.
Preferably, the ratio of weight and number of described each raw material is: 20～40 parts of Rhizoma Dioscoreaes, 20～40 parts of Flos Chrysanthemis, 15～30 parts of Radix Rehmanniae Preparata, 15～30 parts, Poria, 15～30 parts of Cortex Moutans, 15～30 parts, Rhizoma Gastrodiae, 15～30 parts of Ramulus Uncariae Cum Uncis, 15～30 parts of Spica Prunellaes, 15～30 parts of Concha Haliotidis.
Preferably, the ratio of weight and number of described each raw material is: 25 parts of Rhizoma Dioscoreaes, 25 parts of Flos Chrysanthemis, 20 parts of Radix Rehmanniae Preparata, 20 parts, Poria, 20 parts of Cortex Moutans, 20 parts, Rhizoma Gastrodiae, 20 parts of Ramulus Uncariae Cum Uncis, 20 parts of Spica Prunellaes, 20 parts of Concha Haliotidis.
A method of preparing above-mentioned arbitrary treatment hypertensive renal damage pharmaceutical composition, is characterized in that: it comprises the following steps:
S1: take by weight each raw material, add the water soaking 0.5～1 hour of 6～8 times of amounts of medical material after mixing, decoct subsequently 0.5～1 hour, filter and obtain decocting liquid, medicinal residues are for subsequent use;
S2: add the decocting of 6～8 times of medical material amounts to boil 1～1.5 hour the medicinal residues in S1 step again, filter and obtain decocting liquid, medicinal residues discard;
S3: after the decocting liquid in S1 step and S2 step is merged, be condensed into extractum, then extractum vacuum drying obtained to dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant to be prepared 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 comprises starch, magnesium stearate, dextrin and microcrystalline Cellulose.
The application of arbitrary pharmaceutical composition of the present invention in preparation treatment hypertensive renal damage medicine.
Pharmaceutical composition of the present invention can be prepared into the above dosage form of 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.Dosage form on described pharmaceutics comprises: the tablet that uses when oral administration, capsule, pill, powder, granule, syrup, oral liquid etc.; The freeze-dried powder and the injection etc. that in the time of intestinal external administration, use.
For above-mentioned dosage form can be realized, need in the time of these dosage forms of preparation, add the acceptable adjuvant of pharmacy, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, acetic acid chloroethene are determined, Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods; Substrate comprises: 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 Chinese medicine or its processed product that 2010 editions " Chinese Pharmacopoeia " Firsts record.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, and sweet in the mouth, warm in nature is returned liver, kidney channel, have enrich blood, the effect of 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 comes for growing horizontal liver oral liquid for depressing blood pressure (grow 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, show by experiment, grow 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 still approaches with former side.The present invention's novelty of filling a prescription, composition is simple, and each taste principal agent price is all comparatively cheap, and holistic cost is cheap, and then has reduced drug cost, and preparation method of the present invention is simple to operate, applicable to suitability for industrialized production.
The specific embodiment
Below in conjunction with specific embodiment, technical scheme of the present invention is described in further detail, but protection scope of the present invention is not limited to the following stated.
Embodiment 1:
Take 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, adds supplementary product starch 60g to granulate, magnesium stearate 5g, dextrin 50g, microcrystalline Cellulose 50g, evenly make granule, and tabletting, obtains tablet.
Embodiment 2:
Take 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, adds supplementary product starch 400g to granulate, magnesium stearate 40g, dextrin 300g, microcrystalline Cellulose 300g, evenly make granule, and tabletting, obtains tablet.
Embodiment 3:
Take 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, adds supplementary product starch 180g to granulate, magnesium stearate 12g, dextrin 120g, microcrystalline Cellulose 120g, evenly make granule, and tabletting, obtains tablet.
Embodiment 4:
Take 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, adds supplementary product starch 350g to granulate, magnesium stearate 30g, dextrin 300g, microcrystalline Cellulose 300g, evenly make granule, and tabletting, obtains tablet.
Embodiment 5:
Take 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, adds supplementary product starch 150g to granulate, magnesium stearate 20g, dextrin 100g, microcrystalline Cellulose 100g, evenly make granule, and tabletting, obtains tablet.
Embodiment 6:
Take 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, adds supplementary product starch 300g to granulate, magnesium stearate 30g, dextrin 250g, microcrystalline Cellulose 200g, evenly make granule, and tabletting, obtains tablet.
Embodiment 7:
Take 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, adds supplementary product starch 200g to granulate, magnesium stearate 20g, dextrin 150g, microcrystalline Cellulose 150g, evenly make granule, incapsulates, and obtains capsule.
Embodiment 8:
Take 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, adds supplementary product starch 60g to granulate, magnesium stearate 5g, dextrin 50g, microcrystalline Cellulose 50g, be prepared into powder according to common process.
Embodiment 9:
Take 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 to granulate, magnesium stearate 40g, dextrin 300g, microcrystalline Cellulose 300g, be prepared into oral liquid according to common process.
Embodiment 10:
Take 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 to granulate, magnesium stearate 12g, dextrin 120g, microcrystalline Cellulose 120g, be prepared into powder according to common process.
Embodiment 11:
Take 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, adds the water soaking 0.5～1 hour of 6～8 times of amounts of medical material after each raw material is mixed, decoct subsequently 0.5～1 hour, filtration obtains decocting liquid, and medicinal residues are for subsequent use; Add the decocting of 6～8 times of medical material amounts to boil 1～1.5 hour medicinal residues again, filter and obtain decocting liquid, medicinal residues discard; After twice decocting liquid is merged, be condensed into extractum, then extractum vacuum drying obtained to dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant to be prepared into tablet.
Embodiment 12:
Take 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, adds the water soaking 0.5～1 hour of 6～8 times of amounts of medical material after each raw material is mixed, decoct subsequently 0.5～1 hour, filtration obtains decocting liquid, and medicinal residues are for subsequent use; Add the decocting of 6～8 times of medical material amounts to boil 1～1.5 hour medicinal residues again, filter and obtain decocting liquid, medicinal residues discard; After twice decocting liquid is merged, be condensed into extractum, then extractum vacuum drying obtained to dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant to be prepared into capsule.
Embodiment 13:
Take 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, adds the water soaking 0.5～1 hour of 6～8 times of amounts of medical material after each raw material is mixed, decoct subsequently 0.5～1 hour, filtration obtains decocting liquid, and medicinal residues are for subsequent use; Add the decocting of 6～8 times of medical material amounts to boil 1～1.5 hour medicinal residues again, filter and obtain decocting liquid, medicinal residues discard; After twice decocting liquid is merged, be condensed into extractum, then extractum vacuum drying obtained to dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant to be prepared into powder.
Embodiment 14:
Take 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, adds the water soaking 0.5～1 hour of 6～8 times of amounts of medical material after each raw material is mixed, decoct subsequently 0.5～1 hour, filtration obtains decocting liquid, and medicinal residues are for subsequent use; Add the decocting of 6～8 times of medical material amounts to boil 1～1.5 hour medicinal residues again, filter and obtain decocting liquid, medicinal residues discard; After twice decocting liquid is merged, be condensed into extractum, then extractum vacuum drying obtained to dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant to be prepared into oral solutions.
Embodiment 15:
Take 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, adds the water soaking 0.5～1 hour of 6～8 times of amounts of medical material after each raw material is mixed, decoct subsequently 0.5～1 hour, filtration obtains decocting liquid, and medicinal residues are for subsequent use; Add the decocting of 6～8 times of medical material amounts to boil 1～1.5 hour medicinal residues again, filter and obtain decocting liquid, medicinal residues discard, and are prepared into decoction.
Verify beneficial effect of the present invention below by concrete clinical research:
1 physical data
This organizes the inpatient that meets the diagnostic criteria of hypertensive cerebral renal damage of the self-institute of all case selections treatment.Be divided into two groups by random parallel control method, treatment group 46 examples, wherein male 26 examples, female's 20 examples, 31～78 years old age, 56.52 ± 13.34 years old mean age, the elder of hypertensive disease 40 years, the shortest person 5 years, average course of disease 16.45 ± 9.53 years, wherein CKD1 phases 10 example, CKD2 phases 16 example, CKD3 phases 10 example, CKD4 phases 5 example, CKD5 phases 5 example; Matched group 45 examples, wherein male 24 examples, female's 21 examples, 28～81 years old age, 57.13 ± 12.56 years old mean age, the elder of hypertensive disease 44 years, the shortest person 7 years, average course of disease 17.43 ± 9.45 years, wherein CKD1 phases 12 example, CKD2 phases 10 example, CKD3 phases 8 example, CKD4 phases 15 example.The aspects such as the sex of two groups, age, the course of disease, blood pressure, renal function are by statistical procedures, and there was no significant difference, has comparability.
2 diagnostic criterias
Hypertensive cerebral renal damage diagnostic criteria: requirement: be 1. essential hypertension; 2. occur that albuminuria has 5 years above persistence hypertension (the general > 150/100mmHg of degree) as last; 3. have continuous proteinuria (being generally mild to moderate), microscopy visible component is few; 4. there are retinal arteriosclerosis or arteriosclerotic retina to change; 5. various constitutionales and Secondary cases kidney disease except.Assist 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 cerebrovascular accident history; 4. blood uric acid raises; 5. renal tubulounterstitial function injure damages prior to glomerular function; 6. course advancement is slow.
Chronic kidney disease (chronic kidney disease, CKD) diagnosis of diagnosis and by stages CKD is with standard is with reference to endogenous creatinine clearance rate for GFR (Ccr) replacement by stages, and Ccr assay method: Ccr (ml/min)=urine creatine (mg/dl) × urine amount (ml) × 1.73/ serum creatinine (mg/dl) × (60 × 24) (min).
Inclusive criteria: meet hypertensive cerebral renal damage diagnostic criteria requirement all and possess 3 above 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; Strict reach mark blood pressure, first-selected angiotensin converting enzyme inhibitor (ACEI) or Angiotensin Ⅱ receptor antagonist (ARB), the Combined with Calcium antagonistic (CCB) etc. controlled; The first-selected CCB of Scr > 250 μ mol/L, associating beta-blocker, alpha-blocking agent, diuretic etc.; Infection control; Anemia and Water-Electrolyte, acid base imbalance; Adjust fat treatment, complication treatment.
Treatment group: give pharmaceutical composition of the present invention and treat on Primary Care group, 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: give the horizontal liver oral liquid for depressing blood pressure of taste and treat on Primary Care group, material rate is: accurate 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, 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 merit exhaustion guideline " (Zheng Xiao cornel. new Chinese medicine guideline of clinical investigations ［ M ］. Beijing: Chinese Medicine science and technology publishing house, 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 reduce < 10%; Invalid: clinical symptoms without improve or increase the weight of, serum creatinine increase.
Observational technique: the 1. variation of symptom integral before and after treatment: formulate with reference to " new Chinese medicine treatment chronic renal failure guideline " SRS, each symptom according to its order of severity be divided into gently, in, weigh 3 degree, 1～3 point of slight integration, 3～6 points of moderate integrations, 7～9 points of severe integrations.2. clinical observation: blood pressure situation before and after treatment, the symptoms such as weak, soreness of waist and knee joint, urine amount, 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
Adopt SPSS11.5 statistical software to carry out data statistics.Measurement data with
represent, before and after treatment, use paired t-test analysis, between group, relatively check with two sample average t.Grade money grain is analyzed with Ridit.
6 results
Clinical efficacy relatively in table 1, before and after treatment blood pressure relatively in table 2, before and after treatment Scr, BUN, UA, Hgb, Ccr relatively in table 3, before and after treatment 24h urine protein quantitation, urine prohibit water osmotic pressure, urine β 2-MG, urine α 1-MG relatively in table 4.
Table 1 liang group patient total effective rate comparison
After treatment, the effective case for the treatment of group is 15 examples, effectively not 22 examples of case, the effective case of matched group is 16 examples, effectively 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, show that the curative effect of pharmaceutical composition of the present invention and the horizontal liver oral liquid for depressing blood pressure of former side's taste approaches.
Blood pressure comparison before and after table 2 liang group patient treatment
Note: with this group before treatment,
*p<0.05.
Scr, BUN, UA, Ccr, Hgb comparison before and after table 3 liang group patient treatment
Note: with this group before treatment,
*p<0.05.
Table 424h urine protein quantitation, urine are prohibited water osmotic pressure, urine β 2-MG, urine α 1-MG comparison
Above-mentioned experimental result shows, pharmaceutical composition of the present invention is grown former side on the basis of horizontal liver oral liquid for depressing blood pressure and is reduced after Concha Margaritifera, Radix Et Rhizoma Rhei, the Cortex Eucommiae, Herba Taxilli and Radix Cyathulae, the curative effect of its treatment hypertensive renal damage is still comparatively approaching with former side's clinical efficacy, is worth promoting on a large scale clinical.
Claims (8)
1. treat the pharmaceutical composition of hypertensive renal damage for one kind, it is characterized in that: it is made up of the raw material of following ratio of weight and number: 10～60 parts of Rhizoma Dioscoreaes, 10～60 parts of Flos Chrysanthemis, 5～50 parts of Radix Rehmanniae Preparata, 5～50 parts, Poria, 5～50 parts of Cortex Moutans, 5～50 parts, Rhizoma Gastrodiae, 5～50 parts of Ramulus Uncariae Cum Uncis, 5～50 parts of Spica Prunellaes, 5～50 parts of Concha Haliotidis.
2. a kind of pharmaceutical composition for the treatment of hypertensive renal damage according to claim 1, it is characterized in that: the ratio of weight and number of described each raw material is: 15～50 parts of Rhizoma Dioscoreaes, 15～50 parts of Flos Chrysanthemis, 10～40 parts of Radix Rehmanniae Preparata, 10～40 parts, Poria, 10～40 parts of Cortex Moutans, 10～40 parts, Rhizoma Gastrodiae, 10～40 parts of Ramulus Uncariae Cum Uncis, 10～40 parts of Spica Prunellaes, 10～40 parts of Concha Haliotidis.
3. a kind of pharmaceutical composition for the treatment of hypertensive renal damage according to claim 1, it is characterized in that: the ratio of weight and number of described each raw material is: 20～40 parts of Rhizoma Dioscoreaes, 20～40 parts of Flos Chrysanthemis, 15～30 parts of Radix Rehmanniae Preparata, 15～30 parts, Poria, 15～30 parts of Cortex Moutans, 15～30 parts, Rhizoma Gastrodiae, 15～30 parts of Ramulus Uncariae Cum Uncis, 15～30 parts of Spica Prunellaes, 15～30 parts of Concha Haliotidis.
4. a kind of pharmaceutical composition for the treatment of hypertensive renal damage according to claim 1, it is characterized in that: the ratio of weight and number of described each raw material is: 25 parts of Rhizoma Dioscoreaes, 25 parts of Flos Chrysanthemis, 20 parts of Radix Rehmanniae Preparata, 20 parts, Poria, 20 parts of Cortex Moutans, 20 parts, Rhizoma Gastrodiae, 20 parts of Ramulus Uncariae Cum Uncis, 20 parts of Spica Prunellaes, 20 parts of Concha Haliotidis.
5. a method of preparing the treatment hypertensive renal damage pharmaceutical composition described in any one in claim 1～4, is characterized in that: it comprises the following steps:
S1: take by weight each raw material, add the water soaking 0.5～1 hour of 6～8 times of amounts of medical material after mixing, decoct subsequently 0.5～1 hour, filter and obtain decocting liquid, medicinal residues are for subsequent use;
S2: add the decocting of 6～8 times of medical material amounts to boil 1～1.5 hour the medicinal residues in S1 step again, filter and obtain decocting liquid, medicinal residues discard;
S3: after the decocting liquid in S1 step and S2 step is merged, be condensed into extractum, then extractum vacuum drying obtained to dry cream, dried cream powder is broken, add pharmaceutically acceptable adjuvant to be prepared into pharmaceutically conventional pharmaceutical preparation.
6. the preparation method of a kind of pharmaceutical composition for the treatment of hypertensive renal damage according to claim 5, is characterized in that: described pharmaceutical preparation is tablet, capsule, granule, powder or oral liquid.
7. the preparation method of a kind of pharmaceutical composition for the treatment of hypertensive renal damage according to claim 5, is characterized in that: described pharmaceutically acceptable adjuvant comprises starch, magnesium stearate, dextrin and microcrystalline Cellulose.
8. the application of the pharmaceutical composition as described in any one claim in claim 1～4 in preparation treatment hypertensive renal damage medicine.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104256833A (en) * | 2014-10-29 | 2015-01-07 | 陈林 | Uncaria beverage |
| CN106492017A (en) * | 2016-11-18 | 2017-03-15 | 广西大学 | A kind of treat Chinese medicine preparation of hypertensive nephropathy and preparation method thereof |
| CN106563078A (en) * | 2016-11-18 | 2017-04-19 | 广西大学 | Traditional Chinese medicine for treating hypertensive nephropathy |
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Non-Patent Citations (1)
| Title |
|---|
| 梅建伟等: ""滋水平肝法治疗高血压性肾损害的临床研究"", 《四川中医》, vol. 30, no. 8, 31 December 2012 (2012-12-31), pages 79 - 81 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104256833A (en) * | 2014-10-29 | 2015-01-07 | 陈林 | Uncaria beverage |
| CN106492017A (en) * | 2016-11-18 | 2017-03-15 | 广西大学 | A kind of treat Chinese medicine preparation of hypertensive nephropathy and preparation method thereof |
| CN106563078A (en) * | 2016-11-18 | 2017-04-19 | 广西大学 | Traditional Chinese medicine for treating hypertensive nephropathy |
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