CN105596437A - Pharmaceutical composition containing furosemide for treating hypertension and preparation method of pharmaceutical composition - Google Patents

Pharmaceutical composition containing furosemide for treating hypertension and preparation method of pharmaceutical composition Download PDF

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CN105596437A
CN105596437A CN201610175836.4A CN201610175836A CN105596437A CN 105596437 A CN105596437 A CN 105596437A CN 201610175836 A CN201610175836 A CN 201610175836A CN 105596437 A CN105596437 A CN 105596437A
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pharmaceutical composition
frusemide
treatment
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张健
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Jinan Bangwen Pharmaceutical Technology Co Ltd
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Jinan Bangwen Pharmaceutical Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/63Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/42Cucurbitaceae (Cucumber family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a pharmaceutical composition containing furosemide for treating hypertension and a preparation method of the pharmaceutical composition. The pharmaceutical composition containing the furosemide for treating the hypertension is prepared from the following raw materials in parts by weight: 10-30 parts of furosemide, 2,000-4,000 parts of lespedesa virgata, 2,000-4,000 parts of buckwheat leaves, 2,000-4,000 parts of gourds and 2,000-4,000 parts of ferula asafetida. The traditional Chinese medicine is combined with the furosemide, so that the common adverse reaction of the furosemide can be avoided; and the treatment effect on hypertension is improved.

Description

A kind of hypertensive pharmaceutical composition for the treatment of that contains frusemide and preparation method thereof
Technical field
The invention belongs to medical technical field, be specifically related to the hypertensive pharmaceutical composition of a kind for the treatment of that contains frusemideAnd preparation method thereof.
Background technology
Hypertension is Important cause of disease and the hazards of cardiovascular and cerebrovascular disease, and the whole world has the people of 20%-30% to suffer from high bloodPress. Hypertension can affect the 26S Proteasome Structure and Function of the heart, brain, kidney, can significantly increase the onset risk of palsy, heart failure, ESRD.The investigation of 95%, 2002 year that essential hypertension accounts for hypertension incidence be presented at more than 18 years old prevalence of China up to18.8%, number of patients reaches 1.6 hundred million. Therefore hypertensive prevention and treatment, becomes great that China and the whole world pays close attention to the mostPublic health problem.
Current hypertensive methods for the treatment of is except changing habits and customs, and topmost effective interference method is exactly that medicine is controlledMalignant boil, conventional antihypertensive drugs is divided into 5 classes at present, clinically alone the and drug combination two class schemes of main employing. But step-downMedicine still has a lot of ask bad reaction, resistance phenomenon and patients that for example Long-term taking medicine causes in clinical applicationBad compliance. There are some researches show that the patient who accepts medicine treatment only has 53% successfully to control blood pressure, make controlling of blood pressure≤140/90mmHg。
Frusemide is the hypertensive loop diuretics of clinical conventional treatment, and when thiazide is invalid, these product may be effective, especiallyWhen with renal insufficiency or while there is hypertensive crisis, this class medicine is particularly applicable. The common bad reaction of frusemide wasQuick reaction (comprise fash, interstitial nephritis, even heart arrest), incidence is up to 20%, and this bad reaction has limited furan plugRice is in clinical use.
Summary of the invention
In order to solve the large restriction of frusemide side effect end user group's technical problem, the invention provides a kind of frusemide withThe composition of Chinese medicine, by with the compatibility of Chinese medicine, alleviate the bad reaction of frusemide, thereby realize the object of attenuation synergistic.
The present invention realizes by following technical scheme:
The hypertensive pharmaceutical composition for the treatment of that contains frusemide, is made up of the bulk drug of following weight proportion: frusemide10-30 part, virgate lespedeza herb 2000-4000 part, buckwheat leaf 2000-4000 part, cucurbit 2000-4000 part, asafoetide 2000-4000 part.
The above-mentioned hypertensive pharmaceutical composition of the treatment that contains frusemide, its weight portion proportion optimization is: frusemide 15-25 parts, virgate lespedeza herb 2500-3500 part, buckwheat leaf 2500-3500 part, cucurbit 2500-3500 part, asafoetide 2500-3500 part.
The above-mentioned hypertensive pharmaceutical composition of the treatment that contains frusemide, its weight portion proportioning the best is: frusemide 20Part, 3000 parts of virgate lespedeza herbs, 3000 parts of buckwheat leafs, 3000 parts, cucurbit, 3000 parts of asafoetides.
In above composition of the present invention, the weight of each taste Chinese medicine is calculated with crude drug, if in grams, as makesPreparation, because varying in size of preparation can be made into 100-1000 agent. Described 100-1000 agent refers to the dosage form of UD,As tablet 100-1000 sheet, capsule 100-1000 grain, granule l00-1000g, oral liquid l00-l000ml, paste l00-L000g, pill 100-1000 ball etc.
More than composition is by weight as proportioning, can increase or reduce according to corresponding proportion, as on a large scale in the time producingProduction can be taking kg as unit, or taking t(ton) be unit; Preparation also can be taking g as unit on a small scale. Weight can increase orReduce, but the constant rate of raw medicinal herbs weight proportion between each composition.
Through science, screening obtains the ratio of above weight proportion, for especial patient, as severe or light disease, obesityOr the patient of slight of stature, can be corresponding the proportioning of amount of adjustment composition, increase or reduce being no more than 100%, drug effect is substantially constant.
Pharmaceutical composition of the present invention, can add separately or as required some medicines of injection volume acceptable auxiliaryMaterial, can adopt galenic pharmacy routine techniques to prepare this pharmaceutical preparation, as pharmaceutically active substance and the acceptable auxiliary material of medicine are mixedClose. In the time making pharmaceutical preparation, can make any pharmaceutically useful peroral dosage form, these formulations are selected from: granule, tablet, capsuleAgent, oral liquid, suck agent, pill, powder, preferably granule.
The preparation method of the above-mentioned hypertensive pharmaceutical composition for the treatment of that contains frusemide, comprises following steps:
A. by virgate lespedeza herb, buckwheat leaf, cucurbit, asafoetide boiling 2 times, add 6 ~ 8 times of water gagings of injection volume for the 1st time, decoct 1 ~ 2Hour, add for the second time 4 ~ 6 times of water gagings of injection volume, decoct 0.5 ~ 1.5 hour, merge decoction liquor, for subsequent use;
B. decoction liquor is condensed under 55 ~ 65 DEG C ,-0.04 ~-0.08Mpa condition to relative density and is 1.08 ~ 1.12 clearCream, adds ethanol to being 75% containing alcohol amount, places 12 hours, filters, and it is 1.15 ~ 1.20 clear cream that filtrate is concentrated into relative density, spraysMist is dried to obtain dry medicinal powder;
C. frusemide and dry medicinal powder are mixed, granulate, obtain the active material of pharmaceutical composition of the present invention;
D. this active material separately or mix with the acceptable auxiliary material of medicine, makes according to galenic pharmacy conventional method.
In the preparation method of the above-mentioned hypertensive pharmaceutical composition for the treatment of that contains frusemide, in the step a of portion of institute the 1st timeAdd 7 times of water gagings of injection volume, decoct 1.5 hours, add for the second time 5 times of water gagings of injection volume, decoct 1 hour; Described step bMiddle thickening temperature is 60 DEG C, concentrated pressure is-0.06Mpa.
Preferably, state the preparation method of the hypertensive pharmaceutical composition for the treatment of that contains frusemide, detailed step is as follows:
A. by virgate lespedeza herb, buckwheat leaf, cucurbit, asafoetide boiling 2 times, add 7 times of water gagings of injection volume for the 1st time, decoct 1.5 littleTime, add for the second time 5 times of water gagings of injection volume, decoct 1 hour, merge decoction liquor, for subsequent use;
B. decoction liquor is condensed under 60 DEG C ,-0.06Mpa condition to relative density and is 1.08 ~ 1.12 clear cream, add ethanol extremelyBe 75% containing alcohol amount, place 12 hours, filter, it is 1.15 ~ 1.20 clear cream that filtrate is concentrated into relative density, and spraying is dried drylyDry medicinal powder;
C. frusemide and dry medicinal powder are mixed, granulate, obtain the active material of pharmaceutical composition of the present invention;
D. this active material separately or mix with the acceptable auxiliary material of medicine, makes according to galenic pharmacy conventional method.
The acceptable auxiliary material of described medicine is selected from: starch, dolomol, sweet mellow wine, sorbierite, sorbic acid or sylvite,Sodium pyrosulfite, sodium hydrogensulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin A, vitaminC, tie up main plain E, vitamin D, azone, EDETATE SODIUM, Ethylenediaminetetraacetic Acid Calcium Salt, the alkali-metal carbonate of monovalence, acetate, phosphate or itsThe aqueous solution, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, dextran, sweet ammoniaAcid, lactose, mannitol, silicon derivative, cellulose and derivative thereof, alginates, gelatin, polyvinylpyrrolidone, glycerine, thirdGlycol, ethanol, polysorbate60~80, department class~80, beeswax, lanolin, atoleine, hexadecanol, gallate ester, three ethanolAmine, basic amino acid, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, β~ring are stuck with pasteEssence, phospholipid material, kaolin, talcum powder, calcium stearate etc.
The present invention treats hypertensive pharmaceutical composition and is applicable to treat essential hypertension, can be separately or with other step-downsMedicine use in conjunction.
The present invention treats hypertensive pharmaceutical composition usage and dosage:
Oral: to start cumulative dosage from low dose. Conventionally initial dose be one time 1 bag, 2 times on the one; Take with meal.
The present invention treats hypertensive pharmaceutical composition and is cautious use of in 1. anuria or severe renal hypothyroid, because of this class medicineWeak effect, application can cause drug accumulation when heavy dose of, and toxicity increases; 2. severe cardiac pulmonary dysfunction; 3. hyperuricemia orThere is gout medical history person; 4. serious hepatic disorder person, water, electrolyte disturbance can bring out hepatic coma; 5. hypercalcinemia; 6. lowPotassium mass formed by blood stasis; 7. lupus erythematosus, can increase the weight of the state of an illness or stimulate activity; 8. pancreatitis; 9. Sympathectomy person (hypotensive effectStrengthen); 10. there is the baby of jaundice.
In pharmaceutical composition of the present invention,
Virgate lespedeza herb is legume lespedeza virgata Lespedezavirgata(Thunb.) DC.[HedysarumvirgatumThunb.] herb. Taste is sweet; Micro-hardship; Property is put down. Return spleen; Lung channel. The clear heat diuresis of function; Preventing malaria. Main heatstroke; Difficult urination; MalariaDisease; Flu; Hypertension.
Buckwheat leaf is polygonaceae plant buckwheat FagopyrumesculentumMoench[F.sagot-tatumGilib.; PolygoneumfagopyrumL.] leaf. Taste acid; Cold in nature. Function profit knowledge; Lower gas; Hemostasis; Step-down. Dominant eyeBlurred vision is stuck with paste; Tinnitus is hard of hearing; Belch; Purpura; Hypertension.
Cucurbit another name loud, high-pitched sound Bei Zhebu (hiding name), deriving from this product is cucurbitaceous plant cucurbit Lagenariasiceraria(Molina) dry seed of Standl.. Taste acid, puckery, warm in nature. Function antidiarrheal, draws and tells. For hot dysentery, tuberculosis, fash.
The smoked canal of asafoetide another name, Wei Quji, Kazakhstan former times mud, multicolored Wei, RESINA FERULAE are samphire asafoetide FerulaAssafoetidaL., Ferula sinkiangensis FerulasinkiangensisK.MShen, beg health asafoetide FerulaThe resin of the secretion such as fukanensisK.M.Shan. Taste is pungent; Flat; Nontoxic. Return liver; Spleen; Stomach warp. Functionalization disease disappears long-pending; Desinsection;Preventing malaria. Primary symptom lump in the abdomen lump in the abdomen; Malnutrition due to parasitic infestation; Dyspepsia; Fullness and oppression of chest and abdomen; Crymodynia; Malaria; Dysentery.
Beneficial effect of the present invention is: the present invention combines Chinese medicine and frusemide, to avoid the common of frusemideBad reaction, and improve to hypertensive result for the treatment of. Clinical test results shows: oral the present invention is containing frusemide compositionPatient, preliminary judgement is being better than simple application frusemide person controlling aspect blood pressure level. In addition, of the present invention containing furan plugRice pharmaceutical composition is improving aspect frusemide adverse drug reaction than significantly (P < 0.05) of simple application frusemide person effect.Illustrate that the frusemide pharmaceutical composition that contains of the present invention truly has curative effect aspect reducing blood pressure, and have advantages of that side effect is little.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further described, so that those skilled in the art more understandsThe present invention, but therefore do not limit the present invention.
Embodiment 1
One is treated hypertensive pharmaceutical composition, is made up of the bulk drug of following weight portion proportioning:
Frusemide 20g, virgate lespedeza herb 3000g, buckwheat leaf 3000g, cucurbit 3000g, asafoetide 3000g.
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by virgate lespedeza herb, buckwheat leaf, cucurbit, asafoetide boiling 2 times, add injection volume 7 water gagings the 1st time, decoct 1.5 littleTime, add for the second time 5 times of water gagings of injection volume, decoct 1 hour, merge decoction liquor, for subsequent use;
B. decoction liquor is condensed under 60 DEG C ,-0.06Mpa condition to relative density and is 1.08 ~ 1.12 clear cream, add ethanol extremelyBe 75% containing alcohol amount, place 12 hours, filter, it is 1.15 ~ 1.20 clear cream that filtrate is concentrated into relative density, and spraying is dried drylyDry medicinal powder;
C. frusemide and dry medicinal powder are mixed, granulate, obtain the active material of pharmaceutical composition of the present invention;
D. this active material adds injection volume xylitol, sweet mellow wine and β~cyclodextrin, the appropriate granulation agent of adhesive.
Prepare altogether 1000 bags, every bag heavy 5g.
Embodiment 2
One is treated hypertensive pharmaceutical composition, is made up of the bulk drug of following weight portion proportioning:
Frusemide 15g, virgate lespedeza herb 3500g, buckwheat leaf 2500g, cucurbit 3500g, asafoetide 2500g.
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by virgate lespedeza herb, buckwheat leaf, cucurbit, asafoetide boiling 2 times, add injection volume 8 water gagings the 1st time, decoct 2 hours,Add for the second time 6 times of water gagings of injection volume, decoct 1.5 hours, merge decoction liquor, for subsequent use;
B. decoction liquor is condensed under 55 DEG C ,-0.08Mpa condition to relative density and is 1.08 ~ 1.12 clear cream, add ethanol extremelyBe 75% containing alcohol amount, place 12 hours, filter, it is 1.15 ~ 1.20 clear cream that filtrate is concentrated into relative density, and spraying is dried drylyDry medicinal powder;
C. frusemide and dry medicinal powder are mixed, granulate, obtain the active material of pharmaceutical composition of the present invention;
D. this active material adds injection volume xylitol, sweet mellow wine and β~cyclodextrin,, the appropriate granulation agent of adhesive.
Prepare altogether 1000 bags, every bag heavy 5g.
Embodiment 3
One is treated hypertensive pharmaceutical composition, is made up of the bulk drug of following weight portion proportioning:
Frusemide 25g, virgate lespedeza herb 2500g, buckwheat leaf 3500g, cucurbit 2500g, asafoetide 3500g.
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by virgate lespedeza herb, buckwheat leaf, cucurbit, asafoetide boiling 2 times, add injection volume 6 water gagings the 1st time, decoct 1 hour,Add for the second time 4 times of water gagings of injection volume, decoct 0.5 hour, merge decoction liquor, for subsequent use;
B. decoction liquor is condensed under 65 DEG C ,-0.04Mpa condition to relative density and is 1.08 ~ 1.12 clear cream, add ethanol extremelyBe 75% containing alcohol amount, place 12 hours, filter, it is 1.15 ~ 1.20 clear cream that filtrate is concentrated into relative density, and spraying is dried drylyDry medicinal powder;
C. frusemide and dry medicinal powder are mixed, granulate, obtain the active material of pharmaceutical composition of the present invention;
D. this active material adds injection volume xylitol, sweet mellow wine and β~cyclodextrin, the appropriate granulation agent of adhesive.
Prepare altogether 1000 bags, every bag heavy 5g.
Embodiment 4
One is treated hypertensive pharmaceutical composition, is made up of the bulk drug of following weight portion proportioning:
Frusemide 10g, virgate lespedeza herb 4000g, buckwheat leaf 4000g, cucurbit 4000g, asafoetide 4000g.
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by virgate lespedeza herb, buckwheat leaf, cucurbit, asafoetide boiling 2 times, add injection volume 7 water gagings the 1st time, decoct 1.5 littleTime, add for the second time 5 times of water gagings of injection volume, decoct 1 hour, merge decoction liquor, for subsequent use;
B. decoction liquor is condensed under 60 DEG C ,-0.06Mpa condition to relative density and is 1.08 ~ 1.12 clear cream, add ethanol extremelyBe 75% containing alcohol amount, place 12 hours, filter, it is 1.15 ~ 1.20 clear cream that filtrate is concentrated into relative density, and spraying is dried drylyDry medicinal powder;
C. frusemide and dry medicinal powder are mixed, granulate, obtain the active material of pharmaceutical composition of the present invention;
D. this active material adds injection volume xylitol, sweet mellow wine and β~cyclodextrin, the appropriate granulation agent of adhesive.
Prepare altogether 1000 bags, every bag heavy 5g.
Embodiment 5
One is treated hypertensive pharmaceutical composition, is made up of the bulk drug of following weight portion proportioning:
Frusemide 30g, virgate lespedeza herb 2000g, buckwheat leaf 2000g, cucurbit 2000g, asafoetide 2000g.
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by virgate lespedeza herb, buckwheat leaf, cucurbit, asafoetide boiling 2 times, add injection volume 7 water gagings the 1st time, decoct 1.5 littleTime, add for the second time 5 times of water gagings of injection volume, decoct 1 hour, merge decoction liquor, for subsequent use;
B. decoction liquor is condensed under 60 DEG C ,-0.06Mpa condition to relative density and is 1.08 ~ 1.12 clear cream, add ethanol extremelyBe 75% containing alcohol amount, place 12 hours, filter, it is 1.15 ~ 1.20 clear cream that filtrate is concentrated into relative density, and spraying is dried drylyDry medicinal powder;
C. frusemide and dry medicinal powder are mixed, granulate, obtain the active material of pharmaceutical composition of the present invention;
D. this active material adds injection volume xylitol, sweet mellow wine and β~cyclodextrin, the appropriate granulation agent of adhesive.
Prepare altogether 1000 bags, every bag heavy 5g.
The pharmaceutical composition that contains frusemide prepared by embodiment 1 has carried out clinical testing, and result is as follows:
1. data and method
1.1 research object
100 routine primary hypertension patients have been selected in this research, all meet WHO diagnostic criteria in 1999, and meet withLower condition: 1. make a definite diagnosis for the first time or make a definite diagnosis and be no more than that do not treat half a year and systolic pressure >=140mmHg, diastolic pressure >=90mmHg; 2.Without serious acute and chronic complication. Qualified 100 routine patients are divided into observation group and control group at random, every group of 50 examples. Two groupsPatient aspect sex, age, body mass index, the course of disease, blood pressure level etc. very physical data comparing difference not statistically significant (P >0.05), there is comparativity.
1.2 methods for the treatment of
1. control group: apply frusemide treatment on the basis of patient being carried out to the education of hypertension health knowledge, frusemide is each20mg, every day 2 times. 2. observation group: use in conjunction contains furan on the basis of patient being carried out to the education of hypertension health knowledgeThe pharmaceutical composition of plug rice, each 1 bag, every day 2 times. Two groups all taking 1 week as one treatment stage.
1.3 observation index
1. safety indexes: as routine blood test, stool routine examination, liver function, kidney function test, electrocardiogram etc.; 2. health giving quality index: controlBlood pressure level before and after treating, blood pressure normalization rate (systolic pressure≤120mmHg, diastolic pressure≤90mmHg). 3. allergic reaction generation feelingsCondition.
1.4 statistical method
Adopt SPSS17.0 to carry out the statistical analysis of data. Measurement data adopts t inspection (by mean ± standard deviationRepresent); Grouped data adopts χ2Inspection, using P≤0.05 as there being statistical significance, using P≤0.01 as havingHeight statistical significance.
2. result
2.1 clinical efficacy results
Treat the systolic pressure of first two groups and the horizontal comparing difference not statistically significant of diastolic pressure (P > 0.05); After treatment two groupsSystolic pressure and diastolic pressure level all obviously reduce before treatment, and difference has statistical significance (P < 0.05); The patient of observation group existsSystolic pressure and diastolic pressure improve degree aspect and are obviously better than control group, and difference has statistical significance (P < 0.05); Observation group controlsBlood pressure normalization rate 98.0%(49/50 after treating) apparently higher than the 56.0%(28/50 of control group), difference have statistical significance (P <0.05); In table 1.
Table 1 liang group patient clinical curative effect comparison
Group Number of cases Time Systolic pressure (mmHg) Diastolic pressure (mmHg)
Observation group 50 Before treatment 166.25±13.51 109.62±11.47
After treatment 104.15±9.85*# 71.36±4.39*# 5 -->
Control group 50 Before treatment 166.36±13.53 109.66±11.49
After treatment 125.75±11.37* 95.66±5.98*
Note: * represents and front relatively P < 0.05 for the treatment of; # represent with treatment of control group after P < 0.05 relatively
2.2 security observed results
In this test, all experimenter carries out respectively safety indexes detection before and after treatment, and result is not found obviously extremely to changeBecome, illustrate that the pharmaceutical composition that contains frusemide of the present invention uses safety.
A situation arises in 2.3 allergic reactions
In this research, the allergic reaction incidence of observation group is starkly lower than control group, and difference has statistical significance (P < 0.05),In table 2.
A situation arises in a table 2 liang group allergic reaction
Group Number of cases Pityriasis Multiple erythroderma Interstitial nephritis Heart arrest Incidence
Observation group 50 0 0 0 0 0(0.0%)
Control group 50 5 5 1 0 11(22.0%)
The present invention combines Chinese medicine and frusemide, to avoid the common allergic reaction of frusemide, and improves hypertensionResult for the treatment of. Clinical test results shows: oral the present invention is containing the patient of frusemide composition, and preliminary judgement is being controlled blood pressureHorizontal aspect is better than simple application frusemide person. In addition, the frusemide pharmaceutical composition that contains of the present invention is improving frusemide medicineThing allergic reaction aspect, than significantly (P < 0.05) of simple application frusemide person effect, illustrates of the present invention containing frusemide medicine groupCompound is safe and effective aspect reducing blood pressure, and has advantages of that side effect is little.

Claims (7)

1. the hypertensive pharmaceutical composition for the treatment of that contains frusemide, is made up of the bulk drug of following weight portion proportioning: furanPlug rice 10-30 part, virgate lespedeza herb 2000-4000 part, buckwheat leaf 2000-4000 part, cucurbit 2000-4000 part, asafoetide 2000-4000Part.
2. the hypertensive pharmaceutical composition of the treatment that contains frusemide as claimed in claim 1, is characterized in that, by as followsThe bulk drug composition of weight portion proportioning: frusemide 15-25 part, virgate lespedeza herb 2500-3500 part, buckwheat leaf 2500-3500 part, cucurbit2500-3500 part, asafoetide 2500-3500 part.
3. the hypertensive pharmaceutical composition of the treatment that contains frusemide as claimed in claim 2, is characterized in that, by as followsThe bulk drug composition of weight portion proportioning: 20 parts of frusemides, 3000 parts of virgate lespedeza herbs, 3000 parts of buckwheat leafs, 3000 parts, cucurbit, asafoetide3000 parts.
4. the hypertensive pharmaceutical composition of the treatment that contains frusemide as described in claim 1 or 2 or 3, is characterized in that, itsDosage form is granule.
5. the preparation method of the hypertensive pharmaceutical composition for the treatment of that contains frusemide described in claim 1 or 2 or 3, comprisesFollowing steps:
A. by virgate lespedeza herb, buckwheat leaf, cucurbit, asafoetide boiling 2 times, add 6 ~ 8 times of water gagings of injection volume for the 1st time, decoct 1 ~ 2Hour, add for the second time 4 ~ 6 times of water gagings of injection volume, decoct 0.5 ~ 1.5 hour, merge decoction liquor, for subsequent use;
B. decoction liquor is condensed under 55 ~ 65 DEG C ,-0.04 ~-0.08Mpa condition to relative density and is 1.08 ~ 1.12 clearCream, adds ethanol to being 75% containing alcohol amount, places 12 hours, filters, and it is 1.15 ~ 1.20 clear cream that filtrate is concentrated into relative density, spraysMist is dry, obtains dry medicinal powder;
C. frusemide and dry medicinal powder are mixed, granulate, obtain the active material of pharmaceutical composition of the present invention;
D. this active material separately or mix with the acceptable auxiliary material of medicine, makes according to galenic pharmacy conventional method.
6. the preparation method of the hypertensive pharmaceutical composition for the treatment of that contains frusemide as claimed in claim 5, its feature existsIn,
In the step a of portion of institute, add 7 times of water gagings of injection volume for the 1st time, decoct 1.5 hours, add for the second time 5 times of amounts of injection volumeWater, decocts 1 hour; In described step b, thickening temperature be 60 DEG C, concentrated pressure is-0.06Mpa.
7. the preparation method of the hypertensive pharmaceutical composition for the treatment of that contains frusemide as claimed in claim 5, detailed stepAs follows:
A. by virgate lespedeza herb, buckwheat leaf, cucurbit, asafoetide boiling 2 times, add 7 times of water gagings of injection volume for the 1st time, decoct 1.5 littleTime, add for the second time 5 times of water gagings of injection volume, decoct 1 hour, merge decoction liquor, for subsequent use;
B. decoction liquor is condensed under 60 DEG C ,-0.06Mpa condition to relative density and is 1.08 ~ 1.12 clear cream, add ethanol extremelyBe 75% containing alcohol amount, place 12 hours, filter, it is 1.15 ~ 1.20 clear cream that filtrate is concentrated into relative density, and spraying is dried, and obtains dryDry medicinal powder;
C. frusemide and dry medicinal powder are mixed, granulate, obtain the active material of pharmaceutical composition of the present invention;
D. this active material separately or mix with the acceptable auxiliary material of medicine, makes according to galenic pharmacy conventional method.
CN201610175836.4A 2016-03-27 2016-03-27 Pharmaceutical composition containing furosemide for treating hypertension and preparation method of pharmaceutical composition Withdrawn CN105596437A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1958001A (en) * 2005-11-01 2007-05-09 陈绮年 Medication for treating high blood pressure

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1958001A (en) * 2005-11-01 2007-05-09 陈绮年 Medication for treating high blood pressure

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