CN105582192A - Hypertension-treating medicine composition containing bisoprolol fumarate and preparation method thereof - Google Patents

Hypertension-treating medicine composition containing bisoprolol fumarate and preparation method thereof Download PDF

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CN105582192A
CN105582192A CN201610175843.4A CN201610175843A CN105582192A CN 105582192 A CN105582192 A CN 105582192A CN 201610175843 A CN201610175843 A CN 201610175843A CN 105582192 A CN105582192 A CN 105582192A
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bisoprolol fumarate
pharmaceutical composition
treatment
parts
lychnisflos
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不公告发明人
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Jinan Bangwen Pharmaceutical Technology Co Ltd
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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a hypertension-treating medicine composition containing bisoprolol fumarate and a preparation method thereof. The hypertension-treating medicine composition containing bisoprolol fumarate is prepared from, by weight, 1.25-10 parts of bisoprolol fumarate, 2000-4000 parts of salsola ruthenica Iljin, 2000-4000 parts of cycas rumphii Miq., 2000-4000 parts of lychnis fulgens Fisch. and 2000-4000 parts of juncus roots. As Chinese herbs and bisoprolol fumarate are combined, common adverse reactions caused by bisoprolol fumarate can be avoided, and the treatment effect on hypertension can be improved.

Description

A kind of hypertensive pharmaceutical composition for the treatment of that contains bisoprolol fumarate and preparation method thereof
Technical field
The invention belongs to medical technical field, be specifically related to a kind of bisoprolol fumarate's of containing the hypertensive medicine for the treatment ofCompositions and 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。
Bisoprolol fumarate is the hypertensive beta-blocker of clinical conventional treatment. This product is applicable to hypertension and controlsTreat, especially alignment degree hypertension and the young hyperpietic's best results without severe complication, can join with other antihypertensive drugsClose use. But long-term taking bisoprolol fumarate's side effect is also very large to the injury of human body. What allow people has a headache most is canCan cause nervous system bad reaction, such as dizzy, headache, depression, insomnia and dreamful sleep, illusion etc. This bad reaction has limited richnessHorse acid bisoprolol is in clinical use.
Summary of the invention
In order to solve the large restriction of bisoprolol fumarate's side effect end user group's technical problem, the invention provides oneThe composition of bisoprolol fumarate and Chinese medicine, by with the compatibility of Chinese medicine, alleviate bisoprolol fumarate's bad reaction,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 bisoprolol fumarate, by the bulk drug group of following weight proportionBecome: bisoprolol fumarate 1.25-10 part, Herba Salsolae Ruthenicae 2000-4000 part, Cycas rumphii 2000-4000 part, great Hua LychnisFlos-Cuculi2000-4000 part, common rush root 2000-4000 part.
The above-mentioned hypertensive pharmaceutical composition of the treatment that contains bisoprolol fumarate, its weight portion proportion optimization is:Bisoprolol fumarate 2.5-7.5 part, Herba Salsolae Ruthenicae 2500-3500 part, Cycas rumphii 2500-3500 part, great Hua LychnisFlos-Cuculi 2500-3500 parts, common rush root 2500-3500 part.
The above-mentioned hypertensive pharmaceutical composition of the treatment that contains bisoprolol fumarate, its weight portion proportioning the best is:5 parts of bisoprolol fumarates, 3000 parts of Herba Salsolae Ruthenicaes, 3000 parts of Cycas rumphiis, 3000 parts of great Hua LychnisFlos-Cuculis, common rush root 3000Part.
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 bisoprolol fumarate, comprises following stepRapid:
A. by Herba Salsolae Ruthenicae, Cycas rumphii, great Hua LychnisFlos-Cuculi, common rush root boiling 2 times, add 6 ~ 8 times of injection volumes the 1st timeWater gaging, decocts 1 ~ 2 hour, adds for the second time 4 ~ 6 times of water gagings of injection volume, decocts 0.5 ~ 1.5 hour, merges 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. bisoprolol fumarate 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 bisoprolol fumarate, portion of institute stepIn a, 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 water gagings of injection volume, decoct 1 hour;In described step b, thickening temperature be 60 DEG C, concentrated pressure is-0.06Mpa.
Preferably, state the preparation method of the hypertensive pharmaceutical composition for the treatment of that contains bisoprolol fumarate, in detail stepRapid as follows:
A. by Herba Salsolae Ruthenicae, Cycas rumphii, great Hua LychnisFlos-Cuculi, common rush root boiling 2 times, add 7 times of amounts of injection volume for the 1st timeWater, decocts 1.5 hours, adds for the second time 5 times of water gagings of injection volume, decocts 1 hour, merges 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. bisoprolol fumarate 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 treat hypertensive pharmaceutical composition forbid in: 1, acute heart failure or in heart failure lose compensatoryThe patient that phase need treat with quiet note positive inotropic medicament; 2, cardiogenic shock person; 3, two degree or third degree A-V block person (nothingsPacemaker); 4, sick sinus syndrome patient; 5, sino atrial block person; 6, bradycardia person, when treatment starts, heart rate is less than 60Beat/min; 7, hypopiesia person's (dry 100mmHg is forced down in contraction); 8, the trouble that serious bronchial astehma or severe chronic lung blockPerson; 9, peripheral arterial occlusion type terminal stage of a disease and Raynaud's disease syndrome patient; 10, untreated Patients With Pheochromocytoma;11, metabolic acidosis patient.
In pharmaceutical composition of the present invention,
Herba Salsolae Ruthenicae another name salsola collina, large wing salsola collina (" medicine figure will is planted in northeast "), prick fluffy (" middle traditional Chinese medicines are planted illustrated handbook "), tumbleweed(" Jilin Chinese herbal medicine "). For the herb of chenopod Herba Salsolae Ruthenicae. Bitter, cool in nature. Enter liver, kidney channel. The flat liver step-down of function.
Cycas rumphii is root or the seed of cycad Folium Cycadis rumphii CycasrumphiiMiq.. Taste is sweet; Light; PropertyFlat. The flat liver and dispelling wind of function; Detumescence sore. Main high blood pressure; Arthralgia due to wind-dampness; Nameless sores or boils; Skin eczema.
Great Hua LychnisFlos-Cuculi another name mountain safflower, LychnisFlos-Cuculi, little sharp leaf ginseng are pinkwort great Hua LychnisFlos-Cuculi LychnisFulgensFisch. root and herb. Taste is sweet; Cold in nature. Function reducing fever and causing diuresis; Invigorating the spleen; Calm the nerves. Main difficult urination; Children's's infantile malnutrition due to digestive disturbances or intestinalparasitesLong-pending; Night sweat; Headache; Insomnia.
Common rush root another name rush root is rush family plant rush JuncuseffususL.[J.effususL.var.decipiensBuchen.; J.decipiens (Buchen.) Nakai]. root and rhizome. Taste is sweet; Cold in nature. ReturnThe heart; Urinary bladder channel. Function promoting diuresis for stranguria; Clearing away the heart fire and tranquillizing. Main gonorrhoea; Difficult urination; Jaundice with damp-heat pathogen; Palpitation and restlessness.
Beneficial effect of the present invention is: the present invention combines Chinese medicine and bisoprolol fumarate, to avoid rich horseThe common nervous system bad reaction of acid bisoprolol, and improve hypertensive result for the treatment of. Clinical test results shows:Oral the present invention is containing the patient of bisoprolol fumarate's composition, and preliminary judgement is better than and merely should aspect horizontal reducing blood pressureUse bisoprolol fumarate person. In addition, the bisoprolol fumarate's pharmaceutical composition that contains of the present invention is improving fumaric acid peso Lip riverSignificantly (P < 0.05) of the simple application of your adverse drug reaction aspect ratio bisoprolol fumarate person's effect. Illustrate of the present inventionAspect reducing blood pressure, truly have curative effect containing bisoprolol fumarate's pharmaceutical composition, 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:
Bisoprolol fumarate 5g, Herba Salsolae Ruthenicae 3000g, Cycas rumphii 3000g, great Hua LychnisFlos-Cuculi 3000g, common rush root 3000g.
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by Herba Salsolae Ruthenicae, Cycas rumphii, great Hua LychnisFlos-Cuculi, common rush root boiling 2 times, add injection volume 7 amounts the 1st timeWater, decocts 1.5 hours, adds for the second time 5 times of water gagings of injection volume, decocts 1 hour, merges 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. bisoprolol fumarate 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:
Bisoprolol fumarate 7.5g, Herba Salsolae Ruthenicae 3500g, Cycas rumphii 2500g, great Hua LychnisFlos-Cuculi 3500g, common rush root2500g。
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by Herba Salsolae Ruthenicae, Cycas rumphii, great Hua LychnisFlos-Cuculi, common rush root boiling 2 times, add injection volume 8 amounts the 1st timeWater, decocts 2 hours, adds for the second time 6 times of water gagings of injection volume, decocts 1.5 hours, merges 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. bisoprolol fumarate 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:
Bisoprolol fumarate 2.5g, Herba Salsolae Ruthenicae 2500g, Cycas rumphii 3500g, great Hua LychnisFlos-Cuculi 2500g, common rush root3500g。
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by Herba Salsolae Ruthenicae, Cycas rumphii, great Hua LychnisFlos-Cuculi, common rush root boiling 2 times, add injection volume 6 amounts the 1st timeWater, decocts 1 hour, adds for the second time 4 times of water gagings of injection volume, decocts 0.5 hour, merges 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. bisoprolol fumarate 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:
Bisoprolol fumarate 1.25g, Herba Salsolae Ruthenicae 4000g, Cycas rumphii 4000g, great Hua LychnisFlos-Cuculi 4000g, common rush root4000g。
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by Herba Salsolae Ruthenicae, Cycas rumphii, great Hua LychnisFlos-Cuculi, common rush root boiling 2 times, add injection volume 7 amounts the 1st timeWater, decocts 1.5 hours, adds for the second time 5 times of water gagings of injection volume, decocts 1 hour, merges 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. bisoprolol fumarate 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:
Bisoprolol fumarate 10g, Herba Salsolae Ruthenicae 2000g, Cycas rumphii 2000g, great Hua LychnisFlos-Cuculi 2000g, common rush root2000g。
The preparation method of the hypertensive pharmaceutical composition of this treatment:
A. by Herba Salsolae Ruthenicae, Cycas rumphii, great Hua LychnisFlos-Cuculi, common rush root boiling 2 times, add injection volume 7 amounts the 1st timeWater, decocts 1.5 hours, adds for the second time 5 times of water gagings of injection volume, decocts 1 hour, merges 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. bisoprolol fumarate 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 bisoprolol fumarate prepared by embodiment 1 has carried out clinical testing, and result is as follows:
1. data and method
1.1 research object
80 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 80 routine patients are divided into observation group and control group at random, every group of 40 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 bisoprolol fumarate's treatment on the basis of patient being carried out to the education of hypertension health knowledge, richnessThe each 10mg of horse acid bisoprolol, every day 1 time. 2. observation group: on the basis of patient being carried out to the education of hypertension health knowledgeThe pharmaceutical composition that upper use in conjunction contains bisoprolol fumarate, each 1 bag, every day 1 time. Two groups all with 1 Zhou WeiyiTreatment 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. nervous system bad reactionA situation arises.
1.4 statistical method
Adopt SPSS17.0 to carry out the statistical analysis of data. Measurement data adopts t inspection (with mean ± standard deviation tableShow); Grouped data adopts χ2Inspection, using P≤0.05 as there being statistical significance, using P≤0.01 as there being highly statisticsLearn meaning.
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 97.5%(39/40 after treating) apparently higher than the 72.5%(29/40 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 40 Before treatment 169.82±13.76 115.61±12.54
After treatment 103.21±9.55*# 70.75±4.48*#
Control group 40 Before treatment 169.82±13.72 115.64±12.49
After treatment 124.77±12.21* 99.12±5.94*
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 bisoprolol fumarate's of containing of the present invention pharmaceutical composition uses safety.
A situation arises in 2.3 nervous system bad reactions
In this research, the nervous system adverse reaction rate 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 nervous system bad reaction
Group Number of cases Dizzy Headache Depressed Insomnia and dreamful sleep Illusion Incidence
Observation group 40 1 0 0 0 0 1（2.5%）
Control group 40 4 3 1 4 1 13(32.5%)
3. conclusion
The present invention combines Chinese medicine and bisoprolol fumarate, to avoid bisoprolol fumarate's common nervous systemBad reaction, and improve hypertensive result for the treatment of. Clinical test results shows: oral the present invention is containing bisoprolol fumarateThe patient of composition, preliminary judgement is being better than simple application bisoprolol fumarate person aspect control blood pressure level. In addition, originallyImproving aspect the bad reaction of bisoprolol fumarate's medicine nervous system containing bisoprolol fumarate's pharmaceutical composition of inventionThan significantly (P < 0.05) of simple application bisoprolol fumarate person effect. Illustrate of the present invention containing bisoprolol fumarate's medicineCompositions is safe and effective aspect reducing blood pressure, and has advantages of that side effect is little.

Claims (7)

1. contain bisoprolol fumarate's the hypertensive pharmaceutical composition for the treatment of, by the bulk drug of following weight portion proportioningComposition: bisoprolol fumarate 1.25-10 part, Herba Salsolae Ruthenicae 2000-4000 part, Cycas rumphii 2000-4000 part, great Hua LychnisFlos-Cuculi2000-4000 part, common rush root 2000-4000 part.
2. the hypertensive pharmaceutical composition of the treatment that contains bisoprolol fumarate as claimed in claim 1, is characterized in that,Bulk drug by following weight portion proportioning forms: bisoprolol fumarate 2.5-12.5 part, Herba Salsolae Ruthenicae 2500-3500 part, Ci YeSago cycas 2500-3500 part, great Hua LychnisFlos-Cuculi 2500-3500 part, common rush root 2500-3500 part.
3. the hypertensive pharmaceutical composition of the treatment that contains bisoprolol fumarate as claimed in claim 2, is characterized in that,Bulk drug by following weight portion proportioning forms: 5 parts of bisoprolol fumarates, 3000 parts of Herba Salsolae Ruthenicaes, 3000 parts of Cycas rumphiis, large3000 parts of flower LychnisFlos-Cuculis, 3000 parts of common rush roots.
4. the hypertensive pharmaceutical composition of the treatment that contains bisoprolol fumarate as described in claim 1 or 2 or 3, its spyLevy and be, its dosage form is granule.
5. the preparation side of the hypertensive pharmaceutical composition for the treatment of that contains bisoprolol fumarate described in claim 1 or 2 or 3Method, comprises following steps:
A. by Herba Salsolae Ruthenicae, Cycas rumphii, great Hua LychnisFlos-Cuculi, common rush root boiling 2 times, add 6 ~ 8 times of injection volumes the 1st timeWater gaging, decocts 1 ~ 2 hour, adds for the second time 4 ~ 6 times of water gagings of injection volume, decocts 0.5 ~ 1.5 hour, merges 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. bisoprolol fumarate 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 bisoprolol fumarate as claimed in claim 5,It is characterized in that,
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 bisoprolol fumarate as claimed in claim 5,Detailed step is as follows:
A. by Herba Salsolae Ruthenicae, Cycas rumphii, great Hua LychnisFlos-Cuculi, common rush root boiling 2 times, add 7 times of amounts of injection volume for the 1st timeWater, decocts 1.5 hours, adds for the second time 5 times of water gagings of injection volume, decocts 1 hour, merges 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. bisoprolol fumarate 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.
CN201610175843.4A 2016-03-27 2016-03-27 Hypertension-treating medicine composition containing bisoprolol fumarate and preparation method thereof Withdrawn CN105582192A (en)

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Application publication date: 20160518