CN105770220A - Pharmaceutical composition containing losartan and capable of treating hypertension and preparation method thereof - Google Patents
Pharmaceutical composition containing losartan and capable of treating hypertension and preparation method thereof Download PDFInfo
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- CN105770220A CN105770220A CN201610175854.2A CN201610175854A CN105770220A CN 105770220 A CN105770220 A CN 105770220A CN 201610175854 A CN201610175854 A CN 201610175854A CN 105770220 A CN105770220 A CN 105770220A
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- losartan
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- 239000002083 C09CA01 - Losartan Substances 0.000 title claims abstract description 63
- KJJZZJSZUJXYEA-UHFFFAOYSA-N losartan Chemical compound CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=2C(=CC=CC=2)C=2[N]N=NN=2)C=C1 KJJZZJSZUJXYEA-UHFFFAOYSA-N 0.000 title claims abstract description 63
- 229960004773 losartan Drugs 0.000 title claims abstract description 63
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- 231100000611 venom Toxicity 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- 235000019166 vitamin D Nutrition 0.000 description 1
- 239000011710 vitamin D Substances 0.000 description 1
- 150000003710 vitamin D derivatives Chemical class 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
- 229940046008 vitamin d Drugs 0.000 description 1
- 235000014101 wine Nutrition 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction 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 or decoction
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- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention belongs to the technical field of medicine and particularly relates to a pharmaceutical composition containing losartan and capable of treating hypertension and a preparation method thereof. The pharmaceutical composition containing losartan and capable of treating hypertension is prepared from the following active pharmaceutical ingredients in parts by weight: 40-60 parts of losartan, 2000-4000 parts of urtica macrorrhiza, 2000-4000 parts of herba wedeliae, 2000-4000 parts of grape vine and leaves and 2000-4000 parts of typha root. According to the pharmaceutical composition, traditional Chinese medicines are combined with the losartan, so that common adverse reactions of the losartan can be avoided, and the treatment effect on hypertension is improved.
Description
Technical field
The invention belongs to pharmaceutical technology field, be specifically related to the pharmaceutical composition of a kind for the treatment of hypertension containing Losartan
And preparation method thereof.
Background technology
Hypertension is Important cause of disease and the hazards of cardiovascular and cerebrovascular disease, and the people that there is 20%-30% in the whole world suffers from blood
Pressure.Hypertension can affect the 26S Proteasome Structure and Function of the heart, brain, kidney, can dramatically increase the onset risk of palsy, heart failure, ESRD.
Essential hypertension accounts for the 95% of hypertension incidence, and the investigation of 2002 shows at more than 18 years old prevalence of China up to
18.8%, number of patients reaches 1.6 hundred million.Therefore the prevention of hypertension and treatment, becomes China and that the whole world is paid close attention to the most is great
Public health problem.
The methods for the treatment of of hypertension is in addition to changing habits and customs at present, and topmost effective prevention method is exactly that medicine is controlled
Malignant boil, the most conventional antihypertensive drugs is divided into 5 classes, the clinically alone and drug combination two class scheme of main employing.But step-down
Medicine still has in clinical application a lot of asks bad reaction, resistance phenomenon and patient that such as Long-term taking medicine causes
Bad compliance.There are some researches show that the patient accepting drug therapy only has 53% successfully to control blood pressure, make controlling of blood pressure≤
140/90mmHg。
Losartan is the drug for hypertension of first Angiotensin Ⅱ receptor antagonist (AIIA) class, is applicable to various
The hypertension of type.But it is easily caused angioneurotic edema, see face, lip and/or swollem tongue.This bad reaction limits
Losartan is in clinical use.
Summary of the invention
In order to solve the technical problem of Losartan side effect big restriction use crowd, the invention provides a kind of Losartan with
The composition of Chinese medicine, by the compatibility with Chinese medicine, alleviates the bad reaction of Losartan, thus realizes the purpose of attenuation synergistic.
The present invention is to be realized by following technical scheme:
The pharmaceutical composition of a kind for the treatment of hypertension containing Losartan, is made up of the bulk drug of following weight proportion: Losartan
40-60 part, blue or green fiber crops 2000-4000 part, wedelia chinensis 2000-4000 part, european grape stem and leaf 2000-4000 part, the Pu 2000-of living
4000 parts.
The pharmaceutical composition of the above-mentioned treatment hypertension containing Losartan, its weight is preferably: Losartan 45-
55 parts, blue or green fiber crops 2500-3500 part, wedelia chinensis 2500-3500 part, european grape stem and leaf 2500-3500 part, the Pu 2500-3500 of living
Part.
The pharmaceutical composition of the above-mentioned treatment hypertension containing Losartan, its weight most preferably: Losartan 50
Part, blue or green live fiber crops 3000 parts, wedelia chinensis 3000 parts, european grape stem and leaf 3000 parts, Pu 3000 parts.
In the composition described above of the present invention, the weight of each taste Chinese medicine calculates with crude drug, if in grams, as made
Preparation, then can be made into 100-1000 agent because of varying in size of preparation.Described 100-1000 agent refers to the dosage form of UD,
Such as tablet 100-1000 sheet, capsule 100-1000 grain, granule l00-1000g, oral liquid l00-l000ml, paste l00-
L000g, pill 100-1000 ball etc..
Composition described above is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, as on a large scale
Production can in units of kg, or with t(ton) as unit；Preparation can also be in units of g on a small scale.Weight can increase or
Reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, such as severe or mild, obesity
Or the patient of slight of stature, the proportioning of the amount of composition can be adjusted accordingly, be increased or decreased less than 100%, drug effect is basically unchanged.
The pharmaceutical composition of the present invention, some are pharmaceutically acceptable auxiliary individually or can to add injection volume as required
Material, can use galenic pharmacy routine techniques to prepare this pharmaceutical preparation, as mixed with pharmaceutically acceptable auxiliary material by pharmaceutically active substance
Close.Can make any pharmaceutically useful peroral dosage form when making pharmaceutical preparation, these formulations are selected from: granule, tablet, capsule
Agent, oral liquid, suck agent, pill, powder, preferably granule.
The preparation method of the pharmaceutical composition of the above-mentioned treatment hypertension containing Losartan, comprises the steps of:
A. green grass or young crops is lived fiber crops, wedelia chinensis, european grape stem and leaf, Pu boiling 2 times, add injection volume 6 ~ 8 times amount water for the 1st time, pan-fried
Boiling 1 ~ 2 hour, second time adds injection volume 4 ~ 6 times amount water, decocts 0.5 ~ 1.5 hour, merges decoction liquor, standby；
B. by decoction liquor 55 ~ 65 DEG C, be condensed under the conditions of-0.04 ~-0.08Mpa relative density be 1.08 ~ 1.12 clear
Cream, adding ethanol to alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear cream that relative density is 1.15 ~ 1.20, spray
Mist is dried to obtain dry medicinal powder；
C. Losartan is mixed with dry medicinal powder, pelletize, obtain the active material of pharmaceutical composition of the present invention；
D. this active material individually or mixes with pharmaceutically acceptable auxiliary material, prepares according to galenic pharmacy conventional method.
In the preparation method of the pharmaceutical composition of the above-mentioned treatment hypertension containing Losartan, in described step a the 1st time
Adding injection volume 7 times amount water, decoct 1.5 hours, second time adds injection volume 5 times amount water, decocts 1 hour；Described step b
Middle thickening temperature is 60 DEG C, concentrate pressure is-0.06Mpa.
Preferably, stating the preparation method of the pharmaceutical composition for the treatment of hypertension containing Losartan, detailed step is as follows:
A. green grass or young crops is lived fiber crops, wedelia chinensis, european grape stem and leaf, Pu boiling 2 times, add injection volume 7 times amount water, decoction for the 1st time
1.5 hours, second time added injection volume 5 times amount water, decocts 1 hour, merged decoction liquor, standby；
B. by decoction liquor 60 DEG C, be condensed into the clear cream that relative density is 1.08 ~ 1.12 under the conditions of-0.06Mpa, add ethanol extremely
Alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear cream that relative density is 1.15 ~ 1.20, is spray-dried dry
Dry medicinal powder；
C. Losartan is mixed with dry medicinal powder, pelletize, obtain the active material of pharmaceutical composition of the present invention；
D. this active material individually or mixes with pharmaceutically acceptable auxiliary material, prepares according to galenic pharmacy conventional method.
Described pharmaceutically acceptable auxiliary material is selected from: starch, magnesium stearate, mannitol, sorbierite, sorbic acid or sylvite,
Sodium pyrosulfite, sodium hydrogensulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin A, vitamin
C, tie up main element E, vitamin D, azone, EDETATE SODIUM, Ethylenediaminetetraacetic Acid Calcium Salt, the alkali-metal carbonate of monovalence, acetate, phosphate or its
The aqueous solution, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, dextran, sweet ammonia
Acid, lactose, mannitol, silicon derivative, cellulose and its derivates, alginates, gelatin, polyvinylpyrrolidone, glycerine, third
Glycol, ethanol, polysorbate60～80, Span～80, beeswax, lanolin, atoleine, hexadecanol, gallate ester, three ethanol
Amine, basic amino acid, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, β～ring are stuck with paste
Essence, phospholipid material, kaolin, talcum powder, calcium stearate etc..
The present invention treats the pharmaceutical composition of hypertension and is applicable to various types of hypertension, to intractable, severe height blood
Pressure also have good therapeutic effect, can individually or with other depressor use in conjunction.
The present invention treats the pharmaceutical composition usage and dosage of hypertension:
Oral: to start cumulative dosage from low dose.Generally initial dose be one time 1 bag, 2 times on the one；Take with meal.
The present invention treats the pharmaceutical composition of hypertension and disables angiotensin converting enzyme inhibitor allergy sufferers.
In the pharmaceutical composition of the present invention,
Blue or green live fiber crops another name fiber crops alive, nettle, fire fiber crops, tiger fiber crops, derive from Urticaceae Urtica plant Urtica macrorrhiza Hand.-Mazz Urtica
Macrorrhiza Hand.-Mazz., with all herbal medicine.Bitter, pungent, warm in nature.Function wines used as antirheumatic, spasmolysis, removing toxic substances.For rheumatism
Property arthritis, hypertension, child convulsion, postpartum exhausting, nettle rash, venomous snake bite.
Virgate lespedeza herb is legume lespedeza virgata Lespedeza virgata(Thunb.) DC. [Hedysarum
Virgatum Thunb.] herb.Taste is sweet；Micro-hardship；Property flat.Return spleen；Lung channel.Function clear heat diuresis；Preventing malaria.Main heatstroke；Urine
Unfavorable；Malaria；Flu；Hypertension.
Club bottle gourd pericarp another name ground Pu shell, flat Pu shell, for cucurbitaceous plant edible gourd Lagenaria siceraria (Molina)
Standl. the aging pericarp of Var. hispida (Thunb.) Hara.Bitter；Light；Cold in nature.Function inducing diuresis for removing edema.Interarea mesh
Four limbs edema；Expand；Urinary obstruction.
Samantabhadra dish another name Shi Gecai, mound breast bar, for crucifer manyleaf bittercress herb Cardamine macrophylla
Willd. herb.Taste is sweet；Light；Property flat.Function invigorating spleen for diuresis is subsided a swelling；Cooling blood and hemostasis.Main insufficiency of the spleen；Oedema；Difficult urination；Leukorrhea
Uterine bleeding；Hematuria.
The beneficial effects of the present invention is: Chinese medicine is combined by the present invention with Losartan, to avoid the common of Losartan
Angioedema, and improve the result for the treatment of to hypertension.Clinical test results shows: the oral present invention combines containing Losartan
The patient of thing, preliminary judgement is better than simple application Losartan person at the horizontal aspect that reduces blood pressure.It addition, the chloride sand of the present invention
Smooth pharmaceutical composition applies notable (the P ＜ of Losartan person's effect than simple in terms of improving Losartan medicament intravascular oedema
0.05).Illustrate that the present invention's truly has curative effect containing Losartan pharmaceutical composition at the aspect that reduces blood pressure, and it is little to have side effect
Advantage.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further described, in order to those skilled in the art knows more about
The present invention, but and it is not so limited the present invention.
Embodiment 1
A kind of pharmaceutical composition treating hypertension, is made up of the bulk drug of following weight:
Losartan 50g, blue or green fiber crops 3000g, wedelia chinensis 3000g, european grape stem and leaf 3000g, the Pu 3000g of living.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. green grass or young crops is lived fiber crops, wedelia chinensis, european grape stem and leaf, Pu boiling 2 times, add injection volume 7 amount water, decoction for the 1st time
1.5 hours, second time added injection volume 5 times amount water, decocts 1 hour, merged decoction liquor, standby；
B. by decoction liquor 60 DEG C, be condensed into the clear cream that relative density is 1.08 ~ 1.12 under the conditions of-0.06Mpa, add ethanol extremely
Alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear cream that relative density is 1.15 ~ 1.20, is spray-dried dry
Dry medicinal powder；
C. Losartan is mixed with dry medicinal powder, pelletize, obtain the active material of pharmaceutical composition of the present invention；
D. this active material adds injection volume xylitol, mannitol and β～cyclodextrin, and granule made in right amount by adhesive.
Prepare 1000 bags altogether, every bag of weight 5g.
Embodiment 2
A kind of pharmaceutical composition treating hypertension, is made up of the bulk drug of following weight:
Losartan 45g, blue or green fiber crops 3500g, wedelia chinensis 2500g, european grape stem and leaf 3500g, the Pu 2500g of living.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. green grass or young crops is lived fiber crops, wedelia chinensis, european grape stem and leaf, Pu boiling 2 times, add injection volume 8 amount water, decoction 2 for the 1st time
Hour, second time adds injection volume 6 times amount water, decocts 1.5 hours, merges decoction liquor, standby；
B. by decoction liquor 55 DEG C, be condensed into the clear cream that relative density is 1.08 ~ 1.12 under the conditions of-0.08Mpa, add ethanol extremely
Alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear cream that relative density is 1.15 ~ 1.20, is spray-dried dry
Dry medicinal powder；
C. Losartan is mixed with dry medicinal powder, pelletize, obtain the active material of pharmaceutical composition of the present invention；
D. this active material adds injection volume xylitol, mannitol and β～cyclodextrin, granule made in right amount by adhesive.
Prepare 1000 bags altogether, every bag of weight 5g.
Embodiment 3
A kind of pharmaceutical composition treating hypertension, is made up of the bulk drug of following weight:
Losartan 55g, blue or green fiber crops 2500g, wedelia chinensis 3500g, european grape stem and leaf 2500g, the Pu 3500g of living.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. green grass or young crops is lived fiber crops, wedelia chinensis, european grape stem and leaf, Pu boiling 2 times, add injection volume 6 amount water, decoction 1 for the 1st time
Hour, second time adds injection volume 4 times amount water, decocts 0.5 hour, merges decoction liquor, standby；
B. by decoction liquor 65 DEG C, be condensed into the clear cream that relative density is 1.08 ~ 1.12 under the conditions of-0.04Mpa, add ethanol extremely
Alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear cream that relative density is 1.15 ~ 1.20, is spray-dried dry
Dry medicinal powder；
C. Losartan is mixed with dry medicinal powder, pelletize, obtain the active material of pharmaceutical composition of the present invention；
D. this active material adds injection volume xylitol, mannitol and β～cyclodextrin, and granule made in right amount by adhesive.
Prepare 1000 bags altogether, every bag of weight 5g.
Embodiment 4
A kind of pharmaceutical composition treating hypertension, is made up of the bulk drug of following weight:
Losartan 40g, blue or green fiber crops 4000g, wedelia chinensis 4000g, european grape stem and leaf 4000g, the Pu 4000g of living.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. green grass or young crops is lived fiber crops, wedelia chinensis, european grape stem and leaf, Pu boiling 2 times, add injection volume 7 amount water, decoction for the 1st time
1.5 hours, second time added injection volume 5 times amount water, decocts 1 hour, merged decoction liquor, standby；
B. by decoction liquor 60 DEG C, be condensed into the clear cream that relative density is 1.08 ~ 1.12 under the conditions of-0.06Mpa, add ethanol extremely
Alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear cream that relative density is 1.15 ~ 1.20, is spray-dried dry
Dry medicinal powder；
C. Losartan is mixed with dry medicinal powder, pelletize, obtain the active material of pharmaceutical composition of the present invention；
D. this active material adds injection volume xylitol, mannitol and β～cyclodextrin, and granule made in right amount by adhesive.
Prepare 1000 bags altogether, every bag of weight 5g.
Embodiment 5
A kind of pharmaceutical composition treating hypertension, is made up of the bulk drug of following weight:
Losartan 60g, blue or green fiber crops 2000g, wedelia chinensis 2000g, european grape stem and leaf 2000g, the Pu 2000g of living.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. green grass or young crops is lived fiber crops, wedelia chinensis, european grape stem and leaf, Pu boiling 2 times, add injection volume 7 amount water, decoction for the 1st time
1.5 hours, second time added injection volume 5 times amount water, decocts 1 hour, merged decoction liquor, standby；
B. by decoction liquor 60 DEG C, be condensed into the clear cream that relative density is 1.08 ~ 1.12 under the conditions of-0.06Mpa, add ethanol extremely
Alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear cream that relative density is 1.15 ~ 1.20, is spray-dried dry
Dry medicinal powder；
C. Losartan is mixed with dry medicinal powder, pelletize, obtain the active material of pharmaceutical composition of the present invention；
D. this active material adds injection volume xylitol, mannitol and β～cyclodextrin, and granule made in right amount by adhesive.
Prepare 1000 bags altogether, every bag of weight 5g.
The pharmaceutical composition containing Losartan of embodiment 1 preparation has been carried out clinical testing, and result is as follows:
1. data and method
1.1 research object
100 example primary hypertension patients have been selected in present study, all meet WHO diagnostic criteria in 1999, and meet with
Lower condition: make a definite diagnosis the most for the first time or make a definite diagnosis and do not treat and shrink pressure >=140mmHg, diastolic pressure >=90mmHg less than half a year；2. without
Serious acute and chronic complication.Qualified 100 example patients are randomly divided into observation group and control group, often organize 50 examples.Two groups of trouble
Person in terms of 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: applying losartan treatment on the basis of patient carries out hypertension health knowledge education, Losartan is each
50mg, every day 1 time.2. observation group: use in conjunction contains chlorine on the basis of patient is carried out hypertension health knowledge education
The pharmaceutical composition of Sha Tan, each 1 bag, every day 1 time.Two groups all with 1 Zhou Weiyi treatment stage.
1.3 observation index
1. safety indexes: such as routine blood test, stool routine examination, liver function, kidney function test, electrocardiogram etc.；2. health giving quality index: control
Blood pressure level before and after treatment, blood pressure normalization rate (shrinks pressure≤120mmHg, diastolic pressure≤90mmHg)；3. angioneurotic edema is sent out
Raw situation.
1.4 statistical method
SPSS17.0 is used to carry out the statistical analysis of data.Measurement data uses t inspection (with mean ± standard deviation table
Show)；Grouped data uses χ2Inspection, using P≤0.05 as statistically significant, using P≤0.01 as there being height statistics
Learn meaning.
2. result
2.1 clinical efficacy results
Treat contraction pressure and the diastolic pressure level comparing difference not statistically significant (P > 0.05) of first two groups;After treatment two groups
Shrinking before pressure is the most relatively treated with diastolic pressure level and substantially reduce, difference has statistical significance (P < 0.05);Observation group patient exists
Shrinking pressure and diastolic pressure improves degree aspect and is substantially better than control group, difference has statistical significance (P < 0.05)；Observation group controls
Blood pressure normalization rate 96.0%(48/50 after treatment) apparently higher than the 76.0%(38/50 of control group), difference have statistical significance (P <
0.05);It is shown in Table 1.
1 liang of table group patient clinical comparitive study
| Group | Number of cases | Time | Shrink pressure (mmHg) | Diastolic pressure (mmHg) |
| Observation group | 50 | Before treatment | 166.32±14.21 | 118.88±11.41 |
| After treatment | 104.47±9.54*# | 70.15±4.58*# | ||
| Control group | 50 | Before treatment | 166.34±14.32 | 118.83±11.42 |
| After treatment | 123.71±11.56* | 99.26±5.47* |
Note: * represent with treatment before compare P < 0.05;# represents and compares P < 0.05 after treatment of control group
2.2 safety observations results
In this test, whole experimenters carry out safety indexes detection before and after treatment respectively, and result does not finds the most abnormal changing
Become, illustrate that the pharmaceutical composition containing Losartan of the present invention uses safety.
A situation arises for 2.3 angioneurotic edemas
In this research the angioneurotic edema incidence of observation group be significantly lower than control group, difference have statistical significance (P <
0.05) 2, it are shown in Table.
2 liang of table group angioneurotic edema incidence
| Group | Number of cases | Facial edema | Lip oedema | Edema of the tongue | Incidence |
| Observation group | 50 | 0 | 0 | 0 | 0(0.0%) |
| Control group | 50 | 4 | 3 | 2 | 9(18.0%) |
3. conclusion
Chinese medicine is combined by the present invention with Losartan, to avoid the common angioneurotic edema of Losartan, and improve right
The result for the treatment of of hypertension.Clinical test results shows: the oral present invention patient containing Losartan composition, preliminary judgement is in control
Blood pressure level aspect processed is better than simple application Losartan person.It addition, the present invention's is improving chlorine containing Losartan pharmaceutical composition
Husky smooth medicament intravascular nervous edema aspect is more notable (P ＜ 0.05) than simple application Losartan person's effect.Illustrate the present invention's
Safe and effective at the aspect that reduces blood pressure containing Losartan pharmaceutical composition, and there is the advantage that side effect is little.
Claims (7)
1. a pharmaceutical composition for the treatment hypertension containing Losartan, is made up of the bulk drug of following weight: chlorine
Husky smooth 40-60 part, blue or green live fiber crops 2000-4000 part, wedelia chinensis 2000-4000 part, european grape stem and leaf 2000-4000 part, Pu
2000-4000 part.
2. the pharmaceutical composition of the treatment hypertension containing Losartan as claimed in claim 1, it is characterised in that by as follows
The bulk drug composition of weight: Losartan 45-55 part, blue or green fiber crops 2500-3500 part, wedelia chinensis 2500-3500 part, the Portugal of living
Grape rattan leaf 2500-3500 part, Pu 2500-3500 part.
3. the pharmaceutical composition of the treatment hypertension containing Losartan as claimed in claim 2, it is characterised in that by as follows
The bulk drug composition of weight: Losartan 50 parts, the blue or green fiber crops 3000 parts that live, wedelia chinensis 3000 parts, european grape stem and leaf 3000 parts,
Pu 3000 parts.
4. the pharmaceutical composition of the treatment hypertension containing Losartan as described in claim 1 or 2 or 3, it is characterised in that its
Dosage form is granule.
5. the preparation method of the pharmaceutical composition of the treatment hypertension containing Losartan described in claim 1 or 2 or 3, comprises
Following steps:
A. green grass or young crops is lived fiber crops, wedelia chinensis, european grape stem and leaf, Pu boiling 2 times, add injection volume 6 ~ 8 times amount water for the 1st time, pan-fried
Boiling 1 ~ 2 hour, second time adds injection volume 4 ~ 6 times amount water, decocts 0.5 ~ 1.5 hour, merges decoction liquor, standby；
B. by decoction liquor 55 ~ 65 DEG C, be condensed under the conditions of-0.04 ~-0.08Mpa relative density be 1.08 ~ 1.12 clear
Cream, adding ethanol to alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear cream that relative density is 1.15 ~ 1.20, spray
Mist is dried, and obtains dry medicinal powder；
C. Losartan is mixed with dry medicinal powder, pelletize, obtain the active material of pharmaceutical composition of the present invention；
D. this active material individually or mixes with pharmaceutically acceptable auxiliary material, prepares according to galenic pharmacy conventional method.
6. the preparation method of the pharmaceutical composition of the treatment hypertension containing Losartan as claimed in claim 5, its feature exists
In,
Adding injection volume 7 times amount water 1st time in institute's portion's step a, decoct 1.5 hours, second time adds injection volume 5 times amount
Water, decocts 1 hour；In described step b, thickening temperature is 60 DEG C, to concentrate pressure be-0.06Mpa.
7. the preparation method of the pharmaceutical composition of the treatment hypertension containing Losartan as claimed in claim 5, detailed step
As follows:
A. green grass or young crops is lived fiber crops, wedelia chinensis, european grape stem and leaf, Pu boiling 2 times, add injection volume 7 times amount water, decoction for the 1st time
1.5 hours, second time added injection volume 5 times amount water, decocts 1 hour, merged decoction liquor, standby；
B. by decoction liquor 60 DEG C, be condensed into the clear cream that relative density is 1.08 ~ 1.12 under the conditions of-0.06Mpa, add ethanol extremely
Alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear cream that relative density is 1.15 ~ 1.20, is spray-dried, obtains dry
Dry medicinal powder；
C. Losartan is mixed with dry medicinal powder, pelletize, obtain the active material of pharmaceutical composition of the present invention；
D. this active material individually or mixes with pharmaceutically acceptable auxiliary material, prepares according to galenic pharmacy conventional method.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610175854.2A CN105770220A (en) | 2016-03-27 | 2016-03-27 | Pharmaceutical composition containing losartan and capable of treating hypertension and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610175854.2A CN105770220A (en) | 2016-03-27 | 2016-03-27 | Pharmaceutical composition containing losartan and capable of treating hypertension and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105770220A true CN105770220A (en) | 2016-07-20 |
Family
ID=56390930
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610175854.2A Withdrawn CN105770220A (en) | 2016-03-27 | 2016-03-27 | Pharmaceutical composition containing losartan and capable of treating hypertension and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105770220A (en) |
-
2016
- 2016-03-27 CN CN201610175854.2A patent/CN105770220A/en not_active Withdrawn
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