CN105770205A - Pharmaceutical composition containing felodipine and capable of treating hypertension and preparation method thereof - Google Patents
Pharmaceutical composition containing felodipine and capable of treating hypertension and preparation method thereof Download PDFInfo
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- CN105770205A CN105770205A CN201610175849.1A CN201610175849A CN105770205A CN 105770205 A CN105770205 A CN 105770205A CN 201610175849 A CN201610175849 A CN 201610175849A CN 105770205 A CN105770205 A CN 105770205A
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- felodipine
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- 229940079827 sodium hydrogen sulfite Drugs 0.000 description 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
- 239000001540 sodium lactate Substances 0.000 description 1
- 229940005581 sodium lactate Drugs 0.000 description 1
- 235000011088 sodium lactate Nutrition 0.000 description 1
- 235000010262 sodium metabisulphite Nutrition 0.000 description 1
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 description 1
- 229940001474 sodium thiosulfate Drugs 0.000 description 1
- 235000019345 sodium thiosulphate Nutrition 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229940045136 urea Drugs 0.000 description 1
- 210000003462 vein Anatomy 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
Classifications
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/238—Saposhnikovia
-
- 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)
- A61K36/36—Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
-
- 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)
- A61K36/59—Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
-
- 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)
- A61K36/85—Verbenaceae (Verbena family)
- A61K36/855—Clerodendrum, e.g. glorybower
-
- 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
-
- 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
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- 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
- A61K2236/50—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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- Health & Medical Sciences (AREA)
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Abstract
The invention belongs to the technical field of medicine and particularly relates to a pharmaceutical composition containing felodipine and capable of treating hypertension and a preparation method thereof. The pharmaceutical composition containing the felodipine and capable of treating hypertension is prepared from the following active pharmaceutical ingredients in parts by weight: 3-7 parts of felodipine, 2000-4000 parts of Goblin grass, 2000-4000 parts of clerodendrum yunnanense, 2000-4000 parts of Radix Saposhnikoviae and 2000-4000 parts of Radix Stephaniae Tetrandrae. According to the pharmaceutical composition, traditional Chinese medicines are combined with the felodipine, so that common adverse reactions of the felodipine 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 drug regimen of a kind for the treatment of hypertension containing felodipine
Thing 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。
Felodipine is clinical conventional selective cerebrocrast, the main outer calcium of suppression parteriole smooth muscle cell
Interior stream, selectively expansion parteriole, act on without this vein, do not cause postural hypotension, to cardiac muscle also without substantially suppressing to make
With, can be used in combination with other antihypertensive drugs.But, the side effect of long-term taking felodipine is the biggest to the injury of human body.
Allow most people has a headache is possible to cause allergic reaction, mainly shows as allergic hepatitis, fash, itch, even exfoliative dermatitis
Deng.This bad reaction limits felodipine in clinical use.
Summary of the invention
In order to solve the technical problem of felodipine side effect big restriction use crowd, the invention provides ground, a kind of non-Lip river
The flat composition with Chinese medicine, by the compatibility with Chinese medicine, alleviates the bad reaction of felodipine, thus realizes attenuation synergistic
Purpose.
The present invention is to be realized by following technical scheme:
The pharmaceutical composition of a kind for the treatment of hypertension containing felodipine, is made up of the bulk drug of following weight proportion: non-Lip river
Horizon 3-7 part, cliff starwort herb 2000-4000 part, clerodendron yunnanensis Hu 2000-4000 part, windproof 2000-4000 part, root of fangji 2000-4000
Part.
The pharmaceutical composition of the above-mentioned treatment hypertension containing felodipine, its weight is preferably: ground, non-Lip river
Flat 4-6 part, cliff starwort herb 2500-3500 part, clerodendron yunnanensis Hu 2500-3500 part, windproof 2500-3500 part, root of fangji 2500-3500 part.
The pharmaceutical composition of the above-mentioned treatment hypertension containing felodipine, its weight most preferably: non-Lip river ground
Flat 5 parts, cliff starwort herb 3000 parts, clerodendron yunnanensis Hu 3000 parts, windproof 3000 parts, the root of fangji 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 felodipine, comprises the steps of:
A. by cliff starwort herb, clerodendron yunnanensis Hu, windproof, root of fangji boiling 2 times, injection volume 6 ~ 8 times amount water is added the 1st time, decoct 1 ~
2 hours, second time added injection volume 4 ~ 6 times amount water, decocts 0.5 ~ 1.5 hour, merged 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. felodipine 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 felodipine, in described step a the 1st
Secondary addition injection volume 7 times amount water, decocts 1.5 hours, and second time adds injection volume 5 times amount water, decocts 1 hour；Described step
In rapid b, thickening temperature is 60 DEG C, to concentrate pressure be-0.06Mpa.
Preferably, stating the preparation method of the pharmaceutical composition for the treatment of hypertension containing felodipine, detailed step is as follows:
A. by cliff starwort herb, clerodendron yunnanensis Hu, windproof, root of fangji boiling 2 times, add injection volume 7 times amount water the 1st time, decoct 1.5
Hour, second time adds injection volume 5 times amount water, decocts 1 hour, merges 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. felodipine 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 in pregnant woman.
In the pharmaceutical composition of the treatment hypertension of the felodipine of the present invention,
Cliff starwort herb another name muscles and bones dish (" mount emei medicine is planted "), single notopodium, Qing Gucao, gold twine dish (" survey report planted by Kunming medicine "), take out
Muscle grass, coverlet grass, Yunnan chickweed (" Yunnan Chinese herbal medicine ").Derive from the herb for the raw chickweed of pinkwort stone.Peppery, cool.Function
Clearing liver-fire for calming endogenous wind.Control liver public attention Pu, aphasia from apoplexy, facial paralysis, child convulsion.
Clerodendron yunnanensis Hu another name clerodendrum bungei, the short seeds of a tung oil tree, fragrant glorybower root or leaf, Craigia yunnanensis, derive from Verenaceae paulownia platymiscium clerodendron yunnanensis Hu
Clerodendron yunnanense Hu ex Hand.-Mazz., is used as medicine with root and leaf.Taste is pungent, warm in nature.Function is only dispeled the wind
Bitterly, hypotensive.Root: for rheumatic arthritis, pain in waist and lower extremities, hypertension.Leaf: hemorrhoid, prolapse of the anus are controlled in external application.
Windproof another name copper rue, Hui Yun, return grass, hundred, hundred kinds, screen, wind meat, for umbelliferae Saposhnikovia divaricata
Saposhnikouia diuaricata (Turcz.) Schis-chk.[Stenocoelium diuaricatum Turcz.;
Siler diuaricatum (Tur-cz.) Benth. Et Hoo. F. ; Ledebouriella seseloides
Auct. Non Wolff;L.diuaricata (Turcz) Hiroe] root.Taste is pungent；Sweet；Slightly warm in nature.Return bladder；Lung；Spleen；
Liver Channel.Function expels pathogenic wind from the body surface；Win wet pain relieving；Spasmolysis；Antipruritic.Master catches cold；Headache bodily pain；Arthralgia due to wind-dampness；Joint is ached；Abdomen
Pain is had loose bowels；Discharging fresh blood stool；Lockjaw；Rubella itch；Sore from the beginning of.
Root of fangji another name dissociates (" herbal classic "), carries monarch's row (" book on Chinese herbal medicine covers bamboo fish trap "), stone solution (" detailed outline ").Source is menispermaceous plants
Fourstamen Stephania Root, Cocculus trilobus and aristolochiaceae plant Aristolochia fangchi, the root of radix aristolochiae heterophyllae.Bitter, cold in nature.Enter liver,spleen,kidney three warp.Merit
Water can be manageed it, rush down damp-heat in lower-JIAO.Harnessing the river swollen tympanites, hygropyretic beriberi, brothers' contraction pain, tinea scabies swells.
The beneficial effects of the present invention is: Chinese medicine is combined by the present invention with felodipine, to avoid felodipine
Common allergic reaction, and improve the result for the treatment of to hypertension.Clinical test results shows: the oral present invention is containing felodipine
The patient of composition, preliminary judgement is better than simple application felodipine person at the horizontal aspect that reduces blood pressure.It addition, the present invention
Show than simple application felodipine person's effect in terms of improving felodipine drug anaphylaxis containing felodipine pharmaceutical composition
Write (P ＜ 0.05).Illustrate that the present invention's truly has curative effect containing felodipine pharmaceutical composition at the aspect that reduces blood pressure, and have
The advantage that side effect is little.
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:
Felodipine 5g, cliff starwort herb 3000g, clerodendron yunnanensis Hu 3000g, windproof 3000g, root of fangji 3000g.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by cliff starwort herb, clerodendron yunnanensis Hu, windproof, root of fangji boiling 2 times, add injection volume 7 amount water the 1st time, decoct 1.5 little
Time, second time adds injection volume 5 times amount water, decocts 1 hour, merges 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. felodipine 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:
Felodipine 4g, cliff starwort herb 3500g, clerodendron yunnanensis Hu 2500g, windproof 3500g, root of fangji 2500g.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by cliff starwort herb, clerodendron yunnanensis Hu, windproof, root of fangji boiling 2 times, add injection volume 8 amount water, decoct 2 hours for the 1st time,
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. felodipine 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:
Felodipine 6g, cliff starwort herb 2500g, clerodendron yunnanensis Hu 3500g, windproof 2500g, root of fangji 3500g.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by cliff starwort herb, clerodendron yunnanensis Hu, windproof, root of fangji boiling 2 times, add injection volume 6 amount water, decoct 1 hour for the 1st time,
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. felodipine 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:
Felodipine 3g, cliff starwort herb 4000g, clerodendron yunnanensis Hu 4000g, windproof 4000g, root of fangji 4000g.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by cliff starwort herb, clerodendron yunnanensis Hu, windproof, root of fangji boiling 2 times, add injection volume 7 amount water the 1st time, decoct 1.5 little
Time, second time adds injection volume 5 times amount water, decocts 1 hour, merges 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. felodipine 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:
Felodipine 7g, cliff starwort herb 2000g, clerodendron yunnanensis Hu 2000g, windproof 2000g, root of fangji 2000g.
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by cliff starwort herb, clerodendron yunnanensis Hu, windproof, root of fangji boiling 2 times, add injection volume 7 amount water the 1st time, decoct 1.5 little
Time, second time adds injection volume 5 times amount water, decocts 1 hour, merges 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. felodipine 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 felodipine of embodiment 1 preparation has been carried out clinical testing, and result is as follows:
1. data and method
1.1 research object
80 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 80 example patients are randomly divided into observation group and control group, often organize 40 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: apply felodipine treatment, felodipine on the basis of patient is carried out hypertension health knowledge education
5mg, every day 2 times every time.2. observation group: use in conjunction contains on the basis of patient is carried out hypertension health knowledge education
The pharmaceutical composition of felodipine, each 1 bag, every day 2 times.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. allergic reaction generation feelings
Condition.
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 95.0%(38/40 after treatment) apparently higher than the 65.0%(26/40 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 | 40 | Before treatment | 164.51±14.45 | 117.51±11.95 |
| After treatment | 101.42±9.95*# | 70.11±4.57*# | ||
| Control group | 40 | Before treatment | 164.52±14.47 | 117.53±11.88 |
| After treatment | 121.72±11.72* | 99.56±5.59* |
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 felodipine 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 significantly lower than control group, and difference has statistical significance (P < 0.05),
It is shown in Table 2.
2 liang of table group allergic reaction incidence
| Group | Number of cases | Fash | Itch | Exfoliative dermatitis | Allergic hepatitis | Incidence |
| Observation group | 40 | 0 | 0 | 0 | 0 | 0(0.0%) |
| Control group | 40 | 4 | 3 | 3 | 0 | 10(25.0%) |
3. conclusion
Chinese medicine is combined by the present invention with felodipine, to avoid the common allergic reaction of felodipine, and improves height
The result for the treatment of of blood pressure.Clinical test results shows: the oral present invention patient containing felodipine composition, preliminary judgement is in control
Blood pressure level aspect processed is better than simple application felodipine person.It addition, the present invention's is changing containing felodipine pharmaceutical composition
Kind felodipine drug anaphylaxis aspect is more notable (P ＜ 0.05) than simple application felodipine person's effect.The present invention is described
Safe and effective at the aspect that reduces blood pressure containing felodipine pharmaceutical composition, and there is the advantage that side effect is little.
Claims (7)
1. a pharmaceutical composition for the treatment hypertension containing felodipine, is made up of the bulk drug of following weight:
Felodipine 3-7 part, cliff starwort herb 2000-4000 part, clerodendron yunnanensis Hu 2000-4000 part, windproof 2000-4000 part, root of fangji 2000-
4000 parts.
2. the pharmaceutical composition of the treatment hypertension containing felodipine as claimed in claim 1, it is characterised in that by such as
Lower weight bulk drug composition: felodipine 4-6 part, cliff starwort herb 2500-3500 part, clerodendron yunnanensis Hu 2500-3500 part,
Windproof 2500-3500 part, root of fangji 2500-3500 part.
3. the pharmaceutical composition of the treatment hypertension containing felodipine as claimed in claim 2, it is characterised in that by such as
The bulk drug composition of lower weight: felodipine 5 parts, cliff starwort herb 3000 parts, clerodendron yunnanensis Hu 3000 parts, windproof 3000 parts, anti-
Oneself is 3000 parts.
4. the pharmaceutical composition of the treatment hypertension containing felodipine 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 felodipine described in claim 1 or 2 or 3, bag
Containing following steps:
A. by cliff starwort herb, clerodendron yunnanensis Hu, windproof, root of fangji boiling 2 times, injection volume 6 ~ 8 times amount water is added the 1st time, decoct 1 ~
2 hours, second time added injection volume 4 ~ 6 times amount water, decocts 0.5 ~ 1.5 hour, merged 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. felodipine 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 felodipine as claimed in claim 5, its feature
It is,
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 felodipine as claimed in claim 5, walks in detail
Rapid as follows:
A. by cliff starwort herb, clerodendron yunnanensis Hu, windproof, root of fangji boiling 2 times, add injection volume 7 times amount water the 1st time, decoct 1.5
Hour, second time adds injection volume 5 times amount water, decocts 1 hour, merges 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. felodipine 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 |
|---|---|---|---|
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| Application Number | Priority Date | Filing Date | Title |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11998825B2 (en) | 2018-10-31 | 2024-06-04 | Net World Sports Limited | Lifting and transporting assembly for lifting and transporting a goal |
-
2016
- 2016-03-27 CN CN201610175849.1A patent/CN105770205A/en not_active Withdrawn
Non-Patent Citations (1)
| Title |
|---|
| 陈吉生主编: "《新编临床药物学》", 31 August 2013, 中国中医药出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11998825B2 (en) | 2018-10-31 | 2024-06-04 | Net World Sports Limited | Lifting and transporting assembly for lifting and transporting a goal |
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