CN105687451A - Lercanidipine containing pharmaceutical composition for treating hypertension and preparation method thereof - Google Patents
Lercanidipine containing pharmaceutical composition for treating hypertension and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the technical field of medicines and particularly relates to a lercanidipine containing pharmaceutical composition for treating hypertension and a preparation method thereof. The lercanidipine containing pharmaceutical composition for treating the hypertension, provided by the invention, is prepared from the following raw pharmaceutical materials in parts by weight: 8-12 parts of lercanidipine, 2,000-4,000 parts of Apocynum venetum, 2,000-4,000 parts of Lagotis brachystachya, 2,000-4,000 parts of ganoderma lucidum and 2,000-4,000 parts of Elatostema involucratum. According to the lercanidipine containing pharmaceutical composition for treating the hypertension and the preparation method thereof, the traditional Chinese medicines and the lercanidipine are combined, so that common adverse reactions of the lercanidipine can be avoided, and the treatment effect on the hypertension is improved.
Description
Technical field
The invention belongs to pharmaceutical technology field, be specifically related to a kind of pharmaceutical composition for the treatment of hypertension containing lercanidipine and preparation method thereof。
Background technology
Hypertension is Important cause of disease and the risk factor 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 apoplexy, heart failure, end stagerenaldisease。Essential hypertension accounts for the 95% of hypertension incidence, and the investigation of 2002 is shown in more than 18 years old prevalence of China up to 18.8%, and number of patients reaches 1.6 hundred million。Therefore the prevention of hypertension and treatment, becomes China and great public health problem that the whole world is paid close attention to the most。
The Therapeutic Method of current hypertension is except changing living habit, and topmost effective prevention method is exactly that furuncle controlled by medicine, and antihypertensive drugs conventional at present is divided into 5 classes, clinically alone the and drug combination two class scheme of main employing。But antihypertensive drugs still has a lot of bad compliance asking untoward reaction, drug resistance phenomenon and patient that such as Long-term taking medicine causes in clinical application。There are some researches show that the patient accepting Drug therapy only has 53% successfully to control blood pressure, make controlling of blood pressure at≤140/90mmHg。
Lercanidipine is the calcium-channel antagonists of clinical conventional treatment hypertension。This product is applicable to various types of hypertension, intractable, severe hypertension is also had good therapeutic effect, can be used in combination with other antihypertensive drugs。But, the side effect of long-term taking lercanidipine is also very big to the injury of human body。What allow people has a headache most is the vasodilation impact that may result in popularity, and main manifestations be dizzy, headache, and generate heat sense, flushed face in the afternoon, pedal edema and fluid retention etc.。This untoward reaction limits lercanidipine in clinical use。
Summary of the invention
In order to solve the technical problem of the big restriction use crowd of lercanidipine side effect, the invention provides the compositions of a kind of lercanidipine and Chinese medicine, by the compatibility with Chinese medicine, alleviate the untoward reaction of lercanidipine, thus realizing the purpose of attenuation synergistic。
The present invention is realized by following technical scheme:
The pharmaceutical composition of a kind for the treatment of hypertension containing lercanidipine, is made up of the crude drug of following weight proportion: lercanidipine 8-12 part, Herba Apocyni veneti 2000-4000 part, Lagotis brachystachya Maxim. 2000-4000 part, Ganoderma 2000-4000 part, Zlatostema involucratum Franch. Et savat. 2000-4000 part。
The pharmaceutical composition of the above-mentioned treatment hypertension containing lercanidipine, its weight is preferably: lercanidipine 9-11 part, Herba Apocyni veneti 2500-3500 part, Lagotis brachystachya Maxim. 2500-3500 part, Ganoderma 2500-3500 part, Zlatostema involucratum Franch. Et savat. 2500-3500 part。
The pharmaceutical composition of the above-mentioned treatment hypertension containing lercanidipine, its weight the best is: lercanidipine 10 parts, Herba Apocyni veneti 3000 parts, Lagotis brachystachya Maxim. 3000 parts, Ganoderma 3000 parts, Zlatostema involucratum Franch. Et savat. 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 because varying in size of preparation can be made into 100-1000 agent。Described 100-1000 agent refers to the dosage form of unit dose, such as tablet 100-1000 sheet, capsule 100-1000 grain, granule l00-1000g, oral liquid l00-l000ml, unguentum 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 large-scale production can in units of kg, or with t(ton) for unit；Preparation can also 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 serious symptom or mild, fat or modest patient, it is possible to the proportioning of the corresponding amount adjusting composition, increases or reduces less than 100%, and drug effect is basically unchanged。
The pharmaceutical composition of the present invention, individually or as required can add some pharmaceutically acceptable adjuvants of injection volume, it is possible to adopt galenic pharmacy routine techniques to prepare this pharmaceutical preparation, as mixed with pharmaceutically acceptable adjuvant by pharmaceutically active substance。Can make any pharmaceutically useful peroral dosage form when making pharmaceutical preparation, these dosage forms are selected from: granule, tablet, capsule, oral liquid, suck agent, pill, powder, it is preferred that granule。
The preparation method of the pharmaceutical composition of the above-mentioned treatment hypertension containing lercanidipine, comprises the steps of:
A. by Herba Apocyni veneti, Lagotis brachystachya Maxim., Ganoderma, Zlatostema involucratum Franch. Et savat. boiling 2 times, adding injection volume 6 ~ 8 times amount water, decocts 1 ~ 2 hour for the 1st time, second time adds injection volume 4 ~ 6 times amount water, decocts 0.5 ~ 1.5 hour, and merging decoction liquor is standby；
B. by decoction liquor 55 ~ 65 DEG C, be condensed into the clear paste that relative density is 1.08 ~ 1.12 under-0.04 ~-0.08Mpa condition, adding ethanol to alcohol content is 75%, places 12 hours, filters, filtrate is concentrated into the clear paste that relative density is 1.15 ~ 1.20, and spray drying must dry medicated powder；
C. by lercanidipine and the mixing of dry medicated powder, granulate, obtain the active substance of pharmaceutical composition of the present invention；
D. this active substance individually or mixes with pharmaceutically acceptable adjuvant, prepares according to galenic pharmacy conventional method。
In the preparation method of the pharmaceutical composition of the above-mentioned treatment hypertension containing lercanidipine, adding injection volume 7 times amount water the 1st time, decoct 1.5 hours in described step a, second time adds injection volume 5 times amount water, decocts 1 hour；In described step b thickening temperature be 60 DEG C, concentration pressure be-0.06Mpa。
Preferably, the preparation method stating the pharmaceutical composition for the treatment of hypertension containing lercanidipine, detailed step is as follows:
A. by Herba Apocyni veneti, Lagotis brachystachya Maxim., Ganoderma, Zlatostema involucratum Franch. Et savat. boiling 2 times, adding injection volume 7 times amount water, decocts 1.5 hours for the 1st time, second time adds injection volume 5 times amount water, decocts 1 hour, and merging decoction liquor is standby；
B. by decoction liquor 60 DEG C, be condensed into the clear paste that relative density is 1.08 ~ 1.12 under-0.06Mpa condition, adding ethanol to alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear paste that relative density is 1.15 ~ 1.20, and spray drying must dry medicated powder；
C. by lercanidipine and the mixing of dry medicated powder, granulate, obtain the active substance of pharmaceutical composition of the present invention；
D. this active substance individually or mixes with pharmaceutically acceptable adjuvant, prepares according to galenic pharmacy conventional method。
Described pharmaceutically acceptable adjuvant is selected from: starch, magnesium stearate, mannitol, sorbitol, sorbic acid or potassium salt, sodium pyrosulfite, sodium sulfite, 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 aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, dextran, glycine, lactose, mannitol, silicon derivative, cellulose and its derivates, alginate, gelatin, polyvinylpyrrolidone, glycerol, propylene glycol, ethanol, polysorbate60～80, Span～80, Cera Flava, lanoline, liquid paraffin, hexadecanol, gallate ester, triethanolamine, basic amino acid, carbamide, allantoin, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, β～cyclodextrin, phospholipid material, Kaolin, Pulvis Talci, calcium stearate etc.。
The present invention treat hypertension pharmaceutical composition be applicable to various types of hypertension, intractable, severe hypertension are also had 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。Usual initial dose be one time 1 bag, 2 times on the one；Take with meal。
The present invention treat the pharmaceutical composition of hypertension disable in: dihydropyridines allergy sufferers is disabled；Left ventricle spreads out of channel blocking, untreated congestive heart failure, unstable angina pectoris, has serious kidney or hepatic disease and occurred the patient of myocardial infarction to disable in one month；Gestation and women breast-feeding their children, do not take the women at advanced age of any contraceptives；Under-18s patient must not take disabling。
In the pharmaceutical composition of the present invention,
Herba Apocyni veneti another name Ji Jima, Gaster caprae seu Ovis draw angle, Semen astragali sinici, wild tea, Herba Euphorbiae Helioscopiae fiber crops, bluish dogbane, ambary, lanceolata bluish dogbane, little Hua wild flax, open country Folium Camelliae sinensis, draft Folium seu Cortex Nerii, little Hua Herba Apocyni veneti, red building, Herba Euphorbiae Helioscopiae, salt willow, Wild Willow tree, for apocynaceae plant Herba Apocyni veneti ApocynumvenetumL. [Trachomitumvenetum(L.) Woodsom;ApocynumlancifolicumRussan.] leaf。Sweet in the mouth；Micro-hardship；Cool in nature。Function heat clearing away suppressing the hyperactive liver；Inducing diuresis to remove edema。Main hypertension；Dizziness；Headache；Cardiopalmus；Insomnia；Edema urine water。
Lagotis brachystachya Maxim. is the herb of goatweed Lagotis brachystachya Maxim. LagotisbrachystachyaMaxim.。Bitter in the mouth；Cool in nature。Return lung；Liver Channel。Function clearing away lung-heat to relieve cough；Blood pressure lowering regulating menstruation。Main cough due to lung-heat；Hypertension；Menoxenia。
Ganoderma another name three shows, mattress, sesame, Ganoderma lucidum seu Japonicum, Ganoderma Lucidum, Ganoderma, sporophore for On Polyporaceae Ganoderma Ganodermalucidum (Leyss.exFr.) Karst., Ganoderma GanodermasinenseZhao, XuetZhang [G.japonicum (Fr.) Lloyd] etc.。Sweet in the mouth；Property is put down；Nontoxic, return lung；The heart；Spleen；Kidney channel。Function replenishing QI and blood；Tranquilizing mind；Strengthening the spleen and stomach。Main asthenia；Cardiopalmus；Insomnia；Dizzy；Spiritlessness and weakness；Chronic cough is panted；Coronary heart disease；Silicosis；Tumor。
Zlatostema involucratum Franch. Et savat. call thin Herba Pileae Notatae (Herba Oreocnides frutescentis), stone limit adopt, Herba Elatostematis Involucrati, half of mountain, half of umbrella, to always tender, hail is careless, cold water is careless, Long Hanzhu, Radix Cynanchi Paniculati, Hippocampus containing pearl, water Folium Sesami, Herba Thalictri elati, big Elatostema umbellatum, Semen Hoveniae (Fructus Hoveniae) seven, for the herb of contrayerva Zlatostema involucratum Franch. Et savat. ElatostemainvolucratumFranch.Franch.etSav. [E.umbellatum (S.et.z.) Bl.var.majusMaxim.]。Mildly bitter flavor；Cold nature。Return large intestine；Liver；Spleen channel。Function heat-clearing and toxic substances removing；Expelling wind and removing dampness；Inducing diuresis to remove edema；Promoting blood circulation and stopping pain。Main dysentery；Hyperpyrexia and infantile convulsion；Yellow cellulitis；Rheumatic arthralgia；Edema；Stranguria；Amenorrhea；Skin ulcer swells；Mumps；Herpes zoster；Venom；Traumatic injury；Fracture。
The beneficial effects of the present invention is: Chinese medicine is combined with lercanidipine by the present invention, to avoid the vasodilation untoward reaction of the common popularity of lercanidipine, and improve the therapeutic effect to hypertension。Clinical test results shows: the oral present invention patient containing lercanidipine compositions, preliminary judgement reduce blood pressure horizontal in be better than simple application lercanidipine person。It addition, the present invention's applies lercanidipine person effect notable (P < 0.05) than simple containing lercanidipine pharmaceutical composition in improving the vasodilation untoward reaction of lercanidipine medicine popularity。Illustrate that the pharmaceutical composition containing lercanidipine of the present invention truly has curative effect in reducing blood pressure, and there is 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 is not so limited the present invention。
Embodiment 1
A kind of pharmaceutical composition treating hypertension, is made up of the crude drug of following weight:
Lercanidipine 10g, Herba Apocyni veneti 3000g, Lagotis brachystachya Maxim. 3000g, Ganoderma 3000g, Zlatostema involucratum Franch. Et savat. 3000g。
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by Herba Apocyni veneti, Lagotis brachystachya Maxim., Ganoderma, Zlatostema involucratum Franch. Et savat. boiling 2 times, adding injection volume 7 amount water, decocts 1.5 hours for the 1st time, second time adds injection volume 5 times amount water, decocts 1 hour, and merging decoction liquor is standby；
B. by decoction liquor 60 DEG C, be condensed into the clear paste that relative density is 1.08 ~ 1.12 under-0.06Mpa condition, adding ethanol to alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear paste that relative density is 1.15 ~ 1.20, and spray drying must dry medicated powder；
C. by lercanidipine and the mixing of dry medicated powder, granulate, obtain the active substance of pharmaceutical composition of the present invention；
D. this active substance adds injection volume xylitol, mannitol and β～cyclodextrin, and binding agent makes granule in right amount。
Prepare 1000 bags altogether, every bag of weight 5g。
Embodiment 2
A kind of pharmaceutical composition treating hypertension, is made up of the crude drug of following weight:
Lercanidipine 9g, Herba Apocyni veneti 3500g, Lagotis brachystachya Maxim. 2500g, Ganoderma 3500g, Zlatostema involucratum Franch. Et savat. 2500g。
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by Herba Apocyni veneti, Lagotis brachystachya Maxim., Ganoderma, Zlatostema involucratum Franch. Et savat. boiling 2 times, adding injection volume 8 amount water, decocts 2 hours for the 1st time, second time adds injection volume 6 times amount water, decocts 1.5 hours, and merging decoction liquor is standby；
B. by decoction liquor 55 DEG C, be condensed into the clear paste that relative density is 1.08 ~ 1.12 under-0.08Mpa condition, adding ethanol to alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear paste that relative density is 1.15 ~ 1.20, and spray drying must dry medicated powder；
C. by lercanidipine and the mixing of dry medicated powder, granulate, obtain the active substance of pharmaceutical composition of the present invention；
D. this active substance adds injection volume xylitol, mannitol and β～cyclodextrin, binding agent makes granule in right amount。
Prepare 1000 bags altogether, every bag of weight 5g。
Embodiment 3
A kind of pharmaceutical composition treating hypertension, is made up of the crude drug of following weight:
Lercanidipine 11g, Herba Apocyni veneti 2500g, Lagotis brachystachya Maxim. 3500g, Ganoderma 2500g, Zlatostema involucratum Franch. Et savat. 3500g。
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by Herba Apocyni veneti, Lagotis brachystachya Maxim., Ganoderma, Zlatostema involucratum Franch. Et savat. boiling 2 times, adding injection volume 6 amount water, decocts 1 hour for the 1st time, second time adds injection volume 4 times amount water, decocts 0.5 hour, and merging decoction liquor is standby；
B. by decoction liquor 65 DEG C, be condensed into the clear paste that relative density is 1.08 ~ 1.12 under-0.04Mpa condition, adding ethanol to alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear paste that relative density is 1.15 ~ 1.20, and spray drying must dry medicated powder；
C. by lercanidipine and the mixing of dry medicated powder, granulate, obtain the active substance of pharmaceutical composition of the present invention；
D. this active substance adds injection volume xylitol, mannitol and β～cyclodextrin, and binding agent makes granule in right amount。
Prepare 1000 bags altogether, every bag of weight 5g。
Embodiment 4
A kind of pharmaceutical composition treating hypertension, is made up of the crude drug of following weight:
Lercanidipine 12g, Herba Apocyni veneti 4000g, Lagotis brachystachya Maxim. 4000g, Ganoderma 4000g, Zlatostema involucratum Franch. Et savat. 4000g。
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by Herba Apocyni veneti, Lagotis brachystachya Maxim., Ganoderma, Zlatostema involucratum Franch. Et savat. boiling 2 times, adding injection volume 7 amount water, decocts 1.5 hours for the 1st time, second time adds injection volume 5 times amount water, decocts 1 hour, and merging decoction liquor is standby；
B. by decoction liquor 60 DEG C, be condensed into the clear paste that relative density is 1.08 ~ 1.12 under-0.06Mpa condition, adding ethanol to alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear paste that relative density is 1.15 ~ 1.20, and spray drying must dry medicated powder；
C. by lercanidipine and the mixing of dry medicated powder, granulate, obtain the active substance of pharmaceutical composition of the present invention；
D. this active substance adds injection volume xylitol, mannitol and β～cyclodextrin, and binding agent makes granule in right amount。
Prepare 1000 bags altogether, every bag of weight 5g。
Embodiment 5
A kind of pharmaceutical composition treating hypertension, is made up of the crude drug of following weight:
Lercanidipine 8g, Herba Apocyni veneti 2000g, Lagotis brachystachya Maxim. 2000g, Ganoderma 2000g, Zlatostema involucratum Franch. Et savat. 2000g。
The preparation method of the pharmaceutical composition of this treatment hypertension:
A. by Herba Apocyni veneti, Lagotis brachystachya Maxim., Ganoderma, Zlatostema involucratum Franch. Et savat. boiling 2 times, adding injection volume 7 amount water, decocts 1.5 hours for the 1st time, second time adds injection volume 5 times amount water, decocts 1 hour, and merging decoction liquor is standby；
B. by decoction liquor 60 DEG C, be condensed into the clear paste that relative density is 1.08 ~ 1.12 under-0.06Mpa condition, adding ethanol to alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear paste that relative density is 1.15 ~ 1.20, and spray drying must dry medicated powder；
C. by lercanidipine and the mixing of dry medicated powder, granulate, obtain the active substance of pharmaceutical composition of the present invention；
D. this active substance adds injection volume xylitol, mannitol and β～cyclodextrin, and binding agent makes granule in right amount。
Prepare 1000 bags altogether, every bag of weight 5g。
The pharmaceutical composition containing lercanidipine of embodiment 1 preparation has been carried out clinical trial, and result is as follows:
1. data and method
1.1 object of study
100 example primary hypertension patients have been selected in present study, all meet WHO diagnostic criteria in 1999, and meet following condition: 1. make a definite diagnosis 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 matched group, often organize 50 examples。Two groups of patient's comparing difference not statistically significants (P > 0.05) in sex, age, Body Mass Index, the course of disease, blood pressure level etc. very physical data, have comparability。
1.2 Therapeutic Method
1. matched group: patient is being carried out the treatment of application lercanidipine, each 10mg of lercanidipine, every day 1 time on the basis of hypertension health knowledge education。2. observation group: patient is being carried out the pharmaceutical composition that on the basis of hypertension health knowledge education, use in conjunction contains lercanidipine, 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: blood pressure level before and after treatment, blood pressure normalization rate (shrinks pressure≤120mmHg, diastolic pressure≤90mmHg)；3. a situation arises in peripheral vasodilation reaction。
1.4 statistical methods
SPSS17.0 is adopted to carry out the statistical analysis of data。Measurement data adopts t inspection (representing by mean ± standard deviation)；Group data adopts χ2Inspection, using P≤0.05 as statistically significant, using P≤0.01 as there being height statistical significance。
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, the contraction pressure of two groups and diastolic pressure level substantially reduce before all relatively treating, and difference has statistical significance (P < 0.05);Observation group patient is substantially better than matched group in shrinking pressure and diastolic pressure improvement degree, and difference has statistical significance (P < 0.05)；Blood pressure normalization rate 94.0%(47/50 after observation group's treatment) apparently higher than the 74.0%(37/50 of matched group), difference has statistical significance (P < 0.05);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 | 166.53±14.41 | 117.51±11.43 |
| After treatment | 101.41±9.67*# | 70.16±4.52*# | ||
| Matched group | 50 | Before treatment | 166.57±14.45 | 117.57±11.45 |
| After treatment | 122.79±11.72* | 99.22±5.43* |
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 respectively before and after treatment, and result does not find obvious abnormal change, illustrate that the pharmaceutical composition containing lercanidipine of the present invention uses safety。
A situation arises in 2.3 peripheral vasodilation reactions
In this research, the peripheral vasodilation reaction incidence rate of observation group is significantly lower than matched group, and difference has statistical significance (P < 0.05), in Table 2。
2 liang of table group peripheral vasodilation reaction incidence rate
| Group | Number of cases | Headache | Dizziness | Tiredness | Ankle joint edema | Cardiopalmus | Incidence rate |
| Observation group | 50 | 1 | 0 | 0 | 0 | 0 | 1(2.0%) |
| Matched group | 50 | 4 | 3 | 2 | 2 | 1 | 12(24.0%) |
3. conclusion
Chinese medicine is combined by the present invention with lercanidipine, to avoid the common peripheral vasodilation reaction of lercanidipine, and improves the therapeutic effect to hypertension。Clinical test results shows: the oral present invention patient containing lercanidipine compositions, and preliminary judgement is better than simple application lercanidipine person in controlling blood pressure level。It addition, the present invention's applies lercanidipine person effect notable (P < 0.05) than simple containing lercanidipine pharmaceutical composition in improving lercanidipine medicine peripheral vasodilation reaction。Illustrate that the pharmaceutical composition containing lercanidipine of the present invention is safe and effective in reducing blood pressure, and there is the advantage that side effect is little。
Claims (7)
1. a pharmaceutical composition for the treatment hypertension containing lercanidipine, is made up of the crude drug of following weight: lercanidipine 8-12 part, Herba Apocyni veneti 2000-4000 part, Lagotis brachystachya Maxim. 2000-4000 part, Ganoderma 2000-4000 part, Zlatostema involucratum Franch. Et savat. 2000-4000 part。
2. the pharmaceutical composition of the treatment hypertension containing lercanidipine as claimed in claim 1, it is characterized in that, be made up of the crude drug of following weight: lercanidipine 9-11 part, Herba Apocyni veneti 2500-3500 part, Lagotis brachystachya Maxim. 2500-3500 part, Ganoderma 2500-3500 part, Zlatostema involucratum Franch. Et savat. 2500-3500 part。
3. the pharmaceutical composition of the treatment hypertension containing lercanidipine as claimed in claim 2, it is characterized in that, be made up of the crude drug of following weight: lercanidipine 10 parts, Herba Apocyni veneti 3000 parts, Lagotis brachystachya Maxim. 3000 parts, Ganoderma 3000 parts, Zlatostema involucratum Franch. Et savat. 3000 parts。
4. the pharmaceutical composition of the treatment hypertension containing lercanidipine 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 lercanidipine described in claim 1 or 2 or 3, comprises the steps of:
A. by Herba Apocyni veneti, Lagotis brachystachya Maxim., Ganoderma, Zlatostema involucratum Franch. Et savat. boiling 2 times, adding injection volume 6 ~ 8 times amount water, decocts 1 ~ 2 hour for the 1st time, second time adds injection volume 4 ~ 6 times amount water, decocts 0.5 ~ 1.5 hour, and merging decoction liquor is standby；
B. by decoction liquor 55 ~ 65 DEG C, be condensed into the clear paste that relative density is 1.08 ~ 1.12 under-0.04 ~-0.08Mpa condition, adding ethanol to alcohol content is 75%, places 12 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.15 ~ 1.20, spray drying, obtains dry medicated powder；
C. by lercanidipine and the mixing of dry medicated powder, granulate, obtain the active substance of pharmaceutical composition of the present invention；
D. this active substance individually or mixes with pharmaceutically acceptable adjuvant, prepares according to galenic pharmacy conventional method。
6. the preparation method of the pharmaceutical composition of the treatment hypertension containing lercanidipine as claimed in claim 5, it is characterised in that
Adding injection volume 7 times amount water 1st time in institute portion step a, decoct 1.5 hours, second time adds injection volume 5 times amount water, decocts 1 hour；In described step b thickening temperature be 60 DEG C, concentration pressure be-0.06Mpa。
7. the preparation method of the pharmaceutical composition of the treatment hypertension containing lercanidipine as claimed in claim 5, detailed step is as follows:
A. by Herba Apocyni veneti, Lagotis brachystachya Maxim., Ganoderma, Zlatostema involucratum Franch. Et savat. boiling 2 times, adding injection volume 7 times amount water, decocts 1.5 hours for the 1st time, second time adds injection volume 5 times amount water, decocts 1 hour, and merging decoction liquor is standby；
B. by decoction liquor 60 DEG C, be condensed into the clear paste that relative density is 1.08 ~ 1.12 under-0.06Mpa condition, adding ethanol to alcohol content is 75%, places 12 hours, filters, and filtrate is concentrated into the clear paste that relative density is 1.15 ~ 1.20, spray drying, obtains dry medicated powder；
C. by lercanidipine and the mixing of dry medicated powder, granulate, obtain the active substance of pharmaceutical composition of the present invention；
D. this active substance individually or mixes with pharmaceutically acceptable adjuvant, prepares according to galenic pharmacy conventional method。
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