CN102225083B - Pharmaceutical composition for treating hypertension and hyperlipidemia, and application thereof - Google Patents
Pharmaceutical composition for treating hypertension and hyperlipidemia, and application thereof Download PDFInfo
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- CN102225083B CN102225083B CN 201110165408 CN201110165408A CN102225083B CN 102225083 B CN102225083 B CN 102225083B CN 201110165408 CN201110165408 CN 201110165408 CN 201110165408 A CN201110165408 A CN 201110165408A CN 102225083 B CN102225083 B CN 102225083B
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- levamlodipine
- hyperlipidemia
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- apii graveolentis
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Abstract
The invention provides a pharmaceutical composition treating hypertension and hyperlipidemia. The pharmaceutical composition comprises a therapeutically effective amount of levoamlodipine or a pharmaceutically acceptable salt thereof and celery dry powder. The pharmaceutical composition provided by the invention can be used for treating hypertension or hyperlipidemia.
Description
Technical field
The present invention relates to field of medicaments, relate in particular to a kind of compositions that comprises Levamlodipine or its officinal salt and Herba Apii graveolentis dry powder, and the application of this compositions in preparation treatment hypertension, hyperlipidemia or hypertension complicated with hyperlipemia medicine.
Background technology
In recent years, along with improving constantly and the change of diet structure, the increase of life stress, the increase of aging population of China's living standards of the people, the sickness rate of hypertension and hyperlipidemia has the trend that progressively raises.Hypertension, hyperlipidemia can cause the heart, brain, the angiopathys such as atherosclerosis, angina pectoris, myocardial infarction, cerebral infarction, renal damage, lead to grave consequences, so, pay close attention to hypertension, hyperlipidemia, to having very important significance of positive control cardiovascular and cerebrovascular disease, the monotherapy that can treat simultaneously these two kinds of diseases can improve patient's compliance.
Levamlodipine is China's the first chiral separation optical voidness medicine, it also is the first chiral separation antihypertensive drug in the world, it is a kind of long-acting, alkaline dihydropyridine calcium ion antagonist, it works by a kind of site that links to each other with dihydropyridine (N site) on the cell, retardance calcium ion cross-film enters cardiac muscle and vascular smooth muscle cell, make smooth muscle loosening, vascular resistance descends, and reduces blood pressure.At present the clinical experiment evidence Levamlodipine that shows therapeutic dose is atomic or do not have to cardiac contractile force and Atrioventricular Conduction effect; it is to the medicine of sympathetic activation effect minimum in the calcium ion antagonist; it can also treat the hypertension of heart failure; reverse ventricular hypertrophy; improve the lax function of diastole; renal function protecting; slight diuresis; prevention coronary heart disease; myocardial infarction and apoplexy; can also partly reverse unusual blood circadian, slight antiplatelet resists myocardial ischemia; arrhythmia increases insulin sensitivity and certain effects such as atherosclerosis.
The cultivation of Herba Apii graveolentis is in the history in existing more than 2000 year of China.Herba Apii graveolentis belongs to samphire.Two kinds of Herba Oenanthes Javanicae, Herba Apii graveolentis are arranged, and function is close, and is medicinal take Herba Apii graveolentis as good.Herba Apii graveolentis fragrance is denseer, has another name called " Apium graveolens ", also claims " medicine celery ".Traditional medicine is thought, cool in nature, the clearing away heat and promoting diuresis of Herba Apii graveolentis, but removing toxic substances and promoting subsidence of swelling, blood pressure lowering, the intestine moistening of quenching one's thirst.To this, the Compendium of Material Medica of Li Shizhen (1518-1593 A.D.) is early on the books.And for thousands of years, early become widely known proved recipe among the people with the Herba Apii graveolentis antihypertensive.Modern medicine Epidemiological Analysis and pharmacological evaluation have been carried out many times comprehensive study to active ingredient, medical value and the health-care effect of Herba Apii graveolentis.The result shows, the Herba Apii graveolentis of edible q.s just has good blood pressure lowering, blood sugar lowering, blood fat reducing, tranquillizing and allaying excitement, enriches blood, bowel relieving relieving constipation and eliminate the functions such as free radical, anti-bacteria, anti-cancer tumor suppressor.Main function wherein: (1) sedation.Effective to insomnia and neurastheniac.(2) resistance balance between the internal organs amount of blood supply such as vasodilator smooth muscle, the interior heart and brain kidney of control agent and peripheral arterial, the control blood capillary is firmly swollen, and dissolving is deposited on eparterial cholesterol, triglyceride etc. rapidly.(3) recover vessel wall elasticity, alleviate arteriolospasm, reduce tissue to arteriolar pressure, improve microcirculation, thereby reduce blood pressure.(4) dietary fiber in the celery element and chlorophyll have good blood sugar reducing function.And the blood pressure lowering composition of Herba Apii graveolentis is butyl benzene phthaleins material, and the butyl benzene phthaleins material in the Herba Apii graveolentis has the effect of tranquillizing and allaying excitement, so also be the Herba Apii graveolentis valeridin.Although the reason of hypertension morbidity is a lot, the vascular smooth muscle anxiety causes adrenaline secretion excessively prosperous, almost is hyperpietic's general character.The Herba Apii graveolentis valeridin can suppress the vascular smooth muscle anxiety, reduces adrenergic secretion, thereby reduces and steady blood pressure.
Summary of the invention
One object of the present invention is to provide a kind of pharmaceutical composition for the treatment of hypertension, hyperlipidemia, and this pharmaceutical composition is comprised of the Levamlodipine of effective dose or its officinal salt and Herba Apii graveolentis dry powder.
The molecular formula of described Levamlodipine is:
Described Levamlodipine officinal salt is benzene sulfonate, mesylate, acetate, aspat, tartrate, maleate, sulfate, hydrochlorate or hydrobromate.
The molecular formula of the benzene sulfonate-Levamlodipine besylate of described Levamlodipine is:
Levamlodipine can make by several different methods, such as the method for CN00102701.8 and CN03821593.4 record, on the basis that generates Levamlodipine, uses conventional acid-base neutralization reaction to make stable Levamlodipine officinal salt.
Described Herba Apii graveolentis dry powder is squeezed the juice after being cleaned by Herba Apii graveolentis, crosses and filters to remove residue, obtains after the filtrate drying.Preferably use disclosed preparation method among the CN00110792.5.
In the described pharmaceutical composition, take the weight ratio of the Levamlodipine of Levamlodipine or its officinal salt and Herba Apii graveolentis dry powder as 1:(1/3-80) * 10
3, preferred 1:(5/27-30/7) * 10
4
Described effective dose refers to, and described Levamlodipine or its officinal salt and Herba Apii graveolentis dry powder are for the consumption that can effectively treat hypertension, hyperlipidemia or hypertension complicated with hyperlipemia.
Described pharmaceutical composition can be any dosage form, the dosage forms such as the optional tablet of dosage form, pill, capsule, powder, injection.These dosage forms can be according to well known to a person skilled in the art the method preparation.
Described pharmaceutical composition is preferably oral formulations, can also be controlled release form such as slow release or fast dissolving dosage form, and this controlled release preparation can be according to well known to a person skilled in the art the method preparation.
Pharmaceutical composition of the present invention can be used for treating various types of hypertension or hyperlipidemia, especially hypertension complicated with hyperlipemia.
The present invention also further discloses the application of aforementioned pharmaceutical compositions in preparation treatment hypertension, hyperlipidemia or hypertension complicated with hyperlipemia medicine.
Among the present invention, Levamlodipine or its officinal salt and Herba Apii graveolentis dry powder are united use and are had good synergism, and simultaneously, single survival dose of Levamlodipine and Herba Apii graveolentis dry powder is few, reduce the untoward reaction that single medicine heavy dose causes, can improve patient's compliance simultaneously.
The specific embodiment
Embodiment 1
Laboratory animal: Wistar rat (available from Chinese Academy of Sciences's Shanghai Experimental Animal Center), totally 110.
Experimental technique: with two kidneys, one folder type method operation modeling, feed and survey the mean arterial pressures of rats with high lipid food (82% standard feed+10% yolk powder+8% Adeps Sus domestica) after three weeks, increased blood pressure 20mmHg is assessed as hypertension modeling success greater than 120mmHg.
Medicament sources: Levamlodipine besylate (available from Levamlodipine Pharmaceutical group (Jilin) company limited).
Herba Apii graveolentis dry powder: Herba Apii graveolentis adopts the method among the CN00110792.5 embodiment to prepare Herba Apii graveolentis dry powder available from fruit and vegerable market.
Experiment grouping: adopt randomized to be divided into 11 groups, comprising: A group model group (gavaging normal saline every day); B organizes sham operated rats (renal artery not being carried out ligation during operation); C group Herba Apii graveolentis dry powder 0.1g/kg body weight; D group Herba Apii graveolentis dry powder 8g/kg body weight; E organizes Levamlodipine besylate 0.1mg/kg body weight (in Levamlodipine); F organizes Levamlodipine besylate 3mg/kg body weight (in Levamlodipine); G group Levamlodipine besylate 3mg/kg body weight (in Levamlodipine) and Herba Apii graveolentis dry powder 0.1g/kg body weight; H group Levamlodipine besylate 0.1mg/kg body weight (in Levamlodipine) and Herba Apii graveolentis dry powder 8g/kg body weight; I group Levamlodipine besylate 0.54mg/kg body weight (in Levamlodipine) and Herba Apii graveolentis dry powder 1g/kg body weight; J group Levamlodipine besylate 0.14mg/kg body weight (in Levamlodipine) and Herba Apii graveolentis dry powder 6g/kg body weight; K group Levamlodipine besylate 0.27mg/kg body weight (in Levamlodipine) and Herba Apii graveolentis dry powder 2g/kg body weight.
Press above-mentioned dosage gavage every day 1 time, begin Measure blood pressure before administration, each organizes continuous 4 weeks of gavage, and the B group is fed with standard feed, and other groups continue to raise with high lipid food.Every morning 9 employings rat electronic sphygmomanometer is measured rat blood pressure, calculating mean value.Measure the last time triglyceride (TG), cholesterol (TC), HDL-C (HDL-C) after the administration.
Experimental result:
(1) on the impact of blood pressure:
The result shows (seeing Table 1), except A group, B group, every group all has blood pressure lowering in various degree, and C group, D group, E group, F group, G group, H group, I group, J group, K group blood pressure lowering rate are followed successively by 2.0%, 7.0%, 3.5%, 17.1%, 20.6%, 12.6%, 22.4%, 14.2%, 25.2%.
Table 1: on the impact (n=10) of blood pressure
A compares p＜0.05 with model group; B compares p＜0.01 with model group; C compares p＜0.01 with single medicine group C group; D compares p＜0.05 with single medicine group D group; E compares p＜0.01 with single medicine group D group; F compares p＜0.01 with single medicine group E group; G compares p＜0.05 with single medicine group F group.
(2) on the impact of rat cholesterol, triglyceride, HDL-C:
Experimental result (seeing Table 2) compares with the B group, and the A group has obvious difference with the C group, and the modeling success is described.D group, G group, H group, I group, J organize, more all there were significant differences with the hyperlipidemia model group for the K group.
Table 2: on the impact (n=10) of rat TG, TC, HDL-C
H and model group be p＜0.05 relatively; I and model group be p＜0.01 relatively
Conclusion: to sum up state experiment as can be known, Levamlodipine and the successful of Herba Apii graveolentis dry powder coupling than independent use Levamlodipine and Herba Apii graveolentis dry powder, illustrate that Levamlodipine and Herba Apii graveolentis dry powder unites to use and have certain synergism, be better than the curative effect of two kinds of medicines when alone.
Claims (4)
1. pharmaceutical composition for the treatment of hypertension, hyperlipidemia, it is characterized in that this pharmaceutical composition is comprised of Levamlodipine or its officinal salt and Herba Apii graveolentis dry powder, take the weight ratio of the Levamlodipine of Levamlodipine or its officinal salt and Herba Apii graveolentis dry powder as 1:(1/3-80) * 10
3
2. the pharmaceutical composition for the treatment of hypertension according to claim 1, hyperlipidemia is characterized in that described Levamlodipine officinal salt is benzene sulfonate, mesylate, acetate, aspat, tartrate, maleate, sulfate, hydrochlorate or hydrobromate.
3. the pharmaceutical composition for the treatment of hypertension according to claim 1 and 2, hyperlipidemia is characterized in that squeezing the juice after described Herba Apii graveolentis dry powder is cleaned by Herba Apii graveolentis, crosses and filters to remove residue, obtains after the filtrate drying.
4. the application of the pharmaceutical composition of the described treatment hypertension of claim 1, hyperlipidemia in preparation treatment hypertension, hyperlipidemia or hypertension complicated with hyperlipemia medicine.
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| CN 201110165408 CN102225083B (en) | 2011-06-20 | 2011-06-20 | Pharmaceutical composition for treating hypertension and hyperlipidemia, and application thereof |
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| CN102225083B true CN102225083B (en) | 2013-01-16 |
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| CN102716370B (en) * | 2012-07-04 | 2014-07-02 | 施慧达药业集团(吉林)有限公司 | Pharmaceutical composition and application thereof |
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