CN1292747C - Compound formulation for treating hypertension - Google Patents
Compound formulation for treating hypertension Download PDFInfo
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- CN1292747C CN1292747C CNB031468357A CN03146835A CN1292747C CN 1292747 C CN1292747 C CN 1292747C CN B031468357 A CNB031468357 A CN B031468357A CN 03146835 A CN03146835 A CN 03146835A CN 1292747 C CN1292747 C CN 1292747C
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- olmesartan
- indapamide
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Abstract
The present invention discloses a compound formulation for treating hypertension, which comprises the components of the following daily doses: 0.5 to 2.5 mg of indapamide and 2.5 to 40 mg of olmesartan. The blood pressure reducing effect of the present invention is superior to that of a certain medicine with a large single dose, an adverse reaction caused by a certain single medicine can be removed, and a compensatory reaction triggered by blood pressure decrease in a single medicine treatment is prevented. The present invention increases the tolerance of a patient and enhances compliance.
Description
Technical field
The present invention relates to the hypertensive compound preparation of a kind of treatment.
Background technology
Hypertension is modal cardiovascular disease, is the great public health problem in the global range.China 1991 has carried out sample census to 940,000 crowds more than 15 years old, and statistics shows: China's hypertension prevalence has reached 11.26%, increases 25% in the period of 1979～1980 years 10, and the existing hyperpietic of China surpasses 1.3 hundred million.And the impetus of this rising is still continuing.Statistics shows also that simultaneously hypertension therapeutic rate city is 17.4%, and the rural area is 5.4%; Control rate (through treatment systolic pressure＜140mmHg, diastolic pressure＜90mmHg) only 2.9%.From above-mentioned statistics as can be seen China's hypertension prevalence constantly increase, but treatment rate, control rate are low, form huge contrast.According to the WHO prediction, will account for 79% of China's cause of death to the year two thousand twenty noninfectious, wherein the cardiovascular diseases will account for the first place.
The bad hypertension of long-term control can produce grievous injury to target organs such as the heart, brain, kidneys, actively the blood pressure lowering treatment can significantly reduce main cardiovascular diseases's M ﹠ M, and most hypertensive patients need could be with controlling of blood pressure in ideal target blood pressure level with depressor.
The hypertensive medicine of treatment commonly used has diuretic indapamide and angiotensin ii receptor antagonist Olmesartan.
Indapamide (Indapamide), chemistry N-(2-methyl-2,3-dihydro-1H-indyl) by name-3-sulfamoyl-4-chloro-Benzoylamide is a kind of novel thiazine class diuretic, is comparatively ideal at present antihypertensive drug.Molecular formula is C
16H
16ClN
3O
3S, molecular mass is 365.63, shown in the structural formula:
The indapamide structural formula
The characteristics of indapamide are hypotensive effect mitigations and lasting, can recover the diurnal blood pressure rhythm and pace of moving things, and untoward reaction is few and light.Indapamide has diuresis, the calcium antagonism, and the effect of antioxidation and elimination free radical stimulates Prostaglandin PGE
2And PGI
2Synthetic, reduce the hypersensitivity of blood vessel, thereby suppress pharmacological action such as vasoconstriction the blood vessel pressor amine.It has no adverse effects to blood fat, blood glucose, insulin sensitivity, and cardiovascular and kidney are had protective effect, can treat all types of hypertension, and the patient of especially suitable companion's dyslipidemia or diabetes selects for use.
Domestic literature is used for the treatment of the report of hypertension about indapamide, takes medicine and do not wait thoughtful 2 year from 4 observing time 2.5mg every day 1 time mostly, and to light all effective to the hypertension of severe, relatively efficacy of antihypertensive treatment is similar or omit with external report.Indapamide is to severe hyperpietic better effects if, and antihypertensive effect is slight 3 times.The effect of indapamide treatment senile hypertension is also satisfactory, and hypotensive effect occurs early and good effect, and blood pressure drops is progressive and steady.
Olmesartan (Olmesartan) is a kind of non-peptide class angiotensin ii receptor antagonist of high selectivity, and molecular formula is C
29H
30N
6O
6, molecular weight is 558.58, shown in the structural formula:
The Olmesartan structural formula
Olmesartan is a kind of non-peptide class AT1 receptor antagonist of high selectivity, experiment in vitro shows, this medicine can be blocked the combination of bovine adrenal cortex film angiotensin II (AT II) and AT1 receptor fully, and the combination of cattle cerebellum film AT II and AT2 receptor is not influenced.Men's health volunteer oral's Olmesartan 2.5,5,10,20,40mg or placebo, the Olmesartan of all dosage all can significantly suppress the inductive compressive reaction of angiotensin I, and 10～40mg can suppress 50% compressive reaction, and lasting 24h.
Olmesartan is a kind of precursor medicine, can be rapidly after entering in the body, complete hydrolysis is activated metabolite Olmesartan, and absolute bioavailability is 26%, the oral 20～80mgd of hypertensive patient and healthy volunteer
-1, continue 10d, T
1/2Be respectively 9.8～11.4h and 14.1～14.9h.Behind the oral administration, about 5%～12% Olmesartan is with urine excretion.Behind the drug administration by injection, the Olmesartan more than 90% is with defecate.
Double blinding in a large number at random,, multicenter study show that Olmesartan all has significant hypotensive effect to hypertension in various degree.Its controlling of blood pressure effect of 24 hours is suitable with amlodipine, felodipine and atenolol at least., moderate hypertension patient light to 3055 examples gives placebo (n=544) and Olmesartan (n=2511) 2.5～80mg at random, qd, carrying out meta analyzes, the result shows, Olmesartan 〉=20mg has the effect of definite reduction diastolic pressure, and Olmesartan obviously is better than captopril to the reduction effect of seat systolic pressure and diastolic pressure.In another clinical research, compare with other three AT1 receptor blocking agent (losartan, irbesartan and valsartan), olmesartan medoxomil can reduce hyperpietic's diastolic pressure better, and its effect that reduces diastolic pressure is equivalent to the effect that other AT1 receptor blocking agent and hydrochlorothiazide are united use.
The hypertensive patient has good toleration to Olmesartan, and the meta-analysis of 7 random experiments shows that Olmesartan is similar with the untoward reaction that the placebo group causes, wherein headache, upper respiratory tract infection and cold like symptoms are the most common.Cause that in Olmesartan treatment group dizzy incidence rate is more than the placebo group, but do not have significant difference with losartan, valsartan and irbesartan treatment group.
Single treat hypertension than the strong dose thing and bring some untoward reaction sometimes with a kind of; blood pressure reduces the compensation response that triggers during as single therapy; take medicine after weak, dizzy, drowsiness, tinnitus, nauseating, vomiting, epigastric discomfort, constipation appear in regular meeting; sometimes also phenomenons such as postural hypotension, muscular spasm, insomnia can appear; though these phenomenons dying away in the drug administration process continuously, also can be brought inconvenience to the patient mostly.
Summary of the invention
The objective of the invention is to shortcoming at the prior art existence, a kind of compound preparation is provided, said preparation is the different types of antihypertensive drugs of low dose of use in conjunction, its antihypertensive effect is better than single antihypertensive effect with heavy dose of a certain medicine, and can eliminate single with a certain drug-induced untoward reaction, blood pressure reduces the compensation response that triggers when preventing single therapy, increases patient's toleration, improves compliance.
The present invention is achieved by the following technical solutions:
The hypertensive compound preparation of a kind of treatment, contain the component of following daily dose:
Indapamide 0.5～2.5mg
Olmesartan 2.5～40mg.
A kind of preferred as technique scheme, a kind ofly treat the component that hypertensive compound preparation contains following daily dose:
Indapamide 0.5～1.5mg
Olmesartan 5～35mg.
As the hypertensive compound preparation of a kind of more excellent treatment, it contains the component of following daily dose:
Indapamide 1.25mg
Olmesartan 20mg.
As the hypertensive compound preparation of the more excellent treatment of another kind, it contains following component:
Indapamide 0.625mg
Olmesartan 30mg.
Beneficial effect of the present invention is: the present invention is that two kinds of antihypertensive drugs of low dose of use in conjunction are treated hypertensive, better and untoward reaction is less than single with heavy dose of wherein a kind of medicine antihypertensive effect, therapeutic alliance can improve efficacy of antihypertensive treatment, in and the untoward reaction that causes of different pharmaceutical, blood pressure reduces the compensation response that triggers when preventing single therapy, increase patient's toleration, improve compliance, the hyperpietic who is suitable in various degree takes for a long time.
This preparation also contains a certain amount of adjuvant except that containing above two kinds of active drug; In pharmacy procedure, the addition of adjuvant can be determined according to actual needs.
The adjuvant that this preparation is commonly used has: microcrystalline Cellulose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, magnesium stearate, calcium hydrogen phosphate, micropowder silica gel, lactose, dextrin etc.
Compound preparation of the present invention can have multiple mode, as compound recipe indapamide-Olmesartan sheet (ordinary tablet, slow releasing tablet, controlled release tablet and other special tablets), compound recipe indapamide-Olmesartan capsule (conventional capsule, slow releasing capsule, controlled release capsule and other special capsule preparations), compound recipe indapamide-dosage forms such as Olmesartan injection.
Embodiment 1
A kind of compound preparation, contain following component:
Indapamide 1.25mg
Olmesartan 5mg
Microcrystalline Cellulose 20mg.
Present embodiment can be made into compound recipe indapamide-Olmesartan tablet, and preparation method can adopt the preparation method of common pharmaceutical preparation.
The preparation method of the compound preparation of following examples is with embodiment 1.
Embodiment 2
A kind of compound preparation, contain following component:
Indapamide 1.25mg
Olmesartan 20mg
Pregelatinized Starch 30mg.
Embodiment 3
A kind of compound preparation, contain following component:
Indapamide 2.5mg
Olmesartan 2.5mg
Low-substituted hydroxypropyl cellulose 10mg.
Embodiment 4
A kind of compound preparation, contain following component:
Indapamide 0.625mg
Olmesartan 30mg
Micropowder silica gel 50mg.
Carrying out clinical comparison with present embodiment 2 below tests creativeness of the present invention is described:
The clinical verification experiment
1, data and method
1.1 case is selected: outpatient service and 18～65 years old light, moderate hypertension patient being in hospital, SiDBP 95～115mmHg, systolic pressure＜200mmHg, without serious target organ damage, the men and women does not limit.Hypertension diagnosis meets WHO standard.Except following situation: liver or renal function serious hindrance, serious habits of smoking and alcohol drinking, anemia of pregnant woman, women breast-feeding their children and before said medicine is failed to respond to any medical treatment or can not anti-receptor.
1.2 test method: all stop using other 5 of medicines that influence blood pressure before 90 patient more than the half-life, detailed medical history-taking and every inspection, except secondary hypertension.Be divided into 6 groups at random: 1. low-low dosage coupling group: indapamide (Ind) 1.25mg/ Olmesartan (Olm) 5mg; 2. low-middle dosage coupling group: indapamide (Ind) 1.25mg/ Olmesartan (Olm) 20mg; 3. in-and low dosage coupling group: indapamide (Ind) 2.5mg/ Olmesartan (Olm) 2.5mg; 4. the high dose list is with organizing 1: indapamide (Ind) 5mg; 5. the high dose list is with organizing 2: Olmesartan (Olm) 40mg; 6. positive controls: losartan (Losartan, Los) 100mg, once a day, 6 weeks of continuous use.
1.3 observation index and method: by international standard requirement measuring blood pressure, followed up a case by regular visits to weekly 1 time by fixing doctor, go to a doctor in 9:00～11:00, each thought-read rate and seat blood pressure 3 times are got 2 numerical value the higher person and are calculated its meansigma methods.
Row electrocardiogram, hematuria routine, hepatic and renal function, blood glucose, blood fat, blood electrolyte inspection before and after 1.4 the whole patients of lab testing test.
1.5 therapeutic evaluation: the regulation of reporting the council summary according to national cardiovascular epidemiology in 1979 and crowd prevention and treatment: (1) produce effects: diastolic pressure declines 〉=10mmHg, and reduce to normally (＜90mmHg) or more than the decline 20mmHg; (2) effective: diastolic pressure decline 10～19mmHg, or decline＜10mHg, but reached normal; (3) invalid: as not reach above-mentioned standard.
1.6 date processing and statistical method: relatively check with t between group and before and after the group internal therapy, effective percentage is relatively used X 2 test.
2. result
2.1 efficacy analysis:
(1) treatment blood pressure at 6 weekend: treated for 6 weekends, 6 groups of patient's seat DBP, SBP obviously descend, and difference has highly significant statistical significance (P＜0.001) (table 1).The average seat DBP fall of indapamide 1.25mg/ Olmesartan 20mg group is than losartan group bigger (17.9mmHg vs 10.6mmHg), and difference has the remarkable meaning of statistics (P＜0.01).6 groups of patient's seat SBP also have remarkable decline, and the average seat SBP fall of indapamide 1.25mg/ Olmesartan 20mg group is apparently higher than losartan group (21.5mmHg vs 12.9mmHg), and difference has the remarkable meaning of statistics (P＜0.05).Average seat DBP, the SBP fall of indapamide 1.25mg/ Olmesartan 20mg all is significantly higher than single with indapamide group or Olmesartan group, and difference has the remarkable meaning of statistics (P＜0.05).The average seat DBP fall of indapamide 1.25mg/ Olmesartan 5mg also has the significance statistical significance (P＜0.05) with single comparing with indapamide group or Olmesartan group.
(2) the blood pressure lowering effective percentage relatively: indapamide 1.25mg/ Olmesartan 20mg and indapamide 2.5mg/ Olmesartan 2.5mg group patient are at the total effective rate of treatment blood pressure lowering at 6 weekends (DBP decline 〉=10mmHg or treat last DBP＜90mmHg) be respectively 82.1%, 79.5%, all be significantly higher than losartan group (68.3%) (P＜0.01), single with indapamide 5mg (65.8%) (P＜0.01) and single with Olmesartan 40mg (70.1%) (P＜0.01).Indapamide 1.25mg/ Olmesartan 5mg blood pressure lowering total effective rate is 79.7%, also is significantly higher than single with indapamide and single with Olmesartan group (P＜0.01).
2.2 untoward reaction: high dose indapamide list is with organizing headache, nauseating, poor appetite 2 examples; High dose Olmesartan list is dizzy with group, headache 1 example; The dizziness of contrast medicine losartan group, headache, diarrhoea 2 examples, can be alleviated in 72h belong to slightly more.Tangible untoward reaction does not all appear in three groups of drug combination groups.Treat 6 weekend 6 groups of patient's lab testings result and electrocardiogram change no marked difference.
Reach average SiDBP at 6 weekends of treatment, systolic pressure variation before table 1 indapamide 1.25mg/ Olmesartan 5mg, indapamide 1.25mg/ Olmesartan 20mg, indapamide 2.5mg/ Olmesartan 2.5mg, indapamide 5mg, Olmesartan 40mg and the losartan 100mg group patient treatment:
| Group (n=15) | Diastolic pressure (mmHg) | Systolic pressure (mmHg) | Total effective rate | ||||
| Before the treatment | After the treatment | Changing value | Before the treatment | After the treatment | Changing value | ||
| Ind 1.25mg/ Olm 5mg Ind 1.25mg/ Olm 20mg Ind 2.5mg/ Olm 2.5mg Ind 5mg | 102.5±72 100.2±7.3 101.7±8.5 101.5±9.4 | 85.6±6.5 # 82.8±6.9 # 84.6±8.2 # 88.5±6.6 # | 16.8±5.9 * 17.9±7.2 * 15.8±8.6 * 11.8±5.4 | 152.3±6.2 152.8±8.6 151.5±7.5 151.2±8.3 | 135.7±8.9 # 131.5±8.4 # 132.1±8.7 # 138.1±11.4 # | 17.6±9.7 21.5±9.5 * 18.5±7.8 * 12.5±8.3 | 79.7％ * 82.1％ * 79.1％ * 65.8％ |
| Olm40mg Los100mg | 99.8±8.1 100.6±12.4 | 85.4±5.9 # 89.1±9.4 # | 14.2±8.4 10.6±6.7 | 150.5±9.2 151.2±8.8 | 134.7±8.6 # 138.6±9.4 # | 16.8±7.3 12.9±8.4 | 70.1％ 68.3％ |
Annotate: relatively preceding with treatment,
#P＜0.001; Compare with the losartan group,
*P＜0.05; Compare with the indapamide group with single,
*P＜0.05; Compare with the Olmesartan group with single,
*P＜0.05
3. conclusion
This test is contrast with the losartan, and observation indapamide and Olmesartan therapeutic alliance are light, the curative effect and the safety of moderate hypertension.The result shows: low dose of drug combination indapamide 1.25mg/ Olmesartan 5mg, indapamide 1.25mg/ Olmesartan 20mg, indapamide 2.5mg/ Olmesartan 2.5mg all can effectively bring high blood pressure down, after onset time is about 4 weeks of treatment.Compare with losartan, the antihypertensive effect of Olmesartan associating indapamide is more remarkable.The blood pressure lowering effective percentage of indapamide 1.25mg/ Olmesartan 5mg, indapamide 1.25mg/ Olmesartan 20mg, indapamide 2.5mg/ Olmesartan 2.5mg all is higher than losartan 100mg (P＜0.01); Compare with independent medication group, the blood pressure lowering effective percentage of indapamide 1.25mg/ Olmesartan 5mg, indapamide 1.25mg/ Olmesartan 20mg, indapamide 2.5mg/ Olmesartan 2.5mg all is significantly higher than single with indapamide (P＜0.01) or single with Olmesartan group (P＜0.01).The average seat DB fall of indapamide 1.25mg/ Olmesartan 5mg more also has significance statistical significance (P＜0.05) with single with indapamide group or Olmesartan group.Compare with single medicine, the incidence rate of adverse events significantly reduces in the low dose of therapeutic alliance group, and patient tolerability is good.Therefore, use in conjunction indapamide and Olmesartan treatment are light, moderate hypertension can improve efficacy of antihypertensive treatment, reduce drug-induced untoward reaction, are rational medication combined schemes, are worthy to be popularized.
In the test that great majority have been delivered, thiazide diuretic is basic antihypertensive therapy medicine
[5]These tests comprise the ALLHAT test of recent announcement, confirm the effectively cardiovascular complication that causes of prophylaxis of hypertension of diuretic.And diuretic can increase the curative effect of drug combination, helps controlling blood pressure, and is more cheap than other antihypertensive drug.Indapamide and Olmesartan therapeutic alliance can improve efficacy of antihypertensive treatment, and its ill effect can be cancelled out each other or not overlapping at least or addition, increase patient's toleration, improve the cost effectiveness ratio.
Claims (4)
1, the hypertensive compound preparation of a kind of treatment comprises that daily dose is that indapamide and the daily dose of 0.5～2.5mg is 2.5～40mg Olmesartan.
2, the hypertensive compound preparation of treatment according to claim 1 is characterized in that this compound preparation contains the component of following daily dose:
Indapamide 0.5～1.5mg
Olmesartan 5～35mg.
3, the hypertensive compound preparation of treatment according to claim 2 is characterized in that this compound preparation contains the component of following daily dose:
Indapamide 1.25mg
Olmesartan 20mg.
4, the hypertensive compound preparation of treatment according to claim 2 is characterized in that this compound preparation contains the component of following daily dose:
Indapamide 0.625mg
Olmesartan 30mg.
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|---|---|---|---|
| CNB031468357A CN1292747C (en) | 2003-09-16 | 2003-09-16 | Compound formulation for treating hypertension |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031468357A CN1292747C (en) | 2003-09-16 | 2003-09-16 | Compound formulation for treating hypertension |
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| CN1605340A CN1605340A (en) | 2005-04-13 |
| CN1292747C true CN1292747C (en) | 2007-01-03 |
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|---|---|---|---|
| CNB031468357A Expired - Fee Related CN1292747C (en) | 2003-09-16 | 2003-09-16 | Compound formulation for treating hypertension |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102580097A (en) * | 2012-03-16 | 2012-07-18 | 江苏先声药物研究有限公司 | Medicinal composition containing azilsartan |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000010549A1 (en) * | 1998-08-21 | 2000-03-02 | Point Therapeutics, Inc. | Regulation of substrate activity |
| CN1279615A (en) * | 1997-11-19 | 2001-01-10 | 阿迪尔公司 | Combination of hypertensin converting enzyme inhibitor with a diuretic for treating microcirculation disorders |
| WO2001097808A1 (en) * | 2000-06-19 | 2001-12-27 | Smithkline Beecham Plc | Combinations of depeptidyl peptidase iv inhibitors and other antidiabetic agents for the treatment of diabete mellitus |
| CN1410063A (en) * | 2001-10-09 | 2003-04-16 | 吕汇川 | Embedding agent for long acting blood pressure reducing |
-
2003
- 2003-09-16 CN CNB031468357A patent/CN1292747C/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1279615A (en) * | 1997-11-19 | 2001-01-10 | 阿迪尔公司 | Combination of hypertensin converting enzyme inhibitor with a diuretic for treating microcirculation disorders |
| WO2000010549A1 (en) * | 1998-08-21 | 2000-03-02 | Point Therapeutics, Inc. | Regulation of substrate activity |
| WO2001097808A1 (en) * | 2000-06-19 | 2001-12-27 | Smithkline Beecham Plc | Combinations of depeptidyl peptidase iv inhibitors and other antidiabetic agents for the treatment of diabete mellitus |
| CN1410063A (en) * | 2001-10-09 | 2003-04-16 | 吕汇川 | Embedding agent for long acting blood pressure reducing |
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