CN101966190A - Amlodipine and eprosartan-containing compound preparation for treating hypertension - Google Patents

Abstract

A compound preparation containing amlodipine and eprosartan for treating hypertension comprises the following components: amlodipine or amlodipine medicinal salt, hydrochlorothiazide, eprosartan or eprosartan medicinal salt as main component and medicinal carrier. The invention has the advantages that: the curative effect is increased according to the complementary action mechanism of the combined medicine, the standard reaching is realized quickly, the standard reaching rate of the blood pressure reaches 82 percent, the adverse reaction related to the increase of certain dosage is favorably reduced, and the longer acting time is kept. The compound preparation has the characteristics of quick response, high standard reaching rate of blood pressure, small side effect and low cost.

Description

A compound preparation containing amlodipine and eprosartan for treating hypertension

Technical field:

The invention relates to a compound preparation containing amlodipine and eprosartan for treating hypertension, belonging to the field of medicines.

Background technology:

With the rapid growth of my country's economy, the dramatic changes in people's lifestyles, and the acceleration of urbanization and aging, cardiovascular disease has become the first or second cause of death in urban and rural populations. Especially for patients with hypertension, the incidence rate accounts for about 15% of the total population. With such a large number of patients, it is more important to seek therapeutic drugs with significant efficacy and few side effects.

There are many drugs for treating hypertension, such as calcium channel blockers (CCBs), ACE inhibitors (ACEI), angiotensin II receptor antagonists (ARBs), etc. However, it is difficult to achieve the target of hypertension with a single drug in the short term. Most patients need to take two or more antihypertensive drugs to achieve the blood pressure lowering target. In particular, when the blood pressure exceeds the target value of 20/10 mmHg, two drugs are often required at the beginning. Single drugs are more likely to develop drug resistance, and the probability of toxic and side effects is also greater due to the large dose. Most of them are given two or more drugs at the same time for treatment. However, when several drugs are taken at the same time, patients have poor compliance, and the dosage combination of several drugs is often not the most optimized ratio due to the dosage of the preparation and the degree of doctor's cognition. In recent years, although there are many new antihypertensive drugs with good efficacy and few side effects, the rate of blood pressure control reaching the target is relatively low. However, combined medication can use two or more antihypertensive drugs, the dosage of each drug is not large, the therapeutic effect of the drugs should have a synergistic or at least additive effect, and their adverse effects can offset each other or at least not overlap or add. The number of drugs used in combination therapy should not be too many, as too many may cause complex drug interactions. Therefore, choosing the number and type of drugs to be combined is very difficult and requires a lot of research and testing.

Therefore, a new treatment model has gradually been applied in clinical practice, and compound antihypertensive drug preparations are an internationally recognized treatment direction. Since compound antihypertensive drug formulations usually follow the principle of matching drugs with different mechanisms of action, they have the advantages of increasing efficacy or reducing side effects, and have achieved better blood pressure control effects.

Summary of the invention:

The purpose of the present invention is to provide a compound preparation of three antihypertensive drugs with small side effects, convenient administration and effective treatment of hypertension, and the compound preparation can effectively control blood pressure.

The object of the present invention is implemented by the following technical scheme: a compound preparation containing amlodipine and eprosartan for treating hypertension, which comprises the following ingredients: amlodipine or a pharmaceutically acceptable salt of amlodipine, hydrochlorothiazide, eprosartan or a pharmaceutically acceptable salt thereof as main ingredients, and a pharmaceutically acceptable carrier, wherein in each preparation unit, the amlodipine or the pharmaceutically acceptable salt of amlodipine is 2.5-10.0 mg, the eprosartan or a pharmaceutically acceptable salt thereof is 150.0-600.0 mg, and the hydrochlorothiazide is 6.25-25.0 mg.

A compound preparation containing amlodipine and eprosartan for treating hypertension is in the form of capsules, soft capsules, granules, tablets, powders, sustained-release preparations or injections.

The advantages of the present invention are that the combined use of drugs can give full play to the complementary mechanism of action of the drugs and reduce the adverse reactions. The composite preparation of the present invention has the characteristics of rapid effect, high blood pressure reaching standard rate, small side effects and low cost.

Specific implementation method:

The medicine of the present invention is further described below by way of examples. These examples are only for the purpose of illustration and do not limit the scope of the present invention.

Examples 1-5 are listed below:

In the examples, conventional methods in the pharmaceutical industry were used to prepare tablets according to the formula in the table below. The pharmaceutically acceptable carriers used to make the tablets were conventional excipients in the art. The proportions of the main ingredients are as follows:

At the same time, the conventional methods in the pharmaceutical industry are used in the embodiments, and capsules, soft capsules, granules, powders, sustained-release preparations or injection dosage forms can also be prepared, and the pharmaceutically acceptable carriers-the excipients used are all conventional excipients in the field of the dosage form.

Example 6: Experimental study on the efficacy of the compound preparation for treating hypertension of the present invention:

The therapeutic effect of the pharmaceutical composition of the present invention on hypertension will be illustrated below through human pharmacodynamic experiments.

1. General information:

Among 500 clinical patients with hypertension, 170 were aged 40-50 years old, 170 were aged 51-60 years old, and 160 were aged 61-70 years old.

2. Diagnostic criteria: According to the Guidelines for the Prevention and Treatment of Hypertension in China, hypertension is defined as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg without taking antihypertensive drugs.

3. Treatment method: 500 patients with hypertension were randomly divided into 5 groups, each group was treated with the composite preparations of Examples 1-5 of the present invention, prepared into tablets, taken orally once a day, one or two tablets each time, depending on the dosage of the tablets, for 6 days.

4. Efficacy evaluation criteria:

Formulated in accordance with the "Guidelines for the Prevention and Treatment of Hypertension in China". The goal of antihypertensive treatment is to restore blood pressure to "normal" or "ideal" levels. For patients aged 40-60, blood pressure should be reduced to ideal or normal blood pressure (≤130/85 mmHg), and for patients aged 60-70, blood pressure should be reduced to at least the upper normal value (≤140/90 mmHg).

5. Treatment results: Blood pressure was measured on the 1st, 2nd, 3rd, 4th, 5th and 6th day after the administration. The results showed that after 6 days of medication, 410 patients in the 5 groups of 500 hypertensive patients in the embodiment of the present invention had blood pressure that reached the standard, that is, returned to the "normal" or "ideal" level, and the average blood pressure standard rate was 82%, indicating that the compound medicine of the embodiment has a good effect in treating hypertension.

The efficacy is shown in the table below:

Number of cases Total number of cases reaching blood pressure target Total number of cases with substandard blood pressure Average blood pressure compliance rate 500 410 90 82%

discuss

This product is a compound preparation for the treatment of hypertension, and its blood pressure compliance rate is as high as 82%.

Claims (2)

1. The compound preparation containing amlodipine and eprosartan for treating hypertension is characterized by comprising the following components: the amlodipine or the amlodipine pharmaceutically acceptable salt, the hydrochlorothiazide, the eprosartan or the amlodipine pharmaceutically acceptable salt are used as main components and matched with pharmaceutically acceptable carriers, wherein in each preparation unit, the amlodipine or the amlodipine pharmaceutically acceptable salt accounts for 2.5-10.0mg in terms of amlodipine, the eprosartan or the eprosartan pharmaceutically acceptable salt accounts for 150.0-600.0mg in terms of eprosartan, and the hydrochlorothiazide accounts for 6.25-25.0 mg.

2. The amlodipine and eprosartan-containing compound preparation for treating hypertension according to claim 1, wherein the compound preparation is in the form of capsule, soft capsule, granule, tablet, powder, sustained-release preparation or injection.