Pharmaceutical composition

A composition and drug technology, applied in the direction of drug combination, drug delivery, pharmaceutical formulation, etc., can solve the problems of heart failure without obvious curative effect and unsatisfactory effect, so as to improve the control rate of blood pressure, reduce the risk of high blood pressure, and have few side effects Effect

Inactive Publication Date: 2018-11-13
THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Many antihypertensive drugs can effectively reduce the blood pressure of patients, but they have no obvious effect on heart failure in hypertensive patients. Only a few antihypertensive drugs, such as angiotensin converting enzyme inhibitors, angiotensin receptors Although body antagonists can reverse heart failure in patients, the effect is not very satisfactory.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] A compound amlodipine hydrochlorothiazide telmisartan folic acid capsule (1000 capsules), each containing 5 mg amlodipine / 40 mg telmisartan / 12.5 mg hydrochlorothiazide / 1 mg folic acid.

[0036] (1) Preparation of amlodipine besylate sustained-release pellets:

[0037] Amlodipine besylate sustained-release pellets include drug-containing pills and a sustained-release layer; the weight of specific raw materials is as follows:

[0038] Drug-containing pills: 6.93g of amlodipine besylate, 1.5g of povidone (PVP) K30, 50g of sucrose-starch core; sustained-release layer: Eudragit NE30D 11.75g, lactose 0.8g, talc 0.95g.

[0039] The preparation process is as follows:

[0040] (a) Weigh 6.93g of amlodipine besylate, containing 5.0g of amlodipine, and dissolve it in 100ml of ethanol; weigh 1.5g of PVP K30 and dissolve it in 50ml of water, and mix at high speed for 5min; slowly add ammonium chloride to the aqueous solution of PVP K30 Dipine benzene sulfonate solution, stirring w...

Embodiment 2

[0054] Study on Stability of Compound Amlodipine Hydrochlorothiazide Telmisartan Folic Acid Capsules

[0055] The compound amlodipine hydrochlorothiazide telmisartan folic acid capsules prepared according to Example 1 was investigated in a long-term stability test at 25° C. / 60% RH humidity, and the results were as follows:

[0056]

[0057] Experiments have shown that compound amlodipine hydrochlorothiazide telmisartan folic acid capsules have good stability.

Embodiment 3

[0059] Research objects and random grouping 300 patients with H-type hypertension were selected as the research objects, and were divided into the combined drug group and the fixed compound group according to the random number table method. Finally, 273 cases were included in the research objects, including 160 males and 113 females; aged 40 -85 years old, mean (60±6.5 years old).

[0060] There were 136 cases in the combined treatment group and 137 cases in the fixed compound group. Combination drugs take unilateral amlodipine 5mg, telmisartan 40mg, hydrochlorothiazide 12.5mg, folic acid 1mg once a day respectively, and the fixed compound group takes compound amlodipine hydrochlorothiazide telmisartan folic acid prepared according to Example 1 once a day capsule. Patients with coronary heart disease are routinely treated with anti-platelet and lipid-lowering treatments.

[0061] Observation indexes and serum Hcy (homocysteine), IMT (carotid artery intima-media thickness), a...

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PUM

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Abstract

The invention discloses a pharmaceutical composition, which is prepared from amlodipine or pharmaceutically acceptable salts thereof, telmisartan or pharmaceutically acceptable salts thereof, hydrochlorothiazide or pharmaceutically acceptable salts thereof, folic acid, and at least one pharmaceutically acceptable excipient. The pharmaceutical composition provided by the invention can effectively treat hypertension and reduce the risk of cardiovascular and cerebrovascular diseases such as heart failure, stroke, atherosclerosis, kidney disease, and complications of hypertension, heart disease and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a compound preparation containing amlodipine, telmisartan, hydrochlorothiazide and folic acid and a preparation method thereof. Background technique [0002] The report of the World Health Organization points out that cardiovascular and cerebrovascular diseases represented by high blood pressure seriously damage human health, and are called "the number one executioner of human health". 1. Lipid metabolism disorder is closely related to diabetes, which significantly reduces the quality of life of patients, and even endangers life in severe cases. At present, there are six categories of drugs commonly used in the treatment of hypertension: diuretics, beta-receptor blockers, calcium antagonists, angiotensin converting enzyme inhibitors (ACEI), angiotensin II receptor antagonists, peripheral vascular Dilator. However, the current treatment of hypertension is encounteri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/549A61K9/62A61P9/04A61P9/10A61P9/12A61P9/14A61P13/12A61K31/4184A61K31/4422A61K31/519
CPCA61K9/5084A61K31/4184A61K31/4422A61K31/519A61K31/549A61P9/04A61P9/10A61P9/12A61P9/14A61P13/12A61K2300/00
Inventor 蒋廷波徐明珠
Owner THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIV
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