Single layer osmotic pump controlled release preparation containing metoprolol and felodipine
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A single-layer osmotic pump and controlled-release preparation technology, which is applied in the preparation of the preparation and the field of single-layer osmotic pump controlled-release preparations, can solve the problems of low dose-effect curve, lower blood pressure reduction effect, and difficulty in achieving synchronous constant-rate release, etc. , to achieve the effect of simplifying the preparation process
Active Publication Date: 2012-11-21
INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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The advantages of single drug therapy are simplicity and low cost, but there are also many disadvantages: ① single drug can only control the blood pressure of 40%-60% or even less patients, and the effect on severe hypertension is even worse; ② the dose-effect of commonly used drugs The curve is flat and the effect is not good. When the dose is increased, the curative effect will not increase much, but the side effects will increase in a logarithmic order; ③ After the drug lowers blood pressure, the body's compensatory mechanism may produce counter regulation, such as the sympathetic and RAS system Activation and water and sodium r...
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Embodiment 1
[0062] Embodiment 1: Preparation of controlled-release preparation sample 1
[0063] Tablet core prescription is based on 1000 tablets,
[0064]
[0065]
[0066] Coating film prescription (corresponding to 100ml coating solution),
[0067]
[0068] The preparation method is as follows:
[0069] Weigh the prescription amount of the main drug and the excipients HPMC, CMC-Na, PVP, poloxamer, lactose and microcrystalline cellulose (MCC) and mix them thoroughly in equal increments, then sieve and mix well, and add an appropriate amount of 90% ethanol solution , make a suitable soft material, granulate with a 20-mesh sieve, dry at 45°C, add the prescribed amount of magnesium stearate, granulate with a 18-mesh, fully mix, and press the tablet after the granule content is qualified to obtain the tablet core.
[0070] Weigh the prescribed amount of polyethylene glycol 4000, add the prescribed amount of water, shake fully to make it dissolve, add the prescribed amount of a...
Embodiment 2
[0071] Embodiment 2: Preparation of controlled-release preparation sample 2
[0072] Tablet core prescription is based on 1000 tablets,
[0073]
[0074] Coating film prescription (corresponding to 100ml coating solution),
[0075]
[0076] Referring to Example 1 for the preparation method, Sample 2 was obtained.
Embodiment 3
[0077] Embodiment 3: Preparation of controlled-release preparation sample 3
[0078] Tablet core prescription is based on 1000 tablets,
[0079]
[0080]
[0081] Coating film prescription (corresponding to 100ml coating solution),
[0082]
[0083] Referring to Example 1 for the preparation method, Sample 3 was obtained.
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Abstract
The present invention belongs to the field of pharmaceutical preparations, and relates to a single layer osmotic pump controlled release preparation containing metoprolol and felodipine. Specifically the controlled release preparation comprises a tablet core and a semipermeable film coating, wherein the tablet core comprises the following components, by weight, 50-100 parts of metoprolol or a pharmaceutically acceptable salt thereof, 5-10 parts of felodipine, 3-10 parts of hydroxy propyl methyl cellulose, 5-25 parts of povidone, and 5-25 parts of sodium carboxymethyl cellulose. The present invention further relates to a preparation method and a use of the preparation. With the controlled release preparation of the present invention, synchronous and constant speed release of metoprolol and felodipine can be achieved. Compared with preparation of double layer osmotic pump tablets, the preparation method of the present invention has a characteristic of substantial simplification of the preparation process, wherein the method comprises that metoprolol is encapsulated in a pill core, and then conjointly preparing into tablets with felodipine.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations and relates to a single-layer osmotic pump controlled release preparation containing metoprolol and felodipine. The invention also relates to the preparation method and application of the preparation. Background technique [0002] Hypertension is one of the most common cardiovascular diseases, and it is also a major risk factor leading to increased morbidity and mortality of congestive heart failure, stroke, coronary heart disease, renal failure, and aortic aneurysm. [0003] For a long time, the stepwise and sequential treatment strategies adopted in drug treatment of hypertension are based on single drug therapy. The advantages of single drug therapy are simplicity and low cost, but there are also many disadvantages: ① generally, single drug can only control the blood pressure of 40%-60% or even less patients, and the effect on severe hypertension is even worse; ② the dose-effect of c...
Claims
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