CN202211874U - Compound simvastatin niacin double-release capsule - Google Patents

Abstract

The utility model discloses a compound simvastatin niacin double-release capsule, which belongs to the technical field of medicine dosage form structures and comprises a capsule shell and medicines filled into the capsule shell. The medicine dosage forms of the medicine consist of two tablets with different medicine release speeds, the tablets respectively include a sustained release tablet (a) and a quick release tablet (b), the sustained release tablet (a) is a niacin tablet, and the quick release tablet (b) is a simvastatin tablet.

Description

The two sheet capsules of releasing of a kind of compound simvastatin niacin

Technical field

[0001] this utility model relates to a kind of pharmaceutical formulation technical field of structures, is specifically related to the two sheet capsules of releasing of a kind of compound simvastatin niacin.

Background technology

U.S. FDA has been ratified the new compound preparation " niacin simvastatin sustained-release sheet " of ABBOTT company, trade name " SIMCOR " on February 15th, 2008.Be used to treat primary hypercholesterolemia, mixed dyslipidemia and use nicotinic acid separately and the invalid hypertriglyceridemia of Simvastatin Treatment.Said preparation is the novel nicotinic acid and the Statins compound preparation of listing after " compound niacin Lovastatin sustained-release tablets ", also is the medicine of lipid imbalance of treatment mixed type and hypercholesterolemia reducing.Simvastatin and nicotinic acid share, and can reduce low density lipoprotein, LDL (LDL) and triglyceride (TG) level effectively, can increase high density lipoprotein (HDL) level again.After nicotinic acid is processed slow releasing preparation simultaneously, reduce the peak valley fluctuation of this medicine, reduced the nicotinic acid incidence rate of adverse reaction, all be superior to existing lipid lowerers aspect safety and the ease of use.Nicotinic acid and simvastatin drug combination are different from any other single hypolipidemic, can totally improve the blood fat situation.Simvastatin can reduce LDL and T-CHOL, can be used for primary hypercholesterolemia and atherosclerosis.Simvastatin has remarkable result to reducing LDL, but to a little less than the increase HDL effect.The effect of nicotinic acid has very strong increase HDL effect antithesis, but reduces a little less than the LDL effect.Nicotinic acid can effectively increase the level of HDL level, triglyceride reducing and lipoprotein a.Both can both reduce serum triglyceride level.Unite the III phase clinical studies show of using nicotinic acid and simvastatin abroad, two medicine effect additions.Treat after 1 year, the lipid-lowering effect of drug combination is superior to two kinds and forms any of medicine, and side effect does not increase.These article are compared with folk prescription with ordinary preparation, can reduce side effect such as the headache that caused by nicotinic acid, flush to greatest extent, and when strengthening lipid-lowering effect, each item biochemical indicator of blood does not have significant change.The patients with hepatic toxicity and the myopathy incidence rate of taking the slow release niacin preparation are lower.

In clinical research, the patient is usually to these article better tolerance.6% patient ends treatment because of the flushing untoward reaction takes place.Hepatopathy, gastric ulcer or severe haemorrhage patient, anemia of pregnant woman or women breast-feeding their children and to arbitrary composition allergy sufferers forbidding in this preparation.

These article film coating tablet gauge lattice: slow release nicotinic acid/simvastatin 500mg/20mg/ sheet, 750mg/20mg/ sheet, 1000mg/20mg/ sheet.

Summary of the invention

The purpose of this utility model provides a kind of pair and releases the sheet capsule, and in the capsule softgel shell of the present invention, the tablet of being packed into is a single-layer sheet.

This utility model comprises the capsule softgel shell and incapsulates inner medicine composition; The medicine that wherein incapsulates is two kinds of tablet a and tablet b that rate of release is different; Described tablet a is the slow releasing tablet that is made up of nicotinic acid and adjuvant, and described tablet b is the fast-release tablet b that is made up of simvastatin and pharmaceutic adjuvant.

In this utility model; In slow releasing tablet, be added with the slow-release auxiliary material that discharges at gastric; Like hydroxypropyl cellulose, hydroxypropyl emthylcellulose, any in polyethylene acetal diethylin acetic acid and dimethylaminoethyl methacrylate-neutral methacrylic acid esters copolymer.

In the fast-release tablet, contain the adjuvant disintegrating agent, like in coach polyvidone, cross-linking sodium carboxymethyl cellulose, the carboxymethyl starch sodium etc. any one or more.

In this utility model, two tablets are housed in each capsule, wherein in the slow releasing tablet every contain nicotinic acid 500mg, every contains simvastatin 20mg in the fast-release tablet.

Description of drawings

Fig. 1 releases sheet capsule structure sketch map for this utility model compound simvastatin niacin is two.

Fig. 2 releases sheet capsule slow releasing tablet a structural representation for this utility model compound simvastatin niacin is two.

Fig. 3 releases sheet capsule quick-release tablet b structural representation for this utility model compound simvastatin niacin is two.

The specific embodiment

Release the sheet capsule structure and specify a kind of compound simvastatin niacin of this utility model is two below in conjunction with accompanying drawing and specific embodiment to help the content of understanding this utility model.

As shown in Figure 1, the two sheet capsules of releasing of compound simvastatin niacin are made up of capsule softgel shell and the medicine that incapsulates inside, and the form of the volume medicine in wherein incapsulating is two kinds of rate of release different drug tablet a and medicinal tablet b.Tablet a is the slow releasing tablet that is made up of nicotinic acid and pharmaceutic adjuvant, and sheet b is the fast-release tablet that is made up of simvastatin and pharmaceutic adjuvant.Particularly, slow releasing tablet is made up of nicotinic acid, dextrin, hypromellose and magnesium stearate, ethanol.Fast-release tablet is by microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, lactose, and ethanol, magnesium stearate is formed.

During making:

1) get nicotinic acid, dextrin, the 80% hypromellose mix homogeneously of recipe quantity, 20% hypromellose, 70% alcoholic solution is that binding agent is granulated, and dry, granulate with the magnesium stearate mix homogeneously, are pressed into caplets again, promptly get sheet a;

2) get simvastatin, microcrystalline Cellulose, the cross-linking sodium carboxymethyl cellulose of recipe quantity, lactose, mix homogeneously is a wetting agent with 50% alcoholic solution, granulates, dry, dry, again with the magnesium stearate mix homogeneously, tabletting promptly gets sheet b;

3) slow releasing tablet a and fast-release tablet b are incapsulated in the body, cover the capsule capsule and emit, promptly get the two sheet capsules of releasing of this utility model.

Claims (1)

1. two sheet capsules of releasing of a compound simvastatin niacin; Comprise the capsule softgel shell and incapsulate inner tablet; It is characterized in that the described medicine that incapsulates inside is two kinds of tablet forms that rate of release is different; Be respectively slow releasing tablet (a) and quick-release tablet (b), described slow releasing tablet (a) is a nicotinic acid tablet, and described quick-release tablet (b) is the simvastatin sheet.

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