Compound simvastatin nicotinate sustained-release capsules and preparation method thereof

A technology for simvastatin and sustained-release capsules, which is applied in the field of preparation of compound simvastatin niacin sustained-release capsules, can solve the problems of hepatotoxicity and low incidence of diseases, achieve improved oral bioavailability, simple preparation method, The effect of reducing the incidence

Inactive Publication Date: 2012-10-03
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patients taking extended-release niacin formulations had lower rates of hepatotoxicity and disease

Method used

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  • Compound simvastatin nicotinate sustained-release capsules and preparation method thereof
  • Compound simvastatin nicotinate sustained-release capsules and preparation method thereof
  • Compound simvastatin nicotinate sustained-release capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1: Specification: Niacin 250mg / Simvastatin 5mg

[0035]Simvastatin pellets prescription

[0036]

[0037] Niacin sustained-release pellets prescription

[0038]

[0039]

[0040] Niacin Sustained Release Pellets Coated Prescription

[0041]

[0042] a. Preparation of nicotinic acid pills:

[0043] Pulverize nicotinic acid, microcrystalline cellulose (MCC) and low-substituted hydroxypropyl cellulose (L-HPC), pass through a 100-mesh sieve, mix well, add a prescription amount of HPMC (E5) 10% aqueous solution as a binder, Prepare soft materials. Add the prepared soft material into the extruder hopper of a centrifugal pelletizing machine (WL350 type, Wenzhou Pharmaceutical Equipment Factory), extrude through a 1.0mm aperture sieve (extrusion frequency 30Hz), and place the strip extruded product in a ball In the machine, keep the rounding frequency at 35Hz initially for about 2 minutes, then increase the rounding frequency to 60Hz, and after about 20...

Embodiment 2

[0054] Example 2: Specification: Niacin 250mg / Simvastatin 10mg

[0055] Simvastatin pellets prescription

[0056]

[0057] Niacin sustained-release pellets prescription

[0058]

[0059] Niacin Sustained Release Pellets Coated Prescription

[0060]

[0061]

[0062] a. Preparation of nicotinic acid pills:

[0063] Pulverize nicotinic acid, microcrystalline cellulose (MCC) and low-substituted hydroxypropyl cellulose (L-HPC), pass through a 100-mesh sieve, mix well, add a prescription amount of HPMC (E5) 10% aqueous solution as a binder, Prepare soft material. Add the prepared soft material into the extruder hopper of a centrifugal pelletizing machine (WL350 type, Wenzhou Pharmaceutical Equipment Factory), extrude through a 1.0mm aperture sieve (extrusion frequency 30Hz), and place the strip extruded product in a ball In the machine, keep the rounding frequency at 35Hz initially for about 2 minutes, then increase the rounding frequency to 60Hz, and after about 2...

Embodiment 3

[0074] Example 3: Specifications: Niacin 375mg, Simvastatin 10mg

[0075] Simvastatin pellets prescription

[0076]

[0077] Niacin sustained-release pellets prescription

[0078]

[0079] Niacin Sustained Release Pellets Coated Prescription

[0080]

[0081] a. Preparation of nicotinic acid pills:

[0082] Pulverize nicotinic acid, microcrystalline cellulose (MCC) and low-substituted hydroxypropyl cellulose (L-HPC), pass through a 100-mesh sieve, mix well, add a prescription amount of HPMC (E5) 10% aqueous solution as a binder, Prepare soft materials. Add the prepared soft material into the extruder hopper of a centrifugal pelletizing machine (WL350 type, Wenzhou Pharmaceutical Equipment Factory), extrude through a 1.0mm aperture sieve (extrusion frequency 30Hz), and place the strip extruded product in a ball In the machine, keep the rounding frequency at 35Hz initially for about 2 minutes, then increase the rounding frequency to 60Hz, and after about 20 minutes,...

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PUM

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Abstract

The invention discloses a method for preparing compound simvastatin nicotinate sustained-release capsules, and belongs to the field of medicinal preparations. Components of the simvastatin nicotinate sustained-release capsules can exert a synergistic effect in vitro and comprehensively regulate the components of blood fat, so that the medicinal effect is furthest exerted, the toxic or side effect of the medicament can be reduced, fluctuation of blood concentration in vitro is reduced, and the administration frequency of a patient is reduced; and by designing pellets, the contact area between the medicament and the digestive tract is greatly improved, and the bioavailability of the medicament is improved. The method is strong in specificity, good in reproducibility, high in precision and convenient to operate; the capsules can be well applied to treatment of hyperlipidemia and abnormal mixed blood fat; and safety, effectiveness and controllability of clinical medication are really ensured.

Description

technical field [0001] The invention relates to a preparation method of compound simvastatin nicotinic acid sustained-release capsules, belonging to the field of pharmaceutical preparations. Background technique [0002] Cardiovascular disease is currently a killer that threatens human health, and its morbidity and mortality have surpassed tumors and ranked first. A survey on the causes of death in our country showed that cardiovascular diseases accounted for 40%. The most important cause of cardiovascular disease is atherosclerosis, which is the most common and important type of vascular sclerosis. Lesions mainly occurred in the aortic coronary arteries and cerebral arteries, renal arteries and mesenteric arteries also occurred. The pathological changes involve the arterial intima, subintimal layer and middle layer. Lipids accumulate at the lesion site and invade the intracellular or subintimal intercellular spaces, resulting in smooth muscle cell and connective tissue h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/455A61K9/52A61K47/38A61K47/36A61K47/32A61P3/06A61K31/366
Inventor 赵少春李冬梅唐星王蓓黄浩马新亮
Owner 石药集团中诺药业(石家庄)有限公司
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