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Novel niacin compound slow-release preparation for treating hyperlipoidemia

A slow-release preparation, hyperlipidemia technology, applied in pharmaceutical formulations, metabolic diseases, ester active ingredients, etc., can solve problems such as large toxic and side effects, and achieve the effects of reduced toxic and side effects, good therapeutic effect, and reduced content

Inactive Publication Date: 2014-02-26
JIANG SU PHARMAMAXCORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although these preparations can effectively treat corresponding hyperlipidemia patients, the corresponding toxic and side effects are also very large.

Method used

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  • Novel niacin compound slow-release preparation for treating hyperlipoidemia
  • Novel niacin compound slow-release preparation for treating hyperlipoidemia
  • Novel niacin compound slow-release preparation for treating hyperlipoidemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: Preparation of Niacin (300mg) Lovastatin (6mg) Sustained Release Capsules

[0038] Niacin Extended Release Part A:

[0039]

[0040]Lovastatin immediate release part B:

[0041]

[0042] Preparation A of niacin sustained-release pellets: Weigh the prescribed amount of niacin, polyvinylpyrrolidone k90, microcrystalline cellulose, ethyl cellulose, and stearic acid, first pass niacin through a 60-mesh sieve, and then niacin Put it into a wet granulator together with auxiliary materials, add an appropriate amount of purified water to make soft materials, use an extrusion spheronizer to make pellets, dry, and screen 18-30 pellets to obtain niacin sustained-release pellets.

[0043] Preparation B of lovastatin immediate-release pellets: Weigh the prescribed amount of lovastatin, starch, microcrystalline cellulose, dextrin, and lactose, add lovastatin and auxiliary materials to the wet granulator and add appropriate amount of purified water Prepare soft mate...

Embodiment 2

[0046] Example 2: Preparation of Niacin (1200mg) Lovastatin (14mg) Double Layer Tablets

[0047] Niacin Extended Release Part A:

[0048]

[0049]

[0050] Simvastatin Part B:

[0051]

[0052] Part A of Niacin Sustained-release Tablets: Weigh the prescribed amount of Niacin, Polyvinylpyrrolidone K90, and Hypromellose (K15M) added inside. First pass the niacin through a 60-mesh sieve, and then add the niacin and internal auxiliary materials into a wet granulator for granulation. The prepared soft material is wet sized, dried in a fluidized bed, sized, and weighed to calculate the yield. Weigh the added hypromellose (K15M) and stearic acid, mix and set aside.

[0053] Simvastatin immediate-release part B: weigh the prescribed amount of simvastatin, microcrystalline cellulose, pregelatinized starch, lactose, and stearic acid. Use purified water as a wetting agent, manually granulate, wet granules with 16 mesh for soft materials, dry in an oven at 50-55 for 2-5 hours...

Embodiment 3

[0056] Example 3: Preparation of Niacin (800mg) Lovastatin (16mg) Double Layer Tablets

[0057] Niacin Extended Release Part A:

[0058]

[0059]

[0060] Simvastatin Part B:

[0061]

[0062] Part A of Niacin Sustained-release Tablets: Weigh the prescribed amount of Niacin, Polyvinylpyrrolidone K90, and Hypromellose (K15M) added inside. First pass the niacin through a 60-mesh sieve, and then add the niacin and internal auxiliary materials into a wet granulator for granulation. The prepared soft material is wet sized, dried in a fluidized bed, sized, and weighed to calculate the yield. Weigh the added hypromellose (K15M) and stearic acid, mix and set aside.

[0063] Simvastatin immediate-release part B: weigh the prescribed amount of simvastatin, microcrystalline cellulose, pregelatinized starch, lactose, and stearic acid. Use purified water as a wetting agent, manually granulate, wet granules with 16 mesh for soft materials, dry in an oven at 50-55 for 2-5 hours,...

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Abstract

The invention provides a novel niacin compound slow-release preparation for treating hyperlipoidemia. The novel niacin compound slow-release preparation comprises a quick-release part and a slow-release part, wherein the quick-release part comprises statins and pharmaceutical excipients; the slow-release part comprises niacin, polyvinylpyrrolidone k90 and pharmaceutical excipients; the weight ratio of the statins to niacin in the preparation is 1:(10-100), the weight ratio of polyvinylpyrrolidone k90 to niacin in the slow-release part is 1:(20-80), and the dosage form of the compound preparation is slow-release coating tablets. The compound preparation provided by the invention is suitable for treating hyperlipoidemia of Asian people. Compared with the existing niacin statin slow-release preparation, the compound preparation provided by the invention is less in the content of statins and can achieve a very good treatment effect at the same time, so that the toxic and side effects of medicaments are greatly reduced.

Description

[0001] This application is an invention patent filed on 2012-11-23, the patent application number is "201210480605.6", and the title of the invention is "a novel niacin compound sustained-release preparation for the treatment of hyperlipidemia". technical field [0002] The invention relates to a novel niacin compound slow-release preparation for treating hyperlipidemia, which belongs to the field of chemical medicine preparations. Background technique [0003] Hyperlipidemia is "the source of all diseases", and the death toll that eventually leads to it reaches 51% of the total death toll in the world. At the same time, the younger age of dyslipidemia is becoming more and more obvious. Hyperlipidemia is a systemic disease, refers to blood total cholesterol (TC) and / or triglyceride (TG) is too high or high-density lipoprotein cholesterol (HDL-C) is too low, modern medicine is called dyslipidemia . Among them, hyperlipidemia characterized by high levels of cholesterol and t...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/455A61P3/06A61K31/366A61K31/22A61K31/405A61K31/40A61K31/505
Inventor 蒋志君曹家祥郭靖
Owner JIANG SU PHARMAMAXCORP
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