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Lovastatin and niacin sustained-release preparation and preparation method thereof

A technology of lovastatin and sustained-release preparations, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Due to the complex production process and high requirements for storage conditions, the effects of reducing fluctuations, lowering LDL by 45%, and overcoming the need for multiple doses can be achieved.

Inactive Publication Date: 2009-07-08
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the production process of the pellet coating preparation is relatively complicated, and the coating material has high requirements on storage conditions, and it is easy to deteriorate under high and low temperature conditions. The drug release rate of the coated pellet preparation is very slow during storage. Difficult to control stably in ideal state

Method used

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  • Lovastatin and niacin sustained-release preparation and preparation method thereof
  • Lovastatin and niacin sustained-release preparation and preparation method thereof
  • Lovastatin and niacin sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] After the niacin raw material passes through a 100-mesh sieve, according to the weight ratio of 500mg of niacin per tablet, it is fully mixed with 120mg of HPMC K100M skeleton material, and then 50mg of PVPK90 adhesive is added to make a soft material by hand, and wet through a 20-mesh sieve The granules were dried in an oven at 60°C for 2 hours, sieved through a 20-mesh sieve, weighed, added with 6.5 mg of magnesium stearate, and mixed well to make niacin sustained-release layer granules;

[0028] Take lovastatin, pass through a 100-mesh sieve, and mix thoroughly with carboxymethyl starch sodium 5 mg, microcrystalline cellulose 25 mg, starch 15 mg, and lactose 15 mg according to the weight ratio of 20 mg lovastatin per tablet, and add PVPK30 ethanol solution to make it manually For soft materials, pass through a 22-mesh sieve for granulation, place in an oven at 60°C for 1 hour, and granulate the dry granules with a 22-mesh sieve, add 1 mg of magnesium stearate, and mix...

Embodiment 2

[0031] After the niacin raw material passes through a 100-mesh sieve, according to the weight ratio of 500mg of niacin per tablet, it is fully mixed with 130mg of HPMC K100M skeleton material, and then 50mg of PVPK90 adhesive is added to make a soft material by hand, and wet through a 20-mesh sieve The granules were dried in an oven at 60°C for 2 hours, sieved through a 20-mesh sieve, weighed, added with 6.5 mg of magnesium stearate, and mixed well to make niacin sustained-release layer granules;

[0032] Take lovastatin, pass through a 100-mesh sieve, and mix thoroughly with carboxymethyl starch sodium 5 mg, microcrystalline cellulose 25 mg, starch 15 mg, and lactose 15 mg according to the weight ratio of 20 mg lovastatin per tablet, and add PVPK30 ethanol solution to make it manually For soft materials, pass through a 22-mesh sieve for granulation, place in an oven at 60°C for 1 hour, and granulate the dry granules with a 22-mesh sieve, add 1 mg of magnesium stearate, and mix...

Embodiment 3

[0034] After the niacin raw material passes through a 100-mesh sieve, according to the weight ratio of 500mg of niacin per tablet, it is fully mixed with 140mg of HPMC K100M skeleton material, and then 50mg of PVPK90 ethanol solution is added to make a soft material by hand, and wet granules are made through a 20-mesh sieve , placed in an oven and dried at 45°C for 2 hours, granulated through a 20-mesh sieve, weighed, added with 6.5 mg of magnesium stearate, and mixed well to make niacin sustained-release layer granules;

[0035]Take lovastatin, pass through a 100-mesh sieve, and mix thoroughly with carboxymethyl starch sodium 5 mg, microcrystalline cellulose 25 mg, starch 15 mg, and lactose 15 mg according to the weight ratio of 20 mg lovastatin per tablet, and add PVPK30 ethanol solution to make it manually The soft material is granulated through a 22-mesh sieve, dried in an oven at 60°C for 1 hour, the dry granules are granulated through a 22-mesh sieve, and 1 mg of magnesiu...

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Abstract

The invention relates to a lovastatin and niacin sustained-release preparation. Each tablet contains 500mg niacin and 20mg lovastatin according to weight proportion; matrix tablets preparation technology is adopted to prepare the niacin as a sustained-release share and the lovastatin as a quick-release share; and the two shares are compressed to be a compound sustained release tablet. The compound preparation is mainly used for treating hypercholesterolemia, and the HDL is increased by 41%, the LDL is decreased by 45%, and the triglyceride is decreased by 42% after one year treatment. The development of the sustained release tablet can effectively control the release of medicament so that the medicament release rate can reach a preset value, the blood concentration is smoother and the fluctuation phenomenon lead by common preparation is decreased. The invention ensures that not only the toxic side effect caused by the common preparation is reduced, and the deficient of frequent medicine taking is overcame but also the situations of missing or forgetting are avoided and the use is convenient for a patient. When the two are jointly used, synergic action is obtained. The invention has simple preparation process and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a lovastatin nicotinic acid slow-release preparation and a preparation method thereof. Background technique [0002] Nicotinic acid, also known as Nicotinic acid, is a kind of B vitamins and is one of the effective drugs for treating hyperlipidemia. It can reduce the content of low-density lipoprotein and triglyceride, and increase the content of high-density lipoprotein. content. [0003] Lovastatin is a hydroxymethylglutaryl-CoA reductase inhibitor, which is the drug of choice for lowering cholesterol clinically. Clinical studies have proved that taking these two drugs at the same time has a significantly better effect on alleviating hypercholesterolemia than taking either single preparation alone. Combination of the two medicines can generally improve blood lipid status. Chinese Patent No. ZL200510112698.7 discloses "a compound niacin sustained-release capsule and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/455A61K47/38A61P3/06A61K31/366
Inventor 孙桂荣曹瑞山李振霞徐田民
Owner QINGDAO HUANGHAI PHARM CO LTD
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