A kind of highly stable simvastatin tablet and preparation method thereof

A technology of simvastatin and high stability, applied in the field of high stability simvastatin tablets and the preparation thereof, can solve the problems of high requirements for production equipment, high requirements for auxiliary materials and equipment, and troublesome production.

Active Publication Date: 2018-02-23
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] CN103356494 A adopts simvastatin coating and then dry pressing method with other auxiliary materials twice to improve the stability of simvastatin tablets, which solves the poor stability of simvastatin tablets in the prior art, but this method has Production equipment requires high requirements, and production is troublesome
[0005] CN103330692 A provides a simvastatin component with improved stability and a preparation method thereof. The formulation, dosage and addition method of auxiliary materials are reasonably selected in a manner without adding an antioxidant to maintain the stability of simvastatin. However, the method is a direct compression method. Tablets, higher requirements on auxiliary materials and equipment

Method used

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  • A kind of highly stable simvastatin tablet and preparation method thereof
  • A kind of highly stable simvastatin tablet and preparation method thereof
  • A kind of highly stable simvastatin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Simvastatin tablets include the following components: 10g of simvastatin, 15g of pregelatinized starch, 0.05g of butylated hydroxyanisole, 0.5g of povidone K30, 50g of lactose, 40g of microcrystalline cellulose, 4g of hydroxypropyl cellulose, Hypromellose 1g, magnesium stearate 0.6g, micro silica gel 1.2g.

[0049] Above-mentioned simvastatin tablet is prepared by following method:

[0050] Weigh each component according to the formula, pass each component through an 80-mesh sieve, and set aside; bake the pregelatinized starch at 105°C for 2 hours, and set aside; dissolve povidone K30 in absolute ethanol to prepare mass Concentration is 12% dehydrated ethanol solution, standby; Hypromellose is dissolved in water B to make the aqueous solution with mass concentration of 2%, standby;

[0051] Mix simvastatin and pregelatinized starch evenly, dissolve butylated hydroxyanisole in absolute ethanol; use the above-mentioned povidone K30 absolute ethanol solution to make the a...

Embodiment 2

[0056] Simvastatin tablets include the following components: 10g of simvastatin, 10g of pregelatinized starch, 0.04g of butylated hydroxyanisole, 0.3g of povidone K30, 48g of lactose, 38g of microcrystalline cellulose, and 3.5g of hydroxypropyl cellulose , hypromellose 0.8g, magnesium stearate 0.4g, micro silica gel 0.8g.

[0057] Above-mentioned simvastatin tablet is prepared by following method:

[0058] Weigh each component according to the formula, pass each component through a 60-mesh sieve, and set aside; bake the pregelatinized starch at 100°C for 2 hours, and set aside; dissolve povidone K30 in absolute ethanol to make a mass 10% dehydrated ethanol solution for subsequent use; dissolving hypromellose in water ethyl alcohol to prepare an aqueous solution with a mass concentration of 1% for subsequent use;

[0059] Mix simvastatin and pregelatinized starch evenly, dissolve butyl hydroxyanisole in absolute ethanol; use the above-mentioned povidone K30 absolute ethanol so...

Embodiment 3

[0064] Simvastatin tablets include the following components: 20g of simvastatin, 15g of pregelatinized starch, 0.05g of butylated hydroxyanisole, 0.8g of povidone K30, 52g of lactose, 42g of microcrystalline cellulose, and 4.5g of hydroxypropyl cellulose , hypromellose 1.5g, magnesium stearate 1.0g, micro silica gel 1.8g.

[0065] Above-mentioned simvastatin tablet is prepared by following method:

[0066] Weigh each component according to the formula, pass each component through a 100-mesh sieve, and set aside; bake the pregelatinized starch at 110°C for 3 hours, and set aside; dissolve povidone K30 in absolute ethanol to prepare mass Concentration is 15% absolute ethanol solution, for subsequent use; Hypromellose is dissolved in water B to make an aqueous solution with a mass concentration of 3%, for subsequent use;

[0067] Mix simvastatin and pregelatinized starch evenly, dissolve butylated hydroxyanisole in absolute ethanol; use the above-mentioned povidone K30 absolute ...

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Abstract

The invention discloses a highly stable simvastatin tablet. The simvastatin tablet comprises the following components in parts by weight: 5-20 parts of simvastatin, 8-20 parts of pregelatinized starch, butylated hydroxyanisole 0.03‑0.06 part, 0.3‑1 part of povidone K30, 45‑55 part of lactose, 35‑45 part of microcrystalline cellulose, 3‑5 part of hypromellose, 0.5‑2 part of hypromellose, stearin Magnesium acid 0.2-1.2 parts, micro silica gel 0.6-2.4 parts. The preparation of the simvastatin tablet of the present invention adopts two-part granulation, the simvastatin and the pregelatinized starch adopt absolute ethanol, and are baked at a lower temperature to avoid degradation of the simvastatin; the other part is baked at a higher temperature. The granules prepared by the invention have good compressibility and fluidity. The disintegration time of the prepared tablet is suitable, the tablet content, content uniformity and dissolution rate all meet the requirements, has high stability, the production method is simple, and is suitable for industrialized production.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a highly stable simvastatin tablet and a preparation method thereof. Background technique [0002] Simvastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, and is a highly effective hypolipidemic drug. Simvastatin can block the synthesis of cholesterol. Its functions are as follows: 1. Competitively inhibit the rate-limiting enzyme in the cholesterol synthase system - methylhydroxyglutaryl-CoA reductase, so that cholesterol synthesis is inhibited. 2. Increase the low-density lipoprotein receptors on the surface of liver cells, increase the clearance of low-density lipoprotein cholesterol, and also increase the clearance of very low-density lipoprotein, the precursor of low-density lipoprotein. 3. Increase the synthesis of high-density lipoprotein cholesterol, which is beneficial to the transport and removal of cholesterol. The drug ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/366A61K9/20A61K47/38A61K47/36A61K47/32A61K47/26A61K47/02A61K47/04A61P3/06
Inventor 曾培安胡良红吴健民张静刘娟
Owner KAMP PHARMA
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