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Dissolution rate detection method for simvastatin

A technology of simvastatin and detection method, applied in the field of detection of simvastatin dissolution, can solve the problem of not reflecting the release and absorption of simvastatin, and achieve the effect of good linear relationship and strong specificity

Inactive Publication Date: 2013-05-01
JIANG SU PHARMAMAXCORP
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Problems solved by technology

[0003] The detection method of simvastatin dissolution in niacin simvastatin sustained-release tablets, the Chinese Pharmacopoeia adopts HPLC method, but existing method does not reflect the release and absorption of simvastatin in the human body, therefore, a more reasonable method must be established The advanced detection and analysis method can more objectively reflect the dissolution of simvastatin and provide a basis for scientific and safe drug use

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  • Dissolution rate detection method for simvastatin
  • Dissolution rate detection method for simvastatin
  • Dissolution rate detection method for simvastatin

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Embodiment 1

[0036] Embodiment 1 Determination of Simvastatin Dissolution

[0037] The mensuration of simvastatin dissolution rate comprises the following steps:

[0038] 1) Preparation of dissolution medium: Weigh 10.8 g of sodium dihydrogen phosphate dihydrate and 30 g of sodium lauryl sulfate and dissolve them in 6000 mL of degassed water, stir with a glass rod, and adjust the pH to 7.00 with 20% NaOH solution ±0.05.

[0039] 2) Preparation of sample solution: Take niacin / simvastatin sustained-release tablets (500 mg / 20 mg), add the dissolution medium in step 1), add the tablet sinker using the paddle method, at a paddle speed of 50 rpm Under, carry out dissolution experiment, dissolution temperature is 37.0 ± 0.5 ℃, obtains sample solution;

[0040] 3) Preparation of simvastatin reference solution: Accurately weigh about 22 mg to 100-mL volumetric flask of simvastatin reference substance, add about 50 mL of mobile phase to dissolve, add mobile phase to dilute to volume, and mark the ...

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Abstract

The invention provides a dissolution rate detection method for simvastatin, which comprises the following steps: 1) preparation of dissolution medium: dissolving sodium phosphate dibasic dehydrate and sodium dodecyl sulfate in water, stirring, and adjusting the pH value to 6.95-7.005, so as to obtain the dissolution medium; 2 sample solution preparation: adding a nicotinic acid / simvastatin sustained release tablet in the dissolution medium obtained in the step 1), performing a dissolution experiment at the paddle rotating speed of 50 rounds / minute by adopting the paddle method and a tablet sedimentation method, so as to obtain the sample solution; 3) contrast solution preparation: weighing a simvastatin reference product, and adding into a mobile phase for dissolving, so as to obtain the contrast solution; 4) detection: taking the contrast solution and sample solutions at all dissolution time points, recording the chromatogram and analyzing; and 5) calculating the dissolution rate. The dissolution rate detection method can objectively reflect dissolution release action of the simvastatin, and can detect the dissolution rate of the simvastatin simply, conveniently, quickly and accurately, and can accurately detect the quality of the agent.

Description

technical field [0001] The invention relates to a method for detecting the dissolution rate of simvastatin, which belongs to the field of chemical drug analysis. Background technique [0002] Simvastatin is a hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, and is an internationally recognized high-efficiency blood lipid-lowering drug. The drug has strong effects, high curative effect and mild side effects. Because of its safety, high efficiency and low toxicity, it has become the most commonly used blood lipid-lowering drug in the world. Simvastatin has a significant effect on reducing low-density lipoprotein (LDL), but has a weak effect on increasing high-density lipoprotein (HDL). Therefore, it is often used in combination with niacin to make niacin simvastatin sustained-release tablets . The combined use of the two can not only enhance its blood lipid-lowering effect, but also reduce side effects. It is clinically used to treat hypercholesterolemia (type...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 蒋志君黄小棠陈幸幸
Owner JIANG SU PHARMAMAXCORP
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