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Compound simvastatin niacin sustained release tablet and preparation method thereof

A technology for simvastatin and sustained-release tablets, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc. It can solve the problems of niacin adverse reactions, poor patient compliance, skin flushing, etc., and reduce the number of medications , reduce toxic and side effects, reduce the effect of fluctuations

Inactive Publication Date: 2009-11-11
WUXI DINGFU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in large doses of niacin, there are serious adverse reactions, including skin flushing, liver toxicity, etc., which make the tolerance and drug compliance of niacin poor, which greatly limits the application of niacin
Moreover, niacin is metabolized very quickly in the human body, with a half-life of about 45 minutes. It needs to be taken more than 3 times a day, and the patient's compliance is poor.

Method used

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  • Compound simvastatin niacin sustained release tablet and preparation method thereof
  • Compound simvastatin niacin sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Chip:

[0035] Niacin 500mg

[0036] Hypromellose 2208 200mg

[0037] Stearic acid 7mg

[0038] Isolation layer:

[0039] Hypromellose 2910 10mg

[0040] Macrogol 400 1mg

[0041] Simvastatin layer:

[0042] Simvastatin 10mg

[0043] Hypromellose 2910 50mg

[0044] Macrogol 400 5mg

[0045] tert-butylhydroxyanisole 0.3mg

[0046] Protective film coating layer:

[0047] Hypromellose 2910 20mg

[0048] Macrogol 400 2mg

[0049] Titanium Dioxide 2mg

[0050] The preparation method is as follows:

[0051] Preparation of tablet cores: Mix niacin and hypromellose 2208 evenly, make granules with suitable equipment such as a strong mixer, dry and granulate, add stearic acid, mix well, and press into tablets to obtain the product.

[0052] Coating isolation layer: make hypromellose 2910 and polyethylene glycol 400 into a coating solution, place the prepared tablet core in a high-efficiency coating machine or other coating equipment, spray the coating solution, and ...

Embodiment 2

[0056] Chip:

[0057] Niacin 500mg

[0058] Hypromellose 2208 200mg

[0059] Stearic acid 14mg

[0060] Isolation layer:

[0061] Hypromellose 2910 10mg

[0062] Macrogol 400 1mg

[0063] Simvastatin layer:

[0064] Simvastatin 10mg

[0065] Hypromellose 2910 50mg

[0066] Macrogol 400 5mg

[0067] Propyl gallate 0.3mg

[0068] Protective film coating layer:

[0069] Hypromellose 2910 20mg

[0070] Macrogol 400 2mg

[0071] Yellow Iron Oxide 2mg

[0072] The preparation method is as follows:

[0073] Preparation of tablet cores: Mix niacin and hypromellose 2208 evenly, make granules with suitable equipment such as a strong mixer, dry and granulate, add stearic acid, mix well, and press into tablets to obtain the product.

[0074] Coating isolation layer: make hypromellose 2910 and polyethylene glycol 400 into a coating solution, place the prepared tablet core in a high-efficiency coating machine or other coating equipment, spray the coating solution, and blow Ho...

Embodiment 3

[0078] Chip:

[0079] Niacin 500mg

[0080] Hypromellose 2208 200mg

[0081] Stearic acid 7mg

[0082] Povidone 35mg

[0083] Isolation layer:

[0084] Hypromellose 2910 10mg

[0085] Macrogol 400 1mg

[0086] Polysorbate 80 0.25mg

[0087] Simvastatin layer:

[0088] Simvastatin 10mg

[0089] Hypromellose 2910 50mg

[0090] Macrogol 400 5mg

[0091] Polysorbate 80 1.25mg

[0092] Citric acid 0.1mg

[0093] Protective film coating layer:

[0094] Hypromellose 2910 20mg

[0095] Macrogol 400 2mg

[0096] Polysorbate 80 0.5mg

[0097] Tartrazine 2mg

[0098] The preparation method is as follows:

[0099] Preparation of tablet cores: Mix nicotinic acid, hypromellose 2208, and povidone evenly, make granules with suitable equipment such as a strong mixer, dry and granulate, add stearic acid, mix well, and press into tablets to obtain the product.

[0100] Coating isolation layer: make hypromellose 2910, polyethylene glycol 400, and polysorbate 80 into a coating li...

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PUM

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Abstract

The invention discloses a compound simvastatin niacin sustained release tablet and a preparation method thereof. The compound simvastatin niacin sustained release tablet consists of the following four components: (1) a tablet core containing niacin; (2) an isolation layer; (3) a simvastatin layer; and (4) a protective film-coat layer. In the compound preparation, the niacin serves as a sustained release component and the simvastatin serves as a quick release component, thus all components play a synergistic action in vivo to comprehensively adjust the components of blood fat so as to play the drug action to the utmost extent, reduce the toxic side effects of the medicaments, reduce the fluctuation of the blood concentration in vivo, and reduce the dosing frequency of a patient; and the compound simvastatin niacin sustained release tablet is applicable to treating hypercholesteremia and mixed dyslipidemia.

Description

technical field [0001] The invention relates to a compound simvastatin nicotinic acid sustained-release tablet and a preparation method thereof. Background technique [0002] In recent years, with the improvement of people's living conditions and changes in eating habits, the incidence of hypercholesterolemia and mixed dyslipidemia has gradually increased. Hypercholesterolemia and mixed blood lipid abnormalities are the main causes of atherosclerosis, which in turn cause cardiovascular and cerebrovascular diseases, including coronary heart disease, stroke, myocardial infarction, etc., which seriously endanger human health. At present, among various diseases, the morbidity and mortality of cardiovascular and cerebrovascular diseases rank first. [0003] Among blood lipid components, high cholesterol and triglycerides are the main causes of atherosclerosis and further cardiovascular and cerebrovascular diseases; while high-density lipoprotein is just the opposite, it can deco...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/455A61K31/366A61K9/28A61K9/24A61K9/36A61P3/06
Inventor 沈立新梁晓晖刘福双邹济高于威
Owner WUXI DINGFU PHARMA
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