Statin and vitamin D composition and preparation method and application thereof

A composition and vitamin technology, applied in the directions of drug combinations, active ingredients of heterocyclic compounds, pharmaceutical formulations, etc., can solve problems such as rhabdomyolysis, and achieve the effects of improved solubility, small and uniform particle size, and strong drug-carrying capacity

Active Publication Date: 2020-10-13
BEIJING CHAOYANG HOSPITAL CAPITAL MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Muscle toxicity with statins, particularly possible rhabdomyolysis

Method used

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  • Statin and vitamin D composition and preparation method and application thereof
  • Statin and vitamin D composition and preparation method and application thereof
  • Statin and vitamin D composition and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0027] One implementation is:

[0028] The composition includes: a statin composition and vitamin D as active ingredients, wherein the material ratio of the two is 1-80 mg of the statin composition and 1000-50000 units of vitamin D.

[0029] Wherein, the statin composition includes lovastatin, pravastatin, simvastatin, fluvastatin, atorvastatin, rosuvastatin or pitavastatin; vitamin D includes vitamin D2 and / or vitamin D3.

[0030] Another embodiment is: a composition, including: a statin composition and vitamin D as active ingredients, and also includes: an oil phase, a surfactant, a co-surfactant, and a solid adsorbent, wherein the material ratio of the two is The statin composition is 1-80 mg, the vitamin D is 1000-50000 units, and the weight ratio of oil phase, surfactant, co-surfactant and solid adsorbent is 1:1-2:1-3:2-3.

[0031] The statin drug and vitamin D are mixed and then added to the oil phase to stir and dissolve to form an oil phase system. The surfactant and ...

example 1

[0034] Composition, prepared into dispersible tablets;

[0035] Dissolve sodium carboxymethyl cellulose in an appropriate amount of distilled water and stir until gelatinous. Weigh the prescription amount of statin, vitamin D3 composition and starch to mix, add carboxymethyl cellulose sodium solution and mix to prepare soft material, sieve the prepared soft material by extrusion method, and then dry it in an oven at 30°C , after sieving the dry granules and adding sodium carboxymethyl starch for mixing, adding talcum powder and mixing evenly, and performing manual tablet compression with a tablet machine to prepare solid dispersible tablets of the composition of statin and vitamin D3.

[0036] Appropriate amount of statin × 1000, vitamin D3 2000 units × 1000, sodium carboxymethylcellulose 0.5g, talcum powder 0.3g, starch 12.7g, appropriate amount of water, made into 1000 tablets.

[0037] The dosage ratio of each dispersible tablet containing statins and vitamin D3:

[0038]...

example 2

[0040] Composition, prepared into capsules;

[0041] Weigh the prescribed amount of statin and vitamin D2 composition, microcrystalline cellulose, and cross-linked carboxymethyl cellulose, mix evenly for 30 minutes, add an appropriate amount of 2% hypromellose aqueous solution to make a soft material, pass through a 24-mesh sieve to granulate , dried at 60°C, the dry granules passed through a 24-mesh sieve for granulation, added the prescribed amount of talcum powder and mixed evenly, measured the content of intermediates, calculated the filling volume, and filled with 2# capsules.

[0042] Appropriate amount of statin × 1000, vitamin D2 5000 units × 1000, microcrystalline cellulose 14g, croscarmellose 5g, talcum powder 1g, hypromellose solution (2%) appropriate amount, made into 1000 capsules.

[0043] The dosage ratio of statins and vitamin D2 per capsule:

[0044] Simvastatin (SIM, Simvastatin) 10mg; vitamin D2 5000 units.

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Abstract

The invention discloses a composition. The composition comprises statins and vitamin D in proportion as active components, wherein the statins are 1-80mg, and the vitamin D is 1000-50000 unit. The invention further discloses a preparation method and application of solid self microemulsion. Enough vitamin D can be provided for cooperating with the statins for use, so that relevant toxic and side effects of the statins can be reduced and relieved, and the composition has important operation significance in propelling reconstruction of the statins for reducing the low density lipoprotein level tothe maximum extent and preventing cardiovascular diseases.

Description

technical field [0001] The present invention relates to medicines. More specifically, the present invention relates to a composition of statin and vitamin D, its preparation method and application. Background technique [0002] Hyperlipidemia refers to high blood lipid levels, which can directly cause some diseases that seriously endanger human health, such as atherosclerosis, coronary heart disease, pancreatitis, etc. The clinical manifestations of hyperlipidemia are mainly xanthoma caused by lipid deposition in the dermis and arteriosclerosis caused by lipid deposition in the vascular endothelium. Dyslipidemia is often associated with multiple cardiovascular risk factors. The decrease of blood lipid level will make the incidence of cardiovascular disease and mortality decrease with the decrease of serum total cholesterol and LDL cholesterol level. [0003] Statins are first-line lipid-lowering drugs and are widely used in clinical practice. Statins are selective inhibi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/592A61K31/593A61K31/366A61K31/22A61K31/405A61K31/40A61K31/505A61K31/47A61K31/4709A61K9/107A61K47/44A61K47/14A61K47/04A61K47/02A61P3/06A61P9/00A61P1/16A61P13/12A61P29/00
CPCA61K45/06A61K31/592A61K31/593A61K31/366A61K31/22A61K31/405A61K31/40A61K31/505A61K31/47A61K31/4709A61K9/1075A61K47/44A61K47/14A61K47/02A61P3/06A61P9/00A61P1/16A61P13/12A61P29/00A61K2300/00
Inventor 刘丽宏宫丽丽刘河任路路万子睿于晓佳王华光
Owner BEIJING CHAOYANG HOSPITAL CAPITAL MEDICAL UNIV
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