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Pravastatin sodium pharmaceutical co-crystal and preparation method and application thereof

A technology of pravastatin sodium and drugs, which is applied in the field of pravastatin sodium drug co-crystal and its preparation, can solve problems such as inaccurate prediction, and achieve the effects of promoting kinetic advantages, improving mobility, and using less

Active Publication Date: 2015-12-23
NAT INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Despite the success of the synthon approach, it is not yet possible to accurately predict which co-crystals will form, and there are other unknown factors affecting whether they form co-crystals

Method used

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  • Pravastatin sodium pharmaceutical co-crystal and preparation method and application thereof
  • Pravastatin sodium pharmaceutical co-crystal and preparation method and application thereof
  • Pravastatin sodium pharmaceutical co-crystal and preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0043] Put an equimolar amount of pravastatin sodium and the following CCF molecules in an agate mortar, add methanol or water to it, and then grind, add methanol or water continuously during the grinding process, grind for 30 minutes, take it out, and place Dry in a vacuum oven at 60°C to obtain the pravastatin sodium drug co-crystal.

[0044] CCF molecules: amino acids: histidine, lysine, arginine, threonine, isoleucine, serine, methionine, valine, phenylalanine, aspartic acid; ureas: thiourea, Urea; adamantane derivatives: 1-adamantanamine hydrochloride, 1-adamantanecarboxylic acid; other small molecules: saccharin, malic acid.

[0045] In order to confirm the formation of the co-crystal compound, the co-crystal mixture (GM) and the physical mixture (PM, obtained by mixing equimolar amounts of pravastatin sodium and CCF molecules) were compared by Fourier infrared spectroscopy (FT-IR). Investigate the stretching vibration frequency corresponding to -OH, -NH, -C=O at 2500~3...

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Abstract

The invention belongs to the technical field of organic pharmaceutical co-crystals, and particularly relates to a pravastatin sodium pharmaceutical co-crystal and a preparation method and application thereof. The pravastatin sodium pharmaceutical co-crystal comprises co-crystal formations and active components pravastatin sodium. The co-crystal formations are amino acid, urea, adamantine derivatives or other small molecule compounds. The result shows that before and after the co-crystal is formed, the moisture absorption performance of medicine is remarkably changed, for example, the co-crystal hygroscopicity of lysine and urea is increased, and a co-crystal formed by amantadine hydrochloride basically does not absorb moisture at the humidity of 70% or lower.

Description

technical field [0001] The invention belongs to the technical field of organic drug co-crystals, and in particular relates to a pravastatin sodium drug co-crystal, a preparation method and application thereof. Background technique [0002] Pravastatin sodium, the English name is PravastatinSodium, the chemical name is {1S-[1α(βS*, δS*), 2α, 6α, 8β(R*), 8aα]}-1,2,6,7,8, 8a-Hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-1-naphthalene heptanoic acid monosodium salt, is 3-hydroxy 3 -Competitive inhibitor of methylglutaryl coenzyme A reductase (HMG-CoA reductase), is a high-efficiency lipid-lowering drug, and can significantly slow down the process of atherosclerosis, and can be used for hyperlipidemia, familial Hypercholesterolemia. However, pravastatin sodium belongs to the third class of drugs in the Biopharmaceutical Classification System (BCS), and there are still many challenges as a solid oral dosage form, such as low bioavailability (17%), high water solub...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C69/33C07C67/52C07C227/42C07C229/26C07C229/36C07C229/22C07C209/86C07C211/38C07C273/16C07C335/02A61P3/06A61P9/10
CPCC07B2200/13C07C67/52C07C69/33C07C209/86C07C211/38C07C227/42C07C229/22C07C229/26C07C229/36C07C273/16C07C335/02
Inventor 张娜武香香吕扬何兰杨化新
Owner NAT INST FOR FOOD & DRUG CONTROL
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