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Enteric preparation containing stable salts of S-adenosyl-L-methionine and preparation method thereof

A technology for adenosylmethionine and enteric-coated preparations is applied in the field of enteric-coated preparations including S-adenosylmethionine stable salt and its preparation, and can solve the problems of dangerous local drug concentration, unsatisfactory treatment effect of S-adenosylmethionine and the like , to achieve the effect of improving the release behavior of the body, the full effect of the drug, and the improvement of the therapeutic effect.

Inactive Publication Date: 2009-11-25
WUXI DINGFU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since this type of enteric-coated tablet is a preparation for single-dose administration, there is a risk of sudden release of the drug and the disadvantages of excessive local drug concentration after the sudden release of the drug, which makes the therapeutic effect of S-adenosylmethionine in practical applications It is not ideal, and its excellent physiological regulation effect has not been brought into full play

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prepare materials according to the following formula, pulverize raw materials and various pharmaceutical excipients, and pass through a 100-mesh sieve.

[0032] Drug-loaded core:

[0033] Adenosylmethionine Butanedisulfonate (Pharmaceutical Active Ingredient) 10g

[0034] Microcrystalline cellulose (excipient) 70g

[0035] Lactose (auxiliary molding agent) 20g

[0036] Water (wetting agent) appropriate amount

[0037] Isolation coating layer:

[0038] Hypromellose (isolation coating material) 2g

[0039] Polyethylene glycol (plasticizer) 0.8g

[0040] Tween-80 (plasticizer) 0.8g

[0041] Talc powder (anti-sticking agent) 2g

[0042] Water (solvent) 96g

[0043] Enteric coating layer:

[0044]Polyacrylic acid resin (Eudragit L 30D-55) (enteric coating material) 25g

[0045] Talc powder (anti-sticking agent) 3.77g

[0046] Triethyl citrate (plasticizer) 0.76g

[0047] Water (dispersion medium) 17.64g

[0048] Mix the above prescription amount of adenosylmethi...

Embodiment 2

[0049] Example 2: Adenosylmethionine butanedisulfonate enteric-coated pellets (1000 capsules)

[0050] Prepare materials according to the following formula, pulverize raw materials and various pharmaceutical excipients, and pass through a 100-mesh sieve.

[0051] Drug-loaded core:

[0052] Adenosylmethionine Butanedisulfonate (Pharmaceutical Active Ingredient) 10g

[0053] Microcrystalline cellulose (excipient) 70g

[0054] Starch (auxiliary molding agent) 20g

[0055] Cross-linked sodium carboxymethyl starch (disintegrant) 2g

[0056] Water (wetting agent) appropriate amount

[0057] Isolation coating layer:

[0058] Hypromellose (isolation coating material) 2.04g

[0059] Polyethylene glycol (plasticizer) 0.82g

[0060] Tween-80 (plasticizer) 0.82g

[0061] Talc powder (anti-sticking agent) 2.04g

[0062] Water (solvent) 97.92g

[0063] Enteric coating layer:

[0064] Hydroxypropylmethylcellulose acetate succinate (enteric coating material) 25.5g

[0065] Talc po...

Embodiment 3

[0069] Example 3: Adenosylmethionine butanedisulfonate enteric-coated pellets (1000 capsules)

[0070] Prepare materials according to the following formula, pulverize raw materials and various pharmaceutical excipients, and pass through a 100-mesh sieve.

[0071] Drug-loaded core:

[0072] Adenosylmethionine Butanedisulfonate (Pharmaceutical Active Ingredient) 100g

[0073] Microcrystalline cellulose (excipient) 90g

[0074] Lactose (auxiliary molding agent) 10g

[0075] 5% polyvinylpyrrolidone aqueous solution (adhesive) appropriate amount

[0076] Isolation coating layer:

[0077] Hypromellose (isolation coating material) 4g

[0078] Polyethylene glycol (plasticizer) 1.6g

[0079] Tween-80 (plasticizer) 1.6g

[0080] Talc powder (anti-sticking agent) 4g

[0081] Water (solvent) 192g

[0082] Enteric coating layer:

[0083] Polyacrylic acid resin (Eudragit L 30D-55) (enteric coating material) 50g

[0084] Talc powder (anti-sticking agent) 7.54g

[0085] Triethyl c...

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PUM

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Abstract

The invention provides an enteric preparation including stable salts of S-adenosyl-L-methionine and the preparation method thereof. The enteric preparation is made by loading a plurality of independent enteric micropills including stable salts of S-adenosyl-L-methionine into a capsule, and characterized by no phenomenon of medicine burst release or local high concentration, not being affected by food, full medicine function, and slight untoward effect.

Description

technical field [0001] The invention relates to a stable S-adenosylmethionine salt preparation, more specifically, an enteric-coated preparation including a stable S-adenosylmethionine salt and a preparation method thereof. Background technique [0002] S-adenosylmethionine, also known as S-adenosylmethionine (S-adenosyl-L-methionine, SAM), is a metabolic intermediate widely present in animals, plants and microorganisms. Various roles are played in the metabolic process. As an important physiologically active molecule in human tissues and body fluids, S-adenosylmethionine mainly plays the role of transmethylation, transsulfurization, and transaminopropylation. It is cysteine, taurine, glutathione Precursor of important substances such as peptides and coenzyme A. A large number of studies have shown that S-adenosylmethionine plays an important role in promoting and maintaining the normal function of the liver, promoting the injury and healing of cartilage tissue, maintainin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/58A61K9/56A61K31/7076A61P1/16A61P19/02A61P25/24A61P25/28
Inventor 刘福双沈立新李斌邹济高
Owner WUXI DINGFU PHARMA
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