Trimetazidine sustained release capsule and preparation method thereof

A slow-release capsule and trimetazidine technology, applied in the field of medicine, can solve the problems of long coating cycle, uneconomical, large coating amount, etc., and achieve the effects of reducing drug resistance, eliminating peak concentration, and rapidly absorbing

Inactive Publication Date: 2012-07-11
TIANJIN KAIWEN BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Kollicoat SR 30D is an aqueous dispersion of polyvinyl acetate (PVA), which is composed of 27% PVA, 2.7% povidone (PVPK30) and sodium lauryl sulfate, wherein PVPK30 is a water-soluble material; Eudragit NE 30D is a copolymer of ethyl acrylate and methyl methacrylate, which is a medium-permeability coating material; use these two coating materials to coat trimetazidine dihydrochloride with a solubility in water greater than 1000mg / ml Coating controls its release, the coating amount is relatively large, and the coating cycle is relatively long, which is uneconomical in practical applications and is not an ideal method

Method used

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  • Trimetazidine sustained release capsule and preparation method thereof
  • Trimetazidine sustained release capsule and preparation method thereof
  • Trimetazidine sustained release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Trimetazidine hydrochloride sustained-release capsules contain the following components:

[0030] Trimetazidine Hydrochloride 35g

[0031] Hydroxypropylmethylcellulose (HPMC) 10g

[0032] Blank Base Pills 200g

[0033] Eudragit RS 100 20g

[0034] Triethyl citrate 1.2g

[0035] Talc powder 22g

[0036] ------------------------------

[0037] Total 280.2g

[0038] Preparation Process:

[0039] Preparation of drug-containing pellets: Weigh the hydroxypropyl methylcellulose required in the prescription and dissolve it in pure water to make HPMC solution, then add the prescribed amount of trimetazidine hydrochloride, and mix it in a high-shear mixing emulsifier Uniform suspension; put the prescribed amount of blank pellets into the coating pan, adjust the speed of the coating pan, preheat, adjust the blowing temperature, so that the temperature of the pellet bed reaches the required level, spray the above suspension evenly into the coating pan In the blank pellets;...

Embodiment 2

[0043] Trimetazidine hydrochloride sustained-release capsules contain the following components:

[0044] Trimetazidine Hydrochloride 35g

[0045] Hydroxypropylmethylcellulose (HPMC) 9g

[0046] Blank Base Pills 180g

[0047] Eudragit RS 100 20g

[0048] Eudragit S 100 10g

[0049] Triethyl citrate 2.7g

[0050] Talc powder 30g

[0051] --------------------------------

[0052] Total 283.7g

[0053] Preparation Process:

[0054] Preparation of drug-containing pellets: Weigh part of the hydroxypropyl methylcellulose required in the prescription and dissolve it in pure water to make an HPMC solution, then add the prescribed amount of trimetazidine hydrochloride, and mix it in a high-shear mixing emulsifier. into a uniform suspension; put the prescribed amount of blank base pellets into the fluidized bed, adjust the blowing temperature, adjust the air volume, preheat, so that the temperature of the pellet bed reaches the required level, and spray the suspension into the bla...

Embodiment 3

[0058] Trimetazidine hydrochloride sustained-release capsules contain the following components:

[0059] Trimetazidine Hydrochloride 35g

[0060] Hydroxypropylmethylcellulose (HPMC) 10g

[0061] Blank Base Pills 180g

[0062] Eudragit RS30D 25g

[0063] Eudragit L30D-55 5g

[0064] Triethyl citrate 2.2g

[0065] Talc powder 30g

[0066] --------------------------

[0067] Total 279.2g

[0068] Preparation Process:

[0069] Preparation of drug-containing pellets: Weigh the hydroxypropyl methylcellulose required in the prescription and dissolve it in pure water to make HPMC solution, then add the prescribed amount of trimetazidine hydrochloride, and mix it in a high-shear mixing emulsifier Uniform suspension; put the prescribed amount of blank base pills into the fluidized bed, adjust the blowing temperature, adjust the air volume, preheat to make the temperature of the pellet bed reach the required level, and spray the above suspension into the blank pellets evenly; T...

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PUM

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Abstract

The invention relates to a trimetazidine or salt sustained release capsule and a preparation method thereof. The trimetazidine sustained release capsule comprises the following components in percentage by weight: 5-50 percent of trimetazidine, 5-30 percent of auxiliary materials playing a role in sustained release and 45-85 percent if other auxiliary materials. The trimetazidine sustained release capsule and the preparation method thereof are characterized in that (1), a capsule content is a pellet; (2), the medicated pellet is firstly prepared, and a sustained release preparation is then prepared; and (3), the release of a drug is controlled through a controlled release membrane enwrapped by the pellet.

Description

Technical field: [0001] The invention relates to the technical field of medicine, specifically, it designs a sustained-release capsule capable of long-term release for oral administration of trimetazidine or a salt thereof and a preparation method thereof. technical background: [0002] Trimetazidine, 1-(2,3,4-trimethoxybenzyl)piperazine, is a drug that avoids intracellular adenosine triphosphate (ATP) levels by maintaining cellular energy metabolism in hypoxic or ischemic environments reduced substance. This ensures the function of the ion pump and the flow of sodium-potassium across the membrane and keeps the intracellular environment stable. [0003] Trimetazidine salts are mainly dihydrochloride, which is used for the preventive treatment of angina pectoris, chorioretinal damage and the treatment of vertigo (Ménière's vertigo, tinnitus) at the source of blood vessels. [0004] Trimetazidine dihydrochloride has been administered orally at a dose of 40-60 mg / day. Oral d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/495A61K47/30A61K47/32A61K47/34A61K47/36A61K47/38A61K47/44A61P9/00A61P9/10A61P27/16
Inventor 王浩董坚强
Owner TIANJIN KAIWEN BIO TECH
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