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Tamsulosin sustained-release pellet preparation and preparation method thereof

A technology of sustained-release pellets and tamsulosin, which is applied in pharmaceutical formulations, medical preparations of non-active ingredients, urinary system diseases, etc., can solve the problems of difficult control of drug release rate and high requirements for coating parameters, and achieve release Good uniformity, simple preparation process and good repeatability

Inactive Publication Date: 2013-09-25
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Application No. 200910233724.X discloses a kind of tamsulosin hydrochloride containing drug-containing pellet double-coated micropill, which is controlled by double-layer slow-release coating to obtain a preparation whose release degree in acid-base medium meets the quality standard. The disadvantage is that although the drug-containing pills are used to assist in the controlled release, and the double-layer coating is jointly controlled, the requirements for the coating parameters are high, especially for small-scale drugs such as tamsulosin, the release rate is difficult to control

Method used

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  • Tamsulosin sustained-release pellet preparation and preparation method thereof
  • Tamsulosin sustained-release pellet preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] Tamsulosin Hydrochloride Sustained Release Capsules (5000 capsules)

[0104] 1) Sucrose core 605g

[0105] 2) Drug-loaded slow-release layer

[0106] Tamsulosin Hydrochloride 1g

[0107] Cellulose acetate 33.75g

[0108] Tween 80 7.5g

[0109] 3) Coating layer

[0110] Udrake L100-55 11.25g

[0111] Sodium Lauryl Sulfate 7.5g

[0112] Weigh the prescription amount of 2) each component in the drug-loaded sustained-release layer, dissolve it in about 600g of 95% ethanol solution to prepare the drug solution,

[0113] Weigh 3) each component of the coating layer and about 500g of purified water, and prepare the coating solution with the above auxiliary materials.

[0114]Put the blank pellet core in the fluidized bed, control the temperature of the material at 30-35°C, adjust the fluidized state, apply the medicine for about 2 hours, dry for 10 minutes after the medicine is applied, take out the upper pill and sieve, the mesh size of the sieve is 18-30 mesh, take t...

Embodiment 2

[0117] Tamsulosin Hydrochloride Sustained Release Capsules (5000 capsules)

[0118] 1) Sucrose core 505g

[0119] 2) Drug-loaded slow-release layer

[0120] Tamsulosin Hydrochloride 1g

[0121] Ethylcellulose 101g

[0122] Sodium Lauryl Sulfate 7.5g

[0123] ATBC (Acetyl Tributyl Citrate) 3.5g

[0124] 3) Coating layer

[0125] Udrake L100-55 9g

[0126] Sodium Lauryl Sulfate 7.5g

[0127] TEC 4g

[0128] 4) Talc powder 12g

[0129] Preparation

[0130] Step 1: Weigh each component according to the formula, dissolve each component of the drug-loaded sustained-release layer in about 500g of 95% ethanol to prepare a drug solution, apply the drug in a fluidized bed, and control the temperature of the material at 30-55°C to prepare on the pill,

[0131] Step 2: Sieve the upper pills, the mesh number of the sieve is 15-30 mesh,

[0132] Step 3: Take about 550g of ethanol to dissolve the components of the coating layer; place the sieved upper pills in a fluidized bed, co...

Embodiment 3

[0136] Tamsulosin Hydrochloride Sustained Release Capsules (5000 capsules)

[0137] 1) Sucrose core 660g

[0138] 2) Drug-loaded slow-release layer

[0139] Tamsulosin Hydrochloride 10g

[0140] Sodium Alginate 300g

[0141] 3) Coating layer

[0142] Udrake L100-55 10g

[0143] TEC 5g

[0144] 4) Micropowder silica gel 4g

[0145] Talc powder 10g

[0146] Preparation

[0147] Step 1: Weigh each component according to the formula, dissolve each component of the drug-loaded slow-release layer in about 300g ethanol to prepare a drug solution, apply the drug in a fluidized bed, and control the temperature of the material at 40-45°C to prepare the drug solution. pill,

[0148] Step 2: Add micropowder silica gel to 2 times the water, spray it in after homogenizing with a high-speed homogenizer for 5 minutes, dry it for 5 minutes, take it out,

[0149] Step 3: Sieve the upper pill, the mesh number of the sieve is 15-30 mesh,

[0150] Step 4: Take about 100g of ethanol to d...

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Abstract

The invention provides a tamsulosin sustained-release pellet, and the drug release of the sustained-release pellet is controlled through a blank pellet core coated with a drug-loaded sustained-release layer and then coated with an enteric coating, and the drug can be both released in an acidic or weak alkaline environment and is absorbed well in vivo. Also, release homogeneity is good, preparation technology is simple and repeatability is good.

Description

technical field [0001] The invention relates to a novel sustained-release pellet preparation and a preparation method thereof, in particular to a tamsulosin hydrochloride sustained-release pellet preparation and a preparation method thereof. Background technique [0002] Tamsulosin hydrochloride is the third-generation super-selective long-acting α-1 inhibitor for prostate smooth muscle. It is a drug that has a therapeutic effect on urinary tract obstructive lesions caused by benign prostatic hyperplasia. Its daily dose is 0.2~ 0.8 mg. Tamsulosin hydrochloride has higher selectivity to the smooth muscle of the prostate, and its dosage is therefore smaller. In order to prevent side effects such as orthostatic hypotension caused by rapid absorption of tamsulosin hydrochloride, it is necessary to prepare it as a sustained-release preparation. better choice. It was successfully developed by Japan's Yamanouchi Pharmaceutical Co., Ltd., and was approved by the FDA in July 1992 u...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/18A61K47/38A61K47/32A61P13/08
Inventor 蔡状朱德志
Owner COSCI MED TECH CO LTD
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