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Slow-release preparation containing tamsulosin hydrochloride and preparation method thereof

A technology for tamsulosin hydrochloride and sustained-release preparations, which are applied to the sustained-release preparations containing tamsulosin hydrochloride and the field of preparation thereof, to achieve the effects of reducing side effects, reducing the number of times of taking medicines, and prolonging the constant-speed release time

Inactive Publication Date: 2012-07-18
CHONGQING KERUI PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, there are multiple formulations and techniques for preparing sustained-release tablets (agents) of tamsulosin hydrochloride. These methods have their own advantages and disadvantages. For example, the controlled-release formulation containing tamsulosin hydrochloride disclosed in CN101128190A can Solve the preparation of sustained-release agents to a certain extent

Method used

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Examples

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Effect test

preparation example Construction

[0027] The embodiment also provides a preparation method of a sustained-release formulation containing tamsulosin hydrochloride, including steps A to C:

[0028] A) Preparation of plain tablets:

[0029] a) Take tamsulosin hydrochloride and add a wetting agent and stir to dissolve it, then add an adhesive to the solution, and stir thoroughly to obtain the main drug solution; the wetting agent is selected from: water, methanol, ethanol, absolute ethanol , starch slurry, chloroform, acetone, povidone, cross-linked polyvinylpyrrolidone and / or hydroxypropyl methylcellulose, the binder is selected from: water, ethanol, absolute ethanol, starch slurry, polyvinyl ketones, crospovidone and / or hydroxypropylmethylcellulose. b) Stir the filler and the skeleton material to mix evenly, add the main drug solution prepared in step a) after mixing, wash the container wall with a wetting agent to obtain a mixture; put the mixture into the granulator, and continue to stir until into granules,...

Embodiment 1

[0035] formula:

[0036] Tamsulosin Hydrochloride 10g Copovidone 20g microcrystalline cellulose 40 sucrose 80g hypromellose 50g Magnesium stearate 2g Methanol Appropriate amount Opadry 10 g water Appropriate amount production 1000 pieces

[0037] Preparation process:

[0038] 1 Preparation process of plain tablets

[0039] 1.1 Preparation of the main drug-containing adhesive

[0040] Take 10 g of tamsulosin hydrochloride and add 60 g of methanol and stir to dissolve, then add 20 g of copovidone and stir to dissolve, and place it away from light for later use.

[0041] 1.2 Granulation

[0042] Crush the sucrose, pass it through a 80-mesh sieve, and put it into a wet mixing granulator together with microcrystalline cellulose and hypromellose, stir to mix evenly, and then add the binder containing the main ingredient to granulate , Rinse the container wall with an appropriate amount of methanol, and add i...

Embodiment 2

[0051] formula:

[0052] Tamsulosin Hydrochloride 15g povidone 20g microcrystalline cellulose 40g sucrose 40g Ethyl cellulose 40g starch 40g talcum powder 2g ethanol Appropriate amount Opadry 5 g water Appropriate amount production 1000 pieces

[0053] Preparation process:

[0054] 1 Preparation process of plain tablets

[0055] 1.1 Preparation of the main drug-containing adhesive

[0056] Take 15g of tamsulosin hydrochloride and add 70g of ethanol and stir to dissolve, then add 20g of povidone and stir to dissolve, and place it away from light for later use.

[0057] 1.2 Granulation

[0058] Pulverize sucrose, pass through 80-mesh sieve, and put it into a wet mixing granulator together with microcrystalline cellulose, ethyl cellulose, and starch, stir to mix evenly, and add the binder containing the main ingredient after mixing. For granulation, wash the container wall with an appropriate amount...

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Abstract

The invention discloses a slow-release preparation containing tamsulosin hydrochloride. The slow-release preparation is a combination comprising a coating and a plain film coated in the coating. The invention further provides a method for preparing the slow-release preparation containing the tamsulosin hydrochloride according to a formula. In the method, the preparation of the slow-release preparation can be completed by adopting a novel medicament formula and the conventional equipment. The tamsulosin hydrochloride slow-release preparation prepared with the method can be used for effectively controlling the in-vivo release of a medicament, the medicament is only required to be taken once every day, the medicament taking times are reduced, and the in-vivo blood concentration is stable, so that the in-vivo blood concentration of a patient in a medicament taking period is stable and effective, and the safety and effectiveness of the medicament are improved fundamentally.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a slow-release preparation containing tamsulosin hydrochloride and a preparation method thereof. Background technique [0002] Tamsulosin hydrochloride is also known as tamsulosin hydrochloride or tamsulosin hydrochloride or tamsulosin hydrochloride, chemical name 5-[(2R)-2-[2-(2-ethoxyphenylphenoxy)B Base] amino] propyl] -2-methoxybenzenesulfonamide hydrochloride. This product is used for the treatment of benign prostatic hyperplasia. It is an adrenergic α 1 receptor subtype α 1A blocker. Its affinity for α 1 receptors is 5400-24000 times stronger than that of α 2 receptors. Since the α 1 receptors in the urethra, bladder neck and prostate are mainly α 1A receptors, this product has a highly selective blocking effect on the smooth muscle of the urethra, bladder neck and prostate, and has become the first choice in clinical practice. [0003] The slow-release formulat...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/32A61K31/18A61K47/38A61K47/36A61K47/44A61K47/32A61P13/08
Inventor 马滔刘俊敏苏其果蒋倩杨陈孜知杨莲清黄小琴
Owner CHONGQING KERUI PHARMA GRP
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