Tamsulosin hydrochloride sustained-release capsule and preparation method thereof

A technology of tamsulosin hydrochloride and sustained-release capsules, which is applied in the field of oral chemical drug sustained-release preparations, can solve problems such as poor content uniformity, and achieve the effects of low cost, significant economic benefits, and simple and feasible preparation process

Pending Publication Date: 2015-09-02
LUNAN BETTER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Based on this, the inventor thought of preparing tamsulosin hydrochloride into pellet-shaped capsules, which successfully solved the problem of poor content uniformity. Further, in order to improve the dissolution rate of tamsulosin hydrochloride capsules, the inventor added With the addition of an appropriate amount of pH regulator, the dissolution rate is indeed improved, and tamsulosin hydrochloride is in an acidic environment, so the stability of the drug is maintained in long-term storage

Method used

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  • Tamsulosin hydrochloride sustained-release capsule and preparation method thereof
  • Tamsulosin hydrochloride sustained-release capsule and preparation method thereof
  • Tamsulosin hydrochloride sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Prescription and Preparation of Blank Ball Core

[0040]

[0041] Get the microcrystalline cellulose, sorbitol, starch, lactose of recipe quantity and put in centrifugal granulator, use water as binding agent, make the blank ball core that 20 mesh particle diameters are 0.5-2mm;

[0042] Prescription and preparation of the drug-containing layer: 1000 prescriptions

[0043]

[0044] 1. Weigh potassium dihydrogen phosphate and hydroxypropyl-β-cyclodextrin by weight percentage, and make an aqueous solution of 2-6% adhesive with a viscosity of 20mpa.s-35mpa.s;

[0045] 2. Dissolving tamsulosin hydrochloride in the solution in step 1 and stirring slowly to obtain a drug-containing solution, wherein the concentration of tamsulosin hydrochloride solution is 0.08-0.25% by weight;

[0046] 3. The blank ball core is added to the fluidized bed, coated with the drug-containing solution in step 2, and dried to obtain drug-containing pellets of tamsulosin hydrochloride;

[00...

Embodiment 2

[0052] The preparation of blank ball core is identical with embodiment 1;

[0053] The prescription for the drug-containing layer is as follows:

[0054]

[0055] The coating prescription is as follows:

[0056]

[0057] The preparation method is the same as in Example 1.

Embodiment 3

[0059] The preparation of blank ball core is identical with embodiment 1;

[0060] The prescription for the drug-containing layer is as follows:

[0061]

[0062] The coating prescription is as follows:

[0063]

[0064] The preparation method is the same as in Example 1.

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Abstract

The invention provides a tamsulosin hydrochloride sustained-release capsule and a preparation method thereof. Hydroxypropyl-beta-cyclodextrin is added in a prescription, so as to form clathrate compounds on the outer part of tamsulosin hydrochloride together with the tamsulosin hydrochloride, so that the phenomenon of drug burst release in a drug release process is solved, thereby maintaining stable plasma concentration, reducing the incidence rate of adverse reactions and improving the clinical medication safety. In addition, raw materials are easy to obtain, the preparation process is simple and feasible, the yield is high, the cost is low, industrial mass production can be realized, and obvious economic benefits are achieved.

Description

technical field [0001] The invention relates to an oral chemical drug sustained-release preparation, in particular to a tamsulosin hydrochloride sustained-release capsule and a preparation method thereof. Background technique [0002] Tamsulosin hydrochloride chemical name: (R)(-)5-{2-[[2-(2-ethoxyphenyl)etheryl]amino]-2-methyl}-ethyl-2-methoxy Benzenesulfonamide hydrochloride, molecular formula: C 20 h 28 N 2 o 5 S HCl. [0003] Tamsulosin hydrochloride is a new type of a1 receptor blocker, which can selectively block the smooth muscle a1 receptors of the bladder neck, prostate gland and capsule, reduce smooth muscle tension, reduce lower urinary tract resistance, and improve the pain caused by prostatic hypertrophy. Urinary disorders. Animal experiments have shown that tamsulosin can selectively block the adrenaline a1 receptors of rats and rabbits. Its effect is 12-22 times stronger than prazosin and 45-140 times stronger than phentolamine. The a1 receptor blockin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/62A61K47/40A61K31/18A61P13/08A61P13/10A61P13/02A61P7/10A61P7/12
Inventor 张贵民张苏潘绍云
Owner LUNAN BETTER PHARMA
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