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Slow/controlled-release preparation of tamsulosin hydrochloride and preparation method thereof

A technology for tamsulosin hydrochloride and controlled-release preparations, which is applied in the directions of inactive medical preparations, pharmaceutical formulations, inorganic inactive ingredients, etc. The effect of short cycle, convenient use and simple process

Active Publication Date: 2018-06-01
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above-mentioned preparation process not only has cumbersome steps and a long preparation cycle, but also has poor reproducibility due to many steps.

Method used

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  • Slow/controlled-release preparation of tamsulosin hydrochloride and preparation method thereof
  • Slow/controlled-release preparation of tamsulosin hydrochloride and preparation method thereof
  • Slow/controlled-release preparation of tamsulosin hydrochloride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2000

[0058] The prescription of the contents of 2000 tamsulosin hydrochloride sustained-release capsules of the present embodiment is as follows:

[0059]

[0060]

[0061] The preparation method of the capsule content of the present embodiment is as follows:

[0062] (1) Dissolve 0.4g tamsulosin hydrochloride in 120g water, stir until completely dissolved;

[0063] (2) Take the solution prepared in step (1), add 10 g of hypromellose under stirring, and stir for 30 minutes;

[0064] (3) Add 150g of Surelease aqueous dispersion to the solution prepared in step (2), and stir for 30min;

[0065] (4) cross 80 mesh sieves to obtain coating solution;

[0066] (5) Use the fluidized bed bottom spray coating technology to spray liquid on the blank microcrystalline cellulose pellet core. After the coating is finished, the pellets are dried to obtain sustained and controlled release pellets.

Embodiment 2

[0068] The prescription of the contents of 2000 tamsulosin hydrochloride sustained-release capsules of the present embodiment is as follows:

[0069]

[0070] The preparation method of the capsule content of the present embodiment is as follows:

[0071] (1) Dissolve 0.3g tamsulosin hydrochloride in 60g water and stir until completely dissolved;

[0072] (2) Take the solution prepared in step (1), add 5 g of hypromellose under stirring, and stir for 30 minutes;

[0073] (3) Add 75g of Surelease aqueous dispersion to the solution prepared in step (2), and stir for 30min;

[0074] (4) cross 80 mesh sieves to obtain coating liquid A;

[0075] (5) The preparation method of coating liquid B is the same as that of coating liquid A;

[0076] (6) Use the spray coating technology at the bottom of the fluidized bed to spray liquid on the blank microcrystalline cellulose pellet core, first spray liquid with coating liquid A, then spray liquid continuously with coating liquid B, and...

Embodiment 3

[0079] The prescription of the contents of 2000 tamsulosin hydrochloride sustained-release capsules of the present embodiment is as follows:

[0080]

[0081] The preparation method of the capsule content of the present embodiment is as follows:

[0082] (1) Dissolve 0.3g tamsulosin hydrochloride in 90g water, stir until completely dissolved;

[0083] (2) Take the solution prepared in step (1), add 2.5 g of triethyl citrate under stirring, and stir for 30 min;

[0084] (3) Add 95g of Eudragit NE30D into the solution prepared in step (2), and stir for 30min;

[0085] (4) 28g of talcum powder is added to the dispersion liquid prepared in step (3), and stirred until completely dispersed;

[0086] (5) cross 80 mesh sieves to obtain coating liquid A;

[0087] (6) The preparation method of coating liquid B is the same as that of coating liquid A;

[0088] (7) Use fluidized bed bottom spray coating technology to spray liquid on the blank microcrystalline cellulose pellet core,...

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Abstract

The invention relates to a slow / controlled-release preparation of tamsulosin hydrochloride and a preparation method thereof. The slow / controlled-release preparation comprises (i) a pill core which ismade of the following raw material in parts by weight: 135-165 parts of a microcrystal cellulose micro-pill cores; (ii) a slow-release layer which is made of the following raw materials in parts by weight: 0.36-0.44 parts of tamsulosin hydrochloride, 145-200 parts of a slow / controlled release material and 3.8-58 parts of a pore forming agent. Dissolution degree tests show that the slow / controlled-release tamsulosin hydrochloride preparation consisting of a blank pill core and a medicine-carrying slow / controlled release coating layer has a slow-release effect within a relatively pH value range(the pH value is 1.2, 4 or 6.8), has a pH value independent slow-release property, and is capable of solving the problem that absorption of tamsulosin hydrochloride is affected as the pH value of a gastrointestinal tract is changed if a patient takes foods, therefore, the slow / controlled-release preparation of the tamsulosin hydrochloride, which is provided by the invention, can be taken both before or after a meal, and is relatively convenient to take, and absorption of the tamsulosin hydrochloride is not affected.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a tamsulosin hydrochloride sustained and controlled release preparation and a preparation method thereof. Background technique [0002] Tamsulosin hydrochloride is a selective α1 adrenergic receptor blocker, which is mainly used for urinary dysfunction caused by benign prostatic hyperplasia (BPH). Its main mechanism of action is to selectively block the α1 adrenergic receptor in the prostate Body, relaxation of prostate smooth muscle, thereby improving symptoms such as dysuria. When administered in ordinary tablets or capsules, the rapid release of tamsulosin hydrochloride in the body leads to a sudden increase in its plasma concentration, which in turn leads to adverse reactions such as orthostatic hypotension. [0003] In order to solve the above problems, the Japanese Yamanouchi Pharmaceutical Company (ie: the current Astellas Pharmaceutical Group) found through res...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/38A61K47/32A61K47/34A61K47/02A61K31/18A61P13/08A61P13/00
CPCA61K9/501A61K9/5026A61K9/5031A61K9/5047A61K9/5078A61K9/5089A61K31/18
Inventor 严毅强
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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