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A kind of tamsulosin hydrochloride sustained-release microparticles and preparation method thereof

A technology of tamsulosin hydrochloride and slow-release microparticles, which can be used in microcapsules, pharmaceutical formulas, medical preparations of non-active ingredients, etc., and can solve the problems of unfavorable patients taking it

Active Publication Date: 2022-01-04
CHINA PHARM UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] CN 1758903A discloses a kind of tamsulosin intestinal sustained-release microparticles, the preparation is an orally disintegrating enteric-coated sustained-release microparticle tablet, and excessive auxiliary materials are added for tablet compression, which is unfavorable for patients to take
US2004096502A1, CN103585112A, and CN102579359A disclose tamsulosin hydrochloride slow-release microparticles including multi-particles. The microparticles are composed of tamsulosin hydrochloride, microcrystalline cellulose and excipients with slow and controlled release, so that the drug is gradually released from the matrix of the granules. but did not address the effect of food on drug absorption

Method used

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  • A kind of tamsulosin hydrochloride sustained-release microparticles and preparation method thereof
  • A kind of tamsulosin hydrochloride sustained-release microparticles and preparation method thereof
  • A kind of tamsulosin hydrochloride sustained-release microparticles and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Prescription of pill core containing drug coating layer:

[0048]

[0049] Enteric coating layer coating solution prescription (weight gain 2.5%):

[0050]

[0051] Sustained-release coating layer coating solution prescription (weight gain 6%):

[0052]

[0053] The preparation method of tamsulosin hydrochloride slow-release microparticles, the steps are as follows:

[0054] Step (1), take the prescribed amount of tamsulosin hydrochloride and hypromellose, add purified water, stir until dissolved, and obtain a drug-containing solution;

[0055] Step (2), taking a blank microcrystalline cellulose pellet core and placing it in a fluidized bed, setting the coating parameters of the fluidized bed, and using the drug-containing solution prepared in step (1) for coating to obtain a drug-containing pellet core;

[0056] Step (3), take the prescribed amount of triethyl citrate and talcum powder and disperse them in an appropriate amount of purified water, place them ...

Embodiment 2

[0081] Prescription of pill core containing drug coating layer:

[0082]

[0083] Enteric coating layer coating solution prescription (weight gain 2%):

[0084]

[0085] Sustained-release coating layer coating solution prescription (weight gain 6%):

[0086]

[0087] Preparation method: with embodiment 1.

[0088] Determination of release rate: according to the second method of appendix XD of the 2015 edition of Chinese Pharmacopoeia, the release test method under the WS1-(X-333)-2003Z item is measured (n=12), and the average release rate is 23% (2h), respectively. 54% (3h) and 89% (5h), the release rate meets the regulations.

Embodiment 3

[0090] Prescription of pill core containing drug coating layer:

[0091]

[0092] Enteric coating layer coating solution prescription (weight gain 3%):

[0093]

[0094] Sustained-release coating layer coating solution prescription (weight gain 6%):

[0095]

[0096] Preparation method: with embodiment 1

[0097] Determination of release rate: According to the second method of appendix XD of the 2015 edition of the Chinese Pharmacopoeia, the release test method under the item WS1-(X-333)-2003Z is measured (n=12), and the average release rate is 21% (2h), respectively. 57% (3h) and 83% (5h), comply with the regulations.

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Abstract

The invention discloses a tamsulosin hydrochloride slow-release granule. The slow-release granule uses a blank ball core as a ball core, and sprays a medicine coating layer, an enteric coating layer and a slow-release coating layer on the outside of the ball core in sequence; The layer is obtained by spraying the aqueous solution of tamsulosin hydrochloride and binder; the enteric coating layer is obtained by spraying the enteric coating solution containing enteric materials, plasticizers and anti-adhesive agents; It is obtained by spraying the sustained-release coating solution of insoluble sustained-release materials, plasticizers and anti-sticking agents. In the tamsulosin hydrochloride slow-release microparticles of the present invention, not only the absorption or bioavailability of tamsulosin is not affected by food effects and physiological changes of the gastrointestinal tract before and after meals, but also a stable blood drug concentration curve can be obtained And long-term action time, reduce the occurrence of cardiovascular side effects, greatly improve the safety, effectiveness and compliance of patients taking medicine.

Description

technical field [0001] The invention relates to tamsulosin hydrochloride slow-release microparticles and a preparation method thereof. Background technique [0002] Benign prostatic hyperplasia is a common urological disease in elderly men, which refers to the benign adenomatous hyperplasia of cells in the periurethral area of ​​the prostate. Tamsulosin hydrochloride is an alpha 1 adrenergic receptor antagonist used to relieve benign prostatic hyperplasia. Tamsulosin hydrochloride sustained-release microparticles can obtain a stable blood drug concentration curve and long-term action time, reduce the occurrence of cardiovascular side effects, and greatly improve the safety, effectiveness and compliance of patients taking medicine. [0003] Using the same drug for the same disease, some people have achieved good curative effect, while some people not only have no obvious curative effect, but also have serious adverse reactions. In addition to individual differences, the reas...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K47/38A61K47/32A61K31/18A61P13/08
CPCA61K9/5078A61K9/5026A61K9/5047A61K31/18A61P13/08
Inventor 李剑丁静周建平黄春玉许润田丽娟谢俊徐向阳
Owner CHINA PHARM UNIV
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