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Tamsulosin hydrochloride sustained-release pellet and preparation method thereof

A technology of tamsulosin hydrochloride and sustained-release pellets, which can be used in bulk delivery, urinary system diseases, active ingredients of amides, etc., can solve the problems of less application of semi-permeable membrane materials, immature industrialization, etc. Small, stable drug release, good absorption effect

Active Publication Date: 2014-07-16
HYBIO PHARMA WUHAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this patent uses ethyl cellulose and povidone as semi-permeable membrane materials, but the semi-permeable membrane materials are rarely used and the industrialization is immature

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0055] The preparation method of the tamsulosin hydrochloride sustained-release pellets of the present invention includes but not limited to the above preparation method.

[0056] Those skilled in the art can subpackage the tamsulosin hydrochloride sustained-release pellets of the present invention and compress them into tablets or pack them into capsules to make capsules, so that patients can take them conveniently. Wherein, the capsule is preferably a gelatin capsule. The capsule is composed of two precisely processed capsule shells. The sizes of the capsules are various, including No. 000, No. 00, and No. 0 to No. 5 capsules. In some embodiments the capsule is a size 3 capsule.

[0057] Taking the capsules of tamsulosin hydrochloride sustained-release pellets prepared in the embodiment of the present invention as the research object, the content uniformity test was carried out. The results show that A+1.80S=0.6 of the prepared tamsulosin hydrochloride sustained-release p...

Embodiment 1

[0061] Embodiment 1: tamsulosin hydrochloride sustained-release pellets of the present invention

[0062] formula:

[0063]

[0064]

[0065] Preparation method: Weigh the Eudragit L100 of the prescription amount of drug-loaded sustained-release pellets, add it to the ethanol-water system of the prescription amount, stir to dissolve; then add tamsulosin hydrochloride to the solution, stir to dissolve, and obtain Drug solution. Weigh the prescribed amount of ethyl cellulose, starch, and microcrystalline cellulose, mix them evenly, use the drug solution as a binder to wet the mixture to prepare a soft material, and pass the prepared soft material through a Mini250 extrusion-spheronizer to prepare pellets. Drug-loaded sustained-release pellets with diameters ranging from 350 to 700 μm.

[0066]Weigh the raw and auxiliary materials of the prescription amount of enteric-coated pellets, disperse HP-55 in 80% ethanol, stir to dissolve; add triethyl citrate, stir to mix evenly...

Embodiment 2

[0068] Example 2: Detection of content uniformity of tamsulosin hydrochloride sustained-release pellets of the present invention

[0069] The tamsulosin hydrochloride is prepared into sustained-release pellets and loaded into capsules, and the tamsulosin hydrochloride content in each capsule is 0.2 mg. Due to the small dosage specification, it is easy to have the problem of unqualified content uniformity. It is necessary to check the content uniformity of tamsulosin hydrochloride sustained-release capsules. The specific operation and experimental results are as follows.

[0070] Get 1 capsule prepared in specific example 1, pour the contents into a 50mL hard stoppered glass tube, add about 100 glass beads with a diameter of about 5mm, add 20mL of sodium hydroxide solution (1→600) precisely, and place Heat in a water bath at 50°C for 10 minutes, take it out, shake vigorously until the particles are completely broken, add 10 mL of acetonitrile accurately, add 5 mL of 0.2 mol / L h...

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Abstract

The invention belongs to the field of medicinal preparations, and discloses a tamsulosin hydrochloride sustained-release pellet and a preparation method thereof. The tamsulosin hydrochloride sustained-release pellet comprises a drug-loading sustained-release pellet and an enteric coating layer, wherein the drug-loading sustained-release pellet comprises tamsulosin hydrochloride, an enteric coating material A, a solvent A, a water-insoluble material and a diluting agent. According to the tamsulosin hydrochloride sustained-release pellet, the tamsulosin hydrochloride can be uniformly dispersed in the drug-loading sustained-release pellet, and the content of small-dose tamsulosin hydrochloride in the prepared tamsulosin hydrochloride sustained-release pellet can be uniformly distributed; furthermore, the surface of the drug-loading sustained-release pellet is coated with the enteric coating layer, and the tamsulosin hydrochloride sustained-release pellet can be released in a sustained manner and is not influenced by pH of gastrointestinal tracts, can be released in an acidic or alkaline environment, and can be absorbed in the body. The method for preparing the tamsulosin hydrochloride sustained-release pellet is easy to operate, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to tamsulosin hydrochloride sustained-release pellets and a preparation method thereof. Background technique [0002] Benign prostatic hyperplasia (BPH) is the most common benign disease that causes voiding disorders in middle-aged and elderly men, and is a common disease in elderly men. The proliferated prostate squeezes the urethra, leading to a series of symptoms of urination disorders, such as frequent urination, urgency, weak urine stream, and endless urination. Such as acute urinary retention, stones, renal insufficiency, etc.), and even endanger the life of the patient. [0003] BPH-related voiding symptoms are related to the following factors: ①increased smooth muscle tone in the gland of benign prostatic hyperplasia; ②static effect of enlarged prostate tissue; ③changes in detrusor muscle caused by prolonged bladder outlet obstruction. With the gradua...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/18A61P13/08
Inventor 左灵静陶安进马亚平袁建成
Owner HYBIO PHARMA WUHAN CO LTD
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