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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 microcapsules, pharmaceutical formulations, urinary system diseases, etc., and can solve the problems of packaging, transportation, and storage inconvenience, low drug release stability, and large gastrointestinal irritation. problems, to achieve the effect of improving bioavailability, small individual differences, and easy absorption

Inactive Publication Date: 2016-03-23
HEILONGJIANG ZHICHENG MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, in the tamsulosin hydrochloride drug for the treatment of symptoms such as urination disorder caused by benign prostatic hyperplasia, there are low stable drug release effects, great irritation to the gastrointestinal tract, low bioavailability, and inconvenient packaging, transportation, and storage. and complex preparation methods

Method used

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

Examples

Experimental program
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Embodiment 1

[0031] A tamsulosin hydrochloride sustained-release pellet, comprising drug-containing pellets and a coating layer, characterized in that: the coating layer wraps the drug-containing pellets, and the drug-containing pellets include: 0.2 mg tamsulol hydrochloride New, 70mg blank ball core, 150-250mg filler, 25-125mg lubricant, 5-50mg binder, the coating layer includes: 35-175mg Eudragit NE30D, 5-52mg talcum powder.

[0032] The optimal mass ratio of raw materials in the drug-containing pellets is: 0.2 mg tamsulosin hydrochloride, 70 mg blank core, 230 mg filler, 55 mg lubricant, and 10 mg binder.

[0033] The optimal mass ratio of raw materials in the coating layer is: 95mg Eudragit NE30D, 21mg talcum powder.

[0034] The filler is microcrystalline cellulose.

[0035] Described lubricant is talcum powder.

[0036] The binder is hypromellose.

[0037] The coating layer also includes traces of sodium lauryl sulfate or polyethylene glycol.

Embodiment 2

[0039] A preparation method of tamsulosin hydrochloride sustained-release pellets, comprising the following steps:

[0040] Step 1: material preparation: according to the above mass ratio, tamsulosin hydrochloride is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0041] Step 2: Mixing: Take tamsulosin hydrochloride and microcrystalline cellulose according to the above mass ratio and mix them in a three-dimensional mixer for 30 minutes to make a fine powder of the drug, and take it out for later use;

[0042] Step 3: Preparation of adhesive: Weigh an appropriate amount of hypromellose according to the above mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, and set aside;

[0043] Step 4: Pill making: put the mixed drug fine powder into the feeding tank of the centrifugal pellet machine, put the adhesive into the liquid supply tank, put the blank pellet core into the pot, turn on the machine, adjust the pa...

Embodiment 3

[0049] Indications: It is mainly used for symptoms such as urination disorders caused by benign prostatic hyperplasia, such as frequent urination, nocturia, and dysuria. Since this product achieves the therapeutic purpose by improving the smooth muscle function of the urethra, bladder neck and prostate, rather than shrinking hypertrophic glands, it is suitable for mild and moderate patients and those who have not caused severe voiding disorders, such as severe urinary retention. This product should not be taken alone.

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Abstract

The invention relates to a tamsulosin hydrochloride sustained-release pellet. The tamsulosin hydrochloride sustained-release pellet comprises a medicine-containing pellet body and a coating layer, wherein the coating layer wraps the medicine-containing pellet body, the medicine-containing pellet body comprises tamsulosin hydrochloride, a blank pellet core, a filling agent, a lubricating agent and an adhering agent, and the coating layer comprises Eudragit NE30D and talcum powder. A preparation method comprises the following steps: 1, preparing materials; 2, mixing; 3, preparing the adhering agent; 4, pelleting; 5 preparing a coating agent; 6, coating; 7, filling; and 8, packaging by aluminum-plastic for obtaining a finished product. The tamsulosin hydrochloride sustained-release pellet is suitable for the symptoms such as urination disorder caused by benign prostatic hyperplasia, and is good in drug release stability, small in irritation to the gastrointestinal tract, good in bioavailability, convenient to package, transport and store, and suitable for industrial production. The tamsulosin hydrochloride sustained-release pellet is good in absorption after oral medication, and although the tamsulosin hydrochloride sustained-release pellet can be taken on an empty stomach or after the meal, food can increase the total absorptive amount of the tamsulosin hydrochloride sustained-release pellet.

Description

technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, in particular to tamsulosin hydrochloride sustained-release pellets and a preparation method thereof. Background technique [0002] Prostatic hyperplasia (BPH) is one of the common diseases of middle-aged and elderly men, and its incidence is increasing with the aging of the global population. The incidence of benign prostatic hyperplasia increases with age, but there may not be clinical symptoms when there are hyperplasia lesions. The urban incidence rate is higher than that in the rural areas, and racial differences also affect the degree of proliferation. [0003] Frequent urination and increased nocturia Frequent urination is an early symptom. First, the frequency of nocturia increases, but the urine output is not much each time. After bladder detrusor decompensation, chronic urinary retention occurs, the effective capacity of the bladder is reduced, and the inter...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/52A61K31/18A61P13/08A61P13/00
CPCA61K9/0002A61K9/5026A61K31/18
Inventor 张昕
Owner HEILONGJIANG ZHICHENG MEDICAL TECH
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