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Alfuzosin hydrochloride sustained release tablets and preparation method thereof

A technology for alfuzosin hydrochloride and sustained-release tablets, which can be used in pharmaceutical formulations, urinary system diseases, drug combinations, etc., and can solve the problems of packaging, transportation, and storage inconvenience, low drug release stability, and large gastrointestinal irritation. problem, to achieve a stable therapeutic effect, the preparation method is simple and easy to implement, and the effect of easy absorption

Inactive Publication Date: 2016-02-03
HEILONGJIANG ZHICHENG MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, among the alfuzosin hydrochloride medicines on the market for the treatment of symptoms such as urination disorder caused by benign prostatic hyperplasia, there is a low drug release stability effect, which is harmful to the gastrointestinal tract. High irritation, low bioavailability, inconvenient packaging, transportation, storage, and complicated preparation methods

Method used

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  • Alfuzosin hydrochloride sustained release tablets and preparation method thereof

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Effect test

Embodiment 1

[0027] An alfuzosin hydrochloride sustained-release tablet is characterized in that it is made of the following raw materials: 10 mg of alfuzosin hydrochloride, 50-135 mg of hypromellose, and 3-20 mg of lubricant.

[0028] The preferred weight ratio of the raw materials is: 10 mg of alfuzosin hydrochloride, 92 mg of hypromellose, and 5 mg of lubricant.

[0029] The hypromellose can be one or two of the following models: 75hd100cr hypromellose, 75hd4000cr hypromellose, 75hd15000cr hypromellose, 100000cr hypromellose.

[0030] The lubricant is one or both of magnesium stearate, talcum powder and silicon dioxide.

[0031] Its production method includes the following steps:

[0032] Step 1: Prepare materials: according to the above mass ratio, alfuzosin hydrochloride is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0033] Step 2: Mixing: Weigh alfuzosin hydrochloride and hypromellose according to the above mass ratio, put them into a three-di...

Embodiment 2

[0040] Indications: Functional symptoms of benign prostatic hyperplasia.

[0041] Drug Interactions: Combination drugs are not recommended, α-blocker antihypertensives (prazosin, urapidil, monidil): increase the hypotensive effect. There is a risk of severe orthostatic hypotension. Concomitant use of antihypertensive drugs increases the antihypertensive effect and the risk of orthostatic hypotension (additive effect).

[0042] Pharmacology and Toxicology

[0043] Pharmacological action: This product is a quinoline derivative that works through the oral route. It is a selective, postsynaptic α1-adrenoceptor antagonist. In vitro pharmacological studies have confirmed that this product has a selective effect on α1-adrenergic receptors in the prostate, bladder trigone and urethra. By acting directly on the smooth muscle of the prostate tissue, alpha-blockers reduce resistance to bladder outflow. Animal experiments in vivo prove that this product can reduce urethral pr...

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Abstract

The invention discloses alfuzosin hydrochloride sustained release tablets and a preparation method thereof. The sustained release tablets are prepared by adopting the following raw materials: alfuzosin hydrochloride, hydroxypropyl methylcellulose and lubricating agents, and adopting the processing steps of material preparation, mixing, granulation, total blending, tabletting, aluminium-plastic packaging, and the like. The alfuzosin hydrochloride sustained release tablets have the beneficial effects that the alfuzosin hydrochloride sustained release tablets are mainly used for treating functional symptoms of benign prostatic hyperplasia; the more novel sustained release preparation is adopted; sustained release refers to that the rate of absorption of the medicines into bodies is reduced by reducing the rate of release of the medicines from the dosage form, thus achieving the more stable treatment effects; the effective blood concentration can be maintained in a longer time, the toxic and side effects of the medicines can be also reduced and the medicine safety is improved; the alfuzosin hydrochloride sustained release tablets are convenient to use, are especially suitable for chronic disease patients who take medicines for a long term, and have the effect of improving the compliance of the patients; alfuzosin hydrochloride sustained release tablets have the advantages of good medicine stability, convenience in packaging, transportation and storage, and the like; and the preparation method is simple and practicable and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, in particular to an alfuzosin hydrochloride sustained-release tablet 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 inte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/517A61P13/08A61K47/38
Inventor 张昕
Owner HEILONGJIANG ZHICHENG MEDICAL TECH
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