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Mirabegron slow-release mini-pill and preparation method thereof

A technology of slow-release pellets and mirabegron, which is applied in the fields of pharmaceutical formulations, blood diseases, extracellular fluid diseases, etc., can solve the problems of unstable therapeutic effect, low bioavailability, and large toxin effect, so as to improve biological Utilization, drug stability, and convenient storage

Inactive Publication Date: 2016-06-22
HEILONGJIANG ZHICHENG MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there are many drugs for treating urge urinary incontinence on the market, but most of them have relatively high toxin effect, unstable therapeutic effect and low bioavailability

Method used

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  • Mirabegron slow-release mini-pill and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0031] A kind of Mirabegron sustained-release pellets, comprising drug-containing pellets and a coating layer, the coating layer wraps the drug-containing pellets, and the drug-containing pellets include: 25mg Mirabegron, 70mg blank pills Core, 100-200mg filler, 50-150mg 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: 25mg mirabegron, 70mg blank core, 150mg filler, 50mg lubricant and 10mg binder.

[0033] The optimal mass ratio of raw materials in the coating layer is: 35mg Eudragit NE30D, 7mg 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 Mirabegron sustained-release pellets, comprising the following steps:

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

[0041] Step 2: Mixing: Weigh Mirabegron and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make a fine drug powder, 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 parameters, and start spraying When the ball c...

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Abstract

A mirabegron slow-release mini-pill includes a drug-containing mini-pill and a coating layer, the drug-containing mini-pill is coated with the coating layer, the drug-containing mini-pill comprises 25mg of mirabegron, 70mg of a blank pill core, 100-200mg of a filler, 50-150mg of a lubricant and 5-50mg of a binder, the coating layer comprises 35-175mg of Eudragit NE30D and 5-52mg of talc powder, preparation steps are as follows: 1, preparing materials; 2, mixing; 3, preparing the binder; 4, pelleting; 5, preparing a coating agent; 6, coating; 7, filling; and 8, aluminum molding and finishing. The mirabegron slow-release mini-pill is used for urge urinary incontinence, dibetes insipidus overactive bladder, two advanced technologies of a novel slow-release preparation and a mini-pill preparation are used, treatment effect is stable, bioavailability is higher, the mirabegron slow-release mini-pill has the advantages of good drug stability, convenient packaging, transportation, storage and the like, and the preparation method is simple and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of chemical medicine sustained-release preparations, and in particular relates to a mirabegron sustained-release pellet and a preparation method thereof. Background technique [0002] Urge urinary incontinence is a disease in which the patient suddenly has a strong urge to urinate and cannot hold back the urination and the urine flows out quickly. [0003] Although normal people can still control the urge to urinate for a period of time when they have the urge to urinate, but sick people will suddenly have a strong urge to urinate and cannot hold back the urination and the urine will flow out quickly because of excessive tension in the bladder muscles and urethra. Caused by improper cooperation of sphincter muscles. [0004] The most common is stroke patients. In addition, patients with sacral spinal cord or nerve diseases, multiple sclerosis and other diseases often have this symptom. If no special cause ...

Claims

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Application Information

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IPC IPC(8): A61K9/62A61K9/16A61K31/426A61K47/38A61P7/12A61P13/10A61P13/00
Inventor 张昕
Owner HEILONGJIANG ZHICHENG MEDICAL TECH
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