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Mirabegron sustained release tablet as well as preparation method and quality detection method thereof

A technology for mirabegron and sustained-release tablets, applied in the field of medicine, can solve the problems of undetected female patients, excessive tablet weight differences, poor fluidity, etc., and achieve the effects of reducing potential safety hazards, long shelf life, and reducing production costs.

Active Publication Date: 2022-04-12
乐泰药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Smoking cessation reduces lower urinary tract symptoms in men but not in women
②Bladder training: regular urination according to the time and pattern set by oneself can enhance the patient's own urination control ability, avoid the influence of mental factors, and reduce the sensitivity of the bladder. Law does not apply
However, in this invention, there are problems of poor fluidity and excessive tablet weight difference in powder direct compression, and the process requires repeated sieving and mixing, which cannot solve the problem of repeated sieving process equipment handling in production scale-up

Method used

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  • Mirabegron sustained release tablet as well as preparation method and quality detection method thereof
  • Mirabegron sustained release tablet as well as preparation method and quality detection method thereof
  • Mirabegron sustained release tablet as well as preparation method and quality detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] The preparation of embodiment 1 Mirabegron sustained-release tablets

[0089] 1. Raw materials and dosage

[0090] The raw materials and dosages used to prepare Mirabegron sustained-release tablets in this example are shown in Table 1 below:

[0091] Table 1 Amount of raw and auxiliary materials

[0092]

[0093]

[0094] 2. Preparation method

[0095] (1) Take each raw and auxiliary material according to the percentage by weight described in Table 1;

[0096] (2) Premixing: Add Mirabegron, polyoxyethylene, polyethylene glycol and hydroxypropyl cellulose into the wet granulation pot, set the stirring blade at 250 rpm, the cutter at 600 rpm, and premix for 5 minutes.

[0097] (3) Liquid addition: set the rotation speed of the stirring blade to 170rpm, the rotation speed of the cutting knife to 1500rpm, and the atomization pressure to 0.0125MPa, add the wetting agent by spraying, and the liquid addition time is 2min.

[0098] (4) Granulation: set the stirring bl...

Embodiment 2

[0121] The preparation of embodiment 2 Mirabegron sustained-release tablets

[0122] 1. Raw materials and dosage

[0123] The raw materials and dosages used to prepare Mirabegron sustained-release tablets in this example are shown in Table 3 below:

[0124] Table 3 Amount of raw and auxiliary materials

[0125]

[0126] 2. Preparation method

[0127] (1) Take each raw and auxiliary material according to the percentage by weight described in Table 2;

[0128] (2) Premixing: Add mirabegron, polyoxyethylene, polyethylene glycol and hydroxypropyl cellulose into the wet granulation pot, set the stirring blade at 250 rpm, the cutting knife at 600 rpm, and premix for 5 to 10 minutes.

[0129] (3) Liquid addition: set the rotation speed of the stirring blade to 170rpm, the rotation speed of the cutting knife to 1500rpm, and the atomization pressure to 0.0125MPa, add the wetting agent by spraying, and the liquid addition time is 3min.

[0130] (4) Granulation: set the rotation s...

Embodiment 3

[0136] The preparation of embodiment 3 Mirabegron sustained-release tablets

[0137] 1. Raw materials and dosage

[0138] The raw materials and dosages used to prepare Mirabegron sustained-release tablets in this example are shown in Table 4 below:

[0139] Table 4 Amount of raw and auxiliary materials

[0140]

[0141] 2. Preparation method

[0142] (1) Take each raw and auxiliary material according to the percentage by weight described in Table 3;

[0143] (2) Premixing: Add Mirabegron, polyoxyethylene, polyethylene glycol and hydroxypropyl cellulose into the wet granulation pot, set the stirring blade at 150 rpm, the cutter at 600 rpm, and premix for 10 minutes.

[0144] (3) Liquid addition: set the rotation speed of the stirring blade to 150rpm, the rotation speed of the cutting knife to 1500rpm, and the atomization pressure to 0.0125MPa, add the wetting agent by spraying, and the liquid addition time is 1min.

[0145] (4) Granulation: set the rotation speed of the ...

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Abstract

The invention discloses a mirabegron sustained release tablet as well as a preparation method and a quality detection method thereof, and belongs to the technical field of medicines. The mirabegron sustained release tablet is prepared from the following raw materials and auxiliary materials in percentage by weight: 5 to 35 percent of mirabegron, 10 to 40 percent of polyoxyethylene, 0.6 to 6.0 percent of hydroxypropyl cellulose, 0.08 to 0.20 percent of butylated hydroxytoluene, 0.6 to 1.5 percent of magnesium stearate and the balance of polyethylene glycol. Wet granulation is adopted, the tablet fluidity is good, the quality is stable and uniform, the technological operation is simple, and the method is suitable for industrial production. According to the prepared mirabegron sustained release tablet, the formula content of mirabegron accounts for 15-25%, the long-time stable effective drug blood concentration can be maintained, the proportion of the antioxidant is low, the requirements of laws and regulations are met, and the medication safety is guaranteed. The product disclosed by the invention is combined with Shenkangning capsules and pumpkin seed pollen compound protein solid beverage to achieve a relatively good curative effect on patients with overactive bladder and patients with kidney-yang deficiency accompanied with symptoms such as nocturia increase, urinary incontinence, frequent urination and urgent urination.

Description

technical field [0001] The invention relates to a mirabegron sustained-release tablet, a preparation method and a quality detection method thereof, and belongs to the technical field of medicine. Background technique [0002] Overactive bladder (OAB) is defined as urinary urgency, with or without urge incontinence, often with frequency and nocturia. Urinary urgency is the core symptom of OAB, which is a strong desire to urinate, and it is difficult to be suppressed subjectively to delay urination. As the research progressed, the researchers found that detrusor overactivity and OAB are not exactly the same. OAB is a symptomatic diagnosis whereas detrusor overactivity is a urodynamic diagnosis. Not all patients with OAB have detrusor overactivity, and some patients with detrusor overactivity may not have OAB symptoms. [0003] 10.7% of the world's population was affected by OAB in 2008. The current global prevalence is 11.8%, with 12.8% in women and 10.8% in men. In my co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/22A61K31/426A61K47/10A61K47/38A61K47/12A61P13/10G01N30/74
CPCY02A50/30
Inventor 郎伟君
Owner 乐泰药业有限公司
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