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Imidafenacin tablet preparation method

A technology of midanaxin and tablets, which is applied in the field of pharmaceutical preparations, can solve problems such as uniformity, and achieve the effects of improving efficiency, improving practicability, and reducing production costs

Inactive Publication Date: 2017-02-01
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is to provide a method for preparing midanacin tablets, to solve the problem of uniformity of the tablets in the case of low drug content, and to realize direct drying without drying process operation. tablet

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment 1: Midanaxin sheet preparation (in every 1000 sheet amount)

[0016] Table 1:

[0017] Name of raw material Example 1 Comparative example 1 Midana 0.1g 0.1g pregelatinized starch 58g 59.4g Microcrystalline Cellulose PH102 40g 40g Hydroxypropyl Methyl Cellulose E50 1.4g —— Povidone K30 Appropriate amount Appropriate amount Magnesium stearate 0.5g 0.5g

[0018] Embodiment 1 preparation technology:

[0019] Take the pregelatinized starch, microcrystalline cellulose PH102 and povidone K30 of the prescription amount and mix them uniformly at room temperature for 10 minutes, and set aside; Disperse and dissolve in an appropriate amount of absolute ethanol, and set aside; Spray the above-mentioned absolute ethanol containing the main drug on the above-mentioned excipients, then add the prescribed amount of magnesium stearate, mix evenly, and the mixing time is 10 minutes. Press the tablet and coat it. D...

Embodiment 2

[0030] Embodiment 2: preparation of midanacin sheet (in every 1000 sheet amount)

[0031] Table 4:

[0032] Name of raw material Example 2 Comparative example 2 Midana 0.1g 0.1g anhydrous lactose 58g 59.4g Microcrystalline Cellulose pH302 40g 40g Hydroxypropyl Methyl Cellulose E50 1.4g —— Povidone K30 Appropriate amount Appropriate amount Magnesium stearate 0.5g 0.5g

[0033] Embodiment 2 preparation technology:

[0034] Take the prescribed amount of anhydrous lactose, microcrystalline cellulose pH302 and povidone K30 and mix evenly at room temperature for 10 minutes, and set aside; disperse the prescribed amount of midazine and hydroxypropyl methylcellulose E50 Dissolve in an appropriate amount of absolute ethanol, and set aside; spray the above-mentioned absolute ethanol containing the main drug on the above-mentioned excipients, then add the prescribed amount of magnesium stearate, mix evenly, and the mixing time...

Embodiment 3

[0044] Embodiment 3: Midanaxin sheet preparation (in every 1000 sheet amount)

[0045] Table 7:

[0046] Name of raw material Example 3 Comparative example 3-1 Comparative example 3-2 Comparative example 3-3 Midana 0.1g 0.1g 0.1g 0.1g Microcrystalline Cellulose PH102 58g 59.4g 58g 59g Microcrystalline Cellulose PH302 40g 40g 40g 40g Hydroxypropyl Methyl Cellulose E50 1.4g —— —— —— Hydroxypropyl Methyl Cellulose E5 —— —— 1.4g —— glycerin —— —— —— 0.4g Povidone K30 Appropriate amount Appropriate amount Appropriate amount Appropriate amount Magnesium stearate 0.5g 0.5g 0.5g 0.5g

[0047] Embodiment 3 preparation technology:

[0048] Get the prescribed amount of microcrystalline cellulose PH102, microcrystalline cellulose PH302 and povidone K30 and mix them uniformly at room temperature for 10 minutes, and set aside; Disperse and dissolve E50 in an appropriate amount of absolute ethan...

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Abstract

The invention discloses an imidafenacin tablet preparation method. The preparation method comprises the following steps: taking a formulated amount of filler, disintegrant and adhesive, and uniformly mixing to obtain an auxiliary material for later use; dispersing and dissolving a formulated amount of imidafenacin and cosolvent in anhydrous ethanol to obtain a main drug for later use; and uniformly spraying the main drug into the auxiliary material, adding lubricant, uniformly mixing, determining the content of an intermediate compound, and tabletting. According to the imidafenacin tablet preparation method, the main drug is sprayed into the premixed medicinal auxiliary material through a spray gun, thereby well solving the uniformity problem of the tablet under the condition of low drug content. Besides, the low moisture filler is used as the filler of the imidafenacin tablet, so that direct tabletting can be performed without a drying process, and the direct tabletting process is simpler and easier to implement in comparison with wet granulation, fluidized bed, boiling granulation, spray drying and other processes, thereby being suitable for industrial production, being beneficial to product quality control, energy saving and consumption reduction, lowering the production cost, and having favorable practicality.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a method for preparing midanacin tablets. Background technique [0002] Midanacin is a new type of diphenylbutyramide anticholinergic drug jointly developed by Japan Ono Pharmaceutical Co., Ltd. and Kyorin Pharmaceutical Co., Ltd. It has high bladder selectivity and is used for the treatment of overactive bladder. It was launched in Japan in June 2007 . Midanacin has a diphenylbutyramide structure and is a new type of high-efficiency anticholinergic drug that selectively acts on M 3 and M 1 Receptors, block the contraction effect of choline on the detrusor muscle, relax the detrusor muscle, take 0.1mg midazine twice a day, can significantly improve the urgency and frequency of urination caused by overactive bladder , urinary incontinence and other symptoms. Midanacin has dual effects of inhibiting the contraction of bladder smooth muscle and in...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4174A61P13/10
CPCA61K9/2018A61K9/2054A61K9/2059A61K9/2095A61K9/2806A61K31/4174
Inventor 孙英华马攀勤杨亚军刘晓红王永军
Owner SHENYANG PHARMA UNIVERSITY
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