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A new midanate pharmaceutical composition and preparation method thereof

A technology of midanacin and composition, which is applied in the field of pharmaceutical composition for treating urinary incontinence, can solve problems such as low dissolution rate, poor stability, and poor content uniformity, and achieve fast dissolution rate, good stability, and reduced impurities the increased effect of

Active Publication Date: 2018-03-02
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the problems of poor content uniformity, low dissolution rate and poor stability of products that are prone to occur

Method used

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  • A new midanate pharmaceutical composition and preparation method thereof
  • A new midanate pharmaceutical composition and preparation method thereof
  • A new midanate pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Content uniformity and dissolution rate comparison test

[0041] (1) Sample preparation

[0042] Preparation of Sample 1

[0043] Weigh 0.1g of midazine, add polyethylene glycol 200 4.0g, ultrasonically dissolve the midazine, add microcrystalline cellulose 302140g to fully mix, add 50g of pregelatinized starch as diluent, lubricant micropowder silica gel 1.0 g, after mixing evenly, press into tablets. Specification 0.1mg, tablet weight 200mg.

Embodiment 2

[0067] prescription

[0068] Accurately weigh 0.1 g of midanacin, add 2.0 g of polyethylene glycol 200, and sonicate for 10 minutes to dissolve the midanacin. Add microcrystalline cellulose to midanacin polyethylene glycol solution, mix at high speed for 2 minutes, add part of pregelatinized starch, mix at high speed for 1 minute, add binder (HPMC50 5% solution) at high speed After shearing and granulating, after obtaining suitable granules, take the material out of the equipment, dry it in an oven at 50°C for 3 hours, and sieve through a 20-mesh sieve for granulation. Add 0.2% magnesium stearate and mix and compress into tablets.

[0069] Table 4 Dissolution test results

[0070]

Embodiment 3

[0072] Midana new oral disintegration tablet

[0073]

[0074] Make a solution of the prescribed amount of midanacin solvent in polyethylene glycol, add microcrystalline cellulose to absorb the solution, add microscopic silica gel to absorb the excess solution, and obtain a fluid powder; add mannitol, sodium carboxymethylcellulose, Aspartame, the mixed powder is fully mixed with a high-speed shear mixing granulator, the mixed powder is added to the lubricant magnesium stearate and then compressed, and the pressure is adjusted to make the tablet hardness about 4kg.

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Abstract

The technology provides a midanacin pharmaceutical composition with good content uniformity, rapid dissolution and excellent stability and a preparation method thereof. The preparation has the following procedures: (A) using an appropriate inert and non-volatile solvent to dissolve midanacin; (B) selecting a porous excipient to absorb the drug solution A to obtain a fluid powder; (C) preparing a powder from procedure B Mix with disintegrants and excipients, and carry out compression molding process.

Description

technical field [0001] The invention discloses a pharmaceutical composition for treating urinary incontinence, in particular to a method for improving content uniformity, dissolution speed and stability of insoluble low-dose medicine. Background technique [0002] According to statistics, 31.2% of the 2,246 drugs synthesized from 1987 to 1994 had a solubility of less than 20 μg / ml; 10-100 μg / ml. After the oral solid preparation is administered, it must undergo disintegration and dissolution before it can be absorbed by the epithelial cell membrane of the gastrointestinal tract and enter the blood circulation to exert its curative effect. For class II drugs of the biopharmaceutical classification system, due to the high permeability and poor solubility of the drug, the drug dissolves slowly in the body, and the blood drug concentration is difficult to reach the therapeutically effective concentration. Dissolution becomes the rate-limiting step of absorption. The biological ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4174A61P7/12
Inventor 郭红王成港刘欢
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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