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Naftopidil dispersible tablet and preparation method thereof

A kind of technology of nafidil and dispersible tablet, applied in the field of nafidil dispersible tablet and preparation thereof

Inactive Publication Date: 2013-04-03
NINGXIA DUOWEI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, naftopidil bulk drug is insoluble in water, has low gastrointestinal absorption rate and low bioavailability (the gastrointestinal absorption rate of rats is 70%, and the bioavailability of rats and dogs is 10%), so , the bioavailability of ordinary naftopidil tablets is low, which is not conducive to human body absorption

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Embodiment 1: Containing the dispersible tablet preparation of 12.5mg naftopidil

[0061] Prepare raw materials by following weight ratio:

[0062] Naftopidil 12.5g; Saccharin sodium 0.5g; Talc powder 10g; Lactose 20g; Carboxymethyl starch sodium 15g; Methyl microcrystalline cellulose 25g; Hydroxypropyl cellulose 17g; Poloxamer 0.05g; Stearic acid Magnesium 0.5g.

[0063] (1) Grind naftopidil, lactose, hydroxymethyl starch sodium, methyl microcrystalline cellulose, hydroxypropyl cellulose, talcum powder, and sodium saccharin separately, and pass through a 100-mesh sieve;

[0064] (2) Grind and mix the sodium saccharin and the same amount of naftopidil until the visual color is consistent, and then grind and mix the above mixed powder with the remaining naftopidil until the visual color is consistent;

[0065] (3) Mix the mixed powder obtained in the above (2) with lactose, carboxymethyl starch sodium, microcrystalline cellulose, hydroxypropyl cellulose, and talcum p...

Embodiment 2

[0067] Embodiment 2: the dispersible tablet preparation containing 25mg naftopidil

[0068] Prepare raw materials by following weight ratio:

[0069] Naftopidil 25g; Saccharin sodium 1.0g; Talc powder 12.5g; Lactose 22.5g; Carboxymethyl starch sodium 17.5g; Methyl microcrystalline cellulose 30g; Hydroxypropyl cellulose 25g; Poloxamer 0.. 1g; magnesium stearate 0.5g.

[0070] Preparation method is with embodiment 1.

Embodiment 3

[0071] Embodiment 3: the dispersible tablet preparation containing 50mg naftopidil

[0072] Prepare raw materials by following weight ratio:

[0073] Natopidil 50g; Aspartame 0.5g; Talc powder 15g; Lactose 25g; Sodium carboxymethyl starch 20g; Ethyl cellulose 30g; Hydroxypropyl cellulose 25g; Poloxamer 0.1g; Magnesium 1.0g.

[0074] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention discloses a naftopidil dispersible tablet and a preparation method thereof. The naftopidil comprises the following drugs in parts by weight: 12.5-30 parts of naftopidil, 0.5-2 parts of sweetening agent, 10-15 parts of talcum powder, 20-25 parts of sugar, 15-20 parts of explotab, 25-35 parts of cellulose, 17-25 parts of hydroxy propyl cellulose, 0.05-0.1 part of poloxamer and 0.5-1.0 part of magnesium stearate. The naftopidil dispersible tablet is used for treating prostatic hyperplasia, and has the advantages that the disintegration speed and the absorbing speed are quick, the drug dissolution rate and the bioavailability are high, the blood concentration can be stable quickly, and the clinical treatment effect of the prostatic hyperplasia can be improved.

Description

field of invention [0001] The invention belongs to the technical field of medicines, in particular to a naftopidil dispersible tablet and a preparation method thereof. Background technique [0002] Benign prostatic hyperplasia (BPH) is a common disease in elderly men. With the acceleration of population aging, the incidence of benign prostatic hyperplasia is also increasing. According to reports, 50% of men aged 50-60, 60% of men aged 60-70, 70% of men aged 70-80, and 88% of men over 80 years old have different degrees of benign prostatic hyperplasia. May develop symptomatic BPH. [0003] BPH causes bladder neck obstruction, affects the normal function of the urinary system, produces varying degrees of voiding disorders, and eventually causes bladder and kidney lesions, resulting in damage to renal function and seriously affecting the quality of life of patients. In addition to the mechanical obstruction (static factor) caused by the enlarged prostate gland volume, the bla...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/495A61K47/38A61P13/08
Inventor 王帆王景段江英王春红冯艳叶新春
Owner NINGXIA DUOWEI PHARMA
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