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Midodrine hydrochloride medicinal composition

A technology of midodrine hydrochloride and a composition, which is applied in directions such as drug combination, pill delivery, blood diseases, etc., can solve the problems of difficult mixing, complicated process, poor stability, etc., and achieves simplified production process, simple production process, and improved stability. sexual effect

Inactive Publication Date: 2017-06-13
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to avoid the incompatibility of raw and auxiliary materials and ensure that the tablet friability meets the requirements, foreign patents adopt a two-step preparation. The first step is to granulate raw materials and mannitol, and the second step is to use microcrystalline microcrystalline cellulose and lactose to granulate. The two kinds of granules are mixed, and after adding magnesium stearate, they are compressed into tablets, which has the disadvantages of complex process, difficulty in mixing uniformly, poor stability, etc.

Method used

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  • Midodrine hydrochloride medicinal composition
  • Midodrine hydrochloride medicinal composition
  • Midodrine hydrochloride medicinal composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Preparation of Midodrine Hydrochloride Tablets

[0024] Recipe:

[0025]

[0026] Weigh midodrine hydrochloride that has passed through a 100-mesh sieve, mannitol, pregelatinized starch, sodium carboxymethyl starch, magnesium stearate, and micronized silica gel that have passed through a 60-mesh sieve according to the weight parts of the components; Midodrine and part of the mannitol are mixed uniformly in equal increments, then pregelatinized starch, sodium carboxymethyl starch, and the remaining mannitol are added to mix evenly, and the hydroxypropyl methylcellulose aqueous solution is added and mixed evenly to make a soft material 、Sieving granulation; drying at 55℃-65℃ to dryness, the moisture content is controlled within 1%-5.0%; sieve the dried granules, add magnesium stearate and micronized silica gel, mix well, and mix well The granules are compressed.

Embodiment 2

[0028] Recipe:

[0029]

[0030] The preparation method is the same as in Example 1.

Embodiment 3

[0032] Recipe:

[0033]

[0034] The preparation method is the same as in Example 1.

[0035] Control sample 1 Preparation of midodrine hydrochloride tablets (refer to Japanese patent)

[0036] Recipe:

[0037]

[0038] Weigh out midodrine hydrochloride that has passed through a 100-mesh sieve, and mannitol, microcrystalline cellulose, lactose, sodium carboxymethyl starch, and magnesium stearate that have passed through a 60-mesh sieve according to the weight of the components; Methyl cellulose is dissolved in the aqueous solution for later use; the midodrine hydrochloride and mannitol are mixed uniformly in equal increments, the soft material is made from the hydroxypropyl methyl cellulose aqueous solution, and then granulated by sieving; microcrystalline cellulose, Mix lactose evenly, add hydroxypropyl methylcellulose aqueous solution to make soft material, sieving and granulation; dry the two kinds of granules at 55℃-65℃ until the moisture content is within 1.0%-5.0%; sieving the ...

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Abstract

The invention discloses a midodrine hydrochloride pharmaceutical composition, which is characterized in that every 1000 tablets include the following components in parts by weight: 10-35 parts of midodrine hydrochloride, 300-990 parts of mannitol, pregelatinized 100-500 parts of starch, 20-80 parts of sodium carboxymethyl starch, 2-20 parts of magnesium stearate, 2-20 parts of micropowder silica gel, 0-50 parts of hydroxypropyl methylcellulose. The invention has the advantages of using mannitol and pregelatinized starch as auxiliary materials, overcoming the incompatibility of midodrine hydrochloride with microcrystalline cellulose, dextrin and starch, and ensuring the acceptable friability of the tablet. The preparation method of the present invention adopts midodrine hydrochloride, mannitol, pregelatinized starch, and sodium carboxymethyl starch to directly mix and granulate in one step, so that it can ensure that the quality indicators of the product within the validity period are basically stable, and can also improve The uniformity and stability of the product are better, and the production process is simplified.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, and is a midodrine hydrochloride medicine for treating postural hypotension, female stress urinary incontinence, and menopausal urinary incontinence. Background technique [0002] Midodrine hydrochloride is a drug developed by the Austrian Chemid Linz company to treat orthostatic hypotension. It is a kind of prodrug, and after enzymatic hydrolysis, it is metabolized into pharmacologically active substance desglycinate midodrine. Deglycinated midodrine selectively stimulates peripheral α-adrenergic receptors. This drug has no effect on myocardial β-adrenergic receptors. The other effects are basically equivalent to those of other a-sympathetic drugs. [0003] Midodrine hydrochloride chemical name: 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]acetamide hydrochloride. [0004] Structural formula of midodrine hydrochloride: [0005] [0006] Midodrine hydrochloride is a white crystalline pow...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/165A61P9/02A61P7/12A61P13/00
Inventor 吴健民胡良红贺莲
Owner KAMP PHARMA
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