Orally taken medicament formulation of clindamycin phosphate and preparing method thereof

A technology of clindamycin phosphate and pharmaceutical preparations, which is applied in the field of clindamycin phosphate oral pharmaceutical preparations and its preparation, which can solve the problems of slow onset of action, many adverse reactions, and bacterial flora imbalance, and achieve drug concentration High, less adverse reactions, fast onset effect

Inactive Publication Date: 2009-04-08
张宏宇
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] 1. Systemic medication: The drug is distributed to various tissues of the body, which not only causes many adverse reactions, but also affects the whole body flora, which may cause flora imbalance and cause secondary infection, such as pseudomembranous enteritis
[0005]2. Slow onset: the drug is disintegrated and absorbed through the digestive tract or enters the blood through injection, enters the ora

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: raw material proportioning: clindamycin phosphate (in clindamycin) 50kg, sodium starch glycolate 20kg, mannitol 200kg, aspartame 10kg, micropowder silica gel 5kg, magnesium stearate 2kg, Flavor 1kg.

[0027] Preparation method: crush clindamycin phosphate, sieve, mix with mannitol, aspartame, carboxymethyl starch sodium, use 5% povidone solution as wetting agent to make soft material; sieve through 20 mesh Granules, dried, granulated with a 20-mesh sieve, added with micro-powdered silica gel, magnesium stearate, essence, mixed evenly, measured drug content, calculated tablet weight, compressed into tablets, to obtain.

[0028] This buccal tablet has the following characteristics:

[0029] 1. The taste is sweet and fragrant.

[0030] 2. Dissolution test: the dissolution rate is greater than 80% in 45 minutes.

Embodiment 2

[0031] Embodiment 2: Raw material ratio: clindamycin phosphate (calculated by clindamycin) 25kg, microcrystalline cellulose 30kg, sorbitol 50kg, calcium hydrogen phosphate 20kg, stevia 4kg, micropowder silica gel 10kg, stearyl rich Sodium maleate 5kg, talcum powder 2kg.

[0032] The preparation method of the above clindamycin phosphate buccal tablets: take clindamycin phosphate and calcium hydrogen phosphate to pulverize respectively and sieve; get the raw and auxiliary materials and mix them evenly, measure the drug content, calculate the tablet weight, and directly compress the tablet, namely have to.

[0033] The buccal tablets obtained have the following characteristics:

[0034] 1. The taste is sweet and fragrant.

[0035] 2. Dissolution test: the dissolution rate is greater than 80% in 45 minutes.

Embodiment 3-10

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2

[0040] The preparation method of above-mentioned embodiment 3-10 is: (1), get clindamycin phosphate and pulverize, sieve, mix with filler, flavoring agent, disintegrant, mix with water, ethanol or povidone water or soft materials made of ethanol solution or hypromellose solution;

[0041] (2), the above-mentioned soft material is granulated through a 16-40 mesh sieve, dried, granulated with a 16 mesh sieve, added an odor correcting agent, a glidant, a lubricant, and mixed uniformly;

[0042] (3) Measure the content of the uniformly mixed medicine, calculate the weight of the tablet, and compress the tablet.

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PUM

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Abstract

The invention discloses a clindamycin phosphate oral pharmaceutical preparation, which is mainly prepared from raw materials in the following weight ratio: (1) a buccal tablet which comprises 1 to 100 portions of clindamycin phosphate counted on clindamycin, 0 to 100 portions of disintegrant, and 5 to 500 portions of filler; (2) a filmogen which comprises 1 to 100 portions of the clindamycin phosphate counted on the clindamycin, and 5 to 500 portions of film-forming material; and (3) an oral patch which comprises 1 to 100 portions of the clindamycin phosphate counted on the clindamycin, 5 to 500 portions of the filler, and 1 to 100 portions of adhesive material. The clindamycin phosphate oral pharmaceutical preparation is directly applied to a local infection and has high local drug concentration and fast effect, and the dose is low and adverse reactions are few.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a clindamycin phosphate oral pharmaceutical preparation and a preparation method thereof. Background technique [0002] Clindamycin phosphate, 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thiomethyl-7(S)-chloro-6,7 , 8-trideoxy-L-threo-α-D-galactopyranoside-2-dihydrogen phosphate, is an antibiotic. Clindamycin phosphate is a derivative of clindamycin. Its mechanism of action is the same as that of clindamycin and lincomycin. It mainly inhibits the elongation of the peptide chain during protein synthesis, thereby affecting the synthesis of bacterial cell proteins. The site is on the 50S subunit of the ribosome. Preclinical pharmacology studies have shown that, as a semi-synthetic clindamycin derivative, clindamycin phosphate has no antibacterial activity in vitro, and after entering the body, it is rapidly hydrolyzed into clindamycin to display its pharmacological acti...

Claims

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Application Information

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IPC IPC(8): A61K31/7056A61K47/30A61K47/36A61P1/02A61P31/04
Inventor 张宏宇杜军
Owner 张宏宇
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