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Clindamycin palmitate hydrochloride particle composition and preparation method thereof

A technology of clindamycin hydrochloride and palmitate, which is applied in the directions of drug combination, pharmaceutical formula, and non-active ingredient medical preparations

Active Publication Date: 2021-02-26
GUANGZHOU YIPINHONG PHARMA +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, for clindamycin hydrochloride palmitate granules, these methods cannot solve the problem of uniform content

Method used

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  • Clindamycin palmitate hydrochloride particle composition and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0022] 1) Prescription: The composition of the prescription of clindamycin palmitate hydrochloride granules is as follows, in a 1kg preparation, which contains:

[0023] Clindamycin Palmitate Hydrochloride 37.5g (calculated as clindamycin)

[0024] Sucrose 920g

[0025] Poloxamer 13g

[0026] Ethylparaben 0.3g

[0027] Simethicone 0.06g

[0028] Cherry essence 5g

[0029] Medicinal ethanol 20ml

[0030] 2) Preparation method:

[0031] (a) Sieve the sucrose, select the sucrose with a particle size of not more than 25% greater than 600 μm and not more than 20% of the particle size less than 180 μm for later use; grind and sieve the ethylparaben, and select the sucrose with a particle size of not greater than 300 μm for later use;

[0032] (b) take by weighing the clindamycin hydrochloride palmitate and adjuvant of prescription quantity;

[0033] (c) Add the weighed sucrose, ethylparaben, simethicone, poloxamer, and clindamycin palmitate hydrochloride to the wet granulator...

Embodiment 2

[0036] 1) Prescription: The composition of the prescription of clindamycin palmitate hydrochloride granules is as follows, with a 5kg preparation, which contains:

[0037] Clindamycin palmitate hydrochloride 0.5kg (calculated as clindamycin)

[0038] Cane sugar (granulated sugar) 4kg

[0039] Poloxamer 150g

[0040] Ethylparaben 5g

[0041] Simethicone 2g

[0042] Cherry essence 20g

[0043] Medicinal ethanol 150ml

[0044] 2) Preparation method:

[0045] (a) Sieve sucrose (fine granulated sugar), select no more than 25% of sucrose with a particle size greater than 600 μm, and no more than 20% of sucrose with a particle size less than 300 μm for use; crush and sieve ethyl paraben, and select a particle size range not greater than 300 μm spare;

[0046] (b) take by weighing the clindamycin hydrochloride palmitate and adjuvant of prescription quantity;

[0047] (c) Add weighed sucrose, ethylparaben, simethicone, poloxamer, and clindamycin palmitate hydrochloride to the w...

Embodiment 3

[0050] 1) Prescription: The composition of the prescription of clindamycin palmitate hydrochloride granules is as follows, with a 10kg preparation, which contains:

[0051] Clindamycin palmitate hydrochloride 0.75kg (calculated as clindamycin)

[0052] Sucrose (caster sugar) 8.6kg

[0053] Poloxamer 130g

[0054] Ethylparaben 8g

[0055] Simethicone 2g

[0056] Cherry essence 25g

[0057] Medicinal ethanol 200ml

[0058] 2) Preparation method:

[0059] (a) Sieve sucrose (caster sugar), select sucrose with a particle size of not more than 10% greater than 500 μm, and less than 10% of sucrose with a particle size of less than 180 μm for later use; grind and sieve ethyl paraben, and select a particle size range of not greater than 250 μm for later use; (b) Weigh the prescribed amount of sucrose, ethylparaben, simethicone, poloxamer, clindamycin palmitate hydrochloride, add to the wet granulator for premixing, time 180S; add the prescribed amount of ethanol In the wet granula...

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Abstract

The invention relates to a clindamycin palmitate hydrochloride particle composition. The preparation method is characterized by comprising the following components of, (1) 1-10% of clindamycin palmitate hydrochloride; and 2) 70-95% of sucrose, wherein the sucrose with particle size greater than 600 micrometers is no more than 20% and the sucrose with particle size less than 180 micrometers is no more than 20%. Through a large number of researches, the problem of content uniformity of clindamycin palmitate hydrochloride particles is accidentally solved by using the sucrose with a certain particle size range as filler; and the uniformity is poor when the crushed sucrose with particle size similar to that of medicines is used as the filler.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a clindamycin hydrochloride palmitate granule composition and a preparation method thereof. Background technique [0002] Clindamycin palmitate hydrochloride is the prodrug of clindamycin. After oral administration of clindamycin palmitate, it can be hydrolyzed into free clindamycin to take effect and absorbed completely, while clindamycin Lincomycin has a higher antibacterial effect, which is 2 to 8 times that of lincomycin. Clindamycin is active against many Gram-positive aerobic bacteria (excluding Enterococci), Streptococcus, Bacillus, Staphylococcus, and also against many anaerobic bacilli, Chlamydia, Mycoplasma, Plasmodium, and Equine . As a bactericidal drug, this product mainly inhibits the synthesis of bacterial proteins, and has an inhibitory effect on the activation, transfer and binding of amino groups. The action point is at the 50s subunit of the ribosome....

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/7056A61K47/26A61P31/04A61P33/06A61P33/02
CPCA61K31/7056A61K9/1623A61K9/1694A61P31/04A61P33/06A61P33/02Y02A50/30
Inventor 李捍雄王显著蒋平顺
Owner GUANGZHOU YIPINHONG PHARMA
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