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Hydrochloride clindamycin palmitate soft capsule and the preparing method thereof

A technology of clindamycin hydrochloride and palmitate, which is applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve the problems of perishable, unsuitable age patients, low dissolution rate and bioavailability, etc. question

Active Publication Date: 2007-10-31
PKU HEALTHCARE CORP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Because the product has high bioavailability and is not affected by food, it is often made into oral dosage forms, but so far, there are few oral dosage forms at home and abroad, only tablets and granules, which cannot meet the needs of patients of all ages
Moreover, tablets and granules are easy to absorb moisture and deteriorate easily; not only that, the dissolution rate and bioavailability of these current dosage forms after taking are all low, which directly affects the curative effect

Method used

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  • Hydrochloride clindamycin palmitate soft capsule and the preparing method thereof
  • Hydrochloride clindamycin palmitate soft capsule and the preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Weigh 1 kg of gelatin, 0.4 kg of glycerin, and 1 kg of pure water, mix 0.8 kg of water with the gelatin to make the gelatin absorb water and swell; mix the remaining water and glycerin and heat to 50 degrees Celsius, mix well and add the expanded gelatin and heat to 70 degrees Celsius, Stir, melt into a uniform glue, keep warm, stand still, defoam, and filter for subsequent use; Accurately weigh 500 g of clindamycin hydrochloride palmitate in terms of clindamycin, dissolve it in 1.2 kg polyethylene glycol 400, and Heating to 50 degrees centigrade to make it into a uniform medicinal solution; making 6,600 soft capsules with the above-mentioned glue and medicinal solution by the rotating membrane method, drying the obtained soft capsules, cleaning, and drying to obtain a finished product.

Embodiment 2

[0044] Weigh 1 kg of gum arabic, 0.4 kg of glycerin, and 1 kg of pure water, mix 0.8 kg of water with gelatin to make the gelatin absorb water and swell; mix the remaining water and glycerin and heat to 50 degrees Celsius, mix well and add the expanded gelatin and heat to 70 degrees Celsius , stirred, melted into a uniform glue solution, kept warm, static, defoamed, filtered for later use; accurately weighed 500g of clindamycin hydrochloride palmitate in terms of clindamycin, dissolved in 0.8kg propylene glycol 0.4kg soil temperature 80 , and heated to 50 degrees centigrade to make it a uniform medicinal solution; the above-mentioned prepared glue and medicinal solution are made into 6660 soft capsules by the rotating membrane method, and the obtained soft capsules are dried, cleaned, and dried to obtain a finished product.

Embodiment 3

[0046]Weigh 1 kg of gelatin, 0.4 kg of glycerin, and 1 kg of pure water, mix 0.8 kg of water with the gelatin to make the gelatin absorb water and swell; mix the remaining water and glycerin and heat to 50 degrees Celsius, mix well and add the expanded gelatin and heat to 70 degrees Celsius, Stir, melt into a uniform glue, keep warm, stand still, remove foam, and filter for standby; Accurately weigh 500 g of clindamycin hydrochloride palmitate in terms of clindamycin, dissolve it in 0.8 kg of glycerin and 0.4 kg of soil temperature 80, And heated to 50 degrees centigrade to make it into a uniform medicinal solution; the glue and medicinal solution prepared above were made into 6620 soft capsules by the rotating film method, and the obtained soft capsules were dried, washed and dried to obtain finished products.

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Abstract

The invention discloses a muriatic acid clindamycinum palmitate soft capsule preparation and preparing method, which is characterized by the following: comprising muriatic acid clindamycinum palmitate, dissolvent to dissolve muriatic acid clindamycinum palmitate and capsule shell solution; choosing the dissolvent from carbowax, glycerine, soil temperature and dimethyl carbinol; choosing the capsule shell solution from dope or acacia gum, glycerine and water; incorporating 35-200mg clindamycinum of muriatic acid clindamycinum palmitate in each soft capsule. This invention possesses quick effect and best stability.

Description

technical field [0001] The invention relates to a clindamycin hydrochloride palmitate preparation, in particular to a soft capsule containing clindamycin palmitate hydrochloride and a preparation method thereof. Background technique [0002] Clindamycin palmitate hydrochloride (clindamycin palmitate hydrochloride, CPY) is the prodrug of clindamycin, oral absorption is complete, and soon hydrolyzed to free clindamycin to take effect. This product has a higher antibacterial effect, which is 2 to 8 times that of lincomycin. Clindamycin palmitate hydrochloride is active against many Gram-positive aerobic bacteria, anaerobic bacilli, chlamydia, and mycoplasma. Clinically, it is mainly used for sepsis, bacterial endocarditis, respiratory tract infection, soft tissue infection, bone and joint infection, ear infection, genitourinary system infection caused by sensitive bacteria, especially those who are resistant to penicillin and erythromycin and are sensitive to this drug. Bacte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/7056A61K47/34A61K47/10A61K47/42A61P31/04
Inventor 赵洪武李侠王海屿
Owner PKU HEALTHCARE CORP LTD
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