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Clindamycin phosphate vaginal sustained-release gel and its preparation method

A technology of clindamycin phosphate and sustained-release gel, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Easy to fall off and other problems, to achieve the effect of sustained release of drug effect, long residence time and clear treatment effect

Inactive Publication Date: 2012-02-01
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In view of the problems that the existing clindamycin phosphate preparations are easy to fall off in the vagina, the number of administrations is high, and the patient's compliance is poor, the purpose of the present invention is to provide a drug with clear therapeutic effect, long residence time in the vagina, and sustained drug effect release. , long-term onset of effect, good patient compliance clindamycin phosphate vaginal sustained-release gel

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1: prescription composition:

[0019] Clindamycin Phosphate 2%

[0020] Poloxamer (188) 7%

[0021] Poloxamer (407) 18%

[0022] Sodium Carmellose 1%

[0023] Carbomer (980) 1.2%

[0024] Methylparaben 0.02%

[0025] Ethylparaben 0.01%

[0026] EDTA-2Na 0.1%

[0027] water balance

[0028] Preparation:

[0029] Disperse the carbomer in an appropriate amount of water and swell overnight; dissolve the preservative and complexing agent in water at 80°C, let it cool after dissolving, add clindamycin phosphate, poloxamer and carboxymethylcellulose Add plain sodium into it under stirring, place it at 4°C until the dissolution is complete, mix it with the carbomer dispersion, and pack it separately.

Embodiment 2

[0031] Prescription composition:

[0032] Clindamycin Phosphate 2%

[0033] Poloxamer (188) 8%

[0034] Poloxamer (407) 12%

[0035] Sodium Carmellose 1%

[0036] Carbomer (980) 1%

[0037] Methylparaben 0.02%

[0038] Ethylparaben 0.01%

[0039] EDTA-2Na 0.17%

[0040] water balance

[0041] Preparation:

[0042] Disperse the carbomer in an appropriate amount of water and swell overnight; dissolve the preservative and complexing agent in water at 80°C, let it cool after dissolving, add clindamycin phosphate, poloxamer and carboxymethylcellulose Add plain sodium into it under stirring, place it at 4°C until the dissolution is complete, mix it with the carbomer dispersion, and pack it separately.

Embodiment 3

[0044] Prescription composition:

[0045] Clindamycin Phosphate 2%

[0046] Poloxamer (188) 15%

[0047] Poloxamer (407) 8%

[0048] Sodium Carmellose 0.6%

[0049] Carbomer (980) 1%

[0050] Methylparaben 0.02%

[0051] Ethylparaben 0.01%

[0052] EDTA-2Na 0.17%

[0053] water balance

[0054] Preparation:

[0055] Disperse the carbomer in an appropriate amount of water and swell overnight; dissolve the preservative and complexing agent in water at 80°C, let it cool after dissolving, add clindamycin phosphate, poloxamer and carboxymethylcellulose Add plain sodium into it under stirring, place it at 4°C until the dissolution is complete, mix it with the carbomer dispersion, and pack it separately.

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PUM

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Abstract

The invention relates to a clindamycin phosphate vaginal sustained-release gel and its preparation method. The clindamycin phosphate vaginal sustained-release gel comprises the following components of: by weight, 1-5% of clindamycin phosphate, 5-15% of poloxamer (188), 8-20% of poloxamer (407), 0.5-2% of sodium carboxymethyl cellulose, 0.05-2% of carbomer (980), 0.02-5% of an additive and the balance being water. The clindamycin phosphate vaginal sustained-release gel provided by the invention has advantages of clear curative effect, long detention time in vagina, sustained release of the drug effect, long onset time and good compliance of patients.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to an antifungal pharmaceutical preparation, in particular to clindamycin phosphate vaginal sustained-release gel and a preparation method thereof. Background technique [0002] The local environment of the vagina makes it a target for disease and infection. The warm, humid and dark environment in the vagina is conducive to the growth of various microorganisms; in addition, the gaps in the vaginal cavity are conducive to bad bacteria, fungi, yeast and other microorganisms, as well as bacteria from menstruation. These are conducive to the growth of microorganisms, making the vagina a high-incidence site for various infections. [0003] There are also many researches on vaginal administration, and there are mainly two situations, one is to exert its effect locally, and the other is to exert its effect after being absorbed through the vaginal mucosa. Local vaginal administration is mainl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P31/02A61K47/38A61P15/02A61P31/04A61K9/00A61K31/7056
Inventor 范敏华刘海姜双瑜刘华
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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