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Preparation and application of clindamycin phosphate in-situ gel

A technology of clindamycin phosphate and in-situ gel, which is applied in the directions of medical preparations without active ingredients, medical preparations containing active ingredients, sexual diseases, etc.

Inactive Publication Date: 2012-02-01
胡容峰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are currently no formulations for in situ gels on the market

Method used

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  • Preparation and application of clindamycin phosphate in-situ gel
  • Preparation and application of clindamycin phosphate in-situ gel
  • Preparation and application of clindamycin phosphate in-situ gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] Embodiment 1 Preparation of Clindamycin Phosphate Thermosensitive Vaginal Gel

[0105] [Prescription] Clindamycin Phosphate 0.1g

[0106] F127 21.4g

[0107] F68 9.6g

[0108] Add distilled water to the full amount of 100g

[0109] [Preparation method] Take clindamycin phosphate, dissolve it in distilled water, slowly add the prescribed amount of F127 and F68 under stirring conditions, add distilled water to a sufficient amount, store in low temperature refrigeration, make it fully swell, until a clear and uniform solution is formed. The phase transition temperature of the preparation is 35±2°C.

Embodiment 2

[0110] Embodiment 2 Preparation of Clindamycin Phosphate Thermosensitive Vaginal Gel

[0111] [Prescription] Clindamycin Phosphate 0.1g

[0112] F127 17.2g

[0113] F68 7.4g

[0114] Add distilled water to the full amount of 100g

[0115] [Preparation method] Take clindamycin phosphate, dissolve it in distilled water, slowly add the prescribed amount of F127 and F68 under stirring conditions, add distilled water to a sufficient amount, store in low temperature refrigeration, make it fully swell, until a clear and uniform solution is formed. The phase transition temperature of the preparation is 36±0.2°C.

Embodiment 3

[0116] Example 3 Preparation of Clindamycin Phosphate pH Sensitive Vaginal Gel

[0117] [Prescription] Clindamycin Phosphate 0.1%

[0118] Carbomer 980 0.4%

[0119] Poloxamer F127 0.5%

[0120] Add distilled water to the full amount of 100g

[0121] [Preparation method] Take clindamycin phosphate and dissolve it in distilled water with the prescribed amount, slowly add the prescribed amount of Carbomer 980 and F127 under stirring conditions and store in low temperature refrigeration to fully swell until a clear and uniform solution is formed. The viscosity of the preparation is less than 1100mpa.s under non-physiological conditions, and greater than 2500mpa.s under physiological conditions at pH 4.5.

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Abstract

Relating to the field of medical technologies, the invention provides a new dosage form of clindamycin phosphate, i.e. preparation and application of temperature sensitive and pH sensitive clindamycin phosphate in-situ gel. The gel is characterized by preparation and application of the gel that is a solution under a nonphysiological state and is gel through phase transition under a physiological state. The temperature sensitive and pH sensitive clindamycin phosphate gel is finally prepared with Poloxamer 407 (F127 for short) and Poloxamer 188 (F68 for short) in a proper ratio. The pH sensitive in situ gel is prepared by Carbopol 980 and Poloxamer F127 in a proper ratio. The gel has viscosity of less than 1100mpa.s under a nonphysiological condition and viscosity of greater than 2500mpa.s under a physiological condition with pH of 4.5. The gel prolongs the detention time of clindamycin phosphate in the vagina and improves the bioavailability and curative effects, thus boasting good application prospects.

Description

technical field [0001] The invention relates to a new dosage form of clindamycin phosphate, a vaginal drug, which is a solution in a non-physiological state, and is transformed into a gel in a physiological state. Specifically, it is a preparation method and clinical indication of clindamycin phosphate temperature- and pH-sensitive gel. The preparation greatly prolongs the retention time of the drug in the vagina, improves the bioavailability and curative effect, and has a good application prospect. Background technique [0002] Clindamycin phosphate is mainly used clinically for G + It is one of the first choice drugs for the treatment of bacterial vaginosis. At present, domestically produced and marketed vaginal preparations include tablets, suppositories, membranes, capsules and jellies. At present, traditional vaginal preparations such as effervescent tablets release drugs quickly, are easy to use, stable in quality, and have a high degree of mechanization in producti...

Claims

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Application Information

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IPC IPC(8): A61P31/02A61P15/00A61P15/02A61K9/00A61K47/34A61K31/7056
Inventor 胡容峰胡晓徐亚静
Owner 胡容峰
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