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Butoconazole nitrate suppository used in gynaecology, preparation method and application thereof

A technology of butoconazole nitrate suppository and butoconazole nitrate, which is applied in the field of gynecological butoconazole nitrate suppository and its preparation, can solve the problems of inconvenient medication for patients, and achieve the effects of facilitating large-scale production, enhancing stability, and reducing production costs

Inactive Publication Date: 2011-03-02
孙福春
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, at present, butoconazole nitrate is an ointment, and it is inconvenient for patients to use it.

Method used

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  • Butoconazole nitrate suppository used in gynaecology, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The prescription composition and preparation method of butoconazole nitrate suppository are as follows:

[0034] Name of raw materials

[0035] Butoconazole nitrate 100.0g

[0036] Polyoxy(40) stearate 861.8g

[0037] Polyethylene glycol 1000 1202.0g

[0038] Glycerin 30.1g

[0039] Sodium citrate 50.1g

[0040] (1) Crush butoconazole nitrate, pass through a 100-mesh sieve, and set aside.

[0041] (2) Weigh a prescription amount of polyoxyl (40) stearate and polyethylene glycol 1000 in a 50°C water bath to heat and melt, add a prescription amount of glycerin, stir it evenly, and keep it in a 50°C water bath as a matrix.

[0042] (3) Weigh the prescription amount of butoconazole nitrate and slowly add it to the base, stirring while adding, weigh the prescription amount of sodium citrate and add an appropriate amount of water to make a 30% sodium citrate solution, and stir evenly after adding.

[0043] (4) Pour into the mold, cool, cut off the overflow part with a knife, open the mold, ...

Embodiment 2

[0047] The prescription composition and preparation method of butoconazole nitrate suppository are as follows:

[0048] Name of raw materials

[0049] Butoconazole nitrate 1000.0g

[0050] Polyoxy(40) stearate 8618.0g

[0051] Polyethylene glycol 1000 12020.0g

[0052] Glycerin 301.0g

[0053] Sodium citrate 501.0g

[0054] (1) Crush butoconazole nitrate, pass through a 100-mesh sieve, and set aside.

[0055] (2) Weigh a prescription amount of polyoxyl (40) stearate and polyethylene glycol 1000 in a 50°C water bath to heat and melt, add a prescription amount of glycerin, stir it evenly, and keep it in a 50°C water bath as a matrix.

[0056] (3) Weigh the prescription amount of butoconazole nitrate and slowly add it to the base, stirring while adding, weigh the prescription amount of sodium citrate and add an appropriate amount of water to make a 30% sodium citrate solution, and stir evenly after adding.

[0057] (4) Pour into the mold, cool, cut off the overflow part with a knife, open the m...

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Abstract

The invention relates to a butoconazole nitrate suppository used in gynaecology, and a preparation method and application thereof. The preparation method has the characteristics of simple process and lower cost and is convenient for medication. The butoconazole nitrate suppository used in gynaecology comprises the following components in parts by weight: 100 parts of butoconazole nitrate, 100-1000 parts of polyoxyl (40) stearate, 100-2000 parts of polyethylene glycol 1000, 1-50 parts of glycerol and 1-100 parts of sodium citrate.

Description

Technical field [0001] The invention belongs to the new technical field of new drug research and development, and relates to a new dosage form of butoconazole nitrate, and is a gynecological butoconazole nitrate suppository for treating vulvovaginal infections caused by Candida albicans, and a preparation method and application thereof. technical background [0002] Butoconazole nitrate was developed by Syntex in the United States. It was approved by the FDA in 1986 and stored in USP27. It was subsequently registered and marketed in Europe and the Americas. At present, it is mainly produced and sold by KV Pharmaceutical Company in the United States. Recently, KV Pharmaceutical Company in the United States is applying for registration of imported drugs for butoconazole nitrate ointment in China, and has not yet been approved for marketing. [0003] Vulvovaginal candidiasis (Vulvovaginalcandidiasis, VVC) is inflammation of the vulva and vagina caused by Candida invading the vulva and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K31/4174A61P31/10A61P15/00A61P15/02
Inventor 孙福春
Owner 孙福春
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