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Medicine composition for treating valval and/or vaginal diseases

A technique for vaginal diseases and compositions, applied in the field of pharmaceutical compositions

Inactive Publication Date: 2006-11-08
BEIJING JINCHENG TAIER PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no report or corresponding technical inspiration on the combined use of miconazole and promestrine in the treatment of vulvar and vaginal diseases

Method used

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  • Medicine composition for treating valval and/or vaginal diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] According to following formula, make the soft capsule that meets quality standard with the production technology of capsule:

[0020] Recipe 1

[0021] Component Content (mg / grain)

[0022] Promestriene 10

[0023] Miconazole 50

[0024] White Vaseline 500

[0025] Carrageenan 900

[0026] Ethylparaben 200

[0027] Sorbitan Sesquioleate Added to 2000mg, made into 1000 capsules

[0028] Recipe 2

[0029] Component Content (mg / grain)

[0030] Promestriene 8

[0031] Miconazole 60

[0032] White Vaseline 500

[0033] Carrageenan 900

[0034] Ethylparaben 200

[0035] Sorbitan Sesquioleate Added to 2000mg, made into 1000 capsules

[0036] Recipe 3

[0037] Component Content (mg / grain)

[0038] Promestriene 8

[0039] Miconazole 55

[0040] White Vaseline 400

[0041] Carrageenan 900

[0042] Ethylparaben 200

[0043] Sorbitan Sesquioleate Added to 2000mg, made into 1000 capsules

[0044] Recipe 4

[0045] Component Content (mg / grain)

[0046] Promestr...

Embodiment 2

[0065] Embodiment 2: local irritation and acute toxicity research,

[0066] Tested drug: Promestriene / miconazole compound soft capsules, each capsule content (2g) contains 7mg promestriene, miconazole 50mg soft capsules, each gram content contains 0.0285g of drug ingredients.

[0067] High dose: 1.0g per day for each rabbit, 0.5g for one dose, twice a day, 0.0285g of drug ingredients, with an average of 11.9mg / kg, which is 20 times the dosage for humans. Each rat is given 0.2g once a day, and once a day (about 0.2g) the drug composition is 5.7mg, with an average of 23mg / kg, which is 40 times the dosage for humans.

[0068] Medium dose: each rabbit is given 0.5g per day, 0.25g once a day, twice a day, the drug component is 0.0143g, with an average of 5.95mg / kg, which is 9.5 times the dosage for humans. Each rat is given 0.1g once a day, and once a day (about 0.1g) the drug composition is 2.85mg, with an average of 11.5mg / kg, which is 20 times the dosage for humans.

[0069] L...

Embodiment 3

[0075] Example 3: Long-term Toxicity Study of Topical Drugs

[0076] Test drug: same as above

[0077] High dose: each rat is given 0.2g once, once a day (about 0.2g) the drug ingredient is 5.7mg, with an average of 23mg / kg, which is 40% of the human dosage.

[0078] Medium dose: each rat is given 0.1g once a day, once a day (about 0.1g) the drug ingredient is 2.85mg, with an average of 11.5mg / kg, which is 20 times the dosage for humans

[0079] Low dose: 0.05g administered once per rat, 1.43mg of drug ingredient once a day (about 0.05g), with an average of 5.75mg / kg, which is 10 times the dosage for humans

[0080] The body weight of female rats is 0.235-0.260kg. The three doses were administered once a day, continuously observed for 30 days, and the test was repeated three times. The results showed that no toxic reaction and local irritation were found in the animal's whole body and vagina; Drugs in the dose group had no pathogenic effect on each layer of the vagina.

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Abstract

The present invention relates to medicine composition for treating vulval and / or vaginal diseases. The medicine composition for treating vulval and / or vaginal diseases contains promestriene and miconazole in the weight ratio of 1 to 5-1 to 8 as the active components. The daily dose of the medicine composition includes promestriene 6-10 mg, preferably 7 mg; and miconazole 30-80 mg, preferably 50 mg. The medicine composition is prepared into vagina administrating preparation forms, such as suppository, capsule, tablet, etc.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition for treating vulvar and / or vaginal diseases, which uses promestriene and miconazole as active components. Background technique [0002] Vulvar and vaginal diseases caused by Candida are opportunistic bacterial infections, 80%-90% are caused by Candida albicans, and 10%-20% are other Candida and Torulopsis infections. In China, candida infection is quite common among female reproductive infections, but in the United States, the number of patients with female lower reproductive tract infections accounts for the second; sexual intercourse can make both men and women sick, and women patients, their spouses or Candidal balanitis occurs in 5%-20% of sexual partners. [0003] The most prominent symptoms of this disease are increased leucorrhea and vulvovaginal itching. Leucorrhea does not necessarily all have typical physical signs, and there can be various ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/565A61K9/02A61K9/06A61K9/20A61K9/48A61K31/4174A61P17/02
Inventor 杨军
Owner BEIJING JINCHENG TAIER PHARMA CO LTD
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