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Medicinal composition for vagina and its preparation

A composition and drug technology, applied in the direction of drug combination, diseases, etc., can solve the problems of unknown absorption, increased dose blood econazole concentration, and no literature revealing econazole, etc.

Inactive Publication Date: 2008-03-26
沈阳华泰药物研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, increasing the dose may result in undesired blood econazole concentrations
At the same time, there is no literature revealing whether the local absorption of econazole in the vagina has a linear relationship with the dose, that is to say, it is not known whether there will be different degrees of absorption at different doses, especially when the dose changes are relatively large

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1, the preparation of econazole nitrate vaginal tablet

[0021] 1) Prescription screening

[0022] Using hardness, friability, fluidity (angle of repose), and melting time as indicators, the following four formulations (dosage of 100 tablets) were investigated.

[0023] The composition of each recipe is shown in Table 1.

[0024] Table 1 Prescription screening of econazole nitrate vaginal tablets (unit g, dosage of 100 tablets)

[0025] Prescription I

Prescription II

Prescription III

Prescription IV

Econazole Nitrate

Low-substituted hydroxypropyl cellulose

microcrystalline cellulose

lactose

pregelatinized starch

Carboxymethyl Starch Sodium

calcium lactate

lactic acid

10% povidone in water

Magnesium stearate

Talc powder

Sodium dodecyl sulfate

50

-

10

-

10

2.0

3.0

2.4

Appropriate amount

0.6

1.0

...

Embodiment 2

[0046] Embodiment 2, the absorption experiment of econazole nitrate

[0047] Preparation of samples for testing:

[0048] 1. Test preparation: econazole nitrate vaginal tablet, according to the method of embodiment 1, each tablet contains econazole nitrate 200mg.

[0049] The Beagle dose corresponds to the human dose of 500 mg.

[0050] 2. Comparative preparation 1: Econazole nitrate vaginal tablet, according to the method of Example 1, each tablet contains 60 mg of econazole nitrate.

[0051] The Beagle dose corresponds to the human dose of 150 mg.

[0052] 3. Comparative preparation 2: ordinary tablets of econazole nitrate, each tablet containing 60 mg of econazole nitrate was made according to the method of ordinary tablets.

[0053] The Beagle dose corresponds to the human dose of 150 mg.

[0054] Dosing regimen:

[0055] A three-cycle experimental design was adopted, and the time interval between the three cycles was 7 days. 6 Beagle dogs were fasted for 12 hours be...

Embodiment 3

[0071] Embodiment 3, pharmacodynamics experiment

[0072] Test drug: econazole nitrate vaginal tablet, anthropomorphic specification: 500mg / tablet, usage: 1 tablet / time, 1 administration, converted into corresponding rabbit test drug: 47mg / tablet (comparative experiment 1), 94mg / tablet (equivalent to human dosage), 188mg / tablet (comparative experiment 2); Rabbit test drug: 94mg / tablet (equivalent to human dosage, comparative experiment 3); small size econazole nitrate vaginal tablet, commercially available human specification: 150mg / tablet, usage: 1 tablet / time, 1 time / Daily, used 3 times in a row, converted into the corresponding test drug for rabbits (comparative experiment 4): 28mg / tablet; matrix tablet (blank tablet, comparative experiment 5): 94mg / tablet.

[0073] Test animals: Japanese big-eared white rabbits, weighing 1.8-2.2 kg, all female. First-class qualified experimental animals, from Shenyang Yuhong

[0074] Purchased from Qianmin Animal Breeding Factory, cer...

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PUM

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Abstract

The present invention relates to a medicine composition for preventing and curing vaginopathy. In the concrete, it relates to an econazole medicine composition for preventing and curing vaginopathy. Besides, said invention also provides its preparation method.

Description

technical field [0001] The invention relates to a vaginal pharmaceutical composition, in particular, the invention relates to a vaginal econazole pharmaceutical composition. The invention also relates to the preparation of the pharmaceutical composition. Background technique [0002] Candida vaginitis, also known as mycotic vaginitis, is mostly caused by Candida albicans infection in Candida. It is a common disease in gynecological inflammation, so the treatment of this disease is very necessary. [0003] Econazole is a broad-spectrum antifungal drug for external use, and its nitrate, econazole nitrate, is commonly used. Econazole nitrate can be used clinically for the treatment of candidal vaginitis. [0004] Sun Hua et al. ( Journal of Practical Obstetrics and Gynecology, 2000, 16(4): 180 ) Clinical experiments have confirmed that econazole nitrate vaginal suppository (50mg / piece, once a day, for 6 consecutive days) is more effective than miconazole nitrate vaginal supp...

Claims

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Application Information

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IPC IPC(8): A61K31/4164A61K47/38A61P15/02A61K31/191
Inventor 王鹏
Owner 沈阳华泰药物研究有限公司
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