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Medicine composition for treating valval and/or vaginal infection

A technology of vaginal infection and composition, applied in the field of pharmaceutical compositions, can solve the problems of large local irritation of the vagina, unsatisfactory effect, serious adverse reactions, etc., and achieves the promotion of growth recovery, significant local nutrition and anti-seborrheic dermatitis, The effect of enhancing immunity

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

But chlorhexidine acetate / metronidazole compound preparation is only when treating the early infection disease, and effect is more obvious, and on the treatment heavier infection disease effect is not very satisfactory, and chlorhexidine acetate / metronidazole compound preparation is in While treating vaginitis, it shows a large adverse reaction, which is manifested as a large local irritation to the vagina, resulting in local redness and swelling

Method used

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  • Medicine composition for treating valval and/or vaginal infection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1: the preparation of promestriene / chlorhexidine acetate / metronidazole compound soft capsule

[0017] Weigh white petrolatum and 80% carrageenan together and heat to dissolve, keep warm at about 60°C, set aside, and make 1 liquid. Weigh chlorhexidine acetate, metronidazole and the remaining amount of carboxane together, stir to completely dissolve chlorhexidine acetate and metronidazole, then add promestriene to stir evenly, then add the weighed The sorbitan sesquioleate and ethyl paraben are stirred and dissolved, mixed with 1 solution, and fully mixed with a high-speed homogenizer to obtain the content. Add gelatin, glycerin, water, and ethylparaben according to the determined formula, melt the glue at about 60°C, and vacuum degas the glue solution for use on the capsule pressing machine. The liquid medicine and the glue liquid are introduced into the machine for preparing capsules, the machine is adjusted so that each soft capsule is injected with the liq...

Embodiment 2

[0064] Embodiment 2: Stability experiment

[0065] 3 batches of samples of the aluminum-plastic packaging prepared by formula 5 in Example 1 are placed at a temperature of 30 ± 2°C and a relative humidity of 60% ± 5°C (NaNO 2 Saturated solution) in the incubator, samples were taken at the end of the 1st, 2nd, 3rd, and 6th months, and tested according to the relevant stability inspection items. The results are shown in Table 1 below.

[0066]

[0067] The above stability test results show that the compound preparation has good stability, and its properties are very stable under aluminum-plastic packaging, room temperature and dry conditions.

Embodiment 3

[0068] Example 3: Local irritation and toxicity studies

[0069] Soft capsules for experiment were prepared according to formula 5 in Example 1, which contained 8 mg of promestriene, 6 mg of chlorhexidine acetate, and 160 mg of metronidazole. Each preparation contains 174 mg of medicinal ingredients, and each preparation is about 2.000 g. Female rabbits (body weight 2.20-2.60 kg) and female rats (0.225-0.270 kg) provided by the Animal Center Laboratory of West China Medical University were used as experimental animals to carry out local irritation and toxicity tests on the compound soft capsules.

[0070] Use the content of the compound soft capsule prepared above as the test drug; use compound chlorhexidine as the positive control drug, and the administration and dosage are equivalent to 6 mg of chlorhexidine acetate and 160 mg of metronidazole; Soft capsules were used as negative control.

[0071] In the experiment, the test drug was divided into the following three doses:...

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Abstract

The present invention relates to medicine composition, and especially a kind of medicine composition for treating vulval and / or vaginal infection. The daily dose of the medicine composition includes promestriene 5-10 mg, preferably 8 mg; chlorhexidine acetate 3-8 mg, preferably 6 mg; and metronidazole 100-200 mg, preferably 160 mg. The medicine composition is prepared preferably 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 an external pharmaceutical composition for treating vulvar and / or vaginal infection diseases, which uses promestriene, chlorhexidine acetate and metronidazole as active ingredients. Background technique [0002] Gynecological vulva and vaginal infection is a common and frequently-occurring disease among women, and its incidence rate is increasing year by year. Chlorhexidine acetate / metronidazole compound preparation is a commonly used drug for the treatment of such diseases. These preparations include, for example, compound chlorhexidine, Shuangzotai suppository, etc., wherein the content of chlorhexidine acetate is 8 mg / capsule, and the content of metronidazole is 200 mg / capsule, which are used to treat various bacteria, anaerobic bacteria, molds, drops Various vaginitis caused by pathogens such as worms. But chlorhexidine acetate / metronidazole compound preparation is only when ...

Claims

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Application Information

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IPC IPC(8): A61K31/565A61K9/02A61K9/06A61K9/20A61K9/48A61K31/155A61P15/02A61P31/04
Inventor 杨军
Owner BEIJING JINCHENG TAIER PHARMA CO LTD
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