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Metronidazole,clotrimazole and chlorhexidime acetate vaginal effervescent tablet and preparation technique

A technology for effervescent tablet and bisazotide, which is applied to the field of vaginal effervescent tablet and its preparation, can solve the problems of uneasy production, unqualified friability, unqualified tablet properties, etc. , the effect of not easy to operate

Inactive Publication Date: 2009-02-18
WUHU KANGQI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

China ZL94113652.3 and CN 101152176A respectively disclose different Shuangzotai vaginal effervescent tablets and their preparation process, but the above-mentioned patents have the following disadvantages: sticking phenomenon occurs during tablet compression, and it is not easy to operate during production; After one month, the phenomenon of swelling bags began to appear, resulting in foaming volume less than 6ml; unqualified tablet properties: easy to produce splits, unqualified brittleness and stains on one side, usually about 3 tablets out of 10 tablets lobes

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Shuangzotai vaginal effervescent tablets, each containing the following components: Metronidazole 0.2g, clotrimazole 0.16g, chlorhexidine acetate 0.008g, sodium bicarbonate 0.115g, tartaric acid 0.125g, lactose 0.15g, ten Dialkyl sodium sulfate 0.02g, micropowder silica gel 0.03g, calcium hydrogen phosphate 0.015g, magnesium stearate 0.0055g, 95% ethanol 0.12g, povidone K30: 0.005g.

[0021] The preparation technology of described Shuangzotai effervescent tablet comprises the following steps:

[0022] a) pulverize metronidazole, clotrimazole, chlorhexidine acetate and other auxiliary materials respectively, and cross 80 mesh sieves for subsequent use;

[0023] b) Weighing various raw and auxiliary materials according to the ratio;

[0024] c) 5 grams of Povidone K30 are dissolved in 95 grams of 95% ethanol to prepare 5% and Povidone K30 aqueous solution;

[0025] d) Metronidazole and tartaric acid are prepared with an appropriate amount of absolute ethanol to make sof...

Embodiment 2

[0030] In addition to Shuangzotai vaginal effervescent tablets, each tablet contains the following components: metronidazole 0.2g, clotrimazole 0.16g, chlorhexidine acetate 0.008g, sodium bicarbonate 0.08g, tartaric acid 0.1g, lactose 0.1g, Sodium lauryl sulfate 0.015g, micropowder silica gel 0.01g, calcium hydrogen phosphate 0.01g, magnesium stearate 0.005g, 95% ethanol 0.09g, povidone K30: 0.004g;

Embodiment 3

[0032] In addition to Shuangzotai vaginal effervescent tablets, each tablet contains the following components: metronidazole 0.2g, clotrimazole 0.16g, chlorhexidine acetate 0.008g, sodium bicarbonate 0.15g, tartaric acid 0.15g, lactose 0.20g, Sodium lauryl sulfate 0.035g, micropowder silica gel 0.05g, calcium hydrogen phosphate 0.02g, magnesium stearate 0.006g, 95% ethanol 0.15g, povidone K30: 0.006g;

[0033] Embodiments 1, 2, and 3 do not have sticking phenomenon in the tableting process, and it is not easy to operate during production; there is no bag swelling phenomenon after packaging, and Embodiment 1, 2, and 3 are placed at room temperature for 3 years. The foaming volume is 10ml, 12ml, 15ml respectively.

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PUM

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Abstract

The invention discloses a metronidazole, clotrimazole and chlorhexidine acetate effervescent tablet and a preparation method thereof. The compositions of the metronidazole, clotrimazole and chlorhexidine acetate effervescent tablet are 0.2 gram of metronidazole, 0.16 gram of clotrimazole, 0.008 gram of chlorhexidine acetate, 0.08 to 0.15 gram of sodium bicarbonate, 0.10 to 0.15 gram of tartaric acid, 0.10 to 0.20 gram of lactose, 0.015 to 0.035 gram of sodium dodecylsulfate, 0.01 to 0.05 gram of superfine silica gel powder, 0.01 to 0.02 gram of calcium hydrophosphate, 0.005 to 0.006 gram of magnesium stearate, 0.09 to 0.15 gram of 95 percent of alcohol and 0.004 to 0.006 gram of polyvidone K30. Compared with the prior art, the metronidazole, clotrimazole and chlorhexidine acetate effervescent tablet and the preparation method have the advantages that the sticking phenomenon is difficult to generate during the tabletting process and the operation is not difficult during the manufacturing process; a bag can not be expanded after packaging and the foaming amount is controlled to less than or equal to 10 milliliters within the guarantee period; and the tablet is difficult to break.

Description

technical field [0001] The invention belongs to vaginal effervescent tablets and a preparation process thereof, in particular to Shuangzotai vaginal effervescent tablets and a preparation process thereof. Background technique [0002] Shuangzotai vaginal effervescent tablet is a variety recorded in the Chinese Pharmacopoeia, Shuangzotai is a drug for treating vaginitis, metronidazole is the first choice drug for treating trichomonas vaginitis; clotrimazole is a broad-spectrum antifungal drug, Candida vaginitis has the best curative effect; chlorhexidine acetate is a broad-spectrum fungicide, and has a good curative effect on bacterial vaginosis and mixed vaginitis. The combined use of the above three main drugs has a synergistic effect, so the effect of Shuangzotai on the treatment of vaginitis is better than that of other single drugs. China ZL94113652.3 and CN 101152176A respectively disclose different Shuangzotai vaginal effervescent tablets and their preparation process...

Claims

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Application Information

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IPC IPC(8): A61K9/46A61K31/4164A61K31/155A61P15/02
Inventor 方贵林端木于良杨帆甘定娟张玮
Owner WUHU KANGQI PHARMA
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