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CN101288661A - Fenticonazole nitrate vaginal effervescent tablets and preparation method thereof - Google Patents

Fenticonazole nitrate vaginal effervescent tablets and preparation method thereof Download PDF

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Publication number
CN101288661A
CN101288661A CNA200810047727XA CN200810047727A CN101288661A CN 101288661 A CN101288661 A CN 101288661A CN A200810047727X A CNA200810047727X A CN A200810047727XA CN 200810047727 A CN200810047727 A CN 200810047727A CN 101288661 A CN101288661 A CN 101288661A
Authority
CN
China
Prior art keywords
fenticonazole nitrate
parts
fenticonazole
lactose
sodium bicarbonate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CNA200810047727XA
Other languages
Chinese (zh)
Inventor
陈少军
陈亚军
颜锵
田贞东
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
YAOGU SCI-TECH DEVELOPMENT Co Ltd WUHAN
Original Assignee
YAOGU SCI-TECH DEVELOPMENT Co Ltd WUHAN
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by YAOGU SCI-TECH DEVELOPMENT Co Ltd WUHAN filed Critical YAOGU SCI-TECH DEVELOPMENT Co Ltd WUHAN
Priority to CNA200810047727XA priority Critical patent/CN101288661A/en
Publication of CN101288661A publication Critical patent/CN101288661A/en
Pending legal-status Critical Current

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Abstract

The invention relates to a fenticonazole nitrate vagina effervescent tablet and a production method thereof. Each effervescent tablet contains 100mg to 400 mg fenticonazole nitrate and pharmaceutic adjuvant. The pharmaceutic adjuvant mainly comprises 20 parts of lactose, 20 parts of microcrystalline cellulose, 40 parts of citric acid, 20 parts of sodium bicarbonate (weight ratio) and lubricant. The preparation technique is that fenticonazole nitrate, lactose, microcrystalline cellulose and citric acid are evenly mixed to prepare granules; the granules are added with sodium bicarbonate and lubricant with formula dosage for tabletting. The product has the advantages of stable quality, convenient carrying and administration and rapid dissolution of effective components.

Description

Fenticonazole nitrate vaginal effervescent tablets and preparation method thereof
Technical field
The present invention relates to new fenticonazole nitrate external preparation, relate to the novel vaginal effervescent tablet and the preparation method of fenticonazole nitrate particularly, belong to medical technical field.
Background technology
According to incompletely statistics, among the women various gynaecopathia sickness rate more than 65%.Investigation shows, China's gynaecological disease is rejuvenation trend, women of child-bearing age's gynaecopathia sickness rate is more than 70%, the women is 100% vaginitis of suffering from various degree almost in life, have wherein more than 5% due to illness that feelings have had a strong impact on normal work and life, gynecological inflammation also has the characteristics of outbreak repeatedly simultaneously.At present, in the Amino-Cerv on the domestic market, the proportion of medicine for external use constantly rises.Wherein more influential is miconazole, Confort Pessaries, Gyno Canesten vaginal tablet, Nystatin vagina effervescence, JIEERYIN XIYE etc.
Fenticonazole nitrate is mainly used in the treatment fungal infection of vagina, and the mechanism of action of this medicine and other imidazole derivatives are similar, promptly works by suppressing the synthetic of steroid.Imidazoles by suppressing the conversion of lanosterol to ergosterol, causes the change that the fungal cell membrane lipid is formed usually.The change of structure causes the variation of cell permeability, finally causes the infiltrative not normal or growth inhibited of fungal cell.But this chemical compound is better than the similar medicine that other has gone on the market to the oidiomycetic inhibitory action of white in vivo.An opening at random comparative study show that fenticonazole is better than clotrimazole to the therapeutic effect of vaginal candidiasis.Other has clinical research to show, the safety in the treatment of vaginal candidiasis is used of fenticonazole and clotrimazole is suitable.Fenticonazole is better than miconazole to the therapeutical effect of multiple fungus, fungal infection.
Fenticonazole nitrate is Desenex's thing that Italian Rocordati company develops, has wider antimicrobial spectrum, to dermatophytes, yeast with cause that other fungus of dermatomycosis is all effective, when low concentration, has bacteriostasis, have bactericidal action during high concentration, can be used for the treatment of diseases such as candidiasis infection, tinea manus and pedis, tinea corporis and cruris, pityriasis versicolor.Compare with miconazole, clotrimazole, the toxicity of this medicine (LD50) has reduced 3-4 doubly, and extracorporeal antifungal activity is suitable.
Summary of the invention
The purpose of this invention is to provide a kind of is the external novel drugs dosage form of the treatment gynaecopathia of main effective ingredient with fenticonazole nitrate, and this dosage form steady quality is easy to use effective.
Another object of the present invention provides the preparation method of said preparation.
Product of the present invention is by being made of medicine and adjuvant two large divisions, it is characterized in that medicine contains the fenticonazole nitrate of effective dosage as effective ingredient, contain 20 parts of lactose, 20 parts of microcrystalline Cellulose, 40 parts of citric acids, 20 parts of sodium bicarbonate (weight ratio) in the adjuvant, lubricant, every contains 100~400 milligrams of fenticonazole nitrates by weight, and the granularity of fenticonazole nitrate is less than 80 purpose powder.
Described pharmaceutic adjuvant is lactose, microcrystalline Cellulose, citric acid, sodium bicarbonate.
Described lubricant is magnesium stearate, Macrogol 4000.
Preparation method is:
To granulate behind fenticonazole nitrate, lactose, microcrystalline Cellulose, the citric acid mix homogeneously, add recipe quantity sodium bicarbonate and lubricant behind the granulate, tabletting, promptly.
The specific embodiment
Realize further specifying by the following specific embodiment, but should not be understood that any limitation of the invention of the present invention.
Embodiment 1
Prescription:
Fenticonazole nitrate 10g
Lactose 100g
Microcrystalline Cellulose 100g
Citric acid 400g
Sodium bicarbonate 200g
Preparation method:
With above-mentioned supplementary material mix homogeneously, direct compression promptly.Perhaps, will granulate behind fenticonazole nitrate, lactose, microcrystalline Cellulose, the citric acid mix homogeneously, add recipe quantity sodium bicarbonate and lubricant behind the granulate, tabletting, promptly.
Embodiment 2
Prescription:
Fenticonazole nitrate 10g
Lactose 200g
Microcrystalline Cellulose 200g
Citric acid 200g
Sodium bicarbonate 400g
Preparation method:
With above-mentioned supplementary material mix homogeneously, direct compression promptly.Perhaps, will granulate behind fenticonazole nitrate, lactose, microcrystalline Cellulose, the citric acid mix homogeneously, add recipe quantity sodium bicarbonate and lubricant behind the granulate, tabletting, promptly.
Embodiment 3
Prescription:
Fenticonazole nitrate 10g
Lactose 200g
Microcrystalline Cellulose 200g
Citric acid 200g
Sodium bicarbonate 200g
Preparation method:
With above-mentioned supplementary material mix homogeneously, direct compression promptly.Perhaps, will granulate behind fenticonazole nitrate, lactose, microcrystalline Cellulose, the citric acid mix homogeneously, add recipe quantity sodium bicarbonate and lubricant behind the granulate, tabletting, promptly.
Embodiment 4
Prescription:
Fenticonazole nitrate 10g
Lactose 200g
Microcrystalline Cellulose 100g
Citric acid 400g
Sodium bicarbonate 200g
Preparation method:
With above-mentioned supplementary material mix homogeneously, direct compression promptly.Perhaps, will granulate behind fenticonazole nitrate, lactose, microcrystalline Cellulose, the citric acid mix homogeneously, add recipe quantity sodium bicarbonate and lubricant behind the granulate, tabletting, promptly.

Claims (4)

1, a kind of Fenticonazole nitrate vaginal effervescent tablets, constitute by medicine and adjuvant two large divisions, it is characterized in that medicine contains the fenticonazole nitrate of effective dosage as effective ingredient, contain 20 parts of lactose, 20 parts of microcrystalline Cellulose, 40 parts of citric acids, 20 parts of sodium bicarbonate (weight ratio) in the adjuvant, lubricant, every contains 100~400 milligrams of fenticonazole nitrates by weight, and the granularity of fenticonazole nitrate is less than 80 purpose powder.
2, Fenticonazole nitrate vaginal effervescent tablets as claimed in claim 1 is characterized in that described pharmaceutic adjuvant is lactose, microcrystalline Cellulose, citric acid, sodium bicarbonate.
3, Fenticonazole nitrate vaginal effervescent tablets as claimed in claim 1 is characterized in that described lubricant is magnesium stearate, Macrogol 4000.
4, Fenticonazole nitrate vaginal effervescent tablets as claimed in claim 1 is characterized in that the production method of described soft capsule is:
To granulate behind Nitric acid butoconazole, lactose, microcrystalline Cellulose, the citric acid mix homogeneously, add recipe quantity sodium bicarbonate and lubricant behind the granulate, tabletting, promptly.
CNA200810047727XA 2008-05-16 2008-05-16 Fenticonazole nitrate vaginal effervescent tablets and preparation method thereof Pending CN101288661A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CNA200810047727XA CN101288661A (en) 2008-05-16 2008-05-16 Fenticonazole nitrate vaginal effervescent tablets and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CNA200810047727XA CN101288661A (en) 2008-05-16 2008-05-16 Fenticonazole nitrate vaginal effervescent tablets and preparation method thereof

Publications (1)

Publication Number Publication Date
CN101288661A true CN101288661A (en) 2008-10-22

Family

ID=40033222

Family Applications (1)

Application Number Title Priority Date Filing Date
CNA200810047727XA Pending CN101288661A (en) 2008-05-16 2008-05-16 Fenticonazole nitrate vaginal effervescent tablets and preparation method thereof

Country Status (1)

Country Link
CN (1) CN101288661A (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101933895A (en) * 2009-06-30 2011-01-05 严洁 Fenticonazole nitrate vaginal suppository composition
CN104208036A (en) * 2013-06-05 2014-12-17 武汉海鹏医药科技有限公司 Neticonazole hydrochloride vaginal effervescent tablet and production method thereof
CN107735071A (en) * 2015-07-30 2018-02-23 花王株式会社 Solid-like foaminess baths

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101933895A (en) * 2009-06-30 2011-01-05 严洁 Fenticonazole nitrate vaginal suppository composition
CN104208036A (en) * 2013-06-05 2014-12-17 武汉海鹏医药科技有限公司 Neticonazole hydrochloride vaginal effervescent tablet and production method thereof
CN107735071A (en) * 2015-07-30 2018-02-23 花王株式会社 Solid-like foaminess baths
CN107735071B (en) * 2015-07-30 2020-11-03 花王株式会社 Solid foaming bath agent

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C02 Deemed withdrawal of patent application after publication (patent law 2001)
WD01 Invention patent application deemed withdrawn after publication

Open date: 20081022