CN106109398A - A kind of vagina gel containing tioconazole - Google Patents
A kind of vagina gel containing tioconazole Download PDFInfo
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- CN106109398A CN106109398A CN201610413600.XA CN201610413600A CN106109398A CN 106109398 A CN106109398 A CN 106109398A CN 201610413600 A CN201610413600 A CN 201610413600A CN 106109398 A CN106109398 A CN 106109398A
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- Prior art keywords
- gel
- tioconazole
- weight portions
- catechin
- particle diameter
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
Abstract
The invention provides a kind of tioconazole vaginal jellies, this gel is selected hydroxyethyl cellulose to add water after heating and is made gel-type vehicle, and described tioconazole particle size range is 20 ~ 35 μm, and comprises the components such as catechin；When this gel uses, intravaginal retention effect is good, and intravaginal foreign sense, release completely, are easily cleaned, are difficult to pollution clothes, can improve the medication compliance of patient.
Description
Technical field
The invention belongs to field of medicaments, relate to a kind of vagina gel containing tioconazole.
Background technology
Tioconazole, chemistry entitled 1,2-(2-chloro-3-thienyl) methoxyl group-2-(double chlorphenyl) ethyl-1H-imidazoles, be
The imidazoles antifungal agent of a new generation, strong drug action, has a broad antifungal spectrum.The compound that Pfizer proposed tioconazole in 1975 is special
Profit application, Patent No. US4062966；The patent of tioconazole compositions has been applied for again in 1985, Patent No. US717423,
This patent relate to the oral tablet of 100mg, the emulsifiable paste of 1% and 2% content, the ointment of 6.5% and the vaginal tablet of 100mg；In 1986
On December 30, the tioconazole vaginal ointments (trade name VAGISTAT) of Pfizer's local tioconazole 6.5% passes through
FDA new drug certification (NDA19 ~ 355), the prescription of this ointment is by white vaseline (white, soft paraffin), aluminium-magnesium silicate
(aluminum magnesium silicate) and butylated hydroxyanisole (BHA) (BHA) form.
Patent CN101057844A, CN1630509A and CN102462658A disclose a kind of vagina containing tioconazole
Using ointment machin its preparation method, the substrate of emulsifiable paste is made up of oleaginous bases such as vaseline, but at vagina when oiliness ointment uses
Interior anelasticity pollution clothes poor, easy.
Application number CN102123736A discloses the pharmaceutical composition of a kind of antibacterial and prebiotics to monilial vagina
Scorching Therapeutic Method, and disclose a kind of gel containing tioconazole, have employed lactulose, oligosaccharide, oligomeric galactose, gather
The oligosaccharides gel rubber materials such as xylose, are simultaneously introduced probiotic bacteria, utilize oligosaccharide to promote the growth of probiotic bacteria；The shortcoming of this invention
Impurity for oligosaccharide and other sugar therein can promote the growth of other pathogenic microorganism.
Hydroxyethyl cellulose (HEC) is non-ionic water-soluble polymer material, is a kind of white or faint yellow, tasteless,
Nontoxic threadiness or pulverulent solids, prepared by alkali cellulose and oxirane (or 2-chloroethyl alcohol) etherified reaction, belong to non-
Ion-type soluble fiber element ethers.HEC have good thickening, suspend, disperse, emulsifying, bonding, film forming, protection moisture and carry
For characteristics such as protecting colloids, it is widely used in oil exploitation, coating, building, medicine food, weaving, papermaking and macromolecule
The fields such as polyreaction, and be widely used in pharmaceutical preparation, it is mainly used as the thickening of ophthalmic preparation and topical preparations
Agent.
Summary of the invention
The invention provides a kind of tioconazole vaginal jellies, this gel is selected hydroxyethyl cellulose to add water after heating and is made
Become gel-type vehicle, the tioconazole that drug main wants grain diameter of components scope to be 20 ~ 35 μm, and comprise the particle diameter catechu less than 100 μm
The components such as element.When this gel uses, intravaginal retention effect is good, and intravaginal foreign sense, release completely, are easily cleaned, are difficult to
Pollution clothes, can improve the medication compliance of patient；And described catechin and cellulose material are unfavorable for all kinds of pathogenic bacterium
Growth.
The invention provides a kind of tioconazole vagina gel, it is characterised in that containing 6 in the gel of every 100 weight portions
The tioconazole of particle size range 20 ~ 35 μm, the catechin of 1 ~ 50 ppm and the hydroxyethyl cellulose of 1 ~ 15 weight portion of ~ 8 weight portions,
Described catechin particle diameter is less than 100 μm.
Further optimization to the present invention, this gel can also contain solubilizing agent, to increase the moistening of tioconazole and hydrogel,
Improve tioconazole dissolubility in gel.This solubilizing agent is selected from sorbester p17, octanoic acid certain herbaceous plants with big flowers acid glyceride (Labrasol), diethyl two
Alcohol list ethylether (p)、One or more in M1944CS.
This gel can also contain pharmaceutically acceptable antibacterial, and the antibacterial used is selected from Benzalkonii Chloridum, benzene
Prick one or more in bromine ammonium, thimerosal, chlorobutanol and sorbic acid.
In a preferred embodiment of the present invention, the gel of every 100 weight portions includes:
6.5 the tioconazole of weight portion；
The catechin of 1 ~ 50 ppm；
The hydroxyethyl cellulose of 10 weight portions.
In another preferred embodiment of the present invention, the gel of every 100 weight portions includes:
The tioconazole of 6.5 weight portions；
The catechin of 1～50ppm；
The hydroxyethyl cellulose of 5 weight portions；
The TC of 20 weight portions (p)。
In another preferred embodiment of the present invention, the gel of every 100 weight portions includes:
The tioconazole of 6.5 weight portions；
The hydroxyethyl cellulose of 2 weight portions；
The catechin of 1～50ppm；
The TC of 20 weight portions (p)；
The sad certain herbaceous plants with big flowers acid glyceride (Labrasol) of 10 weight portions.
In another preferred embodiment of the present invention, the gel of every 100 weight portions includes:
The tioconazole of 6.5 weight portions；
The hydroxyethyl cellulose of 8 weight portions；
The catechin of 1～50ppm；
The TC of 8 weight portions (p)；
The sad certain herbaceous plants with big flowers acid glyceride (Labrasol) of 8 weight portions；
The Benzalkonii Chloridum of 0.5 weight portion.
The invention provides the preparation method of a kind of tioconazole vaginal jellies, it includes step:
(1) it is 10 ~ 40 μm by tioconazole raw material pulverizing to particle size range, by catechin raw material pulverizing to particle diameter less than 100 μm；
(2) adding the hydroxyethyl cellulose of recipe quantity in the purified water of recipe quantity 30 ~ 50%, 20 ~ 25 DEG C of abundant moistenings are swelling
After, adding the catechin after step (1) pulverizing of 1 ~ 50 ppm and stir, be heated to 60 ~ 70 DEG C of stirring and dissolving, preparation obtains
Gel-type vehicle solution；
(3) residue recipe quantity purified water being heated to 60 ~ 70 DEG C, add the tioconazole after step (1) is pulverized, dispersed with stirring is equal
Even, preparation obtains pastille feed liquid；
(4) pastille feed liquid step (3) joined adds the gel-type vehicle solution prepared to step (2) and collects, and stirring is all
Even, it is cooled to room temperature；
(5) fill is in vagina administration apparatus, seals, obtains tioconazole vaginal jellies.
The pharmaceutically acceptable solubilizing agent of 1 ~ 40 weight portion can also be added in described step (3)；
0.05 ~ 1 weight portion pharmaceutically acceptable antibacterial can also be added in described step (3).
Detailed description of the invention
The present inventor, when studying tioconazole vagina administration preparation, finds the molding of the hydroxyethyl cellulose gel of tioconazole
Property good, medicine is mainly composed of the tioconazole that particle size range is 20 ~ 35 μm, and comprises the particle diameter catechin etc. less than 100 μm
Component, during use, intravaginal retention effect is good, and intravaginal foreign sense, release are complete, it is not easy to clean, and is difficult to pollute clothing
Thing, can improve the medication compliance of patient.
" scope " disclosed herein is with lower limit and the form of the upper limit.One or more lower limit, and one can be respectively
Or the multiple upper limit.Given range is defined by a selected lower limit and a upper limit.Selected lower limit and upper limit limit
Determine the border of special scope.All scopes that can be defined by this way comprise and can be combined, the most any lower limit
A scope can be formed with the combination of any upper limit.Such as, list the scope of 60-120 and 80-110 for special parameter,
It is interpreted as that the scope of 60-110 and 80-120 also expects.If additionally, the minimum zone value 1 and 2 listed, and if
List maximum magnitude value 3,4 and 5, then scope below can all expect: 1-3,1-4,1-5,2-3,2-4 and
2-5.
In the present invention, unless otherwise indicated, between content range and its preferred scope of each component of compositions
Can be mutually combined and form new technical scheme.
In the present invention, unless otherwise indicated, " a combination thereof " represents the multicomponent mixture of described each element, such as two
Kind, three kinds, four kinds and until the multicomponent mixture of maximum possible.
In the present invention, unless otherwise indicated, all " part " and percent (%) all refers to percetage by weight.
In the present invention, unless otherwise indicated, in all compositionss, the percent sum of each component is 100%.
In the present invention, unless otherwise indicated, numerical range " a ~ b " represents the contracting of any real combinings between a to b
Sketch form shows, wherein a and b is real number.Such as numerical range " 0 ~ 5 " expression the most all lists between " 0 ~ 5 "
All real numbers, " 0 ~ 5 " is that the breviary of these combinations of values represents.
In the present invention, unless otherwise indicated, integer numerical range " a ~ b " represents the arbitrary integer combination between a to b
Breviary represent, wherein a and b is integer.Such as integer numerical range " 1 ~ N " represents 1,2 ... N, wherein N is integer.
Without particularly pointing out, the term " a kind of " used by this specification refers to " at least one ".
Without particularly pointing out, the benchmark of percent of the present invention (including percetage by weight) is all described combination
The gross weight of thing.
In this article, except as otherwise noted, ratio or the weight of each component all refers to dry weight.
In the present invention, without particularly explanation, all embodiments mentioned in this article and the side of being preferable to carry out
Formula can be mutually combined and form new technical scheme.
In the present invention, without particularly explanation, all technical characteristics mentioned in this article and preferred feature can
New technical scheme is formed to be mutually combined.
In the present invention, without particularly explanation, mentioned in this article can sequentially carry out in steps, it is also possible to
Carry out at random, but the most sequentially carry out.Such as, described method includes step (a) and (b), represents that described method can be wrapped
Include step (a) and (b) that order is carried out, it is also possible to include step (b) and (a) sequentially carried out.Such as, described side is mentioned described in
Method may also include step (c), represents that step (c) can join described method with random order, and such as, described method can include
Step (a) and (b) and (c), it is possible to include step (a), (c) and (b), it is also possible to include step (c), (a) and (b) etc..
In the present invention, without particularly explanation, " including " mentioned in this article represents open, it is also possible to be envelope
Enclosed.Such as, described " including " can expression can also comprise other elements do not listed, it is also possible to only includes the unit listed
Part.
On the one hand, the invention provides a kind of tioconazole vagina gel, it is characterised in that the gel of every 100 weight portions
In containing the tioconazole of 6 ~ 8 weight portions and the hydroxyethyl cellulose of 1 ~ 15 weight portion.
Further optimization to the present invention, this gel can also contain pharmaceutically acceptable solubilizing agent, to increase thiophene
Health azoles and the moistening of hydrogel, improve tioconazole dissolubility in gel.This solubilizing agent is sweet selected from sorbester p17, octanoic acid certain herbaceous plants with big flowers acid
Grease (Labrasol), TC (p)、One or more in M1944CS, often
In the gel of 100 weight portions, the amount containing described solubilizing agent is 1～40 weight portions, preferably 5～30 weight portions.
This gel can also contain pharmaceutically acceptable antibacterial, and the antibacterial used is selected from Benzalkonii Chloridum, benzene
Prick one or more in bromine ammonium, thimerosal, chlorobutanol and sorbic acid, containing described solubilising in the gel of every 100 weight portions
The amount of agent is 0.05 ~ 1 weight portion, preferably 0.1 ~ 01 weight portion.Inventor also finds tioconazole raw material pulverizing to specifying grain
Footpath scope, and add the particle diameter catechin less than 100 μm of 1 ~ 50 ppm, improve the performance of medicine, and the gel of preparation
There is easily cleaning, be difficult to the characteristic of pollution clothes.
On the other hand the invention provides a kind of method preparing tioconazole gel, it includes step:
(1) by tioconazole raw material pulverizing to 20 ~ 35 μm, by catechin raw material pulverizing to particle diameter less than 100 μm；
(2) adding the hydroxyethyl cellulose of recipe quantity in the purified water of recipe quantity 30 ~ 50%, 20 ~ 25 DEG C of abundant moistenings are swelling
After, adding the catechin after 1 ~ 50 ppm step (1) is pulverized, be heated to 60 ~ 70 DEG C of stirring and dissolving, it is molten that preparation obtains gel-type vehicle
Liquid；
(3) purified water of residue recipe quantity being heated to 60 ~ 70 DEG C, add the tioconazole after step (1) is pulverized, dispersed with stirring is equal
Even, preparation obtains pastille feed liquid；
(4) pastille feed liquid step (3) joined adds the gel-type vehicle solution prepared to step (2) and collects, and stirring is all
Even, it is cooled to room temperature；
(5) fill is in vagina administration apparatus, seals, obtains tioconazole vaginal jellies.
The pharmaceutically acceptable solubilizing agent of 1 ~ 40 weight portion can also be added in described step (3)；
0.05 ~ 1 weight portion pharmaceutically acceptable antibacterial can also be added in described step (3).
Further describe the present invention below by specific embodiment, but do not limit the scope of the invention.
The prescription of embodiment 1 tioconazole vaginal jellies 1:
| Preparation prescription forms | Component content in every 100 grams of gels |
| Tioconazole | 6.5 gram |
| Hydroxyethyl cellulose | 10 grams |
| Catechin | 5 ppm |
| Purified water | Add to 100 grams |
Preparation process:
(1) by tioconazole raw material pulverizing to particle size range 20 ~ 35 μm, by catechin raw material pulverizing to particle diameter less than 100 μm；
(2) adding the hydroxyethyl cellulose of recipe quantity in the purified water of recipe quantity 30 ~ 50%, 20 ~ 25 DEG C of abundant moistenings are swelling
After, adding the catechin after 5 ppm steps (1) are pulverized, be heated to 60 ~ 70 DEG C of stirring and dissolving, preparation obtains gel-type vehicle solution；
(3) it is heated to after 60 ~ 70 DEG C adding the tioconazole after step (1) is pulverized, dispersed with stirring by the purified water of residue recipe quantity
Uniformly, preparation obtains pastille feed liquid；
(4) pastille feed liquid step (3) joined adds the gel-type vehicle solution prepared to step (2) and collects, and stirring is all
Even, it is cooled to room temperature；
(5) fill is in vagina administration apparatus, seals, obtains tioconazole vaginal jellies.
Embodiment 2
The prescription of tioconazole vaginal jellies
Preparation process:
(1) by tioconazole raw material pulverizing to particle size range 20～35 μm, by catechin raw material pulverizing to particle diameter less than 100 μm；
(2) to recipe quantity 30～50% purified water in add the hydroxyethyl cellulose of recipe quantity, 20～25 DEG C of abundant moistenings are molten
After swollen, adding the catechin after 1ppm step (1) is pulverized, be heated to 60～70 DEG C of stirring and dissolving, it is molten that preparation obtains gel-type vehicle
Liquid；
(3) by residue recipe quantity purified water be heated to 60～70 DEG C, add recipe quantity TC (P) adding the tioconazole after step (1) is pulverized after stirring and dissolving, dispersed with stirring is uniform, and preparation obtains containing spice
Liquid；
(4) pastille feed liquid step (3) joined adds the gel-type vehicle solution prepared to step (2) and collects, and stirring is all
Even, it is cooled to room temperature；
(5) fill is in vagina administration apparatus, seals, obtains tioconazole vaginal jellies.
Embodiment 3
The prescription of tioconazole vaginal jellies 3
Preparation process:
(1) by tioconazole raw material pulverizing to particle size range 20～35 μm, by catechin raw material pulverizing to particle diameter less than 100 μm；
(2) to recipe quantity 30～50% purified water in add the hydroxyethyl cellulose of recipe quantity, 20～25 DEG C of abundant moistenings are molten
After swollen, adding the catechin after 3ppm step (1) is pulverized, be heated to 60～70 DEG C of stirring and dissolving, it is molten that preparation obtains gel-type vehicle
Liquid；
(3) by residue recipe quantity purified water be heated to 60～70 DEG C, add recipe quantity TC (P), sad certain herbaceous plants with big flowers acid glyceride (Labrasol) stirring and dissolving of recipe quantity, add step (1) pulverize after thiophene
Health azoles, dispersed with stirring is uniform, and preparation obtains pastille feed liquid；
(4) pastille feed liquid step (3) joined adds the gel-type vehicle solution prepared to step (2) and collects, and stirring is all
Even, it is cooled to room temperature；
(5) fill is in vagina administration apparatus, seals, obtains tioconazole vaginal jellies.
Embodiment 4
The prescription of tioconazole vaginal jellies 4
Preparation process:
(1) by tioconazole raw material pulverizing to particle size range 20～35 μm, by catechin raw material pulverizing particle diameter to less than 100 μm；
(2) to recipe quantity 30～50% purified water in add the hydroxyethyl cellulose of recipe quantity, 20～25 DEG C of abundant moistenings are molten
After swollen, adding the catechin after 4ppm step (1) is pulverized, be heated to 60～70 DEG C of stirring and dissolving, it is molten that preparation obtains gel-type vehicle
Liquid；
(3) by residue recipe quantity purified water be heated to 60～70 DEG C, add recipe quantity TC (P), the sad certain herbaceous plants with big flowers acid glyceride (Labrasol) of recipe quantity and the Benzalkonii Chloridum stirring and dissolving of recipe quantity, then add
Entering the tioconazole after step (1) is pulverized, dispersed with stirring is uniform, and preparation obtains pastille feed liquid；
(4) pastille feed liquid step (3) joined adds the gel-type vehicle solution prepared to step (2) and collects, and stirring is all
Even, it is cooled to room temperature；
(5) fill is in vagina administration apparatus, seals, obtains tioconazole vaginal jellies.
Embodiment 5
The prescription of tioconazole vaginal jellies 5
Preparation process:
(1) by tioconazole raw material pulverizing to particle diameter less than 50 μm, by catechin raw material pulverizing particle diameter to less than 100 μm；
(2) to recipe quantity 30～50% purified water in add the hydroxyethyl cellulose of recipe quantity, 20～25 DEG C of abundant moistenings are molten
After swollen, adding the catechin after 50ppm step (1) is pulverized, be heated to 60～70 DEG C of stirring and dissolving, it is molten that preparation obtains gel-type vehicle
Liquid；
(3) by residue recipe quantity purified water be heated to 60～70 DEG C, add recipe quantity TC (P), the sad certain herbaceous plants with big flowers acid glyceride (Labrasol) of recipe quantity and the Benzalkonii Chloridum stirring and dissolving of recipe quantity, then add
Entering the tioconazole after step (1) is pulverized, dispersed with stirring is uniform, and preparation obtains pastille feed liquid；
(4) pastille feed liquid step (3) joined adds the gel-type vehicle solution prepared to step (2) and collects, and stirring is all
Even, it is cooled to room temperature；
(5) fill is in vagina administration apparatus, seals, obtains tioconazole vaginal jellies.
By aseptic experiment, Example 1 ~ 4 sample spreads upon in LB culture medium, cultivates 24h, does not finds visible colonies
Growth.Example 1 ~ 4 sample is placed on simulated humanbody skin, after 3 ~ 10 hours, sample at different time points different parts
With reference to Tioconazole Cream detection method of content in British Pharmacopoeia BP2013, detect through HPLC, the skin surface of tioconazole
Retained percentage prolongation in time and gradually decrease；External residual quantity after gel topical provided by the present invention is described,
Can be as the reference of research body absorption amount.In experimentation, inventor also finds that this gel also has easily cleaning, no
The easily characteristic of pollution clothes, and the gel being provided without present invention process means does not finds this characteristic.
The foregoing is only presently preferred embodiments of the present invention, be not limited to the substantial technological content model of the present invention
Enclosing, the substantial technological content of the present invention is broadly to be defined in the right of application, any technology that other people complete
Entity or method, if with the right of application defined in identical, also or the change of a kind of equivalence, all by
It is considered to be covered by among this right.
The all documents mentioned in the present invention are incorporated as reference the most in this application, just as each document by individually
It is incorporated as with reference to like that.In addition, it is to be understood that after the foregoing having read the present invention, those skilled in the art can be right
The present invention makes various changes or modifications, and these equivalent form of values fall within the application appended claims limited range equally.
Claims (8)
1. the vagina gel containing tioconazole, it is characterised in that containing 6 ~ 8 weights in the described gel of every 100 weight portions
The tioconazole of amount part, the hydroxyethyl cellulose of 1 ~ 15 weight portion and the catechin of 1 ~ 50 ppm；The particle size range of described tioconazole
Being 20 ~ 35 μm, the particle diameter of described catechin is less than 100 μm, and the particle diameter of described catechin is more than the particle diameter of described tioconazole.
Gel the most according to claim 1, it is characterised in that described gel possibly together with pharmaceutically acceptable solubilizing agent,
Described solubilizing agent selected from sorbester p17, octanoic acid certain herbaceous plants with big flowers acid glyceride (Labrasol), TC (p)、One or more in M1944CS, described solubilizer level is the 1～40% of described gel gross weight.
Gel the most according to claim 1, it is characterised in that described gel possibly together with pharmaceutically acceptable antibacterial,
One or more in Benzalkonii Chloridum, benzalkonium bromide, thimerosal, chlorobutanol and sorbic acid of the antibacterial used,
Described antibacterial content is the 0.05 ~ 1% of described gel gross weight.
Gel the most according to claim 1, it is characterised in that the described gel of every 100 weight portions includes:
6.5 the tioconazole of weight portion；
The hydroxyethyl cellulose of 10 weight portions；
The catechin of 1 ~ 50 ppm；
Wherein, the particle diameter of described catechin is less than 100 μm.
5. the vagina gel containing tioconazole, it is characterised in that the gel of every 100 weight portions includes:
6.5 the tioconazole of weight portion；
The hydroxyethyl cellulose of 5 weight portions；
The TC of 20 weight portions (p)；
The catechin of 1～50ppm；
Wherein, the particle size range of described tioconazole is 20～35 μm, and the particle diameter of described catechin is less than 100 μm.
6. the vagina gel containing tioconazole, it is characterised in that the gel of every 100 weight portions includes:
The tioconazole of 6.5 weight portions；
The hydroxyethyl cellulose of 2 weight portions；
The TC of 20 weight portions (p)；
The catechin of 1～50ppm；
The sad certain herbaceous plants with big flowers acid glyceride (Labrasol) of 10 weight portions；
Wherein, the particle size range of described tioconazole is 20～35 μm, and the particle diameter of described catechin is less than 100 μm.
7. gel as claimed in claim 6, it is characterised in that also include 0.5 weight portion in the described gel of every 100 weight portions
Benzalkonii Chloridum.
8. the gel preparation as described in any claim in claim 5 ~ 7, it is characterised in that the particle diameter model of described tioconazole
Enclosing is 20 ~ 35 μm.
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| CN201610413600.XA CN106109398A (en) | 2016-06-14 | 2016-06-14 | A kind of vagina gel containing tioconazole |
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|---|---|---|---|
| CN201610413600.XA CN106109398A (en) | 2016-06-14 | 2016-06-14 | A kind of vagina gel containing tioconazole |
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| CN106109398A true CN106109398A (en) | 2016-11-16 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110314158A (en) * | 2018-03-22 | 2019-10-11 | 深圳澳美制药技术开发有限公司 | Tioconazole composition and preparation method thereof |
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| CN1832760A (en) * | 2003-08-08 | 2006-09-13 | 米法有限公司 | Bioadhesive gel based on hydroxyethylcellulose |
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| CN105232526A (en) * | 2015-10-15 | 2016-01-13 | 王孝仓 | Application of medicine containing catechin to preparation of antibacterial medicines |
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Application publication date: 20161116 |