CN103845303B - It is a kind of for high valency silver ion effervescent tablet of gynecological disease and preparation method thereof - Google Patents
It is a kind of for high valency silver ion effervescent tablet of gynecological disease and preparation method thereof Download PDFInfo
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- CN103845303B CN103845303B CN201410060844.5A CN201410060844A CN103845303B CN 103845303 B CN103845303 B CN 103845303B CN 201410060844 A CN201410060844 A CN 201410060844A CN 103845303 B CN103845303 B CN 103845303B
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Abstract
The present invention is for high valency silver ion effervescent tablet of gynecological disease and preparation method thereof on a kind of.The present invention formula be（In mass ratio）：Silver iron compound 3 ‰, sodium acid carbonate 25%, tartaric acid 25%, boric acid 7.5%, starch 20%, hydroxypropyl methylcellulose 2.7%, dextrin 7.5%, Macrogol 6000 12%.The main formula of effervescent tablet is：Using silver iron compound, boric acid as antibiotic effective ingredient, by acid source of tartaric acid, sodium acid carbonate be alkali source, soda acid proportioning 1:1st, soda acid total amount is 50%, using starch as filler, and adhesive is hydroxypropyl methylcellulose and dextrin, using Macrogol 6000 as ion embedding medium, and product is made by processes such as Feedstock treating, mixing, granulation, whole grain and tablettings.Product appearance is mellow and full bright and clean, and fractography is close and is easy to preserve, with the features such as disintegration is quick, bioavilability is high.Available for treating various gynecological diseases.
Description
Technical field
It, on a kind of medical supplies, is a kind of external application, the high price silver suitable for gynecological disease more particularly that the present invention, which is,
Ion effervescent tablet and preparation method thereof.
Background technology
The silver system product for gynecological disease occurred in the market has liquid preparation and gel etc., there are no silver from
The appearance of sub- effervescent tablet, similar product only has Nano Silver class product.
When the liquid preparation and gel of silver ion are used to treat gynecological disease, because the physiological structure of vagina is in fold
Shape, liquid preparation, the active ingredient silver ion of gel are not easily accessible inside the plicated layer of vagina, so as to reduce the anti-of preparation
Bacterium performance, in order to change this medication drawback, we have invented silver ion effervescent tablet, silver ion effervescent tablet is acted on behind affected part,
A large amount of foams that disintegration is produced add antimicrobial component and contacted with the direct of diseased region, and can be deep into inside plicated layer, compared with
Above two formulation preferably plays the effect of its curative effect.
The antibiotic effective ingredient of Nano Silver class product is Nano Silver, and Nano Silver is nano level argent simple substance, and particle diameter is
10~100nm, antibacterial effect is closely coupled with nano effect.The anti-microbial property of Nano Silver will be inferior to silver ion, silver ion significantly
With higher oxidation-reduction potential（Ag+Current potential is ± 0.798eV, Ag2+Current potential is ± 1.987eV, Ag3+Current potential for ±
3.36eV 25℃）So reactivity is very big, its constitutionally stable state can reach by reaction.The bactericidal property of silver ion
Closely related with its chemical valence state, the anti-microbial property order of silver ion is Ag3+＞ Ag2+＞ Ag+＞ Ag, high-valence state silver ion reduction
Gesture is high, and the space of surrounding can be made to produce elemental oxygen to greatly improve the argent simple substance in bactericidal effect, Nano Silver
Chemical valence state is zero, i.e., silver-ion antibiotic performance is more many higher than nanometer silver antimicrobial performance under same silver content state.Silver
Ion antibacterial performance it is superior, its curative effect after vagina administration, and the good biocompatibility of silver ion will necessarily be improved, will not
Cause the discomfort of patient part.
Product now applied to relevant diseases such as gynecology colpitis, cervicitises is a lot, and most products with the addition of anti-
Raw element, with increasing using this kind of product number of times, causes germ to produce drug resistance, it is difficult to kill, it has to increase consumption, make
Into vicious circle, and the advantage of silver-ion antibiotic：Have no drug resistance, have killing action, antimicrobial susceptibility to up to 650 kinds bacteriums
Height, is the good product of a treatment gynecological disease.
Silver ion effervescent tablet, which acts on vagina, can treat the various diseases of gynaecology, such as：Bacterial vaginosis BV, trichomonas the moon
The treatment of road inflammation, monilial vaginitis, senile vahinitis, vagina mixed infection and cervical erosion etc..
To so far, in the market not yet has the sale of silver ion effervescent tablet.
The content of the invention
The problem of in order to solve set forth above, the present invention proposes a kind of silver ion effervescent tablet, more particularly on one
High valency silver ion effervescent tablet and preparation method thereof kind for gynecological disease, further illustrate the silver ion for high-valence state silver from
Son.
Silver ion contained by this silver ion effervescent tablet is high-valence state silver ion, the preparation side of the high-valence state silver iron compound
Method is：2L purified waters are added with 10g silver peroxides, 20g persulfates are added, it is water-soluble that stirring reaction obtains high-valence state silver ion
Liquid, evaporating water is concentrated by above-mentioned silver ionized water solution, is crushed, is crossed 80 mesh sieves, obtains white silver iron compound.The silver ion
Compound main component is persulfuric acid silver, and silver content is about 35%, and institute's silver ion is high-valence state silver ion, is+1 valency and+trivalent.
The formula of this silver ion effervescent tablet（In mass ratio）：Silver iron compound 3 ‰, sodium acid carbonate 25%, tartaric acid 25%,
Boric acid 7.5%, starch 20%, hydroxypropyl methylcellulose 2.7%, dextrin 7.5%, Macrogol 6000 12%.The main formula of effervescent tablet
Using silver iron compound, boric acid as antibiotic effective ingredient, by acid source of tartaric acid, sodium acid carbonate be alkali source, soda acid proportioning 1:1、
Soda acid total amount be 50%, using starch as filler, adhesive be hydroxypropyl methylcellulose and dextrin, using Macrogol 6000 as from
Sub- embedding medium, product is made by processes such as Feedstock treating, mixing, granulation, whole grain and tablettings.Product appearance is mellow and full bright and clean, breaks
Covering weave is close and is easy to preserve, with the features such as disintegration is quick, bioavilability is high.The Antibacterial Mechanism of this product is：Work as silver
Ion effervescent tablet discharges a large amount of silver ions, its Antibacterial Mechanism mainly has following two after intravaginal disintegration：The first is quiet
Electro Sorb is sterilized, and the cell membrane and cell membrane of nearly all bacterium all (are mainly by-COO with negative electrical charge-,-O-PO3 -,-S-
Produced Deng anionic group), and silver ion carries positive charge.Because the charges of different polarity are attracting, silver ion is easy to by various thin
Bacterium, while constraining the activity of bacterium, makes the existence microenvironment disorder imbalance of bacterium, suppresses its breathing, finally without selectively adsorbing
Bacterium is caused to occur " contact is dead ".Because this process can also make cell membrane and cell membrane deform, protein and enzyme
Effect is obstructed, and destroys metabolic function, is caused physical perforation rupture, is caused cytoplasm to overflow, is otherwise known as " dissolving is dead ".The
Two kinds of Antibacterial Mechanisms are sterilized for metal dissolving, are discharged after product disintegration after silver ion, silver ion and cells contacting, by electrostatic
Gravitation is adsorbed on the cell membrane with negative electrical charge, replaces the position of cell membrane surface cation, with protein or other it is cloudy from
Subbase group is combined, and original biological function is disappeared, and destroys the metabolism of film, the mesh of antibacterial is reached by destroying the function of cell membrane
's.At the same time, if bacterium surface has the silver ion of surplus, moreover it is possible to which penetration cell film penetrates into the inside of cell and cell space
Part reacts.On the one hand, with-SH ,-NH present in the protein in organism, nucleic acid2Deng sulfur-bearing, ammonia
Functional group reactionses, make protein coagulating, destroy the activity of cell synzyme.Enzyme is the catalyst of all living things, controls micro- life
Thing biochemical reaction, enzyme will cause catalytic efficiency to reduce or performance forfeiture, make its biochemical reaction being catalyzed can not be just once inactivating
Often carry out, and influence other related biochemical reactions, the energetic supersession and metabolism for causing microorganism are obstructed, influence microorganism
The process such as normal breeding, growth, development, so as to reach the purpose of antibacterial.
The silver ion content of silver ion effervescent tablet is 1000 ± 50 μ g/g, and the method for inspection uses Fo Erhadefa, Fo Erha
Moral method is with Fe3+For indicator, such as ferriammonium sulfate [NH4Fe(SO4)2·12H2O], ferric nitrate etc., use NH4It is molten that SCN or KSCN make standard
Drop contains Ag surely+Acid solution.In titration process, white AgSCN is separated out first and is precipitated, when close to stoichiometric point
When, NH4SCN standard liquids and Fe3+The red complex of generation, so as to indicate titration end-point.
This silver ion effervescent tablet is carried out using Macrogol 6000 as ion coating agent to sodium acid carbonate and silver iron compound
Parcel, it is in order to avoid being reacted with tartaric acid, boric acid, can greatly enhance the steady of effervescent tablet to carry out parcel to sodium acid carbonate
It is qualitative, extend the term of validity of product.Macrogol 6000 promotes the slow of silver iron compound to the parcel of silver iron compound
Silver ion is discharged, can so mitigate generation of the silver ion to human body adverse reaction, make product that there is good biocompatibility；
Silver ion, which is shown in after light, to be oxidized easily, and makes product appearance blackening, and the anti-microbial property of reduction silver ion, when silver ion is by poly- second
After glycol 6000 is wrapped up, silver ion can be eliminated and see that light makes the phenomenon of product appearance blackening, product is kept its original brilliant white
Color, does not interfere with the anti-microbial property of silver ion.
Boric acid acts not only as acid source, and boric acid has the function of anti-inflammation, can promote the antibacterial of silver ion
Effect, and silver ion is more stable in acid condition, will not be reduced and change colour, and keeps the original antibiotic property of silver ion
Energy.
Acid/base ratio is 1 in silver ion effervescent tablet formula:1, acid is slightly excessive, and excessive acid is steady also for silver ion
Fixed, we simulate the situation after Effervescent tablet disintegration, and it is 4.0~5.0 that its pH value is measured with acidometer, meets the life of vagina
Environment is managed, intravaginal normal flora (Bacillus acidi lactici) is not influenceed, the recovery of vagina self-purification function, silver ion for sterilization effect can be promoted
Do not influenceed by vaginal pH.
Brief description of the drawings
Fig. 1 is the vertical section schematic diagram of the present invention；
Fig. 2 is the outside drawing of the present invention.
For the deficiency of current common effervesce chip architecture, this silver ion effervescent tablet has carried out technology leather in structure to it
Newly, a technological innovation is that the silver ion effervescent tablet uses double-decker（As shown in figure 1,1 represents outer layer, 2 represents nexine）, it is inner
Layer is formed by outer layer covers, and outer layer is that pure effervesce composition is sodium acid carbonate and tartaric acid, and nexine composition is silver iron compound etc.
The mixture of other compositions and effervesce composition, outer layer effervesce composition accounts for 2/3rds of total effervesce composition, and nexine effervesce composition is accounted for
1/3rd.The double-decker has the advantage that：It is that outer layer effervesce composition collapses first when effervescent tablet, which enters vagina effervesce, to be disintegrated
Solution, forms a small amount of effervesce solution, and and then nexine composition is disintegrated again, then the silver iron compound release of nexine composition
Silver ion enters effervesce solution, such effervesce order will not cause local concentration of silver ions too high, makes silver ion evenly
Spread out, the discomfort of vagina will not be caused, and the disintegration of effervescent tablet is an endothermic process, so affected part can be made to have bright
Aobvious slight chill in the air, can also mitigate influence of the various inflammation to women affected part.Another technological innovation is that the effervescent tablet has in piece shape
Very big innovation, general tablet is circle, ellipse etc., is unfavorable for the medication in women affected part, and we are by Design of the piece shape for partly
Spindle（As shown in Figure 2）, enter vagina beneficial to effervescent tablet, and will not be discharged because of the wriggling of female lower body.
Embodiment 1
This high valency silver ion effervescent tablet, it is formulated and mass percent is as follows：
Silver iron compound 3 ‰
Sodium acid carbonate 25%
Tartaric acid 25%
Boric acid 7.5%
Starch 20%
Hydroxypropyl methylcellulose 2.7%
Dextrin 7.5%
Macrogol 6000 12%
Silver ion effervescent tablet concrete technology：
1st, preparation, the weighing of raw material：Silver iron compound is added and crushed in pulverizer, and crosses 80 mesh sieves, then
The weighing of each raw material is carried out according to formula rate.
2nd, polyethylene glycol pack technique：After Macrogol 6000 is melted, the silver iron compound crushed is added（80
Mesh）, stir, cooling crush crosses 80 mesh sieves；Sodium acid carbonate is wrapped up according to the method described above.Polyethylene glycol in formula
6000 consumption is 12%, wherein parcel silver iron compound consumption is 1%, encapsulated sodium bicarbonate consumption is 11%.
3rd, mix：The outer composition weighed up is put into mixer according to formula rate and mixed, is put after being well mixed
Put standby in stainless steel cask, be then according to the method described above well mixed nexine composition standby.
4th, softwood processed：The outer composition mixed and nexine composition are put into efficient wet granulator respectively and stirred, plus
Enter adhesive, suitable softwood is made according to standard practice.
5th, pelletize：By above two softwood respectively in efficient wet granulator, wet granular of uniform size is made, 40 are crossed
Mesh sieve.
6th, dry：Above two wet granular is put into HighefficientFluidbeddrier, it is all seethed with excitement, steam is opened and adds
Heat, temperature control is dried to moisture content≤1% below 60 DEG C.
7th, whole grain：The two kinds of particles made is passed through into 40 mesh sieve whole grains with pelletizing machine respectively.
8th, tabletting：Bi-layer tablet press is opened, nexine composition is now subjected to precompressed in flakes, outer composition is then added and is pressed
Piece, makes tablet global formation, aluminum-plastic packaged, mounted box.
Embodiment 2
The specification of silver ion effervescent tablet is：1g/ pieces, 12/box.
The scope of application of the silver ion effervescent tablet：The various diseases of gynaecology are treated, such as：It is bacterial vaginosis BV, trichomonas
The treatment of vaginitis, monilial vaginitis, senile vahinitis, vagina mixed infection and cervical erosion etc..
The usage and dosage of the silver ion effervescent tablet：Packaging is opened, effervescent tablet is taken out, takes dorsal position, with disposably finger
Set slowly pushes it into vagina depths.1 every night, continuous was a course for the treatment of using 6 days；Vaginitis：1~2 course for the treatment of；Uterine neck
It is scorching：2~3 courses for the treatment of, severe person's increase course for the treatment of；Mycoplasma choamydiae infection：At least two course for the treatment of.Perineum care：By 2 effervesces
Piece is dissolved in warm water, cleans perineum, 2 times a day, continuous to use 6 days.Other usages are abided by medical care and advised.
The silver ion content of the silver ion effervescent tablet：1000±50μg/g.
The antibacterial effect of the silver ion effervescent tablet is according to GB 15981《Sterilization and the evaluation method and mark of sterilization effect
It is accurate》Test, meet following table requirement.
The silver ion effervescent tablet is according to GB/T 16886.1《BiologicalEvaluationofMedicalDevice part 1：Evaluate and examination
Test》Requirement, biocompatibility should meet following index：1. cell toxicity test, reacts classification and is not more than 2；2. delayed surpasses
Quick reaction test, reaction classification is not more than 1；3. vaginal irritation is tested, and vaginal irritation index is not more than 4.
Claims (1)
1. a kind of high valency silver ion effervescent tablet for gynecological disease, it is formulated as (in mass ratio)：Silver iron compound 3 ‰,
Sodium acid carbonate 25%, tartaric acid 25%, boric acid 7.5%, starch 20%, hydroxypropyl methylcellulose 2.7%, dextrin 7.5%, poly- second two
Alcohol 6,000 12%, the main formula of effervescent tablet using silver iron compound, boric acid as antibiotic effective ingredient, by acid source of tartaric acid,
Sodium acid carbonate is alkali source, soda acid proportioning 1:1st, soda acid total amount is 50%, and using starch as filler, adhesive is hypromellose
Element and dextrin, using Macrogol 6000 as ion embedding medium；
The silver iron compound is high-valence state silver iron compound, and main component is persulfuric acid silver, and silver content is 35%, is+1
Valency and+trivalent；
The preparation method of the high-valence state silver iron compound is：2L purified waters are added with 10g silver peroxides, 20g mistakes are added
Sulfate, stirring reaction obtains high-valence state silver ionized water solution, and above-mentioned silver ionized water solution is concentrated into evaporating water, crushing, mistake
80 mesh sieves, obtain white silver iron compound；
The preparation method of the high valency silver ion effervescent tablet is comprised the steps of：
1) preparation, the weighing of raw material：Will silver iron compound add pulverizer in be crushed, and mistake 80 mesh sieves, then according to
Formula rate carries out the weighing of each raw material；
2) polyethylene glycol pack technique：After Macrogol 6000 is melted, the silver iron compound (80 mesh) crushed is added,
Stir, cooling crush crosses 80 mesh sieves；Sodium acid carbonate is wrapped up according to the method described above.Macrogol 6000 in formula
Consumption be 12%, wherein parcel silver iron compound consumption is 1%, encapsulated sodium bicarbonate consumption is 11%；
3) mix：The outer composition weighed up is put into mixer according to formula rate and mixed, is placed on after being well mixed
It is standby in stainless steel cask, then nexine composition is well mixed according to the method described above standby；
4) softwood processed：The outer composition mixed and nexine composition are put into efficient wet granulator respectively and stirred, is added viscous
Mixture, suitable softwood is made according to standard practice；
5) pelletize：By above two softwood respectively in efficient wet granulator, wet granular of uniform size is made, 40 mesh are crossed
Sieve；
6) dry：Above two wet granular is put into HighefficientFluidbeddrier, it is all seethed with excitement, steam heating, temperature is opened
Degree control is dried to moisture content≤1% below 60 DEG C；
7) whole grain：The two kinds of particles made is passed through into 40 mesh sieve whole grains with pelletizing machine respectively；
8) tabletting：Bi-layer tablet press is opened, nexine composition is now subjected to precompressed in flakes, outer composition is then added and carries out tabletting,
Make tablet global formation, aluminum-plastic packaged, mounted box；
The effervescent tablet employs double-decker, and piece shape is in half spindle；
In the double-decker, nexine is formed by outer layer covers, and outer layer is that pure effervesce composition is sodium acid carbonate and tartaric acid, nexine
Composition is the mixture of silver iron compound, boric acid, starch, Macrogol 6000 and effervesce composition, and outer layer effervesce composition is accounted for always
2/3rds of effervesce composition, nexine effervesce composition accounts for 1/3rd.
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104352527A (en) * | 2014-10-20 | 2015-02-18 | 中山百鸥医药科技有限公司 | Application of cod liver oil to the treatment of gynaecopathia |
| CN104857451A (en) * | 2015-06-05 | 2015-08-26 | 董云霞 | Traditional Chinese medicine for repairing cervix and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1569133A (en) * | 2004-04-29 | 2005-01-26 | 浙江天一堂集团有限公司 | 'Shuanghuanglian' effervescence tablet and its preparation |
| CN101940221A (en) * | 2010-08-30 | 2011-01-12 | 苏州邦安新材料科技有限公司 | Novel sterilizing effervescent tablets and preparation process thereof |
| CN103181911A (en) * | 2011-12-30 | 2013-07-03 | 新昌县冠阳技术开发有限公司 | Vaginal effervescent tablets |
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2014
- 2014-02-24 CN CN201410060844.5A patent/CN103845303B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1569133A (en) * | 2004-04-29 | 2005-01-26 | 浙江天一堂集团有限公司 | 'Shuanghuanglian' effervescence tablet and its preparation |
| CN101940221A (en) * | 2010-08-30 | 2011-01-12 | 苏州邦安新材料科技有限公司 | Novel sterilizing effervescent tablets and preparation process thereof |
| CN103181911A (en) * | 2011-12-30 | 2013-07-03 | 新昌县冠阳技术开发有限公司 | Vaginal effervescent tablets |
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