CN104474547A - Vaginal infection prevention immune globulin compound preservative - Google Patents
Vaginal infection prevention immune globulin compound preservative Download PDFInfo
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- CN104474547A CN104474547A CN201510006259.1A CN201510006259A CN104474547A CN 104474547 A CN104474547 A CN 104474547A CN 201510006259 A CN201510006259 A CN 201510006259A CN 104474547 A CN104474547 A CN 104474547A
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Abstract
The invention relates to the field of biological medicine, in particular to a vaginal infection prevention immune globulin compound preservative. The effective active components of the compound preservative are composed of immune globulin IgY of yolk, chitosan and triclosan. The vaginal infection prevention immune globulin compound preservative is used for preparing medicine for treating the vaginitis, is capable of restraining bacteria and candida in the vagina and not damaging the ecological balance of a normal flora in the vagina, prevents vagina dryness, is free of side effects and is suitable for preventing and treating the early-stage vaginitis.
Description
Technical field
The present invention relates to biomedicine field, especially relate to a kind of anti-vaginal infection immunoglobulin compound preservative.
Background technology
Vaginitis is the common disease of Out-patient Clinic of Department of Gynecology, and wherein modal is colpitis mycotica, caused by monilial infection.The modal symptom of monilial infection is that leucorrhea is many, pudendum and the scorching hot pruritus of vagina, exogen dysuria, typical leucorrhea is curdy or is sheet bulk, and vaginal mucosa height is red and swollen, and visible white thrush sample speckle adheres to, easy stripping, its lower rotten to the corn substrate for impaired mucosa, or form fester, severe patient can leave over ecchymosis.Trimester of pregnancy, the pruritis of colpitis mycotica was particularly serious, and even feel restless, misery is abnormal, also can have the symptom such as frequent micturition, dysurea.The Therapeutic Method of monilial vaginitis comprises: local application, uses miconazole suppository, clotrimazole suppository, nystatin suppository; Systemic administration (recurrent exerbation or can not the patient of vagina administration) uses fluconazol, itraconazole, ketoconazole.These medicines have side effect more, intravaginal normal flora also can be suppressed active thus destroy the normal ecological balance of intravaginal.Be not suitable for trimester of pregnancy treatment, prevention can not be used for.
Summary of the invention
In order to overcome these problems, the invention discloses a kind of anti-vaginal infection immunoglobulin compound preservative, intravaginal antibacterial and candidiasis can be suppressed, be suitable for prevention and early stage colpitic treatment.
The present invention relates to a kind of anti-vaginal infection immunoglobulin compound preservative, a kind of anti-vaginal infection immunoglobulin compound preservative, the effective active component of described compound preservative is made up of Yolk immune globulin IgY, chitosan and triclosan.
In described compound preservative, the content of Yolk immune globulin IgY counts 100-50000 titre by antibody titer, and the content of chitosan is 0.01%-1% by weight, and the content of triclosan is 0.001%-1% by weight.More preferably, the content of described Yolk immune globulin IgY counts 1000-10000 titre by antibody titer, and the content of described chitosan is 0.1%-0.5% by weight, and the content of described triclosan is 0.01%-0.1% by weight.
Other component of described compound preservative comprises salt of weak acid buffer, Polyethylene Glycol and essence.
The concentration of described salt of weak acid buffer is 5-200mM, pH is 3-6.5, and the content of Polyethylene Glycol is 1%-20% by weight, and the content of essence is 0.001%-0.5% by weight.
More preferably, the pH of described salt of weak acid buffer is 3.5-5.
The preparation method of described Yolk immune globulin IgY is as follows:
(1) antigen preparation: obtain antigen emulsion with ultrasonic emulsification after mixing by the mass ratio of 2:1:0.8 with soybean oil and soybean phospholipid through the pathogen of cracking deactivation, for subsequent use; Described pathogen is any one or more combinations in Candida albicans, haemophilus, corynebacterium, Gartner bacterium.
(2) Yolk immune globulin IgY antibody preparation: with antigen emulsion immune hen, collect egg, isolate egg yolk; The 0.1-10% Osmitrol dilution egg yolk of 1-10 times amount is added according to egg yolk weight, centrifugal, collect the supernatant containing antibody, antibody purification, tire with PBS buffer adjustment antibody purification, subpackage, storage, for subsequent use.
The strain adopted in above-mentioned raw materials can be obtained by conventional microorganism isolation and identification method by those skilled in the art, also by commercial channel, as Chinese microorganism strain net-Beijing North Na Chuanlian Bioteknologisk Institut obtains.The culture fluid that bacterium liquid of the present invention is obtained after being and being cultivated by single purifying agaric.
Present invention also offers a kind of preparation method of described anti-vaginal infection immunoglobulin compound preservative, it is characterized in that: first mix egg yolk immune globulin IgY and polyglycol solution, then the mixing of salt of weak acid buffer is added, add chitosan solution mixing again, and then add Triclosan solution, mixing, finally adds essence mixing, subpackage after 0.2 μ-0.45 μ membrane filtration.
The present invention also protects the application of described anti-vaginal infection immunoglobulin compound preservative in the colpitic medicine of preparation treatment.
Immunoglobulin compound preservative of the present invention is a kind of immunostimulant and antibacterial of gentleness, intravaginal antibacterial and candidiasis can be suppressed and do not destroy the ecological balance of intravaginal normal flora, also can prevent vaginal dryness, be free from side effects, be suitable for prevention and early stage colpitic treatment.
Detailed description of the invention
Embodiment 1: antibacterial immunity globulin preparation example:
1) antigen preparation: after respectively Candida albicans bacteria culture fluid and Gartner bacteria culture fluid being incubated deactivation in 10 minutes in 90 DEG C, 10ml composite bacterial solution is mixed to get with respectively getting 5ml after ultrasonic disruption, add soybean oil 5ml and soybean phospholipid and beat 2 minutes by after 4ml mixing with ultrasound wave, just obtained combined antigen emulsion, for subsequent use.
2) egg antibody preparation: with 1) in prepared antigen emulsion immune hen (subcutaneous injection), every per injection 0.3ml, every injection in 12 days once, starts to collect egg after inject 5 times, supplementaryly again every 1 month subsequently injects once); Isolate egg yolk by collecting the egg come, according to egg yolk weight, with add 5 times of volumes 0.2% Osmitrol dilution egg yolk, stir and make muddy rear static centrifugal, collect containing the supernatant of antibody; This supernatant is added to the DEAE ion exchange resin post through sample-loading buffer balance, uses the NaCl buffer solution elution pillar of variable concentrations (from low to high) successively, collect the IgY antibody flow point of the NaCl eluting of 0.5-0.8mM; Antibody purification is adjusted to tire to 1000-5000 titre or more with PBS buffer, subpackage, low temperature storage, for subsequent use.
Embodiment 2: a kind of immunoglobulin compound preservative I formula, preparation method and using method.
A kind of immunoglobulin its main active of compound preservative and content are: 1). Yolk immune globulin IgY, its content counts 1000 titres with antibody titer, and 2). chitosan, its content is 0.1% by weight, 3). triclosan, its content is 0.1% by weight.
Its preparation method following (be 1 be upgraded to example with finished product volume of production):
1). according to antibody stock solution titre, get and be in right amount diluted to antibody titer with PBS buffer and count 5000 titres, prepare 200ml for subsequent use;
2). get appropriate PEG-400 (PEG-20000), be deployed into the aqueous solution of 30% (w/v) concentration with pure water, 100ml is for subsequent use in preparation;
3). get appropriate chitosan and be dissolved in 1% acetic acid solution the solution be deployed into containing 5% chitosan, 20ml is for subsequent use in preparation;
4). get appropriate triclosan ethanol dilution to 10% Triclosan solution, 10ml is for subsequent use in preparation;
5) .A) get citric acid monohydrate 10.5 grams, be settled to 1000ml obtain 50mM aqueous citric acid solution with deionized water dissolving; B) get Sodium Citrate, usp, Dihydrate Powder 14.7 grams, be settled to 1000ml obtain 50mM sodium citrate aqueous solution with deionized water dissolving; C) appropriate A is got) and B), by B) be progressively added to A) inner, limit edged surveys pH value, to pH4.8, just obtains the 50mM citrate buffer of pH5, and more than 800ml is for subsequent use in preparation;
6). get above-mentioned 1 respectively) 200ml and 2) 100ml premixing; Separately get 3) 20ml and 5) the 50mM citrate buffer of 600ml(pH5) after mixing, then add 1) and 2) premix, then add 4) 10ml, the 50mM citrate buffer being uniformly mixed rear pH5 is settled to 1000ml; Finally add 1ml citric acid essence, mixing is obtained immunoglobulin compound preservative just;
7). be divided in vaginal lotion bottle after 0.2 μ-0.45 μ filter membrane aseptic filtration, every bottle of 50ml, separately joins the single use vaginal douche rod that sterile sealing is packed.
Using method: turn on bottle for handling liquid toilet or cosmetic substance bottle cap, tears rinse bars sealing bag, rinse bars is docked with liquid containing bottle and screws; User gets the padded buttocks or squat and rinse bars will definitely insert intravaginal of lying on the back, and slowly washing liquid is injected by extruding liquid containing bottle, extracts rinse bars, keeps former posture 10 minutes, with fungistatic effect of remaining valid.
Embodiment 3 one kinds of immunoglobulin compound preservative II formula, preparation method and usings method.
A kind of immunoglobulin its main active of compound preservative and content are: 1). Yolk immune globulin IgY, its content counts 1000 titres with antibody titer, and 2). chitosan, its content is 0.2% by weight, 3). triclosan, its content is 0.02% by weight.
As described in Example 2, main active concentration appropriately adjusts according to formula for preparation method and using method.
Embodiment 4 one kinds of immunoglobulin compound preservative III formula, preparation method and usings method.
A kind of immunoglobulin its main active of compound preservative and content are: 1). Yolk immune globulin IgY, its content counts 5000 titres with antibody titer, and 2). chitosan, its content is 0.2% by weight, 3). triclosan, its content is 0.02% by weight.
As described in Example 2, main active concentration appropriately adjusts according to formula for preparation method and using method.
Embodiment 5 one kinds of compound preservative IV(are not containing immunoglobulin) formula, preparation method and using method.
A kind of its main active of compound preservative and content are: 1). chitosan, its content is 0.2%, 2 by weight). triclosan, its content is 0.02% by weight.
Preparation method is carried out described in the step 2-7 of preparation method in embodiment 2, and activity component concentration appropriately adjusts according to formula; Using method is undertaken by the using method described in embodiment 2.
The Clinical practice effect of more several different formulations antibacterial of embodiment 6
Clinical practice effect test method: choose and suffer from different colpitic volunteer 80, as shown in table 1, be of all agesly divided into 5 groups at random, often organize each 16 (wherein: bacterial vaginitis 6 people, candidiasis (mycete) property vaginitis 5 people, trichomonal vaginitis 5 people).The compound preservative I-IV prepared by embodiment 2-5 is used respectively to the volunteer of group 1-4, give group 5(matched group) use normal saline, by the using method described in embodiment 2, rinse 1 every day, carry out 15 days continuously, check the vaginitis situation record of often organizing volunteer.The symptom that various vaginitis is corresponding alleviates or disappears and is considered as effectively, constant or become more serious be considered as invalid; Curative effect determinate standard: 1) bacterial vaginitis: vaginal secretions reduces, and fishlike smell alleviates and disappears, and pruritus vulvae or burning sensation alleviate or disappear, and no longer sees clues cell when secretions makes plate coating checking.2) monilial vaginitis: the symptoms such as pruritus vulvae, causalgia, sexual anhedonia alleviate, and the edema of pudendum and vestibule, erythema alleviate or disappear, white stiff is the secretions minimizing of curdled milk or bean dregs sample or disappears.3) trichomonal vaginitis: the thin purulence of vaginal secretions, yellow green, the symptom such as cystose and stink alleviate or disappear; Pruritus vulvae alleviates or disappears; Merge urinary tract infection alleviate or disappear; Vagina glues mucosa hyperemia, and be dispersed in ecchymosis symptom and alleviate or disappear, vagina pH drops to less than 5.0.Result of the test is as shown in table 1.
Antibacterial Clinical practice effect described in table 1. comparing embodiment 2,3,4,5:
Note 1: vaginal mucomembranous irritant test method is undertaken by corresponding test method in " the disinfectant toxicological experiment technology " of Ministry of Public Health " disinfection technology standard " (third edition) first in fascicle " experimental technique specification " (1999).
Note 2: effective percentage=[alleviating number/test number by rear symptom] X100%;
Above result of the test display: each formula of embodiment 2-5 all has no stimulation to vaginal mucosa, also has remarkable therapeutic effect to multiple vaginitis, and matched group normal saline only has slight curative effect (effective percentage only 13%) to bacterial vaginitis.Wherein, effect containing 5000 high titre immunoglobulin antibacterial III (embodiment 4) is the most remarkable in 88%, and only have the antibacterial IV(embodiment 5 of chitosan and triclosan (not containing immunoglobulin)) effect only 50%, containing 1000 titre immunoglobulin antibacterial II(embodiments 3) effect reach 75%, containing low concentration chitosan and triclosan but add 1000 titre immunoglobulin antibacterial I(embodiments 2) also slightly high than the antibacterial IV effect containing higher concentration chitosan and triclosan but not containing immunoglobulin.
Claims (9)
1. an anti-vaginal infection immunoglobulin compound preservative, is characterized in that: the effective active component of described compound preservative is made up of Yolk immune globulin IgY, chitosan and triclosan.
2. anti-vaginal infection immunoglobulin compound preservative according to claim 1, it is characterized in that: in described compound preservative, the content of Yolk immune globulin IgY counts 100-50000 titre by antibody titer, the content of chitosan is 0.01%-1% by weight, and the content of triclosan is 0.001%-1% by weight.
3. anti-vaginal infection immunoglobulin compound preservative according to claim 2, it is characterized in that: the content of described Yolk immune globulin IgY counts 1000-10000 titre by antibody titer, the content of described chitosan is 0.1%-0.5% by weight, and the content of described triclosan is 0.01%-0.1% by weight.
4. anti-vaginal infection immunoglobulin compound preservative according to claim 1, is characterized in that: other component of described compound preservative comprises salt of weak acid buffer, Polyethylene Glycol and essence.
5. anti-vaginal infection immunoglobulin compound preservative according to claim 4, it is characterized in that: the concentration of described salt of weak acid buffer is 5-200mM, pH is 3-6.5, the content of Polyethylene Glycol is 1%-20% by weight, and the content of essence is 0.001%-0.5% by weight.
6. anti-vaginal infection immunoglobulin compound preservative according to claim 5, is characterized in that: the pH of described salt of weak acid buffer is 3.5-5.
7. anti-vaginal infection immunoglobulin compound preservative according to claim 1, is characterized in that: the preparation method of described Yolk immune globulin IgY is as follows:
(1) antigen preparation: obtain antigen emulsion with ultrasonic emulsification after mixing by the mass ratio of 2:1:0.8 with soybean oil and soybean phospholipid through the pathogen of cracking deactivation, for subsequent use; Described pathogen is any one or more combinations in Candida albicans, haemophilus, corynebacterium, Gartner bacterium;
(2) Yolk immune globulin IgY antibody preparation: with antigen emulsion immune hen, collect egg, isolate egg yolk; The 0.1-10% Osmitrol dilution egg yolk of 1-10 times amount is added according to egg yolk weight, centrifugal, collect the supernatant containing antibody, antibody purification, tire with PBS buffer adjustment antibody purification, subpackage, storage, for subsequent use.
8. the preparation method of an anti-vaginal infection immunoglobulin compound preservative according to any one of claim 4-7, it is characterized in that: first mix egg yolk immune globulin IgY and polyglycol solution, then the mixing of salt of weak acid buffer is added, add chitosan solution mixing again, and then add Triclosan solution, mixing, finally adds essence mixing, subpackage after 0.2 μ-0.45 μ membrane filtration.
9. the application of the anti-vaginal infection immunoglobulin compound preservative according to any one of claim 1-7 in the colpitic medicine of preparation treatment.
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Cited By (6)
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CN105749277A (en) * | 2016-03-10 | 2016-07-13 | 陕西瑞凯生物科技有限公司 | Yolk bioprotein foam filler and preparation method thereof |
CN108714214A (en) * | 2018-05-30 | 2018-10-30 | 芬多精(厦门)生物技术有限公司 | A kind of pure natural gynaecology Chinese juniper lotion and preparation method thereof |
CN109602904A (en) * | 2019-01-14 | 2019-04-12 | 江苏润洁生物科技有限公司 | A kind of immune globulin IgY plural gel agent for gynaecological imflammation |
CN109675030A (en) * | 2019-01-14 | 2019-04-26 | 江苏润洁生物科技有限公司 | A kind of compound washing lotion of immune globulin IgY for gynaecological imflammation |
WO2019157340A1 (en) * | 2018-02-08 | 2019-08-15 | Amgen Inc. | Low ph pharmaceutical antibody formulation |
CN111789945A (en) * | 2020-06-09 | 2020-10-20 | 诺德诺美(广州)生物科技有限公司 | Compound external preparation for treating gynecological inflammation |
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CN1454901A (en) * | 2003-06-10 | 2003-11-12 | 雅臣药业集团(远东)有限公司 | Gynaecological anti-infective specificity IgY and its combined preparation |
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105749277A (en) * | 2016-03-10 | 2016-07-13 | 陕西瑞凯生物科技有限公司 | Yolk bioprotein foam filler and preparation method thereof |
WO2019157340A1 (en) * | 2018-02-08 | 2019-08-15 | Amgen Inc. | Low ph pharmaceutical antibody formulation |
CN108714214A (en) * | 2018-05-30 | 2018-10-30 | 芬多精(厦门)生物技术有限公司 | A kind of pure natural gynaecology Chinese juniper lotion and preparation method thereof |
CN109602904A (en) * | 2019-01-14 | 2019-04-12 | 江苏润洁生物科技有限公司 | A kind of immune globulin IgY plural gel agent for gynaecological imflammation |
CN109675030A (en) * | 2019-01-14 | 2019-04-26 | 江苏润洁生物科技有限公司 | A kind of compound washing lotion of immune globulin IgY for gynaecological imflammation |
CN111789945A (en) * | 2020-06-09 | 2020-10-20 | 诺德诺美(广州)生物科技有限公司 | Compound external preparation for treating gynecological inflammation |
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