CN1857243A - Vaginal foam preparation of chlorhexidine acetate and its preparing process - Google Patents
Vaginal foam preparation of chlorhexidine acetate and its preparing process Download PDFInfo
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- CN1857243A CN1857243A CN 200610200224 CN200610200224A CN1857243A CN 1857243 A CN1857243 A CN 1857243A CN 200610200224 CN200610200224 CN 200610200224 CN 200610200224 A CN200610200224 A CN 200610200224A CN 1857243 A CN1857243 A CN 1857243A
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Abstract
The present invention discloses vaginal foam preparation of chlorhexidine acetate and its preparation process. The vaginal foam preparation is prepared with chlorhexidine acetate, blumea oil, triethanolamine, stearic acid, peregal O, glycerin, benzyl alcohol, essence, alcohol and water in certain weight proportion. It has excellent cleaning and bacteriostasis effect, and has the advantages of high safety, high stability, less side effect, low dosage, etc. and is suitable for conventional cleaning of vagina.
Description
Technical field
The present invention relates to a kind of health care of women articles for use and preparation method thereof, specifically is a kind of foam that is used for the vagina cleaning and preparation method thereof.
Background technology
Vagina commonly used both at home and abroad at present is mainly the lotion dosage form with gynecological's cleaning agent.This dosage form is clarification or suspendible liquid, need pour container dilution back cleaning external genital during use into.Lotion is short in the external genital holdup time, can not reach vagina inside, can not play permanent cleaning action to the vagina deep, and needs more aid, uses trouble.Simultaneously manipulation, easily produce cross-contamination.
Summary of the invention
The objective of the invention is to, a kind of vaginal foam agent made from chlorhexidine acetate and preparation method thereof is provided, solve the problem that prior art exists.
Technical scheme of the present invention.Vaginal foam agent with chlorhexidine acetate is made is characterized in that: this foam is to make with the following weight parts proportion raw material; 7.5～22.5 parts of chlorhexidine acetates, 30～70 parts of natural botanical extraction liquids, 97.5～292.5 parts of emulsifying agent A components, 500～1500 parts of emulsifying agent B components, 150～350 parts of benzyl alcohol, 25～75 parts in essence, 100～300 parts of ethanol, 4120～12360 parts of distilled water; Wherein: natural botanical extraction liquid is the Herba Blumeae Balsamiferae wet goods, and emulsifying agent A component is made of triethanolamine, stearic acid and peregal 0 mixing; Emulsifying agent B component is made of 1,2 propylene glycol or glycerol.
Above-mentioned vaginal foam agent made from chlorhexidine acetate, be to make preferably: 7.5～22.5 parts of chlorhexidine acetates, 30～70 parts of Oleum Blumeae Balsamiferaes, 25～75 parts of triethanolamine, 47.5～142.5 parts of stearic acid, 0 25～75 parts of peregals, 1,2 propylene glycol or 500～1500 parts of glycerol, 150～350 parts of benzyl alcohol, 25～75 parts in essence, 100～300 parts of ethanol, 4120～12360 parts of distilled water by the raw material of following weight parts.
Aforesaid vaginal foam agent made from chlorhexidine acetate is to be made by the raw material of following weight parts better; 12～20 parts of chlorhexidine acetates, 40～60 parts of Oleum Blumeae Balsamiferaes, 37.5～62.5 parts of triethanolamine, 72～120 parts of stearic acid, 037.5～62.5 part of peregal, 1,2 propylene glycol or 750～1250 parts of glycerol, 200～300 parts of benzyl alcohol, 40～60 parts in essence, 150～250 parts of ethanol, 6101～10168 parts of distilled water.
Aforesaid vaginal foam agent made from chlorhexidine acetate is preferably made by the raw material of following weight parts; This foam is to be made by the raw material of following weight parts; 15 parts of chlorhexidine acetates, 50 parts of Oleum Blumeae Balsamiferaes, 45 parts of triethanolamine, 105 parts of stearic acid, flatly add 0 45 parts, 1000 parts of propylene glycol, 250 parts of benzyl alcohol, 50 parts in essence, 200 parts of ethanol, 8240 parts of distilled water.
The preparation method of aforesaid vaginal foam agent made from chlorhexidine acetate is characterized in that: by following step preparation;
(1) chlorhexidine acetate of recipe quantity is added dissolve with ethanol and with the natural botanical extraction liquid mix homogeneously, No. 1 liquid;
(2) purified water of 2/3rds amounts that triethanolamine, peregal 0 and the stearic acid of recipe quantity added recipe quantity fully dissolving, mix homogeneously in 75 ℃ water-bath, No. 2 liquid;
(3) in 1,2 propylene glycol or No. 2 liquid of glycerol (glycerol) adding with recipe quantity, mix homogeneously gets No. 3 liquid;
(4) aforesaid 1,2, No. 3 liquid is mixed in 60 ℃ of water-baths, stir, add essence, benzyl alcohol and add the purified water of surplus, mixing, packing is pressed into propellant, and bottling gets product.
The applicant has carried out a series of experiment, with the simple possible that proves that preparation of the present invention is effective, controlled, produce.
Experimental example 1 selects for use emulsifying agent such as triethanolamine, 1,2 propylene glycol or glycerol (glycerol) peregal 0, stearic acid and antiseptic benzyl alcohol, essence to prepare burden each prescription of intuitive analysis to the influence of this foaming cletergent quality, has found out best ratio.After allotting liquid medicine filling, spray volume of foam (cm
3) and foam duration (min) and the ejection total amount (%) carry out comprehensive grading.Wherein (min) sprays into graduated cylinder with medicinal liquid the persistent period, puts 37 ℃ of observing in water-soluble.According to tripartite mask body average evaluation.
| The supplementary material title | Addition (umber) | |||||
| 1 | 2 | 3 | 4 | 5 | ||
| Chlorhexidine acetate | 7.5 | 12 | 15 | 20 | 22.5 | |
| Natural botanical extraction liquid | Oleum Blumeae Balsamiferae | 30 | 40 | 50 | 60 | 70 |
| Emulsion A component | Triethanolamine | 25 | 37.5 | 45 | 62.5 | 75 |
| Stearic acid | 47.5 | 72 | 105 | 120 | 142.5 | |
| Peregal 0 | 25 | 37.5 | 45 | 62.5 | 75 | |
| Emulsion B component | 1,2 propylene glycol or glycerol (glycerol) | 500 | 750 | 1000 | 1250 | 1500 |
| Antiseptic | Benzyl alcohol | 150 | 200 | 250 | 300 | 350 |
| Essence | 25 | 40 | 50 | 60 | 75 | |
| Ethanol | 100 | 150 | 200 | 250 | 300 | |
| Distilled water | 4120 | 6101 | 8240 | 10168 | 12360 | |
| Overall merit | Generally | Better | Measure | Better | Generally | |
Experiment shows: 15 parts of chlorhexidine acetates, 50 parts of Oleum Blumeae Balsamiferaes, 45 parts of triethanolamine, 105 parts of stearic acid, flat when adding 8240 parts of 045 parts, 1000 parts of propylene glycol, 250 parts of benzyl alcohol, 50 parts in essence, 200 parts of ethanol, distilled water and filling a prescription the resultant effect of product best.
Experimental example 2, chlorhexidine acetate foam bacteriostatic test;
Experiment shows: under 20 ± 2 ℃ condition, the chlorhexidine acetate foam is to staphylococcus aureus, escherichia coli, Candida albicans effect 0.5min, and average bacteriostasis rate all reaches 100.00% (100.00%).According to GB15979-2002 " disposable use hygienic article sanitary standard ", think that the chlorhexidine acetate foam has stronger inhibitory action to each indicator bacteria.
Experimental example 3, acute oral toxicity test;
Experiment is by " disinfection technology standard " (version in 2002) 2.3.1 standard.By following experimental technique: (1) contamination approach: once irritate stomach; (2) dosage grouping:, press 20 mices of the disposable filling stomach of 6000mg/kg BW (♀ ♂ half and half) dosage 0.4ml/20g again by 20000,10000, after 5000mg/kg BW carries out trial test; (3) the general situation of animal is observed in the contamination back, and poisoning symptom and death condition are observed 14 days time limits, with median lethal dose(LD 50) (LD
50) determine the acute toxicity classification.
Experimental result shows: the chlorhexidine acetate foam is to white mice acute oral median lethal dose(LD 50) (LD
50) greater than the 5000mg/kg body weight, true border is nontoxic.
Experimental example 4, the skin irritation test;
Experiment is by " disinfection technology standard " (version in 2002) 2.3.3 bar standard.By following experimental technique: in 24 hours early stages of (1) experiment, tame rabbit back spinal column diamond wool is cut the left and right about 3cm * 3cm of unhairing scope; (2) experiment the time is applied to chlorhexidine acetate foam stock solution 0.5ml on 2.5cm * 2.5cm 2 floor gauze and applies ointment or plaster at a side unhairing district skin surface, covers with the non-stimulated plastic sheeting of one deck then, and non-stimulated adhesive plaster of reuse and binder are fixed.Apply after 4 hours, remove the residual thing that tried with distilled water, opposite side unhairing district skin is as blank; (3) remove and tried behind the thing 1,24,48 hour, observe dermoreaction respectively, carry out dermoreaction, integration and stimulus intensity evaluation by the regulation of " sterilization and sterilization experimental technique standard ".
Experiment shows: the chlorhexidine acetate foam is 0.33 to the highest stimulation index of new zealand rabbit skin irritation reaction, belongs to nonirritant.
Experimental example 5, vaginal mucomembranous irritant test;
Experiment is by " disinfection technology standard " (version in 2002) 2.3.5 bar standard.By following experimental technique: (1) test grouping: divide contamination group and matched group, 3 every group.(2) operation sequence: a, be that blunt nosed flexible pipe about 8cm is connected with the 2ml syringe with length, syringe and conduit are filled with and are subjected to test solution standby, and every animal prepared a cover; B, animal is faced upward fixing, expose perineum and vaginal orifice, conduit with being subjected to the soft insertion vagina (4-5cm) in the moistening back of test solution or contrast liquid, is slowly injected 2ml and tried thing, extract conduit out and finish contamination, matched group is done same processing with normal saline; C, contamination back 24h, adopt the aeroembolism method to put to death animal, cut open the belly and take out complete vagina, vertically cut, whether perusal has performances such as hyperemia, edema, reference during for pathologic sampling, then vagina is put into 10% formalin solution fixedly more than the 24h, choose vagina 3 positions in two ends and central authorities organize film-making, carry out histopathological examination after the HE dyeing.
Experimental result shows: chlorhexidine acetate foam stock solution is 0.11 to new zealand rabbit vaginal mucosa irritation index, belongs to nonirritant.
Experimental example 6, the skin allergic reaction test;
Experiment is by " disinfection technology standard " (version in 2002) 2.3.6 bar standard.By following experimental technique:
(1) experimental group: experiment 24 hours in earlier stage, with cropping in guinea pig back left of spine 3cm * 3cm scope, during experiment chlorhexidine acetate foam stock solution 0.5ml is dropped on the two-layer gauze of 2cm * 2cm, and it is applied ointment or plaster in left side unhairing district, cover with non-stimulated plastic sheeting, again with non-stimulated immobilization with adhesive tape.After continuing 6h, the 7th day and the 14th day in kind repeats once.Last was induced back 14 days, chlorhexidine acetate foam stock solution 0.5ml is dropped on the two-layer gauze of 2.0cm * 2.0cm, be applied to guinea pig back right side 3cm * 3cm unhairing district, cover with the non-stimulated plastic sheeting of one deck, again with non-stimulated immobilization with adhesive tape, to apply ointment or plaster behind the 6h and be tried the thing flush away, observe dermoreaction behind 24h and the 48h.
(2) positive controls: the same experimental group of experimental technique, inducer are 2, the 4-dinitrochlorobenzene, and induced concentration 4% excites concentration 1.2%.
(3) negative control group: in last induce excited in back 14 days the contact tried thing, exciting concentration is chlorhexidine acetate foam stock solution.
Experimental result shows: the chlorhexidine acetate foam is 0% to guinea pig skin sensitization rate, does not see skin allergic reaction.
Experimental example 7, the test of mouse bone marrow cells polychromatophilia micronucleus in erythrocytes;
Experiment is by " disinfection technology standard " (version in 2002) 2.3.8.4 bar standard.By following experimental technique: select 50 healthy mices for use, divide 5 groups at random, every group female, male each 5, establish three dosage groups altogether, the dosage design is respectively 5000mg/kgBW, 2000mg/kg BW, 500mg/kg BW, other establishes negative control and positive controls, and negative control group is given distilled water, and positive group gives cyclophosphamide 40mg/kg BW.Adopt 30 hours dose regimens, promptly twice dosing interval is 24 hours, and after the last administration 6 hours, routine was got breastbone film-making, fixing, dyeing, under oily mirror every animal is observed 1000 polychromatic erythrocytes, calculates micronuclear rates, carries out statistical analysis.
Experimental result shows: (1) negative control group micronuclear rates 1.1%
0, positive controls micronuclear rates 34.8%
0, U=17.78＞2.58, P＜0.01, negative control group and positive controls have utmost point significant difference (P＜0.01) that the animal subject sensitivity is described, and test is reliable.
(2) three dosage group micronuclear rateses all＜3%
0, in normal range, not being dose-response relationship, each dosage group is compared the U assay with the solvent control group, no significant difference.
Therefore can estimate this chlorhexidine acetate foam in being subjected to the amount of reagent scope to PCEMNR micronucleus test feminine gender, do not have the micronucleus effect that causes.
Experimental example 8, stability test:
The chlorhexidine acetate foam is placed 14 days, 37 ℃ placements after 90 days through 54 ℃, stock solution is to Candida albicans effect 0.5min, average bacteriostasis rate reaches 100.00% (100.00%), according to GB15979-2002 " disposable use hygienic article sanitary standard ", show that at room temperature this product storage life can be decided to be 2 years.
Compared with prior art, foam of the present invention has good cleaning bacteriostasis, has safety, stable, efficient, the whole body side reaction is little etc. advantage.Foam consumption of the present invention is few, need not wait for dissolution time, directly foaming, and action effect is good; Carry, easy to use, be applicable to the women at home, travel outdoors to the routine cleaning of vagina.The present invention makes full use of the advantage of foam, simultaneously in conjunction with the medicine chlorhexidine acetate and the ethnic drug Oleum Blumeae Balsamiferae that vaginal microbial flora are truly had treatment and preventive effect, other adjuvant of compatibility is made this kind, and test shows, its compatibility is reasonable, can not cause the disorder of vagina normal flora, and by above a series of evidence, these product are stable,, avirulence non-stimulated to vaginal mucosa can be used as standing articles for use and use.
The specific embodiment
Embodiments of the invention: 15 parts of chlorhexidine acetates, 50 parts of Oleum Blumeae Balsamiferaes, 45 parts of triethanolamine, 105 parts of stearic acid, flatly add 045 part, 1000 parts of propylene glycol, 250 parts of benzyl alcohol, 50 parts in essence, 200 parts of ethanol, 8240 parts of distilled water.By following step preparation;
(1) chlorhexidine acetate of recipe quantity is added dissolve with ethanol and with the natural botanical extraction liquid mix homogeneously, No. 1 liquid;
(2) purified water of 2/3rds amounts that triethanolamine, peregal 0 and the stearic acid of recipe quantity added recipe quantity fully dissolving, mix homogeneously in 75 ℃ water-bath, No. 2 liquid;
(3) in 1,2 propylene glycol or No. 2 liquid of glycerol (glycerol) adding with recipe quantity, mix homogeneously gets No. 3 liquid;
(4) aforesaid 1,2, No. 3 liquid is mixed in 60 ℃ of water-baths, stir, add essence, benzyl alcohol and add the purified water of surplus, mixing, packing is pressed into propellant, and bottling gets product.
This product is vagina cleaning, disinfectant.First jolting is even before using, and conduit is inserted the about 7cm of vagina gently, and the pressure-lift valve makes foam just overflow vaginal orifice and is as the criterion and is ampoule.
Claims (5)
1. vaginal foam agent made from chlorhexidine acetate, it is characterized in that: this foam is to make with the following weight parts proportion raw material: 7.5～22.5 parts of chlorhexidine acetates, 30～70 parts of natural botanical extraction liquids, 97.5～292.5 parts of emulsifying agent A components, 500～1500 parts of emulsifying agent B components, 150～350 parts of benzyl alcohol, 25～75 parts in essence, 100～300 parts of ethanol, 4120～12360 parts of distilled water; Wherein: natural botanical extraction liquid is the Herba Blumeae Balsamiferae wet goods, and emulsifying agent A component is made of triethanolamine, stearic acid and peregal 0 mixing; Emulsifying agent B component is made of 1,2 propylene glycol or glycerol.
2. vaginal foam agent made from chlorhexidine acetate according to claim 1 is characterized in that: this foam is to be made by the raw material of following weight parts; 7.5～22.5 parts of chlorhexidine acetates, 30～70 parts of Oleum Blumeae Balsamiferaes, 25～75 parts of triethanolamine, 47.5～142.5 parts of stearic acid, 0 25～75 parts of peregals, 1,2 propylene glycol or 500～1500 parts of glycerol, 150～350 parts of benzyl alcohol, 25～75 parts in essence, 100～300 parts of ethanol, 4120～12360 parts of distilled water.
3. vaginal foam agent made from chlorhexidine acetate according to claim 2 is characterized in that: this foam is to be made by the raw material of following weight parts; 12～20 parts of chlorhexidine acetates, 40～60 parts of Oleum Blumeae Balsamiferaes, 37.5～62.5 parts of triethanolamine, 72～120 parts of stearic acid, 0 37.5～62.5 parts of peregals, 1,2 propylene glycol or 750～1250 parts of glycerol, 200～300 parts of benzyl alcohol, 40～60 parts in essence, 150～250 parts of ethanol, 6101～10168 parts of distilled water.
4. vagina foaming cletergent according to claim 3 is characterized in that: this foam is to be made by the raw material of following weight parts; 15 parts of chlorhexidine acetates, 50 parts of Oleum Blumeae Balsamiferaes, 45 parts of triethanolamine, 105 parts of stearic acid, flatly add 0 45 parts, 1000 parts of propylene glycol, 250 parts of benzyl alcohol, 50 parts in essence, 200 parts of ethanol, 8240 parts of distilled water.
5. as according to the preparation method of the described vaginal foam agent made from chlorhexidine acetate of arbitrary claim in the claim 1 to 4, it is characterized in that: by following step preparation;
(1) chlorhexidine acetate of recipe quantity is added dissolve with ethanol and with the natural botanical extraction liquid mix homogeneously, No. 1 liquid;
(2) purified water of 2/3rds amounts that triethanolamine, peregal 0 and the stearic acid of recipe quantity added recipe quantity fully dissolving, mix homogeneously in 75 ℃ water-bath, No. 2 liquid;
(3) in 1,2 propylene glycol or No. 2 liquid of glycerol (glycerol) adding with recipe quantity, mix homogeneously gets No. 3 liquid;
(4) aforesaid 1,2, No. 3 liquid is mixed in 60 ℃ of water-baths, stir, add essence, benzyl alcohol and add the purified water of surplus, mixing, packing is pressed into propellant, and bottling gets product.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006102002242A CN100427079C (en) | 2006-03-10 | 2006-03-10 | Vaginal foam preparation of chlorhexidine acetate and its preparing process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006102002242A CN100427079C (en) | 2006-03-10 | 2006-03-10 | Vaginal foam preparation of chlorhexidine acetate and its preparing process |
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| Publication Number | Publication Date |
|---|---|
| CN1857243A true CN1857243A (en) | 2006-11-08 |
| CN100427079C CN100427079C (en) | 2008-10-22 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101623251B (en) * | 2009-08-11 | 2011-06-22 | 湖北穆兰同大科技有限公司 | Gynecological antibacterial gel bionic propellant |
| CN101502510B (en) * | 2009-03-19 | 2011-11-09 | 山东京卫制药有限公司 | Medicament composition for treating colpitis symptoms and preparation method thereof |
| CN102614124A (en) * | 2012-04-12 | 2012-08-01 | 石家庄诺利达医疗器械有限公司 | Vaginal sterilizing foaming agent and preparation method thereof |
| CN105456548A (en) * | 2015-12-11 | 2016-04-06 | 郭健 | Foam disinfectant for medical use and preparation process of foam disinfectant |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1084185C (en) * | 1998-06-15 | 2002-05-08 | 贵州宏宇药业有限公司 | Liquid spray for treating oral and throat diseases and its preparing process |
| CN1099282C (en) * | 1998-06-15 | 2003-01-22 | 贵州宏宇药业有限公司 | Foaming medicine for treating gynopathy and preparing process thereof |
| CN1692730A (en) * | 2005-04-08 | 2005-11-09 | 周建国 | Liquid for skin sterilization and checking bank-notes |
| CN1742752A (en) * | 2005-10-08 | 2006-03-08 | 晏四平 | Atomizing agent containing medicinal plant oil |
-
2006
- 2006-03-10 CN CNB2006102002242A patent/CN100427079C/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101502510B (en) * | 2009-03-19 | 2011-11-09 | 山东京卫制药有限公司 | Medicament composition for treating colpitis symptoms and preparation method thereof |
| CN101623251B (en) * | 2009-08-11 | 2011-06-22 | 湖北穆兰同大科技有限公司 | Gynecological antibacterial gel bionic propellant |
| CN102614124A (en) * | 2012-04-12 | 2012-08-01 | 石家庄诺利达医疗器械有限公司 | Vaginal sterilizing foaming agent and preparation method thereof |
| CN102614124B (en) * | 2012-04-12 | 2013-08-21 | 石家庄诺利达医疗器械有限公司 | Vaginal sterilizing foaming agent and preparation method thereof |
| CN105456548A (en) * | 2015-12-11 | 2016-04-06 | 郭健 | Foam disinfectant for medical use and preparation process of foam disinfectant |
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| Publication number | Publication date |
|---|---|
| CN100427079C (en) | 2008-10-22 |
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