CN103081940A - Compound chlorhexidine acetate microemulsion disinfectant and its preparation method - Google Patents
Compound chlorhexidine acetate microemulsion disinfectant and its preparation method Download PDFInfo
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- CN103081940A CN103081940A CN201310043770XA CN201310043770A CN103081940A CN 103081940 A CN103081940 A CN 103081940A CN 201310043770X A CN201310043770X A CN 201310043770XA CN 201310043770 A CN201310043770 A CN 201310043770A CN 103081940 A CN103081940 A CN 103081940A
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Abstract
The invention relates to a disinfectant, and aims to provide a compound chlorhexidine acetate microemulsion disinfectant having the advantages of good water solubility, strong disinfection effect, long disinfection effect maintenance time and good stability, and its preparation method. The compound chlorhexidine acetate microemulsion disinfectant is prepared through using the following raw materials, by weight, 0.02-11.0 parts of chlorhexidine acetate, 0-11.0 parts of benzalkonium bromide, 18.5-30.2 parts of a surfactant, 0-18.6 parts of a cosurfactant, 2.7-5.0 parts of oil and 36.6-67.2 parts of distilled water. The compound chlorhexidine acetate microemulsion disinfectant has the advantages of high chlorhexidine acetate content, use convenience, simple production technology, low production cost, and convenience for the scale production.
Description
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Technical field:
The present invention relates to the disinfectant technical field, particularly a kind of compound chlorhexidine acetate micro emulsion disinfectant and preparation method thereof.
Background technology:
Chlorhexidine acetate has another name called chlorohexidene, belong to the biguanides cationic surfactant, because it has has a broad antifungal spectrum, gram-positive bacteria, negative bacterium etc. all there is more antibiotic, bactericidal action, the advantages such as local irritation and allergy are less, be widely used in clinical, be mainly used in the sterilizations such as skin, mucous membrane, the surface of a wound, apparatus.
Chlorhexidine acetate belongs to low effect disinfectants, is one of active ingredient of many disinfectant preparations and health care compound preparation.For improving its disinfection efficacy, often be prepared into various compound preparations and use in clinical practice.Folk prescription or the compound chlorhexidine acetate formulation developed at present mainly contain suppository, spray, solution, lotion, plastics etc., but the ubiquitous deficiency of these formulations is exactly: because chlorhexidine acetate self has water-soluble low shortcoming, chlorhexidine acetate in preparation only can be met clinical needs, and preparation can not be diluted rear use.Therefore, the water-soluble low key factor that has become restriction chlorhexidine acetate formulation development and application.
Summary of the invention:
The objective of the invention is to overcome the deficiency of existing formulation, a kind of good water solubility is provided, disinfective action is strong, and the disinfective action length of holding time has good stability, the simple compound chlorhexidine acetate of production technology micro emulsion disinfectant and preparation method thereof.
Technical scheme of the present invention is, a kind of compound chlorhexidine acetate micro emulsion disinfectant, it is characterized in that: the raw material by following weight portion is prepared from: chlorhexidine acetate 0.02～11.0 weight portion, benzalkonium bromide 0～11.0 weight portion, surfactant 18.5～30.2 weight portions, cosurfactant 0～18.6 weight portion, oil 2.7～5.0 weight portions, distilled water 36.6～67.2 weight portions.Described surfactant is APEO rilanit special (RH40).Described cosurfactant is any in ethanol, propane diols, isopropyl alcohol and PEG400 (PEG-400).Described oil phase is ethyl acetate.
A kind of preparation method of compound chlorhexidine acetate micro emulsion disinfectant is characterized in that: comprise the following steps:
(1) take respectively by weight chlorhexidine acetate, benzalkonium bromide, surfactant, cosurfactant, oil and distilled water, standby;
(2) first with chlorhexidine acetate and cosurfactant mixing, add afterwards the surfactant mixing, add at last oily mixing, standby;
(3) benzalkonium bromide of recipe quantity is dissolved in after distilled water as water, standby;
(4) under room temperature, Yi Bian slowly add above-mentioned water in system, Yi Bian constantly stir, until form the liquid of clear, namely make a kind of compound chlorhexidine acetate micro emulsion disinfectant of the present invention.
Benzalkonium bromide in the present invention has another name called bromogeramine, is also a kind of disinfectant commonly used.Because itself and chlorhexidine acetate belong to cationic surfactant, and confirmed that both couplings have the Synergistic biocidal effect, therefore has the basis of theory and practice based on compatibilities both, the disinfective action that a kind of compound chlorhexidine acetate micro emulsion disinfectant of the present invention's preparation can significantly strengthen chlorhexidine acetate and benzalkonium bromide when using separately.
RH40 is nonionic surface active agent.In medical industry, it is often used as solubilizer and the emulsifier of some hydrophobic drugs.In the present invention, RH40 is the essential composition of preparation microemulsion formulation, in its individual system that coexists with cationic surfactant chlorhexidine acetate and/or benzalkonium bromide, can be regarded as again the compatibility between surfactant.Not only can there be antagonism in this compatibility, but also all can strengthen bactericidal effect of the present invention.
A kind of compound chlorhexidine acetate micro emulsion disinfectant that the present invention prepares is oil-in-water type (O/W), and particle diameter is between 10～100 nm, and its concentration can add according to clinical needs the distilled water adjustment of arbitrary proportion, convenient clinical use.
A kind of compound chlorhexidine acetate micro emulsion disinfectant of the present invention's preparation mainly is applicable to skin, mucous membrane, the surface of a wound, apparatus and environment disinfected.
The present invention has following beneficial effect:
(1) the invention solves the problem of chlorhexidine acetate poorly water-soluble, improved solvability and the medicament contg of chlorhexidine acetate in preparation.
(2) the present invention both can be used as the chlorhexidine acetate micro emulsion disinfectant use of folk prescription, also can become with the benzalkonium bromide compatibility compound chlorhexidine acetate micro emulsion disinfectant to use.And, due in the preparation of folk prescription or compound preparation, all must add nonionic surface active agent, therefore strengthened respectively disinfection efficacy single, compound preparation.
(3) the present invention take micro emulsion as pharmaceutical carrier, is embedded in chlorhexidine acetate in carrier, has both protected chlorhexidine acetate, has improved again the stability of disinfectant.
(4) the present invention has sustained release performance, can keep for a long time disinfection efficacy, extends disinfection time, thereby reduces the sterilization number of times.
(5) chlorhexidine acetate concentration of the present invention is high, and using dosage is little, and can further add the distilled water of arbitrary proportion to dilute according to the clinical concentration needs, forms the micro emulsion antiseptic solution of clear, and is easy to use.
(6) micro emulsion disinfectant of the present invention has good stability, and is easy to store; The preparation method is simple, and low production cost is convenient to large-scale production.
Description of drawings:
Fig. 1 is the transmission electron microscope photo that adopts the chlorhexidine acetate micro emulsion disinfectant of the present invention that the described proportioning of embodiment 1 and preparation technology prepare
Fig. 2 is the granularmetric analysis figure that adopts the chlorhexidine acetate micro emulsion disinfectant of the present invention that the described proportioning of embodiment 1 and preparation technology prepare
Embodiment:
Following examples are mainly be used to further illustrating the present invention:
(1) take respectively chlorhexidine acetate 11.0 g, benzalkonium bromide 11.0 g, APEO rilanit special (RH40) 18.5 g, ethanol 12.5 g, ethyl acetate 3.4 g and distilled water 43.6 g, standby;
(2) with after the chlorhexidine acetate of recipe quantity and ethanol mixing again with the RH40 mixing, add afterwards the ethyl acetate mixing, standby;
(3) benzalkonium bromide of recipe quantity is dissolved in after distilled water as water, standby;
(4) under room temperature, Yi Bian slowly add above-mentioned water in system, Yi Bian constantly stir, until form the liquid of clear, namely make particle diameter at the compound chlorhexidine acetate micro emulsion disinfectant of 10～100 nm, the clear and bright homogeneous of outward appearance.
Embodiment 2
(1) take respectively chlorhexidine acetate 0.02 g, benzalkonium bromide 0.02 g, APEO rilanit special (RH40) 25 g, propane diols 8.3 g, ethyl acetate 2.7 g and distilled water 64.0 g, standby;
(2) with after the chlorhexidine acetate of recipe quantity and propane diols mixing again with APEO rilanit special (RH40) mixing, add afterwards the ethyl acetate mixing, standby;
(3) benzalkonium bromide of recipe quantity is dissolved in after distilled water as water, standby;
(4) under room temperature, Yi Bian slowly add above-mentioned water in system, Yi Bian constantly stir, until form the liquid of clear, namely make particle diameter at the compound chlorhexidine acetate micro emulsion disinfectant of 10～100 nm, the clear and bright homogeneous of outward appearance.
Embodiment 3
(1) take respectively chlorhexidine acetate 6 g, benzalkonium bromide 3.6 g, APEO rilanit special (RH40) 30.2 g, isopropyl alcohol 18.6 g, ethyl acetate 5.0 g and distilled water 36.6 g, standby;
(2) with after the chlorhexidine acetate of recipe quantity and isopropyl alcohol mixing again with APEO rilanit special (RH40) mixing, add afterwards the ethyl acetate mixing, standby;
(3) benzalkonium bromide of recipe quantity is dissolved in after distilled water as water, standby;
(4) under room temperature, Yi Bian slowly add above-mentioned water in system, Yi Bian constantly stir, until form the liquid of clear, namely make particle diameter at the compound chlorhexidine acetate micro emulsion disinfectant of 10～100 nm, the clear and bright homogeneous of outward appearance.
Embodiment 4
(1) take respectively chlorhexidine acetate 3.8 g, APEO rilanit special (RH40) 23.2 g, ethanol 7.7 g, ethyl acetate 3.5 g, distilled water 61.8 g, standby;
(2) with after the chlorhexidine acetate of recipe quantity and ethanol mixing again with APEO rilanit special (RH40) mixing, add afterwards the ethyl acetate mixing, standby;
(3) with the distilled water of recipe quantity as water, standby;
(4) under room temperature, Yi Bian slowly add above-mentioned water in system, Yi Bian constantly stir, until form the liquid of clear, namely make particle diameter at the compound chlorhexidine acetate micro emulsion disinfectant of 10～100 nm, the clear and bright homogeneous of outward appearance.
(1) take respectively chlorhexidine acetate 3.5 g, APEO rilanit special (RH40) 20.0 g, PEG400 (PEG-400) 13.5 g, ethyl acetate 3.7 g and distilled water 59.3 g, standby;
(2) with after the chlorhexidine acetate of recipe quantity and PEG400 mixing again with APEO rilanit special (RH40) mixing, add afterwards the ethyl acetate mixing, standby;
(3) with the distilled water of recipe quantity as water, standby;
(4) under room temperature, Yi Bian slowly add above-mentioned water in system, Yi Bian constantly stir, until form the liquid of clear, namely make particle diameter at the compound chlorhexidine acetate micro emulsion disinfectant of 10～100 nm, the clear and bright homogeneous of outward appearance.
Embodiment 6
(1) take respectively chlorhexidine acetate 4.5 g, APEO rilanit special (RH40) 25.5 g, ethyl acetate 2.8 g and distilled water 67.2 g, standby;
(2) with chlorhexidine acetate and APEO rilanit special (RH40) mixing of recipe quantity, add afterwards the ethyl acetate mixing, standby;
(3) with the distilled water of recipe quantity as water, standby;
(4) under room temperature, Yi Bian slowly add above-mentioned water in system, Yi Bian constantly stir, until form the liquid of clear, namely make particle diameter at the compound chlorhexidine acetate micro emulsion disinfectant of 10～100 nm, the clear and bright homogeneous of outward appearance.
Embodiment 7
(1) take respectively chlorhexidine acetate 4.0 g, benzalkonium bromide 2.0 g, APEO rilanit special (RH40) 24.5 g, ethyl acetate 2.5 g and distilled water 67.2 g, standby;
(2) with chlorhexidine acetate and APEO rilanit special (RH40) mixing of recipe quantity, add afterwards the ethyl acetate mixing, standby;
(3) benzalkonium bromide of recipe quantity is dissolved in after distilled water as water, standby;
(4) under room temperature, Yi Bian slowly add above-mentioned water in system, Yi Bian constantly stir, until form the liquid of clear, namely make particle diameter at the compound chlorhexidine acetate micro emulsion disinfectant of 10～100 nm, the clear and bright homogeneous of outward appearance.
For further illustrating concrete result of use of the present invention, below adopt experimental data to come proved.
The evaluation of test example 1 micro emulsion and structure type thereof
Adopt whether the standby disinfectant of centrifugal process (15 000 r/min, 15 min) system of identification is microemulsion formulation.This disinfectant lamination do not occur after centrifugal as a result, illustrates that disinfectant of the present invention is microemulsion formulation.
Adopt dilution method to identify the structure type of micro emulsion.Result micro emulsion disinfectant of the present invention can be distilled the water infinite dilution, shows that its structure type is oil-in-water type (O/W).
Test example 2 stability tests
(1) set up ultraviolet specrophotometer analytical method of the present invention
At first, utilize ultraviolet specrophotometer to carry out ultraviolet absorpting spectrum scanning, the maximum absorption wavelength of chlorhexidine acetate and compound chlorhexidine acetate micro emulsion disinfectant is 252 nm as a result, take this wavelength of determining chlorhexidine acetate mensuration as 252 nm.Then, accurate compound concentration is respectively the chlorhexidine acetate standard liquid of 2.5,5.0,10.0,15.0,17.5 μ g/mL, measures each absorbance at 252 nm places.At last, with concentration of standard solution (X), absorbance (Y) is carried out linear regression, the calibration curve equation of trying to achieve chlorhexidine acetate in mensuration micro emulsion disinfectant of the present invention is: Y=0.0479X+0.0305(r=0.9992).Result shows, chlorhexidine acetate is good in 2.5～17.5 μ g/mL concentration range internal linear relations.Set up stability test analytical method of the present invention, and the application in clinical provides method of quality control for it.
(2) stability test
Utilize accelerated test.With the present invention be placed in 37 ℃ of insulating boxs preserve 90 d after, measure respectively the forward and backward active ingredient chlorhexidine acetate of placement with the ultraviolet spectrophotometer method of setting up, calculate its rate of descent.Chlorhexidine acetate rate of descent in the present invention is 2.67% as a result, shows to have good stability.
Test example 3 carrier quantitative germicidal test
Get staphylococcus aureus (ATCC6538), Escherichia coli (8099) and Candida albicans (ATCC10231) 24 h fresh cultured things and be mixed with the test organisms suspension with phosphate buffered solution, then get the 10 μ L bacteria suspensions sheet of dying cloth, make the bacterium sheet after drying.During test, by every 5 mL consumptions, different diluent of the present invention is added in aseptic plate, then the bacterium sheet is immersed in thimerosal fully, positive control is phosphate buffered solution, acts on to the stipulated time, the bacterium sheet is moved into fill in the test tube of 5 mL neutralizers.Neutralization 10 min beat test tube with remaining viable bacteria and mixing on wash-out bacterium sheet.Get eluent 0.5 mL and make count plate, calculate average kill ratio.
The killing effect of table 1 compound chlorhexidine acetate micro emulsion disinfectant to various bacterial strains
Result of the test (seeing Table 1) shows, chlorhexidine acetate be 0.10% micro emulsion disinfectant to staphylococcus aureus, Escherichia coli effect 3 min, to Candida albicans effect 5 min, average kill ratio is all greater than 99.90%; To staphylococcus aureus, Escherichia coli effect 5 min, average kill ratio all can reach 100%.Chlorhexidine acetate and benzalkonium bromide content are 0.10% micro emulsion disinfectant to staphylococcus aureus, Escherichia coli effect 3 min, and average kill ratio has all reached 100%, to the Candida albicans average kill ratio greater than 99.90%; Act on 5 min, the average kill ratios of three kinds of bacterium has all been reached 100%.Presentation of results, disinfective action of the present invention is stronger.
Test 4 on-the-spot hand sterilizing tests
Experimenter right-hand man fully to after rubbing with the hands, samples to its left hand with the cotton swab that has infiltrated blank sample mutually.After sampling, in the sterile working mode, cotton is wiped away sampling end and cut into l0 mL sample solution in vitro, through fully shaking wash-out, get 0.5 mL eluent and pour into inoculated and cultured, as a control group sample.Be 0.02% disinfectant dilution 5.0 mL of the present invention with containing chlorhexidine acetate and benzalkonium bromide, by 6 abundant rubbing both hands 2 min of footwork, replace dilution with neutralizer, the natural bacteria once sampling residual to experimenter's right hand with the same method of positive controls, as the experimental group sample, carry out viable bacteria and cultivate counting, calculate the natural bacteria average kill ratio.And keep not contacting article 2 h, 4 h, 6 h in the sterilization defensive position, sample as stated above and calculate average kill ratio.Result shows, with these compound micro emulsion disinfectant dilution sterilization both hands 2 min, the natural bacteria average kill ratio is reached more than 99.9%; Keep not contacting under the article condition at 2～4 h, still can keep 99.9% above killing rate; Be maintained to 6 h, bacterial population gos up to some extent, but still can keep average kill ratio 97.5%.
Claims (6)
1. compound chlorhexidine acetate micro emulsion disinfectant, it is characterized in that: the raw material by following weight portion is prepared from: chlorhexidine acetate 0.02～11.0 weight portion, benzalkonium bromide 0～11.0 weight portion, surfactant 18.5～30.2 weight portions, cosurfactant 0～18.6 weight portion, oil 2.7～5.0 weight portions, distilled water 36.6～67.2 weight portions.
2. compound chlorhexidine acetate micro emulsion disinfectant as claimed in claim 1, it is characterized in that: described surfactant is the APEO rilanit special.
3. compound chlorhexidine acetate micro emulsion disinfectant as claimed in claim 1, it is characterized in that: described cosurfactant is any in ethanol, propane diols, isopropyl alcohol and PEG400.
4. compound chlorhexidine acetate micro emulsion disinfectant as claimed in claim 1, it is characterized in that: described oil phase is ethyl acetate.
5. the preparation method of a compound chlorhexidine acetate micro emulsion disinfectant is characterized in that: comprise the following steps:
(1) take respectively by weight chlorhexidine acetate, benzalkonium bromide, surfactant, cosurfactant, oil and distilled water, standby;
(2) first with chlorhexidine acetate and cosurfactant mixing, add afterwards the surfactant mixing, add at last oily mixing, standby;
(3) benzalkonium bromide of recipe quantity is dissolved in after distilled water as water, standby;
(4) under room temperature, Yi Bian slowly add above-mentioned water in system, Yi Bian constantly stir, until form the liquid of clear, namely make compound chlorhexidine acetate micro emulsion disinfectant of the present invention.
6. the preparation method of a kind of compound chlorhexidine acetate micro emulsion disinfectant as claimed in claim 5, it is characterized in that: the micro emulsion disinfectant of preparing is oil-in-water type, and particle diameter is between 10～100 nm.
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Cited By (8)
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| CN104606085A (en) * | 2013-11-22 | 2015-05-13 | 中国人民解放军第三军医大学 | Novel efficient antimicrobial chlorhexidine acetate nanoemulsion gargle and preparation method thereof |
| CN105767049A (en) * | 2016-04-11 | 2016-07-20 | 马鞍山中粮生物化学有限公司 | Disinfectant liquid for animals |
| CN105954397A (en) * | 2016-04-25 | 2016-09-21 | 广西壮族自治区梧州食品药品检验所 | Method for simultaneously measuring contents of multiple skin disinfectants in wet tissue |
| CN107691475A (en) * | 2017-11-21 | 2018-02-16 | 安徽省伟业净化设备有限公司 | A kind of preparation method of operating room wall body thimerosal |
| CN108969534A (en) * | 2017-09-26 | 2018-12-11 | 上海利康消毒高科技有限公司 | The preparation of chlorhexidine iodine complexing nano object |
| CN109221117A (en) * | 2018-09-19 | 2019-01-18 | 青岛安特斯生物制药有限公司 | A kind of pet deodorization bacteria-removing liquid and its preparation and application |
| CN110169953A (en) * | 2019-06-06 | 2019-08-27 | 杭州氢源素生物科技有限公司 | A kind of disposable disinfectant of micro-emulsion type and preparation method thereof |
| CN115606601A (en) * | 2022-10-31 | 2023-01-17 | 成都新朝阳作物科学股份有限公司 | Pesticide composition, pesticide fertilizer, and preparation method and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104606085A (en) * | 2013-11-22 | 2015-05-13 | 中国人民解放军第三军医大学 | Novel efficient antimicrobial chlorhexidine acetate nanoemulsion gargle and preparation method thereof |
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| CN105954397A (en) * | 2016-04-25 | 2016-09-21 | 广西壮族自治区梧州食品药品检验所 | Method for simultaneously measuring contents of multiple skin disinfectants in wet tissue |
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| CN109221117A (en) * | 2018-09-19 | 2019-01-18 | 青岛安特斯生物制药有限公司 | A kind of pet deodorization bacteria-removing liquid and its preparation and application |
| CN110169953A (en) * | 2019-06-06 | 2019-08-27 | 杭州氢源素生物科技有限公司 | A kind of disposable disinfectant of micro-emulsion type and preparation method thereof |
| CN115606601A (en) * | 2022-10-31 | 2023-01-17 | 成都新朝阳作物科学股份有限公司 | Pesticide composition, pesticide fertilizer, and preparation method and application thereof |
| CN115606601B (en) * | 2022-10-31 | 2023-12-08 | 成都新朝阳作物科学股份有限公司 | Pesticide composition, pesticide fertilizer, and preparation method and application thereof |
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