CN103081940B - 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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- CN103081940B CN103081940B CN201310043770.XA CN201310043770A CN103081940B CN 103081940 B CN103081940 B CN 103081940B CN 201310043770 A CN201310043770 A CN 201310043770A CN 103081940 B CN103081940 B CN 103081940B
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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
Technical field:
The present invention relates to disinfectant technical field, particularly a kind of compound recipe chlorhexidine acetate microemulsion disinfectant and preparation method thereof.
Background technology:
Chlorhexidine acetate has another name called hibitane, belong to biguanides cationic surfactant, because it has has a broad antifungal spectrum, gram positive bacteria, negative bacterium etc. are all had to more antibacterial, bactericidal action, the advantages such as local irritation and anaphylaxis are less, in clinical, be widely used, be mainly used in the sterilizations such as skin, mucosa, wound surface, apparatus.
Chlorhexidine acetate belongs to low effect disinfectants, is one of effective ingredient of many disinfectant preparations and health care compound preparation.In clinical practice, for improving its disinfection efficacy, be often prepared into various compound preparations and use.Folk prescription or the compound recipe chlorhexidine acetate dosage form developed at present mainly contain suppository, spray, solution, lotion, liniment etc., but the ubiquitous deficiency of these dosage forms is exactly: because chlorhexidine acetate self has the shortcoming that water solublity is low, chlorhexidine acetate in preparation only can be met clinical needs, and preparation can not be diluted rear use.Therefore, the low key factor that has become restriction chlorhexidine acetate formulation development and application of water solublity.
Summary of the invention:
The object of the invention is to overcome the deficiency of existing dosage form, 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 recipe chlorhexidine acetate of production technology microemulsion disinfectant and preparation method thereof.
Technical scheme of the present invention is, a kind of compound recipe chlorhexidine acetate microemulsion 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 polyoxyethylene ether castor oil hydrogenated (RH40).Described cosurfactant is any in ethanol, propylene glycol, isopropyl alcohol and PEG400 (PEG-400).Described oil phase is ethyl acetate.
A preparation method for compound recipe chlorhexidine acetate microemulsion disinfectant, is characterized in that: comprise the following steps:
(1) take respectively by weight chlorhexidine acetate, benzalkonium bromide, surfactant, cosurfactant, oil and distilled water, for subsequent use;
(2) first chlorhexidine acetate and cosurfactant are mixed, add afterwards surfactant to mix, finally add oil to mix, for subsequent use;
(3) after the benzalkonium bromide of recipe quantity is dissolved in distilled water as water, for subsequent use;
(4) under room temperature, slowly add above-mentioned water in system on one side, constantly stir on one side, until form the liquid of clear, make a kind of compound recipe chlorhexidine acetate microemulsion disinfectant of the present invention.
Benzalkonium bromide in the present invention has another name called bromo geramine, is also a kind of conventional disinfectant.Because itself and chlorhexidine acetate belong to cationic surfactant, and confirm that the two coupling has Synergistic biocidal effect, therefore there is the basis of theory and practice based on the two compatibility, disinfective action when a kind of compound recipe chlorhexidine acetate microemulsion disinfectant prepared by the present invention can significantly strengthen chlorhexidine acetate and benzalkonium bromide and uses separately.
RH40 is nonionic surfactant.In medical industry, it is often used as solubilizing agent and the emulsifying agent of some hydrophobic drugs.In the present invention, RH40 is the essential composition of preparing microemulsion formulation, and it coexists in an individual system with cationic surfactant chlorhexidine acetate and/or benzalkonium bromide, can be regarded as again the compatibility between surfactant.Not only can there is not antagonism in this compatibility, but also all can strengthen bactericidal effect of the present invention.
A kind of compound recipe chlorhexidine acetate microemulsion 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, according to the clinical distilled water adjustment that need to add arbitrary proportion, facilitate clinical use.
A kind of compound recipe chlorhexidine acetate microemulsion disinfectant prepared by the present invention is mainly applicable to skin, mucosa, wound surface, apparatus and environment disinfected.
The present invention has following beneficial effect:
(1) the invention solves the problem of chlorhexidine acetate poorly water-soluble, improved dissolubility and the medicament contg of chlorhexidine acetate in preparation.
(2) the present invention both can be used as the chlorhexidine acetate microemulsion disinfectant use of folk prescription, also can become with benzalkonium bromide compatibility compound recipe chlorhexidine acetate microemulsion disinfectant to use.And, due in the preparation of folk prescription or compound preparation, all must add nonionic surfactant, therefore strengthen respectively disinfection efficacy single, compound preparation.
(3) the present invention, taking microemulsion 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 maintain for a long time disinfection efficacy, extends disinfection time, thereby reduces sterilization number of times.
(5) chlorhexidine acetate concentration of the present invention is high, and using dosage is little, and can need to further add the distilled water of arbitrary proportion to dilute according to clinical concentration, forms the microemulsion antiseptic solution of clear, easy to use.
(6) microemulsion disinfectant of the present invention has good stability, and is easy to storage; Preparation method is simple, and low production cost is convenient to large-scale production.
Brief description of the drawings:
Fig. 1 is the transmission electron microscope photo that adopts the chlorhexidine acetate microemulsion disinfectant of the present invention that proportioning described in embodiment 1 and preparation technology prepare
Fig. 2 is the granularmetric analysis figure that adopts the chlorhexidine acetate microemulsion disinfectant of the present invention that proportioning described in embodiment 1 and preparation technology prepare
Detailed description of the invention:
Following examples are mainly used for further illustrating the present invention:
(1) take respectively chlorhexidine acetate 11.0 g, benzalkonium bromide 11.0 g, polyoxyethylene ether castor oil hydrogenated (RH40) 18.5 g, ethanol 12.5 g, ethyl acetate 3.4 g and distilled water 43.6 g, for subsequent use;
(2) mix with RH40 again after the chlorhexidine acetate of recipe quantity and ethanol are mixed, add afterwards ethyl acetate to mix, for subsequent use;
(3) after the benzalkonium bromide of recipe quantity is dissolved in distilled water as water, for subsequent use;
(4) under room temperature, slowly add above-mentioned water in system on one side, constantly stir on one side, until form the liquid of clear, make the compound recipe chlorhexidine acetate microemulsion disinfectant of particle diameter at 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, polyoxyethylene ether castor oil hydrogenated (RH40) 25 g, propylene glycol 8.3 g, ethyl acetate 2.7 g and distilled water 64.0 g, for subsequent use;
(2) mix with polyoxyethylene ether castor oil hydrogenated (RH40) again after the chlorhexidine acetate of recipe quantity and propylene glycol are mixed, add afterwards ethyl acetate to mix, for subsequent use;
(3) after the benzalkonium bromide of recipe quantity is dissolved in distilled water as water, for subsequent use;
(4) under room temperature, slowly add above-mentioned water in system on one side, constantly stir on one side, until form the liquid of clear, make the compound recipe chlorhexidine acetate microemulsion disinfectant of particle diameter at 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, polyoxyethylene ether castor oil hydrogenated (RH40) 30.2 g, isopropyl alcohol 18.6 g, ethyl acetate 5.0 g and distilled water 36.6 g, for subsequent use;
(2) mix with polyoxyethylene ether castor oil hydrogenated (RH40) again after the chlorhexidine acetate of recipe quantity and isopropyl alcohol are mixed, add afterwards ethyl acetate to mix, for subsequent use;
(3) after the benzalkonium bromide of recipe quantity is dissolved in distilled water as water, for subsequent use;
(4) under room temperature, slowly add above-mentioned water in system on one side, constantly stir on one side, until form the liquid of clear, make the compound recipe chlorhexidine acetate microemulsion disinfectant of particle diameter at 10～100 nm, the clear and bright homogeneous of outward appearance.
embodiment 4
(1) take respectively chlorhexidine acetate 3.8 g, polyoxyethylene ether castor oil hydrogenated (RH40) 23.2 g, ethanol 7.7 g, ethyl acetate 3.5 g, distilled water 61.8 g, for subsequent use;
(2) mix with polyoxyethylene ether castor oil hydrogenated (RH40) again after the chlorhexidine acetate of recipe quantity and ethanol are mixed, add afterwards ethyl acetate to mix, for subsequent use;
(3) using the distilled water of recipe quantity as water, for subsequent use;
(4) under room temperature, slowly add above-mentioned water in system on one side, constantly stir on one side, until form the liquid of clear, make the compound recipe chlorhexidine acetate microemulsion disinfectant of particle diameter at 10～100 nm, the clear and bright homogeneous of outward appearance.
(1) take respectively chlorhexidine acetate 3.5 g, polyoxyethylene ether castor oil hydrogenated (RH40) 20.0 g, PEG400 (PEG-400) 13.5 g, ethyl acetate 3.7 g and distilled water 59.3 g, for subsequent use;
(2) mix with polyoxyethylene ether castor oil hydrogenated (RH40) again after the chlorhexidine acetate of recipe quantity and PEG400 are mixed, add afterwards ethyl acetate to mix, for subsequent use;
(3) using the distilled water of recipe quantity as water, for subsequent use;
(4) under room temperature, slowly add above-mentioned water in system on one side, constantly stir on one side, until form the liquid of clear, make the compound recipe chlorhexidine acetate microemulsion disinfectant of particle diameter at 10～100 nm, the clear and bright homogeneous of outward appearance.
embodiment 6
(1) take respectively chlorhexidine acetate 4.5 g, polyoxyethylene ether castor oil hydrogenated (RH40) 25.5 g, ethyl acetate 2.8 g and distilled water 67.2 g, for subsequent use;
(2) chlorhexidine acetate of recipe quantity and polyoxyethylene ether castor oil hydrogenated (RH40) are mixed, add afterwards ethyl acetate to mix, for subsequent use;
(3) using the distilled water of recipe quantity as water, for subsequent use;
(4) under room temperature, slowly add above-mentioned water in system on one side, constantly stir on one side, until form the liquid of clear, make the compound recipe chlorhexidine acetate microemulsion disinfectant of particle diameter at 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, polyoxyethylene ether castor oil hydrogenated (RH40) 24.5 g, ethyl acetate 2.5 g and distilled water 67.2 g, for subsequent use;
(2) chlorhexidine acetate of recipe quantity and polyoxyethylene ether castor oil hydrogenated (RH40) are mixed, add afterwards ethyl acetate to mix, for subsequent use;
(3) after the benzalkonium bromide of recipe quantity is dissolved in distilled water as water, for subsequent use;
(4) under room temperature, slowly add above-mentioned water in system on one side, constantly stir on one side, until form the liquid of clear, make the compound recipe chlorhexidine acetate microemulsion disinfectant of particle diameter at 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 be verified.
the qualification of test example 1 microemulsion and structure type thereof
Adopt whether the standby disinfectant of centrifuging (15 000 r/min, 15 min) system of identification is microemulsion formulation.There is not lamination in this disinfectant of result, illustrate that disinfectant of the present invention is microemulsion formulation after centrifugal.
Adopt the structure type of dilution method qualification microemulsion.Result microemulsion disinfectant of the present invention can be distilled water infinite dilution, shows that its structure type is oil-in-water type (O/W).
test example 2 stability tests
(1) set up ultraviolet spectrophotometer analytical method of the present invention
First, utilize ultraviolet spectrophotometer to carry out ultraviolet absorpting spectrum scanning, the maximum absorption wavelength of result chlorhexidine acetate and compound recipe chlorhexidine acetate microemulsion disinfectant is 252 nm, and the wavelength of determining chlorhexidine acetate mensuration taking this is as 252 nm.Then, accurate compound concentration is respectively the chlorhexidine acetate standard solution of 2.5,5.0,10.0,15.0,17.5 μ g/mL, measures each absorbance at 252 nm places.Finally, with concentration of standard solution (X), absorbance (Y) is carried out to linear regression, the standard curve equation of trying to achieve chlorhexidine acetate in mensuration microemulsion 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 provide method of quality control for its application in clinical.
(2) stability test
Utilize accelerated test.The present invention is placed in 37 DEG C of calorstats and is preserved after 90 d, measure respectively and place forward and backward effective ingredient chlorhexidine acetate with the ultraviolet spectrophotometer method of setting up, calculate its rate of descent.Chlorhexidine acetate rate of descent in result the present invention is 2.67%, shows to have good stability.
test example 3 carrier quantitative germicidal test
Depletion Staphylococcus aureus (ATCC6538), escherichia coli (8099) and Candida albicans (ATCC10231) 24 h fresh cultured things are mixed with test organisms suspension by phosphate buffered solution, then get the 10 μ L bacteria suspensions sheet of dying cloth, make bacterium sheet after dry.When test, by every 5 mL consumptions, different diluent of the present invention is added in aseptic plate, then bacterium sheet is immersed in disinfectant solution completely, positive control is phosphate buffered solution, acts on to the stipulated time, and bacterium sheet is moved into and filled in the test tube of 5 mL nertralizers.Neutralization 10 min, beat test tube with remaining viable bacteria on eluting bacterium sheet and mix.Get eluent 0.5 mL and make count plate, calculate average kill ratio.
The killing effect of table 1 compound recipe chlorhexidine acetate microemulsion disinfectant to various bacterial strains
Result of the test (in table 1) shows, the microemulsion disinfectant that chlorhexidine acetate is 0.10% is to staphylococcus aureus, escherichia coli effect 3 min, and 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% microemulsion disinfectant to staphylococcus aureus, escherichia coli effect 3 min, and average kill ratio has all reached 100%, and Candida albicans average kill ratio is greater than to 99.90%; Act on 5 min, the average kill ratio of three kinds of bacterium has all been reached to 100%.Presentation of results, disinfective action of the present invention is stronger.
test 4 on-the-spot hands sterilizing tests
Experimenter right-hand man, mutually fully to after rubbing with the hands, uses the cotton swab that has infiltrated blank sample to its left hand sampling.After sampling, in sterile working's mode, cotton is wiped to sampling end and cut into l0 mL sample solution in vitro, through fully shaking eluting, get 0.5 mL eluent and pour into inoculated and cultured, sample as a control group.With being 0.02% disinfectant diluent 5.0 mL of the present invention containing chlorhexidine acetate and benzalkonium bromide, by abundant rubbing both hands 2 min of 6 footwork, replace diluent with nertralizer, sampling should be carried out to the residual natural bacteria of experimenter's right hand for the method same with positive controls, as test group sample, carry out viable bacteria and cultivate counting, calculate natural bacteria average kill ratio.And keep not contacting article 2 h, 4 h, 6 h in sterilization defensive position, sample as stated above and calculate average kill ratio.Result shows, with these compound recipe microemulsion disinfectant diluent sterilization both hands 2 min, natural bacteria average kill ratio is reached more than 99.9%; Maintain and do not contact under 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 (1)
1. a compound recipe chlorhexidine acetate microemulsion 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 polyoxyethylene ether castor oil hydrogenated; Described cosurfactant is any in ethanol, propylene glycol, isopropyl alcohol and PEG400; Described oil phase is ethyl acetate, and the microemulsion disinfectant of preparing is oil-in-water type, and particle diameter is between 10～100 nm.
2
.the preparation method of a kind of compound recipe chlorhexidine acetate microemulsion disinfectant as claimed in claim 1, is characterized in that: comprise the following steps:
(1) take respectively by weight chlorhexidine acetate, benzalkonium bromide, surfactant, cosurfactant, oil and distilled water, for subsequent use;
(2) first chlorhexidine acetate and cosurfactant are mixed, add afterwards surfactant to mix, finally add oil to mix, for subsequent use;
(3) after the benzalkonium bromide of recipe quantity is dissolved in distilled water as water, for subsequent use;
(4) under room temperature, slowly add above-mentioned water in system on one side, constantly stir on one side, until form the liquid of clear, make described compound recipe chlorhexidine acetate microemulsion disinfectant.
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| CN104606085B (en) * | 2013-11-22 | 2018-04-27 | 中国人民解放军第三军医大学 | A kind of chlorhexidine acetate nano-emulsion gargle of antibacterial and preparation method thereof |
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| 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 |
| 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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| US5985931A (en) * | 1995-11-13 | 1999-11-16 | The Trustees Of Columbia University In The City Of New York | Triple antimicrobial composition |
| CN1565635A (en) * | 2003-06-21 | 2005-01-19 | 李君� | Chemical disinfectant with broad spectrum sterilization |
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