CN107595827A - 2% chlorhexidine gluconate alcohol thimerosal and preparation method thereof - Google Patents
2% chlorhexidine gluconate alcohol thimerosal and preparation method thereof Download PDFInfo
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- CN107595827A CN107595827A CN201710909513.8A CN201710909513A CN107595827A CN 107595827 A CN107595827 A CN 107595827A CN 201710909513 A CN201710909513 A CN 201710909513A CN 107595827 A CN107595827 A CN 107595827A
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- chlorhexidine gluconate
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Abstract
The present invention relates to a kind of 2% chlorhexidine gluconate alcohol thimerosal and preparation method thereof, belong to skin antiseptic technical field.2% chlorhexidine gluconate alcohol thimerosal of the present invention, is made up of the component of following weight percentage：Ethanol 60% 70%, chlorhexidine gluconate 1.8% 2.2%, moisturizing bleeding agent 0.2% 0.6%, NMF 1.0% 2.0% assign ester agent 0.1% 0.4%, consolidant 0.02% 0.04%, and colouring agent 0.002% 0.008%, surplus is deionized water.2% chlorhexidine gluconate alcohol thimerosal of the present invention, its work fast, anti-interference, antibacterial length, need not de- iodine, color depth, activity high；Invention also provides simple and easy preparation method.
Description
Technical field
The present invention relates to a kind of 2% chlorhexidine gluconate alcohol thimerosal and preparation method thereof, belong to skin antiseptic skill
Art field.
Background technology
In skin antiseptic, the application of Operand has long history, is welcome by numerous medical workers, but due to
Its action time brought is compared with the shortcomings of slow, drying time is slow, fungistatic effect is poor, easy distillation is not easy to maintain, dyeing floor
The use of medical worker is had a strong impact on.
On November 3rd, 2016, WHO was formally issued on its site《Prevent the global guide prevention of surgical site infection》,
It is strongly recommended that alcoholic chlorhexidine gluconate is used during operative site Skin sensitization test.
《Intravenous therapy nursing technical operation specification》Recommend：It is particularly suitable for the special operationals such as blood sampling, remaining needle, venous cannula
Sterilization and catheter-nursing.
In the prior art, it has been disclosed that the patent of some chlorhexidine gluconate thimerosals, but it is mainly used in hand
Sterilization and general skin degerming.And skin penetrating and otch need to sterilize position dyeing the antibacterial time, it is necessary to longer, for skin
Skin punctures and the thimerosal of cutting part is seldom, and can not meet above-mentioned requirements.
The content of the invention
It is an object of the invention to provide a kind of 2% chlorhexidine gluconate alcohol thimerosal, its work fast, it is anti-interference,
Antibacterial length, iodine need not be taken off, color depth, activity height；Invention also provides simple and easy preparation method.
2% chlorhexidine gluconate alcohol thimerosal of the present invention, is made up of the component of following weight percentage：Second
Alcohol 60%-70%, chlorhexidine gluconate 1.8%-2.2%, moisturizing bleeding agent 0.2%-0.6%, NMF 1.0%-
2.0%, assign ester agent 0.1%-0.4%, consolidant 0.02%-0.04%, colouring agent 0.002%-0.008%, surplus for go from
Sub- water.
Preferably, it is made up of the component of following weight percentage：Ethanol 65%-70%, chlorhexidine gluconate
1.9%-2.1%, moisturizing bleeding agent 0.4%-0.6%, NMF 1.5%-2.0%, assign ester agent 0.1%-0.2%, consolidant
0.02%-0.03%, colouring agent 0.002%-0.006%, surplus are deionized water.
It is further preferred that it is made up of the component of following weight percentage：Ethanol 65%, chlorhexidine gluconate
2.0%, moisturizing bleeding agent 0.4%, NMF 1.5%, assign ester agent 0.2%, consolidant 0.02%, colouring agent 0.004%, surplus
For deionized water.
The ethanol is selected from superfine food grade alcohol or top grade food grade alcohol.
The chlorhexidine gluconate is pharmaceutical grade, and wherein tetrachlorobenzene ammonia content control is within 10ppm.As mainly killing
Microbial inoculum, except consideration meets the requirement of Chinese Pharmacopoeia, because chlorhexidine gluconate content is higher, so should more consider its purity,
So it should focus on to consider the influence of wherein tetrachloro phenylamino impurity, the strict content for controlling tetrachloro phenylamino impurity.
The moisturizing bleeding agent is polyglycereol, diisopropyl adipate, diisobutyl adipate, hexyl laurate or meat
The one or two of isopropyl myristate.After ethanol volatilization, described moisturizing bleeding agent will not only reduce bacteriostatic agent glucose
The activity of sour chlorohexidene, its permeability, enhancing activity can be improved on the contrary.
The NMF is the one or two of glycerine or hexylene glycol.
The tax ester agent is one or both of hyaluronic acid or PEG-7 glyceryl cocoates.
The consolidant is allantoin or saualane.
The colouring agent is food grade colorant, is the one or two of lemon yellow, sunset yellow or haematochrome.
The preparation method of 2% described chlorhexidine gluconate alcohol thimerosal, comprises the following steps：
(1) ethanol is added in reactor, opens stirring；
(2) chlorhexidine gluconate, moisturizing bleeding agent, NMF are sequentially added into reactor and assigns ester agent, after stirring
Stand, obtain mixed liquor A；
(3) deionized water of 80-120 times of consolidant quality is added into another reactor, is heated to 70-90 DEG C, is added
Consolidant, the deionized water for adding 120-150 times of consolidant quality are stirred 5-10 minutes again, stirring, obtain mixed liquid B；
(4) deionized water of 80-100 times of colouring agent quality is added into container, colouring agent is added, mixing, obtains mixed liquor
C；
(5) mixed liquid B, mixed liquor C are sequentially added in mixed liquor A；
(6) stir 15-30 minutes, that is, 2% described chlorhexidine gluconate alcohol thimerosal is made.
In above-mentioned steps, deionized water is added in batches, is on the one hand to dissolve consolidant, is on the other hand in order to cold
But the volatile quantity of ethanol is reduced afterwards.
As main material, alcohol mainly has industrial alcohol, reagent alcohol, ethyl alcoh(ol), medicinal alcohol and food alcohol etc.
Species, while food alcohol has a common, top grade and point of superfine, the impurity content such as the purity and methanol of these alcohol, aldehydes
Difference, influenceed for caused by skin and environment also different.In alcohol preparation product in the market on impurity content
Have it is different degrees of exceeded, though using upper without too big difference, it is long-term use of to produce larger difference.
As the substitute of Operand (containing alcohols), alcoholic chlorhexidine gluconate has advantages below：It is faint yellow
Can stain skin, ensure to observe the skin area after sterilization, color water can rinse out；Drying time is fast, sterilizing time
It is short, antibacterial time length；Without de- iodine；Operand (containing alcohols) can be substituted completely.Although alcoholic chlorhexidine gluconate alcohol
With above advantage, but in order to prevent from causing pachylosis, the addition of emollient is essential, but Portugal after alcohol volatilization
The residual activity of grape saccharic acid chlorohexidene can be suppressed by emollient, influence its residual activity.The present invention is by selecting to test on a large scale
Influence of the different esters to bacteriostatic activity, it finally found that and not interfere with residual activity not only, can conversely strengthen residual activity
Assign ester agent.The present invention is not only perfect to solve the various problems that compound iodine containing alcohols is brought, while has that drying time is short, suppression again
The bacterium time grows the safety for being able to ensure that operative site.
Compared with prior art, the invention has the advantages that：
(1) the 2% chlorhexidine gluconate alcohol thimerosal activity described in is lasting, not by body fluid, blood, serum and other richnesses
Disturbed containing protein material；
(2) 2% chlorhexidine gluconate alcohol thimerosal described in is easily wiped；Antibacterial permanent, fungistatic effect is up to 1 week；Only
Need to be completely dried within one minute；
(3) 2% chlorhexidine gluconate alcohol thimerosal described in color depth, is coloured under the shadowless lamp of preoperative skin degerming region
Substantially；
(4) when using described 2% chlorhexidine gluconate alcohol sterilization liquid disinfectant, SSI incidences are lower than PVP-I,
Sterilize speed faster；
(5) preparation method of 2% chlorhexidine gluconate alcohol thimerosal described in is simple and easy, beneficial to industrialized production.
Embodiment
With reference to embodiment, the present invention is further illustrated, but it is not intended to limit the implementation of the present invention.
Embodiment 1
2% chlorhexidine gluconate alcohol thimerosal is made up of the component of following weight percentage：
Ethanol 65%, chlorhexidine gluconate 2.0%, diisopropyl adipate 0.4%, glycerine 1.5%, hyaluronic acid
0.2%, allantoin 0.02%, lemon yellow 0.004%, surplus is deionized water.
The preparation method of 2% chlorhexidine gluconate alcohol thimerosal, comprises the following steps：
(1) superfine food grade alcohol is added in reactor, opens stirring；
(2) chlorhexidine gluconate, diisopropyl adipate, glycerine, hyaluronic acid are sequentially added, it is quiet after stirring
Put, obtain mixed liquor A；
(3) deionized water (for 80-120 times of consolidant dosage) is added into another reactor, is heated to 80 ± 10 DEG C,
Consolidant is added, deionized water is added and is stirred 5-10 minutes again (for 120-150 times of consolidant dosage), stir, obtain mixed
Close liquid B；
(4) deionized water (for 80-100 times of colouring agent) is added into container, colouring agent is added, mixing, obtains mixed liquor
C；
(5) mixed liquid B, mixed liquor C are sequentially added in mixed liquor A；
(6) stir 15-30 minutes, that is, 2% described chlorhexidine gluconate alcohol thimerosal is made.
Embodiment 2
2% chlorhexidine gluconate alcohol thimerosal is made up of the component of following weight percentage：
Ethanol 60%, chlorhexidine gluconate 2.0%, polyglycereol 0.2%, glycerine 1.0%, hyaluronic acid 0.1%, spiny dogfish
Alkane 0.02%, haematochrome 0.002%, surplus are deionized water.
Preparation method is the same as embodiment 1.
Embodiment 3
2% chlorhexidine gluconate alcohol thimerosal is made up of the component of following weight percentage：
Ethanol 70%, chlorhexidine gluconate 1.8%, diisobutyl adipate 0.6%, glycerine 2.0%, PEG-7 glycerine
Cocounut oil acid esters 0.4%, allantoin 0.04%, lemon yellow 0.006%, haematochrome 0.001%, surplus are deionized water.
Preparation method is the same as embodiment 1.
Effect of the emollient to chlorohexidene：
After alcohol volatilization, the fungistatic effect difference of surplus materials, 1 is shown in Table.
Effect of the emollient of table 1 to chlorohexidene
As a result show, assigning the addition of esters will not only suppress, and can improve CHG bacteriostatic activity on the contrary.
Killing action of the invention to microorganism, according to《Disinfection technology standard》(2002 editions) are operated.As a result such as table 2
It is shown.
Killing action (suspension method) of the present invention of table 2 to microorganism
To the toxicity test of mouse：
The experiment of chmice acute Oral toxicity is pressed《Disinfection technology standard》(2002 editions) tests, the product is for male and female little Bai
The oral LD of mouse50＞ 5000mg/Kg, belong to actual nontoxic rank, be shown in Table 3.
The tested material of table 3 is to its mouse oral toxicity test result
To the skin irritation test of rabbit：
Press《Disinfection technology standard》(2002 editions) tests, tested material are stingless to the multiple skin irritation test result of rabbit
Swash property.As shown in table 4.
The tested material of table 4 is to the multiple skin irritation test result of rabbit
Foundation《Disinfection technology standard》(version in 2002) 2.3.8.4 item mice bone marrow micronucleus,
As a result it is that PCEMNR is acted on without aberration inducing.
Table 5 is acted on PCEMNR
Note：* P ＜ 0.01.
Claims (10)
1. a kind of 2% chlorhexidine gluconate alcohol thimerosal, it is characterised in that be made up of the component of following weight percentage：Second
Alcohol 60%-70%, chlorhexidine gluconate 1.8%-2.2%, moisturizing bleeding agent 0.2%-0.6%, NMF 1.0%-
2.0%, assign ester agent 0.1%-0.4%, consolidant 0.02%-0.04%, colouring agent 0.002%-0.008%, surplus for go from
Sub- water.
2. 2% chlorhexidine gluconate alcohol thimerosal according to claim 1, it is characterised in that contained by following weight percent
The component composition of amount：Ethanol 65%-70%, chlorhexidine gluconate 1.9%-2.1%, moisturizing bleeding agent 0.4%-0.6%, protect
Humectant 1.5%-2.0%, ester agent 0.1%-0.2%, consolidant 0.02%-0.03%, colouring agent 0.002%-0.006% are assigned,
Surplus is deionized water.
3. 2% chlorhexidine gluconate alcohol thimerosal according to claim 2, it is characterised in that contained by following weight percent
The component composition of amount：Ethanol 65%, chlorhexidine gluconate 2.0%, moisturizing bleeding agent 0.4%, NMF 1.5%, assign ester agent
0.2%, consolidant 0.02%, colouring agent 0.004%, surplus is deionized water.
4. 2% chlorhexidine gluconate alcohol thimerosal according to claim 1, it is characterised in that：Ethanol is selected from superfine eat
With level alcohol or top grade food grade alcohol.
5. 2% chlorhexidine gluconate alcohol thimerosal according to claim 1, it is characterised in that：Chlorhexidine gluconate
For pharmaceutical grade, wherein tetrachlorobenzene ammonia content control is within 10ppm.
6. 2% chlorhexidine gluconate alcohol thimerosal according to claim 1, it is characterised in that：Moisturizing bleeding agent is poly-
Glycerine, diisopropyl adipate, diisobutyl adipate, the one or two of hexyl laurate or isopropyl myristate.
7. 2% chlorhexidine gluconate alcohol thimerosal according to claim 1, it is characterised in that：NMF be glycerine or
The one or two of hexylene glycol.
8. 2% chlorhexidine gluconate alcohol thimerosal according to claim 1, it is characterised in that：It is hyalomitome to assign ester agent
One or both of acid or PEG-7 glyceryl cocoates.
9. 2% chlorhexidine gluconate alcohol thimerosal according to claim 1, it is characterised in that：Consolidant is allantoin
Or saualane；Colouring agent is food grade colorant, is the one or two of lemon yellow, sunset yellow or haematochrome.
10. a kind of preparation method of any 2% described chlorhexidine gluconate alcohol thimerosals of claim 1-9, its feature exist
In comprising the following steps：
(1) ethanol is added in reactor, opens stirring；
(2) chlorhexidine gluconate, moisturizing bleeding agent, NMF are sequentially added into reactor and assigns ester agent, is stood after stirring,
Obtain mixed liquor A；
(3) deionized water of 80-120 times of consolidant quality is added into another reactor, is heated to 70-90 DEG C, adds healing
Agent, the deionized water for adding 120-150 times of consolidant quality are stirred 5-10 minutes again, stirring, obtain mixed liquid B；
(4) deionized water of 80-100 times of colouring agent quality is added into container, colouring agent is added, mixing, obtains mixed liquor C；
(5) mixed liquid B, mixed liquor C are sequentially added in mixed liquor A；
(6) stir 15-30 minutes, that is, 2% described chlorhexidine gluconate alcohol thimerosal is made.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710909513.8A CN107595827A (en) | 2017-09-29 | 2017-09-29 | 2% chlorhexidine gluconate alcohol thimerosal and preparation method thereof |
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| CN201710909513.8A CN107595827A (en) | 2017-09-29 | 2017-09-29 | 2% chlorhexidine gluconate alcohol thimerosal and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101336910A (en) * | 2008-08-20 | 2009-01-07 | 广州市欧替克消毒剂生产有限公司 | Chlorhexidine composition with colouring function |
| CN101489379A (en) * | 2006-10-27 | 2009-07-22 | 3M创新有限公司 | Antimicrobial compositions |
-
2017
- 2017-09-29 CN CN201710909513.8A patent/CN107595827A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101489379A (en) * | 2006-10-27 | 2009-07-22 | 3M创新有限公司 | Antimicrobial compositions |
| CN101336910A (en) * | 2008-08-20 | 2009-01-07 | 广州市欧替克消毒剂生产有限公司 | Chlorhexidine composition with colouring function |
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