CN107595766A - A kind of lidocaine microemulsion gel and preparation method thereof - Google Patents
A kind of lidocaine microemulsion gel and preparation method thereof Download PDFInfo
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- CN107595766A CN107595766A CN201710735002.9A CN201710735002A CN107595766A CN 107595766 A CN107595766 A CN 107595766A CN 201710735002 A CN201710735002 A CN 201710735002A CN 107595766 A CN107595766 A CN 107595766A
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Abstract
A kind of lidocaine microemulsion gel, it is formed and preparation method is：By lidocaine（2‑6%）, menthol（0‑0.8%）Oil phase is dissolved at 70 DEG C（3.75%）Afterwards, surfactant is added（8.75%）, distilled water is then added dropwise under agitation（82.1%）, into micro emulsion.Add preservative（0.1%）, after standing is cooled to room temperature, it is sprinkled into Carbopol（0.4%）, fully after swelling, stirring, degassing, sterilizing, produce.The present invention is a kind of hurtless measure local anaesthetics, can avoid injecting caused whole body toxic side effect, available for percutaneous surgeries, beauty and micro-shaping etc..
Description
Technical field
The present invention relates to a kind of local anesthetic, the lidocaine microemulsion gel of particularly a kind of hurtless measure percutaneous dosing and
Its preparation method.
Background technology
Percutaneous surgeries, and the tender skin of various a multitude of names, it is crease-resistant, lose hair or feathers, wash the beauty such as eyebrow Minimally Invasive Surgery and
Tattoo and micro-shaping operation etc., can cause human body skin superficial traumatic to some extent and the pain of wellability.Clinically
The general method using injecting anesthetic medicine carries out the analgesia of therapentic part.But injection has the problem of a lot, such as causes to ache
Pain, some injection location difficulty are big, beauty mechanism is unable to valid application injecting anesthetic, it is often more important that injection can cause whole body
Toxic side effect etc..Therefore, develop a kind of non-injection non-infiltration, skin surface directly uses, can be painless and reach local fiber crops
Liquor-saturated preparation, it will seem particularly necessary.With the development increasingly of beauty culture, this preparation will have wide application market.
The percutaneous dosing local anaesthesia preparation of Clinical practice at present, grace is generally used to receive frost both at home and abroad, actually
It is lidocaine emulsifiable paste, by Sweden's development and production, later European and American countries have production and application for it.But grace receive frost maintain fiber crops
Liquor-saturated time average out to 50min, depth of interaction 5mm, it is typically only capable to be applied to some small surgical operation anesthesia, facial plasty etc.
Relatively large operation is then difficult to reach analgesic effect.More distinct issues are that grace receives frost containing analgesic activity is strong, toxic side effect
The third strong cacaine, has vasoconstrictor effects, so as to cause positive iron blood egg in vascular endothelial cell damage, skin whitening, blood
The toxic side effects such as Bai Hanliang increases.In addition, what is clinically used also has totokaine emulsifiable paste, lidocaine gel, benefit card
Because of pressure-sensitive adhesive paster etc., they have with grace receive frost it is identical the problem of, that is, the action time that works is short.
Micro emulsion is a kind of carrier for transdermal delivery for the nano-dispersed that solubilization is strong, mechanism is excellent.By anaesthetic effect
Local anaesthetics lidocaine good, that toxic side effect is small is prepared into microemulsion formulation and reduces toxic side effect to improve its anaesthetic effect, domestic
It is outer to have research and application more.But conventional made micro emulsion surfactant and cosurfactant dosage are big, drugloading rate is relative
Few, its security and validity need to be improved.
The content of the invention
To avoid injecting and infiltrating the caused whole body toxic side effect of administration, the present invention is special provide a kind of hurtless measure percutaneously to
Medicine local anaesthesia preparation, i.e. lidocaine microemulsion gel and preparation method thereof.
A kind of lidocaine microemulsion gel, it is made up of following substances by the mass percent concentration：Lidocaine 2-
6%th, oil phase 3.75%, surfactant 8.75%, penetrating agent 0-0.8%, preservative 0.1%, Carbopol 0.4%, remaining is
Water；The oil phase is the combination of two kinds of oil substances, and described two oil substances are olive oil, tetradecylic acid isopropyl ester, list
Any two kinds in glyceryl stearate, VE-succinate；The surfactant be Crodaret with
Sorbester p17 is with mass ratio 5:1 mixes；The preservative is soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate with mass ratio 1:1 is mixed
Conjunction forms.
In order to improve micro emulsion region, so as to improve solubilizing amount of the micro emulsion to lidocaine, the present invention is used two kinds of greases
Class material compounding, both sides solubilized method each other；In order that final obtained micro emulsion gel is easy to absorb and is coated with, one of which
Grease must be liquid phase at normal temperatures, it is still further preferred that the tetradecylic acid isopropyl ester that percutaneous permeability is strong.
In order to promote the Cutaneous permeation of lidocaine, the Chinese medicine penetrating agent with anaesthetic effect is thin in itself for addition in the present invention
Lotus alcohol, its concentration preferably 0.4%.
In order to be acted on using the drug depot of keratoderma lipid bilayer, according to the dissociation constant of medicine, benefit
Cacaine selects its alkaline.
A kind of lidocaine microemulsion gel and preparation method thereof, comprises the following steps：
（1）After two kinds of oil substances are mutually dissolved into mixing at 70 DEG C, lidocaine, penetrating agent are added, then adds table
Face activating agent, obtains oil-soluble solution；
（2）With distilled water titration step dropwise under 70 DEG C of stirring conditions（1）Oil-soluble solution, be made lidocaine microemulsion；
（3）In step（2）Micro emulsion in add preservative；
（4）By step（3）Micro emulsion stand, be cooled to room temperature after, be sprinkled into Carbopol, fully swelling after, stirring, deaerate, go out
Bacterium, produce.
The present invention improves the solubilising of the content of oil phase in micro emulsion and micro emulsion to lidocaine by the compounding of oil phase
Amount.Moistness, the percutaneous permeation of oil phase substance have important influence to the sustained effectiveness time of lidocaine microemulsion gel, lead to
Crossing the use of screening compounding and penetrating agent can make onset time bring up to more than 340min.
Brief description of the drawings
Fig. 1, lidocaine percutaneous drug administration preparation local anaesthesia effect assessment.
Fig. 2, lidocaine microemulsion gel local anaesthesia effect assessment.
The influence of Fig. 3, oil phase to lidocaine microemulsion gel local anaesthesia effect.
The influence of Fig. 4, menthol to lidocaine microemulsion gel local anaesthesia effect.
Embodiment
2g lidocaine is dissolved in 3.75g olive oil and VE succinic acid fat by embodiment 1 at 70 DEG C（Quality
Than 6:1）Miscella in, add 8.75g surfactant（Crodaret is with sorbester p17 with mass ratio 5:1
Mix）, the desired amount of distilled water is then added dropwise under agitation, into micro emulsion.Add 0.1g preservative（Metagin
Ester sodium and soluble propylhydroxybenzoate are with mass ratio 1:1 mixes）Afterwards, stand and be cooled to room temperature, be then sprinkled into 0.4g carbomer
980, fully after swelling, stirring, degassing, sterilizing, the lidocaine microemulsion gel that 100g concentration is 2% is made.
4g lidocaine is dissolved in 3.75g olive oil and VE succinic acid fat by embodiment 2 at 70 DEG C（Quality
Than 6:1）Miscella in, add 8.75g surfactant（Crodaret is with sorbester p17 with mass ratio 5:1
Mix）, the desired amount of distilled water is then added dropwise under agitation, into micro emulsion.Add 0.1g preservative（Metagin
Ester sodium and soluble propylhydroxybenzoate are with mass ratio 1:1 mixes）Afterwards, stand and be cooled to room temperature, be then sprinkled into 0.4g carbomer
980, fully after swelling, stirring, degassing, sterilizing, the lidocaine microemulsion gel that 100g concentration is 4% is made.
5g lidocaine is dissolved in 3.75g olive oil and VE succinic acid fat by embodiment 3 at 70 DEG C（Quality
Than 6:1）Miscella in, add 8.75g surfactant（Crodaret is with sorbester p17 with mass ratio 5:1
Mix）, the desired amount of distilled water is then added dropwise under agitation, into micro emulsion.Add 0.1g preservative（Metagin
Ester sodium and soluble propylhydroxybenzoate are with mass ratio 1:1 mixes）Afterwards, stand and be cooled to room temperature, be then sprinkled into 0.4g carbomer
980, fully after swelling, stirring, degassing, sterilizing, the lidocaine microemulsion gel that 100g concentration is 5% is made.
6g lidocaine is dissolved in 3.75g olive oil and VE succinic acid fat by embodiment 4 at 70 DEG C（Quality
Than 6:1）Miscella in, add 8.75g surfactant（Crodaret is with sorbester p17 with mass ratio 5:1
Mix）, the desired amount of distilled water is then added dropwise under agitation, into micro emulsion.Add 0.1g preservative（Metagin
Ester sodium and soluble propylhydroxybenzoate are with mass ratio 1:1 mixes）Afterwards, stand and be cooled to room temperature, be then sprinkled into 0.4g carbomer
980, fully after swelling, stirring, degassing, sterilizing, the lidocaine microemulsion gel that 100g concentration is 6% is made.
5g lidocaines are dissolved in 3.75g olive oil and tetradecylic acid isopropyl ester by embodiment 5 at 70 DEG C（Mass ratio 1:1）
Miscella in, add 8.75g surfactant（Crodaret is with sorbester p17 with mass ratio 5:1 mixing and
Into）, the desired amount of distilled water is then added dropwise under agitation, into micro emulsion.Add 0.1g preservative（Soluble metyl hydroxybenzoate and
Soluble propylhydroxybenzoate is with mass ratio 1:1 mixes）Afterwards, stand and be cooled to room temperature, be then sprinkled into 0.4g Carbopol, fill
After dividing swelling, stirring, degassing, sterilizing, the lidocaine microemulsion gel that obtained 100g concentration is 5%.
5g lidocaine is dissolved in 3.75g glycerin monostearates and tetradecylic acid isopropyl ester by embodiment 6 at 70 DEG C
（Mass ratio 1:1）Miscella in, add 8.75g surfactant（Crodaret is with sorbester p17 with quality
Than 5:1 mixes）, the desired amount of distilled water is then added dropwise under agitation, into micro emulsion.Add 0.1g preservative（Buddhist nun
Tortoise beetle ester sodium and soluble propylhydroxybenzoate are moored with mass ratio 1:1 mixes）Afterwards, stand and be cooled to room temperature, be then sprinkled into 0.4g's
After Carbopol, fully swelling, stirring, degassing, sterilizing, the lidocaine microemulsion gel that 100g concentration is 5% is made.
5g lidocaines are dissolved in 3.75g olive oil and tetradecylic acid isopropyl ester by embodiment 7 at 70 DEG C（Mass ratio 1:1）
Miscella in, add 0.4g menthols, add 8.75g surfactant（Crodaret and sorbester p17
With mass ratio 5:1 mixes）, the desired amount of distilled water is then added dropwise under agitation, into micro emulsion.Add 0.1g anti-corrosion
Agent（Soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate are with mass ratio 1:1 mixes）Afterwards, stand and be cooled to room temperature, be then sprinkled into
After 0.4g Carbopol, fully swelling, stirring, degassing, sterilizing, the lidocaine microemulsion gel that 100g concentration is 5% is made.
5g lidocaines are dissolved in 3.75g olive oil and tetradecylic acid isopropyl ester by embodiment 8 at 70 DEG C（Mass ratio 1:1）
Miscella in, add 0.8g menthols, add 8.75g surfactant（Crodaret and sorbester p17
With mass ratio 5:1 mixes）, the desired amount of distilled water is then added dropwise under agitation, into micro emulsion.Add 0.1g anti-corrosion
Agent（Soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate are with mass ratio 1:1 mixes）Afterwards, stand and be cooled to room temperature, be then sprinkled into
After 0.4g Carbopol, fully swelling, stirring, degassing, sterilizing, the lidocaine microemulsion gel that 100g concentration is 5% is made.
Test portion：
The local anaesthetic effect of the made lidocaine microemulsion gel of the present invention is evaluated using needle point method.
Experimental method：It is that the positive middle part skin of 250g ~ 350g cavys back is slightly larger than 2cm by body weight2The hair in region cut only,
Make dermatotome exposed.Every group of each 6 cavy.At room temperature, with cotton swab in exposed district center 2cm2Skin on coating, surveyed with acupuncture
The pain sensation reaction of medicine partial skin Zhou Biankuan on probation about 6mm banded regions.The pain sensation still in the presence of, skin region has contraction existing at stimulation
As referred to as positive reaction；Ungauged regions phenomenon, referred to as negative reaction.Each every cavy in the total costimulation in the difference of banded regions 10 times,
Per minor tick 5s, negative reaction number of the every cavy to stimulation is recorded.After coating in 60min, per 10min test once, 60min with
Tested once per 15min afterwards, per 30min, test once, is tested once after 210min per 1h after 120min.Using the time as horizontal seat
Mark, the average value of 6 cavy negative reaction numbers are mapped for ordinate, so as to the action speed to medicine, onset time, drug release speed
Whether degree is steady, and power of anesthetic effect etc. is made an appraisal.
Test example one：According to above-mentioned acupuncture experimental method, 6 groups of experiments are carried out, as a result as shown in Figure 1.What each curve smeared
Medicine is respectively：Curve 1 is the negative control without lidocaine；Curve 2 is the lidocaine hydrochloride note that injection concentration is 2%
Penetrate agent 0.3ml；The compound lidocaine emulsifiable paste positive reference substance that curve 3 uses for smearing dept. of dermatology of the second the People's Hospital of Taiyuan City
0.3g；Curve 4 is the 2% lidocaine microemulsion gel 0.3g for smearing embodiment 1；Curve 5 is the 4% benefit card for smearing embodiment 2
Because of micro emulsion gel 0.3g；Curve 6 is the 6% lidocaine microemulsion gel 0.3g for smearing embodiment 4.
Shown in Fig. 1, the negative control without lidocaine at the trial in 6 cavy negative reaction numbers average value it is several
Consistent, in contrast, the negative reaction number of remaining 5 line is significantly increased.By contrast, lidocaine hydrochloride injection
It is quick acting injecting 2 ~ 3min, 10min local anaesthesia effects reach peak value, afterwards dramatic decrease；And found in experimentation,
Cavy is lost consciousness until dead in 5min when injection 4.5ml is 90mg containing lidocaine；It is tired to inject cavy when 0.3ml is 6mg
It is idle dizzy, and percutaneous dosing is until dosage reaches 90mg and do not occur the dizzy state of burnout.It can be seen that drug administration by injection easily enters
Blood, the local action of more difficult control.2 ~ 6% made micro emulsion gel of the invention, action speed is faster than positive control, but during action
Between it is short, rate of releasing drug is unstable；The anaesthetic effect of each concentration does not have a concentration dependent, and anaesthetic effect is optimal during middle concentration.
Test example two：According to above-mentioned acupuncture experimental method, 7 groups of experiments are carried out, as a result as shown in Figure 2.What each curve smeared
Medicine is respectively：Curve 1 is the negative control without lidocaine；Curve 2 is positive control, that is, smears the people of Taiyuan City second
The compound lidocaine emulsifiable paste 0.9g that hospital dermatology department uses；Curve 3 is low dose group, that is, smears 5% benefit card of embodiment 3
Because of micro emulsion gel 0.3g；Curve 4 is middle dose group, that is, smears 5% lidocaine microemulsion gel 0.9g of embodiment 3；Curve 5 is
High dose group, that is, smear 5% lidocaine microemulsion gel 1.8g of embodiment 3；Curve 6 is suspended to smear 5% lidocaine of self-control
Agent 0.9g；Curve 7 makes lidocaine emulsifiable paste 0.9g by oneself to smear.
Compared with the negative control of curve 1, the negative reaction number of Lida-Mantle is significantly increased.From the work of antigalactic
Worst by contrast with intensity and action speed etc., supensoid agent takes second place；The made micro emulsion gel of the present invention is in middle dosage and positive
Control is strong compared to anesthetic effect, and action speed is fast, but onset time is short；The micro emulsion gel of low dosage rises compared with positive control
It is fast to imitate speed, but onset time is short, and anaesthetic effect does not have marked difference.The micro emulsion gel of high dose rises compared with positive control
It is fast to imitate speed, but onset time is grown, and drug release rate fluctuation is big, and anaesthetic effect is less than middle low dose group on the contrary.
Test example three：The result of test example one and example two shows that the made micro emulsion gel action speed of the present invention is fast, but works
Time is short, rate of releasing drug is non-constant, does not have correlation between anaesthetic effect and concentration and dosage.Prompting cuticula does not play medicine
The effect of reservoir, medicine only reach the shallow-layer infiltration of skin.Therefore, a kind of oil substances in oil phase are used into Cutaneous permeation
The strong tetradecylic acid isopropyl ester of property, to promote the deep skin of medicine to permeate.According to above-mentioned acupuncture experimental method, 4 groups of experiments are carried out,
As a result it is as shown in Figure 3.The medicine that each curve smears is respectively：Curve 1 be smear embodiment 5 oil phase be tetradecylic acid isopropyl ester with
Olive oil（Mass ratio 1:1）5% lidocaine microemulsion gel 0.9g of mixing；The oil phase that curve 2 smears embodiment 6 is tetradecylic acid
Isopropyl ester and glycerin monostearate（Mass ratio 1:1）5% lidocaine microemulsion gel 0.9g of mixing；Curve 3 is positive right
According to；Curve 4 is the 5% lidocaine microemulsion gel 0.9g for smearing embodiment 3.
By the curve 1,2 in Fig. 3 compared with curve 3,4, when a kind of oil substances use Cutaneous permeation in micro emulsion gel
Property strong tetradecylic acid isopropyl ester after, action speed has declined and less than positive control, drug release rate also not compared with Example 3
Steadily, but onset time significantly extends, especially embodiment 5.
Test example four：Chinese medicine penetrating agent menthol is added in embodiment 5, to further improve the skin of lidocaine
Osmotic effect.According to above-mentioned acupuncture experimental method, 4 groups of experiments are carried out, as a result as shown in Figure 4.The medicine difference that each curve smears
For：Curve 1 is positive control 0.9g；Curve 2 is free of the micro emulsion gel 0.9g of menthol, i.e. embodiment 5 to smear；Curve 3 is
Smear the micro emulsion gel 0.9g containing 0.4% menthol, i.e. embodiment 7.Curve 4 is to smear the micro emulsion gel containing 0.8% menthol
0.9g, i.e. embodiment 8.
From fig. 4, it can be seen that in curve 3, after 0.4% menthol is added, the made micro emulsion gel of the present invention is smearing 340min
After, negative reaction number can also maintain very high level, be significantly higher than the positive control of the expression of curve 1；It is bent compared with curve 2
Line 3 is steady a lot, and negative reaction number significantly improves, and illustrates that menthol can promote the percdation of lidocaine.It is but bent
Shown in line 4, when menthol concentration is 0.8%, drug release is unstable, onset time is even below the curve 2 for being not added with menthol, former
Because being probably the refrigerant effect of menthol, the diffusion velocity of lidocaine is slowed down.
Claims (4)
1. a kind of lidocaine microemulsion gel, it is characterised in that it is made up of following substances by the mass percent concentration：Profit
More cacaine 2-6%, oil phase 3.75%, surfactant 8.75%, penetrating agent 0-0.8%, preservative 0.1%, Carbopol are
0.4%, remaining is water；The oil phase is the combination of two kinds of oil substances, and described two oil substances are olive oil, 14
Any two kinds in sour isopropyl ester, single stearic acid glycerine lipoprotein, VE-succinate are with mass ratio 1:1~6:1 mixing；The table
Face activating agent is Crodaret and sorbester p17 with mass ratio 5:1 mixes；The preservative is Metagin
Ester sodium and soluble propylhydroxybenzoate are with mass ratio 1:1 mixes.
A kind of 2. lidocaine microemulsion gel according to claim 1, it is characterised in that two kinds of oil that the oil phase uses
It is liquid under one of which normal temperature in fat.
3. a kind of lidocaine microemulsion gel according to claim 1, it is characterised in that penetrating agent used has for itself
The menthol of anaesthetic effect, its concentration are 0.4%.
4. a kind of preparation method of lidocaine microemulsion gel, for preparing the lidocaine microemulsion gel described in claim 1,
Characterized in that, it comprises the following steps：
（1）After two kinds of oil substances are mutually dissolved into mixing at 70 DEG C, lidocaine, penetrating agent are added, then adds table
Face activating agent, obtains oil-soluble solution；
（2）With distilled water titration step dropwise under 70 DEG C of stirring conditions（1）Oil-soluble solution, be made lidocaine microemulsion；
（3）In step（2）Micro emulsion in add preservative；
（4）By step（3）Micro emulsion stand, be cooled to room temperature after, be sprinkled into Carbopol, fully swelling after, stirring, then take off
Gas, sterilizing, are produced.
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| CN201710735002.9A CN107595766B (en) | 2017-08-24 | 2017-08-24 | Lidocaine microemulsion gel and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109010117A (en) * | 2018-07-10 | 2018-12-18 | 山西医科大学 | A kind of micro emulsion gel lip care gel and preparation method thereof with moist moisture-keeping function |
| CN112220779A (en) * | 2020-11-12 | 2021-01-15 | 浙江鼎泰药业股份有限公司 | Novel transdermal preparation for local analgesia and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109010117A (en) * | 2018-07-10 | 2018-12-18 | 山西医科大学 | A kind of micro emulsion gel lip care gel and preparation method thereof with moist moisture-keeping function |
| CN109010117B (en) * | 2018-07-10 | 2021-05-25 | 山西医科大学 | Micro-emulsion gel lip-protecting gel with moisturizing and moisturizing effects and preparation method thereof |
| CN112220779A (en) * | 2020-11-12 | 2021-01-15 | 浙江鼎泰药业股份有限公司 | Novel transdermal preparation for local analgesia and preparation method thereof |
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Effective date of registration: 20210329 Address after: 510470 A209, Shangying Creative Park, 387 Helong 5th Road, Renhe Town, Baiyun District, Guangzhou City, Guangdong Province Patentee after: Sanhe Bioengineering (Guangzhou) Co.,Ltd. Address before: 030001 No. 56, Xinjian South Road, Shanxi, Taiyuan Patentee before: SHANXI MEDICAL University |
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