CN102805882A - Method for mixing soft tissue filling agent with anesthetic injecta before use - Google Patents

Method for mixing soft tissue filling agent with anesthetic injecta before use Download PDF

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Publication number
CN102805882A
CN102805882A CN2012103096844A CN201210309684A CN102805882A CN 102805882 A CN102805882 A CN 102805882A CN 2012103096844 A CN2012103096844 A CN 2012103096844A CN 201210309684 A CN201210309684 A CN 201210309684A CN 102805882 A CN102805882 A CN 102805882A
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syringe
fix liquid
soft tissue
volume
injection
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CN2012103096844A
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CN102805882B (en
Inventor
郭学平
付杰
石艳丽
刘爱华
栾贻宏
杨晓燕
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Bloomage Biotech Co Ltd
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BLOOMAGE FREDA BIOPHARM Co Ltd
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Abstract

The invention discloses a method for mixing soft tissue filling agent with anesthetics injecta before use. The method comprises the following steps of: injecting anesthetics injecta into a prefilling injector filled with soft tissue filling agent by a microsyringe for multiple times, after the anesthetics injecta is injected, stewing for a short time, and then performing even mixing. According to the method, the pain caused by the cosmetic injection can be avoided, the method is high in operability, and is low in technical requirements on operating personnel, and the anesthetics injecta and the soft tissue filling agent can be evenly mixed with each other conveniently and quickly. Compared with the existing method for preparing the preparation by directly adding the anesthetics into hyaluronic acid gel, the method has the advantage of not needing the compatibility test, the stability test and even the clinic test of two drugs under the condition of high-temperature sterilization, so that the method is low in cost. Furthermore, after the mixing is carried out by the method, the soft tissue filling agent is free from the chemical reaction phenomena such as degradation, precipitation, turbidness and the like, so that the method is safe.

Description

A kind of soft tissue filler before use with fix liquid method of mixing
Technical field
The present invention relates to a kind ofly will be difficult for two kinds of miscible methods that medicine mixes use before use, be specifically related to a kind of soft tissue filler before use with fix liquid method of mixing.
Background technology
The injection beauty treatment is a kind of of non-operating shaping beauty treatment; Utilize the method for injection that biomaterial or synthetic biocompatible materials are injected into skin corium or subcutaneous, reach the one big type of plastic operation method that reduces skinfold or plastotype through the different mechanism of action.The injection beauty implement need not to perform the operation, advantages such as misery is little, few side effects, instant effect, and the market demand constantly enlarges.
Along with the injection beautifying technique is more and more flourishing, injection beauty treatment crowd is more and more growth also.In exploitation injection cosmetics; Injection beauty treatment person self experiences the factor that also becomes doctor and manufacturer consideration gradually; When injection hyaluronic acid derivatives filler product, the puzzlement that distending pain that pain on injection and injection back filler cause in vivo and sense of discomfort become numerous beauty treatment persons.In order to reduce or reduce patient's misery, to being carried out anaesthetic treatment, following anesthesia is arranged at present usually by the injector:
1, topical anesthesia: anesthesia unguentum such as lignocaine are applied to skin to be injected place, disinfect in alcohol behind the 30-60 min.The method can only be eliminated the pain that causes in the injection process, and the distending pain that filler is caused is invalid.
2, anesthesia injection: injecting anesthetic remover liquid injection, the method also only can be eliminated the pain that causes in the injection filler process, and the distending pain that filler is caused is invalid, and injected with lidocaine also can be brought pain.
3, anesthetis is mixed process compositions in the hyaluronic acid; Thereby thoroughly solve injection pain and filler swelling pain problem; Had a lot of producers that anesthetis such as lignocaine are joined in the filler at present, related patent U.S. Patent No. has CN200980139162.0 (comprising narcotic hyalomitome acidic group gel), CN200980139163.5 (comprising narcotic hyalomitome acidic group gel), CN200880115067.2 (anesthetics compositions, preparation and method for using).Directly admixture anesthetis can be removed the pain of injection and the pain of filling back swelling simultaneously in implant, removes the pain that injection brings to the patient.
Summary of the invention
The present invention is directed to above deficiency; Provide a kind of soft tissue filler before use with fix liquid method of mixing, this method can be before injection with fix liquid and soft tissue filler mix homogeneously in the short period of time, thereby all pain of being brought with the injection back can eliminate injection simultaneously the time; Remove patient's pain; And this method is convenient, fast, need not by special equipment and condition, can not increase the financial burden of user.
The present invention realizes through following measure:
A kind of soft tissue filler before use with fix liquid method of mixing; Said soft tissue filler includes but not limited to hyalomitome acids soft tissue filler (the hyalomitome acids comprises hyaluronic acid or its salt), and said fix liquid is one or more in lignocaine, procaine, ovocaine, prilocaine, bupivacaine, mepivacaine, Carbocainum, etidocaine and the chirocaine injection; Fix liquid is injected soft tissue filler several times, and fix liquid injects the diverse location of soft tissue filler at every turn.It is mix homogeneously that the gained mixture leaves standstill a period of time, and this time is about 5-10 min.
Concrete, mixed method of the present invention may further comprise the steps:
(1) gets in the prefilled syringe that soft tissue filler is housed (being called for short syringe, down together) of sterilization, move behind the catch bar with syringe to make and vacate the space that holds fix liquid in the syringe;
(2) microsyringe with sterilization extracts fix liquid, and is subsequent use;
(3) the soft tissue filler volume is designated as V1, fix liquid is divided into X part, divide and inject syringe X time; Method for implanting is following: at first; The syringe needle of microsyringe is penetrated the bottom until soft tissue filler from the head of syringe, in syringe, inject the fix liquid of a volume, the syringe needle with microsyringe (also is the injector head direction to the injector cephalad direction then; Down with) retreat the distance of V1/X volume; In syringe, inject the fix liquid of a volume again, continue the syringe needle of microsyringe is retreated the distance of V1/X volume to the injector cephalad direction, and then in syringe, inject the fix liquid of a volume; The step that microsyringe repeatedly like this is retreated and injected is all injected syringe until fix liquid;
(4) after fix liquid all injects syringe,, can use at aseptic, normal temperature environment held 5-10 min with the syringe horizontal positioned.
In the above-mentioned mixed method; Fix liquid divides the injection syringe 5-10 time; The number of times that divides many fix liquid more is short more with the time of filler mix homogeneously, also not have too big necessity, 10 injections of a therefore preferred branch syringe but the each volume that injects of fix liquid is too small.
In the above-mentioned mixed method, preferably fix liquid is equally divided into X part, the volume of so each injection syringe is identical.Fix liquid is divided equally back not dividing equally than it with the incorporation time of filler mix weak point, general 5-10 min is a mix homogeneously.
Used anesthetis, narcotic concentration, the narcotic kind of the present invention all belongs to prior art, and those skilled in the art can obtain from prior art.For example; The volume ratio of fix liquid and soft tissue filler adopts the general proportionate relationship of using in the prior art; General volume ratio is 1:5 ~ 1:20; Narcotic concentration (w/w) is generally 0.05%~0.5% in the fix liquid, and used fix liquid can be in lignocaine, procaine, ovocaine, prilocaine, bupivacaine, mepivacaine, Carbocainum, etidocaine and the chirocaine injection one or more, preferred lidocaine injection.
The pain that causes during for fear of the injection beauty treatment; The invention provides a kind of soft tissue filler before use with fix liquid method of mixing; This method is workable; To operator technical require low, can be easy, quickly with fix liquid and soft tissue filler mix homogeneously, fix liquid directly added the method for processing preparation in the hyaluronic acid derivatives compare with disclosed now; Needn't do compatibility experiment, stability experiment even the clinical trial of two kinds of medicines under the high temperature sterilize condition; Cost is low and adopt this method mixing back soft tissue filler can not degrade, and also chemical reaction phenomenons such as deposition, muddiness can not occur, is safe method.
Description of drawings
Fig. 1 for the present invention with soft tissue filler before use with the blended sketch map of fix liquid.
Among the figure, 1, prefilled syringe, 2, catch bar, 3, soft tissue filler, 4, vacant position, 5, microsyringe, 6, fix liquid, 7, syringe needle.
The specific embodiment
The preceding soft tissue filler of the suitable beauty treatment injection of method of the present invention mixes with fix liquid, below in conjunction with Fig. 1 mixed method of the present invention is carried out detailed explanation.
As shown in Figure 1; Prefilled syringe 1 (is called for short syringe; Soft tissue filler (being called for short filler, down together) 3 is housed down together), fix liquid 6 is housed in the microsyringe 5; This fix liquid reaches the purpose of when injection, the patient fully being anaesthetized in strict accordance with the consumption metering of filler.Fix liquid is injected filler several times; Fix liquid injects the diverse location of soft tissue filler at every turn; Fix liquid is dispersed in the diverse location of filler; Like this can be faster and the filler mix homogeneously, the liquid of fix simultaneously adds several times, has prevented once to add problems such as causing bubble and has occurred.
Following mask body is introduced mixed method of the present invention, in order to express easily, the filler volume is designated as V1, and the volume of fix liquid is designated as V2, and fix liquid injects syringe several times, and the injection number of times of fix liquid is designated as X.Before mixing beginning; Elder generation is with the catch bar 2 slow astern segment distances of syringe 1; Make injector head vacate a part of vacant position 4, so that hold the volume of fix liquid, the volume of vacant position preferably equates or is slightly larger than the volume of anesthesia liquid with the volume of fix liquid; Have scale on the syringe, can accurately retreat certain distance according to top scale.After moving behind the catch bar, the syringe needle 7 of microsyringe is penetrated the bottom (being the end position of catch bar) until soft tissue filler from the head of syringe.Fix liquid divides the injection syringe X time; Therefore fix liquid cumulative volume is divided into X part; Therefore each portion that injects X part preferably is divided into X part with fix liquid, and each volume that injects is preferably V2/X; Have scale on the microsyringe, can inject the fix liquid of setting volume accurately according to scale during injection.
Mixed method of the present invention is not with the disposable injection implant of fix liquid, is difficult to mix homogeneously like this, and is easy to generate the difficult injection of bubble.Key problem in technology of the present invention is that fix liquid is divided into different umbers; Filler also is divided into same umber; Every part of fix liquid is injected every part of soft tissue filler that is arranged in diverse location respectively; Fix liquid and filler can be mixed evenly fast, and be difficult for producing bubble.
Be the committed step of mixed method of the present invention below: after the syringe needle of microsyringe is inserted to the bottom of soft tissue filler; In syringe, inject a fix liquid of X part (the fix liquid of preferred V2/X volume); Then the syringe needle of microsyringe is retreated the distance of V1/X volume to the injector head position; In syringe, inject the fix liquid liquid (the fix liquid of preferred V2/X volume) of a volume again; The distance of V1/X volume is retreated the syringe needle of microsyringe in continuation to the injector head position; And then in syringe, inject the fix liquid liquid (the fix liquid of preferred V2/X volume) of a volume, the microsyringe step retreating and inject is all injected syringe until fix liquid so repeatedly.After fix liquid all injects syringe; With syringe under aseptic, normal temperature environment, horizontal positioned, fix liquid is further mixed naturally, through a large amount of experimental datas statistics with filler; Leave standstill that fix liquid and filler are mix homogeneously behind the 5-10 min; Behind the mix homogeneously, set up aseptic syringe needle, can inject use in injector head.
In theory, the number of times that fix liquid injects is many more, and the umber that filler is divided into is also many more; Mix quick more, but consider and operability generally fix liquid be divided into 5-10 part; Be divided into 5-10 injection syringe and get final product, be i.e. X=5-10, preferably X=10.
Generally; The used fix liquid of beauty industry comprises but is not limited to lignocaine, procaine, ovocaine, prilocaine, bupivacaine, mepivacaine, Carbocainum, etidocaine, chirocaine injection etc.; Fix liquid of the present invention can be a kind of in these; Also can be the mixture of the multiple composition in them, preferred lidocaine injection.
General, narcotic concentration (w/w) is 0.05%~0.5% in the fix liquid, can in market now, be chosen in the product of this concentration range; According to required narcotic amount; Fix liquid concentration is big, and employed volume is just smaller relatively, and fix liquid concentration is little; Employed volume is just big; When the present invention mixes used anesthetis and bulking of soft tissue adopt this area consumption commonly used with magnitude relation, be generally fix liquid: the volume ratio of soft tissue filler is 1:5 ~ 1:20, in the specific implementation; The volume ratio that can select fix liquid and soft tissue filler is the arbitrary value in the scope for this reason, for example 1:5,1:10,1:15,1:20 etc.According to narcotic consumption, can select the fix liquid of suitable concn, suitable volumes to mix with implant.And can be according to the big or small parameters such as injection number of times of confirming fix liquid of the volume of fix liquid.
Be example with the benefit caine below; Enumerate preferred embodiment of the present invention, used soft tissue filler commodity profit by name hundred face, general injection by name is modified hyaluronic acid sodium gel (abbreviation gel); Concentration is 1ml:20mg, is produced by China's prosperous Fu Ruida biological medicine company limited; Used lignocaine is the lidocaine hydrochloride injection of concentration (w/w) 0.2%, is produced by Shangdong Hualu Pharmaceutical Co., Ltd..
Embodiment
Get the prefilled syringe that the injection hyaluronic acid sodium gel is housed, 1 ml gel is housed in the prefilled syringe body, extracting 0.1 ml concentration (w/w) with microsyringe is 0.2% lidocaine hydrochloride injection.The catch bar of prefilled syringe is retreated about 0.1 ml; The syringe needle of microsyringe is inserted into the bottom of gel, injects 10 μ l lidocaine hydrochloride injections, then the syringe needle of microsyringe is retreated the distance of 0.1 ml to the prefilled syringe cephalad direction; 10 μ l lidocaine hydrochloride injections reinject; The operation that lidocaine hydrochloride injection was retreated and injected to microsyringe repeatedly like this is all injected prefilled syringe until lidocaine hydrochloride, and injecting number of times is 10 times.
After the mixing,, under aseptic, normal temperature environment, leave standstill 5-10 min, do not have phenomenons such as muddiness, deposition and occur the prefilled syringe horizontal positioned, place 12 h after, the lamp inspection observation is with dosing liquid product there was no significant difference not.
This method is mixed the fix liquid of gained and the mixture of filler carries out clinical trial among a small circle, and the test number is 8 people, male 4 people, and women 4 people, the age, the mean age was 38.4 years old between 20-50 year, all experimenter's healths are all healthy.Before injection, adopt the inventive method in advance lignocaine to be sneaked into injection and modify in the hyaluronic acid sodium gel, leave standstill 10 min, set up aseptic syringe needle in injector head then, injection is modified hyaluronic acid sodium gel inject experimenter's nasolabial fold wrinkle.One side is modified hyaluronic acid sodium gel with the injection of mixing lignocaine, and opposite side is modified hyaluronic acid sodium gel with the conventional narcotic injection that do not contain.The experimenter self is felt as injection: compare with the product of Caledonia caine not, the product that adds lignocaine can significantly alleviate the distending pain after pain on injection and the injection etc., and the ametaboly reaction of injection back or other untoward reaction take place.Simultaneously, experimenter's light pain of Caledonia caine has reduced the side reaction after the injection.The explanation of this phenomenon, the inventive method can be with fix liquid and the abundant mix homogeneously of filler, and safe in utilization, and the pain of having exempted user has alleviated the fear of user, reduction postoperative rate of side effects.

Claims (7)

  1. A soft tissue filler before use with fix liquid method of mixing; It is characterized by said soft tissue filler and include but not limited to hyalomitome acids soft tissue filler, said fix liquid is one or more in lignocaine, procaine, ovocaine, prilocaine, bupivacaine, mepivacaine, Carbocainum, etidocaine and the chirocaine injection; Fix liquid is injected soft tissue filler several times, and fix liquid injects the diverse location of soft tissue filler at every turn.
  2. 2. method according to claim 1 is characterized in that mixing may further comprise the steps:
    (1) gets the prefilled syringe that soft tissue filler is housed, move behind the catch bar with prefilled syringe to make and vacate the space that holds fix liquid in the syringe;
    (2) microsyringe with sterilization extracts fix liquid, and is subsequent use;
    (3) the soft tissue filler volume is designated as V1; Fix liquid is divided into X part, divides and inject syringe X time, method for implanting is following: at first; The syringe needle of microsyringe is penetrated the bottom until soft tissue filler from the head of syringe; In syringe, inject the fix liquid of a volume, then the syringe needle of microsyringe is retreated the distance of V1/X volume to the injector cephalad direction, in syringe, inject the fix liquid of a volume again; The distance of V1/X volume is retreated the syringe needle of microsyringe in continuation to the injector cephalad direction; And then in syringe, inject the fix liquid of a volume, the microsyringe step retreating and inject is all injected syringe until fix liquid so repeatedly;
    (4) after fix liquid all injects syringe,, can use at aseptic, normal temperature environment held 5-10 min with the syringe horizontal positioned.
  3. 3. method according to claim 1 and 2 is characterized in that: fix liquid divides the injection syringe 5-10 time.
  4. 4. method according to claim 3 is characterized in that: fix liquid divides the injection syringe 10 times.
  5. 5. method according to claim 2 is characterized in that: fix liquid is divided into X part, and the volume that at every turn injects syringe is identical.
  6. 6. method according to claim 1 and 2 is characterized in that: the volume ratio of fix liquid and soft tissue filler is 1:5 ~ 1:20.
  7. 7. method according to claim 1 and 2 is characterized in that: said fix liquid is lidocaine injection.
CN201210309684.4A 2012-08-28 2012-08-28 Method for mixing soft tissue filling agent with anesthetic injecta before use Active CN102805882B (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3015290A1 (en) * 2013-12-23 2015-06-26 Vivacy Lab HYALURONIC ACID COMPOSITIONS COMPRISING MEPIVACAINE
US10004824B2 (en) 2015-05-11 2018-06-26 Laboratoires Vivacy Compositions comprising at least one polyol and at least one anesthetic
CN111787966A (en) * 2017-12-19 2020-10-16 大化制药株式会社 Method for manufacturing a prefilled syringe comprising a local anesthetic and a hyaluronic acid hydrogel
CN113546539A (en) * 2020-04-24 2021-10-26 透策生技股份有限公司 Treatment method for accelerating dispersion of injection filler by using pressurization means
CN113648459A (en) * 2013-07-30 2021-11-16 泰奥赛恩公司 Composition comprising hyaluronic acid and mepivacaine

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US4743229A (en) * 1986-09-29 1988-05-10 Collagen Corporation Collagen/mineral mixing device and method
CN101027065A (en) * 2004-06-15 2007-08-29 陈献 Phospholipid compositions and methods for their preparation and use

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US4743229A (en) * 1986-09-29 1988-05-10 Collagen Corporation Collagen/mineral mixing device and method
CN101027065A (en) * 2004-06-15 2007-08-29 陈献 Phospholipid compositions and methods for their preparation and use

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113648459A (en) * 2013-07-30 2021-11-16 泰奥赛恩公司 Composition comprising hyaluronic acid and mepivacaine
FR3015290A1 (en) * 2013-12-23 2015-06-26 Vivacy Lab HYALURONIC ACID COMPOSITIONS COMPRISING MEPIVACAINE
WO2015097261A1 (en) * 2013-12-23 2015-07-02 Laboratoires Vivacy Hyaluronic acid compositions including mepivacaine
JP2017500358A (en) * 2013-12-23 2017-01-05 ラボラトアール ヴィヴァシィ Hyaluronic acid composition containing mepivacaine
EP3173086A1 (en) 2013-12-23 2017-05-31 Laboratoires Vivacy Hyaluronic acid compositions including mepivacaine
FR3044228A1 (en) * 2013-12-23 2017-06-02 Lab Vivacy HYALURONIC ACID COMPOSITIONS COMPRISING MEPIVACAINE
EA031349B1 (en) * 2013-12-23 2018-12-28 Лаборатуар Виваси Hyaluronic acid composition including mepivacaine
EA036502B1 (en) * 2013-12-23 2020-11-17 Лаборатуар Виваси Hyaluronic acid compositions including mepivacaine
EP3799875A1 (en) * 2013-12-23 2021-04-07 Laboratoires Vivacy Hyaluronic acid compositions including mepivacaine
US10004824B2 (en) 2015-05-11 2018-06-26 Laboratoires Vivacy Compositions comprising at least one polyol and at least one anesthetic
CN111787966A (en) * 2017-12-19 2020-10-16 大化制药株式会社 Method for manufacturing a prefilled syringe comprising a local anesthetic and a hyaluronic acid hydrogel
CN113546539A (en) * 2020-04-24 2021-10-26 透策生技股份有限公司 Treatment method for accelerating dispersion of injection filler by using pressurization means

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