CN103170016B - Medical lubricant - Google Patents
Medical lubricant Download PDFInfo
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- CN103170016B CN103170016B CN201310136620.3A CN201310136620A CN103170016B CN 103170016 B CN103170016 B CN 103170016B CN 201310136620 A CN201310136620 A CN 201310136620A CN 103170016 B CN103170016 B CN 103170016B
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Abstract
The invention discloses medical lubricant. The medial lubricant comprises the following components in percentage by weight: 0.02%-0.8% of organic silicon antifoaming agent, 0.2%-3% of dyclocaine hydrochloride, 0.1%-25% of glycerol, 0.1%-10% of xanthan gum and the balance of water. The medical lubricant can be used for realizing good lubricity, a good antifoaming effect and good water solubility; and moreover, the medical lubricant has the effects of a quick surface anesthetic effect and the like.
Description
Technical field
The present invention relates to medical field of lubricant, specifically relate to a kind of lubricant importing for medical apparatus and instruments body cavity.
Background technology
Clinically for making a definite diagnosis various intracavity diseases, be widely used various tract endoscope, at these medical apparatus and instruments (diagnostor such as endoscope, colposcope, cervical clamps, medical catheter), enter in the process of body cavities, often need to apply appropriate lubricant at medical apparatus surface, to reduce the damage of apparatus to tissue.To the requirement of this lubricant, be first to play certain anesthetic action, and corrosion-free to mirror body, self stability is good, and the little and no side effects to patient's zest, has the effects such as anesthesia, sterilization, froth breaking to tract mucomembranous surface.
But in current practical application clinically, the lubricant properties of tract endoscope-use is single, adopt silicone oil, glycerol, liquid paraffin etc., and these medicines can only play lubrication, do not possess local anesthesia and good lubricity more, patient is difficult to accept.Also the dispersion of finding silicone oil in clinical use is uneven, preparation thickness, poorly water-soluble, inhomogeneous, and transparency is inadequate, easily forms the cement of the solid shape of piece after using, and is attached on the tube walls such as digestive tract, blocks on the contrary lesions position, the accuracy that impact checks or undetected.
And carry out clinically tract inspection or when operation, in order to alleviate Principle of Pain conventional tetracain hydrochloride, the repeated multiple times spraying skin of Tetracaine Hydrochloride Solution or mucosa, for example carry out alimentary tract endoscope inspection, conventional tetracaine or tetracaine repeatedly spray into larynx and carry out pharyngeal mucosa after local anesthesia, alleviate that patient wipes mirror, pain and reflexive spasm while wiping pipe.But tetracain hydrochloride, tetracaine do not possess lubricated and defoaming function, and the anaesthetic toxicity such as tetracain hydrochloride, tetracaine is relatively large, and patient needs careful use.
CN200810041064.0 discloses a kind of for gastroscopic composition and method of making the same, simethicone used and Simethicone, and not froth breaking effect, key when it uses is the emulsifying of silicone oil.As incomplete in emulsifying, during use, meeting breakdown of emulsion, affects its result of use.For dyclonine hydrochloride is dissolved, a lot of silicone oil, emulsifying agent and thickening agent have been added.
CN200510040093.1 discloses a kind of oral preparation comprising dyclonine hydrochloride, wherein added polyvinyl alcohol and glycerol, and polyvinyl alcohol dissolves in glycerol at 120～l50 ℃. but become jelly while being chilled to room temperature.
In sum, need clinically a kind of existing good lubrication function, possess again that toxicity is low, local skin and mucomembranous anesthesia function safely and effectively simultaneously, and can also eliminate the tract inner foams such as digestive tract, safely and effectively multi-functional painless medical lubricant.
Summary of the invention
For the deficiency in above-mentioned existing lubricant, main purpose of the present invention is to provide a kind of medical lubricant, can realize that lubricity is good, defoaming effect is good, good water solubility and have the functions such as surperficial quick-anaesthesia effect, meets actual needs.
For achieving the above object, the technical solution used in the present invention is: a kind of medical lubricant, comprise the silicone defoaming agent of 0.02 ﹪～8 ﹪, the glycerol of the dyclonine hydrochloride of 0.2～3 ﹪, 0.1～25 ﹪, the xanthan gum of 0.1 ﹪～10 ﹪, all the other are water, above-mentioned percentage ratio is mass percent.
Preferably, described medical lubricant comprise the silicone defoaming agent of 1 ﹪～8 ﹪, the glycerol of the dyclonine hydrochloride of 0.6 ﹪～3 ﹪, 2 ﹪～25 ﹪, the xanthan gum of 1 ﹪～10 ﹪, all the other are water, above-mentioned percentage ratio is mass percent.
Further, described medical lubricant comprise the silicone defoaming agent of 1 ﹪～4 ﹪, the glycerol of the dyclonine hydrochloride of 0.6 ﹪～1.5 ﹪, 2 ﹪～5 ﹪, the xanthan gum of 1 ﹪～3 ﹪, all the other are water, above-mentioned percentage ratio is mass percent.
Preferably, described medical lubricant viscosity is between 50～200mpa.s.
Preferably, described medical lubricant pH value is between 4.0～7.0.Described medical lubricant is adjusted to pH value 4.0～7.0 with dilute hydrochloric acid.
Further, described medical lubricant viscosity is between 70～100mpa.s.
Further, described medical lubricant pH value is between 4.5～6.5.Described medical lubricant is adjusted to pH value 4.5～6.5 with dilute hydrochloric acid.
Dyclonine hydrochloride described in the present invention, chemical name 1-(4-butyl phenyl ether)-3-(1-piperidyl)-1-acetone hydrochlorate is white or the crystalline solid of white almost.Odorless, mildly bitter flavor, with after have anesthesia sense, be mainly used in local anesthesia, mucosa and skin surface anesthesia, analgesia and antipruritic, is a kind of new and effective analgesia pruritus, and has great bactericidal antiphlogistic effect, rapid-action, the persistent period is of a specified duration, and toxicity is relatively little, safe and reliable non-stimulated.This medicine dissolves in ethanol, slightly molten in water, but silicone defoaming agent energy solubilising dyclonine hydrochloride in the present invention, so need not add ethanol in preparation process.
Silicone defoaming agent described in the present invention, is milky viscous solution, does not have a volatility, good stability, and nonionic characteristic, temperature tolerance is good, 130 ℃ of holes not, floating oil, not stratified.Silicone defoaming agent can destroy and suppress the formation of bubble film, and defoamer enters the bimolecular oriented film of foam, destroys the mechanical balance of oriented film and reaches broken and steep object.The silicone defoaming agent bubble speed of dispelling is fast, can suppress formation of foam simultaneously, and for tract endoscope, can make doctor check and get a clear view, be a kind of good defoamer.Silicone defoaming agent also has lubricating effect simultaneously, complements each other with the xanthan gum in the present invention, collaborative lubricated, froth breaking.What the silicone defoaming agent described in the present invention adopted is the SXP-101-3 silicone defoaming agent of being produced by Suzhou City China Resources Chemical Co., Ltd..
Described in the present invention xanthan gum, be a kind of monospore polysaccharide being produced by the fermentation of the yellow sporangium of vacation, due to its macromole particularity, structure and colloid property, and there is several functions, integrate emulsifying, suspending stabilized, gel thickening, infiltration etc., bionical lubricated, superior performance.Xanthan gum good water solubility, emulsibility is good, energy and silicone defoaming agent be collaborative, dissolving mutually, is uniformly distributed in solvent, is easy to spraying, and the emulsibility and the thickening characteristic that possess due to xanthan gum itself, make need not add again various emulsifying agents and thickening agent in the present invention, just possess certain viscosity, and xanthan gum can make silicone defoaming agent in the present invention, dyclonine hydrochloride etc. can be good at lasting distribution, evenly performance effect, makes froth breaking, anesthesia and lubricated more lasting.Simultaneously the characteristic of xanthan gum is not had a greasy feeling, and easily wiping and disappearing is washed, and macromolecule medical material, utensil are not corroded, and does not destroy, non-stimulated to human body, avirulence.
Traditional with single lubricants such as silicone oil, glycerol in the prior art of comparing, medical lubricant of the present invention adopts the components such as silicone defoaming agent, dyclonine hydrochloride, xanthan gum, glycerol to be used in conjunction with, high lubricating effect, and can play certain anesthetic action, be beneficial to diagnosis in tract.
The invention has the beneficial effects as follows: the medical lubricant of the present invention possesses multi-efficiency: the lubricating when importing of wiping pipe, endoscope, the dryness utensil of body cavities are entered to human body, froth breaking to mucocutaneous local anesthesia and tract foam, multi-functional is integrated in one, save and check and operating time, alleviate patient's body and mind and health painful, improve and check and success rate of operation, significant clinically.
The specific embodiment
Below preferred embodiment of the present invention is described in detail, thereby so that advantages and features of the invention can be easier to be it will be appreciated by those skilled in the art that, protection scope of the present invention is made to more explicit defining.
embodiment 1. silicone defoaming agent 1g, dyclonine hydrochloride 1g, glycerol 3g, xanthan gum 2g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 4.5, adds purified water to 100mL.Mixing and stirring and get final product.
embodiment 2.silicone defoaming agent 4g, dyclonine hydrochloride 0.9g, glycerol 2g, xanthan gum 3g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 6.5, adds purified water to 100mL.Mixing and stirring and get final product.
embodiment 3. silicone defoaming agent 0.02g, dyclonine hydrochloride 0.2g, glycerol 0.1g, xanthan gum 0.1g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 4.0, adds purified water to 100mL.Mixing and stirring and get final product.
embodiment 4. silicone defoaming agent 8g, dyclonine hydrochloride 3g, glycerol 25g, xanthan gum 10g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 7.0, adds purified water to 100mL.Mixing and stirring and get final product.
embodiment 5. silicone defoaming agent 1g, dyclonine hydrochloride 0.6g, glycerol 2g, xanthan gum 1g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 4.5, adds purified water to 100mL.Mixing and stirring and get final product.
embodiment 6. silicone defoaming agent 0.1g, dyclonine hydrochloride 0.8g, glycerol 4g, xanthan gum 2g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 5.0, adds purified water to 100mL.Mixing and stirring and get final product.
embodiment 7. silicone defoaming agent 1g, dyclonine hydrochloride 0.6g, glycerol 3g, xanthan gum 1g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 4.0, adds purified water to 100mL.Mixing and stirring and get final product.
embodiment 8.silicone defoaming agent 4g, dyclonine hydrochloride 1.5g, glycerol 5g, xanthan gum 3g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 4.5, adds purified water to 100mL.Mixing and stirring and get final product.
embodiment 9.silicone defoaming agent 3g, dyclonine hydrochloride 1g, glycerol 3g, xanthan gum 2g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 4.8, adds purified water to 100mL.Mixing and stirring and get final product.
embodiment 10.silicone defoaming agent 5g, dyclonine hydrochloride 2g, glycerol 15g, xanthan gum 6g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 4.5, adds purified water to 100mL.Mixing and stirring and get final product.
All the other dosage groups can, with reference to above-mentioned example, make according to conventional adjusting process prescription.
comparative example 1
Western methyl-silicone oil 40g, dyclonine hydrochloride 1g, glyceryl monostearate 5g, Polyethylene Glycol 35 stearate 5g, hydroxypropyl emthylcellulose 20g, benzoic acid 200mg, adds water to 100mL.Preparation technology: take analgesic or local anaesthetics, thickening agent, add appropriate pure water, stirring and dissolving, obtains thickening fluid, standby; Take western methyl-silicone oil and GMO4G, PET35 stearate 4g, at 70～80 ℃, stir 20min, make melting, stop heating; Then slowly add 20～30 ℃ of hot water, and use stator-rotator type dispersing emulsification machine simultaneously, with 8000rpm, shear 10 minutes, obtain colostrum; By colostrum, under 30～40 ℃ of conditions, the pressure high pressure homogenize of use 300/100bar 5 times, must concentrate breast; This concentrated breast is dispersed in thickening agent liquid to gentle agitation mix homogeneously; With dilute hydrochloric acid, regulating pH value is 2～4.
comparative example 2
Defoamer 3g, dyclonine hydrochloride 1g, propylene glycol 15g, glycerol 40g, with purified water standardize solution 100mL.Mixing and stirring and get final product, regulates pH=4. 0 with dilute hydrochloric acid.Described defoamer is the GP type defoamer of Shijiazhuang Bai Na auxiliary chemicals company limited.
comparative example 3
Dyclonine hydrochloride 1g, methylcellulose 0.75g, sodium benzoate 0.1g, propylene glycol 30mL, distilled water adds to 100m L.Preparation technology: get dyclonine hydrochloride 1g, be dissolved in 40mL and steam in water; Separately get 20mL distilled water and be heated to 80 ℃～90 ℃, slowly add methylcellulose 0.75g, after abundant swelling, add while stirring dyclonine hydrochloride solution, after mix homogeneously, add sodium benzoate 0.1g, propylene glycol 30mL, last adding distil water is to 100mL, with salt acid for adjusting pH value to 4. 0, be stirred to water white transparency, obtain.
comparative example 4
Silicone defoaming agent 0.01g, dyclonine hydrochloride 1g, glycerol 3g, Arabic 3g, adds water appropriate, with dilute hydrochloric acid, regulates pH value to 7.0, adds purified water to 100mL.Mixing and stirring and get final product.
test example one:
Sample is placed under illumination (4500Lux), high temperature (60 ℃) condition each 10 days, accelerate (40 ℃, RH75%) and room temperature condition (25 ℃, RH60%) inspection of medicament contg, Shape Indexes is carried out in lower placement for 6 months.
The study on the stability result of embodiment 2～10 is substantially the same manner as Example 1, at this, does not repeat.
Table 2 embodiment 1 study on the stability result
The above results shows, the medical lubricant good stability of the present invention is placed 6 months under long-term and accelerated test condition, and significant change does not all occur for the content of sample, shape and ph.
test example two:
Get the Lumbricus of heavy 0. 5～5g, being divided into 6 groups, is respectively 1 group of embodiment, the medical lubricant group of import Y.Co company, 1 group of comparative example, 2 groups of comparative examples, 3 groups of comparative examples, 4 groups of comparative examples, every group 18, be stored in water content and be 25%～30% containing in humus soil, before experiment, by 2h in the Ringer liquid of it immigrations ventilation, during experiment, 5 groups of Lumbricuss are immersed respectively in each medicinal liquid of organizing.Every group in 1,3,5,8,12 and 16min respectively get 3 and immerse 1min in 300mL 0. 0125mol/ L HCl, observe sharply withdrawing reaction, calculate its negative response number, be calculated as follows anesthetic index:
Anesthetic index=negative response number/experiment Lumbricus is counted x 100%
Each anesthetic index of organizing Lumbricus is as shown in table n.
Note: each group is all got the medicinal liquid that is equivalent to dyclonine hydrochloride 1g and measured.
Embodiment 1 is basic identical with embodiment 2-10 effect, at this, does not repeat.
Table n anesthetic index measurement result
As seen from the above table, in lubricant of the present invention, dyclonine hydrochloride, because solute effect is good, therefore anaesthetic effect is good, is better than comparative example 1～4.The medical lubricant of import Y.Co. is owing to adding its anaesthetic effect of more anesthetis better.
test example three:
Get the medical lubricant of above-described embodiment 1 and comparative example 1～4 and import Y.Co company and carry out the investigation of froth breaking ability, and 25 ℃ of room temperature conditions, under RH60%, place the inspection of indexs such as carrying out shape and centrifugal stability (400rpm, 15mim) for 6 months.
Prepare foam liquid: take 1g Tween 80 and be dissolved in 100mL distilled water.
Prepare froth breaking liquid: take embodiment 1 sample 20mL; (containing silicone defoaming agent 0.2g)
Take comparative example 1 sample 0.4mL, add water to 20mL; (silicate-containing oil and emulsifying agent 0.2g)
Take comparative example 2 sample 6.7mL, add water to 20mL; (containing defoamer 0.2g)
Take comparative example 4 sample 1.7mL, add water to 20mL; (containing silicone defoaming agent 0.2g)
Take comparative example 3 sample 20mL; (without defoamer)
Take medical lubricant 20 mL of import Y.Co company.
Froth breaking ability assay method: 100mL foam liquid is joined in the 250mL tool plug reagent bottle that internal diameter is approximately 5cm, in 37 ℃ of waters bath with thermostatic control, the vibration pivot angle of take is 10 degree, with 300 ± 30 beats/min, vibrate 10 seconds, add 1mL froth breaking liquid, start timing, occur that first's non-foam liquid level stops timing.
It is substantially the same manner as Example 1 that the froth breaking ability of embodiment 2～10 is investigated result, do not repeat them here.
Table 3 froth breaking ability is investigated result
Above-mentioned experimental result shows, the present invention has good stability, under long-term and accelerated test condition, place 6 months, all there is not significant change in the content of sample, shape and pH, and froth breaking ability measurement result shows, foam time of the present invention is short, and its defoaming effect is obviously better than the medical lubricant product on market, is more better than comparative example 1～4.
test example four:
Friction test is carried out on improved MS-800A type four-ball tester.Get fresh unhairing Corii Sus domestica (moisture content) for lower test piece, do to go up test piece carry out end-face friction with the plastic sheet of Φ=25mm, rotating speed is 200r.p.m, and load is respectively 20N(newton), 39N(newton), 59N(newton).Experiment represents greasy property with coefficient of friction.
The lubricant effect of various samples under various load is listed in the table below in 4.It is substantially the same manner as Example 1 that the lubricating ability of embodiment 2～10 is investigated result, do not repeat them here.
Table 4. measuring friction coefficient result
From table 4, the present invention's coefficient of friction under 20N is in 0.000(instrumental sensitivity), under 39N load, μ of the present invention is still 0.000, under other load, this agent also shows best lubricity.
The foregoing is only embodiments of the invention; not thereby limit the scope of the claims of the present invention; every equivalent structure or conversion of equivalent flow process that utilizes description of the present invention to do; or be directly or indirectly used in other relevant technical fields, be all in like manner included in scope of patent protection of the present invention.
Claims (2)
1. a medical lubricant, it is characterized in that, comprise the silicone defoaming agent of 1 ﹪～4 ﹪, the glycerol of the dyclonine hydrochloride of 0.6 ﹪～1.5 ﹪, 2 ﹪～5 ﹪, the xanthan gum of 1 ﹪～3 ﹪, all the other are water, above-mentioned percentage ratio is mass percent, the pH value of described medical lubricant is between 4.0～7.0, and described medical lubricant viscosity is between 70～100mpa.s.
2. medical lubricant according to claim 1, is characterized in that, the pH value of described medical lubricant is between 4.5～6.5.
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103933621B (en) * | 2014-04-16 | 2015-12-02 | 广西信业生物技术有限公司 | A kind of medical lubricant and preparation method thereof |
| CN104958788B (en) * | 2015-06-30 | 2018-02-09 | 林飘飘 | A kind of medical lubricant and preparation method thereof |
| CN106492231B (en) * | 2016-11-03 | 2019-09-20 | 山东威高药业股份有限公司 | A kind of lidocaine hydrochloride cavity lubrication is dispelled infusion |
| CN110947008B (en) * | 2019-12-20 | 2022-03-18 | 郑州弘新医疗科技有限公司 | Orally-taken oxybuprocaine hydrochloride gastroscope lubricating liquid and preparation method thereof |
| CN111840657A (en) * | 2020-08-21 | 2020-10-30 | 湖南利德森医疗器械有限公司 | Coating preparation for gastroscope detection tube |
| CN113855863A (en) * | 2021-09-08 | 2021-12-31 | 深圳市盛康泰医疗器械有限公司 | Body cavity instrument lubricating liquid and preparation method thereof |
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