CN1197622C - Emulsion-type lubricant and its application in medical rubber product - Google Patents
Emulsion-type lubricant and its application in medical rubber product Download PDFInfo
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- CN1197622C CN1197622C CN 02100016 CN02100016A CN1197622C CN 1197622 C CN1197622 C CN 1197622C CN 02100016 CN02100016 CN 02100016 CN 02100016 A CN02100016 A CN 02100016A CN 1197622 C CN1197622 C CN 1197622C
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Abstract
The present invention relates to a lubricating agent, particularly to an emulsion type lubricating agent and an application thereof to surgical rubber products. The emulsion type lubricating agent contains stable water phase pack oil phase (O/W) emulsions, oil phase pack water phase (W/O) emulsions or multiple emulsions prepared from organic silicon oil base material liquid and a water base material lubricating agent. The used water base material lubricating agent comprises but is not limited by a solution formed from one or several kinds or all kinds of water, ethanediol, propanediol, glycerol, other water soluble toxic molecule with low polarity, water soluble polyethyleneglycol with different molecular weights, water soluble polypentose with different molecular weights, water soluble polyhexose with different molecular weights, etc. An oil base material lubricating agent is oily liquid containing organic silicon. Compared with simple organic silicon oil base material liquid or water base material lubricating agent, the O/W type, W/O type and multiple emulsion type of the present invention have improved lubrication extent. Oil soluble or/water soluble remedial or/and preventive medicine can be added to the emulsions.
Description
Technical field
The present invention relates to chemical lubricants, especially refer to a kind of emulsion-type lubricant of making by aqueous matrix lubricant (perhaps being called soluble oil) and oleaginous base lubricant, the invention still further relates to the application of this class emulsion-type lubricant on some medical apparatus and instruments (as latex or silica gel medical product etc.).
Background technology
The medical lubricant of present widely used human body has two big classes.One class is to be the lubricant of substrate with the oil medium, as vaseline and derivant, mineral oil (as baby oil) etc.; Another kind of aqueous matrix lubricant for making with water-soluble material is as KY lubricant etc.These lubricants are mainly used in the treatment, nursing of human body organ or tissue or exercise in the process such as normal physiological function and are lubricated effect.
In the production or use of the medical apparatus and instruments goods (as condom, medical catheter etc.) that latex, silicone rubber or other plastics etc. are made, often add specific proper amount of lubricating agent improve these medical products serviceability or effect, prevent to cause epidermis injury etc. because of the outer wall of these medical products and the friction of human epidermal.These lubricants should be to not having untoward reaction, should not change the character of medical apparatus and instruments material and should not reducing the normal performance of medical apparatus and instruments in human body.
In all proof oleaginous bases, proved that food oil, mineral oil, vaseline etc. can damage the security performance of the medical apparatus and instruments (such as condom, medical gloves etc.) that natural emulsion makes on distinct program.Such as mineral oil contact with condom be as short as for 60 seconds after, the intensity decreases of condom about 90%.[Bruce Voeller et al:Mineral OilLubricants Cause Rapid Deterioration of Latex Condoms.Contraception.1989,39 (1): 95-102; Yang Juan etc.: the effectiveness of condom, safety and progress.The reproductive medicine magazine.1998，7(2)：117-119]。Therefore, though these lubricants are still being used in others, be eliminated in the world or do not recommended as the lubricant of condom and other medical emulsion products and used.
In the condom manufacture process of decades, the dimethicone (being designated hereinafter simply as ' silicone oil ') that often adds certain viscosity is as lubricant in the past.Silicone oil is a kind of nonpolar silicon polymer, latex had stronger wellability, can be in 3～7 days, pass the condom that is rolled into annulus and the surfaces externally and internally of whole condom is lubricated, cohering between the latex surface in the preservation process can be prevented, certain in actual use lubricity can be provided again.Up to the present, still there is not silicone oil to influence the positive evidence of condom safety at short notice; Still do not find that in the world any other better oleaginous base can provide certain lubricity under the prerequisite of not damaging the latex safety.Therefore, in a period of time from now on, silicone oil will still can become the lubricant of condom manufacture and use.Silicone oil is also used in other medical domain simultaneously, lubricates, is used to prevent or treat intestinal obstruction etc. such as what be used for some latex catheters.
The lubricant of silicone oil substrate has some shortcomings, such as exist potential reduction latex prophylactic security performance may, in not enough, incompatible fully, the use of lubricity in enough yield limits or use greasy feeling and non-easy cleaning etc. are arranged later with the normal juice (for aqueous solution) in the female body.The 1980s, the someone begins the research carrying out the aqueous matrix lubricant and be applied to latex product (especially being applied to condom), and application and obtained the patent protection of some developed countries.The basic characteristics of aqueous matrix lubricant are: adopt the macromolecular water-soluble material as lubricated main body, its lubricity is than the obvious improve of silicone oil, and what have is enhanced about more than once; Reduce the fracture phenomena that takes place in the use of condom; Dissolve each other with the normal juice of female body; There is not oily sensation etc.On the market of Japan, the U.S., Britain and China, the condom commodity of aqueous matrix lubricant as lubricant had appearred using in succession in recent years; Developed country has brought into use the lubricated medical gum-elastic catheter of aqueous matrix lubricant etc.
But the aqueous matrix lubricant also has some shortcomings as the lubricant of druggist rubber sundrier.Such as, after through Long contact time aqueous matrix lubricant, the phenomenon that color is turned white appears in the latex wall of latex product, though still there is not evidence to show that this turning white can influence the safety of latex product, doctor or consumer can produce bad visual experience in use; In the process of the lubricity that further improves the aqueous matrix lubricant, can cause the raising of solution viscosity, thereby the flowability that reduces lubricant influences its result of use; And the aqueous matrix lubricant is poor to the wellability of latex wall, the penetration power difference between the latex wall in being rolled into circular condom etc.
The patent that adds antiviral drugs in soluble oil is abroad arranged.But in needs joined medicine in the lubricant, some are arranged was water miscible, and some are arranged then is oil-soluble.Therefore the lubricant system that simple aqueous matrix lubricant or oleaginous base lubricant can't provide the dissolving certain drug or dissolve two kinds of solvable character medicines of difference.
This shows, the lubricant of simple silicone oil substrate and simple aqueous matrix lubricant respectively have pluses and minuses, and far from ideal on result of use is if can be merged the advantage of the two and potentiation, and overcome shortcoming separately, then can contribute the better medical lubricant of a class.
Summary of the invention
In order further to improve the lubricity of lubricant, the phenomenon of avoiding the aqueous matrix lubricant to cause the latex wall to turn white, the invention provides a kind of novel lubricant of the advantage in conjunction with oleaginous base lubricant and aqueous matrix lubricant, and, this lubricant applications has been obtained extraordinary effect in the rubber medical apparatus at the specific requirement of druggist rubber sundrier to lubricant.
The present invention specifically uses aqueous matrix lubricant and oleaginous base lubricant, at a certain amount of emulsifying agent or/and in the presence of the co-emulsifier, under clean environment, under mechanical shear stress, high velocity fluid strikes, vacuum or ultrasound wave effect, form the stable Wo-emulsion of water bag oil phase (O/W structure), oil phase bag water (W/O structure), or the derivant of these basic structures.
Wherein employed aqueous matrix lubricant is with including, but are not limited to one or more or whole formed solution in the water-soluble poly hexose of water, ethylene glycol, propylene glycol, glycerol, other water-soluble nontoxic low molecule of polarity, the water-soluble polyethylene glycol of various molecular weight, the water-soluble poly pentose of various molecular weight, various molecular weight etc.; Wherein employed oleaginous base lubricant is for containing organosilyl oil-based liquid, and is with the better effects if of the organosilicon oiliness liquid of viscosity between 5～500mpa.s, best with the silicone oil effect of viscosity between 10～200mpa.s.
Wherein use the volume ratio amplitude of variation of oleaginous base lubricant and aqueous matrix lubricant can be very big, optimal proportion then should be according to the viscosity of employed two kinds of lubricants and employed emulsifying systems and specifically determine.For the emulsion-type lubricant of O/W type, generally speaking, the volume ratio of aqueous matrix lubricant and oleaginous base lubricant is 0.5～2.5: relatively good in the time of between 1, and with 1～1.6: the ratio between 1 is better.For the emulsion-type lubricant of W/O type, generally speaking, the ratio of aqueous matrix lubricant and oleaginous base lubricant is relatively good between 1: 0.5～2.5 the time, and better with the ratio between 1: 1～1.8.
Wherein, employed emulsifying agent is generally liquid emulsifier, and solid emulsifier can not be used for the present invention; In being suitable for the emulsifying agent of system of the present invention, comprise natural macromolecular (as water soluble polymers such as arabic gum, animal glue), phospholipid (as lecithin, soybean phospholipid etc.), steroidal class (as cholesterol etc.), and various synthetic emulsifiers (as Arlacels, polyoxyethylene aliphatic alcohol esters, polyoxyethylene aliphatic alcohol ether class, poloxalkol class plasma type and nonionic emulsifier).Employed co-emulsifier is generally ethylene glycol, propylene glycol, glycerol, n-butyl alcohol, hexanol, low polymeric ethylene glycol and analog thereof etc.The selection of optimum emulsification agent and co-emulsifier should be screened definite according to concrete emulsifying systems, but the basic principle of screening is: to animal and human's body nontoxic and untoward reaction minimum, cracking animal cell membrane ability minimum, do not have abnormal flavour or penetrating odor, to human body skin zest minimum, to the stable molecule of light, air, different moisture levels and temperature (temperature range is at least between-20 ℃ to+70 ℃).The volume ratio of emulsifying agent and co-emulsifier is generally 1: 0.2～10; If contain the co-emulsifier that polar molecule can play the effect of co-emulsifier or directly contain appropriate amount in the aqueous matrix lubricant, then in this emulsifying systems, can no longer add co-emulsifier.
The application mode of the emulsion-type lubricant among the present invention is after the druggist rubber sundrier molding, before sealing or after sealing, directly joins on the druggist rubber sundrier.For example, on each condom, add a certain amount of emulsion-type lubricant; The amount of the emulsion-type lubricant that adds is decided according to the specific needs of consumer or consumer groups, generally between 0.05～1.5 milliliter, with the better effects if between 0.2～0.8 milliliter; Perhaps in the packing of medical catheter, add independent seal-packed emulsion-type lubricant, the volume of the emulsion-type lubricant of sealing is generally between 0.5～5 milliliter.Employed medical grade rubber or plastic are for making for employed aqueous matrix lubricant or the stable material of employed oleaginous base lubricant, containing part or all of natural emulsion, the made medical apparatus and instruments better effects if of silicone rubber, for the using method and the effect basically identical of the medical product of difformity, different colours or different-thickness.
Show that through the experiment of animal the novel emulsion-type lubricant of this class or be added with the druggist rubber sundrier nonirritant of emulsion-type lubricant, no oncogenic function, no teratogenesis, does not have other untoward reaction at no mutagenic action; Through the actual use of limited human body (adopt directly smear or directly use the druggist rubber sundrier that is added with emulsion-type lubricant) is shown, novel emulsion-type lubricant of this class or the druggist rubber sundrier that is added with emulsion-type lubricant do not have appreciable zest and other untoward reaction.In the process of preparation emulsion-type lubricant, that employed all material is is highly stable, inertia and to animals and human beings height degree safety, and employed equipment and the material that touches are rustless steel or glass, and the formation of products at different levels is through physical reactions but not chemical reaction carries out.Therefore, also show emulsion-type lubricant or to be added with the druggist rubber sundrier of emulsion-type lubricant consistent with employed various raw materials to the safety of human body and animal in theory.
This class emulsion-type lubricant provided by the invention have higher, the lubricated longer duration of lubricity, liquid fluidity good, can dissolve any water solublity or oil-soluble medicine or other composition.With the latex product of this lubricant have better, the lubricated longer duration of lubricity, can be penetrated at short notice be rolled into circular condom root, wherein the part emulsion-type lubricant can thoroughly be avoided phenomenon that the latex wall surface is turned white.
Preparing according to method provided by the invention in the process of the novel emulsion-type lubricant of this class, can be at the oleaginous base lubricant or/and add needed treatment in the aqueous matrix lubricant or/and preventive medicine, such as spermicide, antibiotics, antiviral drugs, delay ejaculation medicine, enhancing sensitive drug etc., to increase and to expand the effect of this class novel lubricant.Water soluble drug is joined in the aqueous matrix lubricant, oil-soluble medicine is then joined in the oleaginous base lubricant.
Further illustrate the content of patent of the present invention below by specific embodiment.But should be appreciated that the content of patent of the present invention and the content that claimed scope includes, but are not limited to following example.
The specific embodiment
＜embodiment 1 〉
The dimethicone of 100～200 ml waters, 100～200 milliliters of viscosity 〉=100mpa.s and polyoxyethylene aliphatic alcohol ether and 5～15 milliliters of polymeric ethylene glycol of minuent of 10～30 milliliters are mixed, 〉=20, act on 2～5 minutes under 000 rev/min the shearing force, form milky emulsion, viscosity obviously improves.Through 70 ℃ place 7 days after, viscosity degradation ratio≤10%, the separating of oil rate of water≤15%.Appearance color becomes extremely yellowish.Get by adding the emulsion-type lubricant that 0.5ml makes in every natural emulsion condom, in 7 days, whole condom is lubricated basically behind the encapsulated membranes.
＜embodiment 2 〉
With Polyethylene Glycol 1, the 000 aqueous matrix lubricant of making (viscosity＞100mpa.s) 1,000～3,000 milliliter and 1,300～4, the rare polyoxypropylene copolymer of polyoxy second of the silicone oil of 500 milliliters of viscosity 〉=80mpa.s and 100～300 milliliters and glycerol mix, and under the vacuum emulsification machine or 〉=20, act on 5～15 minutes under 000 rev/min the high speed shear power, form milky emulsion, viscosity improves 50%.Through 70 ℃ place 7 days after, the separating of oil rate of water≤10%, appearance color becomes extremely yellowish, viscosity is constant substantially.Add the emulsion-type lubricant that 0.5ml makes in every natural emulsion condom, in 7 days, 70% condom length is lubricated behind the encapsulated membranes.
＜embodiment 3 〉
At the aqueous matrix lubricant of soluble polysaccharide (in 100～300 milliliters of the viscosity 〉=75mpa.s), the viscosity that adds 280～330ml is the dimethicone of 50mpa.s and 5～30 milliliters polyoxyethylene dehydration sorbic acid, effect is more than 10 minutes or 〉=15 in ultrasonic field, act on 3～5 minutes under 000 rev/min the shearing force, make the milky emulsion-type lubricant.Through 70 ℃ place 7 days after, viscosity degradation ratio＜5%, the separating of oil rate of water＜15%, appearance color becomes extremely yellowish; All character are without any significant change after room temperature is placed one month.Get by adding the emulsion-type lubricant that 0.5ml makes in every natural emulsion condom, in 7 days, whole condom is lubricated basically behind the encapsulated membranes.Get the made emulsion-type lubricant of 0.3ml and be added on the urethral catheter, directly be inserted into rabbit urine vagina, the easy degree of insertion is obviously little than the conduit that adds propylene glycol, further checks to show that rabbit vagina epidermis is not had observable stimulation.
＜embodiment 4 〉
Get 100～300 milliliters of propylene glycol, the polyoxyethylene hydrogenated Oleum Ricini 40 that adds 150～380 milliliters, with viscosity be the silicone oil of 100mpa.s, behind the mix homogeneously, 〉=12, under 000 rev/min the shear action, in 5～10 minutes, join gradually in 400～650 milliliters the solution of Polyethylene Glycol 500～1,000 of viscosity 〉=50 (acidity is 6.8), make the milky emulsion-type lubricant.Through 70 ℃ place 7 days after, viscosity degradation ratio＜8%, the separating of oil rate of water＜15%, appearance color becomes yellowish; All character are without any significant change after room temperature is placed one month.Use medical latex glove or disposable plastic latex examination gloves, soaked in the emulsion-type lubricant for preparing with this example one hour, tensile property, the sealing property of altex glove or plastic glove do not have significant change; The altex glove or the plastic glove lubrication when contacting with human epidermal that scribble this lubricant are felt good.Add 0.5 milliliter of lubricant that this example is made in the Polyurethane condom, whole condom is lubricated substantially in about the 10th day; Add lubricant after 30 days, pin hole is checked the ne-leakage phenomenon.
＜embodiment 5 〉
Get the aqueous matrix lubricant (viscosity＞50mpa.s), be dissolved with 1% zinc chloride (having antiviral activity) that 10～30 milliliters PEG400 is made; Get the silicone oil of 13～45 milliliters of viscosity 〉=80mpa.s, be dissolved with the NP-9 (a kind of spermicide) of 1mg/ml; Two series lubricant agents are mixed, and add 1～3 milliliter rare polyoxypropylene copolymer of polyoxy second and glycerol mixture, under the vacuum emulsification machine or 〉=20, act on 3～5 minutes under 000 rev/min the high speed shear power, form milky emulsion.Then, formed Emulsion is slowly joined in 32～95 milliliters the another kind of aqueous matrix lubricant (containing 10% PVP, 1～3 milliliter rare polyoxypropylene copolymer of polyoxy second and glycerol mixture).Add the emulsion-type lubricant that 0.7ml makes in every natural emulsion condom, in 10 days, 50% condom length is lubricated behind the encapsulated membranes.With fresh people's sperm according to 1: 1 ratio respectively with the multiple emulsion type mix lubricant of normal saline and this example preparation, placement is 5 minutes in 37 ℃ of airtight saturated humidity environment, uses optical microscope controlled observation sperm motility situation then.With the survival rate of the blended sperm of normal saline (sperm quantity that moves about/with sperm total quantity under the visual field) be 85%; With the survival rate that meets the blended sperm of emulsion-type lubricant then less than 5%.
Claims (8)
1, a kind of medical apparatus and instruments emulsion-type lubricant, it is characterized in that it is to contain organosilyl oleaginous base lubricant and prepared stable water bag oil phase Emulsion, the oil phase bag water Emulsion that forms of aqueous matrix lubricant, said oleaginous base lubricant is a dimethicone, one or more in the water-soluble poly pentose that said aqueous matrix lubricant is the water-soluble polyethylene glycol that is selected from water, ethylene glycol, propylene glycol, glycerol, various molecular weight, various molecular weight, the water-soluble poly hexose of various molecular weight or whole formed solution.
2, emulsion-type lubricant according to claim 1 is characterized in that said oleaginous base lubricant dimethyl-silicon oil viscosity is between 5～500mpa.s.
3, emulsion-type lubricant according to claim 2 is characterized in that said oleaginous base lubricant dimethyl-silicon oil viscosity is between 10～200mpa.s.
4, emulsion-type lubricant according to claim 1 is characterized in that the ratio of aqueous matrix lubricant and oleaginous base lubricant is 0.5～2.5: between 1 for water bag oil phase emulsion-type lubricant; For oil phase bag water emulsion-type lubricant, the ratio of aqueous matrix lubricant and oleaginous base lubricant is between 1: 0.5～2.5.
5, emulsion-type lubricant according to claim 4 is characterized in that the ratio of water-based nature lubricant and oleaginous base lubricant is 1～1.6: between 1 for water bag oil phase emulsion-type lubricant; For oil phase bag water emulsion-type lubricant, the ratio of aqueous matrix lubricant and oleaginous base lubricant is between 1: 1～1.8.
6, according to each described emulsion-type lubricant of claim 1 to 5, it is characterized in that aqueous matrix lubricant and oleaginous base lubricant are when forming water bag oil phase or oil phase bag water Emulsion liquid, also be added with emulsifying agent and/or co-emulsifier, and the volume ratio of emulsifying agent and co-emulsifier is generally 1: 0.2～10.
7, according to each described emulsion-type lubricant of claim 1 to 5, it is characterized in that before or after being prepared into emulsion-type lubricant, have treatment or/and the medicine of preventive effect at oil phase or/and aqueous phase adds in addition to have, said medicine comprises spermicide, antibiotics, antiviral drugs, delay ejaculation medicine.
8, each described medical apparatus and instruments emulsion-type lubricant application in medical apparatus and instruments of claim 1 to 5, said medical apparatus and instruments comprises medical grade rubber or plastic, and medical grade rubber or plastic comprise natural emulsion or contain natural emulsion condom, Polyurethane condom, natural emulsion or silicone rubber medical catheter, natural emulsion or plastics medical gloves.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02100016 CN1197622C (en) | 2002-01-04 | 2002-01-04 | Emulsion-type lubricant and its application in medical rubber product |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02100016 CN1197622C (en) | 2002-01-04 | 2002-01-04 | Emulsion-type lubricant and its application in medical rubber product |
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| Publication Number | Publication Date |
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| CN1356143A CN1356143A (en) | 2002-07-03 |
| CN1197622C true CN1197622C (en) | 2005-04-20 |
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| CN 02100016 Expired - Lifetime CN1197622C (en) | 2002-01-04 | 2002-01-04 | Emulsion-type lubricant and its application in medical rubber product |
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103892956B (en) * | 2012-12-27 | 2018-10-19 | 浙江相伴乳胶制品有限公司 | A kind of sheath with antivirus action |
| CN103446630B (en) * | 2013-08-23 | 2015-05-20 | 蔡智浙 | Safe and easy-to-clean lubricating oil composition for condoms and preparation method thereof |
| CN109890362A (en) * | 2016-06-30 | 2019-06-14 | 乐福思健康有限公司 | Lubricating fluid and massage gel |
| CN107041973A (en) * | 2016-07-11 | 2017-08-15 | 合肥九研医药科技开发有限公司 | A kind of condom for being coated with maca essential oil |
| CN106700162A (en) * | 2016-12-14 | 2017-05-24 | 宜兴市乐创文化发展有限公司 | Plastic toy material |
| CN110329659B (en) * | 2019-07-11 | 2023-07-28 | 广州万方健医药有限公司 | Novel sealed packing box |
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2002
- 2002-01-04 CN CN 02100016 patent/CN1197622C/en not_active Expired - Lifetime
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Application publication date: 20020703 Assignee: Langsheng Pharmaceutical Co., Ltd., Guangzhou City Assignor: Wanfangjian Medicine Co Ltd, Guangzhou Contract record no.: 2010440000369 Denomination of invention: Emulsion-type lubricant and its application in medical rubber product Granted publication date: 20050420 License type: Exclusive License Record date: 20100412 |
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