CN106178140A - A kind of pure natural water-soluble human body lubricants and preparation method and application - Google Patents
A kind of pure natural water-soluble human body lubricants and preparation method and application Download PDFInfo
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- CN106178140A CN106178140A CN201610612866.7A CN201610612866A CN106178140A CN 106178140 A CN106178140 A CN 106178140A CN 201610612866 A CN201610612866 A CN 201610612866A CN 106178140 A CN106178140 A CN 106178140A
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- human body
- pure natural
- natural water
- soluble human
- body lubricants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/005—Ingredients of undetermined constitution or reaction products thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/30—Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
Abstract
The present invention provides a kind of pure natural water-soluble human body lubricants, it is made up of the component of following mass percent: gellant: 1%~10%, emulsifying agent: 1%~10%, thickening agent: 0.5%~2%, pure Mel: 0.1%~1%, plant extract lubricating fluid: 0.5%~10%, conditioner: 0.5%~2%, surplus is sterilizing deionized water.The lubricant of the present invention has the greasy property of excellence, good stability, safety and environmental protection;Plant extract lubricating fluid therein uses the three-stage filtration technique of " mechanical grading filters microfiltration reverse osmosis concentration and purifies " to prepare, and remains the active component of most practical value;The mode using evacuation to combine with heating improves properties of product;There is sterilization, antiinflammatory, the diffusion of suppression inflammation, drain secretions, promote local metabolic, restrain the multi-efficiencies such as wound, the generation preventing pathological changes and tumor.
Description
Technical field
The invention belongs to medical apparatus and instruments technical field of lubricant, specifically, be about a kind of pure natural water-soluble human body
Lubricant and preparation method and application.
Background technology
During medical apparatus and instruments diagnostors such as () endoscope, colposcope, cervical clamps, medical catheters enters tract,
Generally require and be coated with appropriate lubricant at medical apparatus surface, to reduce the apparatus damage to tissue, major part at present
Hospital-based outpatient obstetrical clinic, in-patient department also use liquid paraffin,light oil, vaseline etc. as lubricant, the oily and all scholar of liquid paraffin
Woods is not only difficult to clean, and the tissues such as body cavity also produce certain zest, and easily mould growth.Conventional therapeutic medical human body
Lubricant is mostly the lubricant of oiliness, owing to the polarity of oily lubricant is less, so there are most of macromolecular materials
Various medical apparatus and instruments, articles for use and apparatus generation corrosivity destruction that macromolecular material is made by the chemical characteristic mixed.
Additionally, oil-soluble lubricant is produced by unstable reacting substance, its degree of stability is poor, and the medical apparatus and instruments employing lubricant needs
Want every day or use coating solution the most frequently, thus adding use cost.
The composition of soluble oil about 80% is water, and raw material used is the most all water soluble polymer raw material, assist with
A small amount of preservative, it is easy to clean, it is easy to degraded, environmental protection, himself stability is preferably and nothing equal to various medical apparatus and instruments
Corrosion, uses the body cavity apparatus after soluble oil lubrication not only to can guarantee that the lubrication playing excellence when importing, and
And to human body non-stimulated and toxic and side effects.Therefore soluble oil is the new developing direction of lubricant.
Chinese patent CN 1225291 discloses the production method of a kind of soluble oil, its primary raw material and proportioning
For glycerol: 10~20%, propylene glycol: 0~5%, Aloe powder: 1~1.2%, hydroxyethyl cellulose: 0.8~1.7%, anticorrosion
Agent: 0.3~1.5%, remaining is water.Although human body lubricants water solublity prepared by the method is relatively good, but from formula just
It can be seen that main component is the downstream cleavage product of the petroleum industries such as substantial amounts of glycerol and propylene glycol, life-time service can be to certain
The equipment of a little plastics or latex class has serious detrimental effect.
Chinese patent CN 103203042A discloses the preparation method of a kind of water-soluble medical lubricant, its primary raw material
And proportioning is: medical glycerol: 0.3%~1.5%, Polyethylene Glycol-300:3%~12%, Polyethylene Glycol-1450:4%~
10%, carbomer: 0.5%~1.5%, methyl parahydroxybenzoate: 0.001%~0.05%, sodium hydroxide: 0.1%~
0.5%, surplus is deionized water.The method be can yet be regarded as a kind of reasonable method preparing water-soluable gel lubricant, but
It is also seen that raw materials used mainly by the water-soluble polymer of Polymer Synthesizing from formula, the gel-type vehicle of use is
Carbomer, and carbomer can become gel in the basic conditions, it is therefore desirable to add sodium hydroxide or potassium hydroxide
Adjust lubricant extremely alkalescence, but sodium hydroxide or potassium hydroxide can increase the medical apparatus and instruments zest to mucosa.
United States Patent (USP) US 5688747 disclose a kind of using organosilicon as Lubrication Composition prepare for medical treatment such as conduits
The preparation method of the water base lubricant that equipment surfaces processes, its major defect is silicone poor stability, the most easily
Gather thus ecological environment is damaged.
Therefore, a kind of water-soluble human body lubricants of research and development, there is the greasy property of excellence, not only little to human body zest,
And good stability, safety and environmental protection just tool is of great significance.
Summary of the invention
First purpose of the present invention is to provide a kind of pure natural water-soluble human body lubricants, to overcome in prior art
Defect, there is excellent lubricating properties, little to human body zest, and good stability, the feature of safety and environmental protection, the most also have and disappear
Effect of sterilization.
Second object of the present invention is to provide the preparation method of described pure natural water-soluble human body lubricants.
For achieving the above object, the present invention adopts the following technical scheme that
A kind of pure natural water-soluble human body lubricants, is made up of the component of following mass percent:
Gellant: 1%~10%;
Emulsifying agent: 1%~10%;
Thickening agent: 0.5%~2%;
Pure Mel: 0.1%~1%;
Plant extract lubricating fluid: 0.5%~10%;
Conditioner: 0.5%~2%;
Surplus is sterilizing deionized water.
At least one in deer ear dish glue, pectin and yellowfin glue of described gellant.
At least one in glucoside, tragacanth and sucrose-fatty monoesters of described emulsifying agent.
Described thickening agent one in xanthan gum and hydroxypropyl methyl cellulose.
At least one in Aloe extraction solution, Flos abelmoschi manihot extracting solution and Rhizoma Dioscoreae extracting solution of described plant extract lubricating fluid.
At least one in Venenum apis, vitamin E and salicylic acid of described conditioner.
The preparation of described plant extract lubricating fluid comprises the steps:
1), being cleaned by plant material, air-dry, pulverize to obtain coarse powder, the sterilized water adding 2 times of quality of coarse powder soaks 24h, then
Filter with screen, obtain just extracting solution;
2), use microporous filter membrane to step 1) first extracting solution filter, obtain plant extraction liquid;
3), use hyperfiltration to step 2) plant extraction liquid purify, obtain plant extract lubricating fluid.
The preparation method of described pure natural water-soluble human body lubricants, comprises the technical steps that:
1), filling the vacuum gel reaction still evacuation of sterilizing deionized water, control vacuum is 0.1MPa, is constantly stirring
Mixing down gellant and the emulsifying agent being sequentially added into formula ratio, controlling temperature is 60 DEG C~80 DEG C, and rotating speed is 500r/min, and stirring is extremely
It is completely dissolved;
2), weighing the plant extract lubricating fluid of formula ratio, thickening agent, pure Mel and conditioner, to be sequentially added into vacuum gel anti-
Answer in still, insulation reaction, and to control vacuum be 0.1MPa, is stirred well to be mixed thoroughly, obtains the pure sky of the present invention
So water-soluble human body lubricants;
3), detecting step 2) viscosity of pure natural water-soluble human body lubricants, microorganism limitation and the pH value prepared, qualified
Rear employing Co 60 γ carries out radiation sterilization, encapsulation, warehouse-in.
The viscosity of described pure natural water-soluble human body lubricants is 15~25Pa.s, and pH value is 5.5~6.5.
The application in medical apparatus and instruments lubricates of the described pure natural water-soluble human body lubricants.
Compared with prior art, there is advantages that
1) the pure natural water-soluble human body lubricants formula pure natural of the present invention, adds without chemistry, has the lubrication of excellence
Performance, and nonirritant, good stability, safety and environmental protection;
2) mode that the pure natural water-soluble human body lubricants of the present invention uses evacuation to combine with heating ensure that profit
The smooth effusion of the bubble produced in lubrication prescription preparation process so that product parcel combines the tightst, improves the performance of product.
3) plant extract lubricating fluid uses the three-stage filtration work of " mechanical grading filters microfiltration reverse osmosis concentration and purifies "
Prepared by skill, remain the active component of most practical value, and pure natural water-soluble human body lubricants also has sterilization, antiinflammatory, presses down
Inflammation processed diffusion, drain secretions, promote local metabolic, restrain the multiple merits such as wound and the generation preventing pathological changes and tumor
Effect.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention will be further described.Should be understood that following example are merely to illustrate this
Invent not for limiting the scope of the present invention.
All raw materials in the present invention are commercially available, wherein: reverse osmosis membrane is the energy-saving ultrafiltration composite membrane of HYDRAcap60.
Method of testing and standard:
To gel preparation phase in detection foundation " Chinese Pharmacopoeia " (2010) of the viscosity of product, microorganism limitation and pH value
Close requirement and detection method detects.
According to annex XIXC in " Chinese Pharmacopoeia " (2010), " crude drug is stable with pharmaceutical preparation in the detection of product stability
Property test direction principle " in the 3rd method " long term test " method detect.
Pure natural water-soluble human body lubricants formula:
Through lot of experiments, preferably go out pure natural water-soluble human body lubricants formula, the most as shown in table 1.
Table 1 pure natural water-soluble human body lubricants formula
The preparation of plant extract lubricating fluid:
1), plant material clean through sterile water wash, air-dry, high speed disintegrator is pulverized, and obtains coarse powder, adds matter in coarse powder
Amount is the sterilized water of meal quality 2 times, soaks 24h, then filters with the screen of 300 mesh, obtains just extracting solution;
2), to use aperture be the filtering with microporous membrane step 1 of 0.8 μm) first extracting solution, filter mechanical particles, planted
Thing extracting solution;
3) use hyperfiltration purification step 2) plant extraction liquid, selectivity remove the impurity such as water, anthocyanin, planted
Thing extracts lubricating fluid.
Embodiment 1-7: the preparation of pure natural water-soluble human body lubricants
The concrete preparation process of pure natural water-soluble human body lubricants is as follows:
1), fill the vacuum gel reaction still evacuation of sterilizing deionized water, under being stirred continuously, be sequentially added into formula ratio
Gellant and emulsifying agent, control vacuum is 0.1MPa, control temperature be 60 DEG C~80 DEG C, rotating speed is 500r/min, stirring
3h so that gellant and emulsifying agent are completely dissolved;
2), weighing the plant extract lubricating fluid of formula ratio, thickening agent, pure Mel and conditioner, to be sequentially added into vacuum gel anti-
Answering in still, keep the state of evacuation during charging, reduction rotating speed, to 300r/min, controls temperature 60 DEG C~80 DEG C insulations
Reaction 5h, is stirred well to be mixed thoroughly, and the vacuum controlled in reactor in whipping process is 0.1MPa, obtains this
Bright pure natural water-soluble human body lubricants product.
3), detecting the viscosity of product, pH value and microorganism limitation, qualified rear employing Co 60 γ carries out radiation sterilization, encapsulation,
Warehouse-in.
Pure natural water-soluble human body lubricants preparation technology parameter is as shown in table 2:
Table 2 pure natural water-soluble human body lubricants technological parameter
Embodiment 8: zest and lubricity test
Use the pure natural water-soluble human body lubricants prepared of embodiment of the present invention 1-7 and Regular Human's lubricant respectively
Painting carries out contrast test, and detection is smeared the catheter of lubricant and to the zest of body cavity mucosa and the penetration of catheter and led
Gravitation, zest scoring and power size (unit N) as shown in Table 3 and Table 4:
Table 3: irritation test result
Table 4: penetration and pull strength result of the test
Can be seen that from the result of table 3 and table 4, smear the thorn of the catheter of the pure natural water-soluble human body lubricants of the present invention
Swash property scoring and penetration and pull strength is all substantially less than matched group.The thorn of the pure natural water-soluble human body lubricants of the present invention
Sharp property is conventional lubricants irritating 67.25~70%, and penetration is about the 66% of conventional lubricants penetration, and pull strength is about
For the 46% of the pull strength of conventional lubricants, illustrate that the pure natural water-soluble human body lubricants product of the present invention uses safety, thorn
Swash property little, excellent lubricating properties.
Embodiment 9: stability test
The pure natural water-soluble human body lubricants prepared embodiment 1-7 respectively carries out stability test, detects each enforcement
Product prepared by example the 0th month, March, June, JIUYUE, December, the 18th month, the 24th month, the stability of the 36th month, survey
Test result shows, product prepared by each embodiment is water white transparency and homogeneous gelinite, without layering, illustrates that the present invention's is pure
Water-soluble human body lubricants good stability, the shelf-life was up to more than 36 months.
Being described in detail the specific embodiment of the present invention above, but it is only used as example, the present invention is not limiting as
In particular embodiments described above.To those skilled in the art, any equivalent modifications that this invention is carried out and replacing
In generation, is the most all among scope of the invention.Therefore, the equalization made without departing from the spirit and scope of the invention converts and repaiies
Change, all should contain within the scope of the invention.
Claims (10)
1. a pure natural water-soluble human body lubricants, it is characterised in that be made up of the component of following mass percent:
Gellant: 1%~10%;
Emulsifying agent: 1%~10%;
Thickening agent: 0.5%~2%;
Pure Mel: 0.1%~1%;
Plant extract lubricating fluid: 0.5%~10%;
Conditioner: 0.5%~2%;
Surplus is sterilizing deionized water.
2. pure natural water-soluble human body lubricants as claimed in claim 1, it is characterised in that described gellant is selected from deer ear dish
At least one in glue, pectin and yellowfin glue.
3. pure natural water-soluble human body lubricants as claimed in claim 1, it is characterised in that described emulsifying agent is selected from glucose
At least one in glycosides, tragacanth and sucrose-fatty monoesters.
4. pure natural water-soluble human body lubricants as claimed in claim 1, it is characterised in that described thickening agent is selected from xanthan gum
With the one in hydroxypropyl methyl cellulose.
5. pure natural water-soluble human body lubricants as claimed in claim 1, it is characterised in that described plant extract lubricating fluid selects
At least one in Aloe extraction solution, Flos abelmoschi manihot extracting solution and Rhizoma Dioscoreae extracting solution.
6. pure natural water-soluble human body lubricants as claimed in claim 1, it is characterised in that described conditioner selected from Venenum apis,
At least one in vitamin E and salicylic acid.
7. pure natural water-soluble human body lubricants as claimed in claim 1, it is characterised in that described plant extract lubricating fluid
Preparation comprises the steps:
1), being cleaned by plant material, air-dry, pulverize to obtain coarse powder, the sterilized water adding 2 times of quality of coarse powder soaks 24h, then with filter
It is sieved through filter, obtains just extracting solution;
2), use microporous filter membrane to step 1) first extracting solution filter, obtain plant extraction liquid;
3), use hyperfiltration to step 2) plant extraction liquid purify, obtain plant extract lubricating fluid.
8. the preparation method of the pure natural water-soluble human body lubricants as according to any one of claim 1~6, including following work
Skill step:
1), filling the vacuum gel reaction still evacuation of sterilizing deionized water, control vacuum is 0.1MPa, under being stirred continuously
Being sequentially added into gellant and the emulsifying agent of formula ratio, controlling temperature is 60 DEG C~80 DEG C, and rotating speed is 500r/min, and stirring is to completely
Dissolve;
2), weigh the plant extract lubricating fluid of formula ratio, thickening agent, pure Mel and conditioner and be sequentially added into vacuum gel reaction still
In, insulation reaction, and to control vacuum be 0.1MPa, is stirred well to be mixed thoroughly, obtains the pure natural water of the present invention
Dissolubility human body lubricants;
3), detecting step 2) viscosity of pure natural water-soluble human body lubricants, microorganism limitation and the pH value prepared, qualified after adopt
Radiation sterilization is carried out with Co 60 γ, encapsulation, warehouse-in.
9. the viscosity of the pure natural water-soluble human body lubricants as according to any one of claim 1-6 is 15~25Pa.s, pH
Value is 5.5~6.5.
10. the answering in medical apparatus and instruments lubricates of the pure natural water-soluble human body lubricants as according to any one of claim 1-6
With.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107998461A (en) * | 2017-11-17 | 2018-05-08 | 深圳市宜丽健康科技发展有限公司 | A kind of sheath that is exclusively used in has the function of the soluble oil of composite antibacterial |
CN109200344A (en) * | 2018-10-16 | 2019-01-15 | 惠州卫生职业技术学院 | A kind of midwifery is with lubricator and preparation method thereof |
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CN101773513A (en) * | 2009-01-14 | 2010-07-14 | 邢建慧 | Water soluble body lubricant with natural antibacterial components and with pH value consistence with pH value of vagina |
CN102077882A (en) * | 2010-12-14 | 2011-06-01 | 广州泽力医药科技有限公司 | Technology for preparing high content tea polyphenol using water as single solvent |
US20150157674A1 (en) * | 2012-05-18 | 2015-06-11 | Bhatia Rishi | Herbal composition for vaginal treatment |
CN104958788A (en) * | 2015-06-30 | 2015-10-07 | 苏州乔纳森新材料科技有限公司 | Medical lubricant and preparing method thereof |
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2016
- 2016-07-29 CN CN201610612866.7A patent/CN106178140B/en active Active
Patent Citations (4)
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CN101773513A (en) * | 2009-01-14 | 2010-07-14 | 邢建慧 | Water soluble body lubricant with natural antibacterial components and with pH value consistence with pH value of vagina |
CN102077882A (en) * | 2010-12-14 | 2011-06-01 | 广州泽力医药科技有限公司 | Technology for preparing high content tea polyphenol using water as single solvent |
US20150157674A1 (en) * | 2012-05-18 | 2015-06-11 | Bhatia Rishi | Herbal composition for vaginal treatment |
CN104958788A (en) * | 2015-06-30 | 2015-10-07 | 苏州乔纳森新材料科技有限公司 | Medical lubricant and preparing method thereof |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107998461A (en) * | 2017-11-17 | 2018-05-08 | 深圳市宜丽健康科技发展有限公司 | A kind of sheath that is exclusively used in has the function of the soluble oil of composite antibacterial |
CN109200344A (en) * | 2018-10-16 | 2019-01-15 | 惠州卫生职业技术学院 | A kind of midwifery is with lubricator and preparation method thereof |
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