[go: up one dir, main page]

CN114939191B - Water-soluble lubricating liquid and preparation method and application thereof - Google Patents

Water-soluble lubricating liquid and preparation method and application thereof Download PDF

Info

Publication number
CN114939191B
CN114939191B CN202210424205.7A CN202210424205A CN114939191B CN 114939191 B CN114939191 B CN 114939191B CN 202210424205 A CN202210424205 A CN 202210424205A CN 114939191 B CN114939191 B CN 114939191B
Authority
CN
China
Prior art keywords
lubricating fluid
salt
hyaluronic acid
hyaluronate
lubricating
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN202210424205.7A
Other languages
Chinese (zh)
Other versions
CN114939191A (en
Inventor
范馨仪
张晓鸥
毛华
陈衍玲
郭学平
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bloomage Biotech Co Ltd
Original Assignee
Bloomage Biotech Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bloomage Biotech Co Ltd filed Critical Bloomage Biotech Co Ltd
Priority to CN202210424205.7A priority Critical patent/CN114939191B/en
Publication of CN114939191A publication Critical patent/CN114939191A/en
Priority to PCT/CN2023/089194 priority patent/WO2023202615A1/en
Application granted granted Critical
Publication of CN114939191B publication Critical patent/CN114939191B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/04Macromolecular materials
    • A61L31/042Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/452Lubricants

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Medicinal Preparation (AREA)

Abstract

The application provides a water-soluble lubricating fluid, which comprises compound polyol, hyaluronic acid or salt thereof, acetylated hyaluronic acid or salt thereof and a rheological agent; the water-soluble lubricating liquid is reasonably compounded by a plurality of components, and when the water-soluble lubricating liquid is used as a condom lubricating liquid, the natural latex condom has large spreading area in unit time, less residues in an aluminum foil bag and almost the same lubricating time as silicone oil. Thereby improving the competitiveness of the product in the aspects of condom production, package, storage and the like.

Description

Water-soluble lubricating liquid and preparation method and application thereof
Technical Field
The application relates to a lubricating fluid, in particular to a water-soluble lubricating fluid and a preparation method thereof, and belongs to the technical field of lubricants.
Background
Due to popularization of scientific knowledge and improvement of health consciousness, more and more people select a safer and easily-cleaned lubricating liquid which can replace an oil lubricating liquid, namely a water-soluble lubricating liquid. However, with the use of water-soluble condom liquid becoming more common, the practical problems associated therewith are also revealed in various links of condom production, packaging, storage, etc. For example, the spreading area of the water-soluble condom liquid on the natural latex condom in unit time is smaller than that of the silicone oil lubricating liquid, namely the time for completely soaking and covering the condom is longer; the lubricating time is shorter than that of the silicone oil lubricating liquid, etc. And the problems faced by both water-soluble condom liquid and silicone oil lubricating liquid: the surface tension of the liquid on the packaging material (aluminum foil bag) is low, so that when the condom is taken out, a certain amount of lubricating liquid still remains in the packaging bag, and the product cost is increased.
In order to solve the problems of practical application of the water-soluble lubricating liquid in production, storage and the like, the water-soluble lubricating liquid is used for comprehensively replacing silicone oil, more careful consideration is needed in development, and a water-soluble condom liquid which has better wettability with natural latex, less residues in an aluminum foil bag and better lubricating function is developed.
Disclosure of Invention
Aiming at the defects existing in the prior art, the application provides the water-soluble lubricating liquid, when the water-soluble lubricating liquid is used as lubricating liquid for condoms, the natural latex condoms have large spreading area in unit time and less residues in aluminum foil bags, and the lubricating liquid has almost the same lubricating time as silicone oil. Thereby improving the competitiveness of the product in the aspects of condom production, package, storage and the like. .
In particular, the application adopts the following technical scheme,
1. a water-soluble lubricating fluid comprises compound polyalcohol, hyaluronic acid or its salt, acetylated hyaluronic acid or its salt, and rheological agent;
preferably consists of a complexing polyol, hyaluronic acid or a salt thereof, acetylated hyaluronic acid or a salt thereof, a rheological agent and water.
2. The lubricating fluid according to item 1, wherein the compound polyol is 10 to 30% by weight of the lubricating fluid, the hyaluronic acid or salt thereof is 0.05 to 1%, the acetylated hyaluronic acid or salt thereof is 0.01 to 0.5%, and the rheological agent is 0.01 to 2%;
preferably, the compound polyol is 15-25%, the hyaluronic acid or salt thereof is 0.1-0.8%, the acetylated hyaluronic acid or salt thereof is 0.05-0.3%, and the rheological agent is 0.01-0.8%.
3. The lubricating fluid according to item 1 or 2, wherein the compound polyol is any two or more of glycerol, polyethylene glycol, sorbitol and pentanediol;
preferably glycerol, sorbitol and polyethylene glycol in a ratio of 5-10:1:1-5, preferably 5-10:1:1-2.
4. The lubricating fluid according to any one of items 1 to 3, wherein the weight average molecular weight of the hyaluronic acid or salt thereof is 1 to 100wDa, preferably 20 to 40wDa.
5. The lubricating fluid according to any one of items 1 to 4, wherein the acetylated hyaluronic acid or salt thereof has a weight-average molecular weight of 3 to 10wDa, preferably 3 to 5wDa.
6. The lubricating fluid according to any one of items 1 to 5, wherein the rheological agent is one or more of xanthan gum, gum arabic or phytosphingosine.
7. The lubricating fluid according to any one of items 1 to 6, wherein the hyaluronate is a water-soluble salt of hyaluronic acid, and is selected from any one of sodium hyaluronate, zinc hyaluronate, magnesium hyaluronate and potassium hyaluronate, preferably sodium hyaluronate.
8. The lubricating fluid according to any one of claims 1 to 7, which has a dynamic viscosity of 500 to 2000mpa.s, preferably 800 to 1000mpa.s.
9. A method of preparing the lubricating fluid of any one of claims 1-8, comprising the steps of:
uniformly mixing hyaluronate, acetylated hyaluronate and compound polyol to obtain a mixture;
adding water into the mixture, heating while stirring, adding a rheological agent, and stirring at the temperature until a uniform solution is obtained;
the rheology agent is preferably added when the temperature is raised to 40-60 ℃.
10. The use of the lubricating fluid according to any one of items 1 to 8 or the lubricating fluid prepared according to item 9 in a lubricating fluid for condoms, medical devices or for humans, preferably in a lubricating fluid for condoms.
11. A lubricating fluid for condoms, a lubricating fluid for medical devices or a lubricating fluid for human bodies, comprising the lubricating fluid according to any one of items 1 to 8 or the lubricating fluid prepared according to item 9.
Effects of the application
According to the lubricating liquid, through the collocation of the compound polyol and the hyaluronate, the lubricating duration of the lubricating liquid is prolonged on the basis of ensuring safety and easy cleaning; by compounding the acetylated hyaluronic acid and the rheological agent, the spreading area of the condom liquid on the natural latex condom in unit time is increased, the residue of the condom liquid in an aluminum foil bag when the condom is taken out is reduced, and the condom liquid can flow out from a nozzle easily when the condom liquid is filled into a bag due to the selection of specific viscosity and the rheological agent, so that less residue exists in a filling pipeline, and the production, packaging and storage costs are further saved; finally, the water-soluble lubricating fluid does not contain preservative, and adverse reaction caused by the use of the preservative is prevented.
After the formula of the application is selected and tested according to the accelerated aging test (placed in a 70 ℃ stability test box for 7 days) in the natural latex condom technical requirement and experimental method, the application passes the pinhole and bursting test, thereby ensuring that the quality of the condom is not affected.
Detailed Description
The application will be further illustrated with reference to the following examples, which are to be understood as merely further illustrating and explaining the application and are not to be construed as limiting the application.
Unless defined otherwise, technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present application, the materials and methods are described herein below. In case of conflict, the present specification, including definitions therein, will control and materials, methods, and examples, will control and be in no way limiting. The application is further illustrated below in connection with specific examples, which are not intended to limit the scope of the application.
The application provides a water-soluble lubricating fluid, which comprises compound polyol, hyaluronic acid or salt thereof, acetylated hyaluronic acid or salt thereof and a rheological agent.
In the present application, the polyol is in accordance with the general definition in the art, and refers to a large class of alcohols having two or more hydroxyl groups in the molecule. The general formula is C n H 2n +2-x (OH) x (x.gtoreq.2). The compound polyol is a composite material obtained by mixing two or more polyols in a certain proportion.
In the present application, the hyaluronic acid is in accordance with the general definition in the art, referring to a biopolymer material consisting of repeating units N-acetyl-D-glucosamine and D-glucuronic acid in a linear linkage. In the present application, hyaluronic acid or a salt thereof is used to include hyaluronic acid itself, a salt thereof, or a combination thereof. Examples of hyaluronate include, but are not limited to: inorganic salts such as sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, magnesium hyaluronate, zinc hyaluronate, gold hyaluronate, cobalt hyaluronate; and organic salts such as tetrabutylammonium hyaluronate. In the present application, hyaluronic acid itself or a salt thereof may be used alone, or a combination of two or more kinds of hyaluronic acid or a salt thereof may be used.
In a preferred embodiment, the hyaluronic acid salt is a water-soluble salt of hyaluronic acid, and more preferably any one of sodium hyaluronate, zinc hyaluronate, magnesium hyaluronate, and potassium hyaluronate. In a specific embodiment, the hyaluronate is sodium hyaluronate.
The weight average molecular weight of the hyaluronic acid or a salt thereof is not limited, and in a preferred embodiment, the weight average molecular weight of the hyaluronic acid or a salt thereof is 1 to 100wDa, and may be, for example, 1wDa, 5wDa, 10wDa, 20wDa, 30wDa, 40wDa, 50wDa, 60wDa, 70wDa, 80wDa, 90wDa, 100wDa, and more preferably 20 to 40wDa.
In the application, the sodium hyaluronate is obtained by acetylation reaction of sodium hyaluronate, and the introduction of acetyl makes the sodium hyaluronate have hydrophilicity and lipophilicity, so that the biological activities of double moisturizing, repairing stratum corneum barrier, improving skin elasticity and the like can be exerted, and simultaneously, the sodium hyaluronate has targeting property due to the lipophilicity. The molecular weight range of the sodium hyaluronate can be obtained by measuring the relative viscosity by using an Ubbelohde viscometer and calculating according to a formula. In the present application, the weight average molecular weight of the acetylated hyaluronic acid or salt thereof is not limited, and in a preferred embodiment, the weight average molecular weight of the acetylated hyaluronic acid or salt thereof is 3 to 10wDa, for example, may be 3wDa, 4wDa, 5wDa, 6wDa, 7wDa, 8wDa, 9wDa, 10wDa, and more preferably 3 to 5wDa.
In the application, the rheological agent refers to an auxiliary agent capable of improving or controlling rheological properties such as liquid viscosity, mainly affecting the rheological properties of liquid and playing a certain role in thickening and suspending. Rheology agents useful in the present application include, but are not limited to, one or more of chitosan, carbomer, sodium or potassium carboxymethyl chitin, sodium or potassium carboxymethyl chitosan, polyquaternium-10, guar gum, polyhexamethylene guanidine, carboxymethyl cellulose, hydroxyethyl cellulose, polyvinylpyrrolidone, sodium polyacrylate, xanthan gum, gum arabic, or phytosphingosine.
In a preferred embodiment, the rheological agent is selected from one or more of xanthan gum, gum arabic or phytosphingosine.
Preferably, the rheology agent is xanthan gum and gum arabic;
preferably, the rheology agent is xanthan gum and phytosphingosine;
preferably, the rheology agent is gum arabic and phytosphingosine;
preferably, the rheological agent is xanthan gum;
preferably, the rheology agent is gum arabic;
preferably, the rheological agent is phytosphingosine.
In the present application, the amounts of the components in the lubricating fluid are not limited, and in a preferred embodiment, are calculated as weight percent of the lubricating fluid,
the compound polyol is 10-30%, for example, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%:
the hyaluronic acid or salt thereof is 0.05-1%,0.05%, 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, 0.45%, 0.5%, 0.55%, 0.6%, 0.65%, 0.7%, 0.75%, 0.8%, 0.85%, 0.9%, 0.95%, 1%;
the acetylated hyaluronic acid or salt thereof is 0.01-0.5%,0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, 0.45%, 0.5%;
the rheological agent is 0.01-2%;0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, 0.45%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2%.
In a preferred embodiment, the complexing polyol is 15-25%, the hyaluronic acid or salt thereof is 0.1-0.8%, the acetylated hyaluronic acid or salt thereof is 0.05-0.3%, and the rheological agent is 0.01-0.8%.
In the present application, the type and amount of the polyol in the compound polyol are not limited, and in some preferred embodiments, the compound polyol is selected from any two or more of propanol, isopropanol, propylene glycol, 1, 3-propanediol, dipropylene glycol, glycerin, diglycerin, butanediol, 1, 3-butanediol, 1, 2-butanediol, 1, 4-butanediol, 2, 3-butanediol, pentanediol, 1, 2-pentanediol, 1, 5-pentanediol, t-butanol, diethylene glycol, triethylene glycol, hexanol, 1, 2-hexanediol, 1, 6-hexanediol, nonanediol, 1, 9-nonanediol, lactitol, octanediol, polyethylene glycol, ethylene glycol, and sorbitol.
In a further preferred embodiment, the compound polyol is any two or more of glycerol, polyethylene glycol, sorbitol and pentanediol. For example, the number of the cells to be processed,
the compound polyol is glycerol, polyethylene glycol and sorbitol;
the compound polyol is glycerol, polyethylene glycol and pentanediol;
the compound polyol is glycerol, sorbitol and pentanediol;
the compound polyol is polyethylene glycol, sorbitol and pentanediol;
the compound polyol is glycerol and polyethylene glycol;
the compound polyol is glycerol and sorbitol;
the compound polyol is glycerol and pentanediol;
the compound polyol is polyethylene glycol and sorbitol;
the compound polyol is polyethylene glycol and pentanediol;
the compound polyol is sorbitol and pentanediol.
In a preferred embodiment, the formulated polyol is a mixture of glycerol, sorbitol, and polyethylene glycol, wherein the glycerol, sorbitol, and polyethylene glycol ratio is 5-10:1:1-5, and may be, for example, 5:1:1, 6:1:1, 7:1:1, 8:1:1, 9:1:1, 10:1:1, 5:1:2, 6:1:2, 7:1:2, 8:1:2, 10:1:2, 5:1:3, 6:1:3, 7:1:3, 8:1:3, 9:1:3, 10:1:3, 5:1:4, 6:1:4, 7:1:4, 8:1:4, 9:1:4, 10:1:4, 5:1:5, 7:1:5, 8:1:5, 9:1:5, 10:1:5. Preferably, the ratio of glycerol, sorbitol and polyethylene glycol is 5-10:1:1-2.
The dynamic viscosity (dynamic viscosity), also known as dynamic viscosity, absolute viscosity or simple viscosity, is defined as the ratio of stress to strain rate, which is numerically equal to 1m in area 2 Two plates 1m apart, when relatively moved at a speed of 1m/s, generate internal friction due to the interaction of the fluids present between them. The unit is N.s/m 2 (Newton seconds per meter square), i.e. Pa.s (Pa.s), the dimension of which is M/(L.T)
The dynamic viscosity of the lubricating fluid of the present application is 500 to 2000mpa.s, and may be 500mpa.s, 600mpa.s, 700mpa.s, 800mpa.s, 900mpa.s, 1000mpa.s, 1100mpa.s, 1200mpa.s, 1500mpa.s, 170 mpa.s, 1500mpa.s, 190 mpa.s, 2000mpa.s, more preferably 800 to 1000mpa.s.
The application further provides a method for preparing any one of the lubricating fluids described above, comprising the steps of:
uniformly mixing hyaluronate, acetylated hyaluronate and compound polyol to obtain a mixture; the mixing process can be any mixing mode commonly used in the field, and the mixing effect can be increased by means of external force such as heating, stirring, ultrasonic and the like.
Adding water to the mixture, heating while stirring to accelerate the dissolution of the mixture, adding a rheological agent, and stirring at the temperature until a uniform solution is obtained; the stirring can be manual stirring or mechanical stirring; the uniform solution refers to the solution prepared by the method that the physical and chemical properties such as density, mass fraction and the like of each part are the same and have no difference.
In a preferred embodiment, the rheological agent is added when the temperature is raised to 40℃to 60℃and may be raised to 40℃41℃42℃43℃44℃45℃46℃47℃48℃49℃50℃51℃52℃53℃54℃55℃56℃57℃58℃59℃60℃60 ℃. Through the screening of the application, the most suitable rheological agent is added when the temperature is raised to 40-60 ℃, the viscosity of the solution is affected by the excessively high temperature, and the solution cannot be dissolved as soon as possible due to the excessively low temperature.
The lubricating fluid prepared by the lubricating fluid or the preparation method provided by the application can be applied to lubricating fluid for condoms, lubricating fluid for medical equipment or lubricating fluid for human bodies, and in a preferred embodiment, the lubricating fluid is applied to the lubricating fluid for condoms. The natural latex condom has large spreading area in unit time, less residue in an aluminum foil bag and little difference with silicone oil in lubrication time.
The application further provides lubricating fluid for a condom, lubricating fluid for a medical device or lubricating fluid for a human body, which comprises the lubricating fluid prepared by any one of the lubricating fluid or the preparation method.
Examples
The present application will be described in detail with reference to examples. It should be understood, however, that the application may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the application to those skilled in the art. The recitation of numerical ranges herein are merely intended to include the data set forth between the two endpoints of the range and each specific value within the range, and the range is intended to cover a new range where the value is combined with the endpoint as desired.
The reagent used in the application:
glycerol (Feng Yi oil science and technology Co., ltd.)
Sorbitol (Shijia Zhuang Ruixue pharmaceutical Co., ltd.)
Polyethylene glycol (Clariant chemical engineering Co., ltd.)
Sodium hyaluronate (Hua Xi Biotech Co., ltd.) has a molecular weight of 40 ten thousand
Sodium hyaluronate (Hua Xi Biotech Co., ltd.) has a molecular weight of 3 ten thousand
Xanthan gum (CP Kelco U.S. lnc)
Example 1
15g of glycerol, 3g of sorbitol, 5.1g of polyethylene glycol, 0.1g of sodium hyaluronate (20-40 wDa), 0.1g of acetylated sodium hyaluronate (3-5 wDa) and uniformly stirring until no visible particles exist, so as to obtain a mixture A;
stirring the mixture A, adding 76.25gg of water, heating while stirring, adding 0.45g of xanthan gum when the temperature reaches 50-55 ℃, stirring at the temperature until a uniform and transparent solution is obtained, and cooling to room temperature to obtain the lubricating liquid, wherein the total mass of the lubricating liquid is 100g.
Examples 1 to 24 and comparative examples 1 to 3
Lubricating fluids of examples 1-24 and comparative examples 1-3 were prepared according to the procedure of example 1, with the contents and parameters of the components in the lubricating fluids being shown in Table 1. Other non-mentioned portions are the same as in example 1.
Test example 1-test for measuring residual Rate of lubricating liquid in finished product packaging
Weighing a plurality of aluminum foil bags, respectively measuring gram weights, recording A1-An, putting one of the same natural latex condoms, respectively dripping lubricating liquid prepared in the examples 1-24 and the comparative examples 1-3 with the same weight, recording the liquid adding amount B, sealing, standing at normal temperature for one month, then unpacking the packaging bags in the same way, slightly taking out the condoms, weighing the gram weights of the aluminum foil bags, and recording C1-Cn.
The residual rate of each lubricating liquid in the finished product package containing the condom, namely an aluminum foil bag, is that:
residual ratio = (Cn-An)/B × 100
In this way, the residual amount of the aluminum foil bag material was determined for each experimental example.
The data obtained are shown in Table 2 below:
TABLE 2 residual Rate of lubricating fluids for examples and comparative examples
Group of Residual percentage%
Example 1 55
Example 2 28
Example 3 19
Example 4 20
Example 5 23
Example 6 48
Example 7 51
Example 8 25
Example 9 23
Example 10 22
Example 11 52
Example 12 25
Example 13 23
Example 14 22
Example 15 46
Example 16 30
Example 17 25
Example 18 21
Example 19 25
Example 20 27
Example 21 28
Example 22 25
Example 23 58
Example 24 53
Comparative example 1 52
Comparative example 2 51
Comparative example 3 55
The above data shows that the type and amount of polyol and rheology agent directly affect the residual lubrication fluid in the aluminum foil pouch. When the alcohol type is changed and the alcohol content is lowered, the residual rate will increase, and when the proper polyol type is selected and the polyol content is raised, the residual rate will decrease. However, too high a polyol content will increase the osmotic pressure of the solution, affecting the female vaginal environment, and secondly the sticky feel will be aggravated, affecting the use experience.
In addition, in the range, the content of the rheological agent is reduced, so that the residual rate is reduced, but when the content is too low or the rheological agent is replaced, the residual rate is greatly increased.
Test example 2 accelerated aging test of Natural latex condoms
The natural latex condoms containing different experimental examples were tested according to the accelerated aging test (placed in a stability test box at 70 ℃ for 7 days) in the technical requirements and experimental methods of natural latex condoms. The blushing of natural latex was examined to determine the impact of each test case on the physical properties of the natural latex condom, i.e., breakage or breakage.
The results obtained are shown in Table 3 below:
TABLE 3 whitening of lubricating fluids for examples and comparative examples
The above data shows that the content of the compound polyol in the application has no influence on the physical properties of the natural latex in a proper range, and the condom has no physical property changes such as blushing, fracture, breakage and the like, however, when the content of the polyol is reduced, the blushing and swelling of the natural latex can be caused, so that the use is influenced.
Test example 3-spreading Rate calculation experiment of lubricating liquid on Natural latex condom
Several natural latex condoms with the same material are weighed and cut into square films with the length of 5cm multiplied by 5 cm. The lubricating liquids prepared in examples 1 to 24 and comparative examples 1 to 3 were dropped on square films at the same height, and the liquid spreading condition after 10 minutes was observed to calculate the area S.
The area calculation method was as follows, the shape was recorded on the film with a marker in a spread form at a time point, the film was washed, dried, covered with transparent weighing paper (5 cm×5cm, weight average about 0.07 g), the edge of the spread area was drawn on the weighing paper, the excess paper edge was cut off, the mass record An was weighed, and the spread area was calculated:
S=(5cm×5cm×An)/0.07g,
and thus a spreading rate:
S/T(min)×100%。
the larger the spreading area, the greater the wetting rate, and the better the wetting of the natural latex condom by the lubricating fluid. The data obtained are given in table 4 below:
TABLE 4 spreading area and spreading Rate of lubricating fluids of examples and comparative examples
Group of An/g Spreading Rate at 10 min%
Example 1 0.012 42.8
Example 2 0.020 71.4
Example 3 0.026 92.8
Example 4 0.016 57.1
Example 5 0.018 64.2
Example 6 0.011 39.2
Example 7 0.014 50.0
Example 8 0.021 75.0
Example 9 0.022 78.5
Example 10 0.021 75.0
Example 11 0.008 27.4
Example 12 0.024 85.7
Example 13 0.023 82.1
Example 14 0.014 50.0
Example 15 0.007 25.0
Example 16 0.017 60.7
Example 17 0.019 67.8
Example 18 0.018 64.2
Example 19 0.018 64.2
Example 20 0.0017 60.7
Example 21 0.016 57.1
Example 22 0.016 57.1
Example 23 0.008 28.5
Example 24 0.011 39.2
Comparative example 1 0.014 50.0
Comparative example 2 0.010 35.7
Comparative example 3 0.014 50.0
The above data shows that the presence or absence of acetylated HA directly affects the spreading area of the lubricating fluid on natural latex condoms. When no acetylated HA was added, the spreading area per unit time became smaller. It should be noted that the amount of acetylated HA and the spreading area are not positively correlated, and when the amount of acetylated HA is too high, the spreadability of the solution cannot be improved without limitation and both the skin feel and the cost of the formulation are affected. The rheological agent and the alcohol have a certain influence on the spreading area of the lubricating liquid on the natural latex condom, when the rheological agent and the alcohol are reduced, the spreading area on the condom is more increased, however, the liquid becomes thinner when the content of the rheological agent is reduced, the residual rate of the lubricating liquid is increased, and the natural latex condom is whitened when the content of the alcohol is reduced, so that the use is influenced. Therefore, factors affecting the spreading speed of the lubricating liquid are complicated, and the content of the optimal component should be considered in many aspects.
Test example 4 measurement of Friction coefficient
The dynamic coefficient of friction μ of each experimental example was measured by the method of measuring the coefficient of friction of the plastic film and sheet of GB 10006-1988, and the results are shown in Table 5 below.
TABLE 5 dynamic Friction coefficients of lubricating fluids for examples and comparative examples
The above data indicate that the presence or absence of HA directly affects the lubricity of the lubricating fluid. When HA is not added, lubricity is reduced. It should be noted that the amount of HA and the lubricity are not positively correlated, and when the HA content is too high, the viscosity increases, the lubricity decreases, which negatively affects the residual rate, does not have a positive effect on the spreading area, and affects both the skin feel and the cost of the formulation. The change in the alcohol and acetylated HA content HAs no obvious effect on the coefficient of friction, and too high or too low a rheology agent content can cause the viscosity of the liquid to be too high or too low, and both can cause the coefficient of friction to be large.
Although the embodiments of the present application have been described above in connection with the above, the present application is not limited to the above-described specific embodiments and fields of application, which are merely illustrative, instructive, and not restrictive. Those skilled in the art, having the benefit of this disclosure, may effect numerous forms of the application without departing from the scope of the application as claimed.

Claims (20)

1. A water-soluble lubricating fluid is characterized in that: comprises a compound polyol, hyaluronic acid or salt thereof, acetylated hyaluronic acid or salt thereof, and a rheological agent; the weight percentage of the lubricating liquid is 10-30%, the weight percentage of the compound polyol is 0.05-1%, the weight percentage of the hyaluronic acid or the salt thereof is 0.01-0.5%, and the weight percentage of the acetylated hyaluronic acid or the salt thereof is 0.01-2%.
2. The lubricating fluid of claim 1, consisting of a complexing polyol, hyaluronic acid or a salt thereof, acetylated hyaluronic acid or a salt thereof, a rheological agent, and water.
3. The lubricating fluid of claim 1, wherein the complexing polyol is 15-25%, the hyaluronic acid or salt thereof is 0.1-0.8%, the acetylated hyaluronic acid or salt thereof is 0.05-0.3%, and the rheological agent is 0.01-0.8%.
4. The lubricating fluid of any one of claims 1 to 3, wherein the compound polyol is any two or more of glycerol, polyethylene glycol, sorbitol, and pentanediol.
5. The lubricating fluid of any one of claims 1 to 3, wherein the compound polyol is a mixture of glycerol, sorbitol and polyethylene glycol in a ratio of 5 to 10:1:1-5.
6. A lubricating fluid according to any one of claims 1 to 3 wherein the ratio is from 5 to 10:1:1-2.
7. A lubricating fluid according to any one of claims 1 to 3 wherein the hyaluronic acid or salt thereof has a weight average molecular weight of from 1 to 100wDa.
8. A lubricating fluid according to any one of claims 1 to 3 wherein the hyaluronic acid or salt thereof has a weight average molecular weight of 20-40wDa.
9. A lubricating fluid according to any one of claims 1 to 3 wherein the acetylated hyaluronic acid or salt thereof has a weight average molecular weight of from 3 to 10wDa.
10. A lubricating fluid according to any one of claims 1 to 3 wherein the acetylated hyaluronic acid or salt thereof has a weight average molecular weight of from 3 to 5wDa.
11. A lubricating fluid according to any one of claims 1 to 3 wherein the rheological agent is one or more of xanthan gum, gum arabic or phytosphingosine.
12. A lubricating fluid according to any one of claims 1 to 3 wherein the hyaluronate salt is a water soluble salt of hyaluronic acid selected from any one of sodium hyaluronate, zinc hyaluronate, magnesium hyaluronate or potassium hyaluronate.
13. A lubricating fluid according to any one of claims 1 to 3 wherein the hyaluronate salt is sodium hyaluronate.
14. A lubricating fluid according to any one of claims 1 to 3, characterised in that the dynamic viscosity of the lubricating fluid is in the range 500 to 2000mpa.s.
15. A lubricating fluid according to any one of claims 1 to 3, characterised in that the dynamic viscosity of the lubricating fluid is 800-1000mpa.s.
16. A method of preparing the lubricating fluid of any one of claims 1 to 15, comprising the steps of:
uniformly mixing hyaluronate, acetylated hyaluronate and compound polyol to obtain a mixture;
water was added to the mixture, the temperature was raised with stirring, and the rheology agent was added, stirring at this temperature until a homogeneous solution was obtained.
17. A method according to claim 16, wherein the rheology agent is added when the temperature is raised to 40-60 ℃.
18. Use of the lubricating fluid of any one of claims 1 to 15 or the lubricating fluid prepared according to claim 16 or 17 in condom lubricating fluid, medical device lubricating fluid or human body lubricating fluid.
19. Use of a lubricating fluid according to any one of claims 1 to 15 or prepared according to claim 16 or 17 in a condom.
20. A lubricating fluid for condoms, a lubricating fluid for medical devices or a lubricating fluid for human bodies, comprising the lubricating fluid according to any one of claims 1 to 15 or the lubricating fluid prepared according to claim 16 or 17.
CN202210424205.7A 2022-04-20 2022-04-20 Water-soluble lubricating liquid and preparation method and application thereof Active CN114939191B (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202210424205.7A CN114939191B (en) 2022-04-20 2022-04-20 Water-soluble lubricating liquid and preparation method and application thereof
PCT/CN2023/089194 WO2023202615A1 (en) 2022-04-20 2023-04-19 Water-soluble lubricating liquid, preparation method therefor and application thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202210424205.7A CN114939191B (en) 2022-04-20 2022-04-20 Water-soluble lubricating liquid and preparation method and application thereof

Publications (2)

Publication Number Publication Date
CN114939191A CN114939191A (en) 2022-08-26
CN114939191B true CN114939191B (en) 2023-09-08

Family

ID=82906496

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202210424205.7A Active CN114939191B (en) 2022-04-20 2022-04-20 Water-soluble lubricating liquid and preparation method and application thereof

Country Status (2)

Country Link
CN (1) CN114939191B (en)
WO (1) WO2023202615A1 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114939191B (en) * 2022-04-20 2023-09-08 华熙生物科技股份有限公司 Water-soluble lubricating liquid and preparation method and application thereof
CN117815456B (en) * 2023-12-20 2024-08-20 山东颐正达医药科技有限公司 Water-based lubricant and preparation method thereof
CN118662706B (en) * 2024-06-17 2025-01-10 韶关朗圣药业有限公司 Human body lubricating liquid and preparation method and application thereof
CN118370875A (en) * 2024-06-25 2024-07-23 浙江夕尔科技有限公司 Aqueous lubricating fluid, lubricating beads, and preparation method and application thereof

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101505719A (en) * 2006-08-25 2009-08-12 兴和株式会社 Emulsion composition giving good feeling in use
CN101905041A (en) * 2009-06-08 2010-12-08 上海市计划生育科学研究所 Vaginal acidic lubricant and its preparation method and use
CN102846690A (en) * 2012-08-29 2013-01-02 江苏康宝医疗器械有限公司 Vagina healthcare and lubrication liquid, and its preparation method
CN103083733A (en) * 2013-02-19 2013-05-08 华熙福瑞达生物医药有限公司 Medical water-based lubricant for introducing instrument into body cavity
CN109200345A (en) * 2018-10-12 2019-01-15 华熙福瑞达生物医药有限公司 A kind of water-soluble lubricating liquid and its preparation method and application
CN110898259A (en) * 2019-12-22 2020-03-24 上海名邦橡胶制品有限公司 Human body-imitating lubricant and preparation method and application thereof
CN113209163A (en) * 2021-05-21 2021-08-06 河南依维意实业有限公司 Hyaluronic acid-containing functional water-soluble lubricant and preparation method thereof
CN114288413A (en) * 2021-12-28 2022-04-08 华熙生物科技股份有限公司 Hyaluronic acid composition, liposome, preparation method and application thereof

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996005233A1 (en) * 1994-08-11 1996-02-22 Shiseido Co., Ltd. Low-molecular-weight acetylated hyaluronic acid, emollient, and processes for producing and purifying the acid
JPH1121230A (en) * 1997-07-03 1999-01-26 Okamoto Ind Inc Water-soluble lubricant for condom and condom coated with water-soluble lubricant for condom
CA2905988C (en) * 2013-03-14 2021-04-06 Church & Dwight Co., Inc. Aqueous lubricant composition comprising hyaluronic acid
CN114099792A (en) * 2020-08-30 2022-03-01 上海名邦橡胶制品有限公司 Human body lubricating liquid and preparation method thereof
CN114939191B (en) * 2022-04-20 2023-09-08 华熙生物科技股份有限公司 Water-soluble lubricating liquid and preparation method and application thereof

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101505719A (en) * 2006-08-25 2009-08-12 兴和株式会社 Emulsion composition giving good feeling in use
CN101905041A (en) * 2009-06-08 2010-12-08 上海市计划生育科学研究所 Vaginal acidic lubricant and its preparation method and use
CN102846690A (en) * 2012-08-29 2013-01-02 江苏康宝医疗器械有限公司 Vagina healthcare and lubrication liquid, and its preparation method
CN103083733A (en) * 2013-02-19 2013-05-08 华熙福瑞达生物医药有限公司 Medical water-based lubricant for introducing instrument into body cavity
CN109200345A (en) * 2018-10-12 2019-01-15 华熙福瑞达生物医药有限公司 A kind of water-soluble lubricating liquid and its preparation method and application
CN110898259A (en) * 2019-12-22 2020-03-24 上海名邦橡胶制品有限公司 Human body-imitating lubricant and preparation method and application thereof
CN113209163A (en) * 2021-05-21 2021-08-06 河南依维意实业有限公司 Hyaluronic acid-containing functional water-soluble lubricant and preparation method thereof
CN114288413A (en) * 2021-12-28 2022-04-08 华熙生物科技股份有限公司 Hyaluronic acid composition, liposome, preparation method and application thereof

Also Published As

Publication number Publication date
CN114939191A (en) 2022-08-26
WO2023202615A1 (en) 2023-10-26

Similar Documents

Publication Publication Date Title
CN114939191B (en) Water-soluble lubricating liquid and preparation method and application thereof
US20200253841A1 (en) Composition for hydrogel sheet, hydrogel sheet manufactured therefrom, and method for manufacturing same
Pavoni et al. Impact of acid type for chitosan dissolution on the characteristics and biodegradability of cornstarch/chitosan based films
Zheng et al. An insight into the retrogradation behaviors and molecular structures of lotus seed starch-hydrocolloid blends
Techawipharat et al. Effects of cellulose derivatives and carrageenans on the pasting, paste, and gel properties of rice starches
CN101088334B (en) Gel-like disinfectant for finger
CN104394934B (en) Composition in an aqueous medium comprising at least one hyaluronic acid and at least one sucrose octasulfate water soluble salt
Katoch et al. Understanding the rheology of novel guar-gellan gum composite hydrogels
CN101244290A (en) Method for preparing crosslinked hyaluronic acid microgel for tissue filling
KR101973478B1 (en) Cleanser composition
Gering et al. Chemical modification strategies for viscosity-dependent processing of gellan gum
CN101759881A (en) Medical cross-linking sodium hyaluronate gel derivative product and preparation method thereof
KR101525403B1 (en) Shape-restoring hydrogel composition for mask pack and producing method thereof
CN105456056A (en) Hydrogel composition for masking pack containing water-soluble polyurethane
Sherahi et al. Effect of temperature, ion type and ionic strength on dynamic viscoelastic, steady-state and dilute-solution properties of Descurainia sophia seed gum
CN105979968A (en) Hyaluronic acid gel composition having sustained release property
JP5876296B2 (en) Gel-like composition
Liu et al. Rheological characteristics and chain conformation of mannans obtained from Saccharomyces cerevisiae
Yang et al. Preparation and properties of monomethoxyl polyethylene glycol grafted O-carboxymethyl chitosan for edible, fresh-keeping packaging materials
US4579259A (en) Composition for sealing sliding contact section
Er et al. Bioactive interpenetrating hybrids of poly (hydroxyethyl methacrylate-co-glycidyl methacrylate): Effect of polysaccharide types on structural peculiarities and multifunctionality
JP2022081439A (en) Hydrogel patch including syneresis pattern adjustment filling fluid and production method thereof
Razavi et al. Influence of different substitution levels of Lallemantia royleana seed gum on textural characteristics of selected hydrocolloids.
CN103463125B (en) Gel preparation for treating gynecological diseases and preparation method thereof
EP3884839A1 (en) Endoscope visual field-securing viscoelastic composition

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant