CN115737536A - Gel for therapeutic instruments and preparation method thereof - Google Patents

Abstract

The invention relates to the field of medical instruments, in particular to gel for therapeutic instruments and a preparation method thereof, and the prepared gel is safe and comfortable when combined with therapeutic instruments and equipment for treatment, has good energy transmission effect in a treatment temperature range, good skin feel, good viscosity stability and long-acting maintenance effect; the preparation of the gel needs to be carried out according to a specific material adding sequence and a specific process; the adding sequence of the raw materials has irreplaceability; mixing the thickening agent and the humectant in proportion to uniformly disperse the thickening agent into fine powder particles under a stirring state, then gelling, adding purified water, and under the condition of greatly reducing the process time of a finished product, multiplying the water absorption swelling speed of the thickening agent, and enhancing the uniformity of the internal and external adsorption lubricants, thereby enhancing the performance uniformity and stability of the finished product; the prepared gel has better biological safety, does not contain antiseptic, other bacteriostatic agent and disinfectant components, but has excellent mild and sedative effects which are not possessed by common lubricant and coupling agent gels.

Description

Gel for therapeutic instruments and preparation method thereof

Technical Field

The invention relates to the field of medical instruments, in particular to gel for therapeutic instruments and a preparation method thereof.

Background

When the radio frequency technology and the high-frequency treatment are clinically used, the electrode probe generally needs to be matched with a coupling agent and a lubricant for use. At present, medical gel which has the effects of lubricating, transmitting high-frequency energy and preventing non-target tissue skin from being scalded and is specially applied to electro-therapeutic apparatus equipment does not exist in the market, most of the medical gel is replaced by a lubricant and a coupling agent of carbomer gel or cellulose gel, but the existing gel has poor adhesion performance, and has the phenomena of mud rubbing, poor pushing and the like.

When the treatment part is a vagina or a part with more body fluid, sodium ions, chloride ions and other salt-containing secretions are filled in the vagina, the viscosity of the gel sold on the market is unstable after contacting the ions, so that the viscosity is suddenly reduced, the gel is easy to fall off after being applied to the body surface, and the gel structure is quickly collapsed to form water, so that doctors or equipment operation technicians need to supplement the gel for many times in a short time, the operation difficulty is increased, and the comfort level and the use body feeling of a patient are influenced to a certain degree.

Disclosure of Invention

The invention aims to provide a gel for therapeutic instruments and a preparation method thereof, which aim to solve the problems in the prior art.

In order to solve the technical problems, the invention provides the following technical scheme:

the gel for the therapeutic apparatus comprises the following components in percentage by mass: 0.15 to 1.5 percent of thickening agent, 5 to 15 percent of humectant, 0.01 to 1.5 percent of regulator, 20 to 70 percent of lubricant, 0.1 to 10 percent of active matter and the balance of purified water.

Aiming at the problems that the prior therapeutic equipment has no special medical gel, multiple lubricants and coupling agents, so that the viscosity stability and the durability after being smeared are poor, the long-acting energy transmission therapeutic effect is poor, and frequent supplement is needed in the treatment process, the gel prepared by the invention is safe and comfortable when combined with the therapeutic equipment for treatment, has good energy transmission effect in the treatment temperature range, stable temperature, good skin feel, stable viscosity and long-acting maintenance effect through reasonable matching of formula components and a special process. Meanwhile, the invention has no preservative, avoids the stimulation and the damage to the skin on the body surface and the sensitive delicate vaginal mucosa, can achieve a certain sedative effect and has good biological safety.

Further, the therapeutic gel has a viscosity of 10000 mPas-150000 mPas.

Preferably, the gel for therapeutic apparatus has a viscosity of 10000mPa & s-100000mPa & s.

Further, the thickening agent is one or a plurality of carbomer, sodium polyacrylate, hydroxypropyl guar gum, xanthan gum, sodium polyacrylate grafted starch, hydroxyethyl acrylate, acryloyl dimethyl sodium taurate copolymer and carboxymethyl starch sodium.

In the invention, in order to keep good adhesion performance, carbomer can be preferably used alone, or one type or a plurality of types of carbomers can be selected and combined with other thickeners; the ratio of thickener to purified water is preferably 1: (5-50); the viscosity of the finished product is between 10000mpa & s-100000mpa & s by controlling the proportion of the thickening agent to the purified water, and the gel has better spreading performance compared with the common gel sold on the market and is more matched with the treatment scene of equipment.

Further, the humectant is one or more of propylene glycol, butanediol, sorbitol, xylitol, sclerotium rolfsii gum, glucomannan, hydroxypropyl trimethyl ammonium chloride honey, saccharide isomerate and polyglycerol-10 laurate.

Further, the lubricant is one or more of glycerin, polyvinyl alcohol, polyethylene glycol, bis-PEG-15 methyl ether polydimethylsiloxane, polysiloxane-11, phenyl trimethicone and PPG-28-butanol polyether-35.

Further, the mass ratio of the lubricant to the humectant to the thickener is (20-70%): (5-15%): (0.15% -1.5%);

optimally, the mass ratio of the lubricant to the humectant to the thickener is (40-70%): (5% -15%): (0.5% -1%).

By controlling the proportion and the process of the lubricant, the humectant and the thickener, the finished product has good sedative performance and lubricating excellent skin feel; the gel system prepared according to the formula of the invention can maintain good adhesiveness and viscosity stability for a long time, and solves the problem that the gel structure can collapse rapidly to dissolve water after a salt ion system and the like. Meanwhile, the gel resistance is controlled within 1000K omega and is closer to the human body resistance, so that the energy transmission is quicker, more uniform and more stable.

Further, the regulator is one or more of arginine, triethanolamine, sodium hydroxide, citric acid, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride or other compounds.

The pH of the whole gel is controlled to be 3-6 by using the regulator to obtain weakly acidic gel, and the gel formed by combining the thickener, the humectant and the lubricant in a specific ratio has an excellent sedative effect, is in line with the use of the female vagina internal environment and other body surface part environments, is safe and effective, and has no sensitization.

Further, the active matter is one or more of sodium hyaluronate, sodium polyglutamate, ceramide, collagen, elastin, silk fibroin, tremella polysaccharide, hydrolyzed conchiolin, hydrolyzed sesame protein, fibronectin, jasminum grandiflorum extract, aureobasidium pullulans and Morinda citrifolia fruit juice.

Further, the preparation method of the gel for the therapeutic apparatus comprises the following steps:

s1: mixing the thickening agent and the humectant, uniformly dispersing, and stirring for 20-40min to completely infiltrate;

s2: adding purified water into the step S1, stirring and mixing, and standing for 8-36h to obtain a swelling matrix;

s3: stirring and homogenizing the swelling matrix for 10-50min to obtain a homogeneous material body;

s4: mixing the homogeneous material, purified water and regulator, and stirring for 20-40min to obtain gel matrix semi-finished product;

s5: mixing the gel matrix semi-finished product and lubricant, and stirring for 20-30min to obtain gel matrix;

s6: mixing gel matrix and active substance, stirring, and stirring for 20-30min to obtain therapeutic gel.

Further, the working conditions of stirring and homogenizing are as follows: stirring at 20-80rpm, homogenizing at 1000-3000rpm for 3-15min for 2-8 times.

Preferably, the stirring speed is 40-80rpm, the homogenizing speed is 1500-3000rpm, the homogenizing time is 5-10min, and the homogenizing times are 2-5 times.

In the stirring and homogenizing process, the homogenizing speed and the homogenizing time need to be controlled, and the obtained gel matrix has the specific adhesion performance and the wire drawing property only if the size is not too large or too small; when the homogenizing speed or time exceeds the limit of the present invention, the viscosity is less than 10000mpa · s, and the drawn character and the adhesion property of the final product are lost. When the homogenizing speed or time is lower than the limit of the invention, the produced finished product colloid is not fine and smooth, has granular feel and poor uniformity.

The gel preparation of the invention needs to obtain the final performance product according to the specific material adding sequence and process.

In actual production and application, the thickening agent is directly added into water to be stirred and dissolved, and if mass production is carried out according to the formula of the invention, the thickening agent is directly added into water to be stirred and dissolved, so that the material body cannot be uniformly swelled and dissolved completely after being soaked and stirred for a long time; because when the aquatic drop into when more thickener, surface powder can begin to absorb water and swell, can stop absorbing water after absorbing to a certain degree, and the inside powder of being wrapped up can't absorb sufficient water, and then can't accomplish even swelling process, leads to the product homogeneity of preparation poor.

The thickening agent and the humectant are mixed in proportion, compared with the method of directly adding the thickening agent into water for dissolving and stirring, the powdery thickening agent does not immediately agglomerate when meeting the humectant and is uniformly dispersed in a stirring state instead of meeting water, the dispersed fine powder particles gradually form gel under continuous stirring, and then purified water is added for soaking, so that the water absorption swelling speed of the gelled thickening agent is doubled; the thickening agent is dispersed into fine powder particles to be gelatinized and then to absorb water for swelling, so that the uniformity of the internal and external adsorption lubricant is enhanced, and the uniformity and the stability of the prepared finished product are enhanced.

According to the conventional process, the thickening agent and the purified water are directly mixed, and the water absorption swelling can be completed after stirring for 3-5 days, but according to the process and the formula disclosed by the invention, the thickening agent is kept stand and soaked in advance for about 8 hours to obtain a gel finished product with good uniformity.

When the gel matrix is prepared, after the thickening agent and the humectant are mixed, the gel matrix is dispersed by homogenization, then the regulator is added for mixing, and finally the lubricant is added, so that the obtained gel matrix has specific adhesion performance and wire drawing property;

when the formula of the invention is adopted, the adding sequence of the raw materials is changed: for example, completely reverse order is adopted, firstly, the lubricant and the regulator are added for mixing, and finally, homogenization is carried out, so that the viscosity of the obtained product can be greatly reduced and the requirement of 10000mpa & s-100000mpa & s on viscosity can not be met; for example, firstly adding a lubricant for mixing, then homogenizing, and finally adding a regulator; the product loses the special wire drawing property, so that the adhesion performance of the finished product is reduced;

because the regulator used in the invention has a certain regulating effect on a swelling matrix formed by the thickening agent, the humectant and the purified water, a specific gel structure is generated, and the wire drawing and adhesion properties of a finished product are determined; the addition of the lubricant can destroy the generation of the gel structure to a certain extent, so that the addition sequence of the raw materials in the invention has irreplaceability.

When the thickening agent is dispersed into the humectant, the dispersion process is a small amount of times, so that the gel dispersion uniformity of the thickening agent and the humectant and the subsequent water absorption swelling speed are doubled.

The invention has the beneficial effects that:

the invention provides a therapeutic apparatus gel and a preparation method thereof, and the prepared gel is safe and comfortable when combined with therapeutic apparatus equipment for treatment, has good energy transmission effect within a treatment temperature range, good skin feel, good viscosity stability, no preservative and long-term maintenance effect.

The gel preparation of the invention needs to obtain a finished product with excellent performance according to a specific material adding sequence and a specific material adding process; in the invention, the regulator is used for regulating a swelling matrix formed by the thickening agent, the humectant and the purified water to generate a specific gel structure, so that the wire drawing adhesion property of a finished product is determined; the addition of the lubricant can destroy the generation of the gel structure to a certain extent, so that the addition sequence of the raw materials in the invention has irreplaceability.

The thickening agent and the humectant are mixed in proportion, so that the thickening agent is uniformly dispersed into fine powder particles under the stirring state, then the colloid is formed, purified water is added, the water absorption swelling speed of the thickening agent is doubled under the condition of greatly reducing the process time of a finished product, and the uniformity of an internal and external adsorption lubricant is enhanced, thereby enhancing the performance uniformity and stability of the finished product.

When the gel matrix is prepared, after the thickening agent and the humectant are mixed, the gel matrix is dispersed by homogenization, then the regulator is added for mixing, finally the lubricant is added, and then the homogenization speed and the homogenization time are controlled in the homogenization process, so that the obtained gel matrix has specific adhesion performance and wiredrawing property.

When the couplant and the lubricant sold on the market are used for treating vaginal diseases, the couplant and the lubricant have high ion content in human body cavities or vaginal mucosa or have a certain working temperature environment, the effect is poor, the viscosity is unstable, and a gel structure can collapse and dissolve water quickly; when the adhesive is used on a continuous heat output device, the excellent adhesion performance can be kept for a long time. The gel prepared by the invention has better biological safety, accords with the internal environment of human vagina, does not contain preservatives, other bacteriostatic agents and disinfectant components, but has excellent mild and sedative effects which are not possessed by common lubricant and coupling agent gels.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention. In the drawings:

FIG. 1 is a process flow diagram of an embodiment of the invention;

FIG. 2 is a graph of the resistance of human hands against the examples of the present invention, the comparative examples, and the human hands;

FIG. 3 is a graph showing the time for the gel to deliver energy to reach a region of suitable temperature in an example of the present invention and a comparative example;

FIG. 4 is a graph comparing the viscosity of gels prepared according to the present invention at 4000 mPa.s, 10000 mPa.s, 20000 mPa.s, 40000 mPa.s, 100000 mPa.s, 150000 mPa.s;

FIG. 5 is a graph comparing the viscosity stability of the body fluids with higher content of simulated ions for example 2 and comparative example 4.

FIG. 6 is a graph comparing the viscosity stability of example 2 of the present invention and comparative example 4 in an environment having a certain operating temperature.

Detailed Description

The technical solutions in the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.

It should be noted that, if the embodiment of the present invention relates to directional indications such as up, down, left, right, front, and back \8230, the directional indications are only used for explaining a specific posture such as relative positional relationship between components, motion situation, etc., and if the specific posture is changed, the directional indications are changed accordingly. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.

The technical solutions of the present invention are further described in detail with reference to specific examples, which should be understood that the following examples are only illustrative and not limiting.

The raw material model number specifications and suppliers in examples 1, 2, 3 are as follows:

example 1:

example 2:

example 3:

examples 1-3 and comparative examples 1-3 were both adjusted to a gel pH of 3-6 using triethanolamine.

Example 1

A preparation method of gel for therapeutic instruments comprises the following steps:

s1: weighing 0.7g of carbomer U20, 0.5g of sodium polyacrylate, 5g of propylene glycol and 15g of PPG-28-butanol polyether-35, and stirring at room temperature and 40rpm for 20min until the carbomer U20, the polypropylene glycol and the PPG-28-butanol polyether are completely wetted and dispersed until no visible powder exists, so as to obtain a dispersion liquid;

s2: adding purified water into the dispersion liquid in the S1, soaking for 8 hours until the dispersion liquid is completely swelled, and homogenizing for 5 times and 5min once at a stirring speed of 40rpm and a homogenizing speed of 2000rpm to obtain a swelling matrix;

s3: weighing 0.5g of triethanolamine, adding into swelling matrix, stirring at 25 deg.C and 50rpm for 30min, and mixing completely to obtain semi-finished product of gel matrix;

s4: weighing 40g of glycerol and 100010.3g of polyethylene glycol, adding into the semi-finished product of the gel matrix, and stirring at 25 ℃ and 60rpm for 30min until the gel matrix is completely and uniformly mixed to obtain the gel matrix;

s5: adding 0.12g collagen and 0.18g silk fibroin into gel matrix, stirring at 35 deg.C and 50rpm for 20min, and mixing completely to obtain therapeutic gel.

Example 2

A preparation method of therapeutic gel comprises the following steps:

s1: weighing 0.4g of carbomer 981, 0.5g of sodium polyacrylate grafted starch and 8g of propylene glycol, stirring at room temperature at 50rpm for 20min until the mixture is completely wetted and dispersed until no visible powder exists, and obtaining a dispersion liquid;

s2: adding purified water into the dispersion liquid in the S1, soaking for 24h until complete swelling, and homogenizing for 3 times and 5min once at a stirring speed of 50rpm and a homogenizing speed of 3000rpm to obtain a swelling matrix;

s3: weighing 0.5g of triethanolamine, adding into swelling matrix, stirring at 25 deg.C and 50rpm for 30min, and mixing completely to obtain semi-finished product of gel matrix;

s4: weighing 45g of glycerol and 100025g of polyethylene glycol, adding into the semi-finished product of the gel matrix, and stirring at 25 ℃ and 60rpm for 30min until the gel matrix is completely and uniformly mixed to obtain the gel matrix;

s5: adding 0.1g sodium hyaluronate and 0.1g sodium polyglutamate into gel matrix, stirring at 35 deg.C and 50rpm for 30min, and mixing completely to obtain therapeutic gel.

Example 3

A preparation method of gel for therapeutic instruments comprises the following steps:

s1: weighing 0.3g of carbomer 981, 0.5g of sodium polyacrylate grafted starch and 15g of propylene glycol, and stirring at room temperature at 50rpm for 30min until the carbomer is completely wetted and dispersed until no visible powder exists, thus obtaining a dispersion liquid;

s2: adding purified water into the dispersion liquid in the S1, soaking for 36h until complete swelling, and homogenizing for 3 times and once for 10min at a stirring speed of 50rpm and a homogenizing speed of 3000rpm to obtain a swelling matrix;

s3: weighing 0.05g of triethanolamine, adding into the swelling matrix, stirring at room temperature at 50rpm for 30min, and mixing completely to obtain semi-finished product of gel matrix;

s4: weighing 30g of glycerol, 10g of polysiloxane-11 and 5g of bis-PEG-15 methyl ether polydimethylsiloxane, adding into the semi-finished product of the gel matrix, and stirring at room temperature at 60rpm for 30min until the gel matrix is completely and uniformly mixed to obtain the gel matrix;

s5: adding 0.05g of ceramide and 0.1g of tremella polysaccharide sodium into the gel matrix, and stirring at 35 ℃ and 50rpm for 20min until the gel is completely mixed to obtain the gel for the therapeutic apparatus.

Comparative example 1

Self-made coupling agent gel 1:

s1: weighing 0.6g of carbomer 981, adding purified water, and completely wetting and dispersing until no visible powder exists to obtain a dispersion liquid; stirring at room temperature and homogenizing at 3000rpm for 3 times, and homogenizing for 10min to obtain swelling matrix;

s2: weighing 0.2g of triethanolamine, adding into the swelling matrix, and stirring at 25 deg.C and 50rpm for 30min until completely and uniformly mixed to obtain semi-finished product of gel matrix;

s4: weighing 5g of glycerol and 0.1g of sodium hyaluronate, adding into the gel matrix semi-finished product, and stirring at 25 ℃ and 60rpm for 30min until the gel matrix is completely and uniformly mixed to obtain the gel matrix.

Comparative example 2

Self-made coupling agent gel 2:

s1: weighing 0.6g of carbomer U20, adding purified water, and completely wetting and dispersing until no visible powder exists to obtain a dispersion liquid; stirring at room temperature and homogenizing at 3000rpm for 3 times, and homogenizing for 10min to obtain swelling matrix;

s2: weighing 0.2g triethanolamine, adding into swelling matrix, stirring at 25 deg.C and 50rpm for 30min, and mixing completely to obtain semi-finished product of gel matrix;

s4: weighing 50g of glycerol and 0.1g of sodium hyaluronate, adding into the gel matrix semi-finished product, and stirring at 25 ℃ and 60rpm for 30min until the gel matrix is completely and uniformly mixed to obtain the gel matrix;

comparative example 3

Self-made coupling agent gel 3:

s1: weighing 0.6g of carbomer 981, adding purified water, and completely wetting and dispersing until no visible powder exists to obtain a dispersion liquid; stirring at room temperature and homogenizing at 3000rpm for 3 times, and homogenizing for 10min to obtain swelling matrix;

s2: weighing 0.2g triethanolamine, adding into swelling matrix, stirring at 25 deg.C and 50rpm for 30min, and mixing completely to obtain semi-finished product of gel matrix;

s4: weighing 50g of glycerol, 5g of propylene glycol and 0.1g of sodium hyaluronate, adding into the gel matrix semi-finished product, and stirring at 25 ℃ and 60rpm for 30min until the gel matrix is completely and uniformly mixed to obtain the gel matrix;

comparative example 4

Commercial coupling agent a: lianlaibao ultrasonic coupling agent.

Comparative example 5

Commercially available lubricant B: a health lubricant for human body.

Comparative example 6

Commercially available lubricant C: a ruffer human body lubricant.

Comparative examples 4, 5, 6 information:

and (3) performance testing: the gels obtained in examples 1 to 3 and comparative examples 1 to 3 were subjected to a performance test;

adhesion property 1: coating 1g of gel on an electrode head of 2cmx2.5cm, freely dropping from the height of 15cm within 15min under the action of gravity, and measuring the gram weight of the gel dropping on weighing paper; the smaller the gram weight is, the better the adhesive property of the gel on the probe equipment is;

adhesion performance 2:1g of gel is evenly coated on the arm of a human body, the center part of the head circumference of a square electrode of 2cmx2.5cm is gently rotated by the size of a coin, and the number of turns is counted until no gel is on the body surface; the more the number of turns is, the better the performance of the gel adhered on the body surface is, and the practical application is more durable and effective;

lubricating property: 1g of the gel was uniformly applied to the arms of a human body, lubrication resistance was evaluated by 5-point system, and the higher the score, the larger the resistance and the worse the lubrication performance, which were averaged from 5 groups of volunteers.

Sedation efficiency: the sedation efficiency was judged by the lactic sting experiment. The experimental scheme is as follows: subjects did not use any product in the test sites 5h prior to the experiment. Marking a circle area with the diameter of 2.5cm on an arm, starting marking the circle area with the diameter of 2.5cm at a position 5cm away from the wrist, washing the arm for 1min after marking, slightly sucking water for 10min by using a paper towel, statically sitting for 10min, smearing 0.5g of 10% lactic acid solution (an aladine chemical reagent net) on a tested part to generate a stabbing pain reaction, respectively smearing 2g of gel on the stabbing pain part after 5min, and scoring the sedation efficiency (the elimination and relief conditions of uncomfortable symptoms such as reaction redness and stabbing pain) after acting for 10 min. The sedation efficiency was assessed using a percentage, with 5 groups of volunteers averaging, the higher the percentage, the more pronounced the sedation effect, and the lower the sedation effect.

Specific data are shown in table 1;

the resistance values of examples 1 to 3, both human hands, and comparative examples 4 to 6 were measured as shown in FIG. 2;

sample(s)	Adhesion Property 1	Adhesion Properties 2	Lubricating performance	Efficiency of sedation
					Example 1	0.00	Over 300 f	0	90％
Example 2	0.10	Over 300 f	0	99％
					Example 3	0.00	200	0	90％
Comparative example 1	0.52	30	1	10％
					Comparative example 2	0.56	42	0	26％
Comparative example 3	0.6	55	0	39％

TABLE 1

As can be seen from Table 1, the gel prepared by the invention has better adhesion performance 1 and 2, and the gel prepared by the invention has excellent sedative performance which is not possessed by common coupling agents and lubricants and durable and effective adhesion which is actually used for combining the electrode tip of equipment.

The internal safety and curative effect of the gel for therapeutic instruments are tested:

16 sexual life women, patients without a cardiac pacemaker or a metal prosthesis in the body of the company need to avoid menstrual period testing; divided into 4 cases of internal yin group, 4 cases of abdomen group and 8 cases of vulva group; the internal yin group is 25-41 years old, and the average (33.8 + -5.891) year old, wherein 3 of primiparity women and 1 of menstruation-lying women; 3 cases of natural delivery and 1 case of cesarean delivery. The vulva group subjects were 25-36 years old, with the average (29 ± 3.742) age, with 4 cases of primiparity and 4 cases of non-maternal; natural delivery 2 cases, cesarean section 2 cases; the subjects in the abdominal group are 26-36 years old, and the average (30.5 +/-2.06155) years old, wherein 3 cases of primiparous women and 1 case of non-maternal women; 3 cases of cesarean delivery and 0 case of natural delivery. The gels prepared in comparative example 2 and example 1 were evaluated for safety and efficacy using the same treatment protocol in combination with a device high frequency treatment apparatus.

And performing a contrast test, wherein the subjects need to be separated by one week, and the subjective comfort feeling, the instant effect and the adverse reaction of the subjects are recorded and the attention of the subjects is replaced. Follow-up was performed 2h, 4h, 6h, 1d, 2d, 3d after the treatment was over and adverse reactions were recorded.

Comfort: whether foreign body sensation, friction sensation, burning sensation, pain sensation and other discomfort occur during the treatment process.

The curative effect is as follows: the vulva has therapeutic effect on fullness, moistness, and pigmentation; whether the internal yin curative effect has a sedative effect and a tightening effect or not; the abdomen curative effect is whether the abdomen is moist or tight and the abdominal circumference is small.

Adverse reactions: whether or not there are reactions such as redness, swelling, exudation, blisters, crusting, infection, pigmentation, skin itching, pain, dryness, etc.

Comfort:

TABLE 2

The curative effect is as follows:

group of	Number of examples	Has obvious improvement	Has no obvious effect	Significant improvement (%)
					Comparative example 4	16	3	13	18.75
Example 1	16	9	7	56.25

TABLE 3

The incidence of adverse reactions:

TABLE 4

As can be seen from tables 2 to 4, the gel prepared by the invention is superior to the existing commercial coupling agent or lubricant products in comfort, and the gel prepared by the invention has no uncomfortable feeling such as hard substance feeling, friction feeling and the like to a subject and has no related adverse reaction in the whole treatment process; the curative effect of the gel prepared by the invention is obviously improved by combining the gel with equipment after treatment, and the curative effect is obviously improved.

Generally speaking, the therapeutic apparatus gel has excellent performance, better comfort level in the treatment process compared with the traditional couplant and lubricant gels, has the characteristics of higher water-wettability, more lasting adhesion maintaining performance, more stable energy transmission and the like, is higher in convenience and better in curative effect, has higher matching degree with equipment, obviously reduces the occurrence of adverse reactions, and particularly has more positive influence on the treatment effect in the vagina.

FIG. 2 is a graph showing the resistance values of examples 1 to 3, comparative examples 4 to 6 and human hands of the present invention, and it can be seen from FIG. 2 that the resistance of the product is preferably in a formulation ratio close to the resistance of human body when the formulation is designed, so that the gel resistance is controlled within 1000K Ω to enhance biocompatibility.

FIG. 3 is a schematic diagram showing the time for the energy transmission of the gels of examples 1 to 3 and comparative examples 4 to 6 of the present invention to reach the temperature-suitable region, and it can be seen from FIG. 3 that the gel generally on the market reaches the temperature-suitable region within 3 min. The gel for the therapeutic apparatus of the invention transmits energy to ensure that the time for the therapy to reach the temperature-suitable area is basically consistent with the coupling agent on the market, about 40-55s, the gel can reach the temperature-suitable area only within about 1min, and the gel has more excellent transmission performance than partial lubricant.

FIG. 4 is a comparison graph of the viscosity of the gel prepared by the present invention being 4000 mpa.s, 10000 mpa.s, 20000 mpa.s, 40000 mpa.s, 100000 mpa.s and 150000 mpa.s, it can be seen from FIG. 4 that the push-out performance is important because the electrode tip of the device needs to be constantly moved to rotate to ensure the uniform transmission of energy when the gel product is applied on the surface of the human body for treatment; the spreading properties of the gel are all 0 if they are scored by frictional resistance, and there is no resistance. However, the viscosity of the gel actually affects the adhesion performance and the spreading performance, and the gel with the viscosity within 10000 mpa-s-150000 mpa-s is best to match with equipment on the human body from the view point of the figure. The viscosity is less than 10000mpa · s, the gel fluidity is too strong, the gel is easy to flow out of the action range of the electrode tip, the viscosity is more than 1500000mpa · s, the gel is too thick, the gel is extruded out of the range of the electrode tip, and the spreading performance is not as good as within 150000mpa · s.

FIG. 5 is a graph comparing the viscosity stability of example 2 of the present invention with that of comparative example 4, in which the viscosity of the coupling agent immediately decreases, a portion of the gel structure collapses, and the rapid decrease in viscosity of the gel does not cause any change in the amount of the coupling agent applied to the electrodes of the device after 1.5mL of the vaginal simulant is sprayed. The gel for the therapeutic apparatus has excellent viscosity stability, has no obvious change after being diluted by contacting self-cleaning secretion of vagina, and still has good viscosity and adhesion performance.

FIG. 6 is a graph comparing the viscosity stability of the gel of example 2 of the present invention with that of comparative example 4 in the treatment process under a certain working temperature environment, the gel of the present invention has significantly better viscosity stability in the application performance than the comparative example when the treatment is performed after the gel product is coated on the electrode of the device and the two gels of the same application amount act for the same time. The gel disclosed by the invention can still keep good viscosity stability in an environment with a certain working temperature, and can keep excellent adhesion performance for a long time when being used on equipment for continuously outputting heat. The couplant of comparative example 4, which is commercially available, starts to lose viscosity at 38 ℃ in an environment with a certain working temperature, the gel loses all water when the temperature reaches 40 ℃ or above, and obvious adverse reactions such as reddening, thermal injury and the like can occur in treatment under the condition of non-uniform viscosity.

Therefore, the invention has stable viscosity and excellent water-insoluble property, can lubricate and hydrate for a long time without frequently replenishing gel, is greatly convenient for the operation of doctors in clinical use, increases the comfort of consumers and ensures the safety of the treatment process.

Viscosity stability test method 1: uniformly coating 1g of gel on a 6cm multiplied by 2.5cm vaginal electrode probe, spraying a vaginal simulation solution at the center of 3cm away from the electrode tip, and observing the gel adhesion condition on the electrode probe; vaginal simulation fluid: the formulation of 1L solution was 3.51g NaCl, 1.4g KOH, 0.22g Ca (OH) ₂ 0.018g bovine serum albumin, 2.00g lactic acid, 1.00g acetic acid, 0.16g glycerol, 0.4g urea and 5.00g glucose, the pH being adjusted to 4.2 using HCI.

Viscosity stability test method 2: treating with high frequency therapeutic apparatus, selecting open treatment test mode, smearing quantitative (2 g) gel product on arm under 10W power, gently rotating around central part of head circumference of square electrode of 2cmx2.5cm, and observing treatment temperature change and corresponding treatment part change of the apparatus within 5min of action time.

The above description is only an example of the present invention, and is not intended to limit the scope of the present invention, and all modifications and equivalents made by the present invention or directly/indirectly applied to other related technical fields within the spirit of the present invention are included in the scope of the present invention.

Claims (10)

1. The gel for the therapeutic apparatus is characterized by comprising the following components in percentage by mass: 0.15 to 1.5 percent of thickening agent, 5 to 15 percent of humectant, 0.01 to 1.5 percent of regulator, 20 to 70 percent of lubricant, 0.1 to 10 percent of active matter and the balance of purified water.

2. The gel for therapeutic devices of claim 1 wherein said gel has a viscosity of 10000-150000 mpa-s.

3. The therapeutic gel of claim 1, wherein the mass ratio of the thickening agent to the purified water is 1: (5-50); the mass ratio of the lubricant to the humectant to the thickener is (40-70%): (5% -15%): (0.5% -1%).

4. The therapeutic gel according to claim 1, wherein the thickener is one or more selected from carbomer, sodium polyacrylate, hydroxypropyl guar gum, xanthan gum, sodium polyacrylate grafted starch, hydroxyethyl acrylate-sodium acryloyldimethyl taurate copolymer, and sodium carboxymethyl starch.

5. The therapeutic gel according to claim 1, wherein the humectant is one or more selected from propylene glycol, butylene glycol, sorbitol, xylitol, scleroglucan, glucomannan, hydroxypropyl trimethyl ammonium chloride, honey, and polyglycerol-10 laurate.

6. The therapeutic gel of claim 1, wherein the modifier is one or more selected from arginine, triethanolamine, sodium hydroxide, citric acid, sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodium chloride.

7. The therapeutic gel of claim 1, wherein the lubricant is one or more selected from the group consisting of glycerin, polyvinyl alcohol, polyethylene glycol, bis-PEG-15 methyl ether polydimethylsiloxane, polysiloxane-11, phenyl trimethicone, and PPG-28-Butanethol-35.

8. The therapeutic gel of claim 1, wherein the active agent is one or more selected from the group consisting of sodium hyaluronate, sodium polyglutamate, ceramide, collagen, elastin, filaggrin, tremella polysaccharide, hydrolyzed conchiolin, hydrolyzed sesamin, fibronectin, jasminum grandiflorum extract, pullulan, and Morinda citrifolia juice.

9. A preparation method of gel for therapeutic instruments is characterized by comprising the following steps:

s1: mixing the thickener and humectant, uniformly dispersing, and stirring for 20-40min to completely infiltrate;

s2: adding purified water into the step S1, stirring and mixing, and standing for 8-36h to obtain a swelling matrix;

s3: stirring and homogenizing the swelling matrix for 10-50min to obtain a homogeneous material body;

s4: mixing the homogeneous material, purified water and regulator, and stirring for 20-40min to obtain gel matrix semi-finished product;

s5: mixing the gel matrix semi-finished product and lubricant, and stirring for 20-30min to obtain gel matrix;

s6: mixing gel matrix and active substance, stirring, and stirring for 20-30min to obtain therapeutic gel.

10. The method for preparing therapeutic gel according to claim 9, wherein the stirring and homogenizing conditions are as follows: stirring at 40-80rpm, homogenizing at 1500-3000rpm for 5-10min for 2-5 times.

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