A method for preparing functional gel

Abstract

The present invention relates to the technical field of functional gel preparation, and in particular to a method for preparing a functional gel. The functional gel preparation steps provided by the present invention are as follows: 50 parts of 50°C water, 11 parts of carbomer, and 5 parts of xanthan gum are mixed and stirred at 150 rpm for 10 minutes to obtain material 1; material 1 is mixed with 6 parts of isopropyl palmitate and stirred at 200 rpm for 20 minutes to obtain material 2; material 2 is cooled to 23°C, mixed with 25 parts of 80% ethanol by volume, 13 parts of 50% n-butanol by volume, 14 parts of glycerol, and 3 parts of propyl paraben, and stirred at 200 rpm for 20 minutes; and the pH is adjusted to 5.4 using sodium carbonate as a pH adjuster to obtain a functional gel. The functional gel prepared by the present invention does not contain any pharmaceutical ingredients, is safe and non-irritating during use, and has excellent therapeutic effects on male sexual dysfunction, with the therapeutic effects comparable to those of existing drugs.

Description

[0001] This application is a divisional application. The application number of the original application is: 202311816148.8, the application date is 2023.12.27, and the name of the invention is: A functional gel and its preparation method and application. Technical Field

[0002] The present invention relates to the technical field of functional gel preparation, in particular to a method for preparing functional gel. Background Art

[0003] Male sexual dysfunction refers to the inability of male sexual function and sexual satisfaction, which is often manifested as sexual desire disorder, erectile dysfunction, premature ejaculation, nocturnal emission and retrograde ejaculation, etc. Most of them are erectile dysfunction. Erectile dysfunction is also called impotence, and the causes are mostly kidney yang deficiency, qi deficiency, etc.

[0004] The most common sexual dysfunctions in men are erectile dysfunction and premature ejaculation. The treatment drugs should be selected according to the different causes. Male erectile dysfunction: When a man's penis is not hard or cannot be erected during sexual intercourse, he can choose to use drugs such as sildenafil citrate, tadalafil hydrochloride, and vardenafil hydrochloride. These drugs mainly increase the blood supply to the corpus cavernosum, increase blood flow to the penis, and improve the symptoms of erectile dysfunction.

[0005] Premature ejaculation: Premature ejaculation refers to a condition in which men experience very short intercourse, or even complete intercourse. Medications used to treat premature ejaculation include dapoxetine hydrochloride, paroxetine, and sertraline lidocaine gel. These effective medications are all selective serotonin reuptake inhibitors (SSRIs). Other medications are also available.

[0006] Different types of drugs for treating sexual dysfunction have different side effects and harms on the body. For example, the main side effect of prostaglandins and dopamine is increased blood pressure, which can cause congestion, edema, and pain. The main side effects of sildenafil are blue vision and flushing. The main side effects of testosterone are spermatogenesis disorders and prostate hyperplasia. Dapoxetine, an antidepressant, can cause neurological symptoms. Madopar can cause increased blood pressure. Therefore, long-term use of drugs for treating sexual dysfunction in the existing technology is not recommended, otherwise there will be obvious side effects.

[0007] Therefore, how to provide a product that does not contain any drug ingredients but can still effectively treat male sexual dysfunction to solve the technical problem of large side effects of drugs for treating sexual dysfunction in the existing technology is an issue that technical personnel in this field urgently need to solve. Summary of the Invention

[0008] The purpose of the present invention is to provide a functional gel and a preparation method and application thereof.

[0009] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0010] The invention provides a functional gel, which is prepared from the following components in parts by mass: 20-30 parts of ethanol, 11-15 parts of n-butanol, 9-13 parts of carbomer, 3-7 parts of xanthan gum, 12-16 parts of glycerol, 4-8 parts of isopropyl palmitate, 2-4 parts of propyl hydroxybenzoate and 40-60 parts of water.

[0011] Preferably, the volume concentration of the ethanol is 75-85%.

[0012] Preferably, the volume concentration of the n-butanol is 40-60%.

[0013] The present invention also provides a method for preparing the functional gel, comprising the following steps:

[0014] (1) Mix 45-55°C water, carbomer, and xanthan gum and stir once to obtain material 1;

[0015] (2) mixing material 1 with isopropyl palmitate and stirring for a second time to obtain material 2;

[0016] (3) Material 2 is cooled to 20-26° C., and then mixed with ethanol, n-butanol, glycerol and propyl paraben three times with stirring. The pH is adjusted with a pH regulator to obtain a functional gel.

[0017] Preferably, the stirring speed in step (1) is 100-200 rpm and the stirring time is 8-12 min.

[0018] Preferably, the rotation speed of the second stirring and the third stirring are both 150-250 rpm, and the time is both 15-25 min.

[0019] Preferably, the pH is adjusted to 5.4-5.8 in step (3).

[0020] Preferably, the pH regulator in step (3) is sodium carbonate.

[0021] The present invention also provides application of the functional gel in preparing medicine for treating male sexual dysfunction.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] The functional gel provided by the present invention does not contain any active pharmaceutical ingredients and therefore cannot stimulate exogenous NO production. However, the ethanol and n-butanol added to the gel have high solubility and volatility. The cooling latent heat generated by the evaporation of the volatile solvent components locally stimulates nerves, thereby enhancing endogenous NO production. Therefore, in highly impaired organs, such as the glans penis, there are sensors that respond to a series of physical senses (such as touch, pressure, and temperature). Topical application of the functional gel of the present invention to these organs can stimulate one of these sensors, causing them to react synergistically and causing penile swelling and erection without the presence of active ingredients.

[0024] However, if ethanol and n-butanol are applied directly, there are still many problems, including insufficient volatilization speed, which leads to the inability to achieve the technical effect of cooling in a short time. The present invention also adds sodium carbonate. Although sodium carbonate is used as a pH regulator, it has the function of promoting the volatilization of ethanol and n-butanol. Sodium carbonate can weaken the intermolecular bonds, making it easier to volatilize, thereby shortening the volatilization time of ethanol and n-butanol.

[0025] Ethanol and n-butanol are somewhat irritating to the skin. The addition of isopropyl palmitate can increase the gel's affinity for the skin, prevent irritation, and reduce the side effects of the functional gel. Propyl paraben is used as a preservative.

[0026] The functional gel prepared by the present invention does not contain any drug ingredients, will not have any problems such as drug dependence and side effects, is safe and non-irritating during use, has an excellent therapeutic effect on male sexual dysfunction, and its use effect is comparable to that of existing drugs. DETAILED DESCRIPTION

[0027] The present invention provides a functional gel, which is prepared from the following components in parts by mass: 20-30 parts of ethanol, 11-15 parts of n-butanol, 9-13 parts of carbomer, 3-7 parts of xanthan gum, 12-16 parts of glycerol, 4-8 parts of isopropyl palmitate, 2-4 parts of propyl hydroxybenzoate and 40-60 parts of water; preferably, it is prepared from the following components in parts by mass: 22-28 parts of ethanol, 12-14 parts of n-butanol, 10-12 parts of carbomer, 4-6 parts of xanthan gum, 13-15 parts of glycerol, 5-6 parts of isopropyl palmitate. 7 parts, propyl paraben 3 parts and 44-56 parts of water; further preferably, it is prepared from the following components in parts by mass: 24-26 parts of ethanol, 13 parts of n-butanol, 11 parts of carbomer, 5 parts of xanthan gum, 14 parts of glycerol, 6 parts of isopropyl palmitate, 3 parts of propyl paraben and 48-52 parts of water; more preferably, it is prepared from the following components in parts by mass: 25 parts of ethanol, 13 parts of n-butanol, 11 parts of carbomer, 5 parts of xanthan gum, 14 parts of glycerol, 6 parts of isopropyl palmitate, 3 parts of propyl paraben and 50 parts of water.

[0028] In the present invention, the volume concentration of the ethanol is 75-85%, preferably 77-83%, more preferably 79-81%, and even more preferably 80%.

[0029] In the present invention, the volume concentration of n-butanol is 40-60%, preferably 44-56%, more preferably 48-52%, and even more preferably 50%.

[0030] The present invention also provides a method for preparing the functional gel, comprising the following steps:

[0031] (1) Mix 45-55°C water, carbomer, and xanthan gum and stir once to obtain material 1;

[0032] (2) mixing material 1 with isopropyl palmitate and stirring for a second time to obtain material 2;

[0033] (3) Material 2 is cooled to 20-26° C., and then mixed with ethanol, n-butanol, glycerol and propyl paraben three times with stirring. The pH is adjusted with a pH regulator to obtain a functional gel.

[0034] In the present invention, the temperature of the water in step (1) is preferably 47-53°C; more preferably 49-51°C; and even more preferably 50°C.

[0035] In the present invention, step (3) is preferably cooled to 21-25°C; more preferably 22-24°C; and even more preferably 23°C.

[0036] In the present invention, the rotation speed of the primary stirring in step (1) is 100 to 200 rpm; preferably 120 to 180 rpm; more preferably 140 to 160 rpm; and more preferably 150 rpm.

[0037] In the present invention, the time for one stirring is 8 to 12 minutes, preferably 9 to 11 minutes, and more preferably 10 minutes.

[0038] In the present invention, the rotation speed of the secondary stirring and the tertiary stirring is 150 to 250 rpm, preferably 170 to 230 rpm, more preferably 190 to 210 rpm, and even more preferably 200 rpm.

[0039] In the present invention, the time for the second stirring and the third stirring is 15 to 25 minutes, preferably 17 to 23 minutes, more preferably 19 to 21 minutes, and even more preferably 20 minutes.

[0040] In the present invention, the pH value in step (3) is adjusted to 5.4 to 5.8, preferably 5.5 to 5.7, and more preferably 5.6.

[0041] In the present invention, the pH regulator in step (3) is sodium carbonate.

[0042] The present invention also provides application of the functional gel in preparing medicine for treating male sexual dysfunction.

[0043] The technical solutions provided by the present invention are described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0044] Example 1

[0045] A method for preparing a functional gel comprises the following steps:

[0046] (1) Mix 40 parts of 45°C water, 9 parts of carbomer, and 3 parts of xanthan gum and stir at 100 rpm for 8 minutes to obtain material 1;

[0047] (2) Mixing material 1 with 4 parts of isopropyl palmitate and stirring at 150 rpm for 15 minutes to obtain material 2;

[0048] (3) Material 2 was cooled to 20° C., and then mixed with 20 parts by volume of 75% ethanol, 11 parts by volume of 40% n-butanol, 12 parts by volume of glycerol, and 1 part by volume of propyl paraben, and stirred at 150 rpm for 15 min. The pH was adjusted to 5.4 using sodium carbonate as a pH regulator to obtain a functional gel.

[0049] Example 2

[0050] A method for preparing a functional gel comprises the following steps:

[0051] (1) Mix 60 parts of 55°C water, 13 parts of carbomer, and 7 parts of xanthan gum and stir at 200 rpm for 12 minutes to obtain material 1;

[0052] (2) Material 1 was mixed with 8 parts of isopropyl palmitate and stirred at 250 rpm for 25 min to obtain material 2;

[0053] (3) Material 2 was cooled to 26° C., and then mixed with 30 parts by volume of 85% ethanol, 15 parts by volume of 60% n-butanol, 16 parts by volume of glycerol, and 4 parts by volume of propyl paraben, and stirred at 250 rpm for 25 min. The pH was adjusted to 5.8 using sodium carbonate as a pH regulator to obtain a functional gel.

[0054] Example 3

[0055] A method for preparing a functional gel comprises the following steps:

[0056] (1) Mix 50 parts of 50°C water, 11 parts of carbomer, and 5 parts of xanthan gum and stir at 150 rpm for 10 minutes to obtain material 1;

[0057] (2) Material 1 was mixed with 6 parts of isopropyl palmitate and stirred at 200 rpm for 20 min to obtain material 2;

[0058] (3) Material 2 was cooled to 23° C., and then mixed with 25 parts by volume of 80% ethanol, 13 parts by volume of 50% n-butanol, 14 parts by volume of glycerol, and 3 parts by volume of propyl paraben, and stirred at 200 rpm for 20 min. The pH was adjusted to 5.4 using sodium carbonate as a pH regulator to obtain a functional gel.

[0059] Comparative Example 1

[0060] The other methods are compared with Example 3, except that isopropyl palmitate is replaced by an equal amount of distilled water.

[0061] Comparative Example 2

[0062] The only difference between the other methods and Example 3 is that the n-butanol with a volume concentration of 50% is replaced by n-butanol with a volume concentration of 20%.

[0063] Comparative Example 3

[0064] The other methods are compared with Example 3, except that sodium carbonate is replaced by sodium hydroxide.

[0065] Comparative Example 4

[0066] The other methods are different from Example 3 only in that n-butanol is replaced by an equal amount of propylene glycol.

[0067] Comparative Example 5

[0068] The other methods are different from Example 3 only in that the ethanol with a volume concentration of 80% is replaced by an equal amount of anhydrous ethanol.

[0069] Experimental Example 1

[0070] Seventy patients diagnosed with erectile dysfunction (ED) were selected. Their average age was 35.2 years and their average disease duration was 32.7 months. They were divided equally into seven treatment groups. Each patient's IIEF-5 score was assessed, and the mean values ​​across the different groups were averaged.

[0071] The functional gel obtained by the method of Example 3 was used as the experimental group; the method of use was: apply the functional gel evenly on the surface of the penis, wait for 30 minutes, and the treatment process was completed, once a day.

[0072] Control groups 1 to 5 are functional gels obtained by the methods of comparative examples 1 to 5 respectively; the method of use is: apply the functional gel evenly on the surface of the penis, wait for 30 minutes, and the treatment process is completed, once a day.

[0073] The prior art group took sildenafil citrate (according to the instructions).

[0074] The experimental group, control group 1 to control group 5, and the prior art group each selected one of the treatment groups for the experiment. The experiment lasted for 42 days. After 42 days, the IIEF-5 scores of the patients were investigated again, and the data of different groups were averaged. The results are shown in Table 1.

[0075] Table 1 IIEF-5 scoring questionnaire

[0076] Group Before treatment After treatment Number of adverse reactions Experimental group 13.1 21.0 0 Control group 1 13.4 19.1 2 Control group 2 13.7 19.3 0 Control group 3 14.5 20.1 1 Control group 4 14.0 19.7 1 Control group 5 13.6 20.6 1 Existing Technology Group 13.2 21.5 3

[0077] As can be seen from the records in Table 1, the functional gel provided by the present invention can effectively improve the IIEF-5 score of patients, and its effect is comparable to the therapeutic effect of the prior art drug sildenafil citrate.

[0078] The data from the control group demonstrate that the components of the present invention are designed to be used in conjunction with one another; omitting one or more of these components significantly impacts the therapeutic efficacy of the functional gel. Furthermore, replacing the components used in the present invention with components having similar functions—for example, replacing sodium carbonate with sodium hydroxide, replacing n-butanol with an equal amount of propylene glycol, or replacing 80% ethanol by volume with an equal amount of anhydrous ethanol—failed to achieve the desired technical effects.

[0079] Experimental Example 2

[0080] In the functional gel cooling test, the experimental group and control group 1 to control group 5 were the same as those in Experimental Example 1.

[0081] The specific test method is:

[0082] (1) Drill a 5 mm diameter hole in the cap of a 15 mL centrifuge tube.

[0083] (2) Use a syringe to place 14 mL of sample gel into a 15 mL centrifuge tube.

[0084] (3) Place the centrifuge tube containing the sample gel (sealed with a normal lid) and the temperature probe in an oven set at 32°C for overnight incubation.

[0085] (4) Place the cap with a 5 mm hole cut out on the centrifuge tube containing the sample gel to block the hole to prevent evaporation until you are ready to take samples.

[0086] (5) Insert the temperature probe into the centrifuge tube containing the sample gel until the bottom of the probe contacts the tube cap (the amount of gel used on the probe is approximately 70 mg).

[0087] (6) The probe was removed from the gel and placed in an oven. The temperature drop in 1 minute, the maximum drop temperature, and the recovery temperature in 25 minutes of the temperature probe of the experimental group and control group 1 to control group 5 were measured three times and the average value was taken. The results are shown in Table 2.

[0088] Maximum temperature drop = ambient temperature (°C) - minimum temperature (°C)

[0089] Recovery temperature (T = 25 minutes) = final temperature (°C) - lowest temperature (°C)

[0090] Table 2 Functional gel cooling experiment questionnaire

[0091] Group Temperature drop in 1 minute Maximum temperature reduction ℃ 25min recovery temperature ℃ Experimental group 13.1 14.7 8.2 Control group 1 11.5 11.8 9.6 Control group 2 11.7 11.9 9.3 Control group 3 11.2 12.0 8.8 Control group 4 12.1 13.6 8.9 Control group 5 12.8 14.2 8.5

[0092] As can be seen from the data in Table 2, the functional gel provided by the present invention can be rapidly volatilized in a short period of time, and the probe surface temperature is rapidly reduced. However, if sodium carbonate is replaced with sodium hydroxide, the volatilization effect of the alcohol will be significantly affected. As can be seen from the data of other control groups, only by adopting the formula of the present invention can the optimal use effect be achieved. If other similar components are replaced, the volatilization rate of the functional gel will be affected.

[0093] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A method for preparing a functional gel, characterized in that: Here are the steps: (1) Mix 50 parts of 50°C water, 11 parts of carbomer, and 5 parts of xanthan gum and stir at 150 rpm for 10 minutes to obtain material 1; (2) Material 1 was mixed with 6 parts of isopropyl palmitate and stirred at 200 rpm for 20 min to obtain material 2; (3) Material 2 was cooled to 23° C., and then mixed with 25 parts by volume of 80% ethanol, 13 parts by volume of 50% n-butanol, 14 parts by volume of glycerol, and 3 parts by volume of propyl paraben, and stirred at 200 rpm for 20 min. The pH was adjusted to 5.4 using sodium carbonate as a pH regulator to obtain a functional gel.