Preparation method of functional gel

Abstract

The invention relates to the technical field of functional gel preparation, in particular to a preparation method of functional gel. The functional gel provided by the invention is prepared by the following steps: mixing 50 parts of water at 50 DEG C, 11 parts of carbomer and 5 parts of xanthan gum, and stirring at 150rpm for 10 minutes to obtain a material 1; mixing the material 1 with 6 parts of isopropyl palmitate, and stirring at 200rpm for 20min to obtain a material 2; and cooling the material 2 to 23 DEG C, mixing the material 2 with 25 parts of ethanol with the volume concentration of 80%, 13 parts of n-butyl alcohol with the volume concentration of 50%, 14 parts of glycerol and 3 parts of propyl hydroxybenzoate, stirring for 20 minutes at the speed of 200rpm, and regulating the pH to 5.4 by using a pH regulator sodium carbonate to obtain the functional gel. The functional gel prepared by the invention does not contain any medicine component, is safe and non-irritant in the use process, has an excellent treatment effect on male sexual dysfunction, and has a use effect equivalent to that of medicines in the prior art.

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 invention relates to the technical field of functional gel preparation, and 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, impotence, premature ejaculation, nocturnal emission and retrograde ejaculation. Most of them are erectile dysfunction. Erectile dysfunction is also called impotence. 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 men have sexual intercourse, if their penis is not hard or cannot be erected, they can choose sildenafil citrate, tadalafil hydrochloride, vardenafil hydrochloride and other drugs for treatment. 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 very short sexual intercourse time for men, and some cannot complete sexual intercourse at all. The drugs used to treat premature ejaculation include dapoxetine hydrochloride, paroxetine, sertraline lidocaine gel, etc. These drugs with relatively obvious effects in treating premature ejaculation are all selective serotonin reuptake inhibitors. In addition, there are other drugs to choose from.

[0006] Drugs for treating sexual dysfunction have different side effects and harms to the body due to their different types. For example, the main side effect of prostaglandins and dopamine is that they cause high blood pressure, which in turn causes congestion, edema and pain. The main side effects of sildenafil are blue vision and blushing. The main side effects of testosterone are spermatogenesis disorders and prostate hyperplasia. Dapoxetine, an antidepressant, can cause neurological symptoms. Madopar can cause high blood pressure. Therefore, drugs for treating sexual dysfunction in the prior art are not recommended for long-term use, 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 in order to solve the technical problem of large side effects of drugs for treating sexual dysfunction in the prior art 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 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 and isopropyl palmitate with 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 propylparaben for three times and stirred. The pH is adjusted with a pH adjuster to obtain a functional gel.

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

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

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

[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 thus cannot stimulate the production of exogenous NO. However, the ethanol and n-butanol added by the present invention both have strong solubility and volatility, and the cooling latent heat generated by the evaporation of the volatile solvent components locally stimulates the nerves to enhance the production of endogenous NO. Therefore, in its highly powerless organs, such as the glans penis, there are a series of sensors that respond to body senses (such as touch, pressure, and temperature). Local application of the functional gel of the present invention to these organs can stimulate one of the above-mentioned sensors, thereby causing them to react synergistically and causing the penis to swell and erect without containing active ingredients.

[0024] However, if ethanol and n-butanol are directly applied, 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 irritating to the skin. The addition of isopropyl palmitate can increase the affinity of the gel to the skin, prevent the gel from irritating the skin, and reduce the side effects of the functional gel. Propyl hydroxybenzoate is used as a preservative.

[0026] The functional gel prepared by the present invention does not contain any drug ingredients, will not have any drug dependence and side effects, is safe and non-irritating during use, has excellent therapeutic effects on male sexual dysfunction, and its use effect is equivalent to the therapeutic effect 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 hydroxybenzoate 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 hydroxybenzoate 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 hydroxybenzoate and 50 parts of water.

[0028] In the present invention, the volume concentration of ethanol is 75-85%, preferably 77-83%, more preferably 79-81%, and 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 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 and isopropyl palmitate with 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 propylparaben for three times and stirred. The pH is adjusted with a pH adjuster 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 more preferably 50°C.

[0035] In the present invention, step (3) is preferably cooled to 21-25°C; more preferably 22-24°C; and 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 of the first stirring is 8 to 12 minutes, preferably 9 to 11 minutes, and more preferably 10 minutes.

[0038] In the present invention, the rotation speeds of the secondary stirring and the tertiary stirring are both 150 to 250 rpm, preferably 170 to 230 rpm, more preferably 190 to 210 rpm, and 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 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 in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0044] Example 1

[0045] A method for preparing a functional gel, comprising 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 min to obtain material 2;

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

[0049] Example 2

[0050] A method for preparing a functional gel, comprising 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) mixing material 1 with 8 parts of isopropyl palmitate and stirring 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 propylparaben, and stirred at 250 rpm for 25 min. The pH was adjusted to 5.8 using a pH regulator, sodium carbonate, to obtain a functional gel.

[0054] Example 3

[0055] A method for preparing a functional gel, comprising 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 min to obtain material 1;

[0057] (2) mixing material 1 with 6 parts of isopropyl palmitate and stirring 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 propylparaben, and stirred at 200 rpm for 20 min. The pH was adjusted to 5.4 using a pH regulator, sodium carbonate, 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 the 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] 70 patients diagnosed with erectile dysfunction were selected, with an average age of 35.2 years and an average course of 32.7 months, and were divided into 7 treatment groups. The IIEF-5 score of each patient was investigated, and the survey data of patients in 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. 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] It can be seen from the records in Table 1 that the functional gel provided by the present invention can effectively improve the IIEF-5 score of patients, and its effect is equivalent to the therapeutic effect of the prior art drug sildenafil citrate.

[0078] From the data of the control group, it can be seen that the various components of the present invention are used in combination. If one or a certain component is discarded, the therapeutic effect of the functional gel will be significantly affected. If the components used in the present invention are replaced with components with similar functions, such as replacing sodium carbonate with sodium hydroxide, replacing n-butanol with an equal amount of propylene glycol, and replacing ethanol with a volume concentration of 80% with an equal amount of anhydrous ethanol, the technical effects of the present invention cannot be achieved.

[0079] Experimental Example 2

[0080] In the functional gel cooling test, the experimental group and the control group 1 to the 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 overnight for incubation.

[0085] (4) Place a 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 sample.

[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 in temperature, and the recovery temperature in 25 minutes of the temperature probe of the experimental group and the control group 1 to the control group 5 were measured three times and the average value was taken. The results are shown in Table 2.

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

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

[0090] Table 2 Functional gel cooling experiment questionnaire

[0091] Group 1min drop in temperature℃ 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 volatilize rapidly in a short time, and the probe surface temperature decreases rapidly. If sodium carbonate is replaced by sodium hydroxide, the volatilization effect of alcohol will be significantly affected. As can be seen from the data of other control groups, only by adopting the prescription of the present invention can the best use effect be achieved. If other similar components are replaced, the volatilization speed 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 principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A method for preparing a functional gel, It is 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 min to obtain material 1; (2) mixing material 1 with 6 parts of isopropyl palmitate and stirring 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 propylparaben, and stirred at 200 rpm for 20 min. The pH was adjusted to 5.4 using a pH regulator, sodium carbonate, to obtain a functional gel.