CN107080732B - A kind of preparation method of simethicone cream - Google Patents

Abstract

The invention provides a novel method for preparing simethicone cream, which is prepared from simethicone, ethylparaben, triethanolamine, glycerol, stearic acid, lanolin, white vaseline and water. The present invention has surprisingly found that, on the basis of the existing preparation method of the dimethicone cream, the dimethicone cream prepared by the specific addition or mixing sequence of the components in the method of the present invention has the advantages of easy control of the production process, white product property, fine texture, good storage stability and favorable transdermal absorption compared with the dimethicone cream prepared by the prior art method.

Description

A kind of preparation method of simethicone cream

technical field

The invention relates to a preparation method of dimethicone cream. It belongs to the field of pharmaceutical preparations.

Background technique

Simethicone cream is a hospital preparation product included in the "Beijing Medical Institutions Preparation Regulations". The product formula is composed of: Simethicone, stearic acid, lanolin, white petrolatum, glycerin, triethanolamine, ethyl paraben and water, whose composition is as follows:

The product method is:

1. Mix simethicone, stearic acid, lanolin, and white petrolatum together, heat until melted, and lower the temperature to about 70°C, set aside;

2. Mix ethyl paraben, triethanolamine, glycerin, and water together, heat until dissolved, and lower the temperature to about 70°C for later use;

3. Slowly add the oil phase components at about 70°C into the water phase components at a similar temperature, and stir in the same direction until coagulation.

There are still many shortcomings in the existing preparation methods, such as:

1. After formulation, the product has rough properties, and the product has poor ductility when applied, which is not easy to apply evenly, and the skin has a greasy feeling, which in turn leads to poor product absorption and penetration, which affects the efficacy of the product, and patients do not like to use it;

2. The color of the paste is deepened, it is yellow-white or almost white cream, not white cream;

3. The product is placed at a high temperature of about 30 ℃ in summer for 2 months, the character is rough, and the surface of the paste has water seepage, showing the state of "demulsification" in which the water phase components and the oil phase components of the product are separated.

SUMMARY OF THE INVENTION

In order to solve the technical defect that existing preparation method makes dimethicone cream, the object of the present invention is to provide a new preparation method of dimethicone cream, thereby solving the problem of the prepared dimethicone emulsion in the prior art Problems such as rough properties, poor stability, and unfavorable transdermal absorption of the cream are provided, and a new preparation method for making the simethicone cream product with good properties, stable quality and favorable transdermal absorption is provided.

The technical scheme of the present invention is as follows:

The present invention provides a method for preparing a dimethicone cream prepared from dimethicone, ethyl paraben, triethanolamine, glycerin, stearic acid, lanolin, white petrolatum and water , which is characterized by comprising the following steps:

(1) triethanolamine and stearic acid are mixed;

(2) mixing simethicone, white vaseline and lanolin;

(3) glycerin, ethyl paraben and water are mixed;

(4) adding the product obtained in step (1) to the product obtained in step (3);

(5) The product obtained in step (2) is added to the product obtained in step (4).

The above-mentioned method of the present invention is characterized in that in the step (1), the temperature at which triethanolamine and stearic acid are mixed and heated is 55-70°C, preferably 58-65°C.

The above-mentioned method of the present invention is characterized in that the temperature of the mixing and heating in the step (2) or the step (3) is 65-85°C, preferably 67-80°C.

The above-mentioned method of the present invention is characterized in that, in the step (1), step (2) or step (3), heating is performed while stirring.

The above-mentioned method of the present invention is characterized in that, in the step (4), stirring is performed uniformly.

The above-mentioned method of the present invention is characterized in that, in the step (5), stirring is performed in one direction until coagulation.

In the above-mentioned method of the present invention, in step (4) or step (5), the temperature is 65-85°C, preferably 65-78°C.

As a specific embodiment of the present invention, the above-mentioned method of the present invention is characterized in that it includes the following steps:

(1) triethanolamine is mixed with stearic acid, stirred and heated to 58-63 ° C, and incubated for 5-10 minutes;

(2) heat and melt simethicone, white petrolatum and lanolin, at a temperature of 67-80°C;

(3) glycerin, ethyl paraben and water are mixed, heated and stirred to dissolve, and the temperature is 67-80 ° C;

(4) adding the product obtained in step (1) to the product obtained in step (3), at a temperature of 65-78 °C, and stirring uniformly;

(5) adding the product obtained in step (2) to the product obtained in step (4), stirring at a temperature of 65-78° C. in one direction until coagulation.

In the above-mentioned method of the present invention, wherein the dimethicone cream, in parts by weight, contains 200 parts of dimethicone, 1 part of ethyl paraben, 20 parts of Triethanolamine, 40 parts of glycerin, 149 parts of stearic acid, 20 parts of lanolin, 70 parts of white petrolatum and the balance of purified water.

The present invention has surprisingly found through experiments that the dimethicone cream prepared by the specific addition or mixing sequence of the components in the method of the present invention, compared with the dimethicone cream prepared by the prior art method, has at least The following unexpected beneficial effects:

1. The preparation method of the present invention breaks the restriction of mixing and emulsification temperature at about 70 ℃ in the prior art, the temperature range is expanded, the production process is easy to control, the product properties are white, and the texture is fine, reducing the adjustment of water phase components and oil phase components. Cooling and cooling and steam heating operations in the process of similar temperature, reduce energy consumption and production hours, and save product costs;

2. The simethicone cream product prepared by the preparation method of the present invention is oily and delicate, and the particle size can reach 1 μm, which is smaller than the particle size of the prepared product in the prior art; The "demulsification" phenomenon of oil and water separation occurs, and the particle size does not change, indicating that the product prepared by the preparation method of the present invention has stable quality, good properties, and is conducive to transdermal absorption;

3. The preparation method of the present invention is simple to operate, does not need to increase equipment, saves production time and energy consumption, and reduces product cost.

Detailed ways

Specific embodiments of the present invention will be described in detail below. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present invention, but not to limit the present invention.

(1) Preparation of simethicone cream

Example 1

product composition:

Preparation:

1.1. Put stearic acid and triethanolamine in the same container, heat to 61°C while stirring in a water bath, and keep the temperature for 8 minutes;

1.2. Put simethicone, vaseline, and lanolin in the same container, stir while heating until the temperature is 75℃, and the oil phase is completely melted;

1.3. Put glycerol, ethyl paraben and purified water in the same container, stir while heating until the temperature is 75°C, and the water phase is completely dissolved;

1.4. Add item 1.1 to item 1.3, temperature 74°C, stir evenly, then add item 1.2 to item 1.3, temperature 73°C, stir in one direction until coagulation, to prepare dimethicone cream.

Example 2

The product composition and technological process are as in Example 1.

1.1. Take stearic acid and triethanolamine and place them in the same container, heat to 63°C while stirring in a water bath, and keep the temperature for 5 minutes;

1.2. Put simethicone, vaseline, and lanolin in the same container, and stir while heating until the temperature is 80°C, and the oil phase is completely melted;

1.3. Put glycerol, ethyl paraben and purified water in the same container, stir while heating until the temperature is 80°C, and the water phase is completely dissolved;

1.4. Add item 1.1 to item 1.3, temperature 78°C, stir evenly, then add item 1.2 to item 1.3, temperature 78°C, stir in one direction until coagulation, to prepare dimethicone cream.

Example 3

Product composition and technological process are with embodiment 1.

1.1. Put stearic acid and triethanolamine in the same container, heat to 58°C while stirring in a water bath, and keep the temperature for 10 minutes;

1.2. Put simethicone, vaseline, and lanolin in the same container, stir while heating until the temperature is 67°C, and the oil phase is completely melted;

1.3. Put glycerin, ethyl paraben and purified water in the same container, stir while heating until the temperature is 67°C, and the water phase is completely dissolved;

1.4. Add item 1.1 to item 1.3, temperature 65℃, stir evenly, then add item 1.2 to item 1.3, temperature 65℃, stir in the same direction until coagulation, to prepare dimethicone cream.

Comparative Example 1:

The product composition is the same as that of Example 1.

Adopt existing simethicone cream preparation method:

1.1. Mix simethicone, stearic acid, lanolin, and white petrolatum together, heat until melted, and lower the temperature to 70°C, set aside for later use;

1.2. Mix ethyl paraben, triethanolamine, glycerin, and water together, heat to dissolve, reduce the temperature to 70°C, and set aside for later use;

1.3. Slowly add item 1.1 at 70°C into item 1.2 at 70°C, and stir in the same direction until coagulation to prepare simethicone cream.

(2) Comparison of test results of simethicone cream products

1. The simethicone cream prepared by Example 1, Example 2, Example 3 and Comparative Example 1 was sampled respectively, smeared, and the particle size of the prepared product was observed under a microscope:

(1) The properties of the prepared product in Example 1 are oily and delicate; the particle size observed under a microscope is generally 1 μm, and the larger is 3-4 μm;

(2) The properties of the prepared product in Example 2 are oily and delicate; the particle size observed under a microscope is generally 1 μm, and the larger is 3-5 μm;

(3) The properties of the prepared product in Example 3 are oily and delicate; the particle size observed under the microscope is generally 1 μm, and the larger is 3-5 μm;

(4) Comparative Example 1 The prepared product is oily and delicate; the particle size observed under the microscope is generally 3-4 μm, the smaller is 2-3 μm, and the larger is 8-10 μm.

2. Place the prepared products of Example 1, Example 2, Example 3 and Comparative Example 1 in a constant temperature and humidity box: under the conditions of temperature 40 ℃ ± 2 ℃, relative humidity 75% ± 5%, place 3 After a month, observe the product properties and observe the particle size under the microscope:

(1) There is no change in the properties of the prepared product in Example 1: oily and delicate; the particle size observed under a microscope is generally 1 μm, and the larger is 3-4 μm;

(2) There is no change in the properties of the prepared product in Example 2: oily and delicate; the particle size observed under a microscope is generally 1 μm, and the larger is 3-5 μm;

(3) There is no change in the properties of the prepared product in Example 3: oily and delicate; the particle size observed under the microscope is generally 1 μm, and the larger is 3-5 μm;

(4) Properties of the product prepared in Comparative Example 1: The appearance of the paste is slightly "oily", slightly rough, and the fineness is slightly changed; the particle size observed under the microscope is generally 5-7 μm, the smaller is 4-5 μm, and the larger is 12- 14μm.

3. Conclusion: the product prepared in the embodiment of the present invention is oily and delicate, and the particle size is smaller than that of the product prepared in the comparative example; after being placed in a constant temperature and humidity drying oven for 3 months, there is no separation of oil phase components and water phase components. The "demulsification" changes, and the particle size does not change, indicating that the simethicone cream product prepared by the method of the present invention has stable quality, good properties, and is conducive to transdermal absorption.

The content of the present invention has been described in detail above in conjunction with the embodiments, but the present invention is not limited to the specific details in the above-mentioned embodiments. All modifications belong to the protection scope of the present invention.

Claims (7)

1. The method for preparing the simethicone cream is characterized by comprising the following steps of:

(1) mixing triethanolamine and stearic acid, stirring and heating to 58-65 ℃, and preserving heat for 5-10 minutes;

(2) mixing dimethicone, white vaseline and lanolin;

(3) mixing glycerol, ethylparaben and water;

(4) adding the product prepared in the step (1) into the product prepared in the step (3);

(5) adding the product obtained in the step (2) into the product obtained in the step (4).

2. The method according to claim 1, wherein the temperature of the mixing heating in the step (2) or the step (3) is 65 to 85 ℃.

3. The method according to claim 2, wherein the temperature of the mixing heating in the step (2) or the step (3) is 67-80 ℃.

4. The method according to any one of claims 1 to 3, wherein heating while stirring is performed in step (1), step (2) or step (3).

5. The method according to any one of claims 1 to 3, wherein the stirring is performed uniformly in the step (4).

6. A method according to any one of claims 1 to 3, wherein in step (5) the agitation is in one direction to coagulation.

7. A method according to any of claims 1-3, characterized by the steps of:

(1) mixing triethanolamine and stearic acid, stirring and heating to 58-65 ℃, and preserving heat for 5-10 minutes;

(2) mixing dimethicone, white vaseline and lanolin, heating to melt at 67-80 deg.C;

(3) mixing glycerol, ethylparaben and water, heating, stirring and dissolving at 67-80 deg.C;

(4) adding the product prepared in the step (1) into the product prepared in the step (3), and uniformly stirring;

(5) adding the product prepared in the step (2) into the product prepared in the step (4), and stirring in one direction until the product is coagulated.