CN111407819A - Tea oil cream suitable for infantile eczema and emulsifying preparation method thereof - Google Patents

Abstract

The invention belongs to the technical field of medicines, and discloses a tea oil cream suitable for infantile eczema and an emulsification preparation method thereof, wherein a tea oil cream matrix comprises 5-11% of tea oil, 6-8% of an emulsifier, 0.2-1% of α -bisabolol, 1.5-5.5% of candelilla wax, 4-18% of glycerol, 3-15% of cetostearyl alcohol and the balance of water, wherein the tea oil content is up to 11%, and meanwhile, the tea oil and the α -bisabolol are main anti-inflammatory components, and the obtained tea oil cream has good appearance and stable quality by adding two matrixes of α -bisabolol and cetostearyl alcohol.

Description

Tea oil cream suitable for infantile eczema and emulsifying preparation method thereof

Technical Field

The invention relates to the technical field of medicines, in particular to tea oil cream suitable for infantile eczema and an emulsifying preparation method thereof.

Background

With the gradual improvement of the quality of life, more and more people hope to adopt the treatment method combining traditional Chinese medicine and external non-trauma to cure diseases. The ointment is a semisolid external noninvasive preparation prepared by uniformly mixing the extract, decoction piece fine powder and a proper matrix, mainly plays roles in lubrication, protection and local treatment, and is mainly used for chronic skin diseases. The ointment has three common bases, which are respectively oleaginous base, water-soluble base and emulsion base. Ointment bases vary in composition and penetration of the drug, as do emulsion bases, which allow for easy transdermal absorption of the drug. The emulsion matrix is a semisolid matrix formed by emulsifying a water phase and an oil phase at a certain temperature by virtue of an emulsifier, has affinity to both oil and water, and has little influence on the normal function of skin. The emulsion type matrix is W/O type, O/W type, W/O/W type, etc., wherein the O/W type is more favorable for releasing compared with other two matrixes. The ointment prepared from the emulsion type matrix is called cream, and the cream mainly has the effects of protecting a wound surface, lubricating the skin and locally treating, is easy to release and absorb, is easier to coat and clean compared with the greasy matrix and has the effect of protecting the skin. Because the cream has the characteristics of convenient use, stable dosage form, easy absorption and the like, more and more raw materials of the medicine are tried to be prepared into the cream, and the percutaneous absorption of the medicine is improved.

The tea oil is mild in texture, fresh, clean and not greasy, high in safety, stable, not easy to oxidize and good in skin affinity, so that the extracted tea oil is gradually used as a main component in skin care products in recent years, and therefore, the cream which is white in appearance, fine in texture, moderate in ductility and good in stability and prepared by using the tea oil has important significance.

Disclosure of Invention

In view of the above, the invention aims to provide the tea oil cream suitable for infantile eczema, which has the advantages of white appearance, fine texture, moderate ductility, good stability, mildness, safety and no irritation, is suitable for infantile eczema and has extremely high popularization value.

In order to achieve the purpose, the invention provides the following technical scheme:

the tea oil cream suitable for infantile eczema comprises the following components in percentage by mass: 5 to 11 percent of tea oil, 6 to 8 percent of emulsifier, 1.5 to 5.5 percent of candelilla wax, 4 to 18 percent of glycerin, 3 to 15 percent of hexadecanol and octadecanol, and the balance of water.

Preferably, the mass ratio of the tea oil in the matrix is 8-9%.

Preferably, the mass percentage of the hexadecanol and the octadecanol in the matrix is 10 to 12 percent.

Preferably, the mass ratio of the emulsifier in the matrix is 7-8%, and preferably, the emulsifier comprises wheat germ milk and/or corn germ milk.

Preferably, the mass ratio of the candelilla wax in the matrix is 1.5-3%.

Preferably, the mass ratio of the glycerol in the matrix is 10-12%.

Further, the base of the tea oil cream also comprises α -bisabolol 0.2-1% and/or lauryl glucoside 3-60%.

Preferably, the α -bisabolol accounts for 0.2-0.5% of the matrix by weight.

In another aspect, the present invention provides an emulsion preparation method for preparing the above tea oil cream, comprising the steps of:

s1, preparing an oil phase; mixing tea oil, an emulsifier, hexadecanol, candelilla wax and a-bisabolol, and continuously heating in a water bath to 75-85 ℃;

s2, preparing a water phase; dissolving glycerol in water, and heating to 75-85 ℃ in a continuous water bath;

s3, mixing; slowly adding the water phase into the oil phase while stirring in the same direction under the heating of a water bath at 75-85 ℃, and stopping heating after the water phase is completely added;

s4, shearing at a high speed for 1-2 min by a homogenizer with the rotating speed of 9000 r/min-10000 r/min, and slowly stirring in the same direction at normal temperature to room temperature to obtain the tea oil cream.

Compared with the prior art, the tea oil cream suitable for infantile eczema and the emulsification preparation method thereof have the following advantages:

(1) the main components of the tea oil cream suitable for infantile eczema of the invention, namely the tea oil and the α -bisabolol, have anti-inflammatory effects, and the content of the tea oil is up to 11 percent, so that the formula of the tea oil cream is safe to select, is suitable for infants, and has the advantages of no stimulation and mildness;

(2) the cream prepared by the tea oil cream matrix proportion is fine and smooth in texture, moderate in ductility and good in stability, and meanwhile, the α -bisabolol and the hexadecahecanol two matrices make the obtained tea oil cream white in appearance and more stable in quality;

(3) the preparation method of the tea oil cream is characterized in that the water phase and the oil phase are heated in a water bath separately, and finer dispersed phase particles can be generated in the process of mixing the water phase with the oil phase.

Drawings

FIG. 1 is a 3D plot and a contour plot of the whiteness of tea oil, emulsifier, candelilla wax in accordance with example 3 of the present invention;

FIG. 2 is a 3D plot and a contour plot of the smoothness of tea oil, emulsifier, candelilla wax according to example 3 of the present invention;

FIG. 3 is a 3D plot and a contour plot of the malleability of tea oil, emulsifier, candelilla wax according to example 3 of the present disclosure;

FIG. 4 is a 3D plot and a contour plot of the centrifugal stability of tea oil, emulsifier, candelilla wax in accordance with example 3 of the present invention;

FIG. 5 is a 3D plot and a contour plot of the heat stability of tea oil, emulsifier, candelilla wax in accordance with example 3 of the present invention;

FIG. 6 is a 3D plot and a contour plot of the cold stability of tea oil, emulsifier, candelilla wax in accordance with example 3 of the present invention;

FIG. 7 is a graph of the linear relationship of the total score provided by Design-expert software according to embodiment 3 of the present invention;

fig. 8 is a 3D plot and a contour plot of the total scores of tea oil, emulsifier, candelilla wax according to example 3 of the present invention.

Detailed Description

The following detailed description of embodiments of the invention refers to the accompanying drawings. It should be understood that the detailed description and specific examples, while indicating embodiments of the invention, are given by way of illustration and explanation only, not limitation.

The endpoints of the ranges and any values disclosed herein are not limited to the precise range or value, and such ranges or values should be understood to encompass values close to those ranges or values. For ranges of values, one or more new ranges of values may be obtained between the endpoints of each range, between the endpoints of each range and the individual values, and between the individual values in combination with each other, and these ranges of values should be considered as specifically disclosed herein.

The invention provides tea oil cream suitable for infantile eczema, wherein a matrix of the tea oil cream comprises tea oil, an emulsifier, candelilla wax, glycerol and cetostearyl alcohol, and the matrix of the tea oil cream comprises the following components in percentage by mass: 5 to 11 percent of tea oil, 6 to 8 percent of emulsifier, 1.5 to 5.5 percent of candelilla wax, 4 to 18 percent of glycerin, 3 to 15 percent of hexadecanol and octadecanol, and the balance of water.

In a preferred embodiment of the present invention, it is preferred that the emulsifier comprises wheat germ milk and/or corn germ milk.

In order to improve the appearance and stability of the tea oil cream, in a preferred embodiment of the present invention, the tea oil is present in an amount of 8 to 9% by mass in the base.

In a preferred embodiment of the present invention, the ratio of the cetostearyl alcohol in the matrix is 10% to 12% by mass.

In a preferred embodiment of the invention, the mass ratio of the emulsifier in the matrix is 7-8%.

In a preferred embodiment of the invention, the mass ratio of the candelilla wax in the matrix is 1.5-3%.

In a preferred embodiment of the present invention, the glycerin accounts for 10 to 12% by mass of the matrix.

According to a preferred embodiment of the present invention, it is preferable that the base of the tea oil cream further comprises α -bisabolol at 0.2% to 1% or lauryl glucoside at 3% to 60%, and it is further preferable that the tea oil cream comprises α -bisabolol at 0.2% to 0.5%.

The cream prepared by adding α -bisabolol and hexadecanodecanol has good appearance and stable quality, wherein the tea oil cream has the functions of resisting inflammation, removing melanin, relieving pain and activating blood due to the tea oil and the α -bisabolol.

The invention also provides an emulsification preparation method of the tea oil cream, which comprises the following steps:

s1, preparing an oil phase; mixing tea oil, an emulsifier, hexadecanol, candelilla wax and a-bisabolol, and continuously heating in a water bath to 75-85 ℃;

s2, preparing a water phase; dissolving glycerol in water, and heating to 75-85 ℃ in a continuous water bath;

s3, mixing; slowly adding the water phase into the oil phase while stirring in the same direction under the heating of a water bath at 75-85 ℃, and stopping heating after the water phase is completely added;

s4, shearing at a high speed for 1-2 min by a homogenizer with the rotating speed of 9000 r/min-10000 r/min, and slowly stirring in the same direction at normal temperature to room temperature to obtain the tea oil cream.

Table 1 shows the instruments and sources of the instruments used in the emulsification process of the tea oil cream of the present invention.

TABLE 1

Table 2 shows the reagents and sources of the reagents used in the preparation of the tea oil cream of the present invention.

TABLE 2

Name of reagent	Sources of reagents
		Tea oil	Jiangxi Baoyuan agriculture development Co Ltd
Emulsifier	Guangzhou Pengyuan chemical Co Ltd
		Candelilla wax	Shanghai Milin Biochemical Co., Ltd
Glycerol	Tianjin constant heart chemical reagent manufacturing Co., Ltd
		Lauryl glucoside	Aike reagent
Hexadecanol and octadecanol	Biological of origin Co Ltd
		α -bisabolol	ZRNCUN Zhenzhu
Ultrapure water

The invention provides the tea oil cream quality evaluation standard method, and the evaluation standard method takes five items of the appearance whiteness, the fineness, the ductility, the centrifugal stability, the cold resistance stability and the heat resistance stability of the tea oil cream as evaluation indexes, wherein each item is 20 minutes, and the total score is 100 minutes for evaluation.

Table 3 is a table of overall quality scores for appearance, ductility, and stability.

1. Appearance rating

Appearance evaluation has two scoring criteria: whiteness and fineness. The score was found to be 20 points in total and is shown in Table 3.

(1) Basic procedure for whiteness evaluation: an equal amount of sample is spread on a glass plate lined with white paper, and the color uniformity and the glossiness are observed, wherein the score of the score is 10 points, and the score is divided into four scores of white, light yellow and yellow.

(2) Basic operation of smoothness evaluation: the equivalent sample is coated on the skin to realize the fine texture, and whether the skin is softened or not is observed after the sample is coated on the skin, and the score of the score is 10 points, namely the score has four indexes of fine, coarse and granular feel.

2. Ductility score

The spreadability is indicative of the spreadability and texture of the cream. Specifically, the method comprises the following steps: taking two glass plates with the size of 10cm x20cm, placing one upper glass plate with the weight of 125g (for the complement weight), placing the lower glass plate on a plane, weighing tea oil cream 1.0g, placing on the middle position of the lower glass plate, covering the upper layer with the glass plate, and measuring the diameter of the extended cream (taking the average of the maximum value and the minimum value) after 1min, wherein the diameter is more than 50mm and less than or equal to 70mm is the best. The ductility of 57mm is taken as a positive control group, the indexes can be divided into 60mm-70mm, 50mm-60mm and 30mm-40mm, the indexes are less than 40mm, the score is full of 20, and the specific score is shown in table 3.

3. Stability test Scoring

(1) Centrifugal stability test

10g of the tea oil cream is placed in a centrifuge, centrifuged at 3000r/min for 30min, and whether oil-water layering and foaming phenomena occur or not is observed. Foaming and oil-water separation are used as evaluation indexes, each item is 10 points, 10 points are respectively used for no foaming and no separation, 0 point is used for foaming and separation, and 20 points are used for full separation. Specific scores are shown in table 3.

(2) Heat and Cold resistance stability test

The cream is respectively placed in an oven at 55 ℃ for 6h and kept at the constant temperature of-15 ℃ for 24h, and the heat resistance stability test shows that the cream has unstable phenomena of oil-water demixing, bubbling, thickening, ductility deterioration and the like. The cold resistance stability scoring index can be divided into four items, namely layering, foaming, softening of the paste and ductility deterioration, wherein each item is 5 points, 20 points in total, and full points are 40 points.

Table 3 is a table of quality evaluation criteria of the tea oil cream of the present invention.

TABLE 3

In the screening experiment of the tea oil cream material provided by the invention, preferably, four substrates in the formula of the tea oil cream are respectively tea oil, an emulsifier, candelilla wax and glycerin, and the optimized mixture ratio of the four substrates is 5-11% of the tea oil, 6-8% of the emulsifier, 1.5-5.5% of the candelilla wax, 4-18% of the glycerin and 0.2-1% of α -bisabolol.

The tea oil cream mixed H L B is 11-13, the optimal H L B of the cream is 12, the cetostearyl alcohol is 3-15%, and the mass fraction of lauryl glucoside is 3-60%.

The present invention will be described in further detail with reference to examples, each of which employs the above-described apparatus, reagent materials, tea oil cream preparation steps, and evaluation criteria.

Example 1

Single factor experiments were performed on the screening matrices:

according to the method, 50g of hexadecanol, 7%, 11% and 15% of hexadecanol are respectively added into a water-oil phase ratio of 5% of tea oil, 8% of emulsifier, 1.5% of candelilla wax, 11% of glycerol and α -bisabolol of 0.2% to prepare tea oil cream, 5%, 13.5%, 20% and 60% of lauryl glucoside are respectively added into a water-oil phase ratio to prepare tea oil cream, 50g of tea oil cream is totally subjected to quality evaluation, and a matrix is determined by screening of evaluation results.

Example 2

Single factor experiments were performed for the dose range:

the preparation method comprises the steps of fixing 5% of tea oil, 8% of an emulsifier, 1.5% of candelilla wax, 11% of glycerol and 0.2% of α -bisabolol, adding 2.5%, 5%, 7.5%, 10%, 12.5% and 15% of lauryl glucoside respectively to prepare tea oil cream, wherein the total amount of the tea oil cream is 50g, evaluating the quality of a sample, and screening and determining a matrix according to evaluation results.

Table 4 shows the influence factors and level test results of the tea oil cream base in examples 1 and 2.

TABLE 4

Factors of the fact	Prescription	Minimum value	Highest value
				A	Tea oil		5％	11％
B	Emulsifier
			6％	8％
C	Candelilla wax				1.5％	5.5％
		D	Glycerol
	4％			18％
		E	Hexadecanol and octadecanol		7.5％	15％
F	Water (W)			42.5％			76％

Tables 5 and 6 show the evaluation results of the addition of cetostearyl alcohol and the addition of lauryl glucoside in examples 1 and 2.

TABLE 5

TABLE 6

Tables 7 and 8 are the results of the single factor experiment by analyzing examples 1 and 2.

TABLE 7

Numbering	Cetostearyl alcohol/%)	Ductility/mm
			1	2.5	52
2	5	52
			3	7.5	44
4	10	42
			5	12.5	46
6	15	42

TABLE 8

Results of the matrix screening one-factor experiment in example 1:

1) the whitening property and the fine property of the hexadecanol and the octadecanol and the lauryl glucoside are both good;

extensibility the extensibility of the cream with the addition of 3% cetostearyl alcohol and the addition of 5% lauryl glucoside was less than 50mm, except that the cream with the addition of 3% cetostearyl alcohol and the addition of 5% lauryl glucoside had extensibility greater than 50 mm;

2) when the centrifugal stability test was performed, lauryl glucoside was all foamed, whereas cetostearyl alcohol was unchanged except for the addition of 3% foaming;

3) when cold resistance stability experiments are carried out, the ductility is poor when the hexadecadecanol and the lauryl glucoside are respectively added, and the ductility is poor when the 60% lauryl glucoside is added, so that the matrix is rough;

4) when the heat resistance stability test is carried out, the phenomena of poor ductility, coarseness and foaming of the matrix are generated after the heat resistance stability test is carried out on all the creams prepared by respectively adding 3% of hexadecadecyl alcohol, 7% of hexadecadecyl alcohol and lauryl glucoside, and the phenomena of poor ductility and coarseness of the matrix are generated after the heat resistance stability test is carried out on all the creams prepared by respectively adding 11% of hexadecadecyl alcohol and 15% of hexadecadecyl alcohol.

According to the above results, cetostearyl alcohol is more stable than lauryl glucoside.

Results of the single factor experiment in the dosage range in example 2:

1) the tea oil cream is white in color, good in glossiness and fine and smooth in feeling;

2) when subjected to the cold resistance stability test, all showed deterioration in ductility;

3) when the heat resistance stability test was carried out, the matrix ductility was deteriorated and the matrix was roughened, in addition, the tea oil cream added with 2.5 percent and 5 percent of the hexadecanol and octadecanol respectively has the phenomenon of foaming when the heat resistance stability test and the centrifugal stability test are carried out, which is shown as that the stability of the prescription is poor, and the phenomenon of foaming is synthesized by the cream of 7 percent of the hexadecanol and octadecanol which is made before, in addition, when the cream of 1 percent and 2 percent of hexadecanol are respectively prepared, the phenomenon of foaming appears when the cream is subjected to heat resistance stability and centrifugal stability, the cream containing 16% and 17.5% of cetostearyl alcohol has poor extensibility, and the extensibility becomes poor in the heat resistance stability test and the cold resistance stability test, and the amount of cetostearyl alcohol may be more preferably in the range of 7.5% to 15% because the amount is inferior to 15% by mass.

Example 3

D-the optimal mixing Design adopts Design-expert software, is a method for applying the optimal Design to the mixing Design, and has the characteristics of less experiment times, high accuracy, multi-factor optimization and the like. A representative point is scientifically selected in the test range by using a D-optimal mixed material design method, and then the test is carried out, so that the proportion of the base material of the tea oil emulsion can be relatively simply optimized.

D-optimum mixing material design test:

table 9 shows the Design table obtained by Design-expert 8.0, and the preparation is carried out according to the prescription dosage in the table and the preparation steps of the tea oil cream prescription.

And performing model fitting and variance analysis on the result, drawing a contour map and a 3D effect surface map, and preferably selecting the proportion of the tea oil cream.

TABLE 9

Note: in the above table: a-tea oil, B-emulsifier, C-candelilla wax, D-glycerin, E-hexadecanol and F-water.

Model fitting analysis was performed according to example 3 for whiteness:

analyzing the mixed material design result through design-expert software, and obtaining a regression equation between the whiteness and six factors as follows:

whiteness-2.21473 a-85.63732B + 17.63396C + 1.85951D-4.01061E-0.41669F +0.97872 a B-0.13673 a C-0.053717 a D +0.086990 a E +0.020896 a F + 0.99516F B + C + 378B D + 0.99837B E + E0.99865B F-0.21994C + 5.66004E-003E

The equation has a correlation coefficient of R²0.9402 and as can be seen from table 10, model P is 0.0010<0.0500, loss of analogy P-0.8860>0.1000, the model is obvious, the test result and the mathematical model are well fitted, and the scoring result of the whiteness can be accurately and truly predicted.

Drawing a contour diagram and a 3D effect surface by software, and referring to figure 1.

The effect on the experimental results of the tea oil cream was large when the tea oil, emulsifier and glycerin were varied, so that the values of fixed glycerin (D), cetostearyl alcohol (E) and water (F) were 11%, 11.25% and 59.25%, respectively, and a contour diagram and a 3D effect surface diagram of the degree of whiteness were plotted, as shown in fig. 1. The other 3 variable factors may be preferably selected to be in the range of: 8.9-11.1% of A, 6-8% of B and 1.5-2% of C.

Table 10 shows the results of the coefficient and variance analysis of each term in the whiteness degree fitting equation.

Watch 10

Model fitting analysis of the smoothness was performed according to example 3:

the mixing design result is analyzed by software, and a regression equation between the fineness and six factors is obtained as follows:

fine fineness-13.35105 a + 96.72783B-19.46514C-3.53000D + 7.02929E + 0.41199F-1.00682 a B +0.42714 a C +0.21073 a D +0.090213 a E +0.17445 a F-1.71865F-0.064630B C-B D-1.18178B-E-1.10058B F + 0.42739C-3642F-0.064630D + 0.040906C

The equation has a correlation coefficient of R²0.8525 and as can be seen from table 11, model P0.0439<0.0500, loss of analogy P-0.7700>0.1000, the model has statistical significance, and the test result is well fitted with the mathematical model.

The values of fixed glycerol (D), cetostearyl alcohol (E) and water (F) were 11%, 11.25% and 59.25%, respectively, and the software plotted a contour plot of the smoothness and a 3D effect plot, and referring to fig. 2, it can be preferred that the ranges for the other 3 variables be: 7.1-11% of A, 6-8% of B and 1.5-2% of C.

Table 11 shows the results of the coefficient and variance analysis of each term in the refinement fitting equation.

TABLE 11

Model fitting analysis of ductility was performed according to example 3:

the mixed material design result is analyzed by software, and a regression equation between the ductility and six factors can be obtained as follows:

ductility-10.28725 a-4.44047B + 10.68957C-1.02104D-1.54172E + 0.27235F-0.34222 a-B-0.024881 a-C-0.12457 a-D-0.073877 a-E-0.11185 a-F-0.1950B C + 0.11084B D + 0.21606B E + 0.054726B F-0.11586C-D-0.22597E-E + 0.011071E + E

The equation has a correlation coefficient of R²Table 12 shows that model P is 0.0265, 0.8706<0.0500, loss of analogy P-0.9977>And 0.1000, the model has statistical significance and higher reliability.

The values for fixed glycerol (D), cetostearyl alcohol (E) and water (F) were 11%, 11.25% and 59.25%, respectively, and the ductility contour plot and 3D effect surface plot are plotted by software, and referring to fig. 3, the ranges for the other 3 variables can be preferably selected as follows: 8.8-9.9% of A, 6-8% of B and 1.5-2% of C.

Table 12 shows the coefficients and analysis of variance of the terms in the ductility fit equation.

TABLE 12

Model fitting analysis of centrifugal stability according to example 3:

the mixing design result is analyzed by software, and a regression equation between the centrifugal stability and six factors can be obtained as follows:

centrifugal stability-20.79232 a + 171.89789B + 74.11438C-3.16581D-7.30530E + 0.74435F-1.68697 a B-1.04802 a C +0.38234 a D +0.29085 a E +0.28834 a F-2.63535F-B C-378B D-1.73951B E-1.97980B F-0.68135C + 0.24147D-E + 0.036890F

The equation has a correlation coefficient of R²0.8562, and as can be seen from table 13, model P0.0399<0.0500, loss of analogy P-0.9913>0.1000, the fitting model of the centrifugal stability has statistical significance and higher significance and reliability.

The values of fixed glycerol (D), cetostearyl alcohol (E) and water (F) were 11%, 11.25% and 59.25%, respectively, and a contour plot and a 3D effect plot of centrifugal stability were plotted by the software, and referring to fig. 4, it can be preferred that the ranges for the other 3 variables be: 5 to 9.7 percent of A, 6 to 8 percent of B and 1.5 to 5 percent of C.

Table 13 shows the coefficients and analysis of variance of the terms in the centrifuge stability fitting equation.

Watch 13

The heat stability was subjected to model fitting analysis according to example 3:

the design result of the mixed material is analyzed by software, and a regression equation between the heat-resistant stability and six factors is obtained as follows:

thermostable stability-23.19290 a-36.13317B + 13.44303C-6.83137D + 0.49639E + 4.62439E-003F +1.02010 a B +0.065909 a C +0.28264 a D +0.30018 a E +0.23349 a F-0.42161B C + 0.65654B D + 0.33356B E + 0.39798B F + 6.32225E-003C + F + 3642C

The equation has a correlation coefficient of R²0.9534, and as can be seen from table 14, model P is 0.0003<0.0100, which shows that the fitting model of the heat-resistant stability has statistical significance and extremely high significance and reliability.

The values of fixed glycerol (D), cetostearyl alcohol (E) and water (F) were 11%, 11.25% and 59.25%, respectively, and a contour plot and a 3D effect profile plot of the heat stability were plotted by the software, and referring to fig. 5, it can be preferred that the ranges for the other 3 variable factors are: 5.3-11% of A, 6-8% of B and 1.5-5.4% of C.

Table 14 shows the coefficient and variance analysis results of the terms in the heat stability fitting equation.

TABLE 14

Model fitting analysis for cold stability according to example 3:

the mixed material design result is analyzed by software, and the regression equation between the cold resistance stability and six factors can be obtained:

cold resistance stability + 39.33830A + 50.00600B + 12.66532C + 1.71629D-3.98478E + 0.30203F-1.20831A-B-0.61734A-C-0.45578A-D-0.45218A-E-0.42583A-F-0.80976F + 0.039495B-D-0.48133B-E-0.52848B-F-0.10367C + E + 0.10135E-0.14145F + 0.039495E-4.31134E

The equation has a correlation coefficient of R²0.8801, and as can be seen from table 15, model P is 0.0195<0.0500, the fitting model for demonstrating cold resistance stability has statistical significance and extremely high significance, and can predict the scoring result more accurately and truly.

The values of fixed glycerol (D), cetostearyl alcohol (E) and water (F) were 11%, 11.25% and 59.25%, respectively, and a contour plot and a 3D effect profile plot of cold stability were plotted by the software, and referring to fig. 6, it can be preferred that the ranges for the other 3 variables be: 5.1-10.8% of A, 6-8% of B and 1.5-5.5% of C.

Table 15 shows the coefficient and variance analysis results of each item in the cold resistance stability fitting equation.

Watch 15

The total score was subjected to model fitting analysis according to example 3:

the mixed material design result is analyzed by software, and a regression equation between the total and six factors is obtained as follows:

total score-8.62804 a + 178.31825B + 111.81348C-10.83254D-8.8176E + 1.25898F-2.11251 a B-1.37641 a C +0.22374 a D +0.22017 a E +0.16455 a F-4.63286F-B C-378B D-1.70021B E-1.99425B F-0.72266C + 0.32678D-E + 0.13362F

The equation has a correlation coefficient of R²0.8682, and as can be seen from table 16, model P0.0284<0.0500, and a mismatching term P is 0.7177 > 0.01, which shows that the fitting model of the total score has statistical significance, higher significance and higher reliability, and as shown in FIG. 7, the linear relation of the total score value is good.

The values of fixed glycerol (D), cetostearyl alcohol (E) and water (F) were 11%, 11.25% and 59.25%, respectively, and a contour plot and a 3D effect plot of the total score were plotted by the software, and referring to fig. 8, it can be preferred that the ranges for the other 3 variable factors be: 8.8 to 9.1 percent of A, 7.8 to 8.06 percent of B, 1.5 to 1.56 percent of C.

Table 16 shows the coefficients and analysis of variance of the terms in the total score fit equation.

TABLE 16

The tea oil cream obtained by the D-optimal mixed material design has the following preferred component ratio: 9% of tea oil, 8% of emulsifier, 1.5% of candelilla wax, 11% of glycerin, 11.25% of hexadecanol and 59.25% of water, and the components of the tea oil cream matrix provided by the invention are in a ratio range.

The test results of example 3 were verified:

according to the proportion of the matrix, the prepared tea oil cream has white appearance, fine texture, moderate ductility and good stability, and the result is shown in Table 17.

The deviation (predicted value-measured value)/predicted value × 100% ], and the predicted value is 80 points.

Compared with the verification result, the deviation between the predicted value and the measured value is 0, 0 and 6.25 percent respectively, and the average deviation is 2.08 percent, which shows that the tea oil cream obtained by the optimization of the method has good appearance, stability and reliability.

Table 17 shows the optimal results for the tea oil cream.

TABLE 17

The invention carries out safety verification on the tea oil-fitting cream obtained in the embodiment, specifically, the tea oil cream is coated on the skin of a healthy infant with the diameter of 1cm, and the skin is observed to have no erythema and edema after being used; meanwhile, the tea oil cream is coated on the eczema skin of the infant with eczema, and the eczema treatment effect is good through observation after the tea oil cream is used.

The results show that the content of the tea oil serving as the main component of the tea oil cream is up to 11 percent, the tea oil and the α -bisabolol are anti-inflammatory main components, the tea oil cream obtained by adding the α -bisabolol and the hexadecadecyl alcohol is good in appearance and stable in quality, and the tea oil cream obtained by mixing the components of the tea oil cream matrix is white in appearance, good in fineness and stable in property, and has high safety, mildness, no stimulation and good eczema treatment effect.

The preferred embodiments of the present invention have been described in detail, however, the present invention is not limited to the specific details of the above embodiments, and various simple modifications may be made to the technical solution of the present invention within the technical idea of the present invention, and these simple modifications are within the protective scope of the present invention.

Claims (9)

1. The tea oil cream suitable for infantile eczema is characterized in that a matrix of the tea oil cream comprises the following components in percentage by mass: 5 to 11 percent of tea oil, 6 to 8 percent of emulsifier, 1.5 to 5.5 percent of candelilla wax, 4 to 18 percent of glycerin, 3 to 15 percent of hexadecanol and octadecanol, and the balance of water.

2. The tea oil cream according to claim 1, wherein the mass ratio of the tea oil in the matrix is 8-9%.

3. The tea oil cream according to claim 1, wherein the proportion of the cetostearyl alcohol in the matrix is 10-12% by mass.

4. The tea oil cream according to claim 1, wherein the mass ratio of the emulsifier in the matrix is 7-8%, and preferably the emulsifier comprises wheat germ milk and/or corn germ milk.

5. The tea oil cream according to claim 1, wherein the mass ratio of the candelilla wax in the matrix is 1.5-3%.

6. The tea oil cream according to claim 1, wherein the glycerin accounts for 10-12% of the matrix by mass.

7. The tea oil cream according to claim 1, wherein the base of the tea oil cream further comprises α -bisabolol at 0.2-1% and/or lauryl glucoside at 3-60%.

8. The tea oil cream according to claim 7, wherein the α -bisabolol is present in the matrix in a ratio of 0.2 to 0.5% by mass.

9. A method for preparing the tea oil cream suitable for infantile eczema as claimed in any one of claims 1-8 by emulsification, the method comprising the steps of:

s1, preparing an oil phase; mixing tea oil, an emulsifier, hexadecanol, candelilla wax and a-bisabolol, and continuously heating in a water bath to 75-85 ℃;

s2, preparing a water phase; dissolving glycerol in water, and heating to 75-85 ℃ in a continuous water bath;

s3, mixing; slowly adding the water phase into the oil phase while stirring in the same direction under the heating of a water bath at 75-85 ℃, and stopping heating after the water phase is completely added;

s4, shearing at a high speed for 1-2 min by a homogenizer with the rotating speed of 9000 r/min-10000 r/min, and slowly stirring in the same direction at normal temperature to room temperature to obtain the tea oil cream.

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