CN113995793A - Chlorhexidine acetate ointment and preparation method thereof - Google Patents
Chlorhexidine acetate ointment and preparation method thereof Download PDFInfo
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Abstract
The invention provides chlorhexidine acetate ointment which is prepared from the following raw materials in parts by weight: 1-6 parts of glycerin monostearate; 1-5 parts of polyglycerol ester; 1-5 parts of lanolin; 2-5 parts of white vaseline; 2-6 parts of stearyl alcohol; 0-5 parts of dimethyl silicone oil; 2-10 parts of propylene glycol; tween 800.5-4.0 parts; 0.5-5 parts of hexyl palmitate; 0.5-12 parts of methyl salicylate; 0.01-0.5 parts of chlorhexidine acetate; 1-20 parts of undecylenic acid; 0-1 part of traditional Chinese medicine extract; 0.5-6 parts of camphor, 1-5 parts of menthol and 0.5-3 parts of borneol. The chlorhexidine acetate ointment has the water-soluble content, the actual value conforms to the theory, oil-water separation does not occur in high-temperature weather, the appearance is fine and smooth and has moderate consistency, the antibacterial effect is ideal, and the clinical effects on softening cutin and on tinea of feet and hands are ideal. The invention also provides a preparation method of the chlorhexidine acetate ointment.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to chlorhexidine acetate ointment and a preparation method thereof.
Background
Chlorhexidine acetate is used as a biguanide compound and has very strong bacteriostatic and bactericidal capabilities, and the pharmacological action mechanism of the chlorhexidine acetate is that the chlorhexidine acetate can be adsorbed on a permeation barrier of a bacterial cell membrane to enable cell contents to leak out, so that the chlorhexidine acetate can inhibit bacteria at low concentration and can kill the bacteria at high concentration, and therefore the chlorhexidine acetate is an ideal broad-spectrum bacteriostatic agent and bactericide. Secondly, because of the rapidness and the persistence of the curative effect, stable property, low toxicity, difficult generation of drug resistance after long-term use and the like, the medicine is widely used in the clinical aspect of China at present.
The chlorhexidine acetate ointment can be used for treating small-area burn, scald, traumatic infection, eczema, acne, tinea pedis, etc. When the content of the chlorhexidine acetate in the chlorhexidine acetate ointment is detected by a high performance liquid chromatography according to the disinfection technical specification, the water-soluble content value is far less than the theoretical feeding amount, and the existing chlorhexidine acetate emulsifiable paste has the defects of oil-water separation, clinical alignment of body, thigh and tinea of feet and hands and unsatisfactory actual effect in high-temperature weather and transportation.
Disclosure of Invention
The invention aims to provide chlorhexidine acetate ointment and a preparation method thereof, wherein the water soluble amount of chlorhexidine acetate can reach the maximum dissolution limit value, and the heat stability is good.
The invention provides chlorhexidine acetate ointment which is prepared from the following raw materials in parts by weight:
1-6 parts of glycerin monostearate; 1-5 parts of polyglycerol ester; 1-5 parts of lanolin; 2-5 parts of white vaseline; 2-6 parts of stearyl alcohol; 0-5 parts of dimethyl silicone oil; 2-10 parts of propylene glycol; tween 800.5-4.0 parts; 0.5-5 parts of hexyl palmitate; 0.5-12 parts of methyl salicylate; 0.01-0.5 parts of chlorhexidine acetate; 1-20 parts of undecylenic acid; 0-1 part of traditional Chinese medicine extract; 0.5-6 parts of camphor, 1-5 parts of menthol and 0.5-3 parts of borneol.
Preferably, the traditional Chinese medicine composition is a mixed solution of radix sophorae flavescentis, snakeworm, cortex phellodendri and scutellaria baicalensis extract.
Preferably, the pH value of the chlorhexidine acetate ointment is 2.5-3.7.
The invention provides a method for preparing chlorhexidine acetate ointment as described above, comprising the following steps:
A) heating and mixing tween 80 and propylene glycol with water to obtain a water phase;
B) heating and mixing glyceryl monostearate, lanolin, white vaseline, stearyl alcohol, polyglycerol ester, methyl silicone oil, hexyl palmitate and methyl salicylate to obtain an oil phase;
C) adding the oil phase into the water phase, homogenizing and mixing, adding ethanol solution of Borneolum Syntheticum, Mentholum, Camphora, chlorhexidine acetate, Chinese medicinal extract and undecylenic acid, and mixing to obtain chlorhexidine acetate ointment.
Preferably, the temperature for heating and mixing in the step A) is 75-90 ℃.
Preferably, the heating and mixing in the step B) is water bath heating and mixing, and the heating and mixing temperature is 75-90 ℃.
Preferably, in the step C), the oil phase is slowly added into the water phase, when the temperature is 40-60 ℃, the ethanol solution of borneol, menthol, camphor, chlorhexidine acetate, the traditional Chinese medicine extract and undecylenic acid are added, the pH value is adjusted to be 2.5-3.7, and the mixture is stirred and cooled to the room temperature to obtain the chlorhexidine acetate ointment.
Preferably, the rotation speed of the homogeneous mixing in the step C) is 0.7-1.0 ten thousand revolutions per minute, and the time of the homogeneous mixing is 5-20 min.
The invention provides chlorhexidine acetate ointment which is prepared from the following raw materials in parts by weight: 1-6 parts of glycerin monostearate; 1-5 parts of polyglycerol ester; 1-5 parts of lanolin; 2-5 parts of white vaseline; 2-6 parts of stearyl alcohol; 0-5 parts of dimethyl silicone oil; 2-10 parts of propylene glycol; tween 800.5-4.0 parts; 0.5-5 parts of hexyl palmitate; 0.5-12 parts of methyl salicylate; 0.01-0.5 parts of chlorhexidine acetate; 1-20 parts of undecylenic acid; 0-1 part of traditional Chinese medicine extract; 0.5-6 parts of camphor, 1-5 parts of menthol and 0.5-3 parts of borneol. The chlorhexidine acetate ointment of the invention is used for detecting the content of chlorhexidine according to water dissolution according to the standard of disinfection technical specification, the actual value is in line with theory, and in high temperature weather (less than or equal to 54 ℃), oil-water separation is not generated, the appearance is fine and smooth and moderate in consistency, the antibacterial effect is ideal, and the effect is ideal for softening cutin and treating tinea of feet and hands in clinic.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.
FIG. 1 shows the dissolution concentration of chlorhexidine acetate ointment in comparative examples and examples 1 to 4 of the present invention;
FIG. 2 shows the results of testing the thermal stability of chlorhexidine acetate ointment of examples 1-4 of the present invention; in fig. 2, the container written "1" contains the chlorhexidine acetate ointment of example 1, the container written "2" contains the chlorhexidine acetate ointment of example 2, the container written "3" contains the chlorhexidine acetate ointment of example 3, and the container written "4" contains the chlorhexidine acetate ointment of example 4;
FIG. 3 is a graph showing the results of the thermal stability test of the chlorhexidine acetate ointment of comparative example 1 of the present invention.
Detailed Description
The invention provides chlorhexidine acetate ointment which is prepared from the following raw materials in parts by weight:
1-6 parts of glycerin monostearate; 1-5 parts of polyglycerol ester; 1-5 parts of lanolin; 2-5 parts of white vaseline; 2-6 parts of stearyl alcohol; 0-5 parts of dimethyl silicone oil; 2-10 parts of propylene glycol; tween 800.5-4.0 parts; 0.5-5 parts of hexyl palmitate; 0.5-12 parts of methyl salicylate; 0.01-0.5 parts of chlorhexidine acetate; 1-20 parts of undecylenic acid; 0-1 part of traditional Chinese medicine extract; 0.5-6 parts of camphor, 1-5 parts of menthol and 0.5-3 parts of borneol.
In the invention, the glyceryl monostearate and the polyglycerol ester are used as emulsifying agents, and the white vaseline, the propylene glycol, the dimethyl silicone oil and the palmitic acid hexyl ester are used as wetting agents; chlorhexidine acetate, undecylenic acid, Chinese medicinal extract, Camphora, Mentholum and Borneolum Syntheticum as effective components.
In the present invention, the glyceryl monostearate is an emulsifier, and the weight part is preferably 1 to 6 parts, such as 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, and preferably any of the above values is an upper limit or a lower limit.
In the present invention, the polyglycerol ester is an emulsifier, and the weight part is preferably 1 to 5 parts, such as 1.5 parts, 2 parts, 3 parts, 4 parts, 5 parts, and preferably any of the above values is a range with an upper limit or a lower limit.
In the invention, the lanolin is preferably 1-5 parts by weight, such as 1 part, 2 parts, 3 parts, 4 parts and 5 parts, and preferably ranges with any value as an upper limit or a lower limit;
the weight part of the white vaseline is preferably 2-5 parts, such as 2 parts, 3 parts, 4 parts and 5 parts, and preferably, any value is a range value with an upper limit or a lower limit;
the weight portion of the stearyl alcohol is preferably 2-6 parts, such as 2 parts, 3 parts, 4 parts, 5 parts and 6 parts, and preferably any value is a range value with an upper limit or a lower limit;
the weight portion of the simethicone is preferably 0-5 parts, such as 0 part, 1 part, 2 parts, 3 parts, 4 parts and 5 parts, and preferably any value is a range value with an upper limit or a lower limit;
the propylene glycol is preferably 2 to 10 parts by weight, such as 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts and 10 parts, and preferably any value is a range value with an upper limit or a lower limit;
the weight portion of the tween 80 is preferably 0.5 to 4.0 portions, such as 0.5 portion, 1 portion, 1.5 portions, 2 portions, 2.5 portions, 3 portions, 3.5 portions and 4 portions, and preferably, any value is a range value with an upper limit or a lower limit.
The weight portion of the palmitic acid hexyl ester is preferably 0.5-5 parts, such as 0.5 part, 1 part, 2 parts, 3 parts, 4 parts and 5 parts, and preferably any value is a range value with an upper limit or a lower limit;
the methyl salicylate is preferably 0.5 to 12 parts by weight, more preferably 1 to 10 parts by weight, such as 0.5 part, 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts by weight, and preferably any of the above values is used as an upper limit or a lower limit.
The chlorhexidine acetate is preferably 0.01-0.5 part by weight, more preferably 0.05-0.45 part by weight, such as 0.01 part, 0.05 part, 0.1 part, 0.15 part, 0.2 part, 0.25 part, 0.3 part, 0.35 part, 0.4 part, 0.45 part and 0.5 part by weight, and preferably the value of any value is a range with an upper limit or a lower limit;
the parts by weight of the undecylenic acid are preferably 1 to 20 parts, such as 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts and 20 parts, and the upper limit or the lower limit of any numerical value is preferably selected; according to the invention, undecylenic acid is added into the ointment formula, the acid-base environment of chlorhexidine in a final product is changed, the product exists in an acid chlorhexidine manner, the detected content value is increased, the chlorhexidine acetate reaches the highest dissolution limit value in the established formula, and meanwhile, dermatophyte infection of tinea capitis, tinea corporis, tinea cruris, tinea manuum and tinea pedis is synergistically treated.
In the invention, the traditional Chinese medicine composition is preferably prepared according to the following steps:
soaking 15-28 parts of radix sophorae flavescentis, 15-30 parts of snake worms, 14-20 parts of golden cypress and 15-21 parts of scutellaria baicalensis in 8 times of purified water for 1 hour, leaching for 2 hours, adding 8 times of purified water, leaching for 2 hours, adding 6 times of purified water, extracting for 1 hour, and concentrating for 1 hour until the relative density is 1.1-1.3. The mass fraction of the traditional Chinese medicine composition is preferably 0-1 part, such as 0.1 part, 0.2 part, 0.3 part, 0.4 part, 0.5 part, 0.6 part, 0.7 part, 0.8 part, 0.9 part and 1 part, and preferably the range value taking any value as the upper limit or the lower limit;
the preferable weight portion of the camphor is 0.5-6 parts, more preferable 1-5 parts, such as 0.5 part, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts and 6 parts, and preferable range values with any value as the upper limit or the lower limit;
the weight portion of the menthol is preferably 1 to 5 portions, such as 1 portion, 2 portions, 3 portions, 4 portions and 5 portions, and preferably, any value is a range value with an upper limit or a lower limit;
the weight portion of the borneol is preferably 0.5-3 parts, such as 0.5 part, 1 part, 1.5 parts, 2 parts, 2.5 parts and 3 parts, and the preferable value is a range value taking any value as an upper limit or a lower limit.
In the invention, the pH value of the chlorhexidine acetate ointment is preferably 2.5-3.7.
The invention also provides a preparation method of the chlorhexidine acetate ointment, which comprises the following steps:
A) heating and mixing tween 80 and propylene glycol with water to obtain a water phase;
B) heating and mixing glyceryl monostearate, lanolin, white vaseline, stearyl alcohol, polyglycerol ester, methyl silicone oil, hexyl palmitate and methyl salicylate to obtain an oil phase;
C) adding the oil phase into the water phase, homogenizing and mixing, adding ethanol solution of Borneolum Syntheticum, Mentholum, Camphora, chlorhexidine acetate, Chinese medicinal extract and undecylenic acid, and mixing to obtain chlorhexidine acetate ointment.
In the present invention, the kinds and the amounts of the respective raw materials are the same as those of the raw materials described above, and the present invention is not described herein again.
Adding Tween 80 and propylene glycol into purified water to 75-90 ℃ to obtain the water phase; the heating of the water phase is preferably direct heating, the heating temperature is preferably 80-85 ℃, the heating time is not particularly limited, and the raw materials can be dissolved in water.
The oil phase is prepared by mixing glyceryl monostearate, lanolin, white vaseline, stearyl alcohol, polyglycerol ester, methyl silicone oil, hexyl palmitate and methyl salicylate, and heating and preserving heat at 75-90 ℃.
In the invention, the heating of the oil phase is preferably water bath heating, the heating temperature is preferably 80-85 ℃, the heating time is not particularly limited, and the raw materials can be dissolved in water.
After obtaining the water phase and the oil phase, slowly adding the oil phase which is kept at 75-90 ℃ into the water phase, homogenizing and mixing, adding the ethanol solution of effective components of borneol, menthol, camphor and chlorhexidine acetate, the traditional Chinese medicine extract and undecylenic acid when the system temperature is 40-60 ℃, adjusting the pH value to 2.5-3.7, and uniformly stirring to obtain the chlorhexidine acetate cream.
In the invention, the rotation speed of the homogeneous mixing is 0.7-1.0 ten thousand revolutions per minute, more preferably 0.8-0.9 ten thousand revolutions per minute, and the time of the homogeneous mixing is preferably 5-20 min, more preferably 10-15 min.
The chlorhexidine acetate ointment of the invention can be used for preparing medicines or cosmetics for improving skin conditions, such as skin infection caused by fungi, such as dermatophytosis, eczema, tinea, and the like.
The invention provides chlorhexidine acetate ointment which is prepared from the following raw materials in parts by weight: 1-6 parts of glycerin monostearate; 1-5 parts of polyglycerol ester; 1-5 parts of lanolin; 2-5 parts of white vaseline; 2-6 parts of stearyl alcohol; 0-5 parts of dimethyl silicone oil; 2-10 parts of propylene glycol; tween 800.5-4.0 parts; 0.5-5 parts of hexyl palmitate; 0.5-12 parts of methyl salicylate; 0.01-0.5 parts of chlorhexidine acetate; 1-20 parts of undecylenic acid; 0-1 part of traditional Chinese medicine extract; 0.5-6 parts of camphor, 1-5 parts of menthol and 0.5-3 parts of borneol. The chlorhexidine acetate ointment of the invention is used for detecting the content of chlorhexidine according to water dissolution according to the standard of disinfection technical specification, the actual value is in line with theory, and in high temperature weather (less than or equal to 54 ℃), oil-water separation is not generated, the appearance is fine and smooth and moderate in consistency, the antibacterial effect is ideal, and the effect is ideal for softening cutin and treating tinea of feet and hands in clinic.
In order to further illustrate the present invention, the chlorhexidine acetate ointment and the preparation method thereof provided by the present invention will be described in detail with reference to the following examples, which should not be construed as limiting the scope of the present invention.
Comparative example 1
Tween 804, propylene glycol 6, glyceryl monostearate 2, lanolin 3, white vaseline 3, stearyl alcohol 5, borneol 0.5, menthol 3, camphor 4, chlorhexidine acetate 0.21, Chinese medicinal extract 0.3, and purified water.
Example 1
Tween 803.5 parts, propylene glycol 6 parts, glyceryl monostearate 2 parts, polyglycerol ester 2 parts, lanolin 2 parts, white vaseline 3 parts, stearyl alcohol 4.5 parts, methyl salicylate 0.5 part, borneol 0.5 part, menthol 2 parts, camphor 4 parts, chlorhexidine acetate 0.21 part, traditional Chinese medicine extract 0.3 part, undecylenic acid 0.2 part and purified water.
Example 2
Tween 803, propylene glycol 5 parts, glyceryl monostearate 3.5 parts, polyglycerol ester 1.5 parts, lanolin 3 parts, white vaseline 3 parts, stearyl alcohol 3 parts, hexyl palmitate 0.5 parts, methyl salicylate 1 part, borneol 0.5 part, menthol 3 parts, camphor 4 parts, dimethyl silicone oil 2 parts, chlorhexidine acetate 0.21 part, traditional Chinese medicine extract 0.3 part, undecylenic acid 0.3 part
Example 3
Tween 803, propylene glycol 3 parts, glyceryl monostearate 4 parts, lanolin 1 part, polyglycerol ester 2 parts, white vaseline 2 parts, stearyl alcohol 2 parts, hexyl palmitate 1 part, methyl salicylate 1 part, borneol 0.5 part, menthol 3 parts, camphor 4 parts, simethicone 2 parts, chlorhexidine acetate 0.21 part, traditional Chinese medicine extract 0.3 part, and undecylenic acid 0.4 part.
Example 4
Tween 803, propylene glycol 3 parts, glyceryl monostearate 6 parts, polyglycerol ester 2 parts, lanolin 1 part, white vaseline 3 parts, stearyl alcohol 2 parts, borneol 0.5 part, menthol 3 parts, camphor 4 parts, simethicone 2 parts, hexyl palmitate 3 parts, methyl salicylate 1 part, chlorhexidine acetate 0.21 part, traditional Chinese medicine extract 0.3 part, and undecylenic acid 0.5 part.
According to the formula in comparative example 1 and examples 1 to 4, chlorhexidine acetate cream was prepared according to the following preparation method:
(a) preparation of an aqueous phase: adding tween 80 and propylene glycol into purified water, and heating to 85 deg.C to obtain water phase;
(b) preparing an oil phase: mixing glyceryl monostearate, lanolin, white vaseline, stearyl alcohol, polyglycerol ester, methyl silicone oil, hexyl palmitate and methyl salicylate, heating and keeping the temperature at 85 ℃ to obtain the oil phase;
(c) preparation of the ointment: slowly adding the oil phase into the water phase, homogenizing at 8000 rpm for 10min, adding mixed solution (radix Sophorae Flavescentis, Serpentis seed, cortex Phellodendri, Scutellariae radix), Borneolum Syntheticum, Mentholum, Camphora, chlorhexidine acetate, alcohol, and undecylenic acid at 40-60 deg.C, adjusting pH to 2.5-3.7, stirring, cooling to room temperature, and packaging to obtain cream.
The content of the ointment in the examples was measured by high performance liquid chromatography
(1) Principle of
Chlorhexidine acetate has ultraviolet absorption at 254nm, and can be separated by reversed phase High Performance Liquid Chromatography (HPLC), and according to retention time, qualitative and quantitative peak area.
(2) Reagent preparation
Acetonitrile (chromatographically pure); 0.02mol/L potassium dihydrogen phosphate solution: weighing 2.7g of monopotassium phosphate, adding distilled water to dissolve the monopotassium phosphate and fixing the volume to 1000mL, and adjusting the pH value to 2.5 by using phosphoric acid; standard solution of chlorhexidine acetate: weighing 0.1g of chlorhexidine acetate standard substance, dissolving with a small amount of distilled water, and fixing the volume to 100mL, wherein each 1L of the solution contains 1g of chlorhexidine acetate.
(3) Reference conditions for chromatography
A chromatographic column: a C18 column (150mm × 4.6mm i.d., 5 μm); mobile phase: mixing 0.02mol/L potassium dihydrogen phosphate solution and acetonitrile at a volume ratio of 65:35, filtering with 0.45 μm filter membrane and vacuum degassing before analysis; flow rate: 1.0 mL/min; ultraviolet detection wavelength: 254 nm; column temperature: at 25 ℃. Under this chromatographic condition, the tR of chlorhexidine acetate was about 3.1 min.
(4) Drawing of standard curve
And preparing standard series with mass concentrations of 0, 0.05, 0.2, 0.4 and 0.5g/L by using the chlorhexidine acetate standard solution. Under the set chromatographic conditions, 5. mu.L of each sample was analyzed. And (4) performing linear regression treatment by taking the mass concentration of the standard series as a horizontal coordinate C and the peak area as a vertical coordinate Y to obtain a linear equation.
(5) Sample assay
If the labeled concentration of chlorhexidine acetate in the disinfectant is too high, the disinfectant needs to be diluted properly, so that the diluted concentration is in the linear range of the standard curve. For solid or paste samples, distilled water is firstly used for preparing aqueous solution. Filtered through a 0.45 μm filter membrane for use. Under the set chromatographic conditions, 5. mu.L of the sample solution was analyzed. According to the peak area, the corresponding chlorhexidine acetate concentration is calculated from the linear equation. And converting the final concentration of the chlorhexidine acetate in the sample according to the sampling amount and the dilution multiple.
The relationship between the amount of the acidic substance added to the samples of examples 1 to 4 and the content of chlorhexidine acetate in the final product is shown in the attached Table 1
TABLE 1 determination of chlorhexidine acetate ointment content in examples 1-4
| Dosage of undecylenic acid | Chlorhexidine acetate content% | |
| Example 1 | 0.2％ | 0.18 |
| Example 2 | 0.3％ | 0.19 |
| Example 3 | 0.4％ | 0.20 |
| Example 4 | 0.5％ | 0.20 |
| Comparative example | 0 | 0.02 |
From example 1 to example 4, it can be seen that the content of the water-soluble chlorhexidine acetate in the product shows a gradually increasing trend with the amount of the acid substance, and when the usage amount of the undecylenic acid is 0.4%, the PH value of the antibacterial substance mixture is adjusted and optimized, the PH value is in the range of 2.5-3.7, and the content of the water-soluble chlorhexidine acetate reaches a peak value of 0.2%, which is consistent with the theoretical amount.
Heat resistance Effect test
The experimental method comprises the following steps: the temperature of the incubator was adjusted to 54 ℃ in advance, and the sample was placed in the incubator for 24 hours, taken out, returned to room temperature, and visually observed. As shown in FIGS. 2 to 3, FIG. 2 shows chlorhexidine acetate ointment of examples 1 to 4 of the present invention, FIG. 3 shows chlorhexidine acetate ointment of comparative example, and it can be seen from FIGS. 2 to 3 that the ointment products of examples 1 to 4 of the present invention were taken out after 24 hours at 54 ℃ in a constant temperature incubator, returned to room temperature, and visually observed, no oil-water separation occurred, and the system was stable.
Evaluation of ointment Properties
TABLE 2 evaluation of the Properties of chlorhexidine acetate ointments in examples 1-4
Evaluation of ointment bacteriostatic effect
TABLE 3 bacteriostatic Effect of chlorhexidine acetate ointments in examples 1-4
As can be seen from table 3, the chlorhexidine acetate ointment of example 4 had the best bacteriostatic effect.
Usage effect of tinea cruris
5 patients with tinea cruris of 18-65 years old were selected.
Patients 5 were: the skin hyperkeratosis, local roughness, swelling and dryness, the skin feels stabbing, the skin is longer and deeper along the texture direction and can reach subcutaneous cracks, the pain is obvious, the product (example 4) is smeared on an affected part before sleep every night, the cutin is obviously lightened after 3 days, the skin is moistened after smearing, the itching and the pain are obviously relieved, the skin is smooth, the skin is recovered to be normal, and the skin does not stabbing.
The product (example 4) is applied to 10 patients suffering from tinea pedis with extremely itchy toes and thick cutin, and is applied 1 time a day after foot washing before sleeping every day, so that after the product is continuously used for 3 days, the itching relieving effect is remarkable, the cutin is softened, the skin at the broken part is well turned after the product is continuously used for 7 days, and no recurrence is caused in the follow-up process.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (8)
1. The chlorhexidine acetate ointment is prepared from the following raw materials in parts by weight:
1-6 parts of glycerin monostearate; 1-5 parts of polyglycerol ester; 1-5 parts of lanolin; 2-5 parts of white vaseline; 2-6 parts of stearyl alcohol; 0-5 parts of dimethyl silicone oil; 2-10 parts of propylene glycol; tween 800.5-4.0 parts; 0.5-5 parts of hexyl palmitate; 0.5-12 parts of methyl salicylate; 0.01-0.5 parts of chlorhexidine acetate; 1-20 parts of undecylenic acid; 0-1 part of traditional Chinese medicine extract; 0.5-6 parts of camphor, 1-5 parts of menthol and 0.5-3 parts of borneol.
2. The chlorhexidine acetate ointment of claim 1, wherein the Chinese medicinal composition is a mixture of extracts of radix Sophorae Flavescentis, fructus Cnidii, cortex Phellodendri, and radix Scutellariae.
3. The chlorhexidine acetate ointment of claim 2, wherein the chlorhexidine acetate ointment has a pH of 2.5-3.7.
4. The method of preparing chlorhexidine acetate ointment of claim 1, comprising the steps of:
A) heating and mixing tween 80 and propylene glycol with water to obtain a water phase;
B) heating and mixing glyceryl monostearate, lanolin, white vaseline, stearyl alcohol, polyglycerol ester, methyl silicone oil, hexyl palmitate and methyl salicylate to obtain an oil phase;
C) adding the oil phase into the water phase, homogenizing and mixing, adding ethanol solution of Borneolum Syntheticum, Mentholum, Camphora, chlorhexidine acetate, Chinese medicinal extract and undecylenic acid, and mixing to obtain chlorhexidine acetate ointment.
5. The method according to claim 4, wherein the temperature of the heating and mixing in the step A) is 75 to 90 ℃.
6. The preparation method according to claim 4, wherein the heating and mixing in the step B) is water bath heating and mixing, and the temperature of the heating and mixing is 75-90 ℃.
7. The preparation method according to any one of claims 4 to 6, wherein in the step C), the oil phase is slowly added into the water phase, when the temperature is 40 to 60 ℃, the ethanol solution of borneol, menthol, camphor, chlorhexidine acetate, the traditional Chinese medicine extract and undecylenic acid are added, the pH value is adjusted to be 2.5 to 3.7, and the mixture is stirred and cooled to the room temperature to obtain the chlorhexidine acetate ointment.
8. The method as claimed in claim 7, wherein the rotation speed of the homogenizing and mixing in step C) is 0.7-1.0 ten thousand rpm, and the time of the homogenizing and mixing is 5-20 min.
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