CN112807339A - Emulsifiable paste for treating infantile eczema and preparation method thereof - Google Patents
Emulsifiable paste for treating infantile eczema and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a cream for treating infantile eczema and a preparation method thereof. The emulsifiable paste for treating infantile eczema is prepared from the following raw materials: lithospermum, gallnut, horse oil, stearic acid, glyceryl monostearate, laurocapram, vaseline, glycerol, triethanolamine, water and ethyl p-hydroxybenzoate. The invention also discloses a preparation method of the cream. According to the cream for treating infantile eczema and the preparation method thereof, the medicines in the formula are all natural Chinese herbal medicine plants, the formula is rigorous and refined, and the cream is good in curative effect, quick to absorb, high in safety and small in side effect.
Description
Technical Field
The invention particularly relates to a cream for treating infantile eczema and a preparation method thereof.
Background
Infantile eczema is clinically common acute, subacute and chronic allergic and pruritic inflammation of skin, belongs to the category of wet toxicity and fetal toxicity in traditional Chinese medicine, is called infantile eczema, and is frequently developed for infants of 0-6 years old. Common local skin lesions of the acute attack symptoms of children patients have small blisters, papules and exudations; the symptoms of repeated infiltration, pruritus, pachynsis, pigmentation, roughness and scale covering on the surface of the infant in the chronic period often interfere the sleep of the infant patient, thereby affecting the health and growth of the infant patient. Western medicine considers that eczema is variable and complex. At present, a large number of researches prove that the eczema skin lesion part is infiltrated by a plurality of inflammatory cells and a large number of inflammatory mediators are released, so that the inflammation of the skin lesion part is promoted. The treatment is carried out on many symptoms, but the symptoms are easy to relapse and cannot be cured radically, and the symptoms are easy to relapse and side effects are many.
At present, no specific treatment medicine exists in Western medicine for treating eczema, and clinically, a compound preparation of corticosteroid hormone is mainly used for treating infantile eczema, but dependence, adverse reaction and the like can be generated after long-term use. Furthermore, infants and young children have thin and tender skin and relatively large body surface area, so that the transdermal absorption amount of the drug is higher than that of the drug administered to adults, and if the corticosteroid hormone is continuously used, the infants and young children are more likely to generate the inhibition of the hypothalamus-pituitary-adrenal axis through systemic absorption than adults due to too long time and too large area, and even if the corticosteroid hormone is weak, the growth inhibition phenomenon may occur after long-term use.
The compliance of the infants is poor, so that the compliance of the oral medicine is low; in addition, the common hormone medicines in the externally applied medicine are used clinically, so the parent acceptance of the children patients is low and the rejection is great.
In view of the above, the invention provides a novel emulsifiable paste for treating infantile eczema and a preparation method thereof, and the emulsifiable paste contains natural Chinese herbal medicine plants as ingredients, so that the compliance of clinically-suffered infants is high.
Disclosure of Invention
The invention aims to provide the emulsifiable paste for treating the infantile eczema, which is externally applied, has the characteristics of practicability, convenience and simple and convenient operation, and can effectively treat the infantile eczema.
In order to realize the purpose, the adopted technical scheme is as follows:
the emulsifiable paste for treating infantile eczema is prepared from the following raw materials: lithospermum, gallnut, horse oil, stearic acid, glyceryl monostearate, laurocapram, vaseline, glycerol, triethanolamine, water and ethyl p-hydroxybenzoate.
Further, the cream is prepared from the following raw materials in parts by weight: 1-8 parts of lithospermum, 3-8 parts of nutgall, 3 parts of horse oil, 3-6 parts of stearic acid, 3-6 parts of glyceryl monostearate and distearate, 0.5-2 parts of laurocapram, 1-6 parts of vaseline, 5-8 parts of glycerol, 0.5-2 parts of triethanolamine, 45-60 parts of water and 0.05-0.2 part of ethyl p-hydroxybenzoate.
Another object of the present invention is to provide a process for the preparation of the above cream, which is simple.
In order to realize the purpose, the adopted technical scheme is as follows:
the preparation method of the cream comprises the following steps:
(1) preparing lithospermum oil:
wetting radix Arnebiae, frying in oleum Sesami until radix Arnebiae turns to withered and oil turns purple black, removing residue, and filtering to obtain radix Arnebiae oil;
(2) preparing an oil phase part: heating horse oil, radix Arnebiae oil, stearic acid, glyceryl monostearate, vaseline, ethyl p-hydroxybenzoate, and laurocapram, and mixing to obtain oil phase part;
preparation of the aqueous fraction: heating water, glycerol and triethanolamine, mixing, and mixing to obtain water phase part;
(3) preparing a cream: gradually adding the water phase part into the oil phase part, continuously stirring until the water phase part is completely added, stirring into cream, adding the nutgall powder, stirring until the mixture is uniformly mixed, and cooling to room temperature to obtain the medicine for treating infantile eczema.
Further, in the step (1), the temperature of the sesame oil is 120-140 ℃.
Further, in the step (1), the mass ratio of the sesame oil to the lithospermum is 5-7: 1.
Further, in the step (2), during the preparation of the oil phase part: heating the raw materials to 80 deg.C, mixing, and cooling to 56-60 deg.C to obtain oil phase part.
Further, in the step (2), the temperature of the aqueous phase part is 56-60 ℃.
Further, in the step (3), nutgall powder is added and stirred for 20min at the temperature of 50-60 ℃.
Compared with the prior art, the invention has the beneficial effects that:
1. the emulsifiable paste is an external medicine and has the characteristics of practicality, convenience and simple operation.
2. The medicines in the emulsifiable paste formula are all natural Chinese herbal medicine plants, the formula is rigorous and refined, and the emulsifiable paste formula is good in curative effect, quick to absorb, high in safety and small in side effect.
Drawings
FIG. 1 shows rats in a normal blank group (i.e., normal group);
FIG. 2 shows rats in a model control group;
fig. 3 is rats administered with Binghuangfule group;
FIG. 4 shows rats administered with dermatitis platypus;
FIG. 5 shows rats in the middle dose group;
FIG. 6 shows rats administered with high dose groups;
FIG. 7 shows rats administered with a low dose group;
FIG. 8 shows rats in a normal blank group (i.e., normal group), a model control group, and a Binghuangfule group and a dermatipide group after administration;
FIG. 9 shows rats with different herb ratio 1 group and different herb ratio 2 group after administration;
figure 10 is a low dose group of rats after administration;
fig. 11 shows rats in the medium-dose and high-dose groups after administration.
Detailed Description
In order to further illustrate the cream for treating infantile eczema and the preparation method thereof, and achieve the intended purpose, the following detailed description is given to the cream for treating infantile eczema and the preparation method thereof according to the present invention, and the detailed implementation mode, structure, characteristics and efficacy thereof are described in detail. In the following description, different "one embodiment" or "an embodiment" refers to not necessarily the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
The cream for treating infantile eczema and the preparation method thereof are further described in detail:
the technical scheme of the invention is as follows:
the emulsifiable paste for treating infantile eczema is prepared from the following raw materials: lithospermum, gallnut, horse oil, stearic acid, glyceryl monostearate, laurocapram, vaseline, glycerol, triethanolamine, water and ethyl p-hydroxybenzoate.
Preferably, the cream is prepared from the following raw materials in parts by weight: 1-8 parts of lithospermum, 3-8 parts of nutgall, 3 parts of horse oil, 3-6 parts of stearic acid, 3-6 parts of glyceryl monostearate and distearate, 0.5-2 parts of laurocapram, 1-6 parts of vaseline, 5-8 parts of glycerol, 0.5-2 parts of triethanolamine, 45-60 parts of water and 0.05-0.2 part of ethyl p-hydroxybenzoate.
The preparation method of the cream comprises the following steps:
(1) preparing lithospermum oil:
wetting radix Arnebiae, frying in oleum Sesami until radix Arnebiae turns to withered and oil turns purple black, removing residue, and filtering to obtain radix Arnebiae oil;
(2) preparing an oil phase part: heating horse oil, radix Arnebiae oil, stearic acid, glyceryl monostearate, vaseline, ethyl p-hydroxybenzoate, and laurocapram, and mixing to obtain oil phase part;
preparation of the aqueous fraction: heating water, glycerol and triethanolamine, mixing, and mixing to obtain water phase part;
(3) preparing a cream: gradually adding the water phase part into the oil phase part, continuously stirring until the water phase part is completely added, stirring into cream, adding the nutgall powder, stirring until the mixture is uniformly mixed, and cooling to room temperature to obtain the medicine for treating infantile eczema.
Preferably, in the step (1), the temperature of the sesame oil is 120-140 ℃.
Preferably, in the step (1), the mass ratio of the sesame oil to the lithospermum is 5-7: 1.
Preferably, in the step (2), during the preparation of the oil phase part: heating the raw materials to 80 deg.C, mixing, and cooling to 56-60 deg.C to obtain oil phase part.
Preferably, in the step (2), the temperature of the aqueous phase part is 56-60 ℃.
Preferably, in the step (3), nutgall powder is added and stirred for 20min at 50-60 ℃.
Gallnut is the insect gall generated by the parasitizing of the honey bee on the gallnut tree, and the gallnut is mainly distributed on the coastal areas of the Mediterranean sea, the Arab, the Turkey, the Greece, the India, the Iran, the Pakistan and the like, particularly the small finesse yield is the most, and the Sinkiang is imported from the Pakistan. The main chemical components of the gallnut are gallic acid, methyl gallate, ethyl gallate, ellagic acid, etc., and have antiinflammatory, antiviral, antibacterial, antiviral, and antitumor effects.
Radix Arnebiae is perennial herb of Lithospermum of Boraginaceae, and its main effective components are naphthoquinone, benzoquinone, alkaloid, etc. The traditional Chinese medicine is mainly used for treating warm heat macula, damp-heat jaundice, eczema and other diseases. Modern pharmacological research shows that the lithospermum has the effects of resisting pathogenic microorganisms, resisting inflammation, resisting allergy, resisting tumor, protecting liver, stopping bleeding and the like.
Example 1.
Preparing raw materials: 5 parts of lithospermum, 5 parts of nutgall, 3 parts of horse oil, 5 parts of stearic acid, 4 parts of glyceryl monostearate and distearate, 1 part of laurocapram, 2 parts of vaseline, 6 parts of glycerol, 1 part of triethanolamine, 50 parts of water and 0.1 part of ethyl p-hydroxybenzoate.
Weighing raw materials according to raw material preparation, and specifically comprising the following operation steps:
(1) preparing lithospermum oil:
sinkiang radix Arnebiae is wetted with small amount of water, rapidly frying in 120-140 deg.C oleum Sesami until radix Arnebiae is withered and the oil is purple black, removing residue, and filtering to obtain radix Arnebiae oil.
Wherein the mass ratio of the sesame oil to the arnebia euchroma is 5-7: 1. And a small amount of frying is adopted, so that the operation safety is improved.
(2) Pulverizing Galla Turcica at low temperature into superfine powder to obtain Galla Turcica powder.
(3) Preparing an oil phase part:
taking horse oil, arnebia oil, stearic acid, glyceryl monostearate, vaseline, ethyl p-hydroxybenzoate and laurocapram (fat-soluble substances), putting into a proper beaker, heating in 80 deg.C water bath, stirring, cooling to 56-60 deg.C, and stirring to obtain oil phase part;
(4) preparation of the aqueous fraction:
taking a certain amount of water-soluble substances such as distilled water, glycerol, triethanolamine and the like, putting the water-soluble substances into a proper beaker, heating the beaker in a water bath kettle to control the temperature of an oil phase to be 56-60 ℃, and stirring the mixture frequently to fully and uniformly mix the oil phase and the water phase to obtain a water phase part;
(5) preparing a cream:
gradually adding 56-60 deg.C water phase into oil phase under stirring, and stirring to obtain cream; adding Galla Turcica powder into the mixed phase, and stirring at 50-60 deg.C for about 20 min. Then taking out, cooling, and cooling to room temperature.
Example 2.
Preparing raw materials: 1 part of lithospermum, 3 parts of gallnut, 3 parts of horse oil, 3 parts of stearic acid, 3 parts of glyceryl monostearate and distearate, 0.5 part of laurocapram, 1 part of vaseline, 5 parts of glycerol, 0.5 part of triethanolamine, 45 parts of water and 0.05 part of ethyl p-hydroxybenzoate.
Weighing raw materials according to raw material preparation, and specifically comprising the following operation steps:
(1) preparing lithospermum oil:
sinkiang radix Arnebiae is wetted with small amount of water, rapidly frying in oleum Sesami at 125 deg.C until radix Arnebiae turns to withered and oil turns purple black, removing residue, and filtering to obtain radix Arnebiae oil.
Wherein the mass ratio of the sesame oil to the arnebia euchroma is 6: 1. And a small amount of frying is adopted, so that the operation safety is improved.
(2) Pulverizing Galla Turcica at low temperature into superfine powder to obtain Galla Turcica powder.
(3) Preparing an oil phase part:
taking horse oil, arnebia oil, stearic acid, glyceryl monostearate, vaseline, ethyl p-hydroxybenzoate and laurocapram (fat-soluble substances), putting into a proper beaker, heating in 80 deg.C water bath, stirring, cooling to 59 deg.C, and stirring to obtain oil phase part;
(4) preparation of the aqueous fraction:
taking a certain amount of water-soluble substances such as distilled water, glycerol, triethanolamine and the like, putting the water-soluble substances into a proper beaker, heating the beaker in a water bath kettle to control the temperature of an oil phase to be 57 ℃, and stirring the mixture frequently to fully and uniformly mix the oil phase and the water phase to obtain a water phase part;
(5) preparing a cream:
gradually adding the water phase part at 57 deg.C into the oil phase part, stirring while stirring, and stirring to obtain cream; adding Galla Turcica powder into the mixed phase, and stirring at 55 deg.C for about 20 min. Then taking out, cooling, and cooling to room temperature.
Example 3.
Preparing raw materials: 8 parts of lithospermum, 8 parts of gallnut, 3 parts of horse oil, 6 parts of stearic acid, 6 parts of glyceryl monostearate and distearate, 2 parts of laurocapram, 6 parts of vaseline, 8 parts of glycerol, 2 parts of triethanolamine, 60 parts of water and 0.2 part of ethyl p-hydroxybenzoate.
Weighing raw materials according to raw material preparation, and specifically comprising the following operation steps:
(1) preparing lithospermum oil:
sinkiang radix Arnebiae is wetted with small amount of water, rapidly frying in oleum Sesami at 130 deg.C until radix Arnebiae turns to withered and oil turns purple black, removing residue, and filtering to obtain radix Arnebiae oil.
Wherein the mass ratio of the sesame oil to the arnebia euchroma is 6: 1. And a small amount of frying is adopted, so that the operation safety is improved.
(2) Pulverizing Galla Turcica at low temperature into superfine powder to obtain Galla Turcica powder.
(3) Preparing an oil phase part:
taking horse oil, arnebia oil, stearic acid, glyceryl monostearate, vaseline, ethyl p-hydroxybenzoate and laurocapram (fat-soluble substances), putting into a proper beaker, heating in 80 deg.C water bath, stirring, cooling to 58 deg.C, and stirring to obtain oil phase part;
(4) preparation of the aqueous fraction:
taking a certain amount of water-soluble substances such as distilled water, glycerol, triethanolamine and the like, putting the water-soluble substances into a proper beaker, heating the beaker in a water bath kettle to control the temperature of an oil phase at 58 ℃, and stirring the mixture frequently to fully and uniformly mix the oil phase and the water phase to obtain a water phase part;
(5) preparing a cream:
gradually adding the water phase part at 58 deg.C into the oil phase part, stirring while adding the water phase part, and stirring to obtain cream; adding Galla Turcica powder into the mixed phase, and stirring at 50-57 deg.C for about 20 min. Then taking out, cooling, and cooling to room temperature.
Example 4.
Preparing raw materials: 7 parts of lithospermum, 4 parts of nutgall, 3 parts of horse oil, 4 parts of stearic acid, 5 parts of glyceryl monostearate and distearate, 0.7 part of laurocapram, 2 parts of vaseline, 6 parts of glycerol, 0.8 part of triethanolamine, 50 parts of water and 0.08 part of ethyl p-hydroxybenzoate.
Weighing raw materials according to raw material preparation, and specifically comprising the following operation steps:
(1) preparing lithospermum oil:
sinkiang radix Arnebiae is wetted with a small amount of water, rapidly frying in oleum Sesami at 120 deg.C until radix Arnebiae turns to withered and oil turns purple black, removing residue, and filtering to obtain radix Arnebiae oil.
Wherein the mass ratio of the sesame oil to the arnebia euchroma is 5: 1. And a small amount of frying is adopted, so that the operation safety is improved.
(2) Pulverizing Galla Turcica at low temperature into superfine powder to obtain Galla Turcica powder.
(3) Preparing an oil phase part:
taking horse oil, arnebia oil, stearic acid, glyceryl monostearate, vaseline, ethyl p-hydroxybenzoate and laurocapram (fat-soluble substances), putting into a proper beaker, heating in 80 deg.C water bath, stirring, cooling to 60 deg.C, and stirring to obtain oil phase part;
(4) preparation of the aqueous fraction:
taking a certain amount of water-soluble substances such as distilled water, glycerol, triethanolamine and the like, putting the water-soluble substances into a proper beaker, heating the beaker in a water bath kettle to control the temperature of an oil phase at 60 ℃, and stirring the mixture frequently to fully and uniformly mix the oil phase and the water phase to obtain a water phase part;
(5) preparing a cream:
gradually adding 60 deg.C water phase part into oil phase part, stirring, and stirring to obtain cream; adding Galla Turcica powder into the mixed phase, and stirring at 50-60 deg.C for about 20 min. Then taking out, cooling, and cooling to room temperature.
Example 5.
Preparing raw materials: 5 parts of lithospermum, 7 parts of nutgall, 3 parts of horse oil, 5 parts of stearic acid, 5 parts of glyceryl monostearate and distearate, 1.2 parts of laurocapram, 3 parts of vaseline, 7 parts of glycerol, 1.2 parts of triethanolamine, 52 parts of water and 0.12 part of ethyl p-hydroxybenzoate.
Weighing raw materials according to raw material preparation, and specifically comprising the following operation steps:
(1) preparing lithospermum oil:
sinkiang radix Arnebiae is wetted with small amount of water, rapidly frying in oleum Sesami at 140 deg.C until radix Arnebiae turns to withered and oil turns purple black, removing residue, and filtering to obtain radix Arnebiae oil.
Wherein the mass ratio of the sesame oil to the arnebia euchroma is 5: 1. And a small amount of frying is adopted, so that the operation safety is improved.
(2) Pulverizing Galla Turcica at low temperature into superfine powder to obtain Galla Turcica powder.
(3) Preparing an oil phase part:
taking horse oil, arnebia oil, stearic acid, glyceryl monostearate, vaseline, ethyl p-hydroxybenzoate and laurocapram (fat-soluble substances), putting into a proper beaker, heating with 80 deg.C water bath, stirring, cooling to 56 deg.C, and stirring to obtain oil phase part;
(4) preparation of the aqueous fraction:
taking a certain amount of water-soluble substances such as distilled water, glycerol, triethanolamine and the like, putting the water-soluble substances into a proper beaker, heating the beaker in a water bath kettle to control the temperature of an oil phase to be 56 ℃, and stirring the mixture frequently to fully and uniformly mix the oil phase and the water phase to obtain a water phase part;
(5) preparing a cream:
gradually adding 56 deg.C water phase into oil phase, stirring, and stirring to obtain cream; adding Galla Turcica powder into the mixed phase, and stirring at 50 deg.C for about 20 min. Then taking out, cooling, and cooling to room temperature.
Example 6 pharmacodynamic test
(1) Material
a experimental animal
[ genus ] rat
[ line ] SD (Sprague Dawley)
[ SOURCE ] Sinkiang college of medicine
[ laboratory animal permit ] permit number: SCXK (New) 2018-.
[ class ] No particular pathogenic bacterium (Specific Pathogen Free, SPF)
[ gender ] sex
[ weight (age) ]
Ordering: 100-140g (4-6 weeks old). Animals reached body weights slightly outside this range (± 10g), and were quarantined and acclimated.
Inclusion test: after quarantine and adaptation, the male and female animals are weighed to obtain the respective mean value, and rats with the body weight within the range of +/-20% are included in the test.
SPF grade SD rats 60 with half male and female, body mass (180 + -20) g. The feed is fed by adopting a standard feed with a fixed formula, and the experiment is started after the feed is freely eaten and drunk in the same environment and is adapted to the environment.
b drugs and agents
Eczema cream (cream prepared in example 1), low, medium and high dose groups (batch No. 190706), Binghuangfule ointment (national standard Z10980140, batch No. 180909); compound dexamethasone acetate cream (999 dermatitidin) huarun sanjiu medicine gmbh; (2, 4-Dinitrochlorobenzene (DNCB), Shanghai Qin chemical reagents, Inc.; propanol solution, Dexinkang, Tex., Disinfection products, Inc.
(2) Method of producing a composite material
Grouping and molding
70 rats were divided into two groups at random by body weight, one group was 10 in the normal blank group, and the other group was 60 in the model group. The skin A, B of the back of the rat is treated by an electric shaver to remove the hair (A) and the hair (B) on the back of the neck of the animal, wherein the area of the A is 2cm multiplied by 2cm, and the area of the B is 4cm multiplied by 4 cm. The rats are sensitized by coating 100 mu L of 7 percent DNCB acetone solution on the skin of the A position by a liquid transfer gun, after sensitization, the rats are seen to have severe pruritus, and scratching and rolling behaviors frequently occur for about 2 hours. After 1 week 200. mu.L of a 7% DNCB acetone solution was applied to B. The rat can be stimulated for 1 time every 5 days, and the rat can have severe pruritus and frequent behaviors of scratching and rolling. And (4) the skin at the position B gradually shows erythema, pimple, edema, scratch and desquamation, the skin damage condition is recorded and scored after each excitation, and the skin damage at the back of each mouse shows erythema, pimple, incrustation and exudation after 6 excitations, so that the excitation is stopped, and the success of preparing the model is shown. The model lasts no less than 9 days.
② administration
The administration method comprises uniformly applying the above materials on the exposed skin of animals according to the corresponding dosage determined by pre-test, wrapping with medical gauze for 2-3 layers, fixing with non-irritant adhesive plaster, removing the cover after about 4 hr, and cleaning with warm purified water. The specific administration per group is shown in table 1.
Blank control group: healthy rats were dosed.
TABLE 1 weight mass of male rats in each group during dosing period: (
n＝5)
Note: the ingredients in the low, medium and high dose groups in the table are the same, except for the amount of nutgall and lithospermum used in preparing the cream. The middle-dose group is the cream prepared in the embodiment 1 of the invention, and the dosage of the gallnut and the lithospermum is half of that of the middle-dose group when the cream of the low-dose group is prepared; when the cream of the high-dose group is prepared, the dosage of the gallnut and the lithospermum is one time of that of the medium-dose group.
[ administration time and frequency ] the medicine is applied every morning and washed every afternoon at intervals of 4-6 h.
[ dosing frequency ] 1 time per day.
[ dosing period ] continuous dosing was performed for 10 days.
Observation index and detection method
a observation of apparent index
The appearance index plays an important role in clinical diagnosis of eczema and is a direct index of the success of an animal model. After the eczema animal model is successfully prepared, the animal has different degrees of pruritus, skin damage and erythema, the glossiness of the fur is reduced, the activity is reduced, and the like.
The measuring instrument: and taking a picture by a camera and observing by naked eyes.
The results of the study are shown in FIGS. 1-7. As can be seen from FIG. 1, the skin of the normal blank group rats was normal. As can be seen from FIG. 2, the skin of the model control group rats had severe ulceration. As can be seen from FIG. 3, the skin of the Binghuangfule rats had healed to some extent. As can be seen from FIG. 4, the skin of the dermatitis plain group rats healed up to some extent. As can be seen from figures 5-7, the skin healing condition of the rats in the cream group is good, and the low-medium dose effect and the medium-high dose effect of the cream prepared by the invention are obviously superior to those of the traditional Chinese medicine control Binghuangfule group and the dermatitis treatment group.
As can be seen from figures 1-7, the middle and high dose groups of the compound gallnut ointment prepared by the invention have obvious effects of inhibiting inflammatory reaction, relieving itching and reducing exudation on a rat eczema model induced by DNCB, and the effect is better than that of a control group.
b body weight
TABLE 2 weight mass of male rats in each group during dosing period: (
n＝5)
Note: comparison with blank control group#P<0.05，##P<0.01; comparison with model control group*P<0.05，**P<0.01。
Table 3 body weight mass of female rats in each group during the administration period: (
n＝5)
Note: comparison with blank control group#P<0.05，##P<0.01; comparison with model control group*P<0.05，**P<0.01
Male rats: the body weight of the rats in the male model control group was significantly reduced during the administration period compared to the blank control group, with a statistical difference (P <0.01), and the body weight of the rats in the male dermatitis pan group was significantly reduced during the administration period compared to the model control group, with a statistical difference (. P < 0.05;. P <0.01), as shown in table 2.
Female rats: during the dosing period, the body weight of rats in the female model control group was significantly reduced compared to the blank control group, with a statistical difference (P <0.01), and the body weight of rats in the female dermatitis pan group was significantly reduced during the dosing period compared to the model control group, with a statistical difference (. about.p <0.01), as shown in table 3.
The test results show that: the body weight of the dermatitis treatment group is obviously reduced compared with that of a model control group, which indicates that the dermatitis treatment group causes side effects on rats during administration, and presumably, the digestive system and the immune system of the rats are damaged, so that the body weight of the rats is obviously reduced.
c weight and coefficient of visceral organs
TABLE 4
The following points can be found in table 4:
(1) spleen weight was significantly increased in model rats compared to the blank control group. Compared with the model group, the spleen weight of the rats is obviously reduced in the dermatitis group; the weight of the spleen of rats in the Binghuangfule ointment group and the eczema ointment group in low, medium and high dose groups has no obvious change.
Compared with a blank control group, the spleen coefficient of a rat in a model group is obviously increased, compared with the model group, the spleen coefficient of a rat in a dermatitis flat group is obviously reduced, compared with the model group, and the spleen coefficients of a low, medium and high dose group of the Binghuangfule ointment group and the eczema ointment group are slightly reduced but are not obviously changed.
(2) Compared with the blank control group, the thymus weights of the rats in the model group have no obvious change. Compared with the model group, the weight of the thymus of the rats in the dermatitis treatment group and the Binghuangfule ointment group is obviously reduced. The weight of thymus of rats in the low, medium and high dose groups of eczema cream has no obvious change.
Compared with a blank control group, the thymus coefficient of the rats in the model group has no obvious change, compared with the model group, the thymus coefficient of the rats in the dermatitis treatment group and the Binghuangfule ointment group is obviously reduced, and the thymus coefficient of the rats in the eczema cream low, medium and high dose groups has no obvious difference.
(3) Compared with the blank control group, the weight of the liver of the rats in the model group has no obvious change. Compared with the model group, the weight of the liver of the rats in the dermatitis treatment group, the Binghuangfule ointment group and the eczema ointment group is slightly changed, but the weight of the liver of each group is not obviously changed.
Compared with a blank control group, the liver coefficients of rats in the model group have no obvious change, compared with the model group, the liver coefficients of rats in the dermatitis flat group, the Binghuangfule ointment group and the eczema ointment group have slight changes, but the liver weight changes of the rats in each group are not obvious.
And (4) conclusion: in the dermatitis treatment group and the Binghuangfule ointment group, the weight and coefficient of the spleen and the thymus are reduced compared with those of the model control group, and the spleen and the thymus may have atrophy and degenerative changes. The weight and coefficient of the viscera of the rats in the eczema cream group have no obvious change, which indicates that the eczema cream does not cause obvious damage to the spleen, thymus and liver of the rats. Meanwhile, the eczema cream is safer compared with the dermatitis ointment and the Binghuangfule ointment.
Example 7.
Based on example 6, a new group with different medicinal material ratios of 1-2 is added. The ratio of different medicinal materials 1 is that the ratio of nutgall to lithospermum oil is 8: 7, the ratio of the nutgall to the arnebia oil in the group 2 of different medicinal materials is 6: 9. and (5) performing apparent index observation. The results are shown in Table 5 and FIGS. 8-11.
Table 5 apparent score of zone B (excitation zone) in rats of each group at the end of dosing
As can be seen from fig. 8-11, at the end of the administration, the normal control group: the skin on the back of the rat is light red, delicate, smooth and tender, soft in texture and clear and visible in skin texture. Chronic eczema model group: the skin damage of the back of the rat is obvious, and the skin can be seen to have erythema, infiltration, scale, scabbing, roughness and thickening, pigmentation and scratch, and still meet the diagnosis standard of chronic eczema. Each administration group was: compared with the model group, the back skin damage of the rats in each administration group is obviously improved, and erythema, infiltration, scale, incrustation and the like are obviously relieved or eliminated.
And as can be seen from the apparent scores and figures 8-10, the effect of treating eczema by using the ZY-001 dose is better than that of 1 group and 2 groups of different medicinal material proportions. The ratio of the gallnut and the lithospermum oil selected by the invention is the best effect for treating eczema.
Example 8: in vitro transdermal test study of horse oil
(1) Preparation of in vitro rat skin: healthy rats were sacrificed by cervical dislocation and subcutaneous adipose tissue and mucus tissue were removed. Removing hair with humectant glycerol solution, cleaning skin with normal saline, soaking the cleaned skin in normal saline, and storing in refrigerator (-18 deg.C). Naturally unfreezing before experiment.
(2) In vitro skin permeation test: shearing rat skin with proper size, fixing the rat skin on a Franz vertical diffusion pool, enabling the stratum corneum of in vitro skin to face a drug supply pool, enabling the dermis layer to face a receiving chamber, placing 7mL of normal saline in the receiving chamber, starting an electromagnetic constant-temperature stirrer, setting the water bath temperature to be 36.5 ℃, simulating the normal human body temperature, paying attention to contact of a receiving liquid with the skin, weighing 0.25g of emulsifiable paste, uniformly smearing the emulsifiable paste on the skin of the sheared rat, recording the starting time, taking 2mL of the receiving liquid at 0.5 hour, 1 hour and 2 hours, taking blank skin as a follow-up control, filtering with a 0.22 mu m microporous filter membrane, and determining the content of gallic acid by an HPLC method.
The determination method comprises the following steps: a chromatographic column: c18(ii) a Methanol-0.4% phosphoric acid solution is used as a mobile phase; gradient elution; the detection wavelength was 273 nm. The number of theoretical plates is not less than 3000 calculated according to gallic acid peak.
TABLE 6 gradient elution schedule
The results are shown in Table 7.
TABLE 7 Gallic acid content (μ g/mL)
The experimental results show that: the detected gallic acid content of the cream added with horse oil is higher, which also indicates that the cream added with horse oil has better transdermal absorption.
The above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any way, and any simple modification, equivalent change and modification made to the above embodiments according to the technical spirit of the present invention are within the scope of the technical solution of the present invention.
Claims (9)
1. The cream for treating infantile eczema is characterized by being prepared from the following raw materials: lithospermum, gallnut, horse oil, stearic acid, glyceryl monostearate, laurocapram, vaseline, glycerol, triethanolamine, water and ethyl p-hydroxybenzoate.
2. The cream of claim 1,
the cream is prepared from the following raw materials in parts by weight: 1-8 parts of lithospermum, 3-8 parts of nutgall, 3 parts of horse oil, 3-6 parts of stearic acid, 3-6 parts of glyceryl monostearate and distearate, 0.5-2 parts of laurocapram, 1-6 parts of vaseline, 5-8 parts of glycerol, 0.5-2 parts of triethanolamine, 45-60 parts of water and 0.05-0.2 part of ethyl p-hydroxybenzoate.
3. A process for the preparation of a cream according to claim 1, characterized in that it comprises the following steps:
(1) preparing lithospermum oil:
wetting radix Arnebiae, frying in oleum Sesami until radix Arnebiae turns to withered and oil turns purple black, removing residue, and filtering to obtain radix Arnebiae oil;
(2) preparing an oil phase part: heating horse oil, radix Arnebiae oil, stearic acid, glyceryl monostearate, vaseline, ethyl p-hydroxybenzoate, and laurocapram, and mixing to obtain oil phase part;
preparation of the aqueous fraction: heating water, glycerol and triethanolamine, mixing, and mixing to obtain water phase part;
(3) preparing a cream: gradually adding the water phase part into the oil phase part, continuously stirring until the water phase part is completely added, stirring into cream, adding the nutgall powder, stirring until the mixture is uniformly mixed, and cooling to room temperature to obtain the medicine for treating infantile eczema.
4. The production method according to claim 1,
in the step (1), the temperature of the sesame oil is 120-140 ℃.
5. The production method according to claim 1,
in the step (1), the mass ratio of the sesame oil to the lithospermum is 5-7: 1.
6. The production method according to claim 1,
in the step (2), during the process of preparing the oil phase part: heating the raw materials to 80 deg.C, mixing, and cooling to 56-60 deg.C to obtain oil phase part.
7. The production method according to claim 1,
in the step (2), the temperature of the water phase part is 56-60 ℃.
8. The production method according to claim 1,
in the step (3), nutgall powder is added and stirred for 20min at the temperature of 50-60 ℃.
9. A cream for treating infantile eczema, which is prepared by the preparation method of any one of claims 3 to 8.
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| WO2010054533A1 (en) * | 2008-11-12 | 2010-05-20 | 常州市第四制药厂有限公司 | Cyproheptadine hydrochloride cream and preparation method thereof |
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