CN105126007B - A kind of patch for treating baby diarrhea - Google Patents

A kind of patch for treating baby diarrhea Download PDF

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CN105126007B
CN105126007B CN201510670816.XA CN201510670816A CN105126007B CN 105126007 B CN105126007 B CN 105126007B CN 201510670816 A CN201510670816 A CN 201510670816A CN 105126007 B CN105126007 B CN 105126007B
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volatile oil
oil
patch
ointment
volatile
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CN105126007A (en
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张军
叶炳皇
王超
梁土亮
刘宇
杨蕊
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Guangzhou University of Chinese Medicine
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Guangzhou University of Chinese Medicine
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Abstract

The present invention relates to a kind of patches for treating baby diarrhea, the patch includes the blank plaster with leakage-proof ring and the ointment being coated in the leakage-proof ring, the ointment is made of effective component, vitamin E and matrix, wherein, the effective component is made of the volatile oil of following weight percent amount: amomum fruit volatile oil 20.5~25.2%, Rhzoma Atractylodis Lanceae volatile oil 20.7~25.2%, Cortex Cinnamomi volatile oil 17.0~21.2%, volatile clove oil 29.1~35.4%;The volatile oil for forming the effective component is made by following methods: fructus amomi, rhizoma atractylodis, cortex cinnamomi and the medicinal powder of cloves taken respectively, and 15 times of amount water are added and impregnate 30 minutes, refluxing extraction under conditions of 100 DEG C;Volatile oil is collected, amomum fruit volatile oil, Rhzoma Atractylodis Lanceae volatile oil, Cortex Cinnamomi volatile oil and volatile clove oil are respectively obtained.The dosage of the vitamin E is the 1.5%~3.0% of effective component weight;The matrix is lanolin.Not only flavour of a drug are few for the patch, but also stabilization effect is good, significant in efficacy.

Description

A kind of patch for treating baby diarrhea
Technical field
The present invention relates to the present invention relates to contain the pharmaceutical preparation for not determining structure from plant, and in particular to containing double The emplastrum for not determining structure of cotyledon plant guiding principle rhizoma atractylodis platymiscium, the emplastrum can be used for treating diarrhea.
Background technique
Baby diarrhea be one group by more cause of diseases, it is multifactor caused by by times of defecation increase with stool change with the characteristics of Pediatric common disease, 6 months -- 2 years old infant morbidity height causes infantile malnutrition, dysplasia and death One of the main reasons.It being counted according to the World Health Organization (WHO), about 1,000,000,000 5 years old or less children suffer from diarrhea every year in the whole world, In there are 4,000,000~5,000,000 children to die of diarrhea;One report of the United Nations in 2009 points out, the every 5 death of child cases in the whole world In just there is a people to die of diarrhea.Domestic baby diarrhea is infectious strong, and disease incidence is high, and main pathogens are enteropathogenic E.Colis And rotavirus, followed by shigella dysenteriae, detection of Salmonella, campylobacter jejuni and certain conditioned pathogens such as field coccus etc..The Ministry of Public Health will It is classified as one of " four diseases " of paediatrics keypoint control, and prevention and control need to put into huge public health resources.
The mostly oral pipemidic acid of western medicine baby diarrhea, gentamicin, ampicillin, erythromycin or butylamine card at present The antibiotic such as that mycin.Antibiotic generates strong influence to intestinal flora balance, they can inhibit or kill sensitive bacteria, promotes Non-sensitive bacterium hyper-proliferative increases suprainfection chance;Quantity, position, the ratio of the normal strain of enteron aisle change, and lead to bacterium Group's imbalance;Can also glucose absorption be made to reduce, disaccharide enzyme activity declines and diarrhea occurs;When largely killing bacterium, thallus is split Solution produces the endotoxin of high concentration, and endotoxin, which enters blood, can increase permeability and peroxide injury, destroys gut barrier function, The phagocytic function and general immunity for inhibiting liver reticuloendothelial system, to aggravate diarrhea or delay diarrhea.Pathogen It makes a variation and newly the appearance of cause of disease, new antibiotic is expensive, the treatment mode based on antibiotic is also made to face huge challenge.
Traditional Chinese medicine prevention baby diarrhea has accumulated clinical experience abundant, wherein unique applying Chinese medicine to the umbilicus therapy occupies a seat Ground.It, which has, applies convenient, cheap, treating both manifestation and root cause of disease advantage, is acted on by umbilicus absorption of drugs and medicine Stimulation of the object to acupuncture point, it is shown that good therapeutic effect.Wherein representative drug be DINGHUIER QITIE but its The effect for treating baby diarrhea is not still very ideal.In addition, eugenol contained by cortex cinnamomi and cloves and cinnaldehydrum are in illumination It is extremely easy in decomposition under (4000lx), high temperature (60 DEG C~80 DEG C), has seriously affected the stability of the patch.Seminar's pre-stage test knot Fruit shows that the accelerated degradation with effective component in patch, anti-diarrhea drug effect also decreased significantly, therefore containing unstable Property effective component patch stabilisation measure, have important druggability value and significance.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of patch for treating baby diarrhea, not only flavour of a drug are few for the patch, And stability is good, and it is significant in efficacy.
The scheme that the present invention solves above-mentioned technical problem is as follows:
A kind of patch for treating baby diarrhea, the patch include having the blank plaster of leakage-proof ring and being coated on described anti- Ointment in leakage circle, the ointment are made of effective component, vitamin E and matrix, wherein
The effective component is made of the volatile oil of following weight percent amount: amomum fruit volatile oil 20.5~25.2%, grey Art volatile oil 20.7~25.2%, Cortex Cinnamomi volatile oil 17.0~21.2%, volatile clove oil 29.1~35.4%;Have described in composition The volatile oil of effect ingredient is made by following methods: taking fructus amomi, rhizoma atractylodis, cortex cinnamomi and the medicinal powder of cloves respectively, 15 times of amounts are added Water impregnates 30 minutes, refluxing extraction under conditions of 100 DEG C;Volatile oil is collected, amomum fruit volatile oil, rhizoma atractylodis volatilization are respectively obtained Oil, Cortex Cinnamomi volatile oil and volatile clove oil;
The dosage of the vitamin E is the 1.5%~3.0% of effective component weight;
The matrix is lanolin.
In above-mentioned ointment, the optimum proportioning of the effective component is amomum fruit volatile oil 23.43%, Rhzoma Atractylodis Lanceae volatile oil 23.85%, Cortex Cinnamomi volatile oil 20.08%, volatile clove oil 32.64%.
Patch of the present invention, wherein the blank plaster is commercially available blank plaster, the blank plaster The characteristics of be middle part be equipped with leakage-proof ring.Above-mentioned blank plaster specifically can be Shandong Xiao Kang Biotechnology Co., Ltd, Anguo Hong Sheng Medical Devices Co., Ltd. of city, Gaotang County Jia Ming Medical Devices Co., Ltd. or the limited public affairs of Beijing Tianyuan apricot woods medical sci-tech The product of department.
Patch of the present invention can be used conventional method and be made, and the method that the present inventor recommends is as follows:
(1) it takes the effective component that vitamin E is added and stirs evenly;
(2) take the matrix, be placed in 100 DEG C of water-baths, water-bath to molten condition, taking-up is put to 50 DEG C, by effectively at Fen ︰ matrix=1 ︰ 9 mass ratio is added the effective component containing vitamin E obtained by step (1) and is uniformly mixed, and medicine is made Cream;
(3) ointment is coated on while hot in the leakage-proof ring of blank plaster by the dosage of every patch 0.2g, after cooling, is covered anti- Glutinous layer to get.
Patch of the present invention presses the combination principle of Chinese medicine by the volatile oil group of fructus amomi, four taste of rhizoma atractylodis, cortex cinnamomi and cloves At with dissipating dampness and activating spleen, the effect of warming middle energizer to stop diarrhea.Compared with existing DINGHUIER QITIE, the present invention considerably reduces mouse kind It rushes down that leaf leads to diarrhea the wet bowel frequency number of model and writhing number, the total effective rate for treating baby diarrhea are up to 92%, is significantly higher than fourth osmanthus The montmorillonite powder of youngster's navel patch and dioctahedral smectite.In addition, joined antioxidant vitamin E in effective component of the present invention, institute Obtain finished product during storage, index components cinnaldehydrum, eugenol, Atisine chloride Atractydin retention rate significantly improve, and stabilization effect is good.
Specific embodiment
Technical effect possessed by the present invention will be proved by effect experiment, stability experiment, clinical trial below.
One, preparation stability and antidiarrheal drug effect influence to test
The discussion that 1 preparation stability influences antidiarrheal drug effect
1.1 experimental material
1.1.1 the preparation of Chinese medicine compound prescription volatile oil
Fructus amomi, rhizoma atractylodis, cortex cinnamomi and the medicinal powder of cloves are taken, 15 times of amount water is separately added into and impregnates 30 minutes, at 100 DEG C Under the conditions of refluxing extraction;Volatile oil is collected, amomum fruit volatile oil, Rhzoma Atractylodis Lanceae volatile oil, Cortex Cinnamomi volatile oil and cloves volatilization are respectively obtained Oil.Precision weighs amomum fruit volatile oil 5.6g, Rhzoma Atractylodis Lanceae volatile oil 5.7g, Cortex Cinnamomi volatile oil 4.8g, volatile clove oil 7.8g, sets In 100ml brown measuring bottle, be ultrasonically treated 5 minutes, shake up, let cool to get.
1.1.2 the preparation of the volatilization ointment containing 13.0% prescription
Lanolin 8.70g (36-42 DEG C of fusing point) is weighed, 100 DEG C of water-baths, water-bath to molten condition are set, taking-up is put to suitable 1.1.1 lower prescription volatile oil 1.30g are added in suitable temperature, uniformly mixed, let cool to get.
1.1.3 the preparation of heated 0,10,15,20 day prescription volatilization ointment
It takes the above-mentioned 13.0% prescription volatilization ointment that contains each appropriate, is loaded in vial, seals, packed with fine aluminium bag, To obtain the final product.It places 20 days under the conditions of 60 DEG C, was sampled in 0,10,15,20 day, measurement calculates These parameters ingredient retention rate.
1.1.4 check experiment group
Model control group: lanolin base
1.1.5 prepared by folium sennae leachate
Folium sennae medicinal powder 10g (20 mesh) is taken, is set in 200ml measuring bottle, the distilled water of 10 times of amounts is added, 90 DEG C are impregnated 0.5 Hour, filtration, take continuous 88 liquid to get.
1.1.6 animal:
NIH mouse is provided by Guangdong Medical Lab Animal Center, and SPF grades, Quality of Experimental Animals credit number:
SCXK (Guangdong) 2008-0020, male, 18~22g of weight.Feeding environment: 23 2 DEG C of room temperature, relative humidity 75 10%.
1.1.7 instrument reagent:
Folium sennae (is purchased from The First Affiliated Hospital of Guangzhou University of Traditional Chinese Med pharmacy);Medicinal plant oil;Happy treasured pure water, happy treasured Pure water Co., Ltd;Precise electronic assay balance, FA/JA series, upper current chart level instruments and meters Co., Ltd;Disposable injection Device etc., 40, mouse cover;1, mouse box;Experimental bench.
1.2 experimental method
1.2.1 influence of the different pharmaceutical to folium sennae induced mice diarrhea
Male mice 60, it is randomly divided into 5 groups, fasting, while distilled water nursing is given, and after 4 hours, weighed weight, mould Type control group presses 0.2g/ and only applies patch bare substrate, 0 day prescription volatilization ointment group of being heated, heated 10 days prescription volatilization ointments Group, heated 15 days prescriptions volatilization ointment group, the heated 20 days volatilization ointment groups containing prescription are only applied that paste drug containing different by 0.2g/ Paste, after two hours, model control group, heated 0 day prescription volatilization ointment group, heated 10 days prescription volatilization ointment groups, Heated 15 days prescription volatilization ointment groups fill folium sennae leaching by 0.3ml/10g weight containing prescription volatilization ointment group in heated 20 days Liquid out, the observation of mouse single cage, lower berth blotting paper make muck counting, how much indicate diarrhoea degree with muck.Replacement blotting paper in time Or cleaning muck, accumulative muck number, computation model control group, heated 0 day prescription volatilization ointment group, heated 10 are recorded per hour Volatilize ointment group, heated 15 days prescriptions volatilization ointment group, heated 20 days volatilization each mouse 4 of ointment group containing prescription of its prescription is small When interior muck sum.T is examined between carrying out group with each group muck number mean, as a result as follows.
1.2.2 statistical procedures
Experimental data is indicated with χ ± s, is examined using t, using SPSS17.0 software statistics packet carry out statistical analysis, * P < 0.05 indicates significant difference;* P < 0.01 indicates that difference is more significant;* * P < 0.001 indicates that difference is extremely significant.
1.2.3 experimental result
1 each group of table result (n=12) compared with model control group
* note: compared with model control group: P < 0.05 *;**P<0.01;***P<0.001;
Compared with heated 0 day prescription volatilization ointment group :+indicate P < 0.0;++ indicate P < 0.01;+++ indicate P < 0.001.
The synthesis retention rate of each index components in 2 60 DEG C of table heated 10,15,20 days oil-containing emplastrums
Note: comprehensive retention rate=cinnaldehydrum retention rate * 1.5/6+ eugenol retention rate * 2.5/6+ Atisine chloride Atractydin retention rate * 2/6
1.3 experiments discuss
The results show that 0 day prescription volatilization ointment group of being heated is to folium sennae induced mice diarrhea compared with model control group There is apparent inhibiting effect;And 10,15,20 days prescription volatilization ointment groups of being heated respectively there are not folium sennae induced mice diarrhea There is apparent inhibiting effect.The result shows that effective component palliating degradation degree increases, antidiarrheal drug effect with the extension in the period that accelerates the failure In decreasing trend.
The confirmatory experiment that 2 preparation stabilities influence antidiarrheal drug effect
2.1 experimental material
2.1.1 the preparation of the volatilization ointment containing 13% prescription
Same 1.1.2.
2.1.2 the preparation of heated 0,10,15 day prescription volatilization ointment
Same 1.1.3.
2.1.3 check experiment group
Same 1.1.4.
2.1.4 prepared by folium sennae leachate
Same 1.1.5.
2.1.5 animal:
Same 1.1.6.
2.1.6 instrument reagent:
Same 1.1.7.
2.2 experimental method
2.2.1 influence of the different pharmaceutical to folium sennae induced mice diarrhea
Male mice 40, it is randomly divided into 4 groups, fasting, while distilled water nursing is given, and after 4 hours, weighed weight, mould Type control group presses 0.2g/ and only applies patch bare substrate, 0 day prescription volatilization ointment group of being heated, heated 10 days prescription volatilization ointments Group, heated 15 days prescription volatilization ointment groups only apply the different paste of patch drug containing by 0.2g/, after two hours, model control group, Heated 0 day prescription volatilization ointment group, heated 10 days prescription volatilization ointment groups, heated 15 days prescription volatilization ointment groups are pressed 0.3ml/10g weight fills folium sennae leachate, the observation of mouse single cage, and lower berth blotting paper is made muck counting, how much indicated with muck Diarrhoea degree.Timely replacement blotting paper or cleaning muck, record accumulative muck number per hour, and computation model control group is heated 0 day Prescription volatilization ointment group, heated 10 days prescription volatilization ointment groups, heated 15 days prescriptions volatilize in each mouse of ointment group 4 hours Muck sum.T is examined between carrying out group with each group muck number mean, as a result as follows.
2.2.2 statistical procedures
Ditto.
2.2.3 experimental result
3 each group of table and blank control group comparison result (n=10)
* note: compared with model control group: P < 0.05 *;**P<0.01;***P<0.001;
Compared with heated 0 day prescription volatilization ointment group :+indicate P < 0.0;++ indicate P < 0.01;+++ indicate P < 0.001.
2.4 experiments discuss
The results show that 0 day prescription volatilization ointment group of being heated is to folium sennae induced mice diarrhea compared with model control group There is apparent inhibiting effect;And 10,15 days prescription volatilization ointment groups of being heated respectively do not have folium sennae induced mice diarrhea Apparent inhibiting effect.The above verification test shows the repeatability of stability Yu drug effect association results, prompts this prescription or similar The stabilisation measure of preparation has pharmacology meaning or clinical meaning.
Two, effect experiment
(1) mouse folium sennae leads to diarrhea model
1, experimental animal and grouping
80 NIH mouse, are provided by Guangdong Medical Lab Animal Center, and SPF grades, Quality of Experimental Animals credit number: SCXK (Guangdong) 2008-0020, male, 18~22g of weight.Feeding environment: 23 2 DEG C of room temperature, relative humidity is 75 10%.80 Mouse is randomly divided into experimental group 1, experimental group 2, experimental group 3, experimental group 4, experimental group 5, experimental group 6, control group and blank group, often Group 10.
2, experimental method
Groups of animals fasting before being administered, while distilled water nursing is given, after 4 hours, weighed weight is simultaneously administered.Wherein, empty White group is only smeared lanolin in the abdomen of NIH mouse by 0.2g/, and controlling application area is 3 ㎝2;Control group is sub- precious medicine company The DINGHUIER QITIE of Group Plc's production;Experimental group 1, experimental group 2, experimental group 3, experimental group 4, experimental group 5, experiment Group 6 only successively smears the ointment of following embodiments 2,3,4,5,6,7 patch and control in the abdomen of NIH mouse by 0.2g/ Application area is 3 ㎝2.After being administered two hours, each group is given folium sennae leachate 0.3mL/10g by the weight of mouse and is filled Stomach.The mouse single cage of stomach-filling is observed, and lower berth blotting paper makees muck counting, is added up muck number every a hour record and is replaced in time How much blotting paper indicates diarrhoea degree with muck, is observed continuously 4 hours.
Above-mentioned folium sennae leachate the preparation method is as follows: take folium sennae medicinal powder 10g (20 mesh), set 200mL measuring bottle In, add 10 times amount distilled water, 90 DEG C impregnate 0.5 hour, filtration, take subsequent filtrate to get.
The experimental data of record is indicated with ± s, is examined using t, carries out statistics using SPSS17.0 software statistics packet Analysis, experimental result is shown in the following table 1.
4 each group of table (n=10) compared with model group antidiarrheal effect
* it infuses, compared with blank group, P < 0.05 indicates significant difference;* P < 0.01 indicates that difference is more significant;***P<0.001 Indicate that difference is extremely significant
3, conclusion
Seen from table 1, the effect of experimental group 1~6 is superior to control group.
(2) writhing analgesic experiment
1, experimental animal and grouping
Ibid.
2, experimental method
Groups of animals fasting before being administered, while distilled water nursing is given, after 10 hours, weighed weight is simultaneously administered.Wherein, empty White group is only smeared lanolin in the abdomen of NIH mouse by 0.2g/, and controlling application area is 3 ㎝2;Control group is sub- precious medicine company The DINGHUIER QITIE of Group Plc's production;Experimental group 1, experimental group 2, experimental group 3, experimental group 4, experimental group 5, experiment Group 6 only successively smears the ointment of following embodiments 2,3,4,5,6,7 navel patch and control in the abdomen of NIH mouse by 0.2g/ Application area is 3 ㎝2.After being administered two hours, 0.5% acetic acid 0.2mL/ is injected intraperitoneally only in each mouse, observes each group in 15min There is the number of writhing response (abdomen indent, stretching, extension hind leg, buttocks are raised) in mouse and the time of writhing occurs in every mouse, counts Calculate the analgesia percentage of each drug.
Analgesia percentage (%)=(blank group writhing response number-experimental group group writhing response number)/blank group writhing React mouse number × 100%.
The experimental data of record is indicated with ± s, is examined using t, carries out statistics using SPSS17.0 software statistics packet Analysis, experimental result is shown in the following table 5.
5 each group of table (n=10) compared with model group analgesic test
* it infuses, compared with blank group, P < 0.05 indicates significant difference;* P < 0.01 indicates that difference is more significant;***P<0.001 Indicate that difference is extremely significant
3, conclusion
By table 5 as it can be seen that the analgesia percentage of experimental group 1~6 can reach 60% or more;From the point of view of writhing number, experiment Group 1~6 all has with blank group extremely significant difference (P < 0.05), while there were significant differences (P < 0.05) with control group;From averagely latent From the point of view of lying prostrate the time, the average latency time of 1~6 writhing animal of experimental group extends nearly 2 times than blank group, and is all larger than control Group.Therefore, the patch of the invention patent preparation has significant inhibitory effect to the pain as caused by acetic acid.
Three, skin irritation and anaphylaxis experiment
It standardizes, is inquired into containing tested according to " Chinese medicine, natural drug local irritation and hemolytic investigative technique guideline " Irritation of 5%, 12.5%, the 20% Chinese medicine compound prescription volatile oil emplastrum of drug to rabbit intact skin;Investigate 12.5% Chinese medicine Anaphylaxis of the compound volatile oil emplastrum to cavy.
1 experimental material
1.1 trial drug
1.1.1 test medicine 5% (g/g) volatilization ointment preparation
Lanolin 9.0g (36-42 DEG C of fusing point) is weighed, 100 DEG C of water-baths, water-bath to molten condition are set, taking-up is put to suitable Temperature (50 DEG C), be added embodiment 1 volatile oil 0.47g, be uniformly mixed, let cool to get.(oil concentration 0.05g/g).
1.1.2 test medicine 12.5% (g/g) volatilization ointment preparation
Lanolin 9.0g (36-42 DEG C of fusing point) is weighed, 100 DEG C of water-baths, water-bath to molten condition are set, taking-up is put to suitable Temperature (50 DEG C), be added embodiment 1 volatile oil 1.29g, be uniformly mixed, let cool to get.(oil concentration 0.125g/g).
1.1.3 test medicine 20% (g/g) volatilization ointment preparation
Lanolin 9.0g (36-42 DEG C of fusing point) is weighed, 100 DEG C of water-baths, water-bath to molten condition are set, taking-up is put to suitable Temperature (50 DEG C), be added embodiment 1 volatile oil 2.25g, be uniformly mixed, let cool to get.(oil concentration 0.20g/g).
1.1.4 check experiment group
2,4- dinitro-chloro-benzene.
1.1.5 blank control group
Lanolin.
1.2 experimental animal
Cavy, weight (220 ± 30) g, half male and half female, Traditional Chinese Medicine University Of Guangzhou's animal experimental center provide SPF grades and move Object;5~8 monthly age health Male New Zealand rabbit, 2.0~2.5Kg of weight are mentioned by Traditional Chinese Medicine University Of Guangzhou's animal experimental center For.
1.3 test apparatus
Pet electric hair cutter, electric shaver, scalpel.
1.4 experimental situation
SPF grades of animal houses of Traditional Chinese Medicine University Of Guangzhou's zoopery environmental facility.
2 experimental methods
The irritant experiment of single and multiple dosing to rabbit intact skin: according to " Chinese medicine, natural drug local irritation With hemolytic investigative technique guideline " specification development.
Cavy anaphylaxis experiment: select weight at 220 ± 3g cavy 9, be divided into 3 groups (n=3) at random, respectively by Try medicine group, positive controls, blank control group.The symmetrical two sides in its back are lost hair or feathers in first 24 hours of test, the every side of area of losing hair or feathers For 3cm × 3cm, and make following test:
(1) sensitization contact: hair removal section on the left of above-mentioned three groups of animals is pasted respectively and whitewashes lanolin 0.2g, containing 12.5% ointment Agent 0.2g and positive sensitizer (1% 2,4- dinitro-chloro-benzene) 0.2mL.Time of contact continues 6 hours, and after administration 7, 14 days above-mentioned administration process of repetition.Wherein with one layer of disinfection oilpaper and two layers of antiseptic gauze covering, glue after positive controls administration Cloth is fixed.
(2) excitation contact: in the sensitization contact stage, 14 days above-mentioned administration process of repetition, medicine-feeding part are the right side after the last administration Side hair removal section, wherein 2, the 4- dinitro-chloro-benzene 0.2mL that positive sensitizer concentration is 1%.Drug is cleaned after excitation 6 hours, At once it observes, then observed cutaneous anaphylaxis again in 24,48,72 hours, according to " Chinese medicine, natural drug immunotoxicity (mistake Quick property, photoallergy) research technological guidance's principle " standards of grading evaluate.
Allergic reaction average value=(erythema forms total score+oedema and forms total score)/total number of animals
Sensitization incidence=animal number of cases/total number of animals of erythema, oedema or systemic anaphylaxis occur
* note: there is the animal number of cases of erythema, oedema or systemic anaphylaxis, no matter answering degree weight.
(3) cutaneous anaphylaxis degree standards of grading are as shown in the following table 6 and table 7:
The standards of grading of 6 cutaneous anaphylaxis degree of table
7 hypersensitive evaluation criterion of table
3 experimental results
3.1 single-dose rabbit intact skin irritation tests
8 intact skin single-dose of table tests dermoreaction integrated value
By table 8 as it can be seen that 5%, 12.5%, the 20% emplastrum single-dose containing volatile oil is 1,24,48 and 72 after removing drug Hour is showed no the tested area of rabbit back intact skin and phenomena such as erythema, oedema occurs.Experimental result prompt, in single-dose man In rabbit intact skin irritation test, test medicine is showed no skin irritation phenomenon.
3.2 multiple dosing rabbit intact skin irritation tests
9 intact skin multiple dosing of table tests dermoreaction average product score value and stimulus intensity
By table 9 as it can be seen that bare substrate and emplastrum containing volatile oil 5%, 12.5% are not in the test of intact skin multiple dosing See irritation, 20% emplastrum containing volatile oil shows recoverable minimal irritation.
The skin hypersensitivity of 3.3 12.5% emplastrums containing volatile oil
It is standardized according to " technological guidance's principle that Chinese medicine, natural drug immunotoxicity (anaphylaxis, photoallergy) are studied ", It inquires into containing 12.5% emplastrum of volatile oil to the skin hypersensitivity of cavy.Experimental result is as follows:
The skin hypersensitivity of 10 test medicine of table is evaluated
The skin hypersensitivity of 11 test medicine of table is evaluated
The results show that during the test, groups of animals does not occur the serious systemics such as asthma, astasia or shock Allergic reaction.Wherein positive controls in 0h, for 24 hours, 48h and 72h sensitivity response mean scores be 1.3,3.7,5 and 6, sensitization rate It is 100%.Blank control group and containing 12.5% volatilization ointment group sensitivity response average mark mean value be all 0, sensitization rate be 0%, Prompt 12.5% emplastrum containing volatile oil has no sensitization to skin.
Conclusion
The volatile oil of embodiment 1 is chosen in this experiment, inquires into 5%, 12.5%, the 20% Chinese medicine compound prescription volatilization containing test medicine Irritation and anaphylaxis of the oily emplastrum to rabbit intact skin.The result shows that bare substrate and containing volatile oil 5%, 12.5% Emplastrum has no irritation, and 20% emplastrum containing volatile oil shows recoverable minimal irritation.It blank control group and is waved containing 12.5% Hair oil paste group sensitivity response average mark mean value is all 0, and sensitization rate is 0%, to skin without sensitization.Animal irritation and allergy Property experiment show that test medicine of the present invention has no irritation and allergic reaction.
Four, clinical effectiveness is investigated
1 general information
150 infants of this group are all from 2012~2013 years infants gone to a doctor to healthcare hospital for women & children.In strict accordance with " Chinese abdomen Rush down disease diagnoses and treatment scheme " diagnostic criteria selection case, wherein male 85, female 65, the age 6~40 months, average 22 Month, 2~30d of the course of disease,
The clinical manifestation of above-mentioned case is that times of defecation is more, and daily 5~15 times, stool is in egg flower water sample or the dilute water of yellow Sample, mostly with mild dehydration, fever, stool routine examination inspection has no pyocyte, phagocyte, and red blood cell, leucocyte are in every visual field 15 hereinafter, blood routine is showed no exception.Patient is randomly divided into control group 1, control group 2 and treatment group, every group 50.Control Group 1 takes traditional treatment method, takes orally the montmorillonite powder of dioctahedral smectite;Control group 2 sticks infant Shenque using DINGHUIER QITIE Cave;Treatment group selects the patch containing following embodiments 1 to stick infant SHENJUE acupoint.Two groups of infants the age, gender, weight, the state of an illness, There was no significant difference for course of disease etc. (P > 0.05), is comparable.
2 treatment methods
Control group 1 only carries out conventional therapy, i.e., adjustment diet, 6~12h of fasting take orally the montmorillonite powder of dioctahedral smectite.Slightly It is dehydrated patient's oral rehydration salts (ORS), middle severe dehydration person vein fluid infusion, correct dehydration and electrolyte disturbance.Control group 2 uses DINGHUIER QITIE sticks infant SHENQUE acupoint, pastes for one time 1, dressing in 24 hours is primary.Treatment group is pasted using the navel of following embodiments 1, One time a day, one time 1 patch, dressing in 24 hours are primary.Three groups as a treatment course with 3d, carries out therapeutic evaluation after a course for the treatment of.Patch Apply during, if occur using uncomfortable situation as umbilical region is rubescent, ulceration, blistering if disable;It avoids pungent food during treatment, seafood, sheep Meat, mushroom etc. send out object.
3 therapeutic evaluatioies
This experiment uses following standard, effective: by the treatment of a course for the treatment of, the daily times of defecation of infant is less than twice, The character of stool and just routine inspection tend to normally, and clinical symptoms completely disappear;It is effective: by the treatment of a course for the treatment of, to suffer from The daily times of defecation of youngster is less than four times, and the character of stool and just routine inspection make moderate progress, and clinical symptoms disappear substantially;Nothing Effect: by the treatment of a course for the treatment of, infant clinical symptoms do not have any improvement exacerbation trend even occur.
4 statistical procedures
Database is established using statistics software SPSS 17.0, by t examine and2It examines and carries out statistical analysis, (P < 0.05) indicate that difference has significant.
5 results
Two groups of Clinical efficacy comparisons are shown in Table 12, and treatment group's total effective rate is 92% (46/50), and 1 total effective rate of control group is 76% (38/50), patient uses uncomfortable situation without appearance during 2 total effective rate of control group is 84% (42/50) and is administered, Two groups of comparing differences are statistically significant (P < 0.05), and treatment group's curative effect is better than control group.The result shows that navel patch of the present invention With significant clinical efficacy.
12 two groups of infant clinical therapeutic efficacies of table compare [example (%)]
* note: compared with the control group: * indicates P < 0.05;Total effective rate=(effective number of cases+effective number of cases)/total number of cases × L00%.
Five, antioxidant is influenced research by thermal stability to Chinese medicine compound volatile oil
1. antioxidant type screening study
1.1 experimental material
1.1.1 the preparation of Chinese medicine compound prescription volatile oil
Fructus amomi, rhizoma atractylodis, cortex cinnamomi and the medicinal powder of cloves are taken, 15 times of amount water is separately added into and impregnates 30 minutes, at 100 DEG C Under the conditions of refluxing extraction;Volatile oil is collected, amomum fruit volatile oil, Rhzoma Atractylodis Lanceae volatile oil, Cortex Cinnamomi volatile oil and cloves volatilization are respectively obtained Oil.Precision weighs amomum fruit volatile oil 5.6g, Rhzoma Atractylodis Lanceae volatile oil 5.7g, Cortex Cinnamomi volatile oil 4.8g, volatile clove oil 7.8g, sets In 100ml brown measuring bottle, be ultrasonically treated 5 minutes, shake up, let cool to get.
1.1.2 the preparation of the emplastrum containing 0.2%VE
It takes 1.1.1 lower prescription volatile oil spare, separately weighs lanolin 45.0g (36-42 DEG C of fusing point), set 60 DEG C of water-baths Pot, water-bath to molten condition, taking-up are put to preference temperature, and VE oil 0.2g (VE content 0.5mg/ is added in volatile oil about 5.0g Mg), it is uniformly mixed, lets cool with matrix.Each 1.5g of paste of group containing VE is taken, is filled in blank patch, seals, is packed with fine aluminium bag, To obtain the final product.(emplastrum is 0.1g/g containing concentration, and VE dosage is the 2% of volatile oil weight)
1.1.3 the preparation of the emplastrum containing 0.2%BHT
It takes 1.1.1 lower prescription volatile oil spare, separately weighs lanolin 45.0g (36-42 DEG C of fusing point), set 60 DEG C of water-baths Pot, water-bath to molten condition, taking-up are put to preference temperature, and BHT0.1g is added in volatile oil about 5.0g, and (2,6- di-t-butyls are to first Phenol), it is uniformly mixed, lets cool with matrix.Each 1.5g of paste of group containing VE is taken, is filled in blank patch, seals, is packed with fine aluminium bag, To obtain the final product.(being 0.1g/g containing concentration, BHT dosage is the 2% of volatile oil weight)
1.1.4 the preparation of the emplastrum containing 0.2%BHA
It takes 1.1.1 lower prescription volatile oil spare, separately weighs lanolin 45g (36-42 DEG C of fusing point), set 60 DEG C of water-baths, To molten condition, taking-up is put to preference temperature for water-bath, and BHA0.1g is added in volatile oil about 5.0g, and (tert-butyl is to hydroxyl fennel Ether), it is uniformly mixed, lets cool with matrix.Each 1.5g of paste of group containing VE is taken, is filled in blank patch, seals, is packed with fine aluminium bag, To obtain the final product.(being 0.1g/g containing concentration, BHA dosage is the 2% of volatile oil weight)
1.2 methods and result
1.2.1 test method
Above-mentioned sample is set in sealing clean container, places 5 days under the conditions of 40 DEG C, 60 DEG C, was taken in 0,3,5 day respectively Sample, measurement calculate These parameters ingredient retention rate.
1.2.2 test solution preparation and measurement
Emplastrum about 0.25g is weighed, it is accurately weighed, it sets in stuffed conical flask, accurate addition methanol 25ml, weighed heavy respectively Amount, ultrasonic 45min is let cool, then weighed weight, and the weight of less loss is supplied with methanol, is shaken up, and is filtered, and takes subsequent filtrate to get for examination Product solution.It is appropriate to draw above-mentioned each test solution, miillpore filter filtration takes subsequent filtrate, as a result hplc determination is seen below Table.
Table 13 does not add the high temperature test result of antioxidant emplastrum
The high temperature test result of 14 emplastrum containing 0.2%VE of table
The high temperature test result of 15 emplastrum containing 0.2%BHT of table
The high temperature test result of 16 emplastrum containing 0.2%BHA of table
1.3 experiments discuss
The results show that compared with the emplastrum that antioxidant is not added, cinnaldehydrum, fourth in 40 DEG C of heated 5 days emplastrums containing VE Fragrant phenol, Atisine chloride Atractydin retention rate slightly above contain BHT emplastrum and emplastrum containing BHA;In heated 5 days emplastrums containing VE of higher temperature 60 C Middle cinnaldehydrum, eugenol, Atisine chloride Atractydin reservation significantly improve, and are significantly higher than emplastrum containing BHT and emplastrum containing BHA, under this condition VE is significantly better than BHT to the protecting effect of index components in emplastrum and containing BHA.Follow-up test further investigates VE pairs of different amounts The protecting effect of index components in emplastrum.
2 antioxidant VE dosages are investigated
2.1 experimental material
2.1.1 the preparation of the emplastrum containing 0.01%VE
It takes 1.1.1 lower prescription volatile oil spare, separately weighs lanolin 45.0g (36-42 DEG C of fusing point), set 60 DEG C of water-baths Pot, water-bath to molten condition, taking-up are put to preference temperature, and VE oil 0.01g (VE content 0.5mg/ is added in volatile oil about 5.0g Mg), it is uniformly mixed, lets cool with matrix.Each 1.5g of paste of group containing VE is taken, is filled in blank patch, seals, is packed with fine aluminium bag, To obtain the final product.(being 0.1g/g containing concentration, VE dosage is the 0.1% of volatile oil weight)
2.1.2 the preparation of the emplastrum containing 0.05%VE
With the preparation of the emplastrum containing 0.01%VE, VE oil 0.05g (VE content 0.5mg/mg) is added in volatile oil about 5.0g, i.e., ?.(being 0.1g/g containing concentration, VE dosage is the 0.5% of volatile oil weight)
2.1.3 the preparation of the emplastrum containing 0.10%VE
With the preparation of the emplastrum containing 0.01%VE, VE oil 0.10g (VE content 0.5mg/mg) is added in volatile oil about 5.0g, i.e., ?.(being 0.1g/g containing concentration, VE dosage is the 1% of volatile oil weight)
2.1.4 the preparation of the emplastrum containing 0.15%VE
With the preparation of the emplastrum containing 0.01%VE, VE oil 0.15g (VE content 0.5mg/mg) is added in volatile oil about 5.0g, i.e., ?.(being 0.1g/g containing concentration, VE dosage is the 1.5% of volatile oil weight)
2.1.5 the preparation of the emplastrum containing 0.3%VE
With the preparation of the emplastrum containing 0.1%VE, VE oil 0.3g (VE content 0.5mg/mg) is added in volatile oil about 5.0g, i.e., ?.(being 0.1g/g containing concentration, VE dosage is the 3% of volatile oil weight)
2.1.6 the preparation of the emplastrum containing 0.6%VE
With the preparation of the emplastrum containing 0.1%VE, VE oil 0.6g (VE content 0.5mg/mg) is added in volatile oil about 5.0g, i.e., ?.(being 0.1g/g containing concentration, VE dosage is the 6% of volatile oil weight)
2.1.7 the preparation of the emplastrum containing 1%VE
With the preparation of the emplastrum containing 0.1%VE, VE oil 1.0g (VE content 0.5mg/mg) is added in volatile oil about 5.0g, i.e., ?.(being 0.1g/g containing concentration, VE dosage is the 10% of volatile oil weight)
2.1.8 the preparation of the emplastrum containing 1.5%VE
With the preparation of the emplastrum containing 0.1%VE, VE oil 1.5g (VE content 0.5mg/mg) is added in volatile oil about 5.0g, i.e., ?.(being 0.1g/g containing concentration, VE dosage is the 15% of volatile oil weight)
2.1.9 the preparation of blank protection emplastrum
It takes 1.1.1 lower prescription volatile oil spare, separately weighs lanolin 45.0g (36-42 DEG C of fusing point), set 60 DEG C of water-baths Pot, water-bath to molten condition, taking-up are put to preference temperature, and volatile oil about 5.0g is added in matrix, is uniformly mixed, lets cool.It takes not Each 1.5g of paste containing antioxidant, fills in blank patch, sealing, with fine aluminium bag pack to get.(being 0.1g/g containing concentration)
2.1.10 DINGHUIER QITIE reagent
20 patches, lot number: 121003
2.2 methods and result
2.2.1 test method
Above-mentioned sample is set in sealing clean container, is placed 5 days under the conditions of 60 DEG C, was sampled in 0,3,5 day, is measured, meter It counts in stating index components retention rate.
2.2.2 test solution preparation and measurement
Emplastrum 0.25g is weighed, it is accurately weighed, it sets in stuffed conical flask, respectively accurate addition methanol 25ml, weighed weight, Ultrasonic 45min, lets cool, then weighed weight, and the weight of less loss is supplied with methanol, is shaken up, and filtration takes subsequent filtrate to get test sample Solution.It is appropriate to draw above-mentioned each test solution, miillpore filter filtration takes subsequent filtrate, as a result hplc determination is seen below Table.
Comparison of the 17 antioxidant VE different amounts of table to the heated protecting effect of cinnaldehydrum
Comparison of the 18 antioxidant VE different amounts of table to the heated protecting effect of eugenol
Comparison of the 19 antioxidant VE different amounts of table to the heated protecting effect of Atisine chloride Atractydin
The results show that compared with the emplastrum without VE, cinnaldehydrum, fourth in 60 DEG C of heated 3,5 days different VE content emplastrums Fragrant phenol, Atisine chloride Atractydin retain preferably, but VE is significantly affected the protecting effect of heterogeneity in emplastrum by VE content, it is excessively high or The too low performance for being unfavorable for VE best protection effect, it is 0.15%~0.3% that wherein cinnaldehydrum, which corresponds to VE dosage in emplastrum, fourth It is 0.1%~2.0% that fragrant phenol, which corresponds to VE dosage in emplastrum, and it is 0.10%~1.5% that Atisine chloride Atractydin, which corresponds to VE dosage in emplastrum, and 60 DEG C of heated 10 days test results shows, are retained containing cinnaldehydrum, eugenol, Atisine chloride Atractydin in 0.15%~0.3%VE emplastrum and are better than Other VE dosage emplastrums.As a result prompt antioxidant VE Optimum (is equivalent to addition volatilization for the 0.15%~0.3% of emplastrum The 1.5%~3.0% of oily weight), cinnaldehydrum, eugenol stability are significantly better than DINGHUIER QITIE in emplastrum.
3. the verifying of preparation stabilization measure: the accelerated stability test containing 0.2%VE, 0.3%VE patch
This research using cinnaldehydrum, eugenol, Atisine chloride Atractydin, Bronyl acetate retention rate as index, using simulation listing packet Dress is fine aluminium bag hermetic package, investigates the accelerated stability containing 0.2%, 0.3%VE patch.
3.1 experimental material
3.1.1 the preparation of the emplastrum containing 0.2%VE
It takes 1.1.1 lower prescription volatile oil spare, separately weighs lanolin 135.0g (36-42 DEG C of fusing point), set 60 DEG C of water-baths Pot, water-bath to molten condition, taking-up are put to preference temperature, and VE powder 0.3g is added in volatile oil about 15.0g, mixes with matrix It is even, it lets cool.Take each 1.5g of paste of group containing VE, fill in blank patch, seal, with fine aluminium bag pack to get.(it is containing concentration 0.1g/g, VE dosage are the 2% of volatile oil weight)
3.1.2 the preparation of the emplastrum containing 0.3%VE
Be added with the preparation of the emplastrum containing 0.2%VE, in volatile oil about 15.0g VE powder 0.45g to get.(it is containing concentration 0.1g/g, VE dosage are the 3% of volatile oil weight)
3.1.3 the preparation of blank protection emplastrum
With the preparation of the emplastrum containing 0.2%VE, be not added in volatile oil about 15.0g VE to get.(it is 0.1g/g containing concentration, Containing VE0%)
3.2 methods and result
3.2.1 test method
Above-mentioned sample is set in sealing clean container, is placed 6 months under the conditions of 30 DEG C, in 0,1,2,3, sampling in June, is surveyed It is fixed, calculate These parameters ingredient retention rate.
3.2.2 test solution preparation and measurement
Emplastrum about 0.25g is weighed, it is accurately weighed, it sets in stuffed conical flask, accurate addition methanol 25ml, weighed heavy respectively Amount, ultrasonic 45min is let cool, then weighed weight, and the weight of less loss is supplied with methanol, is shaken up, and is filtered, and takes subsequent filtrate to get for examination Product solution.It is appropriate to draw above-mentioned each test solution, miillpore filter filtration takes subsequent filtrate, as a result hplc determination is seen below Table.
3.3 experimental results and discussion:
20 accelerated stability test 1 of table, 2,3, retention results in June (cinnaldehydrum, eugenol, Atisine chloride Atractydin)
21 accelerated stability test 1 of table, 2,3, retention results in June (Bronyl acetate)
By cinnaldehydrum, eugenol, rhizoma atractylodis cellulose content in high effective liquid chromatography for measuring different time points preparation, as a result show Show after accelerated test 6 months, cinnaldehydrum in blank protection patch, eugenol, Atisine chloride Atractydin retention rate be respectively 49.9%, 73.6%, 60.1%;In patch containing 0.3%VE cinnaldehydrum, eugenol, Atisine chloride Atractydin retention rate be respectively 68.3%, 89.9%, 78.9%, it is significantly improved.By the content of Bronyl acetate in capillary gas chromatography different time points preparation, As the result is shown after accelerated test June, it is 88.1% that blank, which protects Bronyl acetate in patch, contains 0.2%VE, 0.3%VE Its retention rate is respectively 95.3%, 92.5% in patch, prompts vitamin E significant to Bronyl acetate protective effect in patch. The retention rate of four index components is evaluated by accelerated stability test, in terms of comprehensive, 0.15%~0.30%VE is used in emplastrum Amount (be equivalent to and be added the 1.5%~3.0% of volatile oil weight) is suitable.
Specific embodiment
Embodiment 1 (preparation example of volatile oil)
Medicinal powder (middle powder) each 10kg for weighing fructus amomi, rhizoma atractylodis, cortex cinnamomi and cloves medicine is separately added into 15 times of amount water and impregnates 30 minutes, refluxing extraction under conditions of 100 DEG C;Volatile oil is collected, amomum fruit volatile oil 373.6g, Rhzoma Atractylodis Lanceae volatile oil are respectively obtained 135g, Cortex Cinnamomi volatile oil 212.12g and volatile clove oil 520g.Four kinds of obtained volatile oil seal respectively to be kept in dark place, and supplies Following embodiments 2~7 use.
Embodiment 2
1, prescription: amomum fruit volatile oil 5.6g, Rhzoma Atractylodis Lanceae volatile oil 5.7g, Cortex Cinnamomi volatile oil 4.8g, volatile clove oil 7.8g.This The total weight of four kinds of volatile oil is 23.9g in example.
2, prepare ointment: taking four kinds of volatile oil that the vitamin E of 0.359g is added, (vitamin E dosage is volatile oil weight 1.5%) it is uniformly mixed;Lanolin 215.1g (36-42 DEG C of fusing point) is weighed, is placed in 100 DEG C of water-baths, water-bath to molten condition, Taking-up is put four containing the vitamin E kind volatile oil prepared by being added to 50 DEG C and is uniformly mixed to get ointment.
3, it prepares patch: ointment being coated in the leakage-proof ring of blank plaster while hot by 0.2g/ patch, after cooling, then is covered Upper anti-stick layer, with fine aluminium bag sealing be protected from light pack to get.Wherein, the blank plaster is purchased from Shandong and laughs at health biotechnology Co., Ltd, specification are as follows: empty veneer product is 7cm × 7cm, and the internal diameter of leakage-proof ring is 3.0cm, depth 0.2cm.
Embodiment 3
2, prescription: amomum fruit volatile oil 5.9g, Rhzoma Atractylodis Lanceae volatile oil 5.2g, Cortex Cinnamomi volatile oil 4.6g, volatile clove oil 8.0g.This The total weight of four kinds of volatile oil is 23.7g in example.
2, prepare ointment: taking four kinds of volatile oil that the vitamin E of 0.427g is added, (vitamin E dosage is volatile oil weight 1.8%) it is uniformly mixed;Lanolin 213.3g (36-42 DEG C of fusing point) is weighed, is placed in 100 DEG C of water-baths, water-bath to molten condition, Taking-up is put four containing the vitamin E kind volatile oil prepared by being added to 50 DEG C and is uniformly mixed to get ointment.
3, it prepares patch: ointment being coated in the leakage-proof ring of blank plaster while hot by 0.2g/ patch, after cooling, then is covered Upper anti-stick layer, with fine aluminium bag sealing be protected from light pack to get.Wherein, the blank plaster is purchased from Shandong and laughs at health biotechnology Co., Ltd, specification are as follows: empty veneer product is 7cm × 7cm, and the internal diameter of leakage-proof ring is 3.0cm, depth 0.2cm.
Embodiment 4
1, prescription: amomum fruit volatile oil 5.1g, Rhzoma Atractylodis Lanceae volatile oil 5.5g, Cortex Cinnamomi volatile oil 4.8g, volatile clove oil 8.4g.This The total weight of four kinds of volatile oil is 23.8g in example.
2, prepare ointment: taking four kinds of volatile oil that the vitamin E of 0.476g is added, (vitamin E dosage is volatile oil weight 2%) it is uniformly mixed;Lanolin 214.2g (36-42 DEG C of fusing point) is weighed, 100 DEG C of water-baths are placed in, water-bath to molten condition takes Four containing the vitamin E kind volatile oil prepared by being added to 50 DEG C is put out to be uniformly mixed to get ointment.
3, it prepares patch: ointment being coated in the leakage-proof ring of blank plaster while hot by 0.2g/ patch, after cooling, then is covered Upper anti-stick layer, with fine aluminium bag sealing be protected from light pack to get.Wherein, the blank plaster is purchased from Shandong and laughs at health biotechnology Co., Ltd, specification are as follows: empty veneer product is 7cm × 7cm, and the internal diameter of leakage-proof ring is 3.0cm, depth 0.2cm.
Embodiment 5
1, prescription: amomum fruit volatile oil 5.8g, Rhzoma Atractylodis Lanceae volatile oil 5.9g, Cortex Cinnamomi volatile oil 4.2g, volatile clove oil 7.7g.This The total weight of four kinds of volatile oil is 23.6g in example.
2, prepare ointment: taking four kinds of volatile oil that the vitamin E of 0.543g is added, (vitamin E dosage is volatile oil weight 2.3%) it is uniformly mixed;Lanolin 212.4g (36-42 DEG C of fusing point) is weighed, is placed in 100 DEG C of water-baths, water-bath to molten condition, Taking-up is put four containing the vitamin E kind volatile oil prepared by being added to 50 DEG C and is uniformly mixed to get ointment.
3, it prepares patch: ointment being coated in the leakage-proof ring of blank plaster while hot by 0.2g/ patch, after cooling, then is covered Upper anti-stick layer, with fine aluminium bag sealing be protected from light pack to get.Wherein, the blank plaster is purchased from Shandong and laughs at health biotechnology Co., Ltd, specification are as follows: empty veneer product is 7cm × 7cm, and the internal diameter of leakage-proof ring is 3.0cm, depth 0.2cm.
Embodiment 6
1, prescription: amomum fruit volatile oil 5.5g, Rhzoma Atractylodis Lanceae volatile oil 5.2g, Cortex Cinnamomi volatile oil 5.0g, volatile clove oil 8.1g.This The total weight of four kinds of volatile oil is 23.8g in example.
2, prepare ointment: taking four kinds of volatile oil that the vitamin E of 0.595g is added, (vitamin E dosage is volatile oil weight 2.5%) it is uniformly mixed;Lanolin 214.2g (36-42 DEG C of fusing point) is weighed, is placed in 100 DEG C of water-baths, water-bath to molten condition, Taking-up is put four containing the vitamin E kind volatile oil prepared by being added to 50 DEG C and is uniformly mixed to get ointment.
3, it prepares patch: ointment being coated in the leakage-proof ring of blank plaster while hot by 0.2g/ patch, after cooling, then is covered Upper anti-stick layer, with fine aluminium bag sealing be protected from light pack to get.Wherein, the blank plaster is purchased from Shandong and laughs at health biotechnology Co., Ltd, specification are as follows: empty veneer product is 7cm × 7cm, and the internal diameter of leakage-proof ring is 3.0cm, depth 0.2cm.
Embodiment 7
1, prescription: amomum fruit volatile oil 5.9g, Rhzoma Atractylodis Lanceae volatile oil 5.8g, Cortex Cinnamomi volatile oil 4.6g, volatile clove oil 7.4g.This The total weight of four kinds of volatile oil is 23.7g in example.
2, prepare ointment: taking four kinds of volatile oil that the vitamin E of 0.711g is added, (vitamin E dosage is volatile oil weight 3%) it is uniformly mixed;Lanolin 213.3g (36-42 DEG C of fusing point) is weighed, 100 DEG C of water-baths are placed in, water-bath to molten condition takes Four containing the vitamin E kind volatile oil prepared by being added to 50 DEG C is put out to be uniformly mixed to get ointment.
3, it prepares patch: ointment being coated in the leakage-proof ring of blank plaster while hot by 0.2g/ patch, after cooling, then is covered Upper anti-stick layer, with fine aluminium bag sealing be protected from light pack to get.Wherein, the blank plaster is purchased from Shandong and laughs at health biotechnology Co., Ltd, specification are as follows: empty veneer product is 7cm × 7cm, and the internal diameter of leakage-proof ring is 3.0cm, depth 0.2cm.

Claims (3)

1. a kind of patch for treating baby diarrhea, which includes having the blank plaster of leakage-proof ring and being coated on the leakproof Ointment in circle, the ointment are made of effective component, vitamin E and matrix, wherein
The effective component is made of the volatile oil of following weight percent amount: amomum fruit volatile oil 20.5~25.2%, rhizoma atractylodis are waved Hair oil 20.7~25.2%, Cortex Cinnamomi volatile oil 17.0~21.2%, volatile clove oil 29.1~35.4%;
The volatile oil for forming the effective component is made by following methods: taking fructus amomi, rhizoma atractylodis, cortex cinnamomi and the medicinal material powder of cloves respectively End is added 15 times of amount water and impregnates 30 minutes, refluxing extraction under conditions of 100 DEG C;Volatile oil is collected, fructus amomi volatilization is respectively obtained Oil, Rhzoma Atractylodis Lanceae volatile oil, Cortex Cinnamomi volatile oil and volatile clove oil;
The dosage of the vitamin E is the 1.5%~3.0% of effective component weight;
The matrix is lanolin.
2. a kind of patch for treating baby diarrhea according to claim 1, which is characterized in that the effective component by with The volatile oil of lower weight percent amount forms: amomum fruit volatile oil 23.43%, Rhzoma Atractylodis Lanceae volatile oil 23.85%, Cortex Cinnamomi volatile oil 20.08%, volatile clove oil 32.64%.
3. a kind of patch for treating baby diarrhea according to claim 1 or 2, which is characterized in that the patch is by with lower section Method is made:
(1) it takes the effective component that vitamin E is added and stirs evenly;
(2) matrix is taken, 100 DEG C of water-baths, water-bath to molten condition are placed in, taking-up is put to 50 DEG C, imitates Cheng Fen ︰ base by You Matter=1 ︰ 9 mass ratio is added the effective component containing vitamin E obtained by step (1) and is uniformly mixed, and ointment is made;
(3) ointment is coated on while hot in the leakage-proof ring of blank plaster by the dosage of every patch 0.2g, after cooling, is covered anti-stick Layer to get.
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