CN103251902A - External Chinese medicine for treating infantile digestive diseases as well as preparation method and application of external Chinese medicine - Google Patents
External Chinese medicine for treating infantile digestive diseases as well as preparation method and application of external Chinese medicine Download PDFInfo
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Abstract
The invention discloses an external Chinese medicine for treating infantile digestive diseases as well as a preparation method and application of the external Chinese medicine. The external Chinese medicine is prepared from the following components in percentage by weight: 6-11 percent (4-6g) of cinnamon, 13-23 percent (8-14g) of white pepper, 4-9 percent (3-5g) of clove, 4-9 percent (3-5g) of fructus evodiae, 35-48 percent (22-30g) of fried hawthorn, 12-18 percent (8-10g) of ginger and 12-18 percent (8-10g) of meshed garlic. The preparation method comprises the following steps of: respectively grinding the cinnamon, the white pepper, the clove, the fructus evodiae and the fried hawthorn into fine powder; juicing the ginger and the meshed garlic; then uniformly mixing all the fine powders, adding the ginger and the meshed garlic juice, and uniformly stirring; and then adding a defined amount of Vaseline, beewax, edible oil and the like to prepare ointment pills. The external Chinese medicine has the effects of invigorating spleen and stomach, warming middle-jiao, regulating vital energy, calming adverse-rising energy, preventing vomiting, helping digestion, eliminating dampness, relieving pain, dispelling cold and stopping diarrhea. The external Chinese medicine is suitable for infants suffering from poor digestive ability, retention of food, anorexia, vomit and dyspepsia and is also suitable for infants suffering from functional abdominal pain and non-infectious diarrhea as well as cold and diarrhea symptoms, including diarrhea, abdominal pain, dorborygmus and the like in TCM (Traditional Chinese Medicine) syndrome differentiation.
Description
Technical field
The present invention relates to Chinese medicinal formulae and pharmaceutical field, relate to especially a kind of external application Chinese medicine for the treatment of the digestant for baby disease and its production and use.
Background technology
The digestant for baby disease that the gastrointestinal motility disorder of take is feature, mainly comprise children's functional dyspepsia, functional abdominal pain and noninfectious diarrhea etc., is Pediatric Clinic commonly encountered diseases, frequently-occurring disease.To this modern medicine treatment, also exist obviously puzzled: Western medicine, because significantly untoward reaction and curative effect are very not sure, has limited it in clinical application, the particularly application in department of pediatrics.
The Chinese medicine aspect, have clinically the prescription decoction that the much traditional Chinese medical science is outputed to obtain curative effect, but these decoction are used inconvenience for children's, and medication degree of complying with is not high, lacks relevant hospital preparation and new Chinese medicine.In a word, to the digestant for baby disease, still lack clinically the Chinese medicine preparation that curative effect is sure, easy to use, degree of complying with is high at present.Summary of the invention
The object of the invention is to the puzzlement for current treatment, a kind of Chinese medicine that is used for the treatment of the digestant for baby disease and its production and use is provided, this Chinese medicine not only has invigorating the spleen and stomach, stopping nausea and vomiting by lowering the adverse flow of QI, promoting digestion and removing stagnation effect; And can also regulate the flow of vital energy by warming middle-JIAO, dampness pain relieving, cold expelling antidiarrheal.Be applicable to infantile malnutrition, functional dyspepsia, the empty lack of appetite of body; And children's's noninfectious diarrhea and children's's functional abdominal pain, differential diagnosis in tcm belongs to diarrhea due to wind-cold person, disease opinion is had loose bowels, stomachache, borborygmus etc.
The objective of the invention is to be achieved through the following technical solutions: a kind of external application Chinese medicine for the treatment of the digestant for baby disease, contain percentage by weight and be: Cortex Cinnamomi 6-11%, Radix orixae japonicae 13-23%, Flos Caryophylli 4-9%, Fructus Evodiae 4-9%, Fructus Crataegi (parched) 35-48%, Rhizoma Zingiberis Recens 12-18%, mashed garlic 12-18%.
Described Fructus Crataegi must be Fructus Crataegi (parched).
Route of administration is point-application.
Described acupuncture point is the middle part of gastric cavity, Pishu, tsu san li.
The preparation method of the external application Chinese medicine of described treatment digestant for baby disease, is characterized in that, comprises the following steps:
(1) take material according to mass percent;
(2) get Cortex Cinnamomi, Radix orixae japonicae, Flos Caryophylli, Fructus Evodiae, Fructus Crataegi (parched), in medicinal material pulverizer, break into 100 purpose fine powders, each medicated powder is merged, mix, standby;
(3) get Rhizoma Zingiberis Recens, Bulbus Allii, the water gaging such as add and enter in juice extractor to squeeze the juice, the elimination residue, squeezeding juice is standby;
(4) get above-mentioned Cortex Cinnamomi, Radix orixae japonicae, Flos Caryophylli, Fructus Evodiae, Fructus Crataegi (parched) mixed powder, add Rhizoma Zingiberis Recens and Bulbus Allii squeezeding juice, stir, obtain mixture, standby;
(5) quality of setting said mixture is 100 parts, as benchmark, adds 5 parts of vaseline, 1 part of Cera Flava and 0.5 part of edible oil in mixture, after being uniformly mixed, by pellet processing machine, makes the pill of diameter 1.0-1.2cm.
In described step (2), described medicated powder must be crossed 100 mesh sieves, and in described step (3), Rhizoma Zingiberis Recens Bulbus Allii squeezeding juice must standing rear filtration.
The purposes of the external application Chinese medicine of described treatment digestant for baby disease, a little less than being used for the treatment of the digestant for baby function, easily food stagnation, anorexia, vomiting, dyspepsia and functional abdominal pain, noninfectious diarrhea.
Described purposes, route of administration is point-application.
The invention has the beneficial effects as follows: the external application Chinese medicine for the treatment of digestant for baby disease of the present invention can invigorating the spleen and stomach, stopping nausea and vomiting by lowering the adverse flow of QI, and promoting digestion and removing stagnation, be applicable to treat infantile malnutrition, functional dyspepsia, the empty lack of appetite of body; Can regulate the flow of vital energy by warming middle-JIAO again, cold expelling antidiarrheal, be applicable to children's's noninfectious diarrhea, differential diagnosis in tcm belongs to diarrhea due to wind-cold person, and disease opinion is had loose bowels, stomachache, borborygmus etc.
The accompanying drawing explanation
Fig. 1 treats the external application Chinese medicine of digestant for baby disease to the figure as a result that affects in the body guinea pig ileum.
Fig. 2 is affect the as a result figure of the external application Chinese medicine for the treatment of digestant for baby disease on cholinergic pathway flesh bar.
Fig. 3 is affect the as a result figure of the external application Chinese medicine for the treatment of digestant for baby disease on the motion of rat in vivo stomach.
The specific embodiment
Chinese medicine uses determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs to carry out the treatment of digestant for baby disease, has accumulated more experience.Relate to according to statistics Chinese medicine tens flavors, we sum up according to TCM Document data and clinical practice, utilize the modern pharmacology method, have developed the external application Chinese medicine that stable curative effect is treated the digestant for baby disease reliably, and the applicant is by its called after: infant spleen-tonifying cream.
The present invention treats the Chinese medicine of digestant for baby disease, raw medicinal material and the mass percent thereof of its active ingredient are as follows: Cortex Cinnamomi 6-11%, Radix orixae japonicae 13-23%, Flos Caryophylli 4-9%, Fructus Evodiae 4-9%, Fructus Crataegi (parched) 35-48%, Rhizoma Zingiberis Recens 12-18%, mashed garlic 12-18%, and such as being respectively Cortex Cinnamomi 4-6 grams, Radix orixae japonicae 8-14 grams, Flos Caryophylli 3-5 grams, Fructus Evodiae 3-5 grams, Fructus Crataegi (parched) 22-30 grams, Rhizoma Zingiberis Recens 8-10 grams, mashed garlic 8-10 grams.According to the above-mentioned raw materials medical material, can make the multiple dosage form on pharmaceutics, as pill, unguentum or ointment etc.
The preparation method that the present invention treats the Chinese medicine of digestant for baby disease comprises the following steps:
(1) according to mass percent Cortex Cinnamomi 6-11%(4-6 gram), Radix orixae japonicae 13-23%(8-14 gram), Flos Caryophylli 4-9%(3-5 gram), Fructus Evodiae 4-9%(3-5 gram), Fructus Crataegi (parched) 35-48%(22-30 gram), Rhizoma Zingiberis Recens 12-18%(8-10 gram), mashed garlic 12-18%(8-10 gram) take material.
(2) get Cortex Cinnamomi, Radix orixae japonicae, Flos Caryophylli, Fructus Evodiae, Fructus Crataegi (parched), in medicinal material pulverizer, break into 100 purpose fine powders, each medicated powder is merged, mix, standby;
(3) get Rhizoma Zingiberis Recens, Bulbus Allii, the water gaging such as add and enter in juice extractor to squeeze the juice, the elimination residue, squeezeding juice is standby;
(4) get above-mentioned Cortex Cinnamomi, Radix orixae japonicae, Flos Caryophylli, Fructus Evodiae, Fructus Crataegi (parched) medicated powder, add Rhizoma Zingiberis Recens and Bulbus Allii squeezeding juice to stir, obtain mixture, standby.
(5) quality of setting said mixture is 100 parts, as benchmark, adds 5 parts of vaseline, 1 part of Cera Flava and 0.5 part of edible oil in mixture, after being uniformly mixed, by pellet processing machine, makes the pill of diameter 1.0-1.2cm.
Below by embodiment and the pharmacological results, the invention will be further described.
Embodiment mono-
Get Cortex Cinnamomi 40 grams, Radix orixae japonicae 80 grams, Flos Caryophylli 30 grams, Fructus Evodiae 30 grams, Fructus Crataegi (parched) 220 grams, respectively above-mentioned medical material is broken in pulverizer to 100 purpose fine powders, then merge each medicated powder, mix, standby; Get ginger slice 80 grams, mashed garlic 80 grams, the water gaging such as add and enter in juice extractor to squeeze the juice, the elimination residue, obtain squeezeding juice, standby; Get above-mentioned mixed powder, add Rhizoma Zingiberis Recens and Bulbus Allii squeezeding juice to stir, obtain mixture.Setting mixture quality is 100 parts, as benchmark, adds 5 parts of vaseline, 1 part of Cera Flava and 0.5 part of edible oil, with the mixed powder mixing and stirring, by pellet processing machine, makes the pill of diameter 1.0-1.2cm, obtains infant spleen-tonifying pill of the present invention.
Embodiment bis-
Get Cortex Cinnamomi 60 grams, Radix orixae japonicae 140 grams, Flos Caryophylli 50 grams, Fructus Evodiae 50 grams, Fructus Crataegi (parched) 300 grams, respectively above-mentioned medical material is broken in pulverizer to 100 purpose fine powders, then merge each medicated powder, mix, standby; Get ginger slice 100 grams, mashed garlic 100 grams, the water gaging such as add and enter in juice extractor to squeeze the juice, the elimination residue, obtain squeezeding juice, standby; Get above-mentioned mixed powder, add Rhizoma Zingiberis Recens and Bulbus Allii squeezeding juice to stir, obtain mixture.The quality of setting mixture is 100 parts, as benchmark, adds 5 parts of vaseline, 1 part of Cera Flava and 0.5 part of edible oil, with the mixed powder mixing and stirring, by pellet processing machine, makes the pill of diameter 1.0-1.2cm, obtains infant spleen-tonifying pill of the present invention.
Embodiment tri-
Get Cortex Cinnamomi 50 grams, Radix orixae japonicae 110, Flos Caryophylli 40 grams, Fructus Evodiae 40 grams, Fructus Crataegi (parched) 260 grams, respectively above-mentioned medical material is broken in pulverizer to 100 purpose fine powders, then merge each medicated powder, mix, standby; Get ginger slice 90 grams, mashed garlic 90 grams, the water gaging such as add and enter in juice extractor to squeeze the juice, the elimination residue, obtain squeezeding juice, standby; Get above-mentioned mixed powder, add Rhizoma Zingiberis Recens and Bulbus Allii squeezeding juice to stir, obtain mixture.Setting the quality of mixing medicine is 100 parts, as benchmark, adds 5 parts of vaseline, 1 part of Cera Flava and 0.5 part of edible oil, with the mixed powder mixing and stirring, by pellet processing machine, makes the pill of diameter 1.0-1.2cm, obtains infant spleen-tonifying pill of the present invention.
Embodiment tetra-
Get Cortex Cinnamomi 40 grams, Radix orixae japonicae 80, Flos Caryophylli 30 grams, Fructus Evodiae 30 grams, Fructus Crataegi (parched) 300 grams, respectively above-mentioned medical material is broken in pulverizer to 100 order fine powders, then merge each medicated powder, mix, standby; Get ginger slice 80 grams, mashed garlic 80 grams, the water gaging such as add and enter in juice extractor to squeeze the juice, the elimination residue, obtain squeezeding juice, standby; Get above-mentioned mixed powder, add Rhizoma Zingiberis Recens and Bulbus Allii squeezeding juice to stir, obtain mixture.The quality of setting mixture is 100 parts, as benchmark, adds 5 parts of vaseline, 1 part of Cera Flava and 0.5 part of edible oil, with the mixed powder mixing and stirring, by pellet processing machine, makes the pill of diameter 1.0-1.2cm, obtains infant spleen-tonifying pill of the present invention.
Embodiment five
Get Cortex Cinnamomi 60 grams, Radix orixae japonicae 140, Flos Caryophylli 50 grams, Fructus Evodiae 50 grams, Fructus Crataegi (parched) 220 grams, respectively above-mentioned medical material is broken into to fine powder in pulverizer, then merge each medicated powder, mix, standby; Get ginger slice 90 grams, mashed garlic 90 grams again, the water gaging such as add and enter in juice extractor to squeeze the juice, the elimination residue, obtain squeezeding juice, standby; Get the mixed powder of above-mentioned Cortex Cinnamomi, Radix orixae japonicae, Flos Caryophylli, Fructus Evodiae, Fructus Crataegi (parched), add Rhizoma Zingiberis Recens and Bulbus Allii squeezeding juice to stir, obtain mixture.Setting described amount is 100 parts, as benchmark, adds 5 parts of vaseline, 1 part of Cera Flava and 0.5 part of edible oil, with the mixed powder mixing and stirring, by pellet processing machine, makes the pill of diameter 1.0-1.2cm, obtains infant spleen-tonifying pill of the present invention.
The present invention is to provide a kind of Chinese medicine for the treatment of digestant for baby disease.For proving its therapeutic effect and safety, the ointment that the method that the inventor uses to be provided in above-described embodiment prepares has carried out the relevant test of pesticide effectiveness and safety testing.
Embodiment six
(1) on the impact in the body guinea pig ileum
1.1 the external application Chinese medicine of Drug therapy digestant for baby disease, provided lot number 20120918 by Zhejiang Province Li Tongde hospital.Facing the used time prepares with deionized water.
1.2 animal regular grade Cavia porcellus, male and female half and half, 250-300g, Zhejiang Academy of Medical Sciences provides, the quality certification number: SCXK(Zhejiang) 2009-0005;
1.3 reagent Ke Shi nutrient composition (gL
-1): NaCl5.54, KCl0.35, KH
2pO
40.16, MgSO
47H
2o0.29, NaHCO
32.1, CaCl
20.28, C
6h
12o
62.1, with deionized water, prepare.CaCl wherein
2first with after deionized water dissolving with other aqueous solution, C
6h
12o
6add before nutritional solution is used and dissolve preparation.All reagent is analytical pure.Ethylurethanm (group of nations's chemical reagent company limited, lot number: T20080917), with deionized water, be mixed with 20% aqueous solution.
1.4 instrument super constant temperature water tank 501S type (Shanghai leap medical apparatus and instruments factory); MD2000U Super Lab leads the biological signal collecting analytical system more, the electric institute product of the doctor of Jiangsu BME association.
2 methods
Guinea pig intraperitoneal injection 20% Ethylurethanm 0.8ml100g
-1anaesthetized.Open abdomen in abdominal part and expose gastrointestinal, choose one section ileum of 4cm left and right, peel off the ileum surface fat, the ileum two ends are fixed with cord, keep its normal contraction state, the cord other end lies on the CFS-1J transducer, connects the four-way monitor, records contractile motion.Apply (the calibration: input 2g tension force) of 2g preload to ileum, after stablizing 10-15s, take off load, to trace line and be adjusted to the 2g left and right, after shrinking steady 1-2min, add 40 μ L medicines on ileum, record again 1-2min after it is stable, remove pressure, cleaned to recovering the front state of dosing with 37 ℃ of normal saline.After the observation dosing, guinea pig ileum is shunk situation.
3 results
As shown in Figure 1, the external application Chinese medicine for the treatment of digestant for baby disease can obviously promote the motion of Cavia porcellus at the body ileum.Embodiment seven
Impact on cholinergic pathway flesh bar
1 material
1.1 the external application Chinese medicine of Drug therapy digestant for baby disease, provided lot number 20120918 by Zhejiang Province Li Tongde hospital.Facing the used time prepares with deionized water.
1.2 the clean level of animal SD rat, male and female half and half, 180-220g, Zhejiang Academy of Medical Sciences provides, the quality certification number: SCXK(Zhejiang) 2008-0033.
1.3 reagent Ke Shi nutrient composition (gL
-1): NaCl5.54, KCl0.35, KH
2pO
40.16, MgSO
47H
2o0.29, NaHCO
32.1, CaCl
20.28, C
6h
12o
62.1, with deionized water, prepare.CaCl wherein
2first with after deionized water dissolving with other aqueous solution, C
6h
12o
6add before nutritional solution is used and dissolve preparation.All reagent is analytical pure.
1.4 instrument CFS-1J tension force sensing (transducing) device (Bengbu city match English electronic technology institute); The electric institute of the doctor of MD2000U Super Lab.(Jiangsu BME association); Super constant temperature water tank 501S type (Shanghai leap medical apparatus and instruments factory).
2 methods
The SD rat is fasting 24h before experiment, and drinking-water is not limit.Its head of thumping during experiment is lethal, cuts open the belly and gets stomach along ventrimeson immediately, inserts in oxygen-saturated Ke Shi nutritional solution.Open stomach along greater gastric curvature, with krebs solution, rinse gastric content, remove gastric mucosa.Along perpendicular to stomach long axis direction clip, obtaining the ring muscle bar, along stomach long axis direction clip, obtain vertical shape flesh at the bottom of stomach.At the bottom of stomach, position cuts long 8mm, wide 2mm flesh bar, and by the threading ligation of stomach smooth muscle two ends, an end lies on the ventilation hook, puts down gently in the logical oxygen bath of constant temperature, and the other end lies on the CFS-1J transducer, connects the four-way monitor, records flesh bar contractile motion.It is 20mL that bath is filled with liquid, 37 ± 0.5 ℃ of temperature, and aeration regulation speed is that 1-2 bubble appears in per second, and stomach flesh bar is starting to test preincubation 1h, and every 20min changes 37 ℃ of gram formula liquid.Apply (the calibration: input 1g tension force) of 1g preload to stomach flesh bar, after stablizing 10-15s, take off load, to trace line and be adjusted to the 1g left and right, shrink steady 2-3min, add 40 μ L pharmaceutical aqueous solutions, after it is stable, record again 2-3min, remove pressure, stomach flesh bar is cleaned to recovering the front state of dosing with 37 ℃ of Ke Shi nutritional solutions.Observe stomach flesh bar and shrink situation.
3 results
As shown in Figure 2, the external application Chinese medicine for the treatment of digestant for baby disease can obviously promote the Spontaneous Contraction activity of rat isolated stomach flesh bar, and presents dosage correlation preferably.
Embodiment eight
Impact on the motion of rat in vivo stomach
1 material
1.1 the external application Chinese medicine of Drug therapy digestant for baby disease, provided lot number 20120918 by Zhejiang Province Li Tongde hospital.Facing the used time prepares with deionized water.
1.2 the clean level of animal SD rat, male and female half and half, 180-220g, Zhejiang Academy of Medical Sciences provides, the quality certification number: SCXK(Zhejiang) 2008-0033.
1.3 reagent Ke Shi nutrient composition (gL
-1): NaCl5.54, KCl0.35, KH
2pO
40.16, MgSO
47H
2o0.29, NaHCO
32.1, CaCl
20.28, C
6h
12o
62.1, with deionized water, prepare.CaCl wherein
2first with after deionized water dissolving with other aqueous solution, C
6h
12o
6add before nutritional solution is used and dissolve preparation.All reagent is analytical pure.Ethylurethanm (group of nations's chemical reagent company limited, lot number: T20080917), with deionized water, be mixed with 20% aqueous solution.
1.4 instrument super constant temperature water tank 501S type (Shanghai leap medical apparatus and instruments factory); MD2000U Super Lab leads the biological signal collecting analytical system more, the electric institute product of the doctor of Jiangsu BME association.
2, method
SD rats by intraperitoneal injection 20% Ethylurethanm 0.75ml100g
-1anaesthetized.Open abdomen in abdominal part and expose stomach, peel off stomach surface fat, the stomach two ends are fixed with cord, at the bottom of stomach, position ties whole stomach with cord, keeps stomach normal contraction state, and the cord other end lies on the CFS-1J transducer, connects the four-way monitor, records contractile motion.Apply (the calibration: input 2g tension force) of 2g preload to stomach flesh, after stablizing 10-15s, take off load, to trace line and be adjusted to the 2g left and right, after shrinking steady 1-2min, add 40 μ L medicines on stomach flesh, record again 1-2min after it is stable, remove pressure, cleaned to recovering the front state of dosing with 37 ℃ of normal saline.After the observation dosing, rat stomach flesh shrinks situation.
3 results
As shown in Figure 3, the external application Chinese medicine for the treatment of digestant for baby disease can obviously promote the motion of rat at the body stomach.
Embodiment nine
The antiinflammatory action of the external application Chinese medicine for the treatment of digestant for baby disease
50 of ICR mices, male and female half and half, be divided into 5 groups at random, presses the listed medicine of table 1 and dosage every day in mice left and right ear coating once, continuously coating is three days, after last coating 30 minutes by dimethylbenzene 0.02ml with polishing 4(1/2) number syringe needle evenly is coated with in two sides, every Mus auris dextra front and back.After 15 minutes, by sacrifice of animal, with diameter 8mm belt puncher, the mice ears are cut with the position homalographic, electronic balance (1mg) is weighed.Every Mus auris dextra sheet weight deducts left auricle weight and calculates swelling.The results are shown in Table 1.
The external application Chinese medicine xylol of table 1 treatment digestant for baby disease causes the impact of ear swelling
Compare *: P<0.005 with matched group; *: P<0.01; * *: P<0.001
Result shows: the big or middle dosage of external application Chinese medicine for the treatment of digestant for baby disease can resist dimethylbenzene induced mice ear swelling under this experiment condition, has certain antiinflammatory action.
Embodiment ten
The analgesic activity of the external application Chinese medicine for the treatment of digestant for baby disease
110 of ICR mices, female, body weight 20 ± 2g.(mice is put hot plate and licks the metapedes time to starting first on the hot plate of 55 ℃, to measure the mice pain response time before experiment, in second, the mice that jumps in 10 seconds or still do not jump after 30 seconds is discarded), select the pain reaction time the 13-30 mice of second, be divided at random 5 groups according to the pain reaction time.Second day is pressed the listed medicine of table 2 and the dosage two metapedes coatings mice, morphine hydrochloride group subcutaneous injection 0.01ml/10g, and matched group is coated with the equal-volume ointment base.Each mice was put to hot plate again in after administration 30 minutes, observes the pain reaction time of mice, surpass 60 seconds by 60 seconds.The results are shown in Table 2.
The analgesic activity (hot plate method) of the external application Chinese medicine of table 2 treatment digestant for baby disease to mice
Compare with matched group, check through t: * * * P<0.001, * P<0.05
Result shows: the external application Chinese medicine for the treatment of digestant for baby disease can obviously extend the mice pain response time, illustrates that the external application Chinese medicine for the treatment of digestant for baby disease has certain analgesic activity.
Embodiment 11
The anti-diarrhea effect of the external application Chinese medicine for the treatment of digestant for baby disease
60 of ICR mices, male and female half and half, body weight 20 ± 2g, be divided into 5 groups at random.The external application Chinese medicine group for the treatment of digestant for baby disease by the listed dosage of table 3 every day in Mouse Stomach abdominal part (in advance hair being shaved only) coating once, continuous coating three days; Positive group gives ethenzamide by table 3 dosage gavage every day, continuous three days.After last coating 30 minutes, every mouse stomach gives Folium Sennae 0.4g, then be placed in the plastic casing that is lined with diameter 20cm blank sheet of paper mice is single, changed packing paper every 1 hour, observe altogether the soft stool grain number (diarrhoea number of times) of statistics mice day part and the number (Incidence of Diarrhea) of every group of diarrhea mice 4 hours.The results are shown in Table 3.
The impact of the external application Chinese medicine of table 3 treatment digestant for baby disease on the mice medicamentosus diarrhea
Compare with matched group, check through t: * * * P<0.001, * P<0.05
From table 3, the external application Chinese medicine of heavy dose for the treatment of digestant for baby disease causes diarrhea of mouse to Folium Sennae and has antagonism preferably, and the external application Chinese medicine of middle dosage treatment digestant for baby disease also has certain effect to this.
Embodiment 12
One, the irritation test of the external application Chinese medicine for the treatment of digestant for baby disease to skin
1 material
1.1 animal
Adult healthy is without hindering albino guinea-pig, male and female half and half, and body weight 300～330g, Zhejiang Province's Experimental Animal Center provides, the quality certification number: SCXK (Zhejiang) 2009-0005.
1.2 medicine
Infant spleen-tonifying cream external preparation, provided lot number 20120918 by Zhejiang Province Li Tongde hospital.Excipient, aliquot adjuvant vaseline (5 parts), Cera Flava (1 part) and edible oil (0.5 part) in infant spleen-tonifying cream prescription form.
2 methods
2.1 single coating irritation test
Adopt consubstantiality left and right self-contrast, be divided at random intact skin group and damaged skin group, every group of 6 Cavia porcelluss, male and female half and half.Before test, 24h shaves hair by Cavia porcellus spinal column both sides, every lateral area 4cm * 5cm, the making of damaged skin is by after the Cavia porcellus unhairing, by after both sides skin (unhairing place) sterilization, with the sterile surgical cutter, makes well stroke broken skin skin, the long 2cm of edge of a knife left and right, take oozing of blood as degree, and the damaged degree of left and right sides skin should be basically identical, and left dorsal is coated with infant spleen-tonifying cream, the right side back of the body is coated with excipient, every Cavia porcellus sub-cage rearing.Clean medicine and excipient with warm water after 24h after coating, respectively at 1,24,48, Continuous Observation record the coating position and have or not the situations such as erythema and edema after 72 hours, marked and calculated respectively average response score value of each group by table 4, table 5, makes the zest intensity evaluation.
2.2 many coating irritation tests
Adopt consubstantiality left and right self-contrast, be divided at random intact skin group and damaged skin group, every group of 6 Cavia porcelluss, male and female half and half.Before test, 24h shaves hair, makes damaged skin with single coating irritation test.Left dorsal is coated with infant spleen-tonifying cream, and the right side back of the body is coated with excipient, every twice-daily, every Cavia porcellus sub-cage rearing.Continuous use 8 days, 24h after the last coating, clean medicine and excipient with warm water, respectively at 1,24,48, Continuous Observation record the coating position and have or not the situations such as erythema and edema after 72 hours, marked and calculated respectively average response score value of each group by table 4, table 5, makes the zest intensity evaluation.After this continue to observe 7 days.
Table 4 skin irritation reaction standards of grading
| Irritant reaction (erythema) | Score value | Irritant reaction (edema) | Score value |
| Without erythema | 0 | Without edema | 0 |
| Visible reluctantly | 1 | Visible reluctantly | 1 |
| Obviously visible | 2 | Visible (the high surrounding skin in edge) | 2 |
| Moderate is to serious erythema | 3 | The about 1mm of cutaneous protuberance, clear-cut | 3 |
| The aubergine erythema also has eschar to form | 4 | The above also expanded range of edema protuberance 1mm | 4 |
Table 5 skin irritation intensity evaluation standard
| Mean scores | Estimate | Mean scores | Estimate |
| 0-0.49 | Nonirritant | 3.0-5.99 | The moderate zest |
| 0.5-2.99 | Slight zest | 6.0-8.0 | Strong and stimulating |
3 results
After the single coating stimulates, the intact skin of Cavia porcellus and damaged skin position are showed no erythema and edema, and each irritant reaction mean scores of organizing each different time points in 1-72h is 0.
After repeatedly coating stimulates, the intact skin of Cavia porcellus and damaged skin position have respectively 2 Cavia porcelluss slight erythema to occur, and the average response score value of 1h is 0.45, but recover gradually subsequently, and after 48h, the average response score value is 0.The results are shown in Table 6.
Table 6 multiple dosing is to guinea pig skin irritant experiment result (n=6)
4 brief summaries
The experimental result demonstration, the complete and damaged skin of single medication Cavia porcellus is showed no the irritant reaction such as erythema, edema; Continuous use 8 days, agents area also has no the irritant reaction such as obvious erythema, edema, after this observe again 7 days each Cavia porcelluss all healthy harmless, skin irritation reaction mean scores is less than 0.49, according to " new Chinese medicine preclinical study guideline is about the irritation test evaluation criterion ", belong to the nonirritant rank.Show infant spleen-tonifying cream to the complete and damaged skin of Cavia porcellus all without obvious irritation.
Embodiment 13
The external application Chinese medicine for the treatment of digestant for baby disease is investigated the anaphylaxis of skin
1 material
1.1 animal
The clean level of ICR mice, 130, male and female half and half, body weight 18～22g, Zhejiang Province's Experimental Animal Center provides, the quality certification number: SCXK (Zhejiang) 2008-0033.
1.2 medicine and reagent
The external application Chinese medicine external preparation for the treatment of digestant for baby disease, provided lot number 20120918 by Zhejiang Province Li Tongde hospital.DNFB (north, Tianjin connection fine chemicals development corporation, Ltd., lot number: 20100913); Acetone (Nanjing Chemistry Reagent Co., Ltd., lot number: 080710502); Olive oil (Shanghai Ling Feng chemical reagent company limited, lot number: 091216); Sodium sulfide (Nanjing Chemistry Reagent Co., Ltd., lot number: 10030520096); The IL-4 enzyme-linked immunosorbent assay (ELISA) kit; IFN-γ enzyme-linked immunosorbent assay (ELISA) kit; The SIL-2R enzyme-linked immunologic detecting kit, all build up bio-engineering research institute purchased from Nanjing.
1.3 instrument
PB60-2E type electronic balance (prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit instrument Shanghai company limited); TDL-5-A type centrifuge (manufacture of Shanghai City An Ting scientific instrument factory); Calibrator (Guanglu Digital Measure-Control Co., Ltd., Guilin); Labsystems Finnpipette100 μ l single track pipettor; Thermo50 μ l8 road pipettor, HH-4 digital display thermostat water bath (state China Electrical Appliances Co., Ltd), East China Electronics Co., Ltd DG5033A microplate reader (Nanjing Huadong Electronic Group Medical Equipment LLC); Blender (Shanghai Sample Model Factory's manufacture); Play glue cylinder (China North Industries Group Corporation); Coating device (Guangzhou Sheng Hua chemical industry company limited).
2 methods
2.1 animal grouping
50 ICR mices are divided into to 5 groups at random by the table of random number method, 10 every group; Be respectively: matched group (normal saline); The external application Chinese medicine for the treatment of digestant for baby disease, be divided into low dose, middle dosage, heavy dose of three groups, is mixed with suitable concn with normal saline respectively; Positive group (DNFB, with the acetone of 4:1: olive oil is made into 0.5%, 0.2% two kind of concentration, is used separately as positive sensitization and the positive and excites, now with the current).
2.2 experimentation
The foundation of mouse model: 1d before experiment, mouse web portion loses hair or feathers with 8% sodium sulfide solution, and the about 3cm * 3cm of scope notes not damaging epidermis, then, with normal saline, fully cleans.
Sensitization contact: positive group mice is coated with 0.5%2,4-dinitrochlorobenzene (DNCB) solution, 50 μ l in abdominal part depilation district and is induced sensitization; Each dosage group of external application Chinese medicine for the treatment of digestant for baby disease is coated with respectively the medicinal liquid that is equivalent to 1.0ml, and covers with one deck oilpaper and two layers of gauze, then with non-stimulated adhesive plaster sealing, fixing; The blank group is coated with the 1.0ml normal saline.Within the 2nd day, repeat above operation, strengthen 1 time.
Excite contact: test the 7th day, positive group is applied to the right side of mice ear outward with 0.2%DNCB25 μ l and is excited, and the administration group respectively is coated with the 0.5ml medicinal liquid, and matched group is coated with normal saline 0.5ml in right ear.After 48h, extract after eyeball is got blood and put to death whole mices.
2.3 index determining
2.3.1 the thickness difference of ear is cut the left and right auricle after putting to death mice immediately, measures the thickness at mouse ear middle part with calibrator, calculates left and right ear thickness difference.
2.3.2 the weight difference of ear is by the mice left and right auricle of cutting, with the metal card punch of 0.6 ㎝.In the punching of left and right ear middle part, get the ear tissue of formed objects, use scales/electronic balance weighing, calculate left and right ear weight difference.
2.3.3 the mensuration of cytokine and cytokine receptor adopts euzymelinked immunosorbent assay (ELISA) (ELISA) to detect, and operates in strict accordance with the test kit description.Adopt the eyeball excise method to get blood 10 mices of each group, after whole blood is centrifugal, get serum, measure IL-4, IFN-r and sIF-2R content in serum.
3 results
The date processing data mean with X ± S, with SPSS13.0 software, carry out statistical analysis, relatively adopt the t check between group.The results are shown in Table 1, table 2.
Table 1 is respectively organized mouse ear weight difference, thickness difference (X ± S)
Annotate: with matched group, compare: * * P<0.01
Table 2 is respectively organized IL-4 in mice serum, IFN-γ, sIL-2R content relatively (X ± S, pg/mL)
Annotate: with matched group, compare: * * P<0.01
From table 1,2, with control group mice, compare, positive group mice left and right ear thickness difference, weight difference obviously increase, and the decline of Cytokine of Serum IL-4 level, IFN-γ and sIL-2R level raise, and data have significant difference.This result shows, environmental stimuli causes when mice is irritated, and mice left and right ear thickness difference, weight difference increase, and Cytokine of Serum IL-4 level descends, IFN-γ and sIL-2R level raise, consistent with bibliographical information.With control group mice, compare, each dosage group mice left and right ear thickness difference of external application Chinese medicine, the weight difference for the treatment of digestant for baby disease slightly have increase, but there was no significant difference; Cytokine of Serum IL-4, IFN-γ and sIL-2R level difference are also not obvious, and the potential sensitization of external application Chinese medicine that shows to treat the digestant for baby disease is lower.
Embodiment 14
Long term toxicity test to rabbit
1 material
1.1 the external application Chinese medicine of Drug therapy digestant for baby disease, provided lot number 20120918 by Zhejiang Province Li Tongde hospital.Facing the used time prepares with deionized water.
1.2 the animal new zealand white rabbit, regular grade, body weight 2.2-2.4kg, ♀, ♂ half and half, the animal quality certification number: SCXK(Zhejiang) 2009-0039 is provided by Zhejiang Province's medical experiment animal center.Animal subject skin smooth, not damaged, without dermatosis.
1.3 instrument ZY-10 pedometer (Wuxi weighing apparatus factory), T-200 electronic balance (Changshu two outstanding test instrunment factory), CX5 automatic clinical chemistry analyzer (U.S. Beckman company).Sysmex XS-800i Automatic Blood Cell Analyzer (Japanese East Asia company).
2 methods and result
2.1 the instrument method is selected 24 of adult healthy rabbit, by the sex body weight, is divided at random 4 groups, 6 every group.4 groups is respectively external application Chinese medicine high dose group (the 40g crude drug 100ml of matched group (distilled water) and treatment digestant for baby disease
-1), middle dosage group (20g crude drug 100ml
-1), low dose group (10g crude drug 100ml
-1).Before experiment, 24h forms 50cm by back part of animal with 6% sodium sulfide depilation
2the depilation district, evenly smear respectively every of medicinal liquid 2ml time
-1, after coating, with gauze, covering, the nonirritant immobilization with adhesive tape, wash away residue with warm water after 6h.Continuous 28d.The feed of observed and recorded rabbit, activity, skin and the ordinary circumstances such as mucosa, defecation at any time.Within the 1st week, weigh twice, claim weekly 1 time later.24h after the last administration, randomly draw the blood sampling of 4 Rabbit Hearts for every group, does blood and biochemical analysis, puts to death subsequently, cores, the internal organs such as liver, spleen, lung, kidney weigh and calculate organ coefficient, and above-mentioned internal organs and medicine-feeding part skin are carried out to pathological examination.Residue animal drug withdrawal breeding observing 14d.Measurement data means with X ± S, adopts SPSS10.0 software to carry out variance analysis and t check to data.
2.2 result
2.2.1 general status
During administration, each dosage treated animal outward appearance is normal, active, a quilt hair gloss, and eye, nose, ear, mouth, genitals are without abnormal secretions, and defecation color shape is all normal, each administration treated animal also occurs there are no the system toxicity symptom, does not occur animal dead during administration.
2.2.2 the impact on the rabbit body weight
Each treated animal body weight is all by Zhou Zengchang, administration phase and convalescent period each treated animal body weight and matched group there was no significant difference relatively.The results are shown in Table 4.
The impact (n=6) of the external application Chinese medicine administration 28d of table 4 treatment digestant for baby disease on the rabbit body weight
2.2.3 hematological indices
Each dosage group hematology's indices and matched group relatively there are no significant difference.The results are shown in Table 5.
The impact (n=6) of the external application Chinese medicine administration 28d of table 5 treatment digestant for baby disease on the rabbit blood index
2.2.4 blood biochemical is learned index
After each dosage group blood biochemical indices medication with matched group relatively there are no significant difference.The results are shown in Table 6.
The impact (n=6) of the external application Chinese medicine administration 28d of table 6-1 treatment digestant for baby disease on the rabbit blood biochemical indicator
The impact (n=6) of the external application Chinese medicine administration 28d of table 6-2 treatment digestant for baby disease on the rabbit blood biochemical indicator
2.2.5 become celestial with organ coefficient
Through dissecting, the internal organs of each dosage group of perusal and matched group rabbit, its form, color, quality are all normal.Each dosage group organ coefficient and matched group be there was no significant difference relatively.The results are shown in Table 7.
The external application Chinese medicine of table 7 treatment digestant for baby disease is embrocated impact (n=6, the gKg of 28d on the rabbit organ coefficient
-1)
2.2.6 the impact on tectology
Result shows, administration is respectively organized afterwards the organs and tissues such as the heart, liver, spleen, lung, kidney of rabbit in 28 days and is showed no pathological change.Dermal pathology histology demonstration, each group is showed no the phenomenons such as edema, epidermal hyperplasia, keratinization; Blank group and low dose group are showed no chronic inflammatory cells; Middle dosage group epidermis, corium intersection are dispersed in indivedual lymphocytes; High dose group epidermis, corium intersection have indivedual kitchen range shape lymphocytic infiltrations, see indivedual eosinophilic granulocytes.During the prompting administration, dosage and high dose group skin present slight chronic inflammatory cells change.After convalescent period 14d, middle dosage group has no inflammatory cell, and high dose group is rarely seen is dispersed in indivedual lymphocytes, and middle and high dosage group epidermis, corium intersection are showed no the eosinophilic granulocyte.In prompting, the slight chronic inflammatory disease of dosage skin disappears, and the slight chronic inflammatory disease of high dose group also significantly improves.
3 conclusions
Long term toxicity test shows: the basic, normal, high dosage of external application Chinese medicine for the treatment of digestant for baby disease adopts respectively 2,4,8 times of clinical application amount, and the Main Organ Coefficients such as the body weight of 3 dosage groups, hematology, blood parameters and the heart, liver, spleen, lung, kidney and tissue etc. are all no abnormal.During administration only middle and high dosage group skin slight and mild inflammation cell appear, and die away after drug withdrawal.By the convalescent period observation of carrying out retaining rabbit, do not find the retardance toxic reaction.Results suggest, clinical in the dosage range of drafting continuously the external application Chinese medicine of external curing digestant for baby disease within one week, be safe.
Children Treated with Chinese Traditional Drugs digests the external application Chinese medicine of disease, and clinical easy to use, drug effect is remarkable, but because its application is the children's who bears a pretty, delicate skin, therefore its anaphylaxis problem that may exist can not be ignored.For this reason, this test adopts novel mice allergic model evaluation methodology to be estimated the sensitization of this medicine, result shows, the potential sensitization of the external application Chinese medicine for the treatment of digestant for baby disease, compare there was no significant difference with matched group, illustrate that its potential sensitization is lower, the normal anaphylactoid probability of generation that uses is lower clinically.
Above announcement be only specific embodiments of the invention.All distortion that those of ordinary skill in the art can directly derive or associate from content disclosed by the invention, all should think protection scope of the present invention.
Claims (8)
1. an external application Chinese medicine for the treatment of the digestant for baby disease, is characterized in that, it contains percentage by weight and is: Cortex Cinnamomi 6-11%, Radix orixae japonicae 13-23%, Flos Caryophylli 4-9%, Fructus Evodiae 4-9%, Fructus Crataegi (parched) 35-48%, Rhizoma Zingiberis Recens 12-18%, mashed garlic 12-18%.
2. the external application Chinese medicine for the treatment of digestant for baby disease according to claim 1, is characterized in that, described Fructus Crataegi must be Fructus Crataegi (parched).
3. the external application Chinese medicine for the treatment of digestant for baby disease according to claim 1, is characterized in that, route of administration is point-application.
4. the external application Chinese medicine for the treatment of digestant for baby disease according to claim 3, is characterized in that, described acupuncture point is the middle part of gastric cavity, Pishu, tsu san li.
5. the preparation method of the external application Chinese medicine of a treatment digestant for baby disease according to claim 1, is characterized in that, comprises the following steps:
(1) take material according to mass percent;
(2) get Cortex Cinnamomi, Radix orixae japonicae, Flos Caryophylli, Fructus Evodiae, Fructus Crataegi (parched), in medicinal material pulverizer, break into 100 purpose fine powders, each medicated powder is merged, mix, standby;
(3) get Rhizoma Zingiberis Recens, Bulbus Allii, the water gaging such as add and enter in juice extractor to squeeze the juice, the elimination residue, squeezeding juice is standby;
(4) get above-mentioned Cortex Cinnamomi, Radix orixae japonicae, Flos Caryophylli, Fructus Evodiae, Fructus Crataegi (parched) mixed powder, add Rhizoma Zingiberis Recens and Bulbus Allii squeezeding juice, stir, obtain mixture, standby;
(5) quality of setting said mixture is 100 parts, as benchmark, adds 5 parts of vaseline, 1 part of Cera Flava and 0.5 part of edible oil in mixture, after being uniformly mixed, by pellet processing machine, makes the pill of diameter 1.0-1.2cm.
6. preparation method according to claim 5, is characterized in that, in described step (2), described medicated powder must be crossed 100 mesh sieves, and in described step (3), Rhizoma Zingiberis Recens Bulbus Allii squeezeding juice must standing rear filtration.
7. the purposes of the external application Chinese medicine of a treatment digestant for baby disease according to claim 1, a little less than being used for the treatment of the digestant for baby function, easily food stagnation, anorexia, vomiting, dyspepsia and functional abdominal pain, noninfectious diarrhea.
8. purposes according to claim 7, route of administration is point-application.
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| CN106421709A (en) * | 2016-11-10 | 2017-02-22 | 马玉珍 | Medicine for treating nausea and vomiting in pregnancy |
| CN109010777A (en) * | 2018-09-30 | 2018-12-18 | 杨泓慧 | The external application Chinese medicine and its preparation method and application of one breeding kidney and strengthening spleen promotion upgrowth and development of children |
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2013
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Non-Patent Citations (1)
| Title |
|---|
| 赵岩: ""脐疗治疗小儿泄泻的用药规律研究"", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106421709A (en) * | 2016-11-10 | 2017-02-22 | 马玉珍 | Medicine for treating nausea and vomiting in pregnancy |
| CN109010777A (en) * | 2018-09-30 | 2018-12-18 | 杨泓慧 | The external application Chinese medicine and its preparation method and application of one breeding kidney and strengthening spleen promotion upgrowth and development of children |
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