CN104547056A - Externally used navel patch for treating infantile diarrhea and preparation method thereof - Google Patents
Externally used navel patch for treating infantile diarrhea and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an externally used navel patch for treating infantile diarrhea and a preparation method thereof. The externally used navel patch is prepared from the following raw materials in parts by weight: 50-150 parts of scandent hop and 1-5 parts of pepper. Scandent hop and pepper are determined as main drugs in the main drug formula of the externally used navel patch on the basis of years' clinical practice; the externally used navel patch is prepared from active ingredients extracted from the main drugs; the dosage of administration of the product is accurate; and the externally used navel patch is convenient to use, can be used or taken down at any time, can avoid the first-pass effect of liver, has better application compliance in patients, and is particularly applicable to children patients. The extraction process of the externally used navel patch provided by the invention is determined according to the characteristics of the drugs in a prescription and the pharmacological effects of effective components of the drugs, is reasonable and simple, and is suitable for industrial production.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Chinese medicine for external application for the treatment of infantile diarrhea.
Background technology
Infantile diarrhea belongs to " having loose bowels " category of the traditional Chinese medical science, is the common digestive tract disease of department of pediatrics, increases with defecation frequency, just lower thin, or as water sample, or to have the excrement matter changes etc. such as indigested breast food, residue and mucus concurrently be feature
[1].In " A complete work on Pediatrics, a collection and arrangement of the chief contents from ancient pediatrics, written by Chen Fuzheng " to have loose bowels be described as " husband let out take off this, invariably due to taste.Lid stomach is reservoir of food and drink, and The spleen has the function to transport and transform nutrients.Make spleen stomach invigorating and then water paddy corruption, to be QI and blood go out to go honor in face.If intemperance of taking food, plug is controlled uncomfortable, so that taste are injured, then waterside wets, and paddy is only stagnant, and the gas of elite can not defeatedization, and even platform dirt declines and work of having loose bowels ".
What Chinese medicine thought infantile diarrhea has following four factors: one is being invaded by exogenous pathogen, attacks and diarrhea inducing in the heresy of six climate exopathogens; Two is internal injury diet, intemperance of taking food or lose clean, and impairing the spleen and stomach, causes indigestion, and walks large intestine, forms and has loose bowels; Three is weakness of the spleen and stomach, and transporting is lost strong, and water is wet, indigestion, forms diarrhea due to hypofunction of the spleen; Four is deficiency of spleen-YANG and kidneyYANG, yin-cold excess, clear QI being mixed up with turbid QI, and walks large intestine, causes and has loose bowels incessantly.Modern Chinese medicine worker is according to the pathological characteristic of the physiological characteristics of children's's " immature yin and yang " with " easily cold easily heat, easy to be empty easily real ", and thinking has loose bowels with the passing of time easily causes gas-liquid loss, and impairment of both QI and YIN, very then deficient YIN affecting YANG, develop into the critical deteriorated case of YIN and YANG exhausted simultaneously.Usually be divided into 5 types clinically, that is: diarrhea due to improper diet, wind and cold rush down, damp and hotly to rush down, splenoasthenic diarrhea, deficiency of spleen-YANG and kidneyYANG rush down and protracted course of disease of having loose bowels causes deficiency of both QI and YIN and syndrome of depletion of yin causing yang collapse.
The Therapeutic Method of modern Chinese medicine to infantile diarrhea is tending towards variation, not only adopts internal treatment, and adopts the method such as treatment of the inside combined with the outside, the combination of Chinese and Western medicine, all achieves good curative effect.Umbilical part application therapy in external treatment with Chinese medicine therapy is also a kind of method of relatively more conventional treatment infantile diarrhea, because the subcutaneus adipose tissue of umbilicus, skin are directly connected with fascia, peritoneum, the all rich blood vessel of umbilicus, therefore penetration is strong, be conducive to drug absorption, and be affixed on umbilical part treatment, easy to use, be easy to as infant accepts.
Gel ointment (former title cataplasma) mean extract, decoction pieces or and after chemicals and suitable hydrophilic matrix mix, coat the note unguentum river that back lining materials is made.Compared with traditional external preparation, it is large that gel ointment has drug loading, and moisture retention is strong, good with the compatibility of skin, and dosage is controlled, repeatedly can take off subsides, without advantages such as organic solvent pollutions in suitability for industrialized production.In recent years along with new technique, the new application of adjuvant and the new upsurge of inner disease outer treat, the research of gel ointment comes into one's own day by day.Domestic existing tens kinds listing at present, in the wound such as treatment anti-inflammatory analgesic, invigorating blood circulation trace, soft group of contusion, traumatic injury and orthopaedic disease, gel ointment achieves significant curative effect.
At present, the annual child in the whole world falls ill number about 700,015,000 person-times, the infant of death about 500 ~ 18,000,000 people because of diarrhoea.As can be seen here, diarrhoea is the serious disease of harm child health and life, therefore, strengthens, to the research of infantile diarrhea control, having great importance.
Summary of the invention
The object of the present invention is to provide a kind of external umbilical part patch for the treatment of infantile diarrhea, its good effect and easy to use.
Another object of the present invention is to the preparation method that this external umbilical part patch is provided.
The technical scheme that the present invention realizes above-mentioned purpose is: a kind of external umbilical part patch for the treatment of infantile diarrhea, is characterized in that: active medicine is made up of the raw material of following weight fraction: Herba humuli scandentis 50 ~ 150 parts, 1 ~ 5 part, Fructus Piperis.
Described external umbilical part patch is external pulvis or gel ointment.
Described gel ointment is made up of backing layer and pastille hypothallus, and wherein backing layer is non-woven fabrics, and the weight proportion that pastille hypothallus presses 1: 1 ~ 1: 5 by active medicine and bare substrate mixes obtained.
Described bare substrate comprises the component of following weight fraction: deionized water 60 ~ 80 parts, Carbomer-940 1 ~ 3 part, carbomer-941 10 ~ 20 parts, tween 80 0.01 ~ 0.03 part, disodiumedetate 0.001 ~ 0.004 part, 95% ethanol 1 ~ 3 part.
Treat a preparation method for the external umbilical part patch of infantile diarrhea, it is characterized in that comprising the following steps: mark gets Herba humuli scandentis 50 ~ 150 parts by weight, 1 ~ 5 part, Fructus Piperis; The extracting mode of Herba humuli scandentis is be dried to dry extract after water extraction or alcohol extraction to be used as medicine, and Fructus Piperis is broken into impalpable powder with Fructus Piperis powder and is used as medicine or extracts oil of pepper and be used as medicine or be used as medicine with its ingredient piperine, and the two is mixed to obtain active medicine.
The extraction process by water of described Herba humuli scandentis, for getting Herba humuli scandentis, adds water 6-15 doubly, boils at every turn and extracts 1-3 hour, extracts 1-4 time, merge extractive liquid, filters, and concentrates, and dryly obtains dry extract; The alcohol extraction process of Herba humuli scandentis is for getting Herba humuli scandentis, and add 50%-90% ethanol 6-15 doubly, each reflux, extract, 1-3 hour, extracts 1-4 time, merge extractive liquid, reclaims ethanol, filters, and concentrates, and dryly obtains dry extract.
When described external umbilical part patch is external pulvis, get 1.5-2.5 gram of active medicine in sticking with on rubber paste at every turn.
Preparation process when described external umbilical part patch is gel ointment is: (1) prepares active medicine; (2) get 60 ~ 80 parts of deionized waters, 0.01 ~ 0.03 part of tween 80 mixing, stirring at low speed, adds 1 ~ 3 part of Carbomer-940, stirs, add 10 ~ 20 parts of carbomers-941 in batches, be stirred to evenly, pour kneader into, stir 1-3h, evacuation, stirs, and leaves standstill, obtains bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution and make its pH value be 5-7, slowly add the glycerol accounting for total amount volume 20%-25% simultaneously; (3) be not scattered in 1-3 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring in 1-3 times of bare substrate, dispersed with stirring is even; Evenly be sprayed in said mixture by 0.001 ~ 0.004 part of curing agent ethylene diamine tetraacethyl disodium, dispersed with stirring is even, and sealing and standing, obtains pastille substrate; (4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
The principal agent formula of invention formulation is on clinical practice basis for many years, determine that Herba humuli scandentis and Fructus Piperis are principal agent, extract its principal agent active component and be prepared into external umbilical part patch, product dosage is accurate, easy to use, subsides can be taken off at any time, can bypass the first pass effect of liver, it is better that patient applies compliance, and suitable especially child patient uses.The extraction process of invention formulation determines according to the feature of prescription Chinese medicine and the pharmacological action of active ingredient thereof, and extraction process is rationally simple, is applicable to suitability for industrialized production.
Detailed description of the invention
The present invention is a kind of external umbilical part patch for the treatment of infantile diarrhea, and its active medicine is made up of the raw material of following weight fraction: Herba humuli scandentis 50 ~ 150 parts, 1 ~ 5 part, Fructus Piperis.Preferably, Herba humuli scandentis 80 ~ 120 parts, 2 ~ 4 parts, Fructus Piperis.
Herba humuli scandentis is the herb of Moraceae humulus plants Herba humuli scandentis Humulus scandens (Lour.) Merr..Sweet, bitter, cold.Effect heat-clearing and toxic substances removing, inducing diuresis to remove edema.For pulmonary tuberculosis hectic fever, gastroenteritis, dysentery, cold, fever, dysuria, pyelonephritis, acute nephritis, cystitis, urinary system calculus; Carbuncle furuncle and phyma poison is controlled in external, eczema, venom.Herb contains luteolin (1uteolin), glucoside, choline (choline), asparagine (asparamide), volatilization wet goods.There is the effect such as antidiarrheal, antibacterial, antioxidation, leukemia, antipruritic, antiinflammatory.In addition, Herba humuli scandentis is oral can treat dysentery.
Fructus Piperis is the nearly ripe or mature fruit of the drying of Piperaceae plant Piperaceae plant Fructus Piperis Piper nigrum L..Acrid in the mouth is hot in nature, returns stomach, large intestine channel.There is the function of warming spleen and stomach for dispelling cold, therapeutic method to keep the adverse QI flowing downwards clearing away phlegm, for gastrofrigid vomiting, stomachache have loose bowels, inappetence, epilepsy abundant expectoration etc.Clear ZHAO Xue-Min < External Therapies of Folk Medicine) (1759 Christian eras) note: " controlling dysentery, seven, Semen phaseoli radiati, orange stonecrop herb grain ... mash altogether ... paste on umbilicus ".The report of Fructus Piperis navel-applying therapeutic infantile diarrhea is a lot.About the prescription of children's's external application for curing diarrhoea has Fructus Piperis more in " Chinese Pharmacopoeia " and the national drug standards.Pepper fruits is containing multiple amides compound and volatile oil.There are anticonvulsant action, insecticidal action, boosting etc.
External umbilical part patch can be external pulvis or gel ointment.Gel ointment is made up of backing layer and pastille hypothallus, and wherein backing layer is non-woven fabrics, and the weight proportion that pastille hypothallus presses 1: 1 ~ 1: 5 by active medicine and bare substrate mixes obtained.The proportioning of active medicine and bare substrate is more preferably 1: 2 ~ 1: 5, is most preferably 1: 3.Bare substrate comprises the component of following weight fraction: deionized water 60 ~ 80 parts, Carbomer-940 1 ~ 3 part, carbomer-941 10 ~ 20 parts, tween 80 0.01 ~ 0.03 part, disodiumedetate 0.001 ~ 0.004 part, 95% ethanol 1 ~ 3 part.Preferably, the proportioning of bare substrate is deionized water 70 ~ 80 parts, Carbomer-940 2 ~ 3 parts, carbomer-941 15 ~ 20 parts, tween 80 0.01 ~ 0.03 part, disodiumedetate 0.001 ~ 0.002 part, 95% ethanol 1 ~ 2 part.Most preferred, the proportioning of bare substrate is deionized water 80 parts, Carbomer-940 3 parts, carbomer-941 20 parts, tween 80 0.01 part, disodiumedetate 0.002 part, 95% ethanol 2 parts.
The preparation method of the external umbilical part patch of above-mentioned treatment infantile diarrhea, first comprises the step preparing active medicine: mark gets Herba humuli scandentis 50 ~ 150 parts by weight, 1 ~ 5 part, Fructus Piperis; The extracting mode of Herba humuli scandentis is be dried to dry extract after water extraction or alcohol extraction to be used as medicine, Fructus Piperis is broken into impalpable powder with Fructus Piperis powder and is used as medicine or extracts oil of pepper and be used as medicine or be used as medicine (preferred Fructus Piperis powder is broken into impalpable powder and is used as medicine) with its ingredient piperine, and the two is mixed to obtain active medicine.
Preferably, the extraction process by water of Herba humuli scandentis, for getting Herba humuli scandentis, adds water 6-15 doubly, boils at every turn and extracts 1-3 hour, extracts 1-4 time, merge extractive liquid, filters, and concentrates, and dryly obtains dry extract; The alcohol extraction process of Herba humuli scandentis is for getting Herba humuli scandentis, and add 50%-90% ethanol 6-15 doubly, each reflux, extract, 1-3 hour, extracts 1-4 time, merge extractive liquid, reclaims ethanol, filters, and concentrates, and dryly obtains dry extract.
The grinding mode of the Fructus Piperis fine powder that to be Fructus Piperis be ground into through any mode or impalpable powder or superfine powder.Oil of pepper is the volatile oil through steam distillation or additive method extraction from Fructus Piperis.Piperine is the alkaloid therefrom extracted in Fructus Piperis, and also known as (E, E)-1-[5-(1,3-benzodioxolane-5-base)-1-oxo-2,4-pentadienyl]-piperidines, its molecular formula is C17H19NO3, and molecular weight is 285.3377.
When external umbilical part patch is external pulvis, get the obtained active medicine of 1.5-2.5 gram of preceding method in sticking with on rubber paste at every turn.Preparation method when external umbilical part patch is gel ointment is: (1) prepares active medicine by preceding method; (2) get recipe quantity deionized water, tween 80 mixes, stirring at low speed, add Carbomer-940, moderate-speed mixer, add recipe quantity carbomer-941 in batches, stirring at low speed is to even, pour kneader into, adjustment temperature is 45-55 DEG C, stirs 1-3h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its pH value be 5-7, slowly add the glycerol accounting for total amount volume 20%-25% simultaneously; (3) be scattered in 1-3 times of volume 95% ethanol by step (1) gained active medicine, slowly add under stirring at low speed condition in 1-3 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.The gel ointment smooth in appearance that the present invention obtains, uniform color, without obvious mechanical admixture, edge is neat.Good stability.Moderate-speed mixer in preparation process of the present invention and the rotating speed of stirring at low speed are that the one in this area is sanctified by usage, and specifically low speed is 800 ~ 1000 turns per minute, and middling speed is 1800 ~ 2000 turns per minute.
The using method that the present invention treats the external umbilical part patch of infantile diarrhea is: patch is affixed on umbilicus (SHENQUE acupoint), and the subsides medicine time is generally 3 ~ 6h, every day 1 time.
Following examples are only in order to the present invention is further illustrated, and scope of the present invention is not by the limitation of illustrated embodiment.
Embodiment 1
Get Herba humuli scandentis 150 parts, add water 15 times, boil extraction 3 hours at every turn, extract 3 times, merge extractive liquid, filter, concentrated, dry dry extract.Get 5 parts, Fructus Piperis, be ground into fine powder.The two mix homogeneously is obtained powder.
Get about 2 grams during use at every turn, spread on SHENQUE acupoint (umbilicus) with rubber paste, the subsides medicine time is generally 3 ~ 6h, every day 1 time.
Embodiment 2
Get Herba humuli scandentis 50 parts, add water 6 times, boil extraction 1 hour at every turn, extract 1 time, filter, concentrated, dry dry extract.Get 1 part, Fructus Piperis, be ground into fine powder.The two mix homogeneously is obtained powder.
Embodiment 3
Get Herba humuli scandentis 100 parts, add water 9 times, boil extraction 2 hours at every turn, extract 2 times, merge extractive liquid, filter, concentrated, dry dry extract.Get 1 part, Fructus Piperis, be ground into fine powder.The two mix homogeneously is obtained powder.
Embodiment 4
Get Herba humuli scandentis 150 parts, add water 15 times, boil extraction 3 hours at every turn, extract 3 times, merge extractive liquid, filter, concentrated, dry dry extract.Get 3 parts, Fructus Piperis, be ground into fine powder.The two mix homogeneously is obtained powder.
Embodiment 5
Get Herba humuli scandentis 50 parts, add water 6 times, boil extraction 1 hour at every turn, extract 1 time, merge extractive liquid, filter, concentrated, dry dry extract.Get 2 parts, Fructus Piperis, be ground into fine powder.The two mix homogeneously is obtained powder.
Embodiment 6
Get Herba humuli scandentis 100 parts, add water 9 times, boil extraction 2 hours at every turn, extract 2 times, merge extractive liquid, filter, concentrated, dry dry extract.Get 3 parts, Fructus Piperis, be ground into fine powder.The two mix homogeneously is obtained powder.
Embodiment 7
(1) get Herba humuli scandentis 150 parts, add water 15 times, boil extraction 3 hours at every turn, extract 3 times, merge extractive liquid, filter, to be concentrated into relative density be 1.3 and get final product; Get 5 parts, Fructus Piperis, be ground into fine powder; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 80 parts is got, tween 80 0.03 part mixing, stirring at low speed, add Carbomer-940 3 parts, moderate-speed mixer, add recipe quantity carbomer-941 20 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 3h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 7, slowly add the glycerol accounting for total amount volume 25% simultaneously;
(3) be not scattered in 3 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 3 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.004 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 8
(1) get Herba humuli scandentis 50 parts, add water 6 times, boil extraction 1 hour at every turn, extract 1 time, filter, to be concentrated into relative density be 1.1 and get final product; Get 1 part, Fructus Piperis, be ground into impalpable powder; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 60 parts is got, tween 80 0.01 part mixing, stirring at low speed, add Carbomer-940 1 part, moderate-speed mixer, add recipe quantity carbomer-941 10 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 1h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 5, slowly add the glycerol accounting for total amount volume 20% simultaneously;
(3) be not scattered in 1 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 1 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.001 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 9
(1) get Herba humuli scandentis 100 parts, add water 9 times, boil extraction 2 hours at every turn, extract 2 times, merge extractive liquid, filter, to be concentrated into relative density be 1.2 and get final product; Get 2 parts, Fructus Piperis, be ground into superfine powder; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 70 parts is got, tween 80 0.02 part mixing, stirring at low speed, add Carbomer-940 2 parts, moderate-speed mixer, add recipe quantity carbomer-941 15 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 2h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 6, slowly add the glycerol accounting for total amount volume 22.5% simultaneously;
(3) be not scattered in 2 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 2 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.002 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 10
(1) get Herba humuli scandentis 150 parts, add water 15 times, boil extraction 3 hours at every turn, extract 3 times, merge extractive liquid, filter, to be concentrated into relative density be 1.3 and get final product; Get 5 parts, Fructus Piperis, extract oil of pepper; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 60 parts is got, tween 80 0.01 part mixing, stirring at low speed, add Carbomer-940 1 part, moderate-speed mixer, add recipe quantity carbomer-941 20 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 1h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 7, slowly add the glycerol accounting for total amount volume 20% simultaneously;
(3) be not scattered in 3 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 1 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.001 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 11
(1) get Herba humuli scandentis 50 parts, add water 6 times, boil extraction 1 hour at every turn, extract 1 time, merge extractive liquid, filter, to be concentrated into relative density be 1.1 and get final product; Get 1 part, Fructus Piperis, extract oil of pepper; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 80 parts is got, tween 80 0.01 part mixing, stirring at low speed, add Carbomer-940 1 part, moderate-speed mixer, add recipe quantity carbomer-941 20 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 1h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 7, slowly add the glycerol accounting for total amount volume 20% simultaneously;
(3) be not scattered in 3 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 1 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.003 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 12
(1) get Herba humuli scandentis 100 parts, add water 9 times, boil extraction 2 hours at every turn, extract 2 times, merge extractive liquid, filter, to be concentrated into relative density be 1.2 and get final product; Get the piperine of 98% of 2 parts, suitable Fructus Piperis; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 70 parts is got, tween 80 0.025 part mixing, stirring at low speed, add Carbomer-940 2.5 parts, moderate-speed mixer, add recipe quantity carbomer-941 18 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 2h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 5.5, slowly add the glycerol accounting for total amount volume 23.0% simultaneously;
(3) be not scattered in 1.8 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 1.6 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.003 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 13
(1) get Herba humuli scandentis 150 parts, add 90% ethanol 15 times, each reflux, extract, 3 hours, extract 4 times, merge extractive liquid, reclaim ethanol, filter, to be concentrated into relative density be 1.2 and get final product; Get 5 parts, Fructus Piperis, be ground into fine powder; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 80 parts is got, tween 80 0.03 part mixing, stirring at low speed, add Carbomer-940 3 parts, moderate-speed mixer, add recipe quantity carbomer-941 20 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 3h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 7, slowly add the glycerol accounting for total amount volume 25% simultaneously;
(3) be not scattered in 3 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 3 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.004 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 14
(1) get Herba humuli scandentis 50 parts, add 50% ethanol 6 times, each reflux, extract, 1 hour, extract 1 time, reclaim ethanol, filter, to be concentrated into relative density be 1.0 and get final product; Get 1 part, Fructus Piperis, be ground into impalpable powder; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 60 parts is got, tween 80 0.01 part mixing, stirring at low speed, add Carbomer-940 1 part, moderate-speed mixer, add recipe quantity carbomer-941 10 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 1h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 5, slowly add the glycerol accounting for total amount volume 20% simultaneously;
(3) be not scattered in 1 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 1 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.001 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 15
(1) get Herba humuli scandentis 100 parts, add 70% ethanol 10 times, each reflux, extract, 2 hours, extract 2 times, merge extractive liquid, reclaim ethanol, filter, to be concentrated into relative density be 1.2 and get final product; Get 2 parts, Fructus Piperis, be ground into superfine powder; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 70 parts is got, tween 80 0.02 part mixing, stirring at low speed, add Carbomer-940 2 parts, moderate-speed mixer, add recipe quantity carbomer-941 15 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 2h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 6, slowly add the glycerol accounting for total amount volume 22.5% simultaneously;
(3) be not scattered in 2 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 2 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.002 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 16
(1) get Herba humuli scandentis 80 parts, add 60% ethanol 12 times, each reflux, extract, 1.5 hours, extract 2 times, merge extractive liquid, reclaim ethanol, filter, to be concentrated into relative density be 1.15 and get final product; Get 5 parts, Fructus Piperis, extract oil of pepper; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 60 parts is got, tween 80 0.01 part mixing, stirring at low speed, add Carbomer-940 1 part, moderate-speed mixer, add recipe quantity carbomer-941 20 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 1h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 7, slowly add the glycerol accounting for total amount volume 20% simultaneously;
(3) be not scattered in 3 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 1 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.001 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 17
(1) get Herba humuli scandentis 150 parts, add 50% ethanol 13 times, each reflux, extract, 1.6 hours, extract 3 times, merge extractive liquid, reclaim ethanol, filter, to be concentrated into relative density be 1.1 and get final product; Get 1 part, Fructus Piperis, extract oil of pepper; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 80 parts is got, tween 80 0.01 part mixing, stirring at low speed, add Carbomer-940 1 part, moderate-speed mixer, add recipe quantity carbomer-941 20 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 1h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 7, slowly add the glycerol accounting for total amount volume 20% simultaneously;
(3) be not scattered in 3 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 1 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.003 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Embodiment 18
(1) get Herba humuli scandentis 100 parts, add 80% ethanol 8 times, each reflux, extract, 1.2 hours, extract 2 times, merge extractive liquid, reclaim ethanol, filter, to be concentrated into relative density be 1.21 and get final product; Get the piperine of 98% of 2 parts, suitable Fructus Piperis; The two mix homogeneously is obtained drug component.
(2) recipe quantity deionized water 70 parts is got, tween 80 0.025 part mixing, stirring at low speed, add Carbomer-940 2.5 parts, moderate-speed mixer, add recipe quantity carbomer-941 18 parts in batches, stirring at low speed is to even, pour kneader into, regulate temperature to be 50 DEG C, stir 2h, evacuation, stir, leave standstill, obtain bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution, make its ph value be 5.5, slowly add the glycerol accounting for total amount volume 23.0% simultaneously;
(3) be not scattered in 1.8 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring at low speed condition in 1.6 times of bare substrate, dispersed with stirring is even; By curing agent ethylene diamine tetraacethyl disodium 0.003 part, be evenly sprayed in said mixture, dispersed with stirring is even, and sealing and standing, obtains pastille substrate.
(4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
Research example 1
By the diarrhea of mouse model caused by Folium Sennae, study the effectiveness of Drug therapy of the present invention diarrhoea.
1. experiment material
By embodiment 9 preparation method, get the medical material of following weight proportion, the medicine respectively described in cost study example processed:
Herba humuli scandentis 100 grams, 2 grams, Fructus Piperis, is prepared into Herba humuli scandentis Fructus Piperis diarrhoea gel cream A.
Herba humuli scandentis 100 grams, is prepared into Herba humuli scandentis diarrhoea gel cream B.
2 grams, Fructus Piperis, is prepared into Fructus Piperis diarrhoea gel cream C.
2. grouping and administration
Experiment is divided into 4 groups, excipient control group (model group): every mouse part skin sticks the bare substrate of equivalent; Gel cream A group: every mouse part skin sticks gel cream A; Gel cream B group: every mouse part skin sticks gel cream B; Gel cream C group: every mouse part skin sticks gel cream C.
Get the laboratory rearing cleaning grade mice of 3 days, body weight about 20 ~ 22g, male, by body weight random packet, the administration of each group mice uses Shearing shears unhairing in first 24 hours.Sub-cage rearing, every Mus 1 lattice.Fasting is after 12 hours, each mice of each group respectively by respective medication and dosage to mice medication, after skin of abdomen administration, every mice gavage 30% Folium Sennae solution 0.25ml/10g immediately, and single be placed on be covered with quite large filter paper little cage in observe.To after Folium Sennae 1 ~ 5 hour, per hourly change absorbent paper 1 time.Observe the loose stool number of each mice, loose stool rate and loose stool progression, calculate each Mus Scours index of 5 hours.So continuously modeling administration observes 3 days, calculates the Scours index in 5 hours every days of more each Mus.Experimental result is in table 1.
Table 1 diarrhoea pastes the impact on Folium Sennae induced mice Scours index
With vehicle group than * P < 0.05.
This experimental result shows, the diarrhoea patch treatment diarrhoea that medicine of the present invention is made has and has good therapeutic effect, and is obviously better than Herba humuli scandentis or Fructus Piperis is alone.
Claims (8)
1. treat an external umbilical part patch for infantile diarrhea, it is characterized in that: active medicine is made up of the raw material of following weight fraction: Herba humuli scandentis 50 ~ 150 parts, 1 ~ 5 part, Fructus Piperis.
2. the external umbilical part patch for the treatment of infantile diarrhea according to claim 1, is characterized in that: described external umbilical part patch is external pulvis or gel ointment.
3. the external umbilical part patch for the treatment of infantile diarrhea according to claim 1, it is characterized in that: described gel ointment is made up of backing layer and pastille hypothallus, wherein backing layer is non-woven fabrics, and the weight proportion that pastille hypothallus presses 1: 1 ~ 1: 5 by active medicine and bare substrate mixes obtained.
4. the external umbilical part patch for the treatment of infantile diarrhea according to claim 3, it is characterized in that: described bare substrate comprises the component of following weight fraction: deionized water 60 ~ 80 parts, Carbomer-940 1 ~ 3 part, carbomer-94110 ~ 20 parts, tween 80 0.01 ~ 0.03 part, disodiumedetate 0.001 ~ 0.004 part, 95% ethanol 1 ~ 3 part.
5. treat a preparation method for the external umbilical part patch of infantile diarrhea, it is characterized in that comprising the following steps: mark gets Herba humuli scandentis 50 ~ 150 parts by weight, 1 ~ 5 part, Fructus Piperis; The extracting mode of Herba humuli scandentis is be dried to dry extract after water extraction or alcohol extraction to be used as medicine, and Fructus Piperis is broken into impalpable powder with Fructus Piperis powder and is used as medicine or extracts oil of pepper and be used as medicine or be used as medicine with its ingredient piperine, and the two is mixed to obtain active medicine.
6. the preparation method of the external umbilical part patch for the treatment of infantile diarrhea according to claim 5, is characterized in that: the extraction process by water of described Herba humuli scandentis is for getting Herba humuli scandentis, and the 6-15 that adds water doubly, boil at every turn and extract 1-3 hour, extract 1-4 time, merge extractive liquid, filter, concentrated, dry dry extract; The alcohol extraction process of Herba humuli scandentis is for getting Herba humuli scandentis, and add 50%-90% ethanol 6-15 doubly, each reflux, extract, 1-3 hour, extracts 1-4 time, merge extractive liquid, reclaims ethanol, filters, and concentrates, and dryly obtains dry extract.
7. the preparation method of the external umbilical part patch for the treatment of infantile diarrhea according to claim 5, is characterized in that: when described external umbilical part patch is external pulvis, gets 1.5-2.5 gram of active medicine in sticking with on rubber paste at every turn.
8. the preparation method of the external umbilical part patch for the treatment of infantile diarrhea according to claim 5, is characterized in that: preparation process when described external umbilical part patch is gel ointment is: (1) prepares active medicine; (2) get 60 ~ 80 parts of deionized waters, 0.01 ~ 0.03 part of tween 80 mixing, stirring at low speed, adds 1 ~ 3 part of Carbomer-940, stirs, add 10 ~ 20 parts of carbomers-941 in batches, be stirred to evenly, pour kneader into, stir 1-3h, evacuation, stirs, and leaves standstill, obtains bare substrate; Stirring at low speed bare substrate, and slowly add NaOH solution and make its pH value be 5-7, slowly add the glycerol accounting for total amount volume 20%-25% simultaneously; (3) be not scattered in 1-3 times of volume 95% ethanol by step 1 gained drug component, slowly add under stirring in 1-3 times of bare substrate, dispersed with stirring is even; Evenly be sprayed in said mixture by 0.001 ~ 0.004 part of curing agent ethylene diamine tetraacethyl disodium, dispersed with stirring is even, and sealing and standing, obtains pastille substrate; (4) pastille substrate is coated on non-woven fabrics while hot, is chilled to the size that room temperature cuts into needs.
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| EP3520783A1 (en) * | 2018-01-30 | 2019-08-07 | Nitto Denko Corporation | Transdermal absorption preparation |
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| US11253484B2 (en) | 2018-01-30 | 2022-02-22 | Nitto Denko Corporation | Transdermal absorption preparation |
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