CN100348235C - Chinese preparation for treating infantile diarrhea and its making method thereof - Google Patents

Abstract

The present invention discloses a medicine for treating child diarrhea and a preparation method thereof. The preparation is researched by professor Zhao dongke by combining the modern pharmacology according to the Chinese medicine clinical experience. Pepper, rhubarb, scutellaria root, rehmannia root, cinnamon, nux vomica, notopterygium root, figwort, Chinese ephedra, tree peony bark, phellodendron bark, red peony root, angelica, lindera root, schizonepeta, pubescent angelica root, dahurian angelica and ledebouriella root are selected in a fine mode. Each medicine efficiency generates synergistic effects by the combination of the medicines, and the present invention has the functions of warming the spleen and the stomach for dispelling cold, purging away the heat, discharging the intestine, clearing heat and promoting fluid, expelling wind and eliminating dampness, resolving phlegm, sweating, dissipating blood stasis, guiding qi downward, relieving exterior syndrome, expelling wind, nourishing yin, promoting eruption, eliminating swelling, discharging numbness, warming the spleen, relieving diarrhea, warming the kidney and lowering the adverse flow of qi. Through a large quantity of clinical test and research of pharmacodynamics, the present invention has exact and significant curative effects on child infectivity or non-infectious diarrhea, such as wind-cold, insufficiency of the spleen, insufficiency of both the spleen and the kidney and diarrhea with improper diet type. The present invention has the advantages of fast therapy effect, short course of treatment, high curative effect, convenient operation, simple method, no toxic side effect, low cost, etc. The bitterness of taking medicine of children is avoided.

Description

A kind of Chinese medicine preparation and preparation method for the treatment of infantile diarrhea

Technical field

The invention discloses a kind of medicine and preparation method for the treatment of infantile diarrhea, is the Chinese medicine preparation of feedstock production with Chinese medicine specifically, belongs to the field of Chinese medicines.

Background technology

Infantile diarrhea also claims infantile diarrhea, is the multifactor digestant for baby tract disease that causes of cause of disease more than a group, because the infant internal organs are tender and lovely, the gastrointestinal function developmental immaturity, digestive system function is unsound, gastric acid is few in the gastric juice, the poor activity of digestive enzyme, and infant is in quick growth and development stage, the nutrition that needs is many, and the gastrointestinal burden is heavier relatively, in addition children's cold warm can not self-regulated, diet can not be from joint, therefore, be subject to the pathogen invasion and attack outward, interior is injury due to diet easily.Having loose bowels is the modal disease of children's, is positioned at second of China's common disease in children frequently-occurring disease, is to cause one of infant main causes of death, and the infant below two years old sees that the four seasons all can take place more.Increase with children's's defecation frequency, it be mainly to show that stool character changes (indigestible loose stool, watery stool, mucus just or bloody purulent stool).In addition, also can be low with appetite, vomiting is often arranged, the severe patient coffee sample liquid that can spue, diarrhoea is frequent, defecates every day tens times to tens times, and feces is water sample or egg soup sample, outwards sputter, outward appearance is yellow green, yellow or little yellow, more than the water yield and excrement matter is few.The whole body ordinary circumstance is relatively poor, heating, and body temperature can increase to 39 ℃～40 ℃, minority can be up to more than 41 ℃, and children's shows as dysphoria, lethargy, haziness, even stupor, along with the General Symptoms aggravation, can cause functional disorders such as nervous system, the heart, liver, kidney.Diarrhoea the lighter influences infant nutrition and absorbs, more than the weight person because of with dehydration, acidosis, circulatory disturbance and shock threat to life.Because of primary disease can be invaded respiratory tract, claim " reovirus " 40%～50% patient is arranged again with respiratory symptoms such as coughs.The past people are accustomed to claiming that infantile diarrhea is " dyspepsia " or " enteritis ", are referred to as diarrhoea in recent years.Causing the reason of infantile diarrhea, mainly is being invaded by exogenous pathogen, internal injury diet, weakness of the spleen and stomach etc., and its pathological changes is at taste, and because of stomach master digesting food, it is precise and tiny that The spleen has the function to transport and transform nutrients, if taste are subjected to disease, then diet is gone into stomach, indigestion, and abnormal ascent-descent between clear YANG and turbid YIN, and walk large intestine, satisfy to become to have loose bowels.The nursing too much, very few, variable interval of taking food, the food of take food too early a large amount of starch based and fats, and change food species suddenly, all can cause digestive functional disturbance.The a large amount of antibiotic of prolonged application cause dysbacteriosis also can cause bacterial diarrhea.Infantile diarrhea can be divided into " infectious diarrhea " and " noninfectious diarrhea " again according to its different causes of disease.Infect in the main duodenum 12 of the infectious diarrhea road, can cause by virus, antibacterial, fungus etc.; Noninfectious diarrhea is often relevant with nursing, dietary factor and climate change.Viral diarrhea can be caused by virus, especially sees with rotavirus infection more, betides 6 months to 2 years old infant well, and children's below 6 months generally seldom falls ill because of mother's antibody is arranged.

The treatment of infantile diarrhea is followed the principle of prevention or correct dehydration, continuation diet, rational use of drug for light-duty diarrhoea infant, generally soon can rehabilitation.Doctor trained in Western medicine is to the treatment of infantile diarrhea, main symptomatic treatment, and fluid infusion (oresol), various diarrheas, antibiotic is selected bactrim, furazolidone, amino benzylpenicillin etc. for use as coli-infection; Infection of staphylococcus aureus can be selected penicillin or erythromycin for use; Fungal infection should be selected nystatin or clotrimazole for use, though can reach the effect of controlling symptoms, because toxic and side effects is big, makes the patient be difficult to accept.Though the medicine of Chinese traditional treatment infantile diarrhea is a lot, as Chinese patent medicine: PIKEXIN, invigorating the spleen to arrest diarrhea are loose, changweikang granule etc., those chronic diarrhea are not healed, or with vomiting, the infant of difficulty of taking medicine, controlling symptoms are produced effects slowly, is difficult to tackle the problem at its root.

Summary of the invention

Purpose of the present invention is exactly the problem that exists at above-mentioned prior art, and a kind of heat-clearing and toxic substances removing that has is provided, and antiinflammatory is antibacterial, dampness removing and diarrhea-relieving, the merit of strengthening vital QI to eliminate pathogenic factors is applicable to the treatment of various infantile diarrhea, and the cure rate height, rapid-action, short treating period, easy to use, have no side effect, be worth cheap Chinese medicine preparation, can exempt from the hardship of medication in children.

This preparation is that the pharmacologist professor ZhaoDongKe is excavated the traditional Chinese medical science and enriched clinical experience, in conjunction with modern pharmacological research, tests drawing in a large number, and each amounts of components all has better curative effect in the following weight parts scope:

Fructus Piperis 15-26 part, Radix Et Rhizoma Rhei 1-3 part, Radix Scutellariae 1-3 part, Radix Rehmanniae 1-3 part, Cortex Cinnamomi 10-16 part, Semen Strychni 0.5-1.5 part, Rhizoma Et Radix Notopterygii 1-3 part, Radix Scrophulariae 1-3 part, Herba Ephedrae 1-3 part, Cortex Moutan 0.5-1.5 part, Cortex Phellodendri 1-3 part, Radix Paeoniae Rubra 1-3 part, Radix Angelicae Sinensis 1-3 part, Radix Linderae 1-3 part, Herba Schizonepetae 1-3 part, Radix Angelicae Pubescentis 1-3 part, Radix Angelicae Dahuricae 1-3 part, Radix Saposhnikoviae 1-3 part, Rhizoma Drynariae 1-3 part, Flos Caryophylli 5-15 part.

Be preferably: 19 parts in Fructus Piperis, 2 parts of Radix Et Rhizoma Rhei, 2 parts of Radix Scutellariaes, 2 parts of Radix Rehmanniae, 11 parts of Cortex Cinnamomis, 1 part of Semen Strychni, 2 parts of Rhizoma Et Radix Notopterygiis, 2 parts of Radix Scrophulariaes, 2 parts in Herba Ephedrae, 1 part of Cortex Moutan, 2 parts of Cortex Phellodendris, 2 parts of Radix Paeoniae Rubra, 2 parts of Radix Angelicae Sinensis, 2 parts of the Radixs Linderae, 2 parts of Herba Schizonepetae, 2 parts of Radix Angelicae Pubescentiss, 2 parts of the Radixs Angelicae Dahuricae, 2 parts of Radix Saposhnikoviaes, 2 parts of Rhizoma Drynariae, 10 parts of Flos Caryophyllis.

Fructus Piperis: suffering, heat.Return stomach, large intestine channel, warming spleen and stomach for dispelling cold, the therapeutic method to keep the adverse QI flowing downwards, expectorant; Radix Et Rhizoma Rhei: hardship, cold.Return spleen, stomach, large intestine, liver, pericardium channel.Purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, eliminating blood stasis and inducing menstruation; Radix Scutellariae: cold in nature, bitter in the mouth.The hot dampness that disappears, eliminating fire and detoxication; Radix Rehmanniae: sweet in the mouth, hardship, cold in nature.GUIXIN, liver, lung meridian.Clearing away heat and promoting production of body fluid, removing heat from blood, hemostasis; Radix Rehmanniae Preparata: sweet in the mouth, slightly warm in nature.Return liver, kidney channel.The YIN nourishing of enriching blood effect; Cortex Cinnamomi: suffering, sweet, heat.Return kidney, spleen, the heart, Liver Channel.It is supporing yang to mend fire, dispersing cold for relieving pain, and promoting the flow of QI-blood by warming the meridian is controlled decline of the fire from the gate of life, the cold extremities faint pulse, the YANG-depletion collapse, stomachache is had loose bowels, the colic of cold type renal mass, and empty sun is more floating, heat in the upper and cold in the lower; Semen Strychni: hardship, cold, poisonous.Return liver, spleen channel.Removing obstruction in the collateral to relieve pain, dispersing swelling and dissipating binds; Rhizoma Et Radix Notopterygii: suffering, temperature.Return bladder, kidney channel.Gas is male and loose, and the power of delivering is strong, and the heresy of main loose Taiyang channel ailment said due to cold or exposure and cold-damp has that cold expelling dispels the wind, the merit of removing dampness to relieve pain, kindly controls wind-cold damp pathogen and attacks table, and fever with aversion to cold, the flesh table is lossless, stiffness of the nape, limb aching pain person have a headache; Radix Scrophulariae: sweet, bitter, one-tenth is slightly cold.Return lung, stomach, kidney channel.Heat clearing and blood cooling, eliminating fire and detoxication, YIN nourishing and the production of body fluid promoting, hard masses softening and resolving; Herba Ephedrae: Herba Ephedrae is first medicine that induces sweat, and hot, bitter, temperature, goes into lung, urinary bladder channel, mainly contains diaphoresis, relievings asthma, diuretic, removes the wind effect; Cortex Moutan: cold in nature, bitter in the mouth, suffering.Clearing away heat and cooling blood, blood circulation promoting competent silt; Cortex Phellodendri: hardship, cold.Return kidney, bladder, large intestine channel.Heat clearing and damp drying, eliminating fire and detoxication; Radix Paeoniae Rubra: hardship is slightly cold.Return Liver Channel.Clearing away heat and cooling blood, eliminating stasis to stop pain; Radix Angelicae Sinensis: sweet in the mouth, suffering, warm in nature.Be the key medicine of enriching blood, return liver, the heart, spleen channel.Sweet Wen Zhirun enriches blood and invigorates blood circulation, dispersing cold for relieving pain, detumescence and promoting granulation; The Radix Linderae: warm in nature, hide hot.Pleasant pain, the warming kidney for dispelling cold gone up; Herba Schizonepetae: slightly warm in nature, acrid in the mouth.The diffusing wind that induces sweat, rash; Radix Angelicae Pubescentis: hot, bitter, tepor.Return kidney, urinary bladder channel.Expelling wind and removing dampness, numbness relieving and pain relieving; The Radix Angelicae Dahuricae: suffering, temperature.Return stomach, large intestine, lung meridian.The wind that looses dehumidifies understand things pain-stopping, detumescence and apocenosis; Radix Saposhnikoviae: acrid in the mouth, sweet, warm in nature.Relieving the exterior syndrome by diaphoresis, expelling wind and removing dampness effect are arranged; Rhizoma Drynariae: hardship, temperature.Return kidney, Liver Channel.The kidney invigorating bone strengthening continues and hinders pain relieving; Fourth: suffering, temperature.Return spleen, stomach, lung, kidney channel.Warming middle-JIAO to send down the adverse QI, reinforcing the kidney and supporting YANG.

In the side: Flos Caryophylli, Cortex Cinnamomi, Radix orixae japonicae, the product for the sweet big heat of suffering have warming the kidney to activate YANG, the effect of dispersing cold for relieving pain.So the heresy of the kind YIN-cold of dispelling, can warming middle-JIAO and pain relieving, warm spleen and antidiarrheal are for controlling the key medicine that infant stomachache is had loose bowels.Herba Schizonepetae, Radix Saposhnikoviae, Rhizoma Et Radix Notopterygii, the Radix Angelicae Dahuricae, Herba Ephedrae etc., the cold expelling that induces sweat, eliminating evil and outer also pain relieving is a minister.Assistant has suppressing the hyperactive liver concurrently and presses down carpentery workshop usefulness with Radix Angelicae Sinensis, Radix Paeoniae Rubra, Radix Rehmanniae, tonification sun blood, and Radix Linderae conditioning also is an adjuvant drug about linking up, so compatibility.Yang-energy is shaken, and the visitor is cold to be removed, so the stomachache diarrhea can heal.

Full side share has warming spleen and stomach for dispelling cold, purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, eliminating blood stasis and inducing menstruation, clearing away heat and promoting production of body fluid, the dampness hemostasis, the YIN nourishing of enriching blood, supporing yang pain relieving, promoting the flow of QI-blood by warming the meridian, collateral dredging pathogenic fire purging, hard masses softening and resolving, expelling wind and dampness, the diaphoresis of reducing phlegm, the diuretic of relievining asthma removes and is in fashion the stasis of blood, sweet Wen Zhirun, dissipating blood stasis is pleasant, the diffusing wind that induces sweat, the yin nourishing rash, antiinflammatory is antibacterial, the detumescence blood stasis dispelling, sensible dehumidifying, the kidney invigorating bone strengthening, the continuous warming middle-JIAO of hindering, warm spleen antidiarrheal, eliminating evil suppressing the hyperactive liver, blood activating and promoting tissue regeneration, the merit of the kidney warming sending down the abnormal ascending QI.

Another aspect of the present invention relates to a kind of prescription for the treatment of infantile diarrhea unguentum substrate.

Each substrate, solvent, molten coal consumption all have better effects in the following weight parts scope.

Substrate: rubber 25-40 part, zinc oxide 30-50 part, Colophonium 25-40 part, lanoline 5-10 part, vaseline 2-5 part, liquid paraffin 1-3 part.

Solvent: 110-130# gasoline 70-90 part.

Molten coal: ethanol 5-15 part.

Each substrate, solvent, molten coal consumption are preferably:

Substrate: 32 parts of rubber, 40 parts of zinc oxide, 32 parts of Colophonium, 8 parts of lanolines, 3 parts in vaseline, 2 parts of liquid paraffin.

Solvent: 80 parts in 120# gasoline.

Molten coal: 10 parts of ethanol.

Another aspect of the present invention relates to a kind of preparation method for the treatment of the infantile diarrhea unguentum.

Fructus Piperis, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Rehmanniae, Cortex Cinnamomi, Semen Strychni, Rhizoma Et Radix Notopterygii, Radix Scrophulariae, Herba Ephedrae, Cortex Moutan, Cortex Phellodendri, Radix Paeoniae Rubra, Radix Angelicae Sinensis, the Radix Linderae, Herba Schizonepetae, Radix Angelicae Pubescentis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae 20 flavor medical materials, get Flos Caryophylli, Cortex Cinnamomi, Fructus Piperis respectively 1/20th is ground into impalpable powder, the residue Flos Caryophylli, Cortex Cinnamomi is extracted volatile oil respectively, 18 flavors such as the medicinal residues behind the extraction volatile oil and all the other Radix Et Rhizoma Rhei, ooze with 85-95% ethanol and to make the fluid extract that relative density is 1.1-1.2 (50 ℃), reclaim ethanol, add above-mentioned fine powder and Flos Caryophylli, Cortex Cinnamomi volatile oil, add again by rubber, zinc oxide, Colophonium, lanoline, vaseline, the substrate that liquid paraffin is made, solvent is a gasoline, molten coal is an ethanol, makes coating, is coated with cream, cutting, the lid lining, section, promptly.

This composition of medicine also can be made tincture, Emulsion, cream, spray.

The present invention is described in further detail below in conjunction with instantiation that the inventor provides.

The specific embodiment

Embodiment 1

Take by weighing each raw material according to following weight parts:

15 parts in Fructus Piperis, 1 part of Radix Et Rhizoma Rhei, 1 part of Radix Scutellariae, 1 part of Radix Rehmanniae, 10 parts of Cortex Cinnamomis, 0.5 part of Semen Strychni, 1 part of Rhizoma Et Radix Notopterygii, 1 part of Radix Scrophulariae, 1 part in Herba Ephedrae, 0.5 part of Cortex Moutan, 1 part of Cortex Phellodendri, 1 part of Radix Paeoniae Rubra, 1 part of Radix Angelicae Sinensis, 1 part of the Radix Linderae, 1 part of Herba Schizonepetae, 1 part of Radix Angelicae Pubescentis, 1 part of the Radix Angelicae Dahuricae, 1 part of Radix Saposhnikoviae, 1 part of Rhizoma Drynariae, 5 parts of Flos Caryophyllis.

Preparation method: Fructus Piperis, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Rehmanniae, Cortex Cinnamomi, Semen Strychni, Rhizoma Et Radix Notopterygii, Radix Scrophulariae, Herba Ephedrae, Cortex Moutan, Cortex Phellodendri, Radix Paeoniae Rubra, Radix Angelicae Sinensis, the Radix Linderae, Herba Schizonepetae, Radix Angelicae Pubescentis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae 20 flavor medical materials, get 0.25 part of Flos Caryophylli, 0.5 part of Cortex Cinnamomi, Fructus Piperis is ground into impalpable powder for 0.75 part, the residue Flos Caryophylli, Cortex Cinnamomi is extracted volatile oil respectively, 18 flavors such as the medicinal residues behind the extraction volatile oil and all the other Radix Et Rhizoma Rhei, ooze with 85% ethanol and to make the fluid extract that relative density is 1.1 (50 ℃), reclaim ethanol, add above-mentioned fine powder and Flos Caryophylli, Cortex Cinnamomi volatile oil adds by 25 parts of rubber again, 30 parts of zinc oxide, 25 parts of Colophonium, 5 parts of lanolines, 2 parts in vaseline, 1 part of substrate of making of liquid paraffin, solvent is 70 parts in 1 a 20# gasoline, molten coal is 5 parts of ethanol, makes coating, is coated with cream, cutting, the lid lining, section, promptly.

[usage and dosage] external is pasted for one time 1, changed once in 24～48 hours, with illing skin clean dry after, plaster is sticked.

[taboo] forbidden pasting and used when property of drug changes.

Erythra appears in [points for attention] accidental subsides medicine place skin, but anti symptom treatment.

[storage] is airtight, puts shady and cool place.

[effect duration] 1.5 years.

Embodiment 2

Take by weighing each component raw material according to following weight parts:

26 parts in Fructus Piperis, 3 parts of Radix Et Rhizoma Rhei, 3 parts of Radix Scutellariaes, 3 parts of Radix Rehmanniae, 16 parts of Cortex Cinnamomis, 1.5 parts of Semen Strychni, 3 parts of Rhizoma Et Radix Notopterygiis, 3 parts of Radix Scrophulariaes, 3 parts in Herba Ephedrae, 1.5 parts of Cortex Moutans, 3 parts of Cortex Phellodendris, 3 parts of Radix Paeoniae Rubra, 3 parts of Radix Angelicae Sinensis, 3 parts of the Radixs Linderae, 3 parts of Herba Schizonepetae, 3 parts of Radix Angelicae Pubescentiss, 3 parts of the Radixs Angelicae Dahuricae, 3 parts of Radix Saposhnikoviaes, 3 parts of Rhizoma Drynariae, 15 parts of Flos Caryophyllis.

Preparation method: preparation method: Fructus Piperis, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Rehmanniae, Cortex Cinnamomi, Semen Strychni, Rhizoma Et Radix Notopterygii, Radix Scrophulariae, Herba Ephedrae, Cortex Moutan, Cortex Phellodendri, Radix Paeoniae Rubra, Radix Angelicae Sinensis, the Radix Linderae, Herba Schizonepetae, Radix Angelicae Pubescentis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae 20 flavor medical materials, get 0.75 part of Flos Caryophylli, 0.8 part of Cortex Cinnamomi, Fructus Piperis is ground into impalpable powder for 1.3 parts, the residue Flos Caryophylli, Cortex Cinnamomi is extracted volatile oil respectively, 18 flavors such as the medicinal residues behind the extraction volatile oil and all the other Radix Et Rhizoma Rhei, ooze with 95% ethanol and to make the fluid extract that relative density is 1.2 (50 ℃), reclaim ethanol, add above-mentioned fine powder and Flos Caryophylli, Cortex Cinnamomi volatile oil adds by 40 parts of rubber again, 50 parts of zinc oxide, 40 parts of Colophonium, 10 parts of lanolines, 5 parts in vaseline, 3 parts of substrate of making of liquid paraffin, solvent are 90 parts in 120# gasoline, molten coal is 15 parts of ethanol, make coating, be coated with cream, cutting, the lid lining, section.

Usage, consumption, taboo, points for attention, storage, effect duration are with embodiment 1.

Embodiment 3

Take by weighing each component raw material according to following weight parts:

19 parts in Fructus Piperis, 2 parts of Radix Et Rhizoma Rhei, 2 parts of Radix Scutellariaes, 2 parts of Radix Rehmanniae, 11 parts of Cortex Cinnamomis, 1 part of Semen Strychni, 2 parts of Rhizoma Et Radix Notopterygiis, 2 parts of Radix Scrophulariaes, 2 parts in Herba Ephedrae, 1 part of Cortex Moutan, 2 parts of Cortex Phellodendris, 2 parts of Radix Paeoniae Rubra, 2 parts of Radix Angelicae Sinensis, 2 parts of the Radixs Linderae, 2 parts of Herba Schizonepetae, 2 parts of Radix Angelicae Pubescentiss, 2 parts of the Radixs Angelicae Dahuricae, 2 parts of Radix Saposhnikoviaes, 2 parts of Rhizoma Drynariae, 10 parts of Flos Caryophyllis.

Preparation method: preparation method: Fructus Piperis, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Rehmanniae, Cortex Cinnamomi, Semen Strychni, Rhizoma Et Radix Notopterygii, Radix Scrophulariae, Herba Ephedrae, Cortex Moutan, Cortex Phellodendri, Radix Paeoniae Rubra, Radix Angelicae Sinensis, the Radix Linderae, Herba Schizonepetae, Radix Angelicae Pubescentis, the Radix Angelicae Dahuricae, Radix Saposhnikoviae 20 flavor medical materials, get 0.5 part of Flos Caryophylli, 0.55 part of Cortex Cinnamomi, Fructus Piperis is ground into impalpable powder for 0.95 part, the residue Flos Caryophylli, Cortex Cinnamomi is extracted volatile oil respectively, 18 flavors such as the medicinal residues behind the extraction volatile oil and all the other Radix Et Rhizoma Rhei, ooze with 90% ethanol and to make the fluid extract that relative density is 1.15 (50 ℃), reclaim ethanol, add above-mentioned fine powder and Flos Caryophylli, Cortex Cinnamomi volatile oil adds by 32 parts of rubber again, 40 parts of zinc oxide, 32 parts of Colophonium, 8 parts of lanolines, 3 parts in vaseline, 2 parts of substrate of making of liquid paraffin, solvent are 80 parts in 120# gasoline, molten coal is 10 parts of ethanol, make coating, be coated with cream, cutting, the lid lining, section.

Usage, consumption, taboo, points for attention, storage, effect duration are with embodiment 1.

In order to verify the good effect of medicine of the present invention, the inventor has carried out a large amount of experiments, now is reported as follows, and drug nomenclature of the present invention is ' child antidiarrhea subsides '.

Clinical trial

Child antidiarrhea pastes and to be rubber-emplastrum, is used for the treatment of infant (full moon to three year old) because of being affected by the cold, and the stomachache due to deficiency of spleen-YANG and kidneyYANG, the insufficiency of the spleen and internal damage caused by infantile dyspepsia, has loose bowels.Method is simple but curative effect is higher, can exempt from the hardship of medication in children difficulty.

Because SHENQUE acupoint is superintended and directed through gas phase logically with appointing, and therefore selects for use and pastes this place, can make coordination of YIN and YANG.Make gastrointestinal function recover normal, reach pain relieving antidiarrheal, effect that the preventing or arresting vomiting spasmolytic is astringent or styptic treatment for spontaneous sweating.

Contents such as " infantile diarrhea is prevented and treated scheme ", " the practical department of pediatrics " that diagnostic criteria is issued with reference to Ministry of Public Health in May, 1987, " paediatric internal medicine ", " Doctor-in-charge's lecture ", " TCM Pediatrics " are formulated.

One, the traditional Chinese medical science is examined material:

1, wind-cold type: just rare many foams, foul smell is light, the borborygmus stomachache or the heat that occurs together, nose cold current tears are not tussiculaed, mouthful thirsty, white and moist, the floating pulse of tongue fur.

2, spleen-deficient: in time, end when rushing down or chronic diarrhea is not healed, and just rare or indigestion is whenever done to rush down shallow complexion or pale, pale tongue, white and thin fur, deep-thready pulse in the food back.

3, yang deficiency of spleen and stomache: incessant chronic diarrhea, eat promptly and rush down, excrement matter is rare clearly, aqueous-grainy diarrhea, and perhaps proctoptosis, coldness of the body with chills, complexion is white all of a sudden, lethargy, sleeping with eyes half-closed when sleeping, pale tongue with white fur, pulse condition is thin and delicate.

4, the type of getting ill from overeating: abdominal distention stomachache, cry and scream before rushing down, rush down the back alleviation of pain, it is rancid defecate, vows gas, and halitosis is indigestion and loss of appetite, vomiting, thick fur is bored with or little Huang, rolling pulse.

Two, Western medicine diagnose:

1, all kinds of diarrheal nosetiology classification:

1. escherichia coli enteritis: onset anxious (have slow slightly and increase the weight of gradually), times of defecation increases, and stench flavor being arranged, and is egg soup sample more, and mucus (the visible bloody purulent stool of minority) is arranged.Heat, stomachache vomiting can occur together.Stool routine examination is checked, visible a large amount of leukocyte or pus cell and erythrocyte.The stool antibacterial culturing: escherichia coli are positive.This disease mostly occurs children's below 2 years old, all can fall ill throughout the year, and single summer, sickness rate was the highest.

2. campylobacter jejuni enteritis: heating, headache, backache etc. are arranged earlier, occur vomiting after 1-3 days, suffer from abdominal pain or be angor.Times of defecation increases, and is water sample, or is hemafecia.Stool routine examination is checked, visible leukocyte, pus cell, and a large amount of erythrocyte.The stool antibacterial culturing, campylobacter jejuni can be positive.This sick each age group all can be fallen ill, and summer and autumn, sickness rate was the highest.

3. rotavirus enteritis: onset is anxious, often with heating and upper airway symptoms (cough, watery nasal discharge, pharynx are red etc.), can accompany vomiting, times of defecation increases, and is the yellow-white water sample or is egg soup sample, does not generally have pus and blood, there is not stench flavor, stool routine examination inspection, visible fat drop and small quantities of leukocytes.The stool antibacterial culturing is negative.Stool virus detects: rotavirus can be positive.This disease is more common in children's below 2 years old, with autumn and winter sickness rate the highest.

2, all kinds of diarrheal Clinical typings:

1. light-duty: diarrhoea is less than 10 times/day, and each feces water content is few, and infant does not have dehydration or mild dehydration is only arranged.

2. heavy: diarrhoea is more than 10 times/day, or just time few, and water content is a lot, infant with in, severe dehydration.

3, all kinds of diarrheal stadium classification:

1. acute: the course of disease is in 2 weeks.

2. delay property: the course of disease is in 2 week-2 month.

3. chronic: the course of disease is more than 2 months.

Three, lab testing:

1. routine examination: blood leucocyte sum and differential counting

Stool routine examination

2. etiological examination: stool is sent various antibacterial culturing

Stool is cooked virus and detects, (available quick diagnosis method, the Electronic Speculum of doing with good conditionsi detects) can select 1-2 the primary dcreening operation test of differentiating antibacterial or viral infection if unconditionally carry out the etiological diagnosis inspection, as peripheral blood neutrophil, blue tetrazole reaction of nitro or determination of alkaline phosphatase activity.

3, the electrolyte clearly of can having a blood test in case of necessity is as potassium, sodium, calcium, chlorine trace element.

Four, case load: child antidiarrhea pastes clinical efficacy checking case plan 100-120 example, is used for matched group case plan 30-40 example, and the curative effect checking is intended carrying out at three units.

Five, include standard in:

1, meets the dialectical standard of above-mentioned diagnosis;

2, the age is the person that (contains 12 years old) below 12 years old;

3, without other systemic diseases, no severe malnutrition person.

Six, exclusion standard:

1, medication is not adhered in not medication in accordance with regulations.Or add with antibiotic or other Chinese medicine, and can't judge curative effect or safety person;

2, final diagnosis does not meet and includes standard person in.

Seven, adopt grouping and double-blind method to contrast.

The course of treatment is according to the requirement of criterion of therapeutical effect to each sick kind.

Eight, efficacy evaluation: with reference to health " infantile diarrhea clinical research guideline " promulgated by the ministries or commissions of the Central Government:

1, recovery from illness: rotaviral enteritis, acute dietetic diarrhea treatment three days, escherichia coli and campylobacter jejuni enteritis treatment seven days, delay property and chronic diarrhea treatment ten days, it is normal that times of defecation and character are recovered fully.

2, produce effects: time requirement is the same, and times of defecation obviously reduces (being reduced to 1/3 before treating or following) and character takes a turn for the better, and unusual physical and chemical index obviously improves.

3, effective: time requirement is the same, 1/2 before times of defecation is reduced to and treats, and shape takes a turn for the better, and unusual physical and chemical index makes moderate progress.

4, invalid: time requirement is the same, and times of defecation and character are not improved, or symptom and sign increases the weight of.

Nine, usage and dosage:

Be affixed on infant SHENQUE acupoint (umbilicus) every day 1 time, each 1 pastes, and every subsides can stick 12 hours.

Ten, taboo and attention:

1, should control breast food and guard against children's's abdominal part at night and suffer from cold during the medication.

2, less than three months babies, medicine was affixed under the umbilicus.

3, should paste 1 to 2 after the recovery from illness again pastes to consolidate curative effect.

11, statistics:

Clinical results gathers arrangement must carry out statistical procedures, concludes.

12, reference material:

The high medical college teaching material in the Pediatrics of Chinese Medicine whole nation

Clinical Researches of New Drugs guideline (second batch) bureau of drug administration of Ministry of Health of the People's Republic of China

Test example 1

Child antidiarrhea pastes the clinical verification of treatment infantile diarrhea

Final report

For the checking child antidiarrhea pastes the curative effect and the untoward reaction for the treatment of infantile diarrhea.Through the hospital of traditional Chinese hospital, Xi'an, Xi-an City Central Hospital, No. 4 Hospital of Xi-an City are to research institute: the child antidiarrhea that Yangling Dongke Maidisen Pharmaceutical Co., Ltd produces pastes, and carries out 142 routine clinical observation on the therapeutic effect according to the clinical research plan, now is summarized as follows:

One, physical data:

142 examples are above-mentioned three tame hospital outpatient infants.Male's 78 examples wherein, women's 64 examples.Age: minimum 24 days, maximum 12 years old, wherein＜and 1 years old person's 32 example, 1 to 3 years old person's 61 example was greater than 3 years old person's 49 example.The sick kind: Escherichia coli enteritis 61 examples, campylobacter jejuni enteritis 22 examples, rotaviral enteritis 2 examples, lienteric diarrhea 54 examples, bronchopneumonia merge heart failure companion symptomatic diarrhea 2 examples, and auspicious syndrome merges diarrhoea 1 example.Stadium: acute 121 examples, delay property 12 examples, chronic 9 examples.Typing: light-duty 131 examples, heavy 11 examples.

Two, case is selected:

Diagnostic criteria: include standard in, exclusion standard all pastes clinical research plan standard according to child antidiarrhea and carries out.

Three, criterion of therapeutical effect:

Pasting standard according to child antidiarrhea carries out.

Four, observational technique:

MethodsThe cases enrolled is affixed on infant umbilicus (SHENQUE acupoint) with child antidiarrhea, and 1 time/day, every subsides were removed after 12 hours.

Observe the course of treatment according in the criterion of therapeutical effect sick kind of each kind being required to carry out the course of treatment.

Five, verification method:

Grouping and contrast: finish contrast treatment checking (more than matched group 30 examples) by the hospital of traditional Chinese hospital, Xi'an, MethodsThe cases enrolled adopts the random table method to be divided into treatment group and matched group.Checking is only treated by all the other two tame hospitals.

Six, observe the time limit:

According to criterion of therapeutical effect, each sick kind should meet the time requirement that disease is planted the course of treatment.

Seven, observed result:

It is " bronchopneumonia merges heart failure companion symptomatic diarrhea " that the treatment group has two examples, and 1 example is " an auspicious syndrome companion diarrhoea ", does not all meet the standard of including in 3, and all use other medicines such as antibiotic in the treatment, do not meet discharge standard 1.2, so when statistics given up.Therefore, 109 examples are organized in the treatment of actual summary case, and matched group 30 examples amount to 139 examples.

Each hospital of table one finishes the checking case load

The checking unit	Treatment	Contrast	Add up to
				No. 4 Hospital of Xi-an City of the hospital of traditional Chinese hospital, Xi'an Xi-an City Central Hospital adds up to	30 44 35 109	30 0 0 30	60 44 35 139

Table two treatment group is sick plants and therapeutic effect relationship

The sick kind	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Escherichia coli campylobacter jejuni rotavirus lienteric adds up to	48 19 2 40 109	28 10 0 15 53	12 6 1 11 30	7 2 1 10 20	1 1 0 4 6	97.9 94.7 1 00 90.0 94.5

Table three matched group is sick plants and therapeutic effect relationship

The sick kind	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Escherichia coli campylobacter jejuni rotavirus lienteric adds up to	13 3 0 14 30	2 0 0 2 6	4 1 0 2 7	5 1 0 8 15	2 1 0 2 2	84.6 66.7 85.8 93.3

Table four treatment group and matched group curative effect are relatively

Grouping	Case load	Recovery from illness (%)	Produce effects (%)	Effectively (%)	Invalid (%)	Total effective rate (%)
							The treatment contrast	109 30	53(48.6) 6(20.0)	30(27.5) 7(23.3)	20(1 8.3) 15(50.0)	6(5.5) 2(6.7)	94.5 93.3

Compare two groups of effective percentage statistical procedures: X ²=0.04, degree of freedom=1, P＞0.05 there was no significant difference.So judge the general curative effect and the matched group general curative effect there was no significant difference of treatment group, illustrate that NUANQIGAO (black plaster) changes the effect that does not reduce former side's medicine behind the rubber-emplastrum into.But relatively the two groups of above case treatment of produce effects groups are (83) 76.1%, and matched group is (13) 43.3%.Learn by statistics and handle: X ²=10, degree of freedom=1, P＜0.01 difference highly significant.So it is better than NUANQIGAO (black plaster) to judge that child antidiarrhea pastes.

Dialectical and the therapeutic effect relationship of table five treatment group

Pattern of syndrome	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							The wind-cold type type spleen-deficient yang deficiency of spleen and stomache of getting ill from overeating adds up to	50 34 21 4 109	23 20 10 0 53	20 4 5 1 30	5 8 4 3 20	2 2 2 0 6	96.0 94.1 90.5 100 94.5

Dialectical and the therapeutic effect relationship of table six matched group

Pattern of syndrome	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							The wind-cold type type spleen-deficient yang deficiency of spleen and stomache of getting ill from overeating adds up to	10 9 10 1 30	2 2 2 0 6	3 1 3 0 7	4 5 5 1 2	1 1 0 0 2	90.0 88.9 100 93.3

By table five, six as seen, the curative effect of two groups of each pattern of syndrome is significantly, illustrates that the plaster of two kinds of dosage forms all is applicable to above-mentioned each pattern of syndrome diarrhoea.Less because of table five back amphitypy case load, not statistically significant is not so organize each pattern of syndrome curative effect relatively do treatment.

Table seven treatment group stadium and therapeutic effect relationship

Stadium	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							The chronic total of acute delay	88 12 9 109	47 4 2 53	23 5 2 30	14 3 3 20	4 0 2 6	95.4 100 77.8 94.5

Table eight matched group stadium and therapeutic effect relationship

Stadium	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Acute delay is chronic	24 3 3	6 0 0	5 1 1	12 2 1	1 0 1	95.4 100 66.7

The example number is very few, not statistically significant, and curative effect compares between the stadium so do not do.

Table nine treatment component type and therapeutic effect relationship

Typing	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Light-duty heavy the total	92 17 109	44 9 53	22 8 30	20 0 20	6 0 6	93.5 100 94.5

Table ten matched group and therapeutic effect relationship

Typing	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Light-duty heavy the total	29 1 30	6 0 6	6 1 7	15 0 15	2 0 2	93.1 / 93.3

By table nine, ten as seen, two groups of classification of cases trend are unanimous on the whole.And two groups of light-duty curative effects are approaching substantially.Heavy case is very few, and curative effect compares between the disease type so do not do.

Table ten treatment group recovery from illness case and the course of treatment relation

Stadium	Prescribed time-limit	Cure routine number	One day more	％	Two days more	％	1/2 course of treatment more	％
									The chronic total of acute delay	7 days 7 days 3 days 10 days	28 10 13 2	7 2	25 15.4	5 3 4	17.8 30 30.8	16 7 7 2	57.2 70 53.8 100

Table ten result as can be known, child antidiarrhea pastes the treatment escherichia coli, campylobacter jejuni is evident in efficacy.Use child antidiarrhea to paste and the patient of NUANQIGAO, none example is found to have skin to itch and is waited allergy, irritant reaction, and whole body also has no adverse reaction, and illustrates that these two kinds of clinical drugs application are safe and reliable.

Conclusion:

1, diarrhoea is considered to one of world child four big disease preventing and treating for usual diseases of childhood, frequently-occurring disease.The treatment aspect is selected the external application medicine for use, can exempt the hardship of medication in children.Child antidiarrhea pastes and reaches 94.5% through the clinical verification total effective rate.Than NUANQIGAO (contrasting 30 examples, total effective rate 93.3%) there was no significant difference.Yet the obvious effective rate that child antidiarrhea pastes is 76.1%, significantly is better than 43.3% of NUANQIGAO.The proof child antidiarrhea pastes, and not only clinical use is more convenient, and stronger than NUANQIGAO effect, more easy for patients to accept.

2, child antidiarrhea pastes wind-cold type, the type of getting ill from overeating, and spleen-deficient, the yang deficiency of spleen and stomache infantile diarrhea all has significant curative effect, can think that this medical instrument has warming spleen and stomach for dispelling cold, warming the kidney and strengthening the spleen, pain relieving antidiarrheal effect.And drug application borrows the intersection of whole body negative and positive of qi and blood sensible pivot in SHENQUE acupoint, makes drug effect speed to sick institute, and is quick-acting to get.

3, child antidiarrhea pastes escherichia coli, and jejunum campylobacter bacterial type enteritis is evident in efficacy, and is better than non-source of disease infective enteritis, illustrates that this medical instrument has stronger antiinflammatory, bacteriostasis.

4, the child antidiarrhea subsides are also remarkable to the lienteric diarrhea curative effect, illustrate that this medical instrument has the effect that improves gastrointestinal dysfunction.

5, child antidiarrhea being pasted Clinical results shows: and this medicine treatment infant infection or noninfectious diarrhea (wind and cold, insufficiency of the spleen, deficiency of spleen-YANG and kidneyYANG, the type of getting ill from overeating) determined curative effect, remarkable.And have rapid-action, short treating period, easy to use, have no side effect, be worth advantages such as cheap, be worthy to be popularized.

Test example 2

Child antidiarrhea pastes 60 routine clinical verifications and sums up

Experimental unit: the hospital of traditional Chinese hospital, Xi'an

My institute's department of pediatrics to the treatment infantile diarrhea external used medicine of Yangling Dongke Maidisen Pharmaceutical Co., Ltd's development and production " children's rush down subsides " and matched group medicine " NUANQIGAO " carried out the clinical control checking, now be summarized as follows:

One, physical data:

Each 30 example of treatment group and matched group are my out-patient treatment infant.

Treatment group: male 24 examples, women 13 examples.Age:＜1 years old 8 example, 1-3 year 12 examples,＞year 10 examples.The course of disease: the shortest 1 day, the longest 2 years.The sick kind: infectious diarrhea 20 examples, noninfectious diarrhea 10 examples.

Two, identifying object and method:

(1) case is selected:

Standard is included in diagnostic criteria in, and the standard of sending is all pasted clinical research plan standard according to, child antidiarrhea and carried out.

(2) observational technique:

1, select case to be divided into treatment group and matched group by the random table method.

2, treatment group medication " child antidiarrhea subsides ".

Matched group: " NUANQIGAO ".

During above-mentioned two kinds of drug uses, ointment is affixed on infant umbilicus (SHENQUE acupoint), every day 1 time, each 1 pastes, and every subsides were removed after 12 hours.

3, observe the time limit according to the criterion of therapeutical effect requirement.

(3) criterion of therapeutical effect:

Pasting clinical research plan standard according to child antidiarrhea carries out.

Three, observed result:

Table one treatment group is by the sick classification curative effect of planting

The sick kind	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Escherichia coli campylobacter jejuni rotavirus lienteric adds up to	9 3 1 17 30	2 1 0 2 5	4 1 0 5 10	3 1 1 9 14	0 0 0 1 1	96.6

Table two matched group is by the sick classification curative effect of planting

The sick kind	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Escherichia coli campylobacter jejuni rotavirus lienteric adds up to	13 2 0 15 30	4 1 0 0 5	5 0 0 3 8	4 1 0 10 15	0 0 0 2 2	93.3

Table three liang group curative effect relatively

Grouping	Case load	Recovery from illness (%)	Produce effects (%)	Effectively (%)	Invalid (%)	Total effective rate (%)
							Treatment group matched group	30 30	5(16.7) 5(16.7)	10(33.3) 8(26.7)	14(46.7) 15(50.0)	1(3.3) 2(6.6)	96.7 93.3

Statistical procedures: X ²=0.04, P＞0.05 there was no significant difference.So judge the general curative effect and the matched group general curative effect there was no significant difference of treatment group.

Table four treatment group is pressed the medicine typing curative effect

Pattern of syndrome	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							The wind-cold type type spleen-deficient yang deficiency of spleen and stomache of getting ill from overeating adds up to	9 8 9 4 30	3 1 1 0 5	4 2 3 1 10	2 5 4 3 14	0 0 1 0 1	96.7

Table five matched group is pressed the medicine typing curative effect

Pattern of syndrome	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							The wind-cold type type spleen-deficient yang deficiency of spleen and stomache of getting ill from overeating adds up to	10 10 1 9 30	2 2 0 1 5	3 3 0 2 8	4 5 1 5 15	1 0 0 1 2	93.3

By table four, table five as seen, two groups of medicines all produce effect to above-mentioned four types, and less because of case load, curative effect compares between each pattern of syndrome so do not do.

Four, conclusion:

1, child antidiarrhea paste by Flos Caryophylli, Cortex Cinnamomi, Radix orixae japonicae, Herba Schizonepetae, Radix Saposhnikoviae, Herba Ephedrae, Radix Angelicae Sinensis, Radix Rehmanniae, the Radix Linderae, Mao Jiang etc. 20 simply medicine form.The cold expelling of inducing sweat is arranged, warming the kidney to activate YANG, the merit of warm spleen antidiarrheal, clinical verification all has better curative effect to children's's wind and cold, insufficiency of the spleen, deficiency of spleen-YANG and kidneyYANG, the type of getting ill from overeating diarrhoea, especially to wind and cold, splenoasthenic diarrhea better effects if.

2, the child antidiarrhea subsides are all effective in cure to escherichia coli, campylobacter jejuni property, rotaviral enteritis, illustrate that this medical instrument has antiinflammatory, bacteriostasis.Also good to the lienteric diarrhea effect, illustrate that this medical instrument has the effect that improves gastrointestinal dysfunction.

3, the child antidiarrhea subsides are more more convenient than the NUANQIGAO use, are easy to be accepted by the patient.And clinical total effective rate (96.7%) is also higher than NUANQIGAO (93.3%), illustrates that this medicine effect is good.

4, two groups of drug uses all find no toxic and side effects and untoward reaction, and clinical practice safety is described.

5, this medicine adopts giving drugs into nose external treatment, can exempt the hardship that infant is taken medicine, have letter, just, test, honest and clean characteristics, be worthy to be popularized.

The hospital of traditional Chinese hospital, Xi'an department of pediatrics

Test example 3

Child antidiarrhea pastes 35 routine clinical verification final reports

Experimental unit: Xi'an is four-player people hospitals

I have carried out clinical verification in May, 93 to June to the little anti-diarrheal plaster treatment infantile diarrhea that Yangling Dongke Maidisen Pharmaceutical Co., Ltd produces at institute's department of pediatrics, and am existing that 35 routine observed result final reports are as follows:

One, physical data:

15 examples among the 35 routine infantile diarrhea patients, women 20 examples.Age＜1 year old 6 examples, 1-3 year 22 examples,＞3 years old 7 example.The sick kind: infective enteritis 24 examples, noninfectious diarrhea 11 examples.Dialectical: wind-cold type 21 examples, spleen-deficient 3 examples, the type of getting ill from overeating 11 examples.33 routine acute patients in the above case, 2 examples are the persisting type patient.

Two, case is selected:

Diagnostic criteria: include standard in, exclusion standard all pastes clinical research plan standard according to child antidiarrhea and carries out.

Three, criterion of therapeutical effect:

Pasting standard according to child antidiarrhea carries out.

Four, observational technique:

MethodsThe cases enrolled is affixed on infant umbilicus (SHENQUE acupoint) with child antidiarrhea, and 1 time/day, every subsides were removed after 12 hours.

Observe the course of treatment according in the criterion of therapeutical effect sick kind of each kind being required to carry out the course of treatment.

Five, observed result:

(1) general curative effect: in 35 examples, 16 examples of fully recovering (45.7%), effective 5 examples of produce effects 1 example (34.3%) (14.3%), invalid 2 power (5.7%), total effective rate 94.3%.

(2) the sick therapeutic effect relationship of planting sees Table one.

The sick therapeutic effect relationship of planting of table one

The sick kind	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Escherichia coli campylobacter jejuni lienteric adds up to	20 4 11 35	13 0 3 16	3 3 6 12	4 1 0 5	0 0 2 2	94.3

As shown in Table 1, child antidiarrhea pastes the infective enteritis curative effect is better than lienteric diarrhea, because of case load less, so do not do statistical procedures.

(3) medicine typing and therapeutic effect relationship

Table two medicine typing and therapeutic effect relationship

Pattern of syndrome	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							The wind-cold type spleen-deficient type of getting ill from overeating adds up to	21 3 11 35	8 3 5 16	10 0 2 12	2 0 3 5	1 0 1 2	94.3

Have table two as can be known, child antidiarrhea pastes all to be had than significant curative effect above-mentioned pattern of syndrome diarrhoea, and because of case load is few, curative effect compares between the pattern of syndrome so do not do.

(4) doctor trained in Western medicine typing and therapeutic effect relationship see Table three.

Table three doctor trained in Western medicine typing and therapeutic effect relationship

Typing	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Light-duty heavy type	29 1	13 3	9 3	5 0	2 0	93.1 100

(5) onset time: infant is many to paste the back onset 1, can cure after general 4-5 pastes.

(6) toxicity: 35 examples are used in the child antidiarrhea subsides and are all found no toxicity.Only 1 routine patient 4 pastes the slight cloth hypersensitivity of the local appearance in back, and stopping using was complete obiteration after 1 day.

Six, conclusion:

1, uses child antidiarrhea subsides external application SHENQUE acupoint treatment infantile diarrhea 35 routine total effective rates and reach 94.3%, determined curative effect.

2, this medicine centering doctor wind-cold type, all better curative effect of spleen-deficient, listing type infantile diarrhea, illustrating has the warming spleen and stomach for dispelling cold pain relieving in this medicine, the effect of warm spleen antidiarrheal, the heresy of the kind YIN-cold of dispelling.

3, this medicine can be exempted from the hardship of medication in children with the method for inner disease outer treat, really for one of treatment infantile diarrhea good medicine, is worth of widely use.

Xi'an four-player people pediatric hospital

Test example 4

Child antidiarrhea pastes clinical observation on the therapeutic effect 44 routine final reports

Experimental unit: Xi-an City Central Hospital

My institute's department of pediatrics is treated infantile diarrhea to the child antidiarrhea subsides of Yangling Dongke Maidisen Pharmaceutical Co., Ltd's development and carried out clinical verification, and is existing that 44 routine observed result final reports are as follows:

One, physical data:

44 examples are our out-patient treatment infant, male's 25 examples wherein, women's 19 examples, the age: minimum 56 days, maximum 8 years old,＜1 years old 12 example, 1-3 year 17 examples,＞3 years old 15 example.The course of disease: the shortest 4 days, the longest 6 months.The sick kind: infective enteritis 32 examples, non-infectious enteritis 12 examples.

Two, identifying object and method:

(1) case choice criteria:

Diagnostic criteria: include standard in, exclusion standard pastes clinical research plan standard according to child antidiarrhea and carries out.

(2) observational technique:

1, MethodsThe cases enrolled is affixed on the infant umbilicus 1 time/day with child antidiarrhea, removes after 12 hours.

2, observe the time limit with test example 3.

3, paste the clinical research plan according to child antidiarrhea and require to fill in " clinical observation case card ".

(3) criterion of therapeutical effect:

Pasting clinical research plan standard according to child antidiarrhea carries out.

Two, observed result

Table one is sick plants and therapeutic effect relationship

The sick kind	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Escherichia coli campylobacter jejuni rotavirus lienteric adds up to	19 12 1 12 44	12 10 0 10 32	5 2 1 0 8	1 0 0 1 2	1 0 0 1 2	95.5

By table one as seen, this medicine all has significant curative effect to above-mentioned four kinds of diarrhoea.Because of case load less.Curative effect compares between each sick kind so do not do.

Table two tcm syndrome differentiation and typing and therapeutic effect relationship

Pattern of syndrome	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							The wind-cold type spleen-deficient type of getting ill from overeating adds up to	20 9 15 44	12 6 14 32	6 1 1 8	1 1 2	1 1 2	95.5

By table two as seen, this medicine is all remarkable to the diarrhoea curative effect of above-mentioned three kinds of pattern of syndrome.Less because of each pattern of syndrome case, curative effect compares between each pattern of syndrome so do not do.

Table three doctor trained in Western medicine typing and therapeutic effect relationship

Typing	Case load	Recovery from illness	Produce effects	Effectively	Invalid	Total effective rate (%)
							Light-duty heavy type	39 5	29 3	6 2	2 0	2 0	94.9 100

By table three as seen, this medicine is all satisfied to degree type diarrhoea curative effect.

Four, toxic and side effects:

In the 44 routine clinical observations, do not have 1 example and toxic and side effects occurs, untoward reaction such as skin allergy, it is as safe as a house that the prompting child antidiarrhea pastes external application.

Five, conclusion:

1, above case has all been used a course of treatment, and 2 routine nonresponders use other treatment instead after one course of treatment.This medicine all has significant curative effect (seeing Table) to lienteric diarrhea, escherichia coli enteritis, campylobacter jejuni enteritis.

2, delay property, the chronic diarrhea clinical treatment is rather thorny, and uses child antidiarrhea subsides curative effect comparatively satisfied.8 routine infants are all obtained recovery from illness or produce effects.

3, this medicine to because of affection of exogenous wind-cold, insufficiency of the spleen, get ill from overeating etc. due to diarrhoea produce effects is all arranged, point out this medical instrument that warming spleen and stomach for dispelling cold is arranged, warm spleen antidiarrheal, analgesic effect.

4, height is imitated in this medication, and price is honest and clean, uses easily, welcome by infants ' parents, is worth promoting.

Test example 5

Child antidiarrhea pastes animal skin hypersensitive test data

Be subjected to the reagent thing: child antidiarrhea pastes

Experimental animal: albino guinea-pig, sex is regardless of, body weight 250-300g, shared 10.

Method: the hair guinea pig back before the test is sloughed about 10cm ². tested first day, the 7th day and the 14th day are being tried plaster (3 * 3cm ²) paste with the back depilation after, remove ointment after 6 hours, pasted once again in the 28th day, method is the same, removes plaster after 6 hours, can observe the dermoreaction situation, 24 hours, observed once respectively again in 48 hours and 72 hours, see that skin has or not anaphylaxis to take place.

Result: press the scoring of dermoreaction standard, judge the extent of reaction according to the reaction difference.10 animal average response values are zero (it is zero that erythema and edema form total points), and sensitization rate (%) (skin erythema and edema animal number) also is zero.Conclusion: this product belongs to no sensitization medicine.

The Traditional Chinese Medicine Research Institute, Shanxi Province

Claims (4)

1. Chinese medicine unguentum for the treatment of infantile diarrhea, form by active component and substrate, it is characterized in that making the active component raw material medicine consists of by weight: Fructus Piperis 15-26 part, Radix Et Rhizoma Rhei 1-3 part, Radix Scutellariae 1-3 part, Radix Rehmanniae 1-3 part, Cortex Cinnamomi 10-16 part, Semen Strychni 0.5-1.5 part, Rhizoma Et Radix Notopterygii 1-3 part, Radix Scrophulariae 1-3 part, Herba Ephedrae 1-3 part, Cortex Moutan 0.5-1.5 part, Cortex Phellodendri 1-3 part, Radix Paeoniae Rubra 1-3 part, Radix Angelicae Sinensis 1-3 part, Radix Linderae 1-3 part, Herba Schizonepetae 1-3 part, Radix Angelicae Pubescentis 1-3 part, Radix Angelicae Dahuricae 1-3 part, Radix Saposhnikoviae 1-3 part, Rhizoma Drynariae 1-3 part, Flos Caryophylli 5-15 part;

Substrate consists of by weight: rubber 25-40 part, zinc oxide 30-50 part, Colophonium 25-40 part, lanoline 5-10 part, vaseline 2-5 part, liquid paraffin 1-3 part.

2. the Chinese medicine unguentum of treatment infantile diarrhea as claimed in claim 1 is characterized in that the consumption of described crude drug is: 19 parts in Fructus Piperis, 2 parts of Radix Et Rhizoma Rhei, 2 parts of Radix Scutellariaes, 2 parts of Radix Rehmanniae, 11 parts of Cortex Cinnamomis, 1 part of Semen Strychni, 2 parts of Rhizoma Et Radix Notopterygiis, 2 parts of Radix Scrophulariaes, 2 parts in Herba Ephedrae, 1 part of Cortex Moutan, 2 parts of Cortex Phellodendris, 2 parts of Radix Paeoniae Rubra, 2 parts of Radix Angelicae Sinensis, 2 parts of the Radixs Linderae, 2 parts of Herba Schizonepetae, 2 parts of Radix Angelicae Pubescentiss, 2 parts of the Radixs Angelicae Dahuricae, 2 parts of Radix Saposhnikoviaes, 2 parts of Rhizoma Drynariae, 10 parts of Flos Caryophyllis.

3. the Chinese medicine unguentum of treatment infantile diarrhea as claimed in claim 1 is characterized in that described substrates quantity is: 32 parts of rubber, 40 parts of zinc oxide, 32 parts of Colophonium, 8 parts of lanolines, 3 parts in vaseline, 2 parts of liquid paraffin.

4. the preparation method of the Chinese medicine unguentum of the described treatment infantile diarrhea of claim 1 is characterized in that, follows these steps to carry out:

Flos Caryophylli, Cortex Cinnamomi, the Fructus Piperis of getting in the crude drug respectively 1/20th are ground into impalpable powder;

Residue Flos Caryophylli, Cortex Cinnamomi are extracted volatile oil respectively, extract medicinal residues behind the volatile oil and all the other crude drug one and reinstate 85-95% ethanol and ooze and make the fluid extract that relative density is 1.1-1.2;

Reclaim ethanol, add Flos Caryophylli, Cortex Cinnamomi, Fructus Piperis impalpable powder and the Flos Caryophylli of pulverizing, the volatile oil that Cortex Cinnamomi is extracted, adding the substrate of being made by rubber, zinc oxide, Colophonium, lanoline, vaseline, liquid paraffin again, is solvent with 70-90 part gasoline then, and ethanol 5-15 part is molten coal, make coating, be coated with cream, cutting, lid lining, section, promptly.