CN103405742B - Drug composition for treating infantile diarrhea and preparation method thereof - Google Patents

Abstract

The invention relates to a drug composition for treating infantile diarrhea and a preparation method thereof. The drug composition is prepared from the following raw materials in parts by weight: 30 parts of white hyacinth bean, 27 parts of Chinese pulsatilla root, 25 parts of red peony root, 25 parts of zedoray rhizome, 25 parts of dandelions, 22 parts of radish seed, 22 parts of largehead atractylodes rhizome, 20 parts of pomegranate rinds, 20 parts of agarics, 18 parts of almonds, 18 parts of Indian bread, 18 parts of Chinese trumpet creeper, 15 parts of liquorice, 15 parts of divaricate saposhnikovia root, 15 parts of nutgrass galingale rhizome, 15 parts of perilla leaf, 10 parts of dried ginger, 10 parts of purslane herb, 10 parts of orange fruit, 10 parts of silktree albizia bark, 7 parts of garden burnet root, 7 parts of Sichuan lovage rhizome, 5 parts of amur corktree bark, 3 parts of barbary wolfberry fruit and 3 parts of hawthorns. The drugs are used jointly and bring out the best in each other, so that the drug composition takes an effect on infantile diarrhea quickly and has extensive application prospects.

Description

A kind of pharmaceutical composition for the treatment of infantile diarrhea and preparation method thereof

Technical field

The invention belongs to Chinese medicine technical field, concrete, relate to a kind of pharmaceutical composition for the treatment of infantile diarrhea taking Chinese herbal medicine as raw material and preparation method thereof.

Background technology

Infantile diarrhea disease be one group by multiple cause of disease, many factors causes, to suffer from diarrhoea as the common intestinal tract disease of department of pediatrics of cardinal symptom, is one of principal disease threatening children's health.Modern medicine thinks that 80% children's's infection is caused by virus institute, and rotavirus is main pathogen.Other causes of disease also have antibacterial infection, parasitic infection and fungal infection, are mainly the damages to intestinal mucosa of toxin due to virus, antibacterial and generation thereof, make absorption and the secretory function generation obstacle of Water-Electrolyte, due to large quantity of moisture rests in enteric cavity.Western medical treatment is taking antiviral drugs as main clinically at present, and its treatment measure mainly contains: (1) supplements trace element and the vitamin such as zinc, ferrum, vitamin PP, A, C, B1, B12 and folic acid; (2) intestinal mucosa such as montmorillonite powder protection medicine; (3) micro-Ecological regulation preparation or the flora regulator such as bacillus bifidus, bacillus acidophilus and streptococcus faecalis.Medicine mainly contains five dimension Portugal calcium, dioctahedral smectite, golden bifid or Medilac-Vita.The problems such as above-mentioned curative effect is often undesirable, and has abuse of antibiotics, the fluid infusion of abuse vein.The ill rear state of an illness of children's is critical, and intravenously administrable has certain difficulty, and oral administration infant is often uncooperative, and curative effect is not good enough.Give in treatment and bring a lot of difficulties, make protracted inflammation, also give the head of a family and infant in spirit simultaneously, all brought economically white elephant.

Motherland's medical science thinks that infantile diarrhea claims again to have loose bowels, and increases with times of defecation, and the thin water sample that is of excrement matter is primary symptom, belongs to the Chinese medicine category of " having loose bowels ".Be one of usual diseases of childhood, within two years old, Infants Below is common, and the age is less, and sickness rate is higher, and clinical symptoms is heavier.The spleen and stomach in children fragility, breast food is wound easily, muscles and bones is weak, wind and cold is easily attacked, congenital weakness of the spleen and stomach in addition, so being invaded by exogenous pathogen, internal injury diet, is the main cause of infantile diarrhea, therefore its pathological changes at taste, of a specified duration excessive other internal organs of getting into bed.Cause that the reason of diarrhoea is mainly with being invaded by exogenous pathogen, internal injury diet, weakness of the spleen and stomach person is common.Be the yellow rare stool of water sample according to stool shape, taste is smelly, and times of defecation is many, the heat that occurs together, and sweating, red tongue, tongue is how yellow greasy, and dialectical is diarrhea due to damp-heat.For experiencing damp and hot heresy, pent up taste, bet large intestine, due to the development of evil in febrile disease is neglected one's duty.Control plan clearing away heat-damp and promoting diuresis, removing dampness for regulating stomach.Causing the reason of infantile diarrhea, is mainly 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 the main digesting food of stomach, it is precise and tiny that The spleen has the function to transport and transform nutrients, if taste are subject to disease, diet enters stomach, indigestion, and abnormal ascent-descent between clear YANG and turbid YIN, and walk large intestine, then become to have loose bowels.The nursing too much, very few, variable interval of taking food, the food of take food too early much starch class and fats, and change suddenly food species, all can cause digestive functional disturbance.Treatment infantile diarrhea should be taking invigorating the spleen and benefiting QI, dampness removing and diarrhea-relieving as method, the pathogenesis that can hit, and the famous doctor's Zhang Jingyue of the Ming Dynasty just proposes the diagnosis of " control and let out not diuresis, Fei Qizhi is also ".

Prior art prescriptions of Chinese medicine lacks dialectical, and treatment cycle is long, and suiting the medicine to the illness property is not strong, and curative effect is not obvious, even also can bring side effect to patient, increases patient suffering, finds effective, safe drugs from natural drug, has become clinical infantile diarrhea important directions.

Summary of the invention

The present invention is the invaluable experience to the pathogenetic understanding of infantile diarrhea and treatment with reference to motherland's medical science, consult existing reasonable formula, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, according to Chinese Pharmacopoeia and pharmacology compatibility, push away Chen Zhixin and gain to some extent, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs is the core theory of Chinese medicine disease always, how to take into account less important pathogenesis for main pathogenesis medication simultaneously, taking into account the treatment of general character and individual character, thereby at utmost embody intension and the extension of Chinese traditional treatment disease, is a realistic problem of Chinese patent medicine compatibility.Inventor is for the main pathogenic characteristic of infantile diarrhea, put into practice according to doctor's row for many years in conjunction with a large amount of secret recipes, by the research to Chinese medicine, and in conjunction with dialectical demonstration, in many ways collect the length of many families, seek therapeutic regimen, from motherland's medical treasure-house, filter out heat clearing away loose evil, QI invigorating is relieving convulsion, stomach function regulating preventing or arresting vomiting, the natural Chinese medicine of warming middle-JIAO to stop diarrhea, by theory of Chinese medical science prescription, skim the cream off milk, meticulously be mixed with the pharmaceutical composition that is used for the treatment of infantile diarrhea of the present invention in conjunction with Traditional Chinese Medicine technology, with respect to Western medicine, Chinese medicine of the present invention is rapid-action, effect is strong, short treating period, safe, without obvious toxic-side effects.All medicines share, and bring out the best in each other.Research is found by experiment, originally can make the water damp poison being stranded in intestinal change its course goes from urine, can promote again the recovery of intestinal absorption and the function of motion simultaneously, be conducive to enteric cavity to water, electrolytical absorption, reduce enteric cavity osmotic pressure, reduce the secretion of intestinal juice, strengthen the role of correcting of fluid replacement therapy to dehydration, mistake electrolyte, acid base imbalance.There is facilitating digestion liquid secretion simultaneously, promote diet, effect is told in town, therefore treat infantile diarrhea evident in efficacy.

For realizing the object of the invention, the technical solution used in the present invention is as follows:

Treat a pharmaceutical composition for infantile diarrhea, its raw material by following weight proportioning is prepared and is obtained:

30 parts of Semen Lablab Albums, 27 parts of the Radix Pulsatillaes, 25 parts of Radix Paeoniae Rubra, 25 parts of Rhizoma Curcumae, 25 parts of Herba Taraxacis,

22 parts of Semen Raphanis, 22 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Pericarpium Granatis, 20 parts, Auricularia, 18 parts, Semen Armeniacae Amarum,

18 parts, Poria, 18 parts of Flos Campsiss, 15 parts, Radix Glycyrrhizae, 15 parts of Radix Saposhnikoviaes, 15 parts of Rhizoma Cyperis,

15 parts of Folium Perillaes, 10 parts of Rhizoma Zingiberiss, 10 parts of Herba Portulacaes, 10 parts of Fructus Aurantiis, 10 parts of Cortex Albiziaes,

7 parts of Radix Sanguisorbaes, 7 parts of Rhizoma Chuanxiongs, 5 parts of Cortex Phellodendris, 3 parts of Fructus Lycii, 3 parts of Fructus Crataegis.

Its preparation of pharmaceutical composition of the present invention and instructions of taking are: the crude drug (proportioning unit: gram) of getting above-mentioned parts by weight is prepared capsule, and concrete operations are:

1) take each crude drug, for subsequent use;

2) get Semen Lablab Album, the Radix Pulsatillae, Radix Paeoniae Rubra, Rhizoma Curcumae, Herba Taraxaci, Semen Raphani, the Rhizoma Atractylodis Macrocephalae, Pericarpium Granati, Auricularia and Semen Armeniacae Amarum, mix homogeneously, the water intense fire that adds 5 times of weight boils, and then slow fire boiling 1 hour is filtered and is collected filtrate and filtering residue; In filtering residue, add water, not have filtering residue to be as the criterion, intense fire boils, and then slow fire boiling 30 minutes is filtered and collected filtrate; Merge above-mentioned twice filtrate, cooling after, be condensed into the extractum that density is 1.1-1.2g/ml; After 80 DEG C of oven dry, be ground into powder, be complex A;

2) get Poria, Flos Campsis, Radix Glycyrrhizae, Radix Saposhnikoviae, Rhizoma Cyperi, Folium Perillae, Rhizoma Zingiberis, Herba Portulacae, Fructus Aurantii, Cortex Albiziae, Radix Sanguisorbae, Rhizoma Chuanxiong, Cortex Phellodendri, Fructus Lycii and Fructus Crataegi, add 70% soak with ethanol 0.5-1.5 hour, extract twice, each 1-2 hour, merge extractive liquid,, filters, and is condensed into the extractum that relative density is 1.2g/ml, crushed after being dried, obtains complex B;

3) by complex A and complex B mixing and stirring, sterilization makes capsule product, each 1g of oral <1 year, each 2g of 1-2 year, each 3g of 2-3 year, homogeneous day three times.

The component of medicine of the present invention all adopts natural raw material of Chinese medicine, and its preparation is easy, and medicine source is extensive, with low cost, it follows the prescriptions principle of the traditional Chinese medical science, and all medicines share, bring out the best in each other, preparation dose of the present invention is little, and effective ingredient is easy to discharge, absorb soon, bioavailability is high, and drug effect can be given full play to, through clinical practice checking, it is evident in efficacy reliable, and the property of medicine is gentle, there is not toxic and side effects, have a extensive future.

Detailed description of the invention

Embodiment 1

Treat a pharmaceutical composition for infantile diarrhea, its raw material by following weight proportioning is prepared and is obtained:

30 parts of Semen Lablab Albums, 27 parts of the Radix Pulsatillaes, 25 parts of Radix Paeoniae Rubra, 25 parts of Rhizoma Curcumae, 25 parts of Herba Taraxacis,

22 parts of Semen Raphanis, 22 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Pericarpium Granatis, 20 parts, Auricularia, 18 parts, Semen Armeniacae Amarum,

18 parts, Poria, 18 parts of Flos Campsiss, 15 parts, Radix Glycyrrhizae, 15 parts of Radix Saposhnikoviaes, 15 parts of Rhizoma Cyperis,

15 parts of Folium Perillaes, 10 parts of Rhizoma Zingiberiss, 10 parts of Herba Portulacaes, 10 parts of Fructus Aurantiis, 10 parts of Cortex Albiziaes,

7 parts of Radix Sanguisorbaes, 7 parts of Rhizoma Chuanxiongs, 5 parts of Cortex Phellodendris, 3 parts of Fructus Lycii, 3 parts of Fructus Crataegis.

Its preparation of pharmaceutical composition of the present invention and instructions of taking are: the crude drug (proportioning unit: gram) of getting above-mentioned parts by weight is prepared capsule, and concrete operations are:

1) take each crude drug, for subsequent use;

2) get Semen Lablab Album, the Radix Pulsatillae, Radix Paeoniae Rubra, Rhizoma Curcumae, Herba Taraxaci, Semen Raphani, the Rhizoma Atractylodis Macrocephalae, Pericarpium Granati, Auricularia and Semen Armeniacae Amarum, mix homogeneously, the water intense fire that adds 5 times of weight boils, and then slow fire boiling 1 hour is filtered and is collected filtrate and filtering residue; In filtering residue, add water, not have filtering residue to be as the criterion, intense fire boils, and then slow fire boiling 30 minutes is filtered and collected filtrate; Merge above-mentioned twice filtrate, cooling after, be condensed into the extractum that density is 1.1g/ml; After 80 DEG C of oven dry, be ground into powder art, be complex A;

2) get Poria, Flos Campsis, Radix Glycyrrhizae, Radix Saposhnikoviae, Rhizoma Cyperi, Folium Perillae, Rhizoma Zingiberis, Herba Portulacae, Fructus Aurantii, Cortex Albiziae, Radix Sanguisorbae, Rhizoma Chuanxiong, Cortex Phellodendri, Fructus Lycii and Fructus Crataegi, add 70% soak with ethanol 1 hour, extract twice, each 1-2 hour, merge extractive liquid,, filters, and is condensed into the extractum that relative density is 1.2g/ml, crushed after being dried, obtains complex B;

3) by complex A and complex B mixing and stirring, sterilization makes capsule product, each 1g of oral <1 year, each 2g of 1-2 year, each 3g of 2-3 year, three times on the one.

Embodiment 2

One, toxicity test

This experiment adopts healthy SD rat, drug dose gradient prepared by oral administration embodiment 1 is 0.05mg/kg and 1.0mg/kg, successive administration 30 days, during observing rat administration and after drug withdrawal, within 1 week, growth of animal state, movable diet, hematology, blood biochemical, organs and tissues structure and routine urinalysis etc. all have no significant effect, and show that clinical drug safety is reliable.

Two, on the have loose bowels impact of model of Oleum Ricini induced mice

Get 60 of ICR mices, male and female half and half, are divided into model control group, smecta group, the present invention's (embodiment 1 medicine) group at random, and model group gives equal-volume normal saline, once a day, and continuous three days.After last administration 40 minutes, every animal gavage gives 0.2ml Oleum Ricini.Then under mice being put into, be placed with the cell isolation cage of filter paper, one of every lattice.Observation index: muck counting; The filter paper that spreads one 10cm × 10cm area under every cell is made muck counting.React with muck grain number the degree of having loose bowels, first 1～6 hour replacing filter paper per hour once, changes paper once in 7～24 hours, records the accumulation muck sum of each animal in 24 hours, and result is as follows:

Group	Number of cases	Dosage	24h loose stool number of times
				Model control group	20	?	7.13±1.25
Smecta group	20	0.5g／Kg	2.64±1.33
				Embodiment 1 medicine group	20	0.67g／Kg	1.37±1.08

As seen from the above table, the present invention has remarkable effect to Oleum Ricini induced mice diarrhoea.

Embodiment 3

Test altogether acute and chronic diarrhea patient 103 examples of children's, wherein female's 50 examples, male 53 examples, the age is between between August-2 year old.Above-mentioned patient is divided into two groups at random: treatment group 52 examples, matched group 51 examples;

Diagnostic criteria

According to " practical department of pediatrics diagnosis and treatment specification " infantile diarrhea diagnostic criteria, using pale tongue tongue fur, in vain as the Main Basis of spleen-deficient typing, all patients is all diagnosed as infantile diarrhea patient.

Therapeutic Method

The oral embodiment 1 for the treatment of group prepares medicine, each 1g of <1 year, each 2g of 1-2 year, each 3g of 2-3 year, three times on the one.

The oral dioctahedral smectite of matched group, each 1g of <1 year, each 2g of 1-2 year, each 3g of 2-3 year, homogeneous day three times.

3 days courses for the treatment of of rotaviral enteritis, escherichia coli enteritis, noninfectious diarrhea 6 days are a course for the treatment of.One the course for the treatment of person of completing, can classify statistics case as.In observation process, ban use of the about thing in Chinese and Western of antibiotic and other antidiarrheal, ensure to take separately observation medicine.

The standard of curative effect evaluation

According to " subproposal of diarrhoeal diseases curative effect judging standard " of the revision of the whole nation, Beijing in 1998 organizing committee of diarrhoeal diseases control scientific seminar, formulate following the standard of curative effect evaluation:

Cure: treat in 2 days, diarrhoea number of times reduces in 3 times diarrhoea total amount <150ml; In 3 days, feces shape and number of times recover normal, and General Symptoms disappears.

Effective: in medication 2 days, diarrhoea number of times reduces in 5 times, diarrhoea total amount <250ml; In 3 days, feces shape and number of times are clearly better, and General Symptoms obviously improves.

Invalid: after medication in 2 days, diarrhoea number of times still more than 5 times, diarrhoea total amount >300ml, in 3 days, feces shape, number of times and General Symptoms are all without the even deterioration that is clearly better.

Efficacy result sees the following form:

Group	Number of cases	Cure	Effectively	Invalid	Total effective rate
						Treatment group	52	36	14	2	96.15％
Matched group	51	25	19	7	86.27％

Experimental group is compared with matched group significant difference.

Embodiment 4 model cases

Gold certain, female, one week 2 months, autumn fall ill, suffer from diarrhoea 2 days.Suffer from diarrhoea 6～7 times/day, diarrhoea amount is many, defecates for yellow rare watery stool, and urine amount is few.Have a medical check-up: 37.3 DEG C of body temperature, to grow normally, nutrition is general, eye socket depression, lip is dry, and neck is soft, and two pulmonary respiration sounds are clear, do not hear and rale, and hear sounds is strong, 96 times/min of heart rate, the rhythm of the heart is neat, and abdomen is soft, and liver spleen does not touch, bowel sounds active, limb end is slightly cold.Skin elasticity is poor.Pale and moist tongue, thin white fur of tongue.Be diagnosed as infantile diarrhea, income gives the embodiment of the present invention 1 medicine in hospital, takes medicine 1 day, and the state of an illness is clearly better, suffer from diarrhoea 3 times/day, and be yellow loose stool, amount is few, and urine amount is normal.Continue to take medicine 3 days, without diarrhoea, recovery from illness is left hospital.

Qiu, man, 10 months.Suffer from diarrhoea 3 days.Have a medical check-up: 37.3 DEG C of spirit of body temperature still can, the cardiopulmonary Non Apparent Abnormality of having a medical check-up, abdominal part is smooth, abdomen is soft, does not touch enclosed mass, Immobility voiced sound, bowel sounds active.Stool routine examination inspection is shown: watery stool, with heating, cry and scream, and there is lipochondrion, without erythrocyte.Diagnosis: infantile diarrhea.The treatment of application the inventive method, took after the course for the treatment of, and symptom is clearly better; By after treatment in 3 days, infant was separated the stool that is shaped for 1 time every day, and simultaneous phenomenon disappears.With nothing recurrence in anti-month.

What more than enumerate is only best specific embodiment of the present invention.Obviously, the invention is not restricted to above embodiment, can also have many distortion.All distortion that those of ordinary skill in the art can directly derive or associate from content disclosed by the invention, all should think protection scope of the present invention.

Claims (1)

1. treat a pharmaceutical composition for infantile diarrhea, its raw material by following weight proportioning is prepared and is obtained:

30 parts of Semen Lablab Albums, 27 parts of the Radix Pulsatillaes, 25 parts of Radix Paeoniae Rubra, 25 parts of Rhizoma Curcumae, 25 parts of Herba Taraxacis,

22 parts of Semen Raphanis, 22 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Pericarpium Granatis, 20 parts, Auricularia, 18 parts, Semen Armeniacae Amarum,

18 parts, Poria, 18 parts of Flos Campsiss, 15 parts, Radix Glycyrrhizae, 15 parts of Radix Saposhnikoviaes, 15 parts of Rhizoma Cyperis,

15 parts of Folium Perillaes, 10 parts of Rhizoma Zingiberiss, 10 parts of Herba Portulacaes, 10 parts of Fructus Aurantiis, 10 parts of Cortex Albiziaes,

7 parts of Radix Sanguisorbaes, 7 parts of Rhizoma Chuanxiongs, 5 parts of Cortex Phellodendris, 3 parts of Fructus Lycii, 3 parts of Fructus Crataegis.