CN1253016A - Medicinal mixture for treating infantile diarrhea and its preparing process - Google Patents
Medicinal mixture for treating infantile diarrhea and its preparing process Download PDFInfo
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Abstract
A medicinal mixture for treating infantile diarrhea is prepared from pomegranate bark and hazel bark in ratio of 1 : 1, as well as carboxymethylcellulose, rebaudioside and benzoic acid and through the process of washing pomegranate bark and hazel bark, immersing in water, decocting and filtering twice, concentrating until its specific weight is 1.1, cooling, boiling, adding carboxymethyl cellulose, rebaudioside and distilled water, and further adding benzoic acid for sterilizing. Its advantages are simple process and high curative effect.
Description
The present invention relates to a kind of infantile diarrhea mixture and production method thereof for the treatment of clinically.
Infantile diarrhea is a kind of commonly encountered diseases all over the world, and its pathogenic factor is infectious and non-infectious two classes.Infectious factors mainly is to be caused by virus, antibacterial, fungus, protozoon, and pathogen is many to enter digestive tract with food, propagation such as article of everyday use that also can be by polluting, hands, toy; Non-infectious factor mainly is that dietary factor, climatic factor cause.Clinical manifestation can be divided into acute, chronic, persistent diarrhea.Main clinic symptoms is that times of defecation increases, generally about ten times, have up to tens of times, and low inferior with heating, vomiting, appetite.This is sick if treatment is untimely, often can jeopardize the life of infant.China carried out door-to-door survey in 1998 to the present situation of 21 provinces, cities and autonomous regions' diarrhoeal diseasess, calculated according to the result, and the child of the whole nation below 5 years old just has 2.09 hundred million people to suffer from diarrhoea every year; According to World Health Organization's incomplete statistics, developing country has child below 4,500,000 5 years old to die from this disease every year approximately.At present, having the scholar to think trace element disequilibrium (the especially shortage of zinc) in the health abroad, is the reason that causes primary disease, so during treatment, adopt the way of benefit trace element to can be used to treat this disease.Physiotherapy, chemotherapy (Drug therapy) etc. are also adopted in the treatment of this disease both at home and abroad.Physiotherapy has the people to adopt laser to treat infantile diarrhea, though obtained certain curative effect, owing to be subjected to the restriction of some conditions, can not large tracts of land promote.Drug therapy can be divided into external treatment and internal treatment.External treatment adopts some Chinese medicine card umbilicuss more, sticks with paste arch of the foot etc., though this can alleviate the misery of infant, clinical effectiveness is not too obvious.The internal treatment is that endo-medicine is treated this disease; for the most frequently used clinically at present; Western medicine adopts norfloxacin, pipemidic acid, folic acid, sulfonamides etc. more; can both well treat this disease on these clinical drugs; but these chemical drugss often all have certain toxic and side effects, are not suitable for the body of child " the young sun of young the moon ", and improper use regular meeting brings infringement for child's body and mind; so when using, want SC, its toxic and side effects is reduced to minimum.Chinese medicine is when this disease of treatment, adopt " baby's element ", " ginseng a kind of reed mentioned in ancient books Rhizoma Atractylodis Macrocephalae looses " or decoction etc., these medicines are owing to take inconvenience, be not suitable for child's the characteristics of taking medicine, though it is pretty good to have occurred this sick new drug curative effect of treatment of some joint ventures' productions nearly period clinically, but because of costing an arm and a leg, application clinically is restricted.
The objective of the invention is provides a kind of treatment infantile diarrhea mixture and production method thereof at above-mentioned situation, can solve treatment infantile diarrhea medication problem effectively.
The object of the present invention is achieved like this, according to the principle of Chinese materia medica and clinical practice, diarrhoea belongs to " having loose bowels " category of Chinese medicine, characteristics and popular situation according to its morbidity, diarrhoea is children's's " the spleen tending to insufficiency usually ", the wet spleen that easily is stranded, make hypoactivity of spleen-YANG, fortuneization mistake department, damp heap soil or fertilizer over and around the roots stagnate in large intestine, clear QI being mixed up with turbid QI, lifting disloyal due to.Can adopt the principle of " heat clearing and damp drying, relieving diarrhea with astringents " in view of the above, be that main medicine is made mixture and (is called for short two skin mixture with hazel skin, Pericarpium Granati, as follows), hazel skin bitter in the mouth is cold in nature, returns liver, gallbladder large intestine channel, heat clearing and damp drying, Pericarpium Granati is with relieving diarrhea with astringents, be used for chronic diarrhea chronic dysentery, proctoptosis, sour-puckery flavor is warm in nature, goes into big the intestines and stomach warp, play the merit of " heat clearing and damp drying, relieving diarrhea with astringents " altogether.The spleen sun must be shaken, damp and hot must removing, the various symptoms of infantile diarrhea are improved or eliminate, and therefore, the present invention makes medicine with hazel skin, Pericarpium Granati etc., and through soaking, decoct, concentrating, flavoring gets final product.
The inventive method is simple, and abundant raw materials is cheap, easily produces, and its product effect is good, have no side effect, and be the medicine of good curing infantile diarrhea, have remarkable economical and social benefit.
Below in conjunction with concrete condition and embodiment the present invention is elaborated.
By the compatibility requirement, it is by 300 parts of Pericarpium Granatis by weight that the present invention adopts, 300 parts of hazel skins, 5 parts of steviosides, 5 parts of benzoic acids, carboxymethyl cellulose is made for 1 part, its production method is, Deng measuring Pericarpium Granati, after the washing of hazel skin, the water logging that adds 5 times of amounts was steeped 1 hour, decocted 1.5 hours, filter to get filtrate, will add the water of 4 times of amounts in the medicinal residues again, fried in shallow oil again 1.5 hours, filter to get filtrate, merge filtrate twice, be concentrated into proportion and be 1.1 (about) medicinal liquid, freezing precipitation 24 hours, after the filtration filtrate being heated to boiled, 0.05% the carboxymethyl cellulose (being called for short CMC) that adds total amount, 0.25% stevioside, adding distil water is to aequum, add 0.25% benzoic acid again, the packing sterilization gets final product.
Bottom further specifies product of the present invention and production method in conjunction with specific embodiments again.
With the two skin mixture of preparation 2000ml (milliliter), its medicine is to be restrained by Pericarpium Granati 300 grams, hazel skin 300 grams, stevioside 5 grams, benzoic acid 5 grams, carboxymethyl cellulose 1;
The concrete production method of two skin mixture of preparation 2000m1 is with after Pericarpium Granati 300 grams, the 300 gram washings of hazel skin, adds water 3000ml, soaks after 1 hour to decoct 1.5 hours, filter to get filtrate, add water 2400ml again, decocted 1.5 hours, filter to get filtrate, merge filtrate twice, be concentrated into proportion and be 1.1 medicinal liquid, freezing precipitation 24 hours, after the filtration filtrate being heated to boiled, add carboxymethyl cellulose 1 gram, add stevioside 5 grams, adding distil water is to 2000ml again, and adding 5 gram benzoic acid stir evenly the packing sterilization and get final product.
In medicinal liquid decocts, be heated to earlier and boil, slow fire boils again, with the senior general's medicinal liquid of preventing fires too boil dry (decoction of medicinal liquid, fiery marquis common people know, do not need to state more) in its medicine, Pericarpium Granati, hazel skin constitute effective pharmaceutical compositions, and stevioside is used for flavoring (can claim correctives), facilitates patients, benzoic acid is used for anticorrosion (can claim antiseptic), and carboxymethyl cellulose is used to prevent medicinal liquid precipitation (can claim anti-settling agent).
Two skin mixture of the present invention are compared with the medicine of existing treatment infantile diarrhea outstanding advantage and significant curative effect, has no side effect, and taking convenience is to treat the ideal medicament that youngster's lower abdomen rushes down usefulness at present, and can be confirmed by following situation.
One, zoopery situation
1, gets 40 of mices, male and female half and half, body weight 19-21g, evenly be divided into 4 groups at random, gavaging two skin mixture, normal saline and children's respectively rushes down speed and stops, observation is to the influence of the large and small enterokinesia of normal mouse, and situation sees Table 1: table 1 group number of animals dosage intestinal propulsion percentage rate occur first carbon containing not 8b include charcoal class excrement
(only) be (b) total number of particles just incubation period of (%) feces (g/kg)
(individual) physiological saline group 10 48.6 ± 4.7 1.34 ± 0.27 10.6 ± 2.6 treating infant diarrhea speed stop organizing 10 6 45.4 ± 4.0 1.64 ± 0.27 8.0 ± 1.9 heavy dose of two skin mixture groups, 10 6 43.4 ± 3.9 1.78 ± 0.27 8.1 ± 2.1 low dose of two skin mixture groups, 10 3 46.2 soil 3.8 1.68 ± 0.37 8.1 ± 2.6
Can find out from last table, heavy dose of two skin mixture can significantly be shown and suppress small intestine movement of mice wriggling (p (0.05), can obviously prolong occur first carbon containing feces incubation period and obviously reduce in the 6h the not total number of particles of feces (P＜0.01) of carbon containing, low dose of two skin mixture groups and children's are rushed down the trend (P＞0.05) that speed stops organizing only resistance small intestine movement of mice wriggling, but the incubation period of carbonaceous powder feces and the total number of particles (P＜0.05) of the interior carbonaceous powder feces of the remarkable 6h of minimizing appear in significant prolongation first.
2, two skin mixture are shown in Table 2 the influence to the large and small enterokinesia of mice after the diarrhea inducing agent:
Table 2 two skin mixture to the influence of giving the large and small enterokinesia of mice after the diarrhea inducing agent (the group number of animals dosage intestinal propulsion percentage rate of X ± SD) occur first carbon containing not 8h include not excrement of charcoal
(only) be (h) total number of particles just incubation period of (%) feces (g/kg)
(individual) blank group 10 47.8 ± 8.7 1.74 ± 0.24 10.9 ± 1.9 model group 10 57.5 ± 5.6 0.82 ± 0.27 14.9 ± 3.4 treating infant diarrhea speed stops organizing 10 6 52.8 ± 4.2 1.31 ± 0.32 11.3 ± 2.9 heavy dose of two skin mixture groups, 10 6 48.9 ± 7.6 1.50 ± 0.28 9.2 ± 2.7 low dose of two skin mixture groups 10 3 51.0 ± 5.0 1.35 ± 0.34 10.1 ± 3.1
Can find out and blank group ratio that from last table the model group intestinal propulsion obviously speeds (P＜0.01), occur containing charcoal first and obviously do not shorten the incubation period of feces that 6h includes the granule number showed increased (P＜0.01) that charcoal comes feces, illustrate and make the success of diarrhoea model.With the model group ratio, large and small dosage two skin mixture groups and children's are rushed down the speed group all can obviously resist small intestinal peristalsis reduction propelling percentage rate (P＜0.01), can make and occur obviously prolonging incubation period that charcoal comes feces (P＜0.01) first, large and small dosage two skin mixture groups can make 6h include the granule number that charcoal comes feces obviously to reduce (P＜0.01), children's rush down speed stop organizing can make contain charcoal not the granule number of feces significantly reduce (P＜0.05.
3, the influence that mouse small intestine after the logotype diarrhea inducing agent in 4 days is wriggled
Get 50 of the mices of body weight 19-21g; male and female half and half; evenly divide into groups at random 5 groups; wherein make the diarrhoea model for 4 groups; gavage 100% Radix Et Rhizoma Rhei water decoction 0.3ml/10g every day; 1 group is the normal saline of blank group filling with volume in addition; give diarrhea inducing agent 1 time every day, continuous 4 days, mice fasting (can't help water) 12h before last 1 time is given the diarrhea inducing agent; 30min after giving the diarrhea inducing agent; modeling type 4 components add filling and contain the big of 10% active carbon; two low dose of skin mixture (0.3g/ml; 0.15g/ml; 0.2ml/10g), the children's who contains 10% active carbon rush down speed stop suspension (0.3g/ml, 0.2ml/10g) and contain the normal saline of 10% active carbon with volume; the blank group is given the normal saline that contains 10% active carbon with volume; 15min after administration puts to death mice immediately, dissects; take out small intestinal; stretching gently, lie in the absorbent paper, measure small intestinal total length and powdered carbon advance distance; and calculate the propelling percentage rate, see Table 3.Table 3 two skin mixture to logotype diarrhea inducing agent in 4 days after the influence of mouse small intestine wriggling (X ± SD) group number of animals dosage charcoal does not advance percentage rate
(only) (g/kg) (%) blank group 10 47.8 ± 4.6 model group 10 71.4 ± 7.4 children's rushed down speed and stopped organizing 10 6 64.6 ± 8.0 heavy dose of two skin mixture groups, 10 6 57.0 ± 7.3 low dose of two skin mixture groups 10 3 64.0 ± 7.8
Can find out and blank group ratio that from last table model group small intestinal peristalsis rises appreciably (P＜0.01), illustrate and make the success of diarrhoea model.Can obviously resist small intestinal peristalsis (P＜0.01) with model group than heavy dose of two skin mixture groups, low dose of two skin mixture groups and children's rush down speed stop the group can significantly resist small intestinal peristalsis (P＜0.05).
4, the antibacterial situation of two skin mixture
The bacterium liquid that to get the above-mentioned two skin mixture liquid dilutings of 0.1ml respectively be 10-3 adds in the 1-8 pipe, and positive pipe adds 0.1ml bacterium liquid, and negative tube does not add, and puts into 37 ℃ of incubators behind the mixing together and cultivates observed result 24 hours.If the meat soup muddiness, the expression bacterial growth is if meat soup is limpid fully, the test tube dose that is subjected to that first is limpid is exactly the minimum inhibitory concentration (MIC) that is subjected to reagent, with above-mentioned culture fluid respectively with 15ml nutrient agar mixing, cultivated 24 hours for 37 ℃, the observation situation is shown in table 4,5,6,7.Table 4 two skin mixture are to the inhibitory action diluent drug level escherichia coli of escherichia coli growth
(mg/ml) test tube is cultivated the situation plate and was cultivated situation 1: 2 150.0-01: 4 75.0-01: 8 37.5-01: 16 18.8-01: 32 9.4 ++++++1: 64 4.7 ++++++1: 128 2.4 ++++++1: 256 1.2 ++++++to annotate: "-" expression nutrient solution clear and bright "+" expression is muddy; A small amount of bacterial growth is arranged
" +++expression has a large amount of bacterial growths.
" 0 " expression asepsis growth "+" expression has a small amount of bacterial growth,
" ++ " expression has more bacterial growth.
" +++" expression culture fluid muddiness, the antibacterial raised growth, down together.
Table 5 children's is rushed down the inhibitory action diluent drug level escherichia coli that speed is stopped external escherichia coli growth
(mg/ml) test tube is cultivated the situation plate and is cultivated situation
500 - 0
250 - 0
125 - 0
62.5 - 0
31.2 - 0
15.1 - +
7.55 +++ +++
3.78 the external golden Fructus Vitis viniferae of inhibitory action drug level (mg/ml) of ++++++table 6 two skin mixture to golden grape growth
Test tube is cultivated the situation plate and is cultivated situation
150 - 0
75 - 0
37.5 - 0
18.8 - 0
9.4 - +
4.7 + ++
2.4 + ++
1.2 + ++
0.6+++ table 7 children's is rushed down speed and is stopped the external golden Fructus Vitis viniferae of inhibitory action drug level (mg/ml) to golden grape growth
Test tube is cultivated the situation plate and is cultivated situation
500 -
250 -
125 -
62.5 - 0
31.2 - 0
15.6 + ++
7.8 + ++
3.9 + ++
2.0 + ++
Above-mentioned situation clearlys show that two skin mixture of the present invention all have obvious resistancing action to normal mouse and the large and small enterokinesia of diarrhea mice, have inhibitory action to continuous 4 days diarrhea mice small intestinal peristalsis.External have obvious inhibitory action to escherichia coli, golden yellow Fructus Vitis viniferae pearl bacterium, and the antidiarrheal medical value is remarkable.
5, toxicity test situation
Get 20 of mices, male and female half and half, body weight 19-21g, fasting (can't help water) 12h before the experiment, every Mus gavages the two skin mixture concentrated solutions that maximum can be irritated stomach concentration (0.6g/ml) by maximum administration volume (0.4ml/10g), and within the Yu Yiri continuous 3 times, each 8h at interval, observed 7 days continuously, do not see that the animal generation is dead, mice sees that animal activity reduces, and is calm shape after irritating stomach for the first time, activity gradually recovers behind the general 3-4h, put to death after mice was weighed in the 7th day, dissect, have naked eyes that as seen obvious liver is arranged, the heart, spleen, lung, kidney unusual, it is 20.0 ± 0.8g that mice begins body weight, and body weight was 22.3 ± 1.6g in the 7th day.Accumulating maximum tolerated dose its every day is 72g/kg, and this amount has been about 200 times of clinical consumption, can think the clinical practice totally nontoxic.
Two, clinical practice situation
From nineteen ninety-five successively in 18 months, two skin mixture treatment children's damp-heat type diarrhoea has been carried out 300 examples has observed on probationly, rush down with children's simultaneously that speed stops treating 100 examples and observational study is carried out in norfloxacin treatment 100 example contrasts.
1, Therapeutic Method
Treatment group: oral to intend " two skin mixture " (this mixture is made by hazel skin, Pericarpium Granati equivalent) certainly.Each 10-15ml, every day three times, three is a course of treatment.
Contrast A group: it is oral to give norfloxacin (Xinxiang PLA 9078 plant produced), every day per kilogram of body weight 10-15 milligram, divide three times oral.
Contrast B group: give children's and rush down speed to stop electuary (productions of Xinxiang Bai Quan pharmaceutical factory of traditional Chinese medicine) oral, wrap June-1 years old, 1/3-2/3 at every turn every day 3-4 time less than 6 months each 1/6-1/3; 1-3 year each 2/3-1 bag; 3-7 year each 1-1.5 bag.
Below respectively organize occur together heat, vomiting, dehydrator of infant and give identical anti symptom treatment.
2, criterion of therapeutical effect (by the standard of " new Chinese medicine clinical research guideline " promulgation).
Recovery from illness: times of defecation and character are recovered normally fully, and unusual physical and chemical index recovers normal.
Produce effects: times of defecation obviously reduces (being reduced to treatment preceding 1/3 or following), and character takes a turn for the better, and unusual physical and chemical index obviously improves.
Effectively: it is preceding 1/2 that times of defecation is reduced to treatment, the character improvement, and the abnormity index makes moderate progress.
Invalid: as not meet above standard person.3, the curative effect situation sees Table 8 listed:
Table 8 two skin mixture treatment groups contrast A group contrast B group symptoms and therapeutic effect table
Treatment back group is treated
( ％ ) ( ％ ) ( ％ ) ( ％ ) (＞3/ ) 300 136 87 37 40 45.3 29.0 12.4 86.7 162 115 7 24 15 71.6 4.3 14.8 90.7 83 10 47 11 15 12.0 56.7 13.3 82.0 55 10 33 2 10 18.2 60.0 3.6 81.8A (＞3/ ) 100 32 15 11 42 32.0 15.0 11.0 58.0 61 18 5 4 34 29.5 8.2 6.6 44.3 26 11 6 3 6 42.3 23.1 11.5 76.9 13 3 4 4 2 23.1 30.1 30.1 83.3 (＞3/ ) 100 35 17 15 33 35.0 17.0 15.0 67.0B 58 20 8 2 28 34.5 13.8 3.4 51.7 27 10 6 8 3 37.0 22.2 29.6 88.8 15 5 3 5 2 33.3 20.0 33.3 86.6
As seen from the above table, two skin mixture treatment groups: 136 examples of fully recovering, produce effects 87 examples, effective 37 examples, invalid 40 examples, total effective rate are 86.7%, wherein the retention of damp-heat in the interior type have loose bowels the recovery from illness 116 examples, produce effects 7 examples, effective 23 examples, invalid 15 examples, cure rate 71.6%, total effective rate 90.7%.
Contrast A group: 32 examples of fully recovering, produce effects 15 examples, effective 11 examples, invalid 42 examples, total effective rate is 58%, retention of damp-heat in the interior type recovery from illness 18 examples of having loose bowels wherein, produce effects 5 examples, effective 4 examples, invalid 34 examples, cure rate 29.5%, total effective rate 44.3%.
Contrast B group: 35 examples of fully recovering, produce effects 17 examples, effective 15 examples, invalid 33 examples, total effective rate is 67%, retention of damp-heat in the interior type recovery from illness 20 examples of having loose bowels wherein, produce effects 8 examples, effective 2 examples, invalid 28 examples, cure rate 34.5%, total effective rate 51.7%.
Above-mentioned situation shows that two skin mixture are to the infantile diarrhea cure rate, and obvious effective rate, total effective rate all are significantly higher than contrast A group and contrast B group.
Two skin mixture tastes are good, have quick-acting, long-acting, efficient specialities, are convenient to take, and are easy to carry, and are convenient to stock, and are clinical safe in utilization and have no side effect, and are fit to child's clinical characters and medication characteristics.Two skin mixture are applicable to children's's retention of damp-heat in the interior type, breast food internal injury type, and insufficiency of the spleen mistake fortune type three types diarrhoea, to children's's retention of damp-heat in the interior type diarrhea treatment, effect is best especially.This also is the subject matter that the present invention solves, and also is the place of the invention contribution, is that other treatment children's damp-heat type diarrhoea medicine is incomparable.Its popularizing action will be obtained huge economic and social benefit, creatively brings benefit to the mankind.Relevant situation also can be please referring to adnexa:
1, two skin mixture pharmacodynamic study data are totally 13 pages.
2, two skin mixture treatment children's damp-heat type diarrhoea clinical research data, totally 9 pages.
Claims (4)
1, treatment infantile diarrhea mixture, the pharmaceutical composition that it is characterized in that this two skins mixture is by 300 parts of Pericarpium Granatis, 300 parts of hazel skins, 5 parts of steviosides, 5 parts in benzoic acid, carboxymethyl cellulose are made for 1 part by weight.
2, treatment infantile diarrhea mixture according to claim 1 is characterized in that its pharmaceutical composition is to be restrained by Pericarpium Granati 300 grams, hazel skin 300 grams, stevioside 5 grams, benzoic acid 5 grams, carboxymethyl cellulose 1 in said 2000 milliliter of two skin mixture.
3, realize the production method of treatment infantile diarrhea mixture, it is characterized in that waiting and measure Pericarpium Granati, hazel skin, after the washing, the water logging that adds 5 times of amounts was steeped 1 hour, cut and boil 1.5 hours, filter to get filtrate, will add the water of 4 times of amounts in the medicinal residues again, fried in shallow oil again 1.5 hours, filter to get filtrate, merge filtrate twice, be concentrated into proportion and be 1.1 medicinal liquid, freezing precipitation 24 hours, after the filtration filtrate being heated to boiled, add 0.05% carboxymethyl cellulose of total amount, 0.25% stevioside, adding distil water adds 0.25% benzoic acid packing sterilization again to aequum.
4, the production method of treatment infantile diarrhea mixture according to claim 3, the two skin mixture that it is characterized in that 2000 milliliters of said preparations are with Pericarpium Granati 300 grams, after the 300 gram washings of hazel skin, add 3000 milliliters in water, soak after 1 hour, decocted 1.5 hours, filter to get filtrate, add 2400 milliliters in water again, decocted 1.5 hours, and filtered to get filtrate, merge filtrate twice, be concentrated into proportion and be 1.1 medicinal liquid, freezing precipitation 24 hours filters to get filtrate, and is heated to and boils, add carboxylic toluene cellulose 1 gram, add stevioside 5 grams, adding distil water adds 5 gram benzoic acid and stirs evenly sterilization to 2000ml again.
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