Summary of the invention: the Chinese medicine of treatment infantile anorexia of the present invention, main raw material: Fructus Crataegi 100-300 part, Fructus Hordei Germinatus 100-300 part, Fructus Amomi 10-40 part, Pericarpium Citri Reticulatae 20-60 part by following prescription, Fructus Gardeniae 10-40 part, Rhizoma Zingiberis 20-60 part become tablet, granule, pill or capsule, oral liquid through conventional processes.
In the such scheme: also can add Rhizoma Alpiniae Officinarum 20-60 part.
Traditional theory according to motherland's medical science, we are except studying infantile anorexia, also to the old people because the flatulence stomachache due to the eating accumulation, dyspepsia has been carried out intensive research, summing up China's tradition on the basis of proved recipe, filtering out treating " the mountain wheat spleen invigorating " that infantile anorexia and old people's indigestion have better curative effect and have no side effect.
We are made up of Fructus Crataegi, Fructus Hordei Germinatus, Fructus Amomi, Pericarpium Citri Reticulatae, Rhizoma Alpiniae Officinarum, Rhizoma Zingiberis, Fructus Gardeniae, have digesting and appetizing, stomach warming spleen invigorating, circulation of qi promoting in the accent.Be used for inappetence, the flatulence stomachache due to the eating accumulation, infantile monophagia and apositia, old people's breast abdominal distention is vexed, dyspepsia.
We are at monophagia, surfeit Cheng Xi, gradually give birth to for a long time stagnant, disease such as the taste running is impaired, and sees inappetence, borborygmus abdominal distention and establishing.With the stomach function regulating that helps digestion, circulation of qi promoting is amusing to controlling.Hawthorn digesting eliminate indigestion, Fructus Hordei Germinatus help digestion and in, the two mutual reinforcement between is a usefulness, is ministerial drug altogether.Rhizoma Alpiniae Officinarum, Rhizoma Zingiberis two medicine warming spleen and stomach for dispelling cold, it is gentle to rouse oneself taste, and the merit of therapeutic method to keep the adverse QI flowing downwards relieving distension is arranged, and is adjuvant drug in the side.It is hot and suffocating to remove to share Fructus Gardeniae, is the product of using corrigent in the side.
Make a general survey of full side, invigorating middle warmer has and disappears, and temperature is not and dry, and the liver spleen is ruled together, circulation of qi promoting in the accent, pathogenesis in the medicine, giving consideration to both the incidental and fundamental, evident in efficacy to the be obstructed infantile anorexia of (insufficiency of the spleen wet resistance) of deficiency-weakness of spleen-QI and spleen sun especially, it can promote the infant digestive function, improve the small intestinal absorption function, replenish and regulate the trace element of needed by human, thereby improve the body trace element deficiency state, infant appetite is increased, weight increase, subcutaneous fat increases, and has rosy cheeks, immunologic function improves, and minimizing palindromia, determined curative effect has no side effect.This also is the Chinese patent medicine dissimilarity that infantile anorexia is treated in we and listing at present, also is the characteristics place.
We's dosage form has tablet, granule, pill, capsule, oral liquid.Name of product can be mountain wheat spleen invigorating etc.
The specific embodiment:
Embodiment one
Get 150 parts of Fructus Crataegis, 150 parts in Fructus Hordei Germinatus, 25 parts of Fructus Amomis, 35 parts of Pericarpium Citri Reticulataes, 18 parts of Fructus Gardeniaes, 25 parts of Rhizoma Zingiberiss, above-mentioned primary crude drug mixture is decocted, each 100kg medical material adds the drinking water of 1000L approximately, soak about 30min for the first time and boil, decoct three times, each 45~70 minutes, collect volatile oil simultaneously, get medicinal liquid; The filtration of reuse 200 mesh sieves concentrates with the energy-conservation concentrator of triple effect, and 80 ℃ of effect temperature, two 70 ℃ of effects, triple effect are concentrated into relative density 1.14~1.18 for 60 ℃, get clear paste; Get the powder process of moiety clear paste spray drying, 160~180 ℃ of inlet temperature, 80~100 ℃ of leaving air temps get extract powder; Second half remaining clear paste is granulated with one-step-granulating method, and 60~80 ℃ of inlet temperature, 45~70 ℃ of leaving air temps add volatilization and braised profit 24 hours, get 5000 bags of 4g/ bag granules.Also can be with 50000 of the capsules of particles filled one-tenth 0.4g/ grain.
Embodiment two
With 120 parts of Fructus Crataegis, 125 parts in Fructus Hordei Germinatus, 15 parts of Fructus Amomis, 25 parts of Pericarpium Citri Reticulataes, 30 parts of Fructus Gardeniaes, 45 parts of Rhizoma Zingiberiss, above-mentioned primary crude drug mixture is decocted, each 100kg medical material adds the drinking water of 1000L approximately, soak about 30min for the first time and boil, decoct three times, each 45~70 minutes, collect volatile oil simultaneously, get medicinal liquid; The filtration of reuse 200 mesh sieves concentrates with the energy-conservation concentrator of triple effect, and 80 ℃ of effect temperature, two 70 ℃ of effects, triple effect are concentrated into relative density 1.14~1.18 for 60 ℃, get clear paste; Get the powder process of moiety clear paste spray drying, 160~180 ℃ of inlet temperature, 80~100 ℃ of leaving air temps get extract powder; Remaining second half clear paste and extract powder are granulated with one-step-granulating method, and 60~80 ℃ of inlet temperature, 45~70 ℃ of leaving air temps added volatile oil airtight 24 hours, got grain products; Add the proper amount of lubricating agent tabletting again, the high-efficiency coating machine coating gets 40000 of 0.5g/ sheets.
Embodiment three
With 250 parts of Fructus Crataegis, 240 parts in Fructus Hordei Germinatus, 30 parts of Fructus Amomis, 50 parts of Pericarpium Citri Reticulataes, 12 parts of Fructus Gardeniaes, 25 parts of Rhizoma Zingiberiss, amount to 100kg, with machine pulverizing medicinal materials is become fine powder, sieve, mixing, add Mel and an amount of water, general ball, drying, packing on general ball machine, inspect by ready samples, must 100g/ bottle pill 1500 bottles.
Embodiment four
With 200 parts of Fructus Crataegis, 150 parts in Fructus Hordei Germinatus, 20 parts of Fructus Amomis, 30 parts of Pericarpium Citri Reticulataes, 35 parts of Fructus Gardeniaes, 30 parts of Rhizoma Zingiberiss, above-mentioned primary crude drug mixture is decocted, each 100kg medical material adds the drinking water of 1000L approximately, soak about 30min for the first time and boil, decoct three times, each 45~70 minutes, collect volatile oil simultaneously, get medicinal liquid; Be concentrated into every 1ml medicinal liquid with the energy-conservation concentrator of triple effect after filtering and be equivalent to crude drug 2g approximately, put cold, add the remove impurity of Different concentrations of alcohol precipitate with ethanol, stir evenly, filter about placement 24h, filtrate decompression is concentrated into the extractum shape, filter with an amount of water dilution, add volatile oil and various additives etc., cold preservation, be packaged in the ampoule, promptly to get 20000 bottles in 10ml/ bottle about about 100 ℃ sterilization 30min.
Embodiment five
Get 150 parts of Fructus Crataegis, 150 parts in Fructus Hordei Germinatus, 25 parts of Fructus Amomis, 35 parts of Pericarpium Citri Reticulataes, 25 parts of Fructus Gardeniaes, 30 parts of Rhizoma Zingiberiss, 35 parts of Rhizoma Alpiniae Officinarums, amount to 100kg, above-mentioned primary crude drug mixture is decocted, each 100kg medical material adds the drinking water of 1000L approximately, soak about 30min for the first time and boil, decoct each 45~70 minutes three times, collect volatile oil simultaneously, get medicinal liquid; Be concentrated into every 1ml medicinal liquid with the energy-conservation concentrator of triple effect after filtering and be equivalent to crude drug 2g approximately, put cold, the ethanol precipitate with ethanol remove impurity of adding 95% stirs evenly, and places about 24h to filter, filtrate decompression is concentrated into the extractum shape, filter with an amount of water dilution, add volatile oil and various additives etc., cold preservation, encapsulation is promptly to get 20000 bottles in 10ml/ bottle about about 100 ℃ sterilization 30min.
Embodiment six
With 120 parts of Fructus Crataegis, 125 parts in Fructus Hordei Germinatus, 15 parts of Fructus Amomis, 25 parts of Pericarpium Citri Reticulataes, 15 parts of Fructus Gardeniaes, 20 parts of Rhizoma Zingiberiss, 20 parts of Rhizoma Alpiniae Officinarums, above-mentioned primary crude drug mixture is decocted, each 100kg medical material adds the drinking water of 1000L approximately, soak about 30min for the first time and boil, decoct three times, each 45~70 minutes, collect volatile oil simultaneously, get medicinal liquid; The filtration of reuse 200 mesh sieves concentrates with the energy-conservation concentrator of triple effect, and 80 ℃ of effect temperature, two 70 ℃ of effects, triple effect are concentrated into relative density 1.14~1.18 for 60 ℃, get clear paste; Get the powder process of moiety clear paste spray drying, 160~180 ℃ of inlet temperature, 80~100 ℃ of leaving air temps get extract powder; Remaining second half clear paste and extract powder are granulated with one-step-granulating method, and 60~80 ℃ of inlet temperature, 45~70 ℃ of leaving air temps get granule, and add volatilization and braised profit 24 hours; Add the proper amount of lubricating agent tabletting again, the high-efficiency coating machine coating gets 40000 of 0.5g/ sheets.
Embodiment seven
Get 150 parts of Fructus Crataegis, 250 parts in Fructus Hordei Germinatus, 30 parts of Fructus Amomis, 40 parts of Pericarpium Citri Reticulataes, 25 parts of Fructus Gardeniaes, 30 parts of Rhizoma Zingiberiss, 25 parts of Rhizoma Alpiniae Officinarums, above-mentioned primary crude drug mixture is decocted, each 100kg medical material adds the drinking water of 1000L approximately, soak about 30min for the first time and boil, decoct three times, each 45~70 minutes, collect volatile oil simultaneously, get medicinal liquid; Be concentrated into every 1ml medicinal liquid with the energy-conservation concentrator of triple effect after filtering and be equivalent to crude drug 2g approximately, put cold, the ethanol precipitate with ethanol remove impurity of adding 95% stirs evenly, and places about 24h to filter, filtrate decompression is concentrated into the extractum shape, filter with an amount of water dilution, add various additives etc., cold preservation, be packaged in the control oral liquid bottle, promptly to get 20000 bottles of 10ml/ bottle oral liquids about about 100 ℃ sterilization 30min.
Further specify beneficial effect of the present invention below by the clinical experimental study situation.
1, the clinical observation of product treatment infantile anorexia of the present invention is summed up
Clinical research institute of Sichuan Institute of Tradition Chinese Medicine, Chengdu No. 3 People's Hospital's department of pediatrics, Chengdu children's hospital are February-1993 year March nineteen ninety, selected 120 anorexia infants to take the oral liquid of product of the present invention and 60 anorexia infants at Chengdu Qi Jia kindergarten respectively and taken the syrupy clinical efficacy of children's one star happiness food and carried out paired observation, observed result is summarized as follows:
1.1 clinical setting
1.1.1 case is selected: all anorexia infants except that and the roundworm infection, do not have other acute and chronic infection person and be the object of observation, treatment group infant is taken product oral liquid of the present invention, 14 days is a course of treatment, period in a medicine had not infected other disease patient, matched group is taken children's's one star happiness sugar slurry, and observation condition is identical with the treatment group.
1.1.2 diagnostic criteria
Long-term inappetence, the course of disease is more than February, and infant does not have the desire of initiatively taking food, and appetite obviously is less than healthy children of the same age, 2-3 year≤100g/ day, 4-6 year≤150g/ day.
Lustreless complexion, body are thin partially, and body weight is lower than of the same age with sex children's body weight average.
1.1.3 ordinary circumstance: in 180 anorexia infants of this group, male 88 people, women 92 people, age 2-4 year 50 examples, 4-6 year 110 examples, 20 examples more than 6 years old, have a liking for snacks 82 people, monophagia 88 examples, eating cold and uncooked food excessively 10 people, anorexia year person in February to one 120 people, following person 21 people of hematochrome 110g/L, above person 159 people of 110g/L, pale tongue, white and thin fur person 50 people, thin greasy coating 130 people, red tongue person 15 people.
1.2 observational technique
We adopt random packet, and product oral liquid of the present invention and children's's one star happiness sugar slurry is taken in single blind contrast respectively.Treatment group and matched group are all treated 14 days courses of treatment.The product oral liquid day of 10mltid/ below 4 years old of the present invention, 20mlBid/ day more than 4 years old.Children's's one star happiness sugar slurry 10ml below 4 years old one twice-daily, 10ml is three times on the one more than 4 years old.The infant that does not take 14 day course of treatment is not listed object of statistics in, respectively hemoglobin, body weight, amylase in urine is respectively detected once in two weeks before taking medicine and after taking medicine, and symptom and appetite write down once weekly.
1.3 efficacy assessment standard
After taking medicine 14 days, observed for two weeks, the statistics curative effect is the leading indicator of observation with body weight and appetite with progress.
Produce effects: appetite obviously increases, weight increase 〉=0.25kg; Effectively: appetite takes a turn for the better, weight increase 〉=0.15kg; Invalid: body weight and appetite do not increase or reduce.
1.4 interpretation of result
1.4.1 efficacy analysis: see Table 1, table 2.
Table 1 treatment group and matched group efficacy analysis
The total case produce effects of group enabledisable total effective rate |
Example digital display efficient example number effective percentage example number inefficiency example number total effective rate |
Controlling the clinical institute in Provincial Medicine Research Institute 50 30 60% 13 26% 7 14% 13 86% treats Chengdu No. 3 People's Hospital 30 25 83.3% 1 3.33% 4 13.3% 26 86.7% and forms city children's hospital 40 30 75% 5 12.5% 5 12.5% 35 87.5% |
The clinical institute in Provincial Medicine Research Institute 30 15 50% 4 13.3% 11 36.7% 19 63.3% is formed city children's hospital 15 10 66.7% 2 13.3% 3 20% 12 80% according to Chengdu No. 3 People's Hospital 15 8 53.3% 007 46.7% 8 53.3% |
Table 2 treatment group and matched group Comparison of therapeutic
Group produce effects enabledisable adds up to total effective rate P value |
Treatment group 85 (70.84%) 19 (115.83%) 16 (13.3%) 120 86.7% matched groups 33 (55%) 6 (10%) 21 (35%) 60 65%<0.01 add up to 118 25 37 180 |
X
2=11.50>6.63 P<0.01
Find out that from last table 1 and 2 120 examples are organized in treatment, produce effects 85 examples (70.8%), effective 19 examples (15.9%), invalid 16 examples (13.3%) total effective rate 86.7%; Matched group 60 examples, produce effects 33 examples (55%), effective 6 examples (10%), invalid 1 example (35%), total effective rate 65%, learn handling P<0.01, two by statistics group has significant difference.
1.4.2 treatment back weight increase situation: see Table 3
Table 3 treatment back weight increase result
The total routine number 〉=0.25kg of group 〉=0.15kg no change |
120 89 (74.1%) 20 (16.7%) 11 (9.2%) matched groups 60 33 (55%) 10 (16.7%) 17 (28.3%) are organized in treatment |
1.4.3 treatment back appetite increases situation: see Table 4
Table 4 treatment back appetite increases the result
The total routine number 〉=25g of group 〉=50g no change |
120 51 (42.5%) 52 (43.3%) 17 (14.2%) matched groups 60 28 (46.7%) 15 (25%) 17 (29.3%) are organized in treatment |
1.4.4 the variation of clinical symptoms: pale tongue white and thin fur 73 people (60.8%) before the treatment of treatment group, pale tongue greasy and thin fur 47 people (39.2%), treatment back pale tongue white and thin fur 66 people (55%), pale tongue greasy and thin fur 54 people (45%).Few magnificent 57 people (47.5%) of treatment colour, treatment back lustreless complexion 35 people (39.1%).Twice above person 5 people of times of defecation (41%) before the treatment, treatment back twice above person 1 people of times of defecation (0.083%), the stool character is all normal before and after the treatment.
1.4.5 toxicity:, do not find any untoward reaction in the case of observing treatment.
1.5 experimentation
1.5.1 the mensuration of hemoglobin: 120 infants of treatment group, after treatment, hemoglobin raises in normal range 〉=and infant below the 10g/L has 12 people, has 7 people to rise to (58.33%) more than the 110g/L after treating.Illustrate that this medicine has certain effect to the treatment of infantile anemia, but because of the routine number of anemia very little, curative effect of its treatment anemia can not be affirmed fully, also need do further research.
1.5.2 amylase in urine Determination on content
We adopt iodine amount colorimetry to all doing the active mensuration of amylase in urine before and after 180 infant treatments, learn by statistics and handle u=5.26 P<0.01, and significant difference is arranged.See Table 5:
The comparison of amylase in urine before and after table 5 treatment group and the treatment of control group
After treating before the total routine number treatment of group |
120 163.58 ± 58.20 231.1 ± 64.28 matched group 60 121.95 ± 51.27 180.77 ± 60.21 are organized in treatment |
U=5.26 P<0.01
1.6 60 routine treatment groups and matched group Comparison of therapeutic are analyzed:
We have selected 60 routine anorexia infants, under the essentially identical situations of condition such as age, sex, body weight and appetite, are divided into treatment group and matched group at random, measure curative effect and amylase in urine.Learn by statistics and handle two groups of difference highly significants of result, X
2=4.36>3.85, P<0.05, U=5.94>2.58, P<0.01.See Table 6,7.
Table 6 60 routine treatment groups and matched group Comparison of therapeutic are analyzed
Group produce effects enabledisable adds up to total effective rate p value |
Treatment group 20 (66.7%) 6 (20%) 4 (13.3%) 30 86.7% matched groups 15 (50%) 4 (13.3%) 11 (36.7%) 30 63.3%<0.05 add up to 35 10 15 60 |
X
2=4.36>3.85 P<0.05
The measured value contrast of table 7 60 routine amylases in urine
After treating before the total case treatment of group |
30 162.4 ± 59.70 196.32 ± 60.35 matched group 30 156.24 ± 53.08 181.04 ± 54.52 are organized in treatment |
U=5.94>2.58 P<0.01
Sum up
Infantile anorexia is one of present usual diseases of childhood, can be caused the case that we observe by multiple reason and disease, according to analysis, great majority are because father and mother spoil, and improper feeding causes the imbalance of breast food, nutrition disorder, the stagnant impairment of the spleen, or eating cold and uncooked food excessively melon and fruit or cross and to take cold and cool medicine so that the spleen sun is obstructed, give birth in the phlegm-damp, stop up resistance Central Region, mechanism of qi is not transported, and influences transformation and transportation of the spleen and stomach and causes anorexia.According to above pathogenesis, control and answer digesting and appetizing, the stomach warming spleen invigorating.Product oral liquid of the present invention is formed with digestion-promoting spleen-invigorating medicines such as Fructus Crataegi, Fructus Hordei Germinatus, Fructus Amomis, and full side's invigorating middle warmer has and disappears, temperature and not dry, and circulation of qi promoting in the accent, pathogenesis in the medicine so total effective rate reaches 86.7%, is better than children's's one star happiness sugar and starches matched group (P<0.01).Simultaneously do not find untoward reaction again in drug administration process, determined curative effect is a kind of Chinese patent medicine of safe and reliable treatment infantile anorexia, can produce good social benefit and economic benefit, and the value of promoting the use of is arranged.