The object of the invention provides a kind ofly can treat multiple pediatric diseases such as infantile anemia, infantile anorexia, infantile diarrhea, has nourishing the brain and improving intelligence, replenishing QI to invigorate the spleen, nourishing blood to tranquillize the mind, improves digestive function, promotes the Chinese patent medicine of effect such as children's upgrowth and development.
The Chinese patent medicine of diseases such as another object of the present invention provides that hypoevolutism, mental retardation, children night crying, poor sleep, stool that a kind of treatment causes because of zinc deficiency, iron deficiency, calcium deficiency etc. are not normal, inappetence and rickets.
The raw material prescription of Chinese patent medicine ER KANG NING of the present invention is formed:
Radix Codonopsis 50-70 Radix Astragali 10-30 Rhizoma Atractylodis Macrocephalae 50-70
Poria 30-50 Rhizoma Dioscoreae 50-70 Semen Coicis 50-70
Radix Ophiopogonis 50-70 Radix Polygoni Multiflori 50-70 Fructus Jujubae 10-30
Fructus Crataegi 10-30 Fructus Hordei Germinatus 10-30 Ramulus Mori 30-50
Pericarpium Citri Reticulatae 40-70
Above-mentioned Pericarpium Citri Reticulatae can replace with Oleum Citri Reticulatae, and described Oleum Citri Reticulatae consumption is (a 0.3-0.8 milliliter) with the ratio of other component gross weights: (440-710 gram).
In preparation oral liquid process, every preparation 1000ml ER KANG NING oral liquid can add Oleum Citri Reticulatae 0.3-0.8ml; Can also add an amount of excipient, antiseptic and flavoring agent.
According to such scheme, the used proportioning raw materials of preparation 1000ml ER KANG NING is:
Radix Codonopsis 50-70 gram Radix Astragali 10-30 gram Rhizoma Atractylodis Macrocephalae 50-70 gram
Poria 30-50 Keshan medicine 50-70 gram Semen Coicis 50-70 gram
Radix Ophiopogonis, 50-70 gram Radix Polygoni Multiflori 50-70 gram Fructus Jujubae 10-30 restrained
Fructus Crataegi 10-30 gram Fructus Hordei Germinatus 10-30 gram Ramulus Mori 30-50 gram
Oleum Citri Reticulatae 0.3-0.8 milliliter
In the crude drug of ER KANG NING of the present invention, Radix Polygoni Multiflori preferably uses Radix Polygoni Multiflori Preparata, and Fructus Crataegi is preferably used Fructus Crataegi (parched to brown), and Fructus Hordei Germinatus preferably uses Fructus Hordei Germinatus (parched).
The Oleum Citri Reticulatae that is added also can replace with the extracting solution of Pericarpium Citri Reticulatae, and extracting solution described here can be the aqueous extract of Pericarpium Citri Reticulatae, also can be the ethanol extract of Pericarpium Citri Reticulatae.
The said excipient of the present invention can be sucrose, refined honey.
The said flavoring agent of the present invention can be a citric acid.
The preferred feedstock prescription of Chinese patent medicine ER KANG NING of the present invention is formed:
The Radix Codonopsis 60 gram Radixs Astragali 20 gram Rhizoma Atractylodis Macrocephalaes 60 grams
Poria 40 Keshan medicines 60 gram Semen Coiciss 60 grams
Restrain the Radix Polygoni Multiflori 60 gram Fructus Jujubaes 20 grams Radix Ophiopogonis 60
Fructus Crataegi (parched to brown) 20 gram Fructus Hordei Germinatus (parched)s 20 gram Ramulus Moris 40 grams
Oleum Citri Reticulatae 0.6ml
Chinese patent medicine 'Erkangning ' of the present invention can be made clinical dosage form commonly used such as oral liquid, tablet, capsule, electuary, pill, syrup.
The preparation method of Chinese patent medicine ER KANG NING oral liquid of the present invention is:
With the Radix Codonopsis in the prescription, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Poria, Rhizoma Dioscoreae, Semen Coicis, Radix Ophiopogonis, Radix Polygoni Multiflori Preparata, Fructus Jujubae, Fructus Crataegi (parched to brown), Fructus Hordei Germinatus (parched), Ramulus Mori 12 flavor Chinese medicines, decoct with water twice, collecting decoction filters.Filtrate is concentrated in right amount, adds sucrose, refined honey mixing, filters, and adding citric acid and antiseptic are an amount of, and mixing adds Oleum Citri Reticulatae again, makes product.
The function of medicine of the present invention with cure mainly as follows:
Nourishing the brain and improving intelligence, spleen benefiting and stimulating the appetite, QI invigorating and in.Can accelerate baby, child and teen-age body development and intelligence significantly and increase disease resistance enhancemen.Be suitable for that hypoevolutism, mental retardation, children night crying, poor sleep, stool that zinc deficiency, iron deficiency, calcium deficiency etc. cause are not normal, disease such as inappetence and rickets, resistance difference are easily caught a cold.The neurasthenia that teenager and middle-aged and elderly people are caused because of study, work strain etc., insomnia, forgetful, dyspepsia etc. also have well-content curative effect.
Following pharmacodynamic experiment and clinical experimental data further illustrate the distinguished special-effect of medicine of the present invention.
Curing mainly relevant main pharmacodynamics with function tests as follows:
One, to the influence of intestinal propulsion functions
1, to the influence of normal mouse intestinal propulsion functions
70 of mices are divided into 7 groups at random, and fasting gavaged the ER KANG NING medicinal liquid of same volume (0.4ml/20g body weight) various dose or BUZHONG YIQI TANG, atropine in 18 hours respectively after (but can freely drink water), and matched group is given the tragacanth liquid with volume.Every Mus gavages the tragacanth liquid 0.3ml at 3% charcoal end after 1 hour, and mice pulls neck execution after 20 minutes, cuts open and rounds a gastrointestinal tract, drawing-off is on the white plastic plate gently, with dipstick metering get from pylorus to ileocecus and pylorus to the distance of charcoal end front end, calculate and advance percentage rate, the results are shown in Table 1.The group dosage Mus number that influences of table 1 pair normal mouse intestinal propulsion functions advances percentage rate P value
(g/kg), (only), (%) matched group-10 60 ± 8.5 ER KANG NING 5 10 58.8 ± 7.6>0.05 ER KANG NING 10 10 51.6 ± 6.5<0.05 ER KANG NING 20 10 46.9 ± 7.5<0.01 ER KANG NING 40 10 42.5 ± 6.7<0.01 BUZHONG YIQI TANG 20 10 50.5 ± 7.9<0.05 atropine 0.002 10 32.3 ± 6.5<0.01
By table as seen, ER KANG NING has significant inhibitory effect to normal mouse intestinal propulsion functions, and 5g/kg is invalid, 10g/kg promptly has remarkable result, increases with dosage, and inhibitory action strengthens, but compare with atropine, this inhibition very relaxes, and BUZHONG YIQI TANG also has significantly but very not strong inhibitory action.
2, to the hyperfunction influence of neostigmine induced mice bowel movement
50 of mices are divided into 5 groups at random, and fasting gavages the ER KANG NING medicinal liquid or the tragacanth liquid of equal volume respectively after 18 hours.Every Mus gavages the tragacanth suspension 0.3ml at 3% charcoal end after 1 hour, and mice pulls neck execution after 15 minutes, calculates and advances percentage rate, and neostigmine the results are shown in Table 2 in giving the charcoal end preceding 20 minutes subcutaneous injections.The group dosage Mus number that influences that table 2 pair neostigmine induced mice intestinal movement is hyperfunction advances percentage rate P value
(g/kg) (only) (%) matched group-10 44.3 ± 8.8 neostigmine 0.00012 10 62.5 ± 9.2** ER KANG NING+neostigmine 10+0.00012 10 51.5 ± 8.6<0.05 " " 20+0.00012 10 46.6 ± 8.2<0.01 " " 40+0.00012 10 40.2 ± 9.3<0.01P value compare with the neostigmine group for the administration group; * compares P<0.01 with normal control
By table as seen, neostigmine can excited very significantly intestinal, the promotion ahead running.ER KANG NING is antagonism neostigmine induced mice intestinal ahead running hyperfunction significantly.
3, with the influence to mouse small intestine road propulsion functions when share of bowel movement inhibitor
80 of mices are divided into 8 groups at random, ER KANG NING medicinal liquid or tragacanth liquid that fasting gavaged respectively after (but can freely drink water) with the volume various dose in 18 hours.Every Mus all gavages 3% charcoal end tragacanth liquid 0.3ml after 1 hour, measure the intestinal propulsion percentage rate with method after 20 minutes, in gavaging charcoal end liquid preceding 20 minutes subcutaneous injection atropine 2ml/kg, papaverine 30ml/kg, or, the results are shown in Table 3 in giving charcoal end subcutaneous injection epinephrine 1ml/kg simultaneously.(X ± SD) group dosage Mus number advances percentage rate P value to effect when table 3 advances inhibitor to share with intestinal
(g/kg), (only), (%) healthy and free from worry 20 10 49.8 ± 10.2** atropine, the 0.002 10 33.5 ± 6.2** of control group-10 62.3 ± 8.9 youngster healthy and free from worry+Ah 20+0.002 10 44.3 ± 7.6**<0.01 papaverine, 0.03 10 38.8 ± 6.7** is healthy and free from worry+small-mouthed jar 20+0.03 10 47.9 ± 10.2**<0.05 adrenaline, 0.001 10 46.6 ± 10.9** is healthy and free from worry-kidney 20+0.001 10 51.7 ± 10.1*>0.05P value for only advance the inhibitor person to compare to intestines to compare * P<0.05**P<0.01 with Normal group
By table as seen, but atropine, papaverine and epinephrine be the inhibition mouse intestinal ahead running of highly significant all, ER KANG NING also has the inhibition effect, but when ER KANG NING and above-mentioned intestinal ahead running inhibitor share, not only do not see collaborative inhibition to the intestinal ahead running, on the contrary to suppressing to have remarkable antagonism due to atropine, the papaverine, but person due to the epinephrine there is not remarkable antagonistic effect.
In sum, ER KANG NING has significantly the small intestine movement of mice ahead running but not too strong inhibition effect.Do not have obvious effect when this acts on 5g/kg, 10g/kg then has remarkable result, and strengthens with the dosage increasing.Inhibition to ahead running due to the hyperfunction and atropine of neostigmine induced mice intestinal ahead running, papaverine etc. all has significant antagonistic effect, shows that ER KANG NING has a kind of significant adjustment effect unusually to the intestinal propulsion functions.
Two, to rat stomach, gallbladder, the excretory influence of pancreas
Show that through rat experiment ER KANG NING slightly is inhibition trend to rat stomach liquid measure and gastric acid secretion, but not statistically significant, yet can significantly improve pepsin eliminating amount and peptic activity of stomach.ER KANG NING can significantly promote bile and pancreatic secretion, and makes protein concentration and the increase of eliminating amount in the pancreatic juice.Owing to the variation of pancreatic juice protein amount is parallel with pancreatin (protease, lipase and amylase etc.) is the representative index of each enzyme secretion situation of reflection pancreatic juice, so thereby can think that ER KANG NING can also significantly increase the digestion of the secretion promotion of each digestive enzyme in the pancreatic juice to food.ER KANG NING increases Digestive system such as stomach, gallbladder, pancreas and the excretory effect of digestive enzyme and helps absorption to nutrient substance.
Three, the mouse experiment diarrheal is influenced
Show that through mouse experiment ER KANG NING is to Oleum Ricini, magnesium sulfate and PEG
A{ footmark=212
A{ the experimental diarrhoea of footmark=0} induced mice all has significant inhibitory effect, act as by force with diarrheal due to the above two.
Four, to the influence of rat growthing development
ER KANG NING begins successive administration February in young rat, and is remarkable in fast than matched group except that making body weight gain, and the rat body is long also sees remarkable increase.Be also shown in the rat volume simultaneously, increase arranged than weight average.Owing to serve as light with fatty proportion in the Mus body, skeleton, muscle is than great, thereby shows that ER KANG NING promotes that the effect of young Mus growth promoter is more comprehensive, mainly is skeleton, muscle growth, but not be to tire out gathering of fat.
Five, to central nervous system's influence and nootropic effect
1, to the influence of spontaneous activity in mice
The mice 32 suitable through preliminary election spontaneous activity intensity is divided into 4 groups at random, gavage ER KANG NING medicinal liquid or tragacanth liquid respectively, behind the medicine 1 hour, put into four box spontaneous activity in mice analyzers successively with the volume various dose, spontaneous activity in mice situation in measuring 30 minutes the results are shown in Table 4.
(X ± SD) group dosage Mus is counted on the upright number of times of total displacement and jumps number of times in the influence of table 4 pair spontaneous activity in mice
(g/kg) (only) (cm) (inferior) (inferior) matched group-8 148.8 ± 22.6 452 ± 167 90 ± 43 ER KANG NING 10 8 163.2 ± 37.6 460 ± 131 115 ± 58 ER KANG NING 20 8 152.8 ± 37.4 444 ± 177 114 ± 77 ER KANG NING 40 8 150.4 ± 53.0 482 ± 217 114 ± 59
No matter is that the total distance of walking, the number of times of uprightly probing into or time number average of upward jumping that jumps out of container do not have obvious influence by the visible ER KANG NING of table to spontaneous activity in mice.
2, to the pentobarbital sodium influence of the length of one's sleep
40 of mices are divided into 4 groups at random, gavage ER KANG NING medicinal liquid or tragacanth liquid with the volume various dose respectively, and behind the medicine 1 hour, every Mus lumbar injection pentobarbital sodium 35ml/kg, the single respectively glass jar of putting into, the results are shown in Table 5 at the record righting reflex loss time.
(X ± SD) group dosage Mus is counted length of one's sleep incubation period in the influence of table 5 pair pentobarbital sodium length of one's sleep
(g/kg) (only) (branch) (branch) matched group-10 6.27 ± 1.63 34.9 ± 21.2 ER KANG NING 10 10 6.34 ± 2.68 30.9 ± 19.1 ER KANG NING 20 10 6.66 ± 2.56 48.0 ± 23.0 ER KANG NING 40 10 7.10 ± 2.90 32.7 ± 28.3
Not only do not have collaborative but also do not have the antagonism influence by showing the central inhibitory action of visible ER KANG NING to pentobarbital sodium.
3, the influence that normal mouse memory is obtained
5 groups of 50 branches of mice gavage the medicinal liquid of various dose or tragacanth liquid 1 time every day, and continuous 7 days, carried out the training of diving tower method in 1 hour after the last administration, the results are shown in Table 6.
(X ± SD) group dosage Mus miscounts mistake number of times P value in the table 6 pair influence that normal mouse memory obtains
(g/kg) (only) matched group-10 4.9 ± 2.1 ER KANG NING 10 10 3.2 ± 1.7>0.05 ER KANG NING 20 10 2.9 ± 1.6<0.05 ER KANG NING 40 10 3.0 ± 1.8<0.05 Radix Ginseng decoction 10 10 1.2 ± 1.3<0.01
By table as seen, ER KANG NING can strengthen the mouse memory capacitation, in 20g/kg and 40/kg remarkable result is arranged all, but a little less than the effect, the single Radix Ginseng then has stronger enhancing mouse memory capacitation effect.
4, to amnemonic influence
Show that through mouse experiment ER KANG NING consolidates for memory due to scopolamine induced mice memory acquisition disturbance, the sodium nitrite that the memory represents obstacle all has remarkable antagonism due to obstacle and the ethanol.
In sum, ER KANG NING does not have obvious inhibition or excitation to the central nervous system, but the memory capacitation for normal mouse has certain reinforced effects, remarkable multiple reason induced mice dysmnesia such as antagonism scopolamine, sodium nitrite and ethanol, show that ER KANG NING does not influence central nervous system's normal function, but nootropic effect is arranged.
Six, to Immune Effects
Experimental results show that, ER KANG NING does not influence the normal mouse leukocyte count, but remarkable antagonism caused by cyclophosphamide low leukocyte counts, and can promote inflammatory stimulus the time macrophage to the gathering of scorching kitchen range, strengthen the activity of macrophage phagocytic foreign body, ER KANG NING can also significantly be resisted the damage atrophy of central immune organ due to the cortisone, and The above results shows that ER KANG NING has the nonspecific immunity reinforced effects.
The clinical observation on the therapeutic effect experimental data of ER KANG NING is as follows:
One, ER KANG NING treatment infantile anorexia clinical observation
1, object and method
1) object of observation:, do not establish matched group for the case of the outpatient service of Wuhan City children's hospital and certain kindergarten trouble apositia.
2) choice criteria: appetite depression, appetite reduce, more normally reduce 1/2 or more than, time remaining is got rid of the disease or the cause of disease that can investigate and prosecute with straightforward procedure more than 2 weeks.Non-inclusion criteria: due to the various diseases reason, detest the trencherman, took other treatment apositia medicine person in three days, can not finish whole course of treatment of person entirely.
3) age: minimal ages 1.5 years old, maximum 10 years old age, wherein 1.5-3 year 9 examples, 3-7 year 17 examples, 7-10 year 4 examples, add up to 30 examples.
4) sex: male 17 examples, women 13 examples.
5) anorexia degree: the shortest 2 weeks, the longest 2 years, 2 week-6 month 10 example wherein, 6 months-1 year 11 examples, 1 year-2 years 9 examples.
6) drug dose and usage: each 10ml, every day 3 times, 7 days 1 courses of treatment, totally 3 courses of treatment.
7) observational technique: the observation table is filled in the first visit inspection.Take medicine 1 week back further consultation, if effectively then continue to take medicine, observe once weekly, wind up the case for totally three times.Invalid after 1 week if begin to take medicine, then classify invalid case as, stop to observe.
8) curative effect judging standard: recovery from illness: desire all to recover normal with appetite; Produce effects: appetite increases, appetite increases by 3/4; Effectively: appetite increases, and appetite increases by 1/2; Invalid: appetite, appetite do not have improvement.Appetite appetite is all with the health standard of doing of the same age.
2, result
After the ER KANG NING treatment, 18 examples account for 60% in the back appetite improvement of 1 week; 4 examples account for the back appetite improvement of 13.3%2 weeks.Appetite returns to normal person's 12 examples and accounts for 40%, and appetite returns to normal 3/4 6 examples and accounts for 20%, and appetite returns to normal 1/2 4 examples and accounts for 13.3% (table 7,8).
Table 7 ER KANG NING treatment back appetite is improved situation
Appetite | Before the treatment | After the treatment |
Difference adds up in good | Difference adds up in good |
The example number | 0 8 22 30 | 18 4 8 30 |
Table 8 appetite begins the improvement time
Appetite takes a turn for the better the time | 1 all 2 weeks were not improved total |
The example number | 18 4 8 30 |
Appetite increases: the appetite of whole cases more normally reduces 1/2-3/4 before the treatment, and after the ER KANG NING treatment, the appetite increase returns to normal person's 12 examples, accounts for 40%; Appetite increase by 6 examples account for 20%; Appetite increase by 4 examples account for 13%; (seeing Table 9).
Table 9 ER KANG NING treatment back appetite is improved situation
Appetite | The normal improvement total of 3/4 increase by 1/2 that increases of recovery |
The example number | 12 6 4 8 30 |
Weight increase: all effective cases all show as weight increase, and minimum increase 0.4kg in 3 weeks increases 1.0kg at most, average 0.614 ± the 0.175kg that increases, the weight increase time 27.3%, 31.8% in second week in first week, and 40.9% the 3rd week (seeing Table 10,11).
Table 10 ER KANG NING treatment back body weight is improved situation
Weight increase (kg) | 0.4-0.5 0.6-0.7 0.8-1.0 does not increase total |
The example number | 12 6 4 8 30 |
Table 11 body weight begins rise time
Time | The 2nd week of the 1st week did not increase total in the 3rd week |
The example number | 6 7 9 8 30 |
Complexion is improved: the most performance of apositia infant complexion poor (Rhizoma Curcumae Longae or pale).33.3% complexion is improved after the ER KANG NING treatment, and wherein 16.7% complexion becomes ruddy (table 12).
Complexion is improved situation before and after the treatment of table 12 ER KANG NING
Complexion | Before the treatment | After the treatment |
The pale total of ruddy Rhizoma Curcumae Longae | The pale total of ruddy Rhizoma Curcumae Longae |
The example number | 0 19 11 30 | 5 17 8 30 |
Curative effect: in ER KANG NING treatment three weeks of infantile anorexia, total effective rate is 73.3%, and wherein cure rate 40%, obvious effective rate 20%, effective percentage 13.3%, inefficiency 29.7% (seeing Table 13).
The curative effect of table 13 ER KANG NING
Curative effect | Recovery from illness | Produce effects | Effectively | Invalid | Add up to |
Percentage rate | 40 | 20 | 13.3 | 26.7 | 100 |
Two, ER KANG NING treatment infantile anemia clinical observation
The ER KANG NING iron content is abundant, and the experimental group color have significant difference before and after the clinical observation medication, but the matched group indifference, shows that ER KANG NING can prevent and treat a series of diseases due to children's's iron deficiency, the generation of minimizing iron deficiency anemia.Especially infantile respiratory tract infection repeatedly, poor, the dry stool of appetite there is produce effects.