CN100421694C - Method of extracting gastroenteric power enbancing medicament from natural plant Chinese medicine effective component - Google Patents
Method of extracting gastroenteric power enbancing medicament from natural plant Chinese medicine effective component Download PDFInfo
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Abstract
The present invention relates to a method for extracting medicine for improving gastrointestinal motility from effective components of traditional Chinese medicine, which belongs to natural product pharmacological activity and a method for separating and purifying natural products. The formula is composed of 9.71% of common yan rhizome, 9.71% of largehead atractylodes rhizome, 9.71% of Chinese date, 9.71% of hawthorn fruit(coke), 9.71% of chicken's gizzard membrane, 9.71% of fleece flower root, 9.71% of dried longan pulp, 9.71% of oyster shell, 2.91% of immature orange fruit, 4.85% of angelica and 4.85% of areca seed (seed). The present invention has the positive effect that the method for extracting medicine for improving gastrointestinal motility from effective components of traditional Chinese medicine adopts advanced adsorption effective components of macroporous resin and gas phase finger trace spectrum for fixing the quantity, and the stability and the high quality of the medicine are ensured.
Description
(1) technical field
The present invention relates to extract the method that increases digestive tract power goods medicine in a kind of effective components of Chinese medicinal, belong to natural product pharmacologically active and Separation ﹠ Purification natural material prescription method.Its commodity are called " mountain helps digestion in vain ".
(2) background technology
The contrast medicine is a DASHANZHA WAN.Be primarily aimed at lustreless complexion, anorexia or anorexia, even refusing to eat; Spiritlessness and sparing of words; Distension and fullness in the abdomen, the vomiting of food back; Stool or half congealed let out or the stool of holding concurrently unfavorable; Red tongue or light, few tongue or white and thin fur, thready and weak pulse.People wish that urgently new product comes out.
(3) summary of the invention
Technical scheme comprises prescription new technology, process chart and various toxicity, pharmacology summary.
Technical solution is:
Purpose of the present invention discloses to be extracted the method that increases digestive tract power goods medicine and a kind of highly purified crude drug is provided in a kind of effective components of Chinese medicinal, be that a kind of green medicine belongs to the natural product pharmacologically active and separates.
Rhizoma Dioscoreae 9.71%, the Rhizoma Atractylodis Macrocephalae 9.71%, Poria 9.71%, Fructus Jujubae 9.71%, Fructus Crataegi (Jiao) 9.71%, Endothelium Corneum Gigeriae Galli 9.71%, Radix Polygoni Multiflori 9.71%, Arillus Longan 9.71%, Concha Ostreae 9.71%, Fructus Aurantii Immaturus 2.91%, Radix Angelicae Sinensis 4.85%, Semen Arecae (Jiao) 4.85% product compound recipe increases the digestive tract power goods, adopt under the careful strict condition, use the supercritical fluid carbon dioxide extractant, behind the volatile oil composition of 12 kinds of natural products of extraction, water decocts and separates by the macroporous resin resin absorption again, purification, through under the 85C condition, after the spray drying, after referring to the quantitative assay of trace collection of illustrative plates with the gas phase instrument, make the crude drug of standard.Carry out pharmacodynamic experiment and show, 12 kinds of natural product compound recipes increase the pharmacologically active of digestive tract power goods, have reached beyond thought result.Compound product can significantly promote the intestinal motility of mice, increases the propelling rate, and is dose-dependence.Duodenal self-discipline activity is inhibitory action to compound product to isolated rabbit, when adding compound product, has instantaneous tension force to rise, and promptly changes inhibitory state subsequently over to, and amplitude reduces, frequency deceleration, and along with dosage increases, suppress to deepen.Compound product has significant antagonism to the ileum contracture that Ach causes, makes the myenteron tension force of spasm return to normal level, and can make the intestinal rhythm and pace of moving things shrink recovery.Compound product is significant inhibitory effect to the rabbit ileum contracture that barium chloride causes, can make the myenteron tension force of contracture recover normal, but the rhythmicity contraction recovers not remarkable.Isolated rabbit ileum due to the obvious antagonism epinephrine of compound product energy shrinks and suppresses, and makes it recover the contraction state of restraining oneself.Compound product can significantly increase the rat gastric secretion, improves the acidity of gastric acid, increases total acid output, strengthens pepsin activity, and is dose-dependence.
Extract the method that increases digestive tract power goods medicine in the effective components of Chinese medicinal and adopt advanced macroporous resin adsorption active ingredient and use gas phase to refer to that trace spectrum is quantitative, guarantee the stability and the high-quality of medicine.
Creativeness of the present invention embodies by clinical toxicity, pharmacology, provides in the lump when examination as to substances.
(4) description of drawings
Fig. 1 process chart of the present invention.
Fig. 2 compound product is to the active influence of restraining oneself of isolated rabbit duodenum.
Fig. 3 compound product is to the rabbit ileum spasm due to the acetylcholine.
Fig. 4 compound product is to the antagonism of the rabbit ileum spasm due to the barium chloride.
The antagonism that Fig. 5 compound product suppresses the rabbit ileum due to the epinephrine.
Its technological process is described below:
(1) the present invention's prescription: Chinese yam 50g, bighead atractylodes rhizome 50g, Poria cocos 50g, date 50g, hawthorn (Jiao) 50g, the membrane of a chicken's gizzard 50g, fleece-flower root 50g, arillus longan 50g, oyster 50g, dried immature fruit of citron orange 15g, Radix Angelicae Sinensis 25g, betel nut (Jiao) 25g.
(2) solvent: 1. the supercritical extract solvent is carbon dioxide; 2. water.
(3) extract: brown liquid.
Volatile oil: brownish red grease.
(4) physical parameter
The pressure of supercritical extract is 1～10MPa, and temperature is 20～50 ℃; Water extraction gets,
Resin absorption, spray drying are normal pressure; Wherein, the temperature of water extraction is 100 ℃, and the temperature of resin absorption is a room temperature; Spray-dired temperature is 80～85 ℃.
(5) operating process
1. 12 kinds of medical materials are broken into the little bulk of diameter 1～2cm, extract volatile oil component with the carbon dioxide supercritical fluid extraction device then, volatile oil (1).
2. extract medicinal residues behind the volatile oil and add 3 times of water gagings and decocted 3 hours, filter, filtrate (2); Medicinal residues add 2 times of water gagings and decocted 2 hours, filter, and get filtrate (3); Medicinal residues add 1 times of water gaging again and decocted 1 hour, filter, and get filtrate (4).
3. leave standstill merging filtrate (2), (3), (4), gets supernatant, gets extracting solution (5).
4. extracting solution (5) is adsorbed with macroporous resin.
5. the chemical constituent that will be adsorbed on the resin with 65% ethanol is eluted in the ethanol, gets eluent (6).
6. eluent (6) is advanced reclaim under reduced pressure, concentrated solution (7).
7. concentrated solution (7) is carried out spray drying.Add volatile oil (1) again, get medicated powder, promptly.
Its technology is with 12 kinds of natural product compound recipe raw materials, uses the supercritical fluid carbon dioxide extractant, extracts 12 kinds of natural product volatile oil components, and with gaseous carbon dioxide and 12 kinds of natural product component separating, rectification is standby.To extract raw material behind the volatile oil, every 100kg adds water 300kg, 200kg, 100kg, under 100 ℃ of conditions, extracted respectively 3 hours, 2 hours, 1 hour, the filtrate that merges water extraction, leave standstill, get supernatant, by the pillar that macroporous resin is filled, use macroporous resin adsorption, use 65% ethanol, the composition that is adsorbed on the macroporous resin is eluted in the ethanol, merge with the standby liquid of rectification, under 85 ℃ of conditions, after the spray drying, refer to the quantitative assay of trace collection of illustrative plates with the gas chromatography instrument, and make the standard raw materials medicine.
(5) specific embodiment
Rhizoma Dioscoreae 50g, Rhizoma Atractylodis Macrocephalae 50g, Poria 50g, Fructus Jujubae 50g, Fructus Crataegi (Jiao) 50g, Endothelium Corneum Gigeriae Galli 50g, Radix Polygoni Multiflori 50g, Arillus Longan 50g, Concha Ostreae 50g, Fructus Aurantii Immaturus 15g, Radix Angelicae Sinensis 25g, Semen Arecae (Jiao) 25g.
Its technology is with 12 kinds of natural product compound recipe raw materials, uses the supercritical fluid carbon dioxide extractant, extracts 12 kinds of natural product volatile oil components, and with gaseous carbon dioxide and 12 kinds of natural product component separating, rectification is standby.To extract raw material behind the volatile oil, every 100kg adds water 300kg, 200kg, 100kg, under 100 ℃ of conditions, extracted respectively 3 hours, 2 hours, 1 hour, the filtrate that merges water extraction, leave standstill, get supernatant, by the pillar that macroporous resin is filled, use macroporous resin adsorption, use 65% ethanol, the composition that is adsorbed on the macroporous resin is eluted in the ethanol, merge with the standby liquid of rectification, under 85 ℃ of conditions, after the spray drying, refer to the quantitative assay of trace collection of illustrative plates with the gas chromatography instrument, and make the standard raw materials medicine.Creativeness of the present invention by toxicity, pharmacology is clinical embodies, replenishing during substantive examination provides existing brief introduction as follows:
From the natural plants effective components of Chinese medicinal
Extract the method pharmacological action that increases digestive tract power goods medicine
Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Poria, Fructus Jujubae, Fructus Crataegi (Jiao), Endothelium Corneum Gigeriae Galli, Radix Polygoni Multiflori, Arillus Longan, Concha Ostreae, Fructus Aurantii Immaturus, Radix Angelicae Sinensis, Semen Arecae (Jiao) natural product compound recipe increase the digestive tract power goods (to be called for short: compound product), cure mainly diseases such as infantile anorexia, abdominal distention, accumulation of food in the stomach and intes tine due to indigestion.Carry out pharmacodynamic experiment, its pharmacologically active is as follows:
One, to the influence of mouse small intestine ahead running
Experiment material:
Medicine: the compound product low dose is 5g/kg, and heavy dose is 10g/kg.
Animal: white mice is available from Experimental Animal Center, male and female dual-purpose, body weight 20 ± 2g.
Experimental technique: get healthy mice, be divided into the blank group at random, extract 10 every group of little, the heavy dose of groups of the method that increases digestive tract power goods medicine in a kind of effective components of Chinese medicinal by body weight and sex.Before the experiment, animal fasting 16h can't help water.Each organizes mice by above-mentioned dosage gastric infusion, and 20min after the administration irritates stomach and only gives india ink 0.2ml/.After treating 20min, mice is put to death in cervical vertebra dislocation, cuts open the belly immediately, and the extraction small intestinal is measured the length of pylorus to ileocecus and pylorus to the prepared Chinese ink forward position, and calculated intestinal propulsion rate (2), and relatively administration is respectively organized the intestinal propulsion rate and matched group has or not significant difference.
Experimental result:
Table 1 compound product is to the influence of mouse small intestine ahead running
| Group | Dosage (g/kg) | Number of animals (only) | The intestinal propulsion rate (%, X ± SD) | The P value |
| Blank | - | 10 | 64.83±6.77 | |
| Compound product | 5 | 10 | 78.48±7.70 | ＜0.001 |
| Compound product | 10 | 10 | 89.49±8.46 | ＜0.001 |
Find out that by table 1 compound product can significantly promote the intestinal motility of mice, increase intestinal propulsion rate (P＜0.001), and be dose-dependence.
Two, the influence that the rabbit intestine in vitro is moved
Experiment material:
Animal: large ear rabbit, body weight 2～3kg, male and female dual-purpose.
Instrument: isolated organ analyzer, DC-001 type.
Experimental technique:, observe medicine to the active influence of intestine in vitro by the method that MagnusShi refers to remember isolated rabbit duodenum and ileum.To be truncated into the intestinal segment of 2～3cm, put into isolated organ analyzer bath, the tyrode's solution capacity is 30ml in the bath, and temperature is 38 ± 0.5 ℃.After treating that the intestinal tube activity is stable, add suitable medicine, trace medicine the active influence of intestinal tube.Secondly, at observation post's reagent thing antagonism acetylcholine (Ach), barium chloride (Bacl
2) and epinephrine (Adr) due to the intestinal tube smooth muscle do the time spent, earlier with antagonism acetylcholine (0.5ML * 10
-5) or barium chloride (5%0.5ml) or epinephrine (0.15ml * 10
-4) add in the bath, treat the intestinal tube reacting balance after, add institute's reagent thing again, observe the antagonism of medicine.
Experimental result:
1. to the active influence of restraining oneself of isolated rabbit duodenum
Table 2 compound product is to the active influence of restraining oneself of isolated rabbit duodenum
| Medicine | Drug level (g/ml) | Experiment number | Amplitude suppressing rate (%) | Frequency deceleration (inferior/minute) |
| Compound product | 1.5×10 -2 | 5 | 9.60±5.81 | 1.2±0.5 |
| Compound product | 3×10 -2 | 5 | 32.19±4.50 | 2.4±0.7 |
| Compound product | 6×10 -2 | 5 | 84.27±6.63 | 5.5±1.0 |
As table 2, shown in Figure 2, duodenal self-discipline activity is inhibitory action to compound product to isolated rabbit.When adding medicine in bath, have instantaneous tension force to rise, promptly change inhibitory state subsequently over to, amplitude reduces, frequency deceleration, and along with dosage increases, suppress to deepen.
2. to the influence of the rabbit ileum contracture due to the acetylcholine
Table 3 compound product is to the antagonism of the rabbit ileum contracture due to the antagonism acetylcholine
| Medicine | Drug level (g/ml) | Experiment number | Suppression ratio (%) |
| Compound product | 6×10 -2 | 5 | 97.2±14.8 |
Can find out that from table 3, Fig. 3 compound product has significant antagonism to the ileum contracture that the antagonism acetylcholine causes, make the myenteron tension force of spasm return to normal level, and can make the intestinal rhythm and pace of moving things shrink recovery.
3. to the influence of the rabbit ileum contracture due to the barium chloride
The antagonism of the rabbit ileum contracture that table 4 compound product causes barium chloride
| Medicine | Drug level (g/ml) | Experiment number | Suppression ratio (%) |
| Compound product | 6×10 -2 | 5 | 88.9±11.2 |
From table 4, Fig. 4 as seen, compound product is significant inhibitory effect to the rabbit ileum contracture that barium chloride causes, can make the myenteron tension force of contracture recover normal, but the rhythmicity contraction recovers not remarkable.
4. the rabbit ileum due to the epinephrine is shunk the influence that suppresses
Table 5 compound product shrinks the antagonism that suppresses to the rabbit ileum that epinephrine causes
| Medicine | Drug level (g/ml) | Experiment number | Recovery rate (%) is shunk in self-discipline |
| Compound product | 6×10 -2 | 5 | 56.4±10.1 |
As table 5, shown in Figure 5, the compound product obviously isolated rabbit ileum due to the antagonism epinephrine shrinks and suppresses, and makes it recover the self-discipline contraction state.
Three, to the influence of rat gastric juice secretory function
Experiment material:
Medicine: compound product small dose group dosage is 3.5g/kg, and heavy dose of group is 7.0g/kg.
Defatted milk powder
Animal: Wistar rat, male and female dual-purpose, body weight 150～200g.
Experimental technique: get healthy rat, be divided into blank at random, extract the method low dose that increases digestive tract power goods medicine, heavy dose of 10 every group in a kind of effective components of Chinese medicinal by body weight and sex.Each administration group is by above-mentioned dosage gastric infusion, and the blank group gavages with the volume distilled water, once a day, and continuous 7 days.Before the last administration, animal fasting 16h can't help water.2h behind the gastric infusion, etherization carries out pylorus by the ShayShi method and separates bundle.Water is prohibited in the fasting of postoperative animal, and the cervical vertebra dislocation is put to death behind the 5h, collects gastric juice, and is centrifugal, gets supernatant, measures gastric juice total amount, total acidity, total acid output stomach function regulating proteinase activity.Acidity assaying adopts acid-base titrations, makes indicator with phenolphthalein.Pepsin is measured by LeeShi curdled milk test improved method and is undertaken
(3)Method is as follows: 0.2M calcium chloride solution 5ml is added among the 0.1M acetate buffer solution 95ml, make base fluid with this liquid dissolving 20g defatted milk powder.Get base fluid 5ml, add with 6 times of gastric juice 0.2ml of .05M Chinese holly Stump acid buffer dilution, after fully mixing, put into 35.5 ℃ of temperature immediately and bathe, the tube wall that tilts is constantly observed curdled milk and timing occurred.Calculate the pepsin activity method; Solidified the activity of the base fluid 1ml that contains Lac Bovis seu Bubali at 1 minute,, show with the unit among the gastric juice 1ml (U/ml) numerical table as 1 curdled milk unit.
Experimental result:
Table 6 compound product is to the influence of rat gastric juice secretory function (x ± SD)
| Group | Dosage (g/kg) | Number of animals (only) | Gastric juice amount (ml/5h) | Total acidity (mol/L) | Total acid output (mol/L) | Pepsin activity (U/ml) |
| Blank | - | 10 | 5.1±1.5 | 113.6±15.2 | 0.58±0.21 | 147.8±37.7 |
| Compound product | 3.5 | 10 | 6.8±1.9* | 127.6±12.4* | 0.88±0.32* | 184.5±52.1 |
| Compound product | 7.0 | 10 | 7.6±1.6** | 136.4±18.8** | 1.04±0.31** | 195.9±64.6* |
With compare * P＜0.05, * * P＜0.01
As seen from Table 6, compound product can significantly increase the rat gastric secretion, improves the acidity of gastric acid, increases total acid output, strengthens pepsin activity, and is dose-dependence.
Discuss and conclusion
To sum up experimental result shows:
1. compound product can significantly be accelerated the enterokinesia speed of mice, increases the intestinal propulsion rate; The isolated rabbit duodenum then is motion suppresses, self-discipline is shunk reduce, frequency deceleration, and with the increase of dosage, inhibitory action is deepened.
2. compound product can the antagonism acetylcholine and the ileum smooth muscle contracture that causes of barium chloride, and myenteron tension force is reduced, and self-discipline is shunk and recovered, and spasmolysis is arranged; Also can make the ileum motion that causes by epinephrine suppress to reactivate.Therefore can think that extracting the method that increases digestive tract power goods medicine in a kind of effective components of Chinese medicinal has dual regulation to isolated rabbit ileum motor function, this can explain that these goods can treat abdominal distention, can treat diseases such as diarrhea again.
3. compound product can significantly increase the rat gastric secretion, improves the acidity of gastric juice, increases total acid output, strengthens pepsin activity.
Extract the method clinical research that increases digestive tract power goods medicine in a kind of effective components of Chinese medicinal: diseases such as treatment infantile anorexia, lusterless complexion, lassitude, in order to verify clinical efficacy and pharmacologically active and to investigate its toxic and side effects and carry out clinical trial, observe the case treatment and organize 100 examples, Clinical results is as follows:
Diagnostic criteria:
Digestive functional disturbance disease: inappetence, abdominal distention, diarrhea or vomiting.
Case test item: measure the clean body weight of infant (the special scale of special messenger) before and after the medication respectively; Detect routine blood test, just conventional and general health check-up, treatment group and matched group are done the ptyalin enzymatic activity respectively and are detected; Treatment group picked at random 60 examples are done routine blood test, routine urinalysis, liver function test.
Grouping and dispensing
1. grouping: study subject is divided into compound product group 100 example at random by the table of random number method and Fructus Crataegi is organized 60 examples.
2. dispensing: test group dispensing (at every turn); Every day three times; Fructus Crataegi is used in the matched group dispensing.
Test requirements document: fill in the observation table in detail, and note has progress note.Body weight, ptyalin enzymatic activity, hematuria routine, liver function and primary and secondary disease details before and after the record treatment.
Curative effect determinate standard:
1. recovery from illness: appetite recovers normal, and weight increase or recovery are normal, and skin is full, and stool is normal, all disease disappearances, and the ptyalin enzymatic activity is significantly increased.
2. produce effects: cardinal symptom has clear improvement and (is transferred to not good enough by refusing to eat as appetite) more than secondary or a primary symptom changes in one-level, and other time disease is disappearance person all; The ptyalin enzymatic activity is significantly improved.
3. effective: two cardinal symptoms are improved more than one-level, and other symptom is improvement person to some extent; The ptyalin enzymatic activity increases.
Therapeutic outcome:
One, the comparison of two groups of clinical efficacies
Table 7 clinical efficacy statistical table
**P＜0.01*＜0.05
According to clinical observation result, compound product and Fructus Crataegi group Fructus Crataegi cure rate are respectively 40.0%, 21.6%, and total obvious effective rate is respectively 84.0%, 48.2%, and total effective rate is respectively 97.0%, 80.0%, through X
2Check, P value difference＜0.01 and＜0.05 has significant differences and significant difference, and prompting compound product clinical efficacy is better than the Fructus Crataegi group.
Two, the curative effect of two groups of anorexia card cardinal symptoms relatively
Table 8 liang group anorexia card cardinal symptom curative effect comparison sheet
Annotate: with matched group than * * P＜0.01, * P＜0.05 A-treatment group B-matched group
According to clinical observation result, two groups of Drug therapy anorexia, abdominal distention, stool are uncomfortable etc. has significant differences (P＜0.01) between the cardinal symptom cure rate.Uncomfortable for the treatment stool, the total effective rate of compound product and Fructus Crataegi group is respectively 94.0%, 84.6%, and group difference is (P＜0.05) significantly.Other no significant difference, prompting is aspect each cardinal symptom such as treatment anorexia card anorexia, abdominal distention, stool are uncomfortable, and compound product all is better than the Fructus Crataegi group.
Three, two groups of medicines are to the influence of ptyalin enzymatic activity and body weight
Table 9 liang group medicine is to the active influence of ptyalin (Lignum Sappan Jie Shi unit)
| Grouping | The example number | Before the treatment | After the treatment | On average increase |
| The treatment group | 100 | 4302.0±137.8 | 4445.2±122.8 | 143.0±28.3* |
| Matched group | 60 | 4332.0±131.0 | 4449.0±118.4 | 117.2±22.5 |
Annotate: with matched group than P＜0.05
Table 10 liang group medicine is to the unit that influences of body weight: kg
| Grouping | The example number | Before the treatment | After the treatment | Average weight gain |
| The treatment group | 100 | 21.8±4.4 | 22.4±4.2 | 0.57±0.1* |
| Matched group | 60 | 21.1±4.1 | 21.5±4.2 | 0.4±0.2 |
According to statistics, take the ptyalin enzymatic activity that two groups of medicines all can improve infant, learn by statistics and handle P＜0.05, the effect treatment group of weight increase is handled there was no significant difference P＞0.05 a little more than matched group but learn by statistics.Point out this medicine in a course of treatment, still not have the effect of weight increase significantly.
Four, toxic and side effects and untoward reaction
During treating, by to 60 routine treatment group patient's liver function and routine examinations, any toxicity do not occur and also do not see that untoward reaction is arranged, illustrate that the compound product drug safety is reliable.
From the natural plants effective components of Chinese medicinal
Extracting increases the research of the method pharmacodynamic experiment of digestive tract power goods medicine
The present invention has the effect of reason spleen stomach function regulating, relieving dyspepsia, cure mainly feel sick before anorexia, abdominal distention, accumulation of food in the stomach and intes tine due to indigestion, the food, diseases such as vomiting or diarrhea.Function according to this prescription cures mainly, and has carried out following pharmacodynamic experiment.
One, to the influence of syndrome of spleen-deficiency mice body weight and swimming time
Experiment material:
Be subjected to the reagent thing: compound product of the present invention.
Control drug: DASHANZHA WAN is produced by Yi Tang pharmaceutical factory, sky, Shenyang City, every ball 9 grams.
Animal: Kunming kind white mice is purchased in Shenyang No. 1 Pharmaceutical Factory animal housing, male and female dual-purpose, body weight 20 ± 2g.
Experimental technique: select 50 of healthy mices, be divided into 5 groups at random, 10 every group by body weight and sex.Be divided into blank group, moulding matched group, the large and small dosage of compound product each one group and DASHANZHA WAN group.Weighing mice body weight once before the administration.Each treated animal was irritated stomach and was only given 1g/ml Radix Et Rhizoma Rhei decoct 0.6ml/ except that the blank group morning every day, and once a day, successive administration 10 days is to cause the model of spleen deficiency mice.Meanwhile, afternoon every day, the compound product group gavaged oral liquid 5g/kg and 10g/kg respectively; The DASHANZHA WAN group gavages suspension 20g/kg; Moulding matched group and blank group are irritated stomach and are given with the volume distilled water, once a day, and continuous 10 days.After 10 days, the mice body weight is respectively organized in weighing, the significance that the comparable group mesosome method of double differences is different.Behind the mice fasting 16h, mice is put into the tank of 20 ± 0.1 ℃ of water temperatures, depth of water 16cm, the record mice swims like a tailor's goose at the end, the time that does not refloat, the relatively difference that mice is endured hardships between each group.
Experimental result:
1. to the influence of syndrome of spleen-deficiency mice body weight
As shown in table 11, moulding matched group and blank group compare, and body weight gain significantly reduces (P＜0.001), stays cool substantially.Compound product group and moulding matched group relatively can significantly increase the body weight (P＜0.001) of mice with spleen deficiency, and be dose dependent; Though the DASHANZHA WAN of equivalent also can make mice with spleen deficiency weight increase (P＜0.05), a little less than the compound product effect, there were significant differences for the two (P＜0.01).
Table 11 compound product is to the influence of mice with spleen deficiency body weight
Compare * P＜0.05 with the moulding matched group, * * P＜0.01 is compared with the DASHANZHA WAN group in * * * P＜0.001
3. to the influence of syndrome of spleen-deficiency mice swimming time
As shown in table 12, moulding matched group and blank group compare, and the mice swimming time significantly shortens (P＜0.05).Compound product and moulding matched group compare, but the swimming time of significant prolongation mice with spleen deficiency (P＜0.05), and be dose-dependence; The DASHANZHA WAN group does not have obvious influence (P＞0.05) to the mice with spleen deficiency swimming time.As seen, the compound product antifatigue effect obviously is better than DASHANZHA WAN.
Table 12 compound product is to the influence of mice with spleen deficiency swimming time
| Group | Dosage (g/kg) | Number of animals (only) | Swimming time (min, X ± SD) | The P value |
| Blank | - | 10 | 13.79±2.95 | ＜0.05 |
| The moulding contrast | - | 10 | 10.03±3.01 | |
| The compound product low dose | 5 | 10 | 11.41±3.47 | ＞0.05 |
| The compound product heavy dose | 10 | 10 | 12.90±2.87 | ＜0.05 |
| DASHANZHA WAN | 20 | 10 | 10.63±2.96 | ＞0.05 |
Two, to the influence of mouse small intestine ahead running
Experiment material:
Medicine: the compound product low dose is 5g/kg, and heavy dose is 10g/kg.The DASHANZHA WAN pharmaceutical quantities is 20g/kg.
Animal: Kunming kind white mice is available from Chinese Medical Sciences University's Experimental Animal Center, male and female dual-purpose, body weight 20 ± 2g.
Experimental technique: get 40 of healthy mices, be divided into the blank group at random, 4 groups of little, heavy dose of group of compound product and DASHANZHA WAN, 10 every group by body weight and sex.Before the experiment, animal fasting 16h can't help water.Each organizes mice by above-mentioned dosage gastric infusion, and 20min after the administration irritates stomach and only gives india ink 0.2ml/.After treating 20min, mice is put to death in cervical vertebra dislocation, cuts open the belly immediately, and the extraction small intestinal is measured the length of pylorus to ileocecus and pylorus to the prepared Chinese ink forward position, and calculated the intestinal propulsion rate.The intestinal propulsion rate is respectively organized in the comparison administration and matched group has or not significant difference.
Experimental result:
Table 13 compound product is to the influence of mouse small intestine ahead running
| Group | Dosage (g/kg) | Number of animals (only) | The intestinal propulsion rate (%, X ± SD) | The P value |
| Blank | - | 10 | 64.83±6.77 | |
| The compound product low dose | 5 | 10 | 78.483±7.70 | ＜0.001 |
| The compound product heavy dose | 10 | 10 | 89.49±8.46 | ＜0.001 |
| DASHANZHA WAN | 20 | 10 | 81.06±6.53 | ＜0.001 |
Find out that by table 13 compound product can significantly promote the intestinal motility of mice, increase intestinal propulsion rate (P＜0.001), and be dose-dependence.DASHANZHA WAN also has similar lonely effect (P＜0.001)
Two, the influence that rabbit body intestinal tube is moved
Experiment material:
Animal: large ear rabbit, body weight 2～3kg, the male and female dual-purpose is purchased in the military region, Shenyang military medicine institute animal housing.
Instrument: the isolated organ analyzer, the DC-001 type, analytical tool factory in Nanjing produces.
Experimental technique:, observe medicine to the active influence of intestine in vitro by the method that MagnusShi refers to remember isolated rabbit duodenum and ileum.To be truncated into the intestinal segment of 2～3cm, put into isolated organ analyzer bath, the tyrode's solution capacity is 30ml in the bath, and temperature is 38 ± 0.5 ℃.After treating that the intestinal tube activity is stable, add suitable medicine, trace medicine the active influence of intestinal tube.Secondly, at observation post's reagent thing antagonism acetylcholine (Ach), barium chloride (Bacl
2) and epinephrine (Adr) due to the intestinal tube smooth muscle do the time spent, earlier with antagonism acetylcholine (0.5ML * 10
-5) or barium chloride (5%0.5ml) or epinephrine (0.15ml * 10
-4) add in the bath, treat the intestinal tube reacting balance after, add institute's reagent thing again, observe the antagonism of medicine.
Experimental result:
1. to the active influence of restraining oneself of isolated rabbit duodenum
Table 14 compound product is to the active influence of restraining oneself of isolated rabbit duodenum
| Medicine | Drug level (g/ml) | Experiment number | Amplitude suppressing rate (%) | Frequency deceleration (inferior/minute) |
| Compound product | 1.5×10 -2 | 5 | 9.60±5.81 | 1.2±0.5 |
| Compound product | 3×10 -2 | 5 | 32.19±4.50 | 2.4±0.7 |
| Compound product | 6×10 -2 | 5 | 84.27±6.63 | 5.5±1.0 |
| DASHANZHA WAN | 1×10 -2 | 5 | 10.55±5.38 | 1.4±0.5 |
| DASHANZHA WAN | 2×10 -2 | 5 | 54.74±14.80 | 4.0±1.0 |
As shown in table 14, duodenal self-discipline activity is inhibitory action to compound product to isolated rabbit.When adding medicine in bath, have instantaneous tension force to rise, promptly change inhibitory state subsequently over to, amplitude reduces, frequency deceleration, and along with dosage increases, suppress to deepen.DASHANZHA WAN also is identical effect.
2. to the influence of the rabbit ileum contracture due to the acetylcholine
Table 15 compound product is to the antagonism of the rabbit ileum contracture due to the antagonism acetylcholine
| Medicine | Drug level (g/ml) | Experiment number | Suppression ratio (%) |
| Compound product | 6×10 -2 | 5 | 97.2±14.8 |
| DASHANZHA WAN | 2×10 -2 | 5 | 83.8±13.4 |
Can find out that from table 15 compound product has significant antagonism to the ileum contracture that the antagonism acetylcholine causes, make the myenteron tension force of spasm return to normal level, and can make the intestinal rhythm and pace of moving things shrink recovery.DASHANZHA WAN also has same function.
3. to the influence of the rabbit ileum contracture due to the barium chloride
The antagonism of the rabbit ileum contracture that table 16 compound product causes barium chloride
| Medicine | Drug level (g/ml) | Experiment number | Suppression ratio (%) |
| Compound product | 6×10 -2 | 5 | 88.9±11.2 |
| DASHANZHA WAN | 2×10 -2 | 5 | 17.6±15.2 |
As seen from Table 16, compound product is significant inhibitory effect to the rabbit ileum contracture that barium chloride causes, can make the myenteron tension force of contracture recover normal, but the rhythmicity contraction recovers not remarkable.DASHANZHA WAN does not have tangible antagonism to the ileum contracture due to the barium chloride.
4. the rabbit ileum due to the epinephrine is shunk the influence that suppresses
Table 17 compound product shrinks the antagonism that suppresses to the rabbit ileum that epinephrine causes
| Medicine | Drug level (g/ml) | Experiment number | Recovery rate (%) is shunk in self-discipline |
| Compound product | 6×10 -2 | 5 | 56.4±10.1 |
| DASHANZHA WAN | 2×10 -2 | 5 | 83.5±10.9 |
Shown in table 17, the compound product obviously isolated rabbit ileum due to the antagonism epinephrine shrinks and suppresses, and makes it recover the self-discipline contraction state.This of DASHANZHA WAN kind of effect, strong than compound product.
Four, to the influence of rat gastric juice secretory function
Experiment material:
Medicine: compound product small dose group dosage is 3.5g/kg, and heavy dose of group is 7.0g/kg.DASHANZHA WAN group dosage is 8.0g/kg.
Defatted milk powder is provided by Shenyang City's Dairy Company.
Animal: the Wistar rat is provided by the military region, Shenyang military medicine institute, male and female dual-purpose, body weight 150～200g.
Experimental technique: get 40 of healthy rats, be divided into blank at random, 4 groups of compound product low dose, heavy dose and DASHANZHA WAN, 10 every group by body weight and sex.Each administration group is by above-mentioned dosage gastric infusion, and the blank group gavages with the volume distilled water, and once a day, continuous 7 days, before the last administration, animal fasting 16h can't help water.2h behind the gastric infusion, etherization carries out pylorus by the ShayShi method and separates bundle.Water is prohibited in the fasting of postoperative animal, and the cervical vertebra dislocation is put to death behind the 5h, collects gastric juice, and is centrifugal, gets supernatant, measures gastric juice total amount, total acidity, total acid output stomach function regulating proteinase activity.Acidity assaying adopts acid-base titrations, makes indicator with phenolphthalein.Pepsin is measured by LeeShi curdled milk test improved method and is undertaken.Method is as follows: 0.2M calcium chloride solution 5ml is added among the 0.1M acetate buffer solution 95ml, make base fluid with this liquid dissolving 20g defatted milk powder.Get base fluid 5ml, add with 6 times of gastric juice 0.2ml of 0.05M Chinese holly acid buffer dilution, after fully mixing, go into immediately in 35.5 ℃ of warm baths, the tube wall that tilts is constantly observed curdled milk and timing occurred.Calculate the pepsin activity method; The activity of coagulating because of the base fluid 1ml that contains Lac Bovis seu Bubali at 1 minute as 1 curdled milk unit, is shown with the unit among the gastric juice 1ml (U/ml) numerical table.
Experimental result:
Table 18 compound product is to the influence of rat gastric juice secretory function (X ± SD)
| Group | Dosage (g/kg) | Number of animals (only) | Gastric juice amount (ml/5h) | Total acidity (mol/L) | Total acid output (mol/L) | Pepsin activity (U/ml) |
| Blank | - | 10 | 5.1±1.5 | 113.6±15.2 | 0.58±0.21 | 147.8±37.7 |
| Compound product | 3.5 | 10 | 6.8±1.9* | 127.6±12.4* | 0.88±0.32* | 184.5±52.1 |
| Compound product | 7.0 | 10 | 7.6±1.6** | 136.4±18.8** | 1.04±0.31** | 195.9±64.6* |
| DASHANZHA WAN | 8.0 | 10 | 7.2±1.3** | 128.8±16.8* | 0.91±0.24** | 179.3±53.8 |
* P＜0.05 * * P＜0.01 with compare
From the natural plants effective components of Chinese medicinal
Extract the method Review Study that increases digestive tract power goods medicine
One, the Pharmacodynamic test of active extract research relevant with therapeutical effect
Functional treatment according to this prescription, we have carried out following pharmacodynamic study: compound product is with the influence of syndrome of spleen-deficiency mice body weight and swimming time, to the influence of mouse small intestine ahead running, to the influence of rabbit intestine in vitro motion, research to the influence of rat gastric juice secretory function, and cure mainly similar DASHANZHA WAN to function and contrast, result of the test shows:
1. the present invention can significantly increase the mice with spleen deficiency body weight, prolongs the swimming time of mice with spleen deficiency, points out to have and improves the kind remarkable efficacy of syndrome of spleen-deficiency mice whole body, and this of compound product kind of effect obviously is better than DASHANZHA WAN.
2. the present invention can significantly accelerate the enterokinesia speed of mice, increases small intestinal promotion rate; The isolated rabbit duodenum then is motion suppresses, self-discipline is shunk reduce, frequency deceleration, and with the increase of dosage, inhibitory action is deepened.DASHANZHA WAN is same function also.
3. compound product can the antagonism acetylcholine and the ileum smooth muscle contracture that causes of barium chloride, and myenteron tension force is reduced, and self-discipline is shunk and recovered, on spasmolysis is arranged; The ileum motion system of embracing that is caused by parathyrine under the kidney is reactivated.
Therefore can think that the valiant fighter is good to have dual regulation to isolated rabbit ileum motor function.This can explain this prescription treatment abdominal distention, can treat diseases such as diarrhea again.
4. compound product can significantly increase the rat gastric secretion, improves the acidity of gastric juice, increases total output, strengthens stomach egg enzymatic activity, and DASHANZHA WAN also has similar effect.
Two, the anxious poison of animal, long poison research
1. anxious poison research
Under the prerequisite of maximum dosage-feeding, single administration, LD can not measure, compound product carries out maximum tolerance determination on the one, per os is irritated stomach this product 206g/kg, and the toxic reaction and the phenomena of mortality do not take place white mice, and dosis tolerata is calculated by kg body weight, be equivalent to clinical day more than 1000 times of dosage of people, prompting compound product clinical drug safety.
2. long poison research
Compound product is irritated stomach by 4ml/kg and 20ml/kg (be equivalent to clinical administration dosage 8,40 times) and is given rat, every day 1 time, successive administration 70 days, rat does not have death, the growth of carrying out property of body weight, and the administration group is than blank group fast gaining, hematuria routine, hepatic and renal function are all normal, main organs does not show pathological change, illustrates that the long term administration of this compound product is nontoxic, prompting this product clinical drug safety.
Three, clinical research
According to the clinical research result, the prompting compound product has reason spleen stomach function regulating, the effect of relieving dyspepsia.Be applicable to anorexia; Spiritlessness and sparing of words; On an empty stomach distension, the vomiting of food back, it is uncomfortable defecate, and congenital the grasping of children's have a delicate constitution the not enough day after tomorrow, and intelligence is blunt slow, diseases such as the soft dysplasia of bone.And and DASHANZHA WAN carried out the group between comparative study, total effective rate is respectively 97.0%, 80.0%, and significant difference (P＜0.05) is arranged between group; Total obvious effective rate is respectively 84.4%, 48.2%, and highly significant difference (P＜0.001) is arranged between group, prompting compound product determined curative effect, and be better than DASHANZHA WAN.
During treating, by to 60 routine treatment group patient's liver function and routine examinations, any toxicity does not appear, illustrate that the compound product clinical drug safety is reliable.
Claims (2)
1. extracting method that increases digestive tract power goods medicine, it is characterized in that following 12 natural product Rhizoma Dioscoreaes, the Rhizoma Atractylodis Macrocephalae, Poria, Fructus Jujubae, Fructus Crataegi (parched to brown), Endothelium Corneum Gigeriae Galli, Radix Polygoni Multiflori, Arillus Longan, Concha Ostreae, Fructus Aurantii Immaturus, Radix Angelicae Sinensis, Semen Arecae Prepareta, adopt advanced macroporous resin adsorption active ingredient, and use gas phase to refer to that trace spectrum is quantitative; Its percentage by weight is to be made up of Rhizoma Dioscoreae 9.71%, the Rhizoma Atractylodis Macrocephalae 9.71%, Poria 9.71%, Fructus Jujubae 9.71%, Fructus Crataegi (parched to brown) 9.71%, Endothelium Corneum Gigeriae Galli 9.71%, Radix Polygoni Multiflori 9.71%, Arillus Longan 9.71%, Concha Ostreae 9.71%, Fructus Aurantii Immaturus 2.91%, Radix Angelicae Sinensis 4.85%, Semen Arecae Prepareta 4.85%; With 12 kinds of natural product compound recipe raw materials, use the supercritical fluid carbon dioxide extractant, extract 12 kinds of natural product volatile oil components, with gaseous carbon dioxide and 12 kinds of natural product component separating, rectification is standby; To extract raw material behind the volatile oil, every 100kg adds water 300kg, 200kg, 100kg, under 100 ℃ of conditions, extracted respectively 3 hours, 2 hours, 1 hour, the filtrate that merges water extraction, leave standstill, get supernatant, by the pillar that macroporous resin is filled, use macroporous resin adsorption, use 65% ethanol, the composition that is adsorbed on the macroporous resin is eluted in the ethanol, merge with the standby liquid of rectification, under 85 ℃ of conditions, after the spray drying, refer to the quantitative assay of trace collection of illustrative plates with the gas chromatogram device, make the powder crude drug.
2. according to the described a kind of extracting method that increases digestive tract power goods medicine of claim 1, it is characterized in that described crude drug is prepared into tablet, mixture, pill, capsule, oral liquid and injection.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104509857A (en) * | 2014-12-16 | 2015-04-15 | 浙江宏辉胶丸有限公司 | Health care capsule for promoting bone growth |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1113779A (en) * | 1994-06-17 | 1995-12-27 | 殷广全 | Anti- hepatitis B preparation |
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2004
- 2004-02-02 CN CNB2004100011483A patent/CN100421694C/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1113779A (en) * | 1994-06-17 | 1995-12-27 | 殷广全 | Anti- hepatitis B preparation |
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| CN1650896A (en) | 2005-08-10 |
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