Summary of the invention
Technical problem to be solved by this invention is to overcome the shortcoming of said medicine, and the medicine of gastrointestinal disease after a kind of toxic and side effects a kind of iatrotechnics little, evident in efficacy is provided.
It is with the raw material of Chinese medicine of the following percentage by weight medicinal preparation for oral administration made of formulation method routinely to solve the problems of the technologies described above the technical scheme that adopted:
Radix Et Rhizoma Rhei 6~12% Radixs Astragali 14~26%
Fructus Cannabis 10~15% Fructus Aurantiis 5~10%
Cortex Magnoliae Officinalis 5~10% Rhizoma Atractylodis Macrocephalaes 6~12%
The Radix Aucklandiae 6~12% Radix Angelicae Sinensis 6~12%
Semen Persicae 5~10% Radix Paeoniae Rubra 5~10%
The preferred raw material of Chinese medicine percentage by weight of preparation medicine of the present invention is:
Radix Et Rhizoma Rhei 8~12% Radixs Astragali 16~24%
Fructus Cannabis 10~14% Fructus Aurantiis 6~8%
Cortex Magnoliae Officinalis 6~8% Rhizoma Atractylodis Macrocephalaes 8~10%
The Radix Aucklandiae 8~10% Radix Angelicae Sinensis 8~10%
Semen Persicae 6~8% Radix Paeoniae Rubra 6~8%
The best raw material of Chinese medicine percentage by weight of preparation medicine of the present invention is:
Radix Et Rhizoma Rhei 9.03% Radix Astragali 18.82%
Fructus Cannabis 12.54% Fructus Aurantii 7.83%
Cortex Magnoliae Officinalis 7.83% Rhizoma Atractylodis Macrocephalae 9.43%
The Radix Aucklandiae 9.43% Radix Angelicae Sinensis 9.43%
Semen Persicae 7.83% Radix Paeoniae Rubra 7.83%
The medicinal preparation for oral administration that above-mentioned each component is made according to a conventional method is said tablet or granule or a syrup on the galenic pharmacy.
In the proportioning of medicine of the present invention, Radix Et Rhizoma Rhei has significant discharge function, and the contained combined anthraquinone compounds of Radix Et Rhizoma Rhei generates aglycon at colon through bacterial decomposition, mucous membrane of colon is produced stimulation, strengthen the contraction movement of colon, promote defecation, Radix Et Rhizoma Rhei can also reduce the absorption of enteral moisture, the secretion of promotion intestinal mucosa, the enteral volume is strengthened, stimulate intestinal wall, promote the propelling of intestinal contents, accelerate defecation.The Radix Astragali has the cellular metabolism of promotion, improves immunity, animal is shown good regulating action at body gastrointestinal motility and gastrointestinal electrical activity.Fructus Aurantii, Cortex Magnoliae Officinalis, the Radix Aucklandiae, the Rhizoma Atractylodis Macrocephalae etc. all have tangible regulating action to gastrointestinal smooth muscle.Semen Persicae, Radix Paeoniae Rubra work the effect of invigorating blood circulation.
The preparation method of medicinal granule of the present invention is as follows:
1, with Radix Et Rhizoma Rhei, Cortex Magnoliae Officinalis and Fructus Cannabis with 10 times of amount 80% soak with ethanol reflux, extract, 3 times after 14 hours, each 1 hour, filter, merge extractive liquid,, (0.05~0.07MPa) reclaims ethanol, and being concentrated into relative density is the extractum of 1.20~1.25 (60 ℃) in decompression.
2, the Radix Astragali, Fructus Aurantii, the Rhizoma Atractylodis Macrocephalae, the Radix Aucklandiae, Radix Angelicae Sinensis, Semen Persicae, Radix Paeoniae Rubra seven flavor medicine material are added 10 times of water gagings, the each decoction 1 hour, decoct three times, merge fried liquid, be evaporated to 1: 1, inclining to cool, cold preservation 12 hours, plate-and-frame filtration, filtrate decompression concentrates, and receives cream and is concentrated into the extractum that relative density is 1.25~1.28 (60 ℃).
3, merge two parts extractum, mixing, drying under reduced pressure is pulverized, and crosses 100 mesh sieves, is prepared into extract powder, adds dextrin, and mixing is made wetting agent with 75% ethanol and is granulated, drying, granulate is made granule 1000g.
4, test by quality control standards (QCS) of the present invention, after the assay was approved package sterilization.Every bag heavy 5g, every gram contains crude drug in whole 1.993g, obeys each 1 bag every day three times.
The preparation method of medicinal tablet of the present invention is as follows:
Used raw material of Chinese medicine and the percentage by weight of raw material of Chinese medicine that medicinal tablet of the present invention is used and percentage by weight and medicinal granule of the present invention is identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of granule preparation technology raw material of Chinese medicine of the present invention, and used adjuvant and other processing step are undertaken by the conventional preparation technology of tablet.Every heavy 0.5g, every gram contains raw material of Chinese medicine 7.475g, obeys each 4 every day 2 times.
The preparation technology of medical syrup agent of the present invention is as follows:
Used raw material of Chinese medicine and the percentage by weight of raw material of Chinese medicine that medical syrup agent of the present invention is used and percentage by weight and medicinal granule of the present invention is identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of granule preparation technology raw material of Chinese medicine of the present invention, and used adjuvant and other processing step carry out according to the conventional preparation technology of syrup.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.997g, and each 10mL obeys three every day.
Medicine of the present invention is through the test of pesticide effectiveness, and experimental result shows that medicine of the present invention can promote the defecation process of normal mouse; Medicine of the present invention splits that abdomen tractive small intestinal causes and defecation postpones and minimizing, and the activity of intestinal propulsion type is slowed down, and has significant facilitation; Rat delayed gastric emptying that medicine of the present invention causes abdominal postoperative and intestinal advance and slowly also improve significantly; Medicine of the present invention can resist the attenuation of small intestine activity that compound diphenoxylate causes.Above result is used for complication such as abdominal postoperative abdominal distention, constipation for medicine of the present invention, reliable experimental evidence is provided.
The specific embodiment
The present invention is described in more detail below in conjunction with embodiment, but the invention is not restricted to these embodiment.
Embodiment 1
With production medicinal granule 1000g of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Et Rhizoma Rhei 180g
Radix Astragali 375g
Fructus Cannabis 250g
Fructus Aurantii 156g
Cortex Magnoliae Officinalis 156g
Rhizoma Atractylodis Macrocephalae 188g
Radix Aucklandiae 188g
Radix Angelicae Sinensis 188g
Semen Persicae 156g
Radix Paeoniae Rubra 156g
Dextrin adds to 1000g
Its preparation method is as follows:
With Radix Et Rhizoma Rhei, Cortex Magnoliae Officinalis and Fructus Cannabis with 10 times of amount 80% soak with ethanol reflux, extract, 3 times after 14 hours, each 1 hour, filter, merge extractive liquid,, (0.05~0.07MPa) reclaims ethanol, and being concentrated into relative density is the extractum of 1.20~1.25 (60 ℃) in decompression.
2. the Radix Astragali, Fructus Aurantii, the Rhizoma Atractylodis Macrocephalae, the Radix Aucklandiae, Radix Angelicae Sinensis, Semen Persicae, Radix Paeoniae Rubra seven flavor medicine material are added 10 times of water gagings, the each decoction 1 hour, decoct three times, merge fried liquid, be evaporated to 1: 1, inclining to cool, cold preservation 12 hours, plate-and-frame filtration, filtrate decompression concentrates, and receives cream and is concentrated into the extractum that relative density is 1.25~1.28 (60 ℃).
3. merge two parts extractum, mixing, drying under reduced pressure is pulverized, and crosses 100 mesh sieves, is prepared into extract powder, adds dextrin, and mixing is made wetting agent with 75% ethanol and is granulated, drying, granulate is made granule 1000g.
4. test by quality control standards (QCS) of the present invention, after the assay was approved package sterilization.Every bag heavy 5g, every gram contains crude drug in whole 1.993g, obeys each 1 bag every day three times.
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Et Rhizoma Rhei 337g
Radix Astragali 708g
Fructus Cannabis 469g
Fructus Aurantii 292g
Cortex Magnoliae Officinalis 292g
Rhizoma Atractylodis Macrocephalae 352g
Radix Aucklandiae 352g
Radix Angelicae Sinensis 352g
Semen Persicae 292g
Radix Paeoniae Rubra 292g
Carboxymethyl starch sodium 100g
Pulvis Talci 7.5g
Starch adds to 500g
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every gram contains crude drug 7.475g, obeys each 4 every day 2 times.
With production syrup product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Et Rhizoma Rhei 90g Radix Astragali 188g
Fructus Cannabis 125g Fructus Aurantii 78g
Cortex Magnoliae Officinalis 78g Rhizoma Atractylodis Macrocephalae 94g
Radix Aucklandiae 94g Radix Angelicae Sinensis 94g
Semen Persicae 78g Radix Paeoniae Rubra 78g
Sucrose 300g distilled water adds to 1000mL
Its preparation technology is undertaken by the conventional preparation technology of galenic pharmacy syrup.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.997g, and each 10mL obeys three every day.
In the proportioning of present embodiment, the percentage by weight of each component of raw material of Chinese medicine is:
Radix Et Rhizoma Rhei 9.03% Radix Astragali 18.82%
Fructus Cannabis 12.54% Fructus Aurantii 7.83%
Cortex Magnoliae Officinalis 7.83% Rhizoma Atractylodis Macrocephalae 9.43%
The Radix Aucklandiae 9.43% Radix Angelicae Sinensis 9.43%
Semen Persicae 7.83% Radix Paeoniae Rubra 7.83%
Embodiment 2
With production medicinal granule 1000g of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Astragali 518g
Fructus Cannabis 299g
Radix Et Rhizoma Rhei 239g
Rhizoma Atractylodis Macrocephalae 179g
Radix Aucklandiae 179g
Radix Angelicae Sinensis 179g
Fructus Aurantii 100g
Cortex Magnoliae Officinalis 100g
Semen Persicae 100g
Radix Paeoniae Rubra 100g
Dextrin adds to 1000g
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every gram contains crude drug in whole 1.993g, obeys each 1 bag every day three times.
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Astragali 972g
Fructus Cannabis 561g
Radix Et Rhizoma Rhei 449g
Rhizoma Atractylodis Macrocephalae 336g
Radix Aucklandiae 336g
Radix Angelicae Sinensis 336g
Fructus Aurantii 187g
Cortex Magnoliae Officinalis 187g
Semen Persicae 187g
Radix Paeoniae Rubra 187g
Carboxymethyl starch sodium 100g
Pulvis Talci 7.5g
Starch adds to 500g
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every gram contains crude drug 7.475g, obeys each 4 every day 2 times.
With production syrup product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Astragali 259g Fructus Cannabis 149g
Radix Et Rhizoma Rhei 119g Rhizoma Atractylodis Macrocephalae 90g
Radix Angelicae Sinensis 90g Radix Aucklandiae 90g
Fructus Aurantii 50g Cortex Magnoliae Officinalis 50g
Semen Persicae 50g Radix Paeoniae Rubra 50g
Sucrose 300g distilled water adds to 1000mL
Its preparation technology is undertaken by the conventional preparation technology of galenic pharmacy syrup.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.997g, and each 10mL obeys three every day.
In the proportioning of present embodiment, the percentage by weight of each component of raw material of Chinese medicine is:
Radix Et Rhizoma Rhei 12% Radix Astragali 26%
Fructus Cannabis 15% Fructus Aurantii 5%
Cortex Magnoliae Officinalis 5% Rhizoma Atractylodis Macrocephalae 9%
The Radix Aucklandiae 9% Radix Angelicae Sinensis 9%
Semen Persicae 5% Radix Paeoniae Rubra 5%
Embodiment 3
With production medicinal granule 1000g of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Astragali 280g
Rhizoma Atractylodis Macrocephalae 239g
Radix Aucklandiae 239g
Radix Angelicae Sinensis 239g
Fructus Cannabis 200g
Fructus Aurantii 169g
Cortex Magnoliae Officinalis 169g
Semen Persicae 169g
Radix Paeoniae Rubra 169g
Radix Et Rhizoma Rhei 120g
Dextrin adds to 1000g
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every gram contains crude drug in whole 1.993g, obeys each 1 bag every day three times.
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Astragali 522g
Rhizoma Atractylodis Macrocephalae 449g
Radix Aucklandiae 449g
Radix Angelicae Sinensis 449g
Fructus Cannabis 373g
Fructus Aurantii 318g
Cortex Magnoliae Officinalis 318g
Semen Persicae 318g
Radix Paeoniae Rubra 318g
Radix Et Rhizoma Rhei 224g
Carboxymethyl starch sodium 100g
Pulvis Talci 7.5g
Starch adds to 500g
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every gram contains crude drug 7.475g, obeys each 4 every day 2 times.
With production syrup product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Astragali 139g Rhizoma Atractylodis Macrocephalae 120g
Radix Aucklandiae 120g Radix Angelicae Sinensis 120g
Fructus Cannabis 99g Fructus Aurantii 85g
Cortex Magnoliae Officinalis 85g Semen Persicae 85g
Radix Paeoniae Rubra 85g Radix Et Rhizoma Rhei 59g
Sucrose 300g distilled water adds to 1000mL
Its preparation technology is undertaken by the conventional preparation technology of galenic pharmacy syrup.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.997g, and each 10mL obeys three every day.
In the proportioning of present embodiment, the percentage by weight of each component of raw material of Chinese medicine is:
Radix Et Rhizoma Rhei 6% Radix Astragali 14%
Fructus Cannabis 10% Fructus Aurantii 8.5%
Cortex Magnoliae Officinalis 8.5% Rhizoma Atractylodis Macrocephalae 12%
The Radix Aucklandiae 12% Radix Angelicae Sinensis 12%
Semen Persicae 8.5% Radix Paeoniae Rubra 8.5%
Embodiment 4
With production medicinal granule 1000g of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Astragali 279g
Radix Et Rhizoma Rhei 239g
Fructus Cannabis 199g
Fructus Aurantii 199g
Cortex Magnoliae Officinalis 199g
Semen Persicae 199g
Radix Paeoniae Rubra 199g
Rhizoma Atractylodis Macrocephalae 160g
Radix Aucklandiae 160g
Radix Angelicae Sinensis 160g
Dextrin adds to 1000g
Its preparation technology is undertaken by the preparation technology of granule of the present invention.Every bag heavy 5g, every gram contains crude drug in whole 1.993g, obeys each 1 bag every day three times.
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Radix Astragali 523g
Radix Et Rhizoma Rhei 448g
Fructus Cannabis 374g
Fructus Aurantii 374g
Cortex Magnoliae Officinalis 374g
Semen Persicae 374g
Radix Paeoniae Rubra 374g
Rhizoma Atractylodis Macrocephalae 299g
Radix Aucklandiae 299g
Radix Angelicae Sinensis 299g
Carboxymethyl starch sodium 100g
Pulvis Talci 7.5g
Starch adds to 500g
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.5g, every gram contains crude drug 7.475g, obeys each 4 every day 2 times.
With production syrup product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Radix Astragali 140g Radix Et Rhizoma Rhei 120g
Fructus Cannabis 100g Fructus Aurantii 100g
Cortex Magnoliae Officinalis 100g Semen Persicae 100g
Radix Paeoniae Rubra 100g Rhizoma Atractylodis Macrocephalae 79g
Radix Aucklandiae 79g Radix Angelicae Sinensis 79g
Sucrose 300g distilled water adds to 1000mL
Its preparation technology is undertaken by the conventional preparation technology of galenic pharmacy syrup.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.997g, and each 10mL obeys three every day.
In the proportioning of present embodiment, the percentage by weight of each component of raw material of Chinese medicine is:
Radix Et Rhizoma Rhei 12% Radix Astragali 14%
Fructus Cannabis 10% Fructus Aurantii 10%
Cortex Magnoliae Officinalis 10% Rhizoma Atractylodis Macrocephalae 8%
The Radix Aucklandiae 8% Radix Angelicae Sinensis 8%
Semen Persicae 10% Radix Paeoniae Rubra 10%
In order to verify the therapeutic effect of medicine of the present invention to the postoperative gastric intestinal diseases, the applicant entrusts Xi'an Communications University first hospital pharmacy to adopt the medicinal mixture (during test name be called the art intestinal logical) of the embodiment of the invention 1 proportioning preparation and entrusts Xi'an Jiaotong University Medical College to carry out the main pharmacodynamics test, and various test situation are as follows:
Be subjected to the reagent product: medicine of the present invention, provide by Xi'an Communications University's first hospital pharmacy, be brown ceramic powder, do not contain excipient, face the suspension that is mixed with desired concn with preceding usefulness 0.25% cmc soln.
The test medicine and reagent: compound Aloe capsule, Linxi County, Hebei pharmaceutical factory produces, and lot number is 040614; Cisapride sheet (prepulsid), Xian-Janssen Pharmaceutical Ltd. produces, and lot number is 040521940; Metoclopramide, the strong people pharmaceutical factory in Linfen, Shanxi produces, and lot number is 030302; Methyl-sulfuric acid neostigmine (title abbreviates neostigmine as in the experiment), friendship Jin Zhu pharmaceutcal corporation, Ltd of last Hisense produces, and lot number is 040401; Ketaject injection (anesthesia is used), company of Shanghai No.1 Bio-Chemical Pharmacetical Industry Co., Ltd produces, and lot number is 040304; Compound diphenoxylate (Diphenoxylate Mixture of hydrochloride with atropine sulfate), Kang Pu pharmaceutcal corporation, Ltd in changzhou produces, and lot number is 0407028; Trichloroacetic acid, Beijing Yili Fine Chemicals Co., Ltd. produces, and lot number is 20010323; Phenol red, the packing of sigma company, C
19H
14O
5S=354.37.
Find that in preliminary experiment because the medicine color is darker, mixing with dyestuffs such as phenol red or azovan blue is not easy to distinguish, and utilizes activated carbon powder then to be easy to direct observation, therefore observe that intestinal advances or the defecation experiment in, all adopt carbon powder as indicator substance.
The preparation that the semi-solid carbon powder of trophism is stuck with paste: reference literature and slightly modified, get the 10g sodium carboxymethyl cellulose, be dissolved in the 250mL distilled water, add 16g milk powder, 8g sugar, 8g starch and 4g active carbon end respectively, stir, be mixed with the black semisolid pastel of the about 300g of 300mL, refrigerator cold-storage, the time spent returns to room temperature.
Experimental animal: mice, ICR kind, body weight 20~25g, male and female dual-purpose; Rat, the SD kind, body weight 190~210g, male.Provide by Xi'an Communications University's medical experimental animal center.
Quality certification numbering: mice, word 08-004 is moved in Shan; Rat, word 08-005 is moved in Shan
Experimental apparatus: UV-260 type spectrophotometer, day island proper Tianjin.
1, medicine of the present invention is to the influence of normal mouse defecation time and quantity
(1) test method
81 of mices, male, fasting was weighed after 18 hours, was divided into blank group, medicine 2.5g/kg of the present invention group, medicine 1.25g/kg of the present invention group, medicine 0.25g/kg of the present invention group, cisapride group, compound Aloe capsule 0.40g/kg group.The filling stomach contains the 0.25% carboxymethyl cellulose suspension 0.2ml/10g at medicinal liquid and 5% charcoal end, and the blank group is given the 0.25% carboxymethyl cellulose suspension that contains 5% charcoal end.The single only branch of mice is put after the administration, the defecation grain number in the incubation period and 6 hours of record mice row melena.
(2) result of the test
Experimental result sees Table 1.
Table 1 medicine of the present invention is to the influence of normal mouse defecation (X ± SD)
Group | Number of animals (only) | Defecation incubation period (min) | The defecation number (grain/6h) |
Normal group medicine 2.50g/kg group of the present invention medicine 1.25g/kg group of the present invention medicine 0.63g/kg group of the present invention Cisapride 5mg/kg group compound aloe capsule 0.40g/kg group | 14 14 13 13 14 13 | 315.5±81.7 153.6±51.9** 236.2±66.5** 245.2±46.9** 300.1±71.4 216.7±73.7** | 1.57±1.9 6.71±3.7** 3.00±1.5* 3.15±1.6* 1.14±1.7 3.08±1.6* |
Annotate: defecation adopts rank test incubation period, and the defecation number adopts non-paired t test.
Each administration group is compared with the blank group, * p<0.05, * * p<0.01.
The result shows that each administration group of medicine of the present invention and compound Aloe capsule group all can significantly promote intestinal to advance, and shortens defecation incubation period and increases feces volume.Medicine 2.5g/kg group of the present invention is to defecation incubation period and defecation number average having the highly significant effect.Cisapride does not demonstrate the explicitly effect.
2, medicine of the present invention is to the influence of tractive small intestinal model mice defecation
(1) test method
Test 123 of shared mices, the male and female dual-purpose.After the fasting 18 hours, weigh, etherization, back fixation is opened abdomen along the abdominal part center line, with warm wet gauze tractive small intestinal 30 seconds gently, close abdomen, the tractive operation on intestine is finished by a people, and to guarantee tractive strength unanimity, the back mice of will performing the operation is divided into model control group, medicine 2.5g/kg of the present invention group, medicine 1.25g/kg of the present invention group, medicine 0.63g/kg of the present invention group, compound Aloe capsule 0.40g/kg group at random; Pseudo-operation group mice, hara kiri skin only under the etherization is sewed up then, does not open abdomen; Blank group mice does not undergo surgery.30 fens gastric infusions of postoperative, 0.1ml/10g body weight, model control group, blank group and pseudo-operation group are irritated stomach with the volume distilled water.After the administration 2 hours, the administration group was irritated the suspension that the stomach liquor strength is little a times, contain 7.5% charcoal end, the carboxymethyl cellulose preparation with 0.25%, 0.2ml/10g; Model control group, blank group and pseudo-operation group are irritated the charcoal end suspension that stomach does not contain medicinal liquid.After the administration mice is put single only the branch, write down every mice row melena (charcoal end) incubation period, and total number of the defecation in 10 hours.
(2) result of the test
Result of the test sees Table 2.
Table 2 medicine of the present invention is to the influence of tractive small intestinal postoperative mice defecation incubation period and quantity (X ± SD)
Group | Number of animals (only) | Incubation period (min) | Defecation grain number (grain/10 hours) |
The pseudo-operating comparison model of blank edition with parallel text invention medicine 2.50g/kg group medicine 1.25g/kg group of the present invention medicine 0.63g/kg group of the present invention compound aloe capsule 0.40g/kg | 17 17 18 18 17 18 18 | 327.4±83.9 357.2±91.6 543.3±50.0## 500.0±65.1* 499.4±64.5* 523.3±65.3 510.0±74.9 | 3.94±1.95 3.50±1.86 1.67±1.53## 2.83±1.79* 2.65±1.58 2.72±2.24 2.94±2.13* |
Annotate: defecation adopts rank test incubation period, and the defecation number adopts non-paired t test.
Model group and blank group ratio,
##P<0.01; Administration group and model control group ratio, * p<0.05, * * p<0.01.
The result shows, the tractive small intestinal can obviously prolong mice defecation incubation period, reduce feces volume, but pseudo-operation process is not obvious to the influence of mice defecation.Medicine 2.50g/kg of the present invention group, medicine 1.25g/kg of the present invention group can significance shorten defecation incubation period, and medicine 2.50g/kg group of the present invention can also explicitly increases the feces volume of postoperative mice.The compound Aloe capsule group influences not statistically significant to defecation incubation period, but has explicitly to increase to defecation grain number.
3, medicine of the present invention is split abdomen tractive small intestinal model mice intestinal propulsion motion effects
(1) test method
Get 83 mices, the male and female dual-purpose.Fasting 16 hours is weighed, and mice is divided into model control group, medicine 2.5g/kg of the present invention group, medicine 1.25g/kg of the present invention group, medicine 0.25g/kg of the present invention group, cisapride 5mg/kg group, pseudo-operation group and blank group at random.Administration group and model control group mice, etherization lower edge abdominal part center line is opened abdomen, with warm wet gauze tractive small intestinal 30 seconds gently, injection is by reagent in the duodenum, 0.1ml/10g body weight, the cmc soln 0.1ml/10g body weight of pseudo-operation group injection 0.25% is closed abdomen.The tractive operation on intestine is finished by a people, to guarantee tractive strength unanimity; 11 of pseudo-operation group mices, only hara kiri skin, stitching then under the etherization; Blank group mice does not undergo surgery; Blank group and pseudo-operation group are irritated 0.25% cmc soln solution of the same volume of stomach (0.1ml/10g).After the administration 2 hours, every mice is all irritated stomach medicinal liquid 0.1ml/10g, model control group, pseudo-operation group and blank group are given cmc soln 0.1ml/10g, every mouse stomach active carbon nutrition is only stuck with paste 0.40ml/ after 20 minutes, take off cervical vertebra after 40 minutes and put to death mice, open abdomen, take out small intestinal rapidly, directly be laid on the blank sheet of paper after peeling off gently, measure pylorus to ileocecus total length and pylorus to black semisolid and stick with paste the distance in forward position, it is the intestinal propulsion rate that the distance of sticking with paste the forward position with pylorus to black semisolid accounts for pylorus to the percentage rate of ileocecus total length.
(2) result of the test
Result of the test sees Table 3.
Table 3 medicine of the present invention is to the propulsive influence of abdominal postoperative mice intestinal (X ± SD)
Group | Number of animals (n) | Intestinal propulsion rate (%) |
The pseudo-operative control group model control group of blank group medicine 2.50g/kg group of the present invention medicine 1.25g/kg group of the present invention medicine 0.63g/kg group of the present invention Cisapride 5mg/kg group | 12 11 13 11 12 12 12 | 54.32±7.82 50.40±13.67 31.78±9.78## 43.87±13.04* 43.95±11.57** 38.82±10.07 44.47±11.26** |
Annotate: 1. model group and blank group ratio,
##P<0.01; 2. each administration group is compared with model control group:
*p<0.05,**p<0.01
Result of the test shows that the intestinal propulsion sexual activity obviously weakens behind the model group tractive small intestinal, and the intestinal propulsion rate slows down, and haplotomia skin does not have obvious influence to the intestinal propulsion rate.Medicine 2.5g/kg of the present invention group and medicine 1.25g/kg of the present invention group can significance be improved the intestinal propulsion rate that the tractive small intestinal causes and are slowed down, and medicine 0.63g/kg group of the present invention does not have obviously and acts on.The effect of cisapride group is remarkable.
4, medicine of the present invention causes the mice intestinal to compound diphenoxylate and advances slow influence
(1) test method
Mice is used in test, and the male and female dual-purpose is divided into 7 groups after weighing, every group 10~12, fasting is after 16 hours, medicine group gastric infusion 2.50g/kg of the present invention, 1.25g/kg, 0.63g/kg, 0.2ml/10g body weight, model group and blank group are irritated the cmc soln of stomach with volume 0.25%.After the administration 2 hours, model group and administration group were all irritated stomach compound diphenoxylate 5mg/kg, irritated stomach 5% charcoal end in 30 minutes thereafter, and 0.5ml/ only; To the neostigmine group, neostigmine is in giving the charcoal end preceding 15 minutes lumbar injections.Irritate the stomach charcoal and take off cervical vertebra execution mice after last 15 minutes, open abdomen, separation to the whole small intestinals of ileocecus, is measured small intestinal total length and charcoal end head end to the pylorus distance from pylorus, is calculated as follows small intestinal charcoal end propelling rate:
Small intestinal charcoal end propelling rate (%)=charcoal end head end to pylorus apart from ÷ small intestinal total length * 100
(2) result of the test
Result of the test sees Table 4.
Table 4 medicine of the present invention causes mouse small intestine charcoal end to compound diphenoxylate and advances the influence that delays (X ± SD)
Group | Number of animals (only) | Small intestinal charcoal end propelling rate (%) |
Blank group model group medicine 2.50g/kg group of the present invention medicine 1.25g/kg group of the present invention medicine 0.63g/kg group of the present invention Primperan group 5mg/kg group neostigmine group 0.06mg/kg group | 10 12 12 12 12 12 10 | 70.3±11.9 30.3±5.7
△△ 42.1±4.3** 35.0±7.4 35.2±7.7 41.9±8.8** 76.0±10.6**
|
Annotate: with blank group ratio
△ △P<0.01; The administration group compares with model control group: * p<0.05; * p<0.01
The result shows that compound diphenoxylate can obviously suppress mouse small intestine charcoal end and advance, and medicine 2.50g/kg of the present invention can obviously resist compound diphenoxylate induced mice intestinal propulsion and delay, but 1.25g/kg, 0.63g/kg do not have obviously influence to this.Metoclopramide and neostigmine effect are obvious.
5, medicine of the present invention is to the influence (phenol red method) of splenectomy rat stomach emptying
(1) test method
Test is with 86 of rats, and is all male.After the fasting 16 hours, (50mg/kg opens abdomen under i.p) to Patients Under Ketamine Anesthesia, cut along the hunter's line layering, hemorrhage to reduce, otch is about 3cm, find splenogastric ligament after opening abdomen, after the ligation spleen arteriovenous, again with splenorenal ligament ligation, extract spleen, find vermiform appendix, in 30 seconds of tractive, put back to the abdominal cavity then thereafter, the layer-by-layer suture abdominal incision, pseudo-operation group is only cut skin.The back rat of will performing the operation is divided into model control group, medicine 2.00g/kg of the present invention group, medicine 1.00g/kg of the present invention group, medicine 0.50g/kg of the present invention group, cisapride 5mg/kg group, neostigmine 0.12mg/kg group, blank group at random.Postoperative 4 hours, except that the neostigmine group, other respectively organize equal gastric infusion, the 2ml/100g body weight.Blank group, model control group, pseudo-operation group are irritated stomach 0.25% carboxymethyl cellulose.After the administration 2 hours, every rat oral gavage was with 0.05% phenol red 2ml of 0.25% carboxymethyl cellulose preparation, and neostigmine is in irritating phenol red preceding 15 minutes intraperitoneal injections of stomach.Give phenol red back 15 minutes, take off cervical vertebra and put to death rat, open abdomen immediately, ligation pylorus and cardia are got stomach, cut off the stomach surrounding tissue, and clear water is cleaned and is placed in the 0.1mol/L NaOH solution of 100ml, shreds tissue, make the phenol red dissolving fully of gastric, and mixing left standstill 60 minutes.Get supernatant 5ml, add 20% trichloroacetic acid 1ml, centrifugal (3000r.p.m.) gets supernatant 1ml after 10 minutes, adds the NaOH solution 1ml colour developing of 0.5mol/L, puts UV-260 type spectrophotometer 560nm place colorimetric, the record absorbance A.Zero point control rats irritate stomach 0.05% phenol red after, put to death immediately and get stomach, survey absorbance A
0, be calculated as follows gastric emptying rate:
Gastric emptying rate (%)=[1-(A/A
0)] * 100.
(2) result of the test
Result of the test sees Table 5.
Table 5 medicine of the present invention is to the influence of splenectomy rat stomach emptying (X ± SD)
Group | Number of animals | Gastric emptying rate (%) |
The pseudo-operation group of blank group model group medicine 2.00g/kg group of the present invention medicine 1.00g/kg group of the present invention medicine 0.50g/kg group of the present invention Cisapride group (5mg/kg) neostigmine group (0.12mg/kg) | 10 12 10 11 11 11 11 10 | 82.97±6.31 57.13±18.01
△△ 84.35±10.94
** 73.43±17.93
* 66.98±16.09 73.37±12.92
* 64.14±19.43 78.05±10.59
** |
Annotate: with blank group ratio,
△ △P<0.01; Each administration group and model control group ratio, * p<0.05, * * p<0.01
The result shows that the phenol red Emptying Rate of abdominal postoperative rat stomach obviously reduces, and pseudo-operation group is to this no explicitly influence.Each group of medicine of the present invention to the postoperative rat stomach emptying slow down and all have some improvement, the improvement effect of medicine 2.00g/kg group wherein of the present invention, medicine 0.50g/kg of the present invention group has statistical significance.It is remarkable that neostigmine quickens gastric emptying, but cisapride effect not statistically significant.
6, medicine of the present invention is to the propulsive influence of splenectomy rat small intestine (carbon powder method)
(1) test method
Test is with 82 of rats, and is all male, and fasting is after 16 hours, Patients Under Ketamine Anesthesia (50mg/kg, i.p) open abdomen under, cut along the hunter's line layering, hemorrhage to reduce, otch is about 3cm, finds splenogastric ligament after opening abdomen, after the ligation spleen arteriovenous, with splenorenal ligament ligation, extract spleen again, find vermiform appendix thereafter, in 30 seconds of tractive, operation, tractive operation on intestine are finished by a people, to guarantee tractive strength unanimity, put back to the abdominal cavity then, the layer-by-layer suture abdominal incision, pseudo-operation group is only cut skin.Postoperative 4 hours, the back rat of will performing the operation is divided into model control group, medicine 2.00g/kg of the present invention group, medicine 1.00g/kg of the present invention group, medicine 0.50g/kg of the present invention group, cisapride 5mg/kg group, neostigmine 0.12mg/kg group at random.Every rat is all irritated stomach medicinal liquid 2ml/100g, model control group, pseudo-operation group and blank group are irritated 0.25% the cmc soln of stomach with volume, after the administration 2 hours, every rat oral gavage active carbon nutrition is only stuck with paste 4ml, neostigmine is in sticking with paste preceding 15 minutes intraperitoneal injections for active carbon nutrition, stick with paste for active carbon nutrition and take off cervical vertebra execution rat after 35 minutes, open abdomen, take out small intestinal rapidly, directly be laid on the blank sheet of paper after peeling off gently, measure pylorus to ileocecum portion total length and pylorus to black semisolid and stick with paste the distance in forward position, it is the intestinal propulsion rate that the distance of sticking with paste the forward position with pylorus to black semisolid accounts for pylorus to the percentage rate of ileocecus total length.
(2) result of the test
Result of the test abridged table 6.
Table 6 medicine of the present invention is to the propulsive influence of splenectomy rat small intestine (X ± SD)
Group | Number of animals (only) | Small intestinal charcoal end propelling rate (%) |
The pseudo-operation group of blank group model group medicine 2.00g/kg group of the present invention medicine 1.00g/kg group of the present invention medicine 0.50g/kg group of the present invention Cisapride 5mg/kg group neostigmine group 0.12mg/kg group | 10 12 10 10 10 10 10 10 | 65.84±6.29 44.75±8.02
△△ 66.04±9.73** 51.11±7.56 54.53±6.18** 53.70±7.10* 56.61±7.53** 78.25±7.51**
|
Annotate: with blank group ratio,
△ △P<0.01; Each administration group and model control group ratio, * p<0.05, * * p<0.01
The result shows that the progradation of model group rat small intestine obviously weakens, pseudo-operation group to intestinal propulsion effect do not have obvious influence.Each group of medicine of the present invention advances to slow down to the postoperative rat small intestine and all has some improvement, and the improvement effect of medicine 1.00g/kg group wherein of the present invention, medicine 0.50g/kg of the present invention group has statistical significance.It is remarkable that cisapride, neostigmine quicken the intestinal propulsion effect.
Conclusion: medicine of the present invention can promote the defecation process of normal mouse; Medicine of the present invention splits that abdomen tractive small intestinal causes and defecation postpones and minimizing, and the activity of intestinal propulsion type is slowed down, and has significant facilitation; Rat delayed gastric emptying that medicine of the present invention causes abdominal postoperative and intestinal advance and slowly also improve significantly; Medicine of the present invention can resist the attenuation of small intestine activity that compound diphenoxylate causes.Above result is used for complication such as abdominal postoperative abdominal distention, constipation for medicine of the present invention, reliable experimental evidence is provided.
Function of the present invention: benefiting QI and nourishing blood, regulating qi to disperse stagnation moistens just unimpeded.Be used for diseases such as postoperative gastrointestinal dysfunction such as abdominal part and general anesthesia and caused abdominal part distension thereof, and the generation of the prevention post-operative complication that may cause thus.
The present invention cures mainly: the postoperative gastric intestinal diseases.
Specification of the present invention: every bag heavy 5g of medicinal granule of the present invention, every gram contains raw material of Chinese medicine 1.993g; Every heavy 0.5g of medicinal tablet of the present invention, every gram contains raw material of Chinese medicine 7.475g; Every bottle of 10mL of medicine oral liquid of the present invention, every milliliter contains raw material of Chinese medicine 0.997g.
Usage and dosage of the present invention: obey medicinal granule of the present invention every day three times, each 1 bag; Or every day obey the invention medicinal tablet twice, 4 of each oral tablets; Or every day obey the invention medicine oral liquid three times, each oral oral liquid 10mL.
Storage of the present invention: the shady and cool dry place of sealing storage.
Effect duration of the present invention: 2 years.