CN101380434A - Yisheng granules and preparation method thereof - Google Patents

Yisheng granules and preparation method thereof Download PDF

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CN101380434A
CN101380434A CNA2008102281860A CN200810228186A CN101380434A CN 101380434 A CN101380434 A CN 101380434A CN A2008102281860 A CNA2008102281860 A CN A2008102281860A CN 200810228186 A CN200810228186 A CN 200810228186A CN 101380434 A CN101380434 A CN 101380434A
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yisheng
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granules
crude drug
radix
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CN101380434B (en
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张国刚
�田宏
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Shanghai Zheng Zheng Pharmaceutical Technology Co ltd
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Shenyang Pharmaceutical University
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Abstract

The invention belongs to the medicine technical field and discloses yisheng particles and a preparation method thereof. The particles comprises the following components: 100-300g of white paeony root, 100-300g of red peony, 150-400g of rhizoma corydalis, 150-400g of viscum album, 150-400g of field pennycress, 150-400g of milk veteh, 100-300g of radix scutellariae, 150-400g of coix seed, 100-300g of fructus meliae toosendan, 100-300g of dried orange peel, 100-300g of angelica, 100-300g of radix bupleuri, 100-300g of dandelion. The preparation method is as follows: after part of drug ingredients are used for extracting volatile oil; dregs and other drug ingredients are blended by water extract-alcohol precipitation to prepare extract, the mixture is added with excipients to prepare particles. The test result of bacteriostasis, anti-inflammation, analgesic, immunoregulation and promoting blood circulation by removing blood stasis in vitro and in vivo shows that the particles of the yisheng particles has the functions of bacteriostasis, anti-inflammation, promoting blood circulation by removing blood stasis, analgesic and immunoregulation, and can better cure chronic pelvic inflammation.

Description

Yisheng granules and preparation method thereof
Technical field:
The invention belongs to medical technical field, relate to a kind of Yisheng granules and preparation method thereof, also relate to the application of Yisheng granules in the treatment chronic pelvic inflammatory disease.
Background technology:
Pelvic inflammatory disease is a kind of more common gynaecopathia, is the highest disease of harm WomanHealth sickness rate in the obstetrical and gynecological disease, and especially rural women's sickness rate is higher, influences women productivity greatly.Chronic pelvic inflammatory disease means the other connective tissue of female sex organs and palace thereof, pelvic inflammatory disease film etc. is located to take place chronic inflammatory disease person and is referred to as, clinically with hypogastralgia, leucorrhoea grow in quantity, menoxenia, infertile, waist low miserable etc. be principal character, it is the commonly encountered diseases of serious harm WomanHealth, frequently-occurring disease and outbreak repeatedly, touching difficulty more.Staphylococcus, Hemolytic streptococcus and escherichia coli are main pathogenic bacterium of pelvic inflammatory disease, and its pathogen mostly is gonococcus, tubercule bacillus.Some parasite such as filaricide, schistosomicide or mumps virus also can cause pelvic cavity genitals illness in addition.The main do as one likes of the cause of disease of pelvic inflammatory disease is lived, wound, the infection-induced after the pelvic cavity genitals is undergone surgery.For the treatment of pelvic inflammatory disease, doctor trained in Western medicine is used antibiotics more, the bad and easy recurrence of antiinflammatory effect, and according to the performance of the pathogeny of pelvic inflammatory disease and Chinese medicine as can be known, the treatment by Chinese herbs pelvic inflammatory disease can reach determined curative effect, and can reach the purpose of effecting a permanent cure.The preparation that a lot of treatment chronic pelvic inflammatory diseases are arranged in the prior art, but most bioavailability is low, and uncertain therapeutic efficacy is cut.
Summary of the invention:
The object of the present invention is to provide a kind of pure Chinese medicinal preparation Yisheng granules and preparation method thereof of treatment chronic pelvic inflammatory disease of determined curative effect.
The present invention is achieved through the following technical solutions:
The present invention is made up of following prescription:
Radix Paeoniae Alba 100-300g Radix Paeoniae Rubra 100-300g Rhizoma Corydalis 150-400g Herba Taxilli 150-400g
Herba Patriniae 150-400g Radix Astragali 150-400g Radix Scutellariae 100-300g Semen Coicis 150-400g
Fructus Toosendan 100-300g Pericarpium Citri Reticulatae 100-300g Radix Angelicae Sinensis 100-300g Radix Bupleuri 100-300g
Herba Taraxaci 100-300g
The present invention is prepared from by the following method:
Get this product 13 flavors, Pericarpium Citri Reticulatae, Herba Taraxaci, Radix Angelicae Sinensis, Radix Bupleuri adds the water of 12 times of amounts, soaked 2 hours, volatile oil was extracted in the steam distillation distillation in 6 hours, and the aqueous solution after distillation device is in addition collected medicinal residues and all the other Radixs Astragali, Radix Scutellariae, Semen Coicis, Fructus Toosendan decocts with water secondary, the water that adds for the first time 8 times of amounts, decocted 2 hours, and added the water of 6 times of amounts for the second time, decocted 1.5 hours, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, and being concentrated into relative density is the clear paste of 1.05-1.10 (60 ℃), add ethanol and make that to contain alcohol amount be 60%, cold preservation 24 hours filters, and decompression filtrate recycling ethanol also is concentrated into the clear paste device collection in addition that relative density is 1.05-1.10 (60 ℃).The residue Radix Paeoniae Alba, Radix Paeoniae Rubra, Rhizoma Corydalis, Herba Taxilli, Herba Patriniae are with 80% ethanol extraction secondary, add 8 times of amounts at every turn, reflux, extract, 2 hours, merge extractive liquid, filters, and filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.05-1.10 (60 ℃), merge with above-mentioned clear paste, being evaporated to relative density is the thick paste of 1.30~1.36 (60 ℃), adds dextrin, aspartame is an amount of, mixing, dry, be ground into fine powder, make granule, drying, spray adds above-mentioned volatile oil, mixing is made 1000g, promptly.
Preparation technology of the present invention is simple, and determined curative effect has antibacterial, antiinflammatory, blood circulation promoting and blood stasis dispelling, analgesia, immunoregulatory effect.Has the effect for the treatment of chronic pelvic inflammatory disease preferably.
The specific embodiment:
Embodiment 1:
Get the recipe quantity Pericarpium Citri Reticulatae, Herba Taraxaci, Radix Angelicae Sinensis, Radix Bupleuri adds the water of 12 times of amounts, soaked 2 hours, volatile oil was extracted in the steam distillation distillation in 6 hours, aqueous solution after distillation device is in addition collected, medicinal residues and all the other Radixs Astragali, Radix Scutellariae, Semen Coicis, Fructus Toosendan decocts with water secondary, adds the water of 8 times of amounts for the first time, decocts 2 hours, the water that adds for the second time 6 times of amounts, decocted 1.5 hours, collecting decoction filters, filtrate and above-mentioned aqueous solution merge, being concentrated into relative density is the clear paste of 1.05-1.10 (60 ℃), adds ethanol and makes that to contain alcohol amount be 60%, cold preservation 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste device collection in addition that relative density is 1.05-1.10 (60 ℃).The residue Radix Paeoniae Alba, Radix Paeoniae Rubra, Rhizoma Corydalis, Herba Taxilli, Herba Patriniae are with 80% ethanol extraction secondary, add 8 times of amounts at every turn, reflux, extract, 2 hours, merge extractive liquid, filters, and filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.05-1.10 (60 ℃), merge with above-mentioned clear paste, being evaporated to relative density is the thick paste of 1.30~1.36 (60 ℃), adds dextrin, aspartame is an amount of, mixing, dry, be ground into fine powder, make granule, drying, spray adds above-mentioned volatile oil, mixing is made 1000g, promptly.
Embodiment 2:
The pharmacodynamics test of Yisheng granules
1. extracorporeal bacteria inhibitor test
1.1 the preparation of bacterium liquid: get one of single bacterium colony on the plain agar slant medium of escherichia coli, staphylococcus aureus, Candida albicans and 4 test strains of bacillus pyocyaneus, inoculate respectively in the 10ml broth bouillon 37 ℃ cultivate 16h after, being diluted to concentration with physiological saline solution is that 1.5 * 108cfu/ml is standby.
1.2 the mensuration of minimal inhibitory concentration (MIC): get some of the small test tubes that the 1ml broth bouillon is housed, by double dilution method drug dilution is become a series of concentration, diluent (using after all being diluted to 10-4) the 50 μ l mixings that add each bacterial strain then respectively, cultivate 24h for 37 ℃, the clarifying minimum liquor strength of record test tube, this concentration is minimal inhibitory concentration, the results are shown in Table 1.
By table 1 as seen, Yisheng granules is external to have inhibitory action to escherichia coli, staphylococcus aureus, Candida albicans and bacillus pyocyaneus, and minimal inhibitory concentration is respectively 30.28mg crude drug/ml, 30.28mg crude drug/ml, 30.28mg crude drug/ml and 60.56mg crude drug/ml.
Table 1. Yisheng granules is to the MIC measurement result of each strain
Figure A200810228186D00041
Annotate: growth is observed in "+" expression, and growth is not observed in "-" expression.
2. to the protective effect of infection of staphylococcus aureus mice
2.1 the preparation of bacterium liquid: the depletion Staphylococcus aureus is inoculated in the broth bouillon, cultivates 16h for 37 ℃, with standby behind the turbidimetry for Determination bacterial concentration.
2.2 prerun test: get standby bacterium liquid and put in the sterile test tube, be diluted to the bacteria suspension of variable concentrations by the 1:9 multiplying power, be for experiment with physiological saline solution.Give body weight 20g left and right sides female mice lumbar injection, the death toll of observing each treated animal in the 24h respectively with different injection volumes.Through repeatedly many groups prerun, find out when treating and cause that the minimum bacterial concentration of 100% dead mouse is that 6 * 108cfu/ml and every Mus lumbar injection amount are 0.45ml as formal test.
2.3 formal test: get 120 of body weight 18~22g female mices, be divided into 6 groups at random by body weight, every group of 20 animals, be respectively model control group, FUKE QIANJIN PIAN group (1.65g/kg), Amoxicillin Capsules group (1.04g/kg), Yisheng granules group (10.08g crude drug/kg, 20.16g crude drug/kg, 40.31g crude drug/kg), every day, gastric infusion was 1 time, administration is 5 days altogether, and model control group is given and waited the capacity distilled water.30min behind the last medicine, every Mus lumbar injection concentration is 6 * 108cfu/ml staphylococcus aureus suspension 0.45ml, each treated animal death condition in the observed and recorded 24h is estimated the curative effect of medicine with the mortality rate of animal.The results are shown in Table 2.
Table 2. Yisheng granules is to the protective effect of infection of staphylococcus aureus mice
*P<0.05, *P<0.01 (with the model control group ratio)
By table 2 as seen, (10.08g crude drug/kg, 20.16g crude drug/kg) the dosage group has the effect trend that reduces the infection of staphylococcus aureus mouse death rate to Yisheng granules, Yisheng granules (group of 40.31g crude drug/kg) has the effect of obvious reduction infection of staphylococcus aureus mouse death rate, with model control group than p<0.05.
3. the influence of xylol induced mice ear swelling
Get 60 of body weight 18~22g female mices, divide 6 groups at random by body weight, be respectively model control group, FUKE QIANJIN PIAN group (1.65g/kg), dexamethasone acetate group (3.12mg/kg), Yisheng granules group (10.08g crude drug/kg, 20.16g crude drug/kg, 40.31g crude drug/kg), every group 10, every day, gastric infusion was 1 time, successive administration 5 days, model control group waits the capacity distilled water.30min behind the last medicine, the wide 20 μ l dimethylbenzene that drip of every Mus auris dextra, put to death mice behind the 20min, cut left and right sides ear, draw materials along the punching of left and right sides auricle same area with the 7mm card punch, weigh respectively, as the swelling degree, t checks the significance of each administration group and model control group difference with two ear weight differences.The results are shown in Table 3.
The influence of table 3. Yisheng granules xylol induced mice ear swelling (X ± S)
*P<0.05, *P<0.01 (with the model control group ratio)
By table 3 as seen, each dosage group of Yisheng granules all has the effect of obvious inhibition dimethylbenzene induced mice ear swelling, wherein (group of 10.08 crude drugs/kg) and model control group be than p<0.05, and (group of 20.16g crude drug/kg, 40.31g crude drug/kg) and model control group are than p<0.01 for Yisheng granules for Yisheng granules.
4. to the granulomatous influence of rat due to the agar
Get 60 of body weight 180~220g female rats, divide 6 groups at random, 10 every group by body weight.Be respectively model control group, FUKE QIANJIN PIAN group (1.14g/kg), dexamethasone acetate group (2.16mg/kg), Yisheng granules group (6.98g crude drug/kg, 13.95g crude drug/kg, 27.91g crude drug/kg), under pentobarbital sodium 35mg/kg intraperitoneal anesthesia, the sterile working, at the agar solution 2ml of Mus dorsal line subcutaneous injection 2%, set up rat agar granuloma model.Modeling begins administration next day and irritates stomach, and every day 1 time, model control group gives the isometric(al) distilled water.Cause scorching back the 15th day, pentobarbital sodium anesthesia is put to death rat down, separates the granuloma agar block, takes by weighing weight in wet base with electronic balance, the significance of each administration group and model control group difference.The results are shown in Table 4.
Table 4. Yisheng granules is to (the X ± S) of the granulomatous influence of rat due to the agar
Figure A200810228186D00062
*P<0.05, *P<0.01 (with the model control group ratio)
By table 4 as seen, each dosage group of Yisheng granules has the granulomatous effect of rat due to the obvious inhibition agar, wherein (group of 6.98g crude drug/kg) and model control group be than p<0.05, and (group of 13.95g crude drug/kg, 27.91g crude drug/kg) and model control group are than p<0.01 for Yisheng granules for Yisheng granules.
5. the influence of rat chronic pelvic inflammatory disease model due to Pyrogentisinic Acid's rubber cement
The preparation of phenol rubber cement: liquefied phenol 5ml, tragakanta 1g, glycerol 4ml, adding distil water are made into 25% phenol rubber cement to 20ml.
Selecting body weight for use is 60 of the female rats of 180~220g, be divided into blank group, model control group, FUKE QIANJIN PIAN group (1.14g/kg) group at random by body weight, the Yisheng granules group (6.98g crude drug/kg, 13.95g crude drug/kg, 27.91g crude drug/kg), all the other animals are used pentobarbital sodium 35mg/kg intraperitoneal anesthesia except that the blank group, the abdominal part routine disinfection, take off the about 2cm of abdominal part median incision, expose the uterus, with No. 4 syringe needles at the careful inserting needle in uterus, left side, slowly inject phenol rubber cement 0.04ml to the ovary direction, annotate and finish, abdomen is closed in layering, sterilization art district.10d begins gastric infusion after the modeling, every day 1 time, and continuous 20d, blank group and model control group animal are waited the capacity distilled water.Behind the last administration 24h, win the bilateral uterus, use scales/electronic balance weighing after removing fatty tissue, the weight difference of the left and right sides, uterus is inflammation swelling degree, between organizing relatively.The results are shown in Table 5.
Fix paraffin embedding, conventional section after weighing with 10% formalin.HE dyeing.Light microscopic is observed the uterus morphological changes of various tissue components down.The results are shown in Table 6.
By table 5 as seen, each dosage group of Yisheng granules all has the trend that alleviates rat chronic pelvic inflammatory disease model inflammation of uterus swelling degree due to the phenol rubber cement.
By table 6 as seen, each dosage group of Yisheng granules all can be improved rat chronic pelvic inflammatory disease model endometrium lesion degree due to the phenol rubber cement.
The influence of chronic pelvic inflammatory disease rat model uterus swelling degree due to the living Pyrogentisinic Acid's rubber cement of table 5. heart of a lotus seed (X ± s)
Figure A200810228186D00071
P<0.05, △ △P<0.01 (with blank group ratio)
Table 6. Yisheng granules is to the influence of rat model uterus pathological change (appraisal result)
Figure A200810228186D00072
Figure A200810228186D00081
Pathological observation index and integration standard are:
1. the inaccessible or expansion of official jargon adhesion: "-" no pathological changes note 0 minute; "+"<1/3 pathological changes note 1 minute; " ++ " 1/3-2/3 pathological changes note 2 minutes; " +++" 2/3 above pathological changes note 3 minutes.
2. chamber wall construction pathological changes: the normal note of "-" each layer structure 0 minute; + " disappear note 1 minute of proper mucous membrane gland structure; Demarcate unclear note 2 minutes of " ++ " flesh layer and mucous layer; " +++" unclear note of hierarchy 3 minutes.
3. epithelial cell degeneration necrosis: "-" simple columnar epithelium note 0 minute; "+" epithelial cell is flat or come off<1/3 note 1 minute; Flat or 1/3-2/3 pathological changes note 2 minutes of coming off of " ++ " epithelial cell; " +++" holostrome epithelial cell degeneration necrosis note 3 minutes.
4. chronic inflammation cellular infiltration: "-" no chronic inflammation cell was invaded the profit note 0 minute; "+" decimal be dispersed in or kitchen range and only in proper mucous membrane the note 1 minute; " ++ " is dispersed in or kitchen range but goed deep into flesh layer note 2 minutes; " +++" majority is dispersed in or stratiform is soaked into and involved the holostrome note 3 minutes.
5. inner membrance congestion and edema: "-" no inner membrance congestion and edema note 0 minute: the slight congestion and edema note of "+" lamina propria 1 minute; " ++ " obviously congestion and edema remembers 2 fens; " +++" holostrome congestion and edema note 3 minutes.
6. to the influence of rat chronic pelvic inflammatory disease model due to the escherichia coli
The escherichia coli suspension: coli strain, behind broth bouillon cultivation 16h, be diluted to certain concentration with normal saline, carry out the reduced turbidity inspection, make its concentration reach 6 * 10 6Individual/ml is standby.
Selecting body weight for use is 60 of the female rats of 180~220g, be divided into the blank group at random by body weight, model control group, FUKE QIANJIN PIAN group (1.14g/kg) group, Yisheng granules group (6.98g crude drug/kg, 13.95g crude drug/kg, 27.91g crude drug/kg), all the other animals are used pentobarbital sodium 35mg/kg intraperitoneal anesthesia except that the blank group, the abdominal part routine disinfection, take off the about 2cm of abdominal part median incision, expose the uterus, with No. 4 syringe needles at the careful inserting needle in uterus, left side, before injecting bacterium liquid, use syringe mechanical damage endometrium, slowly inject Escherichia coli bacteria liquid 0.2ml to the ovary direction then, annotate and finish, clamp pin hole, prevent that the bacterium hydrorrhea from going out with tweezers, abdomen is closed in layering, sterilization art district.10d begins gastric infusion after the modeling, every day 1 time, and continuous 20d, blank group and model control group animal are waited the capacity distilled water every day.Behind the last administration 24h, the animal of fasting be can't help water 16h is cut open the belly with pentobarbital sodium 35mg/kg intraperitoneal anesthesia, and the ventral aorta blood sampling detects hemorheology index, compares between organizing.The results are shown in Table 7.
Win the bilateral uterus after the blood sampling, use scales/electronic balance weighing after removing fatty tissue, the weight difference of the left and right sides, uterus is inflammation swelling degree, between organizing relatively.The results are shown in Table 8.
Fix paraffin embedding, conventional section after weighing with 10% formalin.HE dyeing.Light microscopic is observed the uterus morphological changes of various tissue components down.The results are shown in Table 9.
By table 7 as seen, model control group compares whole blood viscosity with the blank group, erythrocyte aggregation index, erythrocyte electrophoretic time, the Kazon viscosity, the Kazon yield stress all has obvious rising (P<0.01), illustrating has due to the escherichia coli blood stasis state to exist in the rat chronic pelvic inflammatory disease model body, each dosage group of Yisheng granules has the effect that improves the blood stasis state of rat chronic pelvic inflammatory disease due to the escherichia coli, above-mentioned every index all has downward trend, Yisheng granules (13.95g crude drug/kg, 27.91g the group of crude drug/kg) descend obviously with model control group than p<0.01, wherein the above-mentioned every index of Yisheng granules (27.91g/kg) group is near normal, with the blank group than no significant difference (p〉0.05).
By table 8 as seen, each dosage group of Yisheng granules all has the effect that obviously alleviates rat chronic pelvic inflammatory disease model inflammation of uterus swelling degree due to the escherichia coli.
By table 9 as seen, each dosage group of Yisheng granules all can be improved rat chronic pelvic inflammatory disease model endometrium lesion degree due to the escherichia coli.
Table 7. Yisheng granules is to the influence of rat chronic pelvic inflammatory disease model hemorheology index due to the escherichia coli (X ± s)
Figure A200810228186D00091
Figure A200810228186D00101
P<0.05, △ △P<0.01 (with blank group ratio); *P<0.05, *P<0.01 (with the model control group ratio)
Table 8. Yisheng granules is to the influence of chronic pelvic inflammatory disease rat model uterus swelling degree due to the escherichia coli (X ± s)
Figure A200810228186D00102
△ △P<0.01 (with blank group ratio); *P<0.05, *P<0.01 (with the model control group ratio)
The life of table 9. heart of a lotus seed is to the influence of rat chronic pelvic inflammatory disease model uterus pathological change (appraisal result) due to the escherichia coli
Figure A200810228186D00103
Pathological observation index and integration standard are:
1. the inaccessible or expansion of official jargon adhesion: "-" no pathological changes note 0 minute; "+"<1/3 pathological changes note 1 minute; " ++ " 1/3-2/3 pathological changes note 2 minutes; " +++" 2/3 above pathological changes note 3 minutes.
2. chamber wall construction pathological changes: the normal note of "-" each layer structure 0 minute; + " disappear note 1 minute of proper mucous membrane gland structure; Demarcate unclear note 2 minutes of " ++ " flesh layer and mucous layer; " +++" unclear note of hierarchy 3 minutes.
3. epithelial cell degeneration necrosis: "-" simple columnar epithelium note 0 minute; "+" epithelial cell is flat or come off<1/3 note 1 minute; Flat or 1/3-2/3 pathological changes note 2 minutes of coming off of " ++ " epithelial cell; " +++" holostrome epithelial cell degeneration necrosis note 3 minutes.
4. chronic inflammation cellular infiltration: "-" no chronic inflammation cell was invaded the profit note 0 minute; "+" decimal be dispersed in or kitchen range and only in proper mucous membrane the note 1 minute; " ++ " is dispersed in or kitchen range but goed deep into flesh layer note 2 minutes; " +++" majority is dispersed in or stratiform is soaked into and involved the holostrome note 3 minutes.
5. inner membrance congestion and edema: "-" no inner membrance congestion and edema note 0 minute: the slight congestion and edema note of "+" lamina propria 1 minute; " ++ " obviously congestion and edema remembers 2 fens; " +++" holostrome congestion and edema note 3 minutes.
7. to the influence of epinephrine induced mice mesentery microcirculation disturbance
Get 60 of body weight 18~22g female mices, divide 6 groups at random, 10 every group by body weight.Be respectively model control group, FUKE QIANJIN PIAN group (1.65g/kg), Anisodamine group (7.80mg/kg), Yisheng granules group (10.08g crude drug/kg, 20.16g crude drug/kg, 40.31g crude drug/kg), irritate stomach every day 1 time, continuous 5 days, water 12h is can't help in fasting before the test, 30min after the last administration, room temperature is controlled about 25 ℃, open thermostatic water bath, temperature (37 ± 0.5) ℃, after doing intraperitoneal anesthesia with pentobarbital sodium 50mg/kg, fixing limbs, lie on the back, hypogastric region is cut only by hair, on the pubic symphysis of abdominal part center, cut an otch that is about 1.5cm, pull out one section intestinal loop gently, mesentery is placed on the platform, intestinal tube immerses the Rockwell liquid (composition: sodium chloride 9.20g of (37 ± 0.5) ℃, potassium chloride 0.42g, sodium bicarbonate 0.15g, glucose 2g adds the 1000ml distilled water) in, adopt transmitted light source, amplification is 4 * 18 times, observe the preceding arteriolar flow velocity of normal bowel mesentery of dripping hydrochloric acid epinephrine, fluidised form, caliber and blood capillary crossing net are counted, dripping concentration then is the adrenalin hydrochloride solution 10 μ l of 50 μ g/ml, in 2,10min observes the arteriolar fluidised form of each mesentery respectively, flow velocity and caliber the results are shown in Table 10.
By table 10 as seen, each dosage group of Yisheng granules all can obviously be improved arteriolar fluidised form, the arteriolar flow velocity of increase of epinephrine induced mice mesentery microcirculation disturbance and increase arteriolar caliber, drip before the arteriolar fluidised form of 10min mesentery behind the NA, flow velocity and caliber and the dropping NA than p〉0.05, and before model control group and the dropping NA than p<0.05.
The life of table 10. heart of a lotus seed is to the microcirculatory influence of mice mesentery live body (X ± s)
Figure A200810228186D00111
*P<0.05, *P<0.01 (with ratio before the NA)
8. to the influence of glacial acetic acid induced mice writhing response
Get 60 of body weight 18~22g female mices, divide 6 groups at random by body weight, be respectively model control group, FUKE QIANJIN PIAN group (1.65g/kg), aspirin tablet group (0.13g/kg), Yisheng granules group (10.08g crude drug/kg, 20.16g crude drug/kg, 40.31g crude drug/kg), every group 10, every day, gastric infusion was 1 time, successive administration 5 days, model control group gives the isometric(al) distilled water, 30min behind the last medicine, the equal lumbar injection 0.6% glacial acetic acid 0.2ml/20g of each Mus, after adapting to 5min, observe mouse writhing reaction times in the 15min, compare the significance of each administration group and model control group differences with the t check.The results are shown in Table 11.
By table 11 as seen, each dosage group of Yisheng granules has obvious inhibition glacial acetic acid induced mice writhing response number of times, with model control group than p<0.01.
The life of table 11. heart of a lotus seed is to the influence of glacial acetic acid induced mice writhing response (X ± s)
Figure A200810228186D00122
* *P<0.01 (with the model control group ratio)
9. hot plate method is caused the influence of mice pain model
Choose body weight 18~22g, pain thresholding 60 of female mices between 5~30s, divide 6 groups at random by body weight, be respectively model control group, FUKE QIANJIN PIAN group (1.65g/kg), bucinnazine hydrochloride sheet group (46.8mg/kg), Yisheng granules group (10.08g crude drug/kg, 20.16g crude drug/kg, 40.31g crude drug/kg), every group 10, gastric infusion, model control group gives the isometric(al) distilled water, after the administration 30,60,90,120min puts into the pain threshold that the hot plate analyzer is measured mice with mice.The results are shown in Table 12.
The life of table 12. heart of a lotus seed causes the influence (X ± s) of mice pain model to hot plate method
Figure A200810228186D00123
Figure A200810228186D00131
*P<0.05, *P<0.01 (with the model control group ratio)
By table 12 as seen, (10.08g crude drug/kg, 20.16g crude drug/kg) dosage group administration 30min has the effect trend that improves hot plate induced mice pain model pain threshold to Yisheng granules, Yisheng granules (the dosage group administration 30min of the 40.31g crude drug/kg) effect of hot plate induced mice pain model pain threshold that is significantly improved, with model control group than p<0.05.
10. to the influence of caused by cyclophosphamide immunologic hypofunction mice reticuloendothelial system phagocytic activity
Get 60 of body weight 18~22g female mices, divide 5 groups at random by body weight, be respectively blank group, model control group, FUKE QIANJIN PIAN group (1.65g/kg), Yisheng granules group (10.08g crude drug/kg, 20.16g crude drug/kg, 40.31g crude drug/kg), every group 10, irritate stomach and give corresponding medicinal liquid, blank group, model control group give the equivalent distilled water, successive administration 7d.The 3rd day every mouse peritoneal injection Cy50mg/kg (the blank group waits the capacity normal saline) except that the blank group, continuous 2d, the animal model of preparation immunologic hypofunction.30min after the last administration accurately injects the india ink 0.1ml/10g body weight of 10 times of dilutions in mouse tail vein, and 1min and 6min get blood 20 μ l with getting the blood suction pipe respectively from the mouse orbit rear vein beard after injecting prepared Chinese ink, are blown into 2ml 0.1% Na at once 2CO 3In the solution, suction pipe sucks in this liquid and blows out 3 times fully to wash out the blood that the suction pipe wall adheres to.After getting blood and finishing, be dissolved in 2ml 0.1% Na with 20 μ l normal mouse blood 2CO 3Liquid school zero, 680nm place colorimetric on spectrophotometer is handled the back and is measured the OD value, is calculated as follows phagocytic index (cleaning up index) K:
K=lgC 1-1gC 2/T 2-T 1
C in the formula 1, C 2Carbon granule concentration (OD value) in the blood during for 1min and 6min.The results are shown in Table 13.
Table 13. Yisheng granules is to the influence of immunologic hypofunction mice reticuloendothelial system phagocytic activity (X ± s)
Figure A200810228186D00141
P<0.05, △ △P<0.01 (with blank group ratio); *P<0.05, *P<0.01 (with the model control group ratio)
By table 13 as seen, the be significantly improved effect of caused by cyclophosphamide immunologic hypofunction mice reticuloendothelial system phagocytic activity of each dosage group of Yisheng granules, wherein (group of 10.08g crude drug/kg, 20.16g crude drug/kg) and model control group be than p<0.05, and (group of 40.31g crude drug/kg) and model control group are than p<0.01 for Yisheng granules for Yisheng granules.
11. influence to the generation of caused by cyclophosphamide immunologic hypofunction mice serum hemolysin
Complement: mix with 3 Cavia porcellus equivalent serum, be mixed with 10% (V/V) with normal saline.
The preparation of chicken erythrocyte suspension: under aseptic condition, venous blood collection under the chicken wing, anticoagulant heparin, put in the 100ml vaccine bottle, add normal saline (NS) mixing that is equivalent to 5 times of Sanguis Gallus domesticus volumes, with NS washing 3 times, with the centrifugal 5min of 1500r/min speed, abandon the leukocytic cream at supernatant and interface.Last continuous centrifugal 2 times (2000r/min, 5min) constant until the packed cell volume value, get chicken red blood cell and be made into 5% red cell suspension (V/V) with NS, standby.
Test method: get 60 of body weight 18~22g female mices, divide 6 groups at random by body weight, be respectively blank group, model control group, FUKE QIANJIN PIAN group (1.65g/kg), Yisheng granules group (10.08g crude drug/kg, 20.16g crude drug/kg, 40.31g crude drug/kg), every group 10, irritate stomach and give corresponding medicinal liquid, blank group, model control group give the equivalent distilled water, successive administration 7d.The 3rd day every Mus ip5% normal saline chicken red blood cell suspension 0.2ml (fresh preparation) carry out immunity, every mouse peritoneal is injected Cy50mg/kg (the blank group waits the capacity normal saline) except that the blank group simultaneously, continuous 2d, the animal model of preparation immunologic hypofunction.30min after the last administration, the eyeground vein clump is got blood, and is centrifugal, get serum with 100 times of normal saline dilutions, get dilute serum 1ml, mix with 5% chicken red blood cell suspension 0.5ml, 10% complement 0.5ml, after in 37 ℃ of calorstats, being incubated 30min, stopped reaction in 0 ℃ of refrigerator.Centrifugal, get supernatant in 721 spectrophotometer 540nm place colorimetrics, measure optical density (OD), other establishes the not blank of increase serum, gets its supernatant as the benchmark than tone " 0 ".As the index of judging serum hemolysin content, the optical density value significance of difference between each administration group and the matched group is compared in the t check, the results are shown in Table 14 with optical density value (OD).
By table 14 as seen, (the 10.08g crude drug/kg) the dosage group has the effect trend of increase to Yisheng granules to the generation of caused by cyclophosphamide immunologic hypofunction mice serum hemolysin.
The influence that table 14. Yisheng granules generates immunologic hypofunction mice serum hemolysin (X ± s)
Figure A200810228186D00142
Figure A200810228186D00151
P<0.05, △ △P<0.01 (with blank group ratio)
12. to 2, the influence of 4-dinitrochlorobenzene induced mice delayed hypersensitivity
Get 50 of body weight 18~22g female mices, divide 5 groups at random by body weight, be respectively the blank group, FUKE QIANJIN PIAN group (1.65g/kg), Yisheng granules group (10.08g crude drug/kg, 20.16g crude drug/kg, 40.31g crude drug/kg), every group 10, the grouping back is with 1.25%2,4-dinitrochlorobenzene acetone solution back subcutaneous injection 20 μ l/ only, begin to irritate stomach next day and give corresponding medicinal liquid, the blank group gives the equivalent distilled water, successive administration 9d (1 time/d), be coated with 1.25%2 in mice left side ear behind the last administration 24h, 4-dinitrochlorobenzene acetone solution 20 μ l/ only, put to death mice behind the 24h, lay the auricle of the left and right sides with the position with the 7mm card punch, precision is weighed, calculate the swelling degree, heavy (the mg)-auris dextra of swelling degree (mg)=left ear heavy (mg), the significance of each administration group and model control group difference is compared in the t check, the results are shown in Table 15.
The life of table 15. heart of a lotus seed is to 2, and the influence of 4-dinitrochlorobenzene induced mice delayed hypersensitivity (X ± s)
Figure A200810228186D00152
*P<0.05, *P<0.01 (with the model control group ratio)
By table 15 as seen, each dosage group of Yisheng granules is to 2, and 4-dinitrochlorobenzene induced mice delayed hypersensitivity has obvious inhibitory action, with model control group than p<0.01.
External bacteriostatic experiment shows, (minimal inhibitory concentration is that (minimal inhibitory concentration is that (minimal inhibitory concentration 60.56mg crude drug/ml) has inhibitory action for 30.28mg crude drug/ml), Candida albicans (minimal inhibitory concentration 30.28mg crude drug) and bacillus pyocyaneus for 30.28mg crude drug/ml), staphylococcus aureus to Yisheng granules to escherichia coli; Bacteriostatic experiment shows in the body, and (40.31g crude drug/kg) effect that reduces the infection of staphylococcus aureus mouse death rate is arranged shows that this product has bacteriostasis to the Yisheng granules high dose group; (((40.31g crude drug/kg) has the effect of the dimethylbenzene of inhibition induced mice ear swelling to the Yisheng granules low dose group for 20.16g crude drug/kg), high dose group for 10.08 crude drugs/kg), middle dosage group; (((27.91g crude drug/kg) has the granulomatous effect of rat due to the agar of inhibition to the Yisheng granules low dose group for 13.95g crude drug/kg), high dose group for 6.98g crude drug/kg), middle dosage group; (((27.91g crude drug/kg) has the trend that alleviates rat chronic pelvic inflammatory disease model inflammation of uterus swelling degree due to the phenol rubber cement to the Yisheng granules low dose group, can improve rat chronic pelvic inflammatory disease model endometrium lesion degree due to the phenol rubber cement for 13.95g crude drug/kg), high dose group for 6.98g crude drug/kg, middle dosage group; (((27.91g crude drug/kg) has the effect that obviously alleviates rat chronic pelvic inflammatory disease model inflammation of uterus swelling degree due to the escherichia coli to the Yisheng granules low dose group, can improve rat chronic pelvic inflammatory disease model endometrium lesion degree due to the escherichia coli for 13.95g crude drug/kg), high dose group for 6.98g crude drug/kg, middle dosage group; Show that this product has antiinflammatory action.Yisheng granules high dose group (the have clear improvement blood stasis state of rat chronic pelvic inflammatory disease model due to the escherichia coli of 27.91g crude drug/kg); The Yisheng granules low dose group (10.08 crude drugs/kg), middle dosage group (20.16g crude drug/kg), high dose group (40.31g crude drug/kg) can obviously improve epinephrine induced mice mesentery microcirculation disturbance arteriolar fluidised form, increase arteriolar flow velocity and increase arteriolar caliber; Show that this product has function of promoting blood circulation to disperse blood clots.(((40.31g crude drug/kg) has the glacial acetic acid of inhibition induced mice writhing response number of times to the Yisheng granules low dose group for 20.16g crude drug/kg), high dose group for 10.08 crude drugs/kg), middle dosage group, (40.31g crude drug/kg) effect that improves hot plate induced mice pain model pain threshold is arranged shows that this product has analgesic activity to the Yisheng granules high dose group.(((the be significantly improved effect of caused by cyclophosphamide immunologic hypofunction mice reticuloendothelial system phagocytic activity of 40.31g crude drug/kg) shows that this product has the effect of enhancing non-specific immunity function to the Yisheng granules low dose group for 20.16g crude drug/kg), high dose group for 10.08 crude drugs/kg), middle dosage group; (10.08g crude drug/kg) has the effect trend of increase to the Yisheng granules low dose group to the generation of caused by cyclophosphamide immunologic hypofunction mice serum hemolysin; The Yisheng granules low dose group (10.08 crude drugs/kg), middle dosage group (20.16g crude drug/kg), high dose group (the 40.31g crude drug/kg) to 2,4-dinitrochlorobenzene induced mice delayed hypersensitivity has obvious inhibitory action, shows that this product has the effect that suppresses the specific cellular immunity function.Conclusion: Yisheng granules has antibacterial, antiinflammatory, blood circulation promoting and blood stasis dispelling, analgesia, immunoregulatory effect.Above result treats chronic pelvic inflammatory disease clinically for Yisheng granules the pharmacodynamics foundation is provided.

Claims (2)

1, Yisheng granules is characterized in that: its prescription is as follows:
Radix Paeoniae Alba 100-300g Radix Paeoniae Rubra 100-300g Rhizoma Corydalis 150-400g Herba Taxilli 150-400g
Herba Patriniae 150-400g Radix Astragali 150-400g Radix Scutellariae 100-300g Semen Coicis 150-400g
Fructus Toosendan 100-300g Pericarpium Citri Reticulatae 100-300g Radix Angelicae Sinensis 100-300g Radix Bupleuri 100-300g
Herba Taraxaci 100-300g.
2, the preparation method of the described Yisheng granules of claim 1 is characterized in that: its technology is as follows:
Get this product 13 flavors, Pericarpium Citri Reticulatae, Herba Taraxaci, Radix Angelicae Sinensis, Radix Bupleuri adds the water of 12 times of amounts, soaked 2 hours, volatile oil was extracted in the steam distillation distillation in 6 hours, and the aqueous solution after distillation device is in addition collected medicinal residues and all the other Radixs Astragali, Radix Scutellariae, Semen Coicis, Fructus Toosendan decocts with water secondary, the water that adds for the first time 8 times of amounts, decocted 2 hours, and added the water of 6 times of amounts for the second time, decocted 1.5 hours, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, and being concentrated into relative density is the clear paste of 1.05-1.10 (60 ℃), add ethanol and make that to contain alcohol amount be 60%, cold preservation 24 hours filters, and decompression filtrate recycling ethanol also is concentrated into the clear paste device collection in addition that relative density is 1.05-1.10 (60 ℃).The residue Radix Paeoniae Alba, Radix Paeoniae Rubra, Rhizoma Corydalis, Herba Taxilli, Herba Patriniae are with 80% ethanol extraction secondary, add 8 times of amounts at every turn, reflux, extract, 2 hours, merge extractive liquid, filters, and filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.05-1.10 (60 ℃), merge with above-mentioned clear paste, being evaporated to relative density is the thick paste of 1.30~1.36 (60 ℃), adds dextrin, aspartame is an amount of, mixing, dry, be ground into fine powder, make granule, drying, spray adds above-mentioned volatile oil, mixing is made 1000g, promptly.
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102600440A (en) * 2012-03-29 2012-07-25 常熟市常福有机复合肥有限公司 Chinese herbal composition for treating chronic pelvic inflammation and preparation method thereof
CN103349707A (en) * 2013-07-23 2013-10-16 宁波立华制药有限公司 Method for preparing eight-treasure granules
CN105250519A (en) * 2015-10-19 2016-01-20 黄淮学院 Traditional Chinese medicine composition for relieving sequelae of pelvic inflammatory disease and application of traditional Chinese medicine composition
CN114887015A (en) * 2022-07-13 2022-08-12 云南琼月企业管理有限公司 Pharmaceutical composition, preparation and application thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100586466C (en) * 2007-07-30 2010-02-03 重庆东田药业有限公司 Film coating tablet for treating gynaecologic disease and method for preparing the same
CN101224281B (en) * 2008-01-23 2010-09-08 李伟 Chinese traditional medicine preparation for purulent inflammation of skin

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102600440A (en) * 2012-03-29 2012-07-25 常熟市常福有机复合肥有限公司 Chinese herbal composition for treating chronic pelvic inflammation and preparation method thereof
CN103349707A (en) * 2013-07-23 2013-10-16 宁波立华制药有限公司 Method for preparing eight-treasure granules
CN105250519A (en) * 2015-10-19 2016-01-20 黄淮学院 Traditional Chinese medicine composition for relieving sequelae of pelvic inflammatory disease and application of traditional Chinese medicine composition
CN105250519B (en) * 2015-10-19 2019-09-03 黄淮学院 It is a kind of alleviate sequelae of pelvic inflammatory disease Chinese medicine composition and its application
CN114887015A (en) * 2022-07-13 2022-08-12 云南琼月企业管理有限公司 Pharmaceutical composition, preparation and application thereof

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