CN1824077A - Chinese medicinal liquid capsule for treating gynecopathy and its preparation method - Google Patents
Chinese medicinal liquid capsule for treating gynecopathy and its preparation method Download PDFInfo
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Abstract
A Chinese medicine in the form of liquid soft capsule for treating gynopathy is prepared from the suspending aid, vegetative oil and powdered extracts of 10 Chinese-medicinal materials including honeysuckle stem, liquorice root, dandelion herb, red peoney root, etc.
Description
Technical field
The present invention relates to a kind of Chinese patent medicine and preparation technology thereof, relate in particular to a kind of herb liquid body capsule for the treatment of gynaecopathia and preparation method thereof.
Background technology
Existing market has a kind of Chinese patent medicine " FULE CHONGJI ", is used for the treatment of diseases such as leukorrhagia that pelvic inflammatory disease, adnexitis, endometritis etc. cause, stomachache, and clinical application effect is better.In " Drug Standard of Ministry of Public Health of the Peoples Republic of China-Chinese traditional patent formulation preparation " (the 8th), find this medicine prescription and preparation method:
Prescription: Caulis Lonicerae 500g Caulis Sargentodoxae 500g Radix Glycyrrhizae 50g Folium Isatidis 150g
Herba Taraxaci 150g Cortex Moutan 150g Radix Paeoniae Rubra 150g Fructus Toosendan 150g
Rhizoma Corydalis (system) 150g Radix Et Rhizoma Rhei (system) 100g
Method for making: above ten flavors, get Radix Et Rhizoma Rhei powder and be broken into coarse powder, according to the percolation under fluid extract and the extractum item, make solvent with 60% ethanol, flood and carry out percolation after 24 hours, collect percolate, filter, being evaporated to relative density is the clear paste of 1.20～1.22 (45～50 ℃), and residue is standby; Nine flavors such as all the other Caulis Loniceraes decoct with water secondary, 2 hours for the first time, after for the second time adding Radix Et Rhizoma Rhei percolation residue, decocted collecting decoction 1 hour, filter, filtrate is concentrated into the clear paste that relative density is 1.06～1.08 (85～90 ℃), merges with above-mentioned clear paste, mixing, spraying drying powder-forming adds right amount of auxiliary materials, make granule, drying, granulate, promptly.
There is following deficiency in above method: 1, the percolation extraction efficiency is low, and length consuming time, one procedure just influence the progress of whole leaching process; 2, the effective ingredient of big portion medical material has pure dissolubility in the prescription, though to a certain extent also can be water-soluble, big minute medical material decocting of former preparation can bring more invalid components and impurity unavoidably, influenced curative effect, returns preparation and causes difficulty; 3, amount of formulation is big, and inconvenient patient takes, carries.
Summary of the invention
The objective of the invention is to: the above-mentioned defective that overcomes existing preparation technology, for the patient provides more effective, takes the herb liquid body capsule medicine of the treatment gynaecopathia that has identical effect more easily, provide production efficiency height, the simpler preparation method of technology simultaneously.
Liquid capsule of the present invention is made up of Chinese medical concrete powder and suspending agent, vegetable oil, and its weight ratio is 1: 0.04-0.10: 0.7-2.0.Described Chinese medical concrete powder is made by Caulis Lonicerae, Caulis Sargentodoxae, Radix Glycyrrhizae, Folium Isatidis, Herba Taraxaci, Cortex Moutan, Radix Paeoniae Rubra, Fructus Toosendan, Rhizoma Corydalis (system), Radix Et Rhizoma Rhei (system), and the weight ratio of each ingredient is: Caulis Lonicerae: Caulis Sargentodoxae: Radix Glycyrrhizae: Folium Isatidis: Herba Taraxaci: Cortex Moutan: Radix Paeoniae Rubra: Fructus Toosendan: Rhizoma Corydalis: Radix Et Rhizoma Rhei=10: 10: 1: 3: 3: 3: 3: 3: 3: 2.
Suspending agent of the present invention can be one or more the mixture in Cera Flava, lecithin, aluminum monostearate, the ethyl cellulose, be preferably Cera Flava, and vegetable oil can be one or more the mixture in soybean oil, Oleum sesami, Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris and other edible plants oil.In view of big, the stay in grade of cheap, output of soybean oil, so be decided to be optimum selection.
According to universal law, the amount of suspensoid is big more, and the stability of suspension is just good more, yet in actual production, the amount of suspensoid is too big, can cause the increase of cost again, also make troubles for production process, therefore must on the basis that can reach stablizing effect, reduce the suspensoid consumption as far as possible, the inventor gropes through experiment, the optimum weight ratio of having determined Chinese medical concrete powder and Cera Flava, soybean oil is 1: 0.06: 1.1, can satisfy the requirement of stability so fully, has saved the consumption of suspensoid again.
Preparation method of the present invention may further comprise the steps:
A. extracting liquorice, Folium Isatidis, Herba Taraxaci, Cortex Moutan, Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Et Rhizoma Rhei seven flavors, with 60～80% alcohol heating reflux of 6～10 times of amounts 2～3 times, each 1～2 hour, merge extractive liquid, filters filtrate recycling ethanol, leave standstill, filter, filtrate is preserved standby;
B. get three flavors such as Caulis Lonicerae, Caulis Sargentodoxae, Fructus Toosendan, the decocting that adds 8～12 times of amounts boils 2～3 times, and each 1～2 hour, collecting decoction, filter filtrate and be condensed into clear paste, add ethanol and make and contain the alcohol amount and reach 60～80%, cold preservation 12～24 hours, filtrate recycling ethanol, leave standstill, filter filtrate for later use;
C. the filtrate among a and the b is merged, after further concentrating, drying is made fine powder;
D. get suspending agent, vegetable oil, 60-70 ℃ of heat fused adds above-mentioned medicated powder, and mixing is made suspension, and 60-70 ℃ of insulation made liquid capsule with the liquid capsule filling machine.
The product of the original relatively technology of the resulting product of the present invention, more refining, the unit formulation drug loading increases, and content of dispersion is accurate, does not have bad abnormal smells from the patient, and patient's taking convenience has overcome the various drawbacks of original technical products substantially, has reached purpose of the present invention.
Through above processing step, prescription the rate of extract is reduced greatly, only be about 5%.And the rate of extract of pressing the parallel laboratory test of " FULE CHONGJI " process conditions can reduce each dose (former dosage form is taken the 15-20 gram at every turn, and the present invention takes the 1-3 gram at every turn) greatly more than 20%.
The specific embodiment
The present invention is described in detail below in conjunction with embodiment.
Embodiment 1:
Get Caulis Lonicerae 10kg, Caulis Sargentodoxae 10kg, Radix Glycyrrhizae 1kg, Folium Isatidis 3kg, Herba Taraxaci 3kg Cortex Moutan 3kg, Radix Paeoniae Rubra 3kg, Fructus Toosendan 3kg, Rhizoma Corydalis (system) 3kg, Radix Et Rhizoma Rhei (system) 2kg; Make according to the following steps again: a. extracting liquorice, Folium Isatidis, Herba Taraxaci, Cortex Moutan, Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Et Rhizoma Rhei seven flavors, with 60% alcohol heating reflux of 6 times of amounts 2 times, each 2 hours, merge extractive liquid, filters, and filtrate recycling ethanol is to there not being the alcohol flavor, leave standstill, filter, filtrate is preserved standby; B. get three flavors such as Caulis Lonicerae, Caulis Sargentodoxae, Fructus Toosendan, the decocting that adds 8 times of amounts boils 2 times, and each 2 hours, collecting decoction, relative density was 1.15～1.20 clear paste when filtration filtrate was condensed into 60 ℃, add ethanol and make and contain alcohol amount and reach 60%, cold preservation 12 hours filters, filtrate recycling ethanol is to there not being the alcohol flavor, leave standstill, filter, filtrate is preserved standby; C. the filtrate among a and the b is merged, after further concentrating, 60-80 ℃ of drying under reduced pressure pulverized, and gets fine powder 2.2kg.D. get soybean oil 1.6kg, Cera Flava 0.10kg, 60-70 ℃ of heat fused adds above-mentioned medicated powder, and mixing is made suspension, and 60-70 ℃ of insulation made liquid capsule with the liquid capsule filling machine.
Embodiment 2:
Get Caulis Lonicerae 10kg, Caulis Sargentodoxae 10kg, Radix Glycyrrhizae 1kg, Folium Isatidis 3kg, Herba Taraxaci 3kg, Cortex Moutan 3kg, Radix Paeoniae Rubra 3kg, Fructus Toosendan 3kg, Rhizoma Corydalis (system) 3kg, Radix Et Rhizoma Rhei (system) 2kg; Make according to the following steps again: a. extracting liquorice, Folium Isatidis, Herba Taraxaci, Cortex Moutan, Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Et Rhizoma Rhei seven flavors, with 80% alcohol heating reflux of 10 times of amounts 3 times, each 2 hours, merge extractive liquid, filters, and filtrate recycling ethanol is to there not being the alcohol flavor, leave standstill, filter, filtrate is preserved standby; B. get three flavors such as Caulis Lonicerae, Caulis Sargentodoxae, Fructus Toosendan, the decocting that adds 12 times of amounts boils 3 times, and each 2 hours, collecting decoction, filter filtrate and be condensed into clear paste, add ethanol and make and contain the alcohol amount and reach 80%, cold preservation 24 hours, filtrate recycling ethanol is to there not being the alcohol flavor, leave standstill, filter filtrate for later use; C. the filtrate among a and the b is merged, relative density is that spray drying is made fine powder 2kg behind 1.15～1.20 the extractum when further being concentrated into 60 ℃; D. get Semen Maydis oil 2kg, Cera Flava 0.12kg, 60-70 ℃ of heat fused adds above-mentioned medicated powder, and mixing is made suspension, and 60-70 ℃ of insulation made liquid capsule with the liquid capsule filling machine.
Embodiment 3:
Get Caulis Lonicerae 10kg, Caulis Sargentodoxae 10kg, Radix Glycyrrhizae 1kg, Folium Isatidis 3kg, Herba Taraxaci 3kg Cortex Moutan 3kg, Radix Paeoniae Rubra 3kg, Fructus Toosendan 3kg, Rhizoma Corydalis (system) 3kg, Radix Et Rhizoma Rhei (system) 2kg; Make according to the following steps again:
A. extracting liquorice, Folium Isatidis, Herba Taraxaci, Cortex Moutan, Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Et Rhizoma Rhei seven flavors, with 70% alcohol heating reflux of 8 times of amounts 3 times, each 2 hours, merge extractive liquid, filtered, and filtrate recycling ethanol leaves standstill to there not being the alcohol flavor, filters, and the filtrate preservation is standby; B. get three flavors such as Caulis Lonicerae, Caulis Sargentodoxae, Fructus Toosendan, the decocting that adds 10 times of amounts boils 2 times, and each 2 hours, collecting decoction, filter filtrate and be condensed into clear paste, add ethanol and make and contain the alcohol amount and reach 70%, cold preservation 24 hours, filtrate recycling ethanol is to there not being the alcohol flavor, leave standstill, filter filtrate for later use; C. the filtrate among a and the b is merged, relative density is that spray drying is made fine powder 2.1kg behind 1.15～1.20 the extractum when further being concentrated into 60 ℃; D. get soybean oil 2.3kg, Cera Flava 0.12kg, 60-70 ℃ of heat fused adds above-mentioned medicated powder, and mixing is made suspension, and 60-70 ℃ of insulation made liquid capsule with the liquid capsule filling machine.
Embodiment 4:
Get vegetable oil 3.6kg, Cera Flava 0.30kg, aluminum monostearate 0.04kg, 60-70 ℃ of heat fused adds above-mentioned medicated powder, and mixing is made suspension, and 60-70 ℃ of insulation made liquid capsule with the liquid capsule filling machine.Other are with embodiment 2.
After the present invention finishes technology contents, for proving its curative effect, also carried out pharmacodynamic study, the result shows that the product that obtains by preparation method of the present invention is inhibited to the non-special pelvic inflammatory disease model of rat due to rat specificity pelvic inflammatory disease model due to the escherichia coli and the phenol paste, and is swollen and mice ear class nonspecific inflammation model is inhibited to rat granuloma; Prompting has therapeutical effect definitely to experimental pelvic inflammatory disease model, and has definitely blood circulation promoting and blood stasis dispelling and antiinflammatory action.
1, experiment material
1.1 animal
Rat: the SD kind, female, body weight 220 ± 20 grams; Male, body weight 160 ± 10 grams, SPF level; Mice: the ICR kind, male, body weight 20 ± 2 grams, SPF level.
1.2 medicine and reagent
Liquid capsule extract of the present invention: make by this bright optimal case.FULE CHONGJI: commercially available.Ofloxacin: commercially available, every contains ofloxacin 200mg.Aspirin tablet: commercially available.The phenol rubber cement: liquefied phenol 5ml, tragacanth 1ml, glycerol 4g, adding distil water is to 20ml.
1.3 strain
Escherichia coli clinical separation strain, broth bouillon, eosin methylene blue agar: all meet the pharmacological research standard.
1.4 instrument
BV-100 hemorheology tester.
2, method and result
2.1 influence to the pelvic inflammatory disease model
2.1.1 the inhibitory action of rat pelvic inflammatory disease model due to the coli-infection
Strain preparation: the escherichia coli after the mice of learning from else's experience is gone down to posterity join in the broth bouillon, cultivate 7 hours through 37 ℃ of incubators, get 0.1ml bacterium liquid and join in the 10ml nutrient broth medium, cultivated again 17 hours, with physiological saline solution nephelometer number, be diluted to 107/ml before using, standby.
Get rat with 0.3% pentobarbital sodium intraperitoneal injection of anesthesia, 1ml/Kg, fixedly animal, under aseptic condition, open abdomen, expose the uterus, left side, extract 0.2ml bacterium liquid, with syringe needle mechanical damage endometrial tissue, limit wearing and tearing marginal not is gone into 0.1ml bacterium liquid, injects remaining 0.1ml bacterium liquid then.Abdomen is closed in layering, sterilization art district.Sham operated rats is only opened abdomen, exposes the uterus, left side and is closed the abdomen operation, does not inject bacterium liquid.After the modeling 10 days, the animal except that sham operated rats is divided into model group, positive drug group, the large, medium and small dosage group of liquid capsule extract of the present invention, 10 every group at random.According to dosage difference gastric infusion in the following table, large, medium and small dosage is distinguished 15,7.5,3.75 times of suitable clinical dosage, successive administration 20 days, every day 1 time, the administration volume is 0.5ml/100g, sham operated rats and model group give consubstantiality hydrops, and the positive control drug group gives Ofloxacin, quite 10 times of clinical dosage.After the last administration 24 hours, animal with 0.3% pentobarbital sodium intraperitoneal injection of anesthesia, is cut open the belly, win the bilateral uterus, get endometrium liquid identify inoculation on the culture medium escherichia coli, put cultivate 24 hours in 37 ℃ of incubators after, check to have or not the escherichia coli length of all being born.After internal organs are removed fatty tissue, divide the weight of another name bilateral uterus and ovary with electronic balance.Difference with left and right sides uterus weight is the swelling degree, calculates the swelling rate.After weighing with uterus and ovary 10% formaldehyde fixed, paraffin embedding, conventional section, HE dyeing, light microscopic is observed the morphologic variation of uterus pathology down, according to grade scale, adopts SSPS software to add up the comparable group differences.
2.1.1.1 to colibacillary inhibitory action
Liquid capsule extract of the present invention administration is after 20 days, after model group rat endometrium liquid is inoculated in escherichia coli evaluation culture medium, cultivated 24 hours, still can detect escherichia coli, the recall rate of escherichia coli bacterium colony is 100%, sham operated rats all can't check escherichia coli, with the sham operated rats significant difference.After positive drug group and administration three dosage group rat endometrium liquid were inoculated in escherichia coli evaluation culture medium, through cultivating, the recall rate of escherichia coli bacterium colony was 10-30%, and recall rate obviously descends.Prompting, liquid capsule extract of the present invention is to having certain inhibitory action in the coli-infection of body uterus.See Table 1.
The influence of table 1 pair bacillary pelvic inflammatory disease rat model endometrium escherichia coli recall rate
| Group | Dosage (the g crude drug/Kg) | Clump count (individual) | Recall rate (%) |
| Dosage group small dose group in the heavy dose of group of sham operated rats model control group ofloxacin group | 0.07 18.6 9.3 4.7 | 0 10 0 1 3 4 | 0 100 # 0 * 10 * 30 * 40 * |
Annotate: rank test: compare #P＜0.01 with sham operated rats; Compare * P＜0.05 with model group.
2.1.1.2 influence to uterus swelling rate
The swelling rate of model group rat uterus and the apparent in view increase of Sham-operated control group, significant difference.The swelling rate of positive drug and administration three dosage group rat uterus and model group more all have to some extent and reduce.See Table 2.
Table 2, to the influence of bacillary pelvic inflammatory disease rat model uterus swelling rate
| Group | Dosage (the g crude drug/Kg) | Swelling rate (%) | Suppression ratio (%) |
| Dosage group small dose group in the heavy dose of group of sham operated rats model group ofloxacin group | 0.07 18.6 9.3 4.7 | 4.91±4.21 25.45±14.26 ## 11.79±7.54 * 13.91±8.93 * 14.80±5.95 * 17.15±7.22 * | 52.87 45.32 42.16 33.91 |
Annotate: compare ##P＜0.01 with sham operated rats; Compare * P＜0.05 with model group.
2.1.1.3 influence to the uterus pathomorphology
The perusal result shows, sham operated rats rat uterus color, hardness are normal, and swelling, hyperemia are seen in the cervix uteri end, the ovary no abnormality seen.Model control group rat part uterus darker in color is red, the obvious swelling of cervix uteri, hyperemia, and uterus weight increases, the slight adhesion in individual animal abdominal cavity, ovary shows no obvious abnormalities.The large, medium and small dosage rat uterus of positive drug and administration swollen neck expands, and hyperemia all has in various degree and alleviates, and ovary shows no obvious abnormalities.
Observed result shows under the mirror, and sham operated rats rat left and right side uterine epithelium is not seen hypertrophy, thickened, and body of gland is not seen pathological changes, and inner membrance does not see and thicken that ovary is not seen obvious pathological changes.Model control group: the coli-infection modeling of uterus, left side, the obvious hypertrophy of endometrium glandular epithelium, thicken, epithelium level showed increased, karyokinesis is mutually more sees that epithelial cell has degeneration necrosis, is flat, it is more to go up subcutaneous outgrowth lymphocyte.Neutral leaflet nuclear fills the air under most of endometrium, and what have reaches myometrium; Right side concurrent control endometrial epithelium hypertrophy, thicken, go up subcutaneous neutral leaflet nuclear and see more.Bilateral ovaries and endometrial gland are not seen obvious pathological changes.
Positive drug control group: the most of inner membrance glandular epithelium in uterus, left side is not seen obvious hypertrophy, thicken and inflammatory cell infiltration, and slight neutral leaflet nuclear is arranged under the individual animal endometrium; Concurrent control most of endometrium glandular epithelium in right side is not seen obvious hypertrophy, is thickened and inflammatory cell infiltration, slight neutral leaflet nuclear is arranged, substantially with the uterus, left side under indivedual endometrium.
Administration group (large, medium and small dosage): heavy dose of group left side endometrial epithelium hypertrophy, thicken and inner membrance under inflammatory cell infiltration alleviate more, in, the small dose group endometrial epithelium has hypertrophy, thickens, and still has inflammatory cell (volume) to soak under the inner membrance; The same substantially left side of right side concurrent control.Each group (positive drug, large, medium and small dosage) ovary of all administrations shows no obvious abnormalities.
According to grade scale, adopt SSPS software, statistical result showed to pelvic inflammatory disease rat model left and right sides uterus lesion degree, the rat uterus lesion degree and the sham operated rats of model group relatively have significant difference, and large, medium and small three dosage group rat uterus lesion degrees of positive drug and liquid capsule extract of the present invention and model group relatively have significant difference.See Table 3,4.
Table 3, to the influence (n=10) of uterus, bacillary pelvic inflammatory disease rat model left side lesion degree
| Group | Dosage (the g crude drug/Kg) | Uterus, left side lesion degree | ||||
| - | + | ++ | +++ | ++++ | ||
| The sham operated rats model control group #Ofloxacin group **Heavy dose of group **Middle dosage group *Small dose group | 0.07 18.6 9.3 4.7 | 10 0 0 0 0 0 | 0 0 5 5 3 3 | 0 4 5 4 7 4 | 0 4 0 1 1 3 | 0 2 0 0 0 0 |
Annotate: rank test: compare #P＜0.01 with sham operated rats; Compare * P＜0.05 with model group.Grade scale:
-: the uterus structure is normal, and mucosa not water breakthrough is swollen, does not see inflammation.
+: the rat uterus mucosa is not seen obvious hypertrophy, does not see obvious inflammatory infiltration under the mucosa.
++: the slight hypertrophy of rat uterus mucosa, mild inflammation soaks under the mucosa.
The obvious hypertrophy of the most of uterine mucosa of +++: has neutral leaflet nuclear to soak under the mucosa.
++ ++: the obvious hypertrophy of most of uterine mucosa epithelium, degeneration necrosis has a large amount of inflammatory infiltrations under the mucosa, see with neutral leaflet nuclear more.
Table 4, to the influence (n=10) of uterus, bacillary pelvic inflammatory disease rat model right side lesion degree
| Group | Dosage (the g crude drug/Kg) | Uterus, right side lesion degree | |||
| - | + | ++ | +++ | ||
| The sham operated rats model control group ##Ofloxacin group *Heavy dose of group *Middle dosage group *Small dose group * | 0.07 18.6 9.3 4.7 | 10 0 0 0 0 0 | 0 1 6 7 5 3 | 0 5 4 3 5 8 | 0 4 0 0 0 0 |
Annotate: rank test: compare ##P＜0.01 with sham operated rats; Compare * P＜0.05 with model group.
Grade scale:
-: normal structure structure, mucosa are not seen edema, and not seeing has cell infiltration.
+: uterine mucosa is not seen obvious hypertrophy, does not see obvious cell infiltration under the mucosa.
++: the slight hypertrophy of uterine mucosa, slight cell infiltration under the mucosa.
The obvious hypertrophy of the most of uterine mucosa of +++: has neutral leaflet nuclear to soak under the mucosa.
2.1.2 inhibitory action to non-specific rat pelvic inflammatory disease model
[2]
Get rat and be divided into the heavy dose of group of normal control group, model control group, positive drug control group and administration, middle dosage group, small dose group, 10 every group at random according to body weight.Except that the normal control group, all the other animals enter the vagina deep and inject 25% phenol rubber cement with special elongated shape irrigation stomach device, every 1.5ml, 3 days 1 time, totally 3 times.Large, medium and small dosage was distinguished 15,7.5,3.75 times of suitable clinical dosage, successive administration 12 days according to dosage difference gastric infusion in the table 5 in the 3rd day after the modeling.With the positive contrast medicine of FULE CHONGJI, quite 20 times of clinical dosage.Every day 1 time, the administration volume is 0.6ml/100g.After time administration 1 hour, sodium pentobarbital anesthetized animal with 3%, abdominal aortic blood, measure hemorheology index, dissect and take out uterus and ovary observation and record finding of naked eye, the vagina of drawing materials is organized to uterus subangle place, put in 10% the formalin fixing, the back circulating water of drawing materials washes, the gradient ethanol dehydration, and dimethylbenzene is transparent, to organize after 3 days and vertically cut from center line, the waxdip embedding, section, HE dyeing, the optical resin mounting, light microscopic is observed the vagina of each treated animal down to uterine cancer cell morphological change and mucosa, the morphologic inflammation of matter changes degree between under the mucosa, adds up the comparable group differences according to grade scale.
2.1.2.1 to hemorheological influence
With the normal control group relatively, the model group rat shear rate be 94.5 and 0.945 o'clock whole blood viscosity all normally control rats obvious rising is arranged, but packed cell volume and plasma viscosity are not had obvious influence.Positive drug and the big or middle dosage group of liquid capsule extract of the present invention rat shear rate be 94.5 and 0.945 o'clock whole blood viscosity all have to some extent and reduce than the model control group rat, effect and model group that small dose group lowers whole blood viscosity are more not remarkable.Prompting, liquid capsule extract of the present invention shows certain function of promoting blood circulation to disperse blood clots on non-specific pelvic inflammatory disease model.See Table 5.
Influence (X ± the S of table 5 pair pelvic inflammatory disease rat model hemorheology index; N=10)
| Group | Dosage (the g crude drug/Kg) | Whole blood viscosity (mpa.s) | Packed cell volume (%) | Blood plasma viscosity (mpa.s) | |
| 94.5 -1 | 0.945 -1 | ||||
| Blank model contrast FULE CHONGJI | - - 4g | 4.22±0.56 5.13±0.54 ## 4.69±0.36 * | 8.89±1.45 12.57±1.58 ## 11.32±1.32 * | 37.52±1.16 37.30±1.42 36.60±1.84 | 1.07±0.03 1.12±0.05 1.07±0.19 |
| Dosage group small dose group in the heavy dose of group of group | 18.6 9.3 4.7 | 4.55±0.47 * 4.62±0.24 * 4.83±0.38 | 11.12±1.52 * 11.44±1.15 * 12.02±1.77 | 38.50±1.84 38.00±2.26 38.30±2.11 | 1.08±0.27 1.03±0.27 1.15±0.23 |
Annotate: T check between group: compare with the normal control group: ##P＜0.01; Compare with model control group: * P＜0.05; * P＜0.01.
2.1.2.2 influence to general form
To the observation of rat vagina collar extension as seen, as seen the vagina collar extension that played most animals after the modeling on the 3rd day has dense condensed secretions, and the activity of animal reduces.The secretions of each administration treated animal vagina collar extension after 5 days, has been compared minimizing to some extent in administration with model group.
Dissect the back perusal as seen, the normal control group: cut off peritoneum, intraperitoneal is not seen redness, and surrounding tissue is not seen significant change.The uterus color, hardness is normal, does not see hyperemia, congestion, the ovary no abnormality seen.Model group: part uterus darker in color is red, the obvious swelling of cervix uteri, hyperemia, and the slight adhesion in individual animal abdominal cavity, ovary shows no obvious abnormalities.The administration group: positive drug group, heavy dose of group, middle dosage group, small dose group are compared with model group, adhesion degree around animal abdominal cavity and metremia, swelling, intracavity exudate and tissue and the abdominal cavity all has alleviating in various degree than model group, and wherein the heavy dose of group of administration obviously alleviates.
2.1.2.3 to the morphologic influence of pathological tissue
As seen mirror is observed down:
The normal control group: endometrium does not see obviously and thickens that the intimal surface epithelium is normal or slight hypertrophy is arranged, and body of gland is not seen pathological changes, does not see obvious lymphocytic infiltration, and ovary is not seen obvious pathological changes.
Model control group: the obvious hypertrophy of endometrium, thicken, the intimal surface epithelial proliferation, karyokinesis is mutually more to be seen, between epithelial cell, the time see apoptotic body and visible more fragment.Between in the matter visible in to the severe cell infiltration, go up subcutaneous being dispersed in or kitchen range shape lymphocyte, neutrophil infiltration.Sometimes see that cell infiltration is in around the inner membrance body of gland or in the lumen of gland.Bilateral ovaries is not seen obvious pathological changes.
Positive drug control group: endometrium adenomatosis and inflammatory cell infiltration degree alleviate to some extent than model control group.Ovary is not seen obvious pathological changes.
The heavy dose of group of liquid capsule of the present invention: endometrial hyperplasia, thicken, the superficial epithelium hyperplasia degree alleviates to some extent than model control group, goes up the subcutaneous slight lymphocytic infiltration that has, and a few sample does not have obvious cell infiltration.
Dosage group in the liquid capsule of the present invention: endometrial epithelium has slight hypertrophy, goes up the subcutaneous slight lymphocytic infiltration that has, and a few sample does not have obvious cell infiltration.
Liquid capsule small dose group of the present invention: endometrial epithelial cell has hypertrophy, thickens, and goes up the subcutaneous slight lymphocytic infiltration that has, and indivedual intimal epitheliums are obvious apoptosis and fragment.
According to grade scale, use SSPS software, the result that the lesion degree of uterus mucosal tissue is added up shows that model group rat uterus mucosa presents obvious pathological changes, and is remarkable with normal control group comparing difference.The lesion degree of each administration group and model group more all have to some extent and alleviate, big or middle dosage group of liquid capsule wherein of the present invention and model group comparing difference, alleviate though the lesion degree of small dose group has to a certain extent, compare there was no significant difference with model group.See Table 6.
The table 6 pair influence (n=10) that non-specific pelvic inflammatory disease rat model pathological tissue changes
| Group | Dosage (the g crude drug/Kg) | The uterine mucosa lesion degree | ||||
| - | + | ++ | +++ | ++++ | ||
| The contrast of normal control model ##FULE CHONGJI **Heavy dose of **Middle dosage **Low dose of | 4g 18.6 9.3 4.7 | 6 0 1 1 1 0 | 4 0 5 6 6 3 | 0 8 4 3 3 7 | 0 0 0 0 0 0 | 0 2 0 0 0 0 |
Annotate: rank test: compare ##P＜0.01 with the normal control group; Compare * * P＜0.01 with model group.
Grade scale: "-": rat pelvic cavity structure is normal; "+": rat pelvic cavity, uterus, ovary, vagina serosal surface are not seen obvious inflammation; " ++ ": rat pelvic cavity, uterus, ovary, vagina serosal surface mild hyperaemia, congestion, the epithelial cell face has inflammation, vagina epithelium hypertrophy, hyperkeratosis; " +++": rat pelvic cavity, uterus, ovary, the obvious congestion of vagina upper end epithelium serosal surface, swelling, inflammatory infiltration is obvious, vagina epithelium hyperkeratosis, the obvious hypertrophy of epithelium.
2.2 influence to the nonspecific inflammation model
2.2.1 to the bullate influence of rat granuloma
[3]
Get 50 of the male rats of body weight 150-170 gram, under ether light anaesthesia condition, make abdominal incision, it is subcutaneous that the cotton balls of constant weight (30mg), sterilization has been implanted rat both sides groin, postoperative is divided into 5 groups at random, every group 10, operation this product on the same day with 18.6,9.3,4.7g/Kg dosage begins gastric infusion, administration volume 0.5ml/100g, successive administration 7 days is with the positive contrast medicine of aspirin.24 hours execution animals after time administration do not peel off and take out granulation tissue, weigh after 1 hour in 60-90 ℃ of baking oven inner drying, deduct the raw cotton ball weight, are the granuloma net weight.Relatively weight between the granuloma group is calculated suppression ratio.See Table 7.
The influence of the swollen dry weight of table 7 pair rat granuloma (X ± SD)
| Group | Dosage (the g crude drug/Kg) | Granulation dry weight (mg) | Suppression ratio (%) |
| Dosage group small dose group in the heavy dose of group of model group aspirin group | 0.10 18.6 9.3 4.7 | 117.81±12.22 80.45±8.02 ** 97.12±9.32 * 97.15±9.52 * 99.88±12.37 | 46 21 21 18 |
Annotate: T check between group: compare with model control group: * P＜0.05; * P＜0.01.
2.2.2 xylol causes the influence of mice ear
[3]
Getting body weight is 25-30 gram male mice, be divided into 5 groups at random, every group 10, with liquid capsule extract 22.0 of the present invention, 11.0,5.5g/Kg gastric infusion is 3 days continuously, the dosage of positive drug aspirin is 0.1g/Kg, after the last administration 1 hour, dimethylbenzene 0.1ml is dripped two sides, front and back in mouse right ear with sample injector, left ear is contrast, 0.5 put to death mice after hour, cut two ears along the auricle baseline, lay round auricle at same position respectively, organize balance to weigh with the card punch of 8mm diameter, deduct left auricle with the auris dextra of every Mus and heavily be the swelling degree, calculate average and the standard deviation of respectively organizing the swelling degree, calculate its suppression ratio, the comparable group differences.
The result shows that this product 22.0,11.0,5.5g/Kg dosage all can suppress the ear swelling of mice caused by dimethylbenzene xylene, and prompting this product has inhibitory action definitely to the non-specific acute inflammation model of mice.See Table 8.
Table 8, to the influence (X ± S of mice ear; N=10)
| Group | Dosage (the g crude drug/kg) | Swelling degree (mg) | Suppression ratio % |
| Dosage group small dose group in the heavy dose of group of model group aspirin group | 0.1 22.0 11.0 5.5 | 20.10±4.78 11.31±3.28 ** 13.43±2.44 ** 14.14±3.02 ** 15.99±5.48 * | 77.70 49.66 42.15 25.70 |
Annotate: T check between group: compare with model control group: * P＜0.05; * P＜0.01.
3, conclusion
3.1 the result of the test of two kinds of pelvic inflammatory disease models shows, the medicine that makes by technical solution of the present invention can suppress due to the escherichia coli the non-special pelvic inflammatory disease model of rat due to the rat specificity pelvic inflammatory disease model and phenol paste, the cell infiltration and the pathologic thereof that suppress rat vagina and Uterine mucosa tissue change, and reduce its blood viscosity.Point out its therapeutical effect preferably that has to pelvic inflammatory disease model due to antibacterial and the non-bacterial infection.
3.2 the result of the test of two kinds of nonspecific inflammation models shows, the medicine that makes by technical solution of the present invention can suppress dimethylbenzene induced mice ear swelling and rat granuloma is swollen.Point out its inhibitory action to meet or exceed the product that former process conditions make to the nonspecific inflammation model.Invention preparation method possesses advance.
Claims (6)
1, a kind of herb liquid body capsule for the treatment of gynaecopathia is characterized in that: be made up of Chinese medical concrete powder and suspending agent, vegetable oil, its weight ratio is 1: 0.04-0.08: 0.70-1.20; Described Chinese medical concrete powder is made by Caulis Lonicerae, Caulis Sargentodoxae, Radix Glycyrrhizae, Folium Isatidis, Herba Taraxaci, Cortex Moutan, Radix Paeoniae Rubra, Fructus Toosendan, Rhizoma Corydalis (system), Radix Et Rhizoma Rhei (system), and the weight ratio of each ingredient is: Caulis Lonicerae: Caulis Sargentodoxae: Radix Glycyrrhizae: Folium Isatidis: Herba Taraxaci: Cortex Moutan: Radix Paeoniae Rubra: Fructus Toosendan: Rhizoma Corydalis: Radix Et Rhizoma Rhei=10: 10: 1: 3: 3: 3: 3: 3: 3: 2.
2, the herb liquid body capsule of treatment gynaecopathia according to claim 1 is characterized in that: described suspending agent can be one or more the mixture in Cera Flava, lecithin, aluminum monostearate, the ethyl cellulose.
3, the herb liquid body capsule of treatment gynaecopathia according to claim 1 and 2 is characterized in that: described vegetable oil can be one or more the mixture in soybean oil, Oleum sesami, Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris and other edible plants oil.
4, the herb liquid body capsule of treatment gynaecopathia according to claim 1 and 2 is characterized in that: described suspending agent is a Cera Flava, and described vegetable oil is a soybean oil.
5, the herb liquid body capsule of treatment gynaecopathia according to claim 1 and 2 is characterized in that: the optimum weight ratio of Chinese medical concrete powder and Cera Flava, soybean oil is 1: 0.06: 1.1.
6, the herb liquid body capsule of treatment gynaecopathia according to claim 1 and 2, it is characterized in that: its preparation method is: a. extracting liquorice, Folium Isatidis, Herba Taraxaci, Cortex Moutan, Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Et Rhizoma Rhei seven flavors, with 60～80% alcohol heating reflux of 6～10 times of amounts 2～3 times, each 1～2 hour, merge extractive liquid, filtered, filtrate recycling ethanol, leave standstill, filter, filtrate is preserved standby;
B. get three flavors such as Caulis Lonicerae, Caulis Sargentodoxae, Fructus Toosendan, the decocting that adds 8～12 times of amounts boils 2～3 times, and each 1～2 hour, collecting decoction, filter filtrate and be condensed into clear paste, add ethanol and make and contain the alcohol amount and reach 60～80%, cold preservation 12～24 hours, filtrate recycling ethanol, leave standstill, filter filtrate for later use;
C. the filtrate among a and the b is merged, after further concentrating, drying is made fine powder;
D. get suspending agent, vegetable oil, 60-70 ℃ of heat fused adds above-mentioned medicated powder, and mixing is made suspension, and 60-70 ℃ of insulation made liquid capsule with the liquid capsule filling machine.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101164576B (en) * | 2006-10-17 | 2010-05-19 | 臧育增 | Traditional Chinese medicine for treating woman pelvic inflammation and adnexa disease and its preparing technology |
| CN105796667A (en) * | 2016-03-24 | 2016-07-27 | 陕西东泰制药有限公司 | Traditional Chinese medicine composition with effects of removing heat to cool blood and relieving swelling and pain and preparation method thereof |
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| CN100375617C (en) * | 2003-07-22 | 2008-03-19 | 范敏华 | Liquid capsule and production method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101164576B (en) * | 2006-10-17 | 2010-05-19 | 臧育增 | Traditional Chinese medicine for treating woman pelvic inflammation and adnexa disease and its preparing technology |
| CN105796667A (en) * | 2016-03-24 | 2016-07-27 | 陕西东泰制药有限公司 | Traditional Chinese medicine composition with effects of removing heat to cool blood and relieving swelling and pain and preparation method thereof |
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