CN104707040B - Cypress gruel disappears vaginal plug and preparation method thereof - Google Patents
Cypress gruel disappears vaginal plug and preparation method thereof Download PDFInfo
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- CN104707040B CN104707040B CN201510083558.5A CN201510083558A CN104707040B CN 104707040 B CN104707040 B CN 104707040B CN 201510083558 A CN201510083558 A CN 201510083558A CN 104707040 B CN104707040 B CN 104707040B
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Abstract
The invention belongs to pharmaceutical technology field, it is related to a kind of cypress gruel and disappears vaginal plug and preparation method thereof, further relates to cypress gruel and disappear application of the vaginal plug in gynaecologic vaginal inflammation is treated.The parts by weight of various bulk drugs are in suppository of the present invention：The 900g of pericarpium zanthoxyli 30, the 1000g of dittany bark 600, the 1000g of the root bark of Chinese wolf-berry 400, the 1000g of frutus cnidii 400, the 1100g of smilax 100, the 1000g of kuh-seng 200, the 1000g of folium artemisiae argyi 100, the 1400g of Patrinia scaniosaefolia 300, the 1000g of golden cypress 50.Preparation technology of the present invention is simple, curative for effect, for clearing heat and detoxicating, eliminating dampness, desinsection itching-relieving efficacies, cure mainly the trichomonas profuse leukorrhea caused by damp invasion of lower energizer, pruritus vulvue, scorching hot pain etc., mycotic, bacillary, nonspecific vaginitis and sees above symptom.
Description
Technical field:
The invention belongs to pharmaceutical technology field, it is related to a kind of cypress gruel and disappears vaginal plug and preparation method thereof, further relate to cypress gruel and disappear
Application of the vaginal plug in gynaecologic vaginal inflammation is treated.
Background technology：
Gynaecologic vaginal inflammation is a kind of more typical gynecological disease, is that the WomanHealth incidence of disease is endangered in obstetrical and gynecological disease most
High disease, especially rural women's incidence of disease is higher, strong influence women labour productive forces.Gynaecologic vaginal inflammation means female
Connective tissue etc. generation chronic inflammation person is referred to as by sexual reproduction device and its palace, clinically with hypogastralgia, leucorrhea increasing, menstruation
Imbalance, infertile, low miserable, external cause itch of waist etc. are principal character, be seriously endanger WomanHealth common disease, frequently-occurring disease and
Recurrent exerbation, it is touching refractory.Staphylococcus, hemolytic streptococcus and Escherichia coli are the Main Pathogenic Bacterias of pelvic infecton, its disease
Substance is mostly gonococcus, tubercle bacillus.Other some parasites such as filaria, blood fluke or mumps virus can also trigger pelvic cavity to give birth to
Grow organ illness.By sexual life, wound, Post operation mainly is carried out to vulva, pelvic cavity reproductive organs for the cause of disease of gynaecologic vaginal inflammation
Infection-induced.Treatment for gynaecologic vaginal inflammation, doctor trained in Western medicine use antibiotic, and anti-inflammatory effects are bad and easy recurrence, according to woman
The pathogenesis of section's episioitis and the performance of Chinese medicine understand that treatment by Chinese herbs gynaecology episioitis can reach curative for effect, and
It can reach the purpose effected a permanent cure.There is the preparation of many treatment gynaecology episioitis in the prior art, but most bioavilabilities are low, treat
Imitate imprecise.
Although clinically there is many medicines to be used to treat vaginitis, curative effect is undesirable.Many patients are highly desirable
There can be the good external used medicine of a kind of easy to use and effect, for various types of vaginitis, and can reach and treat both principal and secondary aspect of disease, within
Outside supporting, and have no toxic side effect, control the preparation of difficulty in relapse after healing.
The content of the invention：
Technical problem solved by the invention be to provide it is a kind of it is curative for effect be used for clearing heat and detoxicating, eliminating dampness, desinsection are antipruritic
Effect, cure mainly trichomonas profuse leukorrhea, pruritus vulvue, scorching hot pain etc. caused by damp invasion of lower energizer, mycotic, bacillary, non-spy
Different in nature vaginitis and see that the pure Chinese medicinal preparation cypress gruel of above symptom disappears vaginal plug and preparation method thereof.
The present invention is achieved through the following technical solutions：
The parts by weight of various bulk drugs are in suppository of the present invention：
Pericarpium zanthoxyli 30-900g dittany bark 600-1000g root barks of Chinese wolf-berry 400-1000g
Frutus cnidii 400-1000g smilax 100-1100g kuh-sengs 200-1000g
Folium artemisiae argyi 100-1000g Patrinia scaniosaefolia 300-1400g golden cypresses 50-1000g.
The parts by weight of described various bulk drugs can be：
Pericarpium zanthoxyli 200-900g dittany bark 600-1000g root barks of Chinese wolf-berry 600-1000g
Frutus cnidii 600-1000g smilax 300-1100g kuh-sengs 400-1000g
Folium artemisiae argyi 300-1000g Patrinia scaniosaefolia 500-1400g golden cypresses 200-1000g.
The parts by weight of described various raw materials can also be：
Pericarpium zanthoxyli 500-800g dittany bark 600-800g root barks of Chinese wolf-berry 600-800g
Frutus cnidii 600-800g smilax 500-800g kuh-sengs 400-800g
Folium artemisiae argyi 500-800g Patrinia scaniosaefolia 800-1200g golden cypresses 400-800g.
More preferably, the parts by weight of described various raw materials are：
Pericarpium zanthoxyli 600-800g dittany bark 600-800g root barks of Chinese wolf-berry 600-800g
Frutus cnidii 600-800g smilax 600-800g kuh-sengs 600-800g
Folium artemisiae argyi 600-800g Patrinia scaniosaefolia 800-1200g golden cypresses 600-800g.
Present invention also offers the preparation method of the suppository：
The taste medicinal material of this product nine is taken, is added water to cook three times, for the first time plus 8-12 times is measured water, decocts 1.5-2 hours, second and third
It is secondary respectively plus 8-10 times is measured water, each to decoct 1-2 hours, collecting decoction, filtration, filtrate is concentrated into relative density as 1.05~1.10
The clear cream of (60 DEG C), add ethanol alcohol content is reached 55-70%, stir evenly, stand 12 hours, take supernatant, filter, filtrate recovery second
Alcohol is simultaneously concentrated into the thick paste that relative density is 1.05~1.25 (60 DEG C), dry, pulverize into fine powder, standby；By water-soluble base
In right amount, mix, be heated to melting, after matrix melting, treat that temperature is down to 55 DEG C, add stock of drugs powder, it is stirring while adding, directly
It is extremely well mixed, it is standby；Above-mentioned fusing drug containing matrix is poured into bolt mould, liquid level slightly overflows die orifice plane 2-3mm, treats that nature is cold
But to solidifying, scabble, open bolt mould, be made 1000, produce.Described matrix is glycerin gelatine, polyethylene glycols, polyoxy second
The stearate of alkene 40, water soluble chitosan, tween 261, the preferably one or more in poloxamer, glycerin gelatine, poly- second
Glycols, the one or more combination in Myrj 52, when matrix is glycerin gelatine, polyethylene glycols, polyoxy
During the combination of the stearate three of ethene 40, its ratio is (1-9)：(2-5)：(1-9).The ratio of drug powder and matrix is 1：
1-1：5, preferably 1：2-1：3.
Preparation technology of the present invention is simple, curative for effect, for clearing heat and detoxicating, eliminating dampness, desinsection itching-relieving efficacies, cure mainly it is damp and hot under
Profuse leukorrhea caused by note, pruritus vulvue, scorching hot pain etc. is trichomonas, mycotic, bacillary, nonspecific vaginitis and see with
Upper symptom.Effect with preferable treatment gynaecologic vaginal inflammation.
Embodiment:
Embodiment 1:
Pericarpium zanthoxyli 900g dittany bark 600g root barks of Chinese wolf-berry 1000g
Frutus cnidii 400g smilax 1100g kuh-sengs 200g
Folium artemisiae argyi 1000g Patrinia scaniosaefolia 300g golden cypresses 1000g.
The taste medicinal material of recipe quantity nine is taken, is added water to cook three times, for the first time plus 12 times are measured water, are decocted 1.5 hours, second and third time
Respectively plus 10 times of amount water, each to decoct 1 hour, collecting decoction, filtration, filtrate are concentrated into relative density as the clear of 1.05 (60 DEG C)
Cream, ethanol is added alcohol content stirred evenly up to 55%, stood 12 hours, take supernatant, filter, filtrate recycling ethanol is simultaneously concentrated into phase
To the thick paste that density is 1.1 (60 DEG C), fine powder is dry, pulverize into, it is standby；By water-soluble base glycerin gelatine, polyethylene glycols,
Appropriate Myrj 52 (ratio 1：2：5), mix, be heated to melting, after matrix melting, treat that temperature is down to 55
DEG C, stock of drugs powder is added, it is stirring while adding, until it is well mixed, it is standby；The ratio of drug powder and matrix is 1：2, will
Above-mentioned fusing drug containing matrix is poured into bolt mould, and liquid level slightly overflows die orifice plane 2-3mm, after naturally cool to solidification, scabbles, and is opened
Bolt mould, 1000 are made, is produced.
Embodiment 2:
Pericarpium zanthoxyli 200g dittany bark 1000g root barks of Chinese wolf-berry 600g
Frutus cnidii 600g smilax 300g kuh-sengs 400g
Folium artemisiae argyi 300g Patrinia scaniosaefolia 500g golden cypresses 200g.
The taste medicinal material of recipe quantity nine is taken, is added water to cook three times, for the first time plus 10 times are measured water, are decocted 1.5 hours, second and third time
Respectively plus 8 times of amount water, each to decoct 1 hour, collecting decoction, filtration, filtrate are concentrated into the clear cream that relative density is 1.05 (60 DEG C),
Ethanol is added alcohol content stirred evenly up to 70%, stood 12 hours, take supernatant, filter, filtrate recycling ethanol is simultaneously concentrated into relatively close
Spend for the thick paste of 1.2 (60 DEG C), dry, pulverize into fine powder, it is standby；By water-soluble base polyethylene glycols, polyoxyethylene, tween
261, appropriate poloxamer (1：1：1：1), mix, be heated to melting, after matrix melting, treat that temperature is down to 55 DEG C, add standby
Drug powder, it is stirring while adding, until it is well mixed, it is standby；The ratio of drug powder and matrix is 1：3, above-mentioned fusing is contained
Medicine matrix is poured into bolt mould, and liquid level slightly overflows die orifice plane 2-3mm, after naturally cool to solidification, scabbles, and is opened bolt mould, is made
1000, produce.
Embodiment 3：
Pericarpium zanthoxyli 800g dittany bark 600g root barks of Chinese wolf-berry 600g
Frutus cnidii 600g smilax 500g kuh-sengs 400g
Folium artemisiae argyi 500g Patrinia scaniosaefolia 800g golden cypresses 400g.
The taste medicinal material of recipe quantity nine is taken, is added water to cook three times, for the first time plus 12 times are measured water, are decocted 1.5 hours, second and third time
Respectively plus 10 times of amount water, each to decoct 1 hour, collecting decoction, filtration, filtrate are concentrated into relative density as the clear of 1.05 (60 DEG C)
Cream, ethanol is added alcohol content stirred evenly up to 70%, stood 12 hours, take supernatant, filter, filtrate recycling ethanol is simultaneously concentrated into phase
To the thick paste that density is 1.2 (60 DEG C), fine powder is dry, pulverize into, it is standby；By water-soluble base polyethylene glycols, polyoxyethylene,
Tween 261, appropriate poloxamer (1：2：1：1), mix, be heated to melting, after matrix melting, treat that temperature is down to 55 DEG C, add
Stock of drugs powder, it is stirring while adding, until it is well mixed, it is standby；The ratio of drug powder and matrix is 1：1, will be above-mentioned molten
To change drug containing matrix to be poured into bolt mould, liquid level slightly overflows die orifice plane 2-3mm, after naturally cool to solidification, scabbles, and opens bolt mould,
1000 are made, is produced.
Embodiment 4：
Pericarpium zanthoxyli 800g dittany bark 800g root barks of Chinese wolf-berry 800g
Frutus cnidii 800g smilax 800g kuh-sengs 800g
Folium artemisiae argyi 800g Patrinia scaniosaefolia 1200g golden cypresses 800g.
The taste medicinal material of recipe quantity nine is taken, is added water to cook three times, for the first time plus 12 times are measured water, are decocted 1.5 hours, second and third time
Respectively plus 10 times of amount water, each to decoct 1 hour, collecting decoction, filtration, filtrate are concentrated into relative density as the clear of 1.05 (60 DEG C)
Cream, ethanol is added alcohol content stirred evenly up to 55%, stood 12 hours, take supernatant, filter, filtrate recycling ethanol is simultaneously concentrated into phase
To the thick paste that density is 1.1 (60 DEG C), fine powder is dry, pulverize into, it is standby；By water-soluble base, mix, be heated to melting, base
After matter melting, treat that temperature is down to 55 DEG C, add stock of drugs powder, it is stirring while adding, until it is well mixed, it is standby；Medicine powder
The ratio of end and matrix is 1：2, above-mentioned fusing drug containing matrix is poured into bolt mould, liquid level slightly overflows die orifice plane 2-3mm, treats certainly
Solidification so is cooled to, is scabbled, bolt mould is opened, is made 1000, produces.Described water-soluble base is glycerin gelatine, poly- second two
Alcohols, Myrj 52, water soluble chitosan, tween 261, the one or more in poloxamer；Adopted in this example
With glycerin gelatine, polyethylene glycols, appropriate Myrj 52 (ratio 1：2：5).
Embodiment 5:
Cypress gruel disappears the pharmacodynamics test of vaginal plug
So that cypress gruel prepared by embodiment 4 disappears pessary as an example：
1. extracorporeal bacteria inhibitor test
The preparation of 1.1 bacterium solutions
Take Escherichia coli, staphylococcus aureus, the MH (A) of 4 test strains of Candida albicans and pseudomonas aeruginosa
Single bacterium colony on culture medium one, it is inoculated with l0ml broth bouillons after 37 DEG C of culture 16h, is diluted to sterile PBS respectively
Concentration is 1.5 × 108Individual/ml (Maxwell opacity tube colorimetric), it is standby after 1000 times of dilutions.The survey of 1.2 minimal inhibitory concentrations (MIC)
It is fixed
Test tube doubling dilution, 11 10ml sterilizing test tubes are taken, number consecutively, every test tube adds 2ml culture mediums, with nothing
Bacterium maneuver adds tested decoction (cypress gruel disappear vaginal plug 3.808g crude drugs/ml) 2ml in the 1st pipe, mixes, and draws 2ml and adds
In 2nd pipe, mix, be diluted to the 9th pipe successively, 2ml is discarded from the 9th pipe.11st pipe adds tested decoction 2ml and mixed, and discards
2ml.1st~10 pipe adds standby bacterium solution 0.1ml, and the 11st pipe is not added with bacterium solution and makees positive control as blank control, the 10th pipe.
As stated above, three groups of 11 10ml sterilizing test tubes are separately taken respectively, for determining middle-jiao yang, function of the spleen and stomach comparison medicine, western positive comparison medicine
And the minimal inhibitory concentration of physiological saline.Number consecutively, every test tube adds 2ml culture mediums, with aseptic manipulation at first group
Middle-jiao yang, function of the spleen and stomach comparison medicine (Baicao Fuyanqing bolt, 670mg/ml) is added in 1st pipe, western positive comparison medicine (polybenzobisoxazole is added in second group of the 1st pipe
Safe bolt, 1g/ml), physiological saline 2ml is added in the 3rd group of the 1st pipe, is mixed, 2ml is drawn from the pipe of each group the 1st respectively adds to phase
In the corresponding pipe of each group the 2nd, mix, be diluted to the 9th pipe successively, 2ml is discarded from the 9th pipe.In being added in first group of the 11st pipe
Positive comparison medicine 2ml, western positive comparison medicine 2ml is added in second group of the 11st pipe, physiological saline 2ml is added in the 3rd group of the 11st pipe, mixes
It is even, discard 2ml.The pipe of each group the 1st~10 adds standby bacterium solution 0.10ml, and the 11st pipe is not added with bacterium solution as blank control, the 10th pipe
Make positive control.
After adding bacterium solution, 37 DEG C of culture 24h, the change of bacterium solution in each test tube is observed, determines minimum inhibitory concentration (MIC).
If clarification is presented in culture tube, is still clarified after shaking, then show that decoction has bacteriostasis；If presented after culture tube shaking mixed
It is turbid, bacteria growing is indicated that, decoction is without bacteriostasis.The minimum liquor strength of test tube clarification is recorded, the concentration is minimum suppression
Bacteria concentration experimental result is shown in Table 1.
The cypress gruel of table 1 disappears MIC measurement result of the vaginal plug to each strain
Note："+", which represents to observe, to be grown, and "-" represents not observe growth.
From table 1, in doubling dilution experiment, the cypress gruel vaginal plug that disappears is 5 to Escherichia coli minimal inhibitory concentration pipe
Number pipe, i.e., 1~No. 5 pipe are clarification, and 6~No. 11 pipes are muddiness, and liquid level attachment White Flocculus, i.e. cypress gruel disappears vaginal plug most
Small Mlc (MIC) is 119mg crude drugs/ml；The minimal inhibitory concentration pipe of middle-jiao yang, function of the spleen and stomach comparison medicine is No. 4 pipes, i.e. Baicao Fuyanqing
Bolt minimal inhibitory concentration (MIC) is 41.88mg/ml；The minimal inhibitory concentration pipe of western positive comparison medicine is No. 8 pipes, i.e. metronidazole,clotrimazole and chlorhexidine acetate suppositories
Minimal inhibitory concentration (MIC) is 7.81mg/ml；Physiological saline group is positive state.
Cypress gruel disappears vaginal plug to pseudomonas aeruginosa, the minimal inhibitory concentration of staphylococcus aureus and Candida albicans
(MIC) it is 119mg crude drugs/ml；The minimal inhibitory concentration (MIC) of middle-jiao yang, function of the spleen and stomach comparison medicine Baicao Fuyanqing bolt is also 41.88mg/
ml；The minimal inhibitory concentration (MIC) of western positive comparison medicine metronidazole,clotrimazole and chlorhexidine acetate suppositories is 7.81mg/ml.Above test result indicates that：Cypress gruel disappears
Vagina is bolted at has certain suppression to make to staphylococcus aureus, pseudomonas aeruginosa, Escherichia coli, Candida albicans in vitro
With minimal inhibitory concentration is 119mg crude drugs/ml.2. the influence pair mouse colpomycosis animal model test
The duplication of 2.1 models：Take mouse 150,18~22g of body weight, all female, it is subcutaneous in 6d starts before inoculation the next day
Inject estradiol benzoate injection 1mg/1mL, 0.05mL/ only, continuous 3 times, mouse is in false heat state.Except normal right
Outer according to group, it is 5 × 10 to be in artificial estrous mouse vagina implantation concentration to remaining every6CFU/ml Candida albicans bacterium
The μ l/ of liquid 20 only, adopt vaginal fluid smear with sterile small cotton swab in the 4th day after inoculation, HE dyeing microscopic examinations, observe mycelia and bud
Sporogenic growing state, to determine whether infection succeeds.
2.2 packets and administration：In addition to Normal group, Candida albicans are divided at random for positive vaginitis model mouse
Into model control group (isometric excipient), cypress gruel disappear the basic, normal, high dosage of vaginal plug (1.11g crude drugs/kg, 2.22g crude drug/
Kg, 4.44g crude drug/kg) group, Chinese medicine positive control drug Baicao Fuyanqing bolt (1.04g/kg) group, Western medicine positive control drug polybenzobisoxazole
Safe bolt (5.20mg/kg) group, every group 20, with totally 7 groups of blank control group (do not infect and do not treat).Given with corresponding medicine vagina
Medicine 1 time a day, administered volume 1.60mL/kg, successive administration 7d.
2.3 observation index：Before administration in 4th day and the 8th day morning took mouse vagina secretion smear HE dyeing microscopic examinations, observed
Candida albicans infection conditions, calculate pathogen and turn out cloudy cure rate.Then mouse is put to death, takes vagina tissue with 10% neutral formalin
Fixed, pathological examination is done in FFPE, section, HE dyeing, observes the inflammation inhibition level of vaginal mucosa.
Mouse vagina mucous membrane tissue histological scores are pressed in the pathological change of mouse vagina mucous membrane, are divided into 0-3 points.
0 point：Without congestion and edema, no cell infiltration under mucous membrane.
1 point：Congestion and edema under mucous membrane, a small amount of cell infiltration, a small amount of inflammatory exudate of intravaginal.
2 points：Congestion and edema under mucous membrane, more cell infiltration, the more inflammatory exudate of intravaginal.
3 points：Congestion and edema under mucous membrane, a large amount of cell infiltrations, a large amount of inflammatory exudates of intravaginal.
Use x2Inspection is compared carrying out group to healing degree.Examined with t and compared carrying out group to inflammatory score, with model pair
It is set to 100% (degree of inflammation) according to the score value of group, medicine group can draw medicine group inflammation inhibiting rate compared with model control group.
2.4 result
Table 2 to mouse colpomycosis cure degree test () (n=20)
Note：With model control group ratio,*P<0.05,**P<0.01
Table 3 to the experiment of the inflammation inhibition level of mouse colpomycosis vaginal mucosa () (n=20)
Note：With model control group ratio,*P<0.05,**P<0.01；With blank control group ratio,△△P<0.01
From table 2, cypress gruel, which disappears after the basic, normal, high dosage group of vaginal plug treats colpomycosis mouse 3d and 7d, cures
Number of elements is more than model control group, the difference significance (P compared with model control group<0.05, P<0.01), cure rate reaches
More than 30%.
From table 3, the cypress gruel basic, normal, high dosage group inflammatory score of vaginal plug that disappears is significantly lower than model control group, with model
Control group compares difference significance (P<0.05, P<0.01), inflammation inhibiting rate reaches more than 36.4%.
3. the influence pair rat bacterial vaginitis animal model
The duplication of 3.1 models：With 200~250g of body weight female rats from vagina injection staphylococcus aureus (1.5 ×
109) and Escherichia coli (1.5 × 10 CFU/mL9) and (1.5 × 10 CFU/mL9CFU/mL) the mixed bacteria liquid of pseudomonas aeruginosa,
Bacterium solution injection rate is 0.05mL/100g, the next day inoculate and take for 1 time, the 5th day and the 7th day vaginal fluid to do microscopy and thin respectively
Bacterium is cultivated, and microscopy and Bacteria Culture are that positive is to infect successful rat.
3.2 packets and administration：In addition to Normal group, successful rat will be infected and be randomly divided into 6 groups, respectively model pair
According to group (isometric excipient), cypress gruel disappears, and (0.77g crude drugs/kg, 1.54g crude drug/kg, 3.08g gives birth to the basic, normal, high dosage of vaginal plug
Medicine/kg) group, Chinese medicine positive control drug Baicao Fuyanqing bolt (0.72g/kg) group, Western medicine positive control drug metronidazole,clotrimazole and chlorhexidine acetate suppositories (0.18g/
Kg) group, every group 20.Vagina administration 1 time a day, administered volume 1.2mL/kg, successive administration 10d.
3.3 observation index：Rat vagina secretion is taken to be identified within the 1st day and the 4th day after drug withdrawal, secondary identification pathogen
It is that feminine gender is set to healing of turning out cloudy, rat lives after being discontinued the 5th day and kills dissection, takes vagina tissue to be fixed with 10% neutral formalin,
Pathological examination is done in FFPE, section, HE dyeing, observes the inflammation inhibition level of vaginal mucosa.
The pathological change of rat vagina mucous membrane presses rat vagina mucous membrane tissue pathology by Liaoning Chinese Medicine Institute's pathology room
Scoring is learned, is divided into 0-3 points.
0 point：Without congestion and edema, no cell infiltration under mucous membrane.
1 point：Congestion and edema under mucous membrane, a small amount of cell infiltration, a small amount of inflammatory exudate of intravaginal.
2 points：Congestion and edema under mucous membrane, more cell infiltration, the more inflammatory exudate of intravaginal.
3 points：Congestion and edema under mucous membrane, a large amount of cell infiltrations, a large amount of inflammatory exudates of intravaginal.
Use x2Inspection is compared carrying out group to cure rate.Examined with t and compared carrying out group to inflammatory score, with model comparison
The score value of group is set to 100% (degree of inflammation), and medicine group can draw medicine group inflammation inhibiting rate compared with model control group.
Table 4 to rat bacterial vaginitis cure degree test ()
Note：With model control group ratio*P<0.05,**P<0.01
Table 5 to the experiment of the inflammation inhibition level of rat bacterial vaginitis vaginal mucosa () (n=20)
Note：With model control group ratio,*P<0.05,**P<0.01；With blank control group ratio,△△P<0.01
From table 4, cypress gruel disappears, and (0.77 crude drug/kg, 1.54g crude drug/kg, 3.08g gives birth to the basic, normal, high dosage of vaginal plug
Medicine/kg) group cure number of elements be more than model control group, the difference significance (P compared with model control group<0.05, P<0.01),
Cure rate reaches more than 35%.
From table 5, cypress gruel disappears, and (0.77g crude drugs/kg, 1.54g crude drug/kg, 3.08g gives birth to the basic, normal, high dosage of vaginal plug
Medicine/kg) group inflammatory score be significantly lower than model control group, the difference significance (P compared with model control group<0.01) it is, scorching
Disease inhibiting rate reaches more than 41.4%.
4. the influence that cavy itch caused by pair histamine phosphate is reacted
Take 200~250g of body weight cavys 60, female, male half and half, it is divided into 6 groups by body weight, model comparison (excipient) group, cypress
Gruel disappears the basic, normal, high dosage of vaginal plug (0.66g crude drugs/kg, 1.32g crude drug/kg, 2.64g crude drug/kg) group, Chinese medicine positive control
Medicine Baicao Fuyanqing bolt (0.62g/kg) group, Western medicine positive control drug Dexamethasone group (1.00g/kg).Every group 10, to medicine body
Product is 1.00mL/kg, and the administration day before yesterday, medicaments uniformity was applied to behind the right side at the shaving of instep by next day by instep shaving behind the right side of cavy,
Continuous 2d, 3d will gently abrade behind the right side about 1cm at the shaving of instep with fine sandpaper at shaving2, then 1 (model control group of coating
To excipient).After last coating 10min, tested material is gently removed with cotton swab, then in the histamine phosphates of surface of a wound Chu Di 0.01%
0.05ml/ only, hereafter every 3min again successively smear 0.02%, 0.03%, 0.04%...... progressive concentrations, be every time
0.05ml/ only, turns one's head to lick right metapedes until there is cavy, finally to there is the phosphoric acid group given when cavy is turned one's head and licks right metapedes
It is itch-threshold to knit amine total amount (μ g), records and compares the itch-threshold of each group.
The cypress gruel of table 6 disappear vaginal plug to caused by histamine phosphate cavy itch react influence ()
Note：With model control group ratio,*P<0.05,**P<0.01
From table 6, cypress gruel disappears, and (0.66g crude drugs/kg, 1.32g crude drug/kg, 2.64g gives birth to the basic, normal, high dosage of vaginal plug
Medicine/kg) group can improve histamine phosphate caused by cavy itch react itch-threshold, difference has significantly compared with model control group
Meaning (P<0.05, P<0.01), show cypress gruel disappear vaginal plug have it is obvious suppress histamine phosphate caused by cavy itch react
Effect.
5. the influence of paraxylene induced mice ear swelling
Take mouse 70,18~22g of body weight, all female, divide 7 groups at random by body weight, model comparison (excipient) group, cypress
Gruel disappears, and vaginal plug is extremely low, basic, normal, high four dosage (0.55g crude drugs/kg, 1.11g crude drug/kg, 2.22g crude drug/kg, 4.44g
Crude drug/kg) group, Chinese medicine positive control drug Baicao Fuyanqing bolt (1.04g/kg) group, Western medicine positive control drug dexamethasone
(5.00g/kg) group, relative medicine being uniformly applied to the inside and outside two sides of the left auricle of mouse by group, auris dextra compares, 1 time a day,
Only, for three days on end, after last dose 1h, the inside and outside two sides that left side auricle is gently washed away with warm water applies the decoction put on the skin and wiped 0.05ml/
After dry, 20 μ l dimethylbenzene are dripped with liquid-transfering gun, mouse dislocates after 20min and put to death, cuts two auricles of left and right, is punched with 8mm diameters
Device, lays round auricle at same position respectively, and precision is weighed the weight of two auricles, swollen using left and right auricle weight difference as inflammation
Expansibility, compares the ear edema degree of each group, and obtains inhibiting rate.Inhibiting rate (%)=(control group swelling-medication group swelling
Degree)/control group swelling × 100%.
The cypress gruel of table 7 disappear vaginal plug paraxylene induced mice ear swelling influence ()
Note：With model control group ratio,*P<0.05,**P<0.01
From table 7, cypress gruel disappears, and (1.11g crude drugs/kg, 2.22g crude drug/kg, 4.44g gives birth to the basic, normal, high dosage of vaginal plug
Medicine/kg) group ear swelling degree be significantly lower than model control group, the difference significance (P compared with model control group<0.05, P<
0.01), inflammation inhibiting rate reaches more than 33.5%, shows that the cypress gruel vaginal plug paraxylene induced mice ear swelling degree that disappears has significantly
Inhibitory action.
6. the influence of Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability
Mouse 60,18~22g of body weight is taken, female, divides 6 groups at random by body weight, model comparison (excipient) group, cypress gruel disappears
The basic, normal, high dosage of vaginal plug (1.11g crude drugs/kg, 2.22g crude drug/kg, 4.44g crude drug/kg) group, Chinese medicine positive control drug hundred
Scorching clear bolt (1.04g/kg) group of careless woman, Western medicine positive control drug dexamethasone (5.00g/kg) group.Vagina administration 1 time a day, is given
Medicine body product is 1.60mL/kg, for three days on end, after last dose 1h, 0.6% acetic acid of intraperitoneal injection 0.2ml/, equal tail after 20min
0.5% azovan blue normal saline solution 0.1ml/10g body weight is injected intravenously, is taken off after intravenous injection azovan blue 20min at neck
Extremely, abdominal cut, with 6ml physiological saline fraction time washing abdominal cavity, suction pipe suctions out cleaning solution, physiological saline is added extremely after merging
10ml.Centrifuge 3000rpm centrifugation 15min are put into, take supernatant spectrophotometer to determine OD value, group at 590nm
Between comparing difference conspicuousness, and obtain inhibiting rate.Inhibiting rate (%)=(control group OD value-medication group OD value)/
Control group OD value × 100%.
The cypress gruel of table 8 disappear vaginal plug Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability influence ()
Note：With model control group ratio,﹡P<0.05,﹡ ﹡P<0.01
From table 8, cypress gruel disappear the middle and high dosage of vaginal plug (2.22g crude drugs/kg, 4.44g crude drug/kg) group OD value
Significantly lower than model control group, the difference significance (P compared with model control group<0.05).Show that cypress gruel disappears vaginal plug energy
It is obvious to suppress azovan blue seepage discharge, reduce capillary permeability.
7. the influence of Dichlorodiphenyl Acetate induced mice writhing response
Mouse 60,18~22g of body weight is taken, female, divides 6 groups at random by body weight, model comparison (excipient) group, cypress gruel disappears
The basic, normal, high dosage of vaginal plug (1.11g crude drugs/kg, 2.22g crude drug/kg, 4.44g crude drug/kg) group, Chinese medicine positive control drug hundred
Scorching clear bolt (1.04g/kg) group of careless woman, Western medicine positive control drug acetylsalicylic acid tablet (0.13g/kg) group.Except Western medicine positive control drug
Acetylsalicylic acid tablet is by outside 25ml/kg gastric infusions, and 1 time a day, administered volume 1.60mL/kg is for three days on end, last for vagina administration
After secondary administration 1h, only, observation gives after acetic acid what mouse writhing reaction in 15min occurred to the acetic acid 0.2ml/ of intraperitoneal injection 0.6%
Number, the conspicuousness of comparing difference between group.
The cypress gruel of table 9 disappear vaginal plug Dichlorodiphenyl Acetate induced mice writhing response influence ()
Note：With model control group ratio,**p<0.01
From table 9, cypress gruel disappears each dosage of vaginal plug (1.11g crude drugs/kg, 2.22g crude drug/kg, 4.44g crude drug/kg)
Group writhing number is less than model control group, but the difference nonsignificance (P compared with model control group>0.05).Show that cypress gruel disappears
Vaginal plug is without obvious analgesic activity.
8. hot plate method in mice analgesic test
Take body weight 18~22g Healthy female mouse, screened in hot plate pain threshold detector, choose pain threshold 5S~30S it
Between mouse be for experiment, do not have to less than 5S or give up higher than 30S person.60 are taken after mouse screening, random point 6 groups, every group 10
Only, model comparison (excipient) group, cypress gruel disappear the basic, normal, high dosage of vaginal plug (1.11g crude drugs/kg, 2.22g crude drug/kg,
4.44g crude drugs/kg) group, Chinese medicine positive control drug Baicao Fuyanqing bolt (1.04g/kg) group, Western medicine positive control drug aspirin
Piece (0.13g/kg) group.In addition to Western medicine positive control drug acetylsalicylic acid tablet presses 25ml/kg gastric infusions, each group mouse is in double hind legs
Applied below knee joint to foot bottom and put corresponding decoction on the skin, 0.05ml/ only, 1 time a day, for three days on end, 30 after last medicine, 60,120 points
Clock determines mouse pain threshold respectively, before being administered compared with each period mouse pain threshold after administration, is examined using t.
The cypress gruel of table 10 disappear vaginal plug hot plate method is caused pain model in mice influence ()
Note：With model control group ratio,*p<0.05,**p<0.01
From table 10, cypress gruel disappears each dosage of vaginal plug (1.11g crude drugs/kg, 2.22g crude drug/kg, 4.44g crude drug/kg)
Group mouse pain threshold difference nonsignificance (P compared with model control group>0.05).
Discuss
Extracorporeal bacteria inhibitor test result shows that cypress gruel disappears vaginal plug to Candida albicans, staphylococcus aureus, large intestine bar
Bacterium, pseudomonas aeruginosa minimal inhibitory concentration are 119g crude drugs/ml, show cypress gruel disappear vaginal plug to above bacterial strain have suppression make
With.
Suppress mould test result in vivo and show that cypress gruel disappears the basic, normal, high dosage of vaginal plug (1.11g crude drugs/kg, 2.22g
Crude drug/kg, 4.44g crude drug/kg) group can increase the healing number of elements of mouse colpomycosis, the difference compared with model control group
Significance (P<0.05, P<0.01), and cure rate reaches more than 30%；Mitigate colpomycosis mouse vagina mucous membrane disease
Become, the difference significance (P compared with model control group<0.05, P<0.01), inflammation inhibiting rate reaches more than 36%.Show
Cypress gruel disappears vaginal plug with the internal mould effect of suppression.
Suppress bacteria test result in vivo and show that cypress gruel disappears the basic, normal, high dosage of vaginal plug (0.77g crude drugs/kg, 1.54g
Crude drug/kg, 3.08g crude drug/kg) group can increase the healing number of elements of rat bacterial vaginitis, the difference compared with model control group
Significance (P<0.05, P<0.01), cure rate reaches more than 35%；Mitigate bacterial vaginitis rat vagina mucous membrane disease
Become, inflammation inhibiting rate reaches more than 41.4%.Show that cypress gruel disappears vaginal plug with suppression Endophytic bacteria effect.
The cypress gruel result of the test that vaginal plug is reacted cavy itch caused by histamine phosphate that disappears shows that cypress gruel disappears vaginal plug
Basic, normal, high dosage group (0.66g crude drugs/kg, 1.32g crude drug/kg, 2.64g crude drug/kg) can be improved caused by histamine phosphate
The itch-threshold of cavy itch reaction, the difference significance (P compared with model control group<0.05, P<0.01), show that cypress gruel disappears
Vaginal plug plays the role of cavy itch caused by significantly suppressing histamine phosphate and reacted.
The disappear result of the test of vaginal plug paraxylene induced mice ear swelling of cypress gruel shows, the cypress gruel vaginal plug that disappears is basic, normal, high
Dosage (1.11g crude drugs/kg, 2.22g crude drug/kg, 4.44g crude drug/kg) group ear swelling degree is significantly lower than model control group, with mould
Type control group compares difference significance (P<0.05, P<0.01), show that cypress gruel disappears vaginal plug paraxylene induced mice ear
Swelling has significant inhibitory action.
The cypress gruel vaginal plug Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability result of the test that disappears shows, cypress gruel disappears vaginal plug
Middle and high dosage (2.22g crude drugs/kg, 4.44g crude drug/kg) group OD value is significantly lower than model control group, with model control group
Compared to difference significance (P<0.05), show that the cypress gruel vaginal plug that disappears can substantially suppress azovan blue seepage discharge, reduce capillary
Vasopermeability.
The disappear result of the test of vaginal plug Dichlorodiphenyl Acetate induced mice writhing response of cypress gruel shows, the cypress gruel vaginal plug that disappears is basic, normal, high
Dosage (1.11g crude drugs/kg, 2.22g crude drug/kg, 4.44g crude drug/kg) group writhing number is less than model control group, but and model
Control group compares difference nonsignificance (P>0.05), show that cypress gruel disappears shadow of the vaginal plug to glacial acetic acid induced mice writhing response
Ring unobvious.
The cypress gruel vaginal plug that disappears shows to hot plate method in mice analgesic test result, and cypress gruel disappears the basic, normal, high dosage of vaginal plug
(1.11g crude drugs/kg, 2.22g crude drug/kg, 4.44g crude drug/kg) organize mouse pain threshold with model control group compared with difference without show
Write meaning (P>0.05), show cypress gruel disappear vaginal plug on hot plate method in mice analgesic test without influence.
Pharmacodynamics test shows：Extracorporeal bacteria inhibitor test cypress gruel disappears vaginal plug to Candida albicans, staphylococcus aureus, big
Enterobacteria, Pseudomonas aeruginosa have inhibitory action, and minimal inhibitory concentration is 12.50mg crude drugs/ml；Bacteriostatic test shows in vivo, cypress
The gruel vaginal plug that disappears can improve the cure rate of mouse colpomycosis, mitigate vaginitis mouse vagina non-cancer lesion.It can improve big
The cure rate of mouse bacterial vaginitis, mitigate bacterial vaginitis rat vagina non-cancer lesion；The cypress gruel vaginal plug that disappears can improve phosphorus
The itch-threshold that cavy itch caused by sour histamine is reacted；Cypress gruel disappear vaginal plug can substantially suppress dimethylbenzene induced mice ear swelling work
With.Azovan blue seepage discharge can substantially be suppressed, reduce capillary permeability；The cypress gruel vaginal plug that disappears has antibacterial, antipruritic, anti-inflammatory
Effect, but analgesic activity is not notable.
Result above clinically treats gynaecologic vaginal inflammation and provides pharmacodynamics foundation for the cypress gruel vaginal plug that disappears.
Embodiment 6：
Pessary is disappeared to 250 bacterial vaginitis, colpomycosis clinically with cypress gruel prepared by embodiment 4
Patient is treated with nonspecific vaginitis, vagina administration, is started medication in clean period after 2-3 days, 1 piece every time, is within 7 days
One course for the treatment of, and observe its curative effect.
Criterion of therapeutical effect：
Cure：Clinical symptoms, sign completely or significantly disappear, and secretion checks that cleannes are I degree.
Effectively：Symptom, sign mitigate, and cleannes take a turn for the better.
It is invalid：Symptom, sign are without change, and cleannes are without change.
Claims (14)
- The vaginal plug 1. cypress gruel disappears, it is characterised in that：The parts by weight of various bulk drugs are in described suppository：Pericarpium zanthoxyli 30-900g dittany bark 600-1000g root barks of Chinese wolf-berry 400-1000gFrutus cnidii 400-1000g smilax 100-1100g kuh-sengs 200-1000gFolium artemisiae argyi 100-1000g Patrinia scaniosaefolia 300-1400g golden cypresses 50-1000g.
- The vaginal plug 2. cypress gruel as claimed in claim 1 disappears, it is characterised in that：The parts by weight of various bulk drugs in described suppository Number is：Pericarpium zanthoxyli 200-900g dittany bark 600-1000g root barks of Chinese wolf-berry 600-1000gFrutus cnidii 600-1000g smilax 300-1100g kuh-sengs 400-1000gFolium artemisiae argyi 300-1000g Patrinia scaniosaefolia 500-1400g golden cypresses 200-1000g.
- The vaginal plug 3. cypress gruel as claimed in claim 1 disappears, it is characterised in that：The parts by weight of various bulk drugs in described suppository Number is：Pericarpium zanthoxyli 500-800g dittany bark 600-800g root barks of Chinese wolf-berry 600-800gFrutus cnidii 600-800g smilax 500-800g kuh-sengs 400-800gFolium artemisiae argyi 500-800g Patrinia scaniosaefolia 800-1200g golden cypresses 400-800g.
- The vaginal plug 4. cypress gruel as claimed in claim 1 disappears, it is characterised in that：The parts by weight of various bulk drugs in described suppository Number is：Pericarpium zanthoxyli 600-800g dittany bark 600-800g root barks of Chinese wolf-berry 600-800gFrutus cnidii 600-800g smilax 600-800g kuh-sengs 600-800gFolium artemisiae argyi 600-800g Patrinia scaniosaefolia 800-1200g golden cypresses 600-800g.
- The preparation method of vaginal plug 5. the cypress gruel as described in claim 1-4 any one disappears, it is characterised in thatNine taste medicinal materials are taken, are added water to cook three times, for the first time plus 8-12 times is measured water, is decocted 1.5-2 hours, second and third time adds respectively 8-10 times is measured water, each to decoct 1-2 hours, collecting decoction, filtration, and it is to survey 1.05~1.10 at 60 DEG C that filtrate, which is concentrated into relative density, Clear cream, add ethanol alcohol content is reached 55-70%, stir evenly, stand 12 hours, take supernatant, filter, filtrate recycling ethanol is simultaneously dense The thick paste that relative density is the survey 1.05~1.25 at 60 DEG C is reduced to, dry, pulverize into fine powder, it is standby；Water-soluble base is mixed, It is heated to melting, after matrix melting, treats that temperature is down to 55 DEG C, add stock of drugs powder, it is stirring while adding, until mixing is equal It is even, it is standby；Above-mentioned fusing drug containing matrix is poured into bolt mould, liquid level slightly overflows die orifice plane 2-3mm, after naturally cool to solidifying Gu scabbling, bolt mould is opened, 1000 is made, produces.
- 6. preparation method as claimed in claim 5, it is characterised in that described water-soluble base is glycerin gelatine, poly- second two Alcohols, Myrj 52, water soluble chitosan, the one or more in poloxamer.
- 7. preparation method as claimed in claim 5, it is characterised in that described water-soluble base is glycerin gelatine, poly- second two Alcohols, the one or more combination in Myrj 52.
- 8. preparation method as claimed in claim 5, it is characterised in that described water-soluble base is glycerin gelatine, poly- second two Alcohols, during the combination of Myrj 52, its ratio is：(1-9)：(2-5)：(1-9).
- 9. such as the preparation method any one of claim 6-7, it is characterised in that described water-soluble base is glycerine Gelatin, polyethylene glycols, during the combination of Myrj 52, its ratio is：(1-9)：(2-5)：(1-9).
- 10. preparation method as claimed in claim 5, it is characterised in that described drug powder and the ratio of water-soluble base For：1：1-1：5.
- 11. such as the preparation method any one of claim 6-8, it is characterised in that described drug powder with it is water-soluble The ratio of property matrix is：1：1-1：5.
- 12. preparation method as claimed in claim 9, it is characterised in that described drug powder and the ratio of water-soluble base For：1：1-1：5.
- 13. the preparation method as described in claim 10 or 12, it is characterised in that the ratio of drug powder and water-soluble base is 1：2-1：3.
- 14. preparation method as claimed in claim 11, it is characterised in that the ratio of drug powder and water-soluble base is 1：2- 1：3.
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| CN108283651A (en) * | 2018-01-25 | 2018-07-17 | 蚌埠医学院 | The method for establishing rat aerobic bacteria property vaginitis model |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101279005A (en) * | 2008-05-04 | 2008-10-08 | 北京中科仁和科技有限公司 | Medicament composition for curing vulva inflammation and vulvar pruritus and method of preparing the same |
| CN102000291A (en) * | 2010-11-02 | 2011-04-06 | 李永胜 | Liquid, powder, capsules and paste for preventing and treating gynecology |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101279005A (en) * | 2008-05-04 | 2008-10-08 | 北京中科仁和科技有限公司 | Medicament composition for curing vulva inflammation and vulvar pruritus and method of preparing the same |
| CN102000291A (en) * | 2010-11-02 | 2011-04-06 | 李永胜 | Liquid, powder, capsules and paste for preventing and treating gynecology |
Non-Patent Citations (1)
| Title |
|---|
| 自拟一洗灵治疗外阴及阴道炎疗效观察;唐壹蓉;《现代中西医结合杂志》;20070531;第16卷(第07期);892-893 * |
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