CN1616004A - Suppository for treating bacterial vaginitis - Google Patents
Suppository for treating bacterial vaginitis Download PDFInfo
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- CN1616004A CN1616004A CNA2004100730903A CN200410073090A CN1616004A CN 1616004 A CN1616004 A CN 1616004A CN A2004100730903 A CNA2004100730903 A CN A2004100730903A CN 200410073090 A CN200410073090 A CN 200410073090A CN 1616004 A CN1616004 A CN 1616004A
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- bacterial vaginitis
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
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Abstract
The suppository for treating bacterial vaginitis contains total phellodendron alkaloid and volatile atractylodes rhizome oil in the weight ratio of 1 to 1.6. The suppository has the effects of resisting bacteria, resisting fungi, resisting vagina trichomonad, resisting inflammation, relieving pain and stopping itch and can reach the effect of curing bacterial vaginitis radically. Pharmacological experiments show that the suppository comprehensive curative effect higher than that of any one kind of chemical medicine. The suppository has obvious inhibiting and deactivating effect on common vagina infecting bacteria, such as escherichia coli, Staphylococcos aureus, bacillus pyocyaneus, etc. Pharmacological experiments proves the use of the composition of total phellodendron alkaloid and volatile atractylodes rhizome oil in treating bacterial vaginitis.
Description
Technical field
The present invention relates to a kind of new Chinese medicine, particularly a kind of suppository that is used for the treatment of bacterial vaginitis, and the compositions of Chinese medicine ingredients Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil constitutes, and is used for the treatment of the medicinal usage of bacterial vaginitis.
Background technology
Bacterial vaginitis is a common gynecological disease, and is often bad because of menstrual period or sexual life health because vagina communicates with the external world, or because of factors such as childbirth and uteroventral operation cause vaginal infection even can make inflammation attack internal reproductive organ, causes pelvic inflammation.Suffer from diabetes, vitamin B group shortage, ovarian function decline in addition, some allergy or infectious disease person be easy infection more.Bacterial vaginitis once was named as your bacterium vaginitis of haemophilis vaginitis, Gardner, non-ly treated different in nature vaginitis, now claimed bacterial vaginosis.Claiming bacillary is because intravaginal has a large amount of different antibacterials, claims that vaginosis is owing to clinical and the change of pathological characters NIP are not vaginitis.Primary disease is actual to be normally to colonize in intravaginal antibacterial ecological balance (flora) imbalance.Under the physiological conditions, intravaginal has various anaerobe and aerobe, wherein preponderates with the lactobacillus that produces hydrogen peroxide.During bacterial vaginosis, the intravaginal lactobacillus is supported and other antibacterial breeds in a large number, mainly contains your bacterium of Gardner, moving curved village bacterium and other anaerobe, and part patient merges mycoplasma infection, wherein in the majority with anaerobe, the concentration of anaerobe can be 100～1000 times of normal women.Can produce amine substance in the time of the anaerobe breeding, the alkalization vagina makes resistance road secretions increase and frowziness.The bacterial vaginitis sickness rate is on the rise in recent years.The foreign scholar notices that also vaginitis can bring out other diseases, as brings out plasma cell membranous endometritis etc.The middle suppository of treatment bacterial vaginitis is more at present, as the fragrant spongy embolus of phoenix, Radix Sophorae Flavescentis Suppositoria, FUNINGSHUAN and compound seabuckthorn fruit oil suppository etc., though certain therapeutic effect is all arranged, the flavour of a drug of Chinese medicine compound are formed numerous, and preparation technology is coarse in addition, even will be used as medicine after the direct pulverizing of Chinese crude drug, not only outward appearance is difficult to accept, face and lower as its absorbance of local application, and the course of treatment is longer, cause into chronic disease easily, punish severely the physical and mental health and the operate as normal that affect the women.So, the numerous women that suffer from bacterial vaginitis thirst for very much having a kind of effectively, curative drug appears on the market fast, easily.
Summary of the invention
One object of the present invention is, a kind of suppository that is used for the treatment of bacterial vaginitis is provided.
The compositions that another object of the present invention provides Chinese medicine ingredients Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil is used for the treatment of the medicinal usage of bacterial vaginitis.
The applicant is with the infiltration healing effect combination of the antibacterial and anti-inflammation functions and the Rhzoma Atractylodis Lanceae volatile oil of Chinese medicine ingredients Cortex Phellodendri total alkaloids, made a kind of suppository that is used for the treatment of bacterial vaginitis, it is 1: 1.6 Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil that this suppository contains weight ratio.
This suppository also contains as the suppository base of adjuvant and Borneolum Syntheticum.
Suppository base is mixed fatty glycerides or other suppository base well known in the art.
Mixed fatty glycerides accounts for 94% of suppository total amount, and Borneolum Syntheticum accounts for 0.8% of suppository total amount.
Its preparation method is: get recipe quantity Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil, mix homogeneously.Add suppository base---the mixed fatty glycerides that has dissolved by amount, add the recipe quantity Borneolum Syntheticum again, stir.Fall in the suppository mould, take out after the stand at low temperature, packing promptly after the passed examination.
Main pharmacodynamics experiment (in-vitro antibacterial experiment, the experiment of external antifungal, the experiment of anti-trichomonal vaginitis, antiinflammatory experiment, analgesic experiment, the antipruritic experiment) result who finishes according to the applicant shows: the every pharmacodynamics index of this suppository is suitable with similar chemicals, reached effect, and comprehensive therapeutic effect is significantly higher than any chemicals to the treating both the principal and secondary aspects of a disease of bacterial vaginitis; Simultaneously, because drug effect is very clear and definite, the mechanism of action is clear, and the medicine dose-effect is relevant, can control its quality and study its physiological disposition with modern analytical technique fully.Compare with middle one-tenth suppository commonly used in the market, aspect the controllability of comprehensive, the quality of curative effect and technology advanced, all have stronger competitiveness.Proved fully that also the compositions of Chinese medicine ingredients Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil is used for the treatment of the medicinal usage of bacterial vaginitis.
The specific embodiment
Adopt the suppository that is used for the treatment of bacterial vaginitis of Chinese medicine ingredients Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil preparation below in conjunction with the applicant, and this suppository that provides in conjunction with the applicant describes in further detail the present invention in the concrete experiment of treatment bacterial vaginitis.
The suppository that is used for the treatment of bacterial vaginitis of the present invention is made of following raw materials by weight: Cortex Phellodendri total alkaloids 2%, Rhzoma Atractylodis Lanceae volatile oil 3.2%, mixed fatty glycerides 94%, Borneolum Syntheticum 0.8%.The called after of this suppository " two wonderful anti-inflammatory suppository for gynecopathies ".
Need to prove, present embodiment is a foundation with the prescription of two wonderful anti-inflammatory suppository for gynecopathies, carry out pharmacodynamic experiment and safety experiment, wherein the composition of Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil is a kind of drug effect prescription for the treatment bacterial vaginitis, because experimental cost is high, differ at this and one to enumerate, but be not limited to this embodiment, can learn from each experimental result that the applicant accumulated, also can realize purpose of the present invention at other suppositorys that contain the different prescription preparations of Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil, have antibiotic equally, antifungal, anti-trichomonal vaginitis, antiinflammatory, analgesia and itching-relieving action, and medicine is safe.
The application's suppository is compound Chinese medicinal preparation, has the effect of heat clearing and damp drying, the clinical treatment that is used for bacterial vaginitis, cervical erosion etc.Result of study shows, this suppository is external to be had than obvious suppression and deactivation vaginal infection common bacteria such as colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, streptococcus faecalis, gonococcus, vagina Gartner bacterium; External also have certain inhibition and deactivation to the common fungus Candida albicans that causes colpitis mycotica, nearly level and smooth beads monilia guilliermondii, candida parakrusei, Oidium tropicale, penicillium, Aspergillus flavus; External can killing effectively obeyed the road trichomonacide.Suppository by 0.93,1.86,3.72g crude drug/Kg is to the administration of rat partial smearing, suppresses the rat acute inflammatory reaction that Ovum Gallus domesticus album brings out, and suppresses the electrical proliferative inflammation reaction of rat that cotton balls stimulates; By 0.93,1.86,3.72g crude drug/Kg is to rat clothes road topical, suppressing foreign body stimulates the rat uterus inflammatory reaction of bringing out.Suppository by 1.3,2.6,5.2g crude drug/Kg is to the administration of mice partial smearing, improves the mice threshold of pain that thermostimulation causes; By 0.93,1.86,3.72g crude drug/Kg is to the administration of Cavia porcellus partial smearing, improves the itch-threshold of histamine to Cavia porcellus.
Experiment one: in-vitro antibacterial experiment
Adopt trace continuously doubling dilution measure the minimal inhibitory concentration (MIC) of two wonderful anti-inflammatory suppository for gynecopathies to the type strain of colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, streptococcus faecalis, gonococcus and colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, streptococcus faecalis, gonococcus, vagina Gartner bacterium clinical separation strain, adopt dull and stereotyped infection protocol to measure the minimal bactericidal concentration (MBC) of two wonderful anti-inflammatory suppository for gynecopathies to above-mentioned antibacterial.Colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, vagina Gartner bacterium are inoculated in MH meat soup, put common incubator and cultivate 24h for 37 ℃; Streptococcus faecalis is inoculated in TPY meat soup (anaerobe nutrient broth), puts the anaerobism incubator and cultivates 48h for 37 ℃; Gonococcus is inoculated in the MH meat soup that contains 5% calf serum, puts 5%CO
2Incubator is cultivated 48h for 37 ℃.
Table 1 two wonderful anti-inflammatory suppository for gynecopathies are to the MIC and the MBC of reference culture
Bacterial strain MIC (MBC of mg crude drug/mL) (the mg medicine/mL)
Escherichia coli ATCC25922 strain 12.5 25
Staphylococcus aureus ATCC25922 strain 0.39 0.78
Pseudomonas aeruginosa ATCC27853 strain 50 100
Staphylococcus epidermidis ATCC26069 strain 0.39 0.78
Proteus vulgaris 49010 strains 25 50
Streptococcus faecalis 32221 strains 0.39 1.56
Gonococcus 29106 strains 0.195 0.39
The clinical separation of vagina Gartner bacterium is with reference to strain 0.78 1.56
By table 1 as seen, two wonderful anti-inflammatory suppository for gynecopathies all have than obvious suppression and deactivation with vagina Gartner bacterium the type strain of testing selected colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, proteus vulgaris, streptococcus faecalis, gonococcus clinical the separation with reference to strain, and its MBC is 2～4 times of MIC.
Table 2 two wonderful anti-inflammatory suppository for gynecopathies are to 405 strain clinical isolates strains
MIC, MIC
50, MIC
99And MBC (the mg crude drug/mL)
MIC MIC is counted in the bacterial strain strain
50MIC
99MBC
Staphylococcus aureus 100 0.39～1.56 1.0257 1.3084 0.78～6.25
Escherichia coli 120 6.25～50 18.9063 23.1657 25～100
Staphylococcus epidermidis 50 0.39～3.13 0.7232 1.5016 1.56～6.25
Bacillus proteus 100 12.5～50 26.125 34.0726 25～100
Gonococcus 24 0.195～0.39 0.2438 0.2715 0.195～0.78
Vagina Gartner bacterium 11 0.39～1.56 0.7800 0.9146 0.78～1.56
By table 2 as seen, two wonderful anti-inflammatory suppository for gynecopathies all have certain inhibition and deactivation to testing 405 selected strain clinical isolates strains, and its MBC is 2～4 times of MIC.
Experiment two: external antifungal experiment
Adopt the continuous doubling dilution of trace to measure two wonderful anti-inflammatory suppository for gynecopathies, adopt dull and stereotyped infection protocol to measure two wonderful anti-inflammatory suppository for gynecopathies oidiomycetic MBC to oidiomycetic MIC.Adopt the continuous doubling dilution of test tube to measure the MIC of two wonderful anti-inflammatory suppository for gynecopathies, adopt dull and stereotyped infection protocol to measure the MBC of two wonderful anti-inflammatory suppository for gynecopathies mycete to mycete.
Table 3 two wonderful anti-inflammatory suppository for gynecopathies are to the MIC and the MBC of experimental strain
Bacterial strain MIC (MBC of mg crude drug/mL) (the mg crude drug/mL)
Candida albicans 85021 canonical reference strains 3.125 6.25
Candida parapsilosis clinical separation strain 1.56 3.125
Also cover clinical separation strain 6.25 6.25 season
The gentle clinical separation strain 1.56 1.56 of secondary gram
Torrid zone clinical separation strain 3.125 6.25
Penicillium clinical separation strain 12.5 25
Aspergillus flavus clinical separation strain 12.5 25
By table 3 as seen, two wonderful anti-inflammatory suppository for gynecopathies are ordered separation and are all had than obvious suppression and deactivation with reference to strain testing selected Candida albicans, Candida parapsilosis, monilia guilliermondii, candida parakrusei, Oidium tropicale, penicillium, Aspergillus flavus type strain or facing, and its MBC is 2～4 times of MIC.
Table 4 two wonderful anti-inflammatory suppository for gynecopathies are to the strain of Candida albicans clinical isolates
MIC, MIC
50, MIC
99And MBC (the mg crude drug/mL)
MIC MIC is counted in strain
50MIC
99MBC
50 1.56～6.25 0.0991 0.1243 6.25～12.5
By table 4 as seen, 50 selected strain Candida albicans clinical isolates pearl clinical isolates strains all have certain inhibition and deactivation to two wonderful anti-inflammatory suppository for gynecopathies to discoloration test.
Experiment three: anti-trichomonal vaginitis experiment
Adopt extracorporeal culture-ing to measure the minimum parasite killing concentration of two wonderful woman's fire bolts to trichomonal vaginitis.Trichomonal vaginitis is cultivated 48h for 37 ℃ in the CPLM culture medium of improvement, and the infusorian motion is active, well-grown, and natural mortality rate＜2%, it is 1.8～2.5 * 10 that experiment contains worm density with trichomonal vaginitis liquid
3/ mL.
The result shows that the minimum effective drug concentration of two wonderful anti-inflammatory suppository for gynecopathy killing in vitro trichomonal vaginitis is 25mg crude drug/mL.
Experiment four: antiinflammatory experiment
(1) to the influence (rat foot claw edema method) of rat acute inflammation
50 of rats, female, be divided into 5 groups at random, 10 every group.First group of negative matched group is to the substrate mixed fatty glycerides 0.1mL/100g of two wonderful anti-inflammatory suppository for gynecopathies; Second group of positive matched group given hydrocortisone injection 30mg/Kg; Third and fourth, five groups be two wonderful anti-inflammatory suppository for gynecopathies little, in, heavy dose of group, give two wonderful anti-inflammatory suppository for gynecopathies 0.93,1.86,3.72g crude drug/Kg respectively.Rat foot claw partial smearing administration 1 time, 0.1mL/100g.Behind the administration 60min, the right back sufficient sole of the foot intradermal injection 10% Ovum Gallus domesticus album 0.1mL of every Mus causes inflammation.And then with method coating 1 time.Cause scorching before and cause scorching back 30in, 1h, 2h, 4h with the right back sufficient pawl thickness of vernier caliper measurement rat so that the difference of sufficient pawl thickness is represented the acute inflammation degree as the swelling degree with the swelling degree before and after scorching.
Table 5 two wonderful anti-inflammatory suppository for gynecopathies are to the influence of rat acute inflammation (x ± s)
Dosage number of animals swelling degree
Group
(g/Kg) (only) 30min 1h 2h 4h
Negative control group 10 0.90 ± 0.39 0.83 ± 0.23 0.95 ± 0.30 0.93 ± 0.30
Hydrocortisone injection 0.03 10 0.66 ± 0.21 0.48 ± 0.21
*0.41 ± 0.15
*0.32 ± 0.23
*
Two wonderful anti-inflammatory suppository for gynecopathies low dose of 0.93 10 0.97 ± 0.34 0.89 ± 0.22 0.57 ± 0.29
*0.36 ± 0.25
*
Dosage 1.86 10 0.80 ± 0.25 0.82 ± 0.25 0.68 ± 0.30 0.59 ± 0.34 in the two wonderful anti-inflammatory suppository for gynecopathies
*
Two wonderful anti-inflammatory suppository for gynecopathies heavy dose of 3.72 10 0.41 ± 0.20
*0.41 ± 0.17
*0.20 ± 0.28
*0.19 ± 0.27
*
Compare with negative control group,
*P＜0.05,
*P＜0.01
By table 5 as seen, two wonderful anti-inflammatory suppository for gynecopathy topicals can obviously suppress the generation and the development of the rat acute inflammation that Ovum Gallus domesticus album brings out, compare with negative control group, 2h, 4h have significant difference (P＜0.01) after the small dose group administration, 4h has significant difference (P＜0.05) after the middle dosage group administration, and 30min, 1h, 2h, 4h all have significant difference (P＜0.01) after the administration of heavy dose of group.Illustrate that two wonderful anti-inflammatory suppository for gynecopathies have Chinese People's Anti-Japanese Military and Political College's Mus acute exudative inflammation effect.The positive control drug hydrocortisone injection also can suppress the rat acute exudative inflammation reaction that Ovum Gallus domesticus album brings out.
(2) to the influence of rat chronic inflammation test
50 of rats, female, be divided into 5 groups at random, 10 every group.First group of negative matched group is to the substrate mixed fatty glycerides 0.1mL/100g of two wonderful anti-inflammatory suppository for gynecopathies; Second group of positive matched group given hydrocortisone injection 30mg/Kg; Third and fourth, five groups be two wonderful anti-inflammatory suppository for gynecopathies little, in, heavy dose of group, give two wonderful anti-inflammatory suppository for gynecopathies 0.93,1.86,3.72g crude drug/Kg respectively.Under the shallow fiber crops of ether, cropping sterilization, in hypogastric region medisection skin, it is subcutaneous that the sterilization cotton balls of heavy 50mg is implanted the both sides groin, skin suture then, streamline, whole process is the sterile working.From the preceding 3 days beginning local applications that perform the operation, fixing, every day 1 time, continuous 10 days.Put to death rat on the 11st day, and carefully peeled off the granulation tissue of taking out cotton balls and parcel, 60 ℃ of dryings were weighed after 12 hours, deducted the raw cotton ball weight and were granulation tissue weight, and the result is expressed as the contained granulation tissue weight of every 100g body weight (bilateral).Represent the chronic inflammatory disease degree with granulation tissue weight.
Table 6 two wonderful anti-inflammatory suppository for gynecopathies are to the influence of rat chronic proliferative inflammation (x ± s)
Granulation tissue weight
Group dosage (g/Kg) number of animals (only)
(mg/100g body weight)
Negative control group 10 50.3 ± 10.7
Hydrocortisone injection 0.03 10 33.6 ± 6.9
*
Two wonderful anti-inflammatory suppository for gynecopathies low dose of 0.93 10 47.7 ± 11.6
Dosage 1.86 10 41.7 ± 11.2 in the two wonderful anti-inflammatory suppository for gynecopathies
Two wonderful anti-inflammatory suppository for gynecopathies heavy dose of 3.72 10 37.1 ± 7.3
*
Compare with negative control group,
*P＜0.01
By table 6 as seen, two wonderful anti-inflammatory suppository for gynecopathies suppress the rat granulation tissue hyperplasia that cotton balls stimulates, and alleviate the weight of granulation tissue, compare with negative control group, heavy dose of group has significant difference (P＜0.01), illustrates that two wonderful anti-inflammatory suppository for gynecopathies have inhibitory action to the electrical proliferative inflammation of rat.The positive control drug hydrocortisone injection also can suppress the rat granulation hyperplasia that cotton balls stimulates.
(3) to the influence of rat uterus inflammation
50 of rats, female, be divided into 5 groups at random, 10 every group.First group of negative matched group is to the substrate mixed fatty glycerides 0.021mL/100g of two wonderful anti-inflammatory suppository for gynecopathies; Second group of positive matched group given hydrocortisone injection 30mg/Kg; Third and fourth, five groups be two wonderful anti-inflammatory suppository for gynecopathies little, in, heavy dose of group, give two wonderful anti-inflammatory suppository for gynecopathies 0.93,1.86,3.72g crude drug/Kg respectively.Under the shallow fiber crops of ether, the cropping sterilization is in hypogastric region medisection skin and stomach wall, expose the uterus, do at the place transverse incision along 1cm on the cornua uteri of left side, plastic tube (the caliber 2mm of an alcohol disinfecting, long 0.5cm) is placed on intrauterine, with the uterine incision sutured, with slip-off preventing.Sew up stomach wall then, sterilization, partial smearing penicillin prevention infection.Operation vagina administration on the same day, every day 1 time, continuous 7 days, 0.02mL/100g.Put to death animal after 7 days, take out the uterus, both sides and weigh, the difference of the two is the swelling degree.Represent the inflammation of uterus degree with the swelling degree, and be calculated as follows the medicine suppression ratio.
Table 7 two wonderful anti-inflammatory suppository for gynecopathies are to the influence of rat uterus inflammation (x ± s)
Group dosage (g/Kg) number of animals (only) swelling degree (mg) suppression ratio (mg)
Negative control group 10 125.8 ± 54.7
Hydrocortisone injection 0.03 10 83.5 ± 29.3
*33.6
Two wonderful anti-inflammatory suppository for gynecopathies low dose of 0.93 10 92.3 ± 40.2 26.6
Dosage 1.86 10 80.9 ± 37.2 in the two wonderful anti-inflammatory suppository for gynecopathies
*35.7
Two wonderful anti-inflammatory suppository for gynecopathies heavy dose of 3.72 10 79.9 ± 39.2
*36.5
By table 7 as seen, two wonderful anti-inflammatory suppository for gynecopathies suppress foreign substances stimulates the rat uterus inflammatory reaction of bringing out, and the swelling degree is reduced, with negative control group relatively, in, heavy dose of group has significant difference (P＜0.05), illustrates that two wonderful anti-inflammatory suppository for gynecopathies have Chinese People's Anti-Japanese Military and Political College's Mus inflammation of uterus effect.The positive control drug hydrocortisone injection also can suppress foreign body stimulates the rat uterus inflammation of bringing out.
Experiment five: analgesic experiment
Licking metapedes with mice and show as pain with 55 ℃ of the constant water temperatures of instrument with the experiment of YD-4 type physiological and pharmacological is many, is threshold of pain index from mice contact hot plate to licking the metapedes required time.Measure the secondary threshold of pain in advance, the mice that is averaged the threshold of pain and is 10～30s is participated in the experiment.Get 50 of female ICR kind mices, be divided into 5 groups at random, 10 every group.First group of negative matched group is to the substrate mixed fatty glycerides of two wonderful anti-inflammatory suppository for gynecopathies; Second group of positive matched group, lumbar injection Pethidine 50mg/Kg; Third and fourth, five groups be two wonderful anti-inflammatory suppository for gynecopathies little, in, heavy dose of group, give two wonderful anti-inflammatory suppository for gynecopathies 1.3,2.6,5.2g crude drug/Kg respectively.Except that positive controls, each organizes mice two metapedes sole of the foot partial smearing administrations 1 time, 0.01mL/10g.Before the administration and after the administration 30,60,90,120min measures the mice threshold of pain respectively,, calculate greater than 60s as the threshold of pain with 60s.
Table 8 two wonderful anti-inflammatory suppository for gynecopathies are to the influence of the mice threshold of pain (x ± s)
The threshold of pain (s) after the pain administration before the administration of dosage number of animals
Group
(g/Kg) (only) threshold (s) 30min 60min 90min 120min
Negative control group 10 17.2 ± 6.0 20.5 ± 8.3 20.7 ± 10.3 23.5 ± 6.5 26.3 ± 11.5
Pethidine 0.05 10 19.7 ± 4.8 57.5 ± 6.9
*46.6 ± 10.7
*43.6 ± 15.4
*40.7 ± 14.3
*
Two wonderful anti-inflammatory suppository for gynecopathies are little
1.3 10 17.1±7.8 30.5±7.5
* 40.7±11.2
**?42.3±13.3
**?25.1±7.9
Dosage
In the two wonderful anti-inflammatory suppository for gynecopathies
2.6 10 16.7±4.4 29.7±9.4
*?37.8±8.5
** 34.7±11.9
* 25.1±9.5
Dosage
Two wonderful anti-inflammatory suppository for gynecopathies are big
5.5 10 16.0±2.8 31.6±14.2
*49.1±14.5
**?39.6±16.4
**?28.8±13.7
Dosage
Compare with negative control group,
*P＜0.05,
*P＜0.01
By table 8 as seen, two wonderful anti-inflammatory suppository for gynecopathies can improve the mice threshold of pain, compare with negative control group, 30in, 60min and each time point of 90min all have significant difference (P＜0.05 or P＜0.01) after each dosage group administration, point out two wonderful anti-inflammatory suppository for gynecopathies that the pain that the mice thermostimulation causes is had analgesic activity, act on about sustainable 90min.The positive control drug Pethidine also can improve the mice threshold of pain.
Experiment six: antipruritic experiment
40 of female Cavia porcelluss are divided into 5 groups at random, 8 every group.First group of negative matched group is to the substrate mixed fatty glycerides of two wonderful anti-inflammatory suppository for gynecopathies; Second group of positive matched group given diphenhydramine hydrochloride injection 0.4mg/Kg; Third and fourth, five groups be two wonderful anti-inflammatory suppository for gynecopathies little, in, heavy dose of group, give two wonderful anti-inflammatory suppository for gynecopathies 0.93,1.86,3.72g crude drug/Kg respectively.Test and shaved hair, local application 1 time, 0.1mL/ foot to each group Cavia porcellus right back instep in preceding 1 day.Test the same day, the unhairing place is abraded gently the about 1cm of area with coarse sandpaper
2, local repaste medicine 1 time.Behind the last administration 10min, every 3min successively by low concentration to high concentration, to every Cavia porcellus wound surface smearing histamine 0.05mL/ only, histamine concentration is followed successively by 1.0 * 10
-4, 2.0 * 10
-4, 3.0 * 10
-4, 4.0 * 10
-413 * 10
-4, 14 * 10
-4, 15 * 10
-4When pruritus reaction appears in Cavia porcellus, promptly lick right back sufficient wound site, or till not occurring the pruritus reaction yet to maximum concentration.Accumulate every Cavia porcellus and lick the itch-threshold of the right back histamine total amount that is given when sufficient (the histamine amount of Cavia porcellus tolerance) as Cavia porcellus.
Table 9 two wonderful anti-inflammatory suppository for gynecopathies are to the itching-relieving action of mouse skin pruritus (x ± s)
Group dosage (/Kg) number of animals (only) itch-threshold (histamine phosphate total amount μ g)
Negative control group 8 18.91 ± 19.42
Diphenhydramine injection 0.4mg 8 69.38 ± 53.07
*
The low dose of 0.93g 8 38.60 ± 31.82 of two wonderful anti-inflammatory suppository for gynecopathies
Dosage 1.86g 8 56.52 ± 38.90 in the two wonderful anti-inflammatory suppository for gynecopathies
*
The heavy dose of 3.72g 8 77.25 ± 57.01 of two wonderful anti-inflammatory suppository for gynecopathies
*
Compare with negative control group,
*P＜0.05
By table 9 as seen, two wonderful anti-inflammatory suppository for gynecopathies can obviously improve the Cavia porcellus itch-threshold, with negative control group relatively, in, heavy dose of group has significant difference (P＜0.05), illustrates that two wonderful anti-inflammatory suppository for gynecopathies have itching-relieving action preferably.The positive control drug diphenhydramine hydrochloride injection also can obviously improve the Cavia porcellus itch-threshold.
Experiment seven: acute toxicity
(1) gastric infusion acute toxicity test
20 of female mices, fasting be after 12 hours, irritates stomach and give two wonderful anti-inflammatory suppository for gynecopathies (0.4ml/10g of 7.5g crude drug/ml), 2 times on the one, 8 hours at interval.The accumulative total dosage is 0.8ml/10g in one day, observes seven days.Viewing duration, the mice hair luster, activity freely, feed and large and small just normal finds no toxic reaction, the weight of animals increases after 7 days, increases to 21.91 ± 1.73g by 19.82 ± 1.21g before the administration, none is only dead.Mice was put to death in the cervical vertebra dislocation when experiment finished, and dissected perusal main organs color and morphological change, and main organs no abnormality seens such as the heart, liver, spleen, lung, kidney, stomach, intestinal change as a result.Presentation of results, two wonderful anti-inflammatory suppository for gynecopathy mouse stomaches maximum dosage-feeding on the one is 600g crude drug/kg, does not see obvious acute toxic reaction.
(2) vaginal mucosa administration acute toxicity test
12 of female white rabbit are divided into 3 groups at random, 4 every group.First group is the substrate matched group, gives two wonderful anti-inflammatory suppository for gynecopathy substrate mixed fatty glycerides 0.5g/ only; Second group is two wonderful anti-inflammatory suppository for gynecopathy low dose group, gives two wonderful anti-inflammatory suppository for gynecopathy 0.5g/ only (10 times to clinical preparation concentration); The 3rd group is two wonderful anti-inflammatory suppository for gynecopathy high dose group, gives two wonderful anti-inflammatory suppository for gynecopathy 0.5g/ only (10 times to clinical preparation concentration).Each organizes the rabbit vagina administration, low dose group administration 1 time, 0.5g/ time; Administration is 2 times in the high dose group one day, 6h at interval, 0.5g/ time, 1g/ altogether; Substrate matched group coating method is identical with high dose group.24h, 48h and the 7th day after the administration, the general situation of observed and recorded rabbit, skin and hair, the variation of eye and mucosa, breathing, circulation, central nervous system and the active variation of extremity etc.; Local simultaneously observation vaginal mucosa has or not hyperemia, edema, erosion etc.Experimental result shows, viewing duration rabbit hair luster is movable normal, feed and large and small just normal, and body weight does not have significant change, and eye and oral cavity do not have secretions, the no abnormal performance of breathing, circulation and central nervous system, none is only dead.Vagina is not seen hyperemia, edema, erosion etc.Tap the head when experiment finishes and put to death rabbit, dissect perusal main organs color and morphological change, main organs no abnormality seens such as the heart, liver, spleen, lung, kidney, stomach, intestinal, bladder change as a result.Presentation of results, two wonderful anti-inflammatory suppository for gynecopathy rabbit vagina mucosal drug deliveries are not seen obvious acute toxic reaction.
Experiment eight: long-term toxicity test for animals
Give the continuous vaginal mucosa topical of female rats three months with high and low two dosage of two wonderful anti-inflammatory suppository for gynecopathies (be equivalent to respectively be grown up consumption 40 times, 20 times), general situation, hematology, blood biochemical, routine urinalysis, electrocardiogram, system's dissection, organ coefficient and histopathology to rat all do not have obvious influence, do not find toxic reaction, convalescent period does not also have the retardance toxic reaction, and it is 8g crude drug/kg that rat non-toxic reaction consumption is provided.
Experiment nine: local application's safety testing
Two wonderful anti-inflammatory suppository for gynecopathies repeatedly give rabbit normal and damaged skin, and the medication part is show speckle, edema and other abnormal response not, and skin irritation reaction mean scores is 0, and histopathology does not also see that normal and damaged skin has zest to rabbit.Two wonderful anti-inflammatory suppository for gynecopathies are the rabbit vagina topical repeatedly, and naked eyes do not see that vaginal mucosa has hyperemia, edema, hemorrhage, ulcer or erosion etc., and histopathology is not also seen has zest to vaginal mucosa.Two wonderful anti-inflammatory suppository for gynecopathy guinea pig skin administrations, skin is show speckle, edema and other anaphylaxis not, and the skin allergy mean scores is 0, and the sensitization rate is 0%.Presentation of results, two wonderful anti-inflammatory suppository for gynecopathies do not have sensitization to rabbit skin and vagina nonirritant to guinea pig skin.
In sum, can prove that the compositions of Chinese medicine ingredients Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil is used for the treatment of the medicinal usage of bacterial vaginitis.
Claims (6)
1. suppository that is used for the treatment of bacterial vaginitis is characterized in that it is 1: 1.6 Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil that this suppository contains weight ratio.
2. the suppository that is used for the treatment of bacterial vaginitis as claimed in claim 1 is characterized in that, also contains suppository base and Borneolum Syntheticum as adjuvant in this suppository.
3. the suppository that is used for the treatment of bacterial vaginitis as claimed in claim 2 is characterized in that described suppository base is mixed fatty glycerides or other suppository base well known in the art.
4. the suppository that is used for the treatment of bacterial vaginitis as claimed in claim 3 is characterized in that described mixed fatty glycerides accounts for 94% of suppository total amount, and Borneolum Syntheticum accounts for 0.8% of suppository total amount.
5. the described suppository preparation method that is used for the treatment of bacterial vaginitis of claim 1 is characterized in that, may further comprise the steps:
1) gets the Cortex Phellodendri total alkaloids and the Rhzoma Atractylodis Lanceae volatile oil of recipe quantity by proportioning, mix homogeneously;
2) be in the mixed fatty glycerides with adding the suppository base that has dissolved by amount in mixed Cortex Phellodendri total alkaloids and the Rhzoma Atractylodis Lanceae volatile oil, add the Borneolum Syntheticum of recipe quantity again, stir; Wherein mixed fatty glycerides accounts for 94% of suppository total amount, and Borneolum Syntheticum accounts for 0.8% of suppository total amount;
3) fall in the suppository mould, take out promptly after the conventional stand at low temperature.
6. the compositions of Chinese medicine ingredients Cortex Phellodendri total alkaloids and Rhzoma Atractylodis Lanceae volatile oil is used for the treatment of the medicinal usage of bacterial vaginitis.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100730903A CN100340263C (en) | 2004-09-17 | 2004-09-17 | Suppository for treating bacterial vaginitis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100730903A CN100340263C (en) | 2004-09-17 | 2004-09-17 | Suppository for treating bacterial vaginitis |
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| Publication Number | Publication Date |
|---|---|
| CN1616004A true CN1616004A (en) | 2005-05-18 |
| CN100340263C CN100340263C (en) | 2007-10-03 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2004100730903A Expired - Fee Related CN100340263C (en) | 2004-09-17 | 2004-09-17 | Suppository for treating bacterial vaginitis |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103610809A (en) * | 2013-11-25 | 2014-03-05 | 天津高新区添一宴食品科技研发有限责任公司 | External prescription for treating gynecological diseases and preparation method thereof |
| CN104971184A (en) * | 2015-06-26 | 2015-10-14 | 周海梅 | Traditional Chinese medicine for treating liver-yin and kidney-yin deficiency type bacterial vaginitis and preparing method |
| CN109675030A (en) * | 2019-01-14 | 2019-04-26 | 江苏润洁生物科技有限公司 | A kind of compound washing lotion of immune globulin IgY for gynaecological imflammation |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1199674C (en) * | 2002-09-13 | 2005-05-04 | 刘军清 | Compound vagina-cleaning flavescent sophora lotion |
-
2004
- 2004-09-17 CN CNB2004100730903A patent/CN100340263C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103610809A (en) * | 2013-11-25 | 2014-03-05 | 天津高新区添一宴食品科技研发有限责任公司 | External prescription for treating gynecological diseases and preparation method thereof |
| CN104971184A (en) * | 2015-06-26 | 2015-10-14 | 周海梅 | Traditional Chinese medicine for treating liver-yin and kidney-yin deficiency type bacterial vaginitis and preparing method |
| CN109675030A (en) * | 2019-01-14 | 2019-04-26 | 江苏润洁生物科技有限公司 | A kind of compound washing lotion of immune globulin IgY for gynaecological imflammation |
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| Publication number | Publication date |
|---|---|
| CN100340263C (en) | 2007-10-03 |
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