CN101579339A - Pharmaceutical composition for treating gynecological diseases - Google Patents
Pharmaceutical composition for treating gynecological diseases Download PDFInfo
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- CN101579339A CN101579339A CNA2008101064306A CN200810106430A CN101579339A CN 101579339 A CN101579339 A CN 101579339A CN A2008101064306 A CNA2008101064306 A CN A2008101064306A CN 200810106430 A CN200810106430 A CN 200810106430A CN 101579339 A CN101579339 A CN 101579339A
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- pharmaceutical composition
- matrine
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- vaginitis
- cervicitis
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Abstract
The invention discloses a traditional Chinese medicine pharmaceutical composition for treating gynecological diseases, which is characterized by comprising 5-200 of matrine and 1-50 of scutelloside according to the parts by weight, wherein 100 of the kushenin and 25 of the scutelloside are adopted according to the parts by weight. Pharmacological research shows that the pharmaceutical composition has certain actions of resisting bacteria, resisting inflammatory, relieving itching and resisting colpitis and provides an effectively pharmacological foundation for treating colpitis and cervicitis.
Description
Affiliated technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of drug regimen that contains matrine and baicalin.
Background technology
Vaginitis, cervicitis are the common disease of gynecological, belong to " leukorrhagia ", " pudendal pruritus " category of the traditional Chinese medical science, and each age group all can be fallen ill.Vagina and urethra, anus adjoin, and be local moist, vulnerable to pollution; Childbearing age women sexual activity is more frequent, and vulvovaginal be childbirth, uteroventral operation must through the road, sustain damage easily and the infection of extraneous pathogen; Postmenopausal women and infant estrogen level are low, and local resistance descends, and also easily infects.And the vagina squamous epithelial cancer continues mutually with the ectocervical squamous epithelial cancer, and colpitis all can cause the ectocervical inflammation.Except that the ectocervical inflammation, the cervix uteri inflammation also comprises the cervical canal mucosal inflammation, morely see, because the cervical canal mucous epithelium is a simple columnar epithelium, anti-infection ability is relatively poor, easily infects, and its pleat is many, in case infect, be difficult to pathogen is removed fully, cause chronic cervicitis disease for a long time and easily.
Vaginitis is the inflammation of connective tissue under vaginal mucosa and the mucosa, is the general name of the multiple vaginal mucosa inflammatory disease that causes of the different causes of disease.Common vaginitis comprises mycotic, infusorian property, non-specific, senile, haemophilus vaginitis.Infantile vaginitis and amebic vaginitis are more rare.The trichomonal vaginitis sickness rate is the highest, per vaginam trichomonal colpitis, and pilosity is born in the child-bearing period women; Colpitis mycotica 80%-90% is a candida albicans infection; All is not to cause vaginitis by institutes such as special pathogen such as mycete, infusorian, gonococcus, the general designation nonspecific vaginitis; Senile vaginitis claims atrophic vaginitis again, is one of commonly encountered diseases of elderly woman.Primary disease mostly occurs the women who reaches the bilateral ovaries excision after the menopause, after the artificial menopause.Primary disease is higher at China's sickness rate, and the patient accounts for 30% of menopausal women, accounts for all vaginitis patients' 5%.How because of due to hypo-ovaria, estrogen level deficiency and the immunologic hypofunction.
The cervicitis pathogen mostly is general suppuration bacterium, as staphylococcus, streptococcus, escherichia coli, gonorrhea diplococcus, tubercule bacillus etc.; Virus, actinomycetes, infusorian, ameba, mycete, chlamydia etc. cause that cervicitis person is more rare.It can be divided into acute cervicitis and chronic cervicitis according to the course of disease.Acute cervicitis is rare than chronic cervicitis.Common symptom is that patient leucorrhea showed increased, lower abdomen weigh down pain and irritation sign of bladder etc.Suppuration bacterium direct infection cervix uteri when being secondary to puerperal infection, septic abortion or miscarriage more.Normal and urethritis, cystitis or acute vaginitis, acute endometritis are also deposited.Chronic cervicitis is the common disease of gynecological, and its patient accounts for the more than half of married woman.Primary disease is changed by acute cervicitis mostly, or pathogen intrusion cervix uteri causes during by childbirth, miscarriage, vagina operation.The patient is the performance of NAI process often.Because the columnar epithelium of neck tube inner membrance is thin, pleat is many, and is vulnerable, and pathogen is invaded wherein, is difficult for thoroughly removing and presents chronic inflammatory disease.Clinical measuring with leucorrhea mostly is common sympton.
In sum, vaginitis and cervix uteri inflammation are gynecological's common disease, because of women's physiological structure special, determined that the sickness rate of primary disease is very high, and be difficult for curing, the Chang Fanfu outbreak, with the passing of time delay into chronic inflammatory disease, even influence patient's emotion, and then influenced its normal work, study.Modern medicine does not still have the special effect medicine therapeutic primary disease, is exactly at pathogen mainly, and topical application antibiotic, hormone etc. keep the local cleaning of individual simultaneously.Chinese medicine has its special advantages for treatment vaginitis, cervicitis, clinical efficacy is comparatively desirable, but also there are some problems, be difficult to reach very soon therapeutic effect as oral formulations, there is report to treat in recent years with methods such as lotion, suppository, demibains, though curative effect increases, operability is not strong, has brought very big trouble to the patient equally.
Summary of the invention
For these reasons, we are that raw material is formed pharmaceutical composition with matrine and baicalin, and the Radix Sophorae Flavescentis with big bitter Great Cold in the side is a monarch drug, and the matrine master goes into the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, the special heat clearing and damp drying of merit, and kind antipruritic especially, and " hardship of Radix Sophorae Flavescentis more, it is dry strong especially for " book on Chinese herbal medicine justice " speech.Can kill the damp and hot worm that gives birth to, than a kind of reed mentioned in ancient books, to connect the strength benefit strong ".Baicalin, bitter cold matter is dry, property master sedimentation, heat clearing and damp drying is longer than the treatment syndrome of dampness-heat in lower jiao especially; The Herba Taraxaci bitter cold, merit is apt to heat-clearing and toxic substances removing, for controlling the panacea of pyretic toxicity card.So, the medicine of the many bitter cold puckeries of Fang Zhongji is in a stove, and clear mutually its power is played heat-clearing and toxic substances removing, the merit of removing dampness to relieve itching altogether.
The present invention is achieved through the following technical solutions.
A kind of Chinese medicine pharmaceutical composition for the treatment of gynaecopathia, it is made up of matrine, baicalin.
Matrine 5-200 weight portion wherein, baicalin 1-50 weight portion.
Matrine 100 weight portions wherein, baicalin 25 weight portions.
Pharmacological research shows, pharmaceutical composition has certain antibiotic, antiinflammatory, antipruritic and anti-vaginitis effect, is used for the treatment of vaginitis, cervicitis provides effective pharmacological basis.Toxicologic study shows that this product acute toxicity is less, single and repeatedly vagina administration do not see the local excitation symptom.The safety in the clinical dosage scope of prompting this product is better, is safe and reliable, the active drug of treatment vaginitis, cervicitis.
Pharmacological evaluation
Experiment 1
Medicine minimal inhibitory concentration (MIC) is measured
According to clinical laboratory of U.S. committee standard (NCCLS).Add 1ml in each sterilization plate behind the discontinuous two-fold dilution of substep, add MHA agar 9ml again.If contrast replaces medicine for not adding medicine (distilled water).To contain dull and stereotyped and dull and stereotyped 6 lattice parts, each part inoculation bacterium liquid 1 ring drawn of contrast of medicine.Bacterium liquid: 6h bacterium liquid, the turbid concentration of thinner ratio are 0.5 Maxwell pipe.Cultural method: 37 ℃ * 24h, observed result.The quantitative sterilization concentration determination
Operating procedure: according to Ministry of Health of the People's Republic of China's " disinfection technology standard " third edition experimental technique standard (2.6-2.7.6); get drug dipping 5ml in the pharmaceutical composition of the present invention; add 18～24 hours bacterium liquid 0.1ml; take out 0.5ml in 4.5ml meat soup or PBS liquid after the effect scheduled time; rotate 80 times; 10 times of serial dilutions fall ware after 10 minutes, 37 ℃ of 48 hours observed results.Calculate (cfu/ml) and killing rate.
From the result as seen: the pharmaceutical composition immersion is 1: 10～1: 20 to staphylococcus aureus, proteus vulgaris, Salmonella typhi, Fu Shi will Hayes, halophilic bacteria, enterococcus faecalis, enterococcus faecalis, staphylococcus epidermidis and C, D group streptococcus minimal inhibitory concentration MIC, and candida albicans bacterium and escherichia coli are in 1: 10 and 1: 10.Its minimum bactericidal concentration is to the effect of escherichia coli 41002,5 minutes killing rates of concentration effect in 1: 5 are 75.23%, acting on 10 minutes killing rates is 92.94%, acting on 15 minutes killing rates is 99.98%, need 30 minutes killing rates action time is 99.99%, dialogue candidiasis original content medicinal liquid killing rate 30 minutes action time reaches 88.39%, effect to staphylococcus aureus 26003, drug level 1: 5, act on 10 minutes and can reach 99.999%, Salmonella typhi, enterococcus faecalis, the effect of B group streptococcus were reached 99.99% in 30 minutes.
Experiment 2
Antiinflammatory action
The influence of xylol induced mice auricle edema:
Get 50 of mices, random packet, promptly blank group, positive controls (giving dexamethasone) and pharmaceutical composition 0.45g/ml of the present invention group.Test to be coated with in mouse right ear in preceding 1 day and be subjected to reagent 3 times, 0.1ml/ time, blank group is given isopyknic substrate (excipient).The same day was respectively organized coating 1 time in experiment, removed after 1 hour and was tried thing, accurately dripped dimethylbenzene 0.1ml to every auris dextra, put to death mice after 20 minutes, laid left and right ear with card punch, weighed respectively, represented the swelling degree with the difference of two ear weight.
The result:
By table 1 result as seen, medicine group of the present invention all can suppress dimethylbenzene induced mice auricle edema significantly, shows that pharmaceutical composition of the present invention has resist inflammation on repercussive function preferably to acute shallow-layer local organization inflammation.
The inhibitory action of table 1 pharmaceutical composition xylol of the present invention induced mice auricle edema
*Compare with the blank group P＜0.01
Experiment 3
Influence to rat toe swelling due to the Ovum Gallus domesticus album:
Method: get 50 of rats, random packet, promptly blank group, positive controls (giving dexamethasone) and pharmaceutical composition 0.45g/ml of the present invention group.At first measure and respectively organize the right back sufficient sole of the foot limbs Zhou Jing of rat, each organized administration 2 days, 0.1ml/ it is inferior, 3 times/day, respectively organized coating 1 time on the 3rd day, 0.5 after hour each is only organized right back sufficient plantar subcutaneous injection 100% fresh albumen 0.05ml/, measure and cause scorching back 0.5 hour, 1.0 hours, 2.0 hours and 4 hours right back sufficient sole of the foot limbs Zhou Jing, calculate and cause scorching right back sufficient inhibitory rate of intumesce.
The result:
By as seen, pharmaceutical composition group of the present invention can suppress rat toes swelling due to the Ovum Gallus domesticus album significantly.
Table 2 pharmaceutical composition of the present invention is to the influence (n=10) of rat toes inhibitory rate of intumesce due to the Ovum Gallus domesticus album
Experiment 4
Itching-relieving action
The method Cavia porcellus, random packet, promptly blank group, positive controls (giving dexamethasone) and pharmaceutical composition 0.45g/ml of the present invention group.Tested preceding 2 days, the Guinea Pig Left metapedes is shaved hair and coating, 2 times/day, 0.1ml/ time, continuous 2 days, abrades left back foot with sand paper and shaves (the area 1cm of hair place in the 3rd day
2), repaste medicine 1 time is removed after 10 minutes and is tried thing, only be coated with 0.01% 0.05ml/ of histamine phosphate at wound surface, after this every 3 minutes by 0.01%, 0.02%, the 0.03%...... progressive concentration, later lick metapedes until Cavia porcellus occurring, the histamine phosphate's total amount that is given is an itch-threshold.Observe the influence of medicine to the Cavia porcellus itch-threshold.
As shown in table 3, medicine group of the present invention can improve 2～3 times of histamine phosphate Cavia porcellus itch-thresholds, and significant significant difference (P＜0.05) is arranged.
Table 3 pharmaceutical composition of the present invention to the influence of Cavia porcellus itch-threshold (x ± s, n=10)
*P＜0.05,
*Compare with the blank group P＜0.01
Experiment 5
Effect to the rat colpitis mycotica
Method:
The foundation of rat colpitis mycotica model:
Modeling rat bilateral ovaries excision: get not 60 of female healthy rats of copulation of body weight 180-220g sexual maturity, water 16～17h is can't help in fasting, and pentobarbital sodium 35mg/kg intraperitoneal injection of anesthesia, aseptic condition are extractd bilateral ovaries down.Postoperative subcutaneous injection penicillin 100,000 U/ only once a day, for three days on end, prevent and treat and infect.Postoperative beginning in the 4th day by only doing vaginal smear examination, for three days on end, is not seen the vagina epithelium keratinocyte, and the modeling rat all is in diestrus, proves that ovariectomy is complete.
Make false rutting period, cause immunologic hypofunction: postoperative the 7th begins subcutaneous injection diethylstilbestrol 2mg/kg greatly, once a day, continuous 4 days, carry out vaginal smear examination, a large amount of superficial cells appear, prove to occur false rutting period.This day begins except the injection diethylstilbestrol, and Cortex Acanthopanacis Radicis is injection hydrocortisone 60mg/kg down, once a day, for three days on end, makes animal general immunity hypofunction.
The vaginal infection Candida albicans: postoperative the 11st day, connect the mice lavage syringe needle with sterilization 1ml syringe, extraction contains Candida albicans 3～5 * 10
7The bacterium liquid of individual/ml, modeling rat are got position upside down, and 0.1ml Candida albicans liquid is injected intravaginal, and original position stops 1～2min, and control bacterium hydrorrhea goes out.Infect again 1 time with quadrat method behind the 24h.Replace subcutaneous injection diethylstilbestrol or hydrocortisone next day of infecting back modeling animal each 2 times,, increase white and read ball in intravaginal susceptibility to keep false rutting period and general immunity hypofunction state.Infect (operation back the 15th day) after 4 days, the pudendum redness of visible modeling rat is accompanied a small amount of white secretions, dips in aseptic cotton carrier and gets secretions, the visible a large amount of circles of Grams dyeing microscopic examination or oval thalline, spore and pseudohypha, modeling success.
Grouping and administration:
The rat of modeling success is divided into matrix group, model group, medicine group 0.45g/ml of the present invention and daktarin positive controls, 10 every group at random.Every animal single administration 0.2ml pushes ointment in the rat vagina with the 1ml syringe, and 1 time/d, continuous 7d.
Pathogen negative conversion rate (%): dipped in aseptic cotton carrier in 1 day after the drug withdrawal and get the secretions smear, drip 10% KOH liquid, covered, direct microscopy Candida albicans mycelia under high power microscope, it is positive that microscopy is seen mycelia, otherwise negative, respectively organizes vagina Candida albicans negative conversion rate.
Colpitis is cured degree: take off cervical vertebra after smear for microscopic examination is intact and put to death rat, separate vagina, put in 20% formalin and fix, through paraffin enclosed mass, section, HE dyeing, mirror is observed pathological change down.The vagina specimen by hyperemia, edema, hemorrhage, soak into four basic indexs and mark
[9]: hyperemia, edema, hemorrhage, soaked into 0 fen, slightly commented 1 fen, moderate was commented 2 fens, severe was commented 3 fens.The summation of every index inflammation score value is the total score value of inflammation, calculates inflammation by following formula and cures degree:
The result:
The pathogen negative conversion rate:
Dipped in aseptic cotton carrier in 1 day after the drug withdrawal and get the secretions plate coating checking, the daktarin positive controls can't check Candida albicans substantially, and model group and matrix group are except that indivedual, can see a large amount of Candida albicans, though and the basic, normal, high dosage group of pharmaceutical composition of the present invention has only minority can not detect Candida albicans, but its quantity is obviously few than model group, and negative conversion rate is respectively 20%, 40% and 40%.Show that pharmaceutical composition of the present invention can not kill Candida albicans fully, but obvious suppression effect (seeing Table 6) is also arranged.
The influence of table 4. pair rat Candida albicans vaginal infection negative conversion rate
Compare with matrix group,
*P＜0.05
Colpitis is cured degree:
Naked eyes are seen model group vaginal orifice adularescent secretions, and vaginal orifice has adhesion phenomenon, and vaginal orifice bleaches and do not have tangible congestion and edema, and it is no hemorrhage but rough to cut off vagina naked eyes sight vaginal wall surface, visible congestion and edema phenomenon; Matrix group is except that no obvious vaginal orifice adhesion phenomenon, and all the other and model group do not have obvious difference; Medicine group inflammation of the present invention changes except that vaginal orifice does not have adhesion, and vaginal wall is smooth than model group, and the congestion and edema phenomenon is obviously lighter, and the positive controls inflammation is obviously lighter.
Preparation embodiment
Embodiment 1
A kind of Chinese medicine pharmaceutical composition for the treatment of gynaecopathia, matrine, baicalin are formed.
Embodiment 2
A kind of Chinese medicine pharmaceutical composition for the treatment of gynaecopathia, matrine 5 grams, baicalin 1 gram.
Embodiment 3
A kind of Chinese medicine pharmaceutical composition for the treatment of gynaecopathia, matrine 200 grams, baicalin 50 grams.
Embodiment 4
A kind of Chinese medicine pharmaceutical composition for the treatment of gynaecopathia, matrine 100 grams, baicalin 25 grams.
Embodiment 5
A kind of Chinese medicine pharmaceutical composition for the treatment of gynaecopathia, matrine 20 grams, baicalin 5 grams.
Embodiment 6
A kind of Chinese medicine pharmaceutical composition for the treatment of gynaecopathia, matrine 190 grams, baicalin 40 grams.
Claims (3)
1, a kind of Chinese medicine pharmaceutical composition for the treatment of gynaecopathia is characterized in that it is made up of matrine, baicalin.
2, a kind of pharmaceutical composition for the treatment of gynaecopathia according to claim 1, matrine 5-200 weight portion wherein, baicalin 1-50 weight portion.
3, a kind of pharmaceutical composition for the treatment of gynaecopathia according to claim 1, matrine 100 weight portions wherein, baicalin 25 weight portions.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101064306A CN101579339A (en) | 2008-05-14 | 2008-05-14 | Pharmaceutical composition for treating gynecological diseases |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2008101064306A CN101579339A (en) | 2008-05-14 | 2008-05-14 | Pharmaceutical composition for treating gynecological diseases |
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| CN101579339A true CN101579339A (en) | 2009-11-18 |
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| CNA2008101064306A Pending CN101579339A (en) | 2008-05-14 | 2008-05-14 | Pharmaceutical composition for treating gynecological diseases |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115844913A (en) * | 2022-01-12 | 2023-03-28 | 南方医科大学皮肤病医院（广东省皮肤病医院、广东省皮肤性病防治中心、中国麻风防治研究中心） | Application of baicalin in preparation of medicine for treating gonococcal and/or drug-resistant gonococcal infection |
-
2008
- 2008-05-14 CN CNA2008101064306A patent/CN101579339A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115844913A (en) * | 2022-01-12 | 2023-03-28 | 南方医科大学皮肤病医院（广东省皮肤病医院、广东省皮肤性病防治中心、中国麻风防治研究中心） | Application of baicalin in preparation of medicine for treating gonococcal and/or drug-resistant gonococcal infection |
| CN115844913B (en) * | 2022-01-12 | 2023-11-07 | 南方医科大学皮肤病医院（广东省皮肤病医院、广东省皮肤性病防治中心、中国麻风防治研究中心） | Application of baicalin in preparation of medicines for treating gonococcus and/or drug-resistant gonococcus infection |
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Open date: 20091118 |