CN1899392B - Chinese medicine composition for treating gynecological inflammation and its preparing method and use - Google Patents
Chinese medicine composition for treating gynecological inflammation and its preparing method and use Download PDFInfo
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Abstract
The present invention is a kind of Chinese medicine composition for treating gynecological diseases and its preparation process and application. The Chinese medicine composition is prepared with oroxylum seed, wild chrysanthemum flower, red peony root, borneol and calm powder. The Chinese medicine composition may be effervescent tablet, effervescent capsule, effervescent granule, lution, supporsitory, gel or other pharmaceutically acceptable preparation forms.
Description
Technical field
The present invention relates to field of medicaments, specifically, relate to a kind of Chinese medicine composition that is used for the treatment of gynaecopathias such as vaginitis, cervicitis, cervical erosion and preparation method thereof.
Background technology
Because the special physiological make-up characteristics of women, vaginitis, cervicitis, cervical erosion are women of child-bearing age's commonly encountered diseases, frequently-occurring disease, sickness rate accounts for the women of child-bearing age's 50%, rural area women of child-bearing age's sickness rate is higher, because vaginitis can cause pruritus vulvae, leucorrhoea grow in quantity, vaginal orifice and urethral orifice burning sensation and pain etc., have a strong impact on women's operate as normal and life, cervicitis, cervical erosion more can be brought out cervical cancer, therefore, active prevention and treatment gynecological inflammation are to ensure female body health, improve the female life quality, prevent the important channel that cervical cancer takes place.
It is a lot of at present to be used for treating colpitic gynecological external use medicine kind on the domestic market, as being the gynecological external use lotion of representative with the JIEERYIN of Chengdu grace prestige pharmaceutical manufacturing, the FUYINJIE that Guangxi Yuan Antang produces; The miconazole of producing with Xi'an Yang Sen is the external suppository of representative; And metronidazole etc. is other conventional dosage forms of representative.But the Western medicine defective is apparent in view, as act on single, easily produce anaphylaxis, zest, Drug resistance etc., being unsuitable for anemia of pregnant woman and women breast-feeding their children uses, intravaginal profitable strain had killing action equally, easily cause dysbacteriosis in the vagina, destroy the self-cleaning system of vagina etc., that some medicine self also has is carcinogenic, the potential danger (as metronidazole, metronidazole etc.) of teratogenesis.Existing Chinese medicine is each some deficiency also, and the prescription that has is bigger, and the technology that has is loaded down with trivial details.JIEERYIN XIYE as Chengdu grace prestige pharmaceutical manufacturing has tens flavor medical materials, and medical material involved in the present invention has only the five tastes, and technology is also very simple.
Summary of the invention
(1) technical problem that will solve
Purpose of the present invention aims to provide a kind of Chinese medicine composition that is used for the treatment of gynaecopathias such as vaginitis, cervicitis, cervical erosion and preparation method thereof.
(2) technical scheme
A kind of Chinese medicine composition that is used for the treatment of gynaecopathias such as vaginitis, cervicitis, cervical erosion provided by the invention is characterized in that described Chinese medicine composition is to make by pressing column weight amount proportion raw material: Semen Oroxyli 100-500 part, Flos Chrysanthemi Indici 200-800 part, Radix Paeoniae Rubra 100-500 part, Borneolum Syntheticum 0.1-5 part, Pulvis concha Mactrae 10-50 part.
Wherein preferred proportioning raw materials is: Semen Oroxyli 270-330 part, Flos Chrysanthemi Indici 450-550 part, Radix Paeoniae Rubra 270-330 part, Borneolum Syntheticum 0.9-1.1 part, Pulvis concha Mactrae 27-33 part.
We are by Semen Oroxyli, Flos Chrysanthemi Indici, Radix Paeoniae Rubra, Borneolum Syntheticum, Pulvis concha Mactrae (Concha Meretricis Seu Cyclinae) five kinds of Chinese medicine is formed, has removing damp-heat, leukorrhagia stopping itching relieving function. Semen Oroxyli in the side, Flos Chrysanthemi Indici is a monarch drug: Semen Oroxyli nature and flavor bitter cold, people's lung, liver two warps, the lung moistening unboiled water is arranged, the merit of soothing liver-QI stomach function regulating. the effect of heat-clearing and toxic substances removing is also arranged, contain with controlling damp and hot poison, the carbuncle skin ulcer of being detained skin and causing is swollen, pruritus flowing water, but prolongedly do not heal. the external heat-clearing and toxic substances removing, removing dampness is antipruritic. and Semen Oroxyli goes into lung meridian, lung governing skin and hair, so skin infection is not held back the person, can reach the effect of holding back skin ulcer. carry as Compendium of Material Medica: " all carbuncle poison do not close up; paste it with this ". at heat-clearing and toxic substances removing, dampness simultaneously, by the inducing diuresis and reducing edema skin ulcer of holding back. Flos Chrysanthemi Indici nature and flavor sweetness and bitterness is hot cool, go into lung, liver two warps, wind and heat dispersing not only, removing toxic substances and promoting subsidence of swelling, also have the removing dampness and killing parasites effect. " book on Chinese herbal medicine converge speech " said: " wash the skin ulcer scabies, wind dispelling insecticide is arranged again. " vulvovaginitis mostly is dampness-heat of the liver and makes a bet due to the vaginal orifice, and also visible protozoon infects, show as profuse leukorrhea more, local redness is itched bitterly. select Semen Oroxyli for use, Flos Chrysanthemi Indici is as principal agent, and heat that can removing summer-heat liver lung again can dampness detumescence parasite killing.
Ministerial drug: Radix Paeoniae Rubra nature and flavor acid is cool, returns liver, spleen two warps, and its sweet in the mouth is cool in nature, is longer than the heat of branchs that purify the blood, eliminating fire and detoxication again, by heat clearing away, dampness, removing heat from blood to detoxify." the southern regions of the Yunnan Province book on Chinese herbal medicine " cloud: " move back heat in blood, attack the carbuncle skin ulcer, control mange ".Its property bitter cold is loose partially and is rushed down partially, again can the dampness diuretic, and auxiliary Flos Chrysanthemi Indici is strengthened the merit of heat-clearing and toxic substances removing dampness.
Pulvis concha Mactrae in the side (Concha Meretricis Seu Cyclinae), Borneolum Syntheticum are adjuvant altogether.Wherein, Pulvis concha Mactrae has the effect of clearing away heat and promoting diuresis reducing swelling and alleviating pain, and external can be controlled eczema.Borneolum Syntheticum clearing away heat to alleviate pain granulation promoting is medicine for external use commonly used, and kind controlling do not held back after ulcer sores is burst.
All medicines share, and can remove damp, heat clearing away poison, reach removing damp-heat, the effect of leukorrhagia stopping itching relieving.
Modern chemistry and pharmaceutical research show, main component in the Semen Oroxyli is oroxylin, chrysin, noroxylin etc., these compositions have good inflammation antagonism, antibacterials such as staphylococcus aureus, streptococcus, epidermophyton and fungus there are inhibitory or killing effect, leptospira, trichomonas vaginitis are also killed or inhibitory action.Flos Chrysanthemi Indici has broad-spectrum antibacterial action, can suppress the growth of staphylococcus aureus, escherichia coli, bacillus pyocyaneus etc.Radix Paeoniae Rubra has stronger inhibitory action to multiple pathogenic microorganism, dysentery, typhoid fever, paratyphoid fever, green pus, large intestine, distortion and daytime are coughed bacillus, staphylococcus, Hemolytic streptococcus, streptococcus pneumoniae, with nearly vibrio cholera inhibitory action is arranged all, some pathogenic fungus is also had bacteriostasis.The main component of Borneolum Syntheticum is Borneolum Syntheticum and isoborneol, and staphylococcus aureus, streptococcus, escherichia coli and pathogenic dermatophytes are all had inhibitory action.
Chinese medicine composition of the present invention can be effervescent tablet, effervescent capsule, effervescent granule, washing liquid, suppository, gel.Wherein used carrier is conventional carrier in the preparation, disintegrating agent commonly used such as sodium bicarbonate and citric acid, polyethylene glycol 6000 etc., excipient such as dextrin, micropowder silica gel mixture, microcrystalline Cellulose, greasing base etc.
The present invention also provides the preparation method of this Chinese medicine composition, and it may further comprise the steps:
(1) gets Semen Oroxyli, Flos Chrysanthemi Indici, Radix Paeoniae Rubra three flavor medical materials, add water 5-15 and doubly measure decoction 1-5 time, each 0.5-3 hour, filter, merge decocting liquid, relative density is the extractum of 1.01-1.25 when being concentrated into 60 ℃, adding ethanol makes the alcohol amount of containing reach 50-90%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is the extractum of 1.15-1.40 when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.
(2) get Borneolum Syntheticum, after the small amount of ethanol dissolving, press Borneolum Syntheticum: beta-schardinger dextrin-: the weight ratio of water=1: 6-10: 60-100, stirred 0.5-2 hour at 60 ℃, carry out inclusion, cold preservation is spent the night, and filters, and inclusion complex is ground into fine powder 30-60 ℃ of cold drying, and is standby.
(3) get Pulvis concha Mactrae, mix with gained Borneolum Syntheticum inclusion complex in gained medicated powder, the step (2) in the step (1), mixing is made or is added suitable adjuvant and makes pharmaceutically acceptable dosage form.
The relative density of gained extractum was 1.10-1.12 when wherein the water extract was concentrated into 60 ℃ in the step (1), and it is 1.25-1.30 that alcohol extract is concentrated into 60 ℃ of gained extractum relative densities.
Wherein Borneolum Syntheticum, beta-schardinger dextrin-, water carry out inclusion according to 1: 8: 80 weight ratio in the step (2).
The present invention also provides another preparation method of this Chinese medicine composition, and it may further comprise the steps:
(1) gets Semen Oroxyli, Flos Chrysanthemi Indici, Radix Paeoniae Rubra three flavor medical materials, add water 5-15 and doubly measure decoction 1-5 time, each 0.5-3 hour, filter, merge decocting liquid, relative density is the extractum of 1.01-1.25 when being concentrated into 60 ℃, adding ethanol makes the alcohol amount of containing reach 50-90%, cold preservation is spent the night, and filters, and filtrate recycling ethanol is to there not being the alcohol flavor.
(2) get Borneolum Syntheticum, after the small amount of ethanol dissolving, get Pulvis concha Mactrae, together add in step (1) the gained extracting solution and mix, mixing is made or is added suitable adjuvant and makes washing liquid.
Chinese medicine composition of the present invention has removing damp-heat, leukorrhagia stopping itching relieving effect, is applicable to leukorrhagia due to the damp invasion of lower energizer, pudendal pruritus disease, profuse leukorrhea, pruritus vulvae or redness, symptoms such as vaginitis, cervicitis, cervical erosion.
(3) beneficial effect
Chinese medicine composition of the present invention is the compound Chinese medicinal preparation with the theory of Chinese medical science prescription, many deficiencies of chemical medicine both can have been overcome, can bring into play the incomparable many-sided therapeutical effect of chemical medicine again (as removing damp-heat, leukorrhagia stopping is antipruritic, putrefaction-removing granulation-promoting, astringing to arrest bleeding or the like), can be widely used in antibacterial, fungus, protozoon, chlamydia, the former caused gynecological inflammation that causes a disease such as mycoplasma, simultaneously, Chinese traditional compound medicine also has the effect of pH buffer agent, by regulating vagina pH, the vagina self-cleaning function is recovered, suppress pathogenic microorganism or protozoacide growth and breeding by self-cleaning system, Chinese medicine will be better than Western medicine far away to the comprehensive inhibitory action of virus, therefore, aspect the treatment gynecological inflammation, the exploitation determined curative effect, the pure Chinese medicinal preparation of dosage form novelty has vast market prospect.
The specific embodiment
Following examples are used for understanding better the present invention, but are not used for limiting the scope of the invention.
The preparation of embodiment 1 Chinese medicine composition effervescent tablet of the present invention
Get Semen Oroxyli 3000g, Flos Chrysanthemi Indici 5000g, Radix Paeoniae Rubra 3000g, add 10 times of amounts of water and decoct each 1 hour 3 times, filter, merge decocting liquid, relative density is 1.10 extractum when being concentrated into 60 ℃, adding ethanol makes and contains alcohol amount and reach 70%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is 1.25 thick paste when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.Get Borneolum Syntheticum 10g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 8: 80, to stir at 60 ℃ and to carry out inclusion in 1 hour, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 40 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 300g, mix with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex, adding adipic acid 450g and sodium bicarbonate 360g and mannitol are an amount of, mixing, and granulation, tabletting, promptly.
The preparation of embodiment 2 Chinese medicine composition effervescent tableies of the present invention
Get Semen Oroxyli 2800g, Flos Chrysanthemi Indici 4800g, Radix Paeoniae Rubra 3200g, add 10 times of amounts of water and decoct each 1 hour 3 times, filter, merge decocting liquid, relative density is 1.10 extractum when being concentrated into 60 ℃, adding ethanol makes and contains alcohol amount and reach 70%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is 1.25 thick paste when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.Get Borneolum Syntheticum 10g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 8: 80, to stir at 60 ℃ and to carry out inclusion in 1 hour, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 40 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 320g, mix with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex, adding adipic acid 450g and sodium bicarbonate 360g and mannitol are an amount of, and mixing is granulated, promptly.
The preparation of embodiment 3 Chinese medicine composition effervescent capsules of the present invention
Get Semen Oroxyli 3000g, Flos Chrysanthemi Indici 5000g, Radix Paeoniae Rubra 3000g, add 10 times of amounts of water and decoct each 1 hour 3 times, filter, merge decocting liquid, relative density is 1.10 extractum when being concentrated into 60 ℃, adding ethanol makes and contains alcohol amount and reach 70%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is 1.25 thick paste when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.Get Borneolum Syntheticum 10g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 6: 60, to stir at 60 ℃ and to carry out inclusion in 1 hour, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 40 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 300g, mix with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex, adding adipic acid 450g and sodium bicarbonate 360g and mannitol are an amount of, and mixing is granulated, and is encapsulated, promptly.
The preparation of embodiment 4 Chinese medicine composition effervescent capsules of the present invention
Get Semen Oroxyli 2800g, Flos Chrysanthemi Indici 4800g, Radix Paeoniae Rubra 3200g adds 10 times of amounts of water and decocts each 1 hour 3 times, filter, merge decocting liquid, relative density is 1.10 extractum when being concentrated into 60 ℃, add ethanol and make and contain alcohol amount and reach 70%, cold preservation is spent the night, and filters, filtrate recycling ethanol, and relative density is 1.25 thick paste when being concentrated into 60 ℃, drying under reduced pressure, be ground into fine powder, standby. get Borneolum Syntheticum 10g,, press Borneolum Syntheticum: beta-schardinger dextrin-: the weight ratio of water=1: 8: 80 with after the small amount of ethanol dissolving, carried out inclusion in 1 hour 60 ℃ of stirrings, cold preservation is spent the night, and filters, and inclusion complex is 40 ℃ of cold drying, be ground into fine powder, standby. get Pulvis concha Mactrae 320g, mix with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex, adding adipic acid 450g and sodium bicarbonate 360g and mannitol are an amount of, mixing, granulate, encapsulated, promptly.
The preparation of embodiment 5 Chinese medicine composition suppositorys of the present invention
Get Semen Oroxyli 2800g, Flos Chrysanthemi Indici 4800g, Radix Paeoniae Rubra 3200g, add 10 times of amounts of water and decoct each 1 hour 3 times, filter, merge decocting liquid, relative density is 1.12 extractum when being concentrated into 60 ℃, adding ethanol makes and contains alcohol amount and reach 70%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is 1.25 thick paste when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.Get Borneolum Syntheticum 10g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 7: 70, to stir at 60 ℃ and to carry out inclusion in 1 hour, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 40 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 320g, mix, add substrate 220g, make suppository, promptly with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex.
The preparation of embodiment 6 Chinese medicine composition suppositorys of the present invention
Get Semen Oroxyli 3200g, Flos Chrysanthemi Indici 5200g, Radix Paeoniae Rubra 2800g, add 10 times of amounts of water and decoct each 1 hour 3 times, filter, merge decocting liquid, relative density is 1.12 extractum when being concentrated into 60 ℃, adding ethanol makes and contains alcohol amount and reach 70%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is 1.25 thick paste when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.Get Borneolum Syntheticum 10g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 9: 90, to stir at 60 ℃ and to carry out inclusion in 1 hour, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 40 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 280g, mix, add substrate 220g, make suppository, promptly with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex.
The preparation of embodiment 7 Chinese medicine composition gels of the present invention
Get Semen Oroxyli 3000g, Flos Chrysanthemi Indici 5000g, Radix Paeoniae Rubra 3000g, add 10 times of amounts of water and decoct each 1 hour 3 times, filter, merge decocting liquid, relative density is 1.10 extractum when being concentrated into 60 ℃, adding ethanol makes and contains alcohol amount and reach 70%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is 1.25 thick pastes when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.Get Borneolum Syntheticum 10g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 8: 80, to stir at 60 ℃ and to carry out inclusion in 1 hour, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 40 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 300g, mix, add substrate 200g, make gel, promptly with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex.
The preparation of embodiment 8 Chinese medicine composition gels of the present invention
Get Semen Oroxyli 2800g, Flos Chrysanthemi Indici 4800g, Radix Paeoniae Rubra 3200g, add 10 times of amounts of water and decoct each 1 hour 3 times, filter, merge decocting liquid, relative density is 1.10 extractum when being concentrated into 60 ℃, adding ethanol makes and contains alcohol amount and reach 70%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is 1.25 thick pastes when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.Get Borneolum Syntheticum 10g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 8: 80, to stir at 60 ℃ and to carry out inclusion in 1 hour, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 40 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 320g, mix, add substrate 200g, make gel, promptly with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex.
The preparation of embodiment 9 Chinese medicine composition effervescent granules of the present invention
Get Semen Oroxyli 1000g, Flos Chrysanthemi Indici 2000g, Radix Paeoniae Rubra 5000g adds 15 times of amounts of water and decocts each 0.5 hour 5 times, filter, merge decocting liquid, relative density is 1.25 extractum when being concentrated into 60 ℃, add ethanol and make and contain alcohol amount and reach 90%, cold preservation is spent the night, and filters, filtrate recycling ethanol, and relative density is 1.40 thick paste when being concentrated into 60 ℃, and drying under reduced pressure is ground into fine powder, standby. get Borneolum Syntheticum 50g, with after the small amount of ethanol dissolving, press Borneolum Syntheticum: beta-schardinger dextrin-: the weight ratio of water=1: 10: 100, carried out inclusion in 2 hours 60 ℃ of stirrings, cold preservation is spent the night, filter, inclusion complex is ground into fine powder 60 ℃ of cold drying, standby. get Pulvis concha Mactrae 100g, mix with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex, it is an amount of to add adipic acid 420g and sodium bicarbonate 350g and mannitol again, mixing, granulate, promptly.
The preparation of embodiment 10 Chinese medicine composition effervescent capsules of the present invention
Get Semen Oroxyli 5000g, Flos Chrysanthemi Indici 8000g, Radix Paeoniae Rubra 1000g, add 5 times of amounts of water and decoct 3 hours 1 time, filter, relative density is 1.01 extractum when being concentrated into 60 ℃, adds ethanol and makes and contain alcohol amount and reach 50%, and cold preservation is spent the night, filter, filtrate recycling ethanol, and relative density is 1.15 thick paste when being concentrated into 60 ℃, drying under reduced pressure, be ground into fine powder, standby.Get Borneolum Syntheticum 1g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 6: 60, to stir at 60 ℃ and to carry out inclusion in 0.5 hour, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 30 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 500g, with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex mixing, it is an amount of to add adipic acid 520g and sodium bicarbonate 420g and mannitol again, and mixing is granulated, and is encapsulated, promptly.
The preparation of embodiment 11 Chinese medicine composition suppositorys of the present invention
Get Semen Oroxyli 3300g, Flos Chrysanthemi Indici 5500g, Radix Paeoniae Rubra 2700g, add 10 times of amounts of water and decoct each 1 hour 3 times, filter, merge decocting liquid, relative density is 1.12 extractum when being concentrated into 60 ℃, adding ethanol makes and contains alcohol amount and reach 70%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is 1.30 thick paste when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.Get Borneolum Syntheticum 9g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 8: 80, to stir at 60 ℃ and to carry out inclusion in 1 hour, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 40 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 330g, mix, add substrate 220g, make suppository, promptly with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex.
The preparation of embodiment 12 Chinese medicine composition effervescent granules of the present invention
Get Semen Oroxyli 2700g, Flos Chrysanthemi Indici 4500g, Radix Paeoniae Rubra 3300g, add 15 times of amounts of water and decoct each 0.5 hour 5 times, filter, merge decocting liquid, relative density is 1.25 extractum when being concentrated into 60 ℃, adding ethanol makes and contains alcohol amount and reach 90%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is 1.40 thick paste when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby.Get Borneolum Syntheticum 11g,, press Borneolum Syntheticum: beta-schardinger dextrin-with after the small amount of ethanol dissolving: the weight ratio of water=1: 10: 100, to stir at 60 ℃ and to carry out inclusion in 2 hours, cold preservation is spent the night, filtration, inclusion complex is ground into fine powder 60 ℃ of cold drying, and is standby.Get Pulvis concha Mactrae 270g, mix with above-mentioned medicated powder and Borneolum Syntheticum inclusion complex, it is an amount of to add adipic acid 420g and sodium bicarbonate 350g and mannitol again, and mixing is granulated, promptly.
The preparation of embodiment 13 Chinese medicine composition washing liquids of the present invention
Get Semen Oroxyli 3000g, Flos Chrysanthemi Indici 5000g, Radix Paeoniae Rubra 3000g, add 10 times of amounts of water and decoct 3 times, each 1 hour, filter, merge decocting liquid, relative density is 1.10 extractum when being concentrated into 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 70%, cold preservation is spent the night, and filters, and filtrate recycling ethanol is to there not being the alcohol flavor.Get Borneolum Syntheticum 10g, after the small amount of ethanol dissolving, get Pulvis concha Mactrae 300g and together add in the said extracted liquid, add 120g polyoxyethylene sorbitan monoleate and 60g sodium benzoate again, add water and be settled to 1000ml, promptly.
The preparation of embodiment 14 Chinese medicine composition washing liquids of the present invention
Get Semen Oroxyli 2800g, Flos Chrysanthemi Indici 4800g, Radix Paeoniae Rubra 3200g, add 10 times of amounts of water and decoct 3 times, each 1 hour, filter, merge decocting liquid, relative density is 1.10 extractum when being concentrated into 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 70%, cold preservation is spent the night, and filters, and filtrate recycling ethanol is to there not being the alcohol flavor.Get Borneolum Syntheticum 10g, after the small amount of ethanol dissolving, get Pulvis concha Mactrae 320g and together add in the said extracted liquid, add 120g polyoxyethylene sorbitan monoleate and 60g sodium benzoate again, add water and be settled to 1000ml, promptly.
The preparation of embodiment 15 Chinese medicine composition washing liquids of the present invention
Get Semen Oroxyli 1000g, Flos Chrysanthemi Indici 2000g, Radix Paeoniae Rubra 5000g, add 5 times of amounts of water and decoct 5 times, each 0.5 hour, filter, merge decocting liquid, relative density is 1.01 extractum when being concentrated into 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 50%, cold preservation is spent the night, and filters, and filtrate recycling ethanol is to there not being the alcohol flavor.Get Borneolum Syntheticum 50g, after the small amount of ethanol dissolving, get Pulvis concha Mactrae 100g and together add in the said extracted liquid, add 140g polyoxyethylene sorbitan monoleate and 70g sodium benzoate again, add water and be settled to 1000ml, promptly.
The preparation of embodiment 16 Chinese medicine composition washing liquids of the present invention
Get Semen Oroxyli 5000g, Flos Chrysanthemi Indici 8000g, Radix Paeoniae Rubra 1000g, add 15 times in water amount and decoct 1 time, 3 hours, filter, relative density is 1.25 extractum when being concentrated into 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation is spent the night, and filters, and filtrate recycling ethanol is to there not being the alcohol flavor.Get Borneolum Syntheticum 1g, after the small amount of ethanol dissolving, get Pulvis concha Mactrae 500g and together add in the said extracted liquid, add 140g polyoxyethylene sorbitan monoleate and 70g sodium benzoate again, add water and be settled to 1000ml, promptly.
The preparation of embodiment 17 Chinese medicine composition washing liquids of the present invention
Get Semen Oroxyli 2700g, Flos Chrysanthemi Indici 4500g, Radix Paeoniae Rubra 3300g, add 8 times of amounts of water and decoct 4 times, each 2 hours, filter, merge decocting liquid, relative density is 1.12 extractum when being concentrated into 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 80%, cold preservation is spent the night, and filters, and filtrate recycling ethanol is to there not being the alcohol flavor.Get Borneolum Syntheticum 11g, after the small amount of ethanol dissolving, get Pulvis concha Mactrae 270g and together add in the said extracted liquid, add 140g polyoxyethylene sorbitan monoleate and 70g sodium benzoate again, add water and be settled to 1000ml, promptly.
The preparation of embodiment 18 Chinese medicine composition washing liquids of the present invention
Get Semen Oroxyli 3300g, Flos Chrysanthemi Indici 5500g, Radix Paeoniae Rubra 2700g, add 12 times of amounts of water and decoct 2 times, each 2 hours, filter, merge decocting liquid, relative density is 1.15 extractum when being concentrated into 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 90%, cold preservation is spent the night, and filters, and filtrate recycling ethanol is to there not being the alcohol flavor.Get Borneolum Syntheticum 9g, after the small amount of ethanol dissolving, get Pulvis concha Mactrae 330g and together add in the said extracted liquid, add 140g polyoxyethylene sorbitan monoleate and 70g sodium benzoate again, add water and be settled to 1000ml, promptly.
Below set forth the effect of this Chinese medicine composition by test.
Experimental example 1 Chinese medicine composition Expermental research on main pharmacodynamics of the present invention
Chinese medicine composition of the present invention adopts in vitro tests and to the direct vagina of animal/cervix uteri administration or local skin administering mode, proves that by experiment Chinese medicine composition of the present invention has:
1, antivirus action is on external HEP-2 cell culture test, and Chinese medicine composition of the present invention all has inhibitory action in various degree to HSV-I, HSV-II pathological changes caused by virus.
2, antibacterial, press down to kill the outer bacteriostatic experiment of infusorian acting body and show, Chinese medicine composition of the present invention infects relevant antibacterial to the common vagina/cervix uteri that is tried, as staphylococcus aureus, escherichia coli, Bacillus proteus, bacillus pyocyaneus, B family streptococcus and fungus Candida albicans, each 11 strain all has inhibitory action in various degree.Bacteriostatic experiment shows that Chinese medicine composition object height of the present invention, middle dosage have inhibitory action to mouse vagina/cervix uteri bacterial infection after the administration in the body, and the fungal infection negative conversion rate is significantly improved.Chinese medicine composition of the present invention institute amount of reagent has killing or suppress the breeding effect in various degree to trichomonas vaginitis.
3, antiinflammatory action Chinese medicine composition of the present invention institute amount of reagent obviously alleviates vagina/cervicitis rat model intravaginal and cervix uteri inflammation degree, and inflammation degree integration has been compared significant difference with model control group.And obviously alleviate the mice ear that Oleum Tiglii brings out.
4, itching-relieving action Chinese medicine composition of the present invention obviously improves the Cavia porcellus itch-threshold, has stronger itching-relieving action.
Above result prove Chinese medicine composition of the present invention have antiviral, antibacterial, press down to kill infusorian, antiinflammatory, itching relieving pharmacological action, declare Chinese medicine the 6th kind new medicine for Chinese medicine composition of the present invention experimental basis be provided.
Experimental example 2 Chinese medicine composition toxicological test researchs of the present invention
1, acute toxicity testing
Chinese medicine composition of the present invention is with 4.0 and 2.0g crude drug/ml, 0.05ml/100g body weight, 4 rat vagina/cervix uteri administrations in 4 hours.Observed 24,48 hours and 7 days.Do not find phenomenons such as vagina/cervix uteri stimulation, allergy, mucosa, breathing, circulation, central nervous system, extremity activity etc. all do not have obvious poisoning manifestations, and body weight all increases to some extent.
2, long term toxicity test
Chinese medicine composition 4.0,2.0 of the present invention, 1.0g crude drug/ml concentration liquid, 0.05ml/100g body weight, 2 rat vagina/cervix uteri administrations in 2 hours (4.0,2.0,1.0g crude drug/kg). continuous 9 weeks, observed for 2 weeks after the drug withdrawal. each is organized rat ordinary circumstance, body weight, food-intake, peripheral hemogram, ten biochemical indicators and compares with matched group with organ index, equal no significant difference, main organs, the no tangible pathological change of tissue. showing the interior no obvious toxicity of Chinese medicine composition institute's amount of reagent scope of the present invention, is comparison safety.
3, sensitivity test
With Chinese medicine composition sensitization of the present invention and excite Cavia porcellus, do not cause skin allergy.
Above result provides reference for data for clinical drug use.
Experimental example 3 traditional Chinese medicine composition for treating women's candida albicans vaginitises of the present invention, trichomonal vaginitis (damp invasion of lower energizer disease) and cervicitis clinical observation are summed up
Be the clinical efficacy of research Chinese medicine composition of the present invention, we observe 50 routine women's candida albicans vaginitises, trichomonal vaginitis (damp invasion of lower energizer disease) and cervicitis patient, and observed result is as follows.
Select in March, the 2002-2002 year outpatient service vaginitis patient of December Beijing Hospital of Traditional Chinese Medicine 50 examples, be divided into two groups at random.Observation group's 30 examples, the age: 20-55 year, trichomonal vaginitis 12 examples wherein, candida albicans vaginitis 10 examples, cervicitis 8 examples.Give one pair of Chinese medicine composition of the present invention, the dense 100ml that fries in shallow oil, behind the cleaning pudendum, the band wire cotton balls is filled in vagina after being stained with medicine, take out after 4 hours, once a day, logotype 7 days.Matched group 20 examples, the age: 19-54 year, trichomonal vaginitis 8 examples wherein, candida albicans vaginitis 6 examples, cervicitis 6 examples.Give 1 of JIEERYIN PAOTENGPIAN, fill in vagina behind the cleaning pudendum, once a day, logotype 7 days.Do not use the related drugs treatment before two groups of patients treat in February, dependencys such as age, the state of an illness, the course of disease relatively there are no significant difference has comparability before treating.
Two group objects ordinary circumstances
Each group is P＞0.05 relatively
Two groups of clinical efficacies relatively
Analyze u=2.16 through Ridit, there is statistical significance .P＜0.05
Result: treatment group: cure rate 63.3%, obvious effective rate 23.3%, effective percentage 10.0%, inefficiency 3.3%, total effective rate 96.7%, matched group: cure rate 35.0%, obvious effective rate 20.0%, effective percentage 35.0%, inefficiency 10.0%, total effective rate 90.0%.
All have no adverse reaction in two groups of patient treatment processes.Two groups of curative effects compare: .P＜0.05, significant difference is arranged, the result shows that observation group's curative effect is higher than matched group, that observation group and matched group more also have is non-stimulated, free from extraneous odour, characteristics such as pollution clothes not, illustrates that Chinese medicine composition of the present invention is the safe and effective desirable medication of treatment women vaginitis, cervicitis, cervical erosion.
Claims (9)
1. a Chinese medicine composition that is used for the treatment of the gynaecopathia of vaginitis, cervicitis, cervical erosion is characterized in that described Chinese medicine composition is to make by pressing column weight amount proportion raw material: Semen Oroxyli 100-500 part, Flos Chrysanthemi Indici 200-800 part, Radix Paeoniae Rubra 100-500 part, Borneolum Syntheticum 0.1-5 part, Pulvis concha Mactrae 10-50 part.
2. Chinese medicine composition as claimed in claim 1 is characterized in that described Chinese medicine composition is to make by pressing column weight amount proportion raw material: Semen Oroxyli 270-330 part, Flos Chrysanthemi Indici 450-550 part, Radix Paeoniae Rubra 270-330 part, Borneolum Syntheticum 0.9-1.1 part, Pulvis concha Mactrae 27-33 part.
3. Chinese medicine composition as claimed in claim 1 or 2 is characterized in that it is effervescent tablet, effervescent capsule, effervescent granule, washing liquid, suppository, gel.
4. as the preparation method of the arbitrary described Chinese medicine composition of claim 1-3, it may further comprise the steps:
(1) gets Semen Oroxyli, Flos Chrysanthemi Indici, Radix Paeoniae Rubra three flavor medical materials, add water 5-15 and doubly measure decoction 1-5 time, each 0.5-3 hour, filter, merge decocting liquid, relative density is the extractum of 1.01-1.25 when being concentrated into 60 ℃, adding ethanol makes the alcohol amount of containing reach 50-90%, cold preservation is spent the night, and filters filtrate recycling ethanol, and relative density is the extractum of 1.15-1.40 when being concentrated into 60 ℃, drying under reduced pressure is ground into fine powder, and is standby;
(2) get Borneolum Syntheticum, after the small amount of ethanol dissolving, press Borneolum Syntheticum: beta-schardinger dextrin-: the weight ratio of water=1: 6-10: 60-100, stirred 0.5-2 hour at 60 ℃, carry out inclusion, cold preservation is spent the night, and filters, and inclusion complex is ground into fine powder 30-60 ℃ of cold drying, and is standby;
(3) get Pulvis concha Mactrae, mix with gained Borneolum Syntheticum inclusion complex in gained medicated powder, the step (2) in the step (1), mixing is made or is added suitable adjuvant and makes pharmaceutically acceptable dosage form.
5. preparation method as claimed in claim 4 is characterized in that the relative density of gained extractum when the water extract is concentrated into 60 ℃ in the step (1) is 1.10-1.12.
6. preparation method as claimed in claim 4 is characterized in that it is 1.25-1.30 that the middle alcohol extract of step (1) is concentrated into 60 ℃ of gained extractum relative densities.
7. preparation method as claimed in claim 4 is characterized in that Borneolum Syntheticum, beta-schardinger dextrin-, water carry out inclusion according to 1: 8: 80 weight ratio in the step (2).
8. as the preparation method of the arbitrary described Chinese medicine composition of claim 1-3, it may further comprise the steps:
(1) gets Semen Oroxyli, Flos Chrysanthemi Indici, Radix Paeoniae Rubra three flavor medical materials, add water 5-15 and doubly measure decoction 1-5 time, each 0.5-3 hour, filter, merge decocting liquid, relative density is the extractum of 1.01-1.25 when being concentrated into 60 ℃, adding ethanol makes the alcohol amount of containing reach 50-90%, cold preservation is spent the night, and filters, and filtrate recycling ethanol is to there not being the alcohol flavor;
(2) get Borneolum Syntheticum, after the small amount of ethanol dissolving, get Pulvis concha Mactrae, together add in step (1) the gained extracting solution and mix, mixing is made or is added suitable adjuvant and makes washing liquid.
9. the application of Chinese medicine composition as claimed in claim 1 or 2 in preparation treatment vaginitis, cervicitis, cervical erosion medicine.
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| CN110302251A (en) * | 2019-07-19 | 2019-10-08 | 江苏省中国科学院植物研究所 | A kind of Chinese medicine composition and its purposes in preparation treatment gynaecological imflammation disease product |
| CN114766518B (en) * | 2022-05-13 | 2024-09-17 | 河北农业大学 | Application of semen oroxyli extract in preparing insecticide, insecticide and application of insecticide |
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| CN1253828A (en) * | 1999-11-25 | 2000-05-24 | 杨新昌 | Chinese medicine preparation for curing gynecologic inflammation and its preparation method |
| CN1745837A (en) * | 2004-09-06 | 2006-03-15 | 毛友昌 | Funing preparation and its making method theref |
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| CN1745837A (en) * | 2004-09-06 | 2006-03-15 | 毛友昌 | Funing preparation and its making method theref |
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