CN105456846A - Traditional Chinese medicine for treating chronic cervicitis - Google Patents
Traditional Chinese medicine for treating chronic cervicitis Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine for treating chronic cervicitis. The traditional Chinese medicine for treating chronic cervicitis is prepared from fructus cnidii, rhizoma smilacis glabrae, fructus kochiae, purslane herb, dahurian patrinia herb, semen coicis, Philippine violet herb, hairyvein agrimony, dandelion, rhizoma alismatis, radix sophorae flavescentis, alumen, realgar, coptis chinensis, cortex phellodendri, rhizoma atractylodis, radix angelica sinensis, common peony roots, moutan bark, salviae miltiorrhizae, rhizoma corydalis, pericarpium citri reticulatae, rhizoma pinellinae praeparata, raw rhizoma atractylodis macrocephalae and raw liquorice root. The traditional Chinese medicine has a definite curative effect and is definitely safe at a clinical application dosage.
Description
Technical field
The present invention relates to technical field of Chinese medicine, particularly relate to a kind of Chinese medicine being used for the treatment of chronic cervicitis.
Background technology
Cervicitis is one of gynecological's common disease, comprises vaginal part of cervix inflammation and cervical canal mucosal inflammation.Because cervical canal portio vaginalis squamous epithelial cancer continues mutually with vagina squamous, colpitis all can cause vaginal part of cervix inflammation.Because cervical canal mucosal epithelium is simple columnar epithelium, anti-infection ability is poor, easily infects.
Common in clinical is acute and chronic cervicitis, and acute cervicitis major part patient is asymptomatic.There is symptom's main manifestations to be that vaginal secretions increases, in mucus purulence, guide secretions to stimulate and can cause pruritus vulvae and burning sensation.In addition, the symptom such as intermenstrual bleeding, postcoital bleeding can be there is.If merging urinary tract infection, urgent micturition, frequent micturition, dysurea can be there is.If infection due to Neisseria gonorrhoeae, because paraurethral gland, greater vestibular gland are got involved, the hyperemia of visible urethral orifice, vaginal orifice mucosa, edema and volume purulent secretion.If acute cervicitis, without timely diagnosis and treatment or pathogen sustainable existence, can cause chronic cervicitis disease.How asymptomatic samples from Patients with Chronic Cervicitis is also, and small number of patients can have vaginal secretions to increase, faint yellow or purulence, postcoital bleeding, intermenstrual bleeding, occasionally has secretions to stimulate and cause pruritus vulvae uncomfortable.Gynecologial examination can find that cervix uteri is that rotten to the corn sample changes, or has yellow secretions to cover cervical orifice or flow out from cervical orifice, also can show as cervical polyp or cervix uteri hypertrophy.
For the treatment of cervicitis; be mainly antibiotic therapy; (1) empirical antibiotic treatment is to having the patient of following sexually transmitted disease (STD) high risk factor (as the age is less than 25 years old; many sexual partners or new sexual partner; and be unprotect sexual intercourse); before not obtaining pathogen detection result, adopt for chlamydial empirical antibiotic treatment.(2) for pathogen antibiotic therapy for acquisition pathogen person, select the antibiotic for pathogen.Because infection due to Neisseria gonorrhoeae is often with chlamydia infection, therefore, if gonococcal cervicitis, during treatment except selecting anti-Diplococcus gonorrhoeae medicine, apply anti-chlamydia infection medicine simultaneously.(3) if the pathogen of the process cervicitis patient of sex partner is chlamydia trachomatis and Diplococcus gonorrhoeae, tackle its sexual partner and check accordingly and treat.Different lesions adopts different Therapeutic Method.To showing as rotten to the corn sample changer, if asymptomatic physiology's columnar epithelium dystopy is without the need to process.Rotten to the corn sample is changed with secretions increase, papillary hyperplasia or contact bleeding, Local physical treatment can be given, comprise the methods such as laser, freezing, microwave, also can give treatment by Chinese herbs or it is as the auxiliary treatment before and after naturopathy.But cervical intraepithelial neoplasia and cervical cancer must be got rid of through examination before treatment.Chronic cervicitis therapeutic scheme is limited to relatively, (1) phlegmatic temperament cervical canal mucositis is to persistence cervical canal mucosal inflammation, need understand with or without the subinfection again of chlamydia trachomatis and Diplococcus gonorrhoeae, whether sexual partner has carried out treats, vagina microorganism group lacks of proper care whether sustainable existence.Treat for the cause of disease.To the unclear person of pathogen, there is no effective Therapeutic Method, can naturopathy be tried out.(2) cervical polyp row polyp enucleation, postoperatively send histopathologic examination by excision polyp.(3) cervix uteri is loose generally without the need to treatment.
In sum, for chronic cervicitis, still there is no good Therapeutic Method, therefore invention formulation is according to the etiology and pathogenesis of chronic cervicitis and clinical manifestation, through a large amount of clinical researches and experimentation, and has carried out rigorous Security test, prove that Chinese medicine preparation of the present invention has clear and definite curative effect, and be perfectly safe under Clinical practice dosage, for expanding Clinical practice scope, the clinical efficacy improving chronic cervicitis provides a kind of new active drug.
Summary of the invention
Technical problem to be solved by this invention there is provided a kind of Chinese medicine being used for the treatment of chronic cervicitis, there is clear and definite curative effect, and be perfectly safe under Clinical practice dosage, for expanding Clinical practice scope, the clinical efficacy improving chronic cervicitis provides a kind of new active drug.
Based on this, the invention provides a kind of Chinese medicine for the treatment of chronic cervicitis, its crude drug comprises Fructus Cnidii, Rhizoma Smilacis Glabrae, the Fructus Kochiae, Herba Portulacae, Herba Patriniae, Semen Coicis, Herba Violae, Herba Agrimoniae, Herba Taraxaci, Rhizoma Alismatis, Radix Sophorae Flavescentis, Alumen, Realgar, Rhizoma Coptidis, Cortex Phellodendri, Rhizoma Atractylodis, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Cortex Moutan, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Pericarpium Citri Reticulatae, Rhizoma Pinelliae Preparatum, Rhizoma Atractylodis Macrocephalae and Radix Glycyrrhizae.
Wherein, in described Chinese medicine, the weight portion of each crude drug is respectively Fructus Cnidii 15 weight portion ~ 20 weight portion, Rhizoma Smilacis Glabrae 15 weight portion ~ 25 weight portion, the Fructus Kochiae 20 weight portion ~ 30 weight portion, Herba Portulacae 20 weight portion ~ 30 weight portion, Herba Patriniae 10 weight portion ~ 25 weight portion, Semen Coicis 10 weight portion ~ 20 weight portion, Herba Violae 15 weight portion ~ 25 weight portion, Herba Agrimoniae 10 weight portion ~ 20 weight portion, Herba Taraxaci 20 weight portion ~ 40 weight portion, Rhizoma Alismatis 15 weight portion ~ 25 weight portion, Radix Sophorae Flavescentis 10 weight portion ~ 20 weight portion, Alumen 5 weight portion ~ 15 weight portion, Realgar 10 weight portion ~ 15 weight portion, Rhizoma Coptidis 20 weight portion ~ 35 weight portion, Cortex Phellodendri 30 weight portion ~ 45 weight portion, Rhizoma Atractylodis 10 weight portion ~ 25 weight portion, Radix Angelicae Sinensis 20 weight portion ~ 30 weight portion, Radix Paeoniae Rubra 10 weight portion ~ 20 weight portion, Cortex Moutan 10 weight portion ~ 20 weight portion, Radix Salviae Miltiorrhizae 15 weight portion ~ 20 weight portion, Rhizoma Corydalis 10 weight portion ~ 15 weight portion, Pericarpium Citri Reticulatae 10 weight portion ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 weight portion ~ 20 weight portion, Rhizoma Atractylodis Macrocephalae 20 weight portion ~ 30 weight portion and Radix Glycyrrhizae 25 weight portion ~ 35 weight portion.
Wherein, in described Chinese medicine, the weight portion of each crude drug is respectively Fructus Cnidii 15 weight portion ~ 20 weight portion, Rhizoma Smilacis Glabrae 15 weight portion ~ 20 weight portion, the Fructus Kochiae 20 weight portion ~ 25 weight portion, Herba Portulacae 25 weight portion ~ 30 weight portion, Herba Patriniae 15 weight portion ~ 20 weight portion, Semen Coicis 10 weight portion ~ 15 weight portion, Herba Violae 20 weight portion ~ 25 weight portion, Herba Agrimoniae 10 weight portion ~ 15 weight portion, Herba Taraxaci 30 weight portion ~ 35 weight portion, Rhizoma Alismatis 15 weight portion ~ 20 weight portion, Radix Sophorae Flavescentis 15 weight portion ~ 20 weight portion, Alumen 5 weight portion ~ 10 weight portion, Realgar 10 weight portion ~ 15 weight portion, Rhizoma Coptidis 25 weight portion ~ 30 weight portion, Cortex Phellodendri 35 weight portion ~ 40 weight portion, Rhizoma Atractylodis 15 weight portion ~ 20 weight portion, Radix Angelicae Sinensis 25 weight portion ~ 30 weight portion, Radix Paeoniae Rubra 15 weight portion ~ 20 weight portion, Cortex Moutan 10 weight portion ~ 15 weight portion, Radix Salviae Miltiorrhizae 15 weight portion ~ 20 weight portion, Rhizoma Corydalis 10 weight portion ~ 15 weight portion, Pericarpium Citri Reticulatae 10 weight portion ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 weight portion ~ 15 weight portion, Rhizoma Atractylodis Macrocephalae 25 weight portion ~ 30 weight portion and Radix Glycyrrhizae 25 weight portion ~ 30 weight portion.
Wherein, in described Chinese medicine, the weight portion of each crude drug is respectively Fructus Cnidii 15 weight portion, Rhizoma Smilacis Glabrae 20 weight portion, the Fructus Kochiae 25 weight portion, Herba Portulacae 25 weight portion, Herba Patriniae 15 weight portion, Semen Coicis 15 weight portion, Herba Violae 20 weight portion, Herba Agrimoniae 15 weight portion, Herba Taraxaci 30 weight portion, Rhizoma Alismatis 20 weight portion, Radix Sophorae Flavescentis 15 weight portion, Alumen 10 weight portion, Realgar 10 weight portion, Rhizoma Coptidis 30 weight portion, Cortex Phellodendri 40 weight portion, Rhizoma Atractylodis 15 weight portion, Radix Angelicae Sinensis 25 weight portion, Radix Paeoniae Rubra 15 weight portion, Cortex Moutan 15 weight portion, Radix Salviae Miltiorrhizae 20 weight portion, Rhizoma Corydalis 10 weight portion, Pericarpium Citri Reticulatae 10 weight portion, Rhizoma Pinelliae Preparatum 15 weight portion, Rhizoma Atractylodis Macrocephalae 25 weight portion and Radix Glycyrrhizae 30 weight portion.
Wherein, described Chinese medicine is prepared into suppository.
Present invention also offers the preparation method of above-mentioned Chinese medicine, it comprises:
The first step, is ground into coarse powder by above-mentioned weight portion respectively by Fructus Cnidii, the Fructus Kochiae, adopts carbon dioxide supercritical fluid extraction device to extract volatile oil, and setting separator pressure 30MPa, temperature 30 DEG C, coarse powder loads in extractor, carries out supercritical CO
2extraction, extraction 60 ~ 90min produces to without extract, from separator collection extract, obtains Fructus cnidii and Fructus Kochiae volatile oil respectively;
Second step, remaining crude drug is taken by above-mentioned weight portion, mix, pulverize to obtain coarse powder, adding determining alcohol is 50% ~ 75% ethanol water reflux, extract, three times, and first time adds 8 ~ 12 times that amount of alcohol is coarse powder weight, backflow 3 ~ 5h, second time adds 6 ~ 8 times that amount of alcohol is coarse powder weight, backflow 2 ~ 3h, and third time adds 3 ~ 5 times that amount of alcohol is coarse powder weight, backflow 1 ~ 2h, merge backflow, filter, obtained extracting solution, extracting solution is condensed into thick paste, dry, pulverize powdered, obtained extract;
3rd step, choose substrate 45 DEG C ~ 55 DEG C heating and melting, add volatile oil obtained above and extract, cooling and shaping makes class warhead shape suppository, and ultraviolet is killed virus.
Wherein, the substrate that described suppository is used is selected from: one or more in semi-synthetic fatty acid glyceride, poloxamer, Polyethylene Glycol, lanoline.
Wherein, described 3rd step is specially described substrate heating and melting under DEG C condition of temperature 45 C ~ 55 further, add volatile oil prepared by the first step and the mixture that extract mix homogeneously prepared by second step obtains, stirring in water bath is even, be mixed into the liquid of thickness, be poured in plastic shape-forming pipe, insert tampon, cooling and shaping makes bullet-shaped suppository.
Wherein, the quality proportioning of the extract mixing that the described first step obtains volatile oil, second step obtain and the mixture quality that obtains and substrate is 1: 2 ~ 1: 4; Described tampon is the tampon of afterbody with cotton thread.
Useful technique effect
The Chinese medicine being used for the treatment of chronic cervicitis provided by the invention, has clear and definite curative effect, and is perfectly safe under Clinical practice dosage, and for expanding Clinical practice scope, the clinical efficacy improving chronic cervicitis provides a kind of new active drug.
Detailed description of the invention
The invention provides a kind of Chinese medicine for the treatment of chronic cervicitis, its crude drug comprises Fructus Cnidii, Rhizoma Smilacis Glabrae, the Fructus Kochiae, Herba Portulacae, Herba Patriniae, Semen Coicis, Herba Violae, Herba Agrimoniae, Herba Taraxaci, Rhizoma Alismatis, Radix Sophorae Flavescentis, Alumen, Realgar, Rhizoma Coptidis, Cortex Phellodendri, Rhizoma Atractylodis, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Cortex Moutan, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Pericarpium Citri Reticulatae, Rhizoma Pinelliae Preparatum, Rhizoma Atractylodis Macrocephalae and Radix Glycyrrhizae.
Chronic cervicitis is delayed by acute cervicitis with the passing of time to develop, for its etiology and pathogenesis and disease progression rule, the traditional Chinese medical science is thought and is developed into the chronic cervicitis stage, and syndrome is mingled with the cards such as damp and hot, blood stasis, poison are evil more, and Chinese medicine preparation of the present invention proposes eliminating damp-heat for disease indicia, the method for the treatment of of promoting blood circulation and detoxication, not only treat for existing symptom, and in line with the thought of traditional Chinese medical science prevention of diseae, add the medicine of replenishing QI to invigorate the spleen, take a tonic or nourishing food to build up one's health in depositing in the hope of healthy energy the day after tomorrow, heresy can not be done.
One, heat clearing and damp drying
Herba Portulacae, Herba Patriniae, Semen Coicis, Herba Agrimoniae, Herba Taraxaci, Rhizoma Alismatis, Radix Sophorae Flavescentis, Rhizoma Coptidis, Cortex Phellodendri, Rhizoma Atractylodis heat clearing and damp drying is employed in invention formulation, wherein Rhizoma Coptidis, Cortex Phellodendri, Radix Sophorae Flavescentis dispelling the damp pathogen with drugs of bitter in taste and cold in nature, for key medicine, coordinate Herba Portulacae, Herba Patriniae clearing away heat-damp and promoting diuresis, wet in Herba Agrimoniae profit blood, Rhizoma Alismatis, Semen Coicis dampness removing are rushed down turbid, giving evil in outlet, reaching the damp and hot effect with going.
Two, removing toxic substances anthelmintic
With the passing of time chronic cervicitis is many delays by acute cervicitis, there are pathogen or bacteriological infection more, good and evil are handed over and are striven with the passing of time, good and evil two are empty, healthy energy is unable eliminating evilly goes out, therefore invention formulation adds removing toxic substances anthelmintic drug as Realgar, Herba Violae, Radix Sophorae Flavescentis, the medicines such as Alumen, wherein Realgar, Rhizoma Coptidis, Radix Sophorae Flavescentis, Fructus Cnidii, Rhizoma Smilacis Glabrae, the Fructus Kochiae has gold-coloured staphylococci, the pathogen such as dysentery bacterium have good antibacterial action, clear and definite Laboratory evidence is also achieved to the effect of inflammatory mediator, therefore all medicines share, there is the anthelmintic action that well detoxifies, pathogen one is gone, only need pacify the ground by heresy, state of an illness legibility.
Three, blood circulation promoting and blood stasis dispelling
The main clinical manifestation of chronic cervicitis is exactly under chronic inflammatory disease stimulates, the hypertrophy of tissue, the traditional Chinese medical science thinks the performance of blood stasis in lower energizer, therefore add some activating blood and removing stasis drugs, as Radix Angelicae Sinensis, Radix Paeoniae Rubra, Cortex Moutan, Radix Salviae Miltiorrhizae, the effect of blood circulation promoting and blood stasis dispelling Xiao Disorder can be played, there are vagina or lower abdomen dull pain in the chronic cervicitis later stage, and invention formulation adds the pain relieving of Rhizoma Corydalis blood-activating and qi-promoting, has the effect well improving symptom.
Four, invigorating the spleen and benefiting QI
Invention formulation is with the thought of traditional Chinese medical science preventive treatment of disease, add Pericarpium Citri Reticulatae, Rhizoma Pinelliae Preparatum, Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, invigorating the spleen and benefiting QI, in the hope for the treatment of the location first where the pathogens havn’t intruded yet, while QI invigorating, anthelmintic drug eliminating the toxic material out by tonification of detoxifying can be assisted, and for the with the passing of time positive QI-insufficiency of patient's delay, play the effect of good reinforcing body resistance.
All medicines share, and play effect of clearing away heat-damp and promoting diuresis removing toxic substances, promoting blood circulation, removing blood stasis and relieving pain, strengthening the body resistance recovery from illness altogether.Invention formulation Clinical practice suppository, Chinese medicine suppository is directly brought into vagina deep, and medicine can be made to go directly disease institute, and drug availability is high, rapid-action, successful.
Further preferably, described Chinese medicine is only prepared from by above-mentioned raw materials medicine.
In described Chinese medicine, the weight portion of each crude drug is respectively Fructus Cnidii 15 weight portion ~ 20 weight portion, Rhizoma Smilacis Glabrae 15 weight portion ~ 25 weight portion, the Fructus Kochiae 20 weight portion ~ 30 weight portion, Herba Portulacae 20 weight portion ~ 30 weight portion, Herba Patriniae 10 weight portion ~ 25 weight portion, Semen Coicis 10 weight portion ~ 20 weight portion, Herba Violae 15 weight portion ~ 25 weight portion, Herba Agrimoniae 10 weight portion ~ 20 weight portion, Herba Taraxaci 20 weight portion ~ 40 weight portion, Rhizoma Alismatis 15 weight portion ~ 25 weight portion, Radix Sophorae Flavescentis 10 weight portion ~ 20 weight portion, Alumen 5 weight portion ~ 15 weight portion, Realgar 10 weight portion ~ 15 weight portion, Rhizoma Coptidis 20 weight portion ~ 35 weight portion, Cortex Phellodendri 30 weight portion ~ 45 weight portion, Rhizoma Atractylodis 10 weight portion ~ 25 weight portion, Radix Angelicae Sinensis 20 weight portion ~ 30 weight portion, Radix Paeoniae Rubra 10 weight portion ~ 20 weight portion, Cortex Moutan 10 weight portion ~ 20 weight portion, Radix Salviae Miltiorrhizae 15 weight portion ~ 20 weight portion, Rhizoma Corydalis 10 weight portion ~ 15 weight portion, Pericarpium Citri Reticulatae 10 weight portion ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 weight portion ~ 20 weight portion, Rhizoma Atractylodis Macrocephalae 20 weight portion ~ 30 weight portion and Radix Glycyrrhizae 25 weight portion ~ 35 weight portion.
Further preferably, in described Chinese medicine, the weight portion of each crude drug is respectively Fructus Cnidii 15 weight portion ~ 20 weight portion, Rhizoma Smilacis Glabrae 15 weight portion ~ 20 weight portion, the Fructus Kochiae 20 weight portion ~ 25 weight portion, Herba Portulacae 25 weight portion ~ 30 weight portion, Herba Patriniae 15 weight portion ~ 20 weight portion, Semen Coicis 10 weight portion ~ 15 weight portion, Herba Violae 20 weight portion ~ 25 weight portion, Herba Agrimoniae 10 weight portion ~ 15 weight portion, Herba Taraxaci 30 weight portion ~ 35 weight portion, Rhizoma Alismatis 15 weight portion ~ 20 weight portion, Radix Sophorae Flavescentis 15 weight portion ~ 20 weight portion, Alumen 5 weight portion ~ 10 weight portion, Realgar 10 weight portion ~ 15 weight portion, Rhizoma Coptidis 25 weight portion ~ 30 weight portion, Cortex Phellodendri 35 weight portion ~ 40 weight portion, Rhizoma Atractylodis 15 weight portion ~ 20 weight portion, Radix Angelicae Sinensis 25 weight portion ~ 30 weight portion, Radix Paeoniae Rubra 15 weight portion ~ 20 weight portion, Cortex Moutan 10 weight portion ~ 15 weight portion, Radix Salviae Miltiorrhizae 15 weight portion ~ 20 weight portion, Rhizoma Corydalis 10 weight portion ~ 15 weight portion, Pericarpium Citri Reticulatae 10 weight portion ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 weight portion ~ 15 weight portion, Rhizoma Atractylodis Macrocephalae 25 weight portion ~ 30 weight portion and Radix Glycyrrhizae 25 weight portion ~ 30 weight portion.
Most preferably, in described Chinese medicine, the weight portion of each crude drug is respectively Fructus Cnidii 15 weight portion, Rhizoma Smilacis Glabrae 20 weight portion, the Fructus Kochiae 25 weight portion, Herba Portulacae 25 weight portion, Herba Patriniae 15 weight portion, Semen Coicis 15 weight portion, Herba Violae 20 weight portion, Herba Agrimoniae 15 weight portion, Herba Taraxaci 30 weight portion, Rhizoma Alismatis 20 weight portion, Radix Sophorae Flavescentis 15 weight portion, Alumen 10 weight portion, Realgar 10 weight portion, Rhizoma Coptidis 30 weight portion, Cortex Phellodendri 40 weight portion, Rhizoma Atractylodis 15 weight portion, Radix Angelicae Sinensis 25 weight portion, Radix Paeoniae Rubra 15 weight portion, Cortex Moutan 15 weight portion, Radix Salviae Miltiorrhizae 20 weight portion, Rhizoma Corydalis 10 weight portion, Pericarpium Citri Reticulatae 10 weight portion, Rhizoma Pinelliae Preparatum 15 weight portion, Rhizoma Atractylodis Macrocephalae 25 weight portion and Radix Glycyrrhizae 30 weight portion.
Each principle medicine pharmacology is as follows:
Fructus Cnidii: latin name cnidiifructus, acrid in the mouth, hardship, warm in nature, enter kidney channel, have the effect of warming the kidney to invigorate YANG, removing dampness and killing parasites, dispelling wind for relieving itching, the impotence in male caused for kidney yang deficiency, woman's cold womb are infertile, the cards such as cold-damp leukorrhagia or chills and pain of the waist and kness.
Rhizoma Smilacis Glabrae: sweet in the mouth, light, property is put down, Liver Channel; Stomach warp; Spleen channel, has removing toxic substances, dehumidifying, and the effect in sharp joint, cures mainly syphilis, stranguria with turbid discharge, muscles and bones spasm and pain, beriberi, and furuncle treats skin ulcer, carbuncle, scrofula, syphilis and the limbs contracture caused by mercurialism, the cards such as bones and muscles pain.
The Fructus Kochiae: latin name KochiaeFructus, cold in nature, acrid in the mouth, hardship, have clearing away heat-damp and promoting diuresis, effect of dispelling wind for relieving itching, cures mainly the cards such as difficulty and pain in micturition, pudendal pruritus leukorrhagia, rubella, eczema, skin pruritus.
Herba Portulacae: latin name Portulacaeherba, sour in the mouth, cold in nature, return large intestine, Liver Channel, there is heat-clearing and toxic substances removing, diuretic dries, loose blood detumescence, dust-collection sterilization, anti-inflammatory analgetic, and effect of hemostasis removing heat from blood, cures mainly dysentery, enteritis, nephritis, puerperal, metrorrhagia, had blood in stool, the diseases such as mastitis.
Herba Patriniae: acrid in the mouth, hardship, cold nature, returns liver, stomach, large intestine channel, has heat-clearing and toxic substances removing, eliminating carbuncle evacuation of pus, effect of stasis-dispelling and pain-killing, and for acute appendicitis, the high heat of lung abscess, coughs vomiting bloody pus, pyretic toxicity skin ulcer furuncle, breast abdomen pain, puerperal abdonimal pain, the cards such as dysmenorrhea.
Semen Coicis: cool in nature, sweet in the mouth, light, return spleen, stomach, lung meridian.Have the function of spleen invigorating eliminating dampness by diuresis, clearing away heat and discharging pus, eliminating impediment, diuretic, for weakness of the spleen and stomach, suffer from diarrhoea in loose stool, or vaginal discharge diseases of women, insufficiency of the spleen leading to overabundance of dampness edema, dysuria, or beriberi swells and ache; Damp and hot arthralgia pain, contracture of the limbs, miserable pain; Lung abscess cough and spit purulent sputum, or enterodynia contracture stomachache.
Herba Violae: bitter in the mouth, pungent, cold in nature, enter the heart, Liver Channel, there is the effect of heat-clearing and toxic substances removing, removing heat from blood detumescence, be mainly used in the treatment for the treatment of furuncle carbuncle furuncle, also have good therapeutic effect to acute conjunctivitis, hordeolum etc., Herba Violae has inhibitory action in various degree to Staphyloccocus aureus, pneumobacillus, escherichia coli, alpha streptococcus, group B streptococcus, hemophilus influenza, diphtheria corynebacterium, bacillus pyocyaneus, white grapes sugar coccus, Candida albicans.
Herba Agrimoniae: bitter in the mouth, puckery, property is put down, and GUIXIN, Liver Channel, have astringing to arrest bleeding, effect of dysentery relieving parasite killing, cures mainly various hemorrhage card, such as: haematemesis, hematuria, have blood in stool, metrorrhagia, spitting of blood, epistaxis, dysentery, impairment caused by overstrain takes off power, carbuncle, traumatic injury, the cards such as wound hemorrhage.
Herba Taraxaci: sweet in the mouth, hardship, cold in nature, enter liver, stomach warp, there is the effect of heat-clearing and toxic substances removing, eliminating carbuncle eliminating stagnation, liver heat removing and eyesight improving, inducing diuresis for treating stranguria syndrome, be mainly used in the treatment of sore swollen toxin, especially remarkable to acute mastitis effect, also can be used for the treatment of the symptoms such as the conjunctival congestion and swelling pain of flaming up of liver-fire.
Rhizoma Alismatis: sweet in the mouth, light, cold in nature, enters kidney, urinary bladder channel, has promoting diuresis to eliminate damp pathogen, purging heat and treating stranguria, the lung that clears away heart-fire, rushes down the effect of kidney fire, is mainly used in insufficiency of the spleen retention of water-damp, the wet hydrosarca of spreading unchecked of water; The tired resistance of the heresy of diseases caused by retention of fluid phlegm-damp, what cause that clear YANG failing to ascend voiced sound do not fall is dizzy; The dysuria of damp invasion of lower energizer, red short puckery pain, and the card such as jaundice due to damp-heat.
Radix Sophorae Flavescentis: latin name SophoraeFlavescentisRadix, bitter in the mouth, cold in nature, enter the heart, stomach, large intestine, urinary bladder channel, there is the effect of heat clearing and damp drying, wind dispelling insecticide, be mainly used in damp-heat dysentery, jaundice, stranguria, Radix Sophorae Flavescentis has obvious inhibitory action to dysentery bacterium, escherichia coli, Bacillus proteus, group B streptococcus and staphylococcus aureus.
Alumen: sour in the mouth, puckery, cold in nature, returns lung, spleen, liver, intestinal, urinary bladder channel, has expectorant, dampness, antidiarrheal, hemostasis, removing toxic substances, effect of parasite killing.Cure mainly epilepsy, sore throat, remorse saliva is stopped up very, hepatitis, jaundice, general edema with yellowish skin, taste-blindness rate, uterine prolapse, leucorrhea, dysentery, epistaxis, aphtha of the mouth and tongue, skin ulcer hemorrhoid scabies, the cards such as water, fire, insect bite.
Realgar: acrid in the mouth, warm in nature, return liver, large intestine channel, there is removing toxic substances parasite killing, removing dampness and eliminating phlegm, effect of preventing the attack (or recurrence) of malaria.For carbuncle furuncle, snake bite and insect sting, abdominal pain due to worm stagnation, infantile convulsion, the cards such as malaria.
Rhizoma Coptidis: bitter in the mouth, cold in nature, enter the heart, lung, gallbladder, stomach, large intestine channel, have heat clearing and damp drying, eliminating fire and detoxication, the effect of cooling blood for improving eyesight, be usually used in the fire for the treatment of removing pathogen in the heart warp, the dysphoria and insomnia that heart-fire is prosperous, and the high fever coma of epidemic febrile disease, the symptom such as vexed, thirsty.
Cortex Phellodendri: latin name PhellodendriChinensisCortex, bitter in the mouth, cold in nature, enter kidney, bladder, large intestine channel, heat clearing and damp drying, eliminating fire and detoxication, except hectic fever due to YIN-deficiency clearind deficient heat.For damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, flaccidity is warded off, hectic fever due to YIN-deficiency consumptive fever, night sweat, and seminal emission, sore swollen toxin, the cards such as eczema pruritus, Cortex Phellodendri has good antibacterial action to multiple gram-positive bacterium.
Rhizoma Atractylodis: acrid in the mouth, hardship, warm in nature, enter spleen, stomach, Liver Channel, have drying damp and strengthening spleen, expelling wind and dampness, the effect of improving eyesight, be mainly used in the stomachache dysentery of retention of dampness in middle-JIAO, the abdominal distention pain of incoordination between the spleen and stomach, vomits indigestion and loss of appetite; The abdomen side of body distending pain, the vomiting with acid regurgitation of incoordination between the liver and stomach; And the card such as the anemofrigid-damp arthralgia of the outer strongly fragrant meridians of cold-damp.
Radix Angelicae Sinensis: latin name angelicaesinensisradix, sweet in the mouth, pungent, bitter, warm in nature, return liver, the heart, spleen channel, having enriches blood invigorates blood circulation, and regulating menstruation relieves the pain, effect of loosening bowel to relieve constipation, and the head curing mainly deficiency of heart-blood is giddy, fatigue and weakness, shortness of breath and palpitation, and other syndrome of deficiency of blood.
Radix Paeoniae Rubra: bitter in the mouth, micro-hardship, returns Liver Channel, has removing fire from the liver, clearing away heat and cooling blood, effect of stasis-dispelling and pain-killing, cure mainly the conjunctival congestion and swelling pain of high liver fire, have a dizzy spell, pain in chest and hypochondrium, the fever of the body crimson tongue of the epidemic febrile disease pathogenic heat attacking blood system in febrile diseases, and macule is hemorrhage, and blood stasis amenorrhea; The haematemesis hematuria of the absurd row of burning hot flourishing forcing blood; The trip of women's heat in blood is through too much; Various pain caused by blood retardance; The cards such as the furuncle carbuncle of heat in blood poison Sheng.
Cortex Moutan: bitter in the mouth, pungent, cold nature, enter the heart, liver, kidney channel, there is effect of clearing away heat and cooling blood, promoting blood circulation to remove blood stasis, cure mainly the epidemic febrile disease pathogenic heat attacking blood system in febrile diseases, send out speckle, tell nosebleed, calentura later stage hot Fu Yin divides heating, deficiency of YIN osteopyrexia and fever, amenorrhea due to stagnation of blood, dysmenorrhea, carbuncle sore tumefacting virus, falls and flutter the card such as the pain of injury, beriberoid pyretic arthralgia.
Radix Salviae Miltiorrhizae: latin name SalviaeMiltiorrhizaeRadixetRhizoma, bitter in the mouth, cold nature, enter the heart, Liver Channel, there is promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, removing heat from blood eliminating carbuncle, clear away heart-fire relieving restlessness, effect of nourishing blood to tranquillize the mind, for menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, the cards such as angina pectoris.
Rhizoma Corydalis: have another name called corydalis tuber, rhizoma corydalis, Rhizoma Corydalis, acrid in the mouth, hardship, warm in nature, enter liver, spleen channel, there is promoting blood circulation to remove blood stasis, the effect of promoting the circulation of QI to relieve pain, for the various pains card that qi depression to blood stasis causes, particularly trusted subordinate's pain commonly use, as depressed liver and heat transmission, the gastral cavilty abdominal distention of incoordination between the liver and stomach, has analgesic effect.
Pericarpium Citri Reticulatae: warm in nature, acrid in the mouth, hardship; Return spleen, lung meridian, for diseases such as distension and fullness of the chest and abdomen.The pungent loose logical temperature of Pericarpium Citri tangerinae, fragrant odour, is longer than and regulates the flow of vital energy, spleen lung can be entered, therefore can go loose sluggishness of lung-QI, again can promoting the circulation of QI to alleviate the stagnation in middle-JIAO, gather around stagnant, chest and diaphragm feeling of fullness and the disease such as stagnation of QI in spleen and stomach, distension and fullness in the abdomen for lung qi, for retention of dampness in middle-JIAO, gastral cavity abdomen painful abdominal mass is swollen, have loose bowels in loose stool, and the card such as abundant expectoration cough.
Rhizoma Pinelliae Preparatum: acrid in the mouth, warm in nature, returns spleen, stomach, lung meridian, has effect of drying dampness to eliminate phlegm, cures mainly abundant expectoration cough, dizziness due to wind-phlegm, the cards such as syncope due to accumulation of phlegm headache.
Rhizoma Atractylodis Macrocephalae: latin name atractylodismacrocephalaerhizoma, sweet in the mouth, hardship, warm in nature, enter spleen, stomach warp, there is spleen reinforcing promoting the circulation of QI, dampness diuretic, strengthening superficial resistance to stop perspiration, effect that activating the spleen is moisturized, cures mainly the feeling of fullness diarrhoea that dysfunction of the spleen in transportation, QI failing to transform into body fluid are caused, phlegm retention edema; The vexed lazyness speech of deficiency of QI in middle-JIAO, metrorrhagia and metrostaxis, proctoptosis with chronic dysentery; The cards such as solid in the playing of deficiency of the spleen causing weakness of QI, sweating due to debility spontaneous perspiration.
Radix Glycyrrhizae: sweet in the mouth, property is put down, and returns 12 warps, has heat-clearing and toxic substances removing, is in harmonious proportion the property of medicine, the effect of expelling phlegm for arresting cough, and can spleen invigorating and in, relieving spasm to stop pain, is mainly used in the abdominal distension and anorexia of weakness of the spleen and stomach, weak, to alleviate in abdomen the cards such as contracture pain.
Present invention also offers the preparation method of above-mentioned Chinese medicine, it comprises:
The first step, is ground into coarse powder by above-mentioned weight portion respectively by Fructus Cnidii, the Fructus Kochiae, adopts carbon dioxide supercritical fluid extraction device to extract volatile oil, and setting separator pressure 30MPa, temperature 30 DEG C, coarse powder loads in extractor, carries out supercritical CO
2extraction, extraction 60 ~ 90min produces to without extract, from separator collection extract, obtains Fructus cnidii and Fructus Kochiae volatile oil respectively;
Second step, remaining crude drug is taken by above-mentioned weight portion, mix, pulverize to obtain coarse powder, adding determining alcohol is 50% ~ 75% ethanol water reflux, extract, three times, and first time adds 8 ~ 12 times that amount of alcohol is coarse powder weight, backflow 3 ~ 5h, second time adds 6 ~ 8 times that amount of alcohol is coarse powder weight, backflow 2 ~ 3h, and third time adds 3 ~ 5 times that amount of alcohol is coarse powder weight, backflow 1 ~ 2h, merge backflow, filter, obtained extracting solution, extracting solution is condensed into thick paste, dry, pulverize powdered, obtained extract;
3rd step, choose substrate 45 DEG C ~ 55 DEG C heating and melting, add volatile oil obtained above and extract, cooling and shaping makes class warhead shape suppository, and ultraviolet is killed virus.
Described suppository substrate used is selected from: one or more in semi-synthetic fatty acid glyceride, poloxamer, Polyethylene Glycol, lanoline; Described substrate is heating and melting under DEG C condition of temperature 45 C ~ 55, add volatile oil prepared by the first step and the mixture that extract mix homogeneously prepared by second step obtains, stirring in water bath is even, be mixed into the liquid of thickness, be poured in plastic shape-forming pipe, insert tampon, cooling and shaping makes bullet-shaped suppository; The quality proportioning of the mixture quality that the extract that the volatile oil that the described first step obtains, second step obtain mixes and obtains and substrate is 1: 2 ~ 1: 4; Described tampon is the tampon of afterbody with cotton thread.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.
Embodiment 1 suppository 1
Fructus Cnidii 15g, Fructus Kochiae 25g are ground into coarse powder respectively, adopt carbon dioxide supercritical fluid extraction device to extract volatile oil, setting separator pressure 30MPa, temperature 30 DEG C, coarse powder loads in extractor, carries out supercritical CO
2extraction, extraction 90min produces to without extract, from separator collection extract, obtains Fructus cnidii and Fructus Kochiae volatile oil respectively, takes Rhizoma Smilacis Glabrae 20g, Herba Portulacae 25g, Herba Patriniae 15g, Semen Coicis 15g, Herba Violae 20g, Herba Agrimoniae 15g, Herba Taraxaci 30g, Rhizoma Alismatis 20g, Radix Sophorae Flavescentis 15g, Alumen 10g, Realgar 10g, Rhizoma Coptidis 30g, Cortex Phellodendri 40g, Rhizoma Atractylodis 15g, Radix Angelicae Sinensis 25g, Radix Paeoniae Rubra 15g, Cortex Moutan 15g, Radix Salviae Miltiorrhizae 20g, Rhizoma Corydalis 10g, Pericarpium Citri Reticulatae 10g, Rhizoma Pinelliae Preparatum 15g, Rhizoma Atractylodis Macrocephalae 25g and Radix Glycyrrhizae 30g, mixes, and pulverizes to obtain coarse powder, adding determining alcohol is 70% ethanol water reflux, extract, three times, and first time adds 10 times that amount of alcohol is coarse powder weight, backflow 5h, second time adds 8 times that amount of alcohol is coarse powder weight, backflow 3h, and third time adds 5 times that amount of alcohol is coarse powder weight, backflow 2h, merges backflow, filters, obtained extracting solution, extracting solution is condensed into thick paste, dry, pulverize powdered, obtained extract, choose substrate poloxamer 300g, 50 DEG C of heating and melting, by volatile oil obtained above and extract mix homogeneously, get 100g mixture, stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, insert tampon, cooling and shaping makes bullet-shaped suppository, and ultraviolet is killed virus, suppository crude drug 1.25g/ piece.
Embodiment 2 suppository 2
Fructus Cnidii 15g, Fructus Kochiae 20g are ground into coarse powder respectively, adopt carbon dioxide supercritical fluid extraction device to extract volatile oil, setting separator pressure 30MPa, temperature 30 DEG C, coarse powder loads in extractor, carries out supercritical CO
2extraction, extraction 90min produces to without extract, from separator collection extract, obtains Fructus cnidii and Fructus Kochiae volatile oil respectively, takes Rhizoma Smilacis Glabrae 15g, Herba Portulacae 25g, Herba Patriniae 15g, Semen Coicis 10g, Herba Violae 20g, Herba Agrimoniae 10g, Herba Taraxaci 30g, Rhizoma Alismatis 15g, Radix Sophorae Flavescentis 15g, Alumen 5g, Realgar 10g, Rhizoma Coptidis 25g, Cortex Phellodendri 35g, Rhizoma Atractylodis 15g, Radix Angelicae Sinensis 25g, Radix Paeoniae Rubra 15g, Cortex Moutan 10g, Radix Salviae Miltiorrhizae 15g, Rhizoma Corydalis 10g, Pericarpium Citri Reticulatae 10g, Rhizoma Pinelliae Preparatum 10g, Rhizoma Atractylodis Macrocephalae 25g and Radix Glycyrrhizae 25g, mixes, and pulverizes to obtain coarse powder, adding determining alcohol is 70% ethanol water reflux, extract, three times, and first time adds 10 times that amount of alcohol is coarse powder weight, backflow 5h, second time adds 8 times that amount of alcohol is coarse powder weight, backflow 3h, and third time adds 5 times that amount of alcohol is coarse powder weight, backflow 2h, merges backflow, filters, obtained extracting solution, extracting solution is condensed into thick paste, dry, pulverize powdered, obtained extract, choose substrate poloxamer 300g, 50 DEG C of heating and melting, by volatile oil obtained above and extract mix homogeneously, get 100g mixture, stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, insert tampon, cooling and shaping makes bullet-shaped suppository, and ultraviolet is killed virus, suppository crude drug 1.25g/ piece.
Embodiment 3 suppository 3
Fructus Cnidii 20g, Fructus Kochiae 25g are ground into coarse powder respectively, adopt carbon dioxide supercritical fluid extraction device to extract volatile oil, setting separator pressure 30MPa, temperature 30 DEG C, coarse powder loads in extractor, carries out supercritical CO
2extraction, extraction 90min produces to without extract, from separator collection extract, obtains Fructus cnidii and Fructus Kochiae volatile oil respectively, takes Rhizoma Smilacis Glabrae 20g, Herba Portulacae 30g, Herba Patriniae 20g, Semen Coicis 15g, Herba Violae 25g, Herba Agrimoniae 10 weight portions ~ 15g, Herba Taraxaci 35g, Rhizoma Alismatis 20g, Radix Sophorae Flavescentis 20g, Alumen 10g, Realgar 15g, Rhizoma Coptidis 30g, Cortex Phellodendri 40g, Rhizoma Atractylodis 20g, Radix Angelicae Sinensis 30g, Radix Paeoniae Rubra 20g, Cortex Moutan 15g, Radix Salviae Miltiorrhizae 20g, Rhizoma Corydalis 15g, Pericarpium Citri Reticulatae 15g, Rhizoma Pinelliae Preparatum 15g, Rhizoma Atractylodis Macrocephalae 30g and Radix Glycyrrhizae 30g, mixes, and pulverizes to obtain coarse powder, adding determining alcohol is 70% ethanol water reflux, extract, three times, and first time adds 10 times that amount of alcohol is coarse powder weight, backflow 5h, second time adds 8 times that amount of alcohol is coarse powder weight, backflow 3h, and third time adds 5 times that amount of alcohol is coarse powder weight, backflow 2h, merges backflow, filters, obtained extracting solution, extracting solution is condensed into thick paste, dry, pulverize powdered, obtained extract, choose substrate poloxamer 300g, 50 DEG C of heating and melting, by volatile oil obtained above and extract mix homogeneously, get 100g mixture, stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, insert tampon, cooling and shaping makes bullet-shaped suppository, and ultraviolet is killed virus, suppository crude drug 1.25g/ piece.
Embodiment 4 drug toxicology is tested
Pharmacology's acute toxicity test
Experiment material
Laboratory animal
Cleaning grade level kunming mice 48,18 ~ 22g, female.
Animal feeding and experimental situation
Test preposition animal to conform in indoor one week, freely ingest and take the photograph water, room temperature 18 ~ 22 DEG C, relative humidity 65 ~ 70%, light and shade round the clock of throwing light on replaces.
Test medicine
Suppository 1:2 times/day prepared by the embodiment of the present invention 1, containing crude drug 1.25g/ piece, 4 DEG C of preservations, for subsequent use, be heated to 36 ~ 39 DEG C during use.
Blank group: vaseline bolt, vagina receives bolt, and all the other conditions are with medicine group of the present invention.
Experimental technique
According to body weight, according to table of random number, mice is divided into 4 groups, often organize 12, be divided into high dose group (crude drug concentration 62.5g/kg/d), middle dosage group (crude drug concentration 31.25g/kg/d), low dose group (crude drug concentration 15.625g/kg/d) and matched group (vaseline bolt 25g/kg/d), every day, vagina received bolt 2 times, vagina receives bolt 7d, record Mouse Weight, feed, drinking-water situation, and record vagina receives the every reaction of mice after bolt, vagina receives the every physiological reaction of bolt interval mice and death condition.
Result and conclusion
Studied by acute toxicological experiment, observe 7d mouse vagina and receive situation after bolt, vagina is received before bolt administration, each treated animal body weight, feed, drinking-water situation no difference of science of statistics, vagina is received after bolt administration, the change of each group Mouse Weight, feed drinking-water situation, no difference of science of statistics., there is not death and other toxic reactions in behavioristics's Non Apparent Abnormality.
This experiment high dose group (crude drug concentration 62.5g/kg/d), middle dosage group (crude drug concentration 31.25g/kg/d), low dose group (crude drug concentration 15.625g/kg/d) dosage, 250 times of clinical adult's medication, 125 times and 62.5 times respectively, modern pharmacology is thought, for Acute toxicity experiment, maximum tolerated dose is equivalent to the clinical daily dosage more than 100 times of people and animal without death, when occurring without overt toxicity response situation, this medicine is safe.Vagina of the present invention receives bolt dosage, and middle dosage group is 125 times of people's clinical application, and animal non-toxic reaction, can assert, the medication of this clinical drug is safe.
Rat chronic toxicity test of the present invention
Experiment material
Laboratory animal
Cleaning grade SD rat, 40, female.According to body weight, suppository 1 low dose group that in the suppository 1 of suppository 1 high dose group being divided into matched group, the embodiment of the present invention 1 to prepare according to table of random number, the embodiment of the present invention 1 preparation prepared by dosage group, the embodiment of the present invention 1, corresponding dosage is 15.625g/kg/d, 12.5g/kg/d, 10.0g/kg/d.It is 20mL/kg that vagina receives bolt amount, and matched group vagina receives bolt vaseline bolt.
Animal feeding and experimental situation
Test preposition animal to conform in indoor one week, freely ingest and take the photograph water, room temperature 18 ~ 22 DEG C, relative humidity 65 ~ 70%, light and shade round the clock of throwing light on replaces.
Test medicine
Suppository 1,2 times/day prepared by the embodiment of the present invention 1, containing crude drug 1.25g/ml, 4 DEG C of preservations, for subsequent use, be heated to 36 ~ 39 DEG C during use.
Blank group: vaseline bolt, vagina receives bolt, and all the other conditions are with medicine group of the present invention.
Experimental technique
According to body weight, according to table of random number, mice is divided into 4 groups, often organizes 10, be divided into high dose group (crude drug concentration 15.625g/kg/d), middle dosage group (crude drug concentration 12.5g/kg/d), low dose group (crude drug concentration 10.0/kg/d) and matched group (vaseline bolt, 20g/kg/d), every day, vagina received bolt 2 times, drug withdrawal after successive administration 6 weeks (clinical application 1 course for the treatment of be 1 ~ 2 week), the recovery observation period is after drug withdrawal 2 weeks.
Experimental result
During adhesive ileus is clinical, adhesion state generally can not more than 4 weeks, but in order to verify the safety that vaginal suppository 1 of the present invention uses, particularly delayed toxicity, this experiment is designed on anxious toxicity test basis, by the successive administration of high, medium and low three dosage, and observed and recorded is carried out to the every physical signs of rat, probe into vagina of the present invention and receive the long_term toxcity of bolt.
In experiment, high, normal, basic dosage is respectively 15.625g/kg/d, 12.5g/kg/d, 10.0g/kg/d, corresponding adult intends 62.5 times, 50 times, 40 times of consumption clinical day, successive administration is after 6 weeks, by Testing index more every with matched group, as a no difference of science of statistics respectively organized by general state, body weight, food-intake, amount of drinking water.By carrying out histopathology relative analysis to each group of rat, have no obvious toxicity sensitive indicator and toxicity target organ.After drug withdrawal observes 2 weeks, the every Testing index of high, medium and low dosage group rat all belongs to normal, has no Delayed onset toxic reaction and cumulative toxicity reaction.
Comprehensive each group long term toxicity test result, suppository 1 prepared by the embodiment of the present invention 1 is applied to rat without obvious toxic-side effects, clinical adult's plan dosage and be in safety range the course for the treatment of.Therefore, in corresponding Clinical practice course for the treatment of of 4 weeks, be also be in safety range.
Embodiment 5 clinical research
Case selection has generally selected my institute outpatient service patients of cervical ruin 170 example since 2012 ~ 2014 years, and cervix uteri anti-cancer smear is feminine gender, and get rid of whole body important organ and blood coagulation disorders, get rid of reproductive tract acute inflammation, leucorrhea cleannes 1 ~ 2 degree, have no infusorian, mycete.
Diagnostic criteria:
3 types are divided into according to rotten to the corn weight; Pure erosion is covered by rotten to the corn face is only simple columnar epithelium, and surface is smooth.Graininess erosion is glandular epithelium hyperplasia and with interstitial proliferation, rotten to the corn face is rough and uneven in surface.The erosion of breast convex is that interstitial proliferation is remarkable, and air spots phenomenon is more remarkable.3 degree are divided into: be slightly less than 1/3 of whole cervix uteri area for rotten to the corn area according to rotten to the corn size; Moderate is that rotten to the corn area accounts for 1/3 ~ 2/3 of whole cervix uteri area; Severe is that rotten to the corn area accounts for more than 2/3 of whole cervix uteri area.
Cervical erosion is difficult to differentiate in pre-term cervical cancer, must do papanicolaou test, does biopsy if desired to determine diagnosis.
Therapeutic Method
170 routine patients are divided into two groups at random, treatment group 90 people, matched group 80 people, at the age, the no difference of science of statistics such as disease typing, P>0.05, has comparability.Treatment group is given and Chinese medicine preparation suppository of the present invention, 1 piece/time, 2 times/day, and matched group is given and Radix Sophorae Flavescentis Suppositoria (medicine forms Radix Sophorae Flavescentis, Cortex Phellodendri, catechu, the Pseudobulbus Bletillae (Rhizoma Bletillae), Borneolum Syntheticum, Olibanum, Myrrha, Herba Taraxaci), 1 piece/time, 2 times/day.7 is a course for the treatment of, and form boundary with normal structure after being used in conjunction 2 ~ 3 courses for the treatment of and strip off, the neck tube cast sample slough stripped out from neck tube claims medicine circular cone.Menstrual period stop using.Prohibitive life and demibain during medication.
Criterion of therapeutical effect
Recovery from illness: heal completely in rotten to the corn face, cervix uteri is smooth, clinical symptom disappearance;
Effective: rotten to the corn face accounts for whole cervix uteri area more than 2/3, clinical symptom disappearance or alleviate;
Invalid: rotten to the corn face and clinical symptoms are without obvious change.
Therapeutic outcome
Table 1 liang group Clinical efficacy comparison
Group | N | Cure | Effective | Invalid | Total effective rate % |
Matched group | 80 | 23 | 46 | 11 | 86.25 |
Treatment group | 90 | 31 | 58 | 1 * | 98.89 * |
Compare with matched group,
*p<0.05
Regular follow-up treatment cervix uteri in rear January is smooth, and shape recovers normal.
Discuss
Chronic cervicitis is common gynecological disease, and traditional therapy has microwave, laser, freezing physics, chemical method.Make its rotten to the corn local epidermal cell necrosis, incrustation comes off, and new epithelize coverage rate reaches therapeutic purposes, but when rotten to the corn face is dark, when hamartoplasia is obvious, the said method treatment degree of depth is limited, only can treat the outer pathological changes of cervix uteri and can not go deep into the hyperplastic tissue of incision cervical canal cervix uteri in.The mechanism of action of Chinese medicine preparation suppository of the present invention is by clearing away heat-damp and promoting diuresis leukorrhagia stopping, putrefaction-removing granulation-promoting sore is main, blood circulation promoting and blood stasis dispelling, effect of hard masses softening and resolving, improve cervical erosion tissue and blood circulation, conditioner body immunity function, improves resistance against diseases, promotes regeneration and restoration, accelerate the normal healing in rotten to the corn face, its advantage is compared with traditional method: (1) short treating period, and healing is fast, evident in efficacy; (2) secretions other naturopathy can being avoided to cause oozes out, infertile, cervical adhesion, hemorrhage side effect of Denging, i.e. restorability life after drug withdrawal to next clean period, patient is acceptant; (3) the cervix uteri matter through following up a case by regular visits to healing is soft, good springiness, without cicatrix and side effect.
By the clinical research of Chinese medicine suppository of the present invention, prove that its invention has good clinical efficacy, be applicable to clinical expansion.
Embodiment 6 experimentation
Experiment material
Bacterial strain mycoplasma hominis (Mh) and Ureaplasma urealyticum (Uu) provide by Shoudu Inst. of Pediatrics.
Reagent
L-arginine (Sanland-ChemInternationalCompany); Metronidazole suppository (medicine limited company of Shanghai medical professionals institute); Lincomycin (Shanghai Zhongxi Pharmaceutical Co., Ltd.).
Animal in kind
Female KM kind mice, 18 ~ 20g.
Method
The preparation of reagent
The various traditional medicine volatile oils of the volatile oil prepared contained by the suppository 1 embodiment of the present invention 1 prepared are dissolved in the tween 80 of 10%, and unification makes the volatile oil tween 80 solution of 10% as reagent.
The preparation of inoculation liquid
Activation Mh and Uu, with color change per unit system counting, makes bacterial concentration reach 10
6ccu/ml.This concentration bacterium liquid is diluted 100 times as inoculation liquid during experiment.
Antibacterial experiment in vitro
On 96 hole polystyrene plates, in every hole, add 100 μ l culture medium.In the first hole, add reagent 100 μ l again, draw 100 μ l after mix homogeneously and add to the second hole, again get 100 μ l after mix homogeneously and add to the 3rd hole, by that analogy, until the 9th hole.Add azithromycin as positive control in tenth hole, 11-holes inoculation bacterium liquid does not add medicinal liquid as negative control, and the 12 hole does not add medicinal liquid and do not inoculate bacterium liquid yet.Then in each hole except the 12 hole, inoculate the inoculation liquid that 100 μ l have diluted again.Drip 100 μ l liquid paraffin sealings in the most backward each hole, build 96 orifice plate plate lids, jog mixes, 37 DEG C of cultivations.Uu growth change is observed in 24h; Mh growth change situation is observed in 24h ~ 48h.If the color change identical with negative control hole appears in medicine feeding hole, represent that added medicine corresponding concentration is to inoculation bacterium unrestraint effect.Do not occur that the Cmin that color changes is the drug level (MIC) that minimum effective suppression mycoplasma grows with medicine feeding hole.Establish tween 80 matched group simultaneously.
Chinese medicine preparation treatment cervicitis of the present invention
Chinese medicine preparation In Vitro Bacteriostasis of the present invention
Get the Chinese medicine preparation aqueous solution 1ml of the present invention prepared, be added to 10 of 2ml
6in ccu/ml bacterium liquid, establish positive controls simultaneously, add the metronidazole suppository after 1ml hot melt, and negative control group, add 1ml Blank gel.37 DEG C of cultivations, observe Uu growth change situation in 24h; Mh growth change situation is observed in 24h ~ 48h.
If culture medium color does not change, represent that Chinese medicine preparation of the present invention has inhibitory action to inoculation bacterium.
The treatment of cervicitis
40 female KM mices, are rationally divided into 5 groups, often organize 8: 1. Normal group, 2. cervicitis model group 3. Chinese drug-treated group 4. metronidazole (positive control) group.2. 1d ~ 3d lincomycin rinse ~ 4. organize mouse vagina, and 20 μ l/ are only.2. 4d ~ 11d, to rub gently ~ 4. mouse vagina with the syringe polishing needle point, inoculate 15 μ lUu and 15 μ lMh bacterium liquid after slight bleeding with micropipettor.After inoculation, be inverted mice and be about 1min, go out with fungi-proofing liquid stream.Administration from 12d, the 3. group often only give 20 μ l Chinese medicine preparation aqueous solution of the present invention, the 4. group often only give the metronidazole suppository after 20 μ l heat fused, and the 1. with the 2. two groups not to any medicine.17d takes off cervical vertebra and puts to death mice, gets cervix uteri and vaginal mucosa in 10% neutral formalin solution, does HE dyeing, observed result after fixing 24h.
Result
The various traditional medicine volatile oil of the fungistatic effect of traditional medicine volatile oil to experimental strain to the inhibitory action of various experimental bacteria in table 2.
Table 2 invention formulation can prepare the traditional medicine volatile oil bacteriostasis of volatile oil
Chinese medicine preparation In Vitro Bacteriostasis result of the present invention
After 24h cultivates, Uu and the Mh culture medium adding metronidazole suppository and Chinese medicine ingredients of the present invention does not all have color to change, Uu and the Mh culture medium color adding Blank gel becomes pink by light yellow.Represent that Chinese medicine preparation of the present invention effectively can suppress the growth of Uu and Mh.
The effect of Chinese medicine preparation treatment cervicitis of the present invention
Histopathologic examination, with the inflammatory infiltration of cervix uteri section, mucosal hyperplasia and interstitial edema for major histological index, each group check pathological section situation is as follows:
1. Normal group: 8 specimen.Vagina is white, translucent, soft, without obvious inflammatory cell infiltration and edema under mucosa.Cervix uteri columnar epithelium marshalling, without obvious inflammatory cell infiltration and edema;
2. model group: 7 specimen.Vaginal walls is coarse, all has edema in various degree, and epithelium blisterization is serious, and inflammatory infiltration is obvious, and has cell necrosis phenomenon.Cervix uteri columnar epithelium has obscission, obviously can see inflammatory cell infiltration under mirror;
3. metronidazole group: 8 specimen.Compared with model group, the inflammatory infiltration phenomenon of vaginal mucosa and cervix uteri all improves significantly.Vagina epithelium blister alleviates, and only has an example to occur subcutaneous cell necrosis phenomena.Cervix uteri columnar epithelium marshalling, only has slight edema;
4. Chinese drug-treated group: 8 specimen.Morphologic features is basic identical with metronidazole group, but is slightly better than metronidazole group to the improvement of inflammatory infiltration.Compared with Normal group, without obvious Morphological Differences.
The inflammatory infiltration phenomenon of vaginal mucosa and cervix uteri is still very serious, occurs epithelium blister in most specimen.In cervix uteri section, there is cervix uteri columnar epithelium obscission in the example also had.Pathomorphology performance is basic identical with model group.With histopathologic change standards of grading for foundation, investigate therapeutic effect.The results are shown in Table 3.
Table 3 Chinese medicine preparation of the present invention to Experimental Mice vagina and
Cervicitis checking therapeutical effect curative effect integration (n=8,
)
Compare with model group, P<0.05, compare with metronidazole group, P<0.05
Result shows the cervical mucosa pathological changes of Chinese medicine preparation of the present invention to Uu and Mh mixed infection induced mice cervicitis significantly protection and repair.
Discuss
Chronic cervicitis is gynecological's common disease, originally thinks that staphylococcus glucose coccus, escherichia coli and Candida albicans are disease-producing pathogens more, but in recent years finds that the non-pouring cervicitis morbidity caused by mycoplasma infection is remarkable ascendant trend.Mycoplasma is easy infection columnar epithelial cell because of its special structure, and cervix uteri is its main infection position.Past, in the treatment of chronic cervicitis, often have ignored the treatment to mycoplasma infection, and the treatment by Chinese herbs of the non-pouring cervicitis of mycoplasma infection also has no report.Select the clinical common mycoplasma of two strains to be tested bacterium herein, find that plurality of Chinese volatile oil can suppress Mh and Uu.Traditional medicine volatile oil contained by Chinese medicine preparation of the present invention, just can suppress Mh and Uu respectively when low concentration.After reasonable formula, we obtain Chinese medicine preparation of the present invention.Experiment in vivo adopts method establishment mouse vagina, the cervicitis model of Mh and Uu mixed infection.The mouse vagina that naked eyes have as seen has purulent secretion to flow out, and sections observation is serious to vagina, cervical mucosa epithelial proliferation, and subcutaneous inflammatory cell infiltration is serious.Apply Chinese medicine preparation vagina administration of the present invention treatment after, mouse vagina all without purulent secretion outflow, sections observation mouse vagina, cervical mucosa epithelial proliferation alleviate, and congestion and edema also obviously alleviates, subcutaneous inflammatory infiltration also be improved significantly.Illustrate that Chinese medicine preparation of the present invention effectively can reduce vagina, cervicitis inflammatory exudation, promote the reparation of impaired vagina and cervix uteri, reach the object for the treatment of cervicitis.
Study by experiment, for Chinese medicine preparation of the present invention treatment chronic cervicitis provides Laboratory evidence, and then provide corresponding data for clinical expansion Chinese medicine preparation of the present invention.
All above-mentioned this intellectual properties of primary enforcement, not setting restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (9)
1. treat a Chinese medicine for chronic cervicitis, it is characterized in that: crude drug comprises Fructus Cnidii, Rhizoma Smilacis Glabrae, the Fructus Kochiae, Herba Portulacae, Herba Patriniae, Semen Coicis, Herba Violae, Herba Agrimoniae, Herba Taraxaci, Rhizoma Alismatis, Radix Sophorae Flavescentis, Alumen, Realgar, Rhizoma Coptidis, Cortex Phellodendri, Rhizoma Atractylodis, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Cortex Moutan, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Pericarpium Citri Reticulatae, Rhizoma Pinelliae Preparatum, Rhizoma Atractylodis Macrocephalae and Radix Glycyrrhizae.
2. the Chinese medicine for the treatment of chronic cervicitis as claimed in claim 1, is characterized in that: in described Chinese medicine, the weight portion of each crude drug is respectively Fructus Cnidii 15 weight portion ~ 20 weight portion, Rhizoma Smilacis Glabrae 15 weight portion ~ 25 weight portion, the Fructus Kochiae 20 weight portion ~ 30 weight portion, Herba Portulacae 20 weight portion ~ 30 weight portion, Herba Patriniae 10 weight portion ~ 25 weight portion, Semen Coicis 10 weight portion ~ 20 weight portion, Herba Violae 15 weight portion ~ 25 weight portion, Herba Agrimoniae 10 weight portion ~ 20 weight portion, Herba Taraxaci 20 weight portion ~ 40 weight portion, Rhizoma Alismatis 15 weight portion ~ 25 weight portion, Radix Sophorae Flavescentis 10 weight portion ~ 20 weight portion, Alumen 5 weight portion ~ 15 weight portion, Realgar 10 weight portion ~ 15 weight portion, Rhizoma Coptidis 20 weight portion ~ 35 weight portion, Cortex Phellodendri 30 weight portion ~ 45 weight portion, Rhizoma Atractylodis 10 weight portion ~ 25 weight portion, Radix Angelicae Sinensis 20 weight portion ~ 30 weight portion, Radix Paeoniae Rubra 10 weight portion ~ 20 weight portion, Cortex Moutan 10 weight portion ~ 20 weight portion, Radix Salviae Miltiorrhizae 15 weight portion ~ 20 weight portion, Rhizoma Corydalis 10 weight portion ~ 15 weight portion, Pericarpium Citri Reticulatae 10 weight portion ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 weight portion ~ 20 weight portion, Rhizoma Atractylodis Macrocephalae 20 weight portion ~ 30 weight portion and Radix Glycyrrhizae 25 weight portion ~ 35 weight portion.
3. the Chinese medicine for the treatment of chronic cervicitis as claimed in claim 1 or 2, is characterized in that: in described Chinese medicine, the weight portion of each crude drug is respectively Fructus Cnidii 15 weight portion ~ 20 weight portion, Rhizoma Smilacis Glabrae 15 weight portion ~ 20 weight portion, the Fructus Kochiae 20 weight portion ~ 25 weight portion, Herba Portulacae 25 weight portion ~ 30 weight portion, Herba Patriniae 15 weight portion ~ 20 weight portion, Semen Coicis 10 weight portion ~ 15 weight portion, Herba Violae 20 weight portion ~ 25 weight portion, Herba Agrimoniae 10 weight portion ~ 15 weight portion, Herba Taraxaci 30 weight portion ~ 35 weight portion, Rhizoma Alismatis 15 weight portion ~ 20 weight portion, Radix Sophorae Flavescentis 15 weight portion ~ 20 weight portion, Alumen 5 weight portion ~ 10 weight portion, Realgar 10 weight portion ~ 15 weight portion, Rhizoma Coptidis 25 weight portion ~ 30 weight portion, Cortex Phellodendri 35 weight portion ~ 40 weight portion, Rhizoma Atractylodis 15 weight portion ~ 20 weight portion, Radix Angelicae Sinensis 25 weight portion ~ 30 weight portion, Radix Paeoniae Rubra 15 weight portion ~ 20 weight portion, Cortex Moutan 10 weight portion ~ 15 weight portion, Radix Salviae Miltiorrhizae 15 weight portion ~ 20 weight portion, Rhizoma Corydalis 10 weight portion ~ 15 weight portion, Pericarpium Citri Reticulatae 10 weight portion ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 weight portion ~ 15 weight portion, Rhizoma Atractylodis Macrocephalae 25 weight portion ~ 30 weight portion and Radix Glycyrrhizae 25 weight portion ~ 30 weight portion.
4. the Chinese medicine of the treatment chronic cervicitis as described in claims 1 to 3, it is characterized in that: in described Chinese medicine, the weight portion of each crude drug is respectively Fructus Cnidii 15 weight portion, Rhizoma Smilacis Glabrae 20 weight portion, the Fructus Kochiae 25 weight portion, Herba Portulacae 25 weight portion, Herba Patriniae 15 weight portion, Semen Coicis 15 weight portion, Herba Violae 20 weight portion, Herba Agrimoniae 15 weight portion, Herba Taraxaci 30 weight portion, Rhizoma Alismatis 20 weight portion, Radix Sophorae Flavescentis 15 weight portion, Alumen 10 weight portion, Realgar 10 weight portion, Rhizoma Coptidis 30 weight portion, Cortex Phellodendri 40 weight portion, Rhizoma Atractylodis 15 weight portion, Radix Angelicae Sinensis 25 weight portion, Radix Paeoniae Rubra 15 weight portion, Cortex Moutan 15 weight portion, Radix Salviae Miltiorrhizae 20 weight portion, Rhizoma Corydalis 10 weight portion, Pericarpium Citri Reticulatae 10 weight portion, Rhizoma Pinelliae Preparatum 15 weight portion, Rhizoma Atractylodis Macrocephalae 25 weight portion and Radix Glycyrrhizae 30 weight portion.
5. the Chinese medicine of the treatment chronic cervicitis as described in Claims 1-4, is characterized in that: described Chinese medicine is prepared into suppository.
6. the preparation method of Chinese medicine described in claim 1 to 5, is characterized in that, comprising:
The first step, is ground into coarse powder by above-mentioned weight portion respectively by Fructus Cnidii, the Fructus Kochiae, adopts carbon dioxide supercritical fluid extraction device to extract volatile oil, and setting separator pressure 30MPa, temperature 30 DEG C, coarse powder loads in extractor, carries out supercritical CO
2extraction, extraction 60 ~ 90min produces to without extract, from separator collection extract, obtains Fructus cnidii and Fructus Kochiae volatile oil respectively;
Second step, remaining crude drug is taken by above-mentioned weight portion, mix, pulverize to obtain coarse powder, adding determining alcohol is 50% ~ 75% ethanol water reflux, extract, three times, and first time adds 8 ~ 12 times that amount of alcohol is coarse powder weight, backflow 3 ~ 5h, second time adds 6 ~ 8 times that amount of alcohol is coarse powder weight, backflow 2 ~ 3h, and third time adds 3 ~ 5 times that amount of alcohol is coarse powder weight, backflow 1 ~ 2h, merge backflow, filter, obtained extracting solution, extracting solution is condensed into thick paste, dry, pulverize powdered, obtained extract;
3rd step, choose substrate 45 DEG C ~ 55 DEG C heating and melting, add volatile oil obtained above and extract, cooling and shaping makes class warhead shape suppository, and ultraviolet is killed virus.
7., as the preparation method of claim 6 Chinese medicine, it is characterized in that: described suppository substrate used be selected from semi-synthetic fatty acid glyceride, poloxamer, Polyethylene Glycol, lanoline one or more.
8. as the preparation method of claim 6 or 7 Chinese medicines, it is characterized in that: described 3rd step is specially described substrate heating and melting under DEG C condition of temperature 45 C ~ 55 further, add volatile oil prepared by the first step and the mixture that extract mix homogeneously prepared by second step obtains, stirring in water bath is even, be mixed into the liquid of thickness, be poured in plastic shape-forming pipe, insert tampon, cooling and shaping makes bullet-shaped suppository.
9. as the preparation method of claim 6 to 8 Chinese medicine, it is characterized in that: the quality proportioning of the mixture quality that the extract that the volatile oil that the described first step obtains, second step obtain mixes and obtains and substrate is 1: 2 ~ 1: 4; Described tampon is the tampon of afterbody with cotton thread.
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