CN104352788A

CN104352788A - External traditional Chinese medicine preparation for treating anal papilla and preparation method thereof

Info

Publication number: CN104352788A
Application number: CN201410620525.5A
Authority: CN
Inventors: 不公告发明人
Original assignee: Qingdao Hengbo Instrument Co Ltd
Current assignee: Qingdao Hengbo Instrument Co Ltd
Priority date: 2014-11-06
Filing date: 2014-11-06
Publication date: 2015-02-18

Abstract

The invention provides an external traditional Chinese medicine preparation for treating anal papilla. The external traditional Chinese medicine preparation for treating anal papilla provided by the invention comprises the following medicinal raw materials in parts by weight: 10-20 parts of carbonized sanguisorba root, 10-20 parts of scutellaria baicalensis, 10-20 parts of hedyotis diffusa, 10-20 parts of ligusticum wallichii, 10-20 parts of honeysuckle, 10-20 parts of the root of red-rooted salvia, 10-20 parts of fried sophora fruit, 10-20 parts of lithospermum, 10-20 parts of charred schizonepeta, 10-20 parts of patrinia, 10-20 parts of golden cypress, 10-20 parts of rheum officinale, 10-20 parts of caulis Spatholobi, 10-20 parts of folium artemisiae argyi, 10-20 parts of dragon's blood, 10-20 parts of radix angelicae, 10-20 parts of rhizoma bletillae, and 10-20 parts of radix sophorae flavescentis. The external traditional Chinese medicine preparation for treating anal papilla disclosed by the invention has the effects of clearing heat, removing toxicity, discharging fire, calming vein, relieving swelling and pain, and removing blood stasis for promoting tissue regeneration; by means of anal injection, drugs are concentrated on focal areas to internally take effect for a long time, so that absorption and efficacy of the drugs are carried out easily; the external traditional Chinese medicine preparation for treating anal papilla disclosed by the invention is used for enhancing local blood circulation, improving permeability of blood capillaries, relieving smooth muscle spasm, lightening pain, reducing exudation and mitigating stimulation to peripheral nerve, and thus, the external traditional Chinese medicine preparation for treating anal papilla has the effects of promoting blood circulation to remove blood stasis, dredging the channel and relieving swelling and pain.

Description

A kind of Chinese medicine for external application for the treatment of anal papillitis and preparation method thereof

Technical field

The present invention relates to the health product containing deriving from plant composition, particularly a kind of Chinese medicine for external application for the treatment of anal papillitis and preparation method thereof.

Background technology

Anal papilla is positioned at the epithelium projection of rectal columns lower end, tooth trace portion, in cone-shaped point down, as Semen phaseoli radiati size, is creamy white, 2-6.Stimulate by chronic inflammatory disease and can increase as the large base of a fruit of column or Semen Juglandis shape top is thin, deviate from outside anus with defecation, clinical easy mistaken diagnosis is rectal polyp.Hypertrophy of anal papilla answers active treatment, carries out prevention.The performance of anal papillitis is not obvious, often can be ignored by patient, go not in time to seek medical advice.Anal papillitis main manifestations is for feel that anal has foreign body sensation at ordinary times, and along with nipple hypertrophy, during defecation, nipple can be deviate from outside anus.Little nipple can get back to anal after an action of the bowels voluntarily, and large need return anal with hand push.As resetted not in time, Anal edema, distending pain can be caused.Enlargement nipple is stimulated or after ulceration, anal gland can be made to secrete to be increased, and causes podex humidity to itch.

Having bottom anal sinus can the anal gland of secreting liquid and anal gland conduit, can secrete viscous liquid at ordinary times, lubrication stool and protection anorectum.Because anal sinus is as a funnel, opening upwards is opened, and feces and other soil, be just easy to accumulate in hole, is also easily staved by the scratch of hard feces simultaneously.Antibacterial will cause infection in anal sinus after invading, and spread along anal gland conduit and anal gland, so anal sinusitis is again the root causing multiple anorectal disease, as ano-rectal manometry, anal fistula, anal fissure, hemorrhoid, anal papillitis etc., the epitheliomatous generation of anal canal, also relevant with the stimulation of chronic anal sinus inflammation.

Rectum anal tube main Physiological Function is defecation.And the protrusion lesion that rectal polyp general reference rectal mucosal surfaces is outstanding to enteric cavity, with on pathology, character differs, there is benign tumor, have inflammatory activity, it is generally acknowledged that colorectal cancer rises from polyp, therefore polyp is as disease before cancer, excise the generation that polyp can reduce cancer early.

The clinical manifestation of anal papillitis, generally can feel that anal has foreign body sensation, during defecation, anal papilla can be deviate from outside anus, large nipple can return anal with hand push, as resetted not in time, can cause Anal edema, swelling and ache, little nipple can get back to anal voluntarily.The nipple of enlargement can cause irritating anal gland to secrete, thus causes pruritus ani and moistening.Toposcopy: the anal papilla that can touch enlargement, can see under specula that little anal papilla is as denation, and large anal papilla is as Semen Glycines or botryoidalis protuberance, and matter is hard, and smooth surface, the large base of a fruit of head is little, can deviate from outside anus.Its surface coated with epithelium, in greyish white or yellow-white.

During defecation, wound or anal sinus inflammation can cause the acute inflammation of anal papilla, due to the long-time stimulus of inadequate drainage and inflammation, make hypertrophy of anal papilla, and defecation action repeatedly can make anal papilla extend gradually and become the swollen thing of the band base of a fruit, likeness in form rectal polyp.The traditional Chinese medical science is thought, primary disease is mainly because damp invasion of lower energizer causes caused by the stagnation of QI-blood of anus local.Doctor trained in Western medicine adopts operation or anti-inflammatory treatment to this, but is easy to cause allergy, repeatedly; Traditional Chinese medical science external treatment, affected part of can going directly, improves cure rate greatly, and reducing recurrence, is feasible method.Primary disease easily occurs repeatedly, and treatments period should note psychological counselling and guidance, informs this pathogenetic reason of patient and law of development, frees one's mind of misgivings, and partner treatment avoids the thing drunk strong tea, coffee or eat pungent stimulation simultaneously.

Summary of the invention

Technical problem to be solved by this invention is, modern Western medicine thinks that anal papillitis is inflammation, antiinflammatory, and current patient can only relief of symptoms, and worse comes to worst with regard to operative treatment.And Chinese medicine because use inconvenience, the smell is awful, to rhythm of life fast modern do not accept.By injection in anus, make medicine concentrate on lesions position and penetrate performance, persistent, be more conducive to the absorption of medicine and the performance of drug effect.The present invention can accelerate local blood circulation, improves the permeability of blood capillary, and alleviate smooth muscle spasm, ease the pain, minimizing is oozed out, and takes away metabolite and induced pain Inflammatory substances, alleviates the stimulation to peripheral nerve.Accelerate local metabolic, impel vasodilation, lymphatic return, improve microcirculation, strengthen local organization nutrition, protect from infection, antiinflammatory, detumescence, pain relieving, accelerate tissue regeneration, improve the growing environment of epithelium and granulation tissue.Thus reach blood circulation promoting and blood stasis dispelling, dredging the meridian, reducing swelling and alleviating pain.

For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine for external application for the treatment of anal papillitis, in Chinese medicine for external application described in it, the parts by weight of various crude drug can be: charred Radix Sanguisorbae 10 ~ 20 parts, Radix Scutellariae 10 ~ 20 parts, Herba Hedyotidis Diffusae 10 ~ 20 parts, Rhizoma Chuanxiong 10 ~ 20 parts, Flos Lonicerae 10 ~ 20 parts, Radix Salviae Miltiorrhizae 10 ~ 20 parts, fry the Fructus Sophorae 10 ~ 20 parts, Radix Arnebiae (Radix Lithospermi) 10 ~ 20 parts, Herba Schizonepetae charcoal 10 ~ 20 parts, Herba Patriniae 10 ~ 20 parts, Cortex Phellodendri 10 ~ 20 parts, Radix Et Rhizoma Rhei 10 ~ 20 parts, Caulis Spatholobi 10 ~ 20 parts, Folium Artemisiae Argyi 10 ~ 20 parts, Sanguis Draxonis 10 ~ 20 parts, the Radix Angelicae Dahuricae 10 ~ 20 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 10 ~ 20 parts, Radix Sophorae Flavescentis 10 ~ 20 parts.

The Chinese medicine for external application of described treatment anal papillitis, in Chinese medicine for external application described in it, the parts by weight of various crude drug can also be: charred Radix Sanguisorbae 10 ~ 15 parts, Radix Scutellariae 10 ~ 15 parts, Herba Hedyotidis Diffusae 10 ~ 15 parts, Rhizoma Chuanxiong 10 ~ 15 parts, Flos Lonicerae 10 ~ 15 parts, Radix Salviae Miltiorrhizae 10 ~ 15 parts, fry the Fructus Sophorae 10 ~ 15 parts, Radix Arnebiae (Radix Lithospermi) 10 ~ 15 parts, Herba Schizonepetae charcoal 10 ~ 15 parts, Herba Patriniae 10 ~ 20 parts, Cortex Phellodendri 10 ~ 20 parts, Radix Et Rhizoma Rhei 10 ~ 20 parts, Caulis Spatholobi 10 ~ 20 parts, Folium Artemisiae Argyi 10 ~ 20 parts, Sanguis Draxonis 10 ~ 20 parts, the Radix Angelicae Dahuricae 10 ~ 20 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 10 ~ 20 parts, Radix Sophorae Flavescentis 10 ~ 20 parts.

The Chinese medicine for external application of described treatment anal papillitis, in Chinese medicine for external application described in it, the parts by weight of various crude drug also can be: charred Radix Sanguisorbae 10 ~ 20 parts, Radix Scutellariae 10 ~ 20 parts, Herba Hedyotidis Diffusae 10 ~ 20 parts, Rhizoma Chuanxiong 10 ~ 20 parts, Flos Lonicerae 10 ~ 20 parts, Radix Salviae Miltiorrhizae 10 ~ 20 parts, fry the Fructus Sophorae 10 ~ 20 parts, Radix Arnebiae (Radix Lithospermi) 10 ~ 20 parts, Herba Schizonepetae charcoal 10 ~ 20 parts, Herba Patriniae 10 ~ 15 parts, Cortex Phellodendri 10 ~ 15 parts, Radix Et Rhizoma Rhei 10 ~ 15 parts, Caulis Spatholobi 10 ~ 15 parts, Folium Artemisiae Argyi 10 ~ 15 parts, Sanguis Draxonis 10 ~ 15 parts, the Radix Angelicae Dahuricae 10 ~ 15 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 10 ~ 15 parts, Radix Sophorae Flavescentis 10 ~ 15 parts.

For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of the Chinese medicine for external application of anal papillitis, and the dosage form of external preparation described in it is that the preparation method of suppository comprises:

A. Folium Artemisiae Argyi, Sanguis Draxonis, the Radix Angelicae Dahuricae and Pseudobulbus Bletillae (Rhizoma Bletillae) distillation are vaporized into crystallization, pulverize for subsequent use;

B. all the other raw material dry in the suns are put into pulverizer well and are broken into coarse granule, to steep in ethanol more than 24 hours, heating and refluxing extraction 2 times, become component 1;

C. the medicinal residues after getting above-mentioned ethanol extraction again add water, heating and refluxing extraction 2 times, become component 2;

D. by above-mentioned crystalline powder, add in above-mentioned two kinds of extracting solution, substrate Mixer pot sets type, and ultraviolet is killed virus.

In described step b, all the other raw materials soaked can be put into ethanol heating and refluxing extraction 2 times, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating be concentrated into paste, stand for standby use, becomes component 1.

In described step c, the medicinal residues that above-mentioned ethanol extraction is crossed can be added 10 times of water gaging heating and refluxing extraction 2 times, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating be concentrated into paste, stand for standby use, becomes component 2.

In described steps d, can by also 2-in-1 to said components 1 and component, insert in economic benefits and social benefits vacuum concentrator after decompression recycling ethanol, when being concentrated into 90 DEG C, relative density is the extractum of 1.05, be concentrated into every 1ml containing 1g crude drug amount, add the crystalline powder that step a obtains, add in above-mentioned concentrated extract, substrate Mixer pot sets type, 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 50 C ~ 60, adds the medicine mastic that described preparation method is obtained, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe.

For solving the problems of the technologies described above, the present invention reoffers a kind of preparation method for the treatment of the Chinese medicine for external application of anal papillitis, described external drug dosage forms is enema, its preparation process is: Sanguis Draxonis, Folium Artemisiae Argyi, Pseudobulbus Bletillae (Rhizoma Bletillae) and the distillation of the Radix Angelicae Dahuricae way of distillation are vaporized into crystallization, pulverizer crosses 120 order dusting covers after pulverizing, and fine powder is for subsequent use; Just remaining raw medicinal material adds the soak by water 2 times of 5-10 times of weight portion, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, then be the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated into pasty state shape, adds the crystalline powder of distillation vaporization, packs after ultraviolet radiation.

Enema using method: get its medicinal liquid, gets supernatant and heats and be concentrated into 200mL after natural sedimentation.Patient gets lateral position, taking liquid 50mL, heats to about 37 DEG C and extracts medicinal liquid with syringe, slowly notes in people's anus.Retain 2 ~ 4h, 1 time every night, 10d was 1 course for the treatment of.1 ~ 2 course for the treatment of of general medication.

The Chinese medicine for external application of described treatment anal papillitis, external drug dosage forms described in it can be: spray, ointment, tincture, unguentum, patch, Chinese medicine fuming-lotion, lotion, suppository or enema.

The present invention has effect of heat-clearing and toxic substances removing, the peaceful network of pathogenic fire purging, reducing swelling and alleviating pain, promoting tissue regeneration by removing blood stasis, and Cortex Phellodendri, Radix Scutellariae, Radix Et Rhizoma Rhei, Sanguis Draxonis in side, confirm there is good antibacterial action through pharmacological action.By injection in anus, make medicine concentrate on lesions position and penetrate performance, persistent, be more conducive to the absorption of medicine and the performance of drug effect.The present invention can accelerate local blood circulation, improves the permeability of blood capillary, and alleviate smooth muscle spasm, ease the pain, minimizing is oozed out, and takes away metabolite and induced pain Inflammatory substances, alleviates the stimulation to peripheral nerve.Accelerate local metabolic, impel vasodilation, lymphatic return, improve microcirculation, strengthen local organization nutrition, protect from infection, antiinflammatory, detumescence, pain relieving, accelerate tissue regeneration, improve the growing environment of epithelium and granulation tissue.Thus reach blood circulation promoting and blood stasis dispelling, dredging the meridian, reducing swelling and alleviating pain.

Primary disease easily occurs repeatedly, and treatments period should note psychological counselling and guidance, informs this pathogenetic reason of patient and law of development, frees one's mind of misgivings, and partner treatment avoids the thing drunk strong tea, coffee or eat pungent stimulation simultaneously.

Detailed description of the invention

Anal papillitis is a kind of important latent infection focus, and the anorectal infection sexually transmitted disease (STD) change of about 85% is infected relevant with anal sinus.Primary disease belongs to motherland's medical science " dysentery " category, because heresy that is damp and hot, pyretic toxicity accumulates poly-anus, qi-blood disharmony, and with the passing of time QI and blood is stopped up and held back, caused by channels stasis blocking.Modern medicine thinks that the vexed dissection arrangement of anus is the major reason of the easy inflammation of anal papilla, and the cup-shaped mouth of this finer structures upward, easily accumulates excrement slag or damaged by during anal canal by the foreign object gulping down people by mistake; Earn under long-term during constipation, cause anus and rectum lower end passive hyperemia, reduce the resistance of local to pathogenic bacteria invasion, pathogenic bacteria causes inflammation from dark people's anal gland bottom it.

During defecation, wound or anal sinus inflammation can cause the acute inflammation of anal papilla, due to the long-time stimulus of inadequate drainage and inflammation, make hypertrophy of anal papilla, and defecation action repeatedly can make anal papilla extend gradually and become the swollen thing of the band base of a fruit, likeness in form rectal polyp.The traditional Chinese medical science is thought, primary disease is mainly because damp invasion of lower energizer causes caused by the stagnation of QI-blood of anus local.

Anal papillitis is a kind of more common anal canal disease, and because this disease often has rheuminess beyond the region of objective existence to overflow, so easy secondary anal eczema and anal cryptitis, even can cause perianal abscess, living normally to people makes troubles.At present to treatment and the prevention of anal papillitis, still lack good method.

The series of advantages such as externally applied ointment has higher denseness, and effective component content is high so it has, speed of separating out slow, effect is long-term lastingly, local efficacy is practical.Effective ingredient of the present invention can penetrate skin and produce the effect such as promoting blood circulation and stopping painization silt, the network that stimulates the menstrual flow away, eliminating dampness and expelling toxin, expelling wind and cold, fundamentally comprehensively play curative effect for pathogenic characteristic, improve perilesional histotrophic nutrition, play the effect of repairing diseased tissues, finally reach healing object.

The traditional Chinese medical science is thought, primary disease is mainly because damp invasion of lower energizer causes caused by the stagnation of QI-blood of anus local.Radix Scutellariae clearing away heat-damp and promoting diuresis in side, Herba Hedyotidis Diffusae, Flos Lonicerae heat-clearing and toxic substances removing, charred Radix Sanguisorbae, the Fructus Sophorae, Radix Paeoniae Rubra, Flos Lonicerae, Rhizoma Chuanxiong, Radix Angelicae Sinensis clearing away heat and cooling blood, promoting blood circulation and stopping pain, Rhizoma Smilacis Glabrae inducing diuresis to remove edema, loosening bowel to relieve constipation.Cortex Phellodendri, Radix Et Rhizoma Rhei, Folium Artemisiae Argyi, charred Radix Sanguisorbae clearing away heat-damp and expelling toxic material in fumigation and wash method side, promoting blood circulation and stopping pain.The present invention has effect of heat-clearing and toxic substances removing, the peaceful network of pathogenic fire purging, reducing swelling and alleviating pain, promoting tissue regeneration by removing blood stasis, and Cortex Phellodendri, Radix Scutellariae, Radix Et Rhizoma Rhei, Sanguis Draxonis in side, confirm there is good antibacterial action through pharmacological action.By injection in anus, make medicine concentrate on lesions position and penetrate performance, persistent, be more conducive to the absorption of medicine and the performance of drug effect.The present invention can accelerate local blood circulation, improves the permeability of blood capillary, and alleviate smooth muscle spasm, ease the pain, minimizing is oozed out, and takes away metabolite and induced pain Inflammatory substances, alleviates the stimulation to peripheral nerve.Accelerate local metabolic, impel vasodilation, lymphatic return, improve microcirculation, strengthen local organization nutrition, protect from infection, antiinflammatory, detumescence, pain relieving, accelerate tissue regeneration, improve the growing environment of epithelium and granulation tissue.Thus reach blood circulation promoting and blood stasis dispelling, dredging the meridian, reducing swelling and alleviating pain.

Charred Radix Sanguisorbae: Radix Sanguisorbae picric acid; Cold; Nontoxic.Return liver; Lung; Kidney; Large intestine channel.Effect cooling blood for hemostasis, heat-clearing and toxic substances removing, detumescence sore.Cure mainly; Spit blood, spitting of blood, epistaxis, hematuria, has blood in stool, hemorrhoidal bleeding, dysentery, metrorrhagia, leucorrhea with red and white discharge, sore, carbuncle and painful swelling, eczema, pudendal pruritus, burn due to hot liquid or fire, snake bite and insect sting." detailed outline ": Radix Sanguisorbae, except part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels heat, controls defecation blood disorder.Hemostasis, get and cut off sheet and fry use, its tip then can promoting the circulation of blood, can not know.Yang Shiying cloud: all skin ulcer pain persons add Radix Sanguisorbae, and the person of itching adds Radix Scutellariae." book on Chinese herbal medicine is looked for the truth ": Radix Sanguisorbae, all books are all sayed because of its bitter cold, then can enter part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels blood system heat extraction, know from lower solution in order to do heat.Yan Xingchen and puckery again, ordinary person's disease suffering from, tells the diseases such as nosebleed metrorrhagia hemorrhoidal hamorrhage dysentery, obtains this and then can not understand by puckery blood.By this not without not tally, Ju knows that its heat is not removed, then blood is more than, and its heat is both clear, then blood is from peace, and the main convergence of its property, can fall clearly, again can astringent therapy, then do not consider clearly it and cross and let out, puckery also do not consider itself or stagnant, the antipyretic hemorrhage of strength is also.Charred Radix Sanguisorbae: " doctor ancestor says about ": " fry black hemostasis." existing, get Radix Sanguisorbae sheet and put in pot, heat with high heat, fry to surface in coke black, inner sepia, spray clear water is a little, and go out most Mars, and taking-up cools completely.The defeated charcoal in ground is longer than hemostasis, is usually used in having blood in stool, hematuria, metrorrhagia etc. go out blood disorder.

Herba Hedyotidis Diffusae is again Herba Hedyotidis Diffusae, two leaves, Herba Commelinae Bengalensis, Chinese Lobelia.Mildly bitter flavor, sweet, cold.Enter stomach, large intestine, small intestine meridian, clearing up internal heat by using drugs of bitter in taste and cold in nature detoxifies, and sweet cold eliminating damp-heat, has stronger removing toxicity for eliminating carbuncles effect to carbuncle, pharyngalgia, snakebite etc.Be generally used for treatment sore, laryngopharynx swelling and pain, abdominalgia with intestinal abscess, venom, also for the puckery pain of pyretic stranguria, dysuria.The good medicine of damp eliminating of drawing out pus by applying a plaster to the affected part.

Radix Scutellariae Radix Scutellariae has heat clearing and damp drying, and removing heat from blood is antiabortive, detoxicating functions.Cure mainly the diseases such as epidemic febrile disease, upper respiratory tract infection, cough due to lung-heat, damp and hot jaundice, pneumonia, dysentery, hemoptysis, conjunctival congestion, frequent fetal movement, hypertension, carbuncle furuncle.The clinical practice of Radix Scutellariae is antibacterial not worse than Rhizoma Coptidis, and does not develop immunity to drugs.We are by the strong feature of broad-spectrum antibacterial action, are used in fungal culture miscellaneous bacteria and infect special severe, fine by Radix Scutellariae extracting solution effect." Bencao Jingshu ": Radix Scutellariae, its property is respectful clearly, so evil removing: bitter in the mouth is so dampness; YIN-cold is so victory heat, therefore main all heat.All hot persons, pathogenic heat with all over heat also, jaundice, intestinal be out-of-the-way, let out dysentery, and the disease of all damp and hot victory also, analyses it, then all diseases are from recover.Bitter cold can except damp and hot, thus small intestinal profit and water from by, source is clearly then flowed also clean.The blood person of closing, excess-heat is at blood system, and instant heating human blood room, it is obstructed to make us amenorrhea, and damp and hot solution, then Ying Qi clearly and voluntarily also.Malignant boil cellulitis erosion person, heat in blood then stays knot, and is that carbuncle stain is also rotten: acute scleritis person, also, removing heat from blood heat extraction, then spontaneous recovery also for fire of moxibustion blood trouble.Radix Scutellariae has antiallergic action and antiinflammatory action: the anaphylaxis contractile response that baicalin contained by Radix Scutellariae and baicalin can obviously suppress sensitized guinea pig rat small intestine in vitro and isolated tracheal to produce antigen, to passive general allergy and the Cavia porcellus passivity skin allergic reaction of Cavia porcellus and mice, baicalin and baicalin also have inhibitory action.Radix Scutellariae has refrigeration function, and most test proves, the active ingredient baicaligenin of Radix Scutellariae has refrigeration function.Radix Scutellariae has Detoxication, and baicalin has obvious Detoxication, and this may be that baicalin decomposites glucuronic acid due under the effect of glucuronidase, and caused by being combined with multiple poisonous substance.The LD 50 that baicalin 10 milligrams can improve strychnine reaches 2.5 times, and the hepatic glycogen content of carbon tetrachloride poisoning mice is increased.

Flos Lonicerae: Compendium of Material Medica is carried " Flos Lonicerae, is good at removing toxic substances, therefore controls carbuncle, toxic swelling, skin ulcer tinea ... ".Since ancient times, Flos Lonicerae is usually used in heat-clearing and toxic substances removing, the heating for the treatment of epidemic febrile disease, toxic-heat and blood stasis, the diseases such as carbuncle and ulcer.Modern pharmacological research shows, Flos Lonicerae has the effect traditional Chinese medical science such as antibacterial, antiviral, antiinflammatory, antipyretic, immunity moderation and thinks, Flos Lonicerae is cold in nature, sweet in the mouth, gas flat, has effect of heat-clearing and toxic substances removing, can treat the disease such as pyretic toxicity abscess, carbuncle furuncle.And have the loose effect of a surname concurrently.Flos Lonicerae antipyretic and antidote functions is quite strong, is conventional product, is generally used for the sore and toxic of red and swollen heat pain in surgery.Fry the Fructus Sophorae: bitter, cold.Return liver, large intestine channel.Function with cure mainly: clearing away heat-fire, cooling blood for hemostasis.Have blood in stool for intestinal heat, hemorrhoid swell hemorrhage, and liver-heat is had a headache, dizzy conjunctival congestion.Fructus Sophorae bitter in the mouth, cold in nature.Return liver, large intestine channel.There are clearing away heat-fire, blood cooling and hemostatic functions.Have blood in stool for intestinal heat, hemorrhoid swell hemorrhage, and liver-heat is had a headache, dizzy conjunctival congestion." book on Chinese herbal medicine asks former " Fructus Sophorae profit liver is nourished blood.Control infantile malnutrition, furuncle, dysentery, collapse blood; Nucleon in its angle, supplementing the brain, parasite killing.

Herba Schizonepetae charcoal has another name called black Herba Schizonepetae.Be by after Herba Schizonepetae cutting, fry with high heat to coke black, sustainability, spray clear water less, take out and dry the person of being used as medicine.Cure mainly: treating hematochezia, metrorrhagia, puerperal blood faints.Get clean Herba Schizonepetae section, fry to surface coke black, inner coke yellow according to parch to black method, spray clear water is a little, extinguishes Mars, takes out, dries.Blood is shown in black, stops, Herba Schizonepetae parch to black, darkish complexion owner blood system, the main convergence of property, therefore is good at hemostasis.Due to this evacuation of Herba Schizonepetae property, therefore the worry too of its charcoal product hemostasis misconvergence, be that treatment department of obstetrics and gynecology are hemorrhage, the common medicine of stool hematochezia.For ensureing the hemostatic healing efficacy that Herba Schizonepetae charcoal is good, optimize the preparation method of Herba Schizonepetae charcoal, it is important for holding objective charcoal processing standard.

Radix Salviae Miltiorrhizae is bitter, is slightly cold.GUIXIN, Liver Channel.Stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia.For costa sternales hypochondriac pain, rheumatic arthralgia, lump in the abdomen lumps, and skin infection swells and ache, and tumbling down is grieved, menoxenia, amenorrhea dysmenorrhea, puerperal stasis of blood pain etc.Treatment costa sternales pain, lump in the abdomen caking, and menoxenia, amenorrhea dysmenorrhoea have good effect." detailed outline " carries: Radix Salviae Miltiorrhizae, and by " the sensible opinion of married woman " cloud, SIWU TANG controls gynecopathy, pays no attention to antenatal puerperal, how many through water, all can be general, and only taste Radix Salviae Miltiorrhizae falls apart, and cures mainly identical with it.Lid Radix Salviae Miltiorrhizae can break stagnated blood, and mend fresh blood, peaceful tire, fall stillborn fetus, only metrorrhagia dysentery, regulating menstruation arteries and veins.Main Compositions of Radix Salviae Miltiorrhizae TANSHINONES has blood vessel dilating, improves circulation, removes the effects such as intravascular coagulation, has effect of invigorating blood circulation trace, and can promote that liver blood circulates, be beneficial to liver cell regeneration.

Rhizoma Chuanxiong is pungent, temperature.Enter liver, gallbladder meridian.Activating QI to alleviate the depression, method wind-dryness is wet, promoting blood circulation and stopping pain.Controlling air-cooled headache revolves dizzy, and hypochondriac pain abdomen aches, arthralgia due to cold clonic spasm of the muscle, amenorrhea, difficult labour, postpartum stagnation block pain, ulcer sores.For menoxenia, amenorrhea dysmenorrhea, abdominal mass is suffered from abdominal pain, the twinge of the breast side of body, tumbling and swelling, headache, rheumatic arthralgia." herbal classic " carries it: main apoplexy enters brain headache, arthralgia due to cold, clonic spasm of the muscle emergency, and gold wound, married woman's blood closes loss of fecundity." not Lu " carries it: " except cold dynamic in brain, on face, urticaria goes, order lacrimation, profuse nasal discharge and spittle, before we notice it as liquor-saturated, all cold gas, the hard pain of trusted subordinate, attacked by pestiferous factors, soldier is anxious to swell and ache, side of body wind pain, warming middle-JIAO endogenous cold." be the good medicine of regulating qi to disperse stagnation.

Caulis Spatholobi property is bitter, sweet, temperature.Return liver, kidney channel, enrich blood, invigorate blood circulation, dredging collateral.For menoxenia, blood deficiency and yellow complexion, paralysis and numbness, rheumatic arthralgia relaxing muscles and tendons to promote blood circulation; Nourishing blood for regulating menstruation, supplementary Amplifications of the Compendium of Materia Medica carries it can cure numb hand and foot; Quadriplegia; Rheumatic arthralgia; Women has through uncomfortable; Dysmenorrhea.Good medicine of invigorating blood circulation.

Cortex Phellodendri cures mainly heat clearing and damp drying, and pathogenic fire purging removes steams, detoxification sore treatment." Chinese Pharmacopoeia " introduces the power of Cortex Phellodendri heat clearing and damp drying, similar to Radix Scutellariae, Rhizoma Coptidis, but to be good except the damp and hot of the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, is the good medicine controlling damp and hot skin infection.

Radix Et Rhizoma Rhei has another name called general's (Lee is when it " medicine record "), Huang Liang, and fire ginseng, skin is as Wu Pu.Ancients are with its " main lower congestion, blood closes, cold and heat, broken lump in the abdomen, and prolonged fluid-retention dyspepsia, cleanses the intestines and stomach, pushes away Chen Zhixin, tonneau water paddy, relieving dyspepsia in tune, peace and the five internal organs ".Radix Et Rhizoma Rhei is used for the treatment of burn, scalds at China's long history." book on Chinese herbal medicine cover mirror " is recorded: " the yin aspect of yin, coagulated the soup clearly if grind chicken into powder, can apply burn and get effect Radix Et Rhizoma Rhei bitter in the mouth, gas Great Cold."; " medicine mirror " is recorded: " large yellow maturity, with then controlling all fire-toxin skin ulcers, does not close up for a long time.Lid is with all malicious burn, and all belong to fire-toxin, large yellow maturity use, then can let out fire-toxin, and reducing swelling and alleviating pain.”

The analgesic therapy of Sanguis Draxonis dissipating blood stasis, hemostasia and promoting granulation.Control traumatic injury to lose, ecchymoma due to internal injury; Continuous bleeding due to traumatic injury, scrofula, ecthyma unhealed for long time.Tang Materia Medica: main the five internal organs pathogen, leukorrhagia, pain relieving, removing mass blood, gold creation meat." Haiyao Bencao, Oversea Materia Medica ": leadingly traumatic fracture damage, all pain, tonify deficiency and vim and vigour stir thorn, and interior blood trouble is gathered, and should wine clothes.Promoting blood circulation to remove blood stasis for oral administration, analgesic therapy, external hemostasia and promoting granulation, sore.Cure mainly congestion amenorrhea, dysmenorrhea, postpartum stagnation.Lump in the abdomen mass in the abdomen, breast ventral spine pain.Traumatic injury, congestion swells and ache.Traumatic hemorrhage, ulcer being unable to heal.Antifungic action: Sanguis Draxonis water logging agent (1: 2) has inhibitory action in various degree to multiple pathomycetes such as trichophyton, trichophyton gypseum, oidium schoenleiniis in trial operation.Anastalsis: zoopery proves, this product can significantly shorten plasma in rabbit recalcification time, thus increases its Blood clotting.Impact on hemorheological property: continuous 3 weeks of Sanguis Draxonis water decoction-alcohol sedimentation liquid (1: 1) 0.5ml/kg intramuscular injection, Sanguis Leporis seu oryctolagi packed cell volume is reduced, erythrocyte and platelet electrophoresis time shorten, but whole blood viscosity ratio and plasma viscosity ratio are had no significant effect.Impact on platelet aggregation: Sanguis Draxonis water decoction-alcohol sedimentation liquid (1: 1) 0.1ml in vitro tests, is added in 0.5ml platelet rich plasma, has inhibitory action to the platelet aggregation of ADP induction

Folium Artemisiae Argyi is pungent, bitter, temperature; Slightly poisonous.Return liver,spleen,kidney warp.Dispersing cold for relieving pain, warming the meridian for stopping bleeding.For few abdomen cold type of pain, coldness and unbalance in meridians, cold womb is infertile, spit blood, epistaxis, metrorrhagia through many, gestation hemorrhage; External treatment skin pruritus, decortication.Vinegar Chinese mugwort charcoal warming the meridian for stopping bleeding.Hemorrhage for deficient cold type.Tang Materia Medica: main hematochezia, epistaxis, purulent dysentery, decocting in water and ball fall apart and appoint.

Pseudobulbus Bletillae (Rhizoma Bletillae) is bitter, sweet, puckery, is slightly cold.Return lung, liver, stomach warp.Tonifying the lung, hemostasis, detumescence, granulation promoting, sore.Control lung and hinder hemoptysis, epistaxis, incised wound is hemorrhage, swollen ulcer drug, canker sores, and soup fire is burnt, rhagadia manus et pedis." herbal classic ": " main carbuncle malignant boil loses cellulitis, the dead flesh of impairment of YIN, pathogen in stomach, and harmful wind miliaria is slow not to be received." " Japan hanako materia medica ": " spasmolytic is evil, blood is evil, and dysentery, acute conjunctivitis, crux, carbuncle on the back, scrofula, hemorrhoidal hamorrhage, hemorrhoid wart, cutter arrow skin ulcer flutters damage, warm malaria, dysentery, sore due to scald and burn, granulation promoting pain relieving, migratory arthralgia.″

Radix Sophorae Flavescentis bitter in the mouth; Cold in nature.Return liver; Kidney; Large intestine; Small intestine meridian; Bladder; Heart channel; Urinary bladder channel.Effect: heat clearing and damp drying: extensive use and multiple humidifier fever, as damp-heat dysentery external can decoct soup washout, for hemorrhoid, women gynecological.Heat clearing and damp drying, parasite killing, diuresis.For hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, scabies leprosy; External treatment trichomonal vaginitis.Beautifying skin-protection function: cold in nature, has heat clearing and damp drying, effect of parasite killing, Radix Sophorae Flavescentis bath can remove damp-heat in lower-JIAO, and killing parasites for relieving itching, there is good mitigation to skin pruritus, vegetable Chinese herbal medicine can Bergamot Mint Extract, dredge and restrain pore, removing skin endotoxin contamination, abundant herbal nutrition, promote growth and the reparation of damaged blood vessels neurocyte, recover subcutaneous capillary cell viability, skin reproduction is compacted fine and smooth, plays the effect of beauty and skin care.Shennong's Herbal: main stagnation of QI in chest and abdomen, lump in the abdomen, jaundice, drowns and has the heeltap, relieve oedema or abdominal distension through diuresis or purgation, except carbuncle, invigorating middle warmer, improving eyesight arresting lacrimation." Mingyi Bielu ": nourishing the liver courage, settling five organs, sedate benefit essence, sharp nine orifices, except latent heat intestinal Bleach, quenches the thirst, relieving alcoholic intoxication, yellowish or reddish urine, and treat malignant boil bottom infections, flat gastric qi, makes us addicted to food.

Radix Angelicae Dahuricae meridian distribution of property and flavor: pungent, temperature.Attach to the lung and stomach meridians.Expelling wind and cold, understand things pain-stopping, detumescence and apocenosis, dampness leukorrhagia stopping." Japan hanako materia medica ": control conjunctival congestion bulbar conjunctiva polyp, and tire patching leaks landing, broken stagnated blood, mend fresh blood, acute mastitis, carbuncle on the back, scrofula, hemorrhoidal hamorrhage, hemorrhoid complicated by anal fistula, evacuation of pus, desolation, scabies, pain relieving granulation promoting, goes face Shao-defect scar.

The manufacturing process of external suppository of the present invention is: by Folium Artemisiae Argyi 1500g, and Sanguis Draxonis 1500g, Radix Angelicae Dahuricae 1500g and Pseudobulbus Bletillae (Rhizoma Bletillae) 1500g distillation is vaporized into crystallization, pulverizes for subsequent use, by all the other raw material charred Radix Sanguisorbae 1500g, Radix Scutellariae 1500g, Herba Hedyotidis Diffusae 1500g, Rhizoma Chuanxiong 1500g, Flos Lonicerae 1500g, Radix Salviae Miltiorrhizae 1500g, fry Fructus Sophorae 1500g, Radix Arnebiae (Radix Lithospermi) 1500g, Herba Schizonepetae charcoal 1500g, Herba Patriniae 1500g, Cortex Phellodendri 1500g, Radix Et Rhizoma Rhei 1500g, Caulis Spatholobi 1500g, Radix Sophorae Flavescentis 1500g, dry in the sun is put into pulverizer well and is broken into coarse granule, to steep in ethanol more than 24 hours, all the other raw materials soaked are put into ethanol heating and refluxing extraction 2 times, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated into paste, stand for standby use, become component 1.The medicinal residues that above-mentioned ethanol extraction is crossed are added 10 times of water gaging heating and refluxing extraction 2 times, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, then be the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated into paste, stand for standby use, becomes component 2.By also 2-in-1 to said components 1 and component, insert in economic benefits and social benefits vacuum concentrator after decompression recycling ethanol, when being concentrated into 90 DEG C, relative density is the extractum of 1.05, be concentrated into every 1ml containing 1g crude drug amount, add the crystalline powder that step a obtains, add in above-mentioned concentrated extract, substrate Mixer pot sets type, 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 50 C ~ 60, adds the medicine mastic that described preparation method is obtained, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe

The preparation process of external enema of the present invention: first by Sanguis Draxonis 1200g, Folium Artemisiae Argyi 1100g, Pseudobulbus Bletillae (Rhizoma Bletillae) 1200g, Radix Angelicae Dahuricae 1200g, way of distillation distillation is vaporized into crystallization, is ground into fine powder for subsequent use, then by charred Radix Sanguisorbae 1200g, Radix Scutellariae 1300g, Herba Hedyotidis Diffusae 1300g, Rhizoma Chuanxiong 1200g, Flos Lonicerae 1100g, Radix Salviae Miltiorrhizae 1200g, fry Fructus Sophorae 1200g, Radix Arnebiae (Radix Lithospermi) 1100g, Herba Schizonepetae charcoal 1200g, Herba Patriniae 1200g, Cortex Phellodendri 1100g, Radix Et Rhizoma Rhei 1100g, Caulis Spatholobi 1200g, Radix Sophorae Flavescentis 1200g, add the immersion 1-2 hour of 5-10 times of water gaging, heating extraction 2 times, each 1-2 hour, remove supernatant, merge extractive liquid, 80-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated, 30 minutes ~ 45 minutes, extract active ingredient, concentrated solution is settled into mass shape, remerge the crystallization adding vaporization, pack after ultraviolet sterilization.

Get its medicinal liquid, get supernatant after natural sedimentation and heat and be concentrated into 200mL.Patient gets lateral position, taking liquid 50mL, heats to about 37 DEG C and extracts medicinal liquid with syringe, slowly notes in people's anus.Retain 2 ~ 4h, 1 time every night, 10d was 1 course for the treatment of.1 ~ 2 course for the treatment of of general medication.

The preparation method of spray of the present invention: first by Sanguis Draxonis 1300g, Folium Artemisiae Argyi 1400g, Pseudobulbus Bletillae (Rhizoma Bletillae) 1200g, Radix Angelicae Dahuricae 1400g, way of distillation distillation is vaporized into crystallization, then by charred Radix Sanguisorbae 1200g, Radix Scutellariae 1100g, Herba Hedyotidis Diffusae 1200g, Rhizoma Chuanxiong 1200g, Flos Lonicerae 1200g, Radix Salviae Miltiorrhizae 1100g, fry Fructus Sophorae 1200g, Radix Arnebiae (Radix Lithospermi) 1200g, Herba Schizonepetae charcoal 1100g, Herba Patriniae 1200g, Cortex Phellodendri 1100g, Radix Et Rhizoma Rhei 1100g, Caulis Spatholobi 1100g, Radix Sophorae Flavescentis 1100g, put into ethanol heating and refluxing extraction 2 times, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated into paste, stand for standby use, become component 1.The medicinal residues that above-mentioned ethanol extraction is crossed are added 10 times of water gaging heating and refluxing extraction 2 times, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, then be the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated into paste, stand for standby use, becomes component 2.By also 2-in-1 to said components 1 and component, insert after decompression recycling ethanol in economic benefits and social benefits vacuum concentrator, when being concentrated into 90 DEG C, relative density is the extractum of 1.05, is concentrated into every 1ml containing 1g crude drug amount, then add the crystalline powder that above-mentioned steps obtains, load in medical spray gun after stirring.

The preparation method of external plaster medicament of the present invention is: first by Sanguis Draxonis 1300g, Folium Artemisiae Argyi 1400g, Pseudobulbus Bletillae (Rhizoma Bletillae) 1400g, Radix Angelicae Dahuricae 1400g, and way of distillation distillation is vaporized into crystallization; Then by charred Radix Sanguisorbae 1300g, Radix Scutellariae 1500g, Herba Hedyotidis Diffusae 1500g, Rhizoma Chuanxiong 1500g, Flos Lonicerae 1400g, Radix Salviae Miltiorrhizae 1500g, fries Fructus Sophorae 1300g, Radix Arnebiae (Radix Lithospermi) 1100g, Herba Schizonepetae charcoal 1500g, Herba Patriniae 1500g, Cortex Phellodendri 1300g, Radix Et Rhizoma Rhei 1200g, Caulis Spatholobi 1500g, Radix Sophorae Flavescentis 1300g; Add in the Oleum Sesami of 5-10 times of weight portion and soak 7-10 days, heating extraction effective ingredient, big fire is boiled, and after Oleum Sesami boiling, firepower reduces, enduring to pharmaceutical presentations is dark brown, and inner coke yellow, pulls medicinal residues out, continued to temper by medicine oil, and constantly stir, refining is to dripping into pearl; Plumbum preparatium is fried to vermilion, removing moisture, cross 100-120 mesh sieve removing impurity; Plumbum preparatium is slowly added in the medicine oil refined, constantly stir, become the thick paste of black, in the slightly cold rear impouring cold water of the plaster refined, soak 5-10 days, change water every day once, releasing fire-toxin; The crystalline powder adding pulverizing after patent medicine stirs, external.

Pharmacological toxicity is tested

One, antibacterial experiment

In body, antibacterial tests result shows, the animal of enema of the present invention to escherichia coli and Bacillus proteus has significant protective effect, can subtract the development of the state of an illness, reduces the mortality rate of animal; Antimicrobial test result shows, the prostatitis antibacterial of urinary system bolt to urinary system infection has antibacterial and bactericidal action in various degree; The prostatitic experimental result that affects of experimental rat is shown, the present invention can anti-bacteria infect after the weightening finish of urinary system body of gland, slow down the development of the state of an illness, suppress the Pathological morphologic change of prostata tissue; Within after administration 2-5 hour, the urine volume of animal can be made obviously to increase; Obvious cooling effect in 5 hours after the rabbit body temperature rising administration that fresh yeast is caused; The animal auricular concha swelling that xylol causes and have obvious inhibitory action to granuloma induced by implantation of cotton pellets tissue, and suppress the increase of capillary permeability; Certain inhibitory action is had to the pain that chemical substance stimulating animal peritoneum or thermal stimulus animal body surface cause.

Result of the test shows: Chinese medicinal enema experiment safety of the present invention.This medicine is 1: 150 to group B streptococcus, staphylococcus aureus, colibacillary minimal inhibitory concentration, gonococcus is 1: 150, Candida albicans is 1: 300, it is 5 minutes to the time of killing during 1: 20 dilution factor, be 10 minutes when 1: 50, being 20 minutes when 1: 100, is 40 minutes when 1: 200, is 8 hours when 1: 400.

Two, animal acute toxicity test research:

When the present invention adopts rectal delivery, the maximum dosage-feeding on the one recording mice is 62.7g/kg (in medicated powder), be about 1567.5 times (people is in 60kg) intending clinical people's consumption, the maximum dosage-feeding 62.7g/kg (in medicated powder) on the one of rat, is about 1567.5 times that intend clinical people's consumption.The equal Continuous Observation of laboratory animal one week, its outward appearance sign, the mental status, diet, drinking-water, feces etc. are showed no obvious abnormalities.At the end of experiment, all healthy survival of animal, body weight increases.

Three, long-term toxicity test for animals research:

This test establishes medicine of the present invention high, in, low dose group and Matrix controls group, blank group, rectal delivery is adopted to give rat, dosage is respectively 3.2, 2.4 and 1.6g/kg (in medicated powder), be equivalent to intend 80 of clinical patient consumption [0.04g (medicated powder)/kg], 60 and 40 times, successive administration 2 months, in administration process, the body weight of each administration group and matrix group rat, dietary amount, outward appearance sign, behavioral activity, the mental status, hair color, feces character compares with blank group, no significant difference (P > 0.05), the weight of animals increasing value and Main Organ Coefficients and blank group comparing difference are not significantly (P > 0.05), hematology and the indivedual index of blood parameters check result administration group and blank group comparing difference are significantly (P < 0.05), but convalescent period terminates rear discrepant hematology and blood parameters has recovered normal all, other indexs and blank comparing difference are not significantly (P > 0.05), administration phase and convalescent period histological examination high dose group animal main organs compare with blank group and have no notable difference, have no slowness toxicity to occur.

Four, animal local excitation test:

The allergic reaction on guinea pigs of enema of the present invention and Rat-rectum medication irritation test.

Result shows: skin anaphylactic test, high dose group 0.8g (medicated powder)/kg, low dose group 0.1g (medicated powder)/kg, be equivalent to 20 times, 2.5 times that intend clinical people's consumption [0.04g (medicated powder)/kg] respectively, through percutaneous drug delivery, be showed no animal and produce allergy; Rectal application irritation test high dose group 5.0g (medicated powder)/kg, low dose group 3.2g (medicated powder)/kg, be equivalent to 125,80 times that intend clinical people's consumption respectively, mucous membrane of rectum is observed all without phenomenons such as hyperemia, edema in official hour, histopathologic examination compares no significant difference with blank group, have no and occur obvious irritative response, often organize its overall health of patients of Some Animals of retention, body weight, breathing, circulation, central nervous system and extremity are movable, equal Non Apparent Abnormality reaction.

Five, vaginal mucomembranous irritant test result

1. test method:

After laboratory animal is quarantined 3 days, select 18 above-mentioned healthy rabbits, be divided into three groups at random, often organize each 6, be respectively: blank, excipient control, enema group of the present invention (by application liquid 5 times of concentration).Be placed in excipient control group and the intravaginal of tested material treated animal with the sterilizing cotton sliver leaching of suitable size with sterile saline and tested material respectively, contact 6 hours with vaginal mucosa, after 24 hours, put to death animal.Taking-up topical vaginal tissue, observes pathological changes situation.

2, result of the test: vaginal mucomembranous irritant test result

Pharmacodynamics test

Test 1, medicine of the present invention are on the impact of mouse peritoneal inflammation

Experimental technique: get some healthy male mices, body weight, between 18 ~ 22 grams, is divided into 6 groups at random, is respectively high, medium and low three the dosage groups of suppository of the present invention, FUKE QIANJIN PIAN group.Authentication code: the accurate word Z43020027 of traditional Chinese medicines.Manufacturing enterprise: Zhuzhou Qianjin Pharmacy Co., Ltd's (being dissolved in ethanol), hydrocortisone matched group and Normal group.Except hydrocortisone group intraperitoneal administration, all the other are the equal rectally of group respectively, after each group of administration 40 minutes, with the blue 4.0mg/kg tail vein injection of 1% she Wen, and simultaneously lumbar injection 0.25% acetic acid 0.4ml/10g, sacrificed by decapitation after 30 minutes, blood-letting, cut open the belly, by sagging for every animal abdominal part, repeatedly abdominal cavity is rinsed with appropriate distilled water, collect washing liquid and adjust to 10ml, move into scale in vitro, centrifugal 2500 revs/min, precipitate is discarded after 10 minutes, supernatant adds 0.1N sodium peroxide 0.1ml, its optical density is surveyed with spectrophotometer 590nm, the seepage discharge of she Wen is obtained by standard curve.Experimental result is in table 1.

Note: compare with Normal group, ※ p < 0.05, ※ ※ p < 0.01; Compare with MAYINGLONGZHICHUANGGAO, Δ p < 0.05, Δ Δ p < 0.01.From upper table result, each administration group is compared with matched group, (p < 0.05 or p < 0.01, with hydrocortisone group for the best, is secondly each dosage group of the present invention all to have obvious inhibitory action to the seepage discharge of her Wen orchid.The present invention's each dosage group is compared with Ma Yinglong also has obvious diversity, and illustrate that her the oozing out of Wen orchid of mice that suppository Dichlorodiphenyl Acetate of the present invention causes has obvious inhibitory action, its effect is better than Ma Yinglong, but not as good as hydrocortisone group.

Test 2. In vitro Bactericidal Experiments

Culture medium: broth bouillon, broth agar culture medium, blood plate, chocolate are dull and stereotyped; Strain: select the strains such as escherichia coli, bacillus pyocyaneus, staphylococcus aureus, Candida albicans, Bacillus proteus, gonococcus, γ-streptococcus, micrococcus catarrhalis; Method: dilution method, by high, medium and low for suppository solution of the present invention dosage meat soup from 1: 5, make doubling dilution at 1: 50 to 1: 100, often pipe is containing medicinal liquid 2ml, 9th pipe, for contrasting without medicine, often adds dilution bacterium liquid 1, hatches 18h for 37 DEG C in pipe, visual results, pastille least concentration is still the minimal inhibitory concentration (MIC) of this medicine in obvious haze-free pipe.Gonococcus is undergrowth in meat soup, uses chocolate plate dilution method instead and surveys minimal inhibitory concentration.As following table:

Bacterial strain	Minimum inhibitory concentration (MIC) (mg/ml)
		Candida albicans	4.135
Gonococcus	11.8
		γ-streptococcus	27
Bacillus pyocyaneus	5.95
		Escherichia coli	51
Micrococcus catarrhalis	23
		Staphylococcus aureus	6.18

Result shows that washing liquid of the present invention is all 5mg/ml to the minimal inhibitory concentration of escherichia coli, bacillus pyocyaneus, staphylococcus aureus, Candida albicans, Bacillus proteus, micrococcus catarrhalis, γ-streptococcus, and gonococcus is 10mg/ml.Obvious bacteriostasis is all had to escherichia coli, bacillus pyocyaneus, staphylococcus aureus, Candida albicans, Bacillus proteus, micrococcus catarrhalis, γ-streptococcus, gonococcus.

Clinical trial

Anal papillitis is because wound during defecation or anal sinus inflammation cause the acute inflammation of anal papilla.An anorectum department commonly encountered diseases for longer, the easy recurrent exerbation of slower development, the course of disease, Chang Bingfa anal papillitis, hypertrophy.We, in JIUYUE employing 1 years January in 2010 herbal drug enema in treatment anal papillitis 40 example, achieve good therapeutic effect, are reported as follows.

1, clinical data

This group 40 example, female 18 example, man 22 example; Age 19-71 year, average 45.2 years old.The course of disease the longest 2 months 1 years, average 10.2 months.Acute stage 8, is routine; Chronic phase 28, is routine, merges other anus 9 examples.All show as proctalgia tenesmus, during stool, pain increases the weight of, sense in the embedding people's anus of scorching hot discomfort, moist pruritus, tenesmus or foreign body in anus at ordinary times.Touch: near anus tooth trace district, tenderness is obvious.Microscopy visible hyperemia edema or have damaged anal sinus, detects with probe, congested anal sinus pain sensitivity.

2 Therapeutic Method

2.1 herbal enemas adopt the present invention, Fang Yong: charred Radix Sanguisorbae 15g, Radix Scutellariae 14g, Herba Hedyotidis Diffusae 13g, Rhizoma Chuanxiong 12g, Flos Lonicerae 11g, Radix Salviae Miltiorrhizae 13g, fry Fructus Sophorae 13g, Radix Arnebiae (Radix Lithospermi) 13g, Herba Schizonepetae charcoal 12g, Herba Patriniae 11g, Cortex Phellodendri 13g, Radix Et Rhizoma Rhei 12g, Caulis Spatholobi 13g, Folium Artemisiae Argyi 13g, Sanguis Draxonis 12g, Radix Angelicae Dahuricae 13g, Pseudobulbus Bletillae (Rhizoma Bletillae) 12g, Radix Sophorae Flavescentis 15g.First soak 20min, then decoct 30min, get its medicinal liquid, get supernatant after natural sedimentation and heat and be concentrated into 200mL.Patient gets lateral position, taking liquid 50mL, heats to about 37 DEG C and extracts medicinal liquid with syringe, slowly notes in people's anus.Retain 2 ~ 4h, 1 time every night, 10d was 1 course for the treatment of.1 ~ 2 course for the treatment of of general medication.

3 results

3.1 criterions of therapeutical effect are with reference to relevant criterion of therapeutical effect.Cure: the transference cure of anal papillitis, touch diseased region tooth trace district tenderness disappears, and the breakage of anoscopy anal sinus congestion and edema recovers normal.Take a turn for the better: the symptom of anal papillitis alleviates, and touch diseased region tooth trace district tenderness alleviates, and anoscopy anal sinus still has a little congestion and edema.Invalid: the symptom of anal papillitis without improvement, touch and anoscopy unchanged.

After 3.2 therapeutic outcomes treat 1 ~ 2 course for the treatment of, this group healing 29 example, accounts for 72.5%, and take a turn for the better 9 examples, accounts for 22.5%, and invalid 2 examples, account for 5%.Total effective rate 95%.Follow up a case by regular visits to March, have no repeatedly.

4 discuss

Claims

1. treat the Chinese medicine for external application of anal papillitis for one kind, it is characterized in that, in described Chinese medicine for external application, the parts by weight of various crude drug comprise: charred Radix Sanguisorbae 10 ~ 20 parts, Radix Scutellariae 10 ~ 20 parts, Herba Hedyotidis Diffusae 10 ~ 20 parts, Rhizoma Chuanxiong 10 ~ 20 parts, Flos Lonicerae 10 ~ 20 parts, Radix Salviae Miltiorrhizae 10 ~ 20 parts, fry the Fructus Sophorae 10 ~ 20 parts, Radix Arnebiae (Radix Lithospermi) 10 ~ 20 parts, Herba Schizonepetae charcoal 10 ~ 20 parts, Herba Patriniae 10 ~ 20 parts, Cortex Phellodendri 10 ~ 20 parts, Radix Et Rhizoma Rhei 10 ~ 20 parts, Caulis Spatholobi 10 ~ 20 parts, Folium Artemisiae Argyi 10 ~ 20 parts, Sanguis Draxonis 10 ~ 20 parts, the Radix Angelicae Dahuricae 10 ~ 20 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 10 ~ 20 parts, Radix Sophorae Flavescentis 10 ~ 20 parts.

2. treat the Chinese medicine for external application of anal papillitis according to claim 1, it is characterized in that, in described Chinese medicine for external application, the parts by weight of various crude drug comprise: charred Radix Sanguisorbae 10 ~ 15 parts, Radix Scutellariae 10 ~ 15 parts, Herba Hedyotidis Diffusae 10 ~ 15 parts, Rhizoma Chuanxiong 10 ~ 15 parts, Flos Lonicerae 10 ~ 15 parts, Radix Salviae Miltiorrhizae 10 ~ 15 parts, fry the Fructus Sophorae 10 ~ 15 parts, Radix Arnebiae (Radix Lithospermi) 10 ~ 15 parts, Herba Schizonepetae charcoal 10 ~ 15 parts, Herba Patriniae 10 ~ 20 parts, Cortex Phellodendri 10 ~ 20 parts, Radix Et Rhizoma Rhei 10 ~ 20 parts, Caulis Spatholobi 10 ~ 20 parts, Folium Artemisiae Argyi 10 ~ 20 parts, Sanguis Draxonis 10 ~ 20 parts, the Radix Angelicae Dahuricae 10 ~ 20 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 10 ~ 20 parts, Radix Sophorae Flavescentis 10 ~ 20 parts.

3. treat the Chinese medicine for external application of anal papillitis according to claim 1, it is characterized in that, in described Chinese medicine for external application, the parts by weight of various crude drug comprise: charred Radix Sanguisorbae 10 ~ 20 parts, Radix Scutellariae 10 ~ 20 parts, Herba Hedyotidis Diffusae 10 ~ 20 parts, Rhizoma Chuanxiong 10 ~ 20 parts, Flos Lonicerae 10 ~ 20 parts, Radix Salviae Miltiorrhizae 10 ~ 20 parts, fry the Fructus Sophorae 10 ~ 20 parts, Radix Arnebiae (Radix Lithospermi) 10 ~ 20 parts, Herba Schizonepetae charcoal 10 ~ 20 parts, Herba Patriniae 10 ~ 15 parts, Cortex Phellodendri 10 ~ 15 parts, Radix Et Rhizoma Rhei 10 ~ 15 parts, Caulis Spatholobi 10 ~ 15 parts, Folium Artemisiae Argyi 10 ~ 15 parts, Sanguis Draxonis 10 ~ 15 parts, the Radix Angelicae Dahuricae 10 ~ 15 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 10 ~ 15 parts, Radix Sophorae Flavescentis 10 ~ 15 parts.

4. according to any one of claims 1 to 3, treat a preparation method for the Chinese medicine for external application of anal papillitis, it is characterized in that, the dosage form of described external preparation is that the preparation method of suppository comprises:

5. treat the preparation method of the Chinese medicine suppository of anal papillitis according to claim 4, it is characterized in that, in described step b, all the other raw materials soaked are put into ethanol heating and refluxing extraction 2 times, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating be concentrated into paste, stand for standby use, becomes component 1.

6. treat the preparation method of the Chinese medicine suppository of anal papillitis according to claim 4, it is characterized in that, in described step c, the medicinal residues that above-mentioned ethanol extraction is crossed are added 10 times of water gaging heating and refluxing extraction 2 times, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating be concentrated into paste, stand for standby use, becomes component 2.

7. treat the preparation method of the Chinese medicine suppository of anal papillitis according to claim 4, it is characterized in that, in described steps d, by also 2-in-1 to said components 1 and component, insert in economic benefits and social benefits vacuum concentrator after decompression recycling ethanol, when being concentrated into 90 DEG C, relative density is the extractum of 1.05, be concentrated into every 1ml containing 1g crude drug amount, add the crystalline powder that step a obtains, add in above-mentioned concentrated extract, substrate Mixer pot sets type, and ultraviolet is killed virus.

8. according to any one of claims 1 to 3, treat the preparation method of the Chinese medicine for external application of anal papillitis for one kind, it is characterized in that, described external drug dosage forms is enema, its preparation process is: Sanguis Draxonis, Folium Artemisiae Argyi, Pseudobulbus Bletillae (Rhizoma Bletillae) and the distillation of the Radix Angelicae Dahuricae way of distillation are vaporized into crystallization, pulverizer crosses 120 order dusting covers after pulverizing, and fine powder is for subsequent use; Just remaining raw medicinal material adds the soak by water 2 times of 5-10 times of weight portion, each 1 ~ 2 hour, 2 extracting solution are merged and leaves standstill, remove supernatant, merge extractive liquid, then be the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, heating is concentrated into pasty state shape, adds the crystalline powder of distillation vaporization, packs after ultraviolet radiation.

9. according to any one of claim 1 ~ 9, treat the Chinese medicine for external application of anal papillitis, it is characterized in that, described external drug dosage forms is: spray, ointment, tincture, unguentum, patch, Chinese medicine fuming-lotion, lotion, suppository or enema.