Summary of the invention
, for solving the problem in hemorrhoid treating and other mucosa inflammatory diseases, the invention provides a kind of mucomembranous nursing antibacterial gel compositions.The present invention can be used for hemorrhoid treating, comprises the rear auxiliary treatment of operation.The present invention also can be used for any nursing that relates to the mucosa inflammation widely.
The technical solution used in the present invention is: a kind of mucomembranous nursing antibacterial gel compositions, in compositions, effective ingredient comprises gel, domiphen bromide, propolis, Radix Sophorae Flavescentis, Rhizoma Curcumae, Mentholum and paclitaxel.
The preparation method of above-mentioned mucomembranous nursing antibacterial gel compositions is as follows:
1) prepare gel: take water-soluble fibre 2.0-5.0 weight portion, be dissolved in the lysate of 100 weight portions, slowly stir, standby;
Described water-soluble fibre is a kind of of carbomer, Carboxymethyl cellulose sodium, hydroxyethyl-cellulose or hydroxypropyl cellulose or two kinds;
Described lysate is water, oil or alcohols solvent; Described alcohols solvent preferred alcohol;
2) get domiphen bromide 0.5-1.5 weight portion, standby;
3) propolis alcoholic solution: get propolis 0.5-1.5 weight portion, be dissolved in 95% ethanol of 10 weight portions, standby;
4) get Rhizoma Curcumae 1-2 weight portion, Radix Sophorae Flavescentis 0.5-1.5 weight portion, Mentholum 0.5-1.0 weight portion, be dissolved in 95% ethanol of 25-35 weight portion, and is standby; 0.01-0.5
5) paclitaxel alcoholic solution: get paclitaxel 0.01-0.5 weight portion, be dissolved in 95% alcoholic solution of 100 weight portions, standby;
6) under agitation,, with the crude drug mix homogeneously that the 1-5 step obtains, with 50% citric acid solution, regulate pH value to 5-7.
The application of compositions of the present invention in preparation treatment hemorrhoid, oral ulcer, rhinocnesmus, vagina or perineum pruritus medicine.
Compositions of the present invention, gel are that water-soluble fibre is dissolved in the translucent colloidal liquid that makes in lysate.Gel is as primary solvent.
Compositions of the present invention, the English Domiphen Bromide by name of domiphen bromide, another name is also that Dumet is fragrant, domiphen, Anaprox, domiphen bromide, Domifene, Domifen, Bradosol Boromide etc.Raw material is white or little yellow flaky crystal; Odorless or little band special smell, bitter in the mouth; Foam, occur in the jolting aqueous solution.Very easily dissolve in ethanol or chloroform, easily molten in water, slightly molten in acetone, almost insoluble in ether.In the present invention, the domiphen bromide active component has disinfection function.Also can be according to actual needs, domiphen bromide is by chlorhexidine (chlorhexidine acetate), or disinfectant any and the gel coupling, such as Bronopol (omnipotent disinfectant) etc. replacement.
Compositions of the present invention, the English of propolis is called Propolis, Latin is called Colla Apis, and the resin that to be a kind of Apis gather from plant spore or trunk is sneaked into a kind of colloidal solid thing with aromatic odor that the secretions of palatine gland on it, wax gland processes.Generally be brown color or yellowish-brown solid block, the heat deliquescing, have viscosity, peculiar aromatic odor.In the present invention, propolis active ingredients has pain-relieving functions.
Compositions of the present invention, the English of Radix Sophorae Flavescentis is called Radix Sophorae flavescens.Be generally used for treating heat clearing and damp drying, parasite killing, diuresis.Be used 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 etc.In the present invention, the Radix Sophorae Flavescentis active component has the anti-bacterial, anti-itching function.
Compositions of the present invention, Rhizoma Curcumae have another name called Peng Curcuma Shu, paulin cowherb, fluffy art, Qiang seven, wide art, evil mind Rhizoma Zingiberis Recens, Rhizoma Curcumae, radix zedoariae, green Rhizoma Zingiberis Recens.The Chinese crude drug formal name used at school is Rhizoma Curcumae; English Aeruginous Turmeric Rhizome by name; Latin is called Rhizoma Curcumae Aeruginosae.Be usually used in the removing blood stasis promoting the circulation of QI to relieve pain, the pain relieving of circulation of qi promoting removing food stagnancy, removing blood stasis (treatment women amenorrhea, or the phlegm-damp congestion lump in the abdomen addiction piece that condenses and form), and promoting the circulation of QI to relieve pain etc.In the present invention, the Rhizoma Curcumae active component has the functions such as antiviral.
Compositions of the present invention, the English name of Mentholum is Mentholum, has another name called menthol, Mentholum.In the present invention, the Mentholum active component has the functions such as pain relieving.Enterprise is according to reality, and Mentholum can also be by Borneolum Syntheticum, Camphora, or the active substance that the aromatic compounds of other extracted form natural plant etc. has a pain-relieving functions replaces.
Compositions of the present invention, paclitaxel are the alcoholic solution of 0.01-0.5%.Paclitaxel other compositions in dosage form are combined, and have the disinfection and anti-inflammation effect.
The dosage form of drug regimen of the present invention can comprise pharmaceutical excipient.Excipient must be to be fit to patient's application, low toxicity commonly used and highly purified.Pharmaceutical excipient is selected according to application form, such as application agent and plaster class, pastes medicine preparation etc.Pharmaceutical excipient should conform to traditional process for preparing medicine, and is that the technical field of the industry is known.For example application and subsides pharmaceutically dosage form can comprise antiseptic, flavoring agent, and coloring agent etc.
Medicine composition dosage form provided by the invention can offer the patient with the acceptable dosage form of any treatment.Preferred drug regimen dosage form is to be prepared into the gel dosage form directly to spread on affected part.But as long as active component can be fully absorbed and utilize, any other form of medication can be applied, such as with pasting the medicine method, being prepared into plaster class dosage form etc.
The invention has the beneficial effects as follows: the present invention adopts seven kinds of effective ingredient, mutual synergism, and to alleviating pain and detumescence, postoperative mucomembranous nursing, protect injured mucosa evident in efficacy.Compositions of the present invention all has curative effect for internal hemorrhoid, external hemorrhoid and mixed hemorrhoid.For hemorrhoid treating, the present invention uses easy to carry, does not need after application to rinse.In mucomembranous nursing application widely, the present invention can also be used for hygienic article, but is curative simultaneously, and therapeutical effect is arranged.
The specific embodiment
1 one kinds of mucomembranous nursing antibacterial gel compositionss of embodiment (gel dosage form)
(1) compositions is composed as follows:
1. the effective ingredient of pharmaceutical composition is: gel, domiphen bromide, propolis, Radix Sophorae Flavescentis, Rhizoma Curcumae, Mentholum and paclitaxel.
(2) preparation method
1. prepare gel: take 2.5 parts of water-soluble fibre Carboxymethyl cellulose sodium (weight portion), be dissolved in pure water 100 parts (weight portion), slowly be stirred to and be dissolved into translucent colloidal liquid, standby.
Water-soluble fibre is not limited to Carboxymethyl cellulose sodium, can be a kind of of carbomer, Carboxymethyl cellulose sodium, hydroxyethyl-cellulose and hydroxypropyl cellulose or two kinds;
2. get 1 part of domiphen bromide (weight portion), standby;
3. propolis: get 1 part of propolis (weight portion), be dissolved in 10 parts of (weight portion) 95% ethanol, standby;
4. paclitaxel alcoholic solution: get 0.1 part of paclitaxel, be dissolved in 100 parts of (weight portion) 95% alcoholic solution, standby;
5. get 1.5 parts of Rhizoma Curcumae (weight portion), 1 part of Radix Sophorae Flavescentis (weight portion), 0.5 part of Mentholum (weight portion), be dissolved in 95% ethanol of 30 parts (weight portions), and is standby;
6. under agitation,, with the crude drug mix homogeneously that the 1-5 step obtains, with 50% citric acid solution, regulate pH value to 5-7, be prepared into semi-finished product;
7., by the requirement of specification loading amount, be sub-packed in polypropylene bullet contracting bottle, be packaged into finished product.
(3) testing result
1. compositions total number of bacterial colonies of the present invention, fungus colony sum, coliform, staphylococcus aureus, bacillus pyocyaneus and Hemolytic streptococcus testing result meet GB15979---2002 regulation.
2. according to GB15979---2002, compositions of the present invention is under experimental condition, and 100% concentration is to staphylococcus aureus effect 2min, and average bacteriostasis rate is 100%, and stronger bacteriostasis is arranged.
3. according to GB15979---2002, compositions of the present invention is under experimental condition, and 100% concentration is to escherichia coli effect 2min, and average bacteriostasis rate is 100%, and stronger bacteriostasis is arranged.
4. according to GB15979---2002, compositions of the present invention is under experimental condition, and 100% concentration is to Candida albicans effect 2min, and average bacteriostasis rate is 100%, and stronger bacteriostasis is arranged.
(4) clinical observation result
1. symptom: medical science indication hemorrhoid comprise internal hemorrhoid, external hemorrhoid, mixed hemorrhoid, anal fissure.Common sympton for hemorrhage, the dyschizia of stool, rectum pendant pain, swollen thing are deviate from, flow point secretion and pruritus ani.
2. application process: the finished product medicament that will as above produce spreads on affected part.Every day 2 times, or according to circumstances, smear every day for several times.
3. therapeutic effect: pharmaceutical composition of the present invention is applied in good analgesic effect behind affected part, quickly alleviating pain, and can play a role for 5 seconds, and it is pure and fresh that the patient feels, nice and cool, comfortable.To 200 routine patients' follow-up investigation, the treatment through 1 month, hemorrhage, the dyschizia of defecating, flow point secretion and pruritus ani symptom disappear, and cure rate reaches 100%.Patient's rectum pendant pain of 90% left and right disappears, and also there is slightly rectum pendant pain in the patient of 10% left and right, and the cure rate of deviating from for swollen thing reaches 95%.To the hemorrhoid operation patient, be applied in for several times affected part every day, thus normal need be in hospital in 7 days, apply compositions of the present invention after second day after operation can go home to recuperate.
The clinical verification of nearly 300 examples that the present invention formula is implemented through Huaxi Hospital Attached to Sichuan Univ anorectal section, Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ anorectal section, anorectal section of People's Hospital, Sichuan Prov., therapeutic effect, the doctor, to suffer from both sides all very satisfied, do not find toxic and side effects.