CN1470236A - Multicomponent preparation for treatnig piles and fissure - Google Patents
Multicomponent preparation for treatnig piles and fissure Download PDFInfo
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- CN1470236A CN1470236A CNA021388369A CN02138836A CN1470236A CN 1470236 A CN1470236 A CN 1470236A CN A021388369 A CNA021388369 A CN A021388369A CN 02138836 A CN02138836 A CN 02138836A CN 1470236 A CN1470236 A CN 1470236A
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- anal fissure
- nifedipine
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Abstract
The invention refers to a multi-component preparation for curing hemorrhoids and anal fissure, which comprises the wound surface convergence protecting agent, the antiseptic, the Ca-ion antagonistic agent and the allowed carrier, said protecting agent can be selectd from the allantoin and their allowed allantoin salt, the concentration of the allantion or the allantion salt 0.5-10%w/w; the antiseptic able to select from Chlorhexidine and the allowed Chlorhexidine salt, that of the acetic acid Chlorhexidine or the acetic acid Chlorhexidine salt 0.2-5%w/w; and the Ca-ion antagonistic agent able to select from the nifedipine and the allowed nifedipine salt, that of the nifedipine or the nifedipine salt 0.1-5%w/w. The drug form of the carrier is suppository, frost, ointment, gel, oil, lotion, suspension, spray, external solution and cataplasm.
Description
Technical field
The invention belongs to a kind of medicine for the treatment of anal fissure and hemorrhoids disease, particularly a kind of multicomponent preparation external used medicine for the treatment of hemorrhoid and anal fissure.
Background technology
Anal fissure is that skin ulcer is split in the stringer of anal canal skin, shows as the anal canal skin holostrome and breaks, and with pain primary symptom, it is young and middle aged that the patient mostly is.Modern medicine thinks, anal fissure is because the close knot of stool, and defecation is too exerted oneself, and causes the skin of anus secondary infection of breaking; Or because of stenosis of anal canal etc. causes damage, infect then, form chronic ulcer gradually and cause a disease.Therefore for the treatment of anal fissure, the method for Cai Yonging has all the time, and edible high fiber food is avoided constipation; Anal dilator; Inboard sphincterotomy; The local injection sealing; Local protecting wound surface agent, the disinfection preservative of using.Recently the another kind of effectively treatment anal fissure of report and the method for hemorrhoid are, local topical nitroglycerin or isosorbidi dinitras think that these two kinds of medicines can alleviate the Resting Pressure of anal, alleviate sphincteral spasm, microcirculation improvement helps treating anal fissure and hemorrhoid.Yet nitrate esters medicine has certain shortcoming, and as pharmaceutical chemistry character instability, action time is short, easily produces toleration and untoward reaction as headache.
Hemorrhoid are venous engorgements of anus surrounding tissue, and external hemorrhoid is positioned at below the tooth trace, by the outer venous plexus of hemorrhoid or anus edge chafing, hypertrophy, the thrombosis stasis of blood stagnates and the lump that forms, are difficult for hemorrhagely, are cardinal symptom with pain and foreign body sensation.Internal hemorrhoid is positioned at more than the tooth trace, is formed by clump expansion of hemorrhoid angular vein and varicose under the mucosa, with hemorrhage and to deviate from be cardinal symptom.
Hemorrhoid are common clinicals, its sickness rate is 60～70%, pathogenic factor is not illustrated so far as yet fully, along with anatomy and physiopathologic further investigation to hemorrhoid, understanding to hemorrhoid has formed new notion, hemorrhoid are rectum lower end lip shape warts or claim anus pad (Anal Cushions), are the normal structure structures that everybody all has.The pathologic hypertrophy of anus pad causes varicosis, and intravascular pressure increases, and tissue is deviate from, and regional flow does not freely form thrombosis and tissue inflammation, is the hemorrhoid disease.The principle of treatment hemorrhoid is the symptoms that alleviate or eliminate hemorrhoid, based on expectant treatment, only just considers operative treatment after the expectant treatment failure.One of important means of expectant treatment is a topical.Most of local applications energy relief of symptoms pacify plain cream and suppository of wild chrysanthemum flower etc. as MAYINGLONGZHICHUANGGAO, hemorrhoid, but its definite pharmacodynamics is not confirmed.
Summary of the invention
The purpose of this invention is to provide and a kind ofly be used for the treatment of the medicine of hemorrhoid and anal fissure multicomponent preparation, substitute therapeutic method of surgery, to overcome above-mentioned deficiency by each a kind of part in wound surface convergence protective agent, disinfection preservative and the calcium ion antagonist.
To achieve these goals, feature of the present invention is: comprise the carrier that allows on a kind of and galenic pharmacy of each that can local be used for anal or perianal wound surface convergence protective agent, disinfection preservative and calcium ion antagonist;
The dosage form of above-mentioned carrier is suppository, cream, ointment, gel, oil preparation, lotion, suspensoid, spray, externally used solution agent and paste.
Above-mentioned wound surface convergence protective agent can be selected from allantoin, aldioxa, carbamide, zinc oxide, two octahedral montomorillonite, and their salt of allowing on pharmacopedics;
Above-mentioned wound surface convergence protective agent is the salt that allows on allantoin or its pharmacopedics, and the concentration of allantoin or its salt is 0.5～10%w/w;
Above-mentioned disinfection preservative can be selected from chlorhexidine acetate, chlorhexidine hydrochloride and chlorhexidine gluconate, and their salt of allowing on pharmacopedics;
Above-mentioned disinfection preservative is the salt that allows on chlorhexidine acetate or its pharmacopedics, and the concentration of chlorhexidine acetate or its salt is 0.2～5%w/w;
Above-mentioned calcium ion antagonist can be selected from nifedipine, nimodipine, nicardipine, nitrendipine, felodipine and diltiazem , and their salt of allowing on pharmacopedics;
Above-mentioned calcium ion antagonist is the salt that allows on nifedipine or its pharmacopedics, and the concentration of nifedipine or its salt is 0.1～5%w/w;
Above-mentioned carrier can be selected semi-synthetic fatty acid ester, Polyethylene Glycol, cacao bean ester, lanoline, vaseline, kappa dried meat, propylene glycol, emulsifiable paste matrix for use.
Calcium ion antagonist has the effect of relaxing smooth muscle, so adopt nifedipine to be applied to the treatment that the esophagus cardia loses slow disease in advance.Cook in 2000 in Br J Surg reported first oral nifedipine have the effect that reduces the anal Resting Pressure, can treat acute or chronic anal.Greece has reported that at Dis Colon Rectum the sublingual administration nifedipine can treat hemorrhoid or merge anal fissure subsequently.Nifedipine also has antiinflammatory action and regulates microcirculatory effect, the therefore formation that helps alleviating sphincteral tensity and improve the external hemorrhoid thrombosis owing to can weaken the contraction of the high patient's sphincter ani internus of anus Resting Pressure.
The more independent curative effect of using of curative effect that the multicomponent preparation part that the present invention is made up of above-mentioned activating agent is used for the treatment of hemorrhoid and anal fissure is outstanding.The protecting wound surface agent helps promoting the reparation and the healing of anal fissure and hemorrhoid ulcer surface epithelial tissue; Disinfection preservative helps the infection on anal fissure and hemorrhoid surface; Calcium ion antagonist can reduce the static pressure of anal, weakens the activeness of the high patient's sphincter ani internus of anus static pressure, and the nifedipine topical application also has the effect of antiinflammatory and microcirculation improvement simultaneously, thereby can alleviate hemorrhoid or anal fissure patient's symptom.Three's drug combination more meets modern medicine about anal fissure and the pathogenetic theory of hemorrhoid.
The specific embodiment
Wound surface convergence protective agent of the present invention can be selected from allantoin, carbamide, zinc oxide, two octahedral montomorillonite, and best results person is an allantoin.Valid density is 0.5～10%w/w.When concentration is 5%, can reach the optimal clinical curative effect that the present invention can bring into play.
Disinfection preservative of the present invention can be selected from hibitane, and their salt of allowing on pharmacopedics.Best results person is a chlorhexidine acetate.Valid density is 0.5～5%.When concentration is 2%, can reach the optimal clinical curative effect that the present invention can bring into play.
Calcium ion antagonist of the present invention can be selected from nifedipine, nimodipine, nicardipine, and best results person is a nifedipine.Valid density is 0.1～5%w/w.When concentration is 1%, can reach the optimal clinical curative effect that the present invention can bring into play.
Also can comprise local anesthetic in the multicomponent preparation of the present invention, as lignocaine.
Multicomponent preparation of the present invention uses 1～2 time general every day, topical application behind the cleaning crissum.In a word, the present inventor provides a kind of local multicomponent preparation for the treatment of anal fissure and hemorrhoid safely and effectively.The production condition is simple, and product quality control method is scientific and reasonable, and product chemistry stable in properties is suitable for large-scale production.
The present invention can adopt the high-efficient liquid phase technique separation determination, and the mobile phase of employing is water-acetonitrile (40: 60), and ultraviolet detection wavelength 254nm effectively controls product quality.
Further specify the present invention below in conjunction with embodiment.
Embodiment 1: get semi-synthetic fatty acid ester suppository base 100g, heating in water bath makes fusing, adds nifedipine 1g, stirs and makes dissolving, add the allantoin 5g and the chlorhexidine acetate 2g of porphyrize, under stirring condition, inject disposable suppository mould, totally 100 pieces, it is solid to put condensation, seals, promptly.Sooner or later each one piece, fill in the anus.
Embodiment 2: taking polyethylene glycol 4000 10g, and heating in water bath makes fusing, adds PEG400 90g, adds allantoin 5g, chlorhexidine acetate 2g, nifedipine 1g is stirred to room temperature, and preparation becomes semisolid, is sub-packed in the ointment tube packing, promptly.Sooner or later once, each 1g is applied topically to anus.
Embodiment 3: card taking crust dried meat 940 1g, add water 30ml, and make swelling complete, other gets ethanol 30ml, PEG400 15ml, glycerol 15ml, add allantoin 5g, chlorhexidine acetate 2g, nifedipine 1g, stirring makes dissolving, add in the above-mentioned substrate, stir, add triethanolamine 2g, stir, make the substrate gelling.Sooner or later once, each 1g is applied topically to anus.
The present invention uses 20 volunteers of suffering from hemorrhoid merging anal fissure to carry out clinical trial.Man's 9 examples, women 11 examples, 28～56 years old age, average 35.5 years old, the course of disease 0.5～16 year, average 5.7 years.After sooner or later cleaning the anus part, 1 piece of suppository is filled in the anus, 14 days courses of treatment.Examine inspection evaluation curative effect according to anus, recovery from illness: hemorrhoid piece and anal fissure disappear, and the pain bleeding disappears.Effectively: hemorrhoid piece and anal fissure mouth diminish, the pain transference cure of bleeding.Invalid: no change or development is arranged.The result: medication is after 1 day, and the patient's anus Resting Pressure on average descends 37%; After finishing the course of treatment, the patient's anus Resting Pressure on average descends 32%, all has extremely significant difference with comparing before the treatment.After treatment in 14 days, 20 routine patients, 15 people that fully recover, effective 4 people, invalid 1 people, total effective rate 95%.No any untoward reaction in therapeutic process is as generations such as flush, headache, dizzy, hypotension or fecal incontinence.
Claims (10)
1, a kind of multicomponent preparation for the treatment of hemorrhoid and anal fissure is characterized in that: comprise the carrier that allows on a kind of and galenic pharmacy of each that can local be used for anal or perianal wound surface convergence protective agent, disinfection preservative and calcium ion antagonist.
2, a kind of multicomponent preparation for the treatment of hemorrhoid and anal fissure according to claim 1, it is characterized in that: the wound surface convergence protective agent can be selected from allantoin, aldioxa, carbamide, zinc oxide, two octahedral montomorillonite, and their salt of allowing on pharmacopedics.
3, a kind of multicomponent preparation for the treatment of hemorrhoid and anal fissure according to claim 1 and 2, it is characterized in that: the wound surface convergence protective agent is the salt that allows on allantoin or its pharmacopedics, and the concentration of allantoin or its salt is 0.5～10%w/w.
4, a kind of multicomponent preparation for the treatment of hemorrhoid and anal fissure according to claim 1, it is characterized in that: disinfection preservative can be selected from chlorhexidine acetate, chlorhexidine hydrochloride and chlorhexidine gluconate, and their salt of allowing on pharmacopedics.
5, according to claim 1 or 4 described a kind of multicomponent preparations for the treatment of hemorrhoid and anal fissure, it is characterized in that: disinfection preservative is the salt that allows on chlorhexidine acetate or its pharmacopedics, and the concentration of chlorhexidine acetate or its salt is 0.2～5%w/w.
6, a kind of multicomponent preparation for the treatment of hemorrhoid and anal fissure according to claim 1, it is characterized in that: calcium ion antagonist can be selected from nifedipine, nimodipine, nicardipine, nitrendipine, felodipine and diltiazem, and their salt of allowing on pharmacopedics.
7, according to claim 1 or 6 described a kind of multicomponent preparations for the treatment of hemorrhoid and anal fissure, it is characterized in that: calcium ion antagonist is the salt that allows on nifedipine or its pharmacopedics, and the concentration of nifedipine or its salt is 0.1～5%w/w.
8, a kind of multicomponent preparation for the treatment of hemorrhoid and anal fissure according to claim 1, it is characterized in that: carrier comprises allantoin, chlorhexidine acetate and nifedipine simultaneously.
9, according to claim 1 or 8 described a kind of multicomponent preparations for the treatment of hemorrhoid and anal fissure, it is characterized in that: the concentration of allantoin is that the concentration of 5%w/w, chlorhexidine acetate is 2%w/w, and the concentration of nifedipine is 1%w/w.
10, a kind of multicomponent preparation for the treatment of hemorrhoid and anal fissure according to claim 1, it is characterized in that: carrier can be selected semi-synthetic fatty acid ester, Polyethylene Glycol, cacao bean ester, lanoline, vaseline, kappa dried meat, propylene glycol, emulsifiable paste matrix for use.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA021388369A CN1470236A (en) | 2002-07-26 | 2002-07-26 | Multicomponent preparation for treatnig piles and fissure |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA021388369A CN1470236A (en) | 2002-07-26 | 2002-07-26 | Multicomponent preparation for treatnig piles and fissure |
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| Publication Number | Publication Date |
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| CN1470236A true CN1470236A (en) | 2004-01-28 |
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| CNA021388369A Pending CN1470236A (en) | 2002-07-26 | 2002-07-26 | Multicomponent preparation for treatnig piles and fissure |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1700597A1 (en) * | 2005-03-04 | 2006-09-13 | Tecnimede-Sociedade Tecnico-Medicinal, S.A. | Pharmaceutical composition containing in association ubidecarenone, dexpanthenol and chlorhexidine or a pharmaceutically acceptable salt thereof for cutaneous application |
| CN101947199A (en) * | 2010-04-03 | 2011-01-19 | 刘加升 | Nifedipine mucilage and preparation method thereof |
| RU2592366C2 (en) * | 2013-07-22 | 2016-07-20 | Общество с ограниченной ответственностью "ХИЛИНГ ФАРМ" | Pharmacological composition for treating proctologic diseases (versions) |
| CN106265295A (en) * | 2016-08-30 | 2017-01-04 | 杭州国光旅游用品有限公司 | A kind of wet tissue alleviating hemorrhoid symptom and preparation method thereof |
| EP3120841A1 (en) * | 2015-07-23 | 2017-01-25 | Christophe Sivanzire | Pharmaceutical preparation |
| CN109641001A (en) * | 2016-06-23 | 2019-04-16 | 安达卢西亚健康服务部 | For treating ischemic ulcer and stretching the composition of scar |
| CN112691104A (en) * | 2021-02-04 | 2021-04-23 | 刘泽陆 | Medicine for treating hemorrhoids and preparation method thereof |
| CN115350212A (en) * | 2022-08-19 | 2022-11-18 | 广州百叶堂医药科技有限公司 | Preparation for preventing and treating hemorrhoids and prostates and preparation method and application thereof |
-
2002
- 2002-07-26 CN CNA021388369A patent/CN1470236A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1700597A1 (en) * | 2005-03-04 | 2006-09-13 | Tecnimede-Sociedade Tecnico-Medicinal, S.A. | Pharmaceutical composition containing in association ubidecarenone, dexpanthenol and chlorhexidine or a pharmaceutically acceptable salt thereof for cutaneous application |
| CN101947199A (en) * | 2010-04-03 | 2011-01-19 | 刘加升 | Nifedipine mucilage and preparation method thereof |
| CN101947199B (en) * | 2010-04-03 | 2014-01-29 | 刘加升 | Nifedipine mucilage and preparation method thereof |
| RU2592366C2 (en) * | 2013-07-22 | 2016-07-20 | Общество с ограниченной ответственностью "ХИЛИНГ ФАРМ" | Pharmacological composition for treating proctologic diseases (versions) |
| EP3120841A1 (en) * | 2015-07-23 | 2017-01-25 | Christophe Sivanzire | Pharmaceutical preparation |
| CN109641001A (en) * | 2016-06-23 | 2019-04-16 | 安达卢西亚健康服务部 | For treating ischemic ulcer and stretching the composition of scar |
| CN106265295A (en) * | 2016-08-30 | 2017-01-04 | 杭州国光旅游用品有限公司 | A kind of wet tissue alleviating hemorrhoid symptom and preparation method thereof |
| CN112691104A (en) * | 2021-02-04 | 2021-04-23 | 刘泽陆 | Medicine for treating hemorrhoids and preparation method thereof |
| CN115350212A (en) * | 2022-08-19 | 2022-11-18 | 广州百叶堂医药科技有限公司 | Preparation for preventing and treating hemorrhoids and prostates and preparation method and application thereof |
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