CN101292969A - Application of butyric acid (butanoic acid) in preparing medicaments for treating anorectal diseases - Google Patents
Application of butyric acid (butanoic acid) in preparing medicaments for treating anorectal diseases Download PDFInfo
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- CN101292969A CN101292969A CNA2007101027976A CN200710102797A CN101292969A CN 101292969 A CN101292969 A CN 101292969A CN A2007101027976 A CNA2007101027976 A CN A2007101027976A CN 200710102797 A CN200710102797 A CN 200710102797A CN 101292969 A CN101292969 A CN 101292969A
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- butanoic acid
- butyrate
- anal
- butyric acid
- intestinal
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Abstract
The invention discloses a new medicinal use of butyric acid, specifically relating to the application of the butyric acid in the preparation of drugs for curing anorectal disease. Anorectal disease comprises hemorrhoids and anal fissure. The butyric acid is produced to be the required dosage form by taking the butyric acid or butyrate as the main active ingredients, with preferred sodium butyrate as the main active ingredients. Other active ingredients can be added to improve the treatment effect.
Description
Technical field
The present invention relates to the new medicine use of butanoic acid (being butyric acid again), be specifically related to butanoic acid or butyrate as the application of main medicament active composition in preparation treatment anal and intestinal disease medicine, anal and intestinal disease comprises hemorrhoid and anal fissure.
Background technology
The anal and intestinal disease men and women all can suffer from and, adult and infant all can fall ill, national reconnaissance information shows that adult's anal and intestinal disease incidence rate is about 60～75%.Though the less life that jeopardizes the people, the heavier person of the state of an illness but usually influences operate as normal and life, even the state of an illness than the lighter, also will be stood the misery of disease every now and then.The most common with hemorrhoid, anal fissure again in the anal and intestinal disease.At present of a great variety at the medicine of anal and intestinal diseases such as hemorrhoid, anal fissure, but therapeutic effect is generally relatively poor, and treatment back relapse rate height is difficult to radical cure, brings the body and mind misery to the patient.But, up to the present, yet there are no the report of anal and intestinal diseases such as using butyrate treatment hemorrhoid, anal fissure, special this patent of invention of application.
Summary of the invention
The inventor makes dosage forms such as suppository, unguentum, enema, enteric coated tablet, enteric coated capsule, enteric-coated microcapsule with butanoic acid (or butyrate) for main medicament active composition by deep research invention, anal and intestinal diseases such as treatment hemorrhoid, anal fissure are evident in efficacy, can add the other medicines active ingredient and improve therapeutic effect.
The main mechanism of anal and intestinal diseases such as butanoic acid (or butyrate) treatment hemorrhoid, anal fissure is:
1, promotes tissue repair
70% of intestinal mucosa institute energy requirement derives from butanoic acid, and butanoic acid is the main energy source and the nutrient substance of intestinal mucosa cells, can provide metabolisable energy for intestinal, promotes enterocyte propagation and mucosa growth.Simultaneously, butanoic acid can stimulate the generation of the gut hormone of mediation enterocyte propagation and intestinal mucosa growth, as gastrin, enteroglucagon, cheese cheese peptide etc.So butanoic acid can promote the healing of intestinal wound surface.
2, improve the intestinal microcirculation
Butanoic acid can be expanded the intestinal blood vessel, increases the intestinal blood flow, improves the intestinal microcirculation, and the nutrition mucosa promotes wound healing.
3, antiinflammatory
Butanoic acid can suppress the overexpression that TNF-d, IL-8 etc. cause inflammatory factor, diminishes inflammation rapidly.
4, promote enterokinesia, the recovery intestinal normally absorbs, secretory function
Constipation is the main pathogenic factor of anal and intestinal diseases such as hemorrhoid, anal fissure, and butanoic acid can promote enterokinesia, recovers normal absorption of intestinal and secretory function, effectively treats constipation, thereby eliminates the old complaint of anal and intestinal disease.
The said anal and intestinal disease of the present invention is not limited to hemorrhoid, anal fissure, also comprises anal and intestinal diseases such as perianal abscess, proctitis, anal fistula, and mechanism of action is the same.
With anal and intestinal diseases such as butyrate treatment hemorrhoid, anal fissure, it generally is the form of butanoic acid being made salt such as sodium butyrate, then with the butyrate of effective dose according to certain preparation process, add excipient substances such as conventional excipient, flavoring agent, disintegrating agent, antiseptic, lubricant, wetting agent, adhesive, solvent, thickening agent, solubilizing agent, make any dosage form that is suitable for using clinically, as suppository, unguentum, enema, enteric coated tablet, enteric coated capsule, enteric-coated microcapsule.The present invention is that invention description is carried out in representative with the sodium butyrate, but the effective constituent that mainly contains of the present invention is not limited to sodium butyrate, butanoic acid and butyro-other salt are all passable, because what finally play a role is the butanoic acid anion, be the same so butanoic acid, sodium butyrate and other butyrate are made the effect of final dosage form treatment anal and intestinal disease.
It is that final solid dosage forms that main active ingredient is made contains butanoic acid or butyrate generally is at least 8mmol/Kg that indication effective dose of the present invention is meant with butanoic acid or butyrate, is preferably 80mmol/Kg.
It is that final liquid dosage form that main active ingredient is made contains butanoic acid or butyrate generally is at least 8mmol/L that indication effective dose of the present invention is meant with butanoic acid or butyrate, is preferably 80mmol/L.
Because it is the application of main medicament active composition in anal and intestinal disease medicines such as preparation treatment hemorrhoid, anal fissure that the present invention discloses with butanoic acid or butyrate first; therefore; make medicament with butanoic acid or butyrate as main medicament active composition and adjuvant combination; or add other active ingredient to improve therapeutic effect; so long as this medicament is used for the treatment of anal and intestinal diseases such as hemorrhoid, anal fissure, all belong to protection scope of the present invention.
Butanoic acid of the present invention or butyrate all have the effect of anal and intestinal diseases such as treatment hemorrhoid, anal fissure when making any dosage form.Any medicament; if contain butanoic acid in its component or butyrate prepares patent medicine; needing only the effect of indicating or pointing out anal and intestinal diseases such as having treatment hemorrhoid, anal fissure on the signs such as its packing or description or on other any propaganda materials, then fall within protection scope of the present invention.
Also butanoic acid or butyrate can be made health food or health care medicine.Health food or health care medicine that butanoic acid or butyrate are made; if, then fall within protection scope of the present invention needing only the effect of indicating or pointing out anal and intestinal diseases such as having treatment hemorrhoid, anal fissure on the signs such as its packing or description or on other any propaganda materials.
The specific embodiment
The explanation of medication preparation example: butanoic acid or butyrate all can be made required dosage forms such as suppository, unguentum, enema, enteric coated tablet, enteric coated capsule, enteric-coated microcapsule according to a conventional method.The present invention with sodium butyrate be main medicament active composition to make suppository be example brief description preparation method, preparation method is not limited to of the present invention, other known conventional method is all passable.
Medication preparation embodiment 1, sodium butyrate suppository preparation method
Get commercially available sodium butyrate 0.88% by weight percentage, mixed fatty glycerides 99.12% makes the final suppository of making contain sodium butyrate 80mmol/Kg.
Get sodium butyrate and before preparation, cross 100 mesh sieves, mixed fatty glycerides is put be heated to 100 ℃ to 105 ℃ fusings in the melting pot again, be incubated 30 minutes, stop heating and treat to add the sodium butyrate dissolving after temperature is reduced to 60 ℃, stir.Inject the bolt mould, scrape off unnecessary material after the cooling, the demoulding promptly.
The clinical observation on the therapeutic effect of clinical trial example 1, sodium butyrate suppository treatment hemorrhoid
1 object and method
1.1 the case data is totally 10 routine hemorrhoid patients, male 5 examples, women 5 examples, 35 years old mean age, sick time 1～10 year.
1.2 medication
Sodium butyrate suppository, every piece of 3.0g (containing sodium butyrate 80mmol/Kg).Each 1 piece, every day 2 times, include anus in behind the cleaning crissum.15～30 days courses of treatment.
1.3 observational technique is established own control, observes treatment front and back doing well,improving situation.
1.4 treatment hemorrhoid efficacy assessment standard
Recovery from illness: symptom after treating (have blood in stool, deviate from or pain) disappears, and checks that hemorrhoid disappear;
Effectively: symptom is obviously improved after treating, and the inspection hemorrhoid are obviously dwindled;
Invalid: no change before symptom and form and the treatment.
2 results
After the treatment, 8 routine patient's recoveries from illness, cure rate 80%; 2 routine patients are effective, effective percentage 20%.Total effective rate 100%.
Model case:
The king * *, 32 years old, the woman suffered from hemorrhoid more than 3 years, mild pain during defecation, and the swelling sense is arranged.Diagnosis: internal hemorrhoid.Through sodium butyrate suppository treatment recovery from illness in 20 days, followed up a case by regular visits to 3 months, there is not recurrence, in order.
3 conclusions
Sodium butyrate suppository treatment hemorrhoid are evident in efficacy and do not have any untoward reaction, are worth clinical application.
The clinical observation on the therapeutic effect of clinical trial example 2, sodium butyrate suppository treatment anal fissure
1 object and method
1.1 the case data is totally 15 routine anal fissure patients, male 10 examples, women 5 examples, 38 years old mean age, sick time 2 months～5 years.
1.2 medication
Sodium butyrate suppository, every piece of 3.0g (containing sodium butyrate 80mmol/Kg).Each 1 piece, every day 2 times, include anus in behind the cleaning crissum.15～30 days courses of treatment.
1.3 observational technique is established own control, observes treatment front and back doing well,improving situation.
1.4 treatment hemorrhoid efficacy assessment standard
Recovery from illness: symptom and complication disappear, and wound heals fully;
Produce effects: symptom and complication disappear, and wound heals substantially;
Effectively: symptom and complication are clearly better, and wound healing is not good enough;
Invalid: symptom, complication, wound all do not have obvious improvement.
2 results
After the treatment, 10 routine patient's recoveries from illness, cure rate 67%; 4 routine patient's produce effects, obvious effective rate 27%; 1 example is effective, effective percentage 6%.Total effective rate 100%.
Model case:
Liu * *, 40 years old, the man, constipation is more than 5 years, proctalgia during defecation, toilet paper band blood after an action of the bowels.Diagnosis: anal fissure.Through sodium butyrate suppository treatment recovery from illness in 30 days, pain disappears, and it is normal that defecation recovers, and followed up a case by regular visits to 3 months, do not have recurrence, in order.
3 conclusions
Sodium butyrate suppository because can promote tissue repair, improve the intestinal microcirculation, antiinflammatory, promotion enterokinesia and recover that intestinal normally absorbs, secretory function, treatment anal fissure is evident in efficacy and do not have any untoward reaction, is worth clinical application.
Claims (5)
1, the application of butanoic acid (butyric acid) in preparation treatment anal and intestinal disease medicine, described application are to be main medicament active composition with butanoic acid, can add other active ingredient and improve therapeutic effect.
2, by the described application of claim 1, it is characterized in that butanoic acid comprises butanoic acid or butyrate.
3, by the described application of claim 2, it is characterized in that butyrate comprises sodium butyrate.
4, by the described application of claim 1, it is characterized in that anal and intestinal disease comprises hemorrhoid, anal fissure.
5,, it is characterized in that the butanoic acid of effective dose or butyrate and pharmaceutically acceptable different carriers are made suppository, unguentum, enema, enteric coated tablet, enteric coated capsule, enteric-coated microcapsule by the described application of claim 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007101027976A CN101292969B (en) | 2007-04-27 | 2007-04-27 | Application of butyric acid (butanoic acid) in preparing medicaments for treating anorectal diseases |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2007101027976A CN101292969B (en) | 2007-04-27 | 2007-04-27 | Application of butyric acid (butanoic acid) in preparing medicaments for treating anorectal diseases |
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| CN101292969A true CN101292969A (en) | 2008-10-29 |
| CN101292969B CN101292969B (en) | 2011-05-25 |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579369A (en) * | 2012-03-31 | 2012-07-18 | 湖北诺鑫生物科技有限公司 | Sodium butyrate enteric sustained release preparation and preparation method thereof |
| CN102824339A (en) * | 2012-05-29 | 2012-12-19 | 中国人民解放军第三军医大学 | Application of sodium butyrate in preparation of hypoxic pulmonary hypertension control medicines |
| RU2506054C1 (en) * | 2012-10-22 | 2014-02-10 | Елена Александровна Рогожкина | Method of treating chronic anal fissure |
| CN108208177A (en) * | 2017-11-28 | 2018-06-29 | 上海交通大学医学院附属新华医院 | Composition and its application containing butyric acid compound |
| JP2018535276A (en) * | 2015-11-27 | 2018-11-29 | ビルベヘール・ベー・フェー | Butyrate for use in inflammatory diseases |
| CN109010327A (en) * | 2018-08-22 | 2018-12-18 | 广州中医药大学(广州中医药研究院) | Application of the sodium butyrate in the drug or functional food of preparation prevention and treatment myocardial hypertrophy |
| WO2021205268A1 (en) * | 2020-04-07 | 2021-10-14 | Caprika Srl | Composition for suppositories for the treatment of the prostatic diseases |
| CN114796174A (en) * | 2022-05-07 | 2022-07-29 | 中国人民解放军军事科学院军事医学研究院 | Application of sodium butyrate in preventing and treating hypercytosis |
| WO2023170597A1 (en) * | 2022-03-08 | 2023-09-14 | Sila S.P.A. | Topical composition for treating injuries or cutaneous inflammatory states or proctological pathologies |
| PL442463A1 (en) * | 2022-10-07 | 2024-04-08 | Probiome Spółka Z Ograniczoną Odpowiedzialnością | Rectal suppositories and their use |
-
2007
- 2007-04-27 CN CN2007101027976A patent/CN101292969B/en active Active
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579369A (en) * | 2012-03-31 | 2012-07-18 | 湖北诺鑫生物科技有限公司 | Sodium butyrate enteric sustained release preparation and preparation method thereof |
| CN102824339A (en) * | 2012-05-29 | 2012-12-19 | 中国人民解放军第三军医大学 | Application of sodium butyrate in preparation of hypoxic pulmonary hypertension control medicines |
| CN102824339B (en) * | 2012-05-29 | 2015-07-22 | 中国人民解放军第三军医大学 | Application of sodium butyrate in preparation of hypoxic pulmonary hypertension control medicines |
| RU2506054C1 (en) * | 2012-10-22 | 2014-02-10 | Елена Александровна Рогожкина | Method of treating chronic anal fissure |
| JP2018535276A (en) * | 2015-11-27 | 2018-11-29 | ビルベヘール・ベー・フェー | Butyrate for use in inflammatory diseases |
| CN108208177A (en) * | 2017-11-28 | 2018-06-29 | 上海交通大学医学院附属新华医院 | Composition and its application containing butyric acid compound |
| CN109010327A (en) * | 2018-08-22 | 2018-12-18 | 广州中医药大学(广州中医药研究院) | Application of the sodium butyrate in the drug or functional food of preparation prevention and treatment myocardial hypertrophy |
| WO2021205268A1 (en) * | 2020-04-07 | 2021-10-14 | Caprika Srl | Composition for suppositories for the treatment of the prostatic diseases |
| WO2023170597A1 (en) * | 2022-03-08 | 2023-09-14 | Sila S.P.A. | Topical composition for treating injuries or cutaneous inflammatory states or proctological pathologies |
| CN114796174A (en) * | 2022-05-07 | 2022-07-29 | 中国人民解放军军事科学院军事医学研究院 | Application of sodium butyrate in preventing and treating hypercytosis |
| PL442463A1 (en) * | 2022-10-07 | 2024-04-08 | Probiome Spółka Z Ograniczoną Odpowiedzialnością | Rectal suppositories and their use |
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|---|---|
| CN101292969B (en) | 2011-05-25 |
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| C41 | Transfer of patent application or patent right or utility model | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20091204 Address after: No. 8, Shanghai Road, Jiaonan, Qingdao, Shandong Applicant after: Qingdao Donghai Pharmaceutical Co., Ltd. Co-applicant after: Beijing Puerkang Medical High Technology Co., Ltd. Address before: No. 8, Shanghai Road, Jiaonan, Qingdao, Shandong Applicant before: Qingdao Donghai Pharmaceutical Co., Ltd. Co-applicant before: Dongfanghaixin Biological Technology Co., Ltdd., Beijing |
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