CN107049940A - A kind of accelerator for promoting Menglusitena per rectum to absorb and its application method - Google Patents

A kind of accelerator for promoting Menglusitena per rectum to absorb and its application method Download PDF

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Publication number
CN107049940A
CN107049940A CN201710141339.7A CN201710141339A CN107049940A CN 107049940 A CN107049940 A CN 107049940A CN 201710141339 A CN201710141339 A CN 201710141339A CN 107049940 A CN107049940 A CN 107049940A
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menglusitena
sodium
rectum
accelerator
application method
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王章阳
桂勤
曹娅琪
代青
贾运涛
齐云
穆云庆
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CHONGQING XI'NAN HOSPITAL
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0031—Rectum, anus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
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Abstract

The invention discloses a kind of accelerator for promoting Menglusitena per rectum to absorb and its application method, Menglusitena forms for rectal administration, Tween 80 1.0%~15% or sodium caprate 0.2%~2.0% or Laurocapram 1.0%~10% or sodium taurocholate 0.1%~1.0% or L arginine 0.5%~1.5% or sodium laurate 0.5%~3.0% in mass ratio is added in such as Enema liquid, suppository, ointment prescription, the bioavilability of Menglusitena per rectum administration can be improved.The present invention filters out the accelerator that Menglusitena per rectum can be promoted to absorb and its amount ranges, and foundation is provided for the research and development of Menglusitena forms for rectal administration.

Description

A kind of accelerator for promoting Menglusitena per rectum to absorb and its application method
Technical field
The invention belongs to medicine and pharmacology technical field, more particularly to a kind of accelerator for promoting Menglusitena per rectum to absorb And its application method.
Background technology
Menglusitena is a kind of selective LTRA, can specificity suppress cysteinyl leukotriene by Body, has effect to the teiology of inflammation, allergic reaction and asthma, for the prevention and long-term treatment being grown up with childhood asthma, bag The SOA at prevention daytime and night is included, the asthma to aspirin-sensitive, bronchoconstriction caused by prevention motion is treated Deng.
Rectally is clinically important administering mode.The administration of medicine per rectum can avoid the wound of drug administration by injection, it is to avoid The inconvenience of infant's oral ingestion and coma patient can not orally wait difficulty, and medicine-feeding part is drug absorption position, and medicine is inhaled Liver first-pass effect can be avoided after receipts, medicine quickly enters blood circulation, is conducive to first aid；Rectally non-invasive, Enema liquid Dosage is easy to adjust, to that orally patient or can not be difficult to oral infant and medicine is extremely advantageous, can accomplish dosage Accurately, it is ensured that drug safety.Presently commercially available Menglusitena drug formulation has only tablet and children's tablet and granule, still Clinic is applied to without forms for rectal administration.
However, test result indicates that, Menglusitena per rectum itself absorbs few, is the bad absorption portion of the medicine Position, therefore effective treatment can not be reached by rectally, it is therefore necessary to improve the absorption of its per rectum using effective ways Situation, to reach the effective rectal absorption of medicine, promotes design, the preparation and application of related forms for rectal administration.
Rectal absorption accelerator is the common method for improving drug absorption transhipment, i.e., certain by being added in preparation prescription Other auxiliary materials of amount, change the permeability of pharmaceutical properties or drug absorption position epithelial cell to improve the biological profit of drug absorption Expenditure, reaches the purpose that medicine is effectively treated.But which accelerator is effectively and concentration scope is unknown.
The content of the invention
It is an object of the invention to provide a kind of accelerator for promoting Menglusitena per rectum to absorb and application method, purport Solve Menglusitena can not per rectum absorb reach effective treatment the problem of.
The present invention is achieved in that a kind of accelerator for promoting Menglusitena per rectum to absorb, the promotion Meng Lu The accelerator that the special sodium per rectum of department absorbs in mass ratio by 0.5%~4% Menglusitena and 1.0%~15% Tween-80 or 0.2%~2.0% sodium caprate or 1.0%~10% Laurocapram or 0.1%~1.0% sodium taurocholate or 0.5%~ 1.5%L- arginine or 0.5%~3.0% sodium laurate composition.
Further, the accelerator pharmaceutically dosage form for promoting Menglusitena per rectum to absorb includes Enema liquid, rectum bolt Agent, rectum ointment.
Another object of the present invention is the application method for providing the accelerator that a kind of promotion Menglusitena per rectum absorbs, Including：
Take in mass ratio by Tween-80 1.0%~15% or sodium caprate 0.2%~2.0% or Laurocapram 1.0%~10% or sodium taurocholate 0.1%~1.0% or L-arginine 0.5%~1.5% or sodium laurate 0.5%~ 3.0%；
Solid or semi-solid poly- second two are codissolved in purified water or are dispersed in 0.5%~4.0% Menglusitena The Enema liquid, suppositories for rectal and rectum ointment of rectally are made in alcohol.
Another object of the present invention is to provide a kind of Enema liquid application method, and the Enema liquid application method includes：
Take 1.0 grams of Menglusitenas to add in 60g purified waters to dissolve, add 1.0 grams of Tween-80s, or 0.5 gram of capric acid Sodium, or 1.0 grams of Laurocaprams, or 0.5 gram of sodium taurocholate, or 1.0 grams of L-arginines, or 1.0 grams of sodium laurates, stirring and dissolving Afterwards, supplement purified water stirs evenly to 100g and produces Enema liquid.
Another object of the present invention is to provide a kind of suppositories for rectal application method, the suppositories for rectal application method bag Include：
It is 1.0%~15% Tween-80 or 0.2%~2.0% sodium caprate or 1.0%~10% bay nitrogen in mass ratio Tall and erect ketone or 0.1%~1.0% sodium taurocholate or 0.5%~1.5%L- arginine or 0.5%~3.0% sodium laurate with 0.5%~4% Menglusitena is molten altogether or is dispersed in 10%~20% liquid polyethylene glycol；By solid polyethylene glycol plus Heat melt after add wherein to full dose 100%, poured into after stirring in bolt mould condense, after the demoulding suppositories for rectal.
Another object of the present invention is to provide a kind of rectum ointment application method, and the rectum uses ointment user Method includes：
It is 1.0%~15% Tween-80 or 0.2%~2.0% sodium caprate or 1.0%~10% bay nitrogen in mass ratio Tall and erect ketone or 0.1%~1.0% sodium taurocholate or 0.5%~1.5%L- arginine or 0.5%~3.0% sodium laurate are absorption Accelerator is total to molten or is dispersed in 10%~20% liquid polyethylene glycol with 0.5%~4% Menglusitena；By solid-state or Added after semisolid polyethylene glycol heating and melting wherein to full dose 100%, be evenly stirred until solidifying, semisolid ointment is made, point It is fitted into medicine applying device for rectum and produces rectum ointment.
The present invention filters out the accelerator that can improve the absorption of Menglusitena per rectum and its amount ranges, is montelukast The research and development of sodium forms for rectal administration provide foundation.
Brief description of the drawings
Fig. 1 is the application method flow for the accelerator that promotion Menglusitena per rectum provided in an embodiment of the present invention absorbs Figure.
Embodiment
In order to make the purpose , technical scheme and advantage of the present invention be clearer, with reference to embodiments, to the present invention It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to Limit the present invention.
The application principle of the present invention is described in detail below in conjunction with the accompanying drawings.
The accelerator provided in an embodiment of the present invention for promoting Menglusitena per rectum to absorb, in mass ratio by 0.5%~ 4% Menglusitena and 1.0%~15% Tween-80 or 0.2%~2.0% sodium caprate or 1.0%~10% bay nitrogen are tall and erect Ketone or 0.1%~1.0% sodium taurocholate or 0.5%~1.5%L- arginine or 0.5%~3.0% sodium laurate composition.
The accelerator pharmaceutically dosage form for promoting Menglusitena per rectum to absorb includes Enema liquid, suppositories for rectal, rectum Use ointment.
As shown in figure 1, the user of the accelerator provided in an embodiment of the present invention for promoting Menglusitena per rectum to absorb Method, comprises the following steps：
S101:Take in mass ratio tall and erect by Tween-80 1.0%~15% or sodium caprate 0.2%~2.0% or bay nitrogen Ketone 1.0%~10% or sodium taurocholate 0.1%~1.0% or L-arginine 0.5%~1.5% or sodium laurate 0.5%~ 3.0%；
S102:Solid is codissolved in purified water or is dispersed in 0.5%~4.0% Menglusitena or semi-solid poly- The Enema liquid, suppositories for rectal and rectum ointment of rectally are made in ethylene glycol.
The embodiment of the present invention provides a kind of Enema liquid application method, and the Enema liquid application method includes：
Take 1.0 grams of Menglusitenas to add in 60g purified waters to dissolve, add 1.0 grams of Tween-80s, or 0.5 gram of capric acid Sodium, or 1.0 grams of Laurocaprams, or 0.5 gram of sodium taurocholate, or 1.0 grams of L-arginines, or 1.0 grams of sodium laurates, stirring and dissolving Afterwards, supplement purified water stirs evenly to 100g and produces Enema liquid.
The embodiment of the present invention provides a kind of suppositories for rectal application method, and the suppositories for rectal application method includes：
It is 1.0%~15% Tween-80 or 0.2%~2.0% sodium caprate or 1.0%~10% bay nitrogen in mass ratio Tall and erect ketone or 0.1%~1.0% sodium taurocholate or 0.5%~1.5%L- arginine or 0.5%~3.0% sodium laurate with 0.5%~4% Menglusitena is molten altogether or is dispersed in 10%~20% liquid polyethylene glycol；By solid polyethylene glycol plus Heat melt after add wherein to prescription full dose 100%, poured into after stirring in bolt mould condense, after the demoulding rectum bolt Agent.
The embodiment of the present invention provides a kind of rectum ointment application method, rectum ointment application method bag Include：
It is 1.0%~15% Tween-80 or 0.2%~2.0% sodium caprate or 1.0%~10% bay nitrogen in mass ratio Tall and erect ketone or 0.1%~1.0% sodium taurocholate or 0.5%~1.5%L- arginine or 0.5%~3.0% sodium laurate are absorption Accelerator is total to molten or is dispersed in 10%~20% liquid polyethylene glycol with 0.5%~4% Menglusitena；By solid-state or Added after semisolid polyethylene glycol heating and melting wherein to prescription full dose (100%), be evenly stirred until solidifying, semisolid is made soft Cream, is distributed into medicine applying device for rectum and produces rectum ointment.
The present invention filters out the accelerator that Menglusitena per rectum can be promoted to absorb and its amount ranges, is montelukast The research and development of sodium forms for rectal administration provide foundation.
The application principle of the present invention is further described with reference to specific embodiment.
Added in montelukast sodium enema liquid the Tween-80 of accelerator 10% or 1% sodium caprate or 0.2% sodium taurocholate or After 4% Laurocapram or 3% sodium laurate or 1.5%L- arginine, blood medicine of the Menglusitena through rabbit rectally In concentration and time relationship, the TG-AUC (AUC) of 0~7 hour, Cmax CmaxIt see the table below.Use Meng Lusi after accelerator The AUC that special sodium per rectum absorbs improves 5~10 times, CmaxImprove 2~6 times.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention Any modifications, equivalent substitutions and improvements made within refreshing and principle etc., should be included in the scope of the protection.

Claims (6)

1. a kind of accelerator for promoting Menglusitena per rectum to absorb, it is characterised in that the promotion Menglusitena is through straight The accelerator of intestinal absorption in mass ratio by 0.5%~4% Menglusitena and 1.0%~15% Tween-80 or 0.2%~ 2.0% sodium caprate or the smart ammonia of 1.0%~10% Laurocapram or 0.1%~1.0% sodium taurocholate or 0.5%~1.5%L- Acid or 0.5%~3.0% sodium laurate composition.
2. the accelerator for promoting Menglusitena per rectum to absorb as claimed in claim 1, it is characterised in that the promotion Meng The accelerator pharmaceutically dosage form that montelukast sodium per rectum absorbs includes Enema liquid, suppositories for rectal, rectum ointment.
3. a kind of application method of the accelerator as claimed in claim 1 for promoting Menglusitena per rectum to absorb, its feature It is, the application method for the accelerator that described promotion Menglusitena per rectum absorbs includes：
Take in mass ratio by Tween-80 1.0%~15% or sodium caprate 0.2%~2.0% or Laurocapram 1.0%~ 10% or sodium taurocholate 0.1%~1.0% or L-arginine 0.5%~1.5% or sodium laurate 0.5%~3.0%；
It is codissolved in purified water or is dispersed in solid or semi-solid polyethylene glycol with 0.5%~4.0% Menglusitena The Enema liquid, suppositories for rectal and rectum ointment of rectally is made.
4. a kind of Enema liquid application method of method as claimed in claim 4, it is characterised in that the Enema liquid application method bag Include：
Take 1.0 grams of Menglusitenas to add in 60g purified waters to dissolve, add 1.0 grams of Tween-80s, or 0.5 gram of sodium caprate, or After 1.0 grams of Laurocaprams, or 0.5 gram of sodium taurocholate, or 1.0 grams of L-arginines, or 1.0 grams of sodium laurates, stirring and dissolving, supplement Purified water stirs evenly to 100g and produces Enema liquid.
5. a kind of suppositories for rectal application method of method as claimed in claim 4, it is characterised in that the suppositories for rectal makes Included with method：
It is that 1.0%~15% Tween-80 or 0.2%~2.0% sodium caprate or 1.0%~10% bay nitrogen are tall and erect in mass ratio Ketone or 0.1%~1.0% sodium taurocholate or 0.5%~1.5%L- arginine or 0.5%~3.0% sodium laurate and 0.5% ~4% Menglusitena is molten altogether or is dispersed in 10%~20% liquid polyethylene glycol；Solid polyethylene glycol heating is melted Added after change wherein to full dose 100%, poured into after stirring in bolt mould condense, after the demoulding suppositories for rectal.
6. a kind of rectum ointment application method of method as claimed in claim 4, it is characterised in that the rectum ointment Agent application method includes：
It is that 1.0%~15% Tween-80 or 0.2%~2.0% sodium caprate or 1.0%~10% bay nitrogen are tall and erect in mass ratio Ketone or 0.1%~1.0% sodium taurocholate or 0.5%~1.5%L- arginine or 0.5%~3.0% sodium laurate promote to absorb Enter agent to be total to molten with 0.5%~4% Menglusitena or be dispersed in 10%~20% liquid polyethylene glycol；By solid-state or half Added after solid polyethylene glycol heating and melting wherein to full dose 100%, be evenly stirred until solidifying, semisolid ointment is made, dispensed Enter to produce rectum ointment in medicine applying device for rectum.
CN201710141339.7A 2017-03-10 2017-03-10 A kind of accelerator for promoting Menglusitena per rectum to absorb and its application method Pending CN107049940A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1852713A (en) * 2003-04-15 2006-10-25 麦克公司 Polymorphic form of montelukast sodium
CN101213177A (en) * 2005-07-05 2008-07-02 特瓦制药工业有限公司 Purification of montelukast
WO2008079256A2 (en) * 2006-12-22 2008-07-03 Schering Corporation Methods for treating nasal congestion in hypertensive or diabetic patients

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1852713A (en) * 2003-04-15 2006-10-25 麦克公司 Polymorphic form of montelukast sodium
CN101213177A (en) * 2005-07-05 2008-07-02 特瓦制药工业有限公司 Purification of montelukast
WO2008079256A2 (en) * 2006-12-22 2008-07-03 Schering Corporation Methods for treating nasal congestion in hypertensive or diabetic patients

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
曹娅琪等: "不同吸收促进剂对孟鲁司特钠家兔直肠吸收的促进作用", 《第三军医大学学报》 *
薛大权著: "《聚乙二醇在医药学领域的应用与技术》", 30 April 2011, 华中科技大学出版社 *

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