CN2525971Y - Pessary of slow-released mifepristone - Google Patents

Pessary of slow-released mifepristone Download PDF

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Publication number
CN2525971Y
CN2525971Y CN 01268469 CN01268469U CN2525971Y CN 2525971 Y CN2525971 Y CN 2525971Y CN 01268469 CN01268469 CN 01268469 CN 01268469 U CN01268469 U CN 01268469U CN 2525971 Y CN2525971 Y CN 2525971Y
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China
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pessary
mifepristone
slow release
release
medicine
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Expired - Fee Related
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CN 01268469
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Chinese (zh)
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董白桦
程定超
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Individual
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Individual
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The utility model relates to an anti-conceptive device, in particular to a pessary of slow-released mifepristone, and the pessary has two types, one is the in the skeleton pattern installation and another is in the tube type installation( or shell type, film type). The utility model is characterized in that: the utility model avoids the interfering and influence for the exudation and adjusting of endogenous sex hormone of human body by the pessary with hormone medicine, synchronously, the utility model can be used for other fields like reproduction health.

Description

A kind of pessary of slow release mifepristone
This utility model belongs to the medical apparatus field, and specifically it has related to the medical instrument in a kind of human contraception of being used for and healthy reproduction field.
People such as Mishell in 1970 have at first reported with intravaginal and have put the mode that can discharge the method for medroxyprogestetone acetate ring tool and realize practising contraception, but ring tool---the research of pessary that has from then on begun to be placed in the vagina arched roof and loaded slow releasing pharmaceutical.
The characteristics of aforementioned pessary are: utilized the drug absorption function of vaginal mucosa preferably, and the characteristics of its drug absorption are that again whole body blood drug level keeps reduced levels, drug side effect is lighter, the liver first-pass effect of no medicine.Pessary places vagina slow releasing pharmaceutical for a long time, has avoided the inconvenience of the frequent administration of oral contraceptive mode.The crowd acceptable aspect, vagina is put pessary, does not have tangible discomfort or foreign body sensation usually, not obviously influences sexual intercourse, and can insert easily as required or take out, and has avoided the deficiency of subdermal implantation slow release medical instrument mode.
Yet, up to now, the medicine of pessary institute slow release all is based on steroid hormone, and having brought more significant exogenous slow releasing pharmaceutical thus to the secretion of human body endogenous gonadal hormone and the interference and the influence of adjusting, i.e. the side effect of aforementioned hormone has restricted the acceptability of pessary contraceptive method and has applied.
This utility model provides a kind of and has realized that with medical macromolecular materials slow release and slow releasing pharmaceutical are the pessary of mifepristone, to overcome the deficiency of aforementioned pessary.It promptly can be used for the contraception of family planning, can be used for other fields such as healthy reproduction again, as: hysteromyoma, endometriosis, abnormal uterine bleeding, ovarian cancer, breast carcinoma expectant treatment etc.
This utility model is realized by following setting:
Slow releasing pharmaceutical of the present utility model is selected mifepristone for use.With regard to pharmacological action, mifepristone is a kind of gestation receptor class medicine, it has become the best medicine that is used for the early pregnancy drug induced abortion up to now, secondly, with its low dose of oral administration, proved that it has the definite emergency contraception or the effect of postcoital contraception, moreover, this medicine still is a kind of calcium channel blocker, therefore also be motionless dose of a kind of sperm, in addition, it all has good effect in healthy reproduction fields such as hysteromyoma, endometriosis, abnormal uterine bleeding, ovarian cancer, breast carcinoma, ectopic pregnancy expectant treatments.
This utility model is closed loop shaped thing, and it has two kinds of set-up modes: one are the matrix type pessary, and the person is cast pessary (or being called shell mould, membranous type) in addition.
Of the present utility model drawing materials is medical high polymer sustained-release and controlled release material.
Matrix type pessary of the present utility model is to be skeleton with medical macromolecular materials, also be the carrier of mifepristone medicine, different requirements according to sustained-release and controlled release, this skeleton can adopt following three kinds of modes to manufacture: one, this skeleton adopts the method for casting to be made into cylindrical annular with water-insoluble medical macromolecular materials and mifepristone medicine uniform mixing then.Its two, with water-insoluble medical macromolecular materials and mifepristone medicine uniform mixing, make cylindrical annular as wetting agent (or as binding agent) with organic solvent.Its three, make pharmaceutical dispersions with solvent method, make its embedding or suck porous having made in the cylindrical annular medical high polymer skeleton that designs.The water-insoluble framework material of aforementioned three kinds of modes is medical grade silicon rubber or ethylene-acetate ethylene copolymer or polyvinyl acetate-acetate fiber or polyethylene trimethylene or polymethacrylates or polyethylene or polrvinyl chloride etc.
Cast of the present utility model (or claim shell mould, membranous type) pessary is to be made of two-layer, and it is outer for not containing the hollow tubular thing that medical high polymer controlled-release material that medicine only plays control drug release is made, and internal layer is the medicated core that contains medicine.The setting of aforementioned medicated core can have following mode: one, this medicated core are medicine.Its two, this medicated core is the framework material that medicine and slow-releasing macromolecular material are made.Aforementioned framework material can have following setting: one, this framework material are insoluble skeleton, its two, this framework material is erodible skeleton, its three, this framework material is the hydrophilic gel skeleton.Wherein, the manufacture method of the method for production of aforesaid insoluble skeleton and aforesaid matrix type pessary is roughly the same, and what distinguished is that the former last shaping thing is cylindrical, inserts in the controlled release pipe being fit to.Aforesaid erodible skeleton is for adopting the strong fat of hydrophobicity, wax family macromolecule material as framework material, and with mifepristone medicine suspendible or be miscible in this class melted material, cooling back medicine is contained to be dipped in the framework material.This erodible framework material is the ester of Cera Flava or Lac or Brazil wax or hydrogenated vegetable oil or higher fatty acids or high fatty alcohol etc.Aforesaid hydrophilic gel skeleton for medicine with make after the macromolecular material of hydrophilic gel mixes, this hydrophilic high molecular material is polyvinyl alcohol or Polyethylene Glycol or polystyrene-maleic anhydride or polyacrylic acid or polyvinylpyrrolidone or hydroxy methocel or hydroxypropyl emthylcellulose etc.This cast pessary is that the medicated core that said method is made is packed in the controlled release pipe of being made by the medical high polymer controlled-release material, this controlled release pipe is made the ring shape of pipe end fit.The medical high polymer controlled-release material of making hollow pipe is a silicone rubber, or ethylene-acetate ethylene copolymer etc.
Ring diameter of the present utility model can be set in the 35mm-60mm scope, and its cross-sectional diameter can be set in the 3.5mm-10mm scope.
The medicament slow release time of the present utility model is set in 3-6 month scope.
For making this utility model promptly have contraception effectiveness, the others that have concurrently again in the non-contraception of healthy reproduction produce effectiveness, this utility model can carry out other design at its method for production and technical elements according to application requirements, to reach the purpose of the required drug dose of constant slow release.Aforesaid other design relates to following scheme: one, and the manufacturing way of aforementioned matrix type pessary and material are changed as required or adjust, as: 1. select different skeleton manufacturing ways; 2. select the different materials of manufacturing skeleton; 3. select to close in the proportioning of framework material that requires and mifepristone medicine; 4. select different size dimension matrix type pessary designs, such as ring diameter, area of section etc.Its two, the system mode of aforementioned cast (shell mould or membranous type) pessary is changed as required or adjusts, as: 1. select different medicated core manufacturing ways; 2. select the different materials of manufacturing medicated core; 3. select to close in the proportioning of medicated core material that requires and mifepristone medicine; 4. select the medicated core design of different size dimensions, as external diameter, the area of section of medicated core; 5. select the material of different controlled release pipes; 6. select wall thickness and its size dimension of different controlled release pipes.Also can between matrix type pessary mode and cast pessary mode, select.
Using method of the present utility model:
The using method of pessary described in the utility model is identical with the using method of pessary in the past, uses Shi Keyou doctor or user that pessary transvaginal mouth is put on vagina arched roof place or the cervix uteri.Take out as the same, very convenient.
Characteristics of the present utility model:
Characteristics of the present utility model are: overcome up to now that the medicine of pessary institute slow release all is based on steroid hormone, and brought the side effect that interference and influence produced of exogenous steroid hormone medicine to human body endogenous sex hormones secretion and adjusting thus.Provide a kind of safe, effective, side reaction is little, promptly can be used in the contraception of family planning, can be used for the pessary in other fields such as healthy reproduction again.This utility model is that pessary opens up a new way aspect slow releasing pharmaceutical, has also expanded new purposes in application facet.Its annular design rationally and meet human body natural's requirement.Its material is taken at medical macromolecular materials, and is good with biocompatible, and have no side effect, do not have three and cause effect, disimmune, the non-activity of material own, performance is good, easy configuration, medicament slow release is constant, and pharmacokinetics belongs to the zero level release type.Because the design of pessary described in the utility model promptly can be used in the contraception of family planning, can be used for again in the more illness treatment of some sickness rate of healthy reproduction, so good use value and promotional value are arranged.
The utility model is described in further detail below in conjunction with accompanying drawing.
Accompanying drawing 1 is the structural representation of this utility model matrix type pessary, and 1 is the medicine skeleton that medical macromolecular materials are made among the figure, and it is made by aforesaid three kinds of matrix type pessary method for production, and medicine is by matrix type mode slow release.
Accompanying drawing 2,3 is the structural representation of this utility model cast (shell mould or membranous type) pessary.This pessary is made of two-layer, and it is not outer 2 for containing the hollow tubular thing that medical high polymer controlled-release material that medicine only plays control drug release is made, and internal layer 3 is for containing the medicated core of medicine.Wherein 3a is the matrix type medicated core in Fig. 2 pipe, and 3b is a mifepristone medicine medicated core in Fig. 3 pipe.

Claims (6)

1. the pessary of a slow release mifepristone, the medicine that it is characterized in that the pessary institute slow release of this slow release mifepristone are the pessaries that are provided with in the matrix type mode or realize sustained-release and controlled release with the pessary that the cast mode is provided with.
2. the pessary of slow release mifepristone according to claim 1 is characterized in that the medicine of the pessary institute slow release of this slow release mifepristone is the mifepristone of gestation receptor class.
3. the pessary of slow release mifepristone according to claim 1, it is characterized in that the pessary that the matrix type mode is provided with has three kinds of forms: one, the pessary that this matrix type mode is provided with are with casting in addition behind water-insoluble medical macromolecular materials and the mifepristone medicine uniform mixing; Its two, the pessary that this matrix type mode is provided with is with water-insoluble medical macromolecular materials and mifepristone medicine uniform mixing, with organic solvent as wetting agent or make as binding agent; Its three, the pessary that this matrix type mode is provided with is to make pharmaceutical dispersions with solvent method, makes its embedding or sucks in the porous Manufactured medical high polymer skeleton.
4. the pessary of slow release mifepristone according to claim 1 is characterized in that the pessary that the cast mode is provided with is to make with the medical high polymer controlled-release material of medicated core and control drug release.
5. the pessary of slow release mifepristone according to claim 4 is characterized in that the medicated core of the pessary that this cast mode is provided with can insoluble skeleton, or with erodible skeleton, or makes in three kinds of modes of hydrophilic gel skeleton.
6. the pessary of slow release mifepristone according to claim 4 is characterized in that this medical high polymer controlled-release material can be silicone rubber, or is ethylene-acetate ethylene copolymer.
CN 01268469 2001-11-13 2001-11-13 Pessary of slow-released mifepristone Expired - Fee Related CN2525971Y (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1899643B (en) * 2005-07-20 2010-12-29 上海市计划生育科学研究所 Pessary or intrauterine medicine release device containing antiestrogenic and anti-pregnant hormone composite preparation and its use
CN102327664A (en) * 2010-07-14 2012-01-25 国家人口计生委科学技术研究所 Intelligent pessulum with memory effect and preparation method thereof
CN102600001A (en) * 2011-01-19 2012-07-25 国家人口计生委科学技术研究所 Slow-release mifepristone vaginal ring preparation and application thereof
CN104117135A (en) * 2014-08-11 2014-10-29 崔仁海 Endovaginal implantable treatment device
CN113164383A (en) * 2019-10-12 2021-07-23 国家卫生健康委科学技术研究所 Vagina slow-release drug delivery system for corpus luteum support and preparation method and application thereof

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1899643B (en) * 2005-07-20 2010-12-29 上海市计划生育科学研究所 Pessary or intrauterine medicine release device containing antiestrogenic and anti-pregnant hormone composite preparation and its use
CN102327664A (en) * 2010-07-14 2012-01-25 国家人口计生委科学技术研究所 Intelligent pessulum with memory effect and preparation method thereof
CN102600001A (en) * 2011-01-19 2012-07-25 国家人口计生委科学技术研究所 Slow-release mifepristone vaginal ring preparation and application thereof
CN104117135A (en) * 2014-08-11 2014-10-29 崔仁海 Endovaginal implantable treatment device
CN113164383A (en) * 2019-10-12 2021-07-23 国家卫生健康委科学技术研究所 Vagina slow-release drug delivery system for corpus luteum support and preparation method and application thereof

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