CN1548013A - Simple vaginal ring making process - Google Patents
Simple vaginal ring making process Download PDFInfo
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- CN1548013A CN1548013A CNA031168930A CN03116893A CN1548013A CN 1548013 A CN1548013 A CN 1548013A CN A031168930 A CNA031168930 A CN A031168930A CN 03116893 A CN03116893 A CN 03116893A CN 1548013 A CN1548013 A CN 1548013A
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Abstract
The present invention relates to the simple vaginal ring making process. Blended silicon rubber is extruded in a extruder to form straight release-controlling circular tube, the circular tube of un-sulfurized silicon rubber is then cut into sections, and the ends of each section are butt connected to form circular ring. Or, medicines may be added into the release-controlling tube sections before butt connecting to form one or several medicine chambers. The ring is finally hot press sulfurized in mold to form. The present invention needs no special apparatus, and is simple, low in cost, and suitable for large scale production.
Description
Technical field:
The present invention relates to the medical apparatus field, be specifically related to a kind of preparation method of pessary.
Background technology:
From domestic and foreign literature data and the external pessary that has entered clinical market, all be to have adopted the injection molding vulcanization process to prepare pessary, yet adopt the injection mould sulfuration to produce, on the one hand, the equipment price costliness, technology is also complicated on the other hand, and that product takies the equipment time is long, the production cost height is difficult to accomplish large-scale production.
Summary of the invention:
Technical problem to be solved by this invention is to adopt common rubber extrusion equipment, provides a kind of easy, prepares the method for pessary cheaply.
Pessary production method disclosed by the invention is controlled release pipe formulation material-mixing silicon rubber to be extruded the silicone rubber controlled release pipe (see figure 1) of a straight type in extruder, its diameter, wall thickness is set by the demand size of all kinds of pessaries, this silicone rubber controlled release pipe that does not vulcanize typing is cut into one section or several sections, with the butt joint of two end end sockets, form the annulus (see figure 2) again; Or in each section controlled release pipe, add different medicines respectively, and again each section pastille silicone rubber controlled release pipe is docked successively, make in tube chamber, to be separated to form a Room or multicellular drug storehouse storage, put into the molding of mould hot-press vulcanization then, see Fig. 3-1～3-3.
The present invention prepares the simple and easy method of pessary, its key is to adjust mixing formula in various medical grade silicon rubbers commonly used at present, described medical grade silicon rubber commonly used comprises HTV (high temperature vulcanized or heat cure, molecular weight 20-100 ten thousand), RTV-2 (bi-component temperature sulfuration, molecular weight 0.74-11 ten thousand), LTV (liquid bi-component temperature vulcanizable silicone rubber, molecular weight 4000-50000), Dow corning silastic-382 medical grade silicone rubber, a Dow corning Q7 medical grade silicone rubber series and an implantation level MDX series, or the medical grade silicone rubber of other respective series.
The present invention prepares silicone rubber controlled release pipe that pessary adopts can suitably be adjusted elastomeric compound according to physics, chemical property and all kinds of preparation of different pharmaceutical to the requirement of release amount prescription, if select addition-type silicon rubber for use, then adopt platinum chromium thing to make catalyst, containing hydrogen silicone oil is made the vulcanization of cross-linking agent, and the baking temperature is controlled at 20 ℃-140 ℃.If select heat vulcanized silicone rubber for use, then adopt benzoyl peroxide to make cross-linking agent, the baking temperature is more than 140 ℃.The concrete scope of adjusting is:
(1) HTV (high temperature vulcanized or heat cure, molecular weight 20-100 ten thousand) silicone rubber 40-80%, silica 1 0-50%, hydroxy silicon oil 5-15%, medical grade barium sulfate 5-30%, iron oxide red 5g, benzoyl peroxide make cross-linking agent 0.5-1.5%.Put into rubber internal mixer and take out after mixing 40 minutes, be extruded into silicone rubber controlled release pipe at general rubber mixing machine then.
(2) add-on type RTV-2 (sulfuration of bi-component temperature, molecular weight 0.74-11 ten thousand) or LTV (liquid bi-component temperature vulcanizable silicone rubber, molecular weight 4000-50000), silicone rubber 40-80%, silicon dioxide 20-60%, hydroxy silicon oil 5-15%, medical grade barium sulfate 5-30%, iron oxide red 5g.Putting into rubber internal mixer takes out after mixing 40 minutes, be divided into two by weight, be the first and second two groups, the first group general rubber mixing machine add platinum catalyst 0.1-1% mixing 20 times evenly, the second group adds evenly being cut into small pieces of mixing 20 times of active hydrogen cross-linking agent 1-10 at general rubber mixing machine and puts into Rubber Extruder.
Described silicon dioxide can be fumed silica or precipitated silica or fumed silanized silicon dioxide.As the fumed silanized silicon dioxide of German wacker-HDK=H20, German digaoso-200 fumed silica, Japanese LP series precipitated silica etc.
Adopt the pastille controlled release pessary of the inventive method preparation, wherein said medicine can be selected for use:
Progestogens:
Levonorgestrel (Leuonogestral), gestodene (gestodene), promise medroxyprogesterone (Normegestodene), gestrinone (R-2323), triketone desogestrel, desogestrel (De80 goestral), norgestrienone (Norgestrienon), demegestone (Demegestone), promegestone (Promegestone), dydrogesterone (Isopregneone), trimegestone (Trimegestone), drospirenone (Drospirenone) etc.
Estrogens:
Estradiol (E
2), estriol (E
3), ethinylestradiol, nilestriol (E
3Ether), premarin (conjugated Estrogenons) etc.
The gestation class:
Mifepristone (R
u-486) etc.
Anti-estrogens:
He is phenol (Tamofen), NSC-70735, Reynolds former times phenol etc. would be better.
Protein anabolic hormone:
Livial (Livial) etc.
Suppress prostaglandin synthetic drug in the uterine cavity:
Antiinflammatory is logical etc.
Hemorrhage:
Tranexamic acid, Trostin M, adona, aminomethylbenzoic acid, carbazochrome salicylate, peace base caproic acid etc.
The present invention prepares the method for pessary, simple to operate, need not special installation, thereby can adjust the release amount that the interior release area of tract is adjusted all kinds of pessaries within a large range easily, and in a pessary, can set more than one medicine releasing cavity easily as required, discharge multiple different types of medicine simultaneously.
Description of drawings
The silicone rubber controlled release pipe of the straight type of Fig. 1
The annulus that the butt joint of Fig. 2 two end end sockets forms
Wherein 1 is the end socket of butt joint
The multicell drug storehouse storage that Figure 31-3 forms
The specific embodiment:
Embodiment 1, left norethindrone contraception pessary
Take by weighing HTV (high temperature vulcanized or heat cure, molecular weight 500,000) silicone rubber 1kg, aerosil 0.5kg, hydroxy silicon oil 100g, medical grade barium sulfate 0.2kg, iron oxide red 5g.Put into rubber internal mixer and take out after mixing 40 minutes, add the 10g bis(2 at general rubber mixing machine then and ly evenly be cut into small pieces and put into Rubber Extruder for mixing 20 times,, extrude the silicone rubber controlled release pipe of internal diameter 3mm, wall thickness 1mm.Be cut into long 12.6cm, put into 20mg left side norethindrone plug (preparation method of application number 01126269.9 medicine applying system in cavity or duct), 180 ℃ of 10min hot-press vulcanizations of grinding tool are put in two connection then, and left norethindrone plug gets final product in the broken tract of repress.
Embodiment 2: the combined type pessary of gestodene+estradiol
Take by weighing the fumed silanized silicon dioxide 0.5kg of silicone rubber 1kg Germany wacker-HDK=H20 of RTV-2 (sulfuration of bi-component temperature, molecular weight 80,000), hydroxy silicon oil 30g, medical grade barium sulfate 0.1kg, iron oxide red 5g.Putting into rubber internal mixer takes out after mixing 40 minutes, be divided into two by weight, be divided into the first and second two groups, the first group general rubber mixing machine add platinum catalyst 0.5g mixing 20 times evenly, the second group adds evenly being cut into small pieces of mixing 20 times of active hydrogen cross-linking agent 5g at general rubber mixing machine and puts into Rubber Extruder,, extrude the silicone rubber controlled release pipe of internal diameter 2.6mm, wall thickness 1.2mm.Be cut into two of long 6.3cml, wherein put into 10mg gestodene's plug for one, another root is put into 5mg estradiol plug (01126700.3 1 kinds of controlled drug delivery devices that are used for the treatment of climacteric syndrome of the preparation method of the preparation method of application number 01126269.9 medicine applying system in cavity or duct and application number 01126269.9 medicine applying system in cavity or duct), 180 ℃ of 10min of grinding tool are put in the connection of four statures then, left norethindrone plug and estradiol plug get final product in the hot-press vulcanization, the broken tract of repress.
Claims (6)
1, a kind of preparation method of pessary, it is characterized in that described method is with after the mixing silicon rubber, in extruder, extrude the silicone rubber controlled release pipe of a straight type, this silicone rubber controlled release pipe that does not vulcanize typing is cut into one section or several sections, with the butt joint of two end end sockets, form annulus again; Or in each section controlled release pipe, add different medicines respectively, and again each section pastille silicone rubber controlled release pipe is docked successively, make in tube chamber, to be separated to form a Room or multicellular drug storehouse storage, obtain after putting into the molding of mould hot-press vulcanization then.
2, the preparation method of pessary according to claim 1, it is characterized in that wherein said silicone rubber is selected from the HTV that molecular weight is 20-100 ten thousand, molecular weight is the RTV-2 of 0.74-11 ten thousand, molecular weight is the LTV of 4000-50000, Dow corning silastic-382 medical grade silicone rubber, a Dow corning Q7 medical grade silicone rubber series and an implantation level MDX series, or the medical grade silicone rubber of other respective series.
3, the preparation method of pessary according to claim 1, the method that it is characterized in that wherein said mixing silicon rubber is to get the HTV40-80% that molecular weight is 20-100 ten thousand, silica 1 0-50%, hydroxy silicon oil 5-15%, medical grade barium sulfate 5-30%, iron oxide red 5g, benzoyl peroxide make cross-linking agent 0.5-1.5%, put into rubber internal mixer and take out after mixing 40 minutes, be extruded into silicone rubber controlled release pipe at general rubber mixing machine then.
4, the preparation method of pessary according to claim 1, the method that it is characterized in that wherein said mixing silicon rubber is that to get RTV-2 or the molecular weight that molecular weight is 0.74-11 ten thousand be 4000-50000 LTV 40-80%, silicon dioxide 20-60%, hydroxy silicon oil 5-15%, medical grade barium sulfate 5-30%, iron oxide red 5g, putting into rubber internal mixer takes out after mixing 40 minutes, be divided into two by weight, be the first and second two groups, the first group general rubber mixing machine add platinum catalyst 0.1-1% mixing 20 times evenly, the second group evenly is cut into small pieces after general rubber mixing machine adds mixing 20 times of active hydrogen cross-linking agent 1-10 and puts into Rubber Extruder and be extruded into silicone rubber controlled release pipe.
5,, it is characterized in that wherein said described silicon dioxide is selected from fumed silica or precipitated silica or fumed silanized silicon dioxide according to the preparation method of claim 3 or 4 described pessaries.
6, the preparation method of pessary according to claim 1 is characterized in that wherein said medicine is selected from prostaglandin synthetic drug in the progestogens, estrogens, gestation class, anti-estrogens, protein anabolic hormone, inhibition uterine cavity, antiinflammatory is logical or hemorrhage etc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03116893 CN1264488C (en) | 2003-05-14 | 2003-05-14 | Simple vaginal ring making process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03116893 CN1264488C (en) | 2003-05-14 | 2003-05-14 | Simple vaginal ring making process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1548013A true CN1548013A (en) | 2004-11-24 |
| CN1264488C CN1264488C (en) | 2006-07-19 |
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ID=34320519
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 03116893 Expired - Fee Related CN1264488C (en) | 2003-05-14 | 2003-05-14 | Simple vaginal ring making process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1264488C (en) |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN103394127A (en) * | 2013-08-02 | 2013-11-20 | 苏州市马尔泰新材料有限公司 | Vaginal mould material containing traditional Chinese medicine and western medicine |
| CN103394128A (en) * | 2013-08-02 | 2013-11-20 | 苏州市马尔泰新材料有限公司 | Mould material containing ligusticum wallichii |
| CN103405810A (en) * | 2013-08-02 | 2013-11-27 | 苏州市马尔泰新材料有限公司 | Vagina mold containing methyl methacrylate resin |
| CN103431930A (en) * | 2013-08-02 | 2013-12-11 | 苏州市马尔泰新材料有限公司 | Methyl ester resin-containing vaginal mold |
| CN103445892A (en) * | 2013-08-02 | 2013-12-18 | 苏州市马尔泰新材料有限公司 | Vaginal stent containing methyl ester resin and diethylstilbestrol |
| CN104546267A (en) * | 2015-01-13 | 2015-04-29 | 安徽农业大学 | Extrauterine contraception device for dogs and contraception method thereof |
| JP2019502702A (en) * | 2015-12-21 | 2019-01-31 | バイエル・オーイュー | Method for manufacturing drug delivery device and drug delivery device manufactured according to the method |
| JP2019504021A (en) * | 2015-12-21 | 2019-02-14 | バイエル・オーイュー | How to make a vaginal ring |
| CN113413358A (en) * | 2021-06-11 | 2021-09-21 | 上海达华药业有限公司 | Preparation method of contraceptive implant drug core |
-
2003
- 2003-05-14 CN CN 03116893 patent/CN1264488C/en not_active Expired - Fee Related
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN103394127A (en) * | 2013-08-02 | 2013-11-20 | 苏州市马尔泰新材料有限公司 | Vaginal mould material containing traditional Chinese medicine and western medicine |
| CN103394128A (en) * | 2013-08-02 | 2013-11-20 | 苏州市马尔泰新材料有限公司 | Mould material containing ligusticum wallichii |
| CN103405810A (en) * | 2013-08-02 | 2013-11-27 | 苏州市马尔泰新材料有限公司 | Vagina mold containing methyl methacrylate resin |
| CN103431930A (en) * | 2013-08-02 | 2013-12-11 | 苏州市马尔泰新材料有限公司 | Methyl ester resin-containing vaginal mold |
| CN103445892A (en) * | 2013-08-02 | 2013-12-18 | 苏州市马尔泰新材料有限公司 | Vaginal stent containing methyl ester resin and diethylstilbestrol |
| CN104546267A (en) * | 2015-01-13 | 2015-04-29 | 安徽农业大学 | Extrauterine contraception device for dogs and contraception method thereof |
| CN104546267B (en) * | 2015-01-13 | 2017-01-04 | 安徽农业大学 | Birth control device and method of birth control thereof outside a kind of dog palace |
| JP2019502702A (en) * | 2015-12-21 | 2019-01-31 | バイエル・オーイュー | Method for manufacturing drug delivery device and drug delivery device manufactured according to the method |
| JP2019504021A (en) * | 2015-12-21 | 2019-02-14 | バイエル・オーイュー | How to make a vaginal ring |
| CN113413358A (en) * | 2021-06-11 | 2021-09-21 | 上海达华药业有限公司 | Preparation method of contraceptive implant drug core |
| CN113413358B (en) * | 2021-06-11 | 2022-11-15 | 上海达华药业有限公司 | Preparation method of contraceptive implant drug core |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1264488C (en) | 2006-07-19 |
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Granted publication date: 20060719 |