CN100418594C - Long-acting vagina administrator with precise control of medicine - Google Patents
Long-acting vagina administrator with precise control of medicine Download PDFInfo
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- CN100418594C CN100418594C CNB031168922A CN03116892A CN100418594C CN 100418594 C CN100418594 C CN 100418594C CN B031168922 A CNB031168922 A CN B031168922A CN 03116892 A CN03116892 A CN 03116892A CN 100418594 C CN100418594 C CN 100418594C
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- controlled release
- medicine
- silicone rubber
- pipe
- release pipe
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Abstract
The present invention relates to a long-acting vaginal administration device which can accurately control and release medicine. The device is a double-layer cavity controlled release device composed of a sealed controlled release pipe of inner lining silicon rubber and a controlled release pipe of outer layer silicon rubber, wherein the sealed controlled release pipe of inner lining silicon rubber contains medicine cores. Compared with the existing controlled release device, the medicine release control of the present invention is more accurate and constant, and the present invention can be used for preparing controlled release devices of various medicines.
Description
Technical field:
The present invention relates to the medical apparatus field, be specifically related to a kind of long-acting vagina administration apparatus of accurate controlled release drug.
Background technology:
The inventor discloses a kind of preparation method of medicine applying system in cavity or duct in Chinese patent application 01126269.9, this method is pressed into the uniform solid medicated core of character with the water of medicine and adjuvant, moistening amount mix homogeneously in certain proportion in mould; Medicated core according to the required medication amount intercepting certain-length of medicine applying system in cavity or duct; Behind the pipe, exert pressure in the medicated core of intercepting packed into, the solid medicated core is ground into Powdered.The preparation method of the cavity/canal drug administration system that this invention provides, it is simple to have a fill, and loading amount is advantage accurately, and can reduce or avoid the explosion of medicine in slow-releasing system to discharge.But use the preparation of this method preparation, when doing long-term release in vitro, the release amount between each ring of finding has certain difference, through dissecting, find that because pessary silicone rubber controlled release pipe has certain thickness exerting pressure outside is difficult to accomplish to pulverize homogeneous when pulverizing in the pipe medicated core, and interior plug produces displacement when mold pressing, cavity length is difficult to control in making, has influenced the area of medicine releasing cavity.
Summary of the invention:
Technical problem to be solved by this invention is improved on the basis of original application 01126269.9, and a kind of long-acting vagina administration apparatus of accurate controlled release drug is provided.
The double-deck chamber controlled-release device that the long-acting vagina administration apparatus of the accurate controlled release drug of energy disclosed by the invention is made up of the liner silicone rubber controlled release pipe and the outer silicone rubber controlled release pipe of the sealing of drug-containing core.
The medicated core that described liner silicone rubber is released in the pipe is that solid dispersion, the liquid state that contains medicine disperses thing, powder or grease.Liner controlled release pipe can be one or several, adds the medicated core that contains the different activities composition in each liner controlled release pipe respectively, forms the medicine-releasing system of one or more medicine releasing cavities.
Another technical problem to be solved by this invention is the preparation method that discloses above-mentioned double-deck chamber controlled-release device.
The preparation of the long-acting vagina administration apparatus of the accurate controlled release drug of the present invention comprises the following steps:
(1) with the water of medicine and adjuvant, moistening amount mix homogeneously in certain proportion, in mould, is pressed into the uniform solid medicated core of character.
(2) according to the amount of required medicine, after in the controlled release pipe of the silicone rubber liner that the medicated core of intercepting certain-length is packed into transparent or semitransparent, seal with the medical grade silicone rubber adhesive at the two ends of internal lining pipe and then exert pressure, make medicated core be milled into uniform powder fully.See Fig. 4.
(3) internal lining pipe is packed in the outer silicone rubber controlled release pipe of pessary, the two ends butt joint circularizes, and puts into mould and carries out the hot-press vulcanization molding, promptly.See Fig. 2-3
Medicine of the present invention is selected from other classification medicine of steroid hormone or suitable pessary or IUD administration, as estrogens, progestogens, such as Gestodene, and Levonorgestrel, Norethadrone, Desogestrel, Nomegestrel, Nestrone, Dienogest, Drospirenone, medroxyprogesterone, megestrol, E2, E3, EE etc., and E+P and androgens, or their combination.
Adjuvant of the present invention is selected from glycerol, cocoa butter, Polyethylene Glycol (molecular weight 400-20000), paraffin oil, vaseline, ethylmethylcellulose (molecular weight 30000-40000), ethyl cellulose, Pulvis Talci, microcrystalline Cellulose, starch, silicon dioxide, dextrin, barium sulfate, aluminium-magnesium silicate, hydroxypropyl emthylcellulose, cyclodextrin (β type molecular weight 1134, γ type molecular weight 1084-2015), silicone rubber kinds, (two-component room-temperature-vulcanized as RTV-2, molecular weight 0.74-11 ten thousand), RTV-1 is (single-component room-temperature vulcanized, molecular weight 0.74-11 ten thousand), LTV (addition vulcanization, molecular weight 100-200000), stearic acid, glyceryl monostearate, dimethicone.
The double-deck chamber of the present invention controlled-release device has following characteristics:
Medicine is uniformly dispersed in tube chamber, and release dosage is stable, and accurate sustained release area is effectively regulated and control release dosage again.
2. can use the solid dispersion or the liquid state of various character to disperse thing, Powdered, medicines such as oily are as medicated core.
3. in a pessary silicone rubber controlled release pipe, can add several medicines that include simultaneously, form the medicine-releasing system of a medicine releasing cavity and a plurality of medicine releasing cavities, and the silicone rubber liner controlled release pipe that can make different wall, different length, diameter according to the physicochemical property and the release amount of medicine.
When 4. the pastille internal lining pipe is put into outer controlled release pipe post-heating compression molding, because of liner inner air tube swollen the rising that be heated, with softish semi-cure or swollen the rising of sulfurized liner tubing, and be close to as yet the not internal chamber wall of the outer controlled release pipe of complete cure, after the heating and mould pressing molding, form closely and paste mutually, do not have the two-layer release-controlled tube chamber of the complete homogeneous in any gap, disengage to guarantee that the medicine homogeneous is constant.
With the LNG pessary that apparatus of the present invention and method obtain, its external release amount sees Table 1:
Table 1
The external release amount of monolayer LNG pessary of original application 01126269.9 sees Table 2:
Table 2
The above results shows that with the LNG pessary that apparatus of the present invention and method obtain, its external release amount is more even, stable.
Description of drawings
Fig. 1 LNG pessary release in vitro curve
Fig. 2 has the pessary of a pastille internal lining pipe
Wherein 1 is outer silicone rubber controlled release pipe, and 2 is the pastille internal lining pipe
Fig. 3 has the pessary of two pastille internal lining pipes
Wherein 1 is outer silicone rubber controlled release pipe, and 2 is the pastille internal lining pipe
Fig. 4 pastille internal lining pipe
Wherein 1 is liner silicone rubber controlled release pipe, and 2 is medicated core, and 3 is gluing blocking
The specific embodiment:
Be after the preparation method of 0112626.9 medicine applying system in cavity or duct is made the medicated core rod at application number with pure levonorgestrel by the inventor, intercepted length is 1.0cm, weight be in the medicated core of 20mg packs liner silicone rubber controlled release pipe into transparent after, seal with the medical grade silicone rubber adhesive at two ends, exert pressure again, the solid medicated core is pulverized the powdered medicine that makes to be uniformly dispersed at the internal lining pipe intracavity, then this pastille internal lining pipe is put into the pessary silicone rubber controlled release pipe of outer field uncured, two ends connect into annular, put into the grinding tool hot-press vulcanization, promptly.
Estradiol 10mg is dissolved in the low molecule silicone oil of 80mg, after accurately taking by weighing in the liner silicone rubber controlled release pipe that 20mg packs into transparent, seal with the medical grade silicone rubber adhesive at two ends, then this pastille internal lining pipe is put into the pessary silicone rubber controlled release pipe of outer field uncured, two ends connect into annular, put into the grinding tool hot-press vulcanization, promptly.
Be after the preparation method of 0112626.9 medicine applying system in cavity or duct is made the medicated core rod at application number with pure levonorgestrel by the inventor, intercepted length is 1.0cm, weight be in the medicated core of 20mg packs liner silicone rubber controlled release pipe into transparent after, seal with the medical grade silicone rubber adhesive at two ends, exert pressure again, the solid medicated core is pulverized the powdered medicine that makes to be uniformly dispersed at the internal lining pipe intracavity, then estradiol 10mg is dissolved in the low molecule silicone oil of 40mg, after accurately taking by weighing in the liner silicone rubber controlled release pipe that 25mg packs into transparent, seal with the medical grade silicone rubber adhesive at two ends, then two pastille internal lining pipes are put into the pessary silicone rubber controlled release pipe of outer field uncured respectively, two ends connect into annular, put into the grinding tool hot-press vulcanization, get final product.
Claims (2)
1. the long-acting vagina administration apparatus of an accurate controlled release drug is characterized in that the double-deck chamber controlled-release device that this device is made up of the liner silicone rubber controlled release pipe and the outer silicone rubber controlled release pipe of the sealing of drug-containing core; Wherein said medicated core is that the solid dispersion that contains medicine, liquid state disperse thing, powder or grease, and liner rubber controlled release pipe is one or several, adds the medicated core that contains the different activities composition in each liner controlled release pipe respectively.
2. the preparation method of a long-acting vagina administration apparatus as claimed in claim 1, its feature comprises the following steps: in the preparation of this device
(1) with the water of medicine and adjuvant, moistening amount mix homogeneously in certain proportion, in mould, is pressed into the uniform solid medicated core of character;
(2) according to the amount of required medicine, after in the controlled release pipe of the silicone rubber liner that the medicated core of intercepting certain-length is packed into transparent or semitransparent, seal with the medical grade silicone rubber adhesive at the two ends of internal lining pipe and then exert pressure, make medicated core be milled into uniform powder fully;
(3) internal lining pipe is packed in the outer silicone rubber controlled release pipe of pessary, the two ends butt joint circularizes, and puts into mould and carries out the hot-press vulcanization molding, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031168922A CN100418594C (en) | 2003-05-14 | 2003-05-14 | Long-acting vagina administrator with precise control of medicine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031168922A CN100418594C (en) | 2003-05-14 | 2003-05-14 | Long-acting vagina administrator with precise control of medicine |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1548176A CN1548176A (en) | 2004-11-24 |
| CN100418594C true CN100418594C (en) | 2008-09-17 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB031168922A Expired - Fee Related CN100418594C (en) | 2003-05-14 | 2003-05-14 | Long-acting vagina administrator with precise control of medicine |
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| Country | Link |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105983173A (en) * | 2015-02-10 | 2016-10-05 | 刘雯倩 | Drug controlled-release equipment |
| CN113941036B (en) * | 2019-12-31 | 2022-11-15 | 浦易(上海)生物技术股份有限公司 | Air flue support |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1366796A (en) * | 1971-12-09 | 1974-09-11 | Upjohn Co | Medicated devices |
| US3993072A (en) * | 1974-08-28 | 1976-11-23 | Alza Corporation | Microporous drug delivery device |
| CN2416900Y (en) * | 2000-04-29 | 2001-01-31 | 上海第二医科大学附属瑞金医院 | Local applying medicine slow-released device for treating gynecopathy |
| CN1397271A (en) * | 2001-07-18 | 2003-02-19 | 上海市计划生育科学研究所 | Process for preparing medicine applying system in cavity or duct |
| CN1403172A (en) * | 2001-09-07 | 2003-03-19 | 上海市计划生育科学研究所 | Medicine release controller for treating women's climacteric syndrome |
-
2003
- 2003-05-14 CN CNB031168922A patent/CN100418594C/en not_active Expired - Fee Related
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1366796A (en) * | 1971-12-09 | 1974-09-11 | Upjohn Co | Medicated devices |
| US3993072A (en) * | 1974-08-28 | 1976-11-23 | Alza Corporation | Microporous drug delivery device |
| CN2416900Y (en) * | 2000-04-29 | 2001-01-31 | 上海第二医科大学附属瑞金医院 | Local applying medicine slow-released device for treating gynecopathy |
| CN1397271A (en) * | 2001-07-18 | 2003-02-19 | 上海市计划生育科学研究所 | Process for preparing medicine applying system in cavity or duct |
| CN1403172A (en) * | 2001-09-07 | 2003-03-19 | 上海市计划生育科学研究所 | Medicine release controller for treating women's climacteric syndrome |
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| Publication number | Publication date |
|---|---|
| CN1548176A (en) | 2004-11-24 |
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Granted publication date: 20080917 |