CN1242819C - Novel pessary and method for preparing same - Google Patents
Novel pessary and method for preparing same Download PDFInfo
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- CN1242819C CN1242819C CN 02111977 CN02111977A CN1242819C CN 1242819 C CN1242819 C CN 1242819C CN 02111977 CN02111977 CN 02111977 CN 02111977 A CN02111977 A CN 02111977A CN 1242819 C CN1242819 C CN 1242819C
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- pessary
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Abstract
The present invention relates to a novel vaginal ring and a preparation method thereof. The vaginal ring disclosed by the present invention has the following structure: the center of the vaginal ring is provided with a hollow silicon rubber inner lining pipe, surfactant is poured in the pipe cavity, a thin layer containing medicine is coated outside the pipe wall, and a silicon rubber layer is coated outside the thin layer containing medicine. The surfactant is separated from the medicine by the present invention, the medicine is continuously and uniformly released by continuously releasing the surfactant, so that the surface of the vaginal ring is more smooth, the intensity is increased, and the medicine is released constantly and uniformly.
Description
Technical field:
The present invention relates to medical instruments field, be specifically related to a kind of novel pessary and preparation method.
Background technology:
The inventor number has been to disclose a kind of silicone rubber pessary that includes medicine in 01112712.0 in Chinese patent application.This pessary provides a kind of lasting, constant, high dose zero-order release system, its Chinese medicine is selected from a kind of or at least a in mifepristone, danazol, Progesterone, the selective estrogen antagonist, as Reynolds former times phenol (Raloxifene), tamoxifen (Tamoxifene), NSC-70735 (Nafoxidine) etc.This pessary can be used for preparing the medicine for the treatment of hysteromyoma, endometriosis and other gynecological's relevant disease, also can be used for preparing the medicine of contraception, and has shown the good effect of answering.
Summary of the invention:
Technical problem to be solved by this invention is further to improve on the basis of first to file 01112712.0, provides the clean degree of a kind of smooth surface better, is more suitable for built-in pessary.
Pessary disclosed by the invention has following structure: have the silicone rubber internal lining pipe of a hollow at the center of pessary, be marked with surfactant in the tube chamber, be covered with the pastille thin layer at the tube wall skin, pastille thin layer outside has coated one deck silastic-layer.Wherein said pastille thin layer is that 5-60% medicine and 0.1-20% dispersant and 20-90% silicone rubber are formed by percentage by weight.
The described silastic-layer thickness that is coated on outside the pastille thin layer is 0.02-1mm.
Medicine of the present invention is selected from a kind of or at least a in mifepristone, Ao Nuosi ketone (ZK98299), lilopristone (ZK98734), danazol, Progesterone, the selective estrogen antagonist and other medicines.Described selective antagonist is selected from Reynolds former times phenol (Raloxifene), tamoxifen (Tamoxifene), NSC-70735 (Nafoxidine), the true azoles of Lay (Anastrozole), aminoglutethimide (Cyladren), chrysin (Chrysin).Described other drug is selected from nitrofural, ciprofloxacin, breath difficult to understand Xining (oxybutynin), hydrochloric acid benzyl oxyephedrine, nemestran, hydrochloric acid Buphenini Hydrochloride, clindamycin, vancomycin, ofloxacin, indometacin, naproxen, ibuprofen etc.
Surfactant of the present invention preferably is selected from span 20-80 for the physiology goes up acceptable surfactant, brejs (Brij) 52-76, alkylphenol polyoxyethylene (OP) emulsifying agent, Polyethylene Glycol (PEG) 400-20000, PVP (polyvidone), pluronic-124 (molecular weight 2090-2360), pluronic-188 (molecular weight 7680-9510), sodium lauryl sulphate, the myristyl sodium sulfonate, one or more surfactant mixtures in dodecyl sodium sulfate and the triethanolamine.
Dispersant of the present invention is gone up the mixture that acceptable dispersant is selected from one or more dispersants in glycerol, propylene glycol, PEG400-20000, succinic acid, cholic acid, deoxycholic acid, hexadecanol, octadecanol, β type cyclodextrin (molecular weight 1134), γ type cyclodextrin (molecular weight 1084-2015), PVP, HPMC (hydroxypropyl emthylcellulose), methylcellulose, ethyl cellulose, hydroxypropyl cellulose and the silicone rubber for the physiology.When one of surfactant is PEG class or pluronic time-like, selected dispersant then is the material that is different from surfactant.
Silicone rubber of the present invention can be HTV (high temperature vulcanized or heat cure, molecular weight 30-100 ten thousand), RTV-2 (double component room temperature vulcanization, molecular weight 0.74-11 ten thousand), RTV-1 is (single-component room temperature vulcanized, molecular weight 0.74-11 ten thousand) or LTV (baking, molecular weight 400-20000), Dow corning silastic-382 medical grade silicone rubber, Dow corning Q7 medical grade silicone series and Dow corning implant level MDX series or corresponding medical grade silicon rubber.
The silastic-layer that is coated on the pastille part is selected from HTV (high temperature vulcanized or heat cure, molecular weight 30-100 ten thousand), RTV-2 (double component room temperature vulcanization, molecular weight 0.74-11 ten thousand), RTV-1 is (single-component room temperature vulcanized, molecular weight 0.74-11 ten thousand) or LTV (baking, molecular weight 400-20000), Dow corning silastic-382 medical grade silicone rubber, Dow corning Q7 medical grade silicone series and Dow corning implant level MDX series or corresponding medical grade silicon rubber.
Another technical problem to be solved by this invention is the preparation method that discloses above-mentioned pessary.
The preparation method of pessary disclosed by the invention comprises the following steps:
1, with behind the described silicone rubber mechanically milling, is pressed into the internal lining pipe of required size;
2, surfactant is poured into the tube cavity of internal lining pipe;
3, medicine is added the dispersant mixing and add the thin skin that mixing silicon rubber forms medicated layer afterwards and is pressed into 0.3～3mm;
4, the pastille thin skin being coated on inner chamber contains on the internal lining pipe of surfactant and hot briquetting;
5, on the product that step 4 obtains, coat the medical grade silicon rubber of one deck 0.02-1mm again.
The inventor's disclosed pessary structure in former first to file 01112712.0 is medicine, dispersant and mixes with surfactant and be in together in the pastille part, because the existence of surfactant is affected the pessary surface smoothness, easily produce sense of discomfort during use.The present invention separates surfactant with drug moiety, the continuous release by surfactant continues medicine, discharge equably, can make the surface of pessary more smooth., do not mix in one simultaneously with medicine because surfactant is placed separately in the in type silicone rubber tube, thus often occur former technology can not occur using the time influence its mechanical strength inadequately because of vulcanizing, and be easy to defective such as cracking.In former technology,, influence the silicon rubber vulcanization polymerization, and when the mold heated molding, very easily melt, overflow mould because of the surfactant moisture absorption very easily, its fusing and the frequent heterogeneity of quantity of overflowing, thus influence the final release quantity of pessary.Therefore use the production in enormous quantities that former technology can't realize the quality homogeneous.Pessary of the present invention had both reached the purpose of a large amount of, constant release medicine, made the processing technology easy operating again, guaranteed the quality of item stable uniform.
Pessary of the present invention also can be applicable to discharge the not enough medicine of drug solubility of milligram level or above quantity, as: indometacin, naproxen, ibuprofen etc.
Description of drawings:
Fig. 1 is the pessary cross sectional representation
Wherein 1 is surfactant, and 2 is the silicone rubber internal lining pipe, and 3 is the pastille thin layer, 4 silastic-layers for coating.
The specific embodiment:
Embodiment one,
1, take by weighing the 2g danazol and add the succinic acid propylene glycol and do dispersant, after be pressed into thin skin (1) after adding mixing silicon rubber;
2, taking by weighing certain amount of H TV medical grade silicon rubber (molecular weight 30-100 ten thousand, the Shandong medical device research is produced) extrusion molding is diameter 4mm tubing, intercepts long 13.8cm, and the centre adds span 20 and Brij, is (2).(1) is wrapped on (2), wraps up the HTV medical grade silicon rubber thin skin of one deck 0.02mm again, compression molding.
Embodiment two,
1, takes by weighing the 0.5g mifepristone and add and add HTV silicone rubber after glycerol disperses, be pressed into thin skin (1) behind the mixing;
2, the diameter that obtains by extrusion molding is to pour into pluronic (molecular weight 2090) 0.2g in the medical grade silicon rubber internal lining pipe of RTV-1 (molecular weight 0.74-11 ten thousand, Shandong medical device research institute) of 4mm, (2);
3, (1) is coated on (2), again the RTV-1 medical grade silicon rubber is pressed into the thin skin of the former degree of 0.02mm, outside being coated on, the hot-press vulcanization molding.
Claims (7)
1, a kind of novel pessary, it is characterized in that described pessary has following structure: the silicone rubber internal lining pipe that has a hollow at the center of pessary, be marked with surfactant in the tube chamber, be covered with the pastille thin layer at the tube wall skin, pastille thin layer outside has coated one deck silastic-layer.
2, a kind of pessary as claimed in claim 1 is characterized in that wherein said pastille thin layer is that 5-60% medicine and 0.1-20% dispersant and 20-90% silicone rubber are formed by percentage by weight.
3, a kind of pessary as claimed in claim 1 is characterized in that the wherein said silastic-layer thickness that is coated on outside the pastille thin layer is 0.02-1mm.
4, a kind of pessary as claimed in claim 1 or 2 is characterized in that wherein said medicine is selected from a kind of or at least a in mifepristone, Ao Nuosi ketone, lilopristone, danazol, Progesterone, the selective estrogen antagonist and other medicines; Described selective antagonist is selected from Reynolds former times phenol, tamoxifen, NSC-70735, the true azoles of Lay, aminoglutethimide, chrysin; Described other drug is selected from nitrofural, ciprofloxacin, breath difficult to understand Xining, hydrochloric acid benzyl oxyephedrine, nemestran, hydrochloric acid Buphenini Hydrochloride, clindamycin, vancomycin, ofloxacin, indometacin, naproxen, ibuprofen etc.;
Described surfactant is selected from one or more surfactant mixtures in span 20-80, brejs 52-76, alkylphenol polyoxyethylene emulsifying agent, PEG400-20000, polyvidone, pluronic-124, pluronic-188, sodium lauryl sulphate, myristyl sodium sulfonate, dodecyl sodium sulfate and the triethanolamine for the physiology goes up acceptable surfactant;
Described dispersant is gone up the mixture that acceptable dispersant is selected from one or more dispersants in glycerol, propylene glycol, PEG400-20000, succinic acid, cholic acid, deoxycholic acid, hexadecanol, octadecanol, β type cyclodextrin, γ type cyclodextrin, polyvidone, hydroxypropyl emthylcellulose, methylcellulose, ethyl cellulose, hydroxypropyl cellulose and the silicone rubber for the physiology; When one of surfactant is polyethylene glycols or pluronic time-like, selected dispersant then is the material that is different from surfactant.
5, a kind of pessary as claimed in claim 1 or 2 is characterized in that wherein said silicone rubber is that high-temperature silicon disulfide rubber HTV, double component room temperature vulcanization silicon rubber RTV-2, single-component room temperature vulcanized silicone rubber RTV-1, baking silicone rubber LTV, 382 Dow corning medical grade silicone rubber, Dow corning Q7 medical grade silicone series or Dow corning are implanted level MDX series medical grade silicon rubber.
6, a kind of pessary as claimed in claim 1 or 2 is characterized in that the wherein said silastic-layer that is coated on the pastille part is selected from high-temperature silicon disulfide rubber HTV, double component room temperature vulcanization silicon rubber RTV-2, single-component room temperature vulcanized silicone rubber RTV-1, baking silicone rubber LTV, Dow corning 382 medical grade silicone rubber, Dow corning Q7 medical grade silicone series or Dow corning and implants level MDX series medical grade silicon rubber.
7, a kind of preparation method of pessary as claimed in claim 1 is characterized in that the preparation method of this pessary comprises the following steps:
(1) with behind the described silicone rubber mechanically milling, is pressed into the internal lining pipe of required size;
(2) surfactant is poured into the tube cavity of internal lining pipe;
(3) medicine is added the dispersant mixing and add the thin skin that mixing silicon rubber forms medicated layer afterwards and is pressed into 0.3～3mm;
(4) the pastille thin skin being coated on inner chamber contains on the internal lining pipe of surfactant and hot briquetting;
(5) on the product that step (4) obtains, coat the medical grade silicon rubber of one deck 0.02-1mm again.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02111977 CN1242819C (en) | 2002-06-07 | 2002-06-07 | Novel pessary and method for preparing same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02111977 CN1242819C (en) | 2002-06-07 | 2002-06-07 | Novel pessary and method for preparing same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1463762A CN1463762A (en) | 2003-12-31 |
| CN1242819C true CN1242819C (en) | 2006-02-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 02111977 Expired - Lifetime CN1242819C (en) | 2002-06-07 | 2002-06-07 | Novel pessary and method for preparing same |
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| Country | Link |
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| CN (1) | CN1242819C (en) |
Families Citing this family (7)
| 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 |
| CN103099703A (en) * | 2013-03-06 | 2013-05-15 | 史凤阳 | Medicated composite silicon rubber assembly for intrauterine device |
| CN104546668B (en) * | 2013-10-23 | 2019-03-05 | 国家卫生计生委科学技术研究所 | Liquid silastic is the preparation and application of the medicine sustained and controlled release system of carrier |
| US10413504B2 (en) * | 2013-12-11 | 2019-09-17 | Merck Sharp & Dohme Corp. | Intravaginal ring drug delivery system |
| CN114073792A (en) * | 2020-08-11 | 2022-02-22 | 上海市生物医药技术研究院 | Vaginal ring containing letrozole, preparation method and application thereof |
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2002
- 2002-06-07 CN CN 02111977 patent/CN1242819C/en not_active Expired - Lifetime
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| Publication number | Publication date |
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| CN1463762A (en) | 2003-12-31 |
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