CN1218686C - Process for preparing medicine applying system in cavity or duct - Google Patents
Process for preparing medicine applying system in cavity or duct Download PDFInfo
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- CN1218686C CN1218686C CN 01126269 CN01126269A CN1218686C CN 1218686 C CN1218686 C CN 1218686C CN 01126269 CN01126269 CN 01126269 CN 01126269 A CN01126269 A CN 01126269A CN 1218686 C CN1218686 C CN 1218686C
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- medicine
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- medicated core
- silicone rubber
- pessary
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Abstract
The present invention provides a process for preparing medicine applying systems in cavities or ducts, which comprises: medicine, auxiliary material and a moist amount of water are uniformly mixed according to a certain proportion and are pressed into a solid medicine core with uniform properties in a mould; a certain length of medicine core is cut according to the needed medicine amount of an administration system in a cavity and a duct; after the cut medicine core is placed in an inner tube, pressure is applied; the solid medicine core is pulverized into powder. The method has the advantages of simple filling and accurate filling quantity and reduces or avoids the blasting release of the medicine in a slow release system.
Description
Technical field
The present invention relates to a kind of preparation method of medicine applying system in cavity or duct, particularly the preparation method of pessary and IUD (intrauterine device) drug-supplying system.
Background technology
At present, the pessary that has come into the market both at home and abroad or studied is put into the medicated core of solid-state version usually in the interior pipe of preparation, be that the mixing agglutination thing of medicine and high polymer adjuvant obtains medicated core, the solid medicated core is integrally put into pipe then, has promptly made standby pessary.The release that this technology can make the limited medicine in the solid medicated core integral body be difficult to keep secular equilibrium, and the medicine in the bank is difficult to make full use of, and the principal agent loss is big, and technology is relatively complicated.In order to overcome these weak points, the technology that also has is to put into powdered drug in the pipe in adopting, but because medication amount is few, accurate computed losses amount during fill, and the while has also influenced the quality of medicine.
The hope always for a long time of present technique field has a kind of preparation technology of medicine applying system in cavity or duct of novelty, its solid-state medicated core that accurate dosage is arranged is entered in the preparation tube chamber, after making product, can be converted into evenly trickle Powdered, help forming long-term, equilibrated delivery system, and can reach the release of maximum with minimum explosive payload.
Summary of the invention
An object of the present invention is to provide the preparation method that a kind of explosive payload is accurate, can evenly discharge the medicine applying system in cavity or duct of medicine.
Purpose of the present invention realizes by such design: a kind of preparation method of medicine applying system in cavity or duct, comprise the water mix homogeneously in certain proportion that makes medicine and adjuvant, moistening amount, and in mould, be pressed into the uniform solid medicated core of character; According to medicine applying system in cavity or duct, as pessary or intrauterine device, the medicated core of required medication amount intercepting certain-length; Behind the pipe, sealing was exerted pressure then in the medicated core of intercepting packed into, and the solid medicated core is ground into Powdered.
Description of drawings
Fig. 1 is a Gestodene pessary release profiles.
Fig. 2 is a megestrol pessary release profiles.
Specific implementation method
Medicine described in the inventive method is selected from other classification medicine of steroid hormone or suitable pessary or intrauterine device 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 described in the inventive method 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 ratio of its Chinese medicine and adjuvant can relate to according to required drug release rate, and this can decide by being familiar with those skilled in the technology concerned, and preferred weight ratio is 1: 0.1-1: 10.
The cross section that is shaped as of the medicated core that makes is cylinder body shapes such as circle, ellipse, rectangle, square, triangle, polygon.Preferably each cross section along cylinder all is identical.
According to the weight ratio of medicine and adjuvant, can obtain the medication amount in the unit length, therefore, can put in the pipe of pessary or IUD according to the medicated core of the required medication amount intercepting certain-length of pessary or IUD.
Pessary or intrauterine device after the sealing powder charge are exerted pressure, and institute's applied pressure can be with receiving a pressure gently, makes solid be ground into powder and gets final product.Preferably apply about 0.5kg-2kgf/cm
2Pressure.
The medicine applying system in cavity or duct of the present invention's preparation has following characteristics:
Medicine in such as the drug-supplying system of pessary or intrauterine device, distribute tiny evenly, therefore reduce or avoided main explosion in slow release medicine system to discharge.
2. make the powder powder charge thing and the adjuvant of loose type, be crushed to solid-state medicated core, after the tract of putting into preparation becomes goods, can recover former loose sprills through light pressure by mould.
3. Load is accurate, and fill operations is easy, is convenient to suitability for industrialized production.
4. the burst size of medicine changes with medicine and adjuvant ratio, so can easily control the burst size of medicine.
Below in conjunction with accompanying drawing and specific implementation method of the present invention the present invention is done further detailed elaboration.
Embodiment 1
Take by weighing 1 gram Gestodene, 8 gram SiO
2, 3 gram starch, 0.5 gram dimethicone and 4 gram distilled water, put into 2mm shape of the mouth as one speaks mould and be squeezed into the long medicated core of diameter 2.5mm, 100mm, every centimeter medicated core contains 10 milligrams of medicines.Intercept 2 centimeters long medicated core, the pessary of packing into one is pressed gently with receiving, and promptly obtains pessary of the present invention.
Embodiment 2
Take by weighing 1 gram megestrol, 8 gram hydroxypropyl emthylcelluloses, 3 gram SiO
2, 0.5 gram polydimethylsiloxane and 4.7 gram distilled water, put into 2mm shape of the mouth as one speaks mould and be squeezed into the long medicated core of diameter 2.5mm, 100mm, every centimeter medicated core contains 10 milligrams of medicines.Intercept 2 centimeters long medicated core, the pessary of packing into one is pressed gently with receiving, and promptly obtains pessary of the present invention.
Embodiment 3
Take by weighing 0.5 gram estrogen, 0.5 gram progestogen, 4 gram cyclodextrin, 5 gram SiO
2, 4 ml distilled waters, 0.7 gram silicone rubber, put into 1.5mm shape of the mouth as one speaks mould and be squeezed into the long medicated core of diameter 2.0mm, 100mm, every centimeter medicated core contains 5 milligrams of medicines.Intercept 2 centimeters long medicated core, the intrauterine device of packing into applies 2kgf/cm to IUD
2Pressure, promptly obtain required intrauterine device.
Release test:
Test 1.Gestodene pessary release test:
Instrument: 1.HPLC island Tianjin LC-10AT
2. constant temperature water bath shaker H28-H
1. get one of nylon filament with the pessary hanging of tested embodiment 1 preparation in 125 milliliters white wide mouthed bottle, place 50 ml distilled water media, design temperature is 37 ℃, oscillation rate is 60 times/minute, continuous oscillation 24 hours.
2. standard substance Gestodene (pregnendione) is provided by Shanghai family planning institute medicament chamber.
3. with C-18-250mm analytical pure (Tianjin, island)
Setting the HPLC testing conditions is: wavelength 240nm, and sensitivity 0.1AUFS, speed 3, Atten3
Standard substance: 2.1 mcg/ml, sample introduction 25 microlitres, AREA 189298
Obtain the release profiles of Gestodene pessary shown in Figure 1 after the test.
Test 2 megestrol pessary release tests:
Instrument: Tianjin, 1.UV2401 island
2. constant temperature water bath shaker H28-H
1. get one of nylon filament with the pessary hanging of tested embodiment 2 preparations in 125 milliliters white wide mouthed bottle, place 50 ml distilled water media, design temperature is 37 ℃, oscillation rate is 60 times/minute, continuous oscillation 24 hours.
2. the standard substance megestrol is provided by Shanghai family planning institute medicament chamber.
3. set UV wavelength 297nm, E1%=630
Standard substance: 3.5 microlitre/milliliters
Obtain the release profiles of megestrol pessary shown in Figure 2 after the test.
Claims (8)
1. the preparation method of pessary or intrauterine device, it comprises the water mix homogeneously in certain proportion that makes medicine and adjuvant, moistening amount, is pressed into the uniform solid medicated core of character in mould; Medicated core according to the required medication amount intercepting certain-length of pessary or intrauterine device; Behind the pipe, sealing was exerted pressure then in the medicated core of intercepting packed into, and the solid medicated core is ground into Powdered.
2. according to the described method of claim 1, wherein said medicine is selected from steroid hormone or estrogens, progestogens and androgens, or their combination.
3. it is that Polyethylene Glycol, paraffin oil, vaseline, the molecular weight of 400-20000 is cyclodextrin, silicone rubber kinds, stearic acid, glyceryl monostearate, the dimethicone of γ type cyclodextrin of ethylmethylcellulose, ethyl cellulose, Pulvis Talci, microcrystalline Cellulose, starch, silicon dioxide, dextrin, barium sulfate, aluminium-magnesium silicate, hydroxypropyl emthylcellulose, the β type cyclodextrin that is selected from molecular weight 1134 and the molecular weight 1084-2015 of 30000-40000 that method according to claim 1, wherein said adjuvant are selected from glycerol, cocoa butter, molecular weight.
4. method according to claim 3, wherein said silicone rubber kinds is selected from the two-component room-temperature-vulcanized silicone rubber that molecular weight is 0.74-11 ten thousand, molecular weight is the single-component room-temperature vulcanized silicone rubber of 0.74-11 ten thousand, and molecular weight is addition vulcanization or the cryogenic vulcanization silicone rubber of 100-200000.
5. method according to claim 1, the weight ratio of its Chinese medicine and adjuvant is 1: 0.1-1: 10.
6. method according to claim 1, wherein the cross section of prepared medicated core is circle, ellipse, rectangle, square, triangle, polygon cylinder body shape.
8. method according to claim 7, wherein each cross section along cylinder all is identical.
9. method according to claim 8 is 0.5kg-2kgf/cm to drug delivery system institute applied pressure after the sealing powder charge
2
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01126269 CN1218686C (en) | 2001-07-18 | 2001-07-18 | Process for preparing medicine applying system in cavity or duct |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01126269 CN1218686C (en) | 2001-07-18 | 2001-07-18 | Process for preparing medicine applying system in cavity or duct |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1397271A CN1397271A (en) | 2003-02-19 |
| CN1218686C true CN1218686C (en) | 2005-09-14 |
Family
ID=4666291
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 01126269 Expired - Lifetime CN1218686C (en) | 2001-07-18 | 2001-07-18 | Process for preparing medicine applying system in cavity or duct |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1218686C (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100418594C (en) * | 2003-05-14 | 2008-09-17 | 上海市计划生育科学研究所 | Long-acting vagina administrator with precise control of medicine |
| CN103566462A (en) * | 2013-11-20 | 2014-02-12 | 上海达华药业有限公司 | Composite vagina dosing device, manufacturing method and application thereof |
| CN103585712A (en) * | 2013-11-26 | 2014-02-19 | 上海市计划生育科学研究所 | Pessulum containing hydrophilic lipophilic carrier |
| KR20240063996A (en) * | 2018-04-19 | 2024-05-10 | 이푸룬 (상하이) 바이오테크놀러지 컴퍼니 리미티드 | Elastic membrane having function of reactivating endometrium basal layer in uterine cavity and preparation method for elastic membrane |
-
2001
- 2001-07-18 CN CN 01126269 patent/CN1218686C/en not_active Expired - Lifetime
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| Publication number | Publication date |
|---|---|
| CN1397271A (en) | 2003-02-19 |
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