CN1397271A - 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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- CN1397271A CN1397271A CN 01126269 CN01126269A CN1397271A CN 1397271 A CN1397271 A CN 1397271A CN 01126269 CN01126269 CN 01126269 CN 01126269 A CN01126269 A CN 01126269A CN 1397271 A CN1397271 A CN 1397271A
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Abstract
A medicine applying system for cavity and duct is prepared through proportionally mixing medicine with additive and water, die pressing to obtain solid core, cutting short, loading in internal tube and compressing to pulverize it. Its advantages are simple process and high quantitative accuracy.
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 IUD, the medicated core of required medication amount intercepting certain-length; Behind the pipe, exert pressure in the medicated core of intercepting packed into, 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 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 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 IUD after the sealing powder charge exert 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 IUD, 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 IUD that packs into applies 2kgf/cm to IUD
2Pressure, promptly obtain required IUD.
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, and Atten 3
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 (9)
1. the preparation method of a medicine applying system in cavity or duct, 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; According to medicine applying system in cavity or duct, the medicated core of required medication amount intercepting certain-length; Behind the pipe, exert pressure in the medicated core of intercepting packed into, the solid medicated core is ground into Powdered.
2. method according to claim 1, wherein said medicine applying system in cavity or duct is a pessary.
3. according to the described method of claim 1, wherein said medicine applying system in cavity or duct is IUD.
4. according to the described method of claim 1, wherein said medicine is selected from steroid hormone or estrogens, progestogens and androgens, or their combination.
5. according to the described method of claim 1, wherein said adjuvant 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.
6. method according to claim 1, the weight ratio of its Chinese medicine and adjuvant is 1: 0.1-1: 10.
7. method according to claim 1, wherein the cross section that is shaped as of prepared medicated core is cylinder body shapes such as circle, ellipse, rectangle, square, triangle, polygon.
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 true CN1397271A (en) | 2003-02-19 |
| CN1218686C CN1218686C (en) | 2005-09-14 |
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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 |
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| Country | Link |
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| CN (1) | CN1218686C (en) |
Cited By (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 |
| CN109925539A (en) * | 2018-04-19 | 2019-06-25 | 易浦润（上海）生物技术有限公司 | A kind of elastic membrane, preparation method and application |
-
2001
- 2001-07-18 CN CN 01126269 patent/CN1218686C/en not_active Expired - Lifetime
Cited By (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 |
| CN109925539A (en) * | 2018-04-19 | 2019-06-25 | 易浦润（上海）生物技术有限公司 | A kind of elastic membrane, preparation method and application |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1218686C (en) | 2005-09-14 |
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