CN109248139A - The preparation method and application of Levonorgestrel Compourd pesseulum - Google Patents
The preparation method and application of Levonorgestrel Compourd pesseulum Download PDFInfo
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- CN109248139A CN109248139A CN201710573614.2A CN201710573614A CN109248139A CN 109248139 A CN109248139 A CN 109248139A CN 201710573614 A CN201710573614 A CN 201710573614A CN 109248139 A CN109248139 A CN 109248139A
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- pesseulum
- medicine core
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
- A61K9/0036—Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- General Health & Medical Sciences (AREA)
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- Gynecology & Obstetrics (AREA)
- Urology & Nephrology (AREA)
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- Inorganic Chemistry (AREA)
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Abstract
The invention belongs to art of pharmacy, and in particular to a kind of preparation and its application of Levonorgestrel Compourd pesseulum.The pesseulum is block type structure, is made of the release-controlled film of one or more snippets medicine core of internal layer and outer layer, wherein being separated among the medicine core of adjacent two sections of drug containings by the blank medicine core of not drug containing containing at most a kind of drug in Levonorgestrel and ethinyloestradiol in each section of medicine core.The invention of the pesseulum solves shortcoming present in the existing administration mode of Levonorgestrel, while the structure of block type makes two kinds of drug influencing each other during release of progestational hormone and estrogen be substantially reduced the Zero order release, it can be achieved that two kinds of drugs.
Description
Technical field:
The invention belongs to art of pharmacy, are related to a kind of preparation of Levonorgestrel Compourd pesseulum.
Background technique:
Annual about 75,000,000 behavior of unwanted pregnant occur in global range, are terminated wherein there are about 45,000,000 people by miscarriage
Gestation, from the point of view of China, annual induced abortion 13,000,000 or more, wherein the stream of people accounts for 50% repeatedly.The multiple stream of people may lead
A series of gynecological disease is played, such as: chronic pelvic inflammatory disease, menoxenia, endometriosis, tubal occlusion, uterine neck are viscous
Even etc., serious person may result in infertile.Therefore it from the perspective of healthy reproduction, avoids conception and control birth to the body to shield women
Heart health is very important.On the other hand, it brings the growth of population under control, realizes that sustainable development is China or even worldwide
Important development target, therefore the fertility that need to be realized a plan by the technology of avoiding conception and controling birth, and then population controlling scale.In conclusion from
From the point of view of two aspects of healthy reproduction and family planning, need to develop the personalized and practical New Products & New Technology that avoids conception and control birth, it is full
Sufficient different crowd, different levels contraception medication individual demand.
Levonorgestrel (Levonorgestrel, LNG) is one of widest progestational hormone of current domestic and international application, is had
Powerful progestin and apparent antiestrogenic, clinical application safety.It mainly acts on hypothalamus and hypophysis, can
Increase cervical mucus consistency, prevents Sperm penetration, and make atrophy of endometrium, be unfavorable for implantation of ovum, to play contraception
Effect.What is listed at present is rich and varied with LNG contraceptive product as main component, including tablet, implants, transdermal patch, palace
The product of the various administration modes such as interior contraceptive.
Levonorgestrel preparation is divided into single preparations of ephedrine and compound preparation.Existing patented technology mainly in single preparations of ephedrine it is main
Dosage form has Pab B, dripping pill, intrauterine device etc..
Wherein Chinese patent CN201110120212.X discloses the preparation side that a kind of ultra micro crushes levonorgestrel altogether
Method discloses a kind of Levonorgestrel drop pills and preparation method thereof, Chinese patent in Chinese patent CN200810016477.3
A kind of pharmaceutical composition containing Levonorgestrel of micronization, Chinese patent are disclosed in CN200910157979.2
CN201510583952.5 discloses a kind of preparation method of levonorgestrel.Pay attention to preparation in above-mentioned patented technology with LNG
Single preparations of ephedrine as main component, dosage form are peroral dosage form, although and oral preparation in use have it is easy to use
Etc. advantages, but it has certain side reaction, such as nausea, vomiting etc., and will lead to contraceptive failure if missed.
Chinese patent CN201020624109.X discloses a kind of Levonorgestrel uterine cavity shape intrauterine device, and advantage is
Contraceptive bracket has selected the closed annular structure of titanium alloy wire bracket, and intrinsic shape can be kept in uterine cavity, is unlikely to deform, together
When closed hoop structure have good occupation time process, contraceptive effect is good, and will not cause the generation of the perforation of uterus.The patent
The intrauterine device prepared in technology needs health care professional to operate in use, and user of service cannot arbitrarily take
It puts, so that it is poor using compliance.
Chinese patent CN98808863.0 discloses a kind of physics for long-time transdermal release Levonorgestrel and change
Learn the stable transdermal therapeutic system of performance.The system has good fixed characteristic, is free of any solvent, does not need to active matter
Matter anti-corrosion, physical and chemical performance are stablized, and have good fixed characteristic when display is administered for a long time.
What the technology that above-mentioned several patents are included was prepared is the single preparations of ephedrine of LNG, root according to relevant report, the list of LNG
Square preparation may cause irregular bleeding in use, and cooperate with estrogen, and preparing compound preparation can be very good
Improve the situation, it is therefore desirable to prepare the new technology of compound preparation.
Chinese patent CN201410838841.X discloses a kind of preparation method of ethinyl estradiol levonorgestrel piece, the patent
Middle preparation is the oral tablet of Levonorgestrel Compourd, as previously mentioned, oral preparation has certain limitation, user's meeting
Because missing or vomitting side effect leads to contraceptive failure, the contraceptive effect of oral preparation is affected.It is new therefore, it is necessary to develop
Dosage form.
Pesseulum is the ring-type drug delivery device made of silicone elastomer or thermoplastic material, by drug loading in no work
Property carrier in, for drug by diffusion, Via vagina mucosa absorption enters blood circulation, and first cross of liver sausage can be avoided to imitate well
It answers, improves the bioavilability of drug, and administration mode is simple and easy, do not need special training or professional helps
It voluntarily picks and places, substantially increases the compliance used, while drug slow release from pesseulum, avoid the peak of blood concentration
Paddy variation, reduces the generation of side effect.
A kind of medicine for vaginal ring and its application are disclosed in Chinese patent CN 01112712.0, which is folk prescription yin
Road ring may generate some side effects in use process.A kind of vagina is disclosed in Chinese patent CN 201180021973.8
Interior drug delivery device can load progestational hormone and estrogen in the device simultaneously, but the device is by the two while to mix negative
It is loaded in host material, so that in drug release process, progestational hormone can be generated with estrogen and be influenced each other for this meeting, so that drug
Expection may be not achieved in release.
Compound pesseulum is prepared using new method in the present invention, has both avoided some side effects of single preparations of ephedrine bring,
Also it solves the problems, such as that two kinds of drugs can generate during release to influence each other.
Summary of the invention:
The invention discloses a kind of preparation method and application of block type Levonorgestrel Compourd pesseulum, solve existing
Single preparations of ephedrine is also easy to produce side effect in technology, and two kinds of drugs, which directly mix, to generate interactional problem to release.
The present invention is realized by following design:
Block type pesseulum is mainly constituted by two layers, and internal layer is divided into the medicine core of the drug containing of multistage, wherein in medicine core respectively
Containing progestational hormone or estrogen, separated between every two sections of medicine cores using the bare substrate material of not drug containing；Outer layer is free from medicine
The controlled release membrane material of object.Internal layer multistage medicine core or bare substrate material are wrapped up by outer layer release-controlled film, through high temperature vulcanized
The compound pesseulum of annular is obtained later.Wherein internal layer medicine core and bare substrate material are using liquid or solid silicon rubber as material
It is prepared, it is firm silicone rubber material that outer layer release-controlled film, which uses,.
The overall diameter of the finally obtained compound pesseulum of the present invention is 40~60mm, cross-sectional area diameter is 4.0~
6.0mm。
The specific preparation method of compound pesseulum is as described below in the present invention:
1. the different component of silicon rubber is stirred mixing according to corresponding proportion；
2. different pharmaceutical (progestational hormone or estrogen) is added in silicon rubber according to different proportion, stir and evenly mix；
3. said mixture is injected into corresponding mold using injection moulding, it is high temperature vulcanized at a proper temperature, it obtains
To drug containing medicine core；
4. the firm silicone rubber material each component for being used to prepare release-controlled film is mixed according to corresponding proportion, using opening
Formula rubber mixing machine is kneaded, and obtains having certain thickness rubber sheet；
5. the medicine core containing different pharmaceutical and bare substrate material selection corresponding length are spelled according to different formulation and technologies
It is connected into ring-type, then above-mentioned release-controlled film is wrapped in outside ring, carries out at a proper temperature high temperature vulcanized, obtains compound vagina
Ring.
Detailed description of the invention:
Fig. 1 is the medicine core skeleton structure schematic diagram of Levonorgestrel Compourd pesseulum, and 1 is the medicine containing Levonorgestrel
Core, 2 be the bare substrate material of not drug containing, and 3 be the medicine core containing ethinyloestradiol.
Fig. 2 is the schematic cross-section of Levonorgestrel Compourd pesseulum, and 1 is internal layer medicine core, and 2 be outer layer release-controlled film.
Fig. 3 is the release in vitro result of Levonorgestrel Compourd pesseulum.
Fig. 4 is the cumulative in vitro releasing result and Zero order release models fitting of Levonorgestrel Compourd pesseulum.
Specific embodiment:
Embodiment 1
Liquid silastic MED-6382 matrix 8g, catalyst 0.04g are accurately weighed, mixing 10min is uniformly mixed it, so
After weigh Levonorgestrel 0.2g, be added in silicon rubber, continue stir 10min make its be uniformly mixed, then mixture is infused
Enter in mold, high temperature vulcanized 20min under the conditions of 80 DEG C, obtain the medicine core of load Levonorgestrel, medicine core outer diameter 50mm is cut
Face diameter 4mm.Liquid silastic MED-6382 matrix 8g, catalyst 0.04g are accurately weighed, mixing 10min is uniformly mixed it,
Then ethinyloestradiol 0.048g is weighed, is added in silicon rubber, continuing stirring 10min is uniformly mixed it, then infuses mixture
Enter in mold, high temperature vulcanized 20min under the conditions of 80 DEG C, obtains the medicine core of load ethinyloestradiol, medicine core outer diameter 50mm, section is straight
Diameter 4mm.Firm silicone rubber C6-165A, B each 15g of two components is accurately weighed, in being kneaded 10min on opening rubber mixing machine, then will
Mixing silicon rubber is placed in mold, and the high temperature vulcanized 20min under the conditions of 130 DEG C obtains the bare substrate material of not drug containing,
The blank material outer diameter 50mm, diameter of section 4mm.Firm silicone rubber C6-165A, B each 15g of two components is accurately weighed, in opening
It is kneaded 10min on formula rubber mixing machine, obtains the release-controlled film with a thickness of 0.8mm.Each section is spliced into the domain according to following ratios, so
One layer of release-controlled film is wrapped up in outside afterwards, is placed in high temperature vulcanized 20min at 130 DEG C, obtains block type Levonorgestrel Compourd pesseulum.
Embodiment 2
Liquid silastic MED-6382 matrix 8g, catalyst 0.04g are accurately weighed, mixing 10min is uniformly mixed it, so
After weigh Levonorgestrel 0.2g, be added in silicon rubber, continue stir 10min make its be uniformly mixed, then mixture is infused
Enter in mold, high temperature vulcanized 20min under the conditions of 80 DEG C, obtain the medicine core of load Levonorgestrel, medicine core outer diameter 50mm is cut
Face diameter 4mm.Liquid silastic MED-6382 matrix 8g, catalyst 0.04g are accurately weighed, mixing 10min is uniformly mixed it,
Then ethinyloestradiol 0.048g is weighed, is added in silicon rubber, continuing stirring 10min is uniformly mixed it, then infuses mixture
Enter in mold, high temperature vulcanized 20min under the conditions of 80 DEG C, obtains the medicine core of load ethinyloestradiol, medicine core outer diameter 50mm, section is straight
Diameter 4mm.Firm silicone rubber C6-165A, B each 15g of two components is accurately weighed, in being kneaded 10min on opening rubber mixing machine, then will
Mixing silicon rubber is placed in mold, and the high temperature vulcanized 20min under the conditions of 130 DEG C obtains the bare substrate material of not drug containing,
The blank material outer diameter 50mm, diameter of section 4mm.Firm silicone rubber C6-165A, B each 15g of two components is accurately weighed, in opening
It is kneaded 10min on formula rubber mixing machine, obtains the release-controlled film with a thickness of 0.8mm.It is prepared by the same way with a thickness of 1.5mm's
Release-controlled film.Each section is spliced into the domain according to following ratios, is then loaded outside Levonorgestrel medicine core and blank material part
The release-controlled film that bread is wrapped up in a thickness of 0.8mm, the release-controlled film that Jacket thickness is 1.5mm outside load ethinyloestradiol medicine core part is placed in
High temperature vulcanized 20min at 130 DEG C obtains block type Levonorgestrel Compourd pesseulum.
Embodiment 3
Liquid silastic MED-4950A, B each 4g of two components are accurately weighed, mixing 10min is uniformly mixed it, then claims
Levonorgestrel 0.2g is taken, is added in silicon rubber, continuing stirring 10min is uniformly mixed it, then injects the mixture into mould
In tool, high temperature vulcanized 20min under the conditions of 80 DEG C obtains the medicine core of load Levonorgestrel, and medicine core outer diameter 50mm, section is straight
Diameter 4mm.Liquid silastic MED-4950A, B each 4g of two components are accurately weighed, mixing 10min is uniformly mixed it, then weighs
Ethinyloestradiol 0.048g, is added in silicon rubber, and continuing stirring 10min is uniformly mixed it, then injects the mixture into mold,
High temperature vulcanized 20min under the conditions of 80 DEG C obtains the medicine core of load ethinyloestradiol, the medicine core outer diameter 50mm, diameter of section 4mm.It is quasi-
Firm silicone rubber C6-165A, B each 15g of two components really is weighed, in being kneaded 10min on opening rubber mixing machine, then by mixing
Silicon rubber is placed in mold, and the high temperature vulcanized 20min under the conditions of 130 DEG C obtains the bare substrate material of not drug containing, the blank material
Expect outer diameter 50mm, diameter of section 4mm.Firm silicone rubber C6-165A, B each 15g of two components is accurately weighed, in opening rubber mixing machine
Upper mixing 10min, obtains the release-controlled film with a thickness of 0.8mm.Each section is spliced into the domain according to following ratios, then outer bread
One layer of release-controlled film is wrapped up in, high temperature vulcanized 20min at 130 DEG C is placed in, obtains block type Levonorgestrel Compourd pesseulum.
Embodiment 4
Liquid silastic MED-6382 matrix 8g, catalyst 0.04g are accurately weighed, stirring 10min is uniformly mixed it, so
After weigh Levonorgestrel 0.2g, be added in silicon rubber, continuing to stir 10min is uniformly mixed it, then injects the mixture into
Mold, high temperature vulcanized 20min under the conditions of 80 DEG C obtain the medicine core of load Levonorgestrel, and medicine core outer diameter 50mm, section is straight
Diameter 4mm.Liquid silastic MED-6382 matrix 8g, catalyst 0.04g are accurately weighed, mixing 10min is uniformly mixed it, then
Ethinyloestradiol 0.048g is weighed, is added in silicon rubber, continuing stirring 10min is uniformly mixed it, then injects the mixture into mould
In tool, high temperature vulcanized 20min under the conditions of 80 DEG C obtains the medicine core of load ethinyloestradiol, medicine core outer diameter 50mm, diameter of section
4mm.Then accurately weighing firm silicone rubber C6-165A, B each 15g of two components will mix in being kneaded 10min on opening rubber mixing machine
Refining silicon rubber is placed in mold, and the high temperature vulcanized 20min under the conditions of 130 DEG C obtains the bare substrate material of not drug containing, should
Blank material outer diameter 50mm, diameter of section 4mm.Firm silicone rubber C6-165A, B each 15g of two components is accurately weighed, in open
It is kneaded 10min on rubber mixing machine, obtains the release-controlled film with a thickness of 1.0mm.Each section is spliced into the domain according to following ratios, then
One layer of release-controlled film is wrapped up in outside, is placed in high temperature vulcanized 20min at 130 DEG C, obtains block type Levonorgestrel Compourd pesseulum.
In Vitro Dissolution experiment:
In Vitro Dissolution experiment is carried out to the Levonorgestrel Compourd pesseulum that embodiment 2 is prepared.
In Vitro Dissolution actual conditions are as follows:
Levonorgestrel Compourd pesseulum is tied up on digestion instrument agitating paddle with thin nylon yarn, dissolution medium selects 250ml
The acetate buffer solution (meeting sink conditions) that pH is 4.0, temperature is 37 DEG C, stirring rate 50r/min, every to sample for 24 hours
Once, fresh dissolution medium is then replaced, 21d is continued for.Sample after 0.45 μm of membrane filtration, take subsequent filtrate storage to
Detection.The detection of sample uses high performance liquid chromatography, and release in vitro result is as shown in Figure 3,4.
It can be seen that Levonorgestrel Compourd pesseulum prepared by the present invention drug release initial stage (first day) have it is certain
Burst release, but releasing dosage releases the drug steady in next 20 days within safe range, meets Zero order release.
Claims (9)
1. a kind of compound pesseulum for avoiding conception and controling birth, the pesseulum by outer layer release-controlled film and one or more snippets by silicon rubber
The medicine core of the carrying medicament of preparation is constituted.Delay while it is characterized in that can realize progestational hormone and estrogen using block structure
It releases, achievees the purpose that avoid conception and control birth.Preparation method is as follows:
(1) preparation of medicine core: by the A of different silicon rubber, B component mixes about 20~60s according to 1: 1~100: 0.5 ratio, so
Drug is added according to the ratio of 0.6%~2.5wt% afterwards, continues to mix about 20~60s, is finally injected into mixture accordingly
In mold, high temperature vulcanized molding, curing temperature is 80~130 DEG C, and vulcanization time is 10~20min；
(2) preparation of release-controlled film: by the A of different silicon rubber, B component is mixed according to 1: 1~100: 0.5 ratio, is used
Opening rubber mixing machine carries out 10~20min of mixing, obtains silicon rubber film, and film thickness is 0.8~1.5mm；
(3) preparation of compound pesseulum: progestational hormone, the medicine core of estrogen and the sky of unsupported drug are loaded respectively with what is prepared
Baiyao core is that material is spliced into one layer of release-controlled film of outer layer covers after the domain, then obtains compound pesseulum after high temperature vulcanized,
Curing temperature is 80~130 DEG C, and vulcanization time is 10~20min, wherein the medicine core length of load progestational hormone is 1/4~1/2 ring,
The medicine core length for loading estrogen is 1/8~1/4 ring, and blank medicine core length is 1/4~1/2 ring.
2. pesseulum according to claim 1, it is characterised in that progestational hormone is Levonorgestrel.
3. pesseulum according to claim 1, it is characterised in that estrogen is ethinyloestradiol.
4. pesseulum according to claim 1, it is characterised in that outer layer controlled release membrane material is selected from Dow corning company C6
And Q7 medical grade silicon rubber series.
5. pesseulum according to claim 1, it is characterised in that it is public that silicon rubber used in preparation medicine core is selected from U.S. Nusil
The MED series silicon rubber of department or the medical grade silicon rubber of other respective series.
6. pesseulum according to claim 1, it is characterised in that the pesseulum outer diameter being prepared is 50~60mm, transversal
Face diameter is 4~5mm, and release-controlled film is with a thickness of 0.8~1.5mm.
7. pesseulum according to claim 1, it is characterised in that the release of progestational hormone and estrogen at least continues 21 days.
8. pesseulum according to claim 1, which is characterized in that the day releasing dosage of progestational hormone is 40~50 μ g, female to swash
The day releasing dosage of element is 10~25 μ g.
9. the Levonorgestrel Compourd pesseulum of preparation is preparing female contraception drug and is controlling according to the method for claim 1
Treat the application in the drug of gynecological disease.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11793750B2 (en) | 2019-12-06 | 2023-10-24 | Prathima CHOWDARY | Sustained release estrogen vaginal ring pessary for treatment of atrophy, cystitis and uterovaginal prolapse |
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