CN109248140A - The preparation method and application of progesterone antibacterial pesseulum - Google Patents
The preparation method and application of progesterone antibacterial pesseulum Download PDFInfo
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- CN109248140A CN109248140A CN201710573615.7A CN201710573615A CN109248140A CN 109248140 A CN109248140 A CN 109248140A CN 201710573615 A CN201710573615 A CN 201710573615A CN 109248140 A CN109248140 A CN 109248140A
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- pesseulum
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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
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/722—Chitin, chitosan
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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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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- Gynecology & Obstetrics (AREA)
- Urology & Nephrology (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention patent belongs to art of pharmacy, and in particular to a kind of preparation and its application of progesterone antibacterial pesseulum.The pesseulum is made of the release-controlled film of one or more snippets skeleton and its outsourcing, the progesterone of micronization is loaded in wherein at least one section of skeleton, contain anti-biotic material in release-controlled film, anti-biotic material can be the chitosan and its derivative or nano silver material of different molecular weight, or the mixture of the two.The invention of the pesseulum solves the technical problem that side effect is big, compliance is bad, safety is low present in existing Luteal phase support technology, provides a kind of new administration mode to carry out Luteal phase support in auxiliary reproductive process.Meanwhile the pesseulum can be used for the diseases such as treatment irregular menstruation as caused by luteal phase defect, dysmenorrhea.The antibacterial material added in pesseulum can both prevent that therapeutic effect can also be played to some infection (such as candida albicans infection) occurred because of infection caused by placing pesseulum.
Description
Technical field:
The invention patent belongs to art of pharmacy, and in particular to a kind of preparation and its application of progesterone antibacterial pesseulum.
Background technique:
Luteal phase defect refers to that the endocrine function deficiency of corpus luteum causes the secretion of progesterone to reduce.In human reproduction's mistake
Cheng Zhong, luteal phase defect are to cause infertile and miscarriage major reason, and Luteal phase support has become most assisted reproductive technologies
One of conventional steps；In addition, progesterone insufficiency also results in the diseases such as menstrual disorder, dysmenorrhea.
Progesterone is a kind of natural progestogen secreted by corpus luteum, the general action with progestational hormone.As endogenous
Property progestational hormone, progesterone playing enough Luteal phase support functions simultaneously, and safety is higher than the progesterone parahormone of synthesis, has become
The choice drug of Luteal phase support is carried out for most reproductive centers.
The progesterone preparation for Luteal phase support produced both at home and abroad at present specifically includes that oral agents, injection, vaginal plug
Agent and gelling agent.Although these preparations have their own advantages but also have deficiency: oral preparation bioavilability is low, and therapeutic effect is poor,
Taking dose, which crosses conference also, can cause CNS to inhibit and increase the side reactions such as pathogenesis of breast carcinoma risk；Injection easily causes trouble
Person's locally or systemically allergic reaction, and injection daily is needed, pain, poor compliance are brought to patient, long term injections can cause to infuse
Penetrate position inflammation, knot furuncle；Vaginal suppository and gelling agent still need daily medication, and vaginal fluid is easily caused to increase, and increase yin
Road infection risk, effluent can also pollution clothes, compliance is still wait improve.
Chinese patent (CN 102098991A) and (CN 104146948A) disclose a kind of corpus luteum for supplementary reproduction
Ketone integral type pesseulum and preparation method thereof is using however, containing hydro carbons or fatty glyceride in the prescription of the pesseulum
These substances can be also gradually released in the vagina of user in the process, easily cause user's vaginal fluid increase or dirty
Clothing is contaminated, compliance need to be improved, and moreover, these hydro carbons or fatty glyceride can equally pass through vaginal epithelial cell
It being absorbed into the blood circulation of user, there may be adverse effects for health of the long-time service to user, therefore, safety
Also it can not ensure.
Chinese patent (CN 1382500A) and (CN 1463762A) disclose two kinds respectively can load including progesterone
A variety of drugs inside and realize drug slow release pesseulum drug delivery system.However, this two kinds of pesseulums using
For solid silicone rubber as skeleton, hardness is larger, and elasticity is bad, and usage comfort is low；Moreover, the pesseulum of the patent is main
Applied to women's postpartum contraception, the Luteal phase support for supplementary reproduction is not appropriate in terms of day burst size；In addition, it uses week
Phase is too long, not only reduces the flexibility of medication, and places pesseulum for a long time and may induce or aggravate vagina local infection
And secretion increases；Furthermore research has shown that the vagina easy infection Candida albicans during forepart pregnant women, and there is no anti-for the pesseulum
The function of bacterium, therefore the purpose of adjuvant treatment is unable to reach for the patient of gestational period infection candida albicans.
Although Chinese patent (CN 1211193A) discloses a kind of contraception release system with antibacterial or antivirus action
System, including the antibacterial containing progesterone or antiviral contraception pesseulum, but this kind of progesterone antibacterial or antiviral yin
Road ring is still that supplementary reproduction field is not particularly suited on releasing dosage and service life suitable for contraception field；It is more important
, used antibacterial agent is the compound with antibacterial or antiviral activity, rather than it has now been found that safety
Higher anti-biotic material.These compounds often also have to a certain degree human body while playing antibacterial or antiviral activity
Damage, be not suitable for be used for a long time, be less applicable to high safety guarantee during pregnancy.
In conclusion the defect of progesterone pesseulum patent all various degrees announced at present, compliance and
Safety is all in urgent need to be improved.
Summary of the invention:
The invention patent solves in the prior art that there are unsatisfactory curative effect, side effects for the preparation variety of Luteal phase support
Greatly, compliance is bad, the low technical problem of safety, provides one kind for supplementary reproduction and treatment by luteal phase defect institute
Progesterone antibacterial pesseulum of the diseases such as irregular menstruation, the dysmenorrhea of cause and preparation method thereof.
The progesterone antibacterial pesseulum that the invention patent provides is realized by arranged below:
The slow releasing pharmaceutical of the invention patent selects the progesterone of micronization.Relative to common progesterone, the corpus luteum of micronization
Since specific surface area increases, solubility increases ketone, and dissolution rate is accelerated, and is conducive to progesterone in the absorption of vagina mucosa, improves
Bioavilability.The ratio range of progesterone and skeleton silastic material is 10%-40%.
The invention patent is depot (or shell mould, membranous type) pesseulum, is constituted by two layers.Its outer layer is not drug containing
And the release-controlled film that the medical grade silicon rubber material containing anti-biotic material is prepared into, internal layer are the medicine core skeleton containing drug.Aforementioned medicine
Core crab is using fluid silicone rubber as framework material, and the silicon rubber of the type has ideal consistency and elasticity, biggish containing
Property, stronger plasticity, it is higher relative to solid silicone rubber practicability, not using pesseulum prepared by such fluid silicone rubber
Only controlled release properties are more preferable, and drug release is more steady, and consistency and elasticity is more ideal, substantially increase patient use it is suitable
Ying Xing.Aforementioned controlled release membrane material is the silastic material different from framework material, can be selected from Q7-4765 or C6-165 silicon rubber bullet
Property body.It has following setting: the controlled release membrane material contains suitable antibacterial agent, and the antibacterial agent can be chitosan, nanometer
Silver, antibiotic etc..
The invention patent is closed hoop object, and there are two types of structural forms: one is whole segment type, i.e., medicine core skeleton is to contain medicine
The unbroken loop of object；One is block type, i.e., medicine core skeleton is that the skeleton containing drug and the blank skeleton of not drug containing are put together.
The ring diameter of the invention patent can be set in 40mm-60mm, and cross-sectional diameter can be in 4.0mm-6.0mm range
Interior setting.
The pharmaceutical release time of the invention patent is set within the scope of 7-14 days.
There is the effectiveness of Luteal phase support to make the invention patent not only, but also have the effectiveness of antibacterial concurrently simultaneously, the invention patent can
It is adjusted correspondingly and changes in terms of preparation method and prescription according to actual application requirement, to reach slowly constant
Drug needed for discharging, and releasing dosage achievees the purpose that required dosage.The adjustment and change is related to following scheme: one, right
The structure and specification and prescription of the medicine core skeleton of aforementioned depot pesseulum are adjusted correspondingly and change according to actual needs, relate to
And arrive: the proportion of 1. selection satisfactory progesterone and silastic material；2. selecting different ring diameters or cross-sectional diameter
Medicine core skeleton；3. selecting the pharmacy skeleton of different structure, whole segment type as the aforementioned or block type structure.Two, to aforementioned controlled release
The material and prescription of film are adjusted correspondingly and change according to actual needs, are related to: the different controlled release membrane material of 1. selections；
2. selecting different controlled release film thicknesses；3. selecting different antibacterial agents.
The invention patent provide progesterone antibacterial pesseulum the preparation method is as follows:
1. the different component of liquid silastic is carried out in proportion uniformly mixed；
2. appropriate amount of drug is taken to be mixed with the silicon rubber matrix mixed, stir to uniformly mixed；
3. the mixture of drug and silicon rubber is injected into mold using injection moulding, and vulcanized at a certain temperature
At drug containing skeleton；
4. the different component of controlled release film silastic is carried out in proportion uniformly mixed；
5. appropriate antibacterial additives is taken to be mixed with the silicon rubber mixed, mix to uniform；
6. uniformly mixed controlled release film silastic, which is pressed into thin slice, is wrapped in molding silicon rubber drug containing skeleton, specific
At a temperature of sulfidization molding.
The progesterone antibacterial pesseulum of the invention patent is easy to use, and patient can voluntarily use without professional health care people
There is no a wound in the participation of member and administration process, a ring can be used 7-14 days, greatly reduces administration number of times, improves patient
Compliance；Meanwhile with uterus targeting effect (drug directly can act on uterus by vagina, blood concentration very
Enough curative effects are played when low), steady release progesterone 10mg, avoids the peak valley effect of blood concentration daily, not only biological
Availability is high, is also greatly reduced the toxic side effect of drug, the safety of medication is higher；In addition, it also has certain antibacterial concurrently
Performance can not only prevent to place the local infection that pesseulum may cause, (such as white for the infection having occurred and that during gestation
The infection of color beads coccus) have the function for the treatment of.
Detailed description of the invention:
Fig. 1 be the invention patent involved in pesseulum basic structure schematic diagram, wherein 1 be drug containing skeleton, 2 for containing
The release-controlled film of antibacterial agent.
Fig. 2 be the invention patent involved in pesseulum schematic cross-section, wherein 1 be the release-controlled film containing antibacterial agent, 2
For drug containing skeleton.
Fig. 3-1 is 1 progesterone antibacterial pesseulum In-vitro release curves figure of embodiment, and Fig. 3-2 is that the accumulation of release in vitro is released
Put curve.
Specific embodiment:
Embodiment 1
Liquid silastic MED-6382 matrix 100g, crosslinking agent 0.5g are taken, stirring 30s is allowed to mix, and weighs 10g progesterone
Being added to stirring 30s in silastic mixture mixes well drug with silastic mixture, will be mixed in right amount with 50ml syringe
It closes object to be transferred in pesseulum mold, avoids bubble from generating as far as possible in operating process, mold is then put into sulphur under 80 DEG C of environment
Change 25min, remove from the mold molded cyclic annular silastic product, which is 50mm, cross-sectional diameter
For 5mm.Two kinds of components of C6-165 medical grade silicon rubber are taken to mix 10min according to 1: 1 ratio, it is mixed that chitosan is added in 3wt% ratio
It is bonded to uniformly, prepares the film of 1.0mm thickness, which is coated on drug containing skeleton ring textures, 125 DEG C of vulcanization 20min are
Obtaining drugloading rate is 10%, and controlled release membrane material is C6-165, with a thickness of the progesterone antibacterial pesseulum of 1.0mm.
Embodiment 2
Liquid silastic MED-6382 matrix 100g, crosslinking agent 0.5g are taken, stirring 30s is allowed to mix, and weighs 10g progesterone
Being added to stirring 30s in silastic mixture mixes well drug with silastic mixture, will be mixed in right amount with 50ml syringe
It closes object to be transferred in pesseulum mold, avoids bubble from generating as far as possible in operating process, mold is then put into sulphur under 80 DEG C of environment
Change 25min, remove from the mold molded cyclic annular silastic product, which is 50mm, cross-sectional diameter
For 5mm.Two kinds of components of Q7-4765 medical grade silicon rubber are taken to mix 10min according to 1: 1 ratio, it is mixed that chitosan is added in 3wt% ratio
It is bonded to uniformly, prepares the film of 1.0mm thickness, which is coated on drug containing skeleton ring textures, 125 DEG C of vulcanization 20min are
Obtaining drugloading rate is 10%, and controlled release membrane material is Q7-4765, with a thickness of the progesterone antibacterial pesseulum of 1.0mm.
Embodiment 3
Liquid silastic MED-6382 matrix 100g, crosslinking agent 0.5g are taken, stirring 30s is allowed to mix, and weighs 10g progesterone
Being added to stirring 30s in silastic mixture mixes well drug with silastic mixture, will be mixed in right amount with 50ml syringe
It closes object to be transferred in pesseulum mold, avoids bubble from generating as far as possible in operating process, then mold is put under 80 DEG C of environment
20min removes from the mold molded pesseulum silastic product, which is 50.0cm, and cross section is straight
Diameter is 5.0mm.It takes two kinds of components of C6-165 medical grade silicon rubber to mix 10min according to 1: 1 ratio, shell is added in the ratio of 3wt%
Glycan is mixed to uniform, prepares the film of 1.2mm thickness, which is coated on molding silicone rubber product surface, 125 DEG C of vulcanizations
20min is 10% up to drugloading rate, and controlled release membrane material is C6-165, with a thickness of the progesterone antibacterial pesseulum of 1.2mm.
Embodiment 4
Liquid silastic MED-6382 matrix 100g, crosslinking agent 0.5g are taken, stirring 30s is allowed to mix, and weighs 10g progesterone
Being added to stirring 30s in silastic mixture mixes well drug with silastic mixture, will be mixed in right amount with 50ml syringe
It closes object to be transferred in pesseulum mold, avoids bubble from generating as far as possible in operating process, then mold is put under 80 DEG C of environment
20min removes from the mold molded pesseulum rubber product, which is 50cm, and cross-sectional diameter is
5.0mm.It takes two kinds of components of C6-165 medical grade silicon rubber to mix 10min according to 1: 1 ratio, chitosan is added in the ratio of 3wt%
It mixes to uniform, prepares the film of 0.8mm thickness, which is coated on molding pesseulum product surface, 125 DEG C of vulcanization 20min
It is 10% up to drugloading rate, controlled release membrane material is C6-165, with a thickness of the progesterone antibacterial pesseulum of 0.8mm.
Embodiment 5
Liquid silastic MED-6382 matrix 100g, crosslinking agent 0.5g are taken, stirring 30s is allowed to mix, and weighs 15g progesterone
Being added to stirring 30s in silastic mixture mixes well drug with silastic mixture, will be mixed in right amount with 50ml syringe
It closes object to be transferred in pesseulum mold, avoids bubble from generating as far as possible in operating process, then mold is put under 80 DEG C of environment
20min removes from the mold molded pesseulum rubber product, which is 50cm, and cross-sectional diameter is
5.0mm.It takes two kinds of components of C6-165 medical grade silicon rubber to mix 10min according to 1: 1 ratio, chitosan is added in the ratio of 3wt%
It mixes to uniform, prepares the film of 1.0mm thickness, which is coated on molding pesseulum product surface, 125 DEG C of vulcanization 20min
It is 15% up to drugloading rate, controlled release membrane material is C6-165, with a thickness of the progesterone antibacterial pesseulum of 1.0mm.
Claims (7)
1. a kind of using fluid silicone rubber as the progesterone antibacterial pesseulum for supplementary reproduction of carrier, by release-controlled film, one section or
Multistage skeleton composition, at least one section of skeleton include drug, contain one or more of antibacterial agents in film, it is characterised in that main ingredient corpus luteum
While releasing from skeleton, the antibacterial agent with antibacterial action can also release ketone from skeleton, thus mentioning
Certain antibacterial action can be reached while for enough Luteal phase supports, be not only avoided that pesseulum induces in use
Vagina infection, moreover it is possible to there is therapeutic effect to the infection occurred, preparation method is as follows:
(1) different component of liquid silastic is mixed into about 10~60s, mixed carrier according to 100: 0.5 ratio
About 10~60s is mixed according to the ratio of 10~40.0wt% with drug, the mixture of drug and carrier is added to injection molding
Sulfidization molding in corresponding mould is re-injected into machine, curing temperature is 80 DEG C, and vulcanization time is 20~30min；
(2) release-controlled film is firm silicone rubber, and different component mixes about 10~600s according to 1: 1 ratio on rubber mixing machine, is mixed
Silicon rubber afterwards is mixed about 10~120s according to 1.0~20.0wt% ratio with one or more of antibacterial agents, then will control
The film that 0.6~1.4mm is made in membrane pressure is released, is wrapped on drug containing skeleton, is placed in mold or heating plate, hot-press vulcanization 20~
30min。
It using liquid silastic is the progesterone antibacterial pesseulum of carrier it is characterized in that the liquid 2. according to claim 1
Body silicon rubber is selected from the MED series silicon rubber of U.S. Nusil company, and controlled release membrane material is selected from Dow corning company C6 and Q7 and cures
With grade silicon rubber series.
It using liquid silastic is the medicine sustained and controlled release system of carrier by release-controlled film, one section or more 3. according to claim 1
Section skeleton composition, at least one section of skeleton include drug, and skeleton can contain one or more of antibacterial additives, it is characterised in that described
Drug containing part composition are as follows:
Drug therein is the progesterone of micronization, and drug containing partial cross sectional diameter is 4~7mm, wherein most preferably 5mm, controlled release
Film thickness is 0.6~2.0mm, wherein most preferably 1.0mm.
4. according to claim 1 or 3 using liquid silastic as the progesterone antibacterial pesseulum of carrier, it is characterised in that yellow
The specification of body ketone antibacterial pesseulum is 50~60mm of outer diameter, wherein most preferably 50mm, 4.5~6mm of cross-sectional diameter, wherein most preferably
For 6mm.
5. according to claim 3 using liquid silastic as the progesterone antibacterial pesseulum of carrier, it is characterised in that wherein
The antibacterial additives include the chitosan and its derivative of different molecular weight, nano silver material or the two by certain ratio
The mixture of example, the method for addition are also possible to either directly mixing during the preparation process with silastic material in pesseulum
Surface coating.
6. according to claim 1 using liquid silastic as the medicine sustained and controlled release system of carrier it is characterized in that daily releases
Dose is 10~15mg, wherein optimal drug release amount is daily 10mg.
7. according to claim 1 using liquid silastic as the progesterone antibacterial pesseulum of carrier it is characterized in that it can be with
For supplementary reproduction field Luteal phase support and treat other as Luteal phase support it is insufficient caused by disease, such as: amenorrhoea, dysmenorrhea, function
It can property uterine hemorrhage, menorrhagia and metrorrhagia.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710573615.7A CN109248140A (en) | 2017-07-14 | 2017-07-14 | The preparation method and application of progesterone antibacterial pesseulum |
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| CN201710573615.7A CN109248140A (en) | 2017-07-14 | 2017-07-14 | The preparation method and application of progesterone antibacterial pesseulum |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021068239A1 (en) * | 2019-10-12 | 2021-04-15 | 国家卫生健康委科学技术研究所 | Vaginal slow-release administration system for luteal support, preparation method therefor and use thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2021068239A1 (en) * | 2019-10-12 | 2021-04-15 | 国家卫生健康委科学技术研究所 | Vaginal slow-release administration system for luteal support, preparation method therefor and use thereof |
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| US11439588B2 (en) | 2019-10-12 | 2022-09-13 | National Research Institute For Family Planning | Vaginal sustained-release drug delivery system for luteal support, method for preparation and use thereof |
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Application publication date: 20190122 |