CN106265482A - A kind of oleuropein suppository - Google Patents
A kind of oleuropein suppository Download PDFInfo
- Publication number
- CN106265482A CN106265482A CN201610838313.3A CN201610838313A CN106265482A CN 106265482 A CN106265482 A CN 106265482A CN 201610838313 A CN201610838313 A CN 201610838313A CN 106265482 A CN106265482 A CN 106265482A
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- CN
- China
- Prior art keywords
- suppository
- oleuropein
- suppository base
- release
- base weight
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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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
- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
-
- 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
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/0031—Rectum, anus
-
- 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
Abstract
The invention discloses a kind of oleuropein suppository, the ingredient of this suppository is oleuropein, by adjusting component and the ratio of suppository base, can obtain rapid release suppository and the suppository of medium rate of release.Suppository intravaginal administration of the present invention can be used for treating the gynaecopathias such as vaginitis, pelvic inflammatory disease and cervical erosion, per rectum is administered and can be used for treating proctitis and rectal cancer, also can enter systemic blood circulation by per rectum submucosal blood vessel, play the antiinflammatory of general, improve the effects such as osteoporosis symptoms.
Description
Technical field
The present invention relates to a kind of suppository, particularly relate to a kind of oleuropein suppository.
Background technology
Vaginitis, pelvic inflammatory disease and cervical erosion are common gynecological disease and frequently-occurring disease, and infection vagina, the microorganism of pelvic cavity include
Antibacterial, candidiasis and infusorian etc., Therapeutic Method conventional clinically for oral anti-anaerobic agent such as metronidazole, tinidazole and gram
Woods mycin combines local suppository in treatment, and conventional suppository includes that metronidazole suppository, miconazole suppository, nystatin suppository are with gram mould
Azoles suppository.But, vaginitis, pelvic inflammatory disease and cervical erosion the most easily recur, recur unclean with Personal hygiene, sexual life is unclean or cloudy
Road is relevant to pelvic cavity environment dysbacteriosis, and the repeated drug taking after recurrence easily causes antibacterial to produce drug resistance, can only be by increasing agent
Amount improves curative effect, and when dosage reaches maximum, inflammation will be difficult to control to, and bring misery and mental burden to patient.
Oleuropein is secoiridoid, is primarily present in leaf of Fructus oleae europaeae.Research finds, oleuropein has
Have the strongest antioxidation and antibacterial action, can effectively suppress the antibacterials such as escherichia coli, staphylococcus aureus and Candida albicans,
The growth of fungus.Oleuropein structure and antifungal mechanism have the biggest difference with conventional intravaginal drug metronidazole, clotrimazole etc., for
Vagina and pelvic disease patient provide a new selection, it is to avoid the drug resistance problems produced because of repeated drug taking.Fructus Canarii albi is bitter
Glycosides is prepared as suppository, and the oleuropein after release can kill patient's vagina and various antibacterials, fungus and other the micro-lifes in pelvic cavity
Thing, effectively treats the gynaecopathias such as pelvic inflammatory disease, vaginitis and cervical erosion.
It addition, oleuropein has active anticancer, colon cancer and rectal cancer there are certain treatment and improvement result.Use
The form of suppository topical, can be used in the treatment of proctitis, rectal cancer and colon cancer.It is thin that oleuropein can also increase skeletonization
Born of the same parents' density, improves osteoporosis symptoms.The oleuropein suppository that per rectum is administered can be entered by capillary absorbance under rectum
Systemic blood circulation, plays it to osteoporosis and the therapeutical effect of systemic infection, it is to avoid liver first-pass effect.
The present inventor is found through experiments the dissolubility of oleuropein and is up to 50mg/mL, and lipid is 5.44, therefore
Infer that it should have good penetration capacity to skin and mucosa, be suitable for applying to mucoadhesive delivery system.There is presently no Fructus Canarii albi bitter
The report of glycosides suppository.
Summary of the invention
It is an object of the invention to provide a kind of oleuropein suppository, this suppository intravaginal administration can treat vaginitis, basin
The gynaecopathias such as chamber inflammation and cervical erosion, per rectum is administered can treat proctitis and rectal cancer, it is possible to per rectum submucosal blood vessel
Enter systemic blood circulation, play the antiinflammatory of general, improve the effects such as osteoporosis symptoms.
For reaching above-mentioned purpose, the oleuropein suppository that the present invention provides, it is made up of oleuropein and suppository base, every
The 10-50mg Han oleuropein in suppository.
Further, described suppository base by account for the PEG6000 of suppository base weight 20%-80%, PEG4000,
One or more combination in PEG1000 and account for PEG200, PEG300, PEG400 of suppository base weight 20-80%
Or PEG600 composition, or by the one or in PEG6000, PEG4000, PEG1000 of accounting for suppository base weight 80%-95%
Planting above combination and account for the hydrogel composition of suppository base weight 5%-20%, the Fructus Canarii albi using above-mentioned suppository base to make is bitter
Glycosides suppository is rapid release suppository.Described rapid release suppository refers to by four 0931 dissolutions of version Chinese Pharmacopoeia in 2015 and drug release determination
Method operates, and rotating speed is set to 50rpm, to the 60min dissolution suppository up to more than 60%.Rapid release suppository is mainly used in inflammation Acute
The treatment of phase.
Further, described suppository base by account for the PEG6000 of suppository base weight 60%-90%, PEG4000,
One or more in PEG1000 combine and account for the fat-soluble substrate of suppository base weight 5%-20% and account for suppository base
The hydrogel composition of weight 5%-20%, uses the bolt that oleuropein suppository is medium rate of release that this suppository base is made
Agent.Described medium rate of release suppository refers to grasp with drug release determination method by four 0931 dissolutions of version Chinese Pharmacopoeia in 2015
Making, rotating speed is set to 50rpm, to 2h dissolution at the suppository of 30%-60% scope.Medium rate of release suppository controls for inflammation
After after treatment, reduce administration number of times.
Further, the carboxymethyl cellulose that described hydrogel uses concentration to be the carbomer solution of 0.2-2%, 1-10%
Sodium solution, the methocel solution of 1-10%, the hypromellose cellulose solution of 1-10% or the sodium alginate soln of 1-15%.
Further, described fat-soluble substrate is glyceryl laurate ester, glyceryl monostearate, cetylate or stearic acid
Propylene glycol ester.
The present invention not only have developed the oleuropein suppository of rapid release, simultaneously through repetition test, medium release is also obtained
The suppository of speed, the 2h release of this suppository, about 50%, to 6h release up to more than 90%, not only has treatment to acute phase inflammatory
Effect, compares with rapid release suppository simultaneously, and extended durations of action, times for spraying can be reduced to every day 2-3 time.Additionally, the present invention is also
Introducing hydrogel in substrate, hydrogel has certain lubrication, but easily causes suppository to feel like jelly, insufficient formability, this
Bright by by fat-soluble substrate and hydrogel combination, suppository being made both to have had good lubricant effect, hardness is moderate again, the most variable
Shape, the most also has certain toughness, and patient's medication is comfortable, and drug release rate is moderate, can reach preferable curative effect.
Suppository intravaginal administration of the present invention can be used for treating the gynaecopathias such as vaginitis, pelvic inflammatory disease and cervical erosion, through straight
Enteral administration can be used for treating proctitis and rectal cancer, it is possible to per rectum submucosal blood vessel enters systemic blood circulation, plays whole body
Property antiinflammatory, improve the effect such as osteoporosis symptoms.
Accompanying drawing explanation
Fig. 1 is the stripping curve of the rapid release oleuropein suppository that embodiment 1 prepares.
Fig. 2 is the stripping curve of the rapid release oleuropein suppository that embodiment 2 prepares.
Fig. 3 is the stripping curve of the oleuropein suppository with medium rate of release that embodiment 3 prepares.
Detailed description of the invention
In order to be more fully understood that the present invention, below in conjunction with specific embodiment, the present invention is described in further detail, but this
The protection domain of invention is not limited to this.
Embodiment 1 rapid release oleuropein suppository
(1) taking carbomer 0.3g, add water 29.7g, stands 4h, and prepared concentration is the carbomer solution i.e. hydrogel of 1%；
(2) oleuropein is taken, finely ground, weigh 3g after crossing 100 mesh sieves, 3g oleuropein is added in hydrogel several times,
Stir；
(3) weigh PEG4000198g, after it is added heat fusing at 80 DEG C, then be placed in 60 DEG C of insulations；
(4) weigh the hydrogel 22g being mixed with oleuropein that step (2) prepares, added in the PEG4000 melted,
Insulated and stirred 20min so that it is mix homogeneously；
(5) substrate containing oleuropein that step (4) obtains is poured in bolt mould while hot, prepare rapid release oleuropein bolt
Agent 100, every weight is 2.2g, every 20mg Han oleuropein, and containing substrate 2.18g, in substrate, PEG4000 accounts for 90.83%,
Hydrogel accounts for 9.17%.
Taking 6 prepared oleuropein suppositorys and measure hardness, average hardness is 7.54 ± 0.06kg；By traditional Chinese medicines in 2015 editions
Four 0931 dissolutions of allusion quotation measure the dissolution of suppository with drug release determination method the second method, and rotating speed 50rpm, stripping curve is shown in Fig. 1.This
Product 60min dissolution reaches 94%, belongs to oleuropein rapid release suppository.
Embodiment 2 rapid release oleuropein suppository
(1) take PEG400 109g, add oleuropein 2g, ultrasonic or the hottest make oleuropein dissolve；
(2) weigh PEG4000 99g, after it is added heat fusing at 80 DEG C, then be placed in 60 DEG C of insulations；
(3) PEG400 containing oleuropein that step (1) obtains is added in melted PEG4000 several times, Bian Jia
Enter limit stirring, finish, continue stirring 30min；
(4) substrate containing oleuropein that step (3) obtains is poured in bolt mould while hot, prepare rapid release oleuropein bolt
Agent 100, every weight is 2.1g, every 20mg Han oleuropein, and containing substrate 2.08g, in substrate, PEG4000 accounts for 47.60%,
PEG400 accounts for 52.4%.
Taking 6 prepared oleuropein suppositorys and measure hardness, average hardness is 1.70 ± 0.22kg；By traditional Chinese medicines in 2015 editions
Four 0931 dissolutions of allusion quotation measure the dissolution of suppository with drug release determination method the second method, and rotating speed 50rpm, stripping curve is shown in Fig. 2.This
Product 60min dissolution reaches 71%, belongs to oleuropein rapid release suppository.
The oleuropein suppository of the medium rate of release of embodiment 3
(1) taking sodium carboxymethyl cellulose 0.3g, add water 29.7g, stands 4h, and prepared concentration is the carboxymethyl cellulose of 1%
Sodium solution i.e. hydrogel；
(2) oleuropein is taken, finely ground, weigh 3g after crossing 100 mesh sieves, 3g oleuropein is added in hydrogel several times,
Stir；
(3) weigh PEG4000 176g and glyceryl monostearate 22g, after it is added heat fusing at 80 DEG C, then be placed in 60
DEG C insulation；
(4) weigh the hydrogel 22g being mixed with oleuropein that step (2) prepares, added to PEG4000 and the list melted
In tristerin, insulated and stirred 20min so that it is mix homogeneously；
(5) substrate containing oleuropein that step (4) obtains is poured in bolt mould while hot, prepare medium rate of release olive
Olive hardship glycosides suppository 100, every weight is 2.2g, and every 20mg Han oleuropein, containing substrate 2.18g, in substrate, PEG4000 accounts for
80.73%, glyceryl monostearate accounts for 10.09%, and hydrogel accounts for 9.17%.
Taking 6 prepared oleuropein suppositorys and measure hardness, average hardness is 4.50 ± 0.17kg；By traditional Chinese medicines in 2015 editions
Four 0931 dissolutions of allusion quotation measure the dissolution of suppository with drug release determination method the second method, and rotating speed 50rpm, stripping curve is shown in Fig. 3.This
Product 60min dissolution reaches 38%, and 2h dissolution 46% reaches 92% through 6h dissolution, belongs to the oleuropein suppository of medium rate of release.
The oleuropein suppository of the medium rate of release of embodiment 4
Oleuropein suppository every the weight 3.44g of the medium rate of release that the present embodiment prepares, every contains oleuropein
40mg, containing substrate 3.4g, in substrate, PEG6000 accounts for 73.53%, and glyceryl laurate ester accounts for 14.71%, and hydrogel accounts for 11.76%.
Hydrogel be concentration be the methocel solution of 5%.
The oleuropein suppository of the medium rate of release of embodiment 5
Oleuropein suppository every the weight 3.8g of the medium rate of release that the present embodiment prepares, every contains oleuropein
50mg, containing substrate 3.75g, in substrate, PEG6000 accounts for 43%, and PEG1000 accounts for 20%, and propylene glycol stearate accounts for 18%, water-setting
Glue accounts for 19%.Hydrogel be concentration be the sodium alginate soln of 10%.
The oleuropein suppository of the medium rate of release of embodiment 6
Oleuropein suppository every the weight 2.8g of the medium rate of release that the present embodiment prepares, every contains oleuropein
10mg, containing substrate 2.79g, in substrate, PEG1000 accounts for 88%, and cetylate accounts for 6%, and hydrogel accounts for 6%.Hydrogel is that concentration is
The carbomer solution of 10%.
Embodiment 7 rapid release oleuropein suppository
Rapid release oleuropein suppository every the weight 3.0g that the present embodiment prepares, every 40mg Han oleuropein, containing substrate
2.96g, in substrate, PEG6000 accounts for 82%, and hydrogel accounts for 18%.Hydrogel be concentration be the methocel solution of 5%.
Embodiment 8 rapid release oleuropein suppository
Rapid release oleuropein suppository every the weight 2.6g that the present embodiment prepares, every 10mg Han oleuropein, containing substrate
2.59g, in substrate, PEG6000 accounts for 65%, and PEG1000 accounts for 30%, and hydrogel accounts for 5%.Hydrogel be concentration be the alginic acid of 8%
Sodium solution.
Embodiment 9 rapid release oleuropein suppository
Rapid release oleuropein suppository every the weight 2.8g that the present embodiment prepares, every 10mg Han oleuropein, containing substrate
2.79g, in substrate, PEG6000 accounts for 22%, and PEG200 accounts for 78%.
Embodiment 10 rapid release oleuropein suppository
Rapid release oleuropein suppository every the weight 3.2g that the present embodiment prepares, every 30mg Han oleuropein, containing substrate
3.17g, in substrate, PEG1000 accounts for 35%, and PEG600 accounts for 45%, and PEG400 accounts for 20%.
Embodiment 11 rapid release oleuropein suppository
Rapid release oleuropein suppository every the weight 3.2g that the present embodiment prepares, every 40mg Han oleuropein, containing substrate
3.16g, in substrate, PEG4000 accounts for 38%, and PEG1000 accounts for 40%, and PEG300 accounts for 22%.
The above is only the preferable embodiment of the present invention, but protection scope of the present invention is not limited thereto, any
The improvement and the replacement that carry out based on the solution of the present invention and design all should be contained within the scope of the present invention.
Claims (5)
1. an oleuropein suppository, is made up of oleuropein and suppository base, the 10-50mg Han oleuropein in every suppository.
Oleuropein suppository the most according to claim 1, it is characterised in that: described suppository base is by accounting for suppository base weight
One or more combination in PEG6000, PEG4000, PEG1000 of 20%-80% and account for suppository base weight
PEG200, PEG300, PEG400 or PEG600 composition of 20%-80%, or by accounting for suppository base weight 80%-95%
One or more combination in PEG6000, PEG4000, PEG1000 and account for the water-setting of suppository base weight 5%-20%
Glue forms, and the oleuropein suppository using above-mentioned suppository base to make is rapid release suppository.
Oleuropein suppository the most according to claim 1, it is characterised in that: described suppository base is by accounting for suppository base weight
One or more in PEG6000, PEG4000, PEG1000 of 60%-90% combine and account for suppository base weight 5%-
The fat-soluble substrate of 20% and account for the hydrogel composition of suppository base weight 5%-20%, uses the Fructus Canarii albi that this suppository base is made
Bitter glycosides suppository is the suppository of medium rate of release.
4. according to the oleuropein suppository described in Claims 2 or 3, it is characterised in that: described hydrogel is adopted as concentration and is
The carbomer solution of 0.2%-2%, the carboxymethylcellulose sodium solution of 1%-10%, the methocel solution of 1%-10%,
The hypromellose cellulose solution of 1%-10% or the sodium alginate soln of 1%-15%.
Oleuropein suppository the most according to claim 3, it is characterised in that: described fat-soluble substrate is lauric acid
Ester, glyceryl monostearate, cetylate or propylene glycol stearate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610838313.3A CN106265482B (en) | 2016-09-21 | 2016-09-21 | A kind of oleuropein suppository |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610838313.3A CN106265482B (en) | 2016-09-21 | 2016-09-21 | A kind of oleuropein suppository |
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| CN106265482A true CN106265482A (en) | 2017-01-04 |
| CN106265482B CN106265482B (en) | 2018-12-25 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109731006A (en) * | 2019-02-28 | 2019-05-10 | 天津国际生物医药联合研究院 | Oleuropein is preparing the application in the drug for treating pulmonary fibrosis disease |
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| CN1326363A (en) * | 1998-11-17 | 2001-12-12 | 大正制药株式会社 | Suppositories |
| EP1315691A1 (en) * | 2000-09-01 | 2003-06-04 | Creagri, Inc. | Method of obtaining a hydroxytyrosol-rich composition from vegetation water |
| US20050276836A1 (en) * | 1997-06-11 | 2005-12-15 | Michelle Wilson | Coated vaginal devices for vaginal delivery of therapeutically effective and/or health-promoting agents |
| CN101244237A (en) * | 2007-05-24 | 2008-08-20 | 海南碧凯药业有限公司 | Suppository and preparation thereof |
| CN101955503A (en) * | 2010-05-25 | 2011-01-26 | 苏州派腾生物医药科技有限公司 | Preparation method of oleuropein |
| CN104910223A (en) * | 2015-05-26 | 2015-09-16 | 南京泽朗医药科技有限公司 | Preparation method of oleuropein |
-
2016
- 2016-09-21 CN CN201610838313.3A patent/CN106265482B/en active Active
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050276836A1 (en) * | 1997-06-11 | 2005-12-15 | Michelle Wilson | Coated vaginal devices for vaginal delivery of therapeutically effective and/or health-promoting agents |
| CN1326363A (en) * | 1998-11-17 | 2001-12-12 | 大正制药株式会社 | Suppositories |
| CN1147320C (en) * | 1998-11-17 | 2004-04-28 | 大正制药株式会社 | Suppositories |
| EP1315691A1 (en) * | 2000-09-01 | 2003-06-04 | Creagri, Inc. | Method of obtaining a hydroxytyrosol-rich composition from vegetation water |
| CN101244237A (en) * | 2007-05-24 | 2008-08-20 | 海南碧凯药业有限公司 | Suppository and preparation thereof |
| CN100490887C (en) * | 2007-05-24 | 2009-05-27 | 海南碧凯药业有限公司 | Suppository and preparation thereof |
| CN101955503A (en) * | 2010-05-25 | 2011-01-26 | 苏州派腾生物医药科技有限公司 | Preparation method of oleuropein |
| CN104910223A (en) * | 2015-05-26 | 2015-09-16 | 南京泽朗医药科技有限公司 | Preparation method of oleuropein |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109731006A (en) * | 2019-02-28 | 2019-05-10 | 天津国际生物医药联合研究院 | Oleuropein is preparing the application in the drug for treating pulmonary fibrosis disease |
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