CN107811964A - Antibacterial conception control gel that is biodegradable and realizing dosed administration - Google Patents
Antibacterial conception control gel that is biodegradable and realizing dosed administration Download PDFInfo
- Publication number
- CN107811964A CN107811964A CN201610811191.9A CN201610811191A CN107811964A CN 107811964 A CN107811964 A CN 107811964A CN 201610811191 A CN201610811191 A CN 201610811191A CN 107811964 A CN107811964 A CN 107811964A
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- CN
- China
- Prior art keywords
- gel
- chitosan
- vagina
- biodegradable
- fibroin albumen
- Prior art date
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- 230000000844 anti-bacterial effect Effects 0.000 title claims abstract description 14
- 108010022355 Fibroins Proteins 0.000 claims abstract description 26
- 229920001661 Chitosan Polymers 0.000 claims abstract description 25
- 239000003433 contraceptive agent Substances 0.000 claims abstract description 20
- 230000002254 contraceptive effect Effects 0.000 claims abstract description 20
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 17
- 210000001215 vagina Anatomy 0.000 claims abstract description 15
- 230000000694 effects Effects 0.000 claims abstract description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 12
- 235000011187 glycerol Nutrition 0.000 claims abstract description 8
- ULWHHBHJGPPBCO-UHFFFAOYSA-N propane-1,1-diol Chemical class CCC(O)O ULWHHBHJGPPBCO-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000000203 mixture Substances 0.000 claims abstract description 7
- 239000000934 spermatocidal agent Substances 0.000 claims abstract description 4
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 3
- 238000002347 injection Methods 0.000 claims abstract 2
- 239000007924 injection Substances 0.000 claims abstract 2
- 239000000499 gel Substances 0.000 claims description 24
- 238000003756 stirring Methods 0.000 claims description 9
- 239000002253 acid Substances 0.000 claims description 5
- 230000003115 biocidal effect Effects 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- 235000005979 Citrus limon Nutrition 0.000 claims description 4
- 239000011159 matrix material Substances 0.000 claims description 4
- 229960000686 benzalkonium chloride Drugs 0.000 claims description 3
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 3
- 230000036541 health Effects 0.000 claims description 3
- 235000015110 jellies Nutrition 0.000 claims description 3
- 239000008274 jelly Substances 0.000 claims description 3
- JYCQQPHGFMYQCF-UHFFFAOYSA-N 4-tert-Octylphenol monoethoxylate Chemical compound CC(C)(C)CC(C)(C)C1=CC=C(OCCO)C=C1 JYCQQPHGFMYQCF-UHFFFAOYSA-N 0.000 claims description 2
- 239000003623 enhancer Substances 0.000 claims description 2
- 238000005461 lubrication Methods 0.000 claims description 2
- 229950004053 octoxinol Drugs 0.000 claims description 2
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 244000248349 Citrus limon Species 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 230000003020 moisturizing effect Effects 0.000 claims 1
- LIXVMPBOGDCSRM-UHFFFAOYSA-N nonylbenzene Chemical compound CCCCCCCCCC1=CC=CC=C1 LIXVMPBOGDCSRM-UHFFFAOYSA-N 0.000 claims 1
- 238000005457 optimization Methods 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 10
- 238000002360 preparation method Methods 0.000 abstract description 10
- 229940079593 drug Drugs 0.000 abstract description 6
- 150000001875 compounds Chemical class 0.000 abstract description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract description 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract description 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract description 3
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract description 3
- 210000005000 reproductive tract Anatomy 0.000 abstract description 3
- 239000000286 vaginal jelly Substances 0.000 abstract description 3
- 208000015181 infectious disease Diseases 0.000 abstract description 2
- 230000002265 prevention Effects 0.000 abstract description 2
- 238000011002 quantification Methods 0.000 abstract 2
- 206010003694 Atrophy Diseases 0.000 abstract 1
- 206010067482 No adverse event Diseases 0.000 abstract 1
- 206010047791 Vulvovaginal dryness Diseases 0.000 abstract 1
- 230000037444 atrophy Effects 0.000 abstract 1
- 238000000034 method Methods 0.000 description 8
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 7
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 6
- 230000006378 damage Effects 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 244000131522 Citrus pyriformis Species 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 4
- AMXOYNBUYSYVKV-UHFFFAOYSA-M lithium bromide Chemical compound [Li+].[Br-] AMXOYNBUYSYVKV-UHFFFAOYSA-M 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 210000004877 mucosa Anatomy 0.000 description 4
- 208000027418 Wounds and injury Diseases 0.000 description 3
- 238000001914 filtration Methods 0.000 description 3
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- 230000004048 modification Effects 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 229910000029 sodium carbonate Inorganic materials 0.000 description 3
- KUXGUCNZFCVULO-UHFFFAOYSA-N 2-(4-nonylphenoxy)ethanol Chemical compound CCCCCCCCCC1=CC=C(OCCO)C=C1 KUXGUCNZFCVULO-UHFFFAOYSA-N 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 2
- 229920003043 Cellulose fiber Polymers 0.000 description 2
- 150000003851 azoles Chemical class 0.000 description 2
- 239000003899 bactericide agent Substances 0.000 description 2
- 238000013270 controlled release Methods 0.000 description 2
- 239000008367 deionised water Substances 0.000 description 2
- 229910021641 deionized water Inorganic materials 0.000 description 2
- 210000000981 epithelium Anatomy 0.000 description 2
- 210000005002 female reproductive tract Anatomy 0.000 description 2
- QUQPHWDTPGMPEX-QJBIFVCTSA-N hesperidin Chemical compound C1=C(O)C(OC)=CC=C1[C@H]1OC2=CC(O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@@H](CO[C@H]4[C@@H]([C@H](O)[C@@H](O)[C@H](C)O4)O)O3)O)=CC(O)=C2C(=O)C1 QUQPHWDTPGMPEX-QJBIFVCTSA-N 0.000 description 2
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- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 description 1
- REPVLJRCJUVQFA-UHFFFAOYSA-N (-)-isopinocampheol Natural products C1C(O)C(C)C2C(C)(C)C1C2 REPVLJRCJUVQFA-UHFFFAOYSA-N 0.000 description 1
- QBYIENPQHBMVBV-HFEGYEGKSA-N (2R)-2-hydroxy-2-phenylacetic acid Chemical compound O[C@@H](C(O)=O)c1ccccc1.O[C@@H](C(O)=O)c1ccccc1 QBYIENPQHBMVBV-HFEGYEGKSA-N 0.000 description 1
- XMAYWYJOQHXEEK-OZXSUGGESA-N (2R,4S)-ketoconazole Chemical compound C1CN(C(=O)C)CCN1C(C=C1)=CC=C1OC[C@@H]1O[C@@](CN2C=NC=C2)(C=2C(=CC(Cl)=CC=2)Cl)OC1 XMAYWYJOQHXEEK-OZXSUGGESA-N 0.000 description 1
- BLSQLHNBWJLIBQ-OZXSUGGESA-N (2R,4S)-terconazole Chemical compound C1CN(C(C)C)CCN1C(C=C1)=CC=C1OC[C@@H]1O[C@@](CN2N=CN=C2)(C=2C(=CC(Cl)=CC=2)Cl)OC1 BLSQLHNBWJLIBQ-OZXSUGGESA-N 0.000 description 1
- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical compound II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 description 1
- MBRHNTMUYWQHMR-UHFFFAOYSA-N 2-aminoethanol;6-cyclohexyl-1-hydroxy-4-methylpyridin-2-one Chemical compound NCCO.ON1C(=O)C=C(C)C=C1C1CCCCC1 MBRHNTMUYWQHMR-UHFFFAOYSA-N 0.000 description 1
- 208000030507 AIDS Diseases 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 206010059866 Drug resistance Diseases 0.000 description 1
- QUQPHWDTPGMPEX-UHFFFAOYSA-N Hesperidine Natural products C1=C(O)C(OC)=CC=C1C1OC2=CC(OC3C(C(O)C(O)C(COC4C(C(O)C(O)C(C)O4)O)O3)O)=CC(O)=C2C(=O)C1 QUQPHWDTPGMPEX-UHFFFAOYSA-N 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- WHXSMMKQMYFTQS-UHFFFAOYSA-N Lithium Chemical compound [Li] WHXSMMKQMYFTQS-UHFFFAOYSA-N 0.000 description 1
- 244000246386 Mentha pulegium Species 0.000 description 1
- 235000016257 Mentha pulegium Nutrition 0.000 description 1
- 235000004357 Mentha x piperita Nutrition 0.000 description 1
- BYBLEWFAAKGYCD-UHFFFAOYSA-N Miconazole Chemical compound ClC1=CC(Cl)=CC=C1COC(C=1C(=CC(Cl)=CC=1)Cl)CN1C=NC=C1 BYBLEWFAAKGYCD-UHFFFAOYSA-N 0.000 description 1
- 206010068052 Mosaicism Diseases 0.000 description 1
- IWYDHOAUDWTVEP-UHFFFAOYSA-N R-2-phenyl-2-hydroxyacetic acid Natural products OC(=O)C(O)C1=CC=CC=C1 IWYDHOAUDWTVEP-UHFFFAOYSA-N 0.000 description 1
- 208000007313 Reproductive Tract Infections Diseases 0.000 description 1
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 1
- HJLSLZFTEKNLFI-UHFFFAOYSA-N Tinidazole Chemical compound CCS(=O)(=O)CCN1C(C)=NC=C1[N+]([O-])=O HJLSLZFTEKNLFI-UHFFFAOYSA-N 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 208000030961 allergic reaction Diseases 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 230000003796 beauty Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- SRSXLGNVWSONIS-UHFFFAOYSA-N benzenesulfonic acid Chemical compound OS(=O)(=O)C1=CC=CC=C1 SRSXLGNVWSONIS-UHFFFAOYSA-N 0.000 description 1
- 229940092714 benzenesulfonic acid Drugs 0.000 description 1
- 239000000227 bioadhesive Substances 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 229940116229 borneol Drugs 0.000 description 1
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 description 1
- 230000031709 bromination Effects 0.000 description 1
- 238000005893 bromination reaction Methods 0.000 description 1
- 210000003679 cervix uteri Anatomy 0.000 description 1
- WIIZWVCIJKGZOK-RKDXNWHRSA-N chloramphenicol Chemical compound ClC(Cl)C(=O)N[C@H](CO)[C@H](O)C1=CC=C([N+]([O-])=O)C=C1 WIIZWVCIJKGZOK-RKDXNWHRSA-N 0.000 description 1
- 229960005091 chloramphenicol Drugs 0.000 description 1
- 229960004375 ciclopirox olamine Drugs 0.000 description 1
- 238000005352 clarification Methods 0.000 description 1
- 229960004022 clotrimazole Drugs 0.000 description 1
- VNFPBHJOKIVQEB-UHFFFAOYSA-N clotrimazole Chemical compound ClC1=CC=CC=C1C(N1C=NC=C1)(C=1C=CC=CC=1)C1=CC=CC=C1 VNFPBHJOKIVQEB-UHFFFAOYSA-N 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- RFHAOTPXVQNOHP-UHFFFAOYSA-N fluconazole Chemical compound C1=NC=NN1CC(C=1C(=CC(F)=CC=1)F)(O)CN1C=NC=N1 RFHAOTPXVQNOHP-UHFFFAOYSA-N 0.000 description 1
- 229960004884 fluconazole Drugs 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 235000001050 hortel pimenta Nutrition 0.000 description 1
- -1 hydroxypropyl methyl Chemical group 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000000622 irritating effect Effects 0.000 description 1
- 229960004125 ketoconazole Drugs 0.000 description 1
- 229910052744 lithium Inorganic materials 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 229960002510 mandelic acid Drugs 0.000 description 1
- 229960000282 metronidazole Drugs 0.000 description 1
- VAOCPAMSLUNLGC-UHFFFAOYSA-N metronidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1CCO VAOCPAMSLUNLGC-UHFFFAOYSA-N 0.000 description 1
- 229960002509 miconazole Drugs 0.000 description 1
- 244000000010 microbial pathogen Species 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 239000011664 nicotinic acid Substances 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 235000008935 nutritious Nutrition 0.000 description 1
- 229960000988 nystatin Drugs 0.000 description 1
- VQOXZBDYSJBXMA-NQTDYLQESA-N nystatin A1 Chemical compound O[C@H]1[C@@H](N)[C@H](O)[C@@H](C)O[C@H]1O[C@H]1/C=C/C=C/C=C/C=C/CC/C=C/C=C/[C@H](C)[C@@H](O)[C@@H](C)[C@H](C)OC(=O)C[C@H](O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@](O)(C[C@H](O)[C@H]2C(O)=O)O[C@H]2C1 VQOXZBDYSJBXMA-NQTDYLQESA-N 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000026731 phosphorylation Effects 0.000 description 1
- 238000006366 phosphorylation reaction Methods 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 239000012460 protein solution Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 238000009738 saturating Methods 0.000 description 1
- 210000003765 sex chromosome Anatomy 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 229910052709 silver Inorganic materials 0.000 description 1
- 239000004332 silver Substances 0.000 description 1
- 229940009188 silver Drugs 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 229960000580 terconazole Drugs 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 229960005053 tinidazole Drugs 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
Classifications
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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
- A61K31/075—Ethers or acetals
- A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
-
- 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
- A61K31/13—Amines
- A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/765—Polymers containing oxygen
-
- 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
-
- 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
-
- 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
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gynecology & Obstetrics (AREA)
- Reproductive Health (AREA)
- Urology & Nephrology (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to contraception spermicide common drug, conception control gel agent specially a kind of biodegradable and with antibacterial action, belong to from principal mode external contraceptive apparatus.On its basis, by disposably long cylinder delivery device, accurate quantification administration can be achieved.Antibacterial conception control gel is made up of spermatocide, biodegradable gel and water.Gel be specially a kind of fibroin albumen and chitosan it is compound after vaginal jellies, include each component of following mass concentration：Fibroin albumen 2 8%；Chitosan 0.5 2%；Acritamer 940 or hydroxypropyl methyl cellulose 0.5 2%；Glycerine and propane diols 5 12%；Water surplus, regulation pH value is between 3.5 5.The product can reach quick killing sperm, play the effect of avoiding conception and controling birth, while have antibacterial action, prevention and the courses of infection for improving genital tract.Its composition is biodegradable, and catabolite can be absorbed, and can improve the effect such as vaginal dryness, atrophy to a certain extent.Gel preparation is quantified and is filled in syringe-type instrument, can direct injection in vagina depths, reach the purpose of accurate quantification administration.The product good biocompatibility, vagina pH will not be impacted, have no adverse reaction, be worth in clinical application.
Description
Technical field
The present invention relates to a kind of preparation of novel contraceptive gel preparation and the improvement of administering mode.Belong to self administration contraception
On the basis of possess antibacterial and improve some vaginal microenvironments effect.
Background technology
With the raising of living standards of the people and the transformation of idea, except part Married couples take upper ring birth control surgery it
Outside, other numerous unmarried or married youth, frequently with rubber condom, oral contraceptive, the class of external applied contraceptive three.As
More contraceptive device is used at present, and there is also the peaces such as slippage in part allergic reaction and rupture and sexual intercourse for the use of condom
Full sex chromosome mosaicism, a certain degree of sense of discomfort in addition be present.Oral contraceptive is disadvantageous in that the first pass effect of liver, can draw
Play women Nausea and vomiting, even bad pair such as colporrhagia etc. is reacted.External applied contraceptive mainly has contraceptive suppository, contraceptive membrane, contraception
Gel (being also jelly) cardinal principle is vagina administration, and sperm is directly killed in vagina, cannot be introduced into sperm
Womb, so as to have the function that contraception.Contraceptive suppository and contraceptive membrane are higher to time requirement, if in actual use process
In, if prospermia, in the state of medicine or bolt shape or membranaceous also complete thawing, medicine is can not effectively to kill essence
Son, often result in contraceptive failure.New contraceptive, it is referred to as " liquid sheath " by people, also someone is referred to as " stealthy
Sheath ", its essence is a kind of bio-adhesive is sustained conception control gel.Outward appearance is semi liquid state shape, somewhat more sticky by one than contraceptive jelly
A bit, laying method is similar.Gel is a kind of new bionic technology preparation, is put into vagina, can be immediately in vagina
Spread out, with vaginal mucosa close adhesion, form layer protecting film, start progressively to degrade after certain time, discharge.By height
Effect spermicidal composition is mounted on the gel, and after inserting vagina, spermicidal composition slowly discharges in diaphragm, can be in a long time
Play contraceptive efficacy.Gel is a kind of current external applied contraceptive contraceptive method of contraceptive rate highest in real process.
In addition, RTI is influence and endangers the common disease of broad masses' especially WomanHealth.Existing treatment
Method is based on bactericide and antibiotic, and bactericide often has local irritant effect, and the deficiency of antibiotic is to easily cause
Drug resistance, the resistance to the action of a drug and the human body of bacterium are also easy to produce side effect after.RTI by a variety of pathogenic microorganisms intrusion
Cause, cause RTI or through RTI (such as AIDS).Female genital tract infection has illness rate high, asymptomatic
Ratio is high, medical ratio is not high and cannot get the characteristics of rational therapy ratio is high, finally results in various severe complications with after
Lose disease.While ensureing to avoid conception and control birth effect and and can improves above-mentioned illness, therefore new type gel preparation, possess slowly, can
Controlled release releases contraceptive, plays birth control effect, while can slowly be degraded in physiological period complete and possess bactericidal etc.
Function, greatly reduce the use of antibiotic, by as avoid conception and control birth method and the healthy reproduction relevant disease of a kind of novel concept
Prevention and treatment method.This preparation main material has drawn from the extensive biomaterial of natural origin, wherein fibroin albumen content
Several amino acid of highest are just the main components of collagen, have good compatibility with epithelial tissue, are easily absorbed, its
Catabolite is nutritious and repair.Contain substantial amounts of hydrophilic radical in fibroin albumen simultaneously, NMF can be played
Effect.It has been used widely using fibroin albumen as the health products of matrix and cosmetics beauty and skin care.Chitosan conduct
A kind of excellent gel and antiseptic are used widely in clinic.The primary raw material such as fibroin albumen and chitosan, adds
Work is easy, and not only contaminated probability is small, good biocompatibility, and can accomplish high-quality low-cost, has more preferable market competition
Power.
The content of the invention
It is an object of the invention to provide a kind of gel system with self administration, the natural pH of biodegradable, similar vagina
Agent, possess antibacterial on the basis of contraception is realized, medicine is possessed sustained release and control-release function and improve vaginal microenvironment purpose.
The present invention relates to contraception spermicide common drug, the vaginal jellies after specially a kind of fibroin albumen and chitosan are compound, including
The each component of following mass concentration：Fibroin albumen 2-8%；Chitosan 0.5-2%；Acritamer 940 or hydroxypropyl methyl fiber
Plain 0.5-2%；Glycerine and propane diols 5-12%；Water surplus, regulation pH value is between 3.5-5.
The preparation method of above-mentioned vaginal jellies is as follows：Chitosan is dissolved in 2% acetic acid solution, fibroin albumen uses bromination
Lithium method is prepared according to standard step, passes through 0.22 μm of filtration sterilization.Then mixed according to different proportion, while add 5-10%
Propane diols and glycerine as wetting agent and NMF and a certain amount of adhesion enhancer, it is equal to be eventually adding spermicide stirring
It is even, with lemon acid for adjusting pH between 3.5-5, surplus is supplied with sterilized water, stirs and both obtains finished product.The present invention relative to
The beneficial effect of prior art is：
(1) by the interaction of 2 kinds of materials of chitosan/fibroin albumen and ratio adjustment, can to form pore size controllable
Gel-type vehicle, realize the sustained release and controlled release of contraceptive, reduce side effects of pharmaceutical drugs as far as possible.It can also pass through 2 kinds of materials simultaneously
Different ratio realize it is other load medicine function (hesperidine of phosphorylation, sulfonated hesperidine, PSS, substitutions
Benzene sulfonic acid copolyoxymethylenes, H2SO4- modification mandelic acid, PVP-I, ketoconazole, Miconazole, Fluconazole, Yi Kang azoles, she
Triaconazole, Te Lakang azoles, metronidazole, clotrimazole, Tinidazole, chloramphenicol, nystatin, ciclopirox olamine and silver etc.)
(2) damage of female reproduction mucous membrane will not be caused, will not also destroy the existence ring of vaginal bacteria and normal flora
Border, antibacterial action is provided simultaneously with, prevents and treats RTI relevant disease.
(3) chitosan/fibroin albumen mixing material can not only degrade, and its catabolite can directly be inhaled by human body
Receive, seldom even can play lubrication without discharge to the genital tract of women, prevent genital tract from sustaining damage.Can also be to the moon
Road is dry and astringent etc. to may also function as certain nutrition and health care effect, improves ill symptomses.
(4) nonoxinol is to think most effective and most widely used external contraceptive medicine, but research shows, extensively, greatly
Amount and long-term use then vagina and epithelium of cervix uteri may rupture, and cause female genital tract mucosa injury.The present invention's is compound solidifying
Glue preparation can not only prevent the infection of pathogen after mucosa injury, and also function to positive role to repairing mucosa injury.
(5) conception control gel pH value of the invention is similar to vaginal environment, will not destroy the balance of vagina normal flora, safeguards
The natural cover of vagina, and reach pre- aseptic effect.Compared with most existing preparation occupation modes, present invention contraception vagina
Gel is equipped with disposable long head drug feeding pipe, and preparation is sent into posterior fornix part, can preferably play insoluble drug release effect.
Embodiment
The present invention is described in further details below by embodiment, these embodiments are only used for illustrating the present invention, and
Do not limit the scope of the invention.
Embodiment 1
It is put into 1. 40g silk cocoons are uniformly shredded in the sodium carbonate liquor that 4L mass concentrations are 0.075%, in 98~100
DEG C processing 0.5 hour and is stirred, and filters suspension after stirring, filter residue is cleaned with deionized water after filtering, is placed again into 4L
Spend in the sodium carbonate liquor for 0.05%, handle 0.5 hour, washed after filtering, being then placed in 4L degree is in 98~100 DEG C
In 0.05% sodium carbonate liquor, make natural silk degumming, sterilized water fully washs, and vacuum drying oven obtains pure silk cellulose fiber after drying.
The lithium-bromide solution that 20g pure silk cellulose fibers are dissolved in the mol/Ls of 100mL 9.3 is weighed, in 60 ± 2 DEG C of stirring and dissolvings into fibroin albumen
Mixed solution, filtered through gauze is applied by 3 layers, removes undissolved silk and other impurity；Then mixed solution is loaded
In bag filter, dialysed 3 days with deionized water, remove lithium bromide, obtain pure silk fibroin protein solution.
2. the chitosan of certain mass is dissolved in 1.0% (V/v) aqueous acetic acid, 12h is stirred at room temperature, is matched somebody with somebody respectively
1wt% chitosan-acetic acid solution is made.Filtered through four layers of hospital gauze, remove the insoluble impurity in part, you can it is saturating to obtain clarification
Bright slightly yellow chitosan solution.Prepared chitosan solution must use in 24 hours.
3. by 4% fibroin albumen；2% chitosan；2% Acritamer 940；Glycerine and propane diols 10% add mixing and stirred one by one
Mix, then add 2% Octoxinol, water surplus, fibroin albumen/chitosan plural gel is both obtained with lemon acid for adjusting pH value to 4.
Embodiment 2
By the fibroin albumen prepared and chitosan according to 6% fibroin albumen, the mixing of 1% chitosan ratio；Add one by one
1% hydroxypropyl methyl cellulose；Glycerine and propane diols 10% mix stirring, then add 10% benzalkonium chloride, water surplus, use lemon
Lemon acid for adjusting pH value both obtains fibroin albumen/chitosan plural gel to 3.5.
Embodiment 3
By the fibroin albumen prepared and chitosan according to 4% fibroin albumen, the mixing of 1.5% chitosan ratio；One by one plus
Enter 0.5% hydroxypropyl methyl cellulose；Glycerine and propane diols 8% mix stirring, then add 4% nonoxinol, peppermint
(Menthapiperata, content 0.01%-0.1%), borneol (Bomeol, content 0.02%-0.1%) water surplus, use lemon
Acid for adjusting pH value both obtains fibroin albumen/chitosan plural gel to 4.5.
Finally, it is also necessary to it is noted that listed above is only specific embodiment of the invention.Obviously, the present invention not
It is limited to above embodiment, there can also be many modifications.One of ordinary skill in the art can be straight from present disclosure
Connect export or that associates include all modifications of fibroin albumen, be considered as protection scope of the present invention.
Claims (4)
1. a kind of contraceptive vagina gel with antibacterial action, it is characterised in that the component of the gel includes conventional spermicidal
Agent, Silk fibroin gel matrix, chitosan gel rubber matrix, NMF, adhesion enhancer and water, and it is made solidifying by following steps
Jelly：By stirring and evenly mixing after prepared by 2 kinds of matrix, add NMF and mix, add spermatocide and stir, finally lead to
PH value is overregulated close to vagina biological value, and gel is made after stirring.
2. conception control gel is filled, by syringe-type tool injection in vagina depths, quantitative accurate administration can be achieved.
3. a kind of fibroin albumen/chitosan plural gel according to claim 1, including mass concentration after following optimization
Each component：Fibroin albumen 4%；Chitosan 1%；0.5% benzalkonium chloride；Acritamer 940 1%；Glycerine and propane diols 10%；More than water
Amount, by lemon acid for adjusting pH value 4.It is finally gel-filled in disposable long cylinder administration tool by made from.
4. the conception control gel agent according to claim 1 with antibacterial action, it is characterised in that spermatocide selects nonylbenzene alcohol
Any one in film, Octoxinol and benzalkonium chloride.The antibacterial action possessed by chitosan carries out antibiotic and sterilizing.Pass through silk
Fibroin and chitosan extremely catabolite possess the effect of moisturizing, lubrication and health care.NMF be selected from propane diols, glycerine and
One or two kinds of combination in polyethylene glycol.Without antibiotic and preservative.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610811191.9A CN107811964A (en) | 2016-09-09 | 2016-09-09 | Antibacterial conception control gel that is biodegradable and realizing dosed administration |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610811191.9A CN107811964A (en) | 2016-09-09 | 2016-09-09 | Antibacterial conception control gel that is biodegradable and realizing dosed administration |
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| CN107811964A true CN107811964A (en) | 2018-03-20 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610811191.9A Pending CN107811964A (en) | 2016-09-09 | 2016-09-09 | Antibacterial conception control gel that is biodegradable and realizing dosed administration |
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| CN109745300A (en) * | 2019-02-02 | 2019-05-14 | 沈阳得康医药科技有限公司 | Physics conception control gel film forming agent without spermicide |
| CN110327286A (en) * | 2019-07-29 | 2019-10-15 | 江苏迦南美地生物科技有限公司 | A kind of antibacterial conception control gel of gynaecology containing sophora alapecuroides ingredient |
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