CN102335113A - Clindamycin phosphate vaginal sustained-release gel and its preparation method - Google Patents
Clindamycin phosphate vaginal sustained-release gel and its preparation method Download PDFInfo
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- CN102335113A CN102335113A CN2010102311280A CN201010231128A CN102335113A CN 102335113 A CN102335113 A CN 102335113A CN 2010102311280 A CN2010102311280 A CN 2010102311280A CN 201010231128 A CN201010231128 A CN 201010231128A CN 102335113 A CN102335113 A CN 102335113A
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- clindamycin phosphate
- poloxamer
- carbomer
- releasing
- water
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- UFUVLHLTWXBHGZ-MGZQPHGTSA-N [(2r,3r,4s,5r,6r)-6-[(1s,2s)-2-chloro-1-[[(2s,4r)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate Chemical compound CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@H](C)Cl)[C@@H]1[C@H](O)[C@H](O)[C@@H](OP(O)(O)=O)[C@@H](SC)O1 UFUVLHLTWXBHGZ-MGZQPHGTSA-N 0.000 title claims abstract description 39
- 229960002291 clindamycin phosphate Drugs 0.000 title claims abstract description 39
- 238000013268 sustained release Methods 0.000 title claims abstract description 7
- 239000012730 sustained-release form Substances 0.000 title claims abstract description 7
- 238000002360 preparation method Methods 0.000 title abstract description 10
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims abstract description 29
- 210000001215 vagina Anatomy 0.000 claims abstract description 26
- 229920002125 Sokalan® Polymers 0.000 claims abstract description 20
- 229960001631 carbomer Drugs 0.000 claims abstract description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 20
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims abstract description 15
- 229920001993 poloxamer 188 Polymers 0.000 claims abstract description 10
- 229920001992 poloxamer 407 Polymers 0.000 claims abstract description 10
- 239000000654 additive Substances 0.000 claims abstract description 9
- 230000000996 additive effect Effects 0.000 claims abstract description 9
- 230000002421 anti-septic effect Effects 0.000 claims description 9
- 239000002738 chelating agent Substances 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 9
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims description 6
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims description 5
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 5
- 239000004599 antimicrobial Substances 0.000 claims description 5
- 239000006185 dispersion Substances 0.000 claims description 5
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 5
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 5
- 239000007788 liquid Substances 0.000 claims description 5
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 5
- GYCKQBWUSACYIF-UHFFFAOYSA-N o-hydroxybenzoic acid ethyl ester Natural products CCOC(=O)C1=CC=CC=C1O GYCKQBWUSACYIF-UHFFFAOYSA-N 0.000 claims description 5
- 238000012856 packing Methods 0.000 claims description 5
- 229920001983 poloxamer Polymers 0.000 claims description 5
- 229960000502 poloxamer Drugs 0.000 claims description 5
- 230000008961 swelling Effects 0.000 claims description 5
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims description 4
- SHWNNYZBHZIQQV-UHFFFAOYSA-J EDTA monocalcium diisodium salt Chemical compound [Na+].[Na+].[Ca+2].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O SHWNNYZBHZIQQV-UHFFFAOYSA-J 0.000 claims description 2
- 235000019445 benzyl alcohol Nutrition 0.000 claims description 2
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims description 2
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims description 2
- 229960003415 propylparaben Drugs 0.000 claims description 2
- 229950004777 sodium calcium edetate Drugs 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 5
- 230000000857 drug effect Effects 0.000 abstract description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 abstract 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 abstract 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 8
- 229940079593 drug Drugs 0.000 description 5
- 208000015181 infectious disease Diseases 0.000 description 4
- OJMMVQQUTAEWLP-UHFFFAOYSA-N Lincomycin Natural products CN1CC(CCC)CC1C(=O)NC(C(C)O)C1C(O)C(O)C(O)C(SC)O1 OJMMVQQUTAEWLP-UHFFFAOYSA-N 0.000 description 3
- 229960002227 clindamycin Drugs 0.000 description 3
- KDLRVYVGXIQJDK-AWPVFWJPSA-N clindamycin Chemical compound CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@H](C)Cl)[C@@H]1[C@H](O)[C@H](O)[C@@H](O)[C@@H](SC)O1 KDLRVYVGXIQJDK-AWPVFWJPSA-N 0.000 description 3
- OJMMVQQUTAEWLP-KIDUDLJLSA-N lincomycin Chemical compound CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@@H](C)O)[C@@H]1[C@H](O)[C@H](O)[C@@H](O)[C@@H](SC)O1 OJMMVQQUTAEWLP-KIDUDLJLSA-N 0.000 description 3
- 229960005287 lincomycin Drugs 0.000 description 3
- 230000000813 microbial effect Effects 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 238000001879 gelation Methods 0.000 description 2
- 230000012010 growth Effects 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 201000009273 Endometriosis Diseases 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 206010021718 Induced labour Diseases 0.000 description 1
- 241001597008 Nomeidae Species 0.000 description 1
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 1
- 206010046798 Uterine leiomyoma Diseases 0.000 description 1
- YVZLYNHKJASIHA-UHFFFAOYSA-L [Na+].[K+].OP(O)([O-])=O.OP(O)([O-])=O Chemical group [Na+].[K+].OP(O)([O-])=O.OP(O)([O-])=O YVZLYNHKJASIHA-UHFFFAOYSA-L 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 210000003756 cervix mucus Anatomy 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000005906 menstruation Effects 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000008057 potassium phosphate buffer Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 229940044977 vaginal tablet Drugs 0.000 description 1
- 239000000003 vaginal tablet Substances 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to a clindamycin phosphate vaginal sustained-release gel and its preparation method. The clindamycin phosphate vaginal sustained-release gel comprises the following components of: by weight, 1-5% of clindamycin phosphate, 5-15% of poloxamer (188), 8-20% of poloxamer (407), 0.5-2% of sodium carboxymethyl cellulose, 0.05-2% of carbomer (980), 0.02-5% of an additive and the balance being water. The clindamycin phosphate vaginal sustained-release gel provided by the invention has advantages of clear curative effect, long detention time in vagina, sustained release of the drug effect, long onset time and good compliance of patients.
Description
Technical field
The present invention relates to the pharmaceutical preparation aspect, relate in particular to a kind of antifungal medicament preparation, particularly clindamycin phosphate vagina slowly-releasing gel and preparation method thereof.
Background technology
The local environment of vagina makes it to become the target of disease and infection, and intravaginal is warm, moist and dark environment is of value to various microbial growths; Slit in the vaginal canal helps undesired bacteria, fungus, yeast and other microorganism in addition and from the delay of menstruation and sexual intercourse residue, these all help microbial growth, make vagina become the position occurred frequently of various infection.
The research of vagina administration is also more, mainly contains two kinds of situation, and a kind of is that the part plays a role, and a kind of is to play a role after absorbing through vaginal mucosa.The vagina topical is mainly used in the partial infection of vagina, endometriosis, hysteromyoma, induced labor etc.
It is synthetic first that clindamycin replaced in lincomycin molecule 7th hydroxyl by Magerlerin etc. with chlorine in 1966, compares with lincomycin, and the antibacterial activity of clindamycin strengthens 4～8 times, and untoward reaction is low.Clindamycin phosphate is the semi-synthetic derivant of lincomycin, is one and has the spectrum antibiotic of seeing anaerobe and aerobe effect concurrently, in external no antibiotic activity, is hydrolyzed into clindamycin rapidly and its pharmacologically active of reality behind the entering human body.Mainly gram-positive cocci and anaerobe there are very strong antibacterial activity, are used to treat the microbial various infectious disease of gram positive bacteria and anaerobism.
The dosage form that is used for the clindamycin phosphate of vagina administration at present mainly is emulsifiable paste, gel, vaginal tablet, vagina effervescence etc.; All belong to ordinary preparation, ordinary preparation is used for vagina administration and mainly contains following problem: a) leak easily, behind the ordinary preparation vagina medicinal; Under vaginal secretions and excremental effect; Generally in 3 hours, will spill or come off, cause drug loss, curative effect is relatively poor; Because medicine be prone to leak, so require patient's preceding administration of sleeping at night, patient's compliance is bad in addition.B) medication is leaked owing to exist often, and medicine is short action time in intravaginal, therefore in most cases, needs repeatedly medication, and the course of treatment is long, and patient's compliance is difficult to guarantee.
Summary of the invention
To existing clindamycin phosphate preparation be prone to come off in intravaginal, administration number of times is many; The problem of patient's poor compliance, the object of the present invention is to provide that a kind of therapeutic effect is clear and definite, long in the intravaginal holdup time, drug effect continues to discharge, can long-time onset, the clindamycin phosphate vagina slowly-releasing gel of good patient compliance.
Another object of the present invention is to provide a kind of method for preparing of clindamycin phosphate vagina slowly-releasing gel.
In order to realize the foregoing invention purpose, the present invention adopts following technical scheme:
Clindamycin phosphate vagina slowly-releasing sustained-release gel; Comprise following components in weight percentage: clindamycin phosphate 1%-5%, poloxamer (188) 5%-15%, poloxamer (407) 8%-20%; Carmethose 0.5%-2%; Carbomer (980) 0.05%-2%, additive 0.02%-5% remains and is water.
Clindamycin phosphate vagina slowly-releasing gel of the present invention preferably includes following components in weight percentage: clindamycin phosphate 1.5%-3%; Poloxamer (188) 5%-10%; Poloxamer (407) 10%-13%, carmethose 0.5%-1.5%, carbomer (980) 0.05%-1.5%; Additive 0.02%-3 remains and is water.
Clindamycin phosphate vagina slowly-releasing gel optimum formula of the present invention comprises following components in weight percentage: clindamycin phosphate 2%, poloxamer (188) 8%, poloxamer (407) 12%; Carmethose 1%; Carbomer (980) 1%, additive 0.2%, water 75.8%.
Described additive is a kind of or the two mixing wherein of antiseptic, chelating agent.
Described antiseptic is one or more mixing in methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben, the benzyl alcohol.
Said is a kind of or its mixing in disodium edetate, the sodium calcium edetate to chelating agent.
The invention also discloses the method for preparing of clindamycin phosphate vagina slowly-releasing gel; At first carbomer is scattered in earlier in an amount of water, treats after its swelling again antiseptic and chelating agent are dissolved in 80 ℃ the water, put cold after waiting to dissolve; Clindamycin phosphate, poloxamer and carmethose are stirred adding down wherein; After 4 ℃ of condition held etc. had been dissolved, after the carbomer dispersion liquid mixed, packing promptly got.
According to the invention to clindamycin phosphate vagina slowly-releasing gel, therapeutic effect is clear and definite, long in the intravaginal holdup time, drug effect continues to discharge, can long-time onset, good patient compliance.
The specific embodiment
Through specific embodiment the present invention is done further explanation below.
Embodiment 1: prescription is formed:
Clindamycin phosphate 2%
Poloxamer (188) 7%
Poloxamer (407) 18%
Carmethose 1%
Carbomer (980) 1.2%
Methyl hydroxybenzoate 0.02%
Ethyl hydroxybenzoate 0.01%
EDTA-2Na 0.1％
Water surplus
Method for preparing:
Carbomer is scattered in an amount of water swelling of spending the night earlier; Antiseptic and chelating agent be dissolved in 80 ℃ the water, put coldly after waiting to dissolve, clindamycin phosphate, poloxamer and carmethose stirred down add wherein, after 4 ℃ of condition held etc. had been dissolved, after the carbomer dispersion liquid mixed, packing promptly got.
Embodiment 2
Prescription is formed:
Clindamycin phosphate 2%
Poloxamer (188) 8%
Poloxamer (407) 12%
Carmethose 1%
Carbomer (980) 1%
Methyl hydroxybenzoate 0.02%
Ethyl hydroxybenzoate 0.01%
EDTA-2Na 0.17％
Water surplus
Method for preparing:
Carbomer is scattered in an amount of water swelling of spending the night earlier; Antiseptic and chelating agent be dissolved in 80 ℃ the water, put coldly after waiting to dissolve, clindamycin phosphate, poloxamer and carmethose stirred down add wherein, after 4 ℃ of condition held etc. had been dissolved, after the carbomer dispersion liquid mixed, packing promptly got.
Embodiment 3
Prescription is formed:
Clindamycin phosphate 2%
Poloxamer (188) 15%
Poloxamer (407) 8%
Carmethose 0.6%
Carbomer (980) 1%
Methyl hydroxybenzoate 0.02%
Ethyl hydroxybenzoate 0.01%
EDTA-2Na 0.17％
Water surplus
Method for preparing:
Carbomer is scattered in an amount of water swelling of spending the night earlier; Antiseptic and chelating agent be dissolved in 80 ℃ the water, put coldly after waiting to dissolve, clindamycin phosphate, poloxamer and carmethose stirred down add wherein, after 4 ℃ of condition held etc. had been dissolved, after the carbomer dispersion liquid mixed, packing promptly got.
Embodiment 4
For estimating the slow-releasing gel used drug release behavior of clindamycin phosphate, carry out the test of release in vitro degree, test method is following:
The gel 5g that gets among the embodiment 1,2,3 places in the semipermeable membrane bag, and two ties, and lies on the oar of digestion instrument; Adopt 2005 editions two appendix XD drug release determinations of Chinese Pharmacopoeia method, second subtraction unit to measure; Release medium is that pH value is sodium hydrogen phosphate-potassium phosphate buffer 500ml of 4.9, and oar method rotating speed is 50rpm, respectively sampling in 2,8,24,48,72,96,120 hours; Adopt the HPLC method to measure, calculate tired only degree of release.The result is following:
| 2 hours | 8 hours | 24 hours | 48 hours | 72 hours | 96 hours | 120 hours | |
| Embodiment 1 | 6.3％ | 21.7％ | 48.3％ | 66.5％ | 79.5％ | 90.3％ | 98.4％ |
| Embodiment 2 | 5.6％ | 18.4％ | 40.8％ | 58.5％ | 72.4％ | 84.3％ | 92.1％ |
| Embodiment 3 | 6.2％ | 22.5％ | 46.2％ | 68.4％ | 81.8％ | 89.1％ | 95.3％ |
The result shows that the sample of three embodiment all can reach 6 days slow release effects, and wherein the sample slow-release time of embodiment 2 preparations is longer.
Claims (7)
1. clindamycin phosphate vagina slowly-releasing sustained-release gel; It is characterized in that comprising following components in weight percentage: clindamycin phosphate 1%-5%, poloxamer (188) 5%-15%, poloxamer (407) 8%-20%; Carmethose 0.5%-2%; Carbomer (980) 0.05%-2%, additive 0.02%-5% remains and is water.
2. clindamycin phosphate vagina slowly-releasing gel according to claim 1; It is characterized in that comprising following components in weight percentage: clindamycin phosphate 1.5%-3%, poloxamer (188) 5%-10%, poloxamer (407) 10%-13%; Carmethose 0.5%-1.5%; Carbomer (980) 0.05%-1.5%, additive 0.02%-3 remains and is water.
3. clindamycin phosphate vagina slowly-releasing gel according to claim 1; It is characterized in that comprising following components in weight percentage: clindamycin phosphate 2%, poloxamer (188) 8%, poloxamer (407) 12%; Carmethose 1%; Carbomer (980) 1%, additive 0.2%, water 75.8%.
4. according to the described clindamycin phosphate vagina slowly-releasing of claim 1～3 gel, it is characterized in that described additive is a kind of or the two mixing wherein of antiseptic, chelating agent.
5. clindamycin phosphate vagina slowly-releasing gel according to claim 4 is characterized in that described antiseptic is one or more mixing in methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben, the benzyl alcohol.
6. said to clindamycin phosphate vagina slowly-releasing gel according to claim 4, it is characterized in that said is a kind of or its mixing in disodium edetate, the sodium calcium edetate to chelating agent.
7. according to the method for preparing of the described clindamycin phosphate vagina slowly-releasing of claim 1～3 gel; It is characterized in that at first carbomer being scattered in earlier in an amount of water, treat after its swelling again antiseptic and chelating agent are dissolved in 80 ℃ the water, put cold after waiting to dissolve; Clindamycin phosphate, poloxamer and carmethose are stirred adding down wherein; After 4 ℃ of condition held etc. had been dissolved, after the carbomer dispersion liquid mixed, packing promptly got.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102311280A CN102335113A (en) | 2010-07-20 | 2010-07-20 | Clindamycin phosphate vaginal sustained-release gel and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102311280A CN102335113A (en) | 2010-07-20 | 2010-07-20 | Clindamycin phosphate vaginal sustained-release gel and its preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102335113A true CN102335113A (en) | 2012-02-01 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010102311280A Pending CN102335113A (en) | 2010-07-20 | 2010-07-20 | Clindamycin phosphate vaginal sustained-release gel and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102335113A (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1850101A (en) * | 2006-03-06 | 2006-10-25 | 李海涛 | Compound vitamin A acid gel preparation for treating acne and its preparing method |
| CN101500583A (en) * | 2006-07-12 | 2009-08-05 | 控制治疗（苏格兰）有限公司 | Drug delivery polymer with hydrochloride salt of clindamycin |
| CN101744833A (en) * | 2008-12-02 | 2010-06-23 | 济南宏瑞创博医药科技开发有限公司 | Medicinal composition for treating bacterial vaginitis |
-
2010
- 2010-07-20 CN CN2010102311280A patent/CN102335113A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1850101A (en) * | 2006-03-06 | 2006-10-25 | 李海涛 | Compound vitamin A acid gel preparation for treating acne and its preparing method |
| CN101500583A (en) * | 2006-07-12 | 2009-08-05 | 控制治疗（苏格兰）有限公司 | Drug delivery polymer with hydrochloride salt of clindamycin |
| CN101744833A (en) * | 2008-12-02 | 2010-06-23 | 济南宏瑞创博医药科技开发有限公司 | Medicinal composition for treating bacterial vaginitis |
Non-Patent Citations (1)
| Title |
|---|
| 杨清华等: "克林霉素磷酸酯阴道凝胶的制备及质量控制", 《中国医院药学杂志》 * |
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Application publication date: 20120201 |