JP5568114B2 - 抗菌性製剤の輸液を調製するための医薬組成物、その製造方法 - Google Patents
抗菌性製剤の輸液を調製するための医薬組成物、その製造方法 Download PDFInfo
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- JP5568114B2 JP5568114B2 JP2012170753A JP2012170753A JP5568114B2 JP 5568114 B2 JP5568114 B2 JP 5568114B2 JP 2012170753 A JP2012170753 A JP 2012170753A JP 2012170753 A JP2012170753 A JP 2012170753A JP 5568114 B2 JP5568114 B2 JP 5568114B2
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- colloidal silica
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- dextrose
- antibacterial
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Classifications
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- A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
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- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
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Description
滅菌注射用水、0.45%塩化ナトリウム溶液、および0.9%塩化ナトリウム溶液に溶解可能な抗菌性製剤の輸液を調製するための医薬組成物であって、本医薬組成物は、粉末形態であり、塩化ナトリウムとコロイダルシリカとをそれぞれ4.5:1〜4.5:5または9:1〜9:5の質量比で含むことを特徴とする。
滅菌注射用水、2%デキストロース溶液、および5%デキストロース溶液に溶解可能な、抗菌性製剤の輸液を調製するための医薬組成物であって、本医薬組成物は、粉末形態であり、さらに、デキストロースとコロイダルシリカとをそれぞれ20:1〜20:5または50:1〜50:5の質量比で含むことを特徴とする。
固形の組成物(NaCl:コロイダルシリカ)の製造
塩化ナトリウムとコロイダルシリカとの質量比が4.5:1、4.5:2、4.5:5、9:1、9:2および9:5のブレンドをドラム式の回転ミルで1、2または4時間処理した。
固形の組成物(デキストロース:コロイダルシリカ)の製造
デキストロースとコロイダルシリカとの質量比が20:1、20:2、20:5、50:1、50:2および50:5のブレンドをドラム式の回転ミルで1、2または4時間処理した。
本医薬組成物の使用に基づく抗菌性製剤の治療効率の決定(抗菌性製剤の静脈注射用溶液を製造した)
ラクタム系抗生物質(アモキシシリン+クラブラン酸塩、セフォタキシム、セフトリアキソン、セフォペラゾン+スルバクタム、セフタジジム、セフェピム、アズトレオナム、メロペネム)、マクロライド系(アジスロマイシン)、アミノグルコシド系(アミカシンスルフェート)、糖ペプチド(バンコマイシン)、抗真菌剤(ボリコナゾール)、加えてホスホマイシンを調査した。
微生物:黄色ブドウ球菌(ATCC番号25923F−49)、大腸菌(АТСС番号25922F−50)、緑膿菌(ATCC番号27853F−51)、カンジダ・アルビカンス(ATCC番号24433)を用いた。
上記マウスに、緑膿菌の1日培養懸濁液0.8mlを5×108CFU/マウスの用量で、または、黄色ブドウ球菌の1日培養懸濁液を1010CFU/マウスの用量で、または、大腸菌の1日培養懸濁液を8×108CFU/マウスの用量で、または、カンジダ・アルビカンスの1日培養懸濁液を1010CFU/マウスの用量で静脈内注射した。マウスのコントロール群に、0.9%NaCl溶液または5%デキストロース溶液を体積0.8mlで注射した。
得られたデータを表3および4に示したが、これらは、3回の独立した実験の結果を反映したものである(それぞれの調製試験ごとに少なくとも30匹の試験動物を用いた)。
1.Kucers’ The use of antibiotics// By M.L.Grauson, S.M.Crowe, J.S.McCarthy et al. 6th ed, 2 vols, 3000 pp. London, UK, Hodder Education/ASM Press, 2010.
2.Abeylath S.C., Turos E. Drug delivery approaches to overcome bacterial resistance to β-lactam antibiotics // Expert Opinion on Drug Delivery. - 2008. - Vol.5.- P.931-949.
3.Bastus N.G., Sanchez-Tillo E., Pujals S. et al. Peptides conjugated to gold nanoparticles induce macrophage activation // Molecular Immunology. - 2009. - Vol.46. - P.743-748.
4.Pinto-Alphandary H., Andremont A., Couvreur P. Targeted delivery of antibiotics using liposomes and nanoparticles: research and applications // International Journal of Antimicrobial Agents. - 2000. - Vol.13. - P.155-168.
5.Ulbrich W., Lamprech A. Targeted drug-delivery approaches by nanoparticulate carriers in the therapy of inflammatory diseases // Journal Royal Society Interface. - 2010. - Vol.7, Suppl. 1. - P.S55-S66.
6.Rosemary M.J., MacLaren I., Pradeep T. Investigation of antibacterial properties of ciprofloxacin@SiO2. // Langmuir. - 2006. - Vol.22. - P.10125-10129.
7.Rai A., Prabhune A., Perry C.C. Antibiotic mediated synthesis of gold nanoparticles with potent antimicrobial activity and their application in antimicrobial coatings // Journal of Materials Chemistry. - 2010. - Vol.20. - P.6789-6798.
8.Zolnik B.S., Gonzalez-Fernandez A., Sadrieh N., Dobrovolskaia V. Minireview: Nanoparticles and the immune system // Endocrinology. - 2010. - Vol.151. - P.458-465.
9.Pinto-Alphandary H., Balland O., Laurent M. et al. Intracellular visualization of ampicillin-loaded nanoparticles in peritoneal macrophages infected in vitro with Salmonella typhimurium // Pharmaceutical Research. - 1994. - Vol.11. - P.38-46.
10.Park J-H., Gu L., Maltzahn G. et al. Biodegradable luminescent porous silicon nanoparticles for in vivo applications // Nature Materials. - 2009. - Vol.8. - P.331-336.
11.Hetrick E.M., Shin J.H., Stasko N.A. et al. Bactericidal efficacy of nitric oxide-releasing silica nanoparticles// ACS Nano. - 2008. - Vol.2. - P.235-246.
12.Pernis B. Silica and the immune system // Acta Biomed. - 2005. - Vol.76, Suppl. 2.- P.38-44.
13.Tasciotti E., Liu X., Bhavane R. Et et al. Mesoporous silicon particles as a multistage delivery system for imaging and therapeutic applications // Nature Nanotechnology. - 2008. - Vol.3. - P.151-157.
14.Seleem M.N., Munusamy P., Ranjan A et al. Silica-antibiotic hybrid nanoparticles for targeting intracellular pathogens // Antimicrobial Agents and Chemotherapy. - 2009. - Vol.53. - P.4270-4274.
15.Chuiko A., Pentyuk A., Shtat’ko E., Chuiko N. Medical aspects of application of highly disperse amorphous silica // Surface Chemistry in Biomedical and Environmental Science. Edited by J.P.Blitz and V. Gun’ko.II. Mathematics, Physics and Chemistry. - 2006. - Vol.228. - P.191-204.
16.Waters K.M., Masiello L.M., Zangar R.C. et al. Macrophage responses to silica nanoparticles are highly conserved across particle sizes // Toxicological Sciences. - 2009. - Vol.107. - P. 553-569.
17.Lucarelli M., Gatti A.M., Savarino G. et al. Innate defence functions of macrophages can be biased by nano-sized ceramic and metallic particles // European Cytokine Network. - 2004. - Vol.15. - P.339-346.
18.Hamilton R.F., Thakur S.A., Mayfair J.K., Holian A. MARCO mediates silica uptake and toxicity in alveolar macrophages from C57BL/6 mice // Journal Biological Chemistry. - 2006. - Vol.281. - P. 34218-34226.
19.Eckhardt С., Fickweiler K., Schaumann R. et al. Therapeutic efficacy of moxifloxacin in a murine model of severe systemic mixed infection with E.coli and B.fragilis // Anaerobe.- 2003.- Vol.9.- P.157-160.
20.Schaumann R., Blatz R., Beer J. et al. Effect of moxifloxacin versus imipenem/cilastatin treatment on the mortality of mice infected intravenously with different strains of Bacteroides fragilis and Escherichia coli // Journal of Antimicrobial Chemotherapy. - 2004. - Vol.53. - P.318-324.
Claims (4)
- 滅菌注射用水、0.45%塩化ナトリウム溶液、および0.9%塩化ナトリウム溶液に溶解可能な抗菌性製剤の注入用溶液を調製するための医薬組成物であって、粉末形態であり、塩化ナトリウムとコロイダルシリカとをそれぞれ4.5:1〜4.5:5または9:1〜9:5の質量比で含むことを特徴とする、上記組成物。
- 滅菌注射用水、2%デキストロース溶液、および5%デキストロース溶液に溶解可能な抗菌性製剤の注入用溶液を調製するための医薬組成物であって、粉末形態であり、デキストロースとコロイダルシリカとをそれぞれ20:1〜20:5または50:1〜50:5の質量比で含むことを特徴とする、上記組成物。
- 粉末塩化ナトリウムと粉末状のコロイダルシリカとを、塩化ナトリウムとコロイダルシリカとの質量比がそれぞれ4.5:1〜4.5:5または9:1〜9:5で混合すること、および、
得られた混合物を、衝撃力と摩擦力の作用により、5マイクロメートルまたはそれ未満のコロイダルシリカ粒子の質量分率が少なくとも2倍に高められるまで機械処理すること、
を含む、抗菌性製剤の注入用液を調製するための医薬組成物の製造方法。 - 粉末デキストロースと粉末状のコロイダルシリカとを、デキストロースとコロイダルシリカとの質量比がそれぞれ20:1〜20:5または50:1〜50:5で混合すること、および、
得られた混合物を、衝撃力と摩擦力の作用により、5マイクロメートルまたはそれ未満のコロイダルシリカ粒子の質量分率が少なくとも2倍に高められるまで機械処理すること、
を含む、抗菌性製剤の注入用液を調製するための医薬組成物の製造方法。
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RU2333920C2 (ru) | 2002-08-09 | 2008-09-20 | Акцо Нобель Коатингс Интернэшнл Б.В. | Кватернизованный полимер с кислотными блокирующими группами, его получение, композиции и применение |
US7563451B2 (en) | 2003-07-22 | 2009-07-21 | Iowa State University Research Foundation, Inc. | Capped mesoporous silicates |
EA013864B1 (ru) * | 2008-08-29 | 2010-08-30 | Лимонова, Анастасия Викторовна | Способ повышения антимикробной активности цефалоспориновых антибиотиков |
EA021875B1 (ru) | 2010-09-20 | 2015-09-30 | ЛИМОНОВ, Виктор Львович | Фармацевтическая композиция антимикробного и ранозаживляющего действия для наружного применения, способ ее получения |
EA021876B1 (ru) * | 2010-09-20 | 2015-09-30 | ЛИМОНОВ, Виктор Львович | Фармацевтическая композиция антимикробного и противовоспалительного действия для парентерального введения, способ ее получения |
RU2476206C1 (ru) | 2011-11-22 | 2013-02-27 | Виктор Львович Лимонов | Фармацевтическая композиция для приготовления инфузионных растворов антимикробных препаратов, способ ее получения (варианты) |
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