CN109771371A - 一种克林霉素磷酸酯注射液及其制备方法 - Google Patents
一种克林霉素磷酸酯注射液及其制备方法 Download PDFInfo
- Publication number
- CN109771371A CN109771371A CN201910207258.1A CN201910207258A CN109771371A CN 109771371 A CN109771371 A CN 109771371A CN 201910207258 A CN201910207258 A CN 201910207258A CN 109771371 A CN109771371 A CN 109771371A
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- CN
- China
- Prior art keywords
- clindamycin phosphate
- injection
- preparation
- water
- clindamycin
- Prior art date
- 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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Links
- 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 55
- 229960002291 clindamycin phosphate Drugs 0.000 title claims abstract description 55
- 238000002347 injection Methods 0.000 title claims abstract description 30
- 239000007924 injection Substances 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 26
- 239000008215 water for injection Substances 0.000 claims abstract description 23
- 230000001954 sterilising effect Effects 0.000 claims abstract description 18
- SRLOHQKOADWDBV-NRONOFSHSA-M sodium;[(2r)-2,3-di(octadecanoyloxy)propyl] 2-(2-methoxyethoxycarbonylamino)ethyl phosphate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCCNC(=O)OCCOC)OC(=O)CCCCCCCCCCCCCCCCC SRLOHQKOADWDBV-NRONOFSHSA-M 0.000 claims abstract description 16
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 7
- 238000003756 stirring Methods 0.000 claims description 16
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 14
- 238000001914 filtration Methods 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 7
- 238000004090 dissolution Methods 0.000 claims description 6
- 239000012467 final product Substances 0.000 claims description 6
- 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 claims description 5
- 229960002227 clindamycin Drugs 0.000 claims description 4
- 238000011082 depyrogenation Methods 0.000 claims description 4
- 238000010521 absorption reaction Methods 0.000 claims description 2
- 229910052799 carbon Inorganic materials 0.000 claims description 2
- 238000005262 decarbonization Methods 0.000 claims description 2
- -1 sorbierite is added Chemical compound 0.000 claims description 2
- 238000001179 sorption measurement Methods 0.000 claims description 2
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 2
- 150000002148 esters Chemical class 0.000 claims 2
- 229910052698 phosphorus Inorganic materials 0.000 claims 2
- 239000011574 phosphorus Substances 0.000 claims 2
- 239000007864 aqueous solution Substances 0.000 abstract description 5
- 239000000126 substance Substances 0.000 abstract description 5
- 239000011265 semifinished product Substances 0.000 description 9
- 230000000052 comparative effect Effects 0.000 description 6
- 239000000463 material Substances 0.000 description 5
- 239000000203 mixture Substances 0.000 description 5
- 239000003708 ampul Substances 0.000 description 4
- 239000003610 charcoal Substances 0.000 description 4
- 238000007689 inspection Methods 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 239000000843 powder Substances 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- JZNWSCPGTDBMEW-UHFFFAOYSA-N Glycerophosphorylethanolamin Natural products NCCOP(O)(=O)OCC(O)CO JZNWSCPGTDBMEW-UHFFFAOYSA-N 0.000 description 1
- KEAYESYHFKHZAL-UHFFFAOYSA-N Sodium Chemical compound [Na] KEAYESYHFKHZAL-UHFFFAOYSA-N 0.000 description 1
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000003796 beauty Effects 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 125000002915 carbonyl group Chemical group [*:2]C([*:1])=O 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 229920001427 mPEG Polymers 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 125000001095 phosphatidyl group Chemical group 0.000 description 1
- 150000003014 phosphoric acid esters Chemical class 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229940079827 sodium hydrogen sulfite Drugs 0.000 description 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000012859 sterile filling Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000004154 testing of material Methods 0.000 description 1
- 241001148471 unidentified anaerobic bacterium Species 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
物料组成 | 处方配比(g) |
克林霉素磷酸酯 | 150(按克林霉素计) |
DSPE-mPEG2000 | 3 |
山梨醇 | 0.1 |
注射用水 | 定容至1000ml |
物料组成 | 处方配比(g) |
克林霉素磷酸酯 | 150(按克林霉素计) |
DSPE-mPEG2000 | 6 |
山梨醇 | 0.05 |
注射用水 | 定容至1000ml |
物料组成 | 处方配比(g) |
克林霉素磷酸酯 | 150(按克林霉素计) |
DSPE-mPEG2000 | 4 |
山梨醇 | 0.07 |
注射用水 | 定容至1000ml |
物料组成 | 处方配比(g) |
克林霉素磷酸酯 | 150(按克林霉素计) |
DSPE-mPEG2000 | 5 |
山梨醇 | 0.06 |
注射用水 | 定容至1000ml |
物料组成 | 对比例1:处方配比(g) | 对比例2:处方配比(g) |
克林霉素磷酸酯 | 150(按克林霉素计) | 150(按克林霉素计) |
DSPE-mPEG2000 | 5 | |
山梨醇 | 0.06 | |
注射用水 | 定容至1000ml | 定容至1000ml |
Claims (9)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201910207258.1A CN109771371B (zh) | 2019-03-19 | 2019-03-19 | 一种克林霉素磷酸酯注射液及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN201910207258.1A CN109771371B (zh) | 2019-03-19 | 2019-03-19 | 一种克林霉素磷酸酯注射液及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN109771371A true CN109771371A (zh) | 2019-05-21 |
CN109771371B CN109771371B (zh) | 2020-03-20 |
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Application Number | Title | Priority Date | Filing Date |
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CN201910207258.1A Active CN109771371B (zh) | 2019-03-19 | 2019-03-19 | 一种克林霉素磷酸酯注射液及其制备方法 |
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Country | Link |
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CN (1) | CN109771371B (zh) |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101461783A (zh) * | 2008-12-16 | 2009-06-24 | 海南美大制药有限公司 | 可静脉注射的硫酸奈替米星纳米胶束制剂及其制备方法 |
CN101579308A (zh) * | 2009-06-24 | 2009-11-18 | 山东新华制药股份有限公司 | 一种克林霉素磷酸酯注射液的制备工艺 |
US20130156853A1 (en) * | 2010-09-01 | 2013-06-20 | Peking University | Liquid Compositions of Insoluble Drugs and Preparation Methods Thereof |
US8637074B2 (en) * | 2009-03-31 | 2014-01-28 | Aphios Corporation | Methods for co-encapsulation of combination drugs and co-encapsulated combination drug product |
CN104083325A (zh) * | 2014-07-18 | 2014-10-08 | 国家纳米科学中心 | 一种盐酸伊立替康纳米脂束制剂及其制备方法 |
CN105056242A (zh) * | 2015-09-09 | 2015-11-18 | 上海市徐汇区牙病防治所 | 一种载抗牙周病原菌药物的外用纳米载药系统 |
CN108420793A (zh) * | 2017-12-26 | 2018-08-21 | 厦门本素药业有限公司 | 一种空白混合胶束及其制备方法和应用 |
-
2019
- 2019-03-19 CN CN201910207258.1A patent/CN109771371B/zh active Active
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101461783A (zh) * | 2008-12-16 | 2009-06-24 | 海南美大制药有限公司 | 可静脉注射的硫酸奈替米星纳米胶束制剂及其制备方法 |
US8637074B2 (en) * | 2009-03-31 | 2014-01-28 | Aphios Corporation | Methods for co-encapsulation of combination drugs and co-encapsulated combination drug product |
CN101579308A (zh) * | 2009-06-24 | 2009-11-18 | 山东新华制药股份有限公司 | 一种克林霉素磷酸酯注射液的制备工艺 |
US20130156853A1 (en) * | 2010-09-01 | 2013-06-20 | Peking University | Liquid Compositions of Insoluble Drugs and Preparation Methods Thereof |
CN104083325A (zh) * | 2014-07-18 | 2014-10-08 | 国家纳米科学中心 | 一种盐酸伊立替康纳米脂束制剂及其制备方法 |
CN105056242A (zh) * | 2015-09-09 | 2015-11-18 | 上海市徐汇区牙病防治所 | 一种载抗牙周病原菌药物的外用纳米载药系统 |
CN108420793A (zh) * | 2017-12-26 | 2018-08-21 | 厦门本素药业有限公司 | 一种空白混合胶束及其制备方法和应用 |
Non-Patent Citations (3)
Title |
---|
CHU-MIN LIU等: "High-performance liquid chromatographic determination of clindamycin in human plasma or serum: application to the bioequivalency study of clindamycin phosphate injections", 《JOURNAL OF CHROMATOGRAPHY B: BIOMEDICAL SCIENCES AND APPLICATIONS》 * |
QIUHONG YANG等: "Cabozantinib Loaded DSPE-PEG2000 Micelles as Delivery System: Formulation, Characterization and Cytotoxicity Evaluation", 《BAOJ PHARM SCI.》 * |
杨淼等: "前列地尔PEG-DSPE胶束的制备及其体内外评价", 《泰州职业技术学院学报》 * |
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Publication number | Publication date |
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CN109771371B (zh) | 2020-03-20 |
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PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
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Denomination of invention: A clindamycin phosphate injection and its preparation method Effective date of registration: 20210326 Granted publication date: 20200320 Pledgee: Taihe County SME Financing Guarantee Co.,Ltd. Pledgor: ANHUI LIANYI PHARMACEUTICAL Co.,Ltd. Registration number: Y2021980001982 |
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Date of cancellation: 20210429 Granted publication date: 20200320 Pledgee: Taihe County SME Financing Guarantee Co.,Ltd. Pledgor: ANHUI LIANYI PHARMACEUTICAL Co.,Ltd. Registration number: Y2021980001982 |
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PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A clindamycin phosphate injection and its preparation method Effective date of registration: 20210507 Granted publication date: 20200320 Pledgee: Taihe County SME Financing Guarantee Co.,Ltd. Pledgor: ANHUI LIANYI PHARMACEUTICAL Co.,Ltd. Registration number: Y2021980003340 |
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PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20220325 Granted publication date: 20200320 Pledgee: Taihe County SME Financing Guarantee Co.,Ltd. Pledgor: ANHUI LIANYI PHARMACEUTICAL Co.,Ltd. Registration number: Y2021980003340 |
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PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Clindamycin phosphate injection and its preparation method Effective date of registration: 20220518 Granted publication date: 20200320 Pledgee: Taihe County SME Financing Guarantee Co.,Ltd. Pledgor: ANHUI LIANYI PHARMACEUTICAL Co.,Ltd. Registration number: Y2022980005773 |
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Date of cancellation: 20220601 Granted publication date: 20200320 Pledgee: Taihe County SME Financing Guarantee Co.,Ltd. Pledgor: ANHUI LIANYI PHARMACEUTICAL Co.,Ltd. Registration number: Y2022980005773 |
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PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Clindamycin phosphate injection and its preparation method Effective date of registration: 20220610 Granted publication date: 20200320 Pledgee: Taihe County SME Financing Guarantee Co.,Ltd. Pledgor: ANHUI LIANYI PHARMACEUTICAL Co.,Ltd. Registration number: Y2022980007392 |