CN109846839B - 一种琥乙红霉素颗粒及其制备方法 - Google Patents
一种琥乙红霉素颗粒及其制备方法 Download PDFInfo
- Publication number
- CN109846839B CN109846839B CN201910095157.XA CN201910095157A CN109846839B CN 109846839 B CN109846839 B CN 109846839B CN 201910095157 A CN201910095157 A CN 201910095157A CN 109846839 B CN109846839 B CN 109846839B
- Authority
- CN
- China
- Prior art keywords
- parts
- erythromycin ethylsuccinate
- sodium bicarbonate
- tween
- wetting agent
- 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.)
- Active
Links
- 229960000741 erythromycin ethylsuccinate Drugs 0.000 title claims abstract description 99
- NSYZCCDSJNWWJL-YXOIYICCSA-N erythromycin ethylsuccinate Chemical compound O1[C@H](C)C[C@H](N(C)C)[C@@H](OC(=O)CCC(=O)OCC)[C@@H]1O[C@H]1[C@@](O)(C)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@](C)(O)[C@@H](CC)OC(=O)[C@H](C)[C@@H](O[C@@H]2O[C@@H](C)[C@H](O)[C@](C)(OC)C2)[C@@H]1C NSYZCCDSJNWWJL-YXOIYICCSA-N 0.000 title claims abstract description 99
- 238000002360 preparation method Methods 0.000 title claims abstract description 23
- 239000008187 granular material Substances 0.000 title claims description 72
- 239000002245 particle Substances 0.000 claims abstract description 34
- 239000000080 wetting agent Substances 0.000 claims abstract description 33
- 235000021552 granulated sugar Nutrition 0.000 claims abstract description 25
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims abstract description 20
- 229920000053 polysorbate 80 Polymers 0.000 claims abstract description 20
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims abstract description 11
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 76
- 238000003756 stirring Methods 0.000 claims description 50
- 238000002156 mixing Methods 0.000 claims description 47
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 38
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 38
- 238000001035 drying Methods 0.000 claims description 35
- 239000007779 soft material Substances 0.000 claims description 31
- 239000000463 material Substances 0.000 claims description 23
- 238000004806 packaging method and process Methods 0.000 claims description 21
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 20
- 239000011812 mixed powder Substances 0.000 claims description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
- 239000000203 mixture Substances 0.000 claims description 18
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 12
- 229930006000 Sucrose Natural products 0.000 claims description 12
- 239000002994 raw material Substances 0.000 claims description 12
- 238000007873 sieving Methods 0.000 claims description 11
- 238000007781 pre-processing Methods 0.000 claims description 10
- 238000010298 pulverizing process Methods 0.000 claims description 10
- 229920000136 polysorbate Polymers 0.000 claims description 4
- 238000004090 dissolution Methods 0.000 abstract description 17
- 239000003814 drug Substances 0.000 abstract description 10
- 230000000694 effects Effects 0.000 abstract description 4
- 239000000243 solution Substances 0.000 description 58
- 239000012535 impurity Substances 0.000 description 15
- 230000000052 comparative effect Effects 0.000 description 13
- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 10
- 238000000034 method Methods 0.000 description 7
- 239000000843 powder Substances 0.000 description 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 5
- 239000007910 chewable tablet Substances 0.000 description 5
- 229940068682 chewable tablet Drugs 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 229960003276 erythromycin Drugs 0.000 description 5
- 238000012937 correction Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 239000005720 sucrose Substances 0.000 description 4
- 229910019142 PO4 Inorganic materials 0.000 description 3
- 230000014759 maintenance of location Effects 0.000 description 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 3
- 239000010452 phosphate Substances 0.000 description 3
- XUKUURHRXDUEBC-SXOMAYOGSA-N (3s,5r)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-SXOMAYOGSA-N 0.000 description 2
- AAEQXEDPVFIFDK-UHFFFAOYSA-N 3-(4-fluorobenzoyl)-2-(2-methylpropanoyl)-n,3-diphenyloxirane-2-carboxamide Chemical compound C=1C=CC=CC=1NC(=O)C1(C(=O)C(C)C)OC1(C=1C=CC=CC=1)C(=O)C1=CC=C(F)C=C1 AAEQXEDPVFIFDK-UHFFFAOYSA-N 0.000 description 2
- 229920002261 Corn starch Polymers 0.000 description 2
- 229930006677 Erythromycin A Natural products 0.000 description 2
- IDRYSCOQVVUBIJ-UHFFFAOYSA-N Erythromycin-B Natural products CC1C(OC2C(C(CC(C)O2)N(C)C)O)C(C)(O)CC(C)C(=O)C(C)C(O)C(C)C(CC)OC(=O)C(C)C1OC1CC(C)(OC)C(O)C(C)O1 IDRYSCOQVVUBIJ-UHFFFAOYSA-N 0.000 description 2
- MWFRKHPRXPSWNT-UHFFFAOYSA-N Erythromycin-C Natural products CC1C(OC2C(C(CC(C)O2)N(C)C)O)C(C)(O)CC(C)C(=O)C(C)C(O)C(O)(C)C(CC)OC(=O)C(C)C1OC1CC(C)(O)C(O)C(C)O1 MWFRKHPRXPSWNT-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 208000007764 Legionnaires' Disease Diseases 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008120 corn starch Substances 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000007865 diluting Methods 0.000 description 2
- IDRYSCOQVVUBIJ-PPGFLMPOSA-N erythromycin B Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@H]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)C)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 IDRYSCOQVVUBIJ-PPGFLMPOSA-N 0.000 description 2
- 210000004211 gastric acid Anatomy 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 238000013112 stability test Methods 0.000 description 2
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 239000012085 test solution Substances 0.000 description 2
- HUKYDKSXFKBBIW-DTOMAXNRSA-N 4-[(2s,3r,4s,6r)-4-(dimethylamino)-2-[[(3r,4s,5s,6r,7r,9r,11r,12r,13s,14r)-14-ethyl-7,12,13-trihydroxy-4-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,7,9,11,13-hexamethyl-2,10-dioxo-oxacyclotetradec-6-yl]oxy]-6-methyloxan-3-yl]oxy-4-ox Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)OC(=O)CCC(O)=O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 HUKYDKSXFKBBIW-DTOMAXNRSA-N 0.000 description 1
- 241000193830 Bacillus <bacterium> Species 0.000 description 1
- 241000606161 Chlamydia Species 0.000 description 1
- DKMROQRQHGEIOW-UHFFFAOYSA-N Diethyl succinate Chemical compound CCOC(=O)CCC(=O)OCC DKMROQRQHGEIOW-UHFFFAOYSA-N 0.000 description 1
- RJQXTJLFIWVMTO-TYNCELHUSA-N Methicillin Chemical compound COC1=CC=CC(OC)=C1C(=O)N[C@@H]1C(=O)N2[C@@H](C(O)=O)C(C)(C)S[C@@H]21 RJQXTJLFIWVMTO-TYNCELHUSA-N 0.000 description 1
- 208000001572 Mycoplasma Pneumonia Diseases 0.000 description 1
- 241000202934 Mycoplasma pneumoniae Species 0.000 description 1
- 201000008235 Mycoplasma pneumoniae pneumonia Diseases 0.000 description 1
- 206010035664 Pneumonia Diseases 0.000 description 1
- 241000191940 Staphylococcus Species 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 241000194017 Streptococcus Species 0.000 description 1
- 238000002835 absorbance Methods 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 244000052616 bacterial pathogen Species 0.000 description 1
- 210000000941 bile Anatomy 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 210000005013 brain tissue Anatomy 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 210000001175 cerebrospinal fluid Anatomy 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- XMGQYMWWDOXHJM-UHFFFAOYSA-N limonene Chemical group CC(=C)C1CCC(C)=CC1 XMGQYMWWDOXHJM-UHFFFAOYSA-N 0.000 description 1
- 239000003120 macrolide antibiotic agent Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- 229960003085 meticillin Drugs 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 206010030861 ophthalmia neonatorum Diseases 0.000 description 1
- 239000007968 orange flavor Substances 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000001384 succinic acid Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 238000000870 ultraviolet spectroscopy Methods 0.000 description 1
- 210000002229 urogenital system Anatomy 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
组分 | 重量/Kg | 份数 |
琥乙红霉素 | 3.125 | 10 |
白砂糖 | 59 | 188.8 |
碳酸氢钠 | 0.07 | 0.224 |
吐温-80 | 0.3 | 0.96 |
30%乙醇(润湿剂) | 5.2 | 16.64 |
香精 | 0.25 | 0.8 |
组分 | 重量/Kg | 份数 |
琥乙红霉素 | 3.125 | 10 |
白砂糖 | 59 | 188.8 |
碳酸氢钠 | 0.07 | 0.224 |
吐温-80 | 0.2 | 0.64 |
70%乙醇(润湿剂) | 5.2 | 16.64 |
香精 | 0.25 | 0.8 |
组分 | 重量/Kg | 份数 |
琥乙红霉素 | 3.125 | 10 |
白砂糖 | 59 | 188.8 |
碳酸氢钠 | 0.07 | 0.224 |
吐温-80 | 0.2 | 0.64 |
50%乙醇(润湿剂) | 5.2 | 16.64 |
香精 | 0.25 | 0.8 |
组分 | 重量/Kg | 份数 |
琥乙红霉素 | 3.125 | 10 |
白砂糖 | 59 | 188.8 |
碳酸氢钠 | 0.07 | 0.224 |
吐温-80 | 0.2 | 0.64 |
60%乙醇(润湿剂) | 5.2 | 16.64 |
香精 | 0.25 | 0.8 |
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201910095157.XA CN109846839B (zh) | 2019-01-31 | 2019-01-31 | 一种琥乙红霉素颗粒及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201910095157.XA CN109846839B (zh) | 2019-01-31 | 2019-01-31 | 一种琥乙红霉素颗粒及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN109846839A CN109846839A (zh) | 2019-06-07 |
CN109846839B true CN109846839B (zh) | 2021-03-16 |
Family
ID=66897096
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201910095157.XA Active CN109846839B (zh) | 2019-01-31 | 2019-01-31 | 一种琥乙红霉素颗粒及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN109846839B (zh) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN117338729B (zh) * | 2023-12-06 | 2024-02-13 | 山东国邦药业有限公司 | 一种硫氰酸红霉素可溶性颗粒及其制备方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4076804A (en) * | 1975-07-18 | 1978-02-28 | Abbott Laboratories | Erythromycin therapy |
CN1110912A (zh) * | 1994-04-30 | 1995-11-01 | 杭州市药物研究所 | 一种改进片剂、颗粒剂性能的方法 |
-
2019
- 2019-01-31 CN CN201910095157.XA patent/CN109846839B/zh active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4076804A (en) * | 1975-07-18 | 1978-02-28 | Abbott Laboratories | Erythromycin therapy |
CN1110912A (zh) * | 1994-04-30 | 1995-11-01 | 杭州市药物研究所 | 一种改进片剂、颗粒剂性能的方法 |
Non-Patent Citations (1)
Title |
---|
琥乙红霉素颗粒生产工艺的改进;张朋臻,等;《齐鲁药事》;20051231;第24卷(第7期);440 * |
Also Published As
Publication number | Publication date |
---|---|
CN109846839A (zh) | 2019-06-07 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
EP0858324B1 (en) | Process for aqueous granulation of clarithromycin | |
CN103417512B (zh) | 一种阿莫西林胶囊剂及其制备方法 | |
CN101912368A (zh) | 一种复方头孢克洛干混悬剂及其制备方法 | |
CN109846839B (zh) | 一种琥乙红霉素颗粒及其制备方法 | |
CN106176646B (zh) | 一种甲苯磺酸妥舒沙星分散片及其制备方法 | |
CN109875965B (zh) | 一种阿奇霉素干混悬剂 | |
CN105085549B (zh) | 一种头孢克洛化合物、该化合物与盐酸溴己新的药物组合物及其制剂 | |
CN102697736A (zh) | 一种头孢克肟颗粒及其制备方法 | |
CN102600083B (zh) | 一种头孢呋辛酯颗粒及其制备方法 | |
CN104095809A (zh) | 克林霉素磷酸酯注射液药物组合物和制法 | |
CN106749174B (zh) | 一种西他沙星二水合物晶型、制备方法及其组合物片剂 | |
CN102311452B (zh) | 头孢克肟晶体、其制备方法及含有该晶体的片剂组合物 | |
CN105534937A (zh) | 一种头孢羟氨苄片剂及其制备方法 | |
CN113288876B (zh) | 一种氟苯尼考缓释颗粒的质量评价与控制方法 | |
CN100415230C (zh) | 青霉素v钾分散片及其制备方法 | |
CN104666253B (zh) | 注射用克林霉素磷酸酯粉针剂药物组合物和制法 | |
CN104721154B (zh) | 注射用谷氨酸诺氟沙星冷冻干燥粉针剂药物组合物 | |
CN110327284B (zh) | 一种注射用头孢地嗪钠及其制备方法 | |
CN105640895A (zh) | 一种头孢羟氨苄颗粒制剂及其制备方法 | |
CN106589022A (zh) | 一种罗红霉素化合物及其制备方法、药物组合物 | |
CN106310286B (zh) | 一种甲苯磺酸妥舒沙星组合物 | |
CN115364059B (zh) | 一种头孢泊肟酯颗粒及其制备方法 | |
US10130627B2 (en) | Phenylephrine formulations with improved stability | |
CN114983964B (zh) | 一种头孢地尼颗粒剂及其制备方法 | |
CN112007002B (zh) | 一种质量稳定的甲硝唑片剂组合物及其制备方法 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
GR01 | Patent grant | ||
GR01 | Patent grant | ||
CP02 | Change in the address of a patent holder |
Address after: No.47 Zhongxing Street, Lincheng Economic Development Zone, Xingtai City, Hebei Province 054300 Patentee after: HEBEI JUNLIN PHARMACEUTICAL Co.,Ltd. Address before: 054300 North Ring East Road, Lincheng Town, Lincheng County, Xingtai City, Hebei Province Patentee before: HEBEI JUNLIN PHARMACEUTICAL Co.,Ltd. |
|
CP02 | Change in the address of a patent holder | ||
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: Erythromycin Ethylsuccinate granules and preparation method thereof Effective date of registration: 20210727 Granted publication date: 20210316 Pledgee: Hebei Lincheng Rural Commercial Bank Co.,Ltd. Pledgor: HEBEI JUNLIN PHARMACEUTICAL Co.,Ltd. Registration number: Y2021130000018 |
|
PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20220712 Granted publication date: 20210316 Pledgee: Hebei Lincheng Rural Commercial Bank Co.,Ltd. Pledgor: HEBEI JUNLIN PHARMACEUTICAL CO.,LTD. Registration number: Y2021130000018 |
|
PC01 | Cancellation 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: Erythromycin Ethylsuccinate granules and its preparation method Effective date of registration: 20220718 Granted publication date: 20210316 Pledgee: Hebei Lincheng Rural Commercial Bank Co.,Ltd. Pledgor: HEBEI JUNLIN PHARMACEUTICAL CO.,LTD. Registration number: Y2022130000050 |
|
PE01 | Entry into force 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: 20230705 Granted publication date: 20210316 Pledgee: Hebei Lincheng Rural Commercial Bank Co.,Ltd. Pledgor: HEBEI JUNLIN PHARMACEUTICAL CO.,LTD. Registration number: Y2022130000050 |
|
PC01 | Cancellation 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: Erythromycin ethylsuccinate granules and its preparation method Effective date of registration: 20230710 Granted publication date: 20210316 Pledgee: Hebei Lincheng Rural Commercial Bank Co.,Ltd. Pledgor: HEBEI JUNLIN PHARMACEUTICAL CO.,LTD. Registration number: Y2023980047932 |
|
PE01 | Entry into force of the registration of the contract for pledge of patent right |