CN100427095C - 含有钙通道阻滞药地尔硫䓬稀释后供静脉注射的注射液 - Google Patents
含有钙通道阻滞药地尔硫䓬稀释后供静脉注射的注射液 Download PDFInfo
- Publication number
- CN100427095C CN100427095C CNB031583733A CN03158373A CN100427095C CN 100427095 C CN100427095 C CN 100427095C CN B031583733 A CNB031583733 A CN B031583733A CN 03158373 A CN03158373 A CN 03158373A CN 100427095 C CN100427095 C CN 100427095C
- Authority
- CN
- China
- Prior art keywords
- injection
- diltiazem
- solvent
- volume ratio
- ethanol
- 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.)
- Expired - Lifetime
Links
- 238000002347 injection Methods 0.000 title claims abstract description 37
- 239000007924 injection Substances 0.000 title claims abstract description 37
- 229960004166 diltiazem Drugs 0.000 title claims abstract description 25
- HSUGRBWQSSZJOP-RTWAWAEBSA-N diltiazem Chemical compound C1=CC(OC)=CC=C1[C@H]1[C@@H](OC(C)=O)C(=O)N(CCN(C)C)C2=CC=CC=C2S1 HSUGRBWQSSZJOP-RTWAWAEBSA-N 0.000 title claims abstract description 21
- 229940127291 Calcium channel antagonist Drugs 0.000 title claims abstract description 11
- 239000000480 calcium channel blocker Substances 0.000 title claims abstract description 11
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 42
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 36
- 239000002904 solvent Substances 0.000 claims abstract description 23
- 150000001875 compounds Chemical class 0.000 claims abstract description 13
- 238000010790 dilution Methods 0.000 claims abstract description 9
- 239000012895 dilution Substances 0.000 claims abstract description 9
- 239000000203 mixture Substances 0.000 claims abstract description 9
- 239000000243 solution Substances 0.000 claims abstract description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 8
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 36
- 238000001990 intravenous administration Methods 0.000 claims description 8
- 150000005846 sugar alcohols Polymers 0.000 claims description 6
- 239000002671 adjuvant Substances 0.000 claims description 5
- 238000012360 testing method Methods 0.000 abstract description 22
- 150000003839 salts Chemical class 0.000 abstract description 10
- 239000002131 composite material Substances 0.000 abstract 2
- ULWHHBHJGPPBCO-UHFFFAOYSA-N propane-1,1-diol Chemical compound CCC(O)O ULWHHBHJGPPBCO-UHFFFAOYSA-N 0.000 abstract 2
- 238000009472 formulation Methods 0.000 abstract 1
- 238000010253 intravenous injection Methods 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 238000011835 investigation Methods 0.000 description 14
- FEDJGPQLLNQAIY-UHFFFAOYSA-N 2-[(6-oxo-1h-pyridazin-3-yl)oxy]acetic acid Chemical compound OC(=O)COC=1C=CC(=O)NN=1 FEDJGPQLLNQAIY-UHFFFAOYSA-N 0.000 description 9
- 229960005316 diltiazem hydrochloride Drugs 0.000 description 9
- 238000000034 method Methods 0.000 description 9
- 238000002360 preparation method Methods 0.000 description 7
- 229910019142 PO4 Inorganic materials 0.000 description 6
- 239000003963 antioxidant agent Substances 0.000 description 6
- 230000003078 antioxidant effect Effects 0.000 description 6
- 235000006708 antioxidants Nutrition 0.000 description 6
- 238000012856 packing Methods 0.000 description 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 6
- 239000010452 phosphate Substances 0.000 description 6
- 239000000843 powder Substances 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 230000007774 longterm Effects 0.000 description 5
- -1 acetyl diltiazem Chemical compound 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 238000005070 sampling Methods 0.000 description 4
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000012046 mixed solvent Substances 0.000 description 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 description 2
- 239000003708 ampul Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000005286 illumination Methods 0.000 description 2
- 229920001184 polypeptide Polymers 0.000 description 2
- 238000004321 preservation Methods 0.000 description 2
- 102000004196 processed proteins & peptides Human genes 0.000 description 2
- 108090000765 processed proteins & peptides Proteins 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- UMGDCJDMYOKAJW-UHFFFAOYSA-N thiourea Chemical compound NC(N)=S UMGDCJDMYOKAJW-UHFFFAOYSA-N 0.000 description 2
- PWKSKIMOESPYIA-UHFFFAOYSA-N 2-acetamido-3-sulfanylpropanoic acid Chemical compound CC(=O)NC(CS)C(O)=O PWKSKIMOESPYIA-UHFFFAOYSA-N 0.000 description 1
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 208000031229 Cardiomyopathies Diseases 0.000 description 1
- RGHNJXZEOKUKBD-SQOUGZDYSA-M D-gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O RGHNJXZEOKUKBD-SQOUGZDYSA-M 0.000 description 1
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical class OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 description 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 1
- 208000019695 Migraine disease Diseases 0.000 description 1
- SHUYNJFEXPRUGR-RTCCEZQESA-N Norcholic acid Chemical class C([C@H]1C[C@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CC(O)=O)C)[C@@]2(C)[C@@H](O)C1 SHUYNJFEXPRUGR-RTCCEZQESA-N 0.000 description 1
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Natural products NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 1
- 230000003281 allosteric effect Effects 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 239000003125 aqueous solvent Substances 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 229940072107 ascorbate Drugs 0.000 description 1
- 235000010323 ascorbic acid Nutrition 0.000 description 1
- 239000011668 ascorbic acid Substances 0.000 description 1
- 229940009098 aspartate Drugs 0.000 description 1
- 229960003328 benzoyl peroxide Drugs 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000000337 buffer salt Substances 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 150000001860 citric acid derivatives Chemical class 0.000 description 1
- 229940121657 clinical drug Drugs 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 229940050410 gluconate Drugs 0.000 description 1
- 229930195712 glutamate Natural products 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
- 239000010977 jade Substances 0.000 description 1
- 229940001447 lactate Drugs 0.000 description 1
- 229940049920 malate Drugs 0.000 description 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N malic acid Chemical compound OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 1
- 239000002609 medium Substances 0.000 description 1
- 206010027599 migraine Diseases 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- 239000013618 particulate matter Substances 0.000 description 1
- 208000002815 pulmonary hypertension Diseases 0.000 description 1
- 230000001148 spastic effect Effects 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- LSNNMFCWUKXFEE-UHFFFAOYSA-L sulfite Chemical class [O-]S([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-L 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (4)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB031583733A CN100427095C (zh) | 2003-09-26 | 2003-09-26 | 含有钙通道阻滞药地尔硫䓬稀释后供静脉注射的注射液 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB031583733A CN100427095C (zh) | 2003-09-26 | 2003-09-26 | 含有钙通道阻滞药地尔硫䓬稀释后供静脉注射的注射液 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1600314A CN1600314A (zh) | 2005-03-30 |
CN100427095C true CN100427095C (zh) | 2008-10-22 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CNB031583733A Expired - Lifetime CN100427095C (zh) | 2003-09-26 | 2003-09-26 | 含有钙通道阻滞药地尔硫䓬稀释后供静脉注射的注射液 |
Country Status (1)
Country | Link |
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CN (1) | CN100427095C (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11241379B2 (en) * | 2015-12-01 | 2022-02-08 | Sun Pharmaceutical Industries Limited | Parenteral dosage form of diltiazem |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102240262A (zh) * | 2010-05-14 | 2011-11-16 | 山东方明药业股份有限公司 | 盐酸地尔硫卓注射液及其制备方法 |
CN112220742A (zh) * | 2019-07-15 | 2021-01-15 | 深圳艾欣达伟医药科技有限公司 | 稳定的ast-3424注射液制剂及制备方法 |
-
2003
- 2003-09-26 CN CNB031583733A patent/CN100427095C/zh not_active Expired - Lifetime
Non-Patent Citations (2)
Title |
---|
盐酸地尔硫卓注射液的制备及稳定性考察. 王璐璐等.中国医院药学杂志,第23卷第5期. 2003 |
盐酸地尔硫卓注射液的制备及稳定性考察. 王璐璐等.中国医院药学杂志,第23卷第5期. 2003 * |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11241379B2 (en) * | 2015-12-01 | 2022-02-08 | Sun Pharmaceutical Industries Limited | Parenteral dosage form of diltiazem |
Also Published As
Publication number | Publication date |
---|---|
CN1600314A (zh) | 2005-03-30 |
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Legal Events
Date | Code | Title | Description |
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C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
ASS | Succession or assignment of patent right |
Owner name: JIANGSU WUZHONG PHARMACEUTICAL GROUP CO., LTD. Free format text: FORMER OWNER: CHANGZHENG-XINKAI PHARMACEUTIC CO., LTD., SUZHOU Effective date: 20130807 |
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C41 | Transfer of patent application or patent right or utility model | ||
TR01 | Transfer of patent right |
Effective date of registration: 20130807 Address after: Soochow road Wuzhong Economic Development Zone in Suzhou City, Jiangsu Province, No. 2, building 8, 215128 Patentee after: JIANGSU WUZHONG PHARMACEUTICAL Group Corp. Address before: 215128 No. 2, Soochow South Road, Jiangsu, Suzhou Patentee before: SUZHOU CHANGZHENG-XINKAI PHARMACEUTICAL CO.,LTD. |
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C41 | Transfer of patent application or patent right or utility model | ||
TR01 | Transfer of patent right |
Effective date of registration: 20161026 Address after: Soochow road 215128 in Jiangsu Province, Suzhou Wuzhong Economic Development Zone No. 2 Building 8 Patentee after: JIANGSU WUZHONG PHARMACEUTICAL Group Corp. Patentee after: SUZHOU PHARMACEUTICAL FACTORY, JIANGSU WUZHONG PHARMACEUTICAL Group Corp. Address before: Soochow road 215128 in Jiangsu Province, Suzhou Wuzhong Economic Development Zone No. 2 Building 8 Patentee before: JIANGSU WUZHONG PHARMACEUTICAL Group Corp. |
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CX01 | Expiry of patent term |
Granted publication date: 20081022 |
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CX01 | Expiry of patent term |