CN102895184A - Epirubicin hydrochloride injection - Google Patents
Epirubicin hydrochloride injection Download PDFInfo
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- CN102895184A CN102895184A CN2012104468007A CN201210446800A CN102895184A CN 102895184 A CN102895184 A CN 102895184A CN 2012104468007 A CN2012104468007 A CN 2012104468007A CN 201210446800 A CN201210446800 A CN 201210446800A CN 102895184 A CN102895184 A CN 102895184A
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- epirubicin hydrochloride
- acid
- injection
- hydrochloride injection
- epirubicin
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Abstract
The invention provides a new epirubicin hydrochloride injection which has the characteristics of being stable in quality, low in content of related substances and simple in technology.
Description
Technical field
The method that the present invention relates to a kind of epirubicin hydrochloride injection and prepare this epirubicin hydrochloride injection.
Background technology
Anthracycline antibiotics has formed one of maximum family of natural bioactive compounds.Some members of this family are effective antitumour medicines clinically.For example comprising daunorubicin, amycin, idarubicin, epirubicin, pirarubicin, zorubicin, aclarubicin and carminomycin.For example, these chemical compounds have been presented in bone marrow transplantation, stem cell transplantation, breast cancer treatment, acute lymphoblastic and non-lymphocytic leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma and other entity tumor useful.
United States Patent (USP) 4,112,076,4,345,068,4,861,870,5,945,518 and 5,874,550 disclosed the method for preparing epirubicin hydrochloride with and as the purposes of anticarcinogen.
The epirubicin hydrochloride heat stability is relatively poor, usually all makes freeze-dried products in injection.Epirubicin hydrochloride is in December, 1984 first in Italy's listing, and the listing dosage form is lyophilized formulations.The commodity of domestic this medicine are called Pharmorubicin RD, and specification has 10mg and 50mg.The prescription of this medicine
Be comprised of epirubicin hydrochloride, lactose and methyl hydroxybenzoate, wherein lactose is proppant, and methyl hydroxybenzoate is antibacterial, and adopts normal compound and freeze-dry process to carry out the preparation of hydrochloride for injection epirubicin medicine.Research is found, this medicine that adopts normal compound and freeze-dry process to prepare, and other single impurity content is higher, reaches approximately 0.6%-0.8%, sometimes exceeds in the target level of product quality requirement to the single limit of impurities.Said preparation exists that its related substances is high, quality is unstable and the shortcoming of poor stability.
Summary of the invention
The invention provides a kind of new epirubicin hydrochloride injection, it has steady quality, and related substances content is low, the simple characteristics of technique.
In one embodiment, the invention provides a kind of epirubicin hydrochloride injection, it comprises the epirubicin hydrochloride that is dissolved in the pharmaceutically acceptable solvent, the pH value of solution is adjusted between the 2.5-3.5 with pharmaceutically acceptable acid, and wherein the concentration of epirubicin hydrochloride is 0.1-100 mg/ml.
In further embodiment, described pharmaceutically acceptable acid is selected from: hydrochloric acid, sulphuric acid, phosphoric acid, methanesulfonic acid, ethane sulfonic acid, tartaric acid, acetic acid, succinic acid, ascorbic acid, citric acid and glutamic acid.
In further embodiment, described epirubicin hydrochloride injection further comprises permeability adjustment reagent.
In further embodiment, the concentration of described epirubicin hydrochloride is 0.1-50 mg/ml, and is preferred, 1-20 mg/ml.
In further embodiment, the pH value of described injection is between the 3.7-3.3.
In further embodiment, described pharmaceutically acceptable solvent is selected from saline, glucose solution and sterilized water.
Embodiment
Embodiment 1:The stability test of epirubicin hydrochloride injection
0.9 g epirubicin hydrochloride is dissolved in the water for injection, and volume is adjusted to 400 ml with water for injection, does not regulate pH value, in contrast group.The test group is adjusted pH value to 3 for 0.9 g epirubicin hydrochloride is dissolved in the water for injection with hydrochloric acid, and last volume is adjusted to 400 ml with water for injection.Two groups of solution were placed for 4 weeks at 4 ℃, 35 ℃ and 55 ℃ respectively, measure final epirubicin concentration with HPLC, be expressed as the percentage ratio of initial concentration.After 4 ℃, 35 ℃ and 55 ℃ of 4 week, the epirubicin concentration of matched group is respectively 99.0%, 86.3% and 69.9% of initial concentration; And the test group is 99.4%, 90.8% and 69.9%.The stability of as seen test group is significantly increased.
Embodiment 2:The stability test of epirubicin hydrochloride injection
0.8 g epirubicin hydrochloride is dissolved in the water for injection, and volume is adjusted to 400 ml with water for injection, does not regulate pH value, in contrast group.The test group is adjusted pH value to 3.2 for 0.8 g epirubicin hydrochloride is dissolved in the water for injection with hydrochloric acid, and last volume is adjusted to 400 ml with water for injection.Two groups of solution were placed for 4 weeks at 4 ℃, 35 ℃ and 55 ℃ respectively, measure final epirubicin concentration with HPLC, be expressed as the percentage ratio of initial concentration.After 4 ℃, 35 ℃ and 55 ℃ of 4 week, the epirubicin concentration of matched group is respectively 98.8%, 86.0% and 69.4% of initial concentration; And the test group is 99.2%, 90.6% and 69.2%.The stability of as seen test group is significantly increased.
Embodiment 3:The stability test of epirubicin hydrochloride injection
0.5 g epirubicin hydrochloride is dissolved in the water for injection, and volume is adjusted to 400 ml with water for injection, does not regulate pH value, in contrast group.The test group is adjusted pH value to 3.7 for 0.8 g epirubicin hydrochloride is dissolved in the water for injection with hydrochloric acid, and last volume is adjusted to 400 ml with water for injection.Two groups of solution were placed for 4 weeks at 4 ℃, 35 ℃ and 55 ℃ respectively, measure final epirubicin concentration with HPLC, be expressed as the percentage ratio of initial concentration.After 4 ℃, 35 ℃ and 55 ℃ of 4 week, the epirubicin concentration of matched group is respectively 98.6%, 85.8% and 68.5% of initial concentration; And the test group is 99.1%, 90.6% and 69.0%.The stability of as seen test group is significantly increased.
Claims (6)
1. epirubicin hydrochloride injection, it comprises the epirubicin hydrochloride that is dissolved in the pharmaceutically acceptable solvent, and the pH value of solution is adjusted between the 2.5-3.5 with pharmaceutically acceptable acid, and wherein the concentration of epirubicin hydrochloride is 0.1-100 mg/ml.
2. according to claim 1 epirubicin hydrochloride injection, described pharmaceutically acceptable acid is selected from: hydrochloric acid, sulphuric acid, phosphoric acid, methanesulfonic acid, ethane sulfonic acid, tartaric acid, acetic acid, succinic acid, ascorbic acid, citric acid and glutamic acid.
3. according to claim 1 epirubicin hydrochloride injection, described epirubicin hydrochloride injection comprise that further permeability adjusts reagent.
4. according to claim 1 epirubicin hydrochloride injection, the concentration of described epirubicin hydrochloride is 0.1-50 mg/ml, and is preferred, 1-20 mg/ml.
5. according to claim 1 epirubicin hydrochloride injection, the pH value of described injection is between the 3.7-3.3.
6. according to claim 1 epirubicin hydrochloride injection, described pharmaceutically acceptable solvent is selected from saline, glucose solution and sterilized water.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104468007A CN102895184A (en) | 2012-11-11 | 2012-11-11 | Epirubicin hydrochloride injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104468007A CN102895184A (en) | 2012-11-11 | 2012-11-11 | Epirubicin hydrochloride injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102895184A true CN102895184A (en) | 2013-01-30 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012104468007A Pending CN102895184A (en) | 2012-11-11 | 2012-11-11 | Epirubicin hydrochloride injection |
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| CN (1) | CN102895184A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105560174A (en) * | 2016-01-06 | 2016-05-11 | 山东新时代药业有限公司 | Epirubicin hydrochloride injection and preparation method thereof |
| CN106913532A (en) * | 2015-12-25 | 2017-07-04 | 山东新时代药业有限公司 | A kind of hydrochloride for injection epirubicin and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614118A (en) * | 2012-03-15 | 2012-08-01 | 北京协和药厂 | Preparation method for epirubicin hydrochloride preparation for injection and preparation |
-
2012
- 2012-11-11 CN CN2012104468007A patent/CN102895184A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614118A (en) * | 2012-03-15 | 2012-08-01 | 北京协和药厂 | Preparation method for epirubicin hydrochloride preparation for injection and preparation |
Non-Patent Citations (2)
| Title |
|---|
| DINESH KUMAR ET.AL.: "Isolation and characterization of degradation impurities in epirubicin hydrochloride injection", 《JOURNAL OF CHROMATOGRAPHY B》 * |
| 林碧英等: "临床药师参与临床用药的实践与体会", 《中国医院药学杂志》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106913532A (en) * | 2015-12-25 | 2017-07-04 | 山东新时代药业有限公司 | A kind of hydrochloride for injection epirubicin and preparation method thereof |
| CN105560174A (en) * | 2016-01-06 | 2016-05-11 | 山东新时代药业有限公司 | Epirubicin hydrochloride injection and preparation method thereof |
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Application publication date: 20130130 |