CN102335123A - Noradrenaline bitartrate injection and preparation technology thereof - Google Patents
Noradrenaline bitartrate injection and preparation technology thereof Download PDFInfo
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- CN102335123A CN102335123A CN2010102290477A CN201010229047A CN102335123A CN 102335123 A CN102335123 A CN 102335123A CN 2010102290477 A CN2010102290477 A CN 2010102290477A CN 201010229047 A CN201010229047 A CN 201010229047A CN 102335123 A CN102335123 A CN 102335123A
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- injection
- noradrenaline bitartrate
- embedding
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Abstract
The invention discloses a formula of noradrenaline bitartrate injection and a preparation technology of the noradrenaline bitartrate injection. The preparation technology of the noradrenaline bitartrate injection comprises the following steps of 1, based on a total preparation volume, adding 90% of injection water into a preparation container, and feeding CO2 into the injection water for 15 minutes, 2, adding respectively appropriate amounts of common salt, sodium pyrosulfite and noradrenaline bitartrate into the injection water obrained by the step 1, and stirring for dissolving, 3, determining a pH value of the solution obtained by the step 2, and adding injection water to the solution until the volume of the solution is equal to the total preparation volume when the pH value is in a range of 3.2 to 3.6, 4, filtering, and 5, carrying out potting of the filtrate obtained by the step 4, wherein N2 is fed into ampoules during the potting, and carrying out disinfection at a temperature of 100 DEG C for 30 minutes, or carrying out aseptic potting according to potting operation procedures, wherein N2 is fed into ampoules during the aseptic potting. The preparation technology of the noradrenaline bitartrate injection realizes aseptic production. The noradrenaline bitartrate injection obtained by the preparation technology satisfies national medicine quality standards.
Description
[technical field]
The present invention relates to pharmaceutical field, especially relate to the chemical drugs injection.
[background technology]
State Food and Drug Administration evaluates the center and has issued [2008] No. 7 literary compositions of state's food medicine prison notes in 2008---and " about issuing the notice that the biochemical medicine injection basic fundamental of chemical drugs injection and multicomponent requires "; Its literary composition regulation: small-volume injection should be taked terminal sterilization technology, and the suggestion first-selection is excessively killed method (F
0>=12), the condition of excessively killing can not be tolerated, remaining probabilistic method (8≤F can be considered to adopt like product
0＜12), but all should guarantee that the SAL (sterilization guarantees horizontal sterility assurance level) after the product sterilization is not more than 10
-6Adopt other F
0Value will not be approved less than the technology of 8 terminal sterilization condition in principle.Can not adopt terminal sterilization technology if any sufficient according to proof, and be the kind of clinical necessary drug administration by injection, can consider to adopt sterile production technology, but should guarantee that SAL is not more than 10
-3Adopted the auxiliary kind of sterilizing of flowing steam simultaneously for filtration sterilization technology, proposed amendments is a terminal sterilization technology, to adopting the kind of terminal sterilization technology really, should be revised as sterile production technology.
And the noradrenaline bitartrate injection adopts in the prior art is 100 ℃ of sterilizations 30 minutes, can not guarantee that the SAL after the product sterilization is not more than 10
-6, so be necessary to seek more advanced preparation technology, in view of these article after 121 ℃ of sterilizations in 12 minutes, each item index is difficult to reach the quality standard of two noradrenaline bitartrate injection of Chinese Pharmacopoeia version in 2010, so show it is adopted sterile production.
The noradrenaline bitartrate injection is mainly used in the hypotension that treatment acute myocardial infarction, extracorporeal circulation etc. cause; To the hypotension after shock, hypotension or the pheochromocytoma excision due to the hypovolemia; The auxiliary treatment of these article replenishment of blood content during as first aid; So that blood pressure gos up, temporarily keep brain and coronary perfusion, have an effect up to the replenishment of blood content treatment; Hypotension when also can be used for blocking in the canalis spinalis and cardiac arrest recovery back blood pressure are kept.
Noradrenaline bitartrate, chemical name are (R)-4-(2-amino-1-hydroxyethyl)-1,2-Benzodiazepines bitartrate monohydrate, and structural formula is following:
Molecular formula: C
8H
11NO
3C
4H
6O
6H
2O, molecular weight: 337.28.
[summary of the invention]
First purpose of the present invention provides a kind of noradrenaline bitartrate injection.
Second purpose of the present invention provides a kind of preparation process of noradrenaline bitartrate injection.
For realizing above-mentioned purpose, the present invention discloses following technical scheme: a kind of noradrenaline bitartrate injection comprises following composition:
Every 10000ml includes,
Noradrenaline bitartrate 22g～50g
Burnt sulfurous 10g
Sodium chloride 88g
Water for injection adds to 10000ml
The preparation process of described noradrenaline bitartrate injection comprises following steps:
(1) in the preparation container, adds the water for injection of preparing cumulative volume amount 90%, logical CO
215 minutes, make it saturated;
(2) with an amount of sodium chloride, sodium pyrosulfite, noradrenaline bitartrate; Add respectively in the water for injection of step (1) acquisition; Stirring makes dissolving, and said being meant in right amount satisfied the described content of above-mentioned each main component of noradrenaline bitartrate injection;
(3) pH value of determination step (2) solution that obtains should be 3.2～3.6, adds water for injection to total amount;
(4) with step (3) the solution that obtains filter with the filter membrane of 0.45 μ m, 0.22 μ m;
(5) step (4) solution that obtains is carried out embedding by the embedding operation sequence, logical N in ampoule during embedding
2, 100 ℃ of sterilizations in 30 minutes; Or carry out aseptic embedding by the embedding operation sequence, logical N in ampoule during embedding
2
Good effect of the present invention:, obtain to satisfy the product of Chinese Pharmacopoeia noradrenaline bitartrate injection quality standard through sterile production technology.
[specific embodiment]
Below in conjunction with embodiment the present invention is done detailed explanation, embodiment is intended to explain and non-limiting technical scheme of the present invention.
Preparation embodiment 1
(1) in the preparation container, adds the water for injection of preparing total amount 90%, logical CO
215 minutes, make it saturated;
(2) with an amount of sodium chloride, sodium pyrosulfite, noradrenaline bitartrate; Add respectively in the water for injection of step (1) acquisition; Stirring makes dissolving, and said being meant in right amount satisfied the described content of each main component of noradrenaline bitartrate injection of the present invention;
(3) pH value of determination step (2) solution that obtains should be 3.2～3.6, adds water for injection to total amount;
(4) with step (3) the solution that obtains filter with the filter membrane of 0.45 μ m, 0.22 μ m;
(5) step (4) solution that obtains is carried out embedding by the embedding operation sequence, logical N in ampoule during embedding
2, 100 ℃ of sterilizations in 30 minutes; Or carry out aseptic embedding by the embedding operation sequence, logical N in ampoule during embedding
2
Preparation embodiment 2
(1) adds the water for injection of 900ml in the container in preparation, logical CO
215 minutes, make it saturated;
(2) with 8.8g sodium chloride, 1g sodium pyrosulfite, 2.2g noradrenaline bitartrate, add respectively in the water for injection of step (1) acquisition, stir and make dissolving;
(3) pH value of determination step (2) solution that obtains should be 3.2～3.6, adds water for injection to 1000ml;
(4) with step (3) the solution that obtains filter with the filter membrane of 0.45 μ m, 0.22 μ m;
(5) step (4) solution that obtains is carried out embedding by the embedding operation sequence, logical N in ampoule during embedding
2, 100 ℃ of sterilizations in 30 minutes; Or carry out aseptic embedding by the embedding operation sequence, logical N in ampoule during embedding
2
Preparation embodiment 3
(1) adds the water for injection of 1800ml in the container in preparation, logical CO
215 minutes, make it saturated;
(2) with 17.6g sodium chloride, 2g sodium pyrosulfite, 4.4g noradrenaline bitartrate, add respectively in the water for injection of step (1) acquisition, stir and make dissolving;
(3) pH value of determination step (2) solution that obtains should be 3.2～3.6, adds water for injection to 2000ml;
(4) with step (3) the solution that obtains filter with the filter membrane of 0.45 μ m, 0.22 μ m;
(5) step (4) solution that obtains is carried out embedding by the embedding operation sequence, logical N in ampoule during embedding
2, 100 ℃ of sterilizations in 30 minutes; Or carry out aseptic embedding by the embedding operation sequence, logical N in ampoule during embedding
2
The above only is a preferred implementation of the present invention; Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; Can also make some improvement and retouching, these improvement and retouching also should be regarded as protection scope of the present invention.
Claims (2)
1. a noradrenaline bitartrate injection is characterized in that, comprises following composition:
Every 10000ml includes,
Noradrenaline bitartrate 22g～50g
Burnt sulfurous 10g
Sodium chloride 88g
Water for injection adds to 10000ml.
2. the preparation process of the described noradrenaline bitartrate injection of claim 1 is characterized in that, comprises following steps:
(1) in the preparation container, adds the water for injection of preparing cumulative volume amount 90%, logical CO
215 minutes, make it saturated;
(2) with an amount of sodium chloride, sodium pyrosulfite, noradrenaline bitartrate, add respectively in the water for injection of step (1) acquisition, to stir and make dissolving, said being meant in right amount satisfied the described content of claim 1;
(3) pH value of determination step (2) solution that obtains should be 3.2～3.6, adds water for injection to total amount;
(4) with step (3) the solution that obtains filter with the filter membrane of 0.45 μ m, 0.22 μ m;
(5) step (4) solution that obtains is carried out embedding by the embedding operation sequence, logical N in ampoule during embedding
2, 100 ℃ of sterilizations in 30 minutes; Or carry out aseptic embedding by the embedding operation sequence, logical N in ampoule during embedding
2
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102290477A CN102335123A (en) | 2010-07-16 | 2010-07-16 | Noradrenaline bitartrate injection and preparation technology thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102290477A CN102335123A (en) | 2010-07-16 | 2010-07-16 | Noradrenaline bitartrate injection and preparation technology thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102335123A true CN102335123A (en) | 2012-02-01 |
Family
ID=45511228
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010102290477A Withdrawn CN102335123A (en) | 2010-07-16 | 2010-07-16 | Noradrenaline bitartrate injection and preparation technology thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102525895A (en) * | 2012-01-04 | 2012-07-04 | 上海禾丰制药有限公司 | Norepinephrine bitartrate injection and preparation process thereof |
| CN103371969A (en) * | 2012-04-17 | 2013-10-30 | 上海禾丰制药有限公司 | Metaraminol bitartrate injection and preparation technology thereof |
| CN106389311A (en) * | 2016-09-18 | 2017-02-15 | 天津金耀药业有限公司 | Norepinephrine bitartrate pharmaceutical composition |
| US10159657B2 (en) | 2017-01-30 | 2018-12-25 | Nevakar Inc. | Norepinephrine compositions and methods therefor |
| CN109394683A (en) * | 2018-12-07 | 2019-03-01 | 远大医药（中国）有限公司 | A kind of preparation method of noradrenaline bitartrate injection |
| CN111004136A (en) * | 2019-12-26 | 2020-04-14 | 武汉武药制药有限公司 | Norepinephrine bitartrate, purification method and application thereof |
| CN111700859A (en) * | 2020-06-18 | 2020-09-25 | 广州瑞尔医药科技有限公司 | Norepinephrine bitartrate injection and preparation method thereof |
| CN115105466A (en) * | 2021-03-23 | 2022-09-27 | 天津金耀药业有限公司 | Noradrenaline bitartrate injection and preparation method thereof |
-
2010
- 2010-07-16 CN CN2010102290477A patent/CN102335123A/en not_active Withdrawn
Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102525895A (en) * | 2012-01-04 | 2012-07-04 | 上海禾丰制药有限公司 | Norepinephrine bitartrate injection and preparation process thereof |
| CN102525895B (en) * | 2012-01-04 | 2013-11-06 | 上海禾丰制药有限公司 | Norepinephrine bitartrate injection and preparation process thereof |
| CN103371969A (en) * | 2012-04-17 | 2013-10-30 | 上海禾丰制药有限公司 | Metaraminol bitartrate injection and preparation technology thereof |
| CN106389311A (en) * | 2016-09-18 | 2017-02-15 | 天津金耀药业有限公司 | Norepinephrine bitartrate pharmaceutical composition |
| US10471026B2 (en) | 2017-01-30 | 2019-11-12 | Nevakar Inc. | Norepinephrine compositions and methods therefor |
| US10226436B2 (en) | 2017-01-30 | 2019-03-12 | Nevakar Inc. | Norepinephrine compositions and methods therefor |
| US10420735B2 (en) | 2017-01-30 | 2019-09-24 | Nevakar Inc. | Norepinephrine compositions and methods therefor |
| US10159657B2 (en) | 2017-01-30 | 2018-12-25 | Nevakar Inc. | Norepinephrine compositions and methods therefor |
| US10568850B2 (en) | 2017-01-30 | 2020-02-25 | Nevakar Inc. | Norepinephrine compositions and methods therefor |
| US10646458B2 (en) | 2017-01-30 | 2020-05-12 | Nevakar Inc. | Norepinephrine compositions and methods therefor |
| US11413259B2 (en) | 2017-01-30 | 2022-08-16 | Nevakar Injectables Inc. | Norepinephrine compositions and methods therefor |
| US11602508B2 (en) | 2017-01-30 | 2023-03-14 | Nevakar Injectables Inc. | Norepinephrine compositions and methods therefor |
| CN109394683A (en) * | 2018-12-07 | 2019-03-01 | 远大医药（中国）有限公司 | A kind of preparation method of noradrenaline bitartrate injection |
| CN111004136A (en) * | 2019-12-26 | 2020-04-14 | 武汉武药制药有限公司 | Norepinephrine bitartrate, purification method and application thereof |
| CN111004136B (en) * | 2019-12-26 | 2022-11-22 | 武汉武药制药有限公司 | Norepinephrine bitartrate, purification method and application thereof |
| CN111700859A (en) * | 2020-06-18 | 2020-09-25 | 广州瑞尔医药科技有限公司 | Norepinephrine bitartrate injection and preparation method thereof |
| CN115105466A (en) * | 2021-03-23 | 2022-09-27 | 天津金耀药业有限公司 | Noradrenaline bitartrate injection and preparation method thereof |
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Open date: 20120307 |