CN102335124A - Artemether injection and process for preparation thereof - Google Patents
Artemether injection and process for preparation thereof Download PDFInfo
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- CN102335124A CN102335124A CN2010102291361A CN201010229136A CN102335124A CN 102335124 A CN102335124 A CN 102335124A CN 2010102291361 A CN2010102291361 A CN 2010102291361A CN 201010229136 A CN201010229136 A CN 201010229136A CN 102335124 A CN102335124 A CN 102335124A
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Abstract
The invention discloses formula components of artemether injection and a process for a preparation of artemether injection. The process comprises the following steps: (1) weighing a desired amount of oil for injection, heating the oil for injection to a temperature of 150 DEG C, and carrying out insulation for 90 minutes, wherein the oil for injection is mixture of chain oil, tea oil and middle chain triglyceride; (2) cooling the oil for injection to a temperature in a range of 48 to 52 DEG C for subsequent usage; (3) adding the oil for injection accounting for 80% of the total volume of the preparation into a preparing barrel; (4) weighing a proper amount of artemether and slowly adding artemether into the preparing barrel with stirring; (5) adding the oil for injection into the preparing barrel until 100% of the preparation is achieved; (6) filtering obtained mixture until clear liquid is obtained, canning and sealing the clear liquid, feeding nitrogen, and disinfecting a finished product under a temperature of 100 DEG C for 30 minutes; or carrying out aseptic production, filtering obtained mixture with terminals having a thickness of 0.45 mu m and 0.22 mu m until clear liquid is obtained, canning and sealing the clear liquid, and feeding nitrogen. The process provided in the invention enables aseptic production to be realized; the product prepared by the process accords with national quality standard of medicines.
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 Artemether 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 Artemether injection is mainly used in malaria treatment.
The chemical name of Artemether is a 12-Beta-methyl dihydroartemisinine, and chemical structural formula is following:
[summary of the invention]
First purpose of the present invention provides a kind of Artemether injection.
Second purpose of the present invention provides a kind of preparation process of Artemether injection.
For realizing above-mentioned purpose, the present invention discloses following technical scheme: a kind of Artemether injection, it is characterized in that, and comprise following composition:
Per 10,000ml includes,
Artemether 400～800g
Oil for injection 10,000ml
Said oil for injection refers to a kind of in refining midchain oil, Oleum Camelliae or the median chain triglyceride oil.
The preparation process of Artemether injection comprises following steps:
(1) measure the oil for injection of amount of preparation, be heated to 150 ℃, be incubated 90 minutes, said oil for injection refers to the mixture of refining midchain oil, Oleum Camelliae, median chain triglyceride oil;
(2) the oil for injection room temperature that step (1) is obtained be cooled to 50 ± 2 ℃ subsequent use;
(3) oil for injection that the step (2) of adding preparation cumulative volume amount 80% obtains in the preparation bucket;
(4) take by weighing an amount of Artemether and slowly add in the preparation bucket and constantly and stir, until dissolving fully, stir stop after, medicinal liquid is after static 10 minutes, drum head portion loses precipitate, it is clear to observe medicinal liquid with the glass beaker sampling, does not have buoyant idea;
(6) oil for injection that in the preparation bucket, adds step (2) acquisition is to total amount;
(7) filter through the collapsible filter membrane of polypropylene 3.0um, extremely clear and bright through 0.45 μ m end-filtration again, embedding, logical nitrogen, 100 ℃ of finished products, sterilization in 30 minutes;
Or sterile production, to clear and bright, nitrogen is led in aseptic embedding through 0.45 μ m, 0.22 μ m end-filtration.
Good effect of the present invention:, obtain to satisfy the product of Chinese Pharmacopoeia Artemether 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) measure the oil for injection of amount of preparation, be heated to 150 ℃, be incubated 90 minutes, said oil for injection refers to a kind of in refining midchain oil, Oleum Camelliae or the median chain triglyceride oil;
(2) the oil for injection room temperature that step (1) is obtained be cooled to 50 ± 2 ℃ subsequent use;
(3) oil for injection that the step (2) of adding preparation cumulative volume amount 80% obtains in the preparation bucket;
(4) take by weighing an amount of Artemether and slowly add in the preparation bucket and constantly and stir, until dissolving fully, stir stop after, medicinal liquid is after static 10 minutes, drum head portion loses precipitate, it is clear to observe medicinal liquid with the glass beaker sampling, does not have buoyant idea;
(6) oil for injection that in the preparation bucket, adds step (2) acquisition is to total amount;
(7) filter through the collapsible filter membrane of polypropylene 3.0um, extremely clear and bright through 0.45 μ m end-filtration again, embedding, logical nitrogen, 100 ℃ of finished products, sterilization in 30 minutes;
Or sterile production, to clear and bright, nitrogen is led in aseptic embedding through 0.45 μ m, 0.22 μ m end-filtration.
Preparation embodiment 2
The preparation process of Artemether injection comprises following steps:
(1) measures the oil for injection 1000ml of amount of preparation, be heated to 150 ℃, be incubated 90 minutes;
(2) the oil for injection room temperature that step (1) is obtained be cooled to 50 ± 2 ℃ subsequent use;
(3) oil for injection that the step (2) of adding preparation cumulative volume amount 80% obtains in the preparation bucket;
(4) take by weighing the 40g Artemether and slowly add in the preparation bucket and constantly stirring, until dissolving fully;
(6) oil for injection that in the preparation bucket, adds step (2) acquisition is to 1000ml;
(7) filter through the collapsible filter membrane of polypropylene 3.0um, extremely clear and bright through 0.45 μ m end-filtration again, embedding, logical nitrogen, 100 ℃ of finished products, sterilization in 30 minutes;
Or sterile production, to clear and bright, nitrogen is led in aseptic embedding through 0.45 μ m, 0.22 μ m end-filtration.
Preparation embodiment 3
The preparation process of Artemether injection comprises following steps:
(1) measures the oil for injection 2000ml of amount of preparation, be heated to 150 ℃, be incubated 90 minutes;
(2) the oil for injection room temperature that step (1) is obtained be cooled to 50 ± 2 ℃ subsequent use;
(3) oil for injection that the step (2) of adding preparation cumulative volume amount 80% obtains in the preparation bucket;
(4) take by weighing the 80g Artemether and slowly add in the preparation bucket and constantly stirring, until dissolving fully;
(6) oil for injection that in the preparation bucket, adds step (2) acquisition is to 2000ml;
(7) filter through the collapsible filter membrane of polypropylene 3.0um, extremely clear and bright through 0.45 μ m end-filtration again, embedding, logical nitrogen, 100 ℃ of finished products, sterilization in 30 minutes;
Or sterile production, to clear and bright, nitrogen is led in aseptic embedding through 0.45 μ m, 0.22 μ m end-filtration.
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. an Artemether injection is characterized in that, comprises following composition:
Per 10,000ml includes,
Artemether 400～800g
Oil for injection 10,000ml
Said oil for injection refers to a kind of in refining midchain oil, Oleum Camelliae or the median chain triglyceride oil.
2. the preparation process of the described Artemether injection of claim 1 is characterized in that, comprises following steps:
(1) measure the oil for injection of amount of preparation, be heated to 150 ℃, be incubated 90 minutes, said oil for injection refers to the mixture of refining midchain oil, Oleum Camelliae, median chain triglyceride oil;
(2) the oil for injection room temperature that step (1) is obtained be cooled to 50 ± 2 ℃ subsequent use;
(3) oil for injection that the step (2) of adding preparation cumulative volume amount 80% obtains in the preparation bucket;
(4) take by weighing an amount of Artemether and slowly add in the preparation bucket and constantly stirring, until dissolving fully;
(6) oil for injection that in the preparation bucket, adds step (2) acquisition is to total amount;
(7) filter through the collapsible filter membrane of polypropylene 3.0um, extremely clear and bright through 0.45 μ m end-filtration again, embedding, logical nitrogen, 100 ℃ of finished products, sterilization in 30 minutes;
Or sterile production, to clear and bright, nitrogen is led in aseptic embedding through 0.45 μ m, 0.22 μ m end-filtration.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102291361A CN102335124A (en) | 2010-07-16 | 2010-07-16 | Artemether injection and process for preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010102291361A CN102335124A (en) | 2010-07-16 | 2010-07-16 | Artemether injection and process for preparation thereof |
Publications (1)
| Publication Number | Publication Date |
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| CN102335124A true CN102335124A (en) | 2012-02-01 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010102291361A Pending CN102335124A (en) | 2010-07-16 | 2010-07-16 | Artemether injection and process for preparation thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103235072A (en) * | 2013-05-14 | 2013-08-07 | 张家港威胜生物医药有限公司 | Method for determining content of artemether in artemether injection with high performance liquid chromatography |
| CN103845322A (en) * | 2012-11-29 | 2014-06-11 | 昆明制药集团股份有限公司 | Use of artemether in preparation of drug for treating leukemia |
| CN104622796A (en) * | 2013-11-06 | 2015-05-20 | 河南辅仁怀庆堂制药有限公司 | Vitamin B12 injection and production technology thereof |
| CN112315905A (en) * | 2020-12-07 | 2021-02-05 | 安徽海洋药业有限公司 | Artemether injection and preparation method thereof |
-
2010
- 2010-07-16 CN CN2010102291361A patent/CN102335124A/en active Pending
Non-Patent Citations (3)
| Title |
|---|
| 《中国医药工业杂志》 19890831 邓蓉仙 我国近几年抗疟药研究新进展 第373页右栏第2-4行 2 第20卷, 第8期 * |
| 聂兆之等: "《注射剂生产工艺及检测》", 30 June 1994, 中国医药科技出版社 * |
| 邓蓉仙: "我国近几年抗疟药研究新进展", 《中国医药工业杂志》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103845322A (en) * | 2012-11-29 | 2014-06-11 | 昆明制药集团股份有限公司 | Use of artemether in preparation of drug for treating leukemia |
| CN103235072A (en) * | 2013-05-14 | 2013-08-07 | 张家港威胜生物医药有限公司 | Method for determining content of artemether in artemether injection with high performance liquid chromatography |
| CN104622796A (en) * | 2013-11-06 | 2015-05-20 | 河南辅仁怀庆堂制药有限公司 | Vitamin B12 injection and production technology thereof |
| CN112315905A (en) * | 2020-12-07 | 2021-02-05 | 安徽海洋药业有限公司 | Artemether injection and preparation method thereof |
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Application publication date: 20120201 |
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